注射用尖吻蝮蛇血凝酶细菌内毒素检查方法的建立  

Establishment of Bacterial Endotoxin Test of Haemocoaguiase Agkistrodon for Injection

作　　者：黄荣富[1] 厉青[1] 李龙健[1] 邵丽晓[1] 

机构地区：[1]武警浙江总队医院,浙江嘉兴314000

出　　处：《中国药房》2013年第17期1602-1603,共2页China Pharmacy

摘　　要：目的:建立注射用尖吻蝮蛇血凝酶细菌内毒素的检查方法。方法:按2010年版《中国药典》附录细菌内毒素凝胶检查法的要求,通过干扰试验确定样品最大无干扰浓度,并进行方法学验证。结果:样品稀释至0.04U/ml时对细菌内毒素检查无干扰作用。结论:所建立的方法可用于注射用尖吻蝮蛇血凝酶的细菌内毒素检查。OBJECTIVE： To establish a method for bacterial endotoxin test of Haemocoaguiase agkistrodon for injection. METHODS： Maximum non-interference concentration of samples was determined by interference test according to bacterial endotoxin gel-clot assay in appendix of Chinese Pharmacopeia （2010 edition）. And then methodology validation was conducted. RESULTS： The interference on bacterial endotoxin test can be excluded when sample was diluted to below 0.04 U/ml. CONCLUSIONS：The established method is feasible to detect the bacterial endotoxin of Haemocoaguiase agkistrodon for injection.

关 键 词：注射尖吻蝮蛇血凝酶 细菌内毒素检查 凝胶法 干扰试验 

分 类 号：R927.12[医药卫生—药学] R973.1