JP3686063B2 - Health supplements that improve sleep disorders - Google Patents
Health supplements that improve sleep disorders Download PDFInfo
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- JP3686063B2 JP3686063B2 JP2003062951A JP2003062951A JP3686063B2 JP 3686063 B2 JP3686063 B2 JP 3686063B2 JP 2003062951 A JP2003062951 A JP 2003062951A JP 2003062951 A JP2003062951 A JP 2003062951A JP 3686063 B2 JP3686063 B2 JP 3686063B2
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Description
【０００１】
【産業上の利用分野】
この発明は不眠症などの睡眠障害の改善作用を有する健康補助食品に関する。
【０００２】
【従来の技術】
近年、殊にも都市生活者においては、活動時間のずれによる昼夜の逆転現象などの生活のリズムの乱れ、ストレスに加え、運動不足の影響もあり、睡眠不足、不眠症を訴える人が増加している。睡眠不足は自覚できる体調の悪化に止まらず、免疫力の低下、ホルモンバランスの失調、肝機能の低下、不整脈など、健康状態に重要な影響を与える原因となることが知られている。
その治療のためには、睡眠薬を処方するのが一般であるが、普通に使用されているベンゾジアゼピン系などの睡眠薬は長期間にわたって服用すると依存症に陥る場合が多く、長期間の連続服用はできるだけ避けなければならない。
【０００３】
【非特許文献１】
三島和夫，佐藤浩徳，菱川泰夫，大川匡子「メラトニンの生体リズム調整作用」神経精神薬理 第１８巻１０号 １９９６年１０月
【０００４】
【発明が解決しようとする問題点】
睡眠障害の原因は多岐にわたり、頭痛、歯痛などの痛み、高血圧、神経症、ビタミン、特にビタミンＤの欠乏、自律神経失調、アデノイド肥大による呼吸障害、風邪、肺結核などが不眠症を引き起こすことが知られている。
脳中の松果体から分泌されるメラトニンは血中濃度の上昇により睡眠を誘い、その消費によって目覚めることが知られている。（非特許文献１）従ってメラトニン剤の服用により催眠効果を得ることも試みられているが、服用者の１０％程度は効果がなかったと云い、他の１０％程度には悪夢、朝のめまい、性欲低下等の副作用が見られたという報告もされている。このため、妊娠中や乳幼児のいる女性、アレルギー症状や自己免疫疾患を持つ者は服用を避けるべきであるとされている。さらに、メラトニン剤はその服用により催眠効果を持つにせよ、睡眠障害への対症療法という面は否定出来ず、上記のような睡眠障害に対する根本からの障害除去の作用を持つわけではない。
上記睡眠障害の原因は、痛みなど、自覚症状が明らかな場合もあるとは言え、ビタミン欠乏、自律神経失調など、本人には自覚することの難しい原因も多く、それらの症状に対して原因除去のための適切な治療を行うことは困難な場合も多い。このような事情に鑑み、本発明は、その摂取によって催眠効果を得られると共に広範にわたる睡眠障害の原因の除去に効果のある健康補助食品を得ようとするものである。
【０００５】
【課題を解決するための手段】
上記目的を達成するための本発明の健康補助食品は、古来の食品由来の天然物を主成分とする組成物であり、以下の成分よりなる。
また、上記の組成物は、その成分として亜鉛を含有することが望ましい。
さらに
セントジョンズワート セイヨウオトギリソウ
パッションフラワー セイヨウチャボトケイソウ 花・葉
バレリアン セイヨウカノコソウ
を配合することが望ましい。
【０００７】
上記本発明の健康補助食品に配合される成分は、それぞれ、以下の薬効を持つとされる（主として神農本草経による。）。
酸棗仁は、betulinic acid(Ｉ), betulin, jujuboside A,B, ebelinlactone(III)を含み、鎮静、催眠・神経強壮等の作用を持ち、心因性神経症の不眠症、健忘症などの症状を改善する。
合歓花は、成分は未詳であるが、鎮静、鎮痛、利尿等の作用を持ち、心煩・不眠などを改善する。
五加参は、各種の配糖体、ビタミンＢ，Ｃ、カロチンなどを含み、抗疲労、強壮、強精、鎮痛作用があり、不眠の改善、集中力を高め、脳機能の正常化に効果がある。
真珠母は、カルシウムが豊富で、精神不安、不眠症、イライラの解消に効果がある。
夜交藤は、アントラキノン類を含み、精神を安定して不眠症を改善する。
百合は、でん粉、脂肪、蛋白質の他の成分は未詳であるが、鎮静、鎮咳、利尿、消炎作用がある。
烏霊参は、地中に生える菌糸類で、成分は未詳であるが、腎脳補強、鎮静作用を持ち、不眠症、健忘症、疲れ、耳鳴り、眩暈症を改善する。
霊芝のエキスは、中枢神経系抑制作用があり、鎮静、強壮作用により、神経衰弱、不眠症を改善する。
冬虫夏草は、cordycepic acid、コレステロール、ergosterol などを含み、心臓と肺の機能強化により疲労回復を促進し、抗ストレス効果を持つ。
纈草の抽出エキスには鎮静作用があり、中枢神経の興奮を和らげて、催眠作用を持つ。
蛤蟆油は、ビタミンＡ，Ｂ，Ｃおよび多種のホルモンを含み、神経衰弱、病後や産後の虚弱等の症状を改善する。
菩提樹は、神径を鎮め、血圧を低下させ、鎮静、鎮痙作用により、不眠症、神経疲労を改善する。
亜鉛は、脳を活性化し、細胞間の刺激伝達物質の合成を助ける。
セントジョンズワートエキス（セイヨウオトギリソウ）は、脳内伝達物質のモノアミンのレベルを調節することにより、軽度〜中程度のうつ症状に効果を示すとされ、ヨーロッパでは古くからうつ病や神経症に用いられてきた。
パッションフラワーエキスは、生理活性物質としてイソビテキシンなどのフラボン配糖体を含み、精神安定作用、鎮静作用、抗けいれん作用を持つ。
バレリアンエキスは、生理活性物質としてバレレニック酸などのセスキテルペンを含み、鎮静作用、抗けいれん作用の他、血圧降下作用を持つ。
【０００８】
上記のように、睡眠障害の原因は多岐にわたり、中には自覚されない原因も少なくない。従って、自覚出来る原因にのみ作用する成分を含む薬剤あるいは健康補助食品を摂取しても、それだけで十分な効果を得ること難しい。このような睡眠障害の特徴に鑑み、原因として存在する可能性の高い症状を広く改善出来る組成物を摂取することが望ましい。本発明では、上記の有効作用を有する各成分を、酸棗仁１５重量％〜２５重量％、合歓花１０重量％〜１５重量％、五加参８重量％〜１３重量％、真珠母５重量％〜１５重量％、夜交藤１５重量％〜２５重量％、百合７重量％〜１２重量％、烏霊参３重量％〜８重量％、霊芝１重量％〜６重量％、冬虫夏草１重量％〜４重量％、纈草３重量％〜８重量％、蛤蟆油１重量％〜４重量％、菩提樹５重量％〜１５重量％の範囲で配合してある。また、上記成分にさらに、亜鉛、セントジョンズワート、パッションフラワー、バレリアンの少なくとも１種類を配合することによって、より相乗効果が期待できる。
【０００９】
本発明の健康補助食品が改善作用を持つ睡眠障害の原因および効果が期待される重な症状は表１の通りである。表１において○を付してあるのが各成分が奏する作用及び薬効である。
【００１０】
【表１】
【発明の実施の態様】
上記の各組成物は、主として漢方生薬ないしエキスとして薬種店で容易に入手可能であり、賦形剤と共に錠剤とするのが最も望ましい。その配合形態および配合比を示せば以下の通りである。
配合例１
１ 酸棗仁 １５重量％〜２５重量％ エキス
２ 合歓花 １０重量％〜１５重量％ エキス
３ 五加参 ８重量％〜１３重量％ エキス
４ 真珠母 ５重量％〜１５重量％ 粉末
５ 夜交藤 １５重量％〜２５重量％ エキス
６ 百合 ７重量％〜１２重量％ エキス
７ 烏霊参 ３重量％〜８重量％ エキス
８ 霊芝 １重量％〜６重量％ エキス
９ 冬虫夏草 １重量％〜４重量％ エキス
１０ 纈草 ３重量％〜８重量％ エキス
１１ 蛤蟆油 １重量％〜４重量％ エキス
１２ 菩提樹 ５重量％〜１５重量％ エキス
【００１２】
配合例２
上記１〜１２の成分に、さらに１３ 亜鉛 ５重量％〜１２重量％を配合した。
配合例３
上記１〜１２の成分に、さらに
１４ セントジョンズワート エキス
１５ パッションフラワー エキス
１６ バレリアン エキス
を配合した。
配合例４
上記配合例２に、さらに配合例３の成分を配合した。そのときの配合量は配合例２の組成物と配合例３の組成物の重量比は６９：１００である。
【００１３】
【実施例】
実施例１
酸棗仁３４mg、合歓花２５mg、五加参２２mg、真珠母１６mg、夜交藤３４mg、百合１８mg、烏霊参９mg、霊芝５mg、冬虫夏草４mg、纈草９mg、蛤蟆油４mg、菩提樹１５mg、残部を賦形剤として、１錠が３００mgの錠剤を作った。
