马来酸桂哌齐特注射液细菌内毒素检查方法的建立

Establishment of Bacterial Endotoxins Test in Cinepazide Maleate Injection

目的:建立马来酸桂哌齐特注射液的细菌内毒素检查方法。方法:按照《中国药典》2010年版(二部)附录细菌内毒素检查法,用2个不同厂家的鲎试剂对3批马来酸桂哌齐特注射液进行干扰试验和细菌内毒素检查。结果:供试品溶液在浓度为0.5mg·mL-1时对鲎试剂与细菌内毒素之间的凝集反应有抑制现象,而浓度低于或等于0.25mg·mL-1时不干扰细菌内毒素检查;样品的细菌内毒素限值确定为1.0EU·mg-1。结论:建立的细菌内毒素检查方法可行,可用于马来酸桂哌齐特注射液的检查。

OBJECTIVE： To establish a method for the detection of bacterial endotoxins in Cinepazide maleate injection. METHODS ： The interference experiment and bacterial endotoxins test of 3 batches of Cinepazide maleate injection were carried out with tachypleus amebocyte lysate from 2 companies according to the guideline and procedures specified in appendix of volume two in Chinese Pharmacopoeia （2010 edition）. RESULTS： It was proved that the samples with concentration of over 0.5 mg. mL-1 in- hibited the congregating reactivity between tachypleus amebocyte lysate and bacterial endotoxins. However, this interference was eliminated by diluting the sample to a concentration of no more than 0.25 mg·mL-1. The limit of bacterial endotoxins was 1.0 EU·mg-1. CONCLUSION： Established method of bacterial endotoxins test is feasible for Cinepazide maleate injection.