Safety, Pharmacokinetic and Pharmacodynamic Studies of Batifiban Injection Following Single- and

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_中英文_附录2 WHO药品GMP指南

These two parts were subsequently supplemented by further guidelines which are integral parts of these GMP for pharmaceutical products. All these texts are available on the Medicines web page (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpc over.html). 这两部分随后通过药品GMP指南不可缺少的一部分内容进一步补充，这些内容可在药品网站上查到： (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpc
9. Personnel 人员 General 概述 Key personnel 关键人员 10. Training 培训 11. Personal hygiene 人员卫生 12. Premises 厂房 General 概述 Ancillary areas 辅助区域 Storage areas 仓储区域 Weighing areas 称量区域 Production areas 生产区域 Quality control areas QC区域 13. Equipment 设备 14. Materials 物料 General 概述 Starting materials 起始物料 Packaging materials 包装材料 Intermediate and bulk products 中间体和成品 Finished products 制剂 Rejected, recovered, reprocessed and reworked materials 不合格、回收、返工和重加工物料 Recalled products 召回产品 Returned goods 退货 Reagents and culture media 试剂和培养基 Reference standards 标准品 Waste materials 废弃物料 Miscellaneous 其他 15. Documentation 文件 General 概述 Documents required 需要的文件 16. Good practices in production 生产良好规范 General 概述 Prevention of cross-contamination and bacterial contamination during production生产过程中交叉污染和额细菌污染的预防

药品注册英文

欢迎阅读Glossary （术语）：RegulatoryAffairs （RA ）：药政事务drugauthority ：药政当局investigationandresearchbeforeprojectapproval ：立项前的调研MarketAuthorization （MA ）：上市许可lifecycle genericdrug ：仿制药CenterforDrugEvaluation （CDE ）：SFDA 下属的药品审评中心QualitybyDesign （QbD ）：质量源于设计CMCPilotProgram ：FDA 在业内开展的关于QbD 的试点研究earlylaunch ：早日上市designspace：设计空间BusinessDevelopment（BD）：业务发展部门ImportedDrugLicense（IDL）：进口药品注册证ManufacturingLicense（ML）：生产许可证ClinicalTrialPermission（CTP）：临床试验批件marketshare：市场占有率salesvolume：销量investigatorbrochure（IB）：研究者手册protocol：临床试验方案priority：优先度packageinsert（PI）：说明书labeling：包装标签PatientInformationLeaflet（PIL）：患者使用的说明书SummaryofProductCharacteristics（SmPC，SPC）：产品特性摘要foil：铝箔carton：装药品的小盒Medical（ClinicalCommercial：商业部门newchemicalentity（NCE）：新化学实体keyopinionleader（KOL）：关键意见领袖off-labeluse：标签外使用patientpool：患者库deadline：最后期限globaltrial：全球性的临床试验，即国际多中心临床试验regionaltrial：区域性的临床试验TPD加拿大卫生部治疗产品局adversedrugreaction,ADR药物不良反应pharmacokinetics(PK)药物代谢动力学。

安全药理学英文

安全药理学英文Safety Pharmacology in EnglishSafety pharmacology is a specialized discipline within pharmacology that focuses on evaluating the potential undesirable or unintended effects of a drug on physiological functions. This field is crucial in the drug development process to ensure the safety of new pharmaceuticals beforethey are administered to humans. The primary goal of safety pharmacology is to identify any adverse effects that could pose a risk to human health.Key Aspects of Safety Pharmacology1. Cardiovascular System: Assessing the impact of a drug on heart function, blood pressure, and rhythm is vital. This includes evaluating the potential for QT interval prolongation, which can lead to life-threatening arrhythmias.2. Central Nervous System: Examining the drug's effectson neurological functions such as consciousness, coordination, and cognitive function is essential to prevent CNS-relatedside effects.3. Respiratory System: Evaluating the drug's potential to affect respiratory rate and function is important to avoid respiratory depression or other breathing issues.4. Renin-Angiotensin System: The impact on the body's fluid and electrolyte balance is assessed to prevent hypotension or other related complications.Methods and TechniquesSafety pharmacology employs a variety of methods and techniques to evaluate drug safety:- In Vitro Studies: These include cell cultures and isolated organ preparations to study the direct effects of a drug on specific tissues or cell types.- In Vivo Studies: Animal models are used to observe the drug's effects on living organisms, providing a more integrated assessment of its impact on physiological functions.- Computational Modeling: Advanced software is used to simulate the drug's behavior and predict potential side effects before experimental testing.Regulatory RequirementsRegulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established guidelines for safety pharmacology studies. These guidelines ensure a standardized approach to evaluating the safety of new drugs.Importance in Drug DevelopmentSafety pharmacology plays a critical role in the drug development pipeline:- It helps to identify potential safety issues early in the development process, reducing the risk of adverse events during clinical trials.- It aids in the selection of safe drug candidates, increasing the chances of successful drug approval.- It contributes to the overall safety profile of a drug, which is a key consideration for regulatory approval and patient use.Future DirectionsThe field of safety pharmacology is continuously evolving with advancements in technology and a deeper understanding of complex physiological systems. Emerging trends include:- The use of personalized medicine to tailor safety pharmacology assessments to individual patient characteristics.- The integration of safety pharmacology into the broader scope of drug safety evaluation, including toxicology and clinical pharmacology.In conclusion, safety pharmacology is an integral part of the pharmaceutical industry's efforts to bring safe andeffective drugs to market. Its focus on evaluating the potential risks of new drugs ensures that the benefits of medication are not outweighed by unintended side effects, thereby protecting public health.。

医药行业专业英语词汇(词典)

FDA 和 EDQM 术语 :CLINICAL TRIAL ：临床试验ANIMAL TRIAL ：动物试验ACCELERATED APPROV AL ：加速批准STANDARD DRUG ：标准药物INVESTIGATOR ：研究人员；调研人员PREPARING AND SUBMITTING ：起草和申报SUBMISSION ：申报；递交BENIFIT （ S）：受益？RISK （ S）：受害？DRUG PRODUCT ：药物产品DRUG SUBSTANCE ：原料药ESTABLISHED NAME ：确定的名称GENERIC NAME ：非专利名称PROPRIETARY NAME ：专有名称；INN （INTERNATIONAL NONPROPRIETARY NAME ）：国际非专有名称ADVERSE EFFECT ：副作用ADVERSE REACTION ：不良反应PROTOCOL ：方案ARCHIV AL COPY ：存档用副本REVIEW COPY ：审查用副本OFFICIAL COMPENDIUM ：法定药典（主要指USP、 NF）．USP（ THE UNITED STATES PHARMACOPEIA ）：美国药典NF （NATIONAL FORMULARY ）：（美国）国家处方集OFFICIAL ＝ PHARMACOPEIAL= COMPENDIAL ：药典的；法定的；官方的AGENCY ：审理部门（指FDA ）IDENTITY ：真伪；鉴别；特性STRENGTH ：规格；规格含量（每一剂量单位所含有效成分的量）LABELED AMOUNT ：标示量REGULATORY SPECIFICATION ：质量管理规格标准（ NDA 提供）REGULATORY METHODOLOGY ：质量管理方法REGULATORY METHODS V ALIDATION ：管理用分析方法的验证COS/CEP 欧洲药典符合性认证ICH （ International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) 人用药物注册技术要求国际协调会议ICH 文件分为质量、安全性、有效性和综合学科 4 类。

药物警戒与用药安全ppt课件

(post marketing surveilance)
新药上市后临床研究 (干预性研究) ---上市新药长期应用的安全性、有效性评价
---上市新药与不同药物联合应用的安全性、有效性评价
(临床药物相互作用研究)
---新药用于特殊人群（如儿童、孕妇、老人或肝肾
功能不良的患者）患者的安全性、有效性评价
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是上市后药品临床安全性评价的重要基础 ADR志愿报告体系的功能取决于ADR报告率的高低和信息
质量优劣 ADR志愿报告体系的建立和完善，依靠国家管理部门
的精心组织和领导，以及医药界同仁及民众的积极参入当ADR报告率达一定高度，报告质量基本反映所报病例
的实际情况，ADR报告制度才可能发挥有效预警作用
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实施ADR报告和监测，有利于全面认识药物作
用的两重性（有效性、安全性），并据此制定
相应防制措施。
(2004. 3）
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10 9
严重和非预期不良反应的实例
药品
氨基比林氯霉素氯碘羟喹依托红霉素氟烷甲基多巴口服避孕药普拉洛尔利舍平他汀类沙利度胺
不良反应
粒细胞缺乏
再生障碍性贫血
亚急性脊髓视神经病（SMON）
龙胆泻肝丸一度作为 OTC 广泛应用，因内含关木通马兜玲酸，可引发致严重肾损害
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29 22
药物治疗错误
(Medication Errors) 是威胁临床用药安全
的重要因素之一
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30 23
药物治疗错误是ADEs的重要因素之一
Medication Errors 是威胁临床用药安全的重要因素 — 美国报道每年因医疗差错(medical error)致死98，000 例

贯叶连翘药物相互作用研究进展

药学服务与研究ＰｈａｒｍＣａｒｅ＆Ｒｅｓ２００８Ｆｅｂ；８（Ｉ）沈燕，等．贯叶连翘药物相互作用研究进展・６３・贯叶连翘药物相互作用研究进展沈燕１，罗启剑２（１．上海市第十人民医院护理部，上海２０００７２；２．复旦大学附属华山医院药剂科，上海２０００４０）・综述・［摘要］目的：介绍贯叶连翘的药物相互作用研究进展。

