精氨酸微生物限度检查方法的验证  

Verification of Microbial Limit Test Method for Arginine

作　　者：周丽[1] 杜旭召[2] 郭小峰[1] 张平月 何影[1] 樊俊红[1] 

机构地区：[1]石药集团中奇制药技术(石家庄)有限公司,河北石家庄050041 [2]河北常山生化药业股份有限公司,河北石家庄050800

出　　处：《食品与药品》2014年第3期198-201,共4页Food and Drug

摘　　要：目的建立精氨酸微生物限度检查方法,并对方法进行验证。方法用薄膜过滤法进行细菌、酵母菌、霉菌计数;用薄膜过滤法进行控制菌检查。结果 5株试验菌回收率均大于70%,符合中国药典2010年版验证试验的基本要求。结论该方法消除了样品的抑菌性,可用于该品种的微生物限度检查。Objective To establish and verify the microbial limit test method for arginine.Methods Membrance filtration was adopted in counting of bacteria,yeasts and fungi and in the check of controlled microorganism.Results The recovery rate of five kinds of test organism was more than 70 ％,meeting the requirements of validation test listed in 2010 version of Chinese pharmacopoeia.Conclusion The method can eliminate the antimicrobial activity of arginine and can be used for the microbial limit test for this drug.

关 键 词：精氨酸 微生物限度检查 薄膜过滤 验证 

分 类 号：R917[医药卫生—药物分析学]