A study for proper usage of medical device-Control a release of plasticizer-

三（2-乙基己基）三甲基酸盐（TOTM）被用作聚氯乙烯（PVC）医疗器械的替代增塑剂。建立了一种液相色谱-串联质谱法（LC-MS/MS）测定静脉注射制剂中PVC医疗器械释放的TOTM的方法。此外，还研究了灭菌，特别是伽马射线灭菌对PVC中TOTM释放量的影响。将我们的方法应用于测定未灭菌和经伽马射线灭菌的PVC管释放的TOTM时，我们发现未灭菌的PVC管释放的TOTM浓度高于经伽马射线灭菌的PVC管。在对辐照样品进行分析时，未观察到降解峰。

Tris(2-ethylhexyl)trimellitate (TOTM) is used as an alternative plasticizer of polyvinyl chloride (PVC) medical devices. A method for the determination of TOTM released from PVC medical devices into intravenous preparations was developed, which uses liquid chromatography-tandem mass spectrometry (LC-MS/MS). In addition, the effect of sterilization, especially gamma-ray sterilization, on the amount of TOTM release from PVC was studied. When our method was applied to the determination of TOTM released from unsterilized and gamma-ray-sterilized PVC tubes, we found that a higher concentration of TOTM was released from the unsterilized PVC tube than from the gamma-ray-sterilized one. No degradation peak was observed when the gamma-ray irradiated sample was analyzed.