摘要
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。
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.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第39期3726-3728,共3页
China Pharmacy
关键词
注射用灯盏花素
细菌内毒素
凝胶法
光度测定法
Breviscapine for injection
Bacterial endotoxin
Gel clot techniques
Photometric techniques
