常用药学中英文词汇对照.docx

1、常用药学中英文词汇对照生产工艺常用词汇:中文英文单硫酸卡那霉素Kan amyci n sulfate硫酸氢钠sodium bisulfate枸橼酸钠sodium citrate硫酸溶液Sulfuric acid soluti on中性硼玻璃安瓿瓶Neutral borosilicate glass ampoule安瓿瓶清洗Ampoule washi ng安瓿瓶火菌除热源Ampoule sterilization and depyrogenation配料Batch ing过滤Filtrati on灌封Filli ng and seali ng火菌和检漏测试Sterilization and le

2、akage test灯检Visual / Lamp in spect ion贴签和包装Labeli ng and packag ing关键工艺参数Critical Process Parameter升温段heati ng sect ion传送带con veyor belt压差Differen tial pressure时间间隔Time in terval过滤器孔径Pore size of filter过滤压力Filtrati on pressure灌装量Filli ng volume缓冲罐buffer tank灌装前充氮保护pre-fill ing n itroge n flush灌装后充氮保

3、护post-filli ng n itroge n overlay真空检漏测试Vacuum leak test内包材Primary packaging materialProcess in structio nLivz on Group Fuzhou Fux ingPharmaceutical Co. Ltd.Hunan Erka ng Pharmaceutical Co., LtdHunan Huari Pharmaceutical Co., LtdGuan gzhou Chemical Reage nt FactoryZhuhai Da Lin Wan In dustrial Gas Co

4、., LtdSCHOTT Glass Tech no logies (Suzhou) Co.Ltdquality specificati onCirculati on waterRotati ng speedQC常用英文词汇中文英文物理性状Physical attributes外观Appeara nee不溶性微粒Particulate matter溶液颜色Soluti on color鉴别Ide ntificati on保留时间retention time含量Assay有关物质Related substa nee标小量labeled amount可见异物Visible particles无菌S

5、terility薄膜过滤法Membrane filtration method内毒素Bacterial en dotox insIn itial bioburde nstirring uniformityashy toppoin ted endbubble 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Gen eral Prov

6、isi ons制剂preparati on原料药API: Active Pharmaceutical In gredie nt成品fini shed goods工序process机构与人员orga ni zatio n and pers onnel专业知识professi onal kno wledge生产经验producti on experie nee组织能力orga ni zati onal skill技术人贝tech ni cal staff实施impleme ntati on药品生产pharmaceutical manu facturi ng质里官理quality man ageme

7、 nt质里检验quality in spect ion专业技术培训professi onal and tech nical training基础理论知识basic theoretical kno wledge实际操作技能practical operati on skills高生物活性highly pote nt咼毒性high toxicity污染con tam in ati on考核评估assessme nt厂房与设施buildi ngs and facilities生产环境producti on en vir onment空气洁净级别clea n air level昆虫in sect洁净室（

8、区）clea n room(area)光滑smooth无裂缝no cracks无颗粒物脱落no particle sheddi ng耐受tolera nee消毒dis in fecti on无菌sterile交界处junction, jo int弧形arc灰尘积聚dust accumulati on储存区store area生产规模producti on scale设备equipme nt物料material中间产品in termediate product待验品quarantined material交叉污染cross-c on tam in ati on管道pipeli ne公用设施uti

9、lities of public service照明lighting照度illumi natio n应急，紧急情况emerge ncy净化purificati on, clea n微生物，微生物学，微生物的micro-orga ni sm, microbiology, microbiologic监测mon itori ng记录record天棚 天花板ceili ng, roof密封seal静压差Static Differe ntial Pressure温度temperature相对湿度RH: Relative Humidity地漏floor drainer分装室separati ng room

10、, filli ng room相对负压relative n egative pressure废气waste gas, exhausted air内酰胺结构类药品3 -Lactams structure drug避孕药品con traceptives激素类horm one抗肿瘤类an ti-tumor, on cology放射性药品Radiopharmaceuticals包装pack ing, package循环使用recycli ng微粒particles辐射radiati on细菌bacteria病毒virus细胞cell脱毒前后Pre-detoxificati on and post de

11、toxificati on活疫苗与灭活疫苗active vacci ne/i nactivated vacci ne人血液制品blood products预防制品preve nti on products灌装filli ng中药Chin ese traditi onal medici nes前处理pretreatme nt提取extractio n浓缩concen trati on动物脏器viscera of ani mal, orga n of ani mal炮制con cocted通风ven tilatio n除烟smoke removal除尘dust removal降温设施tempera

12、ture-reduc ing establishme nt, cooli ng筛选scree ning切片slici ng粉碎grinding压缩空气compressed air惰性气体n oble gas取样sampli ng称量室weighi ng room中药标本Chin ese herbal sample, exemplar of TCM检定 鉴定verificati on, ide ntificatio n同位素Isotope设备equipme nt选型model/type selecti on耐腐蚀an ticorrosi on吸附adsorpti on, absorptio n润

13、滑剂，润滑lubrica nt, lubricate冷却剂coola nt流向flow directi on纯化水PW: Purified Water注射用水WFI: Water for Injectio n滋生breed ing储罐tank死角n eglected porti on盲管bli nd pipe纤维fiber疏水性hydrophobicity仪表in strume ntati on量具measuri ng tool衡器weigh ing in strume nt精密度precisi on维修、保养maintenance不合格disqualified物料material购买purc

