华蟾素注射液细菌内毒素检查法的考察  

Researches on the Feasibility of the Bacterial Endotoxin Inspection Method of Sodium Lactate Ringer's Injection

作　　者：刘渝[1] 周苏萍[2] 黄耀宾 

机构地区：[1]第四军医大学西京医院药剂科,陕西西安710032 [2]总后勤部卫生部药品仪器检验所,北京100071 [3]兰州军区药品仪器检验所,甘肃兰州730050

出　　处：《解放军药学学报》2008年第4期368-369,376,F0003,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立华蟾素注射液细菌内毒素检查的方法。方法以不同厂家的鲎试剂对3批华蟾素注射液分别进行干扰试验。结果华蟾素注射液对鲎试剂的凝集反应无干扰作用,选用标示灵敏度为0.25EU·ml-1的鲎试剂检查华蟾素注射液中的细菌内毒素方法可行、有效。结论细菌内毒素检查法可以用来代替家兔法检查华蟾素注射液中的热原。Aim To establish an endotoxln test method of Huachansu Injection. Methods Bacterial endotoxin was inspected using the method in specified the Addenda of China Pharmacopoeia（ second part ,2005 edition）. Results There was no interference effect of endotoxin for Injection on the agglomeration reaction of tachypleus amebocyte lysate. The method of choosing tachypleus amebocyte lysate whose sensitivity was labelled as 0.25EU ·ml^-1 to exdotoxin was feasible and efficient. Conclusions The bacterial endotoxin inspection can be used as an ordinary method to inspect the endotoxin of Huachansu Injection.

关 键 词：鲎试剂 干扰实验 细菌内毒素 华蟾素注射液 

分 类 号：R927.12[医药卫生—药学]