医药行业专业英语词汇非常有用 (2)教学资料.doc

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1、Good is good, but better carries it.精益求精,善益求善。医药行业专业英语词汇非常有用 (2)-FDA和EDQM术语:CLINICALTRIAL:临床试验ANIMALTRIAL:动物试验ACCELERATEDAPPROVAL:加速批准STANDARDDRUG:标准药物INVESTIGATOR:研究人员;调研人员PREPARINGANDSUBMITTING:起草和申报SUBMISSION:申报;递交BENIFIT(S):受益RISK(S):受害DRUGPRODUCT:药物产品DRUGSUBSTANCE:原料药ESTABLISHEDNAME:确定的名称GENERI

2、CNAME:非专利名称PROPRIETARYNAME:专有名称;INN(INTERNATIONALNONPROPRIETARYNAME):国际非专有名称ADVERSEEFFECT:副作用ADVERSEREACTION:不良反应PROTOCOL:方案ARCHIVALCOPY:存档用副本REVIEWCOPY:审查用副本OFFICIALCOMPENDIUM:法定药典(主要指USP、NF)USP(THEUNITEDSTATESPHARMACOPEIA):美国药典NF(NATIONALFORMULARY):(美国)国家处方集OFFICIALPHARMACOPEIAL=COMPENDIAL:药典的;法定的

3、;官方的AGENCY:审理部门(指FDA)IDENTITY:真伪;鉴别;特性STRENGTH:规格;规格含量(每一剂量单位所含有效成分的量)LABELEDAMOUNT:标示量REGULATORYSPECIFICATION:质量管理规格标准(NDA提供)REGULATORYMETHODOLOGY:质量管理方法REGULATORYMETHODSVALIDATION:管理用分析方法的验证COS/CEP欧洲药典符合性认证ICH(InternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceut

4、icalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。质量技术要求文件以Q开头,再以a,b,c,d代表小项:Q1:药品的稳定性Q2:方法学Q3:杂质Q4:药典Q5:生物技术产品质量Q6:标准规格Q7:GMPQ7a:(原料药的优良制造规范指南)药物活性成分的GMP.GMP英语PIC/S的全称为:PharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme,PIC/S(制药检查草案),药品检查协会(PIC/S),也有人称PIC/S为医药审查会议/

5、合作计划(PIC/S)PIC的权威翻译:药品生产检查相互承认公约API(ActivePharmaceuticalIngrediet)原料药又称:活性药物组分AirLock气闸AuthorizedPerson授权人Batch/Lot批次BatchNumber/Lot-Number批号;BatchNumberingSystem批次编码系统;BatchRecords批记录;BulkProduct待包装品;Calibration校正;Cleanarea洁净区;Consignmecnt(Delivery)托销药品。FDA(FOODANDDRUGADMINISTRATION):(美国)食品药品管理局IND

6、(INVESTIGATIONALNEWDRUG):临床研究申请(指申报阶段,相对于NDA而言);研究中的新药(指新药开发阶段,相对于新药而言,即临床前研究结束)NDA(NEWDRUGAPPLICATION):新药申请ANDA(ABBREVIATEDNEWDRUGAPPLICATION):简化新药申请TREATMENTIND:研究中的新药用于治疗ABBREVIATED(NEW)DRUG:简化申请的新药DMF(DRUGMASTERFILE):药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。只有在DMF持有者或授权代

7、表以授权书的形式授权给FDA,FDA在审查IND、NDA、ANDA时才能参考其内容)HOLDER:DMF持有者CFR(CODEOFFEDERALREGULATION):(美国)联邦法规PANEL:专家小组BATCHPRODUCTION:批量生产;分批生产BATCHPRODUCTIONRECORDS:生产批号记录POST-ORPRE-MARKETSURVEILLANCE:销售前或销售后监督INFORMEDCONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)PRESCRIPTIONDRUG:处方药OTCDRUG(OVERTHECOUNTERDRUG):非处方药GMP

8、文件常见缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:ActiveSubstanceManufacturerATCAnatomicalTherapeuticChemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRA

