JP2021517591A - α−ラクトアルブミンに基づく医薬品または食品サプリメントの調製物 - Google Patents
α−ラクトアルブミンに基づく医薬品または食品サプリメントの調製物 Download PDFInfo
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- JP2021517591A JP2021517591A JP2020572617A JP2020572617A JP2021517591A JP 2021517591 A JP2021517591 A JP 2021517591A JP 2020572617 A JP2020572617 A JP 2020572617A JP 2020572617 A JP2020572617 A JP 2020572617A JP 2021517591 A JP2021517591 A JP 2021517591A
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Abstract
Description
セロトニンは、必須アミノ酸であるトリプトファンから合成され、いくつかの生物学的機能に寄与する胃腸菅の腸クロム親和性細胞によって、および中枢神経系のセロトニン作動性ニューロンによって主に生成されるトリプタミンである。
抹消レベルおよび中枢神経系の両方において、血漿セロトニンは血液脳関門を超えることができない一方、トリプトファンは、トリプトファンが属する、全ての「L型アミノ酸(Large Neutral Amino Acids)」(LNAAs)で共有されるアクティブトランスポーターのおかげで血液脳関門を通りぬけることができるため、セロトニンは、必須アミノ酸であるトリプトファンから合成される。この脳内取り込みに関する競合は、脳内セロトニンの合成の速度としてもたらされ、これは、アミノ酸とその全ての競合相手の合計とのあいだの血漿中比(Trp/LNAAs)によって影響を受ける、トリプトファン取り込みの量に依存している[14]。これを基に、てんかんの患者群における血漿Trp/LNAAs比の測定から、脳内セロトニンの合成の速度の、健康体のコントロールと比較して1/3の低下が見積もられた。
トリプトファンの口腔投与は、Trp/LNAAs比の血漿中での増加をもたらさず、単一のアミノ酸の低い生物学的利用能を示した。血漿中の必須アミノ酸は、食事性タンパク質の解体からのみ由来する[16]。
(α−ラクトアルブミンからのその遊離の結果として生じるTRPの増加という仮説から得られる)期待に反して、実験的および臨床的研究の両方において得られた結果は、血漿トリプトファン/LNAAs比の増加が、α−ラクトアルブミンの解体に由来するトリプトファンに起因しないことを示している。実際に、迅速な吸収があれば、投与から約20〜30分内での迅速な基底値への戻りを伴う、α−ラクトアルブミンを構成するアミノ酸の迅速な血漿ピークが観察されるべきである。
一方、α−ラクトアルブミンは、ヒト初乳、そしてヒト初乳だけの中に多く発現しており、そこで初乳は、消化システムにおいて特別な役割を果たし、最初の授乳とともにそれは活性化されやすくなる。
これらの観察から、消化管全体におけるα−ラクトアルブミンの特異的な作用は、ホエイプロテインそのものによってではなく、胃の中でのその迅速な解体に由来するペプチド画分によって産生されていることは明確であるようである。これに対するさらなる証拠として、α−ラクトアルブミンが初乳と共に摂取される場合、新生児は、彼/彼女の胃がまだそれをすることができないために、それを消化するための特別な唾液酵素を産生することが留意されるべきである。消化システムは、実際、子宮内生活のあいだに形成されており、最初の授乳以前には働いていない。α−ラクトアルブミンの唾液消化は、食物を処理する、および消化菅組織を保護するために必要な全てのものの産生を刺激する、ヒトの、およびヒトのみの消化システムを活性化するという責務を背負っている特異的なペプチドを産生する。いったん消化システムが活性化されると、新生児は唾液の特別な酵素の産生を停止し、そして、消化機能が胃へと移され、それは、離乳のあいだに、徐々に他の、より複合食品を処理する方法を習得する。
食品サプリメントとしてのα−ラクトアルブミンの使用に関する出願人の経験は、それが驚くべきことに、例えばその細胞が栄養の質と量が不十分であるためなどで非常に弱い消化システムをもつ被験者において作用することが困難であることを示していた。この観察は、しばしば複合食品を処理することができないことによってまさに引き起こされる、長期にわたる不足した食事を経験した被験者において特に顕著であった。この種の食事は、消化システムを弱らせ、これは食物を処理することにますます弱くなり、そしてそれゆえ、許容されない食品の種類の累進的な増加をもたらす。
精製ウシ由来α−ラクトアルブミン 500mg
β−ヒドロキシ−β−メチル酪酸 500mg
マンニトール 50mg
香料 10mg
精製ウシ由来α−ラクトアルブミン 800mg
トリブチリン 300mg
無水バター 800mg
マルトデキストリン 90mg
香料 10mg
酪酸ナトリウムの顆粒の分包品
酪酸ナトリウム 300.0mg
水素化されたパーム油 1500mg
炭酸カルシウム 200mg
マルトデキストリン 90mg
香料 10mg
精製ウシ由来α−ラクトアルブミン 500mg
フラクトース 200mg
香料 10mg
α−ラクトアルブミンと酪酸ナトリウムとからなる本発明の調製物の抗痙攣作用が、痙攣誘発剤ペンチレンテトラゾールを用いて上述の動物モデルにおいて、α−ラクトアルブミンおよび酪酸ナトリウムの単一成分の物との比較により評価された。