【００１４】
実施例２
酸棗仁３２mg、合歓花２６mg、五加参２０mg、真珠母１８mg、夜交藤３２mg、百合１５mg、烏霊参８mg、霊芝６mg、冬虫夏草４mg、纈草８mg、蛤蟆油４mg、菩提樹２６mg、亜鉛１mg残部を賦形剤として、１錠が２２０mgの錠剤を作った。
【００１５】
実施例３
実施例２の配合割合にさらに、セントジョンズワート１５mg、パッションフラワー１５mg、バレリアン１５mgを追加して、残部を賦形剤として、１錠が３００mgの錠剤を作った。
【００１６】
実施例４
酸棗仁３５mg、合歓花２５mg、五加参２５mg、真珠母２０mg、夜交藤３５mg、百合２０mg、烏霊参８mg、霊芝８mg、冬虫夏草５mg、纈草１０mg、蛤蟆油５mg、菩提樹３０mg、亜鉛１０mg、セントジョンズワート１５mg、パッションフラワー１５mg、バレリアン１５mg、残部を賦形剤として、１錠が３５０mgの錠剤を作った。
【００１７】
使用例
睡眠障害のため、睡眠薬依存症に陥っている男性１０名、女性１０名を被験者として選び、上記実施例の健康補助食品を投与して、依存症からの脱却を試みた。
その結果について、５使用例については以下に詳細に記載し、他の１５使用例は表２に一覧形式で示す。
Ａ．男性 ４５歳 デザイナー
仕事上のストレスから、睡眠障害に陥り、毎日２錠のロルメタゼバムを服用し、睡眠薬依存症に陥っていた。最初は作用の弱いものを望み実施例２の錠剤を６錠／日服用したが睡眠薬依存症を克服することが出来なかった。
１月後に、実施例４の錠剤に切り替えたところ、１週間後には睡眠薬を半減することが出来、２週間後には睡眠薬を必要としなくなった。しかし、精神的な不安が残っており、現在は実施例３の錠剤を４錠／日摂取し続けている。
Ｂ．女性 ４０歳 主婦
家庭内不和と、パートの職場におけるストレスから、強い睡眠障害に陥り、トリアゾラムを毎日３錠服用し、その依存症に陥り、副作用が心配されていた。実施例４の錠剤を毎日６錠摂取したところ、２週間後にはトリアゾラムの毎日の服用量を２錠に減らすことが出来、３週間後には１錠に、１か月後には本発明の健康補助食品のみにすることが出来た。現在まだ摂取を続けているが、徐々にその必要もなくすよう、次ぎの段階として実施例３に移行する予定である。
Ｃ．女性 ６７歳 無職
夫の死亡により睡眠障害に陥り、ホームドクターに睡眠薬を処方してもら貰っていた。しかし、服用を続けると睡眠薬障害に陥ると注意を受け、何か趣味を持つことを勧められ、ダンス教室に行くようになったが、夜はなかなか寝付けない状態が続いていた。３か月経った頃、実施例１の錠剤を毎日６錠飲み始めたところ、２日後にはぐっすり眠れるようになった。強い睡眠薬よりも朝の目覚めもスッキリして、体調も全般的に改善された。
Ｄ．男性 ５５歳 元会社員
突然のリストラにあい、職探ししているがなかなか希望に見合う職場が見つからず、睡眠障害に陥った。病院で事情を説明したところ、睡眠薬としてニトラゼバム１錠／日を処方された。その効果により、最初の一週間はよく眠れたが、２週間目に入るとまた眠れなくなり、さらに強い睡眠薬を処方された。しかし、３日後にはまた眠れなくなり、睡眠薬障害が心配された。実施例１の健康補助食品と出会い、６錠／日を睡眠薬と共に服用したら、すぐに眠れるようになった。睡眠薬障害の心配から逃れるため、１週間後、実施例１の健康補助食品だけに切り替えたが、それだけでも眠れるようになった。３週間後には健康補助食品の摂取もやめたが、その後睡眠障害は生じていない。
Ｅ．男性 ５８歳 会社員
半年前に帯状疱疹にかかり、痛みのために睡眠障害に陥った。実施例２の錠剤を９錠／日服用したところ、３日目から痛みもやすらぎ、眠れるようになった。一週間後、実施例１の錠剤に移行したが、同様にぐっすり眠ることが出来た。それから３週間後、何も飲まなくても眠れるようになった。帯状疱疹の痛みはまだ残っているが、健康食品の鎮痛、消炎作用のためか大分軽くなり、睡眠を妨げるほどではなくなっている。
【００１８】
【表２】
【００１９】
また、本発明に係る「睡眠障害の改善作用を有する健康補助食品」について中国長春中医学院付属病院に依頼し、本健康補助食品の臨床観察と薬理実験を行った。その臨床観察・薬理試験の結果が得られたので、それを以下に紹介する。
１．臨床観察
不眠症には精神的興奮や不安による不眠と、呼吸系、循環系などの器官病気による不眠の二種類に大きく分けるが、ストレスや環境的な原因によるいわゆる精神生理性不眠が最も多く見られる。今回行った２６例の臨床観察は前者である更年期障害、神経症(ノイローゼ)と後者である脳動脈硬化に伴った不眠患者を対象にして実施したものである。
（１）臨床観察に関する一般データは以下のとおりである。
観察方法は、不眠と訴える患者に一般検査、診断を行った後、「眠れる健康食品」を一日３回１０錠ずつ(中国成人の飲用量)飲用させ、飲用前後の睡眠時間及びそれに伴った諸症状の変化を週１回検査、記録する。また、観察期間は２週間とし、その後データの統計を行った。
（３）観察結果
観察結果は、症例２６例中、著効が９例、有効が１０例、無効が７例で、総有効率は73.08％、無効率は26.92％という結果であった。
また、更年期障害１０例中、著効は２例、有効は６例、無効は２例で、神経症(ノイローゼ)１０例中、著効は６例、有効は２例、無効は２例で、脳動脈硬化６例中、著効は１例、有効は２例、無効は３例であった。この結果を、図１にグラフにして示す。
また、１）睡眠時間 ２）夢を見る頻度 ３）体力気力の衰え ４）錯覚を感じる頻度 ５）孤独を感じる頻度 といった被検者の症状をデータとしてとり蓄積した。その結果を図２、図３にグラフで示す。また、以上の結果を一覧表の形で表３に示す。
【００２０】
【表３】
（４）結果分析
以上の臨床観察を行った結果を分析すると、本発明に係る「眠れる健康食品」は更年期障害、神経症(ノイローゼ)に伴う不眠症状に対する改善効果は良好であったが、脳の動脈硬化に伴う不眠に対する改善効果はそれに比べてやや劣る傾向が見られた。また、効果のあった症例の中で、特に睡眠時間の延長、夢を見る頻度の減少、熟睡時間の延長には顕著な効果が見られたので、精神的ストレスによる不眠には本健康補助食品が効果的だと考えられる。
また、観察期間中２６例はいずれも副作用や不良反応が見られなかったため、安全性が高いものと推定できる。
【００２２】
本発明に係る「眠れる健康食品」の安全性と薬理作用を検討するために、急性毒性実験および薬理実験を行った。その結果を以下に示す。
２．薬理実験
（１）急性毒性実験
この実験の具体的方法であるが、まず、本発明に係る「眠れる健康食品」を一回に大量に与えた場合の毒性実験(半数致死量ＬＤ５０測定)を行ったが、死亡発生がなかった。そこで、更に毒性について精査するためＬＤ５０から最大耐受量ＭＴＤ測定法に切り替えて下記のように行った。
被試験動物はマウス、試験試薬は本発明に係る「眠れる健康食品」、投与量は４０ｍｇ／ｋｇ／日(人体への標準投与量の４６５倍相当)で、投与方法は経口投与で行なった。
上記の実験の観察結果、毒性の反応の発生は認められなかった。
【００２３】
本発明に係る「眠れる健康食品」をマウス、ラットに投与した場合の影響を下記の６項目９種の実験を行った。その結果を以下に示す。
（２）運動性への影響を観察する実験
実験１．「眠れる健康食品」投与したマウス群と、非投与マウス群との観察比較
この実験では、本発明に係る「眠れる健康食品」を投与したマウス群と、非投与マウスとの観察比較を行なった。実験の具体的方法は、「眠れる健康食品」の非投与マウス群と２ｇ／ｋｇ、４ｇ／ｋｇ、６ｇ／ｋｇ（マウスの体重１ｋｇ当りの投与量）投与したマウス群を、運動計測器に入れ、運動回数を比較した。この実験の結果を図４のＡに示す。「眠れる健康食品」の非投与マウスに比べ投与マウスのほうが僅かに運動回数の減少が見られた。したがって、「眠れる健康食品」は運動量を僅かに抑制する作用があるものと解される。
【００２４】
実験２．「眠れる健康食品」投与マウスに対して興奮剤を投与した場合の運動性の影響
この実験では、本発明に係る「眠れる健康食品」投与マウスに対して更に興奮剤を投与した場合の運動性の影響を観察するもので、具体的方法は、正常のマウス群と中枢興奮作用のあるベンゼドリン(アンフェタミン)のみを投与したマウス群と「眠れる健康食品」を２ｇ／ｋｇ、４ｇ／ｋｇ、６ｇ／ｋｇ投与し更にベンゼドリンを投与したマウス群を運動計測器に入れ運動回数を観察した。
【００２５】
実験３．「眠れる健康食品」投与ラットに対して麻酔剤を閾値以下投与した場合の運動性への影響
この実験では本発明に係る「眠れる健康食品」投与ラットに対して麻酔剤を閾値以下投与した場合の運動性への影響を観察した。実験方法は、正常のラットと麻酔作用のあるペントバルビタールナトリウムの閾値以下（微量）を投与したラットと本発明に係る「眠れる健康食品」を２ｇ／ｋｇ、４ｇ／ｋｇ、６ｇ／ｋｇ投与し、更にペントバルビタールナトリウムの閾値以下を投与したラットの滑り板での滑落度を観察した。
【００２６】
（３）睡眠作用への影響を観察する実験
本発明に係る「眠れる健康食品」と麻酔剤による睡眠作用の相乗効果を観察する。
