摘要
目的建立7种具有抑菌成分中成药的微生物限度检查方法。方法按照2010年版《中国药典》的规定测定各品种对5个规定试验菌株的回收率,并对其控制菌检查方法进行验证。结果复方川贝精片、复方穿心莲片、夏桑菊颗粒这3种供试品无抑菌作用,可采用常规方法进行微生物限度检查;吉诺通、维C银翘片、五塔标行军散、普济丸对细菌的抑菌作用较强,需采用静置法或离心沉淀法与薄膜过滤法联用去除其抑菌作用后才能进行微生物限度检查。结论本文建立了7种具有抑菌成分中成药的微生物限度检查方法,可有效控制其质量。
Objective To establish the methods of microbial limit test for seven kinds of Chinese patent medicine with antibacterial ingredients.Methods The recovery rates of five stipulated microorganisms treated respectively by seven Chinese patent medicine were detected according to Chinese Pharmacopoeia 2010,and the microbial limit test methods for the specific micro-organisms were validated.Results Compound Chuanbeijing tablets,Compound Chuanxinlian tablet,and Xiasangju granules didn′t show significant antibacterial activity,for which the microbial limit test could be performed with routine method.Gelomyrtol forte,Vitamin C Yinqiao tablets,Wutabiaoxingjun powder,and Puji pills had strong antibacterial activity,which should be treated by static method or centrifuge sedimentation combined with membrane filtration before the microbial limit test.Conclusion The methods of microbial limit test for seven kinds of Chinese patent medicine were established,which may be used for their quality control.
出处
《广东药学院学报》
CAS
2012年第6期623-627,共5页
Academic Journal of Guangdong College of Pharmacy
基金
广州市食品药品监督管理局科技计划项目(2010GZFDA002)
关键词
微生物限度检查
抑菌作用
方法验证
microbial limit test
antibacterial activity
validation of methods
