欧洲药典-凡例

1、欧洲药典-凡例1.1.GENERALSTATEMENTSTheGeneralNoticesapplytoallmonographsandothertextsoftheEuropeanPharmacopoeia.总论的内容适用于各论和欧洲药典中的其它章节。TheofficialtextsoftheEuropeanPharmacopoeiaarepublishedinEnglishandFrench.TranslationsinotherlanguagesmaybepreparedbythesignatoryStatesoftheEuropeanPharmacopoeiaConvention.In

2、caseofdoubtordispute,theEnglishandFrenchversionsarealoneauthoritative.欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。InthetextsoftheEuropeanPharmacopoeia,theword"Pharmacopoeia"withoutqualificationmeanstheEuropeanPharmacopoeia.TheofficialabbreviationPh.Eur.maybeusedtoindicatetheE

3、uropeanPharmacopoeia.在欧洲药典中，如无特殊规定，药典”是指欧洲药典，缩写Ph.Eur.也指欧洲药典。Theuseofthetitleorthesubtitleofamonographimpliesthatthearticlecomplieswiththerequirementsoftherelevantmonograph.SuchreferencestomonographsinthetextsofthePharmacopoeiaareshownusingthemonographtitleandreferencenumberinitalics.文章中如果引用了各论中的标题和

4、副标题意味着文章内容符合相关各论的要求。文章参考药典中各论内容时，以斜体的各论题目或相关数字表示。Apreparationmustcomplythroughoutitsperiodofvalidity;adistinctperiodofvalidityand/orspecificationsforopenedorbroachedcontainersmaybedecidedbythecompetentauthority.Thesubjectofanyothermonographmustcomplythroughoutitsperiodofuse.Theperiodofvaliditythatis

5、assignedtoanygivenarticleandthetimefromwhichthatperiodistobecalculatedaredecidedbythecompetentauthorityinthelightofexperimentalresultsofstabilitystudies.药品在有效期内必须性质稳定，明确的有效期或说明应由权力机构批准。专论的题目在使用时必须一致。任何药品的有效期和有效期的起始时间由权力机构经稳定性研究的试验结果决定。UnlessotherwiseindicatedintheGeneralNoticesorinthemonographs,stat

6、ementsinmonographsconstitutemandatoryrequirements.Generalchaptersbecomemandatorywhenreferredtoinamonograph,unlesssuchreferenceismadeinawaythatindicatesthatitisnottheintentiontomakethetextreferredtomandatorybutrathertociteitforinformation.除总论和各论中另有说明，各论中的说明为法定要求；除为了提供特定信息，如果各论引用总论中内容时，总论为法定要求。Theacti

7、veingredients(medicinalsubstances),excipients(auxiliarysubstances),pharmaceuticalpreparationsandotherarticlesdescribedinthemonographsareintendedforhumanandveterinaryuse(unlessexplicitlyrestrictedtooneoftheseuses).AnarticleisnotofPharmacopoeiaqualityunlessitcomplieswithalltherequirementsstatedinthemo

8、nograph.ThisdoesnotimplythatperformanceofallthetestsinamonographisnecessarilyaprerequisiteforamanufacturerinassessingcompliancewiththePharmacopoeiabeforereleaseofaproduct.ThemanufacturermayobtainassurancethataproductisofPharmacopoeiaqualityfromdataderived,forexample,fromvalidationstudiesofthemanufac

9、turingprocessandfromin-processcontrols.ParametricreleaseincircumstancesdeemedappropriatebythecompetentauthorityisthusnotprecludedbytheneedtocomplywiththePharmacopoeia.ThetestsandassaysdescribedaretheofficialmethodsuponwhichthestandardsofthePharmacoooeiaarebased.Withtheagreementofthecompetentauthorit

10、y,alternativemethodsofanalysismaybeusedforcontrolpurposes,providedthatthemethodsusedenableanunequivocaldecisiontobemadeastowhethercompliancewiththestandardsofthemonographswouldbeachievediftheofficialmethodswereused.Intheeventofdoubtordispute,themethodsofanalysisofthePharmacopoeiaarealoneauthoritativ

