盐酸米那普仑片微生物限度检查方法的适用性验证

Validation of the applicability of microbial limit test for minapram hydrochloride tablets

目的:建立抗抑郁药物盐酸米那普仑片微生物限度检查方法并对其进行验证。方法:参照2015年版《中国药典》四部通则,采用薄膜过滤法和平皿法测定盐酸米那普仑片对金黄色葡萄球菌等5种试验菌种的回收率,并对其进行了控制菌适用性试验。结果:5种试验菌回收率均在0.5~2.0范围,控制菌可检出。结论:本试验所建立方法可用于盐酸米那普仑片的微生物限度检查。

Objective:To establish and verify the microbial limit test method for minapram hydrochloride tablets.Methods:According to the fourth part of the 2015 edition of Chinese Pharmacopoeia principles,the recovery rates of minapram hydrochloride tablets against 5 kinds of test microorganisms including Staphylococcus aureus were measured by membrane filtration and Petri dish methods,and the applicability test of E.coli as a control bacterium was also performed.Results:The recovery rates of the 5 kinds of experimental microorganisms were in the range of 0.5-2,and the control bacterium could be detected.Conclusion:The methods established in this experiment can be used for the microbial limit test of minapram hydrochloride tablets.