最新制药行业英语词汇

制药厂部分专业词汇

Total synthesis 全合成pharmaceutical 制药的，药品，药剂Natural products 天然产物gelatin 明胶骨胶Semi-synthetic半合成Intermediate 中间体Extract 萃取、提取、蒸馏、萃取物、提取物Extraction 萃取、提取Isolation 分离parameter 参数Recrystallization 重结晶solubility 溶解度、溶解性Intravenous injection 静脉注射ganule颗粒、细粒、微粒Sterilization 消毒、杀菌soybean 大豆、黄豆Antiseptic 防腐（消毒、杀菌）的、防腐剂、消毒剂detergent洗涤剂Spectrum 谱图impurity 杂质Herb 草本植物、药草prescription 处方、药方、规定World health organizatio（WHO）世界卫生组织Artemisinin 青蒿素Qualitative 定性的quantitative 定量的、数量的Stationary phase固定相mobile phase 流动相Pharmacopoeia 药典stopwatch秒表、跑表Spore 孢子、长孢子ingredient 成分、因素Weight variation 重量差异breakdown 崩解In-process control 过程中控制uniformity 一致性、均匀性Lot-to-lot uniformity批与批的均一性tablet-to-tablet uniformity片与片的均一性Granulation 制粒dictate 指令、指示Diluent 稀释的、稀释剂binder 粘合剂Adhesive 胶粘剂、粘合剂disintegrant崩解剂Lubricant 润滑剂colorant 颜料、着色剂Die 冲模、模具screening 筛网、过筛Sieve 筛子、滤网bubble cap 泡罩Mass 聚集、成团、团slurry 浆Sizing 填料、上浆Chopper 粉碎机Wet granulation 湿法制粒vehicles 赋形剂、运载工具Sterile 无菌的irrigate 冲洗Contamination 污染物inhibitor 抑制剂Buffer 缓冲剂antioxidants 抗氧剂Pyrogen 热原specification 说明书、规范、规格Standard operation procedures（SOP）标准操作规程injection 注射、注射剂Stratification 分层water for injection 注射用水Depot 仓库blend 混合Culture medium 培养基inoculum 培养液、接种体Broth 肉汤、清汤starch 淀粉、浆（糊）Ball valve 球阀butterfly valve 蝶阀Diaphragm valve 隔膜阀desiccant干燥剂Personnel Hygiene个人卫生protective garments防护服Premises厂房Batch Processing RecordBatch Production Record 批生产记录Manufacturing Process 生产操作Batch Packaging Record 批包装记录Packaging process 包装操作称量、过筛Weighing＆Sieving 制粒Granulating总混Final blending 压片Tableting压片CompressionCoating 包衣选片Selecting tablets生产过程质量控制In-process Quality ControlRevision History修订历史铝塑包装Aluminum-plastic Packaging枕式包装Pillow Packaging批料平衡率及批产品收率计算Batch Material Balance and Yield Calculation编号/版本号Code/ Rev. No批量Batch Size批号Batch No工序Step批记录审批表Batch Record Approval制定Prepared by审核Reviewed by批准Approved by生效日期Effective Date回顾日期Review DateQA发放Distributed by Quality Assurance车间领取Received by WorkshopQA审核Reviewed by Quality Assurance基准处方Theoretical Quantity检查人/日期Checked by/Date衡器1 Scale1编号Serial No.金属检测器Metal Detector硬度仪Tablet Hardness Tester厚度计Thickness Gauge片剂脆碎度测试仪Friabilator。

制药行业GMP英文词汇

Approve 批准Artwork 药品标签Authorized Person，AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test，FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance，QA 质量保证Qualification 确认Qualified Person，QP 质量受权人Quality Agreement 质量协议Quality Control，QC 质量控制Quality Management，QM 质量管理Quality review 质量审核Quality Unit，QU/Quality Operations，QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test，SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature (signed) 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养欢迎您的下载，资料仅供参考！致力为企业和个人提供合同协议，策划案计划书，学习资料等等打造全网一站式需求。

制药行业GMP英文词汇

制药行业GMP英文词汇Approve 批准Artwork 药品标签Authorized Person，AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test，FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance，QA 质量保证Qualification 确认Qualified Person，QP 质量受权人Quality Agreement 质量协议Quality Control，QC 质量控制Quality Management，QM 质量管理Quality review 质量审核Quality Unit，QU/Quality Operations，QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test，SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature (signed) 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养。