実験４．「眠れる健康食品」投与マウスに対して麻酔剤を閾値以下注射した場合の睡眠作用への影響
この実験では本発明に係る「眠れる健康食品」投与マウスに対して麻酔剤を閾値以下投与した場合の運動性への影響を観察した。実験の方法は、麻酔作用のあるペントバルビタールナトリウムの閾値以下(微量)を注射したマウス群と本発明に係る「眠れる健康食品」を２ｇ／ｋｇ、４ｇ／ｋｇ、６ｇ／ｋｇ投与し更にペントバルビタールナトリウムの閾値以下を注射したマウス群の睡眠状態を観察した。
【００２７】
実験５．「眠れる健康食品」投与マウスに対して麻酔剤の催眠効果用量を投与した場合の睡眠導入時間・睡眠時間への影響
この実験では、本発明に係る「眠れる健康食品」投与マウスに対して麻酔剤の催眠効果用量を投与した場合の睡眠導入時間・睡眠時間への影響を観察した。実験方法は、ペントバルビタールナトリウムの催眠効果用量を投与したマウス群と「眠れる健康食品」を２ｇ／ｋｇ、４ｇ／ｋｇ、６ｇ／ｋｇ投与し更にペントバルビタールナトリウムの催眠効果用量を投与したマウス群の睡眠導入時間、睡眠持続時間を観察した。
註 ＊ペントバルビタールナトリウム注射量：５０ｍｇ／ｋｇ
この実験の結果を図５のＢに示す。この実験から、本発明に係る「眠れる健康食品」の非投与マウスに比べ、投与マウスのほうが、睡眠導入時間の影響は見られなかったが、睡眠持続時間の延長が見られた。したがって、該「眠れる健康食品」は、ペントバルビタールナトリウムの催眠効果用量を投与したマウスに対して睡眠導入時間の短縮は無いが、睡眠持続時間の延長効果があることが確認された。
【００２８】
（４）酸素欠乏環境下での生存力ヘの影響
実験６．酸素欠乏環境下での生存力の強さについて生存時間の長短を観察する。
この実験では、酸素欠乏環境下での生存力の強さについて、本発明に係る「眠れる健康食品」投与マウスと非投与マウスの生存時間の長短を比較観察した。実験方法は、本発明に係る「眠れる健康食品」の非投与マウス群と２ｇ／ｋｇ、４ｇ／ｋｇ、６ｇ／ｋｇ投与したマウス群を密閉容器に入れ酸素欠乏状態にして、マウス群の生存時間を測定観察を行なう。
この実験の結果を図５のＣに示す。この実験から、本発明に係る「眠れる健康食品」の非投与マウスに比べて投与したマウスの方が生存時間の延長が見られた。したがって、「眠れる健康食品」は生命力の強化が確認できた。
【００２９】
（５）不整脈誘発への影響
実験７．不整脈誘発モデルラットヘの「眠れる健康食品」の影響を観察した。
この実験では、薬剤により不整脈誘発モデルラットを作ってこれに対して、抗不整脈剤(プロプラノロール)を投与したラットと、本発明に係る「眠れる健康食品」の１ｇ／ｋｇ、２ｇ／ｋｇ、４ｇ／ｋｇ投与したラットの不整脈発生率、不整脈回復時間を観察記録した。
【００３０】
（６）老化虚弱ラツトヘの血漿ＳＯＤと脳組織ＡＴＰ活性に対する影響
実験８．老化虚弱ラットの「眠れる健康食品」を与えたときの免疫力とエネルギー供給力の影響
この実験では、老化虚弱ラットの「眠れる健康食品」を与えたときの免疫力とエネルギー供給力の影響を調べる。具体的方法は、サイロキシンを一週間投与することにより、老化虚弱化させたモデルラットを作り、「眠れる健康食品」の非投与ラットと１ｇ／ｋｇ、２ｇ／ｋｇ、４ｇ／ｋｇ投与したラットの血漿ＳＯＤの活性を測定することにより免疫力の強さと脳組織ＡＴＰの量を測定し観察した。
【００３１】
（７）学習能力に関する作用の影響
実験９：薬剤を与えることにより学習能力障害を起こさせたマウスに「眠れる健康食品」を投与し、学習能力の回復度合いを調査
この実験では、薬剤を与えることにより学習能力障害を起こさせたマウスに本発明に係る「眠れる健康食品」を投与し、学習能力の回復度合いを調べる。実験方法は、中枢抑制作用のあるスコポラミンを与え学習能力障害を起こさせたモデルマウス群に「眠れる健康食品」の非投与マウス群と１ｇ／ｋｇ、２ｇ／ｋｇ、４ｇ／ｋｇ投与したマウス群をつくり、一箇所の安全地帯以外は電流が流れている箱の中にいれ、マウスが誤って感電した回数を記録し比較する。
註 ＊スコポラミン：中枢抑制作用、副交感神経遮断作用がある。大量投与では、中枢抑制作用により幻覚、錯乱などを引き起こす。
この実験の結果を図６のＣに示す。この実験から、本発明に係る「眠れる健康食品」はスコポラミンにより学習能力障害を起こしたマウスの学習能力回復の著しい回復は認められなかったが、多少の回復は認められる。
【００３２】
次ぎに、４名の人に本発明に係る「眠れる健康食品」を投与し、睡眠状態の度合いを服用しないときとの差を調べる実験を行なった結果を示す。各人には午後８時に「眠れる健康食品」を服用してもらい、午後１０時に就寝して午後１１時、午前２時、午前５時の３回唾液を採取してその中のメラトニンの含有量を測定する方法をとった。このメラトニンは人体の生理作用として能の松果体から分泌されるホルモン物質で、その人の睡眠と鎮静度を測る目安とされるものである。メラトニンは固有の日内変動リズムを持っており、夜間に多く分泌される。この実験結果を表４に示す。服用した「眠れる健康食品」の量は実施例１（酸棗仁３４mg、合歓花２５mg、五加参２２mg、真珠母１６mg、夜交藤３４mg、百合１８mg、烏霊参９mg、霊芝５mg、冬虫夏草４mg、纈草９mg、蛤蟆油４mg、菩提樹１５mg、残部を賦形剤として、１錠が３００mgの錠剤）の錠剤を４錠とした。ただしこの結果において２．８ｐｇ／ｍＬなる数値は検出限界値でそれ以下の数値もこの値となってしまう関係上、この値以下の値であることを示しているだけで２．８という値自体に意味をもたせることはできない。
【表４】
４氏についての結果を図７にグラフ表示して示した。Ａ氏についてはもともと就寝後１時間では眠りが浅く、午前２時そして午前５時と段々に眠りが深くなるタイプであるが、この「眠れる健康食品」を投与したときには就寝後１時間で眠りが深くなっており、午前２時では更に深くそして午前５時には若干浅くなってはいるものの深い状態となっている。Ｂ氏についてはもともと就寝後１時間から午前２時そして午前５時とコンスタントの浅い眠りが続くタイプであるが、この「眠れる健康食品」を投与したときには就寝後１時間、午前２時では飲まないときと変りがないものの午前５時には若干深い状態となっている。Ｃ氏についてはもともと就寝後１時間では眠りが浅く、午前２時には一旦眠りが深くなりそして明け方午前５時には眠りが浅くなるタイプであるが、この「眠れる健康食品」を投与したときには就寝後１時間では普段と変りがないものの、午前２時では眠りが深くなっており、そして午前５時には更に眠りが深い状態となっている。Ｄ氏についてはもともとＢ氏に近く就寝後１時間から午前２時そして午前５時とコンスタントの浅い眠りが続くタイプであるが、この「眠れる健康食品」を投与したときには就寝後１時間で眠りが少し深くなっており、午前２時では更に少し深くそして午前５時には多いに深い眠りの状態となっている。
以上の結果から分かるように本発明に係る「眠れる健康食品」を食した場合、そのきき方に個人差があるものの、いずれの人も普段より眠りの状態が深くなっていることが実証された。
【００３４】
また、メラトニンの日中測定を実施した結果を表５に示す。
【表５】
【００３５】
メラトニンは睡眠中に分泌される物質であるが、目覚めの時に多く分泌され、覚醒を促す物質にＡＣＴＨ（副腎皮質刺激ホルモン）とアドレナリンがある。日中、眠くならないということを、さらに確認する為に、メラトニンの作用と反対に、朝、身体を覚醒させるＡＣＴＨ(副腎皮質刺激ホルモン)とアドレナリンの測定を行った。
ＡＣＴＨはメラトニンの催眠作用と反対に、朝、身体を覚醒する為に副腎皮質を刺激して、覚醒の為の様々な内分泌物質を分泌させるホルモンである。このＡＣＴＨはその分泌に日内変動があり、身体を覚醒する為、朝から午前にかけて分泌が多く午後から低くなり夜間は最も分泌量が少ない。
アドレナリンには様々な作用があるが、その一つにはＡＣＴＨと同様にアドレナリンも身体を覚醒させる作用である。内分泌物質であるアドレナリンもその分泌に日内変動がありＡＣＴＨと同様に、朝、分泌量が多く、夜間は分泌量が少ない。５人の人に協力してもらい連続服用による影響も診るため１週間後の分泌量の測定も行った。その結果を表６に示す。
【表６】
試料は採取した血液で、数値は血液中の濃度ｐｇ／ｍＬ。「眠れる健康食品」の服用は実施例１のものを就寝２時間前２錠、朝食後１錠とし、血液採取は午前９時とした。５氏の結果は図８にグラフで示したとおりである。因みにＡＣＴＨの基準値は７．４乃至５５．７であり、アドレナリンは１００以下である。本実験の結果ではＡＣＴＨについては服用開始直後、服用開始１週間後の２点で、多少の変動はあるものの、服用前と大きく変るものは無い上、変化の傾向も一貫性がみられず５氏共に「眠れる健康食品」の服用の影響は観察されなかった。また、服用後のアドレナリン分泌量についてはＡ氏とＢ氏に若干の上昇がみられ、Ｃ氏、Ｄ氏とＥ氏については服用前と比べアドレナリンの分泌量に特段の変化はみられなかった。以上の結果から、日中の本健康食品の服用によって眠くなるという催眠作用は見られず、多少の覚醒作用があるように思われる。
