三种具有抑菌成分的外用制剂的微生物限度检查方法验证

目的：建立皮炎洗剂、黄芩油膏及烫伤药水这三种具有抑菌成分的外用制剂的微生物限度检查方法。方法按照2010年版《中国药典》的规定测定三种制剂对5种规定试验菌株的回收率，并对其控制菌检查方法进行验证。结果皮炎洗剂采用薄膜过滤法，黄芩油膏采用培养基稀释法，烫伤药水采用预滤过和培养基稀释法联用，5种菌回收率均可达到70％以上，控制菌检查采用常规方法和培养基稀释法。结论该文建立了皮炎洗剂、黄芩油膏及烫伤药水这三种不同剂型的、具有抑菌成分的微生物限度检查方法。

Methodological validation of microbial limit test in three kinds of external preparations with antibacterial ingredients

Objective To establish the methods of microbial limit test for three kinds of external preparations with antibacterial ingredients, such as PiYan lotion, HuangQin ointment and TangShang lotion. Methods According to Chinese Pharmacopoeia 2010, the recovery rates of these five stipulated microorganisms respectively treated by three preparations were detected. And the method of checking control bacteria were also validated.Results Membrane filtration method was proved to be applicable for PiYan lotion. Culture medium diluting method was proper for HuangQin ointment. And the methods combining medium diluting wih pre-filtration were adopted to TangShang lotion. The recovery rate of these five stipulated microorganisms reached 70% by appropriate methods. Routine method and culture medium diluting method were used for validation of the control bacteria test. Conclusion The methods of microbial limit test for these three different kinds of external preparations were established.