两种中药制剂微生物限度检查方法验证  

Methodological validation for microbial limit test of Ziyin Qingre Jiangtang pill and Jinshui Kechuankang capsule

作　　者：陈慧洁 郭华荣 顾崇梅 CHEN Huijie;GUO Huarong;GU Chongmei(Jiuquan Municipal Center of Drug Inspection and Testing,Jiuquan Gansu 735000,China)

机构地区：[1]甘肃省酒泉市药品检验检测中心,甘肃酒泉735000

出　　处：《中兽医医药杂志》2022年第1期68-72,共5页Journal of Traditional Chinese Veterinary Medicine

基　　金：甘肃省药品监督管理局科研项目(2020GSMPA022);酒泉市科技计划项目(2060402应用技术研究与开发)。

摘　　要：建立滋阴清热降糖丸、金水咳喘康胶囊的微生物限度检查方法,并对其进行验证。取滋阴清热降糖丸、金水咳喘康胶囊各10 g,用TSB制成1∶10的供试液,混匀,采用平皿法进行检查,需氧菌采用1∶50、1∶100、1∶1 000 3个稀释度,霉菌、酵母菌采用1∶10、1∶100 2个稀释度,加入金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉,测定回收率。控制菌按照《中华人民共和国药典》2020年版四部中规定检查大肠埃希菌、沙门菌、耐胆盐革兰阴性菌。按上述方法进行验证,测定菌种回收率均为0.5~2.0,方法适用性试验结果满足要求。说明平皿法经验证有效,可用于这两种中药制剂的微生物限度检查,能有效控制药品质量,结果准确可靠。To establish and validate the method of the microbial limit test for specified bacteria for traditional Chinese medicine Ziyin Qingre Jiangtang pill and Jinshui Kechuankang capsule,10 g of Ziyin Qingre Jiangtang pill and Jinshui Kechuankang capsule were prepared into 1∶10 solution by proper method,mixed well and checked by plate method. Aerobic bacteria were used three dilutions of 1∶50,1∶100 and 1∶1 000,mold and yeast were used two dilutions of 1∶10 and 1∶100,adding taphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger,and then the recovery rate was determined. According to the Chinese Pharmacopoeia 2020 edition,Escherichia coli,Salmonella and bile salt resistant gram-negative bacteria were used as control bacteria by conventional methods for verification. According to the above methods,the recovery rate of bacteria was between 0.5 and 2.0,and the applicability method results meet the requirements. The plate method was proved to be effective and could be used for microbial limit test of the drug,which could effectively control the quality of the drug with high accuracy and reliability.

关 键 词：滋阴清热降糖丸 金水咳喘康胶囊 微生物限度检查法 平皿法 

分 类 号：S853.7[农业科学—临床兽医学]