苦参碱葡萄糖注射液细菌内毒素检查法的建立

Bacterial Endotoxins Test for Matrine and Glucose Injection

目的:确立苦参碱葡萄糖注射液细菌内毒素检查方法。方法:参照《中华人民共和国药典》2 0 0 0年版二部附录XIE细菌毒素检查法要求进行试验。结果:该药在稀释2倍后不干扰细菌内毒素试验。结论:该药采用细菌内毒素检查法代替热原检查法,方法可行。

Objective:To establish the method of test for bacterial endotoxins of Matrine and Glucose Injection.Method:Experiment was conducted according to the bacterial endotoxins test in Chinese Pharmacopeia 2000 Volume Ⅱ.Result:Two-fold dilution of Matrine and Glucose Injection did not interfere with bacterial endotoxins test.Conclusion:It is feasible for bacterial endotoxins test instead of pyrogen test.