常用药学中英文词汇对照

1、学习文档 仅供参考学习文档 仅供参考生产工艺常用词汇：中文硫酸氢钠枸橼酸钠硫酸溶液中性硼玻璃安瓿瓶安瓿瓶清洗配料灯检贴签和包装 升温段传送带压差时间间隔 过滤压力 灌装量缓冲罐真空检漏测试 内包材英文Kanamycin sulfate sodium bisulfate sodium citrate Sulfuric acid solutionNeutral borosilicate glass ampoule Ampoule washingAmpoule sterilization and depyrogenation BatchingFiltrationFilling and sealing

2、 Sterilization and leakage test Visual / Lamp inspection Labeling and packaging Critical Process Parameterheating section conveyor belt Differential pressure Time intervalPore size of filter Filtration pressure Filling volume buffer tankpre-filling nitrogen flush post-filling nitrogen overlay Vacuum

3、 leak testPrimary packaging materialProcess instructionLivzonGroupPharmaceutical Co. Ltd.FuxingHunan Erkang Pharmaceutical Co., Ltd Hunan Huari Pharmaceutical Co., Ltd Guangzhou Chemical Reagent Factory Zhuhai Da Lin Wan Industrial Gas Co., Ltd SCHOTT Glass Technologies(Suzhou) Ltdquality specificat

4、ion Circulation water Rotating speedQC中文外观溶液颜色 鉴别含量标 示 量 无菌薄膜过滤法内毒素英文Physical attributes Appearance Particulate matter Solution color Identification retention time AssayRelated substance labeled amount Visible particles SterilityMembrane filtration method Bacterial endotoxinsInitial bioburdenstirrin

5、g uniformity ashy toppointed endbubblehead,flathead,brokencrooked ampoule, emptyampoule;中文药品生产质量管理标准总则制 剂 成 品 工序机构与人员专业知识英文GMP: Good Manufacturing Practice State Food and Drug Administration General ProvisionspreparationAPI: Active Pharmaceutical Ingredient finished goodsprocessorganization and pers

6、onnel professional knowledge生产经验组织能力技术人员实施药品生产质量管理质量检验高生物活性 高毒性污染考核评估 生产环境昆虫光滑无裂缝耐受消 毒 无 菌 弧形储 存 区 设备物料中间产品待验品production experience organizational skill technical staff implementation pharmaceutical quality managementquality inspectionprofessional and technical training basic theoretical knowledge p

7、ractical operation skillshighly potent high toxicity contamination assessmentbuildings and facilities production environment clean air levelinsectclean room(area) smoothno cracksno particle shedding tolerance disinfectionsterile junction, joint arcdust store area production scale equipment materiali

8、ntermediate quarantined 管道照明照度净化监测记录天棚天花密封温度地漏分 装 室 废气避孕药品激 素 类 包装微粒脱毒前后活疫苗与灭活疫苗人血液制品cross-contamination pipelineutilities of public lightingillumination emergency purification, micro-organism, microbiology, microbiologic monitoringrecord ceiling, roof sealStatic Differential Pressure temperatureRH:

9、 Relative Humidity floor drainerseparating room, filling room relative negative pressure waste gas, exhausted air-Lactams structure drug contraceptiveshormoneanti-tumor, oncology Radiopharmaceuticals packing, package recyclingparticles radiation bacteria virus cellPre-detoxification and post detoxif

10、ication active vaccine/inactivated vaccineblood products灌装中药prevention products fillingChinese traditional medicines前处理动物脏器炮制降温设施筛选压缩空气惰性气体取样称 量 室 中药标本检定设 备 选 型 吸附润滑剂,鉴定润滑pretreatmentextraction concentrationviscera of animal, organ of animal concoctedventilation smoke removal dust removaltemperature

