【摘要】：目的:建立測定增塑劑環(huán)己烷-1,2-二甲酸二異壬酯(DINCH)的測定方法,并測定一次性使用體外循環(huán)管道中DINCH在血液中的溶出量,為該產(chǎn)品的安全性評價提供依據(jù)。方法:采用乙酸乙酯萃取血液樣品中的DINCH,并用液質(zhì)聯(lián)用方法(LCMS/MS)測定一次性體外循環(huán)管道中DINCH的溶出量。結(jié)果:LC-MS/MS方法測定DINC質(zhì)量濃度在1.34~53.40μg·m L-1范圍內(nèi)線性關(guān)系良好(r=0.999 5),靈敏度為0.134 ng,儀器精密度RSD5%,液相萃取的回收率為82.11%,用該方法測定一次性體外循環(huán)管道在模擬臨床使用極限條件下DINCH在血液中的溶出量為2.89 mg·套-1。結(jié)論:本法經(jīng)方法學(xué)驗證,可以用于測定DINCH在血液中的溶出量。
[Abstract]:Objective: to establish a method for the determination of (DINCH) in plasticizer cyclohexane-1 and diisononyl dicarboxylate, and to determine the dissolution of DINCH in blood in a single use of cardiopulmonary bypass (CPB) in order to provide the basis for the safety evaluation of the product. Methods: extraction of DINCH, from blood samples by ethyl acetate and determination of DINCH dissolution in single-time extracorporeal circulation conduit by liquid-mass spectrometry (LCMS/MS). Results the linear range of mass concentration of DINC was 1.34 ~ 53.40 渭 g / mL ~ (-1) for DINC determined by 1: LC-MS / MS / MS method (r _ (0.999 ~ 5). The recovery rate of 0.134 ng, instrument was 82.11% for precise RSD5%, extraction. This method was used to determine one-off extracorporeal circulation conduit in simulated clinical use. The dissolution of DINCH in blood under the limit condition was 2.89 mg set -1. Conclusion: this method can be used to determine the dissolution of DINCH in blood.
【作者單位】： 中國醫(yī)學(xué)科學(xué)院輸血研究所;山東威高新生醫(yī)療器械有限公司;
【基金】：國家科技支撐計劃課題“新增塑劑的生物醫(yī)用材料”(編號2012BAI22B07)
【分類號】：R96;O657.63

【參考文獻(xiàn)】

相關(guān)期刊論文 前1條

1 辛鳳鮮;薛云燕;馬才;;體外循環(huán)管道中DEHP溶出量的測定[J];中國醫(yī)療器械信息;2011年06期

【共引文獻(xiàn)】

相關(guān)期刊論文 前2條

1 劉曦;于晶晶;李q，

本文編號：2218562