【００３７】
以上体内分泌物の検査結果、すなわち、本発明の「眠れる健康食品」の服用により就寝時は、メラトニンの分泌増により、より深い睡眠が得られ、質の良い睡眠が得られること、また、日中は、メラトニンの分泌は見られず、ＡＣＴＨの分泌には影響がなかったこと、さらに、アドレナリンについては、朝にアドレナリンの分泌が逆に増加した例が数人に見られたこと、これらを総合すると「眠れる健康食品」は単に睡眠作用を促進させるというものではなく、生体の睡眠覚醒リズムを調整する効能を有するものと解される。したがって、普通に使用されているベンゾジアゼピン系などの睡眠薬は長期間にわたって服用すると依存症に陥る場合が多いが、この「眠れる健康食品」は生体リズムを整えるものであるから分泌ホルモンに悪い影響を与えることはなく副作用も依存症を伴う心配もない。
【００３８】
【発明の効果】
本発明の健康補助食品は、上記の体験例に見られるように、その摂取によって催眠効果を得られると共に広範にわたる睡眠障害の原因の除去に優れた効果が確認できた。また、本発明の健康食品に含まれる成分は、植物系生薬を中心とするものであるので、毒性、副作用の恐れもなく、睡眠障害の原因の除去することができる。
【００３９】
また、臨床観察の結果から、本発明の健康補助食品は、脳の動脈硬化に伴う不眠に対する改善効果はあまりないが、更年期障害、神経症(ノイローゼ)に伴う不眠症状に対する改善効果は良好であることが確認できた。そして、睡眠時間の延長、夢を見る頻度の減少、熟睡時間の延長には顕著な効果が見られたことから、精神的ストレスによる不眠には本健康補助食品が効果的であることが確認できた。更に、観察期間中２６例はいずれも副作用や不良反応が見られなかったため、安全性が高い健康補助食品であることも確認できた。
【００４０】
薬理実験の結果から、
▲１▼急性毒性実験により、本発明の健康補助食品が毒性の反応および死亡の発生はなかったことからも安全性が高い健康補助食品ことが確認できた。
▲２▼運動性への影響は僅かに影響が出るが、薬剤を用いて中枢興奮作用を与えた場合、つまり興奮状態のときには、運動量を抑制するので興奮を鎮める作用があることが確認できた。
▲３▼閾値以下の麻酔剤を与えて運動性を観察したとき、２ｇ／ｋｇでは影響は見られないが、４ｇ／ｋｇ、６ｇ／ｋｇ投与した場合には相乗効果が認められたことから、本発明の健康補助食品は閾値以上の量がある場合には麻酔剤との相乗効果がある。
▲４▼本発明の健康補助食品は、麻酔剤に対して睡眠導入時間に関しては影響が無いが、睡眠持続時間の延長に対して相乗効果が見られることから、良い睡眠が得られ睡眠時間延長の改善効果がある。
▲５▼本発明の健康補助食品は、酸素欠乏環境下での生存時間の延長が見られたことから、生命力強化の作用があることが確認できた。
▲６▼本発明の健康補助食品は、不整脈に対してある程度の改善作用があることが確認できた。
▲７▼本発明の健康補助食品は、血漿ＳＯＤ活性を高めることにより身体組織の免疫力の強化をすると同時に脳組織ＡＴＰ活性を高め脳組織保護能力があることが確認できた。
▲８▼本発明の健康補助食品は、中枢抑制剤による学習能力障害に対して顕著とはいえないが多少の回復能力があることが確認できた。
さらに、睡眠状態をモニターするメラトニン検査の結果からも、本発明に係る「眠れる健康食品」を食した場合、そのきき方に個人差があるものの、いずれの人も普段より眠りの状態が深くなっていることが実証された。
【００４１】
本発明の健康補助食品を服用したときのメラトニン分泌量測定から、そのきき方に個人差があるものの、いずれの人も普段より眠りの状態が深くなっていることが実証された。また、日中の催眠作用がないこともわかった。
本発明の健康補助食品を服用したときのＡＣＴＨ、アドレナリンの分泌量測定から、日中の本健康食品の服用によって眠くなるという催眠作用は見られず、多少の覚醒作用があることが分かった。
以上体内分泌物の検査結果を総合すると「眠れる健康食品」は単に睡眠作用を促進させるというものではなく、生体の睡眠覚醒リズムを調整する効能を有するものと解されので、普通に使用されているベンゾジアゼピン系などの睡眠薬は長期間にわたって服用すると依存症に陥る場合が多いが、この「眠れる健康食品」は生体リズムを整えるものであるから分泌ホルモンに悪い影響を与えることはなく副作用も依存症を伴う心配もない。
【図面の簡単な説明】
【図１】更年期障害、神経症、脳動脈硬化に対する観察結果を示すもので、Ａはデータを表に示したもの、Ｂは棒グラフに示したもの、Ｃは総合結果を円グラフに示したものである。
【図２】上段は症状についての検査結果を表で、下段は帯グラフで示したもので、Ａは睡眠時間、Ｂは夢を見る頻度、そしてＣは体力気力の衰えについてのものである。
【図３】上段は症状についての検査結果を表で、下段は帯グラフで示したもので、Ａは錯覚を感じる頻度、Ｂは孤独を感じる頻度についてのものである。
【図４】上段は薬理実験の結果を表で、下段は棒グラフで示したもので、Ａは本健康補助食品を投与したマウスと非投与のマウスとの比較、Ｂは本健康補助食品を投与したマウスに興奮剤を投与した時の運動観察、Ｃは本健康補助食品を投与したマウスに麻酔剤を投与した時の運動観察結果を示すものである。
【図５】上段は薬理実験の結果を表で、下段は棒グラフで示したもので、Ａは本健康補助食品を投与したマウスに麻酔剤を閾値以下注射した時の睡眠作用を、Ｂは本健康補助食品を投与したマウスに麻酔剤の催眠効果用量を投与した時の睡眠観察、Ｃは酸素欠乏環境下での本健康補助食品を投与したマウスと非投与のマウスとの生存力比較結果を示すものである。
【図６】上段は薬理実験の結果を表で、下段は棒グラフで示したもので、Ａは不整脈誘発への影響を、Ｂは老化虚弱ラットへの血漿ＳＯＤと脳組織ＡＴＰ活性に対する影響、Ｃは学習能力に関する作用の影響の結果を示すものである。
【図７】眠りの深さをモニターするメラトニン分泌量測定の結果を示すグラフである。
【図８】覚醒作用をモニターするＡＣＴＨ、アドレナリンの分泌量測定の結果を示すグラフである。[0001]
[Industrial application fields]
The present invention relates to a health supplement having an effect of improving sleep disorders such as insomnia.
[0002]
[Prior art]
In recent years, especially in urban dwellers, the number of people complaining of lack of sleep and insomnia has increased due to the effects of lack of exercise in addition to disturbances in life rhythms such as day and night reversal phenomenon due to shifts in activity time. ing. It is known that sleep deprivation not only deteriorates the physical condition that can be recognized, but also causes important effects on health such as decreased immunity, poor hormonal balance, decreased liver function, and arrhythmia.
For the treatment, it is common to prescribe sleeping pills, but commonly used sleeping pills such as benzodiazepines often become addicted when taken for a long time, and continuous taking for a long time is possible Must be avoided.
[0003]
[Non-Patent Document 1]
Kazuo Mishima, Hironori Sato, Yasuo Hishikawa, Kyoko Okawa "Melatonin's biological rhythm-regulating action" Neuropsychopharmacology Vol.18 No.10 October 1996
[0004]
[Problems to be solved by the invention]
There are various causes of sleep disorders, such as headaches, toothaches, high blood pressure, neurosis, vitamins, especially vitamin D deficiency, autonomic insufficiency, respiratory disorders due to adenoid hypertrophy, colds, and pulmonary tuberculosis. It has been.
