动态浊度法定量测定肝素钠注射液细菌内毒素的含量  

Determination of bacterial endotoxin in heparin sodium injection by kinetic turbidimetric limulus test

作　　者：迟延青[1] 王复馨[1] 雒琪[1] 

机构地区：[1]山东省立医院药剂科,山东济南250021

出　　处：《中国生化药物杂志》2004年第5期303-305,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的研究肝素钠注射液细菌内毒素的测定方法及影响因素。方法用动态浊度法测定细菌内毒素的含量。结果肝素钠注射液经 10倍稀释后对鲎试剂与细菌内毒素的凝集反应无干扰 ,可应用动态浊度法定量测定。结论用该法测定肝素钠注射液细菌内毒素含量 ,结果准确 ,可替代家兔法。PurposeTo investigate the determination method of bacterial endotoxin in heparin sodium injection and the interferential factors.MethodsUsing kinetic turbidimetric limulus test method to determine the content of bacterial endotoxin.ResultsHeparin sodium injection diluted 10 times could completely eliminate the interference to the TAL (tachypleus amebcyte lysate) test and the bacterial endotoxin could be determined quantitatively.ConclusionThe method could be used to determine the bacterial endotoxin in heparin sodium injection accurately and replace the rabbit pyrogen test method.

关 键 词：动态浊度法 细菌内毒素 肝素钠 

分 类 号：R392.33[医药卫生—免疫学] R973[医药卫生—基础医学]