制药行业专业英语词典

Abbe refractometer 阿贝折射计 absorbance 吸光度absorbance ratio 吸光度比值 absorption curve 吸收曲线 absorption spectrum 吸收光谱 accuracy 准确度acidbase indicator 酸碱指示剂acidbase titration 酸碱滴定 acidimetry 酸量法acidity 酸度acid 酸aciddye colorimetry酸性染料比色法 acid value 酸值acidinsoluble ash 酸不溶性灰分 action and use 作用与用途active constituent 活性成分 additive 添加剂additivity加和性adjusted retention time 调整保留时间 adsorption吸附affinity chromatography亲和色谱法 alkalinity 碱度alkaloid 生物碱alkyloxy determination 烷氧基测定alumina 氧化铝amino acid 氨基酸analysis error 分析误差analytical balance 分析天平analytical chemistry分析化学analysis of variance 方差分析analytical quality control（AQC）分析质量控制 angstrom,Å 埃anhydrous 无水的anhydrous basis，anhydrous substance 干燥品 antioxidant 抗氧剂apparatus error 仪器误差apparent viscosity 表观黏度appendix 附录application of sample 点样area normalization method 面积归一化法 argentimetry 银量法aromatic hydrocarbon 芳烃arsenic 砷arsenic stain 砷斑artificial neural network 人工神经网络artificial intelligence 人工智能ash 灰分assay含量测定asymmetrical stretching vibration 不对称伸缩振动 atmospheric pressure ionization（API）大气压离子化 atomic absorption spectrometry（AAS）原子吸收光谱法 attenuation衰减average 平均值average deviation 平均偏差back extraction 反萃取back titration 反滴定band absorption 谱带吸收bar graph 棒图baseline correction 基线校正 baseline drift 基线漂移base 碱baseline resolved peak 基线分离峰 batch，lot 批biotransformation 生物转化 bioequivalence 生物等效性 bioavailability 生物利用度blank test 空白试验blue shift 蓝移boiling range 沸程British Pharmacopeia (BP) 英国药典 bromate titration溴酸盐滴定法 bromocresol green 溴甲酚绿 bromocresol purple 溴甲酚紫 bromophenol blue 溴酚蓝 bromothymol blue 溴麝香草酚蓝 buffer action 缓冲作用buffer capacity 缓冲容量buffer solutions 缓冲溶液bulk drug，pharmaceutical product 原料药 buret 滴定管byproduct 副产物calibrate 校准calibration curve 校准曲线calomel electrode 甘汞电极capacity factor 容量因子capillary electrophoresis（CE）毛细管电泳 capillary gas chromatography 毛细管气相色谱法 capillary melting point determination 毛细管熔点测定 carrier gas 载气capsule 胶囊剂characteristics，description 性状characteristic spectrum 特征光谱chemical constituent 化学成分chemical drugs 化学药品check sample 对照试样check test 对照试验chelate compound 螯合物chemically bonded phase 化学键合相chemical equivalent 化学当量Chinese Pharmacopoeia (ChP) 中国药典Chinese patent medicine 中成药Chinese materia medica 中药学Chinese materia medica preparation 中药制剂Chinese Pharmaceutical Association （CPA）中国药学会 chiral stationary phase（CSP）手性固定相chiral separation手性分离chirality手性chiral carbon atom手性碳原子chiral molecule 手性分子chloride 氯化物chromatography 色谱法chromatogram色谱图chromatographic column 色谱柱chromatographic condition 色谱条件 chromatographic system 色谱系统chromatographic data processor 色谱数据处理机 chromatographic work station 色谱工作站cistrans isomerism顺反异构clarity澄清度clathrate， inclusion compound 包合物clearance 清除率clinical pharmacy 临床药学coefficient of distribution 分配系数coefficient of variation 变异系数coenzyme 辅酶color reaction 显色反应colorimetric analysis 比色分析column capacity 柱容量column dead volume 柱死体积column interstitial volume 柱隙体积column outlet pressure 柱出口压column temperature 柱温column pressure 柱压column volume 柱体积column overload 柱超载column switching柱切换committee of drug evaluation药品审评委员会 complex 络合物component，constituent 组分compound medicines 复方药concentration浓度controlled trial对照试验coordination compound 配位化合物 correlation coefficient 相关系数 comparative test 比较试验completeness of solution 溶液的澄清度 complexometric titration 络合滴定computeraided pharmaceutical analysis 计算机辅助药物分析 condensation reaction缩合反应condensation substance 缩合物confidence interval 置信区间confidence level 置信水平confidence limit 置信限confidence probability 置信概率congealing point 凝点content 含量，内含物content uniformity 装量差异contrast test 对照试验crude drug 生药crystal结晶crystal violet 结晶紫crystallinity 结晶性（结晶度）cyclodextrin inclusion compound 环糊精包合物cyanide 氰化物dead space 死体积deadstop titration永停滴定法dead time 死时间decomposition point 分解点deflection偏差deflection point 拐点degassing脱气deionized water 去离子水derivative spectrophotometry导数分光光度法detection 检查dextrose 右旋糖，葡萄糖diastereomer 非对映（异构）体diazotization titration method 重氮化滴定法2,6dichlorindophenol titration2，6二氯靛酚滴定法 differential thermal analysis（DTA）差示热分析 differential scanning calorimetry（DSC）差示扫描热量法 differential pulse polarography示差脉冲极谱法 digestion 消化dilute 稀释diphasic titration 双相滴定direct potentiometry直接电位法dissociation constant 解离常数dissociation degree 解离度distribution chromatography 分配色谱distribution coefficient 分配系数dissolubility 溶解度dissolution溶出度disintegration 崩解时限distillation 蒸馏dose 剂量drug release 药物释放度drug quality management 药品质量管理drug control institutions 药检机构drug 药物drug metabolism enzyme 药物代谢酶drug quality control药品质量控制drug standard 药品标准dryness 干燥dual wavelength spectrophotometry 双波长分光光度法 duplicate test 重复试验excipient 赋形剂effective constituent 有效成分efficacy 效能，有效性effective plate number 有效板数efficiency of column 柱效electron transition 电子跃迁electrospray interface 电喷雾接口 electromigration injection电迁移进样elution洗脱eluting effect 洗脱效应elution curve 洗脱曲线elimination 消除emission spectrochemical analysis 发射光谱分析 end absorption末端吸收end point correction 终点校正end point error 终点误差enantiomer 对映（异构）体enzyme immunoassay（EIA）酶免疫分析 enzyme drug 酶类药物enzymatic reaction 酶促反应enzyme induction酶诱导enzyme inhibition 酶抑制epimer 差向异构体epimerization 差向异构化equilibrium constant 平衡常数 equivalence point 等当点equivalence potential等当点电位 equivalent weight 当量error in volumetric analysis 容量分析误差 extraction提取extract 提取物excite 激发excitation spectrum 激发光谱excitation wave length 激发波长 exclusion chromatography 排阻色谱法 expiration date 失效期external standard 外标准extrapolated method 外插法，外推法 expert system专家系统extraction gravimetry 提取重量法 extraction titration提取容量法factor 系数，因数feature 特征Fehling’s reaction费林反应fineness of the particles 颗粒细度finger print region指纹区finger print map 指纹图fixed phase 固定相flame ionization detector (FID)火焰离子化检测器flame emission spectrum 火焰发射光谱fluorimetry 荧光分析法fluorescamine 荧胺fluorescence immunoassay（FIA）荧光免疫分析fluorescence polarization immunoassay（FPIA）荧光偏振免疫分析 fluorescent agent 荧光剂fluorescence spectrophotometry 荧光分光光度法fluorescence detector 荧光检测器fluorescence efficiency 荧光效率fluorescence excitation spectrum 荧光激发光谱foreign odor 异臭foreign pigment 有色杂质formulary处方集freezing test 结冻试验functional group 官能团fused peaks, overlapped peaks 重叠峰gas chromatogram 气相色谱图gas chromatography (GC)气相色谱法gas chromatographflourier transform infrared spectrophotometer 气相色谱傅里叶变换红外光谱联用仪glass electrode 玻璃电极gasliquid chromatography (GLC) 气液色谱法gas purifier 气体净化器gel chromatography凝胶色谱法general identification test 一般鉴别试验gradient elution 梯度洗脱Good Manufacturing Practice and Quality Control of Drug （GMP and QC of Drug）药品生产质量管理规范Good Manufacture Practices(GMP) 药品生产规范Good Laboratory Practice（GLP）实验室管理规范Good Clinical Practice（GCP）临床试验规范Good Supplying Practice（GSP）药品供应规范Gran’s plot 格兰作图法gravimetric analysis 重量分析法half peak width 半峰宽[halide]disk method,wafer method,pellet method 压片法headspace concentrating injector 顶空浓缩进样器heat conductivity 热导率heavy metal重金属height of an effective plate 有效板高度high resolution gas chromatography（HRGC）高分辨气相色谱法hghperformance liquid chromatography高效液相色谱法high performance thinlayer chromatography（HPTLC）高效薄层色谱法hydroxyl value 羟值hyperchromic effect 深色效应hypsochromic effect 浅色效应hypothesis test 假设检验hydrophobicity 疏水性hydrophilicity亲水性hydrate 水合物hydrolysis 水解identification 鉴别immobile phase 固定相impurity 杂质Inactivation 失活index 索引indicator 指示剂indicator electrode 指示电极inhibitor抑制剂infrared absorption spectrum 红外吸收光谱 injecting septum 进样隔膜胶垫injection valve 进样阀integrator积分仪instrumental analysis仪器分析instrument error 仪器误差intermediate 中间体international unit（IU）国际单位internal standard substance 内标物质 iodometry 碘量法ion exchange chromatography 离子交换色谱法 ionic strength 离子强度ionize 电离ion pair chromatography 离子对色谱ion suppression 离子抑制 irreversible potential不可逆电位 isoelectric point 等电点isoosmotic solution 等渗溶液 immunoassay 免疫测定ionexchange cellulose离子交换纤维素 iodoform reaction 碘仿反应ion suppress 离子抑制iodide碘化物irreversible indicator不可逆指示剂 isosbestic point method等吸光点法课外阅读一阿司匹林及其片剂的质量标准（USP ）Aspirin O O H 3C HOOC 9H 8O 4 180.16Benzoic acid, 2(acetyloxy)Salicylic acid acetate [50782].>>Aspirin contains not less than 99.5 percent and not more than 100.5 percent of C 9H 8O 4, calculated on the dried basis. Packaging and storage Preserve in tight containers.USP Reference standards <11>－USP Aspirin RS .Identification －A : Heat it with water for several minutes, cool, and add 1 or 2 drops of ferric chloride TS: a violetred color is produced.B : Infrared Absorption <197K>Loss on drying <731>－Dry it over silica gel for 5 hours: it loses not more than 0.5% of its weight.Readily carbonizable substances <271>－Dissolve 500mg in 5 mL of sulfuric acid TS: the solution has no more color than Matching Fluid Q.Residue on ignition <281>: not more than 0.05%.Substances insoluble in sodium carbonate TS －A solution of 500mg in 10 mL of warm sodium carbonate TS is clear.Chloride <221>－Boil 1.5g with 75 mL of water for 5 minutes, cool, add sufficient water to restore the original volume, and filter. A 25mL portion of the filtrate shows no more chloride than corresponds to 0.10 mL of 0.020 N hydrochloric acid (0.014%).Sulfate Dissolve 6.0g in 37 mL of acetone, and add 3 mL of water. Titrate potentiometrically with 0.02 M lead perchlorate, prepared by dissolving 9.20 g of lead perchlorate in water to make 1000mL of solution, using a pH meter capable of a minimum reproducibility of ±0.1 mV (see pH <791>) equipped with an electrode system consisting of a leadspecific electrode and a silversilver chloride reference glasssleeved electrode containing a solution of tetraethylammonium perchlorate in glacial acetic acid （1 in 44）(see Titrimetry <541>): not more than 1.25mL of 0.02 M lead perchlorate is consumed (0.04%). [NOTE －After use, rinse the leadspecific electrode with water, drain the reference electrode, flush with water, rinse with methanol, and allow to dry.]Heavy metals －Dissolve 2 g in 25 mL of acetone, and add 1 mL of water. Add 1.2 mL of thioacetamideglycerin base TS and 2 mL of pH 3.5 Acetate Buffer (see Heavy Metals <231>), and allow to stand for 5 minutes: any color produced is not darker than that of a control made with 25 mL of acetone and 2 mL of Standard Lead Solution (see Heavy Metals <231>), treated in the same manner. The limit is 10μg per g.Limit of free salicylic acid－Dissolve 2.5g in sufficient alcohol to make 25.0 mL. To each of two matched colorcomparison tubes add 48 mL of water and 1 mL of a freshly prepared, diluted ferric ammonium sulfate solution (prepared by adding 1 mL of 1 N hydrochloric acid to 2 mL of ferric ammonium sulfate TS and diluting with water to 100 mL). Into one tube pipet 1 mL of a standard solution of salicylic acid in water, containing 0.10 mg of salicylic acid per mL. Into the second tube pipet 1 mL of the 1 in 10 solution of Aspirin. Mix the contents of each tube: after 30 seconds, the color in the second tube is not more intense than that in the tube containing the salicylic acid (0.1%).Organic volatile impurities, Method IV<467>: meets the requirements.Assay－Place about 1.5g of Aspirin, accurately weighed, in a flask, add 50.0 mL of 0.5 N sodium hydroxide VS, and boil the mixture gently for 10 minutes. Add phenolphthalein TS, and titrate the excess sodium hydroxide with 0.5 N sulfuric acid VS. Perform a blank determination (see Residual Titrations under Titrimetry <541>). Each mL of 0.5 N sodium hydroxide is equivalent to 45.04 mg of C9H8O4.Aspirin Tablets>> Aspirin Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C9H8O4. Tablets of larger than 81mg size contain no sweeteners or other flavors.N OTETablets that are entericcoated meet the requirements for Aspirin Delayedrelease Tablets.Packaging and storagePreserve in tight containers. Preserve flavored or sweetened Tablets of 81mg size or smaller in containers holding not more than 36 Tablets each.USP Reference standards <11>USP Aspirin RS. USP Salicylic Acid RS.IdentificationA: Crush 1 Tablet, boil it with 50 mL of water for 5 minutes, cool, and add 1 or 2 drops of ferric chloride TS: a violetred color is produced.B: Infrared absorption <197K>Prepare the test specimen as follows. Shake a quantity of finely powdered Tablets, equivalent to about 500 mg of aspirin, with 10 mL of alcohol for several minutes. Centrifuge the mixture. Pour off the clear supernatant liquid, and evaporate it to dryness. Dry the residue in vacuum at 60℃ for 1 hour.Dissolution<711>Medium: 0.5 M acetate buffer, prepared by mixing 2.99 g of sodium acetate trihydrate and 1.66 mL of glacial acetic acid with water to obtain 1000mL of solution having a pH of 4.50±0.05; 500 mL.Apparatus 1 : 50 rpm.Time: 30 minutes.Procedure－Determine the amount of C9H8O4 dissolved from ultraviolet absorbances at the wavelength of the isosbestic point of aspirin and salicylic acid at 265±2nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium. if necessary, in comparison with a Standard solution having a known concentration of USP Aspirin RS in the samemedium. [N OTEPrepare the Standard solution at the time of use. An amount of alcohol not to exceed 1% of the total volume of the Standard solution may be used to bring the Reference Standard into solution prior