利巴韦林细菌内毒素检查法的建立

To establish a method of bacteria endotoxin test of Ribavirin

目的建立利巴韦林原料药细菌内毒素检查方法。方法参照《中国药典》2010年版二部细菌内毒素检查法进行试验。结果样品稀释至25mg.mL-1浓度时,对鲎试剂与细菌内毒素的反应无干扰作用。其细菌内毒素限值定为0.15EU.mg-1。结论利巴韦林原料药可用细菌内毒素检查法(凝胶法)控制其质量。

OBJECTIVE To establish a bacterial endotoxin test for Ribavirin substance.METHODS A refer to the method for bacteria endotoxin test in Chp（2010）Ⅱ.RESULTS The sample was no interference effect on the reaction of bacterial endotoxin and TAL when it had been diluted to 25mg·mL-1 and its endotoxin limit concentration can be established as 0.15EU·mg-1.CONCLUSION Bacterial endotoxin test can be used for the quality control of Ribavirin substance.