歐洲藥典-凡例

1、歐洲藥典-凡例1.1.GENERALSTATEMENTSTheGeneralNoticesapplytoallmonographsandothertextsoftheEuropeanPharmacopoeia.總論的內(nèi)容適用于各論和歐洲藥典中的其它章節(jié)。TheofficialtextsoftheEuropeanPharmacopoeiaarepublishedinEnglishandFrench.TranslationsinotherlanguagesmaybepreparedbythesignatoryStatesoftheEuropeanPharmacopoeiaConvention.In

2、caseofdoubtordispute,theEnglishandFrenchversionsarealoneauthoritative.歐洲藥典以英語和法語形式發(fā)行，歐洲藥典委員會(huì)的簽署國可將藥典內(nèi)容譯成其它語言，但若發(fā)生爭議，應(yīng)以英語和法語版為權(quán)威。InthetextsoftheEuropeanPharmacopoeia,theword"Pharmacopoeia"withoutqualificationmeanstheEuropeanPharmacopoeia.TheofficialabbreviationPh.Eur.maybeusedtoindicatetheE

3、uropeanPharmacopoeia.在歐洲藥典中，如無特殊規(guī)定，藥典”是指歐洲藥典，縮寫Ph.Eur.也指歐洲藥典。Theuseofthetitleorthesubtitleofamonographimpliesthatthearticlecomplieswiththerequirementsoftherelevantmonograph.SuchreferencestomonographsinthetextsofthePharmacopoeiaareshownusingthemonographtitleandreferencenumberinitalics.文章中如果引用了各論中的標(biāo)題和

4、副標(biāo)題意味著文章內(nèi)容符合相關(guān)各論的要求。文章參考藥典中各論內(nèi)容時(shí)，以斜體的各論題目或相關(guān)數(shù)字表示。Apreparationmustcomplythroughoutitsperiodofvalidity;adistinctperiodofvalidityand/orspecificationsforopenedorbroachedcontainersmaybedecidedbythecompetentauthority.Thesubjectofanyothermonographmustcomplythroughoutitsperiodofuse.Theperiodofvaliditythatis

5、assignedtoanygivenarticleandthetimefromwhichthatperiodistobecalculatedaredecidedbythecompetentauthorityinthelightofexperimentalresultsofstabilitystudies.藥品在有效期內(nèi)必須性質(zhì)穩(wěn)定，明確的有效期或說明應(yīng)由權(quán)力機(jī)構(gòu)批準(zhǔn)。專論的題目在使用時(shí)必須一致。任何藥品的有效期和有效期的起始時(shí)間由權(quán)力機(jī)構(gòu)經(jīng)穩(wěn)定性研究的試驗(yàn)結(jié)果決定。UnlessotherwiseindicatedintheGeneralNoticesorinthemonographs,stat

6、ementsinmonographsconstitutemandatoryrequirements.Generalchaptersbecomemandatorywhenreferredtoinamonograph,unlesssuchreferenceismadeinawaythatindicatesthatitisnottheintentiontomakethetextreferredtomandatorybutrathertociteitforinformation.除總論和各論中另有說明，各論中的說明為法定要求；除為了提供特定信息，如果各論引用總論中內(nèi)容時(shí)，總論為法定要求。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各論中描述的有效成分（藥用物質(zhì)），賦形劑（輔料），藥物制劑和其它成分用于人和獸的使用（除非明確限制不可使用）。一種藥品只有在符合各論中各項(xiàng)要求時(shí)，才算藥典中的藥品。但并不要求藥品上市前，供應(yīng)商要做各論中的每項(xiàng)試驗(yàn)以滿足藥典要求。生產(chǎn)商可通過原始數(shù)據(jù)，例如生產(chǎn)過程驗(yàn)證，和過程控制，自檢藥品是否符合藥典要求。權(quán)力機(jī)構(gòu)認(rèn)為充分的環(huán)境條件應(yīng)符合藥典要求。檢測和試驗(yàn)方法應(yīng)基于藥典的標(biāo)準(zhǔn).經(jīng)權(quán)利機(jī)構(gòu)允許可采用其它的分析方法以達(dá)到控制目的，若出現(xiàn)爭論或異議，應(yīng)以藥典方法為準(zhǔn)。Certainmaterialsthatarethesubjectofapharmacopoeia1monographmayexis

