Intrinsic Stability-Control Method for Recursive Filters and Neural Networks

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基于预防检修周期优化的电网稳定控制系统失效风险评估

基于预防检修周期优化的电网稳定控制系统失效风险评估

0 引言
随着大型电网互联以及高压直流、柔性交流、
基金项目:国家电网有限公司科技项目资助“交直流电网安 全 稳 定 控 制 系 统 本 质 安 全 提Байду номын сангаас升 技 术 研 究 ”(5100201940006A-0-0-00)
颜云松 1,孙 宁 1,张 楠 2,李生虎 2
(1.南瑞集团(国网电力科学研究院)有限公司,江苏 南京 211106; 2.合肥工业大学电气与自动化工程学院,安徽 合肥 230009)
摘要:随着大型电网互联,迫切需要安全稳定控制系统(简称稳控系统)更加可靠。预防性检修有助于降低稳控系 统失效风险。从底层模件开始,建立稳控系统故障树,计算其失效概率。考虑隐性故障和预防性检修,建立稳控 系统状态空间模型。以可靠系数和经济成本可靠系数为目标、以状态概率为等式约束、以可行检修周期和允许年 均经济损失为不等式约束,首次建立优化模型,以求解最优检修周期。根据拉格朗日乘子,提出目标函数对检修 周期约束的灵敏度。相对于连续修改参数方法,所提优化及其灵敏度算法计算效率高,且可处理多个变量。算例 结果验证了所提模型和算法的可行性和应用价值。 关键词:安全稳定控制系统;失效风险;预防检修周期;最优化;灵敏度
Abstract: Interconnection of bulk power systems needs a reliable Security & Stability Control System (SSCS). Preventive maintenance may help to reduce the unavailability of the SSCS. In this paper, the fault tree of the SSCS is derived from lower level components to obtain the failure probability of the SSCS. This includes hidden failure and preventive maintenance. The state space model of the SSCS is derived. With the object of the reliability coefficient and the economic cost reliability coefficient, the equality constraints of the state probabilities, and the inequality constraints of the feasible range of the maintenance period and the acceptable annual economic loss, an optimization model is proposed to find the optimal maintenance period. Based on Lagrange multipliers, the sensitivities of the objective function to the constraints of the maintenance period are derived. Compared with the continually modifying parameters, the proposed optimization and sensitivity models are more efficient, and can handle multiple parameters. The numerical results show the feasibility and the application value of the proposed models.

SPECT四象限铅栅法固有空间分辨力和线性稳定性检测的研究

SPECT四象限铅栅法固有空间分辨力和线性稳定性检测的研究
(3)质量控制模体。①四象限铅栅模体,采用各医 疗机构SPECT设备随机附带的四象限铅栅模体中, 40台设备中35台为设备随机附带,5台由检测机构自 带或向邻近医院借用;②点源,用放射性高锝酸钠 (Na99TcmO4淋洗液自行制作;③四象限模体由4个象 限且间隔和宽度不同的平行铅条组成,在同一个象限 内,铅条间隔和宽度相同,4个象限中铅条的宽度为 2.0~6.4 mm,厚度为3 mm[8-9]。每个铅栅按照狭缝宽 度从小到大分别为第1~4象限。 1.2 检测数据采集方法
空间分辨力检测显示,探头1、探头2检测合格的SPECT数量分别为29台、30台,合格率分别为72.5%、75%;在标准允许
5%偏差的情况下,探头1、探头2检测合格的SPECT数量均为37台,合格率均为92.5%;检测不合格的SPECT使用年限均
在10年以上。结论:纳入调查的37家医院中有90%的医院均能自主利用四象限铅栅法完成SPECT固有空间分辨力和固有空
Electrotechnical Commission,IEC)、GBT189892013[3-5]以及国家卫生行业标准“伽玛照相机、单 光子发射断层成像设备(SPECT)质量控制检测规 范”(WS523-2019)[6]等中都有这两项指标的相关内
显像图像的质量与安全,对设备进行质量控制非常 容,其中,WS523-2019标准中将医疗机构对SPECT
使用的40台(37家)SPECT设备进行固有空间分辨力和固有空间线性稳定性的检测,其中36台设备由医院质量控制人员检
测完成,4台设备由SPECT设备保修单位检测完成。结果:在对40台SPECT的固有空间线性检测显示,40台SPECT中1台
SPECT的两个探头的狭缝图像均有明显的弯曲,检测不合格,其他39台的两个探头的检测均合格,合格率为97.5%;固有

TA仪器——采用动态应变流变仪对刚性聚乙烯的溶胶黏度进行表征

TA仪器——采用动态应变流变仪对刚性聚乙烯的溶胶黏度进行表征

RS043 Characterizing Melt Viscosity of Rigid PolyVinyl Compounds using aDynamic Strain RheometerPrakash Hatti, Swayajith Sahadevan, GE India Technology Centre, Bangalore Keywords: thermoplastics, PVC, melt stability, viscosity, rotational rheometer, intrinsic viscosity, capillaryrheometerABSTRACTInjection molding big parts and complex shapes with rigid PVC is probably the most demanding PVC process in terms of melt viscosities. PVC is a material with physical and chemical characteristics that make it process slightly more difficult in comparison with other thermoplastics. The high viscosity contributes to the development of a high amount of heat when the material is subjected to the shear applied by the screw during the plasticization. The thermal instability of the compound results from the breakdown either when it is heated at temperatures higher than admissible or when it remains for too long at high temperature. Hence evaluating the material behavior in terms of its thermal stability and melt viscosity is important for end-users of PVC compounds. This paper attempts to assist engineers who are faced with the task of screening compounds from various suppliers, prior to full-scale evaluation of the compound in production machines. INTRODUCTIONTraditional tests for polymers focus on the amount (mass) of material passing through a known diameter orifice in a given time frame, usually 10 min. This type of test, known as Fluidity Index or Melt Index (MI), provides a single point measurement of the flowability of a material. The standard measurement for Melt Flow of PVC compounds is generally not done according to ASTM D 1238(1). An extension, ASTM D 3364 (2)is used specifically for flow rate measurements of PVC compounds while detecting and controlling various polymer instabilities associated with the flow rate. In this test, no control or knowledge of the material flow pattern exists, and thus the strain history is different for each material studied. This single point value is a composite of both the viscosity and elasticity in the sample. This empirical value is not defined in terms of a particular deformation, but represents a single point value which typically serves to rank or screen materials. Due to the nature of the measurement, it is not possible to determine the effect of the viscosity contribution independent of the elasticity. Many times, samples with the same MI value, process drastically different from each other. This method is best used as quality control(3) for the flow behavior of molten thermoplastics. It does not provides a fundamental property measurement and may or may not correlate with processing behavior.Dynamic measurements, on the other hand, obtained with Strain/Stress Controlled Rheometers provide a valuable means of characterizing information regarding the material’s thermal and flow behavior. These instruments have the ability to rigorously determine both the elastic and viscous response of a sample in a single experiment. The strain-controlled instrument applies a controlled shear strain in the form of displacement and measures the stress through a torque transducer to calculate the modulus, viscosity etc.The materials under investigation comprised three rigid PVC compositions labeled as Sample A, B and C. Each composition is markedly different in their composition with variations in the thermal stabilizer type and concentration, apart from differences in the type of the base PVC resin.1 RS0432 RS043Figure 1: Strain Sweep @ 200°C of PVC sample A SOLUTIONThe complex viscosity is evaluated using thestrain controlled Rheometer RDA III with a parallelplate geometry. The experiments were conducted inaccordance with ASTM D 4440/ISO 6721-10(4, 5).The samples for the test are compression molded into25 mm circular discs, after appropriate pre-drying.Linear visco-elastic behavior is defined, for the purpose of the standard requirement, wherein the modulus is independent of the applied strain. This assumption is necessary for the comparison of the test data. Therefore the amplitude of oscillation is set such that the deformation of the specimen occurs within the linear-viscoelastic region. Figure 1 showsa strain sweep performed on samples A from 1% to100 % strain to define this linear viscoelastic region.All samples A, B, C showed a linearity onset at ~10% strain.A frequency sweep was done on the samples A,B andC to compare the complex viscosity of eachsample and to check the validity of Cox-Merz rule (6).Sample A exhibits the lowest complex viscosity (1173.2 Pa s) at 100 rad/sec. The overlaid results of the measured complex viscosity on the strain-control rheometer for samples A, B, C are shown in figure 2.A capillary rheometer (7) was used to evaluate theapparent viscosity over the practical range of shearrate from 100-10000 s -1. The test conditions were: -die with L/D of 1/30; - temperature of 200 °C. Theshear viscosity was recorded for all samples. As canbe seen from the figure 3, sample A exhibited a lowerviscosity profile (1131.12 Pa s at 100 s -1) across theshear rate range of 100-10000 s -1) compared to thesample B and C.This observation (8) on the capillary rheometer reflects similar trends as observed in the viscosityprofile obtained from the RDAII as shown in table 1.A time sweep was performed to evaluate the melt stability under the following test conditions:Geometry 25 mm parallel plate; Gap 1.93 mm;Frequency 6.2832 rad/sec; Temperature 200ºC;Strain of 10%; Time 1200 seconds.Dynamic viscosity values were compared after ~ 215 seconds and shown in figure 4. Sample A exhibited a dynamic viscosity of 3894.1 Pa s; Sample B of 7656.2 Pa s and Sample C of 11430 Pa s. The complex viscosity for all three samples is slighlyincreasing with time.To further augment the observed viscosity profiles,the ‘K value’ or the ‘Viscosity Number’ defined byISO/R 174-1961 (9) for the PVC resins A, B and Cwere analyzed. Solution with different concentrationsof the PVC resins in cyclohexanone were prepared.The flow times of the solvent and the solutions ofresin were measured at 27°C by UbbelhodeTable 1: Viscosity comparison of PVC samples A, B, CVISCOSITY COMPARISON @ 100 (rad/sec) @ 100 (1/sec)Sample Complex Viscosity, Steady Shear eta*(Strain Control) Viscosity (Capillary)Sample A 1173.2 1131.12Sample B1817.71849.36Sample C2434.32580.95Figure 2: Frequency Sweep @ 200°C of PVC sample A, B, C10102103104M o d u l u s G ' [P a ]Strain γ [%] S t r e s s σ [P a ]101010C o m p l e x V i s c o s i t y η*(ω) [P a ]Frequency ω [rad/s]3 RS043Figure 3: High Shear Viscosity @ 200°C measured in acapillary rheometer Figure 4: Time Sweep @ 200°C for sample A, B Cviscometry and the viscosity number was calculated by extrapolating to zero concentration.The viscosity number (K) as defined by ISO/R 174-1961(9) is calculated as:K= (t -t 0)/ t 0*C CONCLUSIONSample C exhibits a relatively lower viscosity profile compared to sample B and C. The viscositytrend observed can be considered as an indirectmeasure of the material’s intrinsic melt viscosity.This parameter defined by the solution techniques (K-V alue) for linear polymers, correlates with the polymer average molecular weight. The Strain Controlled Rheometer thus provides a valuable,reliable and fast method to evaluate the melt-stability compared to traditional test methods. The melt viscosity serves a useful purpose of characterizing new compounds, screening multiple formulations or providing protocols for quality control. Supplementary techniques such as torque rheometer testing, staticdynamic testing on the 2-roll mills will provide information on the degradation rate, thermal instability, etc. A combination of these techniques generates multiple indicators on the PVC proces/sability prior to full-scale production trails.REFERENCES 1. American Society for Testing and Materials, Standard D 1238-99, Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer 2. American Society for Testing and Materials, Standard D 3364-99, Standard Test Method for Flow Rates for PVC with Molecular Structural Implications 3. Nass, Leonard I., Testing Rigid PVC Products ,Second Edition of Encyclopedia of PVC 4. American Society for Testing and Materials, Standard D 4440-01, Standard Test Method for Plastics: Dynamic Mechanical Properties: Melt Rheology 5. ISO 6721-1, 2001, Determination of Dynamic Mechanical Properties , General Principles Part 16. (Cox Merz Rule)- A well-known empiricism in the rheology of polymer melts is the Cox-Merz rule, which relates the linear dynamic moduli as functions of frequency to the steady shear flow viscosity curves. This relationship is very useful because it allows to estimate steady flow viscosity curves from the more readily obtainable from dynamic mechanic rheological measurements.7. American Society for Testing and Materials, Standard D 3835-961, Standard Test Method for Determination of Properties for Polymeric Materials by means of Capillary Rheometer 8. Cox, W.P, Merz, E.H ., Correlation of dynamic and steady flow viscosities, J. Polym. Sci., 28, 619-622(1959)9. ISO/R 174-1961, Determination of viscosity number of poly (vinyl chloride) resin in solution .where t = time of flow in seconds of the solution,t 0 = time of flow in seconds of the redistilled cyclo-hexanone and C = concentration in g of resin per ml of solution.The viscosity number is reported to the nearest whole number. Sample A shows a markedly low K-value of 53, sample B exhibits a K-value of 56 and sample C of 59. This correlates qualitatively with the differences in the viscosities observed on the strain controlled rheometer & the capillary rheometer.1001000100001010.S h e a r V i s c o s i t y ηs [P a s ]Shear Rate γ [s -1]10C o m p l e x V i s c o s i t y η*(ω) [P a ]Time t [s]。

消防专业词汇英语翻译

消防专业词汇英语翻译

inspection list = punch list 月清单 inspection pit 检查井 inspection shaft 检查 井 inspection switch 检查 开关 inspection 防火检查< 消防队员去 防火责任区 的现场调查 inspector 检验员 inspiration 吸气 instability 不稳定性 installation testing 安 装试验
inner room 内房间 innoxious substance 无害物质 inorganic acid 无机酸 inorganic chemistry 无机化学 inorganic coating 无 机涂料 inorganic 无机的 input module 输 入模块
input 输入 Insce = insurance 保险 insect damage 昆 虫损坏 insect infestation 昆虫骚扰 insecticidal fogging 杀 虫剂喷雾 inside diameter 内径
coverage 保险范围 insurance expense 保 险费 insurance fee 保险费 insurance fraud 诈骗 保险金 insurance in force 有 效保险 insurance
indemnity 保险赔偿金 insurance industry 保 险业
instant fire extinguish ment 紧急 灭火 instant operation 紧急操作 instantane ous combustio n 瞬时燃烧 instantane ous flash 瞬闪 instantane ous radiation 瞬时辐射

基于金纳米粒子局域表面等离子体共振吸收检测卡托普利

基于金纳米粒子局域表面等离子体共振吸收检测卡托普利

基于金纳米粒子局域表面等离子体共振吸收检测卡托普利X许 丹(西南大学化学化工学院,重庆 400715) 摘 要:柠檬酸根稳定的金胶在一定盐浓度下由于盐的电荷屏蔽效应而发生聚集。

加入一定浓度的卡托普利后,由于卡托普利分子中含有巯基和羧基,其分子中的巯基可以通过Au -S 键连在金纳米粒子表面,同时,在pH9.91的条件下,其分子中的羧基去质子化形成-COO -,导致金胶表面负电荷增多,纳米粒子之间的静电排斥力增大,金胶的聚集得到了抑制。

基于金胶由聚集到分散的现象,利用紫外-可见吸收光谱进行表征,建立了定量检测卡托普利含量的方法。

该方法的线性范围为0.04~1.2L M ,检出限为20nM 。

将此方法用于合成样的检测,回收率在86.3%~108.2%之间。

关键词:金纳米粒子;卡托普利;表面等离子体共振吸收 中图分类号:T Q460.7 文献标识码:A 文章编号:1006—7981(2012)03—0006—03 卡托普利(1-[(2S )-2-甲基-3-巯基-1-氧化丙基]-L -脯氨酸,Cap,结构如下图所示)是一种人工合成的血管紧张素转换酶抑制剂,目前广泛应用于治疗高血压及心力衰竭等疾病。

目前,定量测定卡托普利的分析方法有高效液相色谱法[1]、氧化还原滴定法[2]及化学发光法[3]等。

这些方法虽然灵敏度较高,但存在一些缺点如仪器设备昂贵、操作繁琐等。

因此,建立简便、快速、灵敏度高的检测卡托普利的方法仍然具有十分重要的意义。

图1 实验原理图近年来,金纳米粒子由于其独特的表面等离子体共振吸收性质被广泛用于色度传感。

13nm 柠檬酸根包被的金胶呈现酒红色,一旦发生聚集则呈现紫色或蓝色[4]。

这种颜色的改变很容易用肉眼捕获,不需要复杂的仪器。

金胶在一定浓度的NaCl 溶液中发生聚集,在本研究中,我们发现当体系中同时存在卡托普利后,金胶的聚集能得到抑制,基于此现象,建立了一种金胶由聚集到分散的状态来高灵敏检测卡托普利的新方法。

