摘要
目的探讨将药品微生物限度验证方法用于保健品的微生物学检查。方法参照中国药典2005年版微生物限度检查方法中常规法、培养基稀释法、薄膜过滤法验证。结果菌落计数项目检查,试验菌回收率:维生素E胶囊上述各方法均达到70%以上;芦荟胶囊培养基稀释法达到70%;大蒜素薄膜过滤法达到70%。控制菌项目检查:检出阳性对照菌,未检出阴性对照菌。结论根据样品的抑菌性,通过方法学验证选择合适的检验方法。
Objective To study the application of microbial limit test methods in the microbiological examination of health care products.Methods The conventional method,medium-dilution method and membrane fi ltration method were adopted from microbial limit test methods in Chinese Pharmacopoeia(2005 edition).Results The results of colony count showed that the recoveries of test bacteria of various methods were up to 70 % for Vitamin E Capsule,the recoveries of test bacteria of medium-dilution method were 70 % for Aloe...
出处
《食品与药品》
CAS
2010年第11期433-436,共4页
Food and Drug
关键词
保健品
微生物限度
方法验证
health care product
microbial limits
methodology validation