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

13、n.Testmethodsfordeterminationofoneormoreofthesecharacteristicsmaybegiven,alsoforinformation.藥典各論中的某些物質(zhì)有多個(gè)等級可滿足各種需要，除各論中另有說明，要求適用于各等級。在一些各論中，特別是賦形劑，一系列相關(guān)的功能特性都有介紹，其中給出了一些特性的檢測方法。Generalmonographs.Substancesandpreparationsthatarethesubjectofanindividualmonographarealsorequiredtocomplywithrelevant,appl

14、icablegeneralmonographs.總論：各論中介紹的藥物和制劑也應(yīng)符合總論中的相關(guān)要求。Cross-referencestoapplicablegeneralmonographsarenotnormallygiveninindividualmonographs.參照總論中的一些內(nèi)容在各論中不特別指出。GeneralmonographsapplytoallsubstancesandpreparationswithinthescopeoftheDefinitionsectionofthegeneralmonograph,exceptwhereapreamblelimitstheapp

15、lication,forexampletosubstancesandpreparationsthatarethesubjectofamonographofthePharmacopoeia.除非限定了適用條件，如規(guī)定適用于藥典各論中的物質(zhì)，總論的內(nèi)容適用于各論定義范圍內(nèi)的所有藥物和制劑。Generalmonographsondosageformsapplytoallpreparationsofthetypedefined.Therequirementsarenotnecessarilycomprehensiveforagivenspecificpreparationandrequirements

16、additionaltothoseprescribedinthegeneralmonographmaybeimposedbythecompetentauthority.總論中介紹的劑量形式適用于典型定義的所有制劑。對于一特定制劑不必要對所有特性進(jìn)行限定，一些要求可由相關(guān)的機(jī)構(gòu)補(bǔ)充。Conventionalterms.Theterm"competentauthority"meansthenational,supranationalorinternationalbodyororganisationvestedwiththeauthorityformakingdecisionsc

17、oncerningtheissueinquestion.Itmay,forexample,beanationalpharmacopoeiaauthority,alicensingauthorityoranofficialcontrollaboratory.慣用術(shù)語：權(quán)力機(jī)構(gòu)”是指對一些問題進(jìn)行仲裁的國家、超國家、國際機(jī)構(gòu)或授權(quán)組織。例如，國家藥典委員會(huì)等。Theexpression"unlessotherwisejustifiedandauthorised"meansthattherequirementshavetobemet,unlessthecompetentautho

18、rityauthorisesamodificationoranexemptionwherejustifiedinaparticularcase.除另有批準(zhǔn)”是指一些要求修改后，經(jīng)權(quán)利機(jī)構(gòu)允許的。Statementscontainingtheword"should"areinformativeoradvisory.一段話中出現(xiàn)何以”是指此段描述作為信息提供或建議。Incertainmonographsorothertexts,theterms"suitable"and"appropriate"areusedtodescribeareag

19、ent,micro-organism,testmethodetc.;ifcriteriaforsuitabilityarenotdescribedinthemonograph,suitabilityisdemonstratedtothesatisfactionofthecompetentauthority.在某些各論或文章中出現(xiàn)了管適的”和適當(dāng)?shù)摹庇糜诿枋鲆环N試劑、微生物、檢測方法等；若各論中沒有介紹適用性標(biāo)準(zhǔn)，適用性的論述應(yīng)符合權(quán)力機(jī)構(gòu)的要求。Interchangeablemethods.Certaingeneralchapterscontainastatementthatthetextin

20、questionisharmonisedwiththecorrespondingtextoftheJapanesePharmacopoeiaand/ortheUnitedStatesPharmacopeiaandthatthesetextsareinterchangeable.Thisimpliesthatifasubstanceorpreparationisfoundtocomplywitharequirementusinganinterchangeablemethodfromoneofthesepharmacopoeiasitcomplieswiththerequirementsofthe