方法：查阅近几年来国内外有关贯叶连翘药物相互作用的文献并迸行综述。

结栗：贯叶连翘通过诱导细胞色素Ｐ４５０酶系以及改变Ｐ糖蛋白活性，改变多种药物的代谢行为，甚至引发严重不良事件。

结论：应重视贯叶连翘的药物相互作用，合理使用。

［关键词］贯叶连翘；细胞色素Ｐ４５０酶系统；Ｐ糖蛋白；药物相互作用［中图分类号］Ｒ９６９．２［文献标识码］Ａ［文章编号］１６７１—２８３８（２００８）０１—００６３—０３ＡｄｖａｎｃｅｓｉｎｒｅｓｅａｒｃｈｏｎｄｒｕｇｉｎｔｅｒａｃｔｉｏｎｓｗｉｔｈＨｙｐｅｒｉｃｕｍｐｅｒｆｏｒａｔｕｍＳＨＥＮＹａｎｌ，ＬＵＯＱｉ－ｊｉａｎ２（１．ＤｅｐａｒｔｍｅｎｔｏｆＮｕｒｓｉｎｇ，ｔｈｅｌＯｔｈＰｅｏｐｌｅ’ＳＨｏｓｐｉｔａｌｏｆＳｈａｎｇｈａｉ，Ｓｈａｎｇｈａｉ２０００７２，Ｃｈｉｎａ；２．ＤｅｐａｒｔｍｅｎｔｏｆＰｈａｒｍａｃｙ，ＨｕａｓｈａｎＨｏｓｐｉｔａｌ，ＦｕｄａｎＵｎｉｖｅｒｓｉｔｙ，Ｓｈａｎｇｈａｉ２０００４０，Ｃｈｉｎａ）［＇ＡＢＳＴＲＡＣＴ］Ｏｂｊｅｃｔｉｖｅ：ＴｏｉｎｖｅｓｔｉｇａｔｅｔｈｅａｄｖａｎｃｅｉｎｒｅｓｅａｒｃｈｏｎｄｒｕｇｉｎｔｅｒａｃｔｉｏｎｓｗｉｔｈＨｙｐｅｒｉｃｕｍｐｅｒｆｏｒａｔｕｍＬ．．Ｍｅｔｈ－ｏｔｉｓ：ＴｈｅｒｅｌａｔｅｄａｒｔｉｃｌｅｓｉｎｒｅｃｅｎｔｙｅａｒｓｏｎｄｒｕｇｉｎｔｅｒａｃｔｉｏｎｓｗｉｔｈＨｙｐｅｒｉｃｕｍｐｅｒｆｏｒａｔｕｍＬ．ａｒｅｅｘｔｅｎｓｉｖｅｌｙｒｅｖｉｅｗｅｄ．Ｒｅｓｕｌｔｓ：ＨｙｐｅｒｉｃｕｍｐｅｒｆｏｒａｔｕｍＬ．ｃａｎａｌｔｅｒｍｅｔａｂｏｌｉｓｍｂｅｈａｖｉｏｒｏｆｍａｎｙｄｒｕｇｓａｎｄｅｖｅｎｃａｕｓｅｓｅｒｉｏｕｓａｄｖｅｒｓｅｅｖｅｎｔｓｂｙｉｎｄｕｃｉｎｇｔｈｅｃｙｔｏｃｈｒｏｍｅＰ４５０（ＣＹＰ）３Ａ４ｅｎｚｙｍｅｓｙｓｔｅｍａｎｄｃｈａｎｇｉｎｇｔｈｅａｃｔｉｖｉｔｙｏｆＰ－ｇｌｙｃｏｐｒｏｔｅｉｎ．Ｃｏｎｃｌｕｓｉｏｎ：ＡｔｔｅｎｔｉｏｎｓｈｏｕｌｄｂｅｐａｉｄｔＯｓｕｃｈｄｒｕｇｉｎｔｅｒａｃｔｉｏｎｓａｎｄｒａｔｉｏｎａｌｕｓｅｏｆＨｙｐｅｒｉｃｕｍｐｅｒｆｏｒａｔｕｍＬ．．［＇ＫＥＹＷＯＲＤＳ３ＨｙｐｅｒｉｃｕｍｐｅｒｆｏｒａｔｕｍＬ．；ｃｙｔｏｃｈｒｏｍｅＰ－４５０ｅｎｚｙｍｅｓｙｓｔｅｍ；Ｐ－ｇｌｙｃｏｐｒｏｔｅｉｎ；ｄｒｕｇｉｎｔｅｒａｃｔｉｏｎｓ［ＰｈａｒｍＣａｒｅ＆Ｒｅｓ，２００８，８（１）：６３—６５］贯叶连翘（ＨｙｐｅｒｉｃｕｍｐｅｒｆｏｒａｔｕｍＬ．）又名圣约翰草（Ｓｔ．Ｊｏｈｎ’ｓｗｏｒｔ），为藤黄科植物，一直被认为是温和而安全的抗抑郁天然健康产品被广泛使用，成为西欧以及北美国家最畅销的植物药之一。

美国卫生系统药师协会药品不良反应监测及报告指南

１７７１．２．３１．２．１定义ａｎｄＭｏｎｉｔｏｒｉｎｇａｃｔｉｏｎＲｅ— ＤｒｕｇＡｄｖｅｒｓｅｏｎＧｕｉｄｅｌｉｎｅｓ７７—０３Ｍａｒｃｈ，２００９Ｖ０１．６，Ｎｏ．３ＰｈａｒｍａｃｏｖｉｇｉＩａｎｃｅｏｆＪｏｕｒｎａｌＣｈｉｎｅｓｅ２００９年３月第６卷第３期
ቤተ መጻሕፍቲ ባይዱ
１７９（收稿日期：２００８－０７－１６责任编辑赵燕）Ｒｅｐｏｒｔｉｎｇ）ａｎｄＭｏｎｉｔｏｒｉｎｇＲｅａｃｔｉｏｎＤｒｕｇＡｄｖｅｒｓｅｏｎＧｕｉｄｅｌｉｎｅｓ（译自美国卫生系统药师协会ＡＳＨ＿Ｐ患者）。患者进行药物剂量调整（例如肾功能或肝功能损害的数值并保证其在正常的治疗浓度范围内；④为特定的危患者并在其医疗记录中记录；③监测药物血药浓度患者提供ＡＤＲ信息咨询；②鉴别易发生ＡＤＲ的高（２）药师直接向患者提供的服务内容包括：①向重要的ＡＤＲ。（或）生产厂家报告严重ＡＤＲ；⑨向医学界发表或介绍播和使用从ＡＤＲ计划中得到的信息；⑧向ＦＤＡ和内建立、维护和评估ＡＤＲ档案；⑦在医疗机构内传ＡＤＲ计划进行相关内容的宣传教育；⑥在医疗机构医务人员在其中的责任及相互之间的关系；⑤利用明ＡＤＲ计划中药师、医生、护士、风险管理者和其他进药品不良反应监测及报告指南的政策及流程；④说报告；②鉴别易发生ＡＤＲ的高危药物及患者；③改（１）药师应当开展的工作包括：①分析每—份ＡＤＲ部门和风险管理者。来源于医疗人员、护理人员、质量监管人员、医疗记录可和通过。在可能的情况下，指南设计的内容都应该务人员执行委员会”）和机构管理部门得到正式的认通过恰当的委员会（例如“药物和治疗委员会”或“医展、巩固和持续评价中起主导作用，他们的地位应当药师应当在药品不良反应监测及报告指南的发告指南中药师的职责４美国卫生系统药师协会药品不良反应监测及报济上的益处。少医疗机构的纠纷，显示出对ＡＤＲ的防范所带来经（７）通过降低住院率、更好和更经济地用药和减的发现。（６）为使用“药物应用评价计划”提供有质量保证提高他们对ＡＤＲ的认知水平。（５）对医务人员和患者加强药物作用的教育，并（４）衡量ＡＤＲ的发生率。药物的评估。（３）评估药物治疗的安全性，尤其是对近期上市少了医疗机构不必要的纠纷。（２）作为医疗机构风险管理活动及工作的补充，减进行预先监测，间接衡量了医疗机构临床药学的质量。（１）通过发现可防范的ＡＤＲ和对高危药物或患者益，这些效益包括了（但不仅限于）以下方面：为医疗机构、药师、其他医务人员和患者带来实际效不断改进的药品不良反应监测及报告指南能够告指南的效益３美国卫生系统药师协会药品不良反应监测及报促进患者获得好的预后。药品不良反应监测及报告指南的根本目的应是患者的影响。预后和药品不良反应监测及报告指南对整体或个体发生进行宣传教育；④评估处方模式、患者监测、患者势、群发ＡＤＲ及明显的个体ＡＤＲ；③为防范ＡＤＲ的的医护人员进行信息反馈；②持续监测ＡＤＲ的趋动中去。这个过程应当包括以下方面：①向所有合适应当被整合到医疗机构不断持续推进的质量改进活续监测。从药品不良反应监测及报告指南发现的结果（１４）必须对患者的后续结果和ＡＤＲ构成进行持防范和改正的干预措施。报告机制；④回顾总结ＡＤＲ的构成和趋势；⑤建立高大家对ＡＤＲ重要性的认识；③建立ＡＤＲ鉴别与负有以下责任：①为本机构确定ＡＤＲ的定义；②提理小组领导、管理者和药师组成。此小组或委员会应调的ＡＤＲ小组或委员会，建议由医生、护士、质量管（１３）如有可能，在机构中应该设立一个由药房协者隐私。用的多学科综合评价。在整个过程中必须注意保护患Ｍａｒｃｈ．２００９Ｖ０１．６，Ｎｏ．３ＰｈａｒｒｎａｃｏｖｉｇｉｌａｎｃｅｏｆＪｏｕｒｎａｌＣｈｉｎｅｓｅ中国药物警戒２００９年３月第６卷第３期

论药品生产验证总计划(英文版)

Drug Product Manufacturing Validation Master Plan IntroductionThe Drug Product Manufacturing Validation Master Plan outlines the overall strategy for the validation of pharmaceutical manufacturing processes. This document emphasizes the importance of ensuring that drug products are consistently manufactured in accordance with quality standards and regulatory requirements.PurposeThe primary purpose of the Drug Product Manufacturing Validation Master Plan is to establish a comprehensive framework for achieving and maintaining validation of drug manufacturing processes. This plan serves as a roadmap for ensuring the quality, safety, efficacy, and consistency of drug products.ScopeThe scope of this validation master plan includes all aspects of drug product manufacturing, such as equipment qualification, process validation, cleaning validation, and other critical activities. It applies to all drug manufacturing facilities and processes within the organization.ResponsibilitiesThe responsibility for implementing and maintaining the Drug Product Manufacturing Validation Master Plan lies with the Quality Assurance department. The QA department will work closely with manufacturing, engineering, and other relevant departments to ensure compliance with the plan.Validation StrategyThe validation strategy outlined in this master plan is based on international regulatory guidelines, industry best practices, and the company’s quality standards. It includes a risk-based approach to prioritizing and conducting validation activities.Validation ActivitiesEquipment QualificationEquipment qualification is an essential part of the validation process to ensure that manufacturing equipment is properly installed, operational, and capable of consistently producing quality drug products. Qualification activities include designqualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).Process ValidationProcess validation involves the evaluation and confirmation that manufacturing processes are capable of consistently producing drug products that meet predetermined quality attributes. This includes establishing process parameters, conducting process performance qualification (PPQ), and ongoing monitoring and control of the manufacturing process.Cleaning ValidationCleaning validation is necessary to ensure that equipment used in the manufacturing process is thoroughly cleaned to prevent cross-contamination and ensure product quality and safety. This involves developing and executing cleaning procedures, conducting cleaning verification studies, and establishing acceptance criteria.Other Validation ActivitiesIn addition to equipment qualification, process validation, and cleaning validation, the validation master plan includes other critical activities such as computer systems validation, validation of utilities, and validation of analytical methods.Documentation RequirementsProper documentation is essential for validation activities to demonstrate compliance with regulatory requirements and internal quality standards. Documentation requirements include validation protocols, reports, standard operating procedures (SOPs), and records of validation activities.ConclusionThe Drug Product Manufacturing Validation Master Plan provides a structured approach to ensuring the quality and consistency of drug products through comprehensive validation activities. By following this plan, the organization can maintain compliance with regulatory requirements, mitigate risks, and uphold the highest standards of pharmaceutical manufacturing.。

第二代糖肽类抗生素的研究进展_尚新艳

文章编号:1001-8689(2007)05-0263-05第二代糖肽类抗生素的研究进展尚新艳1　阮丽军2,3　许激扬1,*　陈代杰2,3 (1中国药科大学生命科学与技术学院,　南京210009;2上海医药工业研究院,　上海200040;3上海来益生物药物研究开发中心,　上海201203) 摘要:　随着细菌耐药的不断升级,耐万古霉素肠球菌、高度耐糖肽类抗生素的金葡菌的出现,给临床抗感染治疗带来极大困难。

开发新型糖肽类抗生素刻不容缓。

人们对万古霉素等天然糖肽类抗生素进行化学修饰,得到了一系列有价值的衍生物,其中oritavancin 、dalbav ancin 和telavancin 已进入Ⅲ期临床和新药注册。

