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

Research Project

Project/Area Number 19790040
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeSingle-year Grants
Research Field Physical pharmacy
Research InstitutionHoshi University

Principal Investigator

ITO Rie  Hoshi University, 薬学部, 助教 (90398892)

Project Period (FY) 2007 – 2009
Project Status Completed (Fiscal Year 2009)
Budget Amount *help
¥3,540,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥540,000)
Fiscal Year 2009: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2008: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2007: ¥1,200,000 (Direct Cost: ¥1,200,000)
Keywords代替可塑剤 / 医療機器 / 暴露量評価 / リスク評価
Research Abstract

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.

Report

(4 results)
  • 2009 Annual Research Report   Final Research Report ( PDF )
  • 2008 Annual Research Report
  • 2007 Annual Research Report
  • Research Products

    (26 results)

All 2009 2008 2007 Other

All Journal Article (8 results) (of which Peer Reviewed: 8 results) Presentation (18 results)

  • [Journal Article] Effect of gamma-ray irradiation on degradation of di(2-ethylhexyl)phthalate in polyvinyl chloride sheet.2009

    • Author(s)
      Ito R, Miura N, Ushiro M, Kawaguchi M, Nakamura H, Iguchi H, Ogino J, Oishi M, Wakui N, Iwasaki Y, Saito K, Nakazawa H
    • Journal Title

      Int. J. Pharm. 376(1-2)

      Pages: 213-218

    • Related Report
      2009 Final Research Report
    • Peer Reviewed
  • [Journal Article] Effect of gamma-ray irradiation on degradation of di(2-ethylhexyl)phthalate in polyvinyl chloride sheet.2009

    • Author(s)
      Rie Ito, et al.
    • Journal Title

      Int.J.Pharm. 376

      Pages: 213-218

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Determination of tris(2-ethylhexyl)trimellitate released from PVC tube by LC-MS/MS.2008

    • Author(s)
      Ito R, Miura N, Iguchi H, Nakamura H, Ushiro M, Wakui N, Nakahashi K, Iwasaki Y, Saito K, Suzuki T, Nakazawa H
    • Journal Title

      Int. J. Pharm. 360(1-2)

      Pages: 91-95

    • Related Report
      2009 Final Research Report
    • Peer Reviewed
  • [Journal Article] 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.2008

    • Author(s)
      Ito R, Miura N, Kawaguchi M, Ushiro M, Iguchi H, Iwasaki Y, Saito K, Nakazawa H
    • Journal Title

      J. Liq. Chrom. Related Technol. 31

      Pages: 198-209

    • Related Report
      2009 Final Research Report
    • Peer Reviewed
  • [Journal Article] Determination of tris(2-ethylhexyl)trimellitate released from PVC tube by LC-MS/MS2008

    • Author(s)
      Rie Ito, et.al.
    • Journal Title

      Int. J. Pharm 360

      Pages: 91-95

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 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.2008

    • Author(s)
      Rie Ito, et. al.
    • Journal Title

      J. Liq. Chrom. Related Technol. 31

      Pages: 198-209

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Determination of tris (2-ethylhexyl) trimellitate released from PVC tube by LC-MS/MS2008

    • Author(s)
      Rie Ito, et. al.
    • Journal Title

      Int. J. Pharm. (in press)

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Effect of gamma-ray irradiation on degradation of di(2-ethylhexyl)phthalate in polyvinyl chloride sheet

    • Author(s)
      Rie Ito, et.al.
    • Journal Title

      Int. J. Pharm (accepted)

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Presentation] 医療機器からの可塑剤溶出に関する研究2009

    • Author(s)
      伊藤里恵
    • Organizer
      第22回バイオメディカル分析科学シンポジウム
    • Place of Presentation
      内藤記念くすり博物館
    • Related Report
      2009 Annual Research Report 2009 Final Research Report
  • [Presentation] LC/MS-MSによるPVC製医療機器から溶出する可塑剤の分析2008

    • Author(s)
      中村博子、伊藤里恵, 他
    • Organizer
      第52回日本薬学会関東支部大会
    • Place of Presentation
      千葉県(東京理科大野田C)
    • Year and Date
      2008-10-14
    • Related Report
      2008 Annual Research Report
  • [Presentation] 医療用PVCシートからの可塑剤溶出における電子線照射滅菌とガンマ線照射滅菌の比較2008

    • Author(s)
      鵜城 大、伊藤里恵ら
    • Organizer
      日本薬学会第128年会
    • Place of Presentation
      パシフィコ横浜
    • Year and Date
      2008-03-28
    • Related Report
      2007 Annual Research Report
  • [Presentation] PVC製医療機器からのDEHPおよびTOTM溶出量の比較2008

    • Author(s)
      中村博子、伊藤里恵ら
    • Organizer
      日本薬学会第128年会
    • Place of Presentation
      パシフィコ横浜
    • Year and Date
      2008-03-28
    • Related Report
      2007 Annual Research Report
  • [Presentation] ポリ塩化ビニル製医療機器からの可塑剤溶出における滅菌処理の影響2008

