双滤膜过滤方法在药品微生物限度检查中的应用研究

目的: 建立药品微生物限度检查双滤膜过滤方法,验证其消除供试液抑菌活性的有效性.方法: 采用枯草芽孢杆菌、大肠埃希菌、金黄色葡萄球菌、白色念珠菌和黑曲霉为挑战菌株,以中国药典收载的离心沉淀法和培养基稀释法为对照方法,考察双滤膜过滤方法的准确度、精密度、定量限、线性、范围、重现性和耐用性等.结果: 采用双滤膜过滤方法处理具抑菌活性的供试品,准确度、精密度、定量限和线性等检测结果优于或与现行中国药典收载的方法持平,并具有良好的重现性和耐用性.结论: 双滤膜过滤方法处理具有抗菌活性的供试品,实验过程符合中国药典微生物限度检查法相关规定,试验结果有效,可用于药品的微生物限度检查试验.

Objective: To establish the method of double membrane filtration in microbial limit tests for drugs and to verify its efficacy of eliminating the antimicrobial activity of the test samples. Methods: Using Bacillus subtilis, Escherichia coli, Staphylococcus aureus, Candida albicans, Aspergillus niger as the test microorganisms, with the centrifugation method and the medium dilution method as the control methods, the accuracy, precision, detection limit, linearity, range, repeatability and robustness of double membrane filtration were investigated. Results: The accuracy, precision, detection limit, linearity of the double membrane filtration method were equivalent or even superior to Chinese Pharmacopeial method, and showed favorable repeatability and robustness. Conclusion: The procedures taken to remove antimicrobial activity by the double membrane filtration method meet the requirements of microbial limit tests regulated by the Chinese Pharmacopoeia, the test results are valid and the method can be used for microbial limit tests.

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