枸橼酸莫沙必利注射液细菌内毒素检测方法的研究

Determination Method of Bacterial Endotoxins in Mosapride Citrate Injections

目的:建立枸橼酸莫沙必利注射液细菌内毒素的检查方法。方法:按照《中国药典》2010年版二部附录ⅪE指导原则进行灵敏度试验及干扰试验,确定本品中细菌内毒素的限度,并对样品进行了测定。结果:本品中的细菌内毒素均小于5.0EU/mg,符合质量要求。结论 :本法灵敏度高,能够对枸橼酸莫沙必利注射液中的细菌内毒素进行有效测定,可用于该产品的质量控制。

Objective ：To establish a method for the determination of Mosapride Citrate Injections. Methods： The Limulus test was adopted according to Ch. P, Appendix XI E. The sensitivity test and interference test was used to define the limit of Bacterial Endotoxins in Mosapride Citrate Injections. Results： The Bacterial Endotoxins in products were all below 5. 0EU/mg and meet the prescription. Conclusion： The method is high sensitivity and can be better detect the Bacterial Endotoxins in Mosapride Citrate Injections. It is suitable for controlling the quality of the products.