本文对第二代糖肽类抗生素的结构特征、药效学与药动学特征以及临床应用作一综述。

关键词:　第二代糖肽类抗生素;　O ritav ancin;　Dalbavancin;　T elav ancin 中图分类号:R978.1 文献标识码:AAdvance of research on the second generation of glycopeptide antibioticsShang Xin-y an 1,　Ruan Li-jun 2,3　Xu Ji-yang 1　and Chen Dai-jie 2,3 (1Depar tment o f Biological Science and Biotechnolo gy ,China Pharmaceutical U niversity ,Nanjing 210009;2Shang hai Institute of Phar macuetical Indust ry ,　Shang hai 200040;3Health Cr eat ion Center for Biopharm aceutical R&D,　Shang hai 201203) ABSTRACT Developm ent of resistance to antibacterial agents,especially the advent of vancomy cin-resistant Enterococcus (VRE)and glycopeptide-resistant Stap hy lococcus aureus (GRSA)is a mounting problem that continues to compromise the clinical effectiveness of anti -infectious drugs .It is essential to develop new glycopeptide antibi-otics .Three of these new derivatives obtained by sem i -synthesis starting from natural compounds ,are now in clinical development (oritavancin and telavancin,as derivatives of vancom ycin;and dalbavancin,as a derivative of te-icoplanin).T he review focuses on the structures,pharmacokinetic and pharmacody namic parameters and the clinical research status related to the second -generation glycopeptide antibiotics .KEY WORDS The second-generation g lycopeptide antibiotics;　Oritavancin;　Dalbavancin;　T elavancin 收稿日期:2006-03-14 修回日期:2006-07-12作者简介:尚新艳,女,生于1979年,在读硕士研究生。

围手术期羟考酮临床应用进展

China &Foreign Medical Treatment中外医疗疼痛被医学界界定为继呼吸、脉搏、体温、血压之后的第五大生命体征。

术后疼痛是由机体组织损伤导致的伤害性刺激为主的急性疼痛。

严重的术后疼痛可导致一系列并发症,降低患者的生存质量,影响患者术后恢复,延长住院时间。

且这种急性疼痛若控制不佳,常因患者的心理精神改变、外周及中枢敏化等作用而转变为慢性疼痛。

因此,对有效的术后镇痛研究一直是大家关注的焦点。

目前临床上使用的镇痛药物繁多,有纯阿片受体激动剂如吗啡、芬太尼、瑞芬太尼等,部分阿片受体激动拮抗剂布托啡诺、地佐辛等,弱阿片受体激动剂曲马多,非阿片类药物,如非甾体类抗炎药(NSAIDs)、对乙酰氨基酚、局麻药、糖皮质激素、NMDA 受体拮抗剂、α2受体激动剂等。

盐酸羟考酮是一种强阿片类镇痛药,为纯阿片受体激动剂,用于治疗中度至重度急性疼痛,包括手术后引起的中度至重度疼痛。

因其不良反应低,镇痛效果好,安全剂量范围大等优势,在许多国家已取代吗啡成为一线的术后镇痛药物。

由于在国内上市时间短,因此其临床应用经验尚有不足。

该研究就其药理作用、临床应用及安全性等综述如下。

1羟考酮的药理学特性盐酸羟考酮为阿片类生物碱的半合成蒂巴因衍生物,药理作用和作用机制类似于吗啡,为纯阿片μ和κ受体激动药,主要作用部位为中枢神经系统和内脏平滑肌。

其代谢产物中,羟吗啡酮(对μ受体具有更强的亲和力,总镇痛效应是吗啡的8.7倍,峰值镇痛效应是吗啡的13倍)与μ受体的亲和力是羟考酮的10~40倍,但因其脂溶性低于羟考酮,限制了它通过血脑屏障作用于中[作者简介]陈炳权(1986-),男,浙江杭州人,硕士,医师,主要从事麻醉方面的工作。

围手术期羟考酮临床应用进展陈炳权浙江大学医学院附属第一医院麻醉科,浙江杭州310000[摘要]良好的术后镇痛能明显减轻手术创伤引起的剧烈疼痛,降低术后并发症的发生以及提高医疗质量。

盐酸羟考酮是阿片类生物碱的半合成蒂巴因衍生物,为纯阿片μ和κ受体激动药,主要作用部位为中枢神经系统和内脏平滑肌。

ICH 安全性领域常用专业术语中英文对照表()

