盐酸苯海拉明糖浆的微生物限度检查方法验证  

Validation of Microbial Limit Tests of Diphenhydramine Hydrochloride Syrup

作　　者：余晓霞[1] 刘春霞[1] 冯俊杭 

机构地区：[1]中山大学孙逸仙纪念医院药学部,广东广州510120

出　　处：《今日药学》2013年第10期658-660,共3页Pharmacy Today

摘　　要：目的建立盐酸苯海拉明糖浆的微生物限度检查方法。方法测定盐酸苯海拉明糖浆对大肠埃希菌等5种试验菌的回收率,通过观察回收率来确定适宜的检验方法,以及控制菌(大肠埃希菌)的检查方法进行验证。结果用常规法检查本品的细菌数、霉菌数及酵母菌数,其试验菌回收率达到70%以上。用常规法检查本品的大肠埃希菌,其试验组呈阳性反应。结论盐酸苯海拉明糖浆无明显抑菌作用,可直接取样用常规法进行细菌数、霉菌及酵母菌和控制菌大肠埃希菌检查。Objective To establish a method of microbial limit test for Diphenhydramine Hydrochloride Syrup. Methods According to the People＇ s Republic of China pharmacopoeia 2010 edition, the recovery rates of 5 tested strains treated by Diphenhydramine Hydrochloride Syrup were determined by common method,and the test method of the control bacteria was verified. Results Diphenhydramine hydrochloride syrup has no obvious bacteriostasis. Conclusions The common method of the microbial limit tests can be used for Diphenhydramine Hydrochloride Syrup by direct sampling.

关 键 词：盐酸苯海拉明糖浆 微生物限度检查 方法学验证 

分 类 号：R927[医药卫生—药学]