溶出度检查法美国药典USP-711VIP专享

1/20<711>DISSOLUTION溶出度(USP39-NF34Page540)GeneralchapterDissolution v711> isbeingharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopoeiaand/ortheJapanesePharmacopoeia.Thesepharmacopeiashaveundertakentonotmakeanyunilateralchangetothisharmonizedchapter.通则<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。PortionsofthepresentgeneralchaptertextthatarenationalUSPtext,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。Thistestisprovidedtodeterminecompliancewiththedissolutionrequirements+wherestatedintheindividualmonograph+fordosageformsadministeredorally.Inthisgeneralchapter,adosageunitisdefinedas1tabletor1capsuleortheamountspecified.+Ofthetypesofapparatusdesignsdescribedherein,usetheonespecifiedintheindividualmonograph.Wherethelabelstatesthatanarticleisentericcoatedandadissolutionordisintegrationtestdoesnotspecificallystatethatitistobeappliedtodelayed-releasearticlesandisincludedintheindividualmonograph,theprocedureandinterpretationgivenforDelayed-ReleaseDosageFormsareapplied,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 涂有或包含明胶的剂型IfthedosageformcontaininggelatindoesnotmeetthecriteriaintheappropriateAcceptanceTable(seeInterpretation,Immediate-ReleaseDosageForms,Extended-ReleaseDosageForms,orDelayed-ReleaseDosageForms)becauseofevidenceofthepresenceofcross-linking,thedissolutionprocedureshouldberepeatedwiththeadditionofenzymestothemedium,asdescribedbelow,andthedissolutionresultsshouldbeevaluatedstartingatthefirststageoftheappropriateAcceptanceTable.Itisnotnecessarytocontinuetest...