保健食品微生物限度检查的方法学验证

目的:确认对保健食品进行微生物限度检查时,昕采用的细菌、霉菌及酵母菌计数和控制菌检查方法是否适合于该保健食品的微生物限度检查。方法:按2005年版中国药典微生物限度检查法及方法学验证实验要求,对21种保健食品进行了方法学验证。结果:10个品种(血尔口服液、金舒通胶囊、事轻松胶囊、梦玉胶囊等)分别对金黄色葡萄球菌和枯草芽孢杆菌有明显的抑菌作用,阳性对照菌回收率均低于70%。结论:保健食品采用 GB/T4789-2003食品卫生微生物学检查法进行检查时,其检验结果可能不够科学,建议参照2005年版中国药典要求,通过方法验证实验建立合理的检验方法。

Validation of method in microbial limit tests for health foods

Objective:To confirm that if the methods of total aerobic microbial count and absence bacteria test were appropriate in microbial limit tests for health foods.Methods:According to the Chinese Pharmacopoeia 2005,vali- dated the microbiological test method of 21 kinds of health foods.Result:10 kinds of health care products(Xueer o- ral solution,Jinshutong capsule,Shiqingsong capsule and Mengyu capsule,etc.)were antibacterial for Staphylococ- cus aureus and Bacillus subtilis.The average recoveries were below to 70%.Conclusion:The method in foods mi- crobial limit tests GB/T4789-2003 were not suitable for the microbial limit tests of health foods.It should set up more reasonable methods with validation according to the Chinese Pharmacopoeia 2005.