It is known that melatonin secreted from the pineal gland in the brain induces sleep due to an increase in blood concentration and awakens by its consumption. (Non-patent document 1) Therefore, it has been tried to obtain a hypnotic effect by taking melatonin, but about 10% of the users said that it was not effective, and about 10% of other people had nightmares, dizziness in the morning, There are reports that side effects such as decreased libido were observed. For this reason, it is said that women who are pregnant or have infants and those with allergic symptoms or autoimmune diseases should avoid taking them. Furthermore, although melatonin drugs have a hypnotic effect by taking them, the aspect of symptomatic treatment for sleep disorders cannot be denied, and it does not have the effect of removing the fundamental damage to sleep disorders as described above.
Although the causes of the above sleep disorders may be obvious, such as pain, subjective symptoms may be obvious, but there are many causes that are difficult for the person to recognize, such as vitamin deficiency and autonomic dysfunction. Proper treatment for is often difficult. In view of such circumstances, the present invention seeks to obtain a health supplement that can obtain a hypnotic effect by its ingestion and is effective in eliminating the causes of extensive sleep disorders.
[0005]
[Means for Solving the Problems]
The health supplement of the present invention for achieving the above object is a composition mainly composed of natural products derived from ancient foods, and comprises the following components.
Moreover, it is preferable that said composition contains zinc as the component.
further
St. John's wort Hypericum
Passion flower
Valerian valerian
It is desirable to blend.
[0007]
The ingredients blended in the above-described health supplement of the present invention are said to have the following medicinal effects (mainly based on Shinno-honkaku).
Acid soot, including betulinic acid (I), betulin, jujuboside A, B, and ebelinlactone (III), has sedation, hypnosis and nerve tonic effects, and symptoms such as insomnia of psychogenic neurosis and amnesia To improve.
Although the composition is unknown, it has actions such as sedation, analgesia, diuresis, etc. and improves anxiety and insomnia.
Gokasan contains various glycosides, vitamins B, C, carotene, etc., and has anti-fatigue, toughness, toughness, analgesic action, improves insomnia, improves concentration, and normalizes brain function There is.
Pearl mother is rich in calcium and is effective in relieving mental anxiety, insomnia, and irritation.
Yakoto has anthraquinones, stabilizes the mind and improves insomnia.
Lily has no known ingredients for starch, fat and protein, but has sedation, antitussive, diuretic and anti-inflammatory properties.
Ginseng is a mycelium that grows in the ground, and its ingredients are unknown, but it has renal brain reinforcement and sedation, and improves insomnia, amnesia, fatigue, tinnitus, and dizziness.
Ganoderma extract has a central nervous system inhibitory effect, and improves sedation and tonicity to improve nervous breakdown and insomnia.
Cordyceps, including cordycepic acid, cholesterol, and ergosterol, promotes fatigue recovery by strengthening the function of the heart and lungs and has an anti-stress effect.
The extract of licorice has a sedative effect, relieves central nervous excitement and has a hypnotic effect.
Camellia oil contains vitamins A, B, C and various hormones, and improves symptoms such as nervous breakdown, weakness after illness and postpartum.
Bodhi tree calms down the gods, lowers blood pressure, and improves sedation and antispasmodic action to improve insomnia and nerve fatigue.
Zinc activates the brain and assists in the synthesis of stimulus-transmitters between cells.
