细菌内毒素检查法测定利巴韦林注射液的热原

The bacterial endotoxin test for monitoring pyrogen of ribavirin injection

建立利巴韦林注射液的细菌内毒素检查方法。方法 :参照中国药典 1995年版二部收载的细菌内毒素检查方法进行实验。结果 :通过干扰实验证明 ,利巴韦林注射液对鲎试剂的凝集反应无干扰作用 ,用灵敏度为 0 .5EU·ml-1的鲎试剂检查细菌内毒素的方法可行、有效。结论 :可以用细菌内毒素检查法替代家兔热原法来控制三磷酸腺苷二钠注射液的质量。

OBJECTIVE:To establish a bacterial endotoxin method for monitoring pyrogen of ribavirin injection.METHODS:Bacterial endotoxin test method of the chinese pharmacopoeia was used.RESULTS:The test showed that the reaction with amebocyte lysate was not disturbed by ribavirin injection,sensitivity was 0.5 EU·ml -1.CONCLUSIONS:Amebocyte lysate method can be used in place of rabbit method for pyrogen monitoring of ribavinin lnjection.