注射用尿激酶细菌内毒素检查的研究

Study on Bacterial Endotoxins Test for Urokinase for Injection

目的:研究注射用尿激酶的细菌内毒素检查方法。方法:参照中国药典2000年版二部附录Ⅺ E 细菌内毒素检查法和附录Ⅺ XF 细菌内毒素检查法应用指导原则进行试验。结果:供试品在222.22u/ml 浓度下无干扰作用。结论:获得了可靠的实验数据和结果并为本品细菌内毒素检查法的确立提供了依据。

Objective:To study Bacterial Endotoxins Test(BET)for Urokinase for Injection.Methods:According to the CP 2000,Inhibition or Enhancement Test for Bacterial Endotoxins Test was done for Urokinase for Injection.The interfe- ring test for Herbe Houttuyniae Injection was carried out.Results:222.22u/ml solution of Urokinase didn't inhibit or en- hance the test.Conclusion:The Bacterial Endotoxins Test(BET)for this specimen was established.