JP2010513250A - 組成物およびその使用 - Google Patents
組成物およびその使用 Download PDFInfo
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- JP2010513250A JP2010513250A JP2009540783A JP2009540783A JP2010513250A JP 2010513250 A JP2010513250 A JP 2010513250A JP 2009540783 A JP2009540783 A JP 2009540783A JP 2009540783 A JP2009540783 A JP 2009540783A JP 2010513250 A JP2010513250 A JP 2010513250A
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Abstract
Description
高血糖は様々な疾患状態に関連する状態である。症状として高血糖を伴う最も顕著な疾患状態の1つが糖尿病である。糖尿病は継続的な高血糖値から始まる全身疾患である。健常人は、典型的には、ホルモンのインシュリンによって血糖値を制御し、空腹状態で血糖値を約80〜約100mg/dlに保っている。糖尿病患者では、血糖値は125mg/dlを超えることがある。
ビタミンC、グルタミン酸および/またはグルタミン、システイン、リボフラビン、コハク酸、フマル酸、コエンザイムQ10、ならびにナイアシンを含む組成物を投与すると血糖値が下がることが発見された。この発見は本発明を開発するのに利用された。本発明は、少なくとも部分的には、高血糖および/もしくは高血糖関連疾患、例えば、糖尿病を治療するための組成物、高血糖および/もしくは高血糖関連疾患を予防するための組成物、または高血糖および/もしくは高血糖関連疾患の症状の発症を遅延するための組成物、ならびに高血糖および/もしくは高血糖関連疾患を治療する方法、高血糖および/もしくは高血糖関連疾患を予防する方法、または高血糖および/もしくは高血糖関連疾患の症状の発症を遅延する方法に関する。
本明細書で使用する「高血糖」という用語は、被験体における基底値と比較して高い血糖値を意味する。本明細書で使用する「基底値」は、空腹時の正常被験体の血糖値を意味する。一般的に、高血糖は約100mg/dlを超える血糖値を指す。特に、高血糖は、空腹時に約110mg/dlを超え、食事をして2時間後に約140mg/dlを超える血糖値を指す。
本発明は、例えば、補助食品(例えば、健康補助食品もしくは栄養補助食品)または医薬であり得る組成物、高血糖または高血糖関連疾患を有する被験体を本明細書に記載の組成物で治療する方法、ならびにこのような組成物を投与することによって被験体における高血糖および/または高血糖関連疾患を治療および/または予防する方法を特徴とする。本明細書に記載のように、組成物は、グルタミン酸、グルタミン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;システイン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;リボフラビン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;コハク酸、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;フマル酸、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;ナイアシン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;コエンザイムQ10、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;および、任意で、ビタミンC、そのプロドラッグ、またはその塩のうちの1つまたは複数のものを含んでもよい。
本明細書に記載の組成物は補助食品でもよく、食べ物または飲み物、例えば、炭水化物含有量が多い食べ物または飲み物を摂取する前、摂取すると同時に、または摂取した後に摂取することができる。補助食品は様々な配合物として存在することができる。
本明細書に記載の組成物は、薬学的組成物として、例えば、固体または液体の薬学的に許容される適切な担体、賦形剤、または希釈剤と共に製剤化することができる。このような薬学的に許容される担体、賦形剤、および希釈剤は従来のものであり、当業者に公知である(例えば、Harrison's Principles of Internal Medicine, 14th Edition, McGraw-Hill, 1998を参照されたい)。担体の一例は生理食塩水のビヒクルであるが、生理学的濃度の他の無毒の塩、滅菌水などの他の薬学的に許容される担体も使用できることが意図される。場合によっては、適切な緩衝液を使用することが望ましい。
本明細書に記載の組成物は、当業者に公知の様々なやり方でヒトまたは他の動物に投与することができ、例えば、経口投与、静脈内投与、腹腔内投与、およびくも膜下腔内投与することができる(例えば、Harrison's Principles of Internal Medicine, 14th Edition、McGraw-Hill, 1998を参照されたい)。経口投与の場合、薬学的組成物は、補助食品について前述したように製剤化することができる。特定の投与形式および投与計画は、主治医が症例の詳細(例えば、関与する被験体および疾患状態)を考慮することによって選択することができる。
