溶出度实验的开发和验证1092教材.doc

1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION INTRODUCTION Purpose 目的 The dissolution procedure: development and validation 1092 provides a comprehensive approach covering items to consider for developing and validating dissolution procedures and the accompanying analytical procedures. It addresses the use of automation throughout the test and provides guidance and criteria for validation. It also addresses the treatment of the data generated and the interpretation of acceptance criteria for immediate- and modified-release solid oral dosage forms. 溶出度试验的开发和验证1092目的是为溶出度的测定提供了全面的开发和验证的方法以及相应的分析技术。本指导原则贯穿溶出度测定的全部过程，并对方法验证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产生的数据和接受标准进行说明。 Scope 范围 Chapter 1092 addresses the development and validation of dissolution procedures, with a focus on solid oral dosage forms. Many of the concepts presented, however, may be applicable to other dosage forms and routes of administration. General recommendations are given with the understanding that modificaions of the apparatus and procedures as given in USP general 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 in the development and validation of a dissolution test. The sections appear in the 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) 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 Compatibility 滤膜相容性研究 1.2 Determining Solubility and Stability of DrugSubstance in Various Media 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 Volume 溶出介质和体积选择 1.4 Choosing an Apparatus 溶出设备选择（桨法和篮法以及其他方法） 2. METHOD DEVELOPMENT 方法开发 2.1 Deaeration 脱气 2.2 Sinkers 沉降篮 2.3 Agitation 转速 2.4 Study Design 研究设计 2.4.1 Time Points 取样时间点 2.4.2 Observations 观察 2.4.3 Sampling 取样 2.4.4 Cleaning 清洗 2.5 Data Handling 数据处理 2.6 Dissolution Procedure Assessment