加味逍遥丸微生物适用性试验方法与评价

Result analysis and evaluation of microbiological examination of Jiawei Xiaoyao pills

目的建立适合加味逍遥丸的需氧菌、霉菌和酵母菌及控制菌检查方法,对主要污染菌进行结果分析。方法按照2015年版《中国药典》对15家24批次的产品进行方法适用性试验,用建立的方法对15家24批次的加味逍遥丸进行微生物限度检查,细菌鉴定采用VITEK2全自动细菌鉴定系统。结果需氧菌、霉菌和酵母菌计数方法适用性中各试验菌的回收率均为0.5~2.0,在控制菌检查方法适用性试验中,大肠埃希菌检查适用性组可检出大肠埃希菌;耐胆盐革兰阴性菌检查适用性组可检出大肠埃希菌和铜绿假单胞菌;沙门菌检查适用性组可检出沙门菌。样品主要污染的微生物是葡萄球菌和其他根系微生物。结论建立加味逍遥丸的微生物限度检查方法,需氧菌总数、霉菌和酵母菌总数可用常规法进行检验,直接接种方法可用于控制菌检查。

Objective To establish methods for testing total aerobic microbial count, total yeast and mold count and control bacteria test of Jiawei Xiaoyao pills in order to analyze and identify contaminant bacteria. Methods According to Pharmacopoeia of the People＇s Republic of China in 2015, the method validation of the 24 batches of Jiawei Xiaoyao pills from 15 manufacturers was conducted by microbial limit test. Totally 24 batches of Jiawei Xiaoyao pills from 15 manufacturers were tested under the validated method. VITEK 2 identification systems were used for bacterial identification. Results The recoveries of aerobic microbial, yeast and mold counting strains in the tests of total aerobic microbial count, total yeast and mold count were 0.5-2.0. In the method validations of Escherichia eoli, bile-tolerant gram-negative bacteria and Salmonella, all kinds of strains were respectively detected. The main contaminant bacteria were Staphylococcus and other bacteria related to the plant roots. Conclusion The method of microbial limit test of Jiawei Xiaoyao pills is established. The conventional methods can be used for the total aerobic microbial, yeast and mold counting. Direct inoculation method can be used to control bacteria examination.