经典 中英对照 ICH CTD 目录 Module 1, 2, 3, 4, 5

经典 中英对照 ICH CTD 目录 Module 1, 2, 3, 4, 5

Module 1: Administrative Information and Prescribing Information1.1 Table of Contents of the Submission Including Module1.2 Documents Specific to Each Region (for example, application forms, prescribing information)Module 2: Common Technical Document Summaries2.1 Common Technical Document Table of Contents (Modules 2-5)2.2 CTD Introduction2.3 Quality Overall Summary(QOS) 质量综述INTRODUCTION2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药2.3.S.1 General Information (name, manufacturer) 基本信息2.3.S.2 Manufacture (name, manufacturer) 生产2.3.S.3 Characterisation (name, manufacturer) 特性鉴定2.3.S.4 Control of Drug Substance (name, manufacturer) 料药的质量控制2.3.S.5 Reference Standards or Materials (name, manufacturer) 对照品2.3.S.6 Container Closure System (name, manufacturer) 包装系统2.3.S.7 Stability (name, manufacturer).稳定性2.3.P DRUG PRODUCT (NAME, DOSAGE FORM) 制剂2.3.P.1 Description and Composition of the Drug Product (name, dosage form) 剂型及产品组成2.3.P.2 Pharmaceutical Development (name, dosage form) 产品开发2.3.P.3 Manufacture (name, dosage form) 生产2.3.P.4 Control of Excipients (name, dosage form)辅料的控制2.3.P.5 Control of Drug Product (name, dosage form) 制剂的质量控制2.3.P.6 Reference Standards or Materials (name, dosage form)对照品2.3.P.7 Container Closure System (name, dosage form) 包装系统2.3.P.8 Stability (name, dosage form)稳定性2.3.A APPENDICES 附录2.3.A.1 Facilities and Equipment (name, manufacturer) 设施和设备2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer) 外源因子的安全性评价2.3.A.3 Excipients 辅料2.3.R REGIONAL INFORMATION 区域性信息2.4 Nonclinical Overview2.4.1 Overview of the nonclinical testing strategy2.4.2 Pharmacology2.4.3 Pharmacokinetics2.4.4 Toxicology2.4.5 Integrated overview and conclusions2.4.6 List of literature references2.5 Clinical Overview2.5.1 Product Development Rationale2.5.2 Overview of Biopharmaceutics2.5.3 Overview of Clinical Pharmacology2.5.4 Overview of Efficacy2.5.5 Overview of Safety2.5.6 Benefits and Risks Conclusions2.5.7 Literature References2.6 Nonclinical Written and Tabulated SummariesPharmacologyPharmacokineticsToxicology2.6.1 Introduction2.6.2 Pharmacology Written Summary2.6.2.1 Brief Summary2.6.2.2 Primary Pharmacodynamics2.6.2.3 Secondary Pharmacodynamics2.6.2.4 Safety Pharmacology2.6.2.5 Pharmacodynamic Drug Interactions2.6.2.6 Discussion and Conclusions2.6.2.7 Tables and Figures2.6.3 Pharmacology Tabulated Summary (see Appendix B)2.6.3.1 Pharmacology: Overview2.6.3.2 Primary Pharmacodynamics*2.6.3.3 Secondary Pharmacodynamics*2.6.3.4 Safety Pharmacology2.6.3.5 Pharmacodynamic Drug Interactions*2.6.4 Pharmacokinetics Written Summary2.6.4.1 Brief Summary2.6.4.2 Methods of Analysis2.6.4.3 Absorption2.6.4.4 Distribution2.6.4.5 Metabolism (interspecies comparison)2.6.4.6 Excretion2.6.4.7 Pharmacokinetic Drug Interactions2.6.4.8 Other Pharmacokinetic Studies2.6.4.9 Discussion and Conclusions2.6.4.10 Tables and Figures2.6.5 Pharmacokinetics Tabulated Summary (see Appendix B)2.6.5.1 Pharmacokinetics: Overview2.6.5.2 Analytical Methods and Validation Reports*2.6.5.3 Pharmacokinetics: Absorption after a Single Dose2.6.5.4 Pharmacokinetics: Absorption after Repeated Doses2.6.5.5 Pharmacokinetics: Organ Distribution2.6.5.6 Pharmacokinetics: Plasma Protein Binding2.6.5.7 Pharmacokinetics: Study in Pregnant or Nursing Animals2.6.5.8 Pharmacokinetics: Other Distribution Study2.6.5.9 Pharmacokinetics: Metabolism In Vivo2.6.5.10 Pharmacokinetics: Metabolism In Vitro2.6.5.11 Pharmacokinetics: Possible Metabolic Pathways2.6.5.12 Pharmacokinetics: Induction/Inhibition of Drug-Metabolizing Enzymes 2.6.5.13 Pharmacokinetics: Excretion2.6.5.14 Pharmacokinetics: Excretion into Bile2.6.5.15 Pharmacokinetics: Drug-Drug Interactions2.6.5.16 Pharmacokinetics: Other2.6.6 Toxicology Written Summary2.6.6.1 Brief Summary2.6.6.2 Single-Dose Toxicity2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluation)2.6.6.4 Genotoxicity2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations)2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations)2.6.6.7 Local Tolerance2.6.6.8 Other Toxicity Studies (if available)2.6.6.9 Discussion and Conclusions2.6.6.10 Tables and Figures2.6.7 Toxicology Tabulated Summary (see Appendix B)2.6.7.1 Toxicology: Overview2.6.7.2 Toxicokinetics: Overview of Toxicokinetics Studies2.6.7.3 Toxicokinetics: Overview of Toxicokinetics Data2.6.7.4 Toxicology: Drug Substance2.6.7.5 Single-Dose Toxicity2.6.7.6 Repeat-Dose Toxicity: Non-Pivotal Studies2.6.7.7 Repeat-Dose Toxicity: Pivotal Studies2.6.7.8 Genotoxicity: In Vitro2.6.7.9 Genotoxicity: In Vivo2.6.7.10 Carcinogenicity2.6.7.11 Reproductive and Developmental Toxicity: Non-Pivotal Studies2.6.7.12 Reproductive and Developmental Toxicity – Fertility and Early Embryonic Development to Implantation (Pivotal)2.6.7.13 Reproductive and Developmental Toxicity –Effects on Embryo-Fetal Development (Pivotal)2.6.7.14 Reproductive and Developmental Toxicity –Effects on Pre- and Postnatal Development, Including Maternal Function (Pivotal)2.6.7.15 Studies in Juvenile Animalsa2.6.7.16 Local Tolerance2.6.7.17 Other Toxicity Studies2.7 Clinical Summary2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods 2.7.1.1 Background and Overview2.7.1.2 Summary of Results of Individual Studies2.7.1.3 Comparison and Analyses of Results Across Studies2.7.1.4 Appendix2.7.2 Summary of Clinical Pharmacology Studies2.7.2.1 Background and Overview2.7.2.2 Summary of Results of Individual Studies2.7.2.3 Comparison and Analyses of Results Across Studies2.7.2.4 Special Studies2.7.2.5 Appendix2.7.3 Summary of Clinical Efficacy2.7.3.1 Background and Overview of Clinical Efficacy2.7.3.2 Summary of Results of Individual Studies2.7.3.3 Comparison and Analyses of Results Across Studies2.7.3.3.1 Study Populations2.7.3.3.2 Comparison of Efficacy Results of all Studies2.7.3.3.3 Comparison of Results in Sub-populations2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations2.7.3.5 Persistence of Efficacy and/or Tolerance Effects2.7.3.6 Appendix2.7.4 Summary of Clinical Safety2.7.4.1 Exposure to the Drug2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies2.7.4.1.2 Overall Extent of Exposure2.7.4.1.3 Demographic and Other Characteristics of Study Population2.7.4.2 Adverse Events2.7.4.2.1 Analysis of Adverse Events2.7.4.2.2 Narratives2.7.4.3 Clinical Laboratory Evaluations2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety2.7.4.5 Safety in Special Groups and Situations2.7.4.5.1 Intrinsic Factors2.7.4.5.2 Extrinsic Factors2.7.4.5.3 Drug Interactions2.7.4.5.4 Use in Pregnancy and Lactation2.7.4.5.5 Overdose2.7.4.5.6 Drug Abuse2.7.4.5.7 Withdrawal and Rebound2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability2.7.4.6 Post-marketing Data2.7.4.7 Appendix2.7.5 Literature References2.7.6 Synopses of Individual StudiesModule 3: Quality3.1 Table of Contents of Module 33.2 Body of Data(数据汇总)3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药3.2.S.1 General Information (name, manufacturer) 基本信息3.2.S.1.1 Nomenclature (name, manufacturer) 药品名称3.2.S.1.2 Structure (name, manufacturer) 结构3.2.S.1.3 General Properties (name, manufacturer) 基本性质3.2.S.2 Manufacture (name, manufacturer) 生产3.2.S.2.1 Manufacturer(s) (name, manufacturer) 生产商3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer) 生产工艺和工艺控制3.2.S.2.3 Control of Materials (name, manufacturer) 物料控制3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) 关键步骤和中间体的控制3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer) 工艺验证和/或评价3.2.S.2.6 Manufacturing Process Development (name, manufacturer) 生产工艺的开发3.2.S.3 Characterisation (name, manufacturer) 特性鉴定3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) 结构和理化性质3.2.S.3.2 Impurities (name, manufacturer) 杂质3.2.S.4 Control of Drug Substance (name, manufacturer) 原料药的质量控制3.2.S.4.1 Specification (name, manufacturer) 质量标准3.2.S.4.2 Analytical Procedures (name, manufacturer) 分析方法3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) 分析方法的验证3.2.S.4.4 Batch Analyses (name, manufacturer) 批分析3.2.S.4.5 Justification of Specification (name, manufacturer) 质量标准制定依据3.2.S.5 Reference Standards or Materials (name, manufacturer)对照品/标准品3.2.S.6 Container Closure System (name, manufacturer) 包装系统3.2.S.7 Stability (name, manufacturer) 稳定性3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) 稳定性总结和结论3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer) 批准后稳定性研究方案和承诺3.2.S.7.3 Stability Data (name, manufacturer)稳定性数据3.2.P DRUG PRODUCT (NAME, DOSAGE FORM) 制剂3.2.P.1 Description and Composition of the Drug Product (name, dosage form)剂型及产品组成3.2.P.2 Pharmaceutical Development (name, dosage form) 产品开发3.2.P.2.1 Components of the Drug Product (name, dosage form) 处方组成3.2.P.2.1.1 Drug Substance (name, dosage form) 原料药3.2.P.2.1.2 Excipients (name, dosage form)辅料3.2.P.2.2 Drug Product (name, dosage form)制剂3.2.P.2.2.1 Formulation Development (name, dosage form)处方开发过程3.2.P.2.2.2 Overages (name, dosage form)过量投料3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)制剂相关特性3.2.P.2.3 Manufacturing Process Development (name, dosage form)生产工艺的开发3.2.P.2.4 Container Closure System (name, dosage form)包装系统3.2.P.2.5 Microbiological Attributes (name, dosage form)微生物属性3.2.P.2.6 Compatibility (name, dosage form)相容性3.2.P.3 Manufacture (name, dosage form)生产3.2.P.3.1 Manufacturer(s) (name, dosage form)生产商3.2.P.3.2 Batch Formula (name, dosage form)批处方3.2.P.3.3 Description of Manufacturing Process and Process Controls (name, dosage form)生产工艺和工艺控制3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)关键步骤和中间体的控制3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)工艺验证和/或评价3.2.P.4 Control of Excipients (name, dosage form) 辅料的控制3.2.P.4.1 Specifications (name, dosage form)质量标准3.2.P.4.2 Analytical Procedures (name, dosage form)分析方法3.2.P.4.3 Validation of Analytical Procedures (name, dosage form)分析方法的验证3.2.P.4.4 Justification of Specifications (name, dosage form)质量标准制定依据3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form)人源或动物源辅料3.2.P.4.6 Novel Excipients (name, dosage form)新型辅料3.2.P.5 Control of Drug Product (name, dosage form)制剂的质量控制3.2.P.5.1 Specification(s) (name, dosage form)质量标准3.2.P.5.2 Analytical Procedures (name, dosage form)分析方法3.2.P.5.3 Validation of Analytical Procedures (name, dosage form)分析方法的验证3.2.P.5.4 Batch Analyses (name, dosage form)批分析3.2.P.5.5 Characterisation of Impurities (name, dosage form)杂质分析3.2.P.5.6 Justification of Specification(s) (name, dosage form)质量标准制定依据3.2.P.6 Reference Standards or Materials (name, dosage form)对照品/标准品3.2.P.7 Container Closure System (name, dosage form)包装系统3.2.P.8 Stability (name, dosage form) 稳定性3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)稳定性总结和结论3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name, dosage form)批准后稳定性研究方案和承诺3.2.P.8.3 Stability Data (name, dosage form)稳定性数据3.2.A APPENDICES附录3.2.A.1 Facilities and Equipment (name, manufacturer)设施和设备3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)外源因子的安全性评价3.2.A.3 Excipients辅料3.2.R REGIONAL INFORMATION区域性信息3.3 Literature References参考文献Module 4: Nonclinical Study Reports4.1 Table of Contents of Module 44.2 Study Reports(见正文)4.2.1 Pharmacology4.2.1.1 Primary Pharmacodynamics4.2.1.2 Secondary Pharmacodynamics4.2.1.3 Safety Pharmacology4.2.1.4 Pharmacodynamic Drug Interactions4.2.2 Pharmacokinetics4.2.2.1 Analytical Methods and Validation Reports (if separate reports are available) 4.2.2.2 Absorption4.2.2.3 Distribution4.2.2.4 Metabolism4 2.2.5 Excretion4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)4.2.2.7 Other Pharmacokinetic Studies4.2.3 Toxicology4.2.3.1 Single-Dose Toxicity (in order by species, by route)4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations)4.2.3.3 Genotoxicity4.2.3.3.1 In vitro4.2.3.3.2 In vivo (including supportive toxicokinetics evaluations)4.2.3.4 Carcinogenicity (including supportive toxicokinetics evaluations)4.2.3.4.1 Long-term studies (in order by species; including range-finding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)4.2.3.4.2 Short- or medium-term studies (including range-finding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)4.2.3.4.3 Other studies4.2.3.5 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations) (If modified study designs are used, the following sub-headings should be modified accordingly.)4.2.3.5.1 Fertility and early embryonic development4.2.3.5.2 Embryo-fetal development4.2.3.5.3 Prenatal and postnatal development, including maternal function4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated.4.2.3.6 Local Tolerance4.2.3.7 Other Toxicity Studies (if available)4.2.3.7.1 Antigenicity4.2.3.7.2 Immunotoxicity4.2.3.7.3 Mechanistic studies (if not included elsewhere)4.2.3.7.4 Dependence4.2.3.7.5 Metabolites4.2.3.7.6 Impurities4.2.3.7.7 Other4.3 Literature ReferencesModule 5: Clinical Study Reports5.1 Table of Contents of Module 55.2 Tabular Listing of All Clinical Studies5.3 Clinical Study Reports5.3.1 Reports of Biopharmaceutic Studies5.3.1.1 Bioavailability (BA) Study Reports5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports5.3.1.3 In Vitro – In Vivo Correlation Study Reports5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials5.3.2.1 Plasma Protein Binding Study Reports5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies5.3.2.3 Reports of Studies Using Other Human Biomaterials5.3.3 Reports of Human Pharmacokinetic (PK) Studies5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports5.3.3.2 Patient PK and Initial Tolerability Study Reports5.3.3.3 Intrinsic Factor PK Study Reports5.3.3.4 Extrinsic Factor PK Study Reports5.3.3.5 Population PK Study Reports5.3.4 Reports of Human Pharmacodynamic (PD) Studies5.3.4.1 Healthy Subject PD and PK/PD Study Reports5.3.4.2 Patient PD and PK/PD Study Reports5.3.5 Reports of Efficacy and Safety Studies5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication5.3.5.2 Study Reports of Uncontrolled Clinical Studies5.3.5.3 Reports of Analyses of Data from More than One Study5.3.5.4 Other Study Reports5.3.6 Reports of Post-Marketing Experience5.3.7 Case Report Forms and Individual Patient Listings5.4 Literature ReferencesANNEX : Granularity Document参考ICH guidelines:M4E R1M4Q R1M4S R2。