21、EuropeanPharmacopoeia.Intheeventofdoubtordispute,thetextoftheEuropeanPharmacopoeiaisaloneauthoritative.可供選擇的方法：一些章節(jié)中會(huì)出現(xiàn)這樣的描述，此篇文章與JP或USP一致，這意味著一種藥物或制劑采用JP或USP中的任意一種方法時(shí)，同樣符合EP的要求。若出現(xiàn)爭論或異議時(shí)，以EP為準(zhǔn)。1.2.OTHERPROVISIONSAPPLYINGTOGENERALCHAPTERSANDMONOGRAPHS為總論和各論提供的信息Quantities.Intestswithnumericallimitsa

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

23、erenceinthesameconditions,thestatedquantityistakenforexamination.Reagentsareusedintheprescribedamounts.用量：用于試驗(yàn)的量有具體限度時(shí)，規(guī)定用于檢測的量為一大約值。實(shí)際用量不得超過規(guī)定量的10%,由實(shí)際用量計(jì)算結(jié)果。對于限度無規(guī)定值的試驗(yàn)，限度依賴于相同條件下與對照品測試結(jié)果相比較，取規(guī)定量用于試驗(yàn)。使用規(guī)定量的試劑。Quantitiesareweighedormeasuredwithanaccuracycommensuratewiththeindicateddegreeofprecision

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

25、appropriate;otherwise,agraduatedmeasuringcylinderoragraduatedpipettemaybeused.Volumesstatedinmicrolitresaremeasuredusingamicropipetteormicrosyringe.用精密度和準(zhǔn)確度相當(dāng)?shù)膬x器量取一定量的被測物。稱重時(shí)，精密度為末位數(shù)字的正負(fù)0.5個(gè)單位(例如，0.25g是指0.245-0.255g)。體積測量時(shí)，如果小數(shù)點(diǎn)后的數(shù)字為零或末位數(shù)字為零時(shí)(例如10.0ml或0.50ml),體積由吸液管、量瓶或滴定管測量；否則，用量筒或刻度吸量管測定。使用微量吸液管和微

26、量注射器測量可精確到微升。Itisrecognised,however,thatincertaincasestheprecisionwithwhichquantitiesarestateddoesnotcorrespondtothenumberofsignificantfiguresstatedinaspecifiednumericallimit.Theweighingsandmeasurementsarethencarriedoutwithasufficientlyimprovedaccuracy.在某些情況下，如果精確度不符合要求，稱重或測量時(shí)可通過提高準(zhǔn)確度來彌補(bǔ)。Apparatusan

27、dprocedures.VolumetricglasswarecomplieswithClassArequirementsoftheappropriateInternationalStandardissuedbytheInternationalOrganisationforStandardisation.儀器和程序玻璃量具應(yīng)符合國際標(biāo)準(zhǔn)。Unlessotherwiseprescribed,analyticalproceduresarecarriedoutatatemperaturebetween15"Cand25"C.除另有說明，分析過程在15-25C條件下進(jìn)行。Unles

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

29、ftheliquidstobecomparedareexamineddowntheverticalaxisofthetubesagainstawhitebackground,orifnecessaryagainstablackbackground.Theexaminationiscarriedoutindiffuselight.除另有說明外，用中性、無色、透明的平底同質(zhì)試管進(jìn)行對照試驗(yàn)；用內(nèi)徑為16mm的試管取規(guī)定量的液體試劑，若液體用量有調(diào)整可選用內(nèi)徑為其它規(guī)格的試管(2.1.5)。相同量的溶液以白色或黑色為背景水平方向進(jìn)行對照試驗(yàn)，試驗(yàn)在漫射光條件下進(jìn)行。Anysolventrequire

30、dinatestorassayinwhichanindicatoristobeusedispreviouslyneutralisedtotheindicator,unlessablanktestisprescribed.除有空白試驗(yàn)的情況下，用于試驗(yàn)的所有溶劑使用前應(yīng)加入指示劑中和。Water-bath.Theterm"water-bath"meansabathofboilingwaterunlesswateratanothertemperatureisindicated.Othermethodsofheatingmaybesubstitutedprovidedthetem

31、peratureisneartobutnothigherthan100"Cortheindicatedtemperature.水?。撼碛姓f明外，水浴是指在沸水中進(jìn)行。若要求的溫度在100c以下或指定溫度，可用其它的加熱方法。Dryingandignitiontoconstantmass.Theterms"driedtoconstantmass"and"ignitedtoconstantmass"meanthat2consecutiveweighingsdonotdifferbymorethan0.5mg,thesecondweighingfo

