长春西汀氯化钠注射液细菌内毒素检查法的研究

Study on the Determination Method of the Bacterial Endotoxins in Vinpocetine and Sodium chloride Injection

目的:建立长春西汀氯化钠注射液细菌内毒素检查法。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:长春西汀氯化钠注射液细菌内毒素检查法检测限值定为每1mL长春西汀氯化钠注射液中含内毒素的量应小于0.5EU。结论:建立其细菌内毒素检查法是可行的,可用于其质量控制。

Objective:To set up bacterial endotoxins determination method for Vinpocetine and sodium chloride injection.Methods:The experiment was carried on and the result was judged according to the appendix XI E of Chinese Pharmacopocia 2010 volⅡ. Result:Vinpocetine and sodium chloride injection bacterial endotoxin detection limit for each 1mL Vinpocetine and sod ium chloride injection containing the amount of endotoxin should be less than 0.5EU. Conclusion:To establish the method of endotoxins test is feasible for Vinpocetine and sodium chloride injection.