美罗培南无菌检查的方法学验证

目的建立美罗培南的无菌检查标准方法。方法根据中国药典2010年版附录ⅪH无菌检查法中的要求，采用薄膜过滤法进行方法学验证。结果每筒冲洗量600ml（分6次），人工振荡，可以消除样品对6株实验菌的抗菌活性。结论美罗培南采用薄膜过滤法，总冲洗量为1800ml，采取人工振荡，可以用大肠埃希菌作为阳性对照菌进行无菌检测。

Methodology validation of meropenem sterility test

Objective To establish the standard methods of meropenem sterility test.Methods The membrane filtration method was used for methodology validation according to the requirements in Appendix XI H Sterility Test Methods in Chinese Pharmacopoeia 2010.Results The 600 ml of flush volume per cylinder （6 times）and artificial oscillation can eliminate the antibacterial activity of samples to 6 strains of test organisms.Conclusion Meropenem with Escherichia coli as the positive control,can conduct the sterile test through the membrane-filtratidn method,a total flush volume of 1800 ml and artificial oscillation.