2020年新版USP-1092-溶出度试验的开发和验证(中英文对照版).docx

(1092 (1092)溶出度试验的开发和验证【中英文对照版】 INTRODUCTION .、八 、- 刖言 Purpose 目的 The Dissoluti on Procedure: Developme ntand Validati on <1092> provides a comprehe nsive approach coveri ng items to con siderfor develop ing and validati ng dissoluti on procedures and the accompa nyingan alytical procedures. It addresses the use of automati on throughout the testa nd provides guida nee and criteria for validatio n. It also addresses thetreatme nt of the data gen erated and the in terpretati on of accepta nee criteriafor immediate- and modified-release solid oral dosage forms. 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 <1092> addresses the developme nt an dvalidati on of dissoluti on procedures, with a focus on solid oral dosage forms.Ma ny of the con cepts prese nted, however, may be applicable to other dosageforms and routes of adm ini strati on. Gen eral recomme ndati ons are give n with the un dersta nding that modificati ons of the apparatus and procedures as give n in USP gen eral chapters n eed to be justified. <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。 The orga ni zati on of <1092> follows the seque nee of acti ons ofte n performed in the developme nt and validatio n of a dissoluti on test. The secti ons appear in the follow ing seque nee. 在进行溶解度实验的开发和验证时，常遵循指导原则 <1092> ，具体内容如 下： PRELIMINARY ASSESSMENT （FOR EARLY STAGES OF PRODUCTDEVELOPMENT/DISSOLUTION METHOD DEVELOPMENT） 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） Performing Filter Compatibility 1.1滤膜相容性研究 Determining Solubility and Stability of DrugSubstance in Various Media 1.2原料药在不同溶出介质中溶解度测定和稳定性研究 Choos ing a Medium and Volume 1.3溶出介质和体积选择 Choos ing an Apparatus 1.4溶出设备选择（桨法和篮法以及其他方法） METHOD DEVELOPMENT 方法开发 Deaerati on 2.1脱气 Si nkers 2.2沉降篮 Agitatio n 2.3转速 Study Design 2.4研究设计 TimePoi nts 2.4.1取样时间点 Observatio ns 2.4.2观察 Sampli ng 2.4.3取样 Clea ning 2.4.4清洗 Data Ha ndli ng 2.5数据处理 Dissoluti