JP2006519867A - 治療用組成物 - Google Patents
治療用組成物 Download PDFInfo
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- JP2006519867A JP2006519867A JP2006509057A JP2006509057A JP2006519867A JP 2006519867 A JP2006519867 A JP 2006519867A JP 2006509057 A JP2006509057 A JP 2006509057A JP 2006509057 A JP2006509057 A JP 2006509057A JP 2006519867 A JP2006519867 A JP 2006519867A
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- water
- oral composition
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- polysaccharide
- diabetes
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Abstract
Description
本願は、2002年11月12日に出願された同時係属の米国特許出願10/292,831号の一部継続出願である。
本発明は、ギムネマ・シルベスタ(Gymnema sylvestre)の葉から得られた比較的高分子量(HMW)の単離物を提供する。本発明は、水溶性の多糖、好ましくは、グアーガムとともに、前記単離物と、非代謝性、水膨潤性の多糖(好ましくは、ステルキュリア・ウレンス(Sterculia urens)の浸出物)とを、それぞれ、好ましくは5:1から約1:5、より好ましくは約2:1から約1:2の範囲の重量比で、含有する治療用剤形も包含する。上記単離物は、ギムネマ・シルベスタの葉のエタノール抽出の後、インシュリン分泌活性成分を抽出物から単離することによって取得することができる。単離されたインシュリン分泌活性成分は、分子量カットオフ濾過に基づくと、少なくとも約3000ダルトンの分子サイズを有する高分子量画分である。
投薬スケジュール
患者の診断 投薬スケジュール*
高インシュリン血症 1−2カプセル b.i.d.
II型糖尿病(軽症) 2カプセル b.i.d.
II型糖尿病(重症) 2−3カプセル t.i.d.
I型糖尿病(軽症) 1カプセル b.i.d.
インシュリンを補助療法と用いたI型糖尿病(重症) 2カプセル t.i.d.
*b.i.d=1日2回、t.i.d.=1日3回
ギムネマ・シルベスタの新鮮な葉を購入し、植物学者によって確認された。新鮮な葉を、周温で、水道水中に、約18時間浸漬した(約1kgの葉/4Lの水道水)。エチルアルコール水溶液(約90容量パーセントのエタノール)を、十分な量、これに加えて、総アルコールパーセントレベルを約40重量%とし、バッチ全体を10個の三角フラスコ中に、攪拌しながら分配した。フラスコを振盪台の上に置き、約4時間、振盪した。
Linco Research, Inc., St. Louis, MOから購入したRIAキット(カタログNo.RI−13K)を使用し、ラットのインスリノーマ(RIN−58)細胞、I−125標識インシュリン、ラットインシュリン抗血清、及び「Morgan et al., Diabetes 12:115−126(1963)」の二重抗体技術を用いたラジオイムノアッセイ(RIA)によって、実施例1の得られた浸透物及び保持物のインシュリン放出活性を調べた。主な活性は、少なくとも約3000ダルトンのMWCOを有する保持物中に見出された。
インシュリン放出活性のバイオアッセイ
画分 活性
保持物(MW≧3000ダルトン) 9.5ng/mL
浸透物(MW<3000ダルトン) 2.35ng/mL
水に分散させるドリンクとして使用するのに適した経口組成物が、下表3に示されている。
凍結乾燥されたG.シルベスタの画分* 1グラム
S.ウレンスの浸出物 2.5グラム
グアーガム 2.5グラム
クエン酸カルシウム 500ミリグラム
ニコチン酸クロム 120マイクログラム
ナイアシン(ニコチン酸) 120マイクログラム
*分子量≧3000ダルトン
水に分散させるドリンクとして使用するのに適した経口組成物が、下表4に示されている。
凍結乾燥されたG.シルベスタの画分* 0.5グラム
S.ウレンスの浸出物 2.5グラム
グアーガム 2.5グラム
クエン酸カルシウム 500ミリグラム
ニコチン酸クロム 60マイクログラム
ナイアシン(ニコチン酸) 60マイクログラム
*分子量≧3000ダルトン
水に分散させる栄養ドリンクとして使用するのに適しており、表記の用量の抗酸化剤、アミノ酸、ミネラル及び酵素を含有する組成物が下表5に記載されている。
抗酸化剤を加えたドリンクミックス粉末
凍結乾燥されたG.シルベスタの画分* 1グラム
S.ウレンスの浸出物 2.5グラム
グアーガム 2.5グラム
クエン酸カルシウム 500ミリグラム
ニコチン酸クロム 60−200マイクログラム
ナイアシン(ニコチン酸) 60−120ミリグラム
コエンザイムQ10 50−100ミリグラム
松の樹皮の抽出物 10−20ミリグラム
イノシトール 50ミリグラム
L−プロリン 150ミリグラム
L−リジン・HCl 150