常用药学中英文词汇对照

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. . 生产工艺常用词汇: 中文 英文 单硫酸卡那霉素 Kanamycin sulfate

硫酸氢钠 sodium bisulfate 枸橼酸钠 sodium citrate 硫酸溶液 Sulfuric acid solution 中性硼玻璃安瓿瓶 Neutral borosilicate glass ampoule 安瓿瓶清洗 Ampoule washing 安瓿瓶灭菌除热源 Ampoule sterilization and depyrogenation 配料 Batching 过滤 Filtration 灌封 Filling and sealing 灭菌和检漏测试 Sterilization and leakage test 灯检 Visual / Lamp inspection 贴签和包装 Labeling and packaging 关键工艺参数 Critical Process Parameter

升温段 heating section 传送带 conveyor belt 压差 Differential pressure 时间间隔 Time interval 过滤器孔径 Pore size of filter 过滤压力 Filtration pressure 灌装量 Filling volume 缓冲罐 buffer tank 灌装前充氮保护 pre-filling nitrogen flush 灌装后充氮保护 post-filling nitrogen overlay 真空检漏测试 Vacuum leak test 内包材 Primary packaging material

Process instruction Livzon Group Fuzhou Fuxing Pharmaceutical Co. Ltd. Hunan 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) Co. Ltd quality specification Circulation water Rotating speed . . QC常用英文词汇 中文 英文 物理性状 Physical attributes 外观 Appearance 不溶性微粒 Particulate matter 溶液颜色 Solution color 鉴别 Identification 保留时间 retention time 含量 Assay 有关物质 Related substance 标示量 labeled amount 可见异物 Visible particles 无菌 Sterility 薄膜过滤法 Membrane filtration method 内毒素 Bacterial endotoxins Initial bioburden stirring uniformity ashy top pointed end bubble head, flat head, broken ampoule, crooked ampoule, empty ampoule;

中文 英文 药品生产质量管理规范 GMP: Good Manufacturing Practice 国家食品与药品监督管理局 State Food and Drug Administration 总则 General Provisions 制剂 preparation 原料药 API: Active Pharmaceutical Ingredient 成品 finished goods 工序 process 机构与人员 organization and personnel 专业知识 professional knowledge . . 生产经验 production experience 组织能力 organizational skill 技术人员 technical staff 实施 implementation 药品生产 pharmaceutical manufacturing 质量管理 quality management 质量检验 quality inspection 专业技术培训 professional and technical training 基础理论知识 basic theoretical knowledge 实际操作技能 practical operation skills 高生物活性 highly potent 高毒性 high toxicity 污染 contamination 考核评估 assessment 厂房与设施 buildings and facilities 生产环境 production environment 空气洁净级别 clean air level 昆虫 insect 洁净室(区) clean room(area) 光滑 smooth 无裂缝 no cracks 无颗粒物脱落 no particle shedding 耐受 tolerance 消毒 disinfection 无菌 sterile 交界处 junction, joint 弧形 arc 灰尘积聚 dust accumulation 储存区 store area 生产规模 production scale 设备 equipment 物料 material 中间产品 intermediate product 待验品 quarantined material . . 交叉污染 cross-contamination 管道 pipeline 公用设施 utilities of public service 照明 lighting 照度 illumination 应急,紧急情况 emergency 净化 purification, clean 微生物, 微生物学, 微生物的 micro-organism, microbiology, microbiologic 监测 monitoring 记录 record 天棚 天花板 ceiling, roof 密封 seal 静压差 Static Differential Pressure 温度 temperature 相对湿度 RH: Relative Humidity 地漏 floor drainer 分装室 separating room, filling room 相对负压 relative negative pressure 废气 waste gas, exhausted air β-内酰胺结构类药品 β-Lactams structure drug 避孕药品 contraceptives 激素类 hormone 抗肿瘤类 anti-tumor, oncology 放射性药品 Radiopharmaceuticals 包装 packing, package 循环使用 recycling 微粒 particles 辐射 radiation 细菌 bacteria 病毒 virus 细胞 cell 脱毒前后 Pre-detoxification and post detoxification 活疫苗与灭活疫苗 active vaccine/inactivated vaccine 人血液制品 blood products . . 预防制品 prevention products 灌装 filling 中药 Chinese traditional medicines 前处理 pretreatment 提取 extraction 浓缩 concentration 动物脏器 viscera of animal, organ of animal 炮制 concocted 通风 ventilation 除烟 smoke removal 除尘 dust removal 降温设施 temperature-reducing establishment, cooling 筛选 screening 切片 slicing 粉碎 grinding 压缩空气 compressed air 惰性气体 noble gas 取样 sampling 称量室 weighing room 中药标本 Chinese herbal sample, exemplar of TCM 检定 鉴定 verification, identification 同位素 Isotope 设备 equipment 选型 model/type selection 耐腐蚀 anticorrosion 吸附 adsorption, absorption 润滑剂, 润滑 lubricant, lubricate 冷却剂 coolant 流向 flow direction 纯化水 PW: Purified Water 注射用水 WFI: Water for Injection 滋生 breeding 储罐 tank 死角 neglected portion