注射用灯盏花素细菌内毒素检查方法研究

目的:建立注射用灯盏花素细菌内毒素检查方法。方法:按2005年版《中国药典》(一部)要求,采用凝胶法和光度测定法,确定合理的注射用灯盏花素内毒素限值(L),并研究注射用灯盏花素对细菌内毒素与鲎试剂反应的干扰情况,以确定无干扰试验浓度。结果:L=1EU·mg-1,注射用灯盏花素的无干扰浓度为0.25g·L-1。结论:该药品采用细菌内毒素检查法代替热原检查法,方法可行。

Study on Bacterial Endotoxin Test for Breviscapine for Injection

OBJECTIVE：To develop bacterial endotoxin test for breviscapine for injection.METHODS：The limit of bacterial endotoxin（L） in this product was confirmed according to the appendix Ⅰ of Chinese Pharmacopoeia（2005 edition）.We had studied the interference to bacterial endotoxin test by breviscapine for injection in order to confirm the noninterference concentration with gel clot techniques and photomeric techniques.RESULTS：L was 1 EU·mg^-1 Noninterference concentration of breviscapine for injection for bacterial endotoxin test was 0.25 g·L^-1.CONCLUSION：It is feasible for bacterial endotoxin test instead of pyrogen test.