ICH 安全性领域常用专业术语中英文对照表S9-mix constituent S9混合液成分Safeguards 安全监测Safety pharmacology 安全药理学Safety margin 安全范围Salmonella typhimurium 鼠伤寒沙门菌Sampling time 采样时间Satellite groups 卫星组Saturation of absorption 吸收饱和Secondary testing 二期试验Secretion in milk 乳汁分泌Sensitive periods 敏感期Sensitivity 敏感性Sensory functions and reflexes 感觉功能和反射Sexual maturity 性成熟Short term toxicity 短期毒性Short or medium-term carcinogenicity study 短或中期致癌性研究Short treatment 短期处理Sighting studies 预试验Single dose(acute)toxicity 单剂量(急性)毒性Single study design 单一研究设计Site-specific targeted delivery 定位靶向释放Small colony 小集落Small colony mutant 小集落突变体Soft agar method 软琼脂法Soluble genotoxic impurity 可溶性遗传毒性杂质Solvent control 溶剂对照Somatic cell 体细胞Somatic cell test 体细胞试验Species 种属Specificity 特异性Species specificity 种属特异性Sperm analysis 精子分析Sperm count 精子计数Sperm maturation 精子成熟Sperm morphology 精子形态学Sperm motility 精子活动度Sperm viability 精子活力Spermatogenesis 精子形成Spindle apparatus 纺缍体Stages of reproduction 生殖阶段Standard battery of test 标准试验组合Standard 3-test battery 标准三项试验组合Standard battery 标准组合Standard battery system 标准组合系统Standard procedure 标准规程Standard protocol 标准试验方案Standard set of strains 标准菌株组Standard set of tests 标准试验组Standard test battery 标准试验组合Statistical evaluation 统计学评价Steady-state levels 稳态浓度Step-by-step 逐步Stepwise process 阶梯式程序Strain 品系Structural changes 结构改变Structural chromosomal aberration 染色体结构畸变Subgroups 亚组Supravital staining 体外活动染色Surface righting reflex 平面翻正反射Survival 存活率suspension 悬浮物Systemic exposure 全面接触Target organs 靶器官Target cell 靶细胞Target histidine genes 组氨酸目的基因Target tissue 靶组织Target tissue exposure 靶组织接触Teratogenic response 致畸胎反应Terminal sacrifice 终末期处死Test of carcinogenicity 致癌试验Test approach 试验方法Test battery approach 试验组合方法Test compound 受试物Test model 试验模型Test strategy 试验策略Test systems 试验系统Tester strain 试验菌株Therapeutic 治疗Therapeutic confirmatory 疗效确定Therapeutic exploratory 疗效探索Therapeutic indication 治疗适应证Time course 时程Timing conventions 分段计时方法Tissue cross-reactivity 组织交叉反应Tissue distribution 组织分布Tissue exposure 组织接触Tissue uptake 组织吸收Tk locus tk位点Top concentration 最高浓度Topical 局部的Topoisomerase inhibitor 拓朴异构酶抑制剂Total erythrocyte 总红细胞Total litter loss 整窝丢失Toxicity to reproduction 生殖毒性Toxicokinetics 毒代动力学(毒物代谢动力学) Transgene 转基因Transgenic animals 转基因动物Transgenic plants 转基因植物Translocation 移位Treatment regimen 实施方案Tubal transport 输卵管运输Tumor induction 肿瘤诱导Tumor response 肿瘤反应Tumor-related gene 肿瘤相关基因Two or three phase approach 分段(二段或三段)研究Two study design 分段(两段)研究设计Ovulation rate 排卵率Unbound concentration 未结合浓度Unexpected finding 非预期结果Unscheduled DNA synthesis(UDS) 程序外DNA合成Unstable epoxide 不稳定过氧代物Vaginal opening 阴道张开Vaginal plug 阴栓Whole blood 全血Dead offspring at birth 出生时死亡的子代Degradation 降解Delay of parturition 分娩延迟Deletion 缺失Descriptive statistics 描述性统计Detection of bacterial mutagen 细菌诱变剂检测Detection of clastogen 染色体断裂剂检测Determination of metabolites 测定代谢产物Development of the offspring 子代发育Developmental toxicity 发育毒性Diminution of the background lawn 背景减少Direct genetic damage 直接遗传损伤Distribution 分布DNA adduct DNA加合物DNA damage DNA损伤DNA repair DNA修复DNA strand breaks DNA链断裂Dose escalation 剂量递增Dose dependence 剂量依赖关系Dose level 剂量水平Dose-limiting toxicity 剂量限制性毒性Dose-raging studies 剂量范围研究Dose-relatived mutagenicity 剂量相关性诱变性Dose-related 剂量相关Dose-relatived cytotoxicity 剂量相关性细胞毒性Dose-relatived genotoxic activity 剂量相关性遗传毒性Dose-response curve 剂量-反应曲线Dosing route 给药途径Duration 周期Duration of pregnancy 妊娠周期Eaning 断奶Earlier physical malformation 早期躯体畸形Early embryonic development 早期胚胎发育Early embryonic development to implantation 着床早期的胚胎发育Electro ejaculation 电射精Elimination 清除Embryofetal deaths 胚胎和胎仔死亡Embryo-fetal development 胚胎-胎仔发育Embryo-fetal toxicity 胚胎-胎仔毒性Embryonic death 胚胎死亡Embryonic development 胚胎发育Embryonic period 胚胎期Embryos 胚胎Embryotoxicity 胚胎毒性Enantiomer 对映异构体End of pregnancy 怀孕终止Endocytic 内吞噬(胞饮)Endocytic activity 内吞噬活性Endogenous proteins 内源性蛋白Endogenous components 内源性物质Endogenous gene 内源性基因Endonuclease 核酸内切酶Emdpmiclease release from lysosomes 溶酶体释放核酸内切酶End-point 终点Epididymal sperm maturation 附睾精子成熟性Epitope 抗原决定部位Error prone repair 易错性修复Escalation 递增Escherichia coli strain 大肠杆菌菌株Escherichia coli 大肠杆菌Evaluation of test result 试验结果评价Exaggerated pharmacological response 超常增强的药理作用Excretion 排泄(清除)Exposure assessment 接触剂量评价Exposure period 接解期External metabolizing system 体外代谢系统F1-animals 子一代动物False positive result 假阳性结果Fecundity 多产Feed-back 反馈Fertilisation 受精Fertility 生育力Fertility studies 生育力研究Fetal abnormalities 胎仔异常Fetal and neonatal parameters 胎仔和仔鼠的生长发育参数Fetal development and growth 肿仔发育和生长Fetal period 胎仔期Fetotoxicity 胎仔毒性False negative result 假阴性结果First pass testing 一期试验Fluorescence in situ hybridization(FISH) 原位荧光分子杂交Foetuses 胎仔Formulation 制剂Frameshift mutation 移码突变Frameshite point mutation 移码点突变Free-standing 独立Fresh dissection technique 新鲜切片技术Funtional deficits 切能缺陷Functional test 功能试验Functional indices 功能性指标Fusion proteins 融合蛋白Gametes 配子Gender of animals 动物性别Gender-specific drug 性别专一性药物Gene knockout 基因剔除Gene therapy 基因治疗Gene mutation 基因突变Genetic 遗传Genetic change 遗传学改变Genetic damage 遗传学损伤Genetic endpoint 遗传终点Genetic toxicity 遗传毒性Genotoxic activity 遗传毒性作用Genotoxic carcinogen 遗传毒性致癌剂Genotoxic effect 遗传毒性效应Genotoxic hazard 遗传毒性危害Genotoxic potential 潜在遗传毒性Genotoxic rodent carcinogen 啮齿类动物遗传毒性致癌剂Genotoxicity 遗传毒性Genotoxicity test 遗传毒性试验Genotoxicity test battery 毒性试验组合Genotoxycity evaluation 遗传毒性评价Germ cell mutagen 生殖细胞诱变剂Germ line mutation 生殖系统突变GLP 临床前研究质量管理规范Gross chromosomal damage 染色体大损伤Gross evaluation of placenta 胎盘的大体评价Growth factors 生长因子Haemotoxylin staining 苏木素染色Half-life 半衰期Hematopoietic cells 造血细胞Heptachlor 七氯化合物Heritable 遗传Heritable defect 遗传缺陷Heritable disease 遗传性疾病Heritable effect 遗传效应High concentration 高浓度Histologic appearance of reproductive organ 生殖器官的组织学表现Histopathological chang 组织病理学改变Homologous proteins 同系蛋白Homologous series 同系Host cell 宿主细胞Human subjects 人体Human carcinogen 人类致癌剂Human lymphoblastoid TH6cell 人成淋巴TK6细胞Human mutagen 人类致突变剂Humoral immunity 体液免疫Immature erythrocyte 未成熟红细胞Immediate and latent effect 速发和迟发效应Immunogenicity 免疫原性Immunopathological effects 免疫病理反应immunotoxicity 免疫毒性Implantation 着床Implantation sites 着床部位In vitro 体外In vitro test 体外试验In vivo 体内In vivo test 体风试验Incidence of polyploidy cell 多倍体细胞发生率Incisor eruption 门齿萌发Independent test 独立试验Individual fetal body weight 单个胎仔体重Induced and spontaneous models of disease 诱发或自发的疾病模型Inducer of micronuclei 微核诱导剂Inhalation 吸入Inhibitor of DNA metabolism DNA代谢抑制剂Intact animals 完整动物(整体动物)Internal control 内对照Interphase nuclei 分裂间期细胞核Intra-and inter-individual 个体与个体间Isolated organs 离休器官Juvenile animal studies 未成年动物研究Kinetic profile 动力学特点Kinetics 动力学Lactation 授乳、哺乳Large deletion event 大缺失事件Late embryo loss 后期胚胎丢失Level of safety 安全水平Libido 性欲Life threatering 危及生命Lipophilic compound 亲脂性化合物Litter size 每窝胎仔数目Live and deal conceptuese 活胎和死胎Live offspring at birth 出生时存活的子代Local tolerance studies 局部耐受性研究Local toxicity 局部毒性Locu 位点Long-term carcinogenicity study 长期致癌性研究Loss of the tk gene tk基因缺失Major organ formation 主要器官形成Male fertility 雄性生育力Male fertility assessment 雄性生育力评价Mammalian sells 哺乳动物细胞Mammalian species 哺乳类动物Mammalian sell mutation test 哺乳动物细胞致突变试验Marketing approval 上市许可Maternal animal 亲代动物Mating behavior 交配行为Mating period 交配期Mating ratio 交配比例Matrices 基质Maximum tolerated dose(MTD) 最大耐受剂量Mechanism of genotoxicity 遗传毒性机制Mechanistic investigation 机制研究Metabolic activation 代谢活化Metabolic activation pathway 代谢活化途径Metabolic activation system 代谢活化系统Metabolism 代谢Metabolites profile 代谢物的概况Metaphase 中期Metaphase analysis 分裂中期相分析Metaphase cell 分裂中期相细胞Micronucleus 微核Micronucleus formation 微核形成Microtitre 微滴定Mictotitre method 微滴定法mimicking 模拟Mitotic index 有丝分裂指数Molecular characterization 分子特性Molecular technique 分子技术Monitor 监测Monoclonal antibodies 单克隆抗体Non-toxic compound 无毒化合物Mouse lymphoma L5178Y cell 小鼠淋巴瘤L5178Y细胞Mouse lymphoma tk assay 小鼠淋巴溜tk检测Mutagen 诱变原Mutagenic carcinogen 诱变性致癌剂Mutagenic potential of chemical 化合物的潜在致突变性Mutant colony 突变体集落Mutation 突变Mutation induction in transgenes 转基因诱导突变Naked eye 肉眼Necropsy(macroscopic examination) 解剖(大体检查)Negative control 阴性对照Negative result 阴性结果Neonate adaptation to extrauterine life 新生仔宫外生活的适应性Newborn 新生仔Newcleated 有核Non rodent 非啮齿类Non-clinical 非临床Non-genotoxic carcinogen 非遗传毒性致癌剂Non-genotoxic mechanism 非遗传毒性机制Non-human primate 非人灵长类Non-linear 非线性No-toxic-effect dose level 无毒性反应剂量水平Nucleated bone marrow cell 有核骨髓细胞Nucleoside analogue 核苷酸同系物Number of live and dead implantation 宫内活胎和死胎数Numerical chromosomal aberration 染色体数目畸变Numerical chromosome changes 染色体数目改变Oestrous cycle 动情周期Oligonucleotide grugs 寡核苷酸药物One ,twe,three generation studies 一、二、三子代研究Organ development 器官发育Paraffine embedding 石蜡包埋Parameter 参数Parent compound 母体化合物Parenteral 非肠道Particulate material 颗粒物Parturition 分娩Pediatric populations 小儿人群Peproductive competence 生殖能力Peripheral blood erythrocyte 外周血红细胞Pharmacodynamic effects 药效作用Pharmacodynamics 药效学(药效动力学) Pharmacokinetic 药代动力学Phenylene diamine 苯二胺Physical development 身体发育Physiological stress 生理应激Pilot studies 前期研究Pinna unfolding 耳廓张开Plasmid 质粒Plasminogen activators 纤维蛋白溶解酶原激活因子Ploidy 整倍体Point mutation 点突变Polychromatic erythrocyte 嗜多染色红细胞Polycyclic hydrocarbon 多环芳烃Polymer 聚合物Polyploidy cell 多倍体细胞Polyploidy 多倍体Polyploidy induction 多倍体诱导Poorly soluble compound 难溶化合物Positive control 阳性对照Positive result 阳性结果Post meiotic stages 减数分裂后期Post-approval 批准后Postcoital time frame 交配后日期Postimplantation deaths 着床后死亡Postnatal deaths 出生后死亡Postweaning development and growth 断奶后发育和生长Potential 潜在性Potential immunogenecity 潜在免疫原性Potential target organs for toxicity 潜在毒性靶器官Pre-and post-natal development study 围产期的发育研究Pre-and postweaning survival and growth 断奶前后的存少和生长Precipitate 沉淀期Precision 精密度Preclinical safety evaluation 临床前安全性评价Predetermined criteria 预定标准Prediction of carcinogenicity 致癌性预测Pregnant 怀孕Pregnant and lactation animals 怀孕与哺乳期动物Preimplantation stages of the embryo 胚胎着床前期Preimplantation development 着床前发育Preliminary studies 预试验Premating 交配前Premating treatment 交配前给药Pre-screening 预筛选Prevalence of abnormalities 异常情况的普遍程度Preweaning 断奶前Primary active entity 主要活性实体Priority selection 优先选择Pro-drug 前体药物Prolongation of parturition 产程延长Protein binding 蛋白结合率Protocol modification 试验方案修改Quantification of mutant 突变体定量Racemate 消旋体Radiolabeled proteins 放射性同位素标记蛋白Radiolabelled compounds 放性性同位素标记化合物Range-finding test 范围确定试验Rate of preimplantation deaths 着床关死亡率Rational study design 合理的试验设计Receptor properties 受体性质Recombinant DNA proteins DNA重组蛋白Recombinant DNA technology DNA重组技术Recombination 重组Recombinant plasma factors 重组血浆因子Reduction in the number of revertants 回复突变数的减少Relative plating efficiency 相对接种效率Relative suspension growth 相对悬浮生长率Relative total growth 相对总生长率Relevant animal species 相关动物种属Relevant dose 相关剂量Relevant factor 相关因素Repeated-dose toxicity studies 重复剂量毒性研究Reproductive function 生殖功能Reproductive toxicity 生殖毒性Reproductive/developmental toxicity 生殖/发育毒性Reverse mutation 回复突变Reversibility 可恢复性(可逆性)Risk assessment 危险度评价Rodent 啮齿类动物Rodent hematopoietic cell 啮齿类动物造血细胞Route of administration 给药途径Routine testing 常规试验S9-mix constituent S9混合液成分Safeguards 安全监测Safety pharmacology 安全药理学Safety margin 安全范围Salmonella typhimurium 鼠伤寒沙门菌Sampling time 采样时间Satellite groups 卫星组Saturation of absorption 吸收饱和Secondary testing 二期试验Secretion in milk 乳汁分泌Sensitive periods 敏感期Sensitivity 敏感性Sensory functions and reflexes 感觉功能和反射Sexual maturity 性成熟Short term toxicity 短期毒性Short or medium-term carcinogenicity study 短或中期致癌性研究Short treatment 短期处理Sighting studies 预试验Single dose(acute)toxicity 单剂量(急性)毒性Single study design 单一研究设计Site-specific targeted delivery 定位靶向释放Small colony 小集落Small colony mutant 小集落突变体Soft agar method 软琼脂法Soluble genotoxic impurity 可溶性遗传毒性杂质Solvent control 溶剂对照Somatic cell 体细胞Somatic cell test 体细胞试验Species 种属Specificity 特异性Species specificity 种属特异性Sperm analysis 精子分析Sperm count 精子计数Sperm maturation 精子成熟Sperm morphology 精子形态学Sperm motility 精子活动度Sperm viability 精子活力Spermatogenesis 精子形成Spindle apparatus 纺缍体Stages of reproduction 生殖阶段Standard battery of test 标准试验组合Standard 3-test battery 标准三项试验组合Standard battery 标准组合Standard battery system 标准组合系统Standard procedure 标准规程Standard protocol 标准试验方案Standard set of strains 标准菌株组Standard set of tests 标准试验组Standard test battery 标准试验组合Statistical evaluation 统计学评价Steady-state levels 稳态浓度Step-by-step 逐步Stepwise process 阶梯式程序Strain 品系Structural changes 结构改变Structural chromosomal aberration 染色体结构畸变Subgroups 亚组Supravital staining 体外活动染色Surface righting reflex 平面翻正反射Survival 存活率suspension 悬浮物Systemic exposure 全面接触Target organs 靶器官Target cell 靶细胞Target histidine genes 组氨酸目的基因Target tissue 靶组织Target tissue exposure 靶组织接触Teratogenic response 致畸胎反应Terminal sacrifice 终末期处死Test of carcinogenicity 致癌试验Test approach 试验方法Test battery approach 试验组合方法Test compound 受试物Test model 试验模型Test strategy 试验策略Test systems 试验系统Tester strain 试验菌株Therapeutic 治疗Therapeutic confirmatory 疗效确定Therapeutic exploratory 疗效探索Therapeutic indication 治疗适应证Time course 时程Timing conventions 分段计时方法Tissue cross-reactivity 组织交叉反应Tissue distribution 组织分布Tissue exposure 组织接触Tissue uptake 组织吸收Tk locus tk位点Top concentration 最高浓度Topical 局部的Topoisomerase inhibitor 拓朴异构酶抑制剂Total erythrocyte 总红细胞Total litter loss 整窝丢失Toxicity to reproduction 生殖毒性Toxicokinetics 毒代动力学(毒物代谢动力学) Transgene 转基因Transgenic animals 转基因动物Transgenic plants 转基因植物Translocation 移位Treatment regimen 实施方案Tubal transport 输卵管运输Tumor induction 肿瘤诱导Tumor response 肿瘤反应Tumor-related gene 肿瘤相关基因Two or three phase approach 分段(二段或三段)研究Two study design 分段(两段)研究设计Ovulation rate 排卵率Unbound concentration 未结合浓度Unexpected finding 非预期结果Unscheduled DNA synthesis(UDS) 程序外DNA合成Unstable epoxide 不稳定过氧代物Vaginal opening 阴道张开Vaginal plug 阴栓Whole blood 全血。