论文列表 - 河北工业大学

论文列表 - 河北工业大学

论文题目(英文题目要译成中文)期刊名倾斜极化磁多层膜的铁磁共振理论Phys. Rev. B Rapid response mechanism of pi cell(Pi 盒的快速响应机制)Appl. Phys. Lett.Response times in Pi-cell liquidcrystal displaysLiq. Cryst.弱锚定垂面排列液晶显示器的响应时间液晶与显示栅状表面液晶盒的光学属性计算物理中文图形12864点阵液晶显示模块与51单片机的并行接口电路及C51程序设计现代显示Monte Carlo 模拟空间各向异性势向列相液晶微滴计算物理基于修正Gruhn-Hess 两体势模型的内禀锚定研究Physics letters. A基于分级模型的钾离子通道选择性通透机制的研究IEEE 会议论文考虑视轴方向的个性化眼模型的构建光学学报基于个性化模型的人眼色差对视功能影响的研究光子学报The study of wavelength-dependentwavefront aberrations based onindividual eye model (基于个性化眼模型的人眼波像差随波长变化的研究)Optik 基于个体眼光学结构的角膜与晶状体的像差补偿研究光学学报The lower-valence coexistingferrimagnetic Cr2VX (X=Ga, Si, Ge,Sb) Heusler compounds: A first-principles study低价共存的赫斯勒合金Cr2VX(X=Ga, Si, Ge, Sb)的第一性原理研究Ab initio investigation of half-metalstate in 钾通道的结构:钾离子传导和选择性的分子基础《科学》杂志精选论文基于离子通道选择性的水合碱金属阳离子结构的研究中国物理快报Physica BScripta Materialiazinc-blende MnSn and MnC闪锌矿结构的MnSn和MnC的半金属态的从头计算研究用临界点附近的涨落讨论Landau相变理论的适用范围河北工业大学学报“建设国家级实验教学示范中心的探索与实践”《全国高等学校物理基础课程教育学术研讨会论文集》坚持创新教育实验教学理念建设物理实验教学示范中心《第五届全国高等学校物理实验教学研讨会论文集》创建国家级实验教学示范中心及其辐射示范作用的研究与实践《实验技术与管理》大学生自主创新教育应适应社会需求性与尊重学生选择性《第五届全国高等学校物理实验教学研讨会论文集》坚持创新教育实验教学理念建设物理实验教学示范中心《物理实验》(特刊)《关于如何提高基础物理实验课质量的探讨》《科学时代》带电粒子致细胞失活的理论模型中国原子能科学研究院年报2007Two-photon spectroscopic behaviorsand photodynamic effect on the BEL-7402 cancer cells of the newchlorophyll photosensitizer《中国科学》(一种新型叶绿素光敏剂的双光子光谱特性B 辑及其对BEL-7402肝癌细胞的双光子光动力效应)(英文版)Tunneling effect of two horizons froma Gibbons-Maeda black holeChinese Physics LettersTunneling Effect from a Non-static Black Hole with the Internal GlobalMonopole International Journal of TheoreticalPhysicsTunneling effect of two horizons from a Reissner-Nordstrom black hole International Journal of TheoreticalPhysics用新乌龟坐标计算任意直线加速带电黑洞的熵北京师范大学学报自然科学版液晶与显示Physica BTheoretical Models of Cell Inactivation by Ionizing Particles(带电粒子致细胞失活的理论模型)Annual Report of China Institute of Atomic Energy 2007片剂硬度测试仪的液晶显示界面设计克尔黑洞的内视界隧道效应北京师范大学学报自然科学版Order Parameter of theAntiferroelectric Phase Transition ofLead Zirconate,Ferroelectric LettersSymmetry of the AntiferroelectricLead ZirconateFerroelectric LettersInvestigation of Ferroelectric PhaseTransition of Rochelle SaltFerroelectrics 锆酸铅的反铁电相对称性研究人工晶体学报方硼盐本征铁电相变的研究河北工业大学学报The synchronization ofFitzHugh--Nagumo neuronnetwork coupled by gapjunctionChinese Physics BStudy of intrinsic anchoring in nematicliquid crystals based on modifiedGruhn-hess pair potential(基于修正的Gruhn-hess两体势研究向列相液晶的内禀锚定)Phys. Lett. AThe Electrod Effect in LCD Cell(LCD盒中的电极效应)电子器件聚合物稳定向列相液晶显示的上升时间常数现代显示全Heusler 合金Cr2MnAl的第一性原理研究Appl. Phys. Lett.大范围Mn掺杂Heusler-型 Cr3Al的半金属化合物的理论设计J. Appl. Phys.局域键近似下的固体材料热驱动下的弹性软化J. Phys. D: Appl. Phys. Heusler 相 Co2YBi 和半-Heusler 相CoYBi (Y=Mn, Cr)的带结构计算J. Magn. Magn. Mater含时外势作用下玻色-爱因斯坦凝聚的非自治孤子自旋极化电流导致的铁磁金属多层膜中的铁磁共振J. Appl. Phys.“液晶显示器件物理专业方向”的实验设置实验技术与管理混合排列向列相边缘场效应电光特性的模拟计算现代显示Opt. Commun.个性化视觉矫正中人眼波前像差测量数据的修正研究Photonics and Optoelectronics MeetingsDynamical Model of P53-Mdm2-P14/19ARF Network to Radiation inPopulation of Cells 电离辐射作用下多细胞P53-Mdm2-P14/19ARF 网络动力学模型机械波的半波损失条件问题探析河北工业大学成人教育学院学报地方工科高校大学物理课程建设的探索与实践2009年全国高等学校物理基础课程教育学术研讨会论文集A death-survival switch in cell: cross talk between Akt and p53International Conference on Bioinformatics and Biomedical EngineeringModeling of ATM accumulation and ATM-mediated oscillation of p53International Conference on Bioinformatics and Biomedical EngineeringFunctions of oligochitosan inducedprotein kinase in tobacco mosaic virusresistance and pathogenesis related proteins in tobacco (壳寡糖诱导蛋白激酶在烟草对烟草花叶病毒抗性和病理相关蛋白中的作用)Plant Physiology and Biochemistry Neutrino Oscillation in the Space-Time with a Global Monopole 有拓扑缺陷时空的中微子振荡Thermodynamics Properties of theInner Horizon of a Kerr-Newman Black Hole K-N 黑洞的内视界的热性质Tunneling Effect of Two Horizonsfrom a Reissner-Nordstrom Black Hole R-N 黑洞的双视界的隧穿效应太赫兹波在空芯椭圆波导中的传播特性Photonics and Optoelectronics Meetings (POEM) 2008:TerahertzScience and Technology自旋波背景下单轴各向异性铁磁中磁振子密度的新特性Ann. Phys. (New York)BIC-TA2009International Journal of TheoreticalPhysicsInternational Journal of Theoretical Physics International Journal of TheoreticalPhysicsNeutrino oscillationinterference phase in Kerrspace--time克尔时空的中微子振荡干涉相位指形场驱动垂面排列模式的响应机制,Liq. Cryst.,两块栅状表面基板构成的向列相液晶盒的阈值属性Chinese Physics B 挠曲电效应对向列相液晶盒电光效应的影响计算物理双轴向列相液晶在沟槽表面的弹性形变和稳定性Liquid Crystals用光学导波方法区分液晶盒中的预倾角与弱锚定现代显示栅状表面液晶盒的光学特性现代显示平面和高斯光束的非线性吸收系数β的微分分析Photonics and OptoelectronicsMeetingsModel for influences of magneticfields on intracellular calcium oscillations(磁场对细胞内钙振荡影响的理论研究)Commun. Theor. Phys.液晶与显示Chinese Physics B太赫兹波在空芯椭圆波导中的传播特性Photonics and Optoelectronics Meetings (POEM) 2008:Terahertz Science and Technology平行排列向列相液晶的导波研究太赫兹波在空芯镀不同介质膜圆波导中的传播特性Photonics and Optoelectronics Meetings (POEM) 2008:Terahertz Science and TechnologyStability Control System for Four-In-Wheel-Motor Drive Electric Vehicle.The Sixth International Conference onFuzzy Systems and Knowledge Discovery, Tianjin, China, 14–16August ,2009.Propagation characteristics of THzradiation in hollow ellipticalwaveguide Pro. of SPIE光电混合机器人视觉系统中光寻址空间光调制器的噪声处理光子学报A First Principles study on the fullHeusler Compond Compond利用慢度曲面研究晶体的纯模轴人工晶体学报演化网络的拓扑结构河北工业大学学报帐篷映射归宿的完整性探析天津师范大学学报用二进制讨论面包师变换的动力学特性河北工业大学学报克尔-纽曼时空的中微子振荡Class. Quantum Grav.史瓦西-德西特是空的中微子振荡干涉相位Commun. Theor. Phys.Quantitative deviation of the two-photon absorption coefficient based onthree pulse model Chinese Optics LettersTwo-photon absorption coefficientdeviation from the application of laserultra-short pulse models Chinese Physics lettersTwo-photon absorption coefficient inrelation to the typical pulse models oflaser Optics CommunicationsAppl. Phys. Lett.MnAlCr 2MnAl Cr 2罗伯特-沃克度规的中微子振荡和振荡长度的宇宙学蓝移Int J Theor Phys Domain-wall solutions of spinor Bose-Einstein condensates in an opticallattice,Phys. Rev. ANonautonomous bright and darksolitons of Bose-Einstein condensateswith Feshbach- managed time-dependent scattering lengthOpt. Commun.Formation of combined solitons intwo-component Bose-Einsteincondensates Chin. Phys. BBright and Dark Soliton Solutions inGrowing Bose-Einstein CondensatesChin. Phys. B 基于三种激光脉冲模型的双光子吸收系数偏离量研究CHINESE OPTICS LETTERS 扭曲向列相液晶显示器中的响应时间现代显示基于128_64点阵液晶显示的智能温度控制器的设计与实现实验室科学基于TRIZ 原理的航空用毛巾卷圈机折卷部件创新设计机械设计液晶全漏导模的实验研究物理实验温度对向列相液晶阈值电压的影响现代显示FlexoelectricEffectinaHAN-IPSCell Grey Solitons and Soliton interactionof Higher Nonlinear SchrödingerEquation Can. J. Phys.Screw-pitch effect and velocityoscillationof a domain wall in aferromagnetic nanowire driven byspin- polarized current J.Phys.: Condens. MatterTwo-photon absorption coefficient inrelation to the typical pulse models oflaser与若干激光典型超短脉冲模型相关的双光子吸收系数Quantitative deviation of two-photonabsorption coefficient based on threelaser pulse models基于三种激光脉冲模型的双光子吸收系数之间的量化差别Approach dealing with the pulseprofile of pump laser in Z-scanJournal of Optics Z-扫描中处理泵浦激光脉冲时域结构的一种方法曾用名:Journal of Optics A :Pure and Applied Optics双面高斯形刻槽金属纳米光栅表面等离子体传感芯片设计IEEE,Photonics and OptoelectronicA first-principles study onthelower-valencecoexisting Cr2TiX (X ¼ Al,Ga,Si, Ge, Sn,Sb) HeusleralloysJournal of Magnetism and Magnetic Materials 基于修正的Gruhn-Hess 两体势模型研究弯曲形变向列相液晶盒计算物理表面沟槽诱导双轴向列相液晶的弹性畸变液晶与显示LCD 点状缺陷分析与研究现代显示温度对向列相液晶阈值电压的影响现代显示离子与通道相互作用对NaK 通道通透特性影响的研究物理学报Extracelluar Potassium ions Play Important Roles in the Selectivity of Mutant KcsA Channel 2011 4th International Conference on Biomedical Enginerrint andInformaticsFlexibility Between the Linker of theCD and G-Loops Determines the Gating Dynamics of Hte Kir2.1ChannelBiophysical Journal Direct or Indirect Regulation ofCalcium-Activated Chloride Channel by CalciumJ Membrane Biol.离子与通道相互作用对NaK 通道通透特性影响的研究物理学报Characteristics and molecular basis ofcelecoxib modulation on Kv7potassium channelsBr. 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Phys.液晶全漏导模透射率的实验研究大学物理实验离子与通道相互作用对NaK 通道通透特性影响的研究物理学报Extracelluar Potassium ions Play Important Roles in the Selectivity of Mutant KcsA Channel 2011 4th International Conference on Biomedical Enginerrint andInformaticsThe Difference Analysis of Nonlinear Absorption Coefficient β in the Beam Sections of Plain and Gaussian Distribution Nonlinear AbsorptionCoefficient βin the Beam Sections of Plain andGaussian DistributionEffects of Magnetic Fields on the Synchronization of Calcium Oscillations in Coupled Cells Journal of Computational and Theoretical NanoscienceOptimal design of hollow elliptical waveguide for THz radiationJournal of Physics: Conference Series,2011,Volume:276,No.1012229Approach dealing with the pulse profile of pump laser in Z-scantechniqueJournal of Physics: Conference Series,2011,Volume:276,No.1012229Propagation characteristics of THz radiation in hollow rectangle metalwaveguideJournal of Physics: Conference Series,2011,Volume:276,No.1012229ProcSPIE,作者(名次)时间李再东2008孙玉宝,马红梅,张志东3月孙玉宝(2)7月马红梅,王娜红,孙玉宝2月叶文江2008.9李志广2008.7第1张艳君2008.52张艳君2008安海龙(2)May-08刘铭1Feb-08刘铭1Aug-08刘铭1Jun-08刘铭1Aug-08安海龙(1)李佳120082008-3-1安海龙(1)Nov-08李佳12008王双进(第一作者)2008.1魏怀鹏(排名1)、李再东、安莉、张志东、展永,2008.7魏怀鹏(排名1)、张志东、展永2008.1魏怀鹏(排名1)、张志东、展永2008.11,温春东,魏怀鹏(排名2),段雪松,孔祥明,丁军锋,甄芳芳2008.1魏怀鹏(排名1)、张志东、展永2008.11魏怀鹏第一作者2008.4曹 天光1Jun-08ZHAO PeiDe et al第一作者(论文通讯联系人)任军12008.5任军12008.3任军1Jul-08任军12008年2月淮俊霞(第一作者)李佳120082008.6曹 天光1Jun-08Jun-08任军12008年10月周国香12008周国香12008周国香12008周国香12008周国香12008展永12008张志东,张艳君2008.1张志东,赵金良2008.1刘丽媛(学生),刘艳玲(学生),张志东2008.9盖翠丽甄晓玲王纪刚张志东李佳(1)2009李佳(1)2009李佳(1)2009李佳(1)2009李再东第二(通信作者)李再东第二2009张志东,范志新20092008.72008.6李再东第三(通信作者)刘铭(1)2009.03柳辉(1)2009.3柳辉(2)2009.7.Liu Hui (4)2009.7Liu Hui (4)2009.6Liu Hui (8)2009.8刘铭(5)2009任军(第一作者)2009年8月2009.03Liu Hui (1)2009.1任军(第一作者)2009年2月任军(第一作者)2009年7月马红梅,孙玉宝9月叶文江12009.1叶文江12009.1叶文江22009.8叶文江12009.3叶文江22009.11张勇(2)2009.03张玉红(第一)2009叶文江2任军(第一作者)Dec-092009.12张勇(1)2009.032009.03张勇(2)张玉红(第二)2009赵培德第一作者2010通讯联系人第一期赵培德第七2009赵培德第一作者通讯联系人赵培德第二作者通讯联系人周国香第二2009,1周国香第二2009,10周国香第二2009,6周国香第三2009,7周国香第三2009,8任军(1)2010年3月任军(1)2010年4月20092009周国香第三2009,5任军(1)2010年9月李再东,李秋艳,贺鹏斌,梁九卿,刘伍明,傅广生2010李秋艳,李再东,李录,傅广生2010李秋艳,李再东(*),姚淑芳,李录,傅广生2010李秋艳,李再东,贺鹏斌,宋伟为,傅广生。

药品检验英语词汇对照

药品检验英语词汇对照
loss on drying
phase solubility analysis
content uniformity
minimum fill
assay
uniformity of dosage units
dissolution
disintegration
drug release
relative density
multi-wavelength linear regression method
K-ratio method, signal multiplier method
least square method
adaptive least square
partial least square method
nonlinear iterative partial least square
analytical quality control
characteristics
odorless
foreign odor
melting point
melting range
capillary melting point determi-nation
hot stage melting point determi-nation
variate calibration
multivariate calibration
back propagation
optimization method
window diagram technique
chromatographic response function, CRF
chromtographic optimization

Q1A(R2)中英文对照(可编辑修改word版)

Q1A(R2)中英文对照(可编辑修改word版)

人用药品注册技术要求国际协调会ICH三方指导文件新原料药和制剂的稳定性试验Q1A(R2)现第四版2003年2月6日制定Q1A(R2) 文件厉程新原料药和制剂的稳定性试验QIA(R)修订说明本修订的目的为了明确由于采用了 ICHQir在气候带山和【V注册申请的稳定性数据包"而使QIA(R)而产生的变更。

这些变更如下:L在下面章节中将中间储存条件从温度30匸±20柑对湿度60%±5%修改为温度3or±2r/ni 对湿度 65%+5%:2」・7・1原料药•储存条件•一般情况 227」制剂•储存条件•一般情况 227・3在半渗透性容器中包装的制剂 3术语匸中间试验‘‘2・在下面章节中可以使用温度30C±rC/柑对湿度65%±5%替代温度25C±2C/相对湿度60%±5%作为长期稳泄性试验的条件: 2」・7・1原料药•储存条件•一般情况 227」制剂•储存条件•一般情况3・在温度25“C±2°C/tH对湿度40%±5%的基础上增加了温度30匸±2匸/相对湿度35%±5% 作为长期稳定性试验条件,并且在后而的章节中包括了失水比率相关举例的相关情况: 227・3在半透性容器中包装的制剂在试验阶段中间将中间将储存条件从温度30匸±2^7相对湿度60%±5%调整为温度309±2X7相对湿度65%±5%是可以的,但相应的储存条件和调整的日期要在注册申报资料中清楚地说明和列出。

如果适用的话建议ICH三方在公布和执行此修订指南三年后,注册申请资料中完整的试验能够包含在中间储存条件,即温度30匸±20柑对湿度65%±5%下的实验资料。

S TABILITY T ESTING OF N EW新原料药和制剂稳定性试验D RUG S UBSTANCES ANDP RODUCTS1. INTRODUCTIONThe guideline seeks to exemplify the core stability data package for new drug substances and products. but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations andcharacteristics of the materials being evaluated. Alternative approaches can be used when there are scientifically justifiable reasons.间去适应由于特殊的科学考虑和被评估物质 特殊性质而导致的各种不同的具体情况。

机车专业英语词汇

机车专业英语词汇

汉英机车车辆词典A Chinese-English Dictionary of Railway Rolling StockA级绝缘insulation class A A型阀 A type valveA型阀 A valveA型三通阀 A triple valveAB阀AB valveAB制动机AB brake 美国过去的标准型货车制动机,由 AB 阀、制动缸、组成一起的副风缸与紧急风缸、组成一起的集尘器与遮断塞门以及保压阀组成。

ABD阀ABD brake valve 为 AB 阀的改进型,其中常用部分与紧急部内改用膜板活塞与 O 形圈、柱塞阀,使其性能接近 AC 阀,此外,常用缓解较快,整体的制动缸缓解阀在常用部。