11、e各论中描述的有效成分（药用物质），赋形剂（辅料），药物制剂和其它成分用于人和兽的使用（除非明确限制不可使用）。一种药品只有在符合各论中各项要求时，才算药典中的药品。但并不要求药品上市前，供应商要做各论中的每项试验以满足药典要求。生产商可通过原始数据，例如生产过程验证，和过程控制，自检药品是否符合药典要求。权力机构认为充分的环境条件应符合药典要求。检测和试验方法应基于药典的标准.经权利机构允许可采用其它的分析方法以达到控制目的，若出现争论或异议，应以药典方法为准。Certainmaterialsthatarethesubjectofapharmacopoeia1monographmayexis

12、tindifferentgradessuitablefordifferentpurposes.Unlessotherwiseindicatedinthemonograph,therequirementsapplytoallgradesofthematerial.Insomemonographs,particularlythoseonexcipients,alistoffunctionality-relatedcharacteristicsthatareimportantfortheuseofthesubstancemaybeappendedtothemonographforinformatio

13、n.Testmethodsfordeterminationofoneormoreofthesecharacteristicsmaybegiven,alsoforinformation.药典各论中的某些物质有多个等级可满足各种需要，除各论中另有说明，要求适用于各等级。在一些各论中，特别是赋形剂，一系列相关的功能特性都有介绍，其中给出了一些特性的检测方法。Generalmonographs.Substancesandpreparationsthatarethesubjectofanindividualmonographarealsorequiredtocomplywithrelevant,appl

14、icablegeneralmonographs.总论：各论中介绍的药物和制剂也应符合总论中的相关要求。Cross-referencestoapplicablegeneralmonographsarenotnormallygiveninindividualmonographs.参照总论中的一些内容在各论中不特别指出。GeneralmonographsapplytoallsubstancesandpreparationswithinthescopeoftheDefinitionsectionofthegeneralmonograph,exceptwhereapreamblelimitstheapp

15、lication,forexampletosubstancesandpreparationsthatarethesubjectofamonographofthePharmacopoeia.除非限定了适用条件，如规定适用于药典各论中的物质，总论的内容适用于各论定义范围内的所有药物和制剂。Generalmonographsondosageformsapplytoallpreparationsofthetypedefined.Therequirementsarenotnecessarilycomprehensiveforagivenspecificpreparationandrequirements

16、additionaltothoseprescribedinthegeneralmonographmaybeimposedbythecompetentauthority.总论中介绍的剂量形式适用于典型定义的所有制剂。对于一特定制剂不必要对所有特性进行限定，一些要求可由相关的机构补充。Conventionalterms.Theterm"competentauthority"meansthenational,supranationalorinternationalbodyororganisationvestedwiththeauthorityformakingdecisionsc

17、oncerningtheissueinquestion.Itmay,forexample,beanationalpharmacopoeiaauthority,alicensingauthorityoranofficialcontrollaboratory.惯用术语：权力机构”是指对一些问题进行仲裁的国家、超国家、国际机构或授权组织。例如，国家药典委员会等。Theexpression"unlessotherwisejustifiedandauthorised"meansthattherequirementshavetobemet,unlessthecompetentautho

18、rityauthorisesamodificationoranexemptionwherejustifiedinaparticularcase.除另有批准”是指一些要求修改后，经权利机构允许的。Statementscontainingtheword"should"areinformativeoradvisory.一段话中出现何以”是指此段描述作为信息提供或建议。Incertainmonographsorothertexts,theterms"suitable"and"appropriate"areusedtodescribeareag

19、ent,micro-organism,testmethodetc.;ifcriteriaforsuitabilityarenotdescribedinthemonograph,suitabilityisdemonstratedtothesatisfactionofthecompetentauthority.在某些各论或文章中出现了管适的”和适当的”用于描述一种试剂、微生物、检测方法等；若各论中没有介绍适用性标准，适用性的论述应符合权力机构的要求。Interchangeablemethods.Certaingeneralchapterscontainastatementthatthetextin

20、questionisharmonisedwiththecorrespondingtextoftheJapanesePharmacopoeiaand/ortheUnitedStatesPharmacopeiaandthatthesetextsareinterchangeable.Thisimpliesthatifasubstanceorpreparationisfoundtocomplywitharequirementusinganinterchangeablemethodfromoneofthesepharmacopoeiasitcomplieswiththerequirementsofthe

21、EuropeanPharmacopoeia.Intheeventofdoubtordispute,thetextoftheEuropeanPharmacopoeiaisaloneauthoritative.可供选择的方法：一些章节中会出现这样的描述，此篇文章与JP或USP一致，这意味着一种药物或制剂采用JP或USP中的任意一种方法时，同样符合EP的要求。若出现争论或异议时，以EP为准。1.2.OTHERPROVISIONSAPPLYINGTOGENERALCHAPTERSANDMONOGRAPHS为总论和各论提供的信息Quantities.Intestswithnumericallimitsa