St. John's wort extract (hypericum perforatum) is said to be effective for mild to moderate depressive symptoms by regulating the levels of monoamines in the brain transmitter, and has long been used for depression and neurosis in Europe. I came.
Passion flower extract contains a flavone glycoside such as isovitexin as a physiologically active substance, and has a tranquilizing action, a sedative action, and an anticonvulsant action.
Valerian extract contains a sesquiterpene such as valeric acid as a physiologically active substance, and has a blood pressure lowering action in addition to a sedative action and an anticonvulsant action.
[0008]
As described above, there are various causes of sleep disorders, and there are many causes that are not recognized. Therefore, even if a drug or health supplement containing a component that acts only on a cause that can be perceived is taken, it is difficult to obtain a sufficient effect by itself. In view of such characteristics of sleep disorders, it is desirable to take a composition that can broadly improve symptoms that are likely to exist as a cause. In the present invention, the components having the above-mentioned effective action are mixed with 15% to 25% by weight of acid soy sauce, 10% to 15% by weight of joyous flowers, 8% to 13% by weight of ginseng, 5% by weight of mother of pearl -15% by weight, 15% by weight to 25% by weight,
[0009]
Table 1 shows the severe symptoms for which the cause and effect of sleep disorders in which the health supplement of the present invention has an improving action are expected. In Table 1, circles indicate the action and medicinal effect of each component.
[0010]
[Table 1]
BEST MODE FOR CARRYING OUT THE INVENTION
Each of the above-mentioned compositions is easily available at a drugstore mainly as a herbal medicine or extract, and it is most desirable to form tablets together with excipients. The blending form and blending ratio are as follows.
Formulation Example 1
1
2
3
4 5% to 15% by weight of pearl mother powder
5 15% by weight to 25% by weight extract
6 Lily 7wt% -12wt% extract
7
8
9
10 3% to 8% extract by weight
11
12
[0012]
Formulation Example 2
Further, 5 to 12% by weight of 13 zinc was added to the
Formulation Example 3
In addition to the
14 St. John's wort extract
15 Passion flower extract
16 Valerian extract
Was formulated.
Formulation Example 4
The ingredients of Formulation Example 3 were further blended with Formulation Example 2. In this case, the weight ratio of the composition of Formulation Example 2 to the composition of Formulation Example 3 is 69: 100.
[0013]
【Example】
Example 1
34mg of acid potato, 25mg of gojuhana, 22mg of ginseng, 16mg of mother of pearls, 34mg of night mating, 18mg of lily, 9mg of ginseng, 5mg of ginseng, 4mg of cordyceps, 9mg of licorice, 4mg of coconut oil, 15mg of linden tree As an excipient, one tablet made 300 mg.
[0014]
Example 2
Soybean seeds 32mg, Ganka 26mg, Gokasan 20mg, Pearl mother 18mg, Night mater 32mg, Yuri 15mg, Ginseng 8mg, Ganoderma 6mg, Cordyceps 4mg, Licorice 8mg, Bamboo oil 4mg, Bodhi tree 26mg, Zinc 1mg One tablet was made into a tablet of 220 mg with the balance being the excipient.
[0015]
Example 3
Further, St. John's wort 15 mg,
[0016]
Example 4
Acid Soybean 35mg, Gojohana 25mg, Gokasan 25mg, Pearl Mother 20mg, Yakko 35mg, Yuri 20mg, Saiko Ginseng 8mg, Ganoderma 8mg, Cordyceps 5mg, Camellia 10mg, Camellia Oil 5mg, Bodhi Tree 30mg, Zinc 10mg St. John's wort 15 mg,
[0017]
Example of use
Ten males and ten females who have fallen into sleep medicine due to sleep disorders were selected as subjects, and the dietary supplements of the above examples were administered to try to escape from dependence.
The results are described in detail below for 5 usage examples, and the other 15 usage examples are listed in Table 2.
A. Male 45 years old Designer
Due to work stress, he fell into sleep disorder, took 2 tablets of lormetazebam daily and fell into sleep drug addiction. At first, the drug of Example 2 was taken 6 tablets / day in hopes of a weak action, but it was not possible to overcome the hypnotic dependence.
After switching to the tablet of Example 4 after 1 month, the sleeping pill could be halved after 1 week, and no sleeping pill was needed after 2 weeks. However, mental anxiety remains, and currently, the tablet of Example 3 is continuously taken at 4 tablets / day.
B. Female 40-year-old housewife
Due to discomfort in the home and stress at the part-time workplace, he fell into a strong sleep disorder, took 3 tablets of triazolam daily, fell into addiction, and was worried about side effects. When 6 tablets of Example 4 were taken every day, the daily dose of triazolam could be reduced to 2 tablets after 2 weeks, 1 tablet after 3 weeks, and the health aid of the present invention after 1 month. I could only have food. Although it is still ingesting, the next stage is scheduled to move to Example 3 so as to gradually eliminate the necessity.
The husband's death caused sleep disturbance, and his home doctor prescribed a sleeping pill. However, I was warned that I would fall into sleeping pill disorder if I continued to take it, and I was encouraged to have some hobbies and started to go to dance classes, but I was still unable to sleep at night. After 3 months, I started to drink 6 tablets of Example 1 every day. After 2 days, I became able to sleep well. The awakening in the morning is clearer than the strong sleeping pills, and the overall physical condition is improved.
D. Male 55 years old Former employee
After a sudden restructuring, I was looking for a job, but I couldn't find a workplace that met my hopes and fell into sleep disorder. After explaining the situation at the hospital, he was prescribed 1 nitrazebam / day as a sleeping pill. Because of the effect, I slept well in the first week, but again in the second week, I could not sleep again, and I was prescribed a stronger sleeping pill. However, after 3 days, he was unable to sleep again and was worried about sleeping pill disorder. When I met the health supplement of Example 1 and took 6 tablets / day with a sleeping pill, I became able to sleep immediately. In order to escape from worrying about sleeping pill disorders, one week later, only the health supplement of Example 1 was switched, but it became possible to sleep alone. After 3 weeks, she stopped taking dietary supplements, but after that she had no sleep problems.
E. Male 58 years old Office worker
I had shingles half a year ago and fell into sleep because of pain. When the tablet of Example 2 was taken at 9 tablets / day, the pain eased from the 3rd day and it became sleepy. After one week, the tablet was transferred to the tablet of Example 1, but could sleep well as well. Three weeks later, I became able to sleep without drinking anything. Herpes zoster pain remains, but it has become much lighter because of the analgesic and anti-inflammatory effects of health foods, and it is no longer enough to disturb sleep.
[0018]
[Table 2]
[0019]
In addition, the “health supplement having an effect of improving sleep disorder” according to the present invention was commissioned to the Chinese Changchun Medical School Hospital, and clinical observation and pharmacological experiments were conducted on the health supplement. The results of the clinical observation and pharmacological test were obtained, which will be introduced below.
1. Clinical observation
Insomnia can be broadly divided into two types: insomnia due to mental excitement and anxiety, and insomnia due to organ diseases such as the respiratory system and circulatory system, and so-called psychophysiological insomnia due to stress and environmental causes is the most common. The 26 clinical observations conducted this time were conducted in patients with insomnia associated with the former menopause disorder, neurosis (neurose) and the latter cerebral arteriosclerosis.
(1) General data on clinical observations are as follows.
The observation method is to conduct a general examination and diagnosis for patients who complain of insomnia, then drink 10
(3) Observation results
The observation results were 9 cases, 10 cases were effective, and 7 cases were ineffective among the 26 cases. The total effective rate was 73.08% and the invalid rate was 26.92%.
In 10 cases of menopause, 2 cases are effective, 6 cases are effective, 2 cases are ineffective, 10 cases of neurosis (neurose) are 6 cases, 2 cases are effective, 2 cases are ineffective Among the 6 cases of cerebral arteriosclerosis, 1 case was effective, 2 cases were effective, and 3 cases were ineffective. The results are shown as a graph in FIG.
In addition, data on subjects' symptoms such as 1) sleep time, 2) frequency of dreaming, 3) decline in physical fitness, 4) frequency of feeling illusion, and 5) frequency of feeling loneliness were collected as data. The results are shown graphically in FIGS. The above results are shown in Table 3 in the form of a list.
