对含中药成分保健食品微生物检验方法的探讨

Discussion on the method of microbiological test for health foods including Chinese herbal ingredients

中文关键词:  中药成分  保健食品  方法学验证  微生物检验

英文关键词:Chinese herbal ingredients  health foods  method validation  microbiological test

中文摘要:

      目的 分析含中药成分的保健食品进行微生物检验时所采用的菌落计数和控制菌检查方法的合理性。方法 根据GB16740-2014《保健食品》中的微生物限量要求, 结合《中国药典》附录中微生物限度检查法和GB4789《食品微生物学检验》, 对固态茶类和液态口服液类10批次含中药成分的保健食品进行了抑菌性筛查及消除的方法学验证。结果 对菌落计数采用常规法进行方法学验证时, 筛查出3批供试品存在抑菌性: 供试品对菌落计数的抑菌性通过培养基稀释法不能完全消除, 但可通过中和法消除; 对控制菌检查采用常规法进行方法学验证时, 筛查出4批供试品存在抑菌性, 供试品对控制菌金黄色葡萄球菌的抑菌性通过培养基稀释法和中和法等均未能消除。结论 建议采用含中和剂的琼脂培养基进行计数, 并在试验中增加阳性对照菌株进行监控, 含中药成分保健食品的检验方法应参照《中国药典》进行方法学验证。

英文摘要:

      Objective To analyze the rationality of the methods of colony counting and specified micro-organisms in microbial tests for health foods including Chinese herbal ingredients. Methods According to GB16740-2014 Health food microbial limit requirements, Chinese Pharmacopoeia 2010 Appendix microbial limit tests and GB4789 Food microbiological analysis, microbiological test methods of 10 kinds of health foods including Chinese herbal ingredients (tea in solid form and oral liquid) were validated. Results During the methodology validation by conventional method, antibiotic effects of 3 samples on microbial enumeration tests could be eliminated by neutralizing method rather than dilute method. However, antibiotic effects of 4 samples on test of specified microorganism (Staphylococcus aureus) could not be eliminated by the test methods. Conclusion Method of neutralizing agar medium is recommended in microbial enumeration. The positive control strains are also added in the whole experimental process. More reasonable methods which are set up to detect microbe in health foods including Chinese herbal ingredients by reference to Chinese Pharmacopoeia should be validated.