22、ndassays,thequantitystatedtobetakenforexaminationisapproximate.Theamountactuallyused,whichmaydeviatebynotmorethan10percentfromthatstated,isaccuratelyweighedormeasuredandtheresultiscalculatedfromthisexactquantity.Intestswherethelimitisnotnumerical,butusuallydependsuponcomparisonwiththebehaviourofaref

23、erenceinthesameconditions,thestatedquantityistakenforexamination.Reagentsareusedintheprescribedamounts.用量：用于试验的量有具体限度时，规定用于检测的量为一大约值。实际用量不得超过规定量的10%,由实际用量计算结果。对于限度无规定值的试验，限度依赖于相同条件下与对照品测试结果相比较，取规定量用于试验。使用规定量的试剂。Quantitiesareweighedormeasuredwithanaccuracycommensuratewiththeindicateddegreeofprecision

24、.Forweighings,theprecisioncorrespondstoplusorminus5unitsafterthelastfigurestated(forexample,0.25gistobeinterpretedas0.245gto0.255g).Forthemeasurementofvolumes,ifthefigureafterthedecimalpointisazeroorendsinazero(forexample,10.0mlor0.50ml),thevolumeismeasuredusingapipette,avolumetricflaskoraburette,as

25、appropriate;otherwise,agraduatedmeasuringcylinderoragraduatedpipettemaybeused.Volumesstatedinmicrolitresaremeasuredusingamicropipetteormicrosyringe.用精密度和准确度相当的仪器量取一定量的被测物。称重时，精密度为末位数字的正负0.5个单位(例如，0.25g是指0.245-0.255g)。体积测量时，如果小数点后的数字为零或末位数字为零时(例如10.0ml或0.50ml),体积由吸液管、量瓶或滴定管测量；否则，用量筒或刻度吸量管测定。使用微量吸液管和微

26、量注射器测量可精确到微升。Itisrecognised,however,thatincertaincasestheprecisionwithwhichquantitiesarestateddoesnotcorrespondtothenumberofsignificantfiguresstatedinaspecifiednumericallimit.Theweighingsandmeasurementsarethencarriedoutwithasufficientlyimprovedaccuracy.在某些情况下，如果精确度不符合要求，称重或测量时可通过提高准确度来弥补。Apparatusan

27、dprocedures.VolumetricglasswarecomplieswithClassArequirementsoftheappropriateInternationalStandardissuedbytheInternationalOrganisationforStandardisation.仪器和程序玻璃量具应符合国际标准。Unlessotherwiseprescribed,analyticalproceduresarecarriedoutatatemperaturebetween15"Cand25"C.除另有说明，分析过程在15-25C条件下进行。Unles

28、sotherwiseprescribed,comparativetestsarecarriedoutusingidenticaltubesofcolourless,transparent,neutralglasswithaflatbase;thevolumesofliquidprescribedareforusewithtubeshavinganinternaldiameterof16mmbuttubeswithalargerinternaldiametermaybeusedprovidedthevolumeofliquidusedisadjusted(2.1.5).Equalvolumeso

29、ftheliquidstobecomparedareexamineddowntheverticalaxisofthetubesagainstawhitebackground,orifnecessaryagainstablackbackground.Theexaminationiscarriedoutindiffuselight.除另有说明外，用中性、无色、透明的平底同质试管进行对照试验；用内径为16mm的试管取规定量的液体试剂，若液体用量有调整可选用内径为其它规格的试管(2.1.5)。相同量的溶液以白色或黑色为背景水平方向进行对照试验，试验在漫射光条件下进行。Anysolventrequire

30、dinatestorassayinwhichanindicatoristobeusedispreviouslyneutralisedtotheindicator,unlessablanktestisprescribed.除有空白试验的情况下，用于试验的所有溶剂使用前应加入指示剂中和。Water-bath.Theterm"water-bath"meansabathofboilingwaterunlesswateratanothertemperatureisindicated.Othermethodsofheatingmaybesubstitutedprovidedthetem

