盐酸赖氨酸葡萄糖注射液细菌内毒素检查法的研究

Study on the bacterial endotoxin inspection method of lysine hydrochloride and glucose injection

目的:建立盐酸赖氨酸葡萄糖注射液的细菌内毒素检查法。方法:将盐酸赖氨酸葡萄糖注射液经10倍稀释,用标示灵敏度为0.25Eu·ml-1的鲎试剂检测其细菌内毒素。结果:盐酸赖氨酸葡萄糖注射液稀释10倍对鲎试剂无干扰作用。结论:可以用细菌内毒素检查法对盐酸赖氨酸葡萄糖注射液进行热原检查。

Objective To establish a bacterial endotoxin inspection method of lysine hydrochloride and glucose injection. Methods The experiment implemented according to bactiral endotoxin test procedure and guiding principle in Chinese Pharmacopoeia. To dilute lysine hydrochloride and glucose injection 10 times, and bacterial endotoxin can be tested by amebocyte lysate with accuraly of 0.25Eu·ml^-1. Results The interference elements can be excluded by diluting lysine hydrochloride and glucose injection 10 times. Conclusions bacterial endotoxin inspection method can be used for testing the pyrogen of lysine hydrochloride and glucose injection.