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