注射用尤瑞克林细菌内毒素检查方法的建立

Establishment on Bacterial Endotoxin Test of Urinary Kininogenase for Injection

目的:建立注射用尤瑞克林细菌内毒素的检查方法。方法:按照2010年版《中国药典》(二部)附录细菌内毒素检查法的要求,用2个厂家的鲎试剂对3个批号的注射用尤瑞克林进行干扰试验和细菌内毒素检查。结果:样品的浓度≤0.000 75 PNA/ml时对细菌内毒素检查无干扰。结论:细菌内毒素检查法可以用于注射用尤瑞克林细菌内毒素的限量检查。

OBJECTIVE：To establish a method for bacterial endotoxin test of Urinary kininogenase for injection.METHODS：According to the requirements of bacterial endotoxin test stated in Chinese Pharmacopoeia（2010 edition Ⅱ）,interference experiment and bacterial endotoxins test were carried out among 3 batches of Urinary kininogenase for injection with tachypleus amebocyte lysate（TAL）from 2 different manufacturers.RESULTS：The interference on bacterial endotoxin test can be excluded when sample was diluted to below 0.000 75 PNA/ml.CONCLUSIONS：Bacterial endotoxin test is applicable for limit test of bacterial endotoxin for Urinary kininogenase for injection.