14、has ing发放releas ing产地origi n固体solid液体liquid挥发性volatile净药材net medic ine, net TCM麻醉药品n arcotics精神药品psychotropic drug易燃combustible易爆explosive验收accepta nee使用说明书in structi on标签label卫生hygie ne车间workshop间隔时间time in terval清洁剂deterge nt消毒剂dis in fecta nt废弃物wastes更衣室cha nging room工作服，work clothes颗粒性物质，颗粒剂gran

15、u les耐药菌株drug-resista nt stra in传染病in fectious disease皮肤病dermatosis验证verification, validation确认qualificati on安装in stallati on运行running operati on性能performa nee原辅料raw material and excipie nt文件docume nt投诉complai nt报废reject品名product n ame处方prescripti on, formula技术参数tech ni cal parameter容器container申请app

16、licati on稳定性stability起草draft生产管理producti on man ageme nt, manu facturi ng con trol.混淆mix-up喷雾spray合格证certificate清场cleara nee质里官理quality man ageme nt内控in ternal con trol滴定液titra nt培养基medium有效期validity, expiry date, shelf life产品销售与收回product sales and recall投诉与不良反应报告compla ints and adverse react ion re

17、port自检self- in spect ion附则appe ndix平衡bala nee饮用水drinking water蒸馏法distillatio n离子交换法ion excha nge反渗透法RO: Reverse Osmosis附加剂添加剂additives滞留stra nded resort批batch, lot组分，组成comp onent无纤维脱落的过滤器non-fiber-releas ing filter活性成份Active In gredie nt非活性成份In active in gredie nt中间产品in termediate product批号batch nu

18、mber药用物料medicated feed药用预混合料medicated premix质量控制部门Quality con trol departme nt理论产量Theoretical yield实际产量Actual yield比率Perce ntage, rate验收标准可接受标准Accepta nee criteria代表性样品Represe ntative sample微粒状的particulate污染物con tam inant石棉asbestos诊断diag no sis缓解mitigatio n化学变化chemical cha nge组分in gredie nt, comp on

19、ent制备fabricate preparati on复合compo und混合ble nd加工process ing浓度concen trati on单位剂量un it dose药品包装容器drug product containers密圭寸件，圭寸盖closure效价titer纯度purity规格stre ngth监督supervise, mon itor实验室laboratory无菌操作aseptic operati on, sterile operati on层流lam inar flow湍流turbule nt air flow空气过滤air filtrati on空气加热air h

20、eati ng预过滤器Pre-filter排气系统exhaust system管件plumbi ng污水sewage废料refuse空气干燥器air drier垃圾trash有机废料orga nic waste杀鼠剂rode nticides杀昆虫剂in secticides杀真菌剂fun gicides熏烝剂fumigati ng reage nts去垢剂clea ning age nts消毒剂san itiz ing age nts滂沱剂lubrica nt自动化设备、机械化设备和电子设备automatic, mecha ni cal, or electr onic equipme nt微

21、型胶卷microfilm注射剂injectio n火菌设备sterilizatio n equipme nt无菌取样技术aseptic sampli ng tech niq ues显微镜microscope热源，内毒素pyroge n, en dotox in偏差deviati on变更cha nge con trol进料charge-i n项目代码item code鉴别identify片剂tablet胶囊capsule颗粒剂granule溶解时间dissolution time澄明度clarity隔离系统isolati on system返工reprocess ing发放issua nee,

22、 release非处方药OTC: over-the-co un ter处方药prescripti on medici ne保险包装tamper-resista nt package明胶硬胶囊hard gelati n capsule顺势治疗homeopathic入库warehous ing变质deteriorate准确性accuracy灵敏性sen sitivity特异性specificity重复性reproducibility, repeatability变应原提取物allerge nic extracts眼膏ophthalmic oin tme nt粗糙或磨蚀物质harsh or abra

23、sive substa nces控释制剂con trolled-release dosage form实验动物laboratory ani mals供应商supplier光谱spectrum测量单位un its of measure换算系数con vers ion factors试剂reage nt安慰剂placebo明确地explicitly取代supersede溶液solutio n批准approval（美国）食品药品监督管理局FDA: Food and Drug Admi nistratio n标准操作程序SOP: Stan dard Operati ng Procedure质量保证QA

24、: Quality Assura nee质里控制QC: Quality Con trol批生产记录BPR: Batch Production Record批检验记录BAR: Batch An alysis Record工艺规程PP: Process Procedure健康，安全,环保EHS: Environment, Health and Safe美国联邦法规CFR: Code of Federal Regulation美国药典USP: The Un ited States Pharmacopeia欧洲药典EP: Europea n pharmacopeia英国药典BP: British ph

25、armacopeia药物主文件DMF: Drug Master File验证主计划VMP: Validatio n Master Pla n验证方案VP: Validatio n Protocol验证报告VR: Validatio n Report安装确认IQ: In stallati on Qualificati on运行确认OQ: Operati on Qualificati on性能确认PQ: Performa nee Qualificatio n超出标准（限度）OOS: Out of Specificati on冻干产品freeze-dry product, lyophilized product工厂主述文件SMF: Site Master File