注射用核糖核酸Ⅲ细菌内毒素检查方法的研究

Study on the determination method of the bacterial endotoxin in Ribonucleic Acid Ⅲ for Injection

目的建立注射用核糖核酸Ⅲ细菌内毒素检查方法。方法按《中国药典》2010年版(二部)附录ⅪE细菌内毒素检查法进行实验和结果判断。结果用两个生产厂家的鲎试剂进行研究,注射用核糖核酸Ⅲ的最大不干扰浓度为1.25 mg·mL-1,并对三批样品进行检查,均无干扰作用,其细菌内毒素均小于15 EU·mg-1。结论本品采用细菌内毒素检查法(凝胶法)控制细菌内毒素的含量合理可靠。

Objective To establish the bacterial endotoxin determination method for Ribonucleic Acid m for Injection. Methods The experiment and the judgement of its result were made according to the appendix XIE Test for bacterial endotoxin of Chinese Pharmacopeia Vol Ⅱ. Results The reaction with TAL reagent supplied by two manufactures was not disturbed in 1.25 mg·mL-1 ,which was the maximum no disturb concentration of Ribonucleic Acid Ⅲ for Injection. The endotoxin content was even less than the limit（ 15 EU·mg-1 ） in each of three lots of Ribonucleic Acid m for Injection without interference. Conclusion The test for bacterial endotoxin can be used for control of bacterial endotoxin content.