肝素钠注射液对鲎试验干扰作用的定量分析  

Quantitative Analysis of Interference on the Limulus Test from heparin sodium

作　　者：胡冠时[1] 魏纪鲁 贡立青[2] 赵海山[2] 

机构地区：[1]中国人民解放军济南军区总医院药学部,山东济南250031 [2]天津大学无线电厂,天津300072

出　　处：《解放军药学学报》2004年第2期105-107,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　分析不同浓度肝素钠注射液对鲎试验生化反应干扰程度的量变关系。方法　将肝素钠注射液稀释成不同浓度 ,并加入已知的标准内毒素 ,用动态浊度标准曲线法定量检测所加内毒素的回收率 ,测绘稀释 -回收率曲线 ,计算不同浓度肝素钠的干扰作用。结果　标准曲线方程Y =- 0 .4 0 85X +2 .878,r =- 0 .996 2 ,平均回收率为 (1 0 2 .4± 1 0 .1 4 ) %。精密度测定日间差为 8.0 %～ 1 5 .0 %。肝素钠注射液的稀释 -回收率曲线呈两个时相 ,快速相和慢速相。结论　内毒素的回收率随着肝素浓度的减少而增加 ,当肝素钠注射液稀释 4倍时 (1 5 6 2 .5u·ml-1 ) ,回收率已达到 77% 。Aim To analyse quantitative relationship of the interference on Limulus test with different concentration of heparin sodium.Methods A known standard endotoxin(NSE) were added to heparin sodium injection solution.The mixture was diluted in series.The endotoxin of series diluted mixtures was measured by a kinetic turbidity method.The recovery of NSE in the mixtures was analyzed,and a curve of heparin sodium concentration and endotoxin recovery was made.The interference of heparin sodium concentration on the accuracy of endotoxin detected by the Lumulus test was analyzed.Results The standard endotoxin curve was made by the series of NSE solutions.The relationship of concentration and turbidity was described as following formulas:Y=-0.408 5X+2.878,r=-0.996 2.The recovery was (102.4±10.14)%.The daily variant of the precision was 8.0%～15.0%.The recovery curve of NSE in the series diluted heparin sodium mixtures showed diphase,consisting of a rapid-phase and a slow-phase.Conclusion The recovery of endotoxin was increased with the decrease of heparin sodium concentration.When heparin injection concentration was diluted to fourth(1 562.5u·ml -1 ),the interference became no significant and the endotoxin recovery reached up to 77%.

关 键 词：肝素钠注射液 鲎试验 干扰作用 内毒素 生化反应 

分 类 号：R973.2[医药卫生—药品]