医药常用英文名词验证

医药常用英文名词验证Common Medical Terms in English.The medical field is vast and ever-evolving, encompassing a wide range of specialties and treatments. With this complexity comes a terminology that can be both intimidating and essential to understand. Below is a compilation of commonly used medical terms in English, including those related to pharmacology, anatomy, physiology, and other key areas of medicine.Pharmacology:1. Drug: A chemical substance used to diagnose, treat, prevent, or relieve symptoms of a disease or condition.2. Antibiotic: A drug used to kill or slow the growth of bacteria.3. Analgesic: A drug used to relieve pain.4. Antidepressant: A drug used to treat depression.5. Antihistamine: A drug used to treat allergies by blocking the effects of histamine.6. Antipsychotic: A drug used to treat psychotic disorders such as schizophrenia.7. Anticonvulsant: A drug used to prevent or control seizures.8. Cardiovascular Drug: A drug used to treat conditions affecting the heart and blood vessels.Anatomy:1. Anatomy: The study of the structure of the human body.2. Organ: A group of tissues that perform a specific function in the body.3. Bone: The hard tissue that gives shape and structure to the body.4. Muscle: Tissue that contracts to produce movement in the body.5. Nerve: A fiber that carries signals between the brain, spinal cord, and the rest of the body.6. Blood Vessel: A tube that carries blood throughout the body.7. Heart: A muscular pump that circulates blood throughout the body.8. Lung: An organ that allows the exchange of oxygen and carbon dioxide between the blood and the air.Physiology:1. Physiology: The study of the functions and processesof the human body.2. Metabolism: The chemical reactions that occur in the body to maintain life, including the conversion of foodinto energy.3. Hormone: A chemical messenger produced by glandsthat regulates various body functions.4. Immune System: The body's defense mechanism against disease and infection.5. Nervous System: The system that controls movement, sensation, and response to stimuli.6. Cardiovascular System: The system that pumps blood throughout the body, supplying oxygen and nutrients to cells.7. Respiratory System: The system that allows the body to breathe, exchanging oxygen and carbon dioxide between the blood and the air.Other Key Terms:1. Diagnosis: The process of determining the nature and cause of a disease or condition.2. Treatment: The actions taken to cure, relieve, or manage a disease or condition.3. Symptom: A physical or mental indication of a disease or condition.4. Side Effect: An unwanted or unintended effect of a drug or treatment.5. Prevention: Measures taken to avoid the occurrence or recurrence of a disease or condition.6. Prognosis: The predicted course and outcome of a disease or condition.In conclusion, the medical field is rich withterminology that is essential for accurate communication and effective treatment. Understanding these terms can help patients, caregivers, and healthcare providers alike navigate the complexities of medicine and achieve better health outcomes.。

