咽炎片微生物限度检查方法的构建  

A Study on Microbial Limit Test Method of Pharyngitis Tablets

作　　者：刘博 任仲丽 曹鲁娜 李秀菊 张裕民 LIU Bo;REN Zhong-Li;CAO Lu-Na;LI Xiu-Ju;ZHANG Yu-Min(Heze Institute for Food and Drug Control,Heze 274000,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274000

出　　处：《中国药物经济学》2022年第4期120-123,共4页China Journal of Pharmaceutical Economics

摘　　要：目的建立咽炎片的微生物限度检查方法。方法按照《中华人民共和国药典》2020年版四部的规定,采用常规法、增加培养基体积法和薄膜过滤法对咽炎片微生物限度进行方法适用性试验与验证。结果常规法、增加培养基体积法不能消除咽炎片对金黄色葡萄球菌、枯草芽孢杆菌的抑制作用,测得回收率不符合规定,薄膜过滤法可消除这两种菌的抑制作用,测得回收率在50%~200%。控制菌(耐胆盐革兰阴性菌、大肠埃希菌、沙门氏菌)采用常规法测定,结果阳性对照均检出生长良好,阴性对照未检出。结论建立了咽炎片的微生物限度及控制菌的检查方法,该方法有效可行。Objective To establish a microbial limit test method of Pharyngitis Tablets.Methods According to the Chinese Pharmacopoeia of 2020 Version,the method applicability test and verification were carried out on the microbial limit of Yanyan tablets by conventional method,increasing medium volume and membrane filtration method.Results The conventional method and the method of increasing the medium volume cannot eliminate the inhibitory effects of Yanyan Tablets on Staphylococcus aureus and Bacillus subtilis,and the measured recovery rate did not meet the requirements.The membrane filtration method can eliminate the inhibitory effect of the two bacteria,and the measured recovery rate was from 50%to 200%.Control bacteria(bile salt-resistant Gram-negative bacteria,Escherichia coli,Salmonella)were determined by conventional methods.The results showed that the positive controls all grew well,but the negative controls were not detected.Conclusion The microbial limit and control bacteria test of Pharyngitis Tablets are established.The method is effective and feasible.

关 键 词：咽炎片 常规法 增加培养基体积法 薄膜过滤法 

分 类 号：R987[医药卫生—药品] R927.1[医药卫生—药学]