ABDW制动阀ABDW brake valve为美国 80 年代主型的货车阀。

ABS树脂ABS resinAC阀AC valveAC制动机AC brakeALGOL语言ALGOL languageAS树脂AS resinAV型制动机AV brakeB级绝缘Class B insulation materialBASIC语言BASIC languageB级绝缘Class B insulationC级绝缘材料Class C insulation materialCAD computer-aided designCAM computer-aided manufacturingCAT computer-aided testingCOBOL语言COBOL languageC级绝缘class C insulationD型滑阀D-valveFORTRAN语言FORTRAN languageI字梁I-beamK型线圈K ringK型三通阀K triple valveLISP语言LISP languageLN型客车制动机LN passenger car brakeMiller型车钩Miller couplerO型密封圈O seal ringO型圈O-ringPASCAL语言PASCAL languagePC制动机PC(passenger control) brake equipmentPH滴定法PH titration PH度PH valuePH计PH meterPID控制proportional-integral-derivative controlPID调节器PID regulator PM型制动机PM brake PROLOG语言PROLOG language Q值Q value Schlieren型转向架Schlieren bogie SIG转向架SIG bogieSM树脂SM resinS型曲线reverse curveT形接头T-jointT型螺母T-nutT字型折页T-hingeUC客车制动机UC-passenger brake U形柴油机U-diesel engineU形钩cleviceU形管接头return bendU形零件clipU形螺栓U-boltU形螺栓铸件U-bolt castingU形锁环stapleU形弯头close return bendV形柴油机Vee-diesel engineV形膜板bellow diaphragmV字形排列发动机Vee engineX射线X-rayYWE制动机YWE brake equipment γ分布Gamma distributionω型燃烧室toroidal combustion chamber; ω-combustion chamber挨墙柱pilaster矮侧板low side矮端板low end爱车点loading and unloading track 安定性stability; service stability 安哥拉羊毛mohall安排arrangement安培表ammeter安培小时ampere hour (AH)安全玻璃safety glass安全侧线safety siding安全措施safety measure安全带safety strap安全带钩safety strap hook安全带钩挂safety strap hanger安全带连结扣safety strap clasp安全吊safety strap; safety guard; safety hanger安全阀safety valve安全阀及汽笛座safety valve and whistle base 安全杆safety rod; safety bar安全规程safety regulation安全环制动safety loop brake安全检查safety inspection安全警惕紧急制动deadman emergency安全警惕制动safety control application安全警惕装置deadman control安全链吊环safety chain holder安全链挂safety chain bracket安全环制动safety loop brake安全排气口safety vent安全设施safety appliances安全生产safety production安全寿命设计法method of design on safe life 安全踏脚safety tread安全系数factor of safety安全销吊链safety pin chain安全性safety安全因数safety factor安全装置safety device; safe guard 安时表ampere-hour meter安装set up安装角铁fastening plate安装座anchorage; fitting seat 鞍saddle鞍座saddle(罐体)鞍座(tank) saddle氨基甲酸乙酯泡沫塑料urethane form panel氨基树脂amino resin氨基树脂漆amino resin coating氨水aqua ammonia暗淡无光泽sleepy gloss暗孔blind hole按钮press button; push button 按钮开关button switch按钮水阀compression faucet凹底敞车depressed bottom open wagon; depress-ed bottom gondola car凹底平车depressed center flat car凹坑depression indent; indentation; pit 凹痕indent; indentation凹形角焊缝concave fillet weld奥立贡制动机Oerlikon brake奥氏体austenite奥斯特Oersted鳌合滴定chelatometric titration鳌合试剂chelating agent巴bar巴黎交通局Paris Transport Authority巴氏合金Babbitt metal扒渣机ballast raking equipment拔尖tapering of spring bar tail拔模率draft angle钯合金palladium alloy白炽灯incandescent lamp白点fish eye; flake白合金white metal; babbitt metal白合金松动loose lining白口铁white iron白铜cupronickel白蚁termite; white ant白噪声white noise百科全书encyclopedia百叶窗(叶片不能动)louver百叶窗(叶片能动)shutter百叶窗油缸oil cylinder of shutter摆pendulum摆锤balance weight摆动wobble摆动焊道weave bead摆动量wobble; play摆动辗压机swing die press摆渡车ferry push car摆幅range of oscillation摆块centering block; rocker; rocking block摆块吊centering block hanger摆块式旁承rocking side bearing摆门(客车)spring butt rocking door摆式车体pendulum type car body; tilting摆式客车tilting passenger coach扳道员switchman扳钮开关toggle switch扳手spanner; wrench扳手开口wrench clearance; spanner opening 班次(工作班次)shift斑点spot板panel; plate板材矫平机plate flattener板车架plate frame板翅式换热器plate-fin heat-exchanger板翅式散热器plate-fin radiator板弹簧leaf spring板垫圈plate washer板阀plate valve板金工sheet metal work板梁式钢结构plate girder type steel structure 板料剪切机sheet metal sheer板料凸缘折压机plate flanging press板料弯曲机plate bending machine板条bar板形安装座plate type installation base板牙chaser; die nut板状量规flat gauge半窗transom window半导体semi-conductor半导体材料semiconductor material半导体二极管semiconductor diode半导体工艺semiconductor technology半导体三极管transistor半导体陶瓷semi-conductive ceramic半导体整流器semiconductor rectifier半电压电动机half voltage motor半封闭式空气分配semi-develop air distribution半刚性车钩semi-rigid coupler半径radius半径杆radius bar; radius rod; bridle rod 半开窗half drop window半开式燃烧室semi-open combustion chamber半帽half nut半面环弹簧half ring半拖车semi-trailer半悬挂half-suspension半夜灯evening lamp半圆键woodruff key半自动焊semi-automatic welding半自动焊机semi-automatic welding machine半自动机床semi-automatic machine瓣阀clack valve棒材bar棒材轧机bar mill棒料加热炉bar heater包边板waist包带机taping machine包房卧室roomette包封胶sealing compound; encapsulating com-pound包复cladding包复材料bladding material包间compartment包间式卧车corridor type sleeping car包间卧室saloon包角铁corner strapping包络曲线enveloping curve包装packing up; package包装箱填塞物dunnage饱和saturation饱和电抗器saturable reactor饱和度saturation ratio饱和特性saturation characteristic饱和蒸汽saturated steam保持holding保持阀maintaining valve; retaining valve 保持架cage; retainer保持架兜孔pocket of cage保持位holding position保持线圈holding coil保护protection保护电路protection circuit保护阀protective valve保护继电器protection relay保护控制protective control保护气氛浇注protective atmosphere casting保护气氛炉中钎焊brazing in controlled atmos-phere 保护气体protective atmosphere; shielded gas 保护气体流量shield gas flow rate保护特性protection characteristic保护装置protective device保留垫板permanent backing保温材料thermal insulation material保温层heat insulation layer保温车thermal car保温集装箱insulated container保温炉holding furnace保温性能heat insulation property保险insurance保险阀safety valve保险丝fuse保险丝端头fuse terminal保险丝盒fuse box保险装置physical protection device保压lap; pressure holding保压阀pressure retaining valve保压阀管pressure retaining valve pipe保压阀托架pressure retaining valve bracket保压位holding position保养maintenance保有量number on hand保证的缓解insured release报废rejection; retirement; scrap; discard; condemn报废极限condemnable limit; condemning limit; scrapping limit报告report报警warning报警电路alarm circuits报警系统warning system报纸箱paper box刨planing刨床planing and shaping machine刨刀planer tool; planing blade刨花wood wool刨花板chipboard; particle board刨花车wood chip car刨削planing; shaping抱缸piston seizure抱死闸stuck brake抱轴承axle suspension bearing抱轴式电动机axle hung motor抱轴瓦axle suspension bush抱轴悬挂axle hung suspension爆发压力explosive pressure爆燃deflagration; detonation爆炸detonation爆炸包复explosion covering coating爆炸成形explosive forming爆炸焊explosion welding杯cup杯托tumbler holder贝氏炉钢Besemer steel贝氏体bainite备份back-up备份文件back-up file备件spare part备料feed preparation备品表fitting and tool card备用back-up; stand-by备用插座stand-by receptacle备用灯back-up light备用电源back-up power source背back背压back pressure; counter pressure背压试验back pressure test倍频器frequency multiplier倍压整流电路multivoltage rectifying焙烧炉roaster本国的domestic本色intrinsic colour本务机车leading engine; leading locomotive 本务内燃机车leading diesel locomotive苯benzene崩裂bursting泵pump泵盖pump cover泵轮pump impeller泵轮轴pump wheel shaft泵体pump body; pump casing泵柱塞pump plunger鼻式悬挂nose suspension比较comparison比较电路comparison circuit比较器comparator比较仪comparator比例尺scale比例阀proportional valve比例控制proportional control比例调节器proportion regulator比率rate比面积specific floor area比热specific heat比容specific volume比湿specific humidity比重specific gravity比重计hydrometer闭合时间closing time; make time闭合线圈closing coil闭环控制closed-cycle control闭路close circuit闭路电视closed circuit television闭门器door closer闭塞block闭塞区段block section闭塞信号block signal闭式冷却系统close cooling system闭式喷油器close type injector闭式压力机straight sided crank press闭锁机构locking mechanism闭锁位locked position闭锁位置locked position of coupler蓖状缝隙式滤清器laminated split filter壁灯alley lamp; panel lamp; wall lamp 壁灯(安装在支架上)bracket lamp避雷器lightning arrester避难线refuge siding; relief line臂arm臂盖arm cap臂靠arm rest臂靠底版arm rest base臂靠支架arm rest bracket边角料sapwood边界层燃烧boundary layer combustion边界摩擦boundary friction边距edge distance边框stile边缘效应edge effect边走边卸阀hopper car unloading valve while car moving编码coding; encoding 编码器encoder编译程序compiler编组consist; make-up; set off set out; formation编组场classification yard 编组调车场marshalling yard编组站marshalling station; classification station扁平端子flat terminal扁弹簧half elliptic spring; leaf spring 扁尾螺栓lug bolt扁销cotter扁销插销key便餐车lunch counter car便器closet pot; water closet便器盖closet pot lid变刚度弹簧variable stiffness spring变工况性能performance of variable working 变坏deteriorate变换conversion变换器converter变矩器组成torque converter shaft assembly 变量variable变流技术converting technique变流器converter变流装置convertor assembly变摩擦式减振装置varying friction type damping变扭比torque ratio变扭器torque converter变频机frequency converter变频器frequency converter变频调节variable frequency adjusting变频调速frequency control of motor speed 变容二极管variable capacitance diode变送器transducer变速speed change; variable speed变速装置speed changing device变位阀changeover valve变相器phase converter变向阀reverse valve变形deformation; distortion变形试验deformation test变压器transformer变压器保护protection of transformer变压器电势transformer EMF变压器绕组transformer winding变载荷阀variable load valve变质deteriorate变阻器rheostat变阻制动rheostatic braking标称功率nominal power of locomotive标灯beacon标定calibrate标定功率rated power; nominal power标定转速rated speed; nominal speed标高elevation; level height标记mark标记牌notice plate标签label; tag标签盒label box标示板scale plate标示杆弹簧indicator spring标示牌badge plate标志label; notation; mark; tag标志灯marked lamp; marker lamp标准standard标准程序standard program标准齿轮master gear标准大气压standard atmosphere标准大气状况standard atmospheric condition; atmospheric reference condition标准轨距standard gauge标准马力standard horsepower标准偏差standard deviation标准误差standard deviation; standard error 标准压力表master gage标准样板standard profile gauge表袋watch holder表灯gage lamp表钩watch hook表架gauge bracket表面face; surface表面(表盘面或表盘)dial表面保护后处理after treatment for surface protection表面波度surface waviness表面处理surface treatment表面传热系数surface film conductance表面粗糙度surface roughness表面电阻surface resistance表面堆焊surfacing表面放电surface discharge表面光洁度surface finish表面合金化surface alloying表面裂纹surface crack表面切割surface cutting表面缺陷surface defect表面热处理surface heat treatment表面温度surface temperature表面下缺陷sub-surface defect表面硬度surface hardness表面硬化surface hardening; case hardening 表面预处理surface pretreatment表面状态surface state表压gage pressure表针hand; pointer冰点freezing point冰库ice bunker冰盘ice pan冰箱ice tank; refrigerator冰盐cryohydrate丙烷propane丙烯酸树脂漆acrylic resin coating柄shank饼式线圈disc winding并接multiple并励shunt excitation并励电动机shunt motor并励电动机shunt motor并联parallel; shunt并联电抗器shunt reactor并联电容器shunt capacitor; shunt condenser 并列断续角焊缝chain intermittent fillet weld并列复式风泵cross-compound compressor并排椭圆弹簧couplet并行parallel病残货车sick wagon拨叉poking fork; shifting fork拨头shifting block波wave波长wave length波动器pulsator波峰焊crest welding波兰铁路PKP (Polish State Railways)波美度Baume波速speed of propagation波纹板corrugated plate波纹薄板corrugated sheet波纹地板corrugated floor plate波纹管bellows; corrugated pipe; bellow 玻璃棒glass wool玻璃灯罩glass-ware玻璃钢FGRP (fiber glass reinforced plastics)玻璃钢FRP (fiber reinforced plastics)玻璃管水表glass water gage玻璃棉glass contton玻璃水位表glass gauge玻璃丝glass wool玻璃纤维glass fiber玻璃纤维增强塑料glass fiber reinforced plastics剥离flake; peeling剥离试验peeling test剥落shelling; peeling播送transmission播音public address; public announcement 播音机megaphone播音连接器public addressing coupling播音室broadcasting studio; public announcement studio; public addressing room播音装置public addressing system 泊poise泊桑比poison’s ratio泊桑分布poison’s distribution 博览会fair薄壁焊接结构light welding structure; thin wall welding structure薄壁结构thin-walled structure薄壁筒体结构thin-shelled tubular structure; thin-shelled cylindrical structure薄壁铸件thin wall casting; thin section casting薄螺母half nut薄膜membrane; thin film 薄铁板sheet iron补偿电动机compensated motor补偿电路compensating circuit 补偿阀compensating valve 补偿风缸take-up cylinder补偿口compensating port补偿绕组compensating winding 补偿室compensating chamber 补充余隙clearance pocket补焊repair welding; repairing welding; build-up补焊表面surfacing 补机bank engine补机推送banking; assisting in rear; pusher opera-tion补机运行assisted operation补块patching补强reinforce; reinforcement补强板reinforcing plate补心pipe bushing补助机车help locomotive补助梁nailing sill补助梁托nail strip support补助纵向梁sub-sill不垂直度non-perpendicularity不对准misalignment不方正out of square不干胶self-adhesive不间断电源UPS (uninterrupted power supply)不均匀度unevenness不控制的紧急制动non-controlled emergency不控制紧急制动non-delayed emergency不卖票的座席non-revenue seat不平度non-normality; non-planeness不熔化电极non-consumable electrode不衰减的振动undamped vibration不衰减性inexhaustibility不调心misalignment不通孔dead hole不透明的opaque不稳定的制动特性unstable characteristic不稳定性unstability; instability不锈钢stainless steel不锈钢车体stainless steel car body不易燃材料non-flammable material不圆out of round不圆度rotundity; roundness; out of roundness不摘车修in-train repair不正常磨耗abnormal wear不正位malalignment不装载的unladen不足deficiency不足超高under cant布氏硬度Brinell hardness number布氏硬度计Brinell tester布套clothing布线wiring布置arrangement; layout布置图layout步进电动机stepping motor步进缝焊step-by-step welding步进控制step-by-step control步进式炉step transit furnace步进式输送机stepping conveyor部分portion部分常用制动partial service application部分负荷fractional load部分负荷试验partial power test部分负荷性能part-load performance部分缓解partial release部分真空partial vacuum部件component部位location擦圈swab擦伤scoring; scotch; scuffing擦拭wipe材料material; stock材料定额material consumption norm材料力学strength of materials材料利用率stock utilization材料实验material test材料试验机material test machine财务管理financial management采暖heating采暖锅炉heating boiler采暖绕组heating winding采暖设备heating equipment采暖试验heating test采暖系统heating system采暖装置heating equipment; heater采样sampling采样器sampler采样系统sampling system参数parameter餐车dining car; restaurant car餐车洗池sink餐具室pantry餐室dining room餐厅车cafe car餐座dinging seat残车率rate of bad order cars残废人服务设施disabled person service facilities 残余奥氏体residual austenite残余变形residual deformation残余废气residual gas残余废气系数coefficient of residual gas残余氢residual hydrogen残余应力residual stress仓库depot; warehouse操纵manipulation操纵把手operating handle操纵阀operating valve; pilot valve操纵杠杆operating lever操纵模拟control simulation操纵台console操纵装置control device; operating device 操作operation; manipulation操作过电压switching overvoltage操作机构operating machine; manipulator操作系统operating system槽channel; groove; slot; sump槽钢channel steel; steel channel槽焊slot welding槽绝缘slot liner槽铁channel iron; channel 槽头螺丝fillister head screw 槽形钢材channel steel槽形铁channel iron槽型断面channel section槽型鞲鞴十字头导框slotted crosshead草酸oxalic acid侧side侧摆lateral motion侧摆与侧滚rock and roll侧摆振动lateral oscillation; swaying oscillation; rocking; lateral侧板side plank侧板压铁side post wood cover plate 侧壁side wall侧壁承载side wall load-carrying侧部地板梁side nailing strip侧部加载side loading侧部游间side play侧撑side brace侧窗side window侧窗框side window yoke侧灯side lamp侧灯插座side lamp socket侧灯架side lamp bracket侧滚roll侧滚稳定器bolster roll stabilizer侧滚振动rolling; rolling vibration 侧盒side wedge侧护板side protecting plate侧缓冲杆side stem侧架side frame侧架立柱side frame column; bolster guide bar; truck bolster guide bar侧架上弦杆side frame top chord侧架上斜弦杆side frame top oblique chord侧架弹簧承台side frame spring seat侧架下弦杆side frame bottom chord侧架下斜弦杆side frame bottom oblique chord 侧拉门导轨door bracket侧梁side sill; side beam侧炉撑side stay侧门side door侧门底部导架side door bottom guide侧门护铁side door protecting strip侧门脚蹬side door step侧门锁side door lock侧门折页side door hinge侧门轴side door shaft侧门轴托side door shaft bearing侧门装置side door fixture侧面摆动量side wobble侧面角焊缝fillet weld in parallel shear 侧面了望的守车side bay caboose侧排油阀side oil outlet valve侧墙side wall侧墙板side sheathing侧墙板牵引板side sheathing bracing plate侧墙扶手side had hold侧墙构架side frame侧墙木梁side furring侧倾tilt侧倾卸车side dump car侧视图profile侧隙backlash侧线siding; turn out侧向力thrust侧向载荷lateral load侧向振动lateral vibration侧檐side eave侧摇枕side bolster侧缘side plank top rail; side rail 侧缘上立柱side plate stiffing angle侧枕梁结点joint between side sill and body bolster beam侧柱side post; body post; side stake 侧柱插side stake pocket侧柱连铁rail; connecting side posts侧柱内补强inside reinforcement of side post 侧走板side running board侧座side seat厕所water closet; lavatory测长仪length gauge测功器dynamometer测力计dynamometer测力轮对instrumented wheelset测量measure; measurement测量精度measurement accuracy测量误差measurement error测量样板gauge测试技术testing technique测试设备testing equipment测试系统testing system测速发电机tacho-generator测头measuring head测温材料thermometive material测硬度值brinelling层间绝缘interlayer insulation层间温度interpass temperature层流lamina flow层压材laminate层压制品laminated product层状撕裂lamellar tearing层状组织lamellar structure叉车fork lift truck叉头法兰forked flange叉头螺栓jaw bolt叉形物crotch插(插床加工)slot插补insertion插补装置insertion device插齿gear shaping; gear slotting插齿机gear planer; gear slotter插床slotting machine插头plug插图figure插削slotting插销bolt; latch bolt插座receptacle; socket查故障trouble shooting茶炉drinking water boiler茶桌tea table岔道turn out岔尖point差动保护differential protection差动放大器differential amplifier差动继电器differential relay差动中继阀differential valve差分方程differential equation差励绕组differential excited field winding 差压pressure differential拆卸dismantle; dismount; detach; disassemble拆装机具disassembling and assembling facilities柴田式车钩Shibata Shiki coupler 柴油diesel fuel; diesel oil柴油电气多单元车组DEMU (diesel electric mul-tiple unit)柴油机diesel engine柴油机车diesel locomotive柴油机顶部盖罩top deck cover柴油机间diesel engine room柴油机净重量net mass of diesel engine柴油机零部件parts and components of diesel engine柴油机牵引力tractive effort of diesel engine 柴油机水套jacket柴油机特性diesel engine characteristics柴油机循环diesel cycle柴油滤清器fuel filter; diesel fuel filter 柴油指数diesel index产冷量refrigerating capacity; refrigerating effect产量output产品product产值value of output铲除chisel长臂long arm长编组旅客列车passenger train of extended consist长大货物车heavy-duty wagon; long and big cargo freight car长吨(即英吨)long ton长钢轨车long rail car train-set 长时间摩擦制动drag braking长途客车long distance travelling carriage; long distance travelling passenger car长途易腐坏货物列车long-distance perishable freight train长圆孔oblong hole常闭触点normally closed contact 常开触点normally open contact常摩擦式减振装置constant friction type damping device常温固化room-temperature cure常用局减quick service常用全制动full service application常用位service position常用限压阀service pressure limiting valve 常用制动service braking; service常用制动灵敏度service application sensitiveness 厂修works repair; overhaul厂修规程rules for overhaul厂修限度shop limit场field; yard场效应晶体管field effect transistor敞车open top wagon; gondola car唱片disc超长列车extra long train超尺寸oversize超负荷试验overload test超高cant; superelevation超高曲线raised curve超高速铁路ultra high speed railway超高增压over high pressure charging超高增压柴油机super high pressure-charging diesel engine超精加工superfinish超静定结构statically indeterminate structure 超临界速度supercritical speed超声波ultrasonic wave超声波打孔ultrasonic drilling超声波焊ultrasonic welding超声波加工ultrasonic machining超声波检查ultrasonic test超声波净化ultrasonic purification超声波钎焊ultrasonic brazing超声波切割ultrasonic cutting超声波清洗机ultrasonic cleaning machine超声波探伤ultrasonic flaw detection超声波探伤仪ultrasonic flaw detector超声探伤ultrasonic inspection超速保护装置overspeed protection超速试验overspeed test超速停车装置overspeed trip超塑性成形superplastic forming; superplastic deformation超限货物exceptional load超载overload潮湿度dampness车场car yard车窗car window车窗把手window sash holder车窗吊簧window sash balance spring 车窗刮雨器window wiper车窗护杆window guards车窗均衡弹簧window sash balance spring 车窗均衡铁sash balance车窗框销sash pivot车窗上部镶条belt molding车窗锁闩sash bar车窗提手bar sash lift; window sash lift 车窗下挡风胶垫bottom weather strip车床lathe车刀turning tool车刀抖动痕迹chatter mark车底版car bottom plate车底地板blind floor车底电线管electric wire conduit underneath the car车底数number of allocated passenger 车底水箱lower tank车底水箱给水装置lower tank system water supply apparatus车底制动拉杆bottom rod车电调压器lamp regulator车顶roof; roofing车顶冰箱冷藏车overhead brine tank refrigerator 车顶侧梁roof cant rail车顶椽子carline车顶丁字接铁roof sheet splice tee车顶端横梁roof end rail车顶风道ceiling duct车顶扶手roof grab iron车顶高度pitch车顶加冰冷藏车overhead bunker refrigerator car 车顶结构roof frame车顶木梁ceiling furring车顶木弯梁timber carline车顶通风器roof ventilator车顶托梁roof support车顶弯梁carline车顶装货口roof hatch车顶纵梁purlin车端car end车端冰箱冷藏车ice bunker refrigerator car车端椽子end carline车端顶弯梁carline knee iron车端扶手end grab rail车端缓冲装置end-of-car cushioning device车端角架end frame车端立柱collision post车端木梁body end furring车端饰带镶条end fascia车端外皮car end outside sheathing车端下墙板end panel车端装载end loading车队car fleet; fleet车钩coupler车钩闭锁位置anti-creep locking车钩复原装置coupler centering device车钩高coupler height; height of coupler center above rail车钩功率draw-bar power车钩钩舌内侧面coupler pulling face 车钩钩身coupler shank车钩缓冲装置coupler and draft gear 车钩间隙coupler slack车钩开锁位置coupler lock set 车钩连接线coupling line车钩牵引力tractive effort at coupler; drawbar pull车钩全开位置full knuckle throw车钩三态作用three states of coupler operation 车钩锁链keeping chain车钩提杆coupler release rod; uncoupling rod; uncoupling lever车钩提杆吊pull rod carry iron; uncoupling lever hanger车钩提杆装置coupler release rigging车钩提杆座uncoupling keeper; uncoupling lever bracket车钩体coupler body车钩托梁coupler carrier车钩外形轮廓coupler contour车钩尾部coupler butt车钩尾框coupler yoke; draft gear yoke; yoke 车钩尾框隔板coupler yoke partition block车钩尾框托coupler yoke bracket车钩尾框尾销孔coupler yoke key slot车钩尾销draft key; yoke key车钩游间coupler clearance车钩与缓冲装置coupler and draft gear车钩正位装置coupler positioner车钩中心线高度coupler center height; height of coupler center from top of rail车钩中心最大高度coupler maximum center height 车钩中心最小高度coupler minimum center height 车号serial number of car车架car frame; frame车架式内燃机车frame diesel locomotive车间shop; workshop车间焊接shop welding车库shed车辆car; stock; vehicle车辆报废限度car condemning limit车辆标记lettering and marking of car车辆长度与定距比ratio of car body length to length between truck centers车辆厂修car repair in works车辆车间car shop车辆冲击car impact车辆冲击试验car impact test车辆大修car heavy repair车辆电器railway car electrical apparatus 车辆定距length between truck pivot centers车辆定距比ratio of car body length to length between bogie centers车辆动力学railway car dynamics 车辆动力学试验car dynamic test车辆段car depot车辆段修car repair in depot车辆段修台位利用率rate of utilization of repair positions in car depot车辆二位端“A” end of car 即车辆上不装手制动机的一端,另一端为“B”end。

