USP-1092-溶出度试验的开发和验证(中英文对照版)解析.docx

溶出度试验的开发和验证【中英文对照版】INTRODUCTION前言Purpose目的The Dissolution Procedure: Developmentand Validation 1092 provides a comprehensive approach covering items to considerfor developing and validating dissolution procedures and the accompanyinganalytical procedures. It addresses the use of automation throughout the testand provides guidance and criteria for validation. It also addresses thetreatment of the data generated and the interpretation of acceptance 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 development andvalidation of dissolution procedures, with a focus on solid oral dosage forms.Many of the concepts presented, however, may be applicable to other dosageforms and routes of administration. General recommendations are given with theunderstanding that modifications of the apparatus and procedures as given in USPgeneral chapters need 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 organization of 1092 follows the sequence of actions often performed inthe development and validation of a dissolution test. The sections appear inthe following sequence.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：1. PRELIMINARY ASSESSMENT (FOR EARLY STAGES OF PRODUCTDEVELOPMENT/DISSOLUTION METHOD DEVELOPMENT)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）1.1 Performing Filter Compatibility1.1滤膜相容性研究1.2 Determining Solubility and Stability of DrugSubstance in Various Media1.2原料药在不同溶出介质中溶解度测定和稳定性研究1.3 Choosing a Medium and Volume1.3溶出介质和体积选择1.4 Choosing an Apparatus1.4溶出设备选择（桨法和篮法以及其他方法）2. METHOD DEVELOPMENT2.方法开发2.1 Deaeration2.1脱气2.2 Sinkers2.2沉降篮2.3 Agitation2.3转速2.4 Study Design2.4研究设计2.4.1 TimePoints2.4.1取样时间点2.4.2 Observations2.4.2观察2.4.3 Sampling2.4.3取样2.4.4 Cleaning2.4.4清洗2.5 Data Handling2.5数据处理2.6 Dissolution Procedure Assessment2.6溶出方法评估3. ANALYTICAL FINISH3.完成分析3.1 Sample Process