JP2008273939A - 睡眠改善剤 - Google Patents
睡眠改善剤 Download PDFInfo
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- JP2008273939A JP2008273939A JP2008070739A JP2008070739A JP2008273939A JP 2008273939 A JP2008273939 A JP 2008273939A JP 2008070739 A JP2008070739 A JP 2008070739A JP 2008070739 A JP2008070739 A JP 2008070739A JP 2008273939 A JP2008273939 A JP 2008273939A
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- crocetin
- sleep
- acid
- test
- solution
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Abstract
Description
即ち、本発明は、下記(1)式で表されるクロセチン、またはその薬理学的に許容しうる塩を有効成分として含有することを特徴とする睡眠改善剤、からなっている。
本発明の睡眠改善剤を摂取することにより、睡眠中の中途覚醒の回数が減少する。
[色価測定方法]
1)測定する吸光度が0.3〜0.7の範囲になるように、試料を精密に量り、ジメチルスルホキシドに溶かして正確に100mlとする。
2)その5mlを正確に量り、Kolthoff氏緩衝液(50mM Na2B4O7・10H2O−50mM Na2CO3,pH10.0)を加えて50mlとする。
3)その5mlを正確に量り、Kolthoff氏緩衝液(pH10.0)を加えて50mlとする。
4)その5mlを正確に量り、Kolthoff氏緩衝液(pH10.0)を加えて50mlとし、試験溶液とする。
5)Kolthoff氏緩衝液(pH10.0)を対照とし、液層の長さ1cmで420nm付近の極大吸収部における吸光度Aを測定し、下記(4)式により色価を求める。
睡眠障害に対するクロセチンの改善効果を評価するため、表1に示した配合からなる内容物を充填した二種類のカプセル(180mg/1カプセル)を常法にて作製し、「ぐっすり眠った感じがしない」などの軽度の不眠症状を自覚する健常な成人男性(25〜40歳)を対象にして、二重盲検法によるクロスオーバー比較試験を行った。
被験者14名をA群(n=7)とB群(n=7)とに無作為に割り付け、A群を被検薬投与群、B群を対照薬投与群とした。試験に先立って、各被験者にアンケート調査を実施し、下記表2に示す評価基準に従って「眠りの深さ」を評価した。その後、A群には被験薬を、B群には対照薬を1日1カプセル夕食後に服用させ、4週間後に、再び各被験者に同趣旨のアンケート調査を実施した。6週間ウオッシュアウト期間を取った後、A群を対照薬投与群、B群を被験薬投与群として、同様の試験を実施した。
被検薬投与群と対照薬(プラセボ)投与群毎に摂取前の評点と摂取後の評点を集計し、各群の被験者14名の評点の平均値を算出した。結果を表3に示す。
集計された各群のデータに基づき、Willcoxonの順位和検定を行った結果、以下の2群の対比に有意差が認められた。
被検薬投与群(摂取前)vs被検薬投与群(摂取後) : 危険率5%
この結果は、本発明の睡眠改善剤が「眠りの深さ」の改善に有効であることを示すものである。
睡眠障害に対するクロセチンの改善効果を評価するため、アクチグラフ(型式:マイクロミニRR型、米国A.M.I.社製)を用いて、つねひごろの睡眠に満足していないと感じている成人男女(25〜40歳)を対象に試験を行った。アクチグラフは、対象者の活動量を単位時間ごとに測定する方法であり、睡眠・覚醒リズムの大まかな傾向の観察に有効な方法と考えられている。アクチグラフによる睡眠・覚醒の判定は、アクチグラフで測定された活動量をもとに、アルゴリズム(判定式)を用いて行なった。
被験者4名に、入浴および水仕事の時間帯を除き、利き腕でない手首に2日間連続してアクチグラフを装着させ、1分毎の活動量を測定した。次に、表1に記載の被検薬を各被験者に1日1カプセル、1週間連続して服用させた。被検薬服用期間の最後の2日間に再びアクチグラフを装着させ、1分毎の活動量を同様に測定した。試験終了後、アクチグラフのデータをColeらの睡眠・覚醒判定式により解析し、睡眠に関する客観的な指標を算出した。その際、20分以上連続した睡眠判定の始まりを入眠とし、翌朝の20分以上連続した覚醒判定の始まりを起床とし、入眠から起床までの時間(睡眠時間)中での覚醒判定回数を中途覚醒回数とした。アクチグラフから導き出された各睡眠指標について、対応のあるt検定を使用して分析し、p<0.05を統計的有意とした。
結果を図1および図2に示す。
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Cited By (6)
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WO2010061574A1 (ja) * | 2008-11-25 | 2010-06-03 | 財団法人大阪バイオサイエンス研究所 | 睡眠改善剤および鎮静剤ならびにそれらの使用 |
WO2011118468A1 (ja) * | 2010-03-24 | 2011-09-29 | 株式会社明治 | 覚醒時間延長剤 |
JP2011246357A (ja) * | 2010-05-24 | 2011-12-08 | Osaka Bioscience Institute | 睡眠改善剤および鎮静剤ならびにそれらの使用 |
CN101791314B (zh) * | 2009-02-04 | 2012-01-04 | 复旦大学 | 藏红花素在制备催眠类药物中的用途 |
JP2017012059A (ja) * | 2015-06-30 | 2017-01-19 | 富士フイルム株式会社 | 食品組成物 |
US20200009170A1 (en) * | 2016-09-13 | 2020-01-09 | Megumi Tanaka | Sleep display agent property and method for improving sleep disorders |
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WO2006112283A1 (ja) * | 2005-04-13 | 2006-10-26 | Riken Vitamin Co., Ltd. | 抗疲労剤 |
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Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2010061574A1 (ja) * | 2008-11-25 | 2010-06-03 | 財団法人大阪バイオサイエンス研究所 | 睡眠改善剤および鎮静剤ならびにそれらの使用 |
JP5610577B2 (ja) * | 2008-11-25 | 2014-10-22 | 国立大学法人 筑波大学 | 睡眠改善剤および鎮静剤ならびにそれらの使用 |
CN101791314B (zh) * | 2009-02-04 | 2012-01-04 | 复旦大学 | 藏红花素在制备催眠类药物中的用途 |
WO2011118468A1 (ja) * | 2010-03-24 | 2011-09-29 | 株式会社明治 | 覚醒時間延長剤 |
CN102933210A (zh) * | 2010-03-24 | 2013-02-13 | 株式会社明治 | 觉醒时间延长剂 |
JPWO2011118468A1 (ja) * | 2010-03-24 | 2013-07-04 | 株式会社明治 | 覚醒時間延長剤 |
JP2016028097A (ja) * | 2010-03-24 | 2016-02-25 | 株式会社明治 | 覚醒時間延長剤 |
JP2011246357A (ja) * | 2010-05-24 | 2011-12-08 | Osaka Bioscience Institute | 睡眠改善剤および鎮静剤ならびにそれらの使用 |
JP2017012059A (ja) * | 2015-06-30 | 2017-01-19 | 富士フイルム株式会社 | 食品組成物 |
US20200009170A1 (en) * | 2016-09-13 | 2020-01-09 | Megumi Tanaka | Sleep display agent property and method for improving sleep disorders |
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