药品说明书范本.ppt

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1、药品说明书药品说明书阅读、写作与翻译阅读、写作与翻译INSTRUCTONS第一节第一节 药品说明书药品说明书基本结构基本结构 药品说明书药品说明书英文表达方式有：英文表达方式有：n nInstructions，n nDirections，n nDescriptionn n现在多用PackageInsert，或简称Insert，n n也有用Leaflet或DataSheetsn n包括下列内容包括下列内容:n n药品名称药品名称(Drugname)(Drugname)n n性状性状(Description)(Description)n n药理作用药理作用(PharmacologicalActio

2、ns)(PharmacologicalActions)n n适应症适应症(Indication)(Indication)n n禁忌症禁忌症(Contraindication)(Contraindication)n n注意事项注意事项(Precaution)(Precaution)n n副作用副作用(Sideeffects)(Sideeffects)n n剂量和用法剂量和用法(Dosageandadministration)(Dosageandadministration)n n包装包装(Packing)(Packing)n n有效期有效期(Expirydate)(Expirydate)n n出

3、厂日期出厂日期(Manufacturingdate)(Manufacturingdate)n n参考文献参考文献(References)(References)药品名称有商品名药品名称有商品名(Tradename)(Tradename)、通用名（通用名（GenericNameGenericName）化学名（化学名（ChemicalNameChemicalName）药品说明书上最常用的名称是商品名。药品说明书上最常用的名称是商品名。有时在商品名之下（或后）又列有通用名或化学名有时在商品名之下（或后）又列有通用名或化学名.例如：例如：RulideRulide（罗力得）之后（罗力得）之后 列有（列有

4、（RoxithromycinRoxithromycin，罗红，罗红霉素）；霉素）；MinipressMinipress（脉宁平）之后列有（脉宁平）之后列有（PraxosinPraxosin HClHCl，盐酸，盐酸哌唑嗪）哌唑嗪）一药品名称一药品名称(Drug Name)1.1.商品名商品名商品名商品名(Tradename)(Tradename)n n n n商品名是由生产厂家命名并向该国政府有关部门商品名是由生产厂家命名并向该国政府有关部门(国家食品药品管理局国家食品药品管理局)注册的药品名注册的药品名.商品名右商品名右上角往往有一符号上角往往有一符号,意思是注册商标，是意思是注册商标，是R

5、egisterRegister的缩写。的缩写。n n商品名因厂而异商品名因厂而异,因国而异因国而异,一种药物可以有几一种药物可以有几个个,几十个商品名几十个商品名,因此仅根据商品名很难确定该因此仅根据商品名很难确定该药为何种药物药为何种药物,需要查阅其化学结构需要查阅其化学结构.n n药物说明书一开头药物说明书一开头,除了商品名外除了商品名外,还有时标有还有时标有 “Issued to/for the medical profession Issued to/for the medical profession onlyonly”意思为意思为 “仅供医学界专业参考仅供医学界专业参考”2.2.商

6、品名译法商品名译法商品名译法商品名译法 n n药品名称的中文翻译方法有多种，包括音译、意译、药品名称的中文翻译方法有多种，包括音译、意译、音意合译、谐音译以及按药理作用或药物成分翻译。音意合译、谐音译以及按药理作用或药物成分翻译。n na.a.音译音译音译音译 PenicilinPenicilin 盘尼西林，盘尼西林，CedilandCediland(西地兰西地兰),),PersantinPersantin(潘生丁潘生丁),aspirin(),aspirin(阿司匹林阿司匹林)n nb.b.意译意译意译意译 ChlorimycinChlorimycin 氯霉素；氯霉素；TetracyclinT

7、etracyclin 四环素；四环素；CholicCholicAcidAcid胆酸胆酸n nc.c.音意合译音意合译音意合译音意合译 MedemycinMedemycin 麦迪霉素（麦迪霉素（麦迪霉素（麦迪霉素（mycinmycin 霉素）霉素）霉素）霉素）n nd.d.谐音谐音谐音谐音 LegalonLegalon利肝隆，利肝隆，WebilinWebilin胃必灵胃必灵 n ne.e.按药理作用或药物成分翻译按药理作用或药物成分翻译按药理作用或药物成分翻译按药理作用或药物成分翻译 二药品性状（二药品性状（Description）药品性状：包括药品的外观、理化性质、成分、结药品性状：包括药品的

