JP6174885B2 - 睡眠改善剤 - Google Patents
睡眠改善剤 Download PDFInfo
- Publication number
- JP6174885B2 JP6174885B2 JP2013071870A JP2013071870A JP6174885B2 JP 6174885 B2 JP6174885 B2 JP 6174885B2 JP 2013071870 A JP2013071870 A JP 2013071870A JP 2013071870 A JP2013071870 A JP 2013071870A JP 6174885 B2 JP6174885 B2 JP 6174885B2
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- JP
- Japan
- Prior art keywords
- sleep
- general formula
- compound represented
- oil
- improving agent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000003795 chemical substances by application Substances 0.000 claims description 46
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Description
睡眠に不満を感じる健常な成人男女18名の被験者に、下記4種のサンプル2.0gを含浸させた葉書大のろ紙を毎晩就寝直前に枕元に設置して就寝してもらい、2週間後に睡眠に関するアンケートを行い、主観的な睡眠状態を評価した。
睡眠に関するアンケート項目は、就寝前の疲労感に対する睡眠後の疲労回復感が得られたか、翌日朝の目覚めは良いか、入眠時の寝つきは良かったか、中途覚醒などで夜中に目覚めたか、の4項目に関して、それぞれ1から5までの5段階評価(1:まったく思わない、2:やや思う、3:まあまあ思う、4:かなり思う、5:非常に思う)によりスコア化した。
サンプルには、チュニジア産のミルトル油(学名 Myrtus communis,和名 ギンバイカの葉や枝から、水蒸気蒸留によって得られる精油)、ソマリア産のオリバナム油(学名 Boswellia carterii,和名 ニュウコウジュの樹脂から、水蒸気蒸留によって得られる精油)、和光純薬製の酢酸ミルテニルと1,8-シネオールを用いた。コントロールには、何も含浸させないろ紙を使用し、2週間後同様の主観評価を行った。
試験は、精油同士の比較(試験1:ミルトル油とオリバナム油)、単独化合物同士の比較(試験2:酢酸ミルテニルと1,8-シネオール)を行い、その結果を表1及び2に示した。
評価結果は、それぞれのサンプルの平均スコアからコントロールの平均スコアを引き、その差を数値で示し、疲労回復感、翌日の目覚めの良さ、寝つきの良さの項目については、数値が-0.1より小さい場合は×、数値が-0.1〜+0.5の場合は△、数値が+0.5より大きい場合は○とし、夜中の目覚め有りの項目については、数値が+0.5より大きい場合は×、数値が-0.1〜+0.5の場合は△、数値が-0.1より小さい場合は○とした。
・ミルトル油
α-ピネン(14質量%)、リモネン(8質量%)、1,8-シネオール(24質量%)、リナロール(2質量%)、酢酸ミルテニル(20質量%)、α-ターピネオール(4質量%)、酢酸ゲラニル(3質量%)、ミルテノール(1質量%)、メチルオイゲノール(1質量%)、その他
・オリバナム油
α-ピネン(26質量%)、β-ピネン(4質量%)、サビネン(7質量%)、ミルセン(3質量%)、パラ−サイメン(5質量%)、酢酸オクチル(2質量%)、カリオフィレン(2質量%)、その他
また、ミルトル油中の主要成分である、1,8-シネオールと酢酸ミルテニルを比較した試験2においては、酢酸ミルテニルに高い睡眠効果が示されたが、1,8-シネオールには睡眠効果とは反対の覚醒効果が示された。すなわち、1,8-シネオールと酢酸ミルテニルを含むミルトル油には覚醒効果があり、1,8-シネオール単体でも覚醒効果が示されたが、酢酸ミルテニル単体には睡眠効果があることが示された。
