JP4951162B2 - 睡眠改善用組成物 - Google Patents
睡眠改善用組成物 Download PDFInfo
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- JP4951162B2 JP4951162B2 JP2006512057A JP2006512057A JP4951162B2 JP 4951162 B2 JP4951162 B2 JP 4951162B2 JP 2006512057 A JP2006512057 A JP 2006512057A JP 2006512057 A JP2006512057 A JP 2006512057A JP 4951162 B2 JP4951162 B2 JP 4951162B2
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Description
[2]睡眠改善効果が起床時の眠気の改善によることを特徴とする前記[1]記載の睡眠改善用組成物、
[3]睡眠改善効果が睡眠時間を延長することである前記[1]記載の睡眠改善用組成物、
[4]前記〔1〕〜[3]のいずれかに記載の組成物を含有することを特徴とする食品、
[5]前記[1]〜[3]のいずれかに記載の組成物を含有することを特徴とする医薬品、
[6](a)テアニンと、(b)カモミール、ラベンダー、セイントジョーンズワード、カワカワ、バレリアン、パッションフラワー、トリプトファン、5−HTP、セロトニン、γ−アミノ酪酸、メラトニン、及びセドロールからなる群から選択される少なくとも1つ以上の成分とを含有する組成物を投与することを特徴とする睡眠改善方法、
[7]睡眠障害を有する個体に適用するための食品または医薬品の製造のための(a)テアニンと、(b)カモミール、ラベンダー、セイントジョーンズワード、カワカワ、バレリアン、パッションフラワー、トリプトファン、5−HTP、セロトニン、γ−アミノ酪酸、メラトニン、及びセドロールからなる群から選択される少なくとも1つ以上の成分との使用に関する。
本発明の組成物の投与方法、投与回数、投与期間等は、特に限定されるものではなく、ヒト、好ましくは睡眠障害の緩和または改善を所望するヒトに対し、たとえば1回または複数回に分けて、適当な投与形態、好ましくは経口投与により投与することができる。また、本発明の組成物を、日常的に摂取することにより睡眠障害を予防することもできる。
カモミールとは、古代エジプト時代から使われた最も古いハーブのひとつであり、ヨーロッパ原産のキク科の植物を意味している。カモミールには、一年草のジャーマン・カモミール、多年草のローマン・カモミール等が知られているが、本発明には、いずれのカモミールを用いることもできる。カモミールの一回当り用量は、0.004mg/kg体重〜6000mg/kg体重であり、好ましくは0.6mg/kg体重〜4800mg/kg体重であり、更に好ましくは0.6mg/kg体重〜1500mg/kg体重である。また、テアニンとカモミールとを併用する場合には、その質量比は、カモミール/テアニン=0.4〜60、好ましくは6〜60、更に好ましくは6〜30とする。
トリプトファンとは、アミノ酸の一種であり、体内の睡眠化学物質セロトニン及び睡眠ホルモンと呼ばれるメラトニンの元となる。トリプトファンの一回当り用量は、0.0005mg/kg体重〜10000mg/kg体重であり、好ましくは0.01mg/kg体重〜1600mg/kg体重であり、更に好ましくは1mg/kg体重〜100mg/kg体重である。また、テアニンとトリプトファンとを併用する場合には、その質量比は、トリプトファン/テアニン=0.05〜100、好ましくは0.1〜20、更に好ましくは1〜2とする。
セドロールとは、スギやヒノキなどに含まれる樹木の天然香気成分のひとつである。セドロールは揮発性成分であることから、使用する場合には、鼻から吸入可能な気化物とすることが好ましい。セドロール空気中の濃度は、0.01μg/L〜100μg/L、好ましくは0.1μg/L〜10μg/L、更に好ましくは0.5μg/L〜5μg/Lである。
本発明品である組成物は、そのまま、或いは乾燥食品、サプリメント、清涼飲料・ミネラルウォーター・嗜好飲料・アルコール飲料などの液状食品、錠剤、カプセル、粉末剤、顆粒剤、ドリンク剤等の剤形、気化物として摂取することができる。