8、外观、理化性质、成分、结构、特征等。构、特征等。除了用除了用DescriptionDescription外，还常用外，还常用Property/Properties;Property/Properties;Physicalandchemicalproperties;Physicalandchemicalproperties;Characteristics(Characteristics(性状性状)；有些说明书介绍很简单，仅给出化学结构或成分，有些说明书介绍很简单，仅给出化学结构或成分，标题为：标题为：n nChemicalstructure(Chemicalstructure(化学结构化学结构)

9、;);n nComposition(Composition(成分成分)n nActiveingredients(Activeingredients(有效成分有效成分)等等 此部分结构差异较大，长短不一。此部分结构差异较大，长短不一。此部分结构差异较大，长短不一。此部分结构差异较大，长短不一。介绍药物多用介绍药物多用介绍药物多用介绍药物多用被动语态被动语态被动语态被动语态。除了普通性和描述性词汇外，还常涉及到化学除了普通性和描述性词汇外，还常涉及到化学除了普通性和描述性词汇外，还常涉及到化学除了普通性和描述性词汇外，还常涉及到化学化工词汇。化工词汇。化工词汇。化工词汇。由于是对药物性质的一般描述

10、，故由于是对药物性质的一般描述，故由于是对药物性质的一般描述，故由于是对药物性质的一般描述，故多用一般式多用一般式多用一般式多用一般式。1结构特点结构特点：Example 1DescriptionDescriptionn nBuflomedilBuflomedil Hydrochloride,Hydrochloride,the the active active ingredient ingredient of of IkelanIkelan,is is a a vasoactivevasoactive and and nerve nerve protective protective dru

11、g.drug.The The empirical empirical formularformular is is C C1717HH2525NONO4 4.HClHCl,representing representing a a molecular molecular weight weight of of 343.8.343.8.Each Each ampoule ampoule of of IkelanIkelan injection injection contains contains 50mg 50mg BuflomedilBuflomedil Hydrochloride.Hydr

12、ochloride.It It is is a a clear,clear,colorless colorless or or light light yellow yellow solution.solution.Each Each film film coated coated tablet tablet for for oral oral administration administration contains contains 150mg 150mg or or 300mg 300mg of of BuflomedilBuflomedil Hydrochloride.Hydroch

13、loride.Each Each ml ml of of the the oral oral solution solution drops drops contains contains 150mg 150mg BuflomedilBuflomedil Hydrochloride.Hydrochloride.Example 2Example 2PropertiesPropertiesThisdrugisanThisdrugisanangiotensinangiotensinconvertingenzymeconvertingenzymeinhibitorinhibitor（ACEIACEI）

14、.n nExample 3Example 3n nDescriptionDescriptionn nKirinSterilePowdercontainsKirinSterilePowdercontainsspectinomycinspectinomycin hydrochloridewhichisanhydrochloridewhichisanaminocyclitolaminocyclitolantibioticsantibioticsproducedbyaspeciesofsoilmicroorganismdesignatedproducedbyaspeciesofsoilmicroorg

15、anismdesignatedasasStreptomycesStreptomyces spectabilisspectabilis.n nExample4Example4n nDescriptionDescription n nFluconazoleFluconazole is a is a bisbis-trizoletrizole:2-(2,4-difluorophenyl)-:2-(2,4-difluorophenyl)-1,3-bis(11,3-bis(1HH-1,2,4-triazole-1-yl)-2-propanol.It has the-1,2,4-triazole-1-yl

16、)-2-propanol.It has the following structural formula:(omitted)following structural formula:(omitted)n nFluconazoleFluconazole is a white to off-white crystalline powder is a white to off-white crystalline powder which is sparingly soluble in water and saline.It has a which is sparingly soluble in wa