場合によっては、本明細書に記載の薬学的組成物は、第2の薬学的組成物または別の治療方法と併用して投与することができる。糖尿病治療の場合、第2の薬学的組成物または治療方法は、例えば、グルコース吸収阻害剤(例えば、αグルコシダーゼ阻害剤)、肝臓におけるグルコース生成の阻害剤(例えば、ビグアニド)、インシュリン感受性を改善する薬物(例えば、チアゾリジン誘導体)、ならびに/またはインシュリン分泌刺激剤(例えば、スルホニル尿素および/もしくはテナグリニド)を投与することを含んでもよい。好ましくは、薬学的組成物はまた、糖尿病食、例えば、本明細書に記載の糖尿病食、または高血糖を低下もしくは予防するための他の食事療法とも適合する。この併用投与は、組成物がビタミンCを含まない場合に特に好ましい。この態様において、医用薬剤は、例えば、血糖値に影響を及ぼすが、血中インシュリン濃度には影響を及ぼさない、または不十分にしか影響を及ぼさない、さらなる薬学的組成物または治療方法と併用することができる。
本明細書に記載の組成物は、一般的には、被験体の高血糖値および/または高い血中インシュリン濃度を下げるために、特に、高血糖および高血糖関連疾患状態、例えば、糖尿病、例えば、I型糖尿病および/またはII型糖尿病、ステロイド糖尿病(クッシング病)、妊娠糖尿病、および他の疾患状態(例えば、膵炎、肥満)によって誘発される二次性糖尿病;バセドー病、先端肥大症、急性心臓発作、副腎機能亢進、褐色細胞腫、吸入麻酔、ショック、一酸化炭素中毒、中枢神経系障害(例えば、髄膜炎、頭蓋脳損傷、および脳腫瘍)、ならびに新生児における特発性高血糖を予防および/または治療するために、ならびに体内のグルコース代謝を適度にすることによって前述の疾患の発症のリスクを下げるか、または前述の疾患の進行を遅らせるために被験体に投与することができる。
本明細書に記載の組成物は、年齢または性別に関係なく、本明細書に記載の組成物を必要とする任意の種類の被験体、例えば、ヒトまたは非ヒト動物に投与することができる。獣医学では、例えば、ネコ、イヌ、鳥類、ウシ、ウマ、げっ歯類などを治療することができる。
実施例1:補助食品およびボランティア
1グラムのビタミンC、1.5グラムのグルタミン酸、500mgのシステイン、40mgのリボフラビン、100mgのコハク酸、100mgのフマル酸、および10mgのナイアシン、および250mgのAQUAQ10P40(100mgのコエンザイムQ10)を混合することによって、補助食品を調製した。コエンザイムQ10を除く補助食品の全成分をSigma Aldrich Japan(Tokyo, Japan)から購入した。AQUAQ10P40(Nissin Pharma, Tokyo Japan)は40体積%のコエンザイムQ10を含有し、コエンザイムQ10として使用した。グルタミン酸およびグルタミンの効果を比較する実験では、グルタミン酸の代わりとしてグルタミンを補助食品において同様に使用した。ボランティアには、経口糖負荷試験を開始する20分前に補助食品を水100mlと共に服用させた。
スナックパン試験のために、ボランティア1人につきアズキペーストの付いたパンを1枚、甘いクリームの付いたパンを1枚使用した。2枚のパンの全栄養成分は、カロリー:780Kcal、タンパク質:20グラム、脂肪:18グラム、炭水化物:130グラムであった。各ボランティアは2枚のスナックパンを10分以内に食べ、血液サンプリングを実施例1に記載したものと同じ時点で行った。結果の統計解析はt2検定によって行い、p<0.5を有意水準と定義した。スナックパン実験における血糖値および血中インシュリン濃度に及ぼす補助食品の効果を、それぞれ、図3および図4に示した(IRI:免疫反応性インシュリン)。実施例1のOGTT結果と一致して、補助食品は、より複雑な食べ物が摂取された時に、同じ有利な効果をボランティアにもたらした。すなわち、血糖ピークは低下し、血糖は血液から早期に除去され、グルコースクリアランスには少量のインシュリンしか必要とされなかった。
L-グルタミン酸またはL-グルタミンが補助食品に用いられた場合に、OGTTグルコース分解に及ぼす効果に差があるかどうか調べるために、一部の試験ではL-グルタミン酸の代わりにL-グルタミンを補助食品に使用した。これらのグルタミン混合実験でも、血糖およびIRIをモニタリングした。結果の統計解析はt2検定によって行い、p<0.5を有意水準と定義した。
補助食品が、低すぎる血糖値(低血糖)の原因となり得るかどうか評価するために、空腹状態のボランティアに、追加の食べ物も飲み物も与えず補助食品を服用させた。OGTTの血液サンプリングと同じ時点で、血糖およびIRIをモニタリングした。
カニクイザルを非投与群または実施例1に記載の補助食品を投与した群の2つに分けて、経口糖負荷試験(OGTT)を行った。1群あたり3匹の動物を用いた。100mg補助食品/kg体重を水10mlに溶解し、経口胃挿管を介して10分間投与した後に、胃挿管を介してグルコース溶液(100mg/kg体重)も与えた。血液試料を、グルコース溶液を与えて0分後、30分後、60分後、90分後、120分後、150分後、および180分後に集め、グルコース濃度およびインシュリン濃度を求めた。
