孟鲁司特钠片微生物限度检查方法适用性研究  

Study on the Applicability of Microbial Limit Test for Montelukast Sodium Tablets

作　　者：郑露 周剑 陈洁 ZHENG Lu;ZHOU Jian;CHEN Jie(Chongqing Medical and Pharmaceutical College,Chongqing,China 401331;Chongqing Institute for Food and Drug Control·NMPA Key Laboratory of Quality Monitoring of Anaesthetic and Psychotropic Substances,Chongqing,China 401121)

机构地区：[1]重庆医药高等专科学校,重庆401331 [2]重庆市食品药品检验检测研究院·国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆401121

出　　处：《中国药业》2025年第4期76-79,共4页China Pharmaceuticals

摘　　要：目的 建立孟鲁司特钠片的微生物限度检测方法。方法 按2020年版《中国药典(四部)》通则1105、1106要求,分别采用薄膜过滤法和稀释法及常规法对需氧菌总数及霉菌和酵母菌总数计数,控制菌(大肠埃希菌)检查采用常规法。结果 需氧菌总数检查用1∶100(m/V)供试液,采用薄膜过滤法(500 mL/膜)。常规法中,样品对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌有较强抑菌作用,阳性菌回收率均小于0.5;薄膜过滤法和稀释法中,样品对以上菌的回收率均大于0.5,对白色念珠菌、黑曲霉无明显抑菌作用,阳性菌回收率大于0.5;样品对控制菌无明显抑制作用。结论 需氧菌检查宜采用薄膜过滤法;霉菌和酵母菌总数计数及控制菌检查均可采用常规法。Objective requirements of general rules 1105 and 1106 of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),the total count of aerobic bacteria and the total count of molds and yeasts were tested by the membrane filtration+convention and dilution methods,respectively,the control bacteria(Escherichia coli)were tested by the conventional methods.Results The total count of aerobic bacteria was tested by a 1∶100(m/V)test solution and membrane filtration method(500 mL/membrane).In the conventional method,the samples had a strong antibacterial effect on Staphylococcus aureus,Pseudomonas aeruginosa and Bacillus subtilis,and the recovery ratio of positive bacteria was lower than 0.5.In both membrane filtration and dilution methods,the recovery rate of the above bacteria in the samples was greater than 0.5;samples had no significant antibacterial effect on Candida albicans and Aspergillus niger,and the recovery rate of positive bacteria was greater than 0.5.Samples had no significant inhibitory effect on the control bacteria.Conclusion Membrane filtration method is suitable for aerobic bacterial test;conventional methods can be used for mold and yeast counting and control bacteria test.

关 键 词：孟鲁斯特钠片 微生物限度 薄膜过滤法 稀释法 

分 类 号：R917[医药卫生—药物分析学]