摘要
目的对奥拉西坦注射液进行凝胶法干扰试验,建立奥拉西坦注射液细菌内毒素检查的试验方法。方法采用《中国药典》2010年版二部附录收载的细菌内毒素检查方法。结果浓度为12.5mg/mL的样品稀释液对标示灵敏度为0.25EU/mL的鲎试剂无干扰作用。结论使用细菌内毒素检查法检查奥拉西坦注射液中的细菌内毒素是可行的,可用细菌内毒素检查法代替家兔热原检查法。
Objective To establish a method for the determination of bacterial endotoxin of oxiracetam injection.Method According to the method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia 2010 edition.Resu it No interferential effect was under the density 12.5mg/mL of the dilute test solution.The limulus amebocyte lysate reagent with the sensitivity of 0.25 EU/mL could be used in the test.Conclusion It is feasible to detect the bacterial endotoxin of oxiracetam injection by the method of determination of bacterial endotoxin and the method may replace pyrogen test.
出处
《首都医药》
2013年第12期63-64,共2页
Capital Medicine
关键词
奥拉西坦注射液
细菌内毒素试验
鲎试剂
干扰试验
Oxiracetam Injection
Bacterial Endotoxin Test（BET）
Limulus Amebocyte Lysate（LAL）
Inhibition or Enhancement Test
