普卢利沙星薄膜衣片微生物限度检查方法的建立  

Establishment of Method for Microbial Limit Test of Pristinamycins Tablets

作　　者：刘鹏[1] 马仕洪[1] 戴翚[1] 杨美琴[1] 肖璜[1] 胡昌勤[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2013年第4期413-415,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立普卢利沙星薄膜衣片微生物限度检查方法。方法采用定量滤纸对供试液进行过滤,再以薄膜过滤的方法,去除普卢利沙星薄膜衣片的抗菌活性。结果本方法满足《中国药典》2010年版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对普卢利沙星薄膜衣片最敏感,可作为普卢利沙星薄膜衣片微生物限度检查方法的质控菌株。结论该方法可作为普卢利沙星薄膜衣片的常规微生物限度检查方法。Objective To establish a method for microbial limit test of pristinamyeins tablets. Methods The test probational liquid was first poured through quantitative filter paper, and then membrane filtration method was adopted to remove the antimierobial activity. Results The method met the basic requirements of validation test of ＂Chinese pharmacopoeia＂ 2010 version. Bacillus subtilis was the most sensitive strain among the five validation strains, which could be use as a positive control in experiments. Conclusion The method can be used in conventional microbial limit test for pristinamyeins tablets.

关 键 词：普卢利沙星薄膜衣片 定量滤纸 薄膜过滤 质控菌株 

分 类 号：R927.11[医药卫生—药学]