9、BritishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificateofSuitabilityCENTREFORDRUGEVALUATION(CDE)CentreforPharmaceuticalAdministration(CPA)CMSConcernedMemberStateCMS每个成员国COSCertificateofSuitabilityCPMPCommitteeforProprietaryMedicina

10、lProductsCRAClinicalResearchAssociateCRFCaseReportFormCROContractResearchOrganisationCTAClinicalTrialApplicationCTCClinicalTrialCertificateCTDCommonTechnicalDocumentCTXClinicalTrialsExemptionDDDDefinedDailyDoseDGCDailyGlobalComparisonDIADrugInformationAssociationDMFDrugMasterFileDrugRegistrationBran

11、ch(DR,ProductEvaluation&RegistrationDivision,CPAEDQM(EuropeanDirectoratefortheQualityofMedicines)欧洲联盟药品质量指导委员会EEA欧洲经济地区EGMAEuropeanGenericsMedicineAssociationELAEstablishedLicenceApplicationEMEAEuropeanMedicinesEvaluationAgencyEMEA(EuropeanAgencyfortheEvaluationofMedicinalProducts)欧洲联盟药品评价机构EPEurope

12、anPharmacopoeiaEPAREuropeanPublicAssessmentReportsESRAEuropeanSocietyofRegulatoryAffairsEuropeanPharmacopoeiaCommission欧洲药典委员会FDAFDAFoodandDrugAdministrationfinalevaluationreport(FER)freesalecertificates(FSCs)GCPGoodClinicalPracticeGCP药品临床研究管理规范GLPGoodLaboratoryPracticeGLP药品临床前安全性研究质量管理规范GMPGoodManu

13、facturingPracticeGMP药品生产质量管理规范GSP药品销售管理规范HealthSciencesAuthority(HSA)HSAsMedicinesAdvisoryCommittee(MAC)IBInvestigatorsBrochureICHInternationalConferenceforHarmonisationIDMCIndependentData-MonitoringCommitteeIECIndependentEthicsCommitteeINDInvestigationalNewDrugINNInternationalNon-proprietaryNameInt

14、ernationalConferenceonHarmonisation(ICH)IPCInProcessControlIRBInstitutionalReviewBoardLICENCEHOLDERMAMarketingAuthorisationMAAMarketingAuthorisationApplicationMAA上市申请MAHMarketingAuthorisationHolderMAH销售许可持有者MCAMedicinesControlAgencyMHWMinistryofHealthandWelfare(Japan)MRMutualRecognitionMRA美国与欧盟的互认协议

15、MRAs(MutualRecognitionAgreements)互相認證同意MRFGMutualRecognitionFacilitationGroupMRPMutualRecognitionProcedureNASNewActiveSubstanceNCENewChemicalEntityNDANewDrugApplicationnewchemicalentities(NCEs)newdrugapplications(NDAs)NSAIDNonSteroidalAntiInflammatoryDrugNTANoticeToApplicantsOOSOutofSpecificationOTC

16、OverTheCounterPAGBProprietaryAssociationofGreatBritainPhEurEuropeanPharmacopoeiaPILPatientInformationLeafletPLProductLicencePOMPrescriptionOnlyMedicinePRODUCTOWNERPSUPeriodicSafetyUpdatesQAQualityAssuranceQCQualityControlRAJRegulatoryAffairsJournalRMSReferenceMemberStateRMS相互认可另一成员国RSDRelativeStanda

17、rdDeviationRxPrescriptionOnlySAESeriousAdverseEventSMFSiteMasterFileSOPStandardOperatingProcedureSOP(STANDARDOPERATIONPROCEDURE)标准运作程序SPC/SmPCSummaryofProductCharacteristicssummaryofproductcharacteristics(SPC)TherapeuticGoodsAdministration(TGA)USPUSPharmacopoeiaVMFVeterinaryMasterFileVPCVeterinaryPr

