15种中成药微生物限度检查方法验证

目的：建立15种中成药微生物限度检查方法。方法：按《中国药典》（2010年版）的规定，进行各品种微生物限度检查方法的验证。结果：8个品种（青叶胆片、开胸消食片、复方公英片、女金丸、妇舒丸、青阳参片、小儿导赤片、利胆止痛片）无抑菌作用，回收率均大于70%，可采用常规法进行细菌数测定；3个品种（通宣理肺片、田七花叶颗粒、七叶神安片）对枯草芽孢杆菌有不同程度的抑菌作用，可采用培养基稀释法（0.2 mL/皿）进行细菌数测定；2个品种（泻痢消片、七叶神安片）对白色念珠菌有抗菌作用，可采用培养基稀释法（0.2 mL/皿）进行霉菌及酵母菌数测定；3个品种（血塞通片、血塞通胶囊、七叶神安片）对金黄色葡萄球菌和枯草芽孢杆菌有较强的抑菌作用，可采用薄膜过滤法进行细菌数测定；其余品种的细菌、霉菌及酵母数和控制菌均采用常规法进行测定。结论：以上验证方法可作为各品种微生物限度检查方法。

Method Validation of Microbial Limit Test of 15 Kinds of Traditional Chinese Patent Medicines

Objective：To establish a method for microbial limit test of 15 kinds of traditional Chinese patent medicines. Methods：According to the requirements set forth in the Chinese Pharmacopoeia of 2010 edition, method validation should be conducted of microbial limit test for different varieties. Results： Eight species （qingyedan tablets, kaixiongxiaoshi tablets, compound gongying tablets, nvjin pills, fushu pills, qingyangshen tablets, xiaoerdaochi tablets and lidan zhitong tablets）had no bacteriostasis effect with the recovery rate of more than 70%, and the conventional method can be used for bacterial number determination. Three species （tongxuanlifei tablets, tianqihuaye granules and qiyeshen’an tablets） had different degrees of inhibition on bacillus subtilis, and the culture medium dilution method （0.2 mL/plate） can be used for bacterial number determination. Tow species （xielixiao tablets and qiyeshen＇an tablets ） had antibacterial effect on candida albicans, and medium dilution method （0.2 mL/plate） should be used for the determination of mold and yeast counts. Three species （xuesaitong tablets, xuesaitong capsules and qiyeshen’an tablets） had stronger bacteriostasis on staphylococcus aureus and bacillus subtilis, and the bacterial numbers can be tested by membrane filtration. Other kinds of bacteria, mold and yeast counts and control bacteria can be measured by conventional methods. Conclusion： The above verification methods can be used for microbial limit tests of different varieties.