4种含中药原粉的医院中药制剂微生物限度检查方法的建立

Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder

目的:建立4种含中药原粉的医院中药制剂(延芍胃康胶囊、乳灵片、痔可平胶囊和延肾胶囊)的微生物限度检查方法。方法:根据《中华人民共和国药典:四部》(2015年版)通则1105、1106和1107的具体规则作为检测依据。采用平皿法对供试品进行处理,对稀释级别进行摸索。结果:在需氧菌、霉菌和酵母菌总数计数适用性试验中,在允许的稀释级别内,采用平皿稀释法进行试验,均可消除抑菌作用,对各试验菌的回收率均在0.5~2.0范围内。4种制剂均采用直接接种法进行控制菌检查,均无抑菌作用。结论:延芍胃康胶囊、乳灵片、痔可平胶囊和延肾胶囊均可采用平皿法进行需氧菌、霉菌和酵母菌总数检查,控制菌检查均可采用直接接种法。

OBJECTIVE:To establish microbial limit test method for 4 kinds of hospital Chinese medicine preparations(Yanshao Weikang capsules,Ruling tablets,Zhikeping capsules and Yanshen capsules)containing TCM powder.METHODS:According to specific rules of the four general rules 1105,1106 and 1107 of Pharmacopoeia of the People’s Republic of China(2015 edition)for testing basis.Plating method was adopted to process the test sample and explore the dilution level.RESULTS:In the applicability test for the total count of aerobic bacteria,molds and yeasts,within the allowable dilution level,the plating dilution method can eliminate antibacterial effect,and the recovery rate of each test bacteria was 0.5-2.0.All the 4 preparations were tested for bacteria control by direct inoculation method,none of which had antibacterial effect.CONCLUSIONS:Yanshao Weikang capsules,Ruling tablets,Zhikeping capsules and Yanshen capsules can all be tested for the total count of aerobic bacteria,molds and yeasts by plating method,and the control bacteria inspections can be conducted by direct inoculation.