7种中药制剂微生物限度检查方法验证  

Verification of Methodology on the Microbial Limit Test for Seven Traditional Chinese Medicines

作　　者：杨育林 吉莹洁 

机构地区：[1]河南省洛阳市食品药品检验所,洛阳471023

出　　处：《海峡药学》2014年第10期48-50,共3页Strait Pharmaceutical Journal

摘　　要：目的建立7种中药制剂微生物限度检查方法。方法采用常规法、培养基稀释法、薄膜过滤法对7种中药制剂进行方法验证。结果舒筋活血片、元胡止痛片、麻仁润肠丸可采用常规法,鼻舒适片、抗病毒片、小儿解感颗粒用培养基稀释法,消炎利胆片用薄膜过滤法进行微生物限度的细菌检查;霉菌及酵母菌计数、控制菌检查均采用常规法。结论确立了7种中药制剂微生物限度检查方法,可有效控制其质量。OBJECTIVE To establish methods of the microbial limit test for seven traditional Chinese medi： cines. METHODS Common method,dilution method and membrane filtration method were used for the verification of methodology on seven traditional Chinese medicines. RESULTS Common method can be used on Shujinhuoxue tablets, Yuanhuzhitong tablets and Marenrunchang pills ; dilution method can be used on Bishushi tablets, Kangbingdu tablets and Xiaoerjiegan granules ; membrane filtration method can be used on Xiaoyanlidan tablets for count of bacte- ria. Common method can be used for count of molds and yeasts, detection of escherichia coli and coli- form. CONCLUSION Methods of the microbial limit test for seven traditional Chinese medicines are established, and the can be used for quality control of those preparations.

关 键 词：中药制剂 微生物限度检查 方法验证 

分 类 号：R927.11[医药卫生—药学]