乳没活络散微生物限度检查方法适用性分析

Applicability Analysis of Microbial Limit Test Method for Rumohuoluo San

文章旨在建立乳没活络散微生物限度的适用性检查方法。基于《中国药典》对微生物限度检查方式的应用要求,文章运用平皿法充分统计乳没活络散中枯草芽孢杆菌、黑曲霉以及白色念珠菌等的回收情况,并利用基础检验的形式针对性地检验制剂控制菌,然后对平皿法、基础检验方法进行评估,发现乳没活络散检验菌种的回收率可以达到70%,同时均能够对控制菌进行诊断,适应要求标准。由此可知,在进行乳没活络散的微生物限度检查时,运用平皿法和基础检验方法,可以提高限度检查的准确性,值得推荐。

The paper aims to establish a applicability testing method for microbial limits of Rumohuoluo San.Based on the application requirements of the microbial limit test method in the Chinese Pharmacopoeia,the paper uses the plate method to fully analyze the recovery of Bacillus subtilis,Aspergillus niger,and Candida albicans in Rumohuoluo San.The paper uses the form of basic testing to specifically test the control bacteria of the formulation,and then evaluates the plate method and basic testing methods.It is found that the corresponding recovery rate of the tested bacteria in the Rumohuoluo San test meets the index of 70%,and both can diagnose the control bacteria and meet the required standards.From this,it can be seen that for microbial limit testing of Rumohuoluo San,the plate method and basic testing methods should be applied in a timely manner to enhance the accuracy of limit testing,which is worth recommending.