摘要
目的:建立含有金银花的3种中药制剂的微生物限度与控制菌的检查方法并进行验证。方法:按照《中国药典》2015年版的规定,对含有金银花的3种中药制剂的微生物限度与控制菌进行检查及方法学验证。结果:双黄连口服液、金银花复方颗粒、金银花露的需氧菌总数、霉菌和酵母菌总数计数和控制菌检查均可采用常规法。需氧菌总数、霉菌和酵母菌总数验证试验中各菌的回收比值均符合2015年版《中国药典(四部)》相关规定,控制菌检查方法可行。结论:确立了含有金银花的3种中药制剂的微生物限度与控制菌的检查方法。
Objective:To establish and validate the method of the microbial limit and test for specified bacteria for three kinds of traditional Chinese medicine preparations containing Jinyinhua.Method:According to Chinese Pharmacopoeia(2015 edition) method,the methods of the microbial limit and tests for specified microorganisms for three kinds of traditional Chinese medicine preparations containing Jinyinhua were established and validated.Result:The routine method was feasible for the count of amount of aerobic bacteria,mycete,saccharomycetes,and specified bacteria of Shuanghuanglian oral liquid,Jinyinhua compound granules and Jinyinhua distillate.Recovery ratio of validation test of each test bacteria conformed to the regulation in Chinese Pharmacopoeia(2015 edition).The test for specified bacteria was feasible.Conclusion:Method of the microbial limit test and test for specified bacteria for three kinds of traditional Chinese medicine preparations containing Jinyinhua are established.
作者
杜春华
张晓南
游燕
李东娴
王鹏
曹红云
DU Chun-hua;ZHANG Xiao-nan;YOU Yan;LI Dong-xian;WANG Peng;CAO Hong-Yun(Yunnan Institute of Materia Medica,Kunming 650111,Yunnan)
出处
《中药与临床》
2018年第3期19-21,29,共4页
Pharmacy and Clinics of Chinese Materia Medica
关键词
金银花
中药制剂
微生物限度检查
常规法
方法验证
Jinyinhua
traditional Chinese medicine preparation
microbial limit test
the routine method
validation of method