to dilution with Dissolution Medium.] TolerancesNot less than 80% (Q) of the labeled C9H8O4 is dissolved in 30 minutes.Uniformity of dosage units <905>: meet the requirementsLimit of free salicylic acidMobile phase and Diluting SolutionPrepare as directed in the Assay.Standard solutionDissolve an accurately weighed quantity of USP Salicylic Acid RS in the Standard preparation prepared as directed in the Assay, to obtain a solution having a known concentration of about 0.015 mg of salicylic acid per mL.Test preparationUse the Stock solution prepared as directed for Assay preparation in the Assay.Chromatographic systemUse the Chromatographic system described in the Assay. Chromatograph the Standard solution, and record the peak responses as directed under Procedure in the Assay. The relative standard deviation of the salicylic acid peak responses is not more than 4.0%. In a suitable chromatogram, the resolution, R, between salicylic acid and aspirin is not less than 2.0.ProcedureProceed as directed for Procedure in the Assay. The relative retention times are about 0.7 for salicylic acid and 1.0 for aspirin. Calculate the percentage of salicylic acid (C7H6O3) in the portion of Tablets taken by the formula:2000(C/Q A)（r u/r s），in which C is the concentration, in mg per mL, of USP Salicylic Acid RS in the Standard solution, Q A is the quantity, in mg, of aspirin (C9H8O4) in the portion of Tablets taken, as determined in the Assay, and rυ and r s are the peak responses of the salicylic acid peaks obtained from the Test preparation and the Standard solution, respectively: not more than 3.0% is found. In the case that are coated, not more than 3.0% is found.AssayMobile phaseDissolve 2 g of sodium 1heptanesulfonate in a mixture of 850 mL of water and 150 mL of acetonitrile, and adjust with glacial acetic acid to a pH of 3.4.Diluting solutionPrepare a mixture of acetonitrile and formic acid (99:1).Standard preparationDissolve an accurately weighed quantity of USP Aspirin RS in Diluting solution to obtain a solution having a known concentration of about 0.5 mg per mL.Assay preparationWeigh and finely powder not less than 20 Tablets. Transfer an accurately weighed quantity of the powder, equivalent to about 100 mg of aspirin, to a suitable container. Add 20.0 mL of Diluting solution and about 10 glass beads. Shake vigorously for about 10 minutes, and centrifuge (stock solution). Quantitatively dilute an accurately measured volume of the Stock solution with 9 volumes of Diluting solution (Assay preparation). Retain the remaining portion of Stock solution for the test for Limit of salicylic acid.Chromatographic system (see Chromatography <621>)－The liquid chromatograph is equipped with a 280nm detector and a 4.0mm×30cm column containing packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standardpreparation, and record the peak responses as directed under Procedure: the relative standard deviation is not more than 2.0%. In a suitable chromatogram, the tailing factor is not greater than 2.0.ProcedureSeparately inject equal volumes (about 10m L) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of aspirin (C9H8O4) in the portion of Tablets taken by the formula:200C(rυ/r s),in which C is the concentration, in mg per mL, of USP Aspirin RS in the Standard preparation, and rυ and r s are the peak responses of the aspirin peaks obtained from the Assay preparation and the Standard preparation, respectively.课外阅读二分析方法论证ANALYTICAL PERFORMANCE CHARACTERISTICSAccuracyDefinitionThe accuracy of an analytical method is the closeness of test results obtained by that method to the true value. The accuracy of an analytical method should be established across its range.DeterminationIn the case of the assay of a drug substance, accuracy may be determined by application of the analytical method to an analyte of known purity (e.g., a Reference Standard) or by comparison of the results of the method with those of a second, wellcharacterized method, the accuracy of which has been stated or defined.In the case of the assay of a drug in a formulated product, accuracy may be determined by application of the analytical method to synthetic mixtures of the drug product components to which known amounts of analyte have been added within the range of the method. If it is not possible to obtain samples of all drug product components, it may be acceptable either to add known quantities of the analyte to the drug product (i.e., “to spike”) or to compare results with those of a second, wellcharacterized method, the accuracy of which has been stated or defined.In the case of quantitative analysis of impurities, accuracy should be assessed on samples (of drug substance or drug product) spiked with known amounts of impurities. Where it is not possible to obtain samples of certain impurities or degradation products, results should be compared with those obtained by an independent method. In the absence of other information, it may be necessary to calculate the amount of an impurity based on comparison of its response to that of the drug substance; the ratio of the responses of equal amounts of the impurity and the drug substance (response factor) should be used if known.Accuracy is calculated as the percentage of recovery by the assay of the known added amount of analyte in the sample, or as the difference between the mean and the accepted true value, together with confidence intervals.The ICH documents recommend that accuracy should be assessed using a minimum of nine determinations over a minimum of three concentration levels, covering the specified range (i.e., three concentrations and three replicates of each concentration).PrecisionDefinitionThe precision of an analytical method is the degree of agreement among individual test results when the method is applied repeatedly to multiple samplings of a homogeneous sample. The precision of an analytical method is usually expressed as the standard deviation or relative standard deviation (coefficient of variation) of a series of measurements. Precision may be a measure of either the degree of reproducibility or of repeatability of the analytical method under normal operating conditions. In this context, reproducibility refers to the use of the analytical procedure in different laboratories, as in a collaborative study. Intermediate precision expresses withinlaboratory variation, as on different days, or with different analystsor equipment within the same laboratory. Repeatability refers to the use of the analytical procedure within a laboratory over a short period of time using the same analyst with the same equipment. For most purposes, repeatability is the criterion of concern in USP analytical procedures, repeatability is the criterion of concern in USP analytical procedures, although reproducibility between laboratories or intermediate precision may well be considered during the standardization of a procedure before it is submitted to the Pharmacopeia.DeterminationThe precision of an analytical method is determined by assaying a sufficient number of aliquots of a homogeneous sample to be able to calculate statistically valid estimates of standard deviation or relative standard deviation (coefficient of variation). Assays in this context are independent analyses of samples that have been carried through the complete analytical procedure from sample preparation to final test result.The ICH documents recommend that repeatability should be assessed using a minimum of nine determinations covering the specified range for the procedure (i.e., three concentrations and three replicates of each concentration or using a minimum of six deter minations at 100% of the test concentration).SpecificityDefinitionThe ICH documents define specificity as the ability to assess unequivocally the analyte in the presence of components that may be expected to be present, such as impurities, degradation products, and matrix components. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedures. [N OTEOther reputable international authorities (IUPAC, AOAC) have preferred the term “selectivity”, reserving “specificity” for those procedures that are completely selective.] For the test or assay methods below, the above definition has the following implications:IDENTIFICA TION TESTS: ensure the identity of the analyte.PURITY TESTS: ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte (e.g., related substances test, heavy metals limit, organic volatile impurity limit).ASSAYS: provide an exact result, which allows an accurate statement on the content or potency of the analyte in a sample.DeterminationIn the case of qualitative analyses (identification tests), the ability to select between compounds of closely related structure that are likely to be present should be demonstrated. This should be confirmed by obtaining positive results (perhaps by comparison to a known reference material) from samples containing the analyte, coupled with negative results from samples that do not contain the analyte and by confirming that a positive response is not obtained from materials structurally similar to or closely related to the analyte.In the case of analytical procedure for impurities, specificity may be established by spiking the drug substance or product with appropriate levels of impurities and demonstrating that these impurities are determined with appropriated accuracy and precision.In the case of the assay, demonstration of specificity requires that it can be shown that the procedure is unaffected by the presence of impurities or excipients. In practice, this can be done by spiking the drug substance or product with appropriatelevels of impurities or excipients and demonstrating that the assay result is unaffected by the presence of these extraneous materials.If impurity or degradation product standards are unavailable, specificity may be demonstrated by comparing the test results of samples containing impurities or degradation products to a second wellcharacterized procedure (e.g., a pharmacopeial or other validated procedure). These comparisons should include samples stored under relevant stress conditions (e.g., light, heat, humidity, acid/base hydrolysis, oxidation). In the case of the assay, the results should be compared; in the case of chromatographic impurity tests, the impurity profiles should be compared.The ICH documents state that when chromatographic procedures are used, representative chromatograms should be presented to demonstrate the degree of selectivity, and peaks should be appropriatedly labeled. Peak purity tests (e.g., using diode array or mass spectrometry) may be useful to show that the analyte chromatographic peak is not attributable to more than one component.Detection LimitDefinitionThe detection limit is a characteristic of limit tests. It is the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated, under the stated experimental conditions. Thus, limit tests merely substantiate that the amount of analyte is above or below a certain level. The detection limit is usually expressed as the concentration of analyte (e.g., percentage. parts per billion) in the sample.DeterminationFor noninstrumental methods, the detection limit is generally determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be reliably detected.For instrumental procedures, the same method may be used as for noninstrumental. In the case of methods submitted for consideration as official compendial methods, it is almost never necessary to determine the actual detection limit. Rather, the detection limit is shown to be sufficiently low by the analysis of samples with known concentration of analyte above and below the require detection vevel. For example, if it is required to detect an impurity at the level of 0.1%, it should be demonstrated that the procedure will reliably detect the impurity at that level.In the case of instrumental analytical procedures that exhibit back ground noise, the ICH documents describe a common approach, which is to compare measure signals from samples with known low concentrations at which the analyte can reliably be detected is established, Typically acceptable signaltonoise ratios are 2:1 or 3:1. Other approaches depend on the determination of the slope of the calibation curve and the standard deviation of responses. Whatever method is used, the detection limit should be subsequently validated by the analysis of a suitable number of samples known to be near, or prepared at, the detection limit.Quantitation LimitDefinitionThe quantitation limit is a characteristic of quantitative assays for low levels of compounds in sample matrices, such as impurities in bulk drug substances and degradation products in finished pharmaceuticals. It is the lowest amount of analyte in a sample that can be determined with acceptable precision and accuracy under the stated experimental conditions.。