睡眠に不満を感じる健常な成人男女18名の被験者に、下記2種のサンプル10mgを含有するカプセルを1日あたり3カプセル、夕食後〜就寝前に摂取してもらい、2週間後に睡眠に関するアンケートを行い、主観的な睡眠状態を評価した。
睡眠に関するアンケートは、就寝前の疲労感に対する睡眠後の疲労回復感が得られたか、翌日朝の目覚めは良いか、入眠時の寝つきは良かったか、中途覚醒などで夜中に目覚めたか、の4項目に関して、それぞれ1から5までの5段階評価(1:まったく思わない、2:やや思う、3:まあまあ思う、4:かなり思う、5:非常に思う)によりスコア化した。
サンプルには、チュニジア産のミルトル油(学名 Myrtus communis,和名 ギンバイカの葉や枝から、水蒸気蒸留によって得られる精油)から分画した酢酸ミルテニルと、パイン(学名 Pinus palustris Millなど,和名 マツ)から得られるターペンチンを水蒸気蒸留することによって得られるテレビン油から分画したα-ピネンを用い、1カプセルには、前記サンプル10mgのほかに小麦胚芽油190mgを充てんした。コントロールには小麦胚芽油200mgを充てんしたカプセルを用い、2週間後同様の主観評価を行った。
その結果を表3に示した。評価結果は、それぞれのサンプルの平均スコアからコントロールの平均スコアを引き、その差を数値で示し、疲労回復感、翌日の目覚めの良さ、寝つきの良さの項目については、数値が-0.1より小さい場合は×、数値が-0.1〜+0.5の場合は△、数値が+0.5より大きい場合は○とし、夜中の目覚め有りの項目については、数値が+0.5より大きい場合は×、数値が-0.1〜+0.5の場合は△、数値が-0.1より小さい場合は○とした。
女性87名に対し、PSQI(Pittsburgh Sleep Quality Index)試験を行い、スコアの高い(すなわち「睡眠障害あり」と判断されたパネル)14名を選定した。
各パネルには、エアディフューザーにてサンプルを提供した。すなわち、パネルの鼻から40cm以内の枕元にエアディフューザーを設置し、酢酸ミルテニルを含浸させた直径4mmのケイ酸カルシウムのビーズ20gをエアディフーザーにセットし、自然蒸散するサンプルに30秒に5秒間の割合で無音ファンにて送風し、就寝開始から起床までパネルに提供し続けた。無香の場合は、何も含浸させていないケイ酸カルシウムのビーズ20gをそのまま使用した。
無香条件、酢酸ミルテニル条件共に、2晩の慣らし測定の後、5晩の脳波測定を行った(無香、酢酸ミルテニルの順はパネルにより切り替え)。
測定した脳波は、常法に従い解析を行い、入眠潜時、中途覚醒(時間、割合)、覚醒指数(回/時間)、総覚醒回数、睡眠効率(割合)、ノンレム睡眠時のデルタパワー量などの結果について、上記2条件(酢酸ミルテニル条件と無香条件)において分散分析で有意差の検定を行った。
(成分) 含有量(%)
マイクロクリスタリンワックス 9.0
セタノール 3.5
サラシミツロウ 6.0
フィトステロール 1.0
スクワラン 1.5
ワセリン 69.0
酢酸ミルテニル 1.0
流動パラフィン 9.0
(成分) 含有量(%)
硫酸ナトリウム 49.0
炭酸水素ナトリウム 49.0
ヒソップオイル 1.0
酢酸ミルテニル 1.0
(成分) 含有量(%)
アルコール 70.0
精製水 残余
酸化防止剤 1.0
酢酸ミルテニル 10.0
3-メチル-3-メトキシブタノール 5.0
ジベンジリデンソルビトール 5.0
(成分) 含有量(%)
潤沢剤(ショ糖脂肪酸エステル等) 1.0
アラビアガム水溶液(5%) 2.0
酸味料 1.0
着色料 適量
酢酸ミルテニル 2.0
糖質(粉糖又はソルビトール等) 残余
(成分) 含有量(%)
スクラロース 0.2
酢酸ミルテニル 0.5
香味料 6.0
賦形剤(セオラス) 10.0
マルチトール 残余
(成分) 含有量(%)
エタノール 8.0
モノラウリン酸ポリオキシエチレンソルビタン(20E.O.) 0.4
メチルパラベン 0.1
1,3-ブチレングリコール 5.0
N-メチル-L-セリン 0.1
火棘抽出物 0.1
酢酸ミルテニル 0.01
香料 0.1
精製水 残量
(成分) 含有量(%)
グリセリンモノステアレート 2.0
ミツロウ 1.0
ソルビタンモノステアレート 1.0
ワセリン 4.0
