注射用亚胺培南西司他丁钠无菌检查方法学研究

Methodology studies on sterility test of Imipenem and Cilastatin Sodium for Injection

目的:建立注射用亚胺培南西司他丁钠无菌检查方法。方法:采用薄膜过滤+酶法对样品进行无菌检查。结果:注射用亚胺培南西司他丁钠具有较强的抑菌活性,对不同验证菌株的敏感性显著不同。结论:薄膜过滤法+酶法能有效地去除其抑菌性,并通过验证试验保证无菌检查方法的可靠性。

Objective：To establish a methods for sterility test of Imipenem and Cilastatin Sodium for Injection.Methods：The membrane filtrating and enzyme methods were used.Results：The antimicrobial effect of Imipenem and Cilastatin Sodium for Injection was strong.The antibacterial sensitivities to the validating bacteria among the generations of cefonicidum natricum were dramatically different.Conclusion：Membrane filtrating and enzyme methods can effectively eliminate its antimicrobial effect,meanwhile can guarantee the validity of sterility test for the Imipenem and Cilastatin sodium for Injection.