蒲地蓝消炎片微生物限度检查方法的建立及检验结果分析

目的:建立蒲地蓝消炎片微生物限度检查法,并对14个生产企业59批次产品的微生物限度检查结果进行分析。方法:按照《中国药典》2015年版对14家生产企业59批次的蒲地蓝消炎片进行微生物限度检查,细菌鉴定采用MALDI-TOF MS及VITEK 2全自动细菌鉴定试验系统。结果:需氧菌、霉菌和酵母菌计数方法适用性试验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,大肠埃希菌检查阳性对照组和供试品对照组检出大肠埃希菌;耐胆盐革兰阴性菌检查阳性对照组和供试品对照组检出大肠埃希菌和铜绿假单胞菌;沙门菌检查阳性对照组和供试品对照组检出沙门菌。样品主要污染的微生物是阴沟肠杆菌和其他环境常见污染菌。结论:建立蒲地蓝消炎片的微生物限度检查方法,14个生产企业59批次的微生物限度检查结果均符合规定。

Establishment of microbial limit test for Pudilan Xiaoyan tablets and the analysis of the test results LIN Ji-heng, PENG Zhilan, WU Qiansu(Zhoushan Institute for Food and Drug Control, Zhejiang 316021, China)

Objective:To establish the microbial limit test method for Pudilan Xiaoyan tablets,and analyze the test results of 59 batches from 14 manufacturers.Methods:The microbial limit test of 59 batches of Pudilan Xiaoyan Tablets from 14 manufacturers was conducted by ChP 2015.The bacterial strains were identified with MALDI-TOFMS and VITEK2COMPACT.Results:The recoveries of all kinds of test bacteria in the suitability tests of total aerobic microbial count,yeast and mold count were 0.5-2.0.Escherichia coli was detected in the positive control group and test control group of the control bacteria suitability test.Escherichia coli and Pseudomonas aeruginosa were detected in the positive control group and test control group of bile-tolerant gram-negative bacteria test.Salmonella paratyphi B was detected in the positive control group and test control group of Salmonella enterica test.The main contaminant bacteria were Enterobacter cloacae and other bacteria related to the environment.Conclusion:It is satisfactory that the results of microbial limit tests of 59 batches of Pudilan Xiaoyan tabletsfrom 14 manufacturers meet test requirements.