改进《中国药典》2010年版米非司酮片有关物质的检查方法  

Improvment of Test Method for Related Substances of Mifepristone Tablets in Chinese Pharmacopoeia 2010 Edition

作　　者：彭贵子[1,2] 林生文 陶艳 许铄 黄和意 左联 

机构地区：[1]广州朗圣药业有限公司研发中心,广州510670 [2]中山大学药学院,广州510006 [3]广东省食品药品检验所,广州510180

出　　处：《中国药品标准》2015年第3期191-194,共4页Drug Standards of China

摘　　要：目的:改进《中国药典》2010年版米非司酮片有关物质检查方法。方法:改变液相色谱分离条件,增加光照主要降解产物N-去甲基米非司酮的限度,并对不同厂家的米非司酮片进行有关物质测定。结果:改进方法耐用性更好,可以更好分离光照条件下的降解产物。结论:改进方法能更好地控制米非司酮片总杂和N-去甲基米非司酮,建议采用改进后的方法对米非司酮片有关物质进行检查。Objective：To improve the test method for related substances of Mifepristone Tablets in Chinese Pharmacopoeia 2010 Edition.Methods：HPLC separation conditions were altered, the limit of degradation impurity N-demethyl mifepristone under visible-light exposure was estabilshed and the related substances of Mifepristone Tablets from different manufacturers were determined.Results：The improved method was more applicative with higher resolution of degradation impurities under high-light stress condition.Conclusion：The improved test method is good for quality control on the total imprities and N-demethyl mifepritstone, It should be used to control the related substances of Mifepristone Tablets.

关 键 词：米非司酮片 N-去甲基米非司酮 有关物质 降解杂质 

分 类 号：R921.2[医药卫生—药学]