电子信息工程专业英语

电子信息工程专业英语

专业英语复习Lesson3Microprocessors (1)Lesson4Operational Amplifiers (2)Lesson8Clock Sources (3)Lesson12Personal Computer Systems (4)Lesson13Overview of Modern Digital Design (5)Lesson16Basic Concepts of DSP (6)Lesson19High Fidelity Audio (8)Lesson22Digital Image Fundamentals (9)Lesson25Choosing the right core (10)Lesson26Design Languages for Embedded Systems (11)Lesson27Choosing a Real-Time Operating System (12)Lesson28Signal Sources (13)Lesson3Microprocessors1.micron是“微米(百万分之一米)”2.data width是指算术逻辑单元ALU的字长3.MIPS Million Instructions Per Second每秒百万条指令4.Reset复位5.tri-state buffer三态缓冲器A tri-state buffer is a device that allows you to control when an output signal makes it to the bus.When the tri-state buffer's control bit is active,the input of the device makes it to the output.When it's not active,the output of the device is Z,which is high-impedance or,equivalently,nothing.There is no electrical signal is allowed to pass to the output.6.PipeliningA technique where the microprocessor fetches the next instruction before completing execution of the previous instruction,in order to increase processing speed.)流水线是一种在前一条指令全部执行完之前就开始取下一条指令,以提高处理速度的技术。

ICH Guideline (人用药品注册技术规范国际协调会)药物光稳定性指导原则

ICH Guideline (人用药品注册技术规范国际协调会)药物光稳定性指导原则

WC1007 25-Jan-06No.:ICH GuidelineSince the release of the ICH Guideline Atlas Info, WIP has made a correction to its formula for the estimation of test durations at minimum and maximum SUNTEST irradiance levels (see calculations on page 8). Please discard or delete any copies that you may have of the previous version of this document. We would like to thank Chet Harris of Harris Weathering and Andreas Riedl and Cees Van Teylingen for their attention to detail regarding this piece. If you have any questions regarding the document please contact Al Zielnik at azielnik@ or contact your local sales manager.Thank you,Marketing ServicesXLS/XLS+ Conformity to ICHConforming to the ICH Guideline for the Photostability Testing of New Drug Substances and Drug Products (ICH Q1B) Using the AtlasSUNTEST CPS/CPS+ and XLS/XLS+This document summarizes the key requirements in the ICH Guidelines and offers recommendations for operating theAtlas SUNTEST CPS/CPS+ and XLS/XLS+.EXECUTIVE SUMMARY“The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.” From the official website for ICH, .The result of this effort was a guideline, the ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products (ICH Q1A). Photostability testing is further addressed in a separate official ICH document(ICH Q1B). This applies to both forced degradation stress testing and confirmatory studies of the active drug substance, drug product and excipients. ICH Q1B is applicable to small molecules; large molecules (proteins, monoclonal antibodies, etc.) are addressed in the separate document, Stability Testing of Biotechnological/Biological Products (ICH Q5C). Additionally the Q1B protocol has been adopted as the VICH Tripartite Harmonized Guideline covering the Photostability Testing of New Drug Substances and Products in the Veterinary Field.Despite implementation of the ICH stability and photostability guidelines, issues remain that are not specifically covered in the documents and left to the researcher’s discretion. Additionally, several non-equivalent options are available, reflecting different practices for handling drug products on different continents.XLS/XLS+ Conformity to ICHSUMMARY OF KEY Q1B CONTENTS**The numbers and letters correspond to the sections of the official ICH Q1B document; however, not all sections arelisted.1. GeneralThe ICH Harmonized Guideline on Stability Testing of New Drug Substances and Products requires that photostability testing be an integral part of stress testing. The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that light exposure does not result in unacceptable change.B. Light Sources, Option 1ICH recommends the following light sources that emit an output similar to D65/ID65 emission standards. “D65 is the internationally recognized emission standard for outdoor daylight as defined in ISO 10977 (1993) standard. ID65 is the equivalent indoor indirect daylight standard1.” Light sources conforming to D65/ID65 emission standard should contain UV and visible spectrum, such as:- Xenon lamps- Artificial daylight fluorescent lamp combining visible and UV outputs- Metal-halide lampsC. ProcedureICH requires the following two exposure criteria for confirmatory photostability studies: - Not less than 1.2 million Lux hours of Visible (400 to 800 nm) exposure- Not less than 200 Watt·hours/square meter of UV (320 to 400 nm) exposure. The ICH Guideline states that “The minimum Visible light exposure level represents approximately 3 months of continuous exposure to artificial visible light in the pharmacy, warehouse or home with the protective container removed from the product. The UV light exposure roughly corresponds to 1 to 2 days inside close to a window with sunlight exposure2.” However, the ratio of UV to VIS radiation that the ICH estimates to1 S.R. Thatcher, R.K. Mansfield, R.B. Miller, C.W. Davis, and S.W. Baertschi, “A Technical Guide and Practical Interpretation of the ICH Guidelines and Its Application to Pharmaceutical Stability,” Pharmaceutical Technology, March 2001: 102.2 S.R. Thatcher, R.K. Mansfield, R.B. Miller, C.W. Davis, and S.W. Baertschi, “A Technical Guide and Practical Interpretation of the ICH Guidelines and Its Application to Pharmaceutical Stability,” Pharmaceutical Technology, March 2001: 102.XLS/XLS+ Conformity to ICHrepresent the “real” storage conditions differs from the UV/VIS ratio defined in the standard for indoor direct daylight (ID65). ID65 is generally selected as more representative of actual exposure conditions; however, the more severe D65 condition may be useful for “forced degradation” studies.OPTION 1 XENON LIGHT SOURCEFiltered (D65 or ID65) xenon discharge lamps are full-spectrum light sources and simultaneously expose in the UV, Visible and IR spectral regions.Because the spectral distribution of the selected radiation source must conform to theD65 or ID65 standard (Option 1), a total radiant exposure of 200 Watt hours/square meter in the UV region simultaneously underexposes the visible by ca. 60%, and a total luminous exposure of 1.2 million Lux hours in the Visible (400-800 nm) simultaneously overexposes the UV by ca. 240%.At present, no single source provides the combination of simultaneous UV and Visible exposure levels required by the ICH Q1B (D65/ID65) without overexposure to the UV or underexposure to the Visible. However, since the recommended exposures are minimums, exceeding the minimum exposure in the UV or Visible is perfectly acceptable. Overexposure can be avoided by (1) excluding the excess of UV radiation by the use of UV blocking filters around the specimen upon reaching the desired UV dose; (2) removing one half of the specimens after reaching the UV dose and continuing exposure to the Visible dose on the remaining specimens; or (3) running two separate tests, one for each criterion (UV and Visible), with identical specimens. Exceeding the minimum UV dosage is acceptable according to the guidelines, and may actually be a better simulation of end use conditions where the product is exposed to direct daylight or daylight filtered through window glass.The Atlas SUNTEST meets the ID65 spectral criterion with an optical filter system consisting of a coated quartz glass dish, a window glass filter and an ID-65 filter used in combination. The SUNTEST’s filtered xenon light source is a full spectrum light source containing both Visible and UV outputs as required in Option 1, with a UV cut-on of approximately 320 nm and a spectral distribution corresponding to ID65 per ISO 10977.XLS/XLS+ Conformity to ICHThe following filter set is required (in order, starting with the filter closest to the sample tray) to provide ID65 for the SUNTEST CPS/CPS+ and XLS/XLS+ models: P/N 56052388 Coated quartz glass dishP/N 56052372 Window glass filer (310 nm cut-on)P/N 56077769 Solar ID65 (320 nm cut-on)Comparison between ID65 (ISO10977/ISO DIS18909)SUNTEST CPS-Solar ID65-Filter SystemXLS/XLS+ Conformity to ICHIf the more severe D65 condition is desired, the following daylight filter set can be used: P/N 56052388 Coated quartz glass dishP/N 56052371 UV Special glass filterD65 ISO 10977/ISO/DIS 18909SUNTEST CPS Solar D65-800nm)=550W/m²E(300LS/XLS+ Conformity to ICHXDETERMINING TEST DURATIONThe test procedures mentioned previously describe minimum exposure levels for confirmatory testing. Exposure dosage in the Atlas SUNTEST CPS/CPS+ andUNTEST XLS/XLS+ is measured in radiometric units (Kilojoules in the range of 300-800 nm Exposure dand 200 Wh/m 2 (320 – 400 nm) is approximately 8 MJ/m 2 (300 nm - 800 nm) forribing Visible light only For any desired irradiance inance level in Kilolux (klx) can be approximated by the following equation (for ID65): nm)Based on an irradi between 320 – 400 nm can be approximated by the following equation:S ) and exposure duration may be expressed in chronological time (hours). uration is dependent on the irradiance (light intensity) setting. - 1.2 million Lux hours is approximately 19.6 MJ/m 2 in the wavelength range300 nm - 800 nm for the ID65 filter system in the SUNTEST CPS/CPS+XLS/XLS+. -the Solar ID65 filter system for the ID65 filter system in the SUNTEST CPS/CPS+ and XLS/XLS+. Note that light emission in the SUNTEST is controlled between 300 nm (UV region) and 800 nm (Visible region), and a radiometric intensity unit of Watt/m² is used. “Lux-hours” is a photometric term desc weighted to the average spectral response of the human eye.level between 300 – 800 nm, the illum1 klx = 4.415 W/m² (300 – 800ance level between 300 – 800 nm, the irradiance level W/m² (320 – 400 nm) = W/m² (300 – 800 nm) / 10.5SUNTEST CONDITIONS FOR THE ICH Q1B PROTOCOL1. Filters:The SUNTEST uses a group of optical filters to closely match the different spectral requirements, especially in the UV range. The ID65 requirement in the ICH gu can be achiev ideline ed by using the SUNTEST Solar ID 65 filter system. The SUNTEST Solar D 65 filter system is comprised of three filters: Solar ID 65 filter (P/N 56077769) with a 052372) and a coated quartz glass dish (P/NI with a window glass filter (P/N 5656052388).LS/XLS+ Conformity to ICHX an eye. Higher irradiance sults in shorter test duration to reach a given exposure. However, from a practical tures test durations at minimum and maximum SUNTE T200 Wh - At 23.8 W/m 2 at 320 – 400 nm corresponds to the minimum irradiance of 250W/m 2 at 300 – 800 nmm 2 ÷ 72.9 W/m 2 = 2.7 h SUNTEST exposure1.2 mil n - At minimum irradiance 1.2 Mlx h / 56.6 klx = 21.2 h SUNTEST exposureAlternatively, exposure times for the above minimums depend on the irradiance (light intensit PS/CPS+ and XLS/XLS+ have irradiance operating ranges that ive hieve dard temperatures. Using the SunCool even at 45% lower temperatures than using the SUNTEST by itself (typically chamber air temperature in the range of ca. 30 ºC).2. Irradiance and Exposure Duration:The ICH guideline does not recommend a specific irradiance (light intensity) setting. The SUNTEST with the above filter system can accommodate a range of irradiance values from a minimum of 250 W/m 2 in the wavelength range of 300 - 800 nm to a maximum of 765 W/m 2 in the wavelength range of 300 - 800 nm. Lux, as used in the ICH guideline, is a photometric intensity unit for the visible bandwidth between 400 nm and 800 nm, weighted to the spectral response of the hum re consideration, higher irradiance results in higher chamber air and specimen tempera because the xenon emission includes infrared radiation.The following provides an estimation of S irradiance levels to reach the minimum exposure requirements: /m 2 (between 320 and 400 nm):minimum irradiance, 200 Wh/m 2 ÷ 23.8 W/m 2 = 8.4 h SUNTEST exposure- At maximum irradiance 200 Wh/72.9 W/m 2at 320 – 400 nm corresponds to the maximum irradiance of 765W/m 2at 300 – 800 nmlio lx h (between 400 and 800 nm):56.6 klx corresponds to the minimum irradiance at 250W/ m 2at 300 – 800 nm- At maximum irradiance 1.2 Mlx h / 173.3 klx = 6.9 h SUNTEST exposure 173.3 klx corresponds to the maximum irradiance at 765 W/ m 2at 300 - 800 nmy). The SUNTEST C of 250 W/m 2 to 765W/m 2 in the wavelength range of 300 - 800 nm.3. Temperature:Determining thermal stability of drug substances and products is a separate requirement and is conducted independently from the photostability portion of the ICH guideline.However, the infrared energy emitted from the xenon lamp causes the chambertemperature to rise above the ambient temperature. ICH Guideline Q1B requires care be taken to avoid degradation of thermally labile products. To avoid excess temperatures, Atlas recommends using the optional Atlas SunCool air chiller to ac lower test chamber and black stan maximum irradiance will allow 30% toLS/XLS+ Conformity to ICHXThe SUNTEST uses a Black Standard Thermometer (BST) to regulate air temperature conditions in the exposure chamber. The BST sensor is a widely used surfacetemperature probe for monitoring maximum possible surface temperature of a black surface. To achieve the ambient temperature requirement, Atlas recommends setting the ST to 0 °C. The 0 °C setting of BST will activate the Atlas SunCool, which will) while thermal degradation rates will not increase linearly with increasing mperature, but rather will follow typical Arrhenius kinetics. Therefore, more thermal nger test at lower irradiance and temperature than at higher luateing .g., by a factor of 3 to 5-fold). Alternatively, exposure may be continued untilgradation has occurred. These studies are usually conducted on solid drug check for local availability of ISO 17025 accreditation). The Certificate of Calibration sued by Atlas-authorized service is valid for one year; if the equipment is moved to nother location or the electrical supply is changed, Atlas recommends recalibration.B provide the chamber air temperature of near ambient condition, approximately 18 °C to 25°C depending on irradiance and laboratory conditions.Note that photodegradation rates should increase linearly with photon flux (irradiance intensity te degradation can occur in a lo ones.Forced Degradation TestsThe ICH Guideline states that the purpose of “forced degradation” studies is to eva the overall photosensitivity of the material for method development purposes and/or to elucidate the degradation pathways and to validate stability-indicating assays. Unlike conformance testing, no specific testing criteria or minimums are recommended. However, the forced degradation experiment on the drug substance should be conducted using a visible light and UV exposure in excess of that used for formal product test (e significant de substances and also on solutions that are usually more susceptible to degradation.CalibrationAs chemical actinometers have shown inaccuracies, it is advised to calibrate the SUNTEST with approved radiometers. Best laboratory practice would dictate that calibration of any device be verified before and after each test. However, due to the stability of the integral radiometer measuring system of the SUNTEST CPS+ and XLS+ models, common practice is to have the SUNTEST CPS+ and XLS+ models calibrated at intervals of 6 or 12 months by an accredited, Atlas-authorized service representative (is aLS/XLS+ Conformity to ICHXCautionary Note : Radiometers and spectroradiometers must be calibrated for the d power supply. Atlas manufactures specific XenoCal™urther Informationcan be specific type of lamp an irradiance calibrators for use with SUNTEST and other Atlas instruments and the use of third-party devices may result in inaccurate measurements and calibrations.F A more thorough discussion of photostability testing and the ICH Q1B Guideline found in: Photostability of Drugs and Drug Formulations 2nd edition , edited by Ha Hjorth Tonnesen, CRC Press, ©2004, .nne summary of Q1B photostability testing may be found in: S.R. Thatcher, R.K. Mansfield, R.B. Miller, C.W. Davis and S.W. Baertschi, “A Technical Guide and Practical Interpretation of the ICH Guidelines and Its Application to Pharmaceutical Stability” Part 1 & 2. Pharmaceutical Technology, March & April 2001.AFor more information on the Atlas SUNTEST CPS/CPS+, SUNTEST XLS/XLS+ or other Lightfastness, Photostability and WeatheringInstrumentation, please visit us at 。

