高效液相色谱法测定一次性体外循环管道中邻苯二甲酸二(2-乙基)己基酯在全血中的溶出量  

HPLC Method to Determine DEHP Released into Blood from a Disposable Extracorporeal Circulation Tube

作　　者：刘曦[1] 于晶晶[1] 李燊[1] 王红[1] 刘嘉馨[1] 

机构地区：[1]中国医学科学院北京协和医学院输血研究所生物医学工程研究中心,成都610052

出　　处：《生物医学工程学杂志》2013年第4期756-761,共6页Journal of Biomedical Engineering

摘　　要：抗凝全血作为浸提液,模拟临床使用极限条件,建立液相萃取—高效液相色谱法(HPLC)测定一次性体外循环管道中增塑剂邻苯二甲酸二(2-乙基)己基酯(DEHP)溶出量的方法,为本类产品在临床使用过程中的DEHP风险分析提供依据。确定DEHP在甲醇中的特征吸收波长。乙腈与全血浸提液样品以一定体积比混合,液相萃取其中的DEHP得到检验液。利用高效液相色谱分析系统进行DEHP含量检测的方法学研究并测定一次性体外循环管道样品中DEHP溶出量。结果显示:DEHP浓度在5～250μg/mL范围内与峰面积保持良好的线性关系(r=0.999 9)。方法的定量检测限为1μg/mL。仪器精密度RSD<5%。25、100和250μg三个DEHP标准溶液的液相萃取加标回收率分别为(61.91±3.32)%、(69.38±0.55)%和(68.47±1.15)%。此一次性体外循环管道3套平行样在临床使用极限条件下DEHP在全血中的溶出量分别为204.14、106.30和165.34mg/套。本方法准确度高、精确度好、萃取回收率较稳定且操作简单、分析快速。We used blood as leaching medium,simulating clinical operation under maximum condition,to develop Liquid-phase extraction-High Performance Liquid Chromatography（HPLC） method for determination of plasticizer Di-（2-ethylhexyl）phthalate（DEHP） released from Disposable Extracorporeal Circulation Tube in order to lay the foundation of risk analysis of this product.The characteristic wavelength of DEHP in methanol was detected.Acetonitrile was added to the leaching blood in proportion and extracted DEHP from blood.The methodology for HPLC to quantify DEHP was established and the DEHP amount released from this disposable extracorporeal circulation tube was measured.The experiments showed good results as follows.The characteristic wavelength of DEHP was 272nm.The concentration of DEHP（5-250μg/mL） kept good linear relationship with peak area（r=0.999 9）.Method sensitivity was 1μg/mL.Precisions showed RSD5%.The adding standard extraction Recovery Rates of 25,100 and 250μg DEHP standard were 61.91±3.32）%,（69.38±0.55）% and（68.47±1.15）%.The DEHP maximum amounts released from 3 sets of this disposable extracorporeal circulation tube were 204.14,106.30 and 165.34mg/set.Our Liquid-phase Extraction-HPLC method showed high accuracy and precision,and relatively stable recovery rate.Its operation was also convenient.

关 键 词：一次性体外循环管道 液相萃取 高效液相色谱法 增塑剂 邻苯二甲酸二(2-乙基)己基酯 

分 类 号：R318.0[医药卫生—生物医学工程]