保健食品微生物限度检查的方法学验证  

Validation of method in microbial limit tests for health foods

作　　者：特玉香[1] 古丽巴哈尔托乎提 杨洪淼[1] 刘岚 马仕洪[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]新疆维吾尔自治区药品检验所,乌鲁木齐830002 [3]湖南省衡阳市药品检验所,衡阳421200

出　　处：《药物分析杂志》2008年第2期270-274,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：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。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, validated the microbiological test method of 21 kinds of health foods. Result. 10 kinds of health care products （Xueer oral solution, Jinshutong capsule, Shiqingsong capsule and Mengyu capsule, etc. ） were antibacterial for Staphylococcus 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.

关 键 词：方法学验证 微生物限度 回收率 保健食品质量 

分 类 号：R917[医药卫生—药物分析学]