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Improvement of the method for detection of falsified medicines using impurity profiling

Research Project

Project/Area Number 26870220
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Medical pharmacy
Environmental and hygienic pharmacy
Research InstitutionKanazawa University

Principal Investigator

YOSHIDA Naoko  金沢大学, 薬学系, 助教 (20565428)

Research Collaborator SANADA Tomoko  
Project Period (FY) 2014-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000)
Fiscal Year 2015: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2014: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
Keywords偽造医薬品 / 不純物プロファイル / 鑑別 / ラマン散乱
Outline of Final Research Achievements

I wished to improve the accuracy of detection of falsified medicines. Impurity analyses were undertaken to detect falsified samples of Cialis(R) and compared with other analytical methods. Out of 41 samples, all falsified samples of Cialis(R) (n=32) were defined as “falsified medicine” by impurity profiling. These falsified samples of Cialis(R) could be categorized broadly into seven types according to the nature and amount of ingredients. Physical appearance (color, size, weight), Raman spectra (obtained from the tablet surface) and near-infrared spectrum (obtained from the whole tablet) of falsified samples of Cialis(R) were different from authentic samples. These findings suggest that impurity profiling could be a useful method for detection of falsified medicines in pharmaceutical distribution.

Report

(3 results)
  • 2015 Annual Research Report   Final Research Report ( PDF )
  • 2014 Research-status Report
  • Research Products

    (5 results)

All 2016 2015

All Presentation (5 results) (of which Invited: 4 results)

  • [Presentation] インターネットを介して個人輸入されたシアリスの真正性と品質に関する研究2016

    • Author(s)
      眞田智子, 吉田直子, 坪井宏仁, 木村和子
    • Organizer
      日本薬学会第136年会
    • Place of Presentation
      パシフィコ横浜(神奈川県横浜市)
    • Year and Date
      2016-03-29
    • Related Report
      2015 Annual Research Report
  • [Presentation] 途上国における医薬品事情2016

    • Author(s)
      吉田直子
    • Organizer
      日本国際保健医療学会第34回西日本地方会
    • Place of Presentation
      川崎医科大学現代医学教育博物館(岡山県倉敷市)
    • Year and Date
      2016-02-27
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] 偽造医薬品の脅威と撲滅に向けた取り組み2015

    • Author(s)
      吉田直子
    • Organizer
      Hokuriku Women Researchers’ Network シンポジウム
    • Place of Presentation
      金沢歌劇座(石川県金沢市)
    • Year and Date
      2015-12-05
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] OTC医薬品の安全性―忍び寄る偽造医薬品の脅威―2015

    • Author(s)
      吉田直子
    • Organizer
      2015年度 日本OTC医薬品協会安全性情報部会
    • Place of Presentation
      金沢大学(石川県金沢市)
    • Year and Date
      2015-11-13
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] 医薬品の品質管理に貢献する分析-偽造医薬品鑑別における分析手法の活用-2015

    • Author(s)
      吉田直子
    • Organizer
      Matching HUB Kanazawa 2015
    • Place of Presentation
      ANAクラウンプラザホテル金沢(石川県金沢市)
    • Year and Date
      2015-02-23
    • Related Report
      2014 Research-status Report
    • Invited

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Published: 2014-04-04   Modified: 2017-05-10  

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