    • Author(s)
      三浦直子、伊藤里恵ら
    • Organizer
      日本薬学会第128年会
    • Place of Presentation
      パシフィコ横浜
    • Year and Date
      2008-03-28
    • Related Report
      2007 Annual Research Report
  • [Presentation] カラムスイッチング法を用いたLC-MS/MSによるトリメリット酸トリス(2-エチルヘキシル)の分析法を構築2008

    • Author(s)
      中村博子、伊藤里恵ら
    • Organizer
      フィジカル・ファーマフォーラム2008
    • Place of Presentation
      星薬科大学
    • Year and Date
      2008-03-25
    • Related Report
      2007 Annual Research Report
  • [Presentation] Effect of gamma-ray irradiation on degradation of di-(2-ethylhexyl)phthalate in polyvinyl chloride sheet.2008

    • Author(s)
      Rie Ito, et al.
    • Organizer
      HPLC Kyoto
    • Place of Presentation
      京都大学桂キャンパス
    • Related Report
      2009 Final Research Report
  • [Presentation] ポリ塩化ビニル製医療機器から溶出する可塑剤の分析および暴露評価2008

    • Author(s)
      伊藤里恵、中村博子, ら
    • Organizer
      フィジカル・ファーマフォーラム2008
    • Place of Presentation
      星薬科大学
    • Related Report
      2009 Final Research Report 2007 Annual Research Report
  • [Presentation] 医療用ポリ塩化ビニルシートからの可塑剤溶出における電子線照射滅菌とガンマ線照射滅菌の比較2008

    • Author(s)
      鵜城大、伊藤里恵, 他
    • Organizer
      第69回分析化学討論会
    • Place of Presentation
      愛知県(名古屋国際会議場)
    • Related Report
      2008 Annual Research Report
  • [Presentation] 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2008

    • Author(s)
      鵜城大、伊藤里恵, 他
    • Organizer
      日本分析化学会第57年会
    • Place of Presentation
      福岡県(福岡大学七隈C)
    • Related Report
      2008 Annual Research Report
  • [Presentation] Effect of gamma-ray irradiation on degradation of di(2-ethylhexyl)phthalate in polyvinyl chloride sheet2008

    • Author(s)
      Rie ITO et.al.
    • Organizer
      HPLC2008 Kyoto
    • Place of Presentation
      京都(京都大学桂C)
    • Related Report
      2008 Annual Research Report
  • [Presentation] 緩和医療における医療機器の安全性確保に関する研究 (その1)-PCAから溶出する可塑剤測定-2007

    • Author(s)
      伊藤里恵、三浦直子ら
    • Organizer
      第一回 緩和医療薬学会
    • Place of Presentation
      星薬科大学
    • Year and Date
      2007-10-21
    • Related Report
      2007 Annual Research Report
  • [Presentation] 緩和医療における医療機器の安全性確保に関する研究 (その2)-代替可塑剤TOTMの測定-2007

    • Author(s)
      中村博子、伊藤里恵ら
    • Organizer
      第一回 緩和医療薬学会
    • Place of Presentation
      星薬科大学
    • Year and Date
      2007-10-21
    • Related Report
      2007 Annual Research Report
  • [Presentation] ガンマ線照射によるPVC製医療辮からの可塑剤溶出への影響2007

    • Author(s)
      三浦直子、伊藤里恵ら
    • Organizer
      日本分析化学会 第56年会
    • Place of Presentation
      徳島大学
    • Year and Date
      2007-09-19
    • Related Report
      2007 Annual Research Report
  • [Presentation] 紫外線照射によるトリメリット酸トリ(2-エチルヘキシル)の分解挙動2007

    • Author(s)
      中村博子、伊藤里恵ら
    • Organizer
      日本分析化学会 第56年会
    • Place of Presentation
      徳島大学
    • Year and Date
      2007-09-19
    • Related Report
      2007 Annual Research Report
  • [Presentation] 緩和医療における医療機器の安全性確保に関する研究(その1)-PCAから溶出する可塑剤測定-2007

    • Author(s)
      伊藤里恵、三浦直子, ら
    • Organizer
      第1回緩和医療薬学会
    • Place of Presentation
      星薬科大学
    • Related Report
      2009 Final Research Report
  • [Presentation] ガンマ線照射によるPVC製医療機器からの可塑剤溶出への影響2007

    • Author(s)
      三浦直子、伊藤里恵, ら
    • Organizer
      日本分析化学会第56年会
    • Place of Presentation
      徳島大学
    • Related Report
      2009 Final Research Report
  • [Presentation] 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

    • Author(s)
      中村博子、伊藤里恵, ら
    • Organizer
      日本分析化学会第56年会
    • Place of Presentation
      徳島大学
    • Related Report
      2009 Final Research Report

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Published: 2007-04-01   Modified: 2016-04-21  

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