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

（ 1092）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 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 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 Compatibility

1.1滤膜相容性研究

1.2Determining 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

1.3 Choosing a Medium and Volume

1.3溶出介质和体积选择

1.4 Choosing an Apparatus

1.4溶出设备选择（桨法和篮法以及其他方法）

2.METHOD DEVELOPMENT

2.方法开发

2.1 Deaeration

2.1脱气

2.2 Sinkers

2.2沉降篮

2.3 Agitation

2.3转速

2.4 Study Design

2.4研究设计

2.4.1 TimePoints

2.4.1取样时间点

2.4.2 Observations

2.4.2观察

2.4.3Sampling

2.4.3取样

2.4.4Cleaning

2.4.4清洗

2.5数据处理

2.6溶出方法评估

3.ANALYTICAL FINISH

3.完成分析

3.1Sample Processing

3.1样品处理

3.2Filters

3.2过滤

3.3Centrifugation

3.3离心

3.4Analytical Procedure

3.4分析方法

3.5Spectrophotometric Analysis 3.5光谱分析

3.6 HPLC

3.6HPLC法

4.AUTOMATION

4.自动化

4.1 Medium Preparation

4.1介质的配制

4.2 Sample Introduction and Timing 4.2定时进样