医药行业英语专业术语

医药行业英语专业术语1. Pharmaceutical industry: the industry that researches, develops, produces, and markets drugs for medical use.2. Drug development: the process of researching and developing new drugs or therapies, including preclinical and clinical trials.3. Clinical trial: a research study that tests the safety and effectiveness of a new drug or medical treatment on human subjects.4. Generic drug: a drug that is produced and marketed without patent protection, usually after the patent on the original brand-name drug has expired.5. Active pharmaceutical ingredient (API): the chemical substance responsible for the pharmacological effects of a drug.6. Over-the-counter (OTC) drugs: drugs that can be purchased without a prescription, typically used for the treatment of common ailments.7. Prescription drug: a drug that can only be legally obtained with a prescription from a licensed healthcare professional.8. Drug interaction: a situation in which two or more drugs interact with each other and produce unintended effects or alter the effectiveness of one or more of the drugs.9. Pharmacokinetics: the study of how a drug is absorbed,distributed, metabolized, and excreted by the body.10. Pharmacodynamics: the study of the biochemical and physiological effects of drugs and their mechanisms of action.11. Adverse drug reaction (ADR): an unwanted or harmful reaction to a medication, ranging from mild side effects to severe allergic reactions.12. Pharmaceutical formulation: the process of creating a drug product by combining the active pharmaceutical ingredient with other ingredients to produce a dosage form, such as tablets, capsules, or injections.13. Pharmacovigilance: the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.14. Bioavailability: the rate and extent to which an active drug ingredient is absorbed and reaches the systemic circulation to produce its intended effects.15. Pharmacoeconomics: the study of the cost-effectiveness, value, and outcomes of pharmaceutical interventions, including the evaluation of drug pricing and reimbursement models.16. Drug delivery system: a system or device that delivers a drug to the targeted site in the body, such as transdermal patches, inhalers, or implantable devices.17. Pharmaceutical marketing: the activities and strategies aimed at promoting and advertising pharmaceutical products to healthcare professionals and consumers.18. Good Manufacturing Practice (GMP): a set of regulations and guidelines that ensure the quality, safety, and consistency of pharmaceutical products during their manufacturing process.19. Pharmacogenomics: the study of how a person's genes influence their response to drugs, allowing for personalized medicine and optimized drug therapy.20. Biopharmaceuticals: drugs that are produced using biotechnology, such as recombinant DNA technology, typically derived from living organisms.。

医药行业专业英语词汇_非常有用

医药行业专业英语词汇_非常有用1. Medicine (药品): 指用于治疗、预防或诊断疾病的物质。

2. Pharmaceutical (制药): 涉及药品的研究、开发、生产和销售。

3. Clinical trial (临床试验): 在人体上进行的药物或治疗方法测试。

4. Therapeutic (治疗): 指药物或治疗方法的疗效。

5. Side effect (副作用): 药物或治疗方法产生的非预期效果。

6. Dosage (剂量): 药物的使用量。

7. Bioavailability (生物利用度): 药物在体内可被利用的程度。

8. Pharmacokinetics (药代动力学): 研究药物在体内的吸收、分布、代谢和排泄。

9. Pharmacodynamics (药效动力学): 研究药物如何影响生物体。

10. Biopharmaceutics (生物制药学): 研究生物体内药物的物理、化学和生物学性质。

11. Regulatory affairs (法规事务): 涉及药品的法规制定、遵守和监管。

12. Drug discovery (药物发现): 寻找新的药物分子或治疗方法。

13. Drug development (药物开发): 将新发现的药物分子转化为可用的药物。

14. Generic drug (仿制药): 与原研药具有相同活性成分的药物。

15. Biologics (生物制品): 由生物体产生的药物，如抗体、激素等。

16. Overthecounter (OTC) drug (非处方药): 不需要医生处方即可购买的药物。

17. Prescription drug (处方药): 需要医生处方才能购买的药物。

18. Drug interaction (药物相互作用): 两种或多种药物同时使用时产生的相互作用。

19. Adverse event (不良事件): 在药物使用过程中出现的非预期反应。

制药行业常用英语词汇中英文对照表

序号
1 2 3 4 5 6 7 8 9 10 11
制药行业常用英语词汇中英文对照
英文原文 Application file Acceptance criteria Active moiety
Additives Adventitious agents Analytical procedures
Anti-microbial Antimicrobial preservatives
83
Glycosylation sites
84
Guidance
85
Guideline
86
Higher order structure
87
Holding times
88
Human or animal origin
89
Immunological activity
90
Immunochemical properties
Solvents
191
Sorption
192
Specifications
193
Specificity
缩小规模模型放大批次
二级/三级/四级结构次级包装章节子章节灵敏度有效期跳检溶解性溶剂吸附质量标准专属性
194
Stability
195
Starting materials
196
Proprietary name
157
Purification steps
158
Purity
159
Quality
160
Quality module
161
Quality overall summary (QOS)

制药行业一些英语词汇总结

制药行业一些英语词汇总结FDA（Food and drug administration ）：（美国国家）食品药品管理局IND（Investigation new drug）：临床研究申请（指申报阶段，相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（New drug application）：新药申请ANDA（Abbreviated New drug application）：简化新药申请EP诉（Export application）：出口药申请（申请出口不被批准在美国销售的药品）Treatment IND：研究中的新药用于治疗Abbreviated New drug：简化申请的新药DMF（Drug master file）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所及的设备、生产过程或物品。

只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）Holder：DMF持有者CFR（Code of federal regulation）：（美国）联邦法规Panel：专家小组Batch production：批量生产；分批生产Batch production records：生产批号记录Post-or Pre- market surveillance：销售前或销售后监督Informed consent：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）Prescription drug：处方药OTC drug（over—the—counter drug）：非处方药U．S．Public Health Service：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所Clinical trial：临床试验Animal trial：动物试验Accelerated approval：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Benefit（S）：受益Risk (S）：受害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Narrative summary记叙体概要Adverse effect：副作用Adverse reaction：不良反应Archival 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（现已和NF合并一起出版）NF（National formulary）：（美国）国家药品集OFFICIAL＝Pharmacopeia = COMPENDIAL：药典的；法定的；官方的Agency：审理部门（指FDA等）Sponsor：主办者（指负责并着手临床研究者）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（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）Regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement：食用补充品COS/CEP 欧洲药典符合性认证ICH （International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals forHuman Use)人用药物注册技术要求国际协调会议Acceptance Criteria: 接收标准(接收测试结果的数字限度、范围或其它合适的量度标准) Active Pharmaceutical Ingredient (API) (or Drug Substance): 活性药用成分(原料药)旨在用于药品制造中的任何一种物质或物质的混合物，而且在用于制药时，成为药品的一种活性成分。

