医药热点医疗途径中增塑剂DEHP的溶出及其安全性研究概况.pdfVIP

·医药热点· 医疗途径中增塑剂DEHP 的溶出及其安全性研究概况 ＊ # 陈 琳 ，钱 青，张 吉吉，张恩娟（第三军医大学新桥医院药剂科，重庆市 400037） 中图分类号 R 197.39 文献标识码 C 文章编号 1001-0408（2011）33-3073-03 摘 要 目的：为了解医疗途径中增塑剂邻苯二甲酸二（2-乙基己基）酯（DEHP ）的溶出及其对人体的安全性提供参考。方法：查 阅相关文献，从DEHP 的理化性质、毒性作用、溶出及体内药动学、各种医疗途径中人体的摄入量及耐受摄入量、目前国际上对含 DEHP 医疗器材的规定等方面进行分析。结果：DEHP 易从聚氯乙烯医疗器材中溶出，进入人体后产生慢性毒性，毒性大小取决 于摄入量和个体敏感性，其中新生儿接受全静脉营养、肠道营养、换血、体外心肺循环以及成人接受肠道营养、大量输血（外伤）、体 外心肺循环、冠状动脉绕道、人工心脏移植等医疗途径时，会处于DEHP 介导的不良反应的高风险中。结论：部分医疗途径中存在 因DEHP 释放使人体摄入量超过了耐受摄入量而产生危害的风险，应引起有关方面的高度重视。 关键词 邻苯二甲酸二（2-乙基己基）酯；增塑剂；溶出；安全性 Dissolution and Safety of Plasticizer DEHP during Medical Procedures CHEN Lin ，QIAN Qing ，ZHANG Zhe ，ZHANG En-juan （Dept. of Pharmacy ，Xinqiao Hospital of Third Mili- tary Medical University ，Chongqing 400037，China ） ABSTRACT OBJECTIVE ：To investigate the dissolution of plasticizer di- （2-ethylhexyl）phthalate （DEHP ）during medical proce- dure and provide reference for its safety evaluation. METHODS ：The safety of patients when they used PVC medical device were analyzed from physico-chemical property of DEHP ，toxic effect ，dissolution ，pharmacokinetics ，patients intake and tolerable intake （TI ），international regulations of DEHP medical device by reviewing pertinent literature. RESULTS ：DEHP was easily released from medical devices and produced chronic toxicity which depended on patient intake and individual sensitivity after entering the body. The infants were at increasing risk from exposing to DEHP undergoing total parenteral nutrition and enteral nutrition ，ex- change transfusion and ECMO. The adult patients were at increasing risk from exposing to DEHP receiving transfused with large volumes of blood ，ECMO ，artificial heart transplantation ，coronary artery bypass and enteral nutrition. CONCLUSION ：Patients are at high risk when the dose of DEHP received by patients exceeds the T