注射用盐酸罗沙替丁醋酸酯细菌内毒素检查法的研究

Study on Determination Method of Bacterial Endotoxins in Roxatidine Acetate Hydrochloride for Injection

目的:建立注射用盐酸罗沙替丁醋酸酯细菌内毒素检查法。方法:参照中国药典2010年版二部附录XI E进行实验和结果判断。结果:注射用盐酸罗沙替丁醋酸酯细菌内毒素检查法检测限值定为每1mg注射用盐酸罗沙替丁醋酸酯中含内毒素的量应小于4EU。结论:可用细菌内毒素检查法来检测注射用盐酸罗沙替丁醋酸酯中的细菌内毒素的量。

Objective: To set up bacterial endotoxins determination method for Roxatidine Acetate Hydrochloride For Injection.Methods: The experiment was carried on and the result was judged according to the appendix XI E of Chinese Pharmacopocia 2010 vol Ⅱ.Result: Roxatidine Acetate Hydrochloride For Injection bacterial endotoxin detection limit for each 1ml Roxatidine Acetate Hydrochloride For Injection containing the amount of endotoxin should be less than 4EU.Conclusion:To establish the method of endotoxins test is feasible for Roxatidine Acetate Hydrochloride For Injection.