制药行业英语词汇

Oral solid dosage form / Oral solid preparation 口服固体制剂Materials [mə'tɪərɪəlz]物料，材料Raw materials 原辅料Starting materials 起始物料Packing materials 包装材料Active pharmaceutical ingredient API [,fɑːmə'suːtɪk(ə)l; -'sjuː-]原料ingredient [ɪn'griːdɪənt] n. 原料；要素；组成部分adj. 构成组成部分的Excipient , adjuvant 辅料excipient [ik'sipint] n. 【药物】赋形剂adjuvant ['ædʒʊv(ə)nt] n. [药] 佐药；助理员adj. 辅助的Diluents 稀释剂Fillers 填充剂Starch 淀粉starch [stɑːtʃ]Dextrin 糊精dextrin ['dekstrɪn]Lactose 乳糖lactose ['læktəʊz; -s]Moistening agent , humectant [hjʊ'mekt(ə)nt]润湿剂Adhesive , binder 粘合剂[əd'hiːsɪv; -zɪv]Ethanol['eθənɒl]乙醇Disintegrants disintegrant [dɪs'ɪntɪɡrənt] 崩解剂Lubricant ['luːbrɪk(ə)nt]润滑剂Glidants 助流剂Antiadherent 抗粘剂Talc [tælk] 滑石粉Intermediates 中间体Finished product 最终成品Supper 供应商Distributor 分销商Manufacturer [,mænjʊ'fæktʃ(ə)rə(r)] 生产商Audit ['ɔːdɪt]审计Tablet 片剂Granules [grænju:ls]颗粒剂Capsules 胶囊剂Powder 散剂Pills 丸剂Compressed tablet 普通片Coated tablet 包衣片Sugar coated tablet 糖衣片Film coated tablet 薄膜衣片Enteric coated tablet 肠溶衣片Effervescent tablet [efə'vesənt]泡腾片Chewable tablet 咀嚼片Dispersible tablet 分散片Sustained release tablet 缓释片Controlled release tablet 控释片Multilayer tablet ['mʌltɪleɪə]多层片Manufacturing process 生产工艺Milling / grinding ['graɪndɪŋ]碾碎Sifting 过筛Dispensing 配料Blending ['blendɪŋ]混合Granulating / granulation [,ɡrænjʊ'leɪʃən]成粒，制粒Drying 干燥Tablet compression 压片compression [kəm'preʃ(ə)n] n. 压缩，浓缩；压榨，压迫Dedust [di:'dʌst]除尘Coating 包衣Polish ['pɒlɪʃ] 抛光Dies arrangement 配模arrangement [ə'reɪn(d)ʒm(ə)nt] n. 布置；整理；准备dies ['daii:z] n. [机] 模具（名词die的复数）；（拉）日n. (Dies)人名；(英)戴斯；(西)迭斯v. 死亡；消失（动词die的第三人称单数形式）；凋谢Packing 包装Bottle washing 洗瓶Bottle drying 烘瓶Packaging 包装，打包Labeling 贴签Filling 填充，灌装Capsule shell 胶囊壳shell [ʃel]n. 壳，贝壳；炮弹；外形vt. 剥皮；炮轰vi. 剥落；设定命令行解释器的位置Blister packing 起泡包装Inner packing material 内包材Outer packing material 外包材Whole test 全检Weight 重量Fineness 细度，粒度Particle size 粒度Loss on drying 干燥失重Content 含量Disintegration 崩解度Dissolution 溶出度Appearance 外观Quality 质量Quantity 数量Equipment / facility / apparatus / device 设备Process step 工艺步骤Weighing & dispensing 称配Granulation 制粒Compression 压片Coating 包衣Capsule filling 胶囊填充Batch production instruction / order 批生产指令Standard operation procedure 标准操作规程Formulation 处方Verification 确认，检定Calibration 校准Qualification 确认Validation 验证Authentication 认证Weighing cover 称重罩Weighting box 称重柜Balance 天平Electronic platform scale 电子台秤Vibrating sieve 振荡筛Mesh 网眼Grinder / pulverizer 粉碎机Inlet 进料口Steel tooth 钢齿Annular sieve plate 换装筛板Outlet 出粉口Charging hole 加料口Horizontal shaft 水平轴Shaking device 抖动装置Air bleeding pocket 放气袋Wet granulation 湿法制粒Dry granulation 干法制粒Spray granulation 喷雾制粒Mixing granulator 混合制粒机Pneumatic lid-opening device 启动开盖装置Cutting motor 切割电机Cooling water enters 冷却水进口Air admission orifice 进气管口Cooling water out 冷却水出口Touch screen 触摸屏Stirring motor 搅拌电机Power supply 电源Compressed air source 压缩空气源Controller 控制器Cutting knife 造粒刀Drum lid 桶盖Drum 盛料筒Discharge hole 出料口Stirrer 搅拌器Driving belt 传送皮带Machine base 机座Fluid bed granulator 流化床制粒机Hot air circulating oven 热风循环烘箱Heater 加热器Fan 风扇Filter gauze 滤网Mixing machine 混合机Quality test 质量检查Weight difference 片重差异Hardness 硬度Rigidity 脆碎度Rotary tablet press 旋转式压片机Die 冲模Punch 冲头Upper punch 上冲Upper pinch roller 上压轮Filling support 填充架Powder scraper 刮粉器Die 模圈Lower punch 下冲Tablet weight adjuster 片中调节器Lower pinch roller 下压轮ourlet adjuster 出片调节器coating 包衣isolated layer 隔离层sub-coating layer 粉衣层sugar-coating layer 糖衣层colored sugar-coating layer 有色糖衣层polishing 打光coating machine / coater 包衣机sidedoor 侧门upper box 上箱体lower box 下箱体airtight chamber 密闭工作室coating platen 包衣滚筒big sprocket 大链轮tensioner 涨紧轮cycle chain 链条washing pan 清洗盘small sprocket 小链轮electromotor 电动机capsule filling machine 胶囊填充机adjusting screw 填充杆调节螺钉upper die-set 上模架column 立柱powder loop 盛粉环metering plate 计量盘lock screw 锁紧螺钉fixed screw 固定螺钉gland flange 压板scale 标尺cover 盖板filling bar 填充杆powder scraper 刮粉器hopper 胶囊料斗liner bearing 直线轴承fork slider 拨叉滑块sliding valve 滑动门阀knob 旋钮baffle 挡板fastening screw 紧固螺钉order fork 顺序叉shifting fork 胶囊拨叉inverted trough 胶囊导槽lyophilized products / freeze drying preparation 冻干产品personnel 人员equipment 设备materials 物料regulations 法规environment 环境cross-contamination 交叉污染positive pressure 正压negative pressure 负压weighing room 称量室downflow booth 垂直层流工作室fan drive system 风机驱动系统HEPA filterHigh efficiency particulate air filter 高效过滤器Bleed air 排风Containment zone 控制区Background environment 背景环境Clean area 洁净区Grade A BUnclean area 一般区Differential pressure 压差Air speed 风速Temperature 温度Humidity 湿度Electronic balance 电子天平Operation keys 操作键Display with backlight 背光显示屏Model plate 型号标牌Draft shield element 放风圈Weighing pan 秤盘Draft shield 防风罩Leveling feet 水平调节脚Hager 秤钩AC adapter socket 交流电源适配器插座Interface 接口Solution preparation 配液Thick preparation 浓配Thin preparation 稀配Tanks for solution preparation 配液灌Sight glass 视镜Hatch 人孔Liquid level meter 液位计Liquid outlet 出液口Condensate water 冷凝水Steam inlet 蒸汽入口Automatic control 自动化控制Sterile filtration 无菌过滤Clean in place 在线清洗Sterilization in place 在线灭菌Critical process parameter 关键工艺参数Visible particles 可见异物Pressure parameter 压力参数Process water 工艺用水Drinking water 饮用水Purified water 纯化水Water for injection (WFI) 注射用水Cooling / chilled water 冷冻水Pure steam 纯蒸汽Compressed air 压缩空气Activated carbon 活性炭Adsorbent temperature 吸附温度Circulating temperature 循环温度Pass box 传递窗Stainless steel nozzle 不锈钢喷嘴Vision glass 观察窗High strength hinge 高强度合页Pass window 传递窗Air handling panel 通风板Handle 把手Electronic interlock 电子互锁机构Primary meshed plate 初校网孔板Purification fan unit 净化风机Differential pressure gauge 压差表Intercom device 对讲机Ultraviolet lamp 紫外灯Unpowered roller 无动力滚筒Cleaning and sterilization 清洗灭菌Filter element 过滤器滤芯Visible foreign matters 可见异物Insoluble particles 不溶性微粒Autoclave 高压灭菌器Document 文件Record 记录Report 报告Vial washing machine 洗瓶机Vertical ultrasonic washing machine 立体超声波清洗机Cycle index 循环次数Sterilizing and drying 灭菌干燥Heated air circulation sterilizing oven 热风循环烘箱Tunnel sterilizing oven 隧道烘箱Suction blower 吸风机Laminar flow 层流Valve 阀门Plenum chamber 静压箱Air bellow 风箱、Surface air cooler 表冷器Net belt 网带Rubber stopper cleaning machine 胶塞清洗机Bacterial endotoxin 细菌内毒素Filling and partially stoppering 灌装和半加塞Filling machine 灌装机Content adjustment 装量调节Laminar flow protection 层流保护Content uniformity 装量差异Samples 样品Stoppering system 加塞系统Feeding system 上料系统Freeze-drying system 冻干系统Sublimation 升华Desorption 解吸附Freeze dryer /lyophilizer 冻干机Chamber 冻干箱Shelves 板层Condense 冷肼Hydraulic 液压Circulation system 循环系统Vacuum system 真空系统Control system 控制系统Refrigeration system 制冷系统Compressor 压缩机Condensor 冷凝器Expansion valve 膨胀阀Evaporator 蒸发器Oil pump 油泵Crankcase heater 曲轴箱加热器Intake port 吸气口Junction box 接线盒Flusher 喷洒装置Mameplate 名牌Safety valve 安全阀Vacuum gauge 真空计Electrical heater 电加热Plate heat exchanger 板式加热器Pressure gauge 压力表Relay 继电器Pneumatic ball valve 气动球阀Diaphragm valve 隔膜阀Rolling cover operation 扎盖Rolling-cover machine 轧盖机Turntable 转台Orbit 轨道Bottle distribution 理瓶Capping structure 压盖结构Main motor 主电机Operation panel 操作面板Loading & unloading system 进出料系统Artificial feeding system 人工上料系统Laminar car 层流车Battery container 蓄电池箱Universal wheel 万向轮Fan filter unit 风机过滤单元Barrier system 隔离系统Isolator 隔离器Glove box 手套箱Half suit 半身衣。

制药工程专业英语词汇

medicinal药品,药物, 药的,药用的，治疗的medical 医学的，医术的pharmaceutical 药学的，制药的，药品be split into 分成，分为alkaloid 生物碱enzyme 酶polysaccharide 多糖，多聚糖precursor 前体steroid甾体peptide 肽hormone 激素gall 胆汁insulin 胰岛素pancreas胰腺serum/sera血清，浆液vaccine 疫苗cholesterol 胆固醇gelatine 骨胶，明胶antibiotic 抗生素，抗菌的interferon 干扰素antibody 抗体fermentation 发酵therapy 治疗/ therapeutic治疗的therapeutic margin caffeine咖啡因dopamine多巴胺yeast 酵母mucous membrane粘液的，分泌粘液的plasma 血浆，淋巴液，等离子体penicillin 青霉素penicillium 青霉菌derivative衍生物sterile无菌的，不能生育的aerobic 需氧的oxygen feedstuff 饲料lymph淋巴，淋巴液starch 淀粉regiospecific reaction区域专一性反应stereospecific reaction立体专一性反应glucose葡萄糖immobilize 固定heterogeneous 不均匀的，多相的contamination污染genetic 创始的，遗传学的hygienic 卫生学的，卫生的intermediate中间体extraction 萃取recrystallization 重结晶/ crystal 晶体，晶体的xylene 二甲苯toluene 甲苯ether 醚synthesize 综合，合成benzene苯/ chlorobenzene氯苯synthetic, 合成的，人造的；化学合成品synthesis [复syntheses] 综合,综合物，合成(法)semisynthetic, lead structure先导结构preparation 制备，制剂isolate使分离，使离析/ isolation heart glycoside tocopherol 生育酚hydrolysis水解/hydrolysate水解产物/hydrolyze水解hydroxylation 羟基化dextran 葡聚糖，代血浆wool 羊毛ーlactamβ-内酰胺amino acid 氨基酸/ amino 氨基的penicilamine 青霉胺ammonia 氨ammonium 铵/ ammonium sulfate硫酸铵amine 胺amide酰胺microorganism 微生物microbiological微生物学的mutant 变异的；突变型，突变体starting material 起始原料natural source天然来源organ器官/target organ 靶器官pancreas 胰腺natural product 天然产物mould 霉，霉菌；发霉high performance 高效bacterial 细菌的protein 蛋白质degradation 降解metabolism新陈代谢/ metabolize metabolite代谢物molecule /molecular weight food additive organiclactic acid乳酸citric acid 柠檬酸tetracycline 四环素carbon dioxide 二氧化碳carbohydrate 碳水化合物saccharide 糖/多糖polysaccharide nitrogen 氮urea 尿素phosphate 磷酸盐optimal 优化的，最佳的separate vt 分离absorption 吸收absorb vt. 吸收filtration 过滤filtrate 滤液filte 过滤（vt），过滤器（n）recombinant 重组的，重组子purification 纯化encode把(电文等)译成电码(或密码), 编码calcium 钙chromatographic procedure 色谱操作步骤isomerization异构化/isomeric phenol 酚fructose 果糖fumaric acid 富马酸countless test 非计数的diagnose诊断diagnostic analysis分析/analyze 分析vt / analyst分析家/ analytical分析的protease 蛋白酶Ingredient 成分in combination with 结合Digestion 消化。

