黄藤素片微生物限度检查方法验证研究  

The Research on the Method Validation of Microbial Limit Test for Huangtengsu Tablets

作　　者：董建英 赵会兰 

机构地区：[1]云南丽江市人民医院,云南丽江674100 [2]云南丽江市食品药品检验所

出　　处：《中国执业药师》2012年第5期36-39,共4页China Licensed Pharmacist

摘　　要：目的:建立黄藤素片微生物限度检查方法。方法:按《中国药典》2005年版的规定,进行该品种微生物限度检查方法的验证。结果:常规法试验显示黄藤素片对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌均有抗菌作用,不同批产品其抗菌活性有差异,回收率小于70%;培养基稀释法可消除本品对上述4种菌株的抗菌作用,回收率大于70%;常规法试验和稀释法试验均有1批未检出大肠埃希菌;采用薄膜过滤法冲洗300或400 mL,检出大肠埃希菌。结论 :本品不能用常规法进行细菌、霉菌和酵母菌数测定,可采用稀释法进行测定;不能用常规法和稀释法进行控制菌检验,可采用薄膜过滤法进行检验。Objective： To establish the method of microbial limit tests for Huangtengsu tablets. Methods： According to the 2005 edition of the Chinese Pharmacopoeia,the microbiological test methods on Huangtengsu tablets were validated. Results： By using the conventional test methods, the antibacterial actions of Huangtengsu tablets were showed for escherichia coil,staphylococcus aureus ,bacillus subtilis, and candida albicans ,of which the antimicrobial activity varied with different product batches ,and the recovery rate was less than 70%. The culture medium dilution method could eliminate the antibacterial activity of the product for the above four strains and the recovery rate was greater than 70%. Both conventional test methods and dilution method failed to detect escherichia coli in one batch of the product, which was improved by membrane filtration flushing with 300 or 400 mL. Conclusion： For the product, the dilution method can be used for the tests of bacteria （and mould or yeast） counts and membrane filtration can be used for bacteria detection rather than the conventional test methods.

关 键 词：黄藤素片 微生物限度 方法验证 

分 类 号：R927.33[医药卫生—药学]