JP2019180364A - 認知機能改善用食品組成物、認知機能改善剤、及び、これらの製造方法 - Google Patents
認知機能改善用食品組成物、認知機能改善剤、及び、これらの製造方法 Download PDFInfo
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Abstract
Description
本実施形態は、L−エルゴチオネインを有効成分として含有する認知機能改善剤である。本実施形態の認知機能改善剤(認知機能改善用の食品組成物又は医薬組成物)は、認知機能改善に関し、記憶力の改善に用いることができるし、軽度認知症を改善又は予防するため(例えば、軽度認知症における記憶力低下を改善するため)に用いることができるし、認知症を改善又は予防するためにも用いることができる。つまり、本実施形態の認知機能改善剤は、経口的に摂取させることで、軽度認知症又は認知症など記憶力改善を必要とする患者の記憶力改善方法に用いることができる。また、本実施形態の認知機能改善剤は、注意力の改善に用いることができる。
本実施形態の認知機能改善剤の製造方法(以下、「本製造方法」と言う場合がある。)について説明する。
式1:D=E×Bx×α
6名の被験者について、1日当たりのL−エルゴチオネインの摂取量10mgの被験者3名と、1日当たりのL−エルゴチオネインの摂取量25mgの被験者3名とに分けた。各被験者は、最初の検査日の翌日から、割り当てられた摂取量の試験用組成物を摂取した。そして、検査のスケジュールについて、最初の検査日を起算日として、摂取0週時(0w:最初の検査日)、摂取2週時(2w:最初の検査日から14日後)、摂取4週時(4w:最初の検査日から28日後)の各々のタイミングで、各被験者の血中濃度(μg/ml)を検査した。なお、各被験者とも、摂取期間中は、キノコ類の多量摂取は控える以外、特に指定はなく自由に食事を行った。
上述の臨床試験としてプラセボ対照ランダム化並行群間二重盲検比較試験を行った。試験用組成物としては、L−エルゴチオネインを4錠当たり5mg含有する認知機能改善剤(1錠当たり1.25mg)を用いた。また、比較用組成物としては、L−エルゴチオネインを含有しない認知機能改善剤(プラセボ組成物)を用いた。具体的に、比較用組成物は、認知機能を改善する効果がある有効成分を含まない、エルゴチオネインを4錠当たり0g含有する錠剤を用いた。
(1)スクリーニング検査によるMMSEの結果が23点以上の者
(2)年齢:20歳以上80歳未満の者
(3)性別:問わない
(4)喫煙習慣のない者
(5)エルゴチオネインを多量に含む食事を摂る習慣がない者(エルゴチオネインを多量に含む食事:キノコ類、レバー、穀類、豆類)
(6)サプリメント・健康食品を常用していない者
(7)生活習慣病(高血圧、糖尿病など)やリウマチ、肝障害、腎障害、その他慢性疾患に罹患していない者
(8)悪性腫瘍、心不全、心筋梗塞の治療の既往歴がない者
(9)エルゴチオネインを多量に含むキノコ類、医薬品にアレルギー既往のない者
(10)治療を目的とした通院、投薬をしていない者
(11)臨床試験の内容を十分に理解し、文書による同意を受けている者
(1)妊娠しているもしくは授乳中の女性あるいは試験期間中に妊娠意思のある者
(2)他の治験あるいは臨床試験に参加中の者および3ヶ月以内に他の治験あるいは臨床試験に参加した者
(3)担当医師及び医療機関スタッフの指示に従えない者
(4)その他、試験実施担当者により何らかの問題があると判断された者
Claims (15)
- L−エルゴチオネインを有効成分として含有する、認知機能改善用食品組成物。
- 記憶力の改善に用いられる、請求項1に記載の認知機能改善用食品組成物。
- 軽度認知症を改善又は予防するために用いられる、請求項1に記載の認知機能改善用食品組成物。
- 認知症を改善又は予防するために用いられる、請求項1に記載の認知機能改善用食品組成物。
- 注意力の改善に用いられる、請求項1に記載の認知機能改善用食品組成物。
- 前記L−エルゴチオネインの摂取量が、成人1人1日当たり2mg〜30mgである、請求項1乃至5の何れか1つに記載の認知機能改善用食品組成物。
- 前記L−エルゴチオネインを成人1人1日当たり2mg〜30mg含むように固化又は包装された形態である、請求項1乃至5の何れか1つに記載の認知機能改善用食品組成物。
- L−エルゴチオネインを有効成分として含有する、認知機能改善剤。
- 記憶力の改善に用いられる、請求項8に記載の認知機能改善剤。
- 軽度認知症を改善又は予防するために用いられる、請求項8に記載の認知機能改善剤。
- 認知症を改善又は予防するために用いられる、請求項8に記載の認知機能改善剤。
- 注意力の改善に用いられる、請求項8に記載の認知機能改善剤。
- 前記L−エルゴチオネインの摂取量が、成人1人1日当たり2mg〜30mgである、請求項8乃至12の何れか1つに記載の認知機能改善剤。
- 前記L−エルゴチオネインを成人1人1日当たり2mg〜30mg含むように固化又は包装された形態である、請求項8乃至12の何れか1つに記載の認知機能改善剤。
- タモギタケエキスをフリーズドライする工程を有する、請求項1乃至7の何れか1つに記載の認知機能改善用食品組成物、又は、請求項8乃至14の何れか1つに記載の認知機能改善剤の製造方法。
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JP2018078871A JP2019180364A (ja) | 2018-04-17 | 2018-04-17 | 認知機能改善用食品組成物、認知機能改善剤、及び、これらの製造方法 |
TW108112777A TW201943417A (zh) | 2018-04-17 | 2019-04-12 | 認知功能改善用食品組成物、認知功能改善劑、及其製造方法 |
PCT/JP2019/015894 WO2019203136A1 (ja) | 2018-04-17 | 2019-04-12 | 認知機能改善用食品組成物、認知機能改善剤、及び、これらの製造方法 |
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WO2022230489A1 (ja) * | 2021-04-26 | 2022-11-03 | サントリーホールディングス株式会社 | 抗不安用組成物 |
WO2023090260A1 (ja) * | 2021-11-17 | 2023-05-25 | サントリーホールディングス株式会社 | ヒスタミン-n-メチルトランスフェラーゼ阻害用組成物 |
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CN112641777B (zh) * | 2021-01-07 | 2023-02-03 | 山东华熙海御生物医药有限公司 | 麦角硫因类物质在制备防治缺血性脑卒中药物中的应用 |
CN113332318B (zh) * | 2021-05-13 | 2022-11-29 | 四川省食用菌研究所 | 一种具有改善抑郁症状功效的药物组合物及其制备方法 |
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