摘要
目的:建立奥拉西坦注射液细菌内毒素检查方法。方法:参照《中国药典》2005年版(二部)附录细菌内毒素检查法及其指导原则进行试验。结果:干扰试验表明供试品稀释60倍可消除干扰。结论:奥拉西坦注射液细菌内毒素检查法可代替家兔法热原检查。
Objective： To establish a bacterial endotoxin test for oxiracetam injection.Methods： According to the ChP 2005 Ed,inhibition or enhancement test for bacterial endotoxin test was carried out of oxiractam injection.Result： The injection did not interfere with the limulus agent in 60 times diluted concentration.Conclusion： Bacterial endotoxin test may be used for quality control of oxiracetam injection.
出处
《天津药学》
2011年第4期1-2,共2页
Tianjin Pharmacy
关键词
奥拉西坦注射液
细菌内毒素检查
干扰试验
oxiracetam injection
bacterial endotoxin test
inhibition or enhancement test
