溶出度检查法美国药典.docx

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1、<711>DISSOLUTION溶出度(USP39-NF34Page540)Generalchapter Dissolution <711> isbeingharmonizedwiththecorrespondingtextsofthe EuropeanPharmacopoeia and/orthe JapanesePharmacopoeia.Thesepharmacopeiashaveundertakentonotmakeanyunilateralchangetothisharmonizedchapter.通则<

2、711>溶出度与欧盟药典和日本药典中的相应部分相统一。这三部药典承诺不做单方面的修改。Portionsofthepresentgeneralchaptertextthatarenational USP text,andthereforenotpartoftheharmonizedtext,aremarkedwithsymbolstospecifythisfact.本章中的部分文字为本国USP内容，并没有与其他药典统一。此部分以（   ）标注。Thistestisprovidedtodeterminecomplian

3、cewiththedissolutionrequirements  wherestatedintheindividualmonograph  fordosageformsadministeredorally.Inthisgeneralchapter,adosageunitisdefinedas1tabletor1capsuleortheamountspecified.  Ofthetypesofapparatusdesignsdescribedherein,usetheonespecifiedintheindivi

4、dualmonograph.Wherethelabelstatesthatanarticleisentericcoatedandadissolutionordisintegrationtestdoesnotspecificallystatethatitistobeappliedto delayed-release articlesandisincludedintheindividualmonograph,theprocedureandinterpretationgivenfor Delayed-ReleaseDos

5、ageForms areapplied,unlessotherwisespecifiedintheindividualmonograph.本测试用于检测药品口服制剂的溶出度是否符合各论中的规定。本章中，除另有规定外，单位制剂定义为1片或1粒胶囊。对于本章中所述多种仪器，使用各论中规定的种类。除各论中另有规定外，如果检品是肠溶衣片且各论中的溶出度或崩解时限检查项下没有特别指出适用迟释剂的，使用本章中适用于迟释剂的流程和解释。 FORDOSAGEFORMSCONTAININGORCOATEDWITHGELATIN涂有或

6、包含明胶的剂型Ifthedosageformcontaininggelatindoesnotmeetthecriteriaintheappropriate AcceptanceTable (see Interpretation, Immediate-ReleaseDosageForms, Extended-ReleaseDosageForms,or Delayed-ReleaseDosageForms)becauseofevidenceofthepresenceofcross-linking,thedissolut

7、ionprocedureshouldberepeatedwiththeadditionofenzymestothemedium,asdescribedbelow,andthedissolutionresultsshouldbeevaluatedstartingatthefirststageoftheappropriate AcceptanceTable.Itisnotnecessarytocontinuetestingthroughthelaststage(upto24units)whencriteriaareno

8、tmetduringthefirststagetesting,andevidenceofcross-linkingisobserved.如果剂型中含有明胶，其不符合验收表中的标准（见判断，速释制剂，延释制剂，缓释制剂），因为存在明胶交联结合作用，它的溶解过程与外加的媒介酶是重复的，见下面的描述，并且溶解结果可以通过适当的验收表的开始的第一阶段标准进行评估。如