[0020]
[Table 3]
(4) Result analysis
Analyzing the results of the above clinical observations, the `` sleeping health food '' according to the present invention was good in improving the insomnia associated with climacteric disorder and neurosis (neurose), but accompanied by cerebral arteriosclerosis The improvement effect on insomnia tended to be slightly inferior to that. In addition, among the effective cases, this health supplement was especially effective for insomnia due to mental stress, as it was particularly effective in extending sleep time, reducing the frequency of dreaming, and extending deep sleep time. Is considered effective.
Moreover, since no side effects or bad reactions were observed in any of the 26 cases during the observation period, it can be estimated that the safety is high.
[0022]
In order to examine the safety and pharmacological action of the “sleeping health food” according to the present invention, acute toxicity experiments and pharmacological experiments were conducted. The results are shown below.
2. Pharmacological experiment
(1) Acute toxicity experiment
A specific method of this experiment is as follows. First, a toxicity experiment (half-lethal dose LD) when a large amount of the “sleeping health food” according to the present invention is given at one time.50Measurement), but no death occurred. Therefore, to further investigate the toxicity, LD50Was switched to the maximum tolerable MTD measurement method as follows.
The test animal was a mouse, the test reagent was “healthy health food” according to the present invention, the dose was 40 mg / kg / day (corresponding to 465 times the standard dose to the human body), and the administration method was oral administration.
As a result of observation of the above experiment, no toxic reaction was observed.
[0023]
The following 6 items and 9 types of experiments were conducted on the effects of administration of the “sleeping health food” according to the present invention to mice and rats. The results are shown below.
(2) Experiments to observe the effect on mobility
In this experiment, an observation comparison was made between a group of mice administered with the “sleeping health food” according to the present invention and a non-administered mouse. The specific method of the experiment was to put a group of mice not administered with “sleeping health food” and a group of mice administered with 2 g / kg, 4 g / kg, and 6 g / kg (doses per kg body weight of the mouse) into an exercise measuring instrument. Compared the number of exercises. The result of this experiment is shown in FIG. There was a slight decrease in the number of exercises in the treated mice compared to the non-treated mice with the “sleeping health food”. Therefore, it is understood that “sleeping health food” has an action of slightly suppressing the amount of exercise.
[0024]
In this experiment, the effect of motility when a stimulant is further administered to the “sleeping health food” -administered mouse according to the present invention is observed. A group of mice administered only with a certain benzedrine (amphetamine) and a group of mice administered with 2 g / kg, 4 g / kg, and 6 g / kg of “sleeping health food” and further administered with benzedrine were placed in an exercise meter and the number of exercises was observed.
[0025]
In this experiment, the effect on the motility when an anesthetic was administered below the threshold was observed in rats administered with the “sleeping health food” according to the present invention. The experimental method is to administer 2 g / kg, 4 g / kg, and 6 g / kg of the “sleeping health food” according to the present invention and a rat administered with a normal rat and an anesthetic action of pentobarbital sodium below the threshold (a trace amount), Furthermore, the degree of sliding on the sliding plate of rats administered with sodium pentobarbital below the threshold was observed.
[0026]
(3) Experiment to observe the effect on sleep action
The synergistic effect of the sleep action of the “sleeping health food” according to the present invention and the anesthetic is observed.
In this experiment, the effect on the motility when an anesthetic was administered below the threshold to mice administered with “sleeping health food” according to the present invention was observed. The experimental method consists of administering 2 g / kg, 4 g / kg, and 6 g / kg of the “sleeping health food” according to the present invention to the group of mice injected with an anesthetic action of pentobarbital sodium below the threshold (a trace amount), and pentobarbital. The sleep state of the group of mice injected with sodium below the threshold was observed.
[0027]
In this experiment, the effect on sleep induction time and sleep time when a hypnotic effect dose of an anesthetic was administered to mice administered with “sleeping health food” according to the present invention was observed. The experimental method consists of a group of mice administered with a hypnotic effect dose of sodium pentobarbital and a group of mice administered with a hypnotic effect dose of 2 g / kg, 4 g / kg, 6 g / kg of “sleeping health food” and further administered with a hypnotic effect dose of sodium pentobarbital. Sleep induction time and sleep duration were observed.
註 * Pentobarbital sodium injection amount: 50mg / kg
The result of this experiment is shown in FIG. From this experiment, compared with the non-administered mouse of the “sleeping health food” according to the present invention, the administration mouse did not show the influence of the sleep introduction time, but the sleep duration was prolonged. Therefore, it was confirmed that the “sleeping health food” has an effect of prolonging the sleep duration, although the sleep induction time is not shortened in mice administered with the hypnotic effect dose of pentobarbital sodium.
[0028]
(4) Effects on viability in an oxygen-deficient environment
In this experiment, regarding the strength of viability in an oxygen-deficient environment, the survival time of the “sleeping health food” -administered mouse and the non-administered mouse according to the present invention was compared and observed. The experimental method is that the non-administered mouse group of the “sleeping health food” according to the present invention and the mouse group administered with 2 g / kg, 4 g / kg, and 6 g / kg are placed in a sealed container to be in an oxygen-deficient state, Measure and observe.
The result of this experiment is shown in FIG. From this experiment, it was found that the survival time of the mice administered was longer than that of the mice not administered with the “sleeping health food” according to the present invention. Therefore, it was confirmed that “sleeping health food” has enhanced vitality.
[0029]
(5) Effects on induction of arrhythmia
In this experiment, an arrhythmia induction model rat was made with a drug and an antiarrhythmic agent (propranolol) was administered to the rat, and 1 g / kg, 2 g / kg, 4 g / kg of the “sleeping health food” according to the present invention. Arrhythmia incidence and arrhythmia recovery time of rats administered with kg were observed and recorded.
[0030]
(6) Effects of aging frail ratchet on plasma SOD and brain tissue ATP activity
In this experiment, we will examine the effects of immunity and energy supply when aging frail rats are given “sleeping health food”. Specifically, thyroxine was administered for one week to make a model rat with aging weakness, and the plasma of rats not administered with “sleeping health food” and rats administered with 1 g / kg, 2 g / kg, or 4 g / kg. By measuring the activity of SOD, the strength of immunity and the amount of brain tissue ATP were measured and observed.
[0031]
(7) Effects of effects on learning ability
Experiment 9: “Sleeping health food” was administered to mice that had impaired learning ability by giving drugs, and the degree of recovery of learning ability was investigated.
In this experiment, a “sleeping health food” according to the present invention is administered to a mouse that has been impaired in learning ability by giving a drug, and the degree of recovery of learning ability is examined. The experimental method consists of a group of mice not administered with “sleeping health food” and a group of mice administered with 1 g / kg, 2 g / kg, or 4 g / kg. Make it and put it in a box where current is flowing, except for one safety zone, and record and compare the number of times the mouse accidentally got an electric shock.
* Scopolamine: Central inhibitory action, parasympathetic nerve blockade. Large doses cause hallucinations and confusion due to central inhibitory action.
The result of this experiment is shown in FIG. From this experiment, the “sleeping health food” according to the present invention did not show a significant recovery in learning ability recovery of mice that had impaired learning ability due to scopolamine, but some recovery was observed.
[0032]
Next, the result of conducting an experiment to examine the difference from when not taking the degree of sleep state by administering "sleeping health food" according to the present invention to four people. Each person takes “sleeping health food” at 8 pm, goes to sleep at 10 pm, collects saliva three times at 11 pm, 2 am, and 5 am and contains melatonin content The method of measuring was taken. Melatonin is a hormonal substance secreted from the pineal gland as a physiological function of the human body, and is used as a standard for measuring the sleep and sedation of the person. Melatonin has a unique circadian rhythm and is secreted more at night. The experimental results are shown in Table 4. The amount of "healthy health food" taken was Example 1 (acid soy sauce 34 mg, gojuhana 25 mg,
[Table 4]
The results for Mr. 4 are shown graphically in FIG. As for Mr. A, it is a type in which sleep is shallow at 1 hour after bedtime, and sleep is gradually deepened at 2 am and 5 am, but when this “sleeping health food” is administered, it is possible to sleep 1 hour after bedtime. It is deeper, deeper at 2am but slightly shallower at 5am. Mr. B is a type of constant sleep that lasts from 1 hour to 2 am and 5 am after going to bed, but when this “healthy health food that sleeps” is administered, it will not be taken for 1 hour after going to bed or 2 am Although it does not change from time to time, it is slightly deep at 5 am. As for Mr. C, it is a type that sleep is shallow at 1 hour after bedtime, sleeps deeply at 2 am, and sleeps at 5 am at dawn. When this “sleeping health food” is administered, it is 1 hour after bedtime. In the morning, however, there is no change, but at 2 am, sleep is deep, and at 5 am, sleep is deeper. About Mr. D, it is a type that is close to Mr. B from 1 hour to 2 am and 5 am after bedtime, and a constant light sleep continues, but when this “healthy health food” is administered, you can sleep 1 hour after bedtime. It is a little deeper, a little deeper at 2am and a much deeper sleep at 5am.
