注射用磷霉素钠细菌内毒素检查法的应用研究

Apply Research of Bacterial Endotoxin Test in Fosfomycin Sodium for Injection

目的：探讨细菌内毒素检查法用于注射用磷霉素钠质量监控的可行性。方法：按中国药典2000年版附录ⅪE、ⅪⅩF进行实验和结果判断。结果：通过稀释的方法干扰可排出,不干扰浓度大于最大有效稀释倍数(MVD)浓度。结论：细菌内毒素检查法代替家兔热原检查法用于注射用磷霉素钠的质量监控是可行的。

Objective：To investigate the possibility of quality control of Fosfomycin Sodium for Injection by bacterial endotoxin test. Method：The experiment was made and the result was judged according to the appendix Ⅺ E, Ⅺ X F of Chinese Pharmacopeia（2000）vol Ⅱ . Results：By diluting the samples,the disturbance effect of Fosfomycin Sodium for Injection,the non-interfered content is bigger than the content of maximum valid dilution（MVD）. Conclusion：Bacterial endotoxin test can be used in place of the rabbit method for quality monitoring of fosfomycin sodium for injection.