11、-reducing establishment, cooling screeningslicing grinding compressed air noble gas sampling weighing roomChinese herbal sample, exemplar of TCM verification, identificationIsotope equipmentmodel/type selection anticorrosion adsorption, absorptionlubricant, lubricate冷却剂流 向 纯化水注射用水滋生储罐死角coolantflow d

12、irectionPW: Purified WaterWFI: Water for Injection breedingtankneglected portion盲管纤 维 仪 表 量 具 衡 器 不合格物 料 购 买 发 放 产 地 固 体 液 体 易燃标签间隔时间blind pipefiber hydrophobicity instrumentation measuring tool weighing instrument precision maintenance disqualified materialpurchasing releasing origin solid liquid v

13、olatilenet medicine, net narcotics psychotropic drug combustibleexplosive acceptance instruction label hygiene workshoptime interval清洁剂消毒剂废弃物更衣室工作服,颗粒性物质,耐药菌株颗粒剂detergent disinfectant wastes changing room work clothes granulesdrug-resistant strain传染病皮肤病验 证 确 认 安 装 运 行 性 能 原辅料文 件 投 诉 报 废 品 名 处方技术参数容

14、器 申 请 稳定性起草生产管理混 淆 喷 雾 清场内控滴定液培养基有效期产品销售与收回投诉与不良反应报告自检附 则 平 衡 饮用水infectious disease dermatosisverification, validation qualification installationrunning operation performanceraw material and excipient documentcomplaint reject product nameprescription, formula technical parameter containerapplication

15、 stability draftproduction management, manufacturing l.mix-up spray certificate clearancequality management internal control titrantmediumvalidity, expiry date, shelf life product sales and recallcomplaints and adverse reaction report self-inspectionappendix balance drinking water蒸馏法离子交换法反渗透法附加剂添加剂滞

16、留批组分, 组成无纤维脱落的过滤器活性成份中间产品 批号药用物料理论产量实际产量比率验收标准可接受标准代表性样品污 染 物 石棉组分单位剂量药品包装容器distillation ion exchangeRO: Reverse additivesstranded batch, lot componentnon-fiber-releasing filter Active IngredientInactive ingredient intermediate product batch number medicated feed medicated premixQuality controlTheor

17、etical yieldActual yield Percentage, rate Acceptance criteria Representative sample particulate contaminantasbestos diagnosis mitigation chemical ingredient, component fabricate preparation compoundblend processing concentration unit dosedrug product containers密封件, 封盖效价纯 度 规 格 监 督 实验室层流湍流管件垃圾有机废料杀 鼠

18、 剂 杀昆虫剂杀真菌剂熏 蒸 剂 去 垢 剂 消 毒 剂 滂沱剂自动化设备、机械化设备和电子设备微型胶卷注 射 剂 灭菌设备无菌取样技术显微镜热源, 内毒素偏差closure titer purity strengthsupervise, monitor laboratoryaseptic operation, sterile operation laminar flowturbulent air flow air filtrationair heating Pre-filter exhaust plumbing sewagerefuse air trashorganic waste rode

19、nticides insecticides fungicides fumigating reagents cleaning agents sanitizing agents lubricantautomatic, mechanical, or electronic tmicrofilm injectionsterilization equipment aseptic sampling techniques microscopepyrogen, endotoxin deviation鉴别片 剂 胶 囊 颗粒剂澄 明 度 返工发放非处方药处 方 药 保险包装顺势治疗 入库变 质 准确性灵敏性特异性

20、重复性变应原提取物眼膏粗糙或磨蚀物质控释制剂供 给 商 光谱试剂抚慰剂change control charge-initem code identify tablet capsule granuledissolution time clarity isolation reprocessingissuance, release OTC: over-the-counter prescription tamper-resistant hard gelatin capsule homeopathicwarehousing deteriorate accuracy sensitivity specificityreproducibility, allergenic extractsophthalmic ointmentharsh or abrasive substances controlled-release dosage form laboratory animalssupplier spectrumunits of measure conversion reage