鲎试剂法检测平衡液中细菌内毒素

Bacterial endotoxins in equilibrium liquid determined by LLA

目的 建立平衡液的细菌内毒素检查方法。方法 参照中国药典2000年版细菌内毒素检查法及热原检查法。结 果 干扰试验表明,供试品对细菌内毒素检查法不存在干扰作用。结论 细菌内毒素检查法可代替家兔法进行平衡液热原 检查。

Objective To establish a method for testing bacterial endotoxins in equilibrium liquid.Methods The methods of bacterial endotoxins test and pyrogen test in Chinese pharmacopeia 2000 were used. Results The results of the bacterial endotoxins test and pyrogen test for many batches of samples were identical.Conclusion The bacterial endotoxins test can replacement the rabbit method for pyrogen test.