不同厂家二丁颗粒微生物限度检查方法建立及结果分析评价

Research on Establishment of Microbial Limit Test Methods and Result Analysis and Evaluation for Erding Granules from Different Manufacturers

本研究遵照《中国药典》2020年版对5个厂家15个批次的二丁颗粒进行微生物限度检查,研究发现在需氧菌、霉菌和酵母菌计数方法的适用性试验中,各试验菌的回收率均在0.5~2.0之间;在控制菌检查方法的适用性试验中,大肠埃希菌检查阳性对照组和供试品对照组中均没有检出大肠埃希菌。最终结果表明,按照文章所建立的二丁颗粒微生物限度检查法进行检查,5个厂家15批次的微生物限度检查结果均符合规定。

According to the Chinese Pharmacopoeia(2020 Edition),the paper conducted microbial limit tests on 15 batches of Erding granules from 5 manufacturers and found that the recovery rates of each test strain in the applicability test of aerobic,mold,and yeast counting methods were 0.5-2.0;In the applicability test of the control bacteria test method,Escherichia coli was detected in the positive control group and the test substance control group.The final results indicate that the microbial limit inspection method for Erding granules established in the study meets the requirements for 15 batches of microbial limit inspection results from 5 manufacturers.