補助食品におけるビタミンCの役割およびOGTTの結果に及ぼすそれの効果を調べるために、ヒト健常ボランティアのうちの3人に対して実験を行った。実験は、投与される補助食品の中に様々な量/濃度のビタミンCを用いたOGTTとして行った。初回の実験において、ボランティアには、4.0gのビタミンCをさらに添加した実施例1に記載の補助食品(総ビタミンCは5.0gであった)を与えた。後の実験では、同じボランティアに、ビタミンCを含まない実施例1に記載の補助食品を与えた。ボランティアには、D-グルコース溶液を飲む20分前に補助食品を摂取させた。血糖値およびIRI値を、D-グルコース溶液を飲んで0分後、30分後、60分後、90分後、および120分後にモニタリングした。結果を、それぞれ、図10および図11に示した(対照:補助食品を前投与のないOGTT;補助食品:補助食品の前投与のあるOGTT;補助食品-ビタミンC:ビタミンCを含まない補助食品の前投与のあるOGTT;補助食品+ビタミンC 4g:ビタミンC含有量を増やした補助食品(1g+4g=5g)の前投与のあるOGTT)。結果を実施例1のデータと比較した。結果の統計解析はt2検定によって行い、p<0.5を有意水準と定義した。
Claims (27)
- (a)グルタミン酸、グルタミン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;
(b)システイン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;
(c)リボフラビン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;
(d)コハク酸、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;
(e)フマル酸、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;
(f)ナイアシン、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;
(g)コエンザイムQ10、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの;および、任意で、
(h)ビタミンC、そのプロドラッグ、またはその塩のうちの1つまたは複数のもの
を含む、組成物。 - (a)、(b)、(c)、(d)、(e)、(f)、(g)、および任意で(h)からなる、請求項1記載の組成物。
- グルコースを含まない、請求項1または2記載の組成物。
- (h)を含まない、請求項1〜3のいずれか一項記載の組成物。
- (a)〜(g)および任意で(h)を含む組成物であって、
(a)が約0.1g〜約10gのグルタミン酸、グルタミン、またはグルタミン酸およびグルタミンの組み合わせを含み;
(b)が約0.1g〜約10gのシステインを含み;
(c)が約0.01g〜約1gのリボフラビンを含み;
(d)が約0.01g〜約1gのコハク酸を含み;
(e)が約0.01g〜約1gのフマル酸を含み;
(f)が約1mg〜約30mgのナイアシンを含み;
(g)が約0.01g〜約1gのコエンザイムQ10を含み;かつ
(h)が約0.1g〜約10gのビタミンCを含む、
請求項1〜4のいずれか一項記載の組成物。 - (a)〜(g)および任意で(h)からなる組成物であって、
(a)が約0.1g〜約10gのグルタミン酸、グルタミン、またはグルタミン酸およびグルタミンの組み合わせを含み;
(b)が約0.1g〜約10gのシステインを含み;
(c)が約0.01g〜約1gのリボフラビンを含み;
(d)が約0.01g〜約1gのコハク酸を含み;
(e)が約0.01g〜約1gのフマル酸を含み;
(f)が約1mg〜約30mgのナイアシンを含み;
(g)が約0.01g〜約1gのコエンザイムQ10を含み;かつ
(h)が約0.1g〜約10gのビタミンCを含む、
請求項1〜5のいずれか一項記載の組成物。 - (a)が約1.5gのグルタミン酸、グルタミン、またはグルタミン酸およびグルタミンの組み合わせを含む、請求項1〜6のいずれか一項記載の組成物。
- (b)が約0.5gのシステインを含む、請求項1〜7のいずれか一項記載の組成物。
- (c)が約0.04gのリボフラビンを含む、請求項1〜8のいずれか一項記載の組成物。
- (d)が約0.1gのコハク酸を含む、請求項1〜9のいずれか一項記載の組成物。
- (e)が約0.1gのフマル酸を含む、請求項1〜10のいずれか一項記載の組成物。
- (f)が約0.01gのナイアシンを含む、請求項1〜11のいずれか一項記載の組成物。
- (g)が約0.25gのコエンザイムQ10を含む、請求項1〜12のいずれか一項記載の組成物。
- (h)が約1gのビタミンCを含む、請求項1〜13のいずれか一項記載の組成物。
- 錠剤形態、カプセル形態、散剤形態、または液体形態である、請求項1〜14のいずれか一項記載の組成物。
- 請求項1〜15のいずれか一項記載の組成物を含む、栄養補助食品。
- 請求項1〜15のいずれか一項記載の組成物を含む、薬学的組成物。
- 治療的有効量の請求項1〜15のいずれか一項記載の組成物を被験体に投与し、それによって高血糖を治療または予防する工程を含む、高血糖の治療または予防を必要とする被験体において高血糖を治療または予防する方法。
- 治療的有効量の請求項1〜15のいずれか一項記載の組成物を被験体に投与し、それによって高血糖関連疾患を治療または予防する工程を含む、高血糖関連疾患の治療または予防を必要とする被験体において高血糖関連疾患を治療または予防する方法。
- 高血糖関連疾患が、I型糖尿病、II型糖尿病、ステロイド糖尿病、妊娠糖尿病、二次性糖尿病、バセドー病、先端肥大症、急性心臓発作、副腎機能亢進、褐色細胞腫、吸入麻酔、ショック、一酸化炭素中毒、髄膜炎、頭蓋脳損傷、脳腫瘍、特発性高血糖、空腹時血糖異常(IFG)、または耐糖能障害(IGT)である、請求項19記載の方法。
- インシュリン療法と併用して請求項1〜15のいずれか一項記載の組成物を被験体に投与し、それによって被験体における糖尿病を治療する工程を含む、被験体における糖尿病を治療する方法。
- 請求項1〜15のいずれか一項記載の組成物を、糖尿病を発症するリスクのある被験体に投与し、それによって被験体における糖尿病の症状の発症を阻止または遅延する工程を含む、被験体における糖尿病の症状の発症を阻止または遅延する方法。
