散结粉微生物限度检查方法学研究

Methodology Study of Microbial Limit Test of Sanjie Powder

文章旨在构建散结粉的微生物限度检查方法,依据《中国药典》2020版四部通则1105、1106中的实验方法展开研究。当需氧菌总数的计数采用常规法(1∶10供试液,m/V),霉菌和酵母菌总数的计数采用稀释法(1∶50供试液,m/V)进行时,回收率为0.5~2.0,而当控制菌检查采用常规检查法进行时,阳性对照组生长良好,阴性对照组无菌落生长。由此可知,联合使用常规法和稀释法的微生物计数法可以有效消除散结粉中微生物的抑菌作用,有利于检出潜在污染微生物。

This article aims to establish a method for microbial limit test of Sanjie powder,and conduct the research based to the experimental methods outline in the general principles 1105 and 1106 of the Chinese Pharmacopoeia Part Four 2022.The recovery rate was within the range of 0.5-2 when the the total number of aerobic bacteria was counted by using the routine method(1∶10 of test solution,m/V)and the total number of mould and yeast was counted by using the dilution method(1∶50 of test solution,m/V).However,control bacteria examination when conventional examination method was used,positive control group grew well,negative control group did not grow colony.The microbial count method combined with the routine method and dilution method can effectively remove the antibacterial effect of microorganisms in Sanjie powder,which is conducive to the detection of potentially contaminated microorganisms.