32、llowinganadditionalperiodofdryingorofignitionrespectivelyappropriatetothenatureandquantityoftheresidue.干燥或熾灼至恒重：干燥或熾灼至恒重是指烘干或熾灼后，殘?jiān)鼉纱芜B續(xù)稱重偏差小于0.5mg。干燥或熾灼的第二次稱重分別根據(jù)殘?jiān)男再|(zhì)和量繼續(xù)干燥或熾灼一定時(shí)間后進(jìn)行。Wheredryingisprescribedusingoneoftheexpressions"inadesiccator"or"inuacuo",itiscarriedoutusingthe

33、conditionsdescribedunder2.2.32.Lossondrying.干燥是在干燥器或真空中進(jìn)行，操作條件參見干燥失重(2.2.32)中所示。REAGENTS試齊TheproperconductoftheanalyticalproceduresdescribedinthePharmacopoeiaandthereliabilityoftheresultsdepend,inpart,uponthequalityofthereagentsused.Thereagentsaredescribedingeneralchapter4.Itisassumedthatreagentsofa

34、nalyticalgradeareused;forsomereagents,teststodeterminesuitabilityareincludedinthespecifications.藥典中規(guī)定的分析方法和測試結(jié)果的可靠性依賴于所使用試劑的性質(zhì)。試劑在總論4中有描述。一些情況下，試劑要求分析純；對于其它一些試劑，適用性有其它規(guī)定。SOLVENTS溶齊1JWherethenameofthesolventisnotstated,theterm"solution"impliesasolutioninwater.溶劑如無特殊說明，溶液是指水溶液。Wheretheuseofw

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

36、terincontainers)arenotrelevant.Theterm"distilledwater"indicatespurifiedwaterpreparedbydistillation.藥典中規(guī)定用于分析操作或制備試劑的水，應(yīng)符合各論中純化水(0008)的要求，被內(nèi)毒素(批量的純化水)或微生物污染(容器中的純化水)后不得使用。蒸儲(chǔ)水是指純化水經(jīng)蒸儲(chǔ)后制得。Theterm"ethanol"withoutqualificationmeansanhydrousethanol.Theterm"alcohol"withoutqual

37、ificationmeansethanol(96percent).Otherdilutionsofethanolareindicatedbytheterm"ethanol"or"alcohol"followedbyastatementofthepercentagebyvolumeofethanol(C2H5O)required.除另有特殊說明，"ethanol”是指無水乙醇，"alcohol”是指96%的乙醇。其它的乙醇稀溶液濃可用"ethanol"或"alcohol"表示，濃度用百分比表示(m

38、l/ml).EXPRESSIONOFCONTENT內(nèi)容的說明Indefiningcontent,theexpression"percent"isusedaccordingtocircumstanceswithoneoftwomeanings:- percentm/m(percentage,massinmass)expressesthenumberofgramsofsubstancein100gramsoffinalproduct,- percentVfl(percentage,volumeinvolume)expressesthenumberofmillilitresofs

39、ubstancein100millilitresoffinalproduct.Theexpression"partspermillion(ppm)"referstomassinmass,unlessotherwisespecified.在定義的內(nèi)容中，百分比有以下兩個(gè)含義：%(g/g)表示100g溶液中含有溶質(zhì)若干克；%(ml/ml)表示100ml溶液中含有溶質(zhì)若干毫升；ppm表示溶質(zhì)的含量為百萬分之幾。TEMPERATURE溫度Whereananalyticalproceduredescribestemperaturewithoutafigure,thegeneralte

40、rmsusedhavethefollowingmeaning:- inadeep-freeze:below-15"C,- inarefrigerator:2"Cto8"C,- coldorcool:8"Cto15"C,- roomtemperature:15"Cto25"C.如分析操作中所規(guī)定的溫度無具體描述，通常使用的術(shù)語的含義如下所示：- 低溫冷凍：-15C以下- 冷藏柜中：2-8C- 冷卻：8-15C- 室溫：15-25CGENERALCHAPTERSCONTAINERS總論內(nèi)容Materialsusedforcontainersaredescribedingeneralchapter3.1.Generalnamesusedformaterials,particularlyplasticmaterials,eachcoverarangeofp