17、ter and saline.It has a molecular weight of 306.3.molecular weight of 306.3.FluconazoleFluconazole is available as is available as gelatin capsule containing 50mg,an intravenous gelatin capsule containing 50mg,an intravenous infusion containing infusion containing FluconazoleFluconazole 2mg/ml in a

18、saline 2mg/ml in a saline solutionsolution.n n 例例1 1FolicacidisayellowishtoorangeFolicacidisayellowishtoorange，crystallinecrystallinepowder;powder;odourlessodourlessoralmostoralmostodourlessodourless.n n叶酸是淡黄色至橙色结晶粉沫，无臭或几乎无臭。叶酸是淡黄色至橙色结晶粉沫，无臭或几乎无臭。n n例例2 2IntraliposIntralipos10%isawhiteopaquefatemuls

19、ionfor10%isawhiteopaquefatemulsionforintravenousinjectionintravenousinjection，containing10W/V%ofpurifiedcontaining10W/V%ofpurifiedsoybeanoil.soybeanoil.n n脂肪乳剂（脂肪乳剂（10%10%）是白色，不透明，供静脉注射用）是白色，不透明，供静脉注射用的脂肪乳剂，含有的脂肪乳剂，含有10%10%（W/VW/V）的精制大豆油。）的精制大豆油。n n 例例3 3UrsosanUrsosanTablet50mgisawhiteplaintabletwh

20、ichTablet50mgisawhiteplaintabletwhichcontains50mgofcontains50mgofursodeoxycholicursodeoxycholicacid.acid.n n熊去氧胆酸片为白色素片，每片含熊去氧胆酸片为白色素片，每片含50mg50mg熊去氧胆酸。熊去氧胆酸。n n例例4 4SterileSterilepyrogenpyrogen-free-free，orangeredorangered，freeze-driedfreeze-driedpowderinvialscontaining10mgand50mgofpowderinvialscon

21、taining10mgand50mgofdoxorubicinhydrochloridewithlactose.doxorubicinhydrochloridewithlactose.n n（本品）为小瓶装，灭菌无热原，桔红色冻干粉沫，（本品）为小瓶装，灭菌无热原，桔红色冻干粉沫，每小瓶含有每小瓶含有10mg10mg盐酸阿霉素和盐酸阿霉素和50mg50mg的乳糖。的乳糖。n n例例5 5Itoccursasawhitetooff-whiteItoccursasawhitetooff-white，crystallinesolidcrystallinesolid，poorlysolubleinwa

22、terpoorlysolubleinwater，diluteacidandmostdiluteacidandmostorganicsolvents.organicsolvents.n n本品（炎痛息康）为白色至类白色结晶固体，难溶本品（炎痛息康）为白色至类白色结晶固体，难溶于水、稀酸及大多数有机溶剂中。于水、稀酸及大多数有机溶剂中。n n例例6 6PaminePamine，chemicallyknownaschemicallyknownasepoxytropineepoxytropine tropatetropate methylbromidemethylbromide，hastheempir

23、icalformulahastheempiricalformulaC C1818H H2424NONO4 4Brandthemolecularweight398.3.Brandthemolecularweight398.3.哌明的化学名称为环氧莨菪碱托品酸酯溴代甲烷，哌明的化学名称为环氧莨菪碱托品酸酯溴代甲烷，实验式为实验式为C18H24NO4BrC18H24NO4Br，分子量为，分子量为398.3398.3。n n例例7 7KanendomycinKanendomycinisaverystableantibioticisaverystableantibiotic，anditsanditsac

24、tivitydoesnotdecreasewhenthepowderisplacedinactivitydoesnotdecreasewhenthepowderisplacedinanairtightcontainerandkeptatroomtemperaturesforanairtightcontainerandkeptatroomtemperaturesformorethan2years.morethan2years.卡内多霉素是一种很稳定的抗生素，其粉沫置于密卡内多霉素是一种很稳定的抗生素，其粉沫置于密封容器中，在室温下保存二年以上，活性不减。封容器中，在室温下保存二年以上，活性不减。

