金感胶囊微生物限度检查方法适用性研究

Study on the Applicability of Microbial Limit Test for Jingan Capsules

目的:建立符合2015年版《中国药典》规定的金感胶囊微生物限度检查方法。方法:结合供试液稀释法与平皿法进行计数方法的适用性研究,采用常规法进行控制菌大肠埃希菌的检查。结果:计数方法中,分别采用1∶100、1∶80稀释倍数供试液,需氧菌总数、霉菌和酵母菌总数回收比值均能达到0.5。控制菌检查中,阳性对照菌能在试验组中被检出。结论:本研究所得方法能用于本品的微生物限度检查。

Objective To establish a microbial limit test method for Jingan capsule in accordance with the Chp(2015 edition).Methods The applicability of the counting method was studied with dilution of sample solution and plating. Meanwhile the routine method was used in the examination of Escherichia coli. Results Among the part of counting method, the recovery ratioes of total aerobic bacteria, mould and yeast could reach 0.5 with the dilution times of 1∶100 and 1∶80 for the sample solution respectively. Positive control bacteria can be detected in the test group. Conclusion The method established in the study can be used for microbial limit test of this product.