18、oductsCommitteeAAAAdditionandAmendments增补和修订ACAirConditioner空调器ADRAdverseDrugReaction药物不良反应AFDOAssociationofFoodandDrugOfficials食品与药品官员协会(美国)ACCAccept接受AQLAcceptableQualityLevel合格质量标准ADNAAbbreviatedNewDrugApplication简化的新药申请BOMBillofMaterial物料清单BPCBulkpharmaceuticalChemiclls原料药CBERCenterforBiologicsE

19、valuationResearch生物制品评价与研究中心CFUColonyFormingUnet菌落形成单位DMFDrugMasterFile药品管理档案CDERCemterforDrugEvaluationamdResearch药物评价与研究中心CICorporateIdentity(Image)企业识别(形象)CIPCleaninginPlace在线清洗CSIConsumerSafetyInsepctor消费者安全调查员CLPCleaningLineProcedure在线清洗程序DALDefectActionLevel缺陷作用水平DEADrugEnforcementAdminestrati

20、on管制药品管理DSDocumentationSystim文件系统FDAFoodandDrugAdministration食品与药品管理局(美国)GATTGeneralAgreemerntonTariffsandTrade关贸总协会GMPGoodManufacturingPracticeGvp药品生质量管理规范GCPGoodClinicalPractice药品临床实验管理规范GLPGoodLaboratoryPractice实验室管理规范GSPGoodSupplyPractice药品商业质量规范GRPGookRaTAILPractice药品零业质量管理规范GAPGoodAgricultureP

21、ractice药材生产管理规范GVPGookValidationPrctice验证管理规范GUPGookUsePractice药品重用规范HVACHeatingVentilationAirConditioning空调净化系统ISOIntematonalOrganizationforStandardization车际标准化组织MOUMemorandumofUnderstanding谅解备忘录PFPorductionFile生产记录用表格OTCOvertheCounter(Drug)非处方药品PLAProductLicenseApplication产品许可申请QAQualityAssurance质

22、量保证QCQualityControl质量控制QMPQualityManagementProcedure质量管理程序SDAStateDrugAdministration国家药品监督管理局SMPStandardManagmertProcedure标准管理程序SOPStandardOperatingProcedure标准操作程序TQCTatalQualityControl全面质量管理USAUnetedStatesPharmacopeia美国药典专业英语词汇词素(词根)1.haplo,mono,uni:单,一,独haploid单倍体monoxide一氧化碳monoatomic单原子的2.bi,di,

23、dipl,twi,du::二,双,两,偶biocolor双色,dichromatic双色的,diplobacillus双杆菌dikaryon双核体twin:孪生dual双重的3.tri:三,丙triangle三角triacylglycerol三酰甘油tricarboxylicacidcycle三羧酸循环4.quadri,quadru,quart,tetr,tetra:四quadrilateral四边的quadrivalent四价的quadruped四足动物tetrode四极管tetracycline四环素5.pent,penta,quique五pentose戊糖pentagon五角形penta

24、ne戊烷quintuple五倍的pentose戊糖pentomer五邻粒6.hex,hexa,sex六hexose已糖hexapod六足动物hexapoda昆虫纲hexamer六聚体7.hepta,sept七heptane庚烷heptose庚糖heptoglobin七珠蛋白8.oct八octpus章鱼octagon八角形octane辛烷octase辛糖9.enne,nona九nonapeptide九肽enneahedron九面体10.deca,deka十:decapod十足目动物decahedron十面体decagram十克11.hecto,百hectometer百米hectoliter百升h

25、ectowatt百瓦12.kilo,千kilodalton(KD)千道尔顿kilobase千碱基kiloelectronvolt千电子伏特13.deci,十分之一,分decimeter分米decigram十分之一克14.centi,百分之一15.milli,千分之一,毫millimole毫摩(尔)milliliter毫升16.micro,百万分之一,微,微小,微量microgram微克microogranism微生物microecology微生态学micropipet微量移液器17.nano十亿分之一,毫微,纳nanosecond十亿分之一秒nanometer纳米18.demi,hemi,se