生物制药相关英文词汇

生物制药专业英语词汇手册Aabsolute lethal dose; LD100绝对致死剂量absorption rate constant吸收速率常数accelerated testing加速试验acetylcholinesterase乙酰胆碱酯酶acetylcholine乙酰胆碱acrylic acid resin丙烯酸树酯activation激活作用activator激活剂active targeting preparation主动靶向制剂acute toxicity test急性毒性实验additive effect累加效应additive附加剂adenosine phosphate腺苷磷酸adhersive strength粘附力adhesion粘附性adhesives粘合剂adjuvant佐剂adrenergic nerve肾上腺素能神经adrenergic receptor肾上腺素能受体adverse reaction不良反应aerogel气凝胶aerosil微粉硅胶aerosol of micropowders for inspiration 吸入粉雾剂aethylis oleas油酸乙酯agglomerate聚结物aggregation聚集air suspension空气悬浮法albumin microballoons白蛋白微球制剂alkaloid生物碱alkalosis;alkali-poisoning碱中毒allergy; allergic reaction变态反应allotted date of drug quality ensuring by manufacturer药品负责期all-trans全反式alterntae addition method两相交替加入法amebocyte lysate变形细胞溶解物amorphous forms无定型anaphylactic drug reaction过敏性药物反应anaphylatoxin过敏毒素anatoxin;toxoid类毒素angle of repose休止角antagonism拮抗作用antiadherent抗粘剂antibacterial spectrum抗菌谱antibody抗体antigen抗原antioxidants抗氧剂antipode对映体antisepesis防腐antiserum抗血清antitoxin抗毒素apparent solubility表现溶解度aprotinin抑酞酶aromatic pound芳族化合物aromatic waters芳香水剂Arrhenius 方程阿仑尼乌斯方程artificial antigen人工合成抗原artificial immunization人工免疫aseptic technique无菌操作法astringent收敛药autoimmunity自身免疫Bbactericidal activity杀菌活性bactericidal effect杀菌作用bacteriophage噬菌体bacteriostatic activity抑菌活性bactriostasis抑菌作用ball mill球磨机base adsorption基质吸附率bases基质beeswax蜂蜡bending弯曲力bioavailability生物利用度bioavailability生物利用度biochemical approach生物学方法biochemistry生物化学biogenic amine生物胺biological half life生物半衰期biological product生物制品biometrics;biometry生物统计学biopharmacy生物药剂学blood coagulation血液凝固blood concentration血药浓度blood products血液制品blood volume expander血容量扩充剂blood-cerebral barrier血脑屏障body fluid体液body surface area体表面积bound water结合水分breakage (Bk)脆碎度broad-spectrum antibiotic广谱抗生素bulk density松密度、堆密度burst effect突释效应Ccaking结饼capillary state毛细管状capsules胶囊剂carcinogenic test致癌实验carcinogen致癌物carrier载体catecholamine儿茶酚胺CD圆二色谱法cellular immunity细胞免疫cellulose acetate (CA)醋酸纤维素chelating agent螯合剂chemical analysis化学分析chemical disinfection化学消毒法chemical physics化学物理学chemotherapy化学药物治疗chewable tablets咀嚼片chiral drug手性药物Chitosan壳聚糖chlinical pharmacy临床药学cholinesterase胆碱酯酶chronaxia;chronaxy时值chronic toxicity test; long term toxicity test慢性毒性实验chronopathology时辰病理学chronopharmacology时辰药理学chronosusceptability时间感受性chronotherapy时间治疗cipher prescription协定处方Clausius-Clapeyron方程克劳修斯－克拉珀龙方程clinical pharmaceutics临床药剂学clinical pharmacology临床药理学cloud point对聚氧乙烯型非离子表面活性剂CMC-Na羧甲基纤维素纳CMS-Na羧甲基淀粉钠coagulation聚沉coated tablets包衣片coating material表材cocoa butter可可豆脂coefficient of diffusion扩散系数coenzyme辅酶cohesion凝聚性、粘着性cohesive strength聚力cold pression method汽压法cold-homogenization冷却一匀化法cold-storage冷藏colon-targeted capsules结肠靶向胶囊剂pactibility成形性plement system补体系统plement补体plete antigen完全抗原plex coacervation复凝聚法plex solubilizer助溶剂pliance顺应性pressed tablets普通片pressibility压缩度pressibility压缩性pression压缩力pressive work压缩功concentration浓度cone and plate viseter圆椎平板粘度计consistency curve稠度曲线content uniformity含量均匀度controllability可控性controlled release preparation控释制剂controlled release tablets控释片controlled-release preparation 控释制剂convective mixing对流混合convective transport传递透过coordination number配位数core material表心物cosolvency潜溶cosolvent潜溶剂coulter counter method库尔特计数法count basis个数基准covalent bond共价键cracemization外消旋作用critical relative humidity（CRH）临界相对湿度critical velocity临界速度crude drugs; natural drugs天然药物crude drugs生药crushing粉碎crystal form晶型crystal habit晶态、晶癖、结晶习性cumulative size distribution 累积分布cumulative urinary excretion curves累积尿排泄曲线cutting剪切力cyclodextrin (CYD)环糊精cylinder model圆栓体模型cytotoxic hexitols己糖醇细胞毒剂cytotoxicity细胞素Ddecoction汤剂degree of circularity圆形度degree of sphericility球形度delipidization角质层去脂质化desiccant; drying agent干燥剂detoxication解毒作用dextrin糊精dextrorotatory form右旋体dextrose右旋糖dialysis cell method渗析池法dicetyl phosphate磷酸二鲸蜡脂dielectric constant介电常数differential scanning calorimetry DSC差示扫描显热法Differential thermal analysis DTA差示热分析法diffusion扩散diffusive mixing扩散混合dilatant flow胀性流动diluents稀释剂、填充剂dimethicone (silicones)二甲基硅油、硅油、硅酮directed pharmaceutical preparations定向药物制剂discontinuous sterilization间歇灭菌法disinfection消毒disintegrants崩解剂disintegration崩解度disk assemble method圆盘法dispensing pharmacy调剂学disperse medium分散介质disperse phase分散相disperse system分散体系dispersed phase分散相、相、非连续相dispersible tablets分散片displacement value (DV)置换价dissolution; dissolving溶解distilled water蒸馏水DLVO理论引力势能与斥力势能DME二甲醚DMSO二甲基亚矾dosage form剂型dosage regimen or dose rate给药方案或给药速度dosage; dose剂量dose or concentration dependency剂量或浓度的依存性dosing interval给药间隔double-blind technique双盲法drop dentifrices滴牙剂drug absorption药物吸收drug accumulation药物蓄积drug administration law药品管理法drug batch number药品批号drug carrier药物载体drug bination合并用药drug distribution药物分布drug elimination药物消除drug excretion药物排泄drug interaction药物相互作用drug metablic enzyme药物代酶drug metabolism药物代drug reaction药物反应drug sensitive test药敏试验Drug Standard of Ministry of Public Health of the People's Republic of China中华人民国卫生部药品标准drug standard药品质量标准drug tolerance耐药性drug-induced diseases药源性疾病drug-loading rate载药量drug-time curve药—时曲线dry bulb temperature干球温度dumping effect突释效应Eear drops滴耳剂effective concentration有效浓度effective halt有效半衰期effective rate有效率effectiveness有效性effector效应器effector效应物effect效应effervescent disintegrants泡腾崩解剂effervescent tablets泡腾片elastic deformation弹性变形elastic recovery (E R)弹性复原率elastic work弹性功elasticity弹性electrolyte电解质electrolyzation电解electroporesis电致孔法electuary煎膏剂elimination rate constant消除速率常数emulsifer in water method 水中乳化剂法、湿胶法emulsifier in oil method油中乳化剂法、干胶法emulsions乳剂emulsion普通乳enamine烯胺endocytosis呑endotoxin毒素enteric coated tablets肠溶衣片enteric coating肠溶衣enteric controlled release tablets肠溶控释片enterohepatic circulation肠肝循环entrapment rate包封率environmental pharmacology环境药理学epidermis表皮epimerization差向异构作用equilibrium solubility平衡溶解度equilibrium water平分essential aminoacid必需氨基酸essential drugs基本药物essential fatty acid必需脂肪酸ethical (prescription) drug处方药ethnopharmacology人种药理学ethycellulose (EC)乙基纤维素etiological treatment对因治疗evaporation蒸发excipients辅料excitability兴奋性exotoxin外毒素expiry date; date of expiration药品有效期external phase分散介质、外相、连续相extracts浸膏剂extravascular administration血管外给药eye drop滴眼剂eye ointments眼膏剂Ffactorial design析因设计fatal dose; lethal dose致死量fatty oils脂肪油fermentation发酵fillers填充剂film coated tablets薄膜衣片film dispersion method薄分散法film-coating薄膜衣films膜剂filter aid助滤剂filtration过滤first pass effect of hepar肝首过效应first-pass effect首过效应fliud extracts流浸膏剂flocculation value絮凝度flocculation絮凝flow curve流动曲线flow velocity流出速度flowability流动性fluid-energy mills流能磨、气流式粉碎机fluidity buffer流动性缓冲剂fluidized bed coating流化床包衣法free water自由水分freely movable liquid自由流动液体freezing; refrigeration冷冻frequency size distribution 频率分布funicular state索带状fusion融合Ggas analysis气体分析gas permeability method气体透过法GCP药物临床试验管理规gelatin glycerin甘油胫胶gelatinization糊化gelatin明胶general acid-base catalysis广义酸碱催化Geneva nomenclature日瓦命名法geometric diameter几何学粒子径geometric isomerization几何异构ghost cell影细胞glidants助流剂GLP药物非临床研究管理规gluconeogenesis糖异生作用glycerins甘油剂glyceryl monostearate硬脂酸、甘油酯glycolic acid羟基乙酸glycolysis酵解GMP药品生产质量管理规granule density颗粒密度granules颗粒剂growth curve生长曲线guest molecules客分子Hhalf lethal dose ; median lethal dose; LD50半数致死剂量half-life period; half life time半衰期halogenide卤化物haptene半抗原hard capsules硬胶囊剂hardness硬度hemolysis溶血histamine组胺holonzyme and prosthetic group全酶与辅基hormone激素host molecules主分子humidity湿度humoral immunity体液免疫hydration of stratum corneum 角质层的水化作用hydrogel水性凝胶hydrolysis水解（作用）hydrophile-lipophile balance 亲水亲油平衡值hydrotropy agent助溶剂hydrotropy助溶hydroxypropyl methylcellulose羟丙甲纤维素hygroscopicity吸湿性hyperreactivity高敏性hypodermic tablets皮下注射用片IIDDS植入给药系统IEC离子交换色谱法IEF等电点聚焦immobile liquid不可流动液体immunoenhancement免疫增强剂immunogenicity免疫原性immunosuppressant;immuno inhibitor免疫抑制剂impact mill冲击式粉碎机impact冲击力implant tablets植入片implants埋植剂inclusion pound包含物inplete antigen不完全抗原indirect carcinogenesis间接致癌individual differences; individual variation个体差异性industrial pharmacy工业药剂学infusion solution输液inhalation吸入法injection注射液in-liquid drying液中干燥法（乳化－溶剂挥发法）innocuity test method安全试验法interface polycondensation 界面缩聚法intermediate中间体intoxication; poisoning中毒intra-arterial route动脉注射intracorporal process of drugs药物的体过程intradermal (ID) route皮注射intramuscular (IM) route肌肉注射intrathecal injection鞘注射intravascular administration血管给药intravenous (IV) route静脉注射intrinsic dissolution rate特性溶出速率inverse targeting反向靶向iontophoresis离子渗透法IR红外光谱isoclectric focusingIEF等电点聚焦isomerase异构酶isoosmotic solution等渗溶液isotonic solution等溶液isotope同位素Llag time时滞large unilamellar vesicles大单室脂质体least significant difference最小显著差数length basis长度基准levorotatory form左旋体levulose左旋糖light quantum光量子limit date of using a drug after its production药品使用期Limulus Amebocyte Lysate assay for endotoxin毒素鲎试剂测定法limulus lysate test鲎试验法linear correlation直线相关liniments搽剂liposome脂质体liquid immersion method 液浸法liquid injection无针液体注射器liquid paraffin液体石碏long term toxicity test长期毒性实验long-circulating liposomes 长循环脂质体long-term testing长期试验lotions洗剂low density lipoprotein低密度脂蛋白lubricants润滑剂lysozyme溶菌酶Mmacromolecule大分子magnetic controlled release dosage form磁性控释制剂magnetic medicinal preparations磁性药物制剂martin diameter定方向等分径mass basis质量基准matrix type骨架型maxial noneffective dose; EDO最大无作用剂量maximal tolerable dose; LDO最大耐受剂量maximum additive concentration MAC最大增溶浓度mechanical interlocking bonds 粒子间机械镶嵌mediator; transmitter; medium介质medical colloidal solution胶体溶液型药剂medicinal liquor酒剂melt-homogenization熔融－匀化法membrane wall表膜壁壳membrane-moderated type TTS 膜控释型TTS mesomer消旋体methyl acrylate-methacrylate co 甲基丙烯酸-丙烯酸甲酯micellar emulsion胶团乳micelle胶束microcapsules微表microemulsion微乳microencapsulation微型包表术、微表化micromeritics粉体学microreservoir-type TTS微贮库型microscropic method显微镜法microsomal enzyme微粒体酶Microspheres微球microstreaming超微束minimal effective dose最小有效量minimal lethal dose;MLD最小致死剂量minitablet小片mixture合剂moistening agent润湿剂moisture absorption吸湿性mol fraction concentration摩尔分数浓度molar volume;mole volume摩尔分子体积molarity摩尔浓度molecular biology分子生物学molecular capsules分子囊molecular disease分子病molecular pharmacology分子药理学molecular solution分子溶液mole摩尔monoclonal antibody单克隆抗体multifunctional enzyme多功能酶multilamellar vesicles多宝脂质体multilayer tablets多层片multiorfice-centrifugal process多孔离心法multiple dose administration多剂量给药mutation突变Nnacent soap method新生皂法nanocapsules纳米囊nanoemulsion纳米乳nanoliposomes纳米脂质体nanospheres纳米球naonparticle纳米粒nasal drops滴鼻剂natural antibody天然抗体natural antigen天然抗原natural immunity天然免疫neurotoxin神经毒素newtonian equation牛顿粘度定律newtonian fluid牛顿流体niosomes类脂质体，泡囊nitrite poisoning亚硝酸盐中毒nonbound water非结合水分nondepolarizer非去极化型肌松药non-essential amino acid非必需氨基酸nonionic surfactant vesicles 非离子表面活性剂囊泡non-Newtonian fluid非牛顿流体nonprescription drug非处方药nucleation theory成核作用理论nucleotide核苷酸nutrient营养素Oocular inserts眼用膜剂official formula法定处方ointments软膏剂oligosaccharides低聚糖opitical isomerization光学异构oral administration口腔给药ORD旋光色散orthologonal design区交设计osmotic pressure渗透压OSSDDS口服定位释药系统over the counter (OTC)非处方药oversize distribution筛上分布Ppacking fraction充填章paints涂剂paints涂膜剂pan coating锅包衣法paraffin石蜡particle size distribution粒度分布partition coefficient (P)分配系数parts per billion concentration PPB浓度parts per hundred concentration PPH浓度parts per hundred million concentration pphm浓度parts per million concentration ppm浓度passive immunity被动免疫passive targeting preparation 被动靶向制剂passive transport被动转运peak concentration of drug药峰浓度peak time of drug药峰时间pendular state钟摆状penetration enhancers穿透促进剂penetration enhancers经皮吸收促进剂percentage concentration百分浓度phagocytosis吞噬作用pharmaceutical analysis药物分析pharmaceutical chemistry制药化学pharmaceutical engineering 制剂学pharmaceutical equivalence药剂等效性pharmaceutical manufacturing制剂pharmaceutical preparation 药物制剂pharmaceutics药剂学pharmacia淀粉微球pharmacodynamics药效动力学pharmacogenetics药物遗传学pharmacokinetics model药物动力学模型pharmacokinetics药物动力学pharmacological availability 药理利用度pharmacology药理学phase inversion critical point 转相临界点phase separation相分离法（物理化学法）phase transition temperature 相转变湿度phase volume ratio相比phonophoresis超声波法photodegradation光化降解physical dependence身体依赖性physical pharmaceutics物理药剂学pill滴丸剂placebo安慰剂plasma protein binding ratio血浆蛋白结合率plasma substitute血浆代用液plasma血浆plaster硬膏剂plastic deformation塑性变形plastic viscosity塑性粘度plastisity塑性polymerization聚合polymers in pharmaceutics 药用高分子材料学polymorphism多晶型polyose多糖polypeptide多肽porosity空隙率potency unit效价单位potency效价potency效价强度powder injection无针粉未注射器powders散剂powerful drug剧药preformulation处方前工作pregelatinized starch淀粉、预胶化淀粉、可压性淀粉preparation制剂prescription;recipe处方preservative防腐剂pressure sensitive adhersive 压敏胶pressure-sensitive tape council剥离实验prickle cell layer棘层primary particle一级粒子prodrug前体药物proenzyme酶原prohormone激素原prolonged action preparation长效制剂propellents抛射剂propylene glycol丙二醇prosthetic group辅基pseudo steady state伪稳态pseudoplastic flow假塑性流动psychic dependence精神依赖性pulsed/pulsatile release脉冲释药pyometer比重瓶pyrogen热原Qquantum pharmacology量子药理学quasi-viscous flow假粘性流动Rraceme外消旋体racemization外消旋化作用radiopharmaceutics放射药剂学radiotoxicology放射毒理学raman拉曼random floc不规则絮凝物rate of shear剪切速度、切速率、速度梯度receptor antagonist受体拮抗剂receptor stimulant受体激动剂receptor感受器receptor受体rectal administration直肠给药relative dosage interval相对给药间隔relative humidity (RH)相对湿度resistance to drugs抗药性response surface methodology效应面优化法restrictive holagogue限制性剧药retardants阻滞剂reverse osmosis反渗透rheology流变学ribonucleic acid; RNA核糖核酸rolling ball tack test滚球试验RP-HPLC反相高效液相色潽法rubbing研磨力Ssafety coefficient安全系统safety range安全围safety安全性safflower藏红花油saponins皂甙saturated solution饱和溶液second particle二级粒子sedimentation method沉降法sedimentation rate沉降容积比selectivity选择性self-adjusted system自调式释药系统semi-logarithmic curve of drug-time药—时半对数曲线semisynthetic antibiotics半合成抗生素SEM扫描电镜sensitivity敏感性sensitization test致敏试验sensitization敏化作用sensitization致敏作用sequential design序贯设计serum血清settling velocity diameter 有效径shape factor形状系数shear mixing剪切混合shearing force剪切应力、剪切力、切力short term carcinogenic test短期致癌实验side effect副作用sieving diameterDa，筛分径sieving method筛分法simple coacervation单凝聚法simplex method单纯形优化法single unilamellar vesicles 小单室脂质体sink condition漏槽skin and mucocutaneous administration皮肤、粘膜表面给药slow pathway慢通道soft capsules软胶囊剂soft paraffin软石蜡solid bridges粒子间固体桥solid lipid nanospheres (SLN) 固体脂质纳米粒solubility parameter溶解度参数solubility溶解度solubilization增溶solubilizer增溶剂solute溶质solution tablets溶液片solutions溶液剂solvent; dissolvent溶剂solvent-nonsolvent溶剂－非溶剂法soybean-derived sterol大豆甾醇specific acid-base catalysis 专属酸碱催化specific surface area method 地表面积法specific surface area地表面积specific volume松比客spermaceti鲸蜡spirits醑剂spongia, spongc海绵剂spray congealing喷雾凝结法spray drying喷雾干燥法State food and drug administration SFDA国家食品药品管理局steady state plasma concentration稳态血药浓度sterility无菌sterilization灭菌steroid withdrawal syndrome类固醇停药综合征sticky powder粘性粉体stress relaxation应力缓和stress testing影响因素试验、强化试验striping of stratum corneum 去除角质层subacute intoxication;subacute poisoning亚急性中毒subcutaneous (SC) route皮下注射sublingual tablets舌下片subnanoemulsion亚纳米乳sugar coated tablets糖衣片supercritical Fluid (SCF)超临界流体（萃取）superinfection二重感染superoxide过氧化物suppositories栓剂surface activity表面活性surface basis面积基准surface tension表面力suspending agents助悬剂suspending agent助悬剂Suspensions混悬剂suspension悬浮液Sustained release tablets缓释片Sustained-release preparation 缓释制剂symptomatic treatment对症治疗synergism协同作用synergists协同剂synthesis of bioconvertible Prod 生物转化前体药物的合成synthesis of lipophilic analogs 脂质类物质的合成Synthesis of prodrugs前体药物的合成synthetic drugs合成药物syrups糖浆剂Ttablet hardness片剂硬度tablets片剂tachyphylaxis快速耐受tacking strength快粘力talc滑石粉tap density振实密度target cell靶细胞targetable drug delivery向靶给药targeting drug system (TDS) 靶向给药系统TDDS经皮传递系统technology of pharmaceutics制剂学TEM透射电镜tensile strength (Ts)抗强度teratogenic test致畸试验teratogen致畸物the Merck index默克索引the technique of sterilization 灭菌技术theory of depletion stabilization 空缺稳定理论therapeutic action治疗作用therapeutic dose治疗量therapeutic drug monitoring; TDM治疗药物临测therapeutic equivalence治疗等效（值）therapeutic index TI治疗指数thermal energy温热热能法threshold dose阈剂量thumb tack test拇指实验time clock定时钟time controlled explosive system 时控-突释系统time-effect relationship时效关系tincture酊剂tincture酊剂titer抗体滴度titration curve滴定曲线titration滴定tolerance耐受性topochemical reactions局部化学反应toroches口含片toxic response; toxic reaction毒性反应toxicology毒理学trace element微量元素transdermal therapeutic system 反向靶向transfersome传递体transmitter递质tricarboxylic acid cycle三羧酸循环true density真密度TTS经皮治疗制剂tween聚氧乙烯失水山梨醇脂肪酸酯Uunder distribution筛下分布uniform design均匀设计Vvaginal tablets阴道片vander walls 华力vaselin凡士林vertebra caval route脊椎腔注射viscoelasticity粘弹性viscosity coefficient粘度系数viscosity curve粘度曲线viscosity粘度viscosity粘性void ratio空隙比volume basis体积基准volume by volume concentration体积比浓度Wwet bulb temperature湿球温度Wet granulation湿法制粒wetting润湿性wool fat anhydrous无水羊毛脂wool fat羊毛脂World Health Organization; WHO世界卫生组织。