睡眠状態の判定に用いる診断方法には、主にアメリカ睡眠障害連合会が中心となり作成した睡眠障害国際分類、アメリカ精神医学界が作成した精神障害の診断・統計マニュアルDMS−IVの睡眠障害の項目、およびWHOの診断基準であるICDの睡眠障害の項目の3つの診断分類があり、数多くの睡眠障害の病名が列挙されている。
本発明における入眠改善とは、入眠過程における寝つきに対する心理評価が改善されることをいい、入眠過程とは就床から入眠に至るまでの状態を言う。不眠症の分類の一つに入眠障害が挙げられており、入眠障害とは本人が眠ろうと意識した時から寝付くまでの時間の延長であり、不眠症の症状でよくみられるものである。すなわち本発明は、入眠障害を改善することを意味する。また、不眠症の原因には不眠をもたらす薬剤の機会的使用やカフェインやニコチンの過剰摂取によってももたらされるが、これらの原因による入眠障害は含まれない。
本発明における睡眠後半とは、睡眠時間を2等分したときの起床に近い時間帯を意味する。睡眠後半ではレム睡眠が良く認められるという特徴がある。
本発明における睡眠効率とは、床に入っている時間に対して実際に眠っている時間の割合を意味している。中途覚醒があると睡眠効率は悪くなる。
本発明の対象は、主にヒトであるが、この他にも睡眠が認められる動物(例えば、イヌ、ネコ、牛、馬、ハムスター、モルモット、ラット、マウスなどの哺乳類、インコ、オウム、ジュウシマツなどの鳥類など)にも適用できる。
本発明の組成物を含有する食品の形状としては特に限定されるものではないが、通常のチュアブル状、タブレット状、カプセル状、顆粒状、粉末状、ドリンク状などが挙げられる。
また、本発明の組成物には、更に生薬、ハーブ、アミノ酸、ビタミン、ミネラル、その他食品に許容される素材・原料を併用することができる。ここにおいて、使用する生薬とは特に限定されるものではないが、カノコソウ、当帰、芍薬、牡丹、高麗人参などが挙げられる。
ビタミンについては特に限定されるものではないが、例えば、ビタミンA、ビタミンB1、ビタミンB2、ビタミンB6、ビタミンB12、ビタミンC、ビタミンD、ビタミンE、ビタミンK、葉酸、ニコチン酸、リボ酸、パントテン酸、ビオチン、ユビキノン等が挙げられ、好ましくはビタミンB1、ビタミンB6、ビタミンB12である。更に、ビタミンはそれぞれの誘導体も含まれる。
ミネラルについては特に限定されるものではないが、カルシウム、鉄、マグネシウム、銅、亜鉛、セレン、カリウム等が例示される。
本発明の製品形態としては、溶液、懸濁物、粉末、固体成形物等の任意の形態が例示されるが、これらに限定するものではない。食品としては、具体的には固形状食品または液状食品として前記例示したものの他、調味料、スープ、コーヒー、ココア、乳製品等が挙げられる。医薬品としては、用途、剤型等に応じて適宜選択される公知の任意の担体、本発明の組成物とその他の併合物を配合してなる錠剤、カプセル、注射剤等が例示される。
参考例1 酵素法によるテアニンの製造
0.3Mグルタミン及び1.5M塩酸エチルアミンを0.05Mホウ酸緩衝液(pH11)中、0.3Uグルタミナーゼ(市販品)存在下にて、30℃、22時間反応させ225nmolのテアニンを得た。次いで、反応液をDowex 50×8、Dowex 1×2カラムクロマトグラフィー(共に室町化学工業(株)製)にかけ、これをエタノール処理することにより、反応液から目的物質を単離し、8.5gのテアニンを得た。
茶(Camellia sinensis)葉10kgを熱水で抽出後、カチオン交換樹脂(室町化学工業(株)製、Dowex HCR W−2)に通し、1N NaOHにより溶出した。溶出画分を活性炭(二村化学工業(株)製太閤活性炭SG)に通し、15%エタノールによる溶出画分をRO膜(日東電工(株)製、NTR 729 HF)を用いて濃縮し、カラムクロマトグラフィーにて精製し、更に再結晶を行い、24.8gのテアニンを得た。
なお、以下における各試験及び各組成物の製造にはテアニン[商品名:サンテアニン、太陽化学株式会社製]を用いた。
睡眠改善用組成物の1例として、下表1に示す原料を混合後打錠し、テアニンとカモミールとを配合する錠剤を製造した。
実施例2〜実施例11
実施例1のカモミールに代えて、ラベンダー、セイントジョーンズワード、カワカワ、バレリアン、パッションフラワー、トリプトファン、5−HTP、セロトニン、γ−アミノ酪酸、またはメラトニンを下表2に示す重量%だけ添加したことを除き、実施例1と同様に操作して1粒1000mgの錠剤を打錠した(以下、実施例1〜実施例11の錠剤を「試験用錠剤」という)。