(完整版)药学英语专业词汇

（完整版）药学英语专业词汇一、药物分类及命名1. 抗生素（Antibiotics）青霉素（Penicillin）头孢菌素（Cephalosporins）大环内酯类（Macrolides）2. 抗病毒药物（Antiviral Drugs）抗流感病毒药物（Antiviral for Influenza）抗艾滋病病毒药物（Antiviral for HIV）3. 抗肿瘤药物（Anticancer Drugs）化疗药物（Chemotherapeutic Agents）靶向治疗药物（Targeted Therapy Drugs）4. 心血管系统药物（Cardiovascular Drugs）抗高血压药物（Antihypertensive Drugs）抗心绞痛药物（Antianginal Drugs）抗心律失常药物（Antiarrhythmic Drugs）5. 消化系统药物（Gastrointestinal Drugs）抗胃溃疡药物（Antigastric Ulcer Drugs）止泻药物（Antidiarrheal Drugs）泻药（Laxatives）6. 中枢神经系统药物（Central Nervous System Drugs）抗抑郁药物（Antidepressants）抗精神病药物（Antipsychotic Drugs）镇痛药物（Analgesics）二、药物剂型及给药途径1. 剂型（Dosage Forms）片剂（Tablets）胶囊（Capsules）注射剂（Injections）2. 给药途径（Routes of Administration）口服（Oral）肌内注射（Intramuscular）静脉注射（Intravenous）三、药物作用及不良反应1. 药物作用（Pharmacological Actions）抗菌作用（Antibacterial Action）抗病毒作用（Antiviral Action）镇痛作用（Analgesic Action）2. 不良反应（Adverse Reactions）过敏反应（Allergic Reactions）胃肠道反应（Gastrointestinal Reactions）肝脏毒性（Hepatotoxicity）四、药学专业英语词汇1. 药理学（Pharmacology）药物代谢（Drug Metabolism）药物动力学（Pharmacokinetics）药效学（Pharmacodynamics）2. 药剂学（Pharmaceutics）制剂工艺（Preparation Technology）药物稳定性（Drug Stability）药物质量控制（Drug Quality Control）3. 药物化学（Medicinal Chemistry）药物合成（Drug Synthesis）药物结构（Drug Structure）药物设计（Drug Design）本文档旨在帮助药学专业学生和从业者掌握药学英语专业词汇，提高专业英语水平，为学术交流和临床实践提供便利。

外资药企常用英语单词

外资药企常用英语单词一、药品相关1. Drug [drʌɡ] (n.)：药物，药品。

例如：This new drug has shown great effectiveness in treating the disease.（这种新药在治疗这种疾病方面显示出极大的有效性。

）2. Medicine ['medsn] (n.)：药，医学。

可以指内服药，与drug通用，但更侧重于医学意义上的药物。

如：Traditional Chinese medicine has a long history.（传统中医有着悠久的历史。

）3. Pill [pɪl] (n.)：药丸，药片。

例如：Take one pill three times a day.（每天服用三次，每次一粒药丸。

）4. Capsule ['kæpsjuːl] (n.)：胶囊。

例如：The doctor prescribed some capsules for my cold.（医生为我的感冒开了一些胶囊。

）5. Syrup ['sɪrəp] (n.)：糖浆。

例如：This cough syrup tastes sweet.（这种止咳糖浆尝起来很甜。

）二、研发相关1. Research [rɪ'sɜːtʃ] (n. & v.)：研究。

作名词时，例如：Our company is doing a lot of research on new drugs.（我们公司正在进行许多新药的研究。

）作动词时：They research the possible side effects of the medicine.（他们研究这种药物可能的副作用。

）2. Development [dɪ'veləpmənt] (n.)：开发，发展。

例如：The development of new drugs is a long - term process.（新药的开发是一个长期的过程。

全球制药术语英汉双解词典

全球制药术语英汉双解词典全球制药术语英汉双解词典一、药品分类1. Over-the-counter drugs（OTC药品）：指非处方药，可以在药店等地方自由购买并使用。

2. Prescription drugs（处方药）：指需要医生处方才能购买和使用的药品。

3. Generic drugs（普通药品）：指与特定品牌药物成分相同的非专利药物。

4. Brand-name drugs（品牌药品）：指由公司拥有专利保护并使用特定商标名称销售的药品。

二、药品生产、研发和注册1. Active ingredient（活性成分）：指制备药物的主要成分。

2. Formulation（配方）：指药物中的各种成分的比例和方法。

3. Pharmacokinetics（药代动力学）：指药物在体内的吸收、分布、代谢和排泄过程。

4. Good Manufacturing Practice（GMP）：指药品制造过程中遵守的良好生产规范。

5. Clinical trials（临床试验）：指药物在人体中进行的测试以评估其安全性和有效性。

6. New drug application（新药申请）：指药物研发完成后，向监管机构提交的申请文件。

7. Biologics License Application（生物制品许可申请）：指生物制品（如疫苗和生物仿制药）上市许可的申请文件。

三、药品销售和市场营销1. Formulary（药品名录）：指医保计划或医疗机构批准使用的药品列表。

2. Pharmacy benefit manager（药店福利管理员）：指为保险公司管理处方药福利计划的公司。

3. Detailing（详细介绍）：指制药公司代表向医生详细介绍其产品的做法。

4. Direct-to-consumer advertising（直接面向消费者的广告）：指制药公司直接向消费者推销药品的广告活动。

5. Off-label use（离标用药）：指医生开处方让患者使用药物的用途与药品标签上所规定的不同。

制药行业GMP英文词汇

制药行业G M P英文词汇标准化管理处编码[BBX968T-XBB8968-NNJ668-MM9N]Approve 批准Artwork 药品标签Authorized Person，AQ WHO关于质量受权人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生产Blending 混合Blending batches 混批Calibration 校验Calibration 校准Campaign-based production 阶段性生产Checked 校验Cleanance or site cleaning 清场Cleaning 清洁Cleaning Validation 清洁验证Clinical Trials 临床研究Contamination 污染Contamination Control 污染控制Continuous production 连续生产Contract manufacturing 委托生产Contract Analysis 委托检验Cool Storage 阴凉储存Critical Deviation 关键偏差Critical Process Parameter 关键工艺参数Critical Processing Step 关键操作步骤Cross contamination 交叉污染Design qualification, DQ 设计确认Deviation 偏差Drinking Water 饮用水Dry Place 干燥储存education 个人学历Equipment logbook 设备使用日志Excessive heat 过热Expected Yield, expected 预期收率experience 工作经验Expiry Date 有效期Factory Acceptance Test，FAT 供应商工厂的验收测试Freezer Storage 冷冻储存Holding Time 贮存期I：Implemente 执行Impurity profile 杂质概况In-process Controls 过程控制In-process Sampling 过程取样Installation qualification, IQ 安装确认Intermediate 中间体Logbook 使用日志Maintenance Basic Practice 维护基本实践Maintenance Best Practice 维护最佳实践Maintenance Good Practice 维护良好实践Maintenance Plan 维护计划Maintenance Program 维护管理程序Manufacture 制造Master Cell Bank , MCB 主细胞库mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 运行确认Out of Specification , OOS 超标Performance qualification, PQ 性能确认Preliminary Cell Bank ,PCB 原始细胞库Preventive Maintenance 预防性维护Production 生产Production Operations 生产操作Purified Water 纯化水Qaultiy Assurance，QA 质量保证Qualification 确认Qualified Person，QP 质量受权人Quality Agreement 质量协议Quality Control，QC 质量控制Quality Management，QM 质量管理Quality review 质量审核Quality Unit，QU/Quality Operations，QO质量管理部门Responsible 负责Rechecked 复验Reconciliation 物料平衡Refrigerator Storage 冷藏储存Reject 拒收Retest dates 复验期Risk Assessment 风险评估Room Temperature Storage 室温储存Safety Environment Health, EHS 环境、健康及安全Semi-continuous production 半连续生产Site Acceptance Test，SAT 用户工厂的验收测试Specification 质量标准Stability 稳定性Sterile Purified Water 灭菌纯化水Sterile Water for Inhalation 灭菌吸入用水Sterile Water for Injection 灭菌注射用水Sterile Water for Irrigation 灭菌冲洗用水Subdividing Operation 分装操作Tamper Evidence 防篡改封签Time Limits 生产时限training 培训Update Batch Production Record, BPR 批记录User Requirement Specification, URS 用户需求标准Validation 验证Validation master plan 验证主计划Verification 复核Verification 检定Water for Injection 注射用水Working Cell Bank , WCB 工作细胞库Worst Case 最差情况Yield 收率Yield , actual 实际收率Signature (signed) 签名CIP 在线清洗SIP 在线灭菌消毒MAINTENANCE 维护保养。