化药药学、非临床、临床研究过程中常用英文缩写短语列表

最大耐受剂量
MFD
Maximal feasible dose
最大给药量
MID
Minimum Infective Dose
最小感染剂量
NOAEL
No observed adverse effect level
无明显损害作用水平/未观察到林唇膏不良反应的剂量水平
NOEL
no observed effect level
从0点到最后一个时间点t的血药浓度-时间曲线下面积
Cmax
Maximum plasma concentration
血药浓度峰值
Kd
Dissociation constant
解离常数
Papp
Permeability coefficient
渗透系数
Tmax
Time to maximum plasma concentration
标准治疗
Organization
CRO
Contract Research Organization
合同研究组织
SMO
Site Management Organization
现场管理组织
CRA
Clinical Research Associate
临床监察员
CRC
Clinical Research Coordinator
新化学实体
NEC
New Drug Entity
新化学实体
PCC
Preclinical candidate compounds
临床前候选化合物
MEC
MolarExtinctionCoefficient
摩尔吸光系数/摩尔消光系数
MAC

医药研发药物安全性评价与监管指南

医药研发药物安全性评价与监管指南在医药研发过程中，药物的安全性评价和监管至关重要。

随着科技的不断发展，药物研发领域面临着越来越多的挑战和机遇。

为确保新药的安全有效性，各国纷纷制定并完善了相应的药物安全性评价与监管指南。

一、药物安全性评价的重要性药物的安全性评价是保证患者用药安全的基础。

通过对药物在体内的代谢和排泄途径、毒理学特性、药物相互作用等方面进行全面评估，可以预测药物的不良反应和安全性问题，从而制定出合理的用药方案和措施，减少药物使用过程中的风险。

二、国际药物安全性评价与监管指南1. 美国药物安全性评价与监管指南美国食品药品监督管理局（FDA）制定了一系列药物安全性评价与监管指南，如临床试验设计、药物不良反应监测和风险管理计划等。

这些指南要求临床试验必须建立科学合理的研究设计，确保试验结果的可靠性和代表性。

2. 欧洲药物安全性评价与监管指南欧洲药品管理局（EMA）发布了药品安全性评价指南，其中包括了药物前期评估、临床试验设计和安全性风险评估等环节。

这些指南鼓励药物研发企业与监管机构建立密切合作关系，共同追求药物的安全性和效果。

3. 中国药物安全性评价与监管指南中国食品药品监督管理局（CFDA）也颁布了一系列药物安全性评价与监管指南，包括药品临床试验管理要求、不良反应监测与报告、药物风险管理等。