セドロールについては、揮発成分であることから、セドロールの空気中濃度が約1μg/Lとなるように計算し、下記比較例1のテアニン含有錠剤と共に摂取することにより併用試験を行った。
比較例1 対照錠剤の製造
比較例として、下表3に示す原料を混合後打錠し、対照錠剤を製造した。
試験例1 被験者の選定
被験者は、研究内容に関して十分な説明を受け、協力に同意した健常日勤男性25〜36歳(28.6±1.1歳)13名および健常男子大学生20〜33歳(26.8±1.3歳)13名とした。被験者には、モーズレー性格検査、CMI健康調査、睡眠健康調査票を事前に施行し、問題となるような治療中の疾患や過去の既往歴がないこと、著しい性格的偏りを有さないこと、睡眠健康に関して著しい不都合のないことを確認した。
実験期間中、被験者には規則正しい生活スタイルを心がけさせ、就床・起床時刻は各被験者の普段どおりの時刻から1時間以上ずれないよう、休日も勤務日とほぼ同じ就床時刻、起床時刻となるよう要請した。また、規則正しく食事をとること、薬や大量のアルコールを飲まない、さらに夕食後は、コーヒーや紅茶、緑茶、ウーロン茶、健康ドリンクなどカフェインの入った飲料を飲まないよう指示した。積極的に昼寝を取ること、床がかわる旅行、日常と異なる過激な運動や水泳は禁止した。
日勤男性においては13名の被験者のうち1名は、実施例1の試験用錠剤の服用第1、2夜に睡眠内省が極端に悪化し、この例の実施例1の試験用錠剤の服用初期における極端な睡眠内省の悪化はその後徐々に回復していった。また、この例のスクリーニングでの性格特性を検討した結果、実施例1の試験用錠剤の服用による直接的な影響では無いと判断された。この例では、実施例1の試験用錠剤の服用以外の要因により睡眠状態を問題となる水準まで悪化したと判断され解析の対照から除外した。このことから、日勤男性の最終的な対象者は、25〜36歳(28.0±1.0歳)の12名とした。男子大学生においては13名の被験者のうち、2名は「研究協力期間中の生活スタイル」に違反したため解析対象から除外し、1名は実施例1の試験用錠剤の服用期間中に風邪による胃痛を訴えたため実験を中止した。したがって、男子大学生の最終的な対象者は、20〜33歳(27.0±1.5歳)の健常男子大学生10名とした。起床時の睡眠内省および心理状態に対する実施例1の試験用錠剤の効果については、上記の日勤男性および男子大学生22名(27.5±0.9歳)を解析の対象とした。
第1因子の起床時眠気、第2因子の入眠と睡眠維持および第3因子の夢みについての結果を評価したところ、起床時の眠気において、実施例1の錠剤が比較例1の対照錠剤に比べて、有意に改善(p<0.05)していることが認められた(図2右)。また、入眠と睡眠維持、及び夢みについては、有意差は見られなかった。
第4因子の起床時の疲労回復感、及び第5因子の睡眠時間の延長感についての結果を解析したところ、いずれについても、実施例1の錠剤と比較例1の対照錠剤とで有意差は見られなかった。
男子学生10例の活動量の連続記録について、Coleらの方式に従い覚醒と睡眠を判別した。22時以降の10分以上連続した睡眠の始まりを入眠とし、翌朝の10時以前の10分以上連続、安定した覚醒の始まりを起床とした。入眠から起床までを主睡眠期とし、その間に出現した睡眠時間の累計を睡眠時間とした。睡眠効率は、(睡眠時間/主睡眠期の時間)x100で算出した。アクチグラフィにより測定した睡眠時間の結果を解析した。主睡眠期の睡眠時間は、対照群では約6時間20分、実施例1の錠剤では約6時間53分であり、有意差(p<0.05)が認められた(図2左)。また、睡眠効率については、有意差は認められなかった。なお、本実験における対象者は若年の青年期男子であり、元来睡眠効率は良好で、比較例1の対照錠剤条件においても94%弱と良好であった。
実施例1〜実施例11の各試験用錠剤、及び実施例12のテアニンとセドロールとの併用について、上記試験例1及び試験例2と同様にして、対象錠剤との効果を比較した。
その結果、下の表4及び表5に示す効果が得られた。
このように、テアニンとその他の成分とを併用したところ、テアニン単独で摂取した場合に比べると、起床時の眠気、及び睡眠時間の延長について、有意差が確認された。このため、テアニン単独で投与する場合に比べ、テアニンとその他の成分とを併用すると、より良好な睡眠を促進できることがわかった。