制药专业英语词汇大全

制药专业英语Accelerated testing 加速试验Reproducibility 重复性Climatic zones 气候带Detection limit 检测限Commitment batches 承诺批次Quantitation limit 定量限Container closure system 包装容器Linearity 线性Drug substance 原料药Range 范围Excipient 赋型剂Robustness 耐用性Expiration date 有效日期Chemical development studies 化学开发研究Formal stability studies 正式稳定性研究Enantiomeric impurity 异构体杂质Intermediate testing 中间试验Extraneous contaminant 外源性污染Long term testing 长期试验Identified impurity 鉴定的杂质New molecular entity 新分子实体Identified threshold 鉴定阙值（鉴定限）Primary batch 申报批次Impurity 杂质Production batch 大生产批次Impurity profile 杂质概况Re-test date 复检日期Intermediate 中间体Re-test period 复检期New drug substance 新原料药Specification 质量标准Precision 精密度Stress testing (drug substance) 强降解试验Repeatability 重复性Analytical procedure 分析方法Intermediate precision 中间精密度Accuracy 准确度Polymorphic form 多晶型Potential impurity 潜在杂质Combination product 复方制剂Qualification threshold 界定阙值（界定限）Chiral 手性Reagent 试剂Degradation product 降解产物Reporting threshold 报告阙值（报告限）Enantiomer 异构体Solvent 溶剂Identified impurity 鉴定杂质Specified impurity 特定杂质In-process tests 过程中检测Starting material 起始物料Polymorphism 多晶型Unidentified impurity 未鉴定杂质New drug substance 新原料药Acceptance criteria 可接受标准Racemate 外消旋体Permitted daily exposure 每日可接受药物中残留溶剂的最大摄入量Quality 质量Universal test 常规检测Specification 质量标准Acceptance criteria 可接受标准Solvent 溶剂Active pharmaceutical ingredient 药物活性组分（原料药）Specific test 专属性试验API starting material API起始物料 Specified impurity 特定杂质Batch 批Unidentified impurity 未鉴定杂质Batch number 批号Contract manufacturer 合同制造商Calibration 校验Critical 关键Computer system 计算机系统Cross-contamination 交叉污染Computerized system 计算机化系统Deviation 偏差Contamination 污染Expiry date 失效日期Lot 批In-process control 生产过程控制Lot number 批号Mother liquor 母液Packaging material 包装材料Reprocessing 再处理Material 物料Retest date 复测期Procedure 规程Reworking 返工Process aids 工艺辅助材料Signature(signed) 签名Process control 工艺控制Validation 验证Qualification 确认Validation protocol 验证方案Quality assurance 质量保证Yield, Expected 预期产量Quality control 质量控制Yield, Theoretical 理论产量Quality unit 质量部Design space 设计空间Production 生产Formal experimental design 正式实验设计Reference standard, primary 一级标准品Quarantine 待验Reference standard, secondary 二级标准品Raw material 原辅料Risk 风险Corrective action 纠正措施Risk management 风险管理Enabler 支持者Risk reduction 风险降低Key performance indicators 关键性能指标Decision maker 决策制定者Innovation 创新Detectability 检测能力Knowledge management 知识管理Product lifecycle 产品生命周期Pharmaceutical quality system 药品质量体系Quality risk management 质量风险管理Outsourced activities 外包活动Quality system 质量系统Preventive action 预防措施Requirements 要求Production realisation 产品实现Risk acceptance 风险认可Quality manual 质量手册Risk analysis 风险分析Quality planning 质量计划Risk assessment 风险评估Quality policy 质量方针Risk communication 风险通报Quality risk management 质量风险管理Risk control 风险控制Senior management 最高管理Risk evaluation 风险评价State of control 控制状态Risk identification 风险鉴定Change management 变更管理Risk review 风险回顾Trend 趋势Severity 严重性Continual improvement 持续改进Stakeholder 利益相关者Control strategy 控制策略Air lock 气锁 D value D值Alert level 警戒标准Dynamic 动态的Action level 纠偏标准Endotoxin 内毒素Aseptic manufacturing area 无菌生产区Gowning qualification 更衣确认Aseptic processing facility 无菌生产厂房HEPA filter 高效过滤器Aseptic processing room 无菌操作间HVAC 空调净化系统Asepsis 无菌（状态）Intervention 干预Bioburden 含氧菌（生物负荷）Isolator 隔离操作器Barrier 屏障Laminar flow 层流Biological indicator BI 生物指示剂Operator 操作人员Clean area 洁净区Overkill sterilization process 过度杀灭灭菌程序Component 组分Pyrogen 热原Colony Forming Unit(CFU) 菌落形成单位（菌落数）Sterile product 无菌产品Critical surface 关键区域Sterilizing filter 除菌过滤器Decontamination 去污染Quality control unit 质量部门Disinfection 消毒Unidirectional flow单向流Depyrogenation 去热原Terminal sterilization 最终灭菌Validation 验证ULPA filter 超低穿透过滤器Worse case 最差条件Vessel 管道Reaction 反应Vent排气口Tank 桶罐Tare 皮重Flush 冲洗Purified water 纯化水Gross weight 毛重Dry 干燥Unload 缷料centrifuge 离心机crystallize 结晶Rinse 漂洗Filtrate 过滤Precipitation 沉淀Separate 分离Adjust pH to 调节pH至Solvent 溶剂Transport container 周转桶Intermediate 中间体Organic layer 有机层Aqueous layer 水层Extraction 萃取Cleaning agent 清洁剂Vacuum distill 减压蒸馏Contamination 污染Hydrolyze 水解Residual 残留Time complete 终止时间G.L.R 搪玻璃反应器Time started 起始时间The stainless steel reactor 不锈钢反应器Condenser 冷凝器Reactor 反应釜Reflux 回流batch number 批号Heat 加热Preparation 制备Temperature 温度Charge 投料Net weight 净重Stir 搅拌Jacket 夹套Take a sample 取样Bottom valve 底阀Suck 吸入Sample retention 留样Recrystallization 重结晶Pressure 压力Spin dry 旋转干燥Purification 精制，提纯Monitor 监测Blending 混合Sponsor 主办者（指负责并着手临床研究者）Labeled amount 标示量Agency 审理部门（指FDA）Identity 真伪；鉴别；特性NF （美国）国家药品集USP 美国药典INN 国际非专有名称Protocol 方案Established name 确定的名称Adverse effect 副作用Preparing and submitting 起草和申报Benefit 受益Animal trial 动物试验Accelerated approval 加速批准Batch production record 生产批号记录POST-OR PRE- MARKET SURVEILLANCE 销售前或销售后监督Batch production 批量生产DMF holder DMF 持有者CFR （美国）联邦法规Panel 专家小组ANDA 简化新药申请DMF 药物主文件FDA （美国）食品药品管理局NDA 新药申请Adapter 接液管Air condenser 空气冷凝管Beaker 烧杯Crucible tongs 坩埚钳Boiling flask 烧瓶Condenser-Allihn type 球型冷凝管boiling flask-3-neck 三口烧瓶Condenser-west tube 直型冷凝管Burette clamp 滴定管夹Claisen distilling head 减压蒸馏头Burette stand 滴定架台Busher funnel 布氏漏斗Crucible with cover 带盖的坩埚Distilling head 蒸馏头Distilling tube 蒸馏管Erlenmeyer flask 锥型瓶Evaporating dish (porcelain) 瓷蒸发皿Filter flask(suction flask) 抽滤瓶Florence flask 平底烧瓶Fractionating column 分馏柱Geiser burette (stopcock) 酸氏滴定管graduated cylinder 量筒Hirsch funnel 赫氏漏斗Long-stem funnel 长颈漏斗Medicine dropper 滴管Mohr burette for use with pinchcock 碱氏滴定管Mohr measuring pipette 量液管Mortar 研钵Pestle 研杵Pinch clamp 弹簧节流夹Plastic squeeze bottle 塑料洗瓶Rubber pipette bulb 吸耳球Wide-mouth bottle 广口瓶Tripod 三角架Transfer pipette 移液管Watch glass 表皿volumetric flask 容量瓶Thiele melting point tube 提勒熔点管Test tube 试管Test tube holde 试管夹Separatory funnel 分液漏斗Stemless funnel 无颈漏斗Validation 验证Qualification/Verification 验证Stability 稳定性In compliance with 符合Active ingredients 主药Excipient 辅料Buffering agent 缓冲剂Towards lower limit 偏低限pH value 酸碱度Formulated amount 处方量。

