维吾尔药外用制剂阿娜尔妇洁液微生物限度检查方法的建立  

Establishment of method for microbial limit test of Uygur drug for Anaer external liquid preparation

作　　者：热孜万古丽.司马义 王伟萍 

机构地区：[1]新疆医科大学第一附属医院药学部,新疆乌鲁木齐830011 [2]新疆维吾尔自治区食品药品检验所,新疆乌鲁木齐830054

出　　处：《沈阳药科大学学报》2011年第12期969-972,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立维吾尔药外用制剂阿娜尔妇洁液微生物限度检查方法。方法采用5种阳性对照菌活菌数回收测定进行方法选择、培养基选择及确定敏感菌株。结果本方法满足2005年版《中华人民共和国药典》验证试验的要求。5株验证菌株中金黄色葡萄球菌为敏感菌,可作为阿娜尔妇洁液微生物限度检查方法的质控菌株。除金黄色葡萄球菌外各试验菌的回收率均高于70%,采用培养基稀释法对金黄色葡萄球菌的回收率也达到了70%以上。结论本方法可有效地对阿娜尔妇洁液中的微生物数量和种类进行检测,可作为阿娜尔妇洁液的微生物限度检查方法。Objective To establish a method to determine the microbial limit viable counting tests for Anaer external liquid preparation. Methods The method and the culture medium were selected and the sensitive strain was determined based on the viable counting of five test bacteria. Results The method can compatible with the validation test of Chinese Pharmacopoeia （2005 version）. The Staphylococcus aureus was the sensitive strain among the five validation strains, which was recommend as positive control in experiments. The recovery rate of every trail bacteria was higher than 70%, and the recovery rate of bacteria in culture medium dilution method（0. 2 mL/dish）trail was higher than 70%. Conclusions This method is effective and are used in microbial limit test for Anaer external liquid preparation.

关 键 词：阿娜尔妇洁液 验证试验 培养基稀释法 敏感菌株 

分 类 号：R917[医药卫生—药物分析学]