蔗糖铁注射液细菌内毒素检测法研究  

Study on bacterial endotoxin test of iron sucrose injection

作　　者：任韡[1] 李欣[1] 

机构地区：[1]解放军总医院药品供应中心,北京100853

出　　处：《中国药物应用与监测》2016年第3期148-150,共3页Chinese Journal of Drug Application and Monitoring

基　　金：解放军总医院临床科研扶持基金项目(2012FCCXYY-4008)

摘　　要：目的:建立检查蔗糖铁注射液细菌内毒素的检测方法(凝胶法),以控制药物质量,减少临床热原反应的发生。方法:按《中国药典》2015年版(四部)收载的细菌内毒素检测方法及指导原则进行实验,系统观察蔗糖铁注射液对鲎试剂与细菌内毒素凝集反应的干扰,确定凝胶法检测细菌内毒素的不干扰浓度。结果:蔗糖铁注射液稀释20倍后对鲎试剂无干扰作用,对2个厂家的8批样品进行检查,结果均符合规定。结论:细菌内毒素检测方法(凝胶法)可用于蔗糖铁注射液的内毒素检查,结果准确、重现性好。Objective: To set up the bacterial endotoxin determination method of iron sucrose injection(the gel-clot method) for the quality control of the drug and prevention of pyrogen reaction in clinical practice. Methods: The experiment was performed according to the Chinese Pharmacopoeia 2015 edition(4). A systematic study was carried out to investigate the interferences of iron sucrose injection with limulus reagent and agglutination reaction to bacterial endotoxin in order to detect the non-interference concentration of bacterial endotoxin. Results: There was no interference in the bacterial endotoxin test when iron sucrose injection was diluted 20-fold. The results of 8 batches of samples from 2 manufacturers complied with the requirements.Conclusion: The established method of endotoxin test was feasible, accurate and repeatable for iron sucrose injection.

关 键 词：蔗糖铁注射液 细菌内毒素 鲎试剂 干扰试验 

分 类 号：R927[医药卫生—药学]