【摘要】 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。更多还原

【Abstract】 ObjectiveTo establish a test method for bacterial endotoxins in Zedoary Turmeric Oil Injection for intravenous injection.MethodsThe experiment was implemented according to the loacterial test endotoxins in China Pharmacopoeia（Ⅱ,2005ed）.ResultsThe delimitation of bacterial endotoxins of this medicament should be fixed less than 4.38 EU·ml^-1.The concentration 1.25mg·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.ConclusionThe bacterial endotoxins test can be used for Zedoary Turmeric Oil Injection.更多还原