目的建立注射用维库溴铵细菌内毒素的检查方法。方法按《中国药典》2005年版二部附录XIE进行实验和结果判断。结果用三个不同生产厂家,不同标示灵敏度鲎试剂进行研究,注射用维库溴铵最大不干扰浓度为0.1mg/ml,并对两个生产厂家的6批样品进行检查,均无干扰作用,其细菌内毒素量均小于5EU/mg。结论本品可以用细菌内毒素检查法(凝胶法)控制细菌内毒素的含量,其细菌内毒素限值为5EU/mg。 Objective To establish a method for the detection of bacterial endotoxin of vecuronium bromide for injection. Methods According to the “Chinese Pharmacopoeia” 2005 edition two appendix XIE experiments and results to determine. Results Three different manufacturers with different labeling sensitivity were used for the study. The maximum undisturbed concentration of vecuronium for injection was 0.1 mg / ml. Six samples from two manufacturers were examined without interference. The bacterial endotoxin levels were less than 5EU / mg. Conclusion This product can be used bacterial endotoxin test (gel method) to control bacterial endotoxin content, the bacterial endotoxin limits 5EU / mg.