FDA《行业指南:注射产品可见颗粒的检查》,中英文对照版来了!

FDA《行业指南:注射产品可见颗粒的检查》,中英文对照版来了!

FDA《⾏业指南:注射产品可见颗粒的检查》,中英⽂对照版来了!⾏业指南:注射剂可见异物的检查》草案,该⽂件已完成翻译,现12⽉14⽇,FDA发布了《⾏业指南:注射剂可见异物的检查分享给⼤家,如下:Inspection of Injectable Productsfor Visible Particulates注射产品中可见颗粒的检查Guidance for Industry⾏业指南TABLE OFCONTENTS⽬录I. INTRODUCTION介绍II. STATUTORY AND REGULATORY FRAMEWORK法律法规框架III. CLINICAL RISK OF VISIBLE PARTICULATES可见颗粒物的临床风险IV. QUALITY RISK ASSESSMENT质量风险评估V. VISUAL INSPECTION PROGRAM CONSIDERATIONS⽬视检查的程序考虑A. 100% Inspection100%检查1. Components and Container Closure Systems部件和容器密封系统2. Facility and Equipment设施和设备3. Process⼯艺4. Special Injectable Product Considerations特殊注射产品的考虑B. Statistical Sampling统计学抽样C. Training and Qualification培训和确认D. Quality Assurance Through a Life Cycle Approach通过⽣命周期⽅法实现质量保证E. Actions To Address Nonconformance解决不符合问题的措施VI. REFERENCES参考⽂献I. INTRODUCTION介绍Visibleparticulates in injectable products can jeopardize patient safety. Thisguidanceaddresses the development and implementation of a holistic, risk-basedapproach to visibleparticulate control that incorporates product development,manufacturing controls, visualinspection techniques, particulate identification,investigation, and corrective actions designedto assess, correct, and preventthe risk of visible particulate contamination.2The guidance alsoclarifies that meeting an applicable United StatesPharmacopeia (USP)3compendialstandardalone is not generally sufficient for meeting the current goodmanufacturing practice (CGMP)requirements for the manufacture of injectableproducts. The guidance does not coversubvisible particulates4 or physical defects that products are typicallyinspected for along withinspection for visible particulates (e.g., containerintegrity flaws, fill volume, appearance of lyophilized cake/suspensionsolids).注射产品中的可见颗粒物会危及患者安全。

金属管转子流量计用户手册(版本21)说明书

金属管转子流量计用户手册(版本21)说明书

Metal Tube Rotameter User Manual(Version21)1.Safety Instructions (1)2.Introduction (3)2.1General Description (3)2.3Features (4)2.4Drawing (5)2.5Technical Parameters (9)3.Intended Use (10)4.Wiring (12)5.Limit Switch (15)6.Flow Table (17)7.Operation (19)7.1Main Parameters (19)7.2Clear Total Flow (20)7.34mA correction (21)7.420mA Correction (22)7.5Flow Unit (23)7.6Damp (24)7.7Small Signal Cutoff (25)7.8Measuring Range (26)8.Trouble Shooting (27)1.Safety Instructions Thank you for purchasing ourproduct.Wehavewritten this guide to provide the persons responsible for the installation,operation and maintenance of your flow meter with the product specific information they will need.In order to prevent damage to instrument and make the instrument in the best performance and stable operation,please read this manual thoroughly before installation.Please have a safekeeping of this manual and together with the instrument after reading.Please pass this manual to technical department of end user to keep.This manual classifies important grade of safety attentions by Caution and Warning.Caution Error operation in case of ignoring the tips might cause the personal injury or damage to the instrument and property.WarningError operation in case of ignoring the tips might cause the personal injury or major accident.Select explosion-proof instrument for explosive environment applicationConfirm whether the nameplate of instrument has the identifiers of explosion-proof certification and temperature class,the instrument can ’t be used in explosive environment without those identifiers.The explosion-proof temperature class of instrument must meet the explosion-proof and temperature of environmental requirements on siteWhen the instrument is in used explosion-proof environment,make sure that the explosion-proof certification and temperature class of instrument meet to theThis manual contents the following icons:Indicates safety attentions which are dangerous.Indicates safety attentions which are needed to pay attention to.Indicates safety attentions which are forbidden.requirements on site.No opening while working in explosive environmentBefore wiring,please power instrument off.The protection class of instrument must meet the working conditionrequirements on siteThe requirement of protection class on site should be under or the same as the protection class of instrument to ensure that the instrument is working fine.Confirm the working environment of instrument and medium temperatureThe environment on site and the maximum medium temperature should be under the nominal value of instrument.Confirm the ambient pressure of instrument and medium pressureThe ambient pressure on site and the maximum medium pressure should be under the nominal value of instrument.If doubting that the instrument in the event of failure,please do not operate itIf there are something wrong with the instrument or it had been damaged,please contact us.ImportantBefore use,read this manual thoroughly and familiarize yourself fully with the features,operations and handling of rotameter to have the instrument deliver its full capabilities and to ensure its efficient and correct use.WarningWhen using a metal tube rotameter,the total system design must be considered to ensure safe and troublefree performance.Function,material compatibility,adequate ratings,proper installation,operation,and maintenance are the responsibilities of the system designer and user.Improper selection or misuse of the product may result in serious personal injury or property damage.InformationMetal Tube Rotameter may be used only for flow measurements of fluid and gaseous media.The manufacturer shall not be liable for damages that may result from unintended or inappropriate use.When dealing with an aggressive medium,clarify the material resistance of all wetted parts.When using the device in hazardous areas,follow the applicable national installation rules.CautionInstallation,start-up and operating personnelOnly trained specialists authorized by the system operator may carry out the installation,electrical installations,startup,maintenance and operation.They must read and understand the operating manual and follow its instructions.The required mounting,electrical installation,start-up and maintenance work may only be carried out by expert and authorized persons designated by the plant operator. Basically,follow the conditions and provisions applicable in your country.2.Introduction2.1General DescriptionLZ Series intelligent Metal tube rotameter is a variable area flow meter which is based on the float position measurement.With full-metal structure,it has the features of small size,low pressure loss,large range ratio(10~20:1),optional transmitter with HART communication function,and convenient installation&maintenance etc.It is widely used in flow measurement and process control of small flow,low flow rate, and various industries under complex and harsh environments.2.3Features 1.Robust all-metalstructure design.2.Suitable for gas and liquid measurement in various industries.3.Cone-shape measuring tube design,which has wide measuring range and good linearity.4.Wetted parts material are optional:Stainless steel,Titanium,Hastelloy,PTFE,FEP,etc.5.Adopt advanced magnetic coupling system design,improve the accuracy and stability6.The upper row displays the instantaneous flow,the lower row displays the total flowInstantaneous flow 0.000-99999Total flow 0.00-99999999Current range 3.80-21.00mA Instantaneous flow percentage 0-100%Pointer angle 0.00-90.00°Ambient temperature-40--+150℃Total flow small signal cutoff 0-10%Damping time setting range 0-10secondsVarious flow units are optional,the range is automatically converted when unit is changed.2.2Working PrincipleThe flow meter consists of a measuring tube and a float inside it.The flow pushes the float to an equilibrium point.The area obtained between the float and the tube is proportional to the flow rate.The point of equilibrium depends on:•E =Force of the fluid flow •Ff =Weight of the float •Al =Free area of flowwhere:Al=A0(calibrated orifice area)-Af (float area)7.For the digital LCD display type,the flow range of the instantaneous flow can be corrected on-site based on the different measuring medium.8.It adopts advanced six level data backup technology,data of total flow can be saved automatically when power-off,(the total flow sending period is0.3S).9.Besides AC/DC power supply,it supports battery power supply function.10.No need to open the cover,it can be operated by a magnetic pen;the key operation function is also available.11.Through the HART protocol,you can use the handheld operator or host computer software to perform partial or full configuration operations on the flowmeter.2.4Drawing·Standard Dimensions and WeightCaliber DN15DN25DN50DN80DN100DN150L (mm)250250250250250250Weight (kg) 5.0 6.51015.51735Square Convertor Round Convertor·Jacket Type Dimensions and Weight Caliber DN15DN25DN50DN80DN100DN150L (mm)250250250250250250Weight (kg)7.51013192138·FEP Liner type Dimensions and weight Caliber DN15DN25DN50DN80DN100DN150L (mm)250250250250250250Weight (kg) 5.0 6.51015.516.532Insulation Jacket typeSquare Convertor Round Convertor·FEP Liner type Dimensions and weight Caliber DN15DN25DN50DN80DN100DN150L (mm)250250250250250250Weight (kg) 5.0 6.51015.51732·Side outlet type:Dimensions,weight and pressure loss(DN15~DN25)·Bottom inlet and side outlet type:Dimensions,weight and pressure lossCaliberDN15DN25F(mm)120120L(mm)250250Weight(kg)67.2Pressure loss(kpa)2130CaliberDN15DN25F(mm)120120L(mm)250250H(mm)67.2Weight(kg)67.2Pressure loss(kpa)2130Square Convertor Round(DN15~DN25)·Horizontal mounting type:Dimensions ,weight and pressure loss Caliber 15202540506580100125150L (mm)250250250300300400400400500500(DN15~DN150Gas)Caliber 15202540506580100125150L (mm)250250250250250250250250250250(DN15~DN150Liquid)·Additional structure and installation instructionsStraight pipe type With Filter Liner FEP with Filter Liner FEP straight pipe typeDiameter DN15DN25DN50DN80DN100DN150 Front straight pipe H1≥(mm)75125250400500750 After straight pipe H2≥(mm)250250250250250250φd(mm)951151652002202852.5Technical Parameters3.Intended UseInstallation drawingEx-proof mark Flame-proof :ExdIICT4~6GbIntrinsically Safe Explosion Proof:ExialICT3-6Sensor body SS304FloatSS304,SS316,Hastelloy,FEPh1:Outlet straight pipe h2:Inlet straight pipe,5D h3:Magnetic filter1.Remote type flow meter need to be earth grounded to get good electromagnetic compatibility.2.Upstream section≥5DN and downstream≥250mm to eliminate the whirlpool effect.3.The welding slag in the pipeline must be cleaned,and there mustn't be any magnetic particles in the magnetic coupling part.4.When install anti-corrosion type flow meter,the strength should be moderately when fasten bolts of flanges to avoid damage to the sealing surface.5.Please properly handle the waterproof problem of the cable connector to prevent rainwater from entering the case.6.If there's magnetic particles in the medium,magnetic filter should be installed in the inlet.If there's non-magnetic particles,filter should be installed.If there is bubbles,exhaust should be installed.7.Control valve should be installed in the downstream of flow meter.Working pressure should be more than pressure loss to make sure flow meter can work stably.8.If medium is pulsating flow,a buffer device should be installed.9.Open the control valve slowly to avoid damaging to the flow meter.10.If pressure is unstable,especially for gas,a damping structure should be adopted.4.WiringNote1:When wiring in accordance with intrinsically safe explosion-proof requirements,please combine the wiring method of the relevant safety barrier. Note2:24VDC power supply and pulse output are not in common ground!Note3:Battery powered model,use a specific power socket,no output.Two-wires4-20mA output connection(with HART)Intrinsic safety connectionRelay output and pulse output connectionAC power supply connectionBattery powered connectionHartThe HART375handheld tool can be connected to the HART instrument in the remote control room or on-site for communication operations.The handheld tool can be connected in parallel to the HART protocol device or to its load resistance(250Ω).Don’t need to consider the polarity of the lead when connecting.In order to ensure the normal communication of the handheld tool,there must be a minimum load resistance of250Ωin the loop.The handheld tool does not directly measure the loop current.After checking that the power supply of the meter loop is normal,press the key of the handheld tool for more than one second to turn on it.After the handheld starting,it will automatically search for the HART device with the polling address zero on the 4-20mA loop.Note:The zero-trim function can correct instrument output zero deviation caused by the installation location and it generally can be conducted at the beginning of the HART devices and instruments periodic verification.The use of this feature requires the authorization of the HART instrument owner,or it may cause the error of the output of HART instrument.5.Limit SwitchOne or two limit switches can be installed in the pointer,when it reaches to the set value,the switch will send a alarm signal,the values have been set according to client’s requests before delivery,values also can be set by client.SC3.5-No limit switch is intrinsic safety explosion proof,it should be used together with transistor amplifier WE77/EX1or WE77/EX2.SC3.5-NO limit switch is direct connection type,power supply is24VDC,three wire output is23.5V electric signal to the PLCFlow Range TableSpecial specifications can be customized according to customer’s inquiry.7.1Main Parameters7.2Clear Total Flow7.5Flow Unit7.6Damp7.7Small Signal Cutoff7.8Measuring Range8.Trouble ShootingNote:Above is some normal trouble shooting.If you have any more question,please contact with manufacturer.SMERI s.r.l.Via Mario Idiomi 3/13。

