中国药业2025，Vol.34Issue(4)：76-79,4.DOI:10.3969/j.issn.1006-4931.2025.04.018
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
郑露 1周剑 2陈洁2
作者信息
- 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
- 折叠
摘要
Abstract
Objective To establish a microbial limit test method for Montelukast Sodium Tablets.Methods Based on the requirements of general rules 1105 and 1106 of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),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Key words
Montelukast Sodium Tablets/microbial limit/membrane filtration method/dilution method分类
医药卫生引用本文复制引用
郑露,周剑,陈洁..孟鲁司特钠片微生物限度检查方法适用性研究[J].中国药业,2025,34(4):76-79,4.