26、mi半demibariel半桶hemicerebrum大脑半球semiopaque半透明semi-allel半等位基因semi-conductor半导体19.holo全,整体,完全holoenzyme全酶holoprotein全蛋白holocrine全(质分)泌20.mega巨大,兆,百万megaspore大孢子,megabasse兆碱基megakaryocyte巨核细胞megavolt兆伏megalopolitan特大城市21.macro大,巨大,多macrophage巨噬细胞macrogamete大配子macroelement常量元素macromolecular大分子22.poly,mul

27、ti,mult多,复合polyacrylate聚丙烯酸酯polymerase聚合酶multichain多链的multinucleate多核的multicistronicmRNA多顺反子mRNAmulticopy多拷贝1chrom颜色chromophore生色团chromosome染色体chromatography色谱法2melan,melano,nigr黑melanoma黑素瘤melanin黑色素melanophore黑色素细胞3xantho,flavo,fla,flavi,lute黄xanthophyl叶黄素xanthous黄色的,黄色人种xathine黄嘌呤flavin黄素flavone黄

28、酮letein黄体素,叶黄素flavinadeninedinucleotide(FAD)黄素腺嘌呤二核苷酸4erythro,rub,rubrm,ruf,红erythrocyte红细胞erythromycin红霉素erythropoitin(EPO)促红细胞生成素5chloro,chlor绿,氯chlorophyll叶绿素chloride氯化物chloramphenicol氯霉素6cyan,cyano蓝,青紫色,氰cyanophyceae蓝藻纲cyanobacteria蓝细菌cyanide氰化物7aur,glid,chrys金色aureomycin金霉素chrysose金藻淀粉chrysanth

29、emum菊花glidstone金沙石glid镀金8leu,leuco,leuk,leuko,blan,alb无色,白色leucine亮氨酸leukaemia=leucosis白血病bleachingpowder漂白粉albomycin白霉素四表示方位和程度的词素1endo,ento,内,在内endocrine内分泌endocytosis胞吞作用endogamy近亲繁殖endolysin内溶素entoderm内胚层2ec,ect,exc,extra外,外面,表面ectoblast外胚层ectoparasite外寄生生物extract抽取,浸出3meso中,中间mesosphere中圈,中层mes

30、oplast中胚层质4intra,intro,inter在内,向内intra-allelicinteraction等位基因内相互作用intracellular(细)胞内的interurban城市之间5centri,centro,medi,mid中心,中央,中间centrifuge离心centriole中心粒centrosome中心体centrogeng着丝基因6epi,peri上,外,旁epidermalgrowthfactor(EGF):表皮生长因子epibranchial上鳃的perilune近月点7sub,suc,suf,sug下,低,小suborder亚目submucosa粘膜下层su

31、bclone亚克隆subcellular亚细胞subsection小节,分部8super,supra上,高,超superconductor超导体superfluid超流体superoxide超氧化物supramolecular超分子的9hyper超过,过多hypersensitive过敏的hyperelastic超弹性的hypertension高血压hyperploid超倍体10hypo下,低,次hypoglycaemia低血糖hypotension低血压hypophysis脑下垂体11iso等,相同,同iso-osmotic等渗的isopod等足目动物isotope同位素12oligo,ol

32、ig少,低,寡,狭oligohaline狭盐性oligogene寡基因oligomer寡聚体oligophagous寡食性oligarchy寡头*13eury多,宽,广eurythermal广温的euryhaline广盐性eurytopicspecies广幅种14ultr超ultra-acoustics超声学ultra-structure超微结构ultroviolet紫外线15infra下,低,远infralittoral潮下带,远岸的infrahuman类人生物infrared红外线的infrastructure基础结构,基本结构五表示动物不同器官和组织的词素1cephal,capit,cr

33、an头,头颅2cyte细胞3carn,my,mya,myo,肉,肌肉4haem,haemat,hem,aem,sangul血5soma,corp体,身体6some,plast体,颗粒7hepa,hepat肝heparin肝素hepatopancreas肝胰腺hepatocyte肝细胞hepatoma肝癌8ren,nephr肾adrnal肾上腺的nephridia肾管nephron肾单位9card,cord心cardiotoxin心脏毒素cardiovascularcenter心血管中枢electrocardiogram心电图concord一致,和谐10ophthalm,ocell,ocul眼o