As can be seen from the above results, when eating the "sleeping health food" according to the present invention, although there are individual differences in how to eat, it has been demonstrated that each person has a deeper sleep state than usual .
[0034]
Table 5 shows the results of daytime measurement of melatonin.
[Table 5]
[0035]
Melatonin is a substance secreted during sleep, but is secreted in awakening and ACTH (adrenocorticotropic hormone) and adrenaline are substances that promote arousal. In order to further confirm that the patient does not become sleepy during the day, ACTH (adrenocorticotropic hormone) and adrenaline, which awaken the body, were measured in the morning, as opposed to the action of melatonin.
In contrast to the hypnotic action of melatonin, ACTH is a hormone that stimulates the adrenal cortex to awaken the body in the morning and secretes various endocrine substances for awakening. This ACTH has daily fluctuations in its secretion, and since it awakens the body, the secretion is high from morning to morning and low from the afternoon, and it is the lowest at night.
Adrenaline has a variety of actions, one of which is the action that awakens the body as well as ACTH. The secretion of adrenaline, which is an endocrine substance, also varies within the day, and as with ACTH, the amount of secretion is large in the morning and is small at night. In order to examine the effects of continuous use with the cooperation of five people, the amount of secretion after one week was also measured. The results are shown in Table 6.
[Table 6]
The sample is the collected blood, and the value is the concentration in blood pg / mL. “Sleepable health food” was taken in Example 1 with 2
[0037]
As described above, the results of the examination of the endocrine secretions, that is, when sleeping at the time of taking the “sleeping health food” of the present invention, it is possible to obtain deeper sleep due to increased secretion of melatonin and to obtain good quality sleep. Among them, melatonin secretion was not observed, and ACTH secretion was not affected. Furthermore, regarding adrenaline, several cases of adrenaline secretion increased in the morning were observed. In summary, it is understood that “sleeping health food” does not merely promote sleep action, but has the effect of adjusting the sleep-wake rhythm of the living body. Therefore, commonly used hypnotics such as benzodiazepines often become addicted when taken for a long time, but this `` sleeping health food '' adjusts the biological rhythm and thus adversely affects secreted hormones There is no worry about side effects and addictions.
[0038]
【The invention's effect】
As can be seen from the experience examples described above, the health supplement of the present invention was able to obtain a hypnotic effect by ingestion, and was able to confirm an excellent effect in removing a wide range of causes of sleep disorders. In addition, since the ingredients contained in the health food of the present invention are mainly herbal medicines, the cause of sleep disorders can be eliminated without fear of toxicity and side effects.
[0039]
In addition, from the results of clinical observation, the health supplement of the present invention has little improvement effect on insomnia associated with cerebral arteriosclerosis, but the improvement effect on insomnia associated with climacteric disorder and neurosis (neurose) is good. I was able to confirm. In addition, it was confirmed that this supplement is effective for insomnia caused by mental stress, as it has shown significant effects in extending sleep time, reducing the frequency of dreaming, and extending sleep time. It was. Furthermore, since no adverse reactions or adverse reactions were observed in any of the 26 cases during the observation period, it was also confirmed that the supplements were highly safe.
[0040]
From the results of pharmacological experiments,
(1) From the acute toxicity experiment, it was confirmed that the health supplement of the present invention was highly safe because no toxicity reaction or death occurred.
(2) Although the effect on motility is slightly affected, when a central excitatory action was given using a drug, that is, in an excited state, it was confirmed that it has an action to suppress excitement because it suppresses the amount of exercise. .
(3) When motility was observed by applying an anesthetic below the threshold, no effect was observed at 2 g / kg, but a synergistic effect was observed when administered at 4 g / kg or 6 g / kg. The health supplement of the present invention has a synergistic effect with an anesthetic when there is an amount above the threshold.
(4) The health supplement of the present invention has no effect on the sleep induction time with respect to the anesthetic agent, but since a synergistic effect is seen with respect to the extension of the sleep duration, good sleep is obtained and the sleep time is extended. There is an improvement effect.
(5) It was confirmed that the health supplement of the present invention has an effect of enhancing vitality since the survival time was extended in an oxygen-deficient environment.
{Circle around (6)} It was confirmed that the health supplement of the present invention has a certain improvement effect on arrhythmia.
(7) It was confirmed that the health supplement of the present invention enhances the immunity of the body tissue by increasing the plasma SOD activity and at the same time increases the brain tissue ATP activity and has the ability to protect the brain tissue.
{Circle around (8)} It was confirmed that the health supplement of the present invention has some recovery ability although it is not remarkable for learning ability disorder due to central inhibitors.
Furthermore, from the results of the melatonin test that monitors the sleep state, when eating the “sleeping health food” according to the present invention, there are individual differences in how to eat it, but each person has a deeper sleep state than usual. It was proved that.
[0041]
From the measurement of melatonin secretion when taking the dietary supplement of the present invention, it has been proved that although there are individual differences in how to use it, all people are deeply asleep. It was also found that there was no daytime hypnotic effect.
From the measurement of secreted amounts of ACTH and adrenaline when the health supplement of the present invention was taken, it was found that there was no hypnotic effect of becoming sleepy by taking this health food during the day, and there was some arousal action.
In summary, the results of endocrine secretions are considered to mean that “sleeping health foods” do not simply promote sleep action, but are thought to have the effect of adjusting the sleep-wake rhythm of living bodies. Sleeping drugs such as benzodiazepines often cause addiction if taken for a long time, but this `` sleeping health food '' adjusts the biological rhythm, so it does not adversely affect secreted hormones and side effects are also dependent There are no worries.
[Brief description of the drawings]
FIG. 1 shows observation results for menopause, neurosis, and cerebral arteriosclerosis. A shows data in a table, B shows a bar graph, and C shows a comprehensive result in a pie chart. It is.
[Fig. 2] The upper graph shows the test results for the symptoms, the lower graph is the band graph, A is the sleep time, B is the frequency of dreaming, and C is the decline in physical fitness.
FIG. 3 is a table showing the test results for the symptoms in the upper row, and the lower row is shown in a band graph, where A is the frequency of feeling an illusion and B is the frequency of feeling lonely.
FIG. 4 is a table showing the results of pharmacological experiments in the upper row, and the lower row is shown in a bar graph. A is a comparison between mice administered with this dietary supplement and mice not administered, and B is administered with this dietary supplement. The motion observation when the stimulant is administered to the mouse, C shows the motion observation result when the anesthetic is administered to the mouse administered with the health supplement.
FIG. 5 is a table showing the results of pharmacological experiments in the upper row, and the lower row is shown in a bar graph. A shows the sleep action when an anesthetic is injected below the threshold in mice administered with this dietary supplement, and B shows Sleep observation when a hypnotic effect dose of an anesthetic is administered to a mouse administered a health supplement, C is a survival comparison result between a mouse administered this health supplement and a non-administered mouse in an oxygen-deficient environment. It is shown.
FIG. 6 is a table showing the results of pharmacological experiments in the upper row, and the lower row is shown in a bar graph, where A is an effect on induction of arrhythmia, B is an effect on plasma SOD and brain tissue ATP activity in aged weak rats, and C Indicates the result of the effect of the action on learning ability.
FIG. 7 is a graph showing the results of melatonin secretion measurement for monitoring the depth of sleep.
FIG. 8 is a graph showing the results of measuring the secretion amount of ACTH and adrenaline for monitoring wakefulness.
Claims (4)
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