中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
3期
191-194
,共4页
彭贵子%林生文%陶艳%许铄%黄和意%左联
彭貴子%林生文%陶豔%許鑠%黃和意%左聯
팽귀자%림생문%도염%허삭%황화의%좌련
米非司酮片%N-去甲基米非司酮%有关物质%降解杂质
米非司酮片%N-去甲基米非司酮%有關物質%降解雜質
미비사동편%N-거갑기미비사동%유관물질%강해잡질
Mifepristone Tablets%N-demethyl mifepristone%related substance%degradation impurity
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。
目的：改進《中國藥典》2010年版米非司酮片有關物質檢查方法。方法：改變液相色譜分離條件，增加光照主要降解產物N-去甲基米非司酮的限度，併對不同廠傢的米非司酮片進行有關物質測定。結果：改進方法耐用性更好，可以更好分離光照條件下的降解產物。結論：改進方法能更好地控製米非司酮片總雜和N-去甲基米非司酮，建議採用改進後的方法對米非司酮片有關物質進行檢查。
목적：개진《중국약전》2010년판미비사동편유관물질검사방법。방법：개변액상색보분리조건，증가광조주요강해산물N-거갑기미비사동적한도，병대불동엄가적미비사동편진행유관물질측정。결과：개진방법내용성경호，가이경호분리광조조건하적강해산물。결론：개진방법능경호지공제미비사동편총잡화N-거갑기미비사동，건의채용개진후적방법대미비사동편유관물질진행검사。
Objective:To improve the test method for related substances of Mifepristone Tablets in Chinese Pharmacopoeia 2010 Edi-tion.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.
