10种中成药微生物限度检查法的建立

Microbial Limit Test Methods for 10 Chinese Patent Medicines

目的:建立黄柏胶囊等10种中成药的微生物限度检查法。方法:用常规法测定各品种对5个规定试验菌株的回收率,并对必检控制菌的检查法进行验证。结果:人参首乌胶囊无抑菌作用;更年乐片、小儿解表颗粒、消癌平片、解心痛胶囊、消渴胶囊、慢肾安颗粒、接骨七厘分散片、保婴丹等对细菌有一定的抑菌作用;黄柏胶囊对细菌的抑菌作用很强;接骨七厘分散片、保婴丹和黄柏胶囊对霉菌有一定的抑菌作用。结论:无抑菌作用的品种可用常规法检查微生物限度;有一定抑菌作用的品种可用培养基稀释法检查;抑菌作用强的品种可用沉降法+薄膜过滤法检查。各品种控制菌检查均用常规法即可检出。

OBJECTIVE： To establish microbial limit test method for 10 Chinese patent medicines including Huangbo capsule. METHODS： The recovery rates of 5 stipulated test microorganisms treated respectively by 10 Chinese medicines were detected by routine method; and the microbial limit test method for the specified micro- organisms was validated. RESULTS： Renshen shouwu capsule showed no bacteriostatic action, but Gengnian le tablet, Xiao＇ erjiebiao granule, Xiao＇ aiping tablet, Jiexintong capsule, Xiaoke capsule, Manshen＇ an granule, Jieguqili dispersible tablet and Baoying dan did have bacteriostatic actions; Huangbo capsule showed potent antibacterial action. Jieguqili dispersible tablet, Baoying dan and Huangbo capsule showed bacteriostatic action on mould. CONCLUSION： Routine method can be applied for the microbial limit test for those kinds without bacteriostatic action; culture medium diluted method is applicable for those with antibacterial action; sedimentation plus membrane filtration method is applicable for those kinds of specified microorganisms. with potent antibacterial action. Routine method is suitable for all