冠心苏合制剂微生物限度检查方法研究  

Microbial Limit Test of Guanxin Suhe Preparations

作　　者：程龙 陈霞 CHENG Long;CHEN Xia(Chengdu Institute for Food and Drug Control,Chengdu 610041,China)

机构地区：[1]成都市食品药品检验研究院

出　　处：《中医药信息》2019年第6期8-11,共4页Information on Traditional Chinese Medicine

摘　　要：目的:研究冠心苏合胶囊和冠心苏合丸微生物限度检查方法的适用性。方法:按照2015年版《中国药典》对冠心苏合制剂的需氧菌总数、霉菌和酵母菌总数、大肠埃希菌、沙门菌和耐胆盐革兰阴性菌的检查方法进行验证。结果:冠心苏合制剂具有一定的抑菌性,其需氧菌总数需采用1∶1 000供试液按薄膜过滤法计数,霉菌和酵母菌总数可采用1∶10供试液按平皿法计数,控制菌均可采用常规法进行检查。结论:本研究建立了冠心苏合胶囊和冠心苏合丸的微生物限度检查方法,适用性高。Objective:To explore the method applicability of the microbial limit test for Guanxin Suhe Capsule and Guanxin Suhe Pill.Methods:According to general rules of the Chinese Pharmacopoeia(2015 edition),method was established to detect the total counting of aerobic bacteria,mold and yeast,escherichia coli,salmonella,and bile-resistant gram-negative bacteria.Results:Guanxin Suhe preparations have certain antibacterial activity.The aerobic bacteria were counted by the membrane filtration method using 1∶1 000 test solution,mold and yeast were counted by the plating method using 1∶10 test solution.The controlled bacteria were tested by the routine method.Conclusion:This study established the method of microbial limit test for Guanxin Suhe Capsule and Guanxin Suhe Pill,and the method has high applicability.

关 键 词：冠心苏合胶囊 冠心苏合丸 微生物限度检查 方法适用性 

分 类 号：R286.0[医药卫生—中药学]