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

正确使用医疗器械的研究-控制增塑剂的释放-

• 批准号: 19790040
• 负责人: ITO Rie
• 金额: $ 2.27万
• 依托单位: Hoshi University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Young Scientists (B)
• 财政年份: 2007
• 资助国家: 日本
• 起止时间: 2007 至 2009
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-19790040/
• 关键词: 代替可塑剤; 医療機器; 暴露量評価; リスク評価

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.

偏苯三酸三（2-乙基己基）酯（TOTM）用作聚氯乙烯（PVC）医疗器械的替代增塑剂。采用液相色谱-串联质谱法（LC-MS/MS），建立了PVC医疗器械中TOTM释放量的测定方法。此外，还研究了灭菌，特别是γ射线灭菌对PVC中TOTM释放量的影响。当我们的方法被应用到从未灭菌和γ-射线灭菌的PVC管释放的TOTM的测定，我们发现，一个更高的浓度的TOTM释放从未灭菌的PVC管比从γ-射线灭菌的。当分析γ射线照射的样品时，没有观察到降解峰。

项目成果

Effect of gamma-ray irradiation on degradation of di(2-ethylhexyl)phthalate in polyvinyl chloride sheet

• DOI: 10.1016/j.ijpharm.2009.04.019
• 发表时间: 2009-07-06
• 期刊: INTERNATIONAL JOURNAL OF PHARMACEUTICS
• 影响因子: 5.8
• 作者: Ito, Rie;Miura, Naoko;Nakazawa, Hiroyuki
• 通讯作者: Nakazawa, Hiroyuki

医療機器からの可塑剤溶出に関する研究

医疗器械中增塑剂的洗脱研究

• 发表时间: 2009
• 作者: Rie Ito;et.al.;伊藤里恵
• 通讯作者: 伊藤里恵

医療用ポリ塩化ビニルシートから溶出する可塑剤類の同時分析法の構築

医用聚氯乙烯片材中增塑剂洗脱同步分析方法的构建

• 发表时间: 2008
• 作者: 鵜城大、伊藤里恵;他
• 通讯作者: 他

紫外線照射によるトリメリット酸トリス(2-エチルヘキシル)の分解挙動

偏苯三酸三(2-乙基己基)酯的紫外辐射分解行为

• 作者: 中村博子、伊藤里恵;ら
• 通讯作者: ら

Simultaneous Determination of Di(2‐ethylhexyl)phthalate, Mono(2‐ethylhexyl)phthalate, and Phthalic Acid Migrating from Gamma‐Ray Irradiated Polyvinyl Chloride Sheet by Liquid Chromatography‐Tandem Mass Spectrometry

液相色谱-串联质谱法同时测定伽马射线辐照聚氯乙烯片中的邻苯二甲酸二(2-乙基己基)酯、邻苯二甲酸单(2-乙基己基)酯和邻苯二甲酸

• DOI: 10.1080/10826070701738811
• 发表时间: 2007
• 期刊: Journal of Liquid Chromatography & Related Technologies
• 影响因子: 1.3
• 作者: R. Ito;Naoko Miura;Migaku Kawaguchi;Masaru Ushiro;H. Iguchi;Yusuke Iwasaki;Koichi Saito;H. Nakazawa
• 通讯作者: H. Nakazawa