PVC一次性输液器中DEHP和TOTM增塑剂溶出量对比

目的偏苯三酸三辛酯(trioctyl trimellitate,TOTM)被认为是可替代邻苯二甲酸二乙基乙酯bis(2-ethylhexyl)phthalate,DEHP],提高医用输血输液器中聚氯乙烯(polyvinyl chloride,PVC)管路使用安全性的新型医用增塑剂。本实验对比两种增塑剂的溶出量,考察TOTM的安全性。方法采用硝酸甘油、单硝酸异山梨酯两种药物及45%乙醇水模拟药液,模拟临床使用。药液经过输液器后采用HPLC进行测试,测量两种药物及模拟药液中的TOTM和DEHP,考察采用上述两种增塑剂的输液器中增塑剂的溶出情况。结果两种药物中均未检出两种增塑剂。在乙醇水模拟药液中,检出两种增塑剂,且TOTM的溶出量较DEHP高。结论模拟药液评价增塑剂的溶出性能存在局限性,因此,需要医疗器械生产企业和医疗器械监管机构协同合作,模拟临床实际使用进行检测,确保医疗器械的安全性。

Comparison of DEHP and TOTM releasing from PVC disposable infusion set

Objective Trioctyl trimellitate( TOTM),a new plasticizer,is considered an alternative to bis(2 -ethylhexyl)phthalate( DEHP)in order to improve the safety of polyvinyl chloride( PVC)- based medical infusion pipes. The release of the two plasticizers from medical infusion tubes is compared in this study for a safety analysis of TOTM. Methods To simulate clinical situation, nitroglycerin solution, isosorbidemononitrate solution and 45% ethanol aqueous solution were allowed to transfuse through both types of tubes,respectively, and were collected at multiple time points for a quantitative determination of the plasticizers content using HPLC. Results No plasticizer was found in the nitroglycerin or the isosorbidemononitrate solutions,whilst both TOTM and DEHP were detected in the ethanol water simulation solution,and the content of TOTM was higher than DEHP. Conclusions The simulation solution is insufficient to evaluate the safety of the plasticizer migration. Therefore,it calls for a closer collaboration between the medical device manufacturers and relevant regulatory bodies for the evaluations in mimicking clinical practices to guarantee the safety of infusion sets.