10种中成药微生物限度检查法的建立

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。

Microbial Limit Test Methods for 10 Chinese Patent Medicines

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 with potent antibacterial action.Routine method is suitable for all kinds of specified microorganisms.