25、n n例例8 8ThisproductispreparedfromunitsofThisproductispreparedfromunitsofhumanplasmawhichhavebeentestedandhumanplasmawhichhavebeentestedandfoundfoundnonreactivenonreactiveforhepatitisassociatedforhepatitisassociated(Australia)antigen.(Australia)antigen.n n本品由人血浆制备，此血浆业经检验，本品由人血浆制备，此血浆业经检验，并且证明对肝炎（澳大利

26、亚）抗原无反应。并且证明对肝炎（澳大利亚）抗原无反应。2.常用词语n n(1)性状部分常用词语表达性状部分常用词语表达n ncolorcolor颜色颜色tastetaste味道味道n ntastelesstasteless无味无味colorlesscolorless无色无色 n ncrystallinecrystalline结晶的结晶的solubilitysolubility溶解度溶解度n nyellowishyellowish淡黄色淡黄色bitterbitter苦味苦味n nwhitishwhitish微白色的微白色的odourodour气味气味n ngreenishgreenish淡绿色的

27、淡绿色的odourlessodourless 无嗅无嗅 n nsterilesterile灭菌，无菌的灭菌，无菌的n norangeredorangered桔红色的桔红色的n npyrogenpyrogen-free-free无热原的无热原的n nsolublesoluble可容的可容的insolubleinsolublen nbrownbrown棕色棕色n n brownishbrownish浅棕色的浅棕色的n ntransparenttransparent透明的透明的 n n opaqueopaque不透明的不透明的n noff-whiteoff-white类白色类白色 或或 黄白色的黄白

28、色的n nstablestable稳定的稳定的n nmolecularmolecularformularformularinjectionliquidinjectionliquidn nmolecularweightsolutionpowdermolecularweightsolutionpowdern nchemicalstructuretabletsolidchemicalstructuretabletsolid(2)(2)表示组成、来源、制备方法的常用表达表示组成、来源、制备方法的常用表达表示组成、来源、制备方法的常用表达表示组成、来源、制备方法的常用表达n nconstituentsc

29、onstituents组成组成;n nprepareprepare制备制备,n nbederivedfrombederivedfrom由由衍生衍生;n nbeobtainedfrombeobtainedfrom由由制的制的;n nbepreparedfrombepreparedfrom由由制备制备;n nobtainedbyobtainedby由由获得获得;n nconsistofconsistof由由组成组成;n nbecomposedofbecomposedof由由组成组成;n ncontain;have;possesscontain;have;possess有（具有）有（具有）三三.药理

30、作用药理作用(Pharmacological Actions)n n较详细的药品说明书一般要介绍药品的临床药理、体较详细的药品说明书一般要介绍药品的临床药理、体外实验、药效、药物代谢、毒性和毒理作用等。该部外实验、药效、药物代谢、毒性和毒理作用等。该部分常用的标题为：分常用的标题为：n nPharmacologicalActionsPharmacologicalActions药理作用药理作用n nPharmacologyPharmacology药理学药理学n nPharmacologicalPropertiesPharmacologicalProperties药理性质药理性质n nAction

31、sandpropertiesActionsandproperties作用与性质作用与性质n nMechanismofActionMechanismofAction作用机理作用机理n nModeofActionModeofAction作用方式作用方式n nClinicalExperimentsClinicalExperiments临床实验临床实验n nPharmacologyandtoxicologyPharmacologyandtoxicology药理学与毒理学药理学与毒理学n nBiologicalActivityBiologicalActivity生物活性（若为抗生素类药品，常生物活性（若

32、为抗生素类药品，常用之）用之）n n有时还列出小标题，例如：n nClinicalPharmacologyn n临床药理学;n nClinicaleffect/usen n临床效果/用途;n nPharmacodynamics药效学;n nPharmacokineticsn n药物代谢动力学。n n1 1结构特点结构特点结构特点结构特点 n n该部分涉及到多学科的词汇，如该部分涉及到多学科的词汇，如 药理学（药效学，药理学（药效学，药物代谢动力学）、生理学、毒理学、化学与微生物药物代谢动力学）、生理学、毒理学、化学与微生物学等专业的词汇，有时较难理解。学等专业的词汇，有时较难理解。n n此外，

