常用药学中英文词汇对照.doc

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1、.生产工艺常用词汇：中文英文单硫酸卡那霉素Kanamycinsulfate硫酸氢钠sodiumbisulfate枸橼酸钠sodiumcitrate硫酸溶液Sulfuricacidsolution中性硼玻璃安瓿瓶Neutralborosilicateglassampoule安瓿瓶清洗Ampoulewashing安瓿瓶灭菌除热源Ampoulesterilizationanddepyrogenation配料Batching过滤Filtration灌封Fillingandsealing灭菌和检漏测试Sterilizationan

2、dleakagetest灯检Visual/Lampinspection贴签和包装Labelingandpackaging关键工艺参数CriticalProcessParameter升温段heatingsection传送带conveyorbelt压差Differentialpressure时间间隔Timeinterval过滤器孔径Poresizeoffilter过滤压力Filtrationpressure灌装量Fillingvolume缓冲罐buffertank灌装前充氮保护pre-fillingnitrogenflush

3、灌装后充氮保护post-fillingnitrogenoverlay真空检漏测试Vacuumleaktest内包材PrimarypackagingmaterialProcessinstructionLivzonGroupFuzhouFuxingPharmaceuticalCo.Ltd.HunanErkangPharmaceuticalCo.,LtdHunanHuariPharmaceuticalCo.,LtdGuangzhouChemicalReagentFactoryZhuhaiDaLinWanIndustrialGa

4、sCo.,LtdSCHOTTGlassTechnologies(Suzhou)Co.LtdqualityspecificationCirculationwaterRotatingspeed资料..QC常用英文词汇中文英文物理性状Physicalattributes外观Appearance不溶性微粒Particulatematter溶液颜色Solutioncolor鉴别Identification保留时间retentiontime含量Assay有关物质Relatedsubstance标示量labeledamount可见异物

5、Visibleparticles无菌Sterility薄膜过滤法Membranefiltrationmethod内毒素BacterialendotoxinsInitialbioburdenstirringuniformityashytoppointedendbubblehead,flathead,brokenampoule,crookedampoule,emptyampoule;中文英文药品生产质量管理规范GMP:GoodManufacturingPractice国家食品与药品监督管理局StateFoodandDrugA

6、dministration总则GeneralProvisions制剂preparation原料药API:ActivePharmaceuticalIngredient成品finishedgoods工序process机构与人员organizationand personnel专业知识professionalknowledge资料..生产经验productionexperience组织能力organizationalskill技术人员technicalstaff实施implementation药品生产pharmaceutica

7、lmanufacturing质量管理qualitymanagement质量检验qualityinspection专业技术培训professionalandtechnicaltraining基础理论知识basictheoreticalknowledge实际操作技能practicaloperationskills高生物活性highlypotent高毒性hightoxicity污染contamination考核评估assessment厂房与设施buildingsand facilities生产环境productionenvir

8、onment空气洁净级别cleanairlevel昆虫insect洁净室（区）cleanroom(area)光滑smooth无裂缝nocracks无颗粒物脱落noparticleshedding耐受tolerance消毒disinfection无菌sterile交界处junction,joint弧形arc灰尘积聚du