硫酸镁注射液细菌内毒素检查法的可行性研究

The researches on the feasibility for the bacterial endotoxin inspection method of magnesium sulfate injection

目的 建立硫酸镁注射液的细菌内毒素检测方法。方法 按《中国药典》二部 2 0 0 0年版附录细菌内毒素检查法 ,考察硫酸镁注射液对细菌内毒素法检查的干扰作用。结果 硫酸镁注射液稀释 10倍 ,对细菌内毒素法无干扰作用。

AIM To establish a bacterial endotoxin test of magnesium sulfate injection. METHODS To inspect bacterial endotoxin according to the method in addend of China Pharmacopoeia (second part) 2000 edition, the interference of magnesium sulfate injection to the process of bacteria endotoxin test was studied. RESULTS Magnesium sulfate injection has no interference to the bacterial endotoxins test, when it is diluted for 10 times. CONCLUSIONS Bacteria endotoxin test could be used in place of the rabbit for pyrogen test of magnesium sulfate injection.