33、在本部分还经常遇到一些医学缩略词，如：此外，在本部分还经常遇到一些医学缩略词，如：CNSCNS（中枢神经系统）、（中枢神经系统）、EEGEEG（脑电图）、（脑电图）、LDLD5050（半数（半数致死量）、致死量）、EDED5050（半数有效量）、（半数有效量）、t t1/21/2(半衰期半衰期)等。等。该项该项一般用陈述句一般用陈述句，句子结构有时比较复杂。，句子结构有时比较复杂。n nExample 1.Example 1.n nPharmacodynamicPharmacodynamic and Pharmacokinetic Properties and Pharmacokinetic

34、Propertiesn nBuflomedilBuflomedilisaweak,non-specific,calciumantagonistand-isaweak,non-specific,calciumantagonistand-adrenergicreceptorinhibitor.Itimprovesmicrocirculationbyadrenergicreceptorinhibitor.Itimprovesmicrocirculationbyincreasingerythrocyteflexibility,inhibitingplateletaggregation,increasi

35、ngerythrocyteflexibility,inhibitingplateletaggregation,decreasingvascularresistance.Thedrugalsoimprovestissuedecreasingvascularresistance.ThedrugalsoimprovestissueoxygenationandincreasesATPproduction.oxygenationandincreasesATPproduction.n nTheabsolutebioavailabilityofthedrugrangesfrom50%to80%Theabso

36、lutebioavailabilityofthedrugrangesfrom50%to80%aftertheadministrationofasingleoraldose.Thedegreeofproteinaftertheadministrationofasingleoraldose.ThedegreeofproteinbindingofbindingofBuflomedilBuflomedilchangesaccordingtotheserumconcentration.changesaccordingtotheserumconcentration.Proteinbindingis81%a

37、t0.5mg/L,6l%at5mg/Land25%at50Proteinbindingis81%at0.5mg/L,6l%at5mg/Land25%at50mg/L.Themeaneliminationhalf-lifeis2to4hours.12%to28%ofmg/L.Themeaneliminationhalf-lifeis2to4hours.12%to28%ofasingleora1ori.v.doseiseliminatedunchangedintheurineoverasingleora1ori.v.doseiseliminatedunchangedintheurineover48

38、hours,andanequalpercentageasthe48hours,andanequalpercentageasthepara-demethylpara-demethylmetabolite.metabolite.n nExample2Example2n nClinicalPharmacologyClinicalPharmacologyn nSpectinomycinSpectinomycinhydrochlorideisaninhibitorofhydrochlorideisaninhibitorofproteinsynthesisinthebacterialcell;thesit

39、eofproteinsynthesisinthebacterialcell;thesiteofactionisthe30Sribosomalsubunit.actionisthe30Sribosomalsubunit.n nInvitrostudieshaveshownInvitrostudieshaveshownspectinomycinspectinomycin hydrochloridetobeactiveagainstmoststrainsofhydrochloridetobeactiveagainstmoststrainsofNeisseriaNeisseria gonorrhoea

40、gonorrhoea(minimuminhibitory(minimuminhibitoryconcentrationconcentration7.5to20mcg/ml).Definitivein7.5to20mcg/ml).Definitiveinvitrostudieshaveshownnocross-resistanceofN.vitrostudieshaveshownnocross-resistanceofN.gonorrheabetweengonorrheabetweenspectinomycinspectinomycinhydrochloridehydrochlorideandp

41、enicillin.Theantibioticisnotsignificantlyandpenicillin.Theantibioticisnotsignificantlyboundtoplasmaprotein.boundtoplasmaprotein.n nExample 3Example 3n nHuman PharmacologyHuman Pharmacologyn nKirinSterilePowder(KirinSterilePowder(spectinomycinspectinomycinhydrochloride)hydrochloride)israpidlyabsorbed

