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药品微生物限度检查验证方法在保健品中的应用研究
引用本文:高新贞,陈静,白秀萍. 药品微生物限度检查验证方法在保健品中的应用研究[J]. 山东食品科技, 2010, 0(11)
作者姓名:高新贞  陈静  白秀萍
作者单位:淄博市药品检验所
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。

关 键 词:保健品  微生物限度  方法验证

Application of Microbial Limit Test Methods in Health Care Products
GAO Xin-zhen; CHEN Jing; BAI Xiu-ping. Application of Microbial Limit Test Methods in Health Care Products[J]. , 2010, 0(11)
Authors:GAO Xin-zhen   CHEN Jing   BAI Xiu-ping
Affiliation:GAO Xin-zhen; CHEN Jing; BAI Xiu-ping(Zibo Institute for Drug Control; Zibo 255000; China);
Abstract: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...
Keywords:health care product  microbial limits  methodology validation
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