溶出度试验的开发和验证概要1.docx

《溶出度试验的开发和验证概要1.docx》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、INTRODUCTION前言Purpose目的TheDissolutionProcedure:DevelopmentandValidation<1092>providesacomprehensiveapproachcoveringitemstoconsiderfordevelopingandvalidatingdissolutionproceduresandtheaccompanyinganalyticalprocedures.Itaddressestheuseofautomationthroughoutthetestandprovidesguidanceandcriter

2、iaforvalidation.Italsoaddressesthetreatmentofthedatageneratedandtheinterpretationofacceptancecriteriaforimmediate-andmodified-releasesolidoraldosageforms.溶出实验:开发和验证（1092）指导原则提供了在溶出度方法开发和验证过程中以及采用相应分析方法时需要考虑的因素。本指导原则贯穿溶出度实验的全部过程，并对方法提供了指导和验证标准。同时它还涉及对普通制剂和缓释制剂所生成的数据和接受标准进行说明。Scope范围Chapter<

3、1092>addressesthedevelopmentandvalidationofdissolutionprocedures,withafocusonsolidoraldosageforms.Manyoftheconceptspresented,however,maybeapplicabletootherdosageformsandroutesofadministration.Generalrecommendationsaregivenwiththeunderstandingthatmodificationsoftheapparatusandproceduresasgi

4、veninUSPgeneralchaptersneedtobejustified.<1092>章节讨论了溶出度实验的开发和验证，重点是口服固体制剂。所提出的许多概念也可能适用于其他剂型和给药途径。关于设备和方法的修改部分在USP通则中给出了合理的说明。Theorganizationof<1092>followsthesequenceofactionsoftenperformedinthedevelopmentandvalidationofadissolutiontest.Thesectionsappearinthefollowingsequence.在进行溶解度实验的开发和

5、验证时，常遵循指导原则<1092>，具体内容如下：1.PRELIMINARYASSESSMENT(FOREARLYSTAGESOFPRODUCTDEVELOPMENT/DISSOLUTIONMETHODDEVELOPMENT)1.前期评估（对产品开发以及溶出度方法开发的前期研究评估）1.1PerformingFilterCompatibility1.1滤膜相容性研究1.2DeterminingSolubilityandStabilityofDrugSubstanceinVariousMedia1.2原料药在不同溶出介质中溶解度测定和稳定性研究1.3ChoosingaMedi

6、umandVolume1.3溶出介质和体积选择1.4ChoosinganApparatus1.4溶出设备选择（桨法和篮法以及其他方法）2.METHODDEVELOPMENT2.方法开发2.1Deaeration2.1脱气2.2Sinkers2.2沉降篮2.3Agitation2.3转速2.4StudyDesign2.4研究设计2.4.1TimePoints2.4.1取样时间点2.4.2Observations2.4.2观察2.4.3Sampling2.4.3取样2.4.4Cleaning2.4.4清洗2.5DataHandling2.5数据处理2.6DissolutionP

7、rocedureAssessment2.6溶出方法评估1.PRELIMINARYASSESSMENT(FOREARLYSTAGESOFPRODUCTDEVELOPMENT/DISSOLUTIONMETHODDEVELOPMENT)1.前期评估（产品开发/溶出度方法开发的初期阶段）Beforemethoddevelopmentcanbegin,itisimportanttocharacterizethemoleculesothatthefilter,medium,volumeofmedium,andapparatus