富马酸卢帕他定片微生物限度检查的适用性试验

Suitability of Microbial Limit Test for Rupatadine Fumarate Tablets

目的:建立富马酸卢帕他定片微生物限度检查方法。方法:按照2015年版《中国药典》四部通则1105和1106微生物限度检查法中的微生物计数法和控制菌检查法进行验证。结果:所有试验菌(金黄色葡萄球菌、铜绿假单胞菌、枯草芽胞杆菌、白色念珠菌、黑曲霉)的回收率均在0.5～2范围内,采用常规法即可检出大肠埃希菌。结论:该方法有效可行,可用于富马酸卢帕他定片的微生物限度检查。

Objective:To establish the method of microbial limit test for rupatadine fumarate tablets.Methods:A validation was conducted on the microbial limit test in accordance with the microbial enumeration tests and test for specified microorganisms stated in the general rules 1105 and 1106 in Chinese Pharmacopoeia(2015 edition).Results:The recoveries of all the tested strains(Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger)were within the range of 0.5~2,and Escherichia coli could be detected by the conventional method.Conclusion:The method is effective and feasible for the microbial limit test of rupatadine fumarate tablets.