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.
出处
《食品与药品》
CAS
2014年第3期198-201,共4页
Food and Drug
关键词
精氨酸
微生物限度检查
薄膜过滤
验证
arginine
microbial limit test
membrane filtration
validation
