浅谈溶出度检查方法的分辨力  

Studies onthe discriminatory power of dissolution test

作　　者：王亚敏[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《药物分析杂志》2012年第11期2094-2096,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：溶出度检查方法的分辨力是溶出度检查方法研究的重要内容,选择具有良好分辨力的溶出度检查方法是药品技术审评中关注的内容。本文参考相关文献,介绍溶出度检查方法分辨力的意义和一般方法,并以非布司他片为例探讨建立具有分辨力的溶出度检查方法。Studies on the discriminatory power of dissolution test is important in the development of dissolution method. How to select a dissolution method with high discriminatory power is a major concern in pharmaceutical technology evaluation. This article is intended to introduce the importance of discriminatory power and the general method for dissolution test based on research articles. Febuxostat tablets were taken as the sample to investigate how to establish a dissolution method with high discriminatory power.

关 键 词：溶出度 分辨力 质量控制 药品技术审评 非布司他 

分 类 号：R917[医药卫生—药物分析学]