细菌内毒素检测法用于蔗糖铁注射液检测的可行性研究  

Feasibility Study on Bacterial Endotoxins Test of Iron Sucrose Injection

作　　者：马建丽[1] 陈新文[1] 王明媚[1] 周亮[1] 

机构地区：[1]解放军总医院第一附属医院,北京100037

出　　处：《中国药物应用与监测》2009年第3期147-149,共3页Chinese Journal of Drug Application and Monitoring

摘　　要：目的:建立蔗糖铁注射液的细菌内毒素检查方法。方法:采用细菌内毒素凝胶法,用不同厂家的鲎试剂对提供的蔗糖铁注射液连续3批样品进行了干扰试验。结果:蔗糖铁注射液稀释至0.5mg·mL-1,用灵敏度分别为0.25EU·mL-1和0.125 EU·mL-1的鲎试剂检测细菌内毒素,无干扰因素影响。结论:蔗糖铁注射液细菌内毒素限值确定为1.5 EU·mg-1,可应用鲎试剂进行细菌内毒素法检查。Objective： To establish the method for bacterial endotoxins test of iron sucrose injection. Methods： The gel-clot method was used to determine the bacterial endotoxin. And three batch samples of iron sucrose injection were successively tested by different manufacturers＇tachypleus amebocyte lysate （TAL） for an interfering test. Results： The maximum concentration of iron sucrose injection was 0.5 mg ·mL^-1 and the sensitivity of TAL in 0.25 EU ·mL^-1 and 0.125 EU ·mL^-1 respectively were non-interferential. Conclusion： The results suggest that bacterial endotoxins test can be used for the detection of endotoxin in iron sucrose injection and the limit of bacterial endotoxin is 1.5 EU · mg^-1.

关 键 词：蔗糖铁注射液 细菌内毒素 凝胶法 干扰试验 

分 类 号：R927[医药卫生—药学]