190批大黄䗪虫丸微生物限度检查结果分析

Microbial Limit Test of 190 Batches of Dahuang Zhechong Pills

目的:通过对全国13家药品生产企业生产的190批大黄?虫丸微生物限度检查结果进行分析,了解该品种的微生物负荷现状。方法:参照《中国药典》(2015年版)非无菌产品微生物限度检查法<1105><1106>和企业标准,建立并验证微生物计数和控制菌检查方法。用验证的方法对190批大黄?虫丸进行微生物限度检查。需氧菌总数检查采用培养基稀释法(0.2ml/皿),霉菌和酵母菌总数、控制菌检查均采用常规法进行。结果:190批大黄?虫丸样品中需氧菌总数<1×10^1cfu/g共121批(占63.68%),10^1cfu/g≤需氧菌总数<10^2cfu/g共29批(占15.26%),10^2cfu/g≤需氧菌总数<10^3cfu/g共38批(占20.00%),需氧菌总数≥10^3cfu/g共2批(占1.05%);霉菌和酵母菌总数<1×10^1cfu/g共174批(占91.58%),10^1cfu/g≤霉菌和酵母菌总数<10^2cfu/g共16批(占8.42%)。190批大黄?虫丸样品均未检出控制菌。结论:国产各企业生产的大黄?虫丸微生物限度结果总体良好。

Objective:The microbial limit test results of 190 batches of Dahuang Zhechong pills produced by 13 pharmaceutical manufacturers in China were assayed to unveil the bioburden of this drug.Methods:According to the microbial limit test for non-sterile product ordered in the 2015 edition of Chinese Pharmacopoeia<1105><1106>,the microbial counting and test for specified microorganisms were carried out.Results:The results of microbial limit test of 190 batches of Dahuang Zhechong pills were all comply with the requirements.The total mold and yeast count in 174 batches(91.58%)were found lower than 1×10^1cfu/g,and 16 batches(8.42%)between 10^1cfu/g and 10^2cfu/g.Meanwhile,121 batches(63.68%)were found with aerobic bacteria count lower than 1×10^1cfu/g,29 batches(15.26%)between 10^1cfu/g and 10^2cfu/g,38 batches(20.00%)lower than10^2cfu/g and 2 batches(1.05%)higher than 10^3cfu/g.No specified bacteria were detected in all 190 batches of Dahuang Zhechong pills.Conclusion:The microbial condition of 190 batches of Dahuang Zhechong pills was good.