医用聚氯乙烯医疗器械产品增塑剂(TOTM)安全性分析  

Safety Assessment of Plasticizer (TOTM) in PVC Medical Device

作　　者：张莉[1] 郑健[1] 韩银[1] 徐萍华[1] 文燕[1] 徐方明[1] 王敏珠[1] 鲍娇慧 

机构地区：[1]国家食品药品监督管理局杭州医疗器械质量监督检验中心,浙江杭州310009

出　　处：《塑料工业》2017年第3期138-141,共4页China Plastics Industry

基　　金：浙江省科技厅计划项目(项目编号:2015F30010)

摘　　要：偏苯三酸三辛酯(TOTM)被认为是可替代邻苯二甲酸二(2-乙基己基)酯(DEHP)的一种优良增塑剂。通过理论及实验考察医用聚氯乙烯医疗器械产品增塑剂(TOTM)使用安全性。首先根据国内外已有相关研究资料与数据依据GB/T 16886.17—2005/ISO 10993-17:2002建立TOTM的安全限量;再通过实验对比分析了TOTM和DEHP在临床药液中的溶出量及其与药液相容性。在同等条件下,聚氯乙烯(PVC)中增塑剂TOTM的溶出量比DEHP的溶出量小,对药物的吸附作用基本相同。通过理论与实验相结合综合分析了医用聚氯乙烯医疗器械产品增塑剂(TOTM)安全性,为此类产品的安全监管提供依据。Trioctyl trimellitate （TOTM） is considered to be an excellent plasticizer substituting for di（2-ethylhexyl） phthalate （DEHP）. The paper focused on the safety of TOTM as a plasticizer for polyvinyl chloride （PVC） medical devices through the theoretical and experimental study. First, the safety limit of TOTM was established according to the standards including GB/T 16886. 17-2005 and ISO 10993-17 ： 2002 and other research reports. The compatibility between the two PVC plasticizers of TOTM and DEHP and several different pharmaceutical solutions was investigated and compared through experiments. Under the same conditions, the released amount of TOTM in PVC is less than that of DEHP, and they have basically the same drug absorption. Based on the theoretical and experimental study, the safety of TOTM in PVC medical devices was evaluated, which could be an evidence for security control.

关 键 词：聚氯乙烯 增塑剂 药物相容性 偏苯三酸三辛酯 

分 类 号：TQ325.3[化学工程—合成树脂塑料工业]