睡眠改善用組成物の1例として、下表6に示す原料を用いてテアニン・カモミール配合キャンディーを製造した。
なお、キャンディー中のテアニンの含量を測定した結果、含量は1コ1.2gで89.6mg/gであった。
実施例13のカモミールに代えて、ラベンダー、セイントジョーンズワード、カワカワ、バレリアン、パッションフラワー、トリプトファン、5−HTP、セロトニン、γ−アミノ酪酸、またはメラトニンを下表7に示す重量だけ添加したことを除き、実施例13と同様に操作してキャンディーを製造した(以下、実施例13〜実施例24のキャンディーを「試験用キャンディー」という)。
セドロールについては、揮発成分であることから、セドロールの空気中濃度が約1μg/Lとなるように計算し、実施例13のカモミールを除いたテアニン含有キャンディーと共に摂取することにより併用試験を行った。
実施例25 テアニン・カモミール配合ブルーベリー飲料の製造
睡眠改善用組成物の1例として、下表8に示す原料を用いてテアニン・カモミール配合飲料を製造した。
実施例25のカモミールに代えて、ラベンダー、セイントジョーンズワード、カワカワ、バレリアン、パッションフラワー、トリプトファン、5−HTP、セロトニン、γ−アミノ酪酸、またはメラトニンを下表9に示す重量だけ添加したことを除き、実施例25と同様に操作して飲料を製造した(以下、実施例25〜実施例35の飲料を「試験用飲料」という)。
セドロールについては、揮発成分であることから、セドロールの空気中濃度が約1μg/Lとなるように計算し、実施例25のカモミールを除いたテアニン含有飲料と共に摂取することにより併用試験を行った。
実施例37 テアニン・カモミール配合グレープフルーツ飲料の製造
睡眠改善用組成物の1例として、下表10に示す原料を用いてテアニン・カモミール配合飲料を製造した。
実施例37のカモミールに代えて、ラベンダー、セイントジョーンズワード、カワカワ、バレリアン、パッションフラワー、トリプトファン、5−HTP、セロトニン、γ−アミノ酪酸、またはメラトニンを下表11に示す重量だけ添加したことを除き、実施例37と同様に操作して飲料を製造した(以下、実施例37〜実施例47の飲料を「試験用飲料」という)。
セドロールについては、揮発成分であることから、セドロールの空気中濃度が約1μg/Lとなるように計算し、実施例37のカモミールを除いたテアニン含有飲料と共に摂取することにより併用試験を行った。
実施例13〜実施例24の試験用キャンディー、実施例25〜実施例36の試験用飲料、実施例37〜実施例48の試験用飲料について、それぞれ睡眠前に飲用したところ、起床時の疲労軽減、睡眠時間の延長感、入眠と睡眠維持、夢み、睡眠時間、中途覚醒(主睡眠期全体)、主睡眠期後半の中途覚醒、睡眠効率の全般に渡って、実施例1〜実施例12と同様の効果を示した。すなわち、睡眠障害の改善について、テアニン単独と比較すると、テアニンとその他の成分とを併用することにより、起床時の眠気を改善し、睡眠時間を延長させることにより、より良好な睡眠を促進できることがわかった。
Claims (1)
- (a)1mg/kg体重〜50mg/kg体重のテアニンと、(b)6mg/kg体重〜1500mg/kg体重のカモミール、2mg/kg体重〜300mg/kg体重のラベンダー、及び1mg/kg体重〜100mg/kg体重のγ−アミノ酪酸からなる群から選択される少なくとも1つ以上の成分とを含有することを特徴とする睡眠改善用剤であって、
睡眠改善効果が起床時の眠気の改善、及び睡眠時間の延長である睡眠改善用剤。
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TWI364285B (ja) | 2012-05-21 |
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DE602005023003D1 (de) | 2010-09-30 |
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JPWO2005097101A1 (ja) | 2008-02-28 |
EP1743633A1 (en) | 2007-01-17 |
EP1743633A4 (en) | 2007-05-16 |
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