Claims (20)
- 中枢神経系(CNS)の障害の処置における使用のための、α−ラクトアルブミンと、酢酸、プロピオン酸、酪酸、β−ヒドロキシ−β−メチル酪酸、吉草酸、ならびにそれらの塩、エステル、および、モノ−、ジ−、およびトリ−グリセリドからなる群より選択される少なくとも一つの短鎖脂肪酸またはその前駆体またはその誘導体とを含む医薬品または食品サプリメントの調製物。
- 前記CNS障害が、セロトニン不全に関連したCNS障害である請求項1記載の使用のための医薬品または食品サプリメントの調製物。
- 前記セロトニン不全に関連したCNS障害が、てんかん、パーキンソン病およびハンチントン病不随意運動である精神神経性障害、うつ病、不安神経症、ドーパミン様作用神経病、情緒不安定、強迫性障害、不眠症、および頭痛を含む群のあいだから選択される請求項2記載の使用のための医薬品または食品サプリメントの調製物。
- 前記少なくとも一つの短鎖脂肪酸またはその前駆体またはその誘導体が、薬学的または食品の見地から許容可能な担体とともに、少なくとも一つの第1の用量ユニット中に含まれ、そして、前記α−ラクトアルブミンは、薬学的または食品の見地から許容可能な担体とともに、少なくとも一つの第2の用量ユニット中に含まれ、前記用量ユニットが、同時のまたは別の投与を意図されている別個のユニットである請求項1〜3のいずれか1項に記載の使用のための医薬品または食品サプリメントの調製物。
- 医薬品または食品サプリメントの調製物が、前記少なくとも一つの短鎖脂肪酸またはその前駆体またはその誘導体と前記α−ラクトアルブミンとを、薬学的または食品の見地から許容可能な担体とともに含む医薬品または食品サプリメントの組成物からなる請求項1〜3のいずれか1項に記載の使用のための医薬品または食品サプリメントの調製物。
- 前記α−ラクトアルブミンが、0.1〜2.0g、より好ましくは0.3〜1.0gの範囲の量で含まれる請求項4記載の調製物。
- 前記α−ラクトアルブミンが、0.1〜2.0g、より好ましくは0.3〜1.0gの範囲の量で含まれる請求項5記載の調製物。
- 前記少なくとも一つの第2の用量ユニットが、マグネシウムおよび/またはビタミンB群をさらに含む請求項4または6記載の調製物。
- 前記医薬品または食品サプリメントの組成物が、マグネシウムおよび/またはビタミンB群をさらに含む請求項5または7記載の調製物。
- 口腔投与に適していることを特徴とする請求項1〜9のいずれか1項に記載の調製物。
- 前記医薬品または食品サプリメントの組成物が、タブレット、シロップ、カプセル、フィルム被膜タブレット、または粉末もしくは顆粒の分包品の形状である請求項5、7または9記載の調製物。
- 前記少なくとも一つの第1および少なくとも一つの第2の用量ユニットが、独立して、タブレット、カプセル、フィルム被膜タブレット、または粉末もしくは顆粒の分包品の形状である請求項4、6または8記載の調製物。
- 前記少なくとも一つの短鎖脂肪酸またはその前駆体またはその誘導体が、酪酸およびβ−ヒドロキシ−β−メチル酪酸およびそれらのアルカリまたはアルカリ土類塩およびそれらのグリセロールとのエステルからなる群のあいだから、好ましくは、酪酸ナトリウム、グリセリルトリブチラート、モノ酪酸グリセロール、炭水化物の酪酸エステルおよび炭水化物ポリオールから選択される請求項1〜12のいずれか1項に記載の調製物。
- 前記少なくとも一つの短鎖脂肪酸またはその前駆体またはその誘導体が、0.1〜5.0g、好ましくは0.2〜1.0gの範囲の量で含まれる請求項13記載の調製物。
- CNSの障害の処置における、酢酸、プロピオン酸、酪酸、β−ヒドロキシ−β−メチル酪酸、吉草酸、ならびにそれらの塩、エステル、および、モノ−、ジ−、およびトリ−グリセリドからなる群より選択される少なくとも一つの短鎖脂肪酸またはその前駆体またはその誘導体を伴った使用のためのα−ラクトアルブミン。
- 前記CNS障害が、セロトニン不全に関連している請求項15記載の使用のためのα−ラクトアルブミン。
- 前記セロトニン不全に関連しているCNS障害が、てんかん、パーキンソン病およびハンチントン病不随意運動である精神神経性障害、うつ病、不安神経症、ドーパミン様作用神経病、情緒不安定、強迫性障害、不眠症、および頭痛を含む群のあいだから選択される請求項16記載の使用のためのα−ラクトアルブミン。
- 薬学的または食品の見地から許容可能な担体とともに、酢酸、プロピオン酸、酪酸、β−ヒドロキシ−β−メチル酪酸、吉草酸、ならびにそれらの塩、エステル、および、モノ−、ジ−、およびトリ−グリセリドからなる群より選択される少なくとも一つの短鎖脂肪酸またはその前駆体またはその誘導体を含む少なくとも一つの第1の用量ユニットと、薬学的または食品の見地から許容可能な担体とともに、α−ラクトアルブミンを含む少なくとも一つの第2の用量ユニットと、上述の障害の処置において前記少なくとも一つの第1および少なくとも一つの第2の用量ユニットの同時使用のための指示書とを含む、CNS障害の処置における使用のためのキット。
- 前記CNS障害が、セロトニン不全に関連している請求項18記載の使用のためのキット。
- 前記セロトニン不全に関連したCNS障害が、てんかん、パーキンソン病およびハンチントン病不随意運動である精神神経性障害、うつ病、不安神経症、ドーパミン様作用神経病、情緒不安定、強迫性障害、不眠症、および頭痛からなる群のあいだから選択される請求項19記載の使用のためのキット。
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