常用药学中英文词汇知识整合对照

1、生产工艺常用词汇:中文英文单硫酸卡那霉素Kan amyc in 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 wash ing安瓿瓶火菌除热源Ampoulesterilizati onanddepyroge nati on配料Batch ing过滤Filtrati on灌封Filli ng and seali ng火菌和检漏测试Sterilization and leakage test灯

2、检Visual / Lamp in spect ion贴签和包装Labeli ng and packagi ng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-filling nitrogen flush灌装后充氮保护post-filling

3、nitrogen overlay真空检漏测试Vacuum leak test内包材Primary packaging materialProcess in structio nLivz onGroupFuzhouFux ingPharmaceutical Co. Ltd.Hunan Erka ng Pharmaceutical Co., LtdHunan Huari Pharmaceutical Co., LtdGuan gzhou Chemical Reage nt FactoryZhuhai Da Lin Wan In dustrialGas Co.,LtdSCHOTT Glass Tec

4、hno logies (Suzhou)Co. Ltdquality specificatio nCirculati 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Sterility薄膜过滤法Membrane

5、filtration method内毒素Bacterial en dotox insIn itial bioburde nstirring uniformityashy toppoin ted endbubble head, flat head, broke n ampoule, crookedampoule, empty ampoule;中文英文药品生产质量管理规范GMP: Good Manu facturi ngPractice国家食品与药品监督管理局State Food and Drug Admi nistratio n总则Gen eral Provisi ons制剂preparati

6、on原料药API: Active PharmaceuticalIn gredie nt成品fini shedgoods工序process机构与人员orga ni zati on and pers onnel专业知识professi onalkno wledge生产经验product ionexperie nee组织能力orga ni zati onalskill技术人员tech ni cal staff实施impleme ntati on药品生产pharmaceuticalmanu facturi ng质里官理quality man ageme nt质里检验qualityin spect io

7、n专业技术培训professionaland technical training基础理论知识basic theoretical knowledge实际操作技能practicaloperati onskills高生物活性highlypote 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product ionenvironment空气洁净级别clean air level昆虫in sect洁净室（区）clea n room(area)光滑smooth无裂缝no crac

8、ks无颗粒物脱落no particle shedding耐受tolera nee消毒dis in fecti on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product ionscale设备equipme nt物料material中间产品in termediateproduct待验品quara nti nedmaterial交叉污染cross-c on tam in atio n管道pipeli ne公用设施utilities of public service照明lighting照度illum

9、i natio n应急，紧急情况emerge ncy净化purification, clean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 ngroom, filli ngroom相对负压relative n egative pressure废

10、气waste gas, exhausted airB内酰胺结构类药品3-Lactams structuredrug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-detoxificationand post detoxification活疫苗与灭活疫苗active vacc ine/in activatedvacc

11、i ne人血液制品blood products预防制品preve nti onproducts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 animal, organ of animal炮制con cocted通风ven tilatio n除烟smoke removal除尘dust removal降温设施temperature-reduci ng establishme nt,cooli ng筛选scree ning切片slici

12、ng粉碎grinding压缩空气compressed air惰性气体no ble gas取样sampli ng称量室weighi ng room中药标本Chinese herbal sample, exemplar of TCM检定鉴定verification, identification同位素Isotope设备equipme nt选型model/type select ion耐腐蚀an ticorrosi on吸附adsorpti on, absorpti on润滑剂，润滑lubrica nt, lubricate冷却剂coola nt流向flow directi on纯化水PW: Pur

13、ified Water注射用水WFI: Water for Injection滋生breedi ng储罐tank死角n eglectedporti 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precisio n维修、保养maintenance不合格disqualified物料material购买purchas ing发放releas ing产地origin固体solid液体liquid挥发性volatile净药材net medici

14、ne, net TCM麻醉药品n arcotics精神药品psychotropicdrug易燃combustible易爆explosive验收accepta nee使用说明书in structio n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 ngingroom工作服，work clothes颗粒性物质，颗粒剂granu les耐药菌株drug-resista ntstra in传染病in fectiousdisease皮肤病dermatosis验证ver

15、ificati on, validati on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applicati on稳定性stability起草draft生产管理product ion man ageme nt,manu facturi

16、ngcontrol.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internalcon 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 adversereact ionreport自检self- in specti on附则appe ndix平衡bala nee饮用水drinking water蒸馏法distillatio

17、n离子父换法ion exchange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-releasing filter活性成份ActiveIn gredie nt非活性成份In active in gredie nt中间产品in termediateproduct批号batch nu mber药用物料medicated feed药用预混合料medicated premix质量控制部门Qualitycon troldepartme nt理论产量T

18、heoretical 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mitigati on化学变化chemicalcha nge组分in gredie nt, comp onent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unit

19、 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,sterileoperati on层流lam inar flow湍流turbule ntair flow空气过滤air filtration空气加热air heating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

20、料orga nicwaste杀鼠剂rode nticides杀昆虫剂in secticides杀真菌剂fun gicides熏烝剂fumigati ngreage nts去垢剂clea ningage 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automatic, mechanical, or electronicequipme设备nt微型胶卷microfilm注射剂injectio n火菌设备sterilization equipment无菌取样技术aseptic sampli ng tech niq ues显微镜microsc

21、ope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iden tify片剂tablet胶囊capsule颗粒剂granule溶解时间dissoluti ontime澄明度clarity隔离系统isolatio n system返工reprocess ing发放issua nee, release非处方药OTC: over-the-counter处方药prescription medicine保险包装tamper-resista ntpackage明胶硬胶囊hard gelat

22、i ncapsule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ophthalmicoin tme nt粗糙或磨蚀物质harsh or abrasive substances控释制剂con trolled-releasedosage form实验动物laboratoryani mals供应商supplier光谱spectrum测量单位units of measure换算系数conversion factors试剂reage nt安慰剂placebo明确地explicitly取