- 糖尿病を発症するリスクのある被験体を特定し、被験体に請求項1〜15のいずれか一項記載の組成物を投与し、それによって被験体における糖尿病の症状の発症を阻止または遅延する工程を含む、被験体における糖尿病の症状の発症を阻止または遅延する方法。
- 糖尿病を発症するリスクのある被験体を特定し、被験体に請求項1〜15のいずれか一項記載の組成物を投与し、それによって被験体における糖尿病の症状の発症を阻止または遅延する工程を含む、被験体における糖尿病の症状の発症を阻止または遅延する方法。
- 人間医学および獣医学において使用するための請求項1〜15のいずれか一項記載の組成物。
- 高血糖および高血糖関連疾患状態、特に、I型糖尿病、II型糖尿病、ステロイド糖尿病、妊娠糖尿病、二次性糖尿病、バセドー病、先端肥大症、急性心臓発作、副腎機能亢進、褐色細胞腫、吸入麻酔、ショック、一酸化炭素中毒、髄膜炎、頭蓋脳損傷、脳腫瘍、特発性高血糖、空腹時血糖異常(IFG)および/または耐糖能障害(IGT)を治療または予防するための医薬を製造するための、請求項1〜15のいずれか一項記載の組成物の使用。
- インシュリンと併用して投与するために製剤が製剤化される、請求項26記載の方法。
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JP2014533295A (ja) * | 2011-11-15 | 2014-12-11 | ティーマ ファウンデーション | 細胞傷害作用からの防御のための組成物 |
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US9301938B2 (en) | 2009-09-23 | 2016-04-05 | Biokier, Inc. | Composition and method for treatment of diabetes |
WO2012095509A1 (en) * | 2011-01-14 | 2012-07-19 | Tima Foundation | Composition for accelerating alcohol metabolism and for reducing the risk of alcohol induced diseases |
EP2594141A1 (en) * | 2011-11-15 | 2013-05-22 | TIMA Foundation | Composition for protection against cell-damaging effects |
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EP3177278A1 (en) * | 2014-08-08 | 2017-06-14 | Nestec S.A. | Vitamin b2 and its use |
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- 2007-12-14 EA EA200900835A patent/EA016926B1/ru not_active IP Right Cessation
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- 2007-12-14 WO PCT/EP2007/063970 patent/WO2008071790A2/en active Application Filing
- 2007-12-14 EP EP07857604.8A patent/EP2117596B1/en active Active
- 2007-12-14 KR KR1020097014206A patent/KR101487852B1/ko active IP Right Grant
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2014533295A (ja) * | 2011-11-15 | 2014-12-11 | ティーマ ファウンデーション | 細胞傷害作用からの防御のための組成物 |
Also Published As
Publication number | Publication date |
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WO2008071790A3 (en) | 2008-10-09 |
CA2673054C (en) | 2016-05-10 |
EP2117596B1 (en) | 2018-01-03 |
CA2673054A1 (en) | 2008-06-19 |
AU2007331447B2 (en) | 2012-09-06 |
JP2014132017A (ja) | 2014-07-17 |
KR20090100385A (ko) | 2009-09-23 |
JP5580050B2 (ja) | 2014-08-27 |
EA200900835A1 (ru) | 2009-12-30 |
KR101487852B1 (ko) | 2015-01-29 |
EP2117596A2 (en) | 2009-11-18 |
AU2007331447A1 (en) | 2008-06-19 |
EA016926B1 (ru) | 2012-08-30 |
WO2008071790A2 (en) | 2008-06-19 |
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