参松养心胶囊微生物限度检查方法研究  

Study on Microbial Limit Test of Shensong Yangxin Capsule

作　　者：武玲 曹鲁娜 任颖慧 赵蕊蕊 WU Ling;CAO Lu-Na;REN Ying-Hui;ZHAO Rui-Rui(Heze Institute for Food and Drug Control,Heze 274032,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274032

出　　处：《中国药物经济学》2022年第6期93-96,100,共5页China Journal of Pharmaceutical Economics

摘　　要：目的 对参松养心胶囊的微生物限度检查进行方法适用性研究。方法 按照《中华人民共和国药典》2020年版四部通则1105、1106和1107,分别采用平皿倾注法、增加稀释倍数及中和法联合使用等方法进行研究,根据回收比值确定样品的检查方法。结果 参松养心胶囊的需氧菌总数计数采用1∶100稀释中和法、霉菌和酵母菌总数计数采用平皿倾注法(1∶10)时,各试验菌回收比值均在0.5~2范围内;控制菌检查大肠埃希菌、耐胆盐革兰阴性菌采用常规培养基体积,沙门菌采用培养基稀释法。结论 本研究确定的方法准确可行,可有效控制微生物限度,同时为药品检验机构对该品种的监督检验提供参考。Objective To study the applicability of microbial limit test for Shensong Yangxin capsule.Methods According to the general rules 1105,1106 and 1107 of the fourth part of the Chinese Pharmacopoeia(2020 edition),the methods of plate pouring,increasing dilution multiple and neutralization were used to study,and the detection method of samples was determined according to the recovery ratio.Results When the total aerobic count of Shensong Yangxin capsule was counted by 1∶100dilution neutralization method,and the total mold and yeast count was counted by plate pouring method(1∶10),the recovery ratio of each test bacteria was in the range of 0.5~2;Routine culture medium volume was used for escherichia coli and gram-negative bacteria resistant to bile salt and culture medium dilution method was used for salmonella.Conclusion The method determined in this study is accurate and feasible,and can effectively control the microbial limit.At the same time,it provides a reference for the supervision and inspection of the drug inspection agencies.

关 键 词：参松养心胶囊 微生物限度 平皿倾注法 中和法 培养基稀释法 

分 类 号：R286[医药卫生—中药学]