42、afterintramuscu1arinjection.Aisrapidlyabsorbedafterintramuscu1arinjection.Asingle,twograminjectionproducespeakserumsingle,twograminjectionproducespeakserumconcentrations(averagingabout100mg/mlatoneconcentrations(averagingabout100mg/mlatonehour.Averageserumconcentrationsof15mg/mlhour.Averageserumconc

43、entrationsof15mg/mlforthetwogramdosewaspresenteighthoursforthetwogramdosewaspresenteighthoursafterdosing.)afterdosing.)n nExample 4Example 4n nBasedoninspectionofeachpatientsBasedoninspectionofeachpatientspharmacokineticcurves,thedistributionpharmacokineticcurves,thedistributionphaseofWR2721sremoval

44、fromplasmaphaseofWR2721sremovalfromplasmapredominatesandiscompletewithin6minpredominatesandiscompletewithin6minafterdrugadministration.afterdrugadministration.2常用词语常用词语（1 1）动词）动词）动词）动词：n nIndicateIndicate表明，提示；表明，提示；n nMaintainMaintain维持；维持；n nDemonstrateDemonstrate显示；显示；n nexert(actionon)exert(acti

45、onon)起一作用起一作用n nExhibitExhibit显示；显示；n nInhibit抑制；n nAccumulate积蓄（积累）；n nmetabolize代谢；n nAdminister给药；n nExcrete排泄；n nTolerate耐受（2）形容词）形容词：n naveragemean平均的；n nbeeffectiveagainst对有效；n nberelatedto与有关；n n（be）sensitiveto对敏感；n n（be）resistantto对有耐药（3）名）名 词词 n nActivity活性；n nMechanism机理；n nAbsorption吸收；n

46、nDistribution分布；n nElimination清除；n nExcretion排泄，n nSerumconcentration血清浓度；n nTolerance耐受性;n nClearancerate廓清率；n nToxicity毒性；n nPlasmalevel血浆浓度（水平）；n nHalflife半衰期；n nEffecton对的作用;n nInvitro体外；n ninvivo体内。四适应症四适应症 Indicationsn n该项是药品说明书的重点，常用标题：n nIndications 适应症;n nIndications and Usage 适应症与用途；n nMaj

47、or Principal Indications 主要适应症；n nUses 用途；n nAction and Use 作用与用途。n n1结构特点结构特点n n一般说，该项仅列出疾病名称，或用短语表一般说，该项仅列出疾病名称，或用短语表示该药能治疗的疾病。示该药能治疗的疾病。n n较详细的说明书亦用完整的句子表述该药能较详细的说明书亦用完整的句子表述该药能治疗什么病，及对哪些细菌和微生物有效或治疗什么病，及对哪些细菌和微生物有效或无效。由于疾病和细菌、病毒名称太多，请无效。由于疾病和细菌、病毒名称太多，请查阅英汉医学词汇等工具书。查阅英汉医学词汇等工具书。n nExample 1Exampl

48、e 1n nIndicationsIndicationsn nPreventionandlong-termtreatmentofanginaPreventionandlong-termtreatmentofanginapectoris.pectoris.n nTreatmentofsevereheartfailureincombinationTreatmentofsevereheartfailureincombinationwithcardiacglycosides,preparationspromotingwithcardiacglycosides,preparationspromoting

49、secretionofurine,ACEinhibitors,drugscausingsecretionofurine,ACEinhibitors,drugscausingadilationofthearterialbloodvessels.adilationofthearterialbloodvessels.n nHighpressureinthepu1monarycirculation.Highpressureinthepu1monarycirculation.n nExample 2Example 2n nIndicationsIndicationsn nTimentinTimentin

50、isindicatedforawiderangeofinfectionsisindicatedforawiderangeofinfectionsforwhichsusceptibleorganismshavebeenforwhichsusceptibleorganismshavebeendetectedoraresuspected.Typicalindicationsdetectedoraresuspected.Typicalindicationsinclude:include:n nSevereinfections,forexample:Severeinfections,forexample