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11种口服中成药微生物限度检查方法验证 被引量:10

Validation of Microbial Limit Test Method of 11 Kinds of Oral Chinese Patent Medicines
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摘要 目的:研究11种口服中成药的抑菌作用,建立并验证其微生物限度检查方法。方法:采用常规法、培养基稀释法和薄膜过滤法对各试验菌株做回收率试验,以验证所建立方法的科学性和可行性。结果:丹芪偏瘫胶囊对金黄色葡萄球菌、枯草芽孢杆菌有较强的抑制作用,心舒宁片、扶正合剂、肾康宁合剂、清肾消毒饮对金黄色葡萄球菌有一定的抑制作用,板蓝根颗粒对枯草芽孢杆菌有一定的抑制作用,但均可通过培养基稀释法消除。结论:胶藕胶囊、止咳宁嗽胶囊、溶胆石颗粒、散结明目胶囊、降脂软脉片可按常规法进行微生物限度检查,心舒宁片、扶正合剂、肾康宁合剂、清肾消毒饮、板蓝根颗粒、丹芪偏瘫胶囊可按培养基稀释法进行微生物限度检查。各品种控制菌检查均可用常规法。 OBJECTIVE: To study the antimicrobial effect of 11 kinds of oral Chinese patent medicines and to establish microbial limit test method for them. METHODS: Common method and culture medium dilution method and sticked filter membrane method were used to do the recovery test in order to validate the scientificity and feasibility of established method. RESULTS : Danqi piantan capsule showed strong inhibition effect on Staphylococcus aureus and Bacillus subtilis. Xinshuning tablet, Fuzheng mixture, Shenkangning mixture, Qingshen xiaodu oral liquid had antimierobial effect on Staphylococcus aureus to some extent. Banlangen granule had antimicrobial effect on Bacillus subtilis. The effect can be eliminated by culture medium dilution method. CONCLUSION: The common method can be used for the microbial limit test of Jiaoou capsule, Zhike ningsou capsule, Rongdanshi granule, Sanjie mingmu capsule, Jiangzhi ruanmai tablet. Dilution method can be used for the microbial limit test of Xinshuning tablet, Fuzheng mixture, Shenkangning mixture, Qingshen xiaodu oral liquid, Banlangen granule, Danqi piantan capsule. The common method is suitable for all kinds of specified microorganisms.
出处 《中国药房》 CAS CSCD 北大核心 2010年第11期1029-1032,共4页 China Pharmacy
关键词 中成药 微生物限度检查 方法验证 Chinese patent medicines Microbial limit test Validation of method
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