31、peratureisneartobutnothigherthan100"Cortheindicatedtemperature.水浴：除另有说明外，水浴是指在沸水中进行。若要求的温度在100c以下或指定温度，可用其它的加热方法。Dryingandignitiontoconstantmass.Theterms"driedtoconstantmass"and"ignitedtoconstantmass"meanthat2consecutiveweighingsdonotdifferbymorethan0.5mg,thesecondweighingfo

32、llowinganadditionalperiodofdryingorofignitionrespectivelyappropriatetothenatureandquantityoftheresidue.干燥或炽灼至恒重：干燥或炽灼至恒重是指烘干或炽灼后，残渣两次连续称重偏差小于0.5mg。干燥或炽灼的第二次称重分别根据残渣的性质和量继续干燥或炽灼一定时间后进行。Wheredryingisprescribedusingoneoftheexpressions"inadesiccator"or"inuacuo",itiscarriedoutusingthe

33、conditionsdescribedunder2.2.32.Lossondrying.干燥是在干燥器或真空中进行，操作条件参见干燥失重(2.2.32)中所示。REAGENTS试齐TheproperconductoftheanalyticalproceduresdescribedinthePharmacopoeiaandthereliabilityoftheresultsdepend,inpart,uponthequalityofthereagentsused.Thereagentsaredescribedingeneralchapter4.Itisassumedthatreagentsofa

34、nalyticalgradeareused;forsomereagents,teststodeterminesuitabilityareincludedinthespecifications.药典中规定的分析方法和测试结果的可靠性依赖于所使用试剂的性质。试剂在总论4中有描述。一些情况下，试剂要求分析纯；对于其它一些试剂，适用性有其它规定。SOLVENTS溶齐1JWherethenameofthesolventisnotstated,theterm"solution"impliesasolutioninwater.溶剂如无特殊说明，溶液是指水溶液。Wheretheuseofw

35、aterisspecifiedorimpliedintheanalyticalproceduresdescribedinthePharmacopoeiaorforthepreparationofreagents,watercomplyingwiththerequirementsofthemonographonPurifiedwater(0008)isused,exceptthatformanypurposestherequirementsforbacterialendotoxins(Purifiedwaterinbulk)andmicrobialcontamination(Purifiedwa

36、terincontainers)arenotrelevant.Theterm"distilledwater"indicatespurifiedwaterpreparedbydistillation.药典中规定用于分析操作或制备试剂的水，应符合各论中纯化水(0008)的要求，被内毒素(批量的纯化水)或微生物污染(容器中的纯化水)后不得使用。蒸储水是指纯化水经蒸储后制得。Theterm"ethanol"withoutqualificationmeansanhydrousethanol.Theterm"alcohol"withoutqual

37、ificationmeansethanol(96percent).Otherdilutionsofethanolareindicatedbytheterm"ethanol"or"alcohol"followedbyastatementofthepercentagebyvolumeofethanol(C2H5O)required.除另有特殊说明，"ethanol”是指无水乙醇，"alcohol”是指96%的乙醇。其它的乙醇稀溶液浓可用"ethanol"或"alcohol"表示，浓度用百分比表示(m

38、l/ml).EXPRESSIONOFCONTENT内容的说明Indefiningcontent,theexpression"percent"isusedaccordingtocircumstanceswithoneoftwomeanings:- percentm/m(percentage,massinmass)expressesthenumberofgramsofsubstancein100gramsoffinalproduct,- percentVfl(percentage,volumeinvolume)expressesthenumberofmillilitresofs

39、ubstancein100millilitresoffinalproduct.Theexpression"partspermillion(ppm)"referstomassinmass,unlessotherwisespecified.在定义的内容中，百分比有以下两个含义：%(g/g)表示100g溶液中含有溶质若干克；%(ml/ml)表示100ml溶液中含有溶质若干毫升；ppm表示溶质的含量为百万分之几。TEMPERATURE温度Whereananalyticalproceduredescribestemperaturewithoutafigure,thegeneralte

40、rmsusedhavethefollowingmeaning:- inadeep-freeze:below-15"C,- inarefrigerator:2"Cto8"C,- coldorcool:8"Cto15"C,- roomtemperature:15"Cto25"C.如分析操作中所规定的温度无具体描述，通常使用的术语的含义如下所示：- 低温冷冻：-15C以下- 冷藏柜中：2-8C- 冷却：8-15C- 室温：15-25CGENERALCHAPTERSCONTAINERS总论内容Materialsusedforcontainersaredescribedingeneralchapter3.1.Generalnamesusedformaterials,particularlyplasticmaterials,eachcoverarangeofp