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Safety evaluation of red yeast rice extract: Focusing on standardization and interaction with pharmaceuticals

Research Project

Project/Area Number 18K14425
Research Category

Grant-in-Aid for Early-Career Scientists

Allocation TypeMulti-year Fund
Review Section Basic Section 38050:Food sciences-related
Research InstitutionShowa Women's University

Principal Investigator

Yokotani Kaori  昭和女子大学, 食健康科学部, 講師 (20732150)

Project Period (FY) 2018-04-01 – 2022-03-31
Project Status Completed (Fiscal Year 2021)
Budget Amount *help
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2020: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2019: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2018: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Keywordsベニコウジエキス / 安全性 / シトクロムP450 / 医薬品との相互作用 / 標準化 / モナコリンK / ロバスタチン / ベニコウジ / 健康食品 / 薬物代謝酵素
Outline of Final Research Achievements

In this study, the effects of red yeast rice (RYR) extract on hepatic cytochrome P450 (CYP) were investigated using an in vivo evaluation system in mice and an in vitro evaluation system in microsomes. The effects of RYR extract on hepatic CYP were minor, and interactions with pharmaceuticals through RYR extract are thought unlikely to occur at realistic intakes. In addition, component analysis of RYR products sold domestically and internationally was performed. The amount of active ingredients in RYR products varied widely from product to product; this is considered to be one of the factors that make it difficult to evaluate safety and efficacy in humans.

Academic Significance and Societal Importance of the Research Achievements

ベニコウジエキスによる肝薬物代謝酵素に対する影響は軽微であり、ヒトが通常健康食品から摂取する量では、医薬品の代謝障害は起こりにくいと考えられた。本研究はベニコウジエキスの安全性評価に対する新たな科学的知見を示すものであり、健康食品素材の安全確保に貢献するものと考えられた。さらに、ベニコウジエキス含有健康食品の成分含有量は製品によるばらつきが大きく、含有成分と含有量の標準化の必要性を示す知見となった。

Report

(5 results)
  • 2021 Annual Research Report   Final Research Report ( PDF )
  • 2020 Research-status Report
  • 2019 Research-status Report
  • 2018 Research-status Report

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Published: 2018-04-23   Modified: 2023-01-30  

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