34、phthalmology眼科学ophthalmia眼炎ophthalmologist眼科专家11branchi鳃filibranch丝鳃lamellibrnch瓣鳃sencondarybranchium次生鳃12brac,brachi腕,手臂brachiolaria短腕幼虫brachionectin臂粘连蛋白bracelet手镯13dent,odont牙齿dentin牙质odontphora齿舌odontoblast成牙质细胞14plum羽plumatus羽状的plumule绒毛plumage(鸟的)羽毛15foli,foil叶follicle滤泡foiling叶形foliage叶子folio

35、se多叶的药名常用词首ace-乙(酰基)acet-醋;醋酸;乙酸acetamido-乙酰胺基acetenyl-乙炔基acetoxy-醋酸基;乙酰氧基acetyl-乙酰(基)aetio-初allo-别allyl-烯丙(基);CH2=CH-CH2-amido-酰胺(基)amino-氨基amyl-淀粉戊(基)amylo-淀粉andr-雄andro-雄anilino-苯胺基anisoyl-茴香酰;甲氧苯酰anti-抗apo-阿朴;去水aryl-芳(香)基aspartyl-门冬氨酰auri-金(基);(三价)金基aza-氮(杂)azido-叠氮azo-偶氮basi-碱baso-碱benxoyl-苯酰;苯

36、甲酰benzyl-苄(基);苯甲酰bi-二;双;重biphenyl-联苯基biphenylyl-联苯基bis-双;二bor-硼boro-硼bromo-溴butenyl-丁烯基(有1、2、3位三种)butoxyl-丁氧基butyl-丁基butyryl-丁酰caprinoyl-癸酰caproyl-己酰calc-钙calci-钙calco-钙capryl-癸酰capryloyl-辛酰caprylyl-辛酰cef-头孢(头孢菌素族抗生素词首)chlor-氯绿chloro-氯绿ciclo-环cis-顺clo-氯crypto-隐cycl-环cyclo-环de-去;脱dec-十;癸deca-十;癸dehyd

37、ro-去氢;去水demethoxy-去甲氧(基)demethyl-去甲(基)deoxy-去氧des-去;脱desmethyl-去甲(基)desoxy-去氧dex-右旋dextro-右旋di-二diamino-二氨基diazo-重氮dihydro-二氢;双氢endo-桥epi-表;差向epoxy-环氧erythro-红;赤estr-雌ethinyl-乙炔(基)ethoxyl-乙氧(基)ethyl-乙基etio-初eu-优fluor-氟荧光fluoro-氟荧光formyl-甲酰(基)guanyl-脒基hepta-七;庚hetero-杂hexa-六;己homo-高(比原化合物多一个-CH2-)hyp

38、o-次io-碘indo-碘iso-异keto-酮laevo-左旋leuco-白levo-左旋mercapto-巯基meso-不旋;内消旋中(间)中(位)(蒽环的9、10位)meta-间(有机系统用名)偏(无机酸用)methoxy-甲氧基methyl-甲基mono-一;单neo-新nitro-硝基nitroso-亚硝基nona-九;壬nor-去甲;降;正nov-新novo-新oct-八;辛octa-八;辛octo-八;辛ortho-邻(位)正原oxalo-草oxo-氧代oxy-氧羟基(误称,但常用)para-对(位)副(俗名)penta-五;戊per-高过phen-苯pheno-苯phenoxy

39、-苯氧(基)phenyl-苯基phospho-磷;磷酸phosphor-磷;磷酸phosphoro-磷;磷酸phyllo-叶poly-多;聚propyl-丙基proto-原pseudo-假;伪;拟ribosyl-核糖基sec-另(指CH3CH2CH(CH3)-型烃基semi-半silico-硅strept-链strepto-链sulf-硫sulfa-磺胺(磺胺类药物词头)sulfo-硫代磺基sulph-硫代sulpho-硫代磺基tert-特(指CH3C(CH3)2-型烃基)叔tetra-四thio-硫trans-反(式);转tri-三undeca-十一valyl-缬氨酰(基)vinyl-乙烯基

