摘要
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600 ml(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1800 ml,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。
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.
出处
《中国当代医药》
2013年第34期68-69,71,共3页
China Modern Medicine
关键词
美罗培南
无菌检查
方法学验证
薄膜过滤
Meropenem
Sterility test
Methodology validation
Membrane filtration
