普那霉素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] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2010年第2期303-306,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立普那霉素片微生物限度检查方法。方法:采用十四烷酸异丙酯作为溶剂,再以薄膜过滤和在冲洗液中加入增溶剂的方法,去除普那霉素片的抗菌活性。结果:满足中国药典2005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那霉素片最敏感,可作为普那霉素片微生物限度检查方法的质控菌株。结论:该方法可作为普那霉素片的常规微生物限度检查方法。Objective：To establish a method for microbial limit test of pristinamycins tablets.Method：The filtration method was used to inhibit the residual antimicrobial activity when the isopropyl myristate was firstly used as solvent and then the solubilizer was added into the solution.Result：The method can pass the validation test of Chinese pharmacopoeia 2005 version.The bacillus subtilis is the most sensitive strain among the five validation strains,which is recommend as positive control in experiments.Conclusion：The method has been used in microbial limit test for pristinamycins tablets preparation control.

关 键 词：普那霉素片 十四烷酸异丙酯 薄膜过滤 增溶剂 质控菌株 

分 类 号：R917[医药卫生—药物分析学]