Fluent流体数值模拟软件中英对照

Fluent流体数值模拟软件中英对照

Aabort 异常中断, 中途失败, 夭折, 流产, 发育不全,中止计划[任务] accidentally 偶然地, 意外地accretion 增长activation energy 活化能active center 活性中心addition 增加adjacent 相邻的aerosol浮质(气体中的悬浮微粒,如烟,雾等), [化]气溶胶, 气雾剂, 烟雾剂Air flow circuits 气流循环ambient 周围的, 周围环境amines 胺amplitude 广阔, 丰富, 振幅, 物理学名词annular 环流的algebraic stress model(ASM) 代数应力模型algorithm 算法align 排列,使结盟, 使成一行alternately 轮流地analogy 模拟,效仿analytical solution 解析解anisotropic 各向异性的anthracite 无烟煤apparent 显然的, 外观上的,近似的approximation 近似arsenic 砷酸盐assembly 装配associate 联合,联系assume 假设assumption 假设atomization 雾化axial 轴向的Axisymmetry 轴对称的BBaffle 挡流板battlement 城垛式biography 经历bituminous coal 烟煤blow-off water 排污水blowing devices 鼓风(吹风)装置body force 体积力boiler plant 锅炉装置(车间)Boiling 沸腾Boltzmann 玻耳兹曼Bounded central differencing:有界中心差分格式Brownian rotation 布朗转动bulk 庞大的bulk density 堆积密度burner assembly 燃烧器组件burnout 燃尽Ccapability 性能,(实际)能力,容量,接受力carbon monoxide COcarbonate 碳酸盐carry-over loss 飞灰损失Cartesian 迪卡尔坐标的casing 箱,壳,套catalisis 催化channeled 有沟的,有缝的char 焦炭、炭circulation circuit 循环回路circumferential velocity 圆周速度clinkering 熔渣clipped 截尾的clipped Gaussian distribution 截尾高斯分布closure (模型的)封闭cloud of particles 颗粒云close proximity 距离很近cluster 颗粒团coal off-gas 煤的挥发气体coarse 粗糙的coarse grid 疏网格,粗网格Coatingcoaxial 同轴的coefficient of restitution 回弹系数;恢复系数coke 碳collision 碰撞competence 能力competing process 同时发生影响的competing-reactions submodel 平行反应子模型component 部分分量composition 成分computational expense 计算成本cone shape 圆锥体形状configuration 布置,构造confined flames 有界燃烧confirmation 证实, 确认, 批准Configuration 构造,外形conservation 守恒不灭conservation equation 守恒方程conserved scalars 守恒标量considerably 相当地consume 消耗contact angle 接触角contamination 污染contingency 偶然, 可能性, 意外事故, 可能发生的附带事件continuum 连续体Convection 对流converged 收敛的conveyer 输运机convolve 卷cooling duct 冷却管cooling wall 水冷壁coordinate transformation 坐标转换correlation 关联(式)correlation function 相关函数corrosion 腐蚀,锈coupling 联结, 接合, 耦合Cp:等压比热crack 裂缝,裂纹creep up (水)渗上来,蠕升critical 临界critically 精密地cross-correlation 互关联cumulative 累积的curtain wall 护墙,幕墙curve 曲线custom 习惯, 风俗, <动词单用>海关, (封建制度下)定期服劳役, 缴纳租税, 自定义, <偶用作>关税v.定制, 承接定做活的Cyan青色cyano 氰(基),深蓝,青色cyclone 旋风子,旋风,旋风筒cyclone separator 旋风分离器[除尘器]cylindrical 柱坐标的cylindrical coordinate 柱坐标Ddead zones 死区decompose 分解decouple 解藕的defy 使成为不可能Deforming:变形demography 统计Density:密度deposition 沉积derivative with respect to 对…的导数derivation 引出, 来历, 出处, (语言)语源, 词源design cycle 设计流程desposit 积灰,结垢deterministic approach 确定轨道模型deterministic 宿命的deviation 偏差devoid 缺乏devolatilization 析出挥发分,液化作用diffusion 扩散diffusivity 扩散系数digonal 二角(的), 对角的,二维的dilute 稀的diminish 减少direct numerical simulation 直接数值模拟discharge 释放discrete 离散的discrete phase 分散相, 不连续相discretization [数]离散化deselect 取消选定dispersion 弥散dissector 扩流锥dissociate thermally 热分解dissociation 分裂dissipation 消散, 分散, 挥霍, 浪费, 消遣, 放荡, 狂饮distribution of air 布风divide 除以dot line 虚线drag coefficient 牵引系数,阻力系数drag and drop 拖放drag force 曳力drift velocity 漂移速度driving force 驱[传, 主]动力droplet 液滴drum 锅筒dry-bottom-furnace 固态排渣炉dry-bottom 冷灰斗,固态排渣duct 管dump 渣坑dust-air mixture 一次风EEBU---Eddy break up 漩涡破碎模型eddy 涡旋effluent 废气,流出物elastic 弹性的electro-staic precipitators 静电除尘器emanate 散发, 发出, 发源,[罕]发散, 放射embrasure 喷口,枪眼emissivity [物]发射率empirical 经验的endothermic reaction 吸热反应enhance 增,涨enlarge 扩大ensemble 组,群,全体enthalpy 焓entity 实体entrain 携带,夹带entrained-bed 携带床Equation 方程equilibrate 保持平衡equilibrium 化学平衡ESCIMO-----Engulfment(卷吞)Stretching(拉伸)Coherence(粘附)Interdiffusion-interaction(相互扩散和化学反应)Moving-observer(运动观察者)exhaust 用尽, 耗尽, 抽完, 使精疲力尽排气排气装置用不完的, 不会枯竭的exit 出口,排气管exothermic reaction 放热反应expenditure 支出,经费expertise 经验explicitly 明白地, 明确地extinction 熄灭的extract 抽出,提取evaluation 评价,估计,赋值evaporation 蒸发(作用)Eulerian approach 欧拉法Ffacilitate 推动,促进factor 把…分解fast chemistry 快速化学反应fate 天数, 命运, 运气,注定, 送命,最终结果feasible 可行的,可能的feed pump 给水泵feedstock 填料Filling 倒水fine grid 密网格,细网格finite difference approximation 有限差分法flamelet 小火焰单元flame stability 火焰稳定性flow pattern 流型fluctuating velocity 脉动速度fluctuation 脉动,波动flue 烟道(气)flue duck 烟道fluoride 氟化物fold 夹层块forced-and-induced draft fan 鼓引风机forestall 防止Formulation:公式,函数fouling 沾污fraction 碎片部分,百分比fragmentation 破碎fuel-lean flamefuel-rich regions 富燃料区,浓燃料区fuse 熔化,熔融Ggas duct 烟道gas-tight 烟气密封gasification 气化(作用)gasifier 气化器Gauge 厚度,直径,测量仪表,估测。

微晶纤维素的极限聚合度的英文单词

微晶纤维素的极限聚合度的英文单词

微晶纤维素的极限聚合度的英文单词全文共3篇示例,供读者参考篇1The Limiting Degree of Polymerization of Microcrystalline CelluloseIntroductionMicrocrystalline cellulose is a renewable and sustainable material that is widely used in various industries such as pharmaceuticals, food, cosmetics, and textiles. One important property of microcrystalline cellulose is its degree of polymerization, which refers to the number of glucose units in the cellulose chain. The degree of polymerization of microcrystalline cellulose can have a significant impact on its physical and chemical properties, and therefore it is important to determine the limiting degree of polymerization of this material.Factors Affecting the Degree of PolymerizationThe degree of polymerization of microcrystalline cellulose can be influenced by various factors such as the source of cellulose, the method of extraction and purification, the conditions of hydrolysis, and the degree of crystallinity. Forexample, cellulose from different sources such as wood, cotton, or bamboo may have different degrees of polymerization due to differences in the cellulose structure. Similarly, the method of extraction and purification can also affect the degree of polymerization as impurities and processing conditions may impact the cellulose chain length.Methods for Determining the Limiting Degree of PolymerizationThere are several methods for determining the limiting degree of polymerization of microcrystalline cellulose. One common method is gel permeation chromatography (GPC), which separates cellulose chains based on their size and provides information on the distribution of chain lengths. Another method is viscometry, which measures the intrinsic viscosity of cellulose solutions and can be used to calculate the degree of polymerization. Additionally, techniques such as X-ray diffraction and solid-state NMR spectroscopy can provide information on the crystalline structure of cellulose and its impact on the degree of polymerization.Importance of Limiting Degree of PolymerizationThe limiting degree of polymerization of microcrystalline cellulose is important as it can affect the properties andperformance of products made from this material. For example, in pharmaceutical applications, the degree of polymerization can impact the flowability, compressibility, and disintegration properties of tablets made from microcrystalline cellulose. In food applications, the degree of polymerization can influence the texture, mouthfeel, and stability of products such as sauces, dressings, and baked goods. Therefore, understanding and controlling the limiting degree of polymerization of microcrystalline cellulose is essential for ensuring the quality and consistency of products.ConclusionIn conclusion, the limiting degree of polymerization of microcrystalline cellulose plays a crucial role in determining its properties and performance in various applications. Factors such as the source of cellulose, extraction and purification methods, and crystallinity can influence the degree of polymerization of this material. Methods such as GPC, viscometry, X-ray diffraction, and solid-state NMR spectroscopy can be used to determine the limiting degree of polymerization of microcrystalline cellulose. By understanding and controlling the degree of polymerization, manufacturers can optimize the performance of products and ensure consistency in quality.篇2Title: The Limit Aggregate Degree of Microcrystalline CelluloseIntroductionMicrocrystalline cellulose, also known as MCC, is a type of purified cellulose derived from natural wood pulp. It is widely used in pharmaceuticals, food products, and other industries as a non-toxic and biodegradable additive. One of the key characteristics of MCC is its aggregate degree, which refers to the extent to which individual cellulose particles are bound together. Understanding the limit aggregate degree of MCC is crucial for optimizing its properties and applications.Factors affecting aggregate degreeSeveral factors can influence the aggregate degree of microcrystalline cellulose. The primary factor is the manufacturing process used to produce MCC. Different processing techniques, such as acid hydrolysis or mechanical grinding, can result in varying degrees of aggregation in the final product. In addition, the particle size, shape, and surface properties of MCC particles can also impact their tendency toaggregate. For example, smaller particles tend to form tighter aggregates compared to larger particles.Measurement techniquesThere are several methods available for measuring the aggregate degree of microcrystalline cellulose. One common approach is dynamic light scattering, which can provide information about the size, distribution, and stability of MCC aggregates. Another widely used technique is electron microscopy, which allows for direct visualization of the structure of MCC particles and aggregates. Additionally, methods such as rheology and spectroscopy can be used to study the mechanical and chemical properties of MCC aggregates.Importance of limit aggregate degreeThe limit aggregate degree of microcrystalline cellulose is critical for controlling its behavior in various applications. For example, in pharmaceutical formulations, the degree of aggregation can affect the flow properties, compressibility, and disintegration of MCC-based tablets. In food products, the aggregate degree can impact the texture, stability, and mouthfeel of MCC-containing formulations. By understanding and optimizing the aggregate degree of MCC, manufacturerscan tailor its properties to meet specific requirements in different industries.ConclusionIn conclusion, the limit aggregate degree of microcrystalline cellulose is a key parameter that influences its performance in various applications. By studying the factors that affect aggregation, employing appropriate measurement techniques, and controlling the aggregate degree, manufacturers can optimize the properties of MCC for specific uses. Further research into the relationship between aggregate degree and the properties of MCC will continue to enhance the understanding and utilization of this versatile cellulose material.篇3Microcrystalline cellulose (MCC) is a widely used excipient in pharmaceutical formulations due to its unique properties such as high surface area, low density, and excellent compressibility. MCC is produced by acid hydrolysis of purified cellulose, resulting in a network of microcrystalline particles with a high degree of polymerization.Polymerization refers to the process of joining together monomers to form a polymer chain. In the case of cellulose,polymerization involves the repeated linking of glucose units to form long chains. The degree of polymerization (DP) of cellulose refers to the number of glucose units in each polymer chain. The higher the DP, the longer the cellulose chain and the larger the molecule size.The DP of MCC is typically in the range of 200-250, which is significantly lower than that of native cellulose. This low DP is achieved through the controlled hydrolysis process, which breaks down the cellulose chains into shorter, microcrystalline particles. The limited polymerization of MCC is essential for its functional properties in pharmaceutical applications.The low DP of MCC plays a crucial role in its compressibility and flow properties. The shorter polymer chains allow for tighter packing of the particles, resulting in higher bulk density and improved flow characteristics. The high surface area of MCC particles also facilitates better binding with active pharmaceutical ingredients, enhancing tablet hardness and disintegration.Furthermore, the low DP of MCC contributes to its excellent water absorption capacity and swelling behavior. The reduced polymerization allows for increased porosity within the MCC structure, providing more sites for water adsorption. Thisproperty is particularly advantageous in controlled-release formulations, where the gradual uptake of water helps regulate drug release.In summary, the limited polymerization of microcrystalline cellulose is a key factor in its unique properties and widespread use as a pharmaceutical excipient. The low DP of MCC enables optimal compressibility, flowability, water absorption, and binding capabilities, making it an indispensable ingredient in tablet formulations. Researchers continue to explore ways to control and optimize the polymerization of MCC to further enhance its performance in pharmaceutical applications.。

工业药剂学专业名词英文及相关名词解释

工业药剂学专业名词英文及相关名词解释

工业药剂学专业名词英文及相关名词解释第一章绪论1、药剂学(pharmaceutics或pharmacy)2、剂型(dosage forms):适合于疾病的诊断、治疗或预防的需要而制备的不同给药形式。

3、药物制剂(pharmaceutical preparations):原料药物按照某种剂型制成一定规格并具有一定质量标准的具体品种。

4、辅料(excipients或adjuvants):药物制剂中除主药外一切其他成分的总称。

5、药物给药系统(drug delivery system DDS)6、靶向给药系统(targeting drug delivery systems)7、药典(pharmacopoeia):一个国家记载药品规格和标准的法典8、药品生产质量管理规范(Good Manufacturing Practice GMP)9、动态药品生产管理规范(Current Good Manufacturing Practice cGMP)10、药品非临床实验管理规范(Good Laboratory Practice GLP)11、药物临床试验管理规范(Good Clinical Practice GCP)12、良好供应规范(Good Supply Practice GSP)第二章基本理论与方法第一节溶解溶出理论1、特性溶解度(intrinsic solubility):药物不含任何杂质,在溶剂中不发生解离、缔合,不与溶剂中的其他物质发生相互作用时所形成的饱和溶液的浓度。

2、平衡溶解度(equilibrium solubility):不能完全排除药物解离和溶剂影响而测得的溶解度。

3、增溶剂(solubilizing agent):具有增溶作用的表面活性剂4、助溶剂(hydrotropy agent):作为外加物质加入体系与药物反应生成高溶解性物质的物质5、潜溶与潜溶剂(cosolvency, cosolvent):在混合溶剂中各溶剂比例在某一比例中,药物的溶解度比在各单纯溶剂中的溶解度大,且出现极大值的现象成为潜溶,对应的混合溶剂成为潜溶剂。