流動パラフィン 12.0
N-ステアロイル-L-グルタミン酸ナトリウム 1.0
キサンタンガム 0.2
カムカムエキス 0.1
メチルパラベン 0.1
酢酸ミルテニル 0.05
香料 0.2
精製水 残量
(成分) 含有量(%)
L-塩化カルニチン 0.5
グリチルリチン酸ジカリウム 0.1
テンニンカ抽出物 0.001
水素添加大豆リン脂質 2.0
コレステロール 1.0
スクワラン 2.0
トリス(トリメトキシ)メチルシラン 5.0
イソノナン酸イソノニル 5.0
ミリスチン酸オクチルドデシル 7.0
1,3-ブチレングリコール 5.0
ジプロピレングリコール 5.0
濃グリセリン 1.0
ジグリセリン 5.0
ポリエチレングリコール4000 3.0
アクリル酸・メタクリル酸アルキル共重合体 0.1
カルボキシビニルポリマー 0.2
キサンタンガム 0.1
水酸化カリウム 0.08
エデト酸二ナトリウム 0.02
フェノキシエタノール 0.3
酢酸ミルテニル 0.01
香料 0.09
酵母エキス(*1) 0.1
ハクガイシ加水分解エキス(*2) 0.1
混合植物抽出液(*3) 0.1
カロットエキス(*4) 0.1
ブクリョウエキス(*5) 0.1
タイソウエキス(*6) 0.1
精製水 残量
*1;イーストリキッドZB(一丸ファルコス社製)
*2;シナブランカーWH(テクノーブル社製)
*3;マルチフルーツBSC(Arch Personal Care Products L.P.社製)
*4;ベジタブルコラーゲン(高研社製)
*5;ファルコレックスブクリョウE(一丸ファルコス社製)
*6;タイソウ抽出液BG-J(丸善製薬社製)
(成分) 含有量(%)
ベルガモットオイル 2.0
リナリールアセテート 1.5
メチルアンスラニレート 0.2
ペチグレインオイル 0.5
オーランチオール 10%PG 1.0
アミルアリルグリコレート 1%PG 0.5
ガルバナムオイル 1%PG 0.1
ブラックカラントバズアブソリュート 10%PG 1.5
タジェットオイル 10%PG 0.8
イランイランオイルエキストラ 2.0
ベンジールアセテート 5.0
メチルジヒドロジャスモネート 13.0
シスジャスモン 1%PG 1.0
オレンジフラワーアブソリュート 0.5
インドール 5%PG 0.5
L-シトロネロール 0.5
ローズオイル 0.5
ローズアブソリュート 0.5
ダマセノン 1%PG 0.5
L-ローズオキサイド 1%PG 0.5
ジメチルベンジルカーボニルアセテート 1.0
ヒドロキシシトロネラール 4.5
リラール 3.5
シクラメンアルデヒド 0.5
アルファイソメチルヨノン 4.0
オリスコンクリート 10%PG 0.8
メチルイソオイゲノール 0.5
イソEスーパー 2.5
ベルトフィックスクール 4.0
ベチバーアセテート 2.0
サンダルウッドオイル 1.5
バグダノール 10%PG 1.0
パチュリーオイル 10%PG 0.2
エベルニール 10%PG 1.5
ガラクソリッド 50%ベンジールベンゾエート 10.0
シクロペンタデカノリッド 4.0
ヘリオトロピン 0.5
クマリン 0.5
バニリン 10%PG 0.5
エチルバニリン 10%PG 2.5
ラズベリーケトン 10%PG 0.5
ガンマウンデカラクトン 10%PG 1.5
ガンマデカラクトン 10%PG 1.5
ラブダナム アブソリュート 10%PG 0.5
プロピレングリコール 残量
合計 100.0
※ PG:プロピレングリコールによる希釈物
Claims (5)
- 剤形が、経口組成物、皮膚外用剤、毛髪外用剤及び噴霧・散布剤から選択される1種である請求項1に記載の睡眠改善剤。
- 剤形が経口組成物であって、一般式(1)で表される化合物として1〜500mg/日経口投与される請求項2に記載の睡眠改善剤。
- 剤形が皮膚外用剤又は毛髪外用剤であって、一般式(1)で表される化合物を0.0001〜30質量%含有する請求項2に記載の睡眠改善剤。
- 剤形が噴霧・散布剤であって、使用者の周りの空間における一般式(1)で表される化合物の濃度が0.01〜10000ppbとなるように噴霧又は散布される請求項2に記載の睡眠改善剤。
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