莪术油注射液静脉滴注用药时的细菌内毒素检查

Bacterial Endotoxins Test of Zedoray Turmeric Oil Injection for Intravenous Injection

目的建立莪术油注射液静脉滴注用药时细菌内毒素的检查方法。方法根据《中国药典》2005年版Ⅱ部收载的细菌内毒素检查法的要求进行实验。结果莪术油注射液的内毒素限值应定为4.38EU.m l-1,该药稀释至1.25mg.m l-1浓度时对细菌内毒素检查无干扰,用标示灵敏度为0.5EU.m l-1的鲎试剂进行细菌内毒素检查是有效的。结论鲎试剂可用于莪术油注射液静脉滴注用药时的细菌内毒素检查。

Objective To establish a test method for bacterial endotoxins in Zedoary Turmeric Oil Injection for intravenous injection. Methods The experiment was implemented according to the loacterial test endotoxins in China Pharmacopoeia （ 11 , 2005ed）. Results The delimitation of bacterial endotoxins of this medicament should be fixed less than 4.38 EU · ml^-1. The concentration 1.25 mg·ml^-1 of Zedoary Turmeric Oil Injection for intravenous injection should not interfere the test , and be effective that the baterial endotoxins could be tested by amebocyte lysate with accuracy of 0.5EU ml^-1. Conclusion The bacterial endotoxins test can be used for Zedoary Turmeric Oil Injection.