PVC输液器中DEHP析出因素的实验研究  

Experimental Study on Migration Parameters of DEHP in PVC Infusion

作　　者：王军 吴艳 包世勇 姜红强 沈国理[2] 陈宁清 WANG Jun;WU Yan;BAO Shiyong;JIANG Hongqiang;SHEN Guoli;CHEN Ningqing(Center for Medical Device Evaluation in Zhejiang Province, Hangzhou, 310009;Zhejiang Crops Hospital of CAPF, Hangzhou, 310051)

机构地区：[1]浙江省医疗器械审评中心,杭州市310009 [2]武警浙江省总队医院,杭州市310051

出　　处：《中国医疗器械杂志》2019年第2期132-135,共4页Chinese Journal of Medical Instrumentation

基　　金：浙江省食品药品监管系统科技计划项目(YQ201702)

摘　　要：基于前期对PVC输液器中DEHP析出的试验模型的研究,探索PVC输液器在临床实际使用中DEHP析出的量,评价其在输液过程中的安全性。采用模拟临床输液方式,分别收集不同浸提条件下的浸提液,利用气相色谱-质谱联用仪(GC-MS)测试样本中DEHP析出量。DEHP的析出行为受到输液器储存时间、储存温度、浸提温度、滴速、灭菌过程、浸提液体积、浸提液性质的显著影响。The work explored the DEHP migration parameters in PVC infusion in clinic, based on the previous research on the test model of DEHP migrated from PVC infusion, to assess the safety of PVC infusion. The leaching solution samples in different conditions were evaluated by analysis of the DEHP in leaching solution using GC-MS under simulated clinical transfusion way. The release behavior of DEHP was significantly affected by the storage time,storage temperature,surrounding temperature,dripping speed,sterilization process,volume of the leaching solution,and the property of the leaching solution.

关 键 词：DEHP 析出因子 PVC输液器 

分 类 号：R114[医药卫生—卫生毒理学]