Study on evaluation system for drug cardiotoxicity using on-chip cell-besed analysis and quality examination of generic products of injection

• Project/Area Number: 20590147
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: Nagasaki University
• Principal Investigator: NAKASHIMA Mikiro Nagasaki University, 大学院・医歯薬学総合研究科, 教授 (00260737)
• Co-Investigator(Kenkyū-buntansha): SASAKI Hitoshi 長崎大学, 病院, 教授 (00170689) ; NAKASHIMA Mihoko 長崎大学, 大学院・医歯薬学総合研究科, 准教授 (00301367)
• Project Period (FY): 2008 – 2010
• Project Status: Completed (Fiscal Year 2010)
• Budget Amount: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000); Fiscal Year 2010: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2009: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2008: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
• Keywords: 医薬品情報 / 安全性学 / 後発医薬品 / 品質試験 / 毒性試験 / 薬剤応答性 / セロミクス / 動物実験 / 薬剤仮応性 / 薬剤反応性

Research Abstract

We investigated the pharmaceutical quality and safety of generic products of injection using a cultured cell and an experimental animal, and examined the development of the method to evaluate drug cardiotoxicity by an on-chip cardiomyocyte network cell-based analysis. As a result, monitoring of effects on the beating rhythms of the network cells after treatment of agents could us estimate the ionic channel conditions, suggesting that it might be useful as a cell-based measurement system for drug cardiotoxicity. The pharmaceutical quality and safety of generic injections tested in this study were comparable to the innovator injections.

Research Products

• [Journal Article] オンチップ心筋拍動細胞ネットワークを用いた抗不整脈薬の薬物応答性の解析 (2008)
  • Author(s): 中嶋幹郎、大脇裕一、向江俊彦、梅野繁智、柳原克紀、河野茂、冨永留美、荒木良介、寺薗英之、北原隆志、藤秀人、佐々木均
  • Journal Title: 長崎医学会雑誌 83 Pages: 59-66
  • NAID: 110007148533
  • Peer Reviewed
• [Journal Article] オンチップ心筋拍動細胞ネットワークを用いた抗不整脈薬の薬物応答性の解析 (2008)
  • Author(s): 中嶋幹郎
  • Journal Title: 長崎医学会雑誌 83 Pages: 59-66
  • NAID: 110007148533
  • Peer Reviewed
• [Presentation] 注射薬の後発医薬品に関する品質及び安全性の評価 (2010)
  • Author(s): 中嶋幹郎、荒木良介、中嶋弥穂子、中村純三、佐々木均、八坂貴宏
  • Organizer: 第4回日本ジェネリック医薬品学会学術大会
  • Place of Presentation: さいたま
• [Presentation] 注射薬の後発医薬品に関する品質及び安全性の評価 (2010)
  • Author(s): 中嶋幹郎
  • Organizer: 第4回日本ジェネリック医薬品学会学術大会
  • Place of Presentation: さいたま市
• [Presentation] 市販注射薬の先発医薬品と後発医薬品における同等性の検討(2):塩酸リトドリン注射薬の品質比較 (2009)
  • Author(s): 荒木良介、八坂貴宏、藤井貴玄、田中栄美、向江俊彦、大脇裕一、西田孝洋、中村純三、中嶋弥穂子、中嶋幹郎
  • Organizer: 第26回日本薬学会九州支部大会
  • Place of Presentation: 福岡
• [Presentation] 市販注射薬の先発医薬品と後発医薬品における同等性の検討(2) : 塩酸リトドリン注射薬の品質比較 (2009)
  • Author(s): 荒木良介
  • Organizer: 第26回日本薬学会九州支部大会
  • Place of Presentation: 福岡
• [Presentation] Effects of antiarrhythmic agents on beating rhythm of cultured cradiomyocyte networks on an agarose microchamberchip (2009)
  • Author(s): Yuichi Ohwaki
  • Organizer: The Second Asian Symposium on Pharmaceutical Sciences
  • Place of Presentation: Nagasaki
• [Presentation] Effects of antiarrhythmic agents on beating rhythm of cultured cardiomyocyte networks on an agarose microchamber chip
  • Author(s): Ohwaki Y、Araki R、Tominaga R、Terazono H、To H、Sasaki H、Nakashima M
  • Organizer: The Second Asian Symposium on Pharmaceutical Sciences
  • Place of Presentation: Nagasaki,、Japan