止痛擦剂微生物限度检查方法验证  

Validation of Microbial Limit Test Method of ZhiTong Liniment

作　　者：高珊[1] 唐蕾[1] 赵伟国[1] 

机构地区：[1]中山大学附属中山医院,中山528403

出　　处：《海峡药学》2018年第2期51-54,共4页Strait Pharmaceutical Journal

基　　金：中山市医学科研基金项目(项目编号:2016J032)

摘　　要：目的建立止痛擦剂的微生物限度检查方法。方法依据《中国药典》2015年版(四部)1105~1107项的相关要求,分别对样品进行5种试验菌株的回收率试验和控制菌检查方法验证来确定适宜的检查方法。结果需氧菌计数采用薄膜过滤法(冲洗量为200m L),霉菌和酵母菌计数采用平皿法,各菌的回收比值可达到0.5~2;采用常规法可检出铜绿假单胞菌,采用培养基稀释法(500m L)法可检出金黄色葡萄球菌。结论建立的方法可考虑作为止痛擦剂的微生物限度检查方法。OBJECTIVE To establish the method of microbial limit test for Zhi Tong liniment. METHODS The recovery tests of 5 bacterial strains and the methodological validation of control bacteria examination method were done referring to the microbial limit test methods recorded in the general rules（1105 ~ 1107） of Chinese Pharmacopoeia Ⅳ（2015 edition）. RESULTS The membrane filtration method can be used for the total aerobic microbial count. The number of yeasts andmolds was determined by plating method. Recovery ratios of all 5 validation strains were among 0. 5 ~ 2. The controlled bacteria Pseudomonas aeruginosa was tested by routine method,Staphylococcus aureus was tested by using increased culture volume（500 m L）. CONCLUSION The method can be considered for microbial limit test of Zhi Tong liniment.

关 键 词：止痛擦剂 《中国药典》2015年版 微生物限度检查 方法验证 

分 类 号：R927[医药卫生—药学]