制药行业英语词汇汇编

Oral solid dosage form / Oral solid preparation 口服固体制剂Materials [mə'tɪərɪəlz]物料，材料Raw materials 原辅料Starting materials 起始物料Packing materials 包装材料Active pharmaceutical ingredient API [,fɑːmə'suːtɪk(ə)l; -'sjuː-]原料ingredient [ɪn'griːdɪənt] n. 原料；要素；组成部分adj. 构成组成部分的Excipient , adjuvant 辅料excipient [ik'sipint] n. 【药物】赋形剂adjuvant ['ædʒʊv(ə)nt] n. [药] 佐药；助理员adj. 辅助的Diluents 稀释剂Fillers 填充剂Starch 淀粉starch [stɑːtʃ]Dextrin 糊精dextrin ['dekstrɪn]Lactose 乳糖lactose ['læktəʊz; -s]Moistening agent , humectant [hjʊ'mekt(ə)nt]润湿剂Adhesive , binder 粘合剂[əd'hiːsɪv; -zɪv]Ethanol['eθənɒl]乙醇Disintegrants disintegrant [dɪs'ɪntɪɡrənt] 崩解剂Lubricant ['luːbrɪk(ə)nt]润滑剂Glidants 助流剂Antiadherent 抗粘剂Talc [tælk] 滑石粉Intermediates 中间体Finished product 最终成品Supper 供应商Distributor 分销商Manufacturer [,mænjʊ'fæktʃ(ə)rə(r)] 生产商Audit ['ɔːdɪt]审计Tablet 片剂Granules [grænju:ls]颗粒剂Capsules 胶囊剂Powder 散剂Pills 丸剂Compressed tablet 普通片Coated tablet 包衣片Sugar coated tablet 糖衣片Film coated tablet 薄膜衣片Enteric coated tablet 肠溶衣片Effervescent tablet [efə'vesənt]泡腾片Chewable tablet 咀嚼片Dispersible tablet 分散片Sustained release tablet 缓释片Controlled release tablet 控释片Multilayer tablet ['mʌltɪleɪə]多层片Manufacturing process 生产工艺Milling / grinding ['graɪndɪŋ]碾碎Sifting 过筛Dispensing 配料Blending ['blendɪŋ]混合Granulating / granulation [,ɡrænjʊ'leɪʃən]成粒，制粒Drying 干燥Tablet compression 压片compression [kəm'preʃ(ə)n] n. 压缩，浓缩；压榨，压迫Dedust [di:'dʌst]除尘Coating 包衣Polish ['pɒlɪʃ] 抛光Dies arrangement 配模arrangement [ə'reɪn(d)ʒm(ə)nt] n. 布置；整理；准备dies ['daii:z] n. [机] 模具（名词die的复数）；（拉）日n. (Dies)人名；(英)戴斯；(西)迭斯v. 死亡；消失（动词die的第三人称单数形式）；凋谢Packing 包装Bottle washing 洗瓶Bottle drying 烘瓶Packaging 包装，打包Labeling 贴签Filling 填充，灌装Capsule shell 胶囊壳shell [ʃel]n. 壳，贝壳；炮弹；外形vt. 剥皮；炮轰vi. 剥落；设定命令行解释器的位置Blister packing 起泡包装Inner packing material 内包材Outer packing material 外包材Whole test 全检Weight 重量Fineness 细度，粒度Particle size 粒度Loss on drying 干燥失重Content 含量Disintegration 崩解度Dissolution 溶出度Appearance 外观Quality 质量Quantity 数量Equipment / facility / apparatus / device 设备Process step 工艺步骤Weighing & dispensing 称配Granulation 制粒Compression 压片Coating 包衣Capsule filling 胶囊填充Batch production instruction / order 批生产指令Standard operation procedure 标准操作规程Formulation 处方Verification 确认，检定Calibration 校准Qualification 确认Validation 验证Authentication 认证Weighing cover 称重罩Weighting box 称重柜Balance 天平Electronic platform scale 电子台秤Vibrating sieve 振荡筛Mesh 网眼Grinder / pulverizer 粉碎机Inlet 进料口Steel tooth 钢齿Annular sieve plate 换装筛板Outlet 出粉口Charging hole 加料口Horizontal shaft 水平轴Shaking device 抖动装置Air bleeding pocket 放气袋Wet granulation 湿法制粒Dry granulation 干法制粒Spray granulation 喷雾制粒Mixing granulator 混合制粒机Pneumatic lid-opening device 启动开盖装置Cutting motor 切割电机Cooling water enters 冷却水进口Air admission orifice 进气管口Cooling water out 冷却水出口Touch screen 触摸屏Stirring motor 搅拌电机Power supply 电源Compressed air source 压缩空气源Controller 控制器Cutting knife 造粒刀Drum lid 桶盖Drum 盛料筒Discharge hole 出料口Stirrer 搅拌器Driving belt 传送皮带Machine base 机座Fluid bed granulator 流化床制粒机Hot air circulating oven 热风循环烘箱Heater 加热器Fan 风扇Filter gauze 滤网Mixing machine 混合机Quality test 质量检查Weight difference 片重差异Hardness 硬度Rigidity 脆碎度Rotary tablet press 旋转式压片机Die 冲模Punch 冲头Upper punch 上冲Upper pinch roller 上压轮Filling support 填充架Powder scraper 刮粉器Die 模圈Lower punch 下冲Tablet weight adjuster 片中调节器Lower pinch roller 下压轮ourlet adjuster 出片调节器coating 包衣isolated layer 隔离层sub-coating layer 粉衣层sugar-coating layer 糖衣层colored sugar-coating layer 有色糖衣层polishing 打光coating machine / coater 包衣机sidedoor 侧门upper box 上箱体lower box 下箱体airtight chamber 密闭工作室coating platen 包衣滚筒big sprocket 大链轮tensioner 涨紧轮cycle chain 链条washing pan 清洗盘small sprocket 小链轮electromotor 电动机capsule filling machine 胶囊填充机adjusting screw 填充杆调节螺钉upper die-set 上模架column 立柱powder loop 盛粉环metering plate 计量盘lock screw 锁紧螺钉fixed screw 固定螺钉gland flange 压板scale 标尺cover 盖板filling bar 填充杆powder scraper 刮粉器hopper 胶囊料斗liner bearing 直线轴承fork slider 拨叉滑块sliding valve 滑动门阀knob 旋钮baffle 挡板fastening screw 紧固螺钉order fork 顺序叉shifting fork 胶囊拨叉inverted trough 胶囊导槽lyophilized products / freeze drying preparation 冻干产品personnel 人员equipment 设备materials 物料regulations 法规environment 环境cross-contamination 交叉污染positive pressure 正压negative pressure 负压weighing room 称量室downflow booth 垂直层流工作室fan drive system 风机驱动系统HEPA filterHigh efficiency particulate air filter 高效过滤器Bleed air 排风Containment zone 控制区Background environment 背景环境Clean area 洁净区Grade A BUnclean area 一般区Differential pressure 压差Air speed 风速Temperature 温度Humidity 湿度Electronic balance 电子天平Operation keys 操作键Display with backlight 背光显示屏Model plate 型号标牌Draft shield element 放风圈Weighing pan 秤盘Draft shield 防风罩Leveling feet 水平调节脚Hager 秤钩AC adapter socket 交流电源适配器插座Interface 接口Solution preparation 配液Thick preparation 浓配Thin preparation 稀配Tanks for solution preparation 配液灌Sight glass 视镜Hatch 人孔Liquid level meter 液位计Liquid outlet 出液口Condensate water 冷凝水Steam inlet 蒸汽入口Automatic control 自动化控制Sterile filtration 无菌过滤Clean in place 在线清洗Sterilization in place 在线灭菌Critical process parameter 关键工艺参数Visible particles 可见异物Pressure parameter 压力参数Process water 工艺用水Drinking water 饮用水Purified water 纯化水Water for injection (WFI) 注射用水Cooling / chilled water 冷冻水Pure steam 纯蒸汽Compressed air 压缩空气Activated carbon 活性炭Adsorbent temperature 吸附温度Circulating temperature 循环温度Pass box 传递窗Stainless steel nozzle 不锈钢喷嘴Vision glass 观察窗High strength hinge 高强度合页Pass window 传递窗Air handling panel 通风板Handle 把手Electronic interlock 电子互锁机构Primary meshed plate 初校网孔板Purification fan unit 净化风机Differential pressure gauge 压差表Intercom device 对讲机Ultraviolet lamp 紫外灯Unpowered roller 无动力滚筒Cleaning and sterilization 清洗灭菌Filter element 过滤器滤芯Visible foreign matters 可见异物Insoluble particles 不溶性微粒Autoclave 高压灭菌器Document 文件Record 记录Report 报告Vial washing machine 洗瓶机Vertical ultrasonic washing machine 立体超声波清洗机Cycle index 循环次数Sterilizing and drying 灭菌干燥Heated air circulation sterilizing oven 热风循环烘箱Tunnel sterilizing oven 隧道烘箱Suction blower 吸风机Laminar flow 层流Valve 阀门Plenum chamber 静压箱Air bellow 风箱、Surface air cooler 表冷器Net belt 网带Rubber stopper cleaning machine 胶塞清洗机Bacterial endotoxin 细菌内毒素Filling and partially stoppering 灌装和半加塞Filling machine 灌装机Content adjustment 装量调节Laminar flow protection 层流保护Content uniformity 装量差异Samples 样品Stoppering system 加塞系统Feeding system 上料系统Freeze-drying system 冻干系统Sublimation 升华Desorption 解吸附Freeze dryer /lyophilizer 冻干机Chamber 冻干箱Shelves 板层Condense 冷肼Hydraulic 液压Circulation system 循环系统Vacuum system 真空系统Control system 控制系统Refrigeration system 制冷系统Compressor 压缩机Condensor 冷凝器Expansion valve 膨胀阀Evaporator 蒸发器Oil pump 油泵Crankcase heater 曲轴箱加热器Intake port 吸气口Junction box 接线盒Flusher 喷洒装置Mameplate 名牌Safety valve 安全阀Vacuum gauge 真空计Electrical heater 电加热Plate heat exchanger 板式加热器Pressure gauge 压力表Relay 继电器Pneumatic ball valve 气动球阀Diaphragm valve 隔膜阀Rolling cover operation 扎盖Rolling-cover machine 轧盖机Turntable 转台Orbit 轨道Bottle distribution 理瓶Capping structure 压盖结构Main motor 主电机Operation panel 操作面板Loading & unloading system 进出料系统Artificial feeding system 人工上料系统Laminar car 层流车Battery container 蓄电池箱Universal wheel 万向轮Fan filter unit 风机过滤单元Barrier system 隔离系统Isolator 隔离器Glove box 手套箱Half suit 半身衣。

317个制药行业的英语词汇

制药行业的英语词汇制药行业常用英语词汇（中英对照）1、药品生产质量管理规范GMP：Good ManufacturingPractice2、国家食品与药品监督管理局State Food andDrug Administration3、总则GeneralProvisions4、《中华人民共和国药品管理法》the DrugAdministration Law of the People's Republic of China5、制剂Preparation6、原料药API: Active PharmaceuticalIngredient7、成品finished goods8、工序process9、机构与人员organization and personnel10、专业知识professional knowledge11、生产经验production experience12、组织能力organizational skill13、技术人员technical staff14、实施implementation15、药品生产pharmaceutical manufacturing 16、质量管理quality management17、质量检验quality inspection18、专业技术培训professional and technicaltraining 19、基础理论知识basic theoreticalknowledge20、实际操作技能practical operationskills 21、高生物活性highly potent22、高毒性high toxicity23、污染contamination24、考核评估assessment25、厂房与设施buildings and facilities 26、生产环境production environment 27、空气洁净级别clean air level28、昆虫insect29、洁净室（区）clean room(area)30、光滑smooth31、无裂缝no cracks32、无颗粒物脱落no particle shedding 33、耐受endure34、消毒disinfection35、无菌sterile36、交界处junction, joint37、弧形arc38、灰尘积聚dues accumulation 39、储存区store area40、生产规模production scale 41、设备equipment42、物料material43、中间产品intermediate product 44、待验品quarantined material 45、交叉污染cross-contamination 46、管道pipeline, ductwork47、风口tuber48、公用设施, 公用工程utilities of publicservice 49、照明lighting50、照度illumination。