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Study on quality evaluation of health food by pharmaceutical test applied to medicine

Research Project

Project/Area Number 16K00942
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Eating habits
Research InstitutionOsaka Institute of Public Health

Principal Investigator

kajimura keiji  地方独立行政法人 大阪健康安全基盤研究所, 衛生化学部, 課長 (40250336)

Co-Investigator(Kenkyū-buntansha) 川口 正美  地方独立行政法人 大阪健康安全基盤研究所, 衛生化学部, 主任研究員 (30260368)
Project Period (FY) 2016-04-01 – 2020-03-31
Project Status Completed (Fiscal Year 2019)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2018: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2017: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2016: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywords健康食品 / 製剤試験 / 崩壊試験 / 溶出試験 / 重量偏差試験 / 硬度試験 / 経時変化 / ビタミン / 製剤均一性試験
Outline of Final Research Achievements

Quality evaluation of health foods was conducted by formulation tests ( disintegration test, dissolution test, weight variation test and hardness test) applied to pharmaceuticals. For the quality related to disintegratability, capsule type products disintegrated within 20 minutes. On the other hand, in tablet type health foods, there was a large difference in disintegration time. Products with extremely poor disintegration properties were also confirmed. In health foods of the tablet type, there were products with large variations in hardness among individuals. The quality relating to dissolution property was greatly different depending on the product There was a product with poor elution of vitamin B2.
When the health food was stored under the accelerate condition (temperature: 40℃, relative humidity: 75%) for 6 months, product with significant moisture absorption was found

Academic Significance and Societal Importance of the Research Achievements

「いわゆる健康食品」は多くの国民に常用されているが、ほとんどの製品には法律上の定義が無く、家内工業に近い環境で製造されているものが存在するなど、品質に関して大きな不安が残る。本研究では健康食品を対象として、医薬品に適用される製剤試験(重量偏差、溶出試験、硬度試験および崩壊試験)を実施し、製剤学的な品質の実態を明らかにした。また、健康食品を加速条件下(温度:40℃、相対湿度:75%)で6ヶ月間保存し、製剤学的な品質の時系列的な変化についても調査を行った。

Report

(5 results)
  • 2019 Annual Research Report   Final Research Report ( PDF )
  • 2018 Research-status Report
  • 2017 Research-status Report
  • 2016 Research-status Report
  • Research Products

    (1 results)

All 2016

All Journal Article (1 results) (of which Peer Reviewed: 1 results)

  • [Journal Article] Simultaneous analysis of highly polar pharmaceutical adulterants in slimming products by hydrophilic interaction liquid chromatography2016

    • Author(s)
      A. Nakamura, T. Tagami, K. Kajimura, K. Yamasaki, Y. Sawabe, H. Obana
    • Journal Title

      Journal of Liquid Chromatography & Related

      Volume: 39 Issue: 15 Pages: 691-697

    • DOI

      10.1080/10826076.2016.1231691

    • Related Report
      2016 Research-status Report
    • Peer Reviewed

URL: 

Published: 2016-04-21   Modified: 2021-02-19  

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