他们强调了药物安全性评价的重要性，要求临床试验时应充分考虑特定人群的特殊情况，对药物的不良反应进行全面监测和报告。

三、药物安全性监管体系的建立为了加强药物安全性监管，各国纷纷建立了相应的监管体系。

这些监管体系主要包括以下几个方面：1. 制定监管政策和准则：各国制定了药物安全性评价和监管准则，明确了药物研发、上市和使用过程中的安全性要求和数据要求。

2. 建立监管机构：各国设立了专门的药品监管机构，负责药物的安全性监督和管理，制定相关政策和法规。

3. 建立数据库和信息共享平台：通过建立数据库和信息共享平台，实现药物安全性数据的收集、交流和共享，提高评估的准确性和全面性。

药学专业英语——药学词汇

半合成抗生素 semisynthetic antibiotics 半抗原 haptene半数致死剂量 half lethal dose ; median lethal dose; LD50制剂学 technology of pharmaceutics 制药化学 pharmaceutical chemistry安慰剂placebo 螯合剂chelating agent 安全范围 safety range 安全试验法 innocuity test method辅基 prosthetic group 辅料 excipients辅酶 coenzyme 副作用 side effect附加剂 additive 干燥剂 desiccant;drying agent肝首过效应 first pass effect of hepar 感受器 receptor高敏性 hyperreactivity个体差异性 individual differences; individual variation给药方案或给药速度 dosage regimen or dose rate给药间隔 dosing interval 工业药剂学 industrial pharmacy共价键 covalent bond 非去极化型肌松药 nondepolarizer分子药理学 molecular pharmacology放射毒理学 radiotoxicology 放射药剂学 radiopharmaceutics致癌实验 carcinogenic test 致癌物 carcinogen致畸试验 teratogenic test 致畸物 teratogen致敏试验sensitization test 最小有效量minimal effective dose 最小致死剂量 minimal lethal dose;MLD 致敏作用 sensitization致死量 fatal dose; lethal dose 制剂 preparation治疗等效（值） therapeutic equivalence 变态反应 allergy; allergic reaction表面活性 surface activity 表面张力 surface tension短期致癌实验 short term carcinogenic test半衰期 half-life period; half life time崩解度disintegration 崩解剂disintegrants 单克隆抗体 monoclonal antibody 胆碱酯酶 cholinesterase 等张溶液 isotonic solution 薄膜衣 film-coating 饱和溶液 saturated solution 不良反应 adverse reaction搽剂 liniments 酊剂 tincture包衣片 coated tablet 长期毒性实验 long term toxicity test 肠肝循环 enterohepatic circulation 肠溶控释片 enteric controlled release tablets 肠溶衣 enteric coating 处方 prescription;recipe滴丸剂 pill 递质 transmitter定向药物制剂directed pharmaceutical preparations 长效制剂 prolonged action preparation 中毒 intoxication; poisoning毒理学 toxicology 毒性反应 toxic response; toxic reaction对因治疗 etiological treatment 对症治疗 symptomatic treatment多功能酶 multifunctional enzyme 多剂量给药 multiple dose administration儿茶酚胺 catecholamine 二重感染 superinfection过滤 filtration 过敏毒素 anaphylatoxin过敏性药物反应 anaphylactic drug reaction 过氧化物 superoxide含量均匀度 content uniformity 合并用药 drug combination合成药物 synthetic drugs 合剂 mixture脂质体 liposome 直肠给药 rectal administration剂型 dosage form 剂量 dosage; dose基本药物 essential drugs 急性毒性实验 acute toxicity test剂量或浓度的依存性 dose or concentration dependency环境药理学 environmental pharmacology 胶体溶液型药剂 medical colloidal solution生物半衰期 biological half life 生物碱 alkaloid生物利用度 bioavailability 生物药剂学 biopharmacy生物制品 biological product 生药 crude drugs稳态血药浓度 steady state plasma concentration物理药剂学 physical pharmaceutics 药物学 pharmacology; materia medica吸入法 inhalation 吸收速率常数 absorption rate constant 时辰药理学 chronopharmacology 时间治疗 chronotherapy时间感受性 chronosusceptability 时效关系 time-effect relationship嚼用片 chewable tablets 酵解 glycolysis拮抗作用 antagonism 解毒作用 detoxication介质 mediator; transmitter; medium 精神依赖性 psychic dependence剧药 powerful drug 绝对致死剂量 absolute lethal dose; LD100 广谱抗生素 broad-spectrum antibiotic抗毒素 antitoxin 抗菌谱 antibacterial spectrum抗药性 resistance to drugs 控释制剂 controlled release preparation 口腔内给药 oral administration 快速耐受 tachyphylaxis扩散 diffusion 扩散系数 coefficient of diffusion累积尿排泄曲线 cumulative urinary excretion curves累加效应 additive effect 类毒素 anatoxin;toxoid类固醇停药综合征 steroid withdrawal syndrome量子药理学 quantum pharmacology 调剂学 dispensing pharmacy临床药理学 clinical pharmacology 临床药学 chlinical pharmacy耐受性 tolerance 耐药性 drug tolerance内毒素 endotoxin 片剂硬度 tablet hardness内毒素鲎试剂测定法 Limulus Amebocyte Lysate assay for endotoxin内消旋体 mesomer 浓度 concentration皮肤、粘膜表面给药 skin and mucocutaneous administration气凝胶 aerogel 气溶胶 aerosol气体分析 gas analysis 气雾剂 aerosol前体药物 prodrug 鞘内注射 intrathecal injection限制性剧药 restrictive holagogue 相对给药间隔 relative dosage interval 相加作用 additive effect; addition 向靶给药 targetable drug delivery药效动力学 pharmacodynamics 药源性疾病 drug-induced diseases乙酰胆碱乙酰胆碱 acetylcholine 乙酰胆碱酯酶 acetylcholinesterase抑菌活性 bacteriostatic activity 抑菌作用 bactriostasis异构酶 isomerase消除速率常数 elimination rate constant 效价 potency效价单位 potency unit 效价强度 potency效应 effect 效应器 effector效应物 effector 协同作用 synergism兴奋性 excitability 选择性 selectivity悬浮液 suspension血管内给药 intravascular administration 血管外给药 extravascular administration 血浆 plasma 血浆代用液 plasma substitute血浆蛋白结合率 plasma protein binding ratio血脑屏障 blood-cerebral barrier 血药浓度 blood concentration血清 serum 血液凝固 blood coagulation血容量扩充剂 blood volume expander 血液制品 blood products亚急性中毒 subacute intoxication;subacute poisoning亚硝酸盐中毒 nitrite poisoning 眼用膜剂 ocular inserts药—时半对数曲线 semi-logarithmic curve of drug-time药—时曲线 drug-time curve 药峰浓度 peak concentration of drug药峰时间 peak time of drug 药剂等效性 pharmaceutical equivalence药剂学 pharmaceutics 药理学 pharmacology药敏试验 drug sensitive test药物代谢 drug metabolism 药物代谢酶 drug metablic enzyme药物的体内过程 intracorporal process of drugs药物动力学模型 pharmacokinetics model药物反应 drug reaction 药物分布 drug distribution药物排泄 drug excretion 药物吸收 drug absorption药物相互作用 drug interaction 药物消除 drug elimination药物蓄积 drug accumulation 全酶与辅基 holonzyme and prosthetic group 人工合成抗原 artificial antigen 人工免疫 artificial immunization人种药理学 ethnopharmacology 埋植剂 implants慢通道 slow pathway 敏感性 sensitivity慢性毒性实验 chronic toxicity test; long term toxicity test酶 enzyme 酶原 proenzyme免疫抑制剂 immunosuppressant;immuno inhibitor免疫原性 immunogenicity 免疫增强剂 immunoenhancement抗体 antibody 抗血清 antiserum抗原 antigen 溶解 dissolution; dissolving溶菌酶 lysozyme 溶血 hemolysis溶质 solute 三羧酸循环 tricarboxylic acid cycle 杀菌活性 bactericidal activity 杀菌作用 bactericidal effect身体依赖性 physical dependence 神经毒素 neurotoxin肾上腺素能神经 adrenergic nerve 肾上腺素能受体 adrenergic receptor 渗透压 osmotic pressure 溶剂 solvent; dissolvent收敛药 astringent 手性药物 chiral drug首过效应 first-pass effect 受体 receptor水解（作用） hydrolysis 糖异生作用 gluconeogenesis双盲法 double-blind technique 天然药物 crude drugs; natural drugs硬膏剂 plaster 有效半衰期 effective halt有效率 effective rate 有效浓度 effective concentration治疗量 therapeutic dose 治疗药物临测 therapeutic drug monitoring; TDM 治疗指数 therapeutic index TI 治疗作用 therapeutic action右旋糖 dextrose 右旋体 dextrorotatory form阈剂量 threshold dose 载体 carrier受体激动剂 receptor stimulant 受体拮抗剂 receptor antagonist外毒素 exotoxin 外消旋体 raceme药物分析 pharmaceutical analysis 药物化学 pharmaceutical chemistry药品负责期 allotted date of drug quality ensuring by manufacturer药品管理法 drug administration law 药品批号 drug batch number药品使用期 limit date of using a drug after its production药品有效期 expiry date; date of expiration 药品质量标准 drug standard发酵 fermentation 法定处方 official formula协定处方 cipher prescription 序贯设计 sequential design多糖 polyose 多肽 polypeptide电解 electrolyzation 电解质 electrolyte激活剂 activator 激活作用 activation激素 hormone 激素原 prohormone中间体 intermediate 助滤剂 filter aid助溶剂 complex solubilizer 助悬剂 suspending agent自身免疫 autoimmunity 组胺 histamine最大耐受剂量 maximal tolerable dose; LDO 最大无作用剂量 maxial noneffective dose; EDO 最小显着差数 least significant difference佐剂 adjuvant左旋糖 levulose 左旋体 levorotatory form6-磷酸葡萄糖脱氢酶 glucose-6-phosphate dehydrogenase不完全抗原 incomplete antigen Janbon综合症 Janbon's syndrome PPB浓度 parts per billion concentration pphm浓度 parts per hundred million concentrationPPH浓度 parts per hundred concentration ppm浓度 parts per million concentration安全系统 safety coefficient 靶细胞 target cell白蛋白微球制剂 albumin microballoons 百分浓度 percentage concentration贝克勒尔 Becquerel 被动免疫 passive immunity被动转运 passive transport 必需氨基酸 essential aminoacid必需脂肪酸 essential fatty acid 丙种射线 gamma rays 补体 complement 补体系统 complement system穿透促进剂 penetration enhancers磁性控释制剂 magnetic controlled release dosage form磁性药物制剂 magnetic medicinal preparations大分子 macromolecule 当量浓度 normality当量 equivalent weight 当量定律 equivalent law当量溶液 normal solution 低聚糖 oligosaccharides低密度脂蛋白 low density lipoprotein 滴定 titration滴定曲线 titration curve 对映体 antipode芳族化合物 aromatic compound 非必需氨基酸 non-essential amino acid分子病 molecular disease 分子溶液 molecular solution分子生物学 molecular biology 光量子 light quantum核糖核酸 ribonucleic acid; RNA 核苷酸 nucleotide痕量元素 trace element 化学分析 chemical analysis化学物理学 chemical physics 化学消毒法 chemical disinfection化学药物治疗 chemotherapy 基因 gene己糖醇细胞毒剂 cytotoxic hexitols 间接致癌 indirect carcinogenesis碱中毒 alkalosis;alkali-poisoning 克当量 gram-equivalent weight克当量数 gram-equivalent number 克分子 gram-molecule; gram-mol克分子分数 molar fraction 克分子量 gram molecular weight克分子浓度 molar comcentratin; molal comcentration克原子 gram-atom 冷藏 cold-storage冷冻 freezing;refrigeration 卤化物 halogenide摩尔 mole 摩尔分数浓度 mol fraction concentration 摩尔分子体积 molar volume;mole volume 摩尔浓度 molarity默克索引 the Merck index 日内瓦命名法 Geneva nomenclature生长曲线 growth curve 生物胺 biogenic amine生物化学 biochemistry 生物统计学 biometrics;biometry时值 chronaxia;chronaxy 时滞 lag time世界卫生组织 World Health Organization; WHO噬菌体 bacteriophage 体表面积 body surface area体积比浓度 volume by volume concentration体液 body fluid 体液免疫 humoral immunity天然抗体 natural antibody 天然抗原 natural antigen天然免疫 natural immunity 完全抗原 complete antigen同位素 isotope 突变 mutation吞噬作用 phagocytosis 微粒体酶 microsomal enzyme王水 aqua regia; nitrohydrochloric acid 微量元素 trace element细胞免疫 cellular immunity 腺苷磷酸 adenosine phosphate药物遗传学 pharmacogenetics 营养素 nutrient皂甙 saponins 直线相关 linear correlation纸型片剂 oral medicaed soluble paper中华人民共和国卫生部药品标准 Drug Standard of Ministry of Public Health of the People's Republic of China。

FDA医药英文词汇

FDA医药英文词汇Compiled by: Yaw-Tsong LeeLast updated: November 21, 2010[Top] [Laws & Regulations] [FDA Organization] [SFDA国食药监]防撬包装[Top] [Laws & Regulations] [FDA Organization] [SFDA][Top] [Laws & Regulations] [FDA Organization] [SFDA]FDA Organization Charts[Top] [Laws & Regulations] [FDA Organization] [SFDA][Top] [Laws & Regulations] [FDA Organization] [SFDA]1 of the Bureau of Customs and Border Protection (CBP)2 a biologic response modifier, is a single-chain polypeptide containing 140 amino acids3 An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time4 Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.5 A negative experience encountered by an individual during the course of a clinical trial that is associated with the drug.6The basic premise of AIP is: If FDA determines that a company’s applications are not reliable, the agency will not perform substantive review of any of the company’s applications until confidence in the data is restored.7 An alanine aminotransferase (ALT) test measures the amount of this enzyme in the blood. ALT is measured to see if the liver is damaged or diseased.8 to check for liver disease or damage to the liver. Symptoms of liver disease can include jaundice, belly pain, nausea, and vomiting. An ALP test may also be used to check the liver when medicines that can damage the liver are taken or to check bone problems (sometimes found on X-rays), such as rickets, osteomalacia, bone tumors, Paget's disease, or too much of the hormone that controls bone growth (parathyroid hormone).9 An allograft is a transplanted organ or tissue from a genetically non-identical member of the same species10 is a general linear model with a continuous outcome variable (quantitative) and two or more predictor variables where at least one is continuous (quantitative) and at least one is categorical (qualitative). ANCOVA is a merger of ANOVA and regression for continuous variables. ANCOVA tests whether certain factors have an effect on the outcome variable after removing the variance for which quantitative predictors (covariates) account. The inclusion of covariates can increase statistical power because it accounts for some of the variability11 Any of the treatment groups in a randomized trial.12 Low levels of AST are normally found in the blood. When body tissue or an organ such as the heart or liver is diseased or damaged, additional AST is released into the bloodstream. The amount of AST in the blood is directly related to the extent of the tissue damage.13 A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.14 in an "as treated" (or "observed data") analysis only those patients still taking the assigned treatment are analyzed; those who drop out are "censored."15指由不直接涉及试验的人员所进行的一种系统性检查，以评价试验的实施、数据的记录和分析是否与试验方案、标准操作规程以及药物临床试验相关法规要求相符16一种批准用于治疗2型糖尿病的药物17 Benzodiazepines have also been used as a "date rape" drug because they can markedly impair and even abolish functions that normally allow a person to resist or even want to resist sexual aggression or assault18本类药物也称弱安定药，包括氯氮卓(利眠宁，chlordiazepoxide，商品名Librium)、地西泮(安定，diazepam，商品名valium)、硝西泮(硝基安定，nitrazepam)、氟西泮(氟安定，flurazepam)及奥沙西泮(去甲羟基安定，舒宁，oxazepam)。

特殊性质药品的污染控制丁之章1赵汝萍2

特殊性质药品的污染控制丁之章1 赵汝萍2发布时间：2023-07-05T05:45:47.389Z 来源：《健康世界》2023年7期作者：丁之章1 赵汝萍2 [导读] 在生产过程中，特殊性质药品的污染控制是药品生产企业极为重视的环节，因为特殊性质药品的特点，如，高活性、精神类、麻醉类等，将直接或间接影响普通药品的用药安全，因此，药品生产企业对于特殊性质药品的生产管理，都会采取极为严格的污染控制措施。

常见的污染控制措施有单独生产厂房、专线、专用设备等。

本文分析了国内外各官方针对特殊药品的污染控制措施，可作为药品生产企业的参考。

江苏海岸药业有限公司江苏省苏州市吴江区 215211摘要：在生产过程中，特殊性质药品的污染控制是药品生产企业极为重视的环节，因为特殊性质药品的特点，如，高活性、精神类、麻醉类等，将直接或间接影响普通药品的用药安全，因此，药品生产企业对于特殊性质药品的生产管理，都会采取极为严格的污染控制措施。