你是否认为保护野生动物很重要英文作文

你是否认为保护野生动物很重要英文作文

你是否认为保护野生动物很重要英文作文全文共3篇示例,供读者参考篇1The protection of wild animals is an essential issue that concerns not only the environment but also the future of our planet. It is crucial that we take actions to safeguard the habitats and populations of these animals to ensure their survival and maintain the delicate balance of ecosystems.There are several reasons why protecting wild animals is important. Firstly, many species are facing extinction due to habitat destruction, poaching, and climate change. It is estimated that thousands of animal species are at risk of disappearing in the coming years if we do not take immediate action to protect them. These animals play a pivotal role in maintaining the biodiversity of our planet and their loss would have catastrophic consequences for ecosystems worldwide.Furthermore, wild animals are integral to the health of the environment. They help control insect populations, disperse seeds, and regulate the food chain. Without their presence, ecosystems would become imbalanced and the health of theenvironment would deteriorate. Protecting wild animals ensures that these vital ecological processes continue to function effectively.In addition, wild animals also have intrinsic value and deserve to be protected for their own sake. They have evolved over millions of years to inhabit specific environments and play unique roles in the ecosystem. Each species is a part of the intricate web of life on Earth and has a right to exist independently of its usefulness to humans.Moreover, wild animals are a source of inspiration and wonder for people around the world. They are a part of our cultural heritage and have inspired countless stories, myths, and works of art. Their presence in the wild enriches our lives and connects us to the natural world in a profound way.Protecting wild animals requires a concerted effort from governments, conservation organizations, and individuals. Measures such as establishing protected areas, enforcinganti-poaching laws, and promoting sustainable tourism can help ensure the survival of vulnerable species. Education and awareness campaigns are also crucial in engaging the public and fostering a sense of stewardship towards wild animals.In conclusion, the protection of wild animals is a responsibility that we all share. By safeguarding their habitats and populations, we can help preserve the rich biodiversity of our planet and ensure a sustainable future for generations to come. It is essential that we take action now to protect these magnificent creatures and the ecosystems they inhabit. Let us all work together to ensure a world where wild animals can thrive in their natural habitats.篇2Protecting wildlife is crucial for the preservation of our planet's biodiversity and ecosystems. The conservation of species such as elephants, tigers, and rhinos is essential to maintain a healthy balance in the natural world. Unfortunately, many animal species are currently at risk of extinction due to habitat destruction, poaching, and climate change. In this essay, I will discuss the importance of protecting wildlife and the ways in which we can contribute to their conservation.Firstly, wildlife plays a crucial role in maintaining ecological balance. Each species in an ecosystem has a unique role to play, and the loss of one species can have a cascading effect on the entire ecosystem. For example, predators help to control the population of herbivores, which in turn prevents overgrazing andhabitat destruction. By protecting wildlife, we are ensuring the stability of our ecosystems and the services they provide, such as clean air, water, and fertile soil.Secondly, wildlife is a vital source of genetic diversity. Each species has its own unique genetic makeup, which contains valuable information that can be used for scientific research and medical advancements. For example, many plants and animals have provided us with important medications, such as penicillin and aspirin. By protecting wildlife, we are preserving these genetic resources for future generations and the potential benefits they may offer.Furthermore, many wildlife species have cultural and aesthetic value. For centuries, animals such as elephants, lions, and birds have been revered in various cultures around the world. They are often seen as symbols of strength, beauty, and wisdom. By protecting wildlife, we are preserving our cultural heritage and the inspiration they provide for art, literature, and spirituality.Despite the importance of protecting wildlife, many species are facing significant threats. Illegal poaching for ivory, rhino horn, and exotic pets remains a prevalent issue, driven by demand in the black market. Habitat destruction, caused bydeforestation, agriculture, and urban development, is also a major threat to wildlife populations. Climate change is exacerbating these threats by altering habitats and leading to more frequent extreme weather events.Fortunately, there are actions we can take to help protect wildlife. One of the most effective ways is to support conservation organizations that work to preserve habitats, enforce wildlife protection laws, and raise awareness about the importance of wildlife conservation. By donating to these organizations, volunteering your time, or participating in conservation projects, you can make a positive impact on wildlife conservation efforts.Additionally, we can make sustainable choices in our daily lives to reduce our impact on wildlife and their habitats. This includes reducing our consumption of products made from endangered species, such as ivory and exotic pets, and choosing sustainable and eco-friendly products whenever possible. By minimizing our carbon footprint, recycling, and reducing waste, we can help mitigate the effects of climate change and habitat destruction on wildlife populations.In conclusion, protecting wildlife is essential for the health of our planet and future generations. By preserving biodiversity,maintaining ecological balance, and respecting the cultural and aesthetic value of wildlife, we can ensure a sustainable future for all species. To effectively protect wildlife, we must take action at the individual, community, and global levels to address the threats facing wildlife populations and work towards a world where all species can thrive.篇3Protecting wild animals is of vital importance to the preservation of our planet's biodiversity and the balance of its ecosystems. The survival of many species of animals is at risk due to human activities such as deforestation, poaching, pollution, and climate change. It is our responsibility to take action to protect these animals and their habitats before it is too late.One of the main reasons why protecting wild animals is important is because every species plays a unique role in the ecosystem. For example, predators help to control the population of prey species, thereby preventing overgrazing and habitat destruction. Pollinators like bees and butterflies are essential for the reproduction of plants, which in turn provide food and shelter for other animals. By conserving the diversity of species in an ecosystem, we ensure its resilience to environmental changes and disruptions.Furthermore, wild animals have intrinsic value and deserve to live free from harm and exploitation. They have a right to their habitats and natural behaviors, and it is our duty to respect and protect these rights. The loss of a species due to human activities is a tragedy that cannot be undone, and we must do everything in our power to prevent such irreparable harm.In addition, protecting wild animals benefits human society in many ways. Many animals provide ecosystem services that are crucial for our survival, such as clean water, air, and soil. Wildlife tourism is also a major source of income for many countries, providing jobs and economic opportunities for local communities. By safeguarding wild animals, we are investing in our own well-being and the well-being of future generations.In conclusion, protecting wild animals is not just a moral imperative, but a necessity for the health and sustainability of our planet. We must take urgent action to address the threats facing these animals and their habitats, and promote policies and practices that prioritize conservation and sustainability. Together, we can make a difference and ensure a future where all species can thrive in harmony with nature.。

保护森林和野生动物的重要性英语作文

保护森林和野生动物的重要性英语作文

保护森林和野生动物的重要性英语作文Protecting forests and wildlife is of great importancefor the well-being of our planet. Forests play a crucialrole in maintaining the balance of the ecosystem,regulating the climate, and providing habitats for a wide variety of plant and animal species. Meanwhile, wildlife is an integral part of the natural world and contributes tothe overall biodiversity of our planet.First and foremost, forests act as carbon sinks, absorbing carbon dioxide from the atmosphere and helping to mitigate the effects of climate change. Deforestation and forest degradation not only release large amounts of carbon dioxide into the atmosphere but also reduce the capacity of the forests to absorb carbon. This contributes to the greenhouse effect and exacerbates global warming. Therefore, protecting forests is essential for combating climate change and preserving the stability of the Earth's climate.Furthermore, forests are home to countless species of plants, animals, and microorganisms. They provide food, shelter, and breeding grounds for a diverse range of wildlife, from insects to large mammals. By protectingforests, we are also protecting the habitats of these species and ensuring their survival. Many of these species are also crucial for maintaining the balance of the ecosystem, as they play roles in pollination, seed dispersal, and nutrient cycling. Therefore, conserving forests is essential for preserving biodiversity and ensuring the resilience of the natural world.In addition to the ecological benefits, forests also provide numerous social and economic benefits to human societies. They are a source of food, medicine, and raw materials for countless communities around the world. Moreover, forests support various industries, such as timber, paper, and pharmaceuticals, which contribute to the global economy. By protecting forests, we are also safeguarding these valuable resources and ensuring their sustainable use for future generations.Similarly, wildlife plays a crucial role in maintaining the balance of the ecosystem and contributing to theoverall health of the planet. Different species of animals and plants are interconnected in complex food webs, and the loss of any one species can have cascading effectsthroughout the ecosystem. For example, the decline of pollinators such as bees and butterflies can have serious implications for the pollination of crops and the production of food. Therefore, protecting wildlife is essential for preserving the stability and functionality of ecosystems.Furthermore, wildlife has intrinsic value andcontributes to the cultural and spiritual heritage of human societies. Many indigenous communities have deep connections to the land and the wildlife that inhabit it, and their cultural identities are closely tied to the natural world. Protecting wildlife is not only a matter of ecological necessity but also a matter of respecting the diversity of life and the rights of indigenous peoples.In conclusion, protecting forests and wildlife is of paramount importance for the well-being of our planet. Itis essential for preserving the stability of the climate, maintaining biodiversity, and ensuring the sustainability of natural resources. Additionally, it is crucial for supporting the social, economic, and cultural well-being of human societies. Therefore, it is imperative that we takecollective action to conserve forests and wildlife for the benefit of current and future generations.保护森林和野生动物对于地球的福祉至关重要。

迈克罗斯督导指南说明书

迈克罗斯督导指南说明书

Thawing and Use of Plateable and Suspension Cryopreserved HepatocytesHepatocyte Thaw Medium MethodPub. No. MAN0018379 Rev. 2.0WARNING! Read the Safety Data Sheets (SDSs) and follow the handling instructions. Wear appropriate protective eyewear,clothing, and gloves. Safety Data Sheets (SDSs) are available from /support.IMPORTANT! Use universal safety precautions and appropriate biosafety cabinet when handing primary hepatocytes.IntroductionThis user bulletin covers the thawing and preparation of cryopreserved hepatocytes for their subsequent use in applications suchas metabolic stability (intrinsic clearance), metabolite ID/profiling, enzyme induction, hepatotoxicity, transporter uptake and efflux, environmental bioaccumulation and liver disease research. Methods are described for suspension lots and for plating and overlay of plateable hepatocytes.Required materials not suppliedUnless otherwise indicated, all materials are available through .Procedural guidelines•If plating hepatocytes with an overlay, refer to the specification sheet for Geltrex™ LDEV-Free, hESC-Qualified, Reduced Growth Factor Basement Membrane Matrix (Cat. No. A1413201), which will provide the lot concentration and technical tips. Geltrex™ Matrix should be thawed on ice for 2–3 hours prior to application, or overnight at 4°C, and kept ice-cold to prevent gelling.•Read the instructions for the Primary Hepatocyte Maintenance Supplements (Cat. No. CM4000) and Primary Hepatocyte Thawing and Plating Supplements (Cat. No. CM3000) and prepare Maintenance and Plating Media using William's E Medium.•Once thawed, cryopreserved hepatocytes must be used immediately and will not retain metabolic activities if re-frozen.•Not all cryopreserved hepatocytes are suitable for plating. If using this protocol for plating hepatocytes, confirm that the lot is plateable.Reagents referenceThaw, spin, resuspend1.Warm media to 37°C in a water bath:•Hepatocyte Thaw Medium for human or animalhepatocytes•Plating Medium (if plating hepatocytes; this is William's E Medium supplemented with Primary Hepatocyte Thawingand Plating Supplements)•Incubation Medium (for suspension only, this is William'sE Medium supplemented with Primary HepatocyteMaintenance Supplements)2.Thaw cryopreserved hepatocytes in 37°C water bath for<2 minutes.3.Wipe the vial with 70% alcohol in the hood; pour oruse wide-bore pipette tip to transfer hepatocytes intoHepatocyte Thaw Medium.4.Centrifuge at room temperature:•Human hepatocytes, 100 × g for 10 minutes.•Dog hepatocytes, 100 × g for 10 minutes.•Monkey hepatocytes, 110 × g for 10 minutes.•Rat hepatocytes, 100 × g for 10 minutes.•Mouse hepatocytes, 80 × g for 10 minutes.5.Pour supernatant off into waste bottle and invert completely.Do not shake.6.Add ~3 mL of the following media and gently resuspendthe cells by gently rocking the tube front and back until nocell clump is observed. Avoid mixing hepatocytes by rapidpipetting which can cause cellular damage.•Plating Medium, if plating the hepatocytes•Pre-warmed Incubation Medium, if using cells insuspensionCount, plate, and incubate cells1.Manually count live and dead cells using hemocytometer.Determine cell viability and yield.Hepatocytes are very fragile and often automated cellcounting instruments will give false viabilities and yields. We suggest manual counting for better accuracy, as the correct plating density is critical for good results.2.If using the hepatocytes in suspension, add additionalmedium to bring cells to desired concentration (i.e.1 × 106 cells/mL) — do not proceed with the subsequentplating steps.3.Dilute to correct seeding density with Plating Medium.(Table 1, Table 2).4.Pipet cells into multi-well plate, with a serological pipet orwide-bore pipet tips.Note: If 96‑well plate is used to culture cells, pre-wet theplate by adding 60 µL of Plating Medium to each well, thenadd 65 µL of hepatocyte stock to each pre-wetted well for a total of 125 µL media per well.Resuspend the hepatocyte stock every few wells to ensure a homogeneous mixture.5.Place plate in incubator, and with hand on top of lid dispersecells with north/south and east/west motions.6.Incubate plate at 37°C for 4–6 hours.Do not move/disturb plate during this time to allow cells tosettle and form a monolayer—cells will pool to middle ofplate if agitated.Note: If not overlaying, prior to feeding plates 4–6 hours later, pre-warm Incubation Medium (this isWilliam's E Medium supplemented with Primary Hepatocyte Maintenance Supplements (Serum-free)).Note: If you are using an overlay, the Incubation Mediumneeds to be kept ice cold. See the overlay section for moreinformation.7.After incubation, shake plate on hood surface to loosendebris and aspirate medium.8.If using an overlay, proceed to the next step. If not usingan overlay, replace medium with pre-warmed IncubationMedium, or alternative medium, depending on yourapplication.Do not let the hepatocytes dry out—replace medium quickly. OverlayIMPORTANT! Geltrex™ LDEV-Free, hESC-Qualified, Reduced Growth Factor Basement Membrane Matrix and the Incubation Medium used for its dilution must be kept ice cold to prevent premature gelling. Keep Geltrex™ Matrix and Incubation Medium on ice; preferably use cold pipettes when mixing.1.Calculate the amount of Incubation Medium needed to feedthe plated hepatocytes and place this volume on ice.Generally, this is 12 mL per plate; consider adding 1–2 mLfor a slight excess of solution.2.Find the protein concentration of Geltrex™ matrix on itsspecification sheet—each lot is slightly different.3.Multiply the amount of Incubation Medium by ourrecommended final Geltrex™ matrix concentration of 0.35mg/mL, and divide by the protein concentration of Geltrex™matrix to get the amount of Geltrex™ matrix that needs to be added to the Incubation Medium:•For Human or Monkey: (mL Incubation Medium × 0.35mg/mL) / Geltrex™ protein conc. = mL of Geltrex™ matrixto add•For Rat or Mouse: (mL Incubation Medium × 0.6mg/mL) / Geltrex™ protein conc. = mL of Geltrex™ matrixto add•For Dog: (mL Incubation Medium × 0.25 mg/mL) /Geltrex™ protein conc. = mL of Geltrex™ matrix to add4.Add Geltrex™ matrix to the cold Incubation Medium on ice.Mix well by pipeting several times and invert media to ensure homogeneous solution.5.Apply overlay to plated hepatocytes and incubate at leasttwo hours or up to 24 hours prior to use.The gel layer will settle out of the media over the top of the hepatocytes.6.Replace Incubation Medium daily.Plating guidelinesTable 1 General seeding density guide for cyropreserved hepatocytes12 mL media per plate. Each lot may require slight adjustments in seeding density to form optimal monolayer.Table 2 Approximate number of cells per plate12 mL media per plate.Limited product warrantyLife Technologies Corporation and/or its affiliate(s) warrant their products as set forth in the Life Technologies' General Terms and Conditions of Sale at /us/en/home/global/terms-and-conditions.html. If you have any questions, please contact Life Technologies at /support.Life Technologies Corporation | 3175 Staley Road | Grand Island, NY 14072For descriptions of symbols on product labels or product documents, go to /symbols-definition.The information in this guide is subject to change without notice.DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these products, you accept the terms and conditions of all applicable Limited Use Label Licenses.©2021 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified./support | /askaquestion。

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IEEE TRANSACTIONS ON CIRCUITS AND SYSTEMS—II: ANALOG AND DIGITAL SIGNAL PROCESSING, VOL. 47, NO. 8, AUGUST 2000
797
Intrinsic Stability-Control for Recursive Filters and Neural Networks
or in normalized lattice form [1]. Other stability-control techniques include the hyperstable adaptive recursive gilter (HARF) [1] that imposes some conditions on the transfer function, which cannot be easily guaranteed in practice [3]. It is known that the reparametrization-for-stability method can also be used in ARMA system identification to guarantee the stability using the Levinson–Durbin recursion [5], [6]. Such a method can be successfully applied to the efficient lattice IIR filters that are more suitable for on-line applications. In [4], an adaptation algorithm is presented for lattice filters in the context of log-area ratio parameters, which effectively uses reparametrization. This paper considers the reparametrization-for-stability method for the on-line adaptation of IIR adaptive filters. The coefficients are adapted such that the stability is intrinsically assured, improving the speed of adaptation with respect to methods that employ a bound on the step size [3] or the rate of convergence with respect to methods that do not control stability or that use the simple strategy of no adaptation when instability arises. A new technique is presented, based on the further adaptation of the squashing function, which allows to improve the rate of convergence of the algorithm. The proposed technique, developed as doctorate research by the first author in [19] and briefly introduced in [16], can be applied to various IIR implementations (direct forms, cascade, or parallel of second-order sections, lattice form), as well as to locally recurrent neural networks to which classical techniques such as SHARF [1] cannot be applied. In this brief, the case of normalized lattice filters is particularly considered for stability control; an analysis of the stabilization effects is also presented both analytically and experimentally. II. IS TECHNIQUE Let us suppose that the slow coefficient variation hypothesis is satisfied. For the sake of clarity the simplest case, the first-order IIR filter considered as follows:
Paolo Campolucci and Francesco Piazza
Abstract—Linear recursive filters can be adapted on-line but with instability problems. Stability-control techniques exist, but they are either computationally expensive or nonrobust. For the nonlinear case, e.g., locally recurrent neural networks, the stability of infinite-impulse response (IIR) synapses is often a condition to be satisfied. This brief considers the known reparametrization-for-stability method for the on-line adaptation of IIR adaptive filters. A new technique is also presented, based on the further adaptation of the squashing function, which allows to improve the convergence performance. The proposed method can be applied to various filter realizations (direct forms, cascade or parallel of second order sections, lattice form), as well as to locally recurrent neural networks, such as the IIR multi-layer perceptron (IIR-MLP), with improved performance with respect to other techniques and to the case of no stability control. In this brief, the case of normalized lattice filters is particularly considered; an analysis of the stabilization effects is also presented both analytically and experimentally. Index Terms—Adaptive IIR filters, recurrent neural networks, stability control.
I. INTRODUCTION In the linear infinite-impulse response (IIR) adaptive filter literature various techniques have been proposed to control stability [1]–[6]. A static causal filter is asymptotically stable if and only if (iff) the poles of its transfer function lie inside the unit circle of the complex plane. In the time-variant case (on-line adaptation), the above condition is not sufficient anymore: a second condition of “slow-coefficient-variation” must be added to assure stability [1], [3]. In practice, this second condition is often neglected, since the first condition on the poles is sufficient for real-world signals [2], being “pathological” [2] in the cases when this is not true. On the contrary, the second condition can be important when the IIR filter must operate near the instability region [1]. Ensuring stability is also an important problem for dynamic neural networks that are drawing an increasing interest in the signal processing community for their nonlinear modeling capabilities [7]–[9]. In particular, locally recurrent neural networks have an intrinsic capability to efficiently deal with temporal sequences [10]–[12], and recently some efficient learning algorithms, such as causal recursive back propagation (CRBP) [13] or truncated recursive back propagation (TRBP) [14], have been proposed for them. The stability control in general recurrent neural structures is a very complex problem [15]; in many IIR layered structures, however, the stability of the internal IIR filters is a condition that must be satisfied anyway. The simplest stability-control technique for an IIR filter consists in skipping the adaptation step when this will bring one or more poles outside the unit circle. In fact, efficient criteria are available to monitor the pole positions, such as the Jury’s criterion that avoids the explicit computation of the poles. The methods based on pole projection [2] instead, which consider the reflection of the poles inside the unit circle, are more complex but usually faster and more robust. To make the stability control easier, the IIR filter can be implemented in cascade or parallel form using second order sections [1], [2], in lattice form [2],
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