两种规格奥硝唑胶囊微生物限度检查方法探讨

目的建立两种规格奥硝唑胶囊的微生物限度检查方法。方法采用人工污染5种试验菌测定其回收率菌,验证该药品是否有抑菌作用。采用薄膜过滤法,对规格为0.1g和0.25g的奥硝唑胶囊分别用冲洗液300mL分3次冲洗,测定其细菌数;采用常规法测定霉菌和酵母菌;控制菌检查大肠埃希菌采用薄膜过滤法。结果薄膜过滤法（供试液1mL/膜,冲洗液300mL/膜）能有效消除奥硝唑对细菌的抑制作用,回收率达85%以上;控制菌大肠埃希菌可用薄膜过滤法进行检测;奥硝唑对金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌有强抑制性,对白色念珠菌和黑曲霉无抑制作用。结论采用薄膜过滤法测定细菌数,常规法测定霉菌和酵母菌数,薄膜过滤法（供试液10mL/膜）检查控制菌大肠埃希菌,可有效控制奥硝唑胶囊的质量。

Validation Method for Microbial Limit Tests of Two Specifications of Ornidazole Capsules

Objective To establish a method for microbial limit examination of two specifications of Ornidazole Capsules.Methods The artificial contamination 5 types of test bacteria were used to detect the bacterial recovery rate for verifying the bacteriostasis.According to the method for the microbial limit examination in the Chinese Pharmacopoeia（2005 edition）,the membrane filtration method was adopted to wash 0.1 g and 0.25 g of Ornidazole Capsules for 3 times with 300 mL of washing fluid and determine the number of bacteria.The conventional method was used to detect mould and yeasts.The membrane filtration method was used to detect Escherichia coli as control bacterium.Results The membrane filtration method（sampling 1 mL /membrane,washing fluid 300 mL /membrane） could effectively eliminate the antimicrobial effect of the preparation,with the recovery rate of more than 85%.Escherichia coli as control bacterium could be detected by the membrane filtration method.The preparation had strong bacteriostatic effect to staphylococcus aureus,Escherichia coli,bacillus subtilis,but no bacteriostatic effect to Candida albicans.Conclusion The membrane filtration method can be used for microbial limit examination of two specifications of Ornidazole Capsules preferably with accurate result and reaching the objective.The conventional method can be used for mould and yeast test;the membrane filtration method（sampling 10 mL /membrane） can be used for Escherichia coli test.