目的对奥拉西坦注射液进行凝胶法干扰试验,建立奥拉西坦注射液细菌内毒素检查的试验方法。方法采用《中国药典》2010年版二部附录收载的细菌内毒素检查方法。结果浓度为12.5mg/mL的样品稀释液对标示灵敏度为0.25EU/mL的鲎试剂无干扰作用。结论使用细菌内毒素检查法检查奥拉西坦注射液中的细菌内毒素是可行的,可用细菌内毒素检查法代替家兔热原检查法。 OBJECTIVE To test the interference of oxiracetam gel by gel method and to establish the test method of bacterial endotoxin test of oxiracetam injection. Methods The bacterial endotoxin test method contained in the two appendixes of Chinese Pharmacopoeia (2010 edition) was used. Results Sample dilutions at a concentration of 12.5 mg / mL had no interference with the titration reagent with a labeling sensitivity of 0.25 EU / mL. Conclusion Bacterial endotoxin test to examine the bacterial endotoxin in Oxiracetam injection is feasible, bacterial endotoxin test method can be used instead of the rabbit pyrogen test.