两种中药酊剂微生物限度方法适用性研究

Study on The Applicability of Two Methods for Microbial Limit Test of Chinese Medicine Tincture

目的:建立两种中药酊剂微生物限度检查方法。方法:进行需氧菌、霉菌和酵母菌及控制菌进行微生物检查方法适用性试验,根据其抑菌作用强度不同,采取合适的供试品处理方法。结果:两种制剂均对需氧菌有抑制作用,通过薄膜过滤法可消除供试品溶液的抑菌作用,5种试验菌种的回收比值均在0.5~2.0范围内。结论:方法符合《中国药典》2015年版的要求,检验结果准确可靠,可用于该两种制剂的微生物限度项目检查。

Objective:To establish two microbial limit test methods for Chinese medicine tincture.Methods:Aerobic bacteria,molds,yeasts and control bacteria of two kinds of Chinese medicine tincture preparations were tested for the applicability of microbial inspection methods.According to the different bacteriostatic effects,appropriate treatment methods were adopted.Results:Both of the two preparations had inhibitory effect on aerobic bacteria.The antibacterial effect of the test solution could be eliminated by membrane filtration method.The recovery ratio of the five test strains between 0.5 and 2.0.Conclusion:The inspection methods meet the requirements of Pharmacopoeia of the people's Republic of China(2015 Edition)and the test results are accurate and reliable,which can be used for the inspection of drug microbial limit items.