精制冠心片微生物限度检查方法的建立

Establishment of Microbial Limit Test of Jingzhi Guanxin Tablets

目的:对精制冠心片微生物限度检查方法进行方法验证/适用性试验。方法:根据中国药典2010年版和2015年版方法,分别进行试验。结果:精制冠心片对枯草芽孢杆菌有明显的抑制作用;按中国药典2010年版方法,细菌计数采用培养基稀释法;按中国药典2015年版方法,需氧菌计数采用薄膜过滤法,霉菌和酵母菌计数采用平皿法,控制菌的检查采用常规法。结论:建立了精制冠心片的微生物限度检查方法。

Objective： To establish a method for the microbial limit test of Jingzhi Guanxin tablets. Methods： According to the methods in the 2010 edition and 2015 edition of Chinese Pharmacopoeia, the test was performed respectively. Results： Jingzhi Guanxin tablets showed obvious inhibitory effect on Bacillus subtilis. The bacteria count could be carried out by the culture medium diluting methods in the 2010 edition. The total amount of aerobe could be detected by the membrane filtration method in the 2015 edition. The total combined molds and yeasts count could be performed by the plate count method and the specified microorganism could be tested with the routine method. Conclusion： The above methods can be used for the microbial limit test of Jingzhi Guanxin tablets.