注射用新鱼腥草素钠静脉滴注用药时细菌内毒素的检测

Determination of Bacterial Endotoxins While Using Sodium New Houttuyfonate for Intravenous Injection

目的:建立新鱼腥草素钠注射液静滴用药时细菌内毒素的检查方法。方法:根据中国药典2000年版Ⅱ部细菌内毒素检查法要求进行实验。结果:注射用新鱼腥草素钠的内毒素限值应定为8.75 EU.mg-1,该药稀释至0.029 mg.ml-1浓度时对细菌内毒素检查无干扰。结论:鲎法检测注射用新鱼腥草素钠静滴用药时的细菌内毒素可行。

Objective：To establish a test method for bacterial endotoxins in sodium new houttuyfonate for intravenous injection. Methods： The experiment was conducted according to the request of bacterial endotoxins in testing method collected in the 2nd Edition of China Pharmacopeia,2000. Results：The delimitation of bacterial endotoxins of this medicament should be fixed less than 8.75EU·mg^-1,0.029 mg·ml^-1 of sodium new houttuyfonate for intravenous injection did not interfere in the test. Conclusion：The TAL may be used for detection of bacterial endotoxins in Sodium New Houttuyfonate for intravenous injection.