40、xantho-黄色药名常用词尾-al醛-aldehyde醛-amide酰胺-amidine脒-amine胺-ane烷-ase酶-ate盐酯-azide叠氮;-N3-caine卡因(局部麻醉药词尾)-carbonyl羰基-carboxamide甲酰胺-carboxylicacid羧酸-cidin杀菌素-cillin青霉素;西林(青霉素族抗生素词尾)-cycline四环素(四环素族抗生素词尾)-diol二醇二酚-dione二酮-disulfide二硫(化物)-ene烯-enol烯醇-ester酯-flavine黄素-form仿(俗名词尾)-genin甙元(旧称配基)-hydrin醇-ine碱;素(

41、生物碱词尾)-lactone内酯-lysin溶素(俗名词尾)-micin霉素(抗生素词尾)-mycetin霉素;菌素(抗生素词尾)-mycin霉素(抗生素词尾)-nitrile腈-ol醇酚-olol心安(心安类药物词尾)-one酮-ose糖-oside糖甙-oxide氧;氧化物-oyl酰-quine奎(俗名尾词)-sporin孢菌素(抗生素词尾)-sullide硫(化物)-sulfone砜-sulfoxide亚砜-thioicacid硫代酸-thione硫酮-thione硫酮-toxin毒-triol三醇-tropin托品(俗名尾词)-urea脲-xanthin黄质-yl基(一价基)-yne炔

42、常用分析化学词汇(CtoE)玻璃漏斗Glassfunnellongstem试管testtubetesttubebrushtesttubeholdertesttuberack蒸发皿evaporatingdishsmall烧杯beaker锥形瓶Erlenmeyer量筒gradcylinder洗瓶plasticwashbottle勺皿casserole,smallstopperedflask分液漏斗separaloryfunnelwaterbath/oilbathstrringbarmagneticstirrer冷凝器condenserBallastbottle圆颈烧瓶Round-buttomfla

43、sk试剂瓶reagentbottles托盘天平platformbalance台秤0.1g托盘pan指针刻度表pointerandscalecrossbeamsandslidingweights游码分析天平two-pan/single-pananalyticalbalance滴定管buretteglassbead(basic)nozzle移液管pipette胖肚elongatedglassbulb洗耳球rubbersuctionbulb玻棒glassrod玻璃活塞stopcock容量瓶pyknowmeterflasks比重瓶(one-mark)volumetricflasks胖肚吸管one-ma

44、rkpipette刻度吸管graduatedpipettes实验仪器清单1、柜子中四、抽屉中:锥形瓶(conicalflask)250ml4药匙(medicinespoon)1(Erlenmeyerflask)100ml3滴管(driptube;dropper)2烧杯(beaker)500ml1玻棒(Glassstic)2250ml3木试管夹(testtubeclamp;testtubeholder)1100ml3胖肚吸管(straws)25ml150ml210ml1容量瓶(volumetricflask)100ml2乳钵(morta)150ml4洗耳球(earwadhingbulb)碘量瓶(

45、iodinnumoeflask;iodineflask)500ml3试剂瓶(reagentbottle)(无色)2(棕色)2配洗液:量筒(cylinder)100ml1K2Cr2O72g+5ml水65mlH2SO4(graduatedcylinder)10ml1边加边搅拌(stir)。二、台面上仪器:一般仪器的洗涤(wash)铁支架(siderocradle)+蝴蝶架白瓷板(WhitePorcelainBoard)(一)清点仪器(tocount;tomakeaninventory)酸式滴定管(Acidburette)25ml1配洗液(Lotion)碱式滴定管(Alkaliburette)25ml1一般仪器的洗涤三、公用柜中:(二)滴定管(buret;burette)直型冷凝器(rectocondensor)1容量瓶(volumetricflask)漏斗架(funnelstand)2移液管(pipe)水浴锅(waterbathkettle)1温度计(Thermometer;hygrometer;hydroscope)1电炉(

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