熟地黄微生物限度检查方法适用性研究  

Method Suitability Test for Microbial Limit Test of Prepared Rehmannia Root

作　　者：叶宝玉 莫小丹 李蔚 刘俊文 YE Bao-Yu;MO Xiao-Dan;LI Wei;LIU Jun-Wen(Zhanjiang Institute for Food and Drug Control,Zhanjiang 524000,China;College of Traditional Chinese Medicine,Guangdong Pharmaceutical University,Guangzhou 510000,China)

机构地区：[1]湛江市食品药品检验所,广东湛江524000 [2]广东药科大学中药学院,广州510000

出　　处：《中国药物经济学》2023年第9期102-106,共5页China Journal of Pharmaceutical Economics

摘　　要：目的建立熟地黄微生物限度检查方法。方法依据《中华人民共和国药典》2020版四部中的中药饮片微生物限度检查法,进行方法适用性研究。结果微生物计数方法适用性试验:将熟地黄按1∶50稀释后,进行需氧菌总数试验,各菌株回收率均达到《中华人民共和国药典》要求。霉菌和酵母菌总数试验采用常规法,各菌株回收率均达到《中华人民共和国药典》要求。控制菌试验采用直接接种法,试验组均能检出试验菌。结论熟地黄微生物限度检查法中,需氧菌总数可用溶液稀释法检查;霉菌和酵母菌总数可用常规法检查;控制菌可用直接接种法检查。Objective To establish a microbial limit test method for Prepared Rehmannia Root.Methods The method suitability test was established according to the microbial limit test method of Chinese herbal decoction pieces in the fourth part of Pharmacopoeia of the People's Republic of China(2020 edition).Results The results showed that the recovery rate of Prepared Rehmannia Root meet the requirements of Chinese Pharmacopoeia When solution dilution method(1∶50)was used to test the aerobic bacteria count.Routine method was used to test the total number of mold and yeast.When the direct inoculate method was used to test the control bacteria,all the positive bacteria could be detected.Conclusion In the microbial limit test of Prepared Rehmannia Root,solution dilution method can be used to test the aerobic bacteria count,routine method can be used to test the total number of mold and yeast and direct inoculate method can be used to test the control bacteria in Prepared Rehmannia Root.

关 键 词：熟地黄 微生物限度检查 方法适用性 控制菌检查 

分 类 号：R927.1[医药卫生—药学]