保健食品微生物检验方法验证的分类研究

Classification of validation method in microbiological test of health food

目的按照所含功能成分的不同将保健食品分类,针对不同类别的保健食品,分别进行微生物方法学验证,并得到相应的检验方法。方法参考中国药典2010年版附录微生物限度检查法,分别采用常规法、培养基稀释法和薄膜过滤法,对6种,31批的保健食品进行方法学验证。结果采用常规法,有22批次(占总批次71%)的保健食品有一株或多株细菌的回收率低于70%,说明保健食品存在一定的抑菌作用。针对含功能成分不同的保健食品,分别提出了推荐的菌落总数、霉菌和酵母菌数的检验方法。结论按照所推荐方法进行该种类保健食品的微生物检验,可以有效提高菌落总数、霉菌和酵母菌数测定的结果的准确性。避免假阴性结果的出现。

Objective To classify the health foods according to different functional components and find the optimal detection method by method validation of microbiological test for different foods. Methods Routine method, medium dilution method and membrane filtration method were used for microbiological test in 31 batches of six kinds of health food according to CP 2010. Results Recovery of one or more bacteria strains in 22 batches （71%） was less than 70% by routine method, indicating the obvious antibiotic effect of health foods. Test methods of total bacteria count, molds and yeasts count were recommended respectively to foods containing different functional components. Conclusion Accuracy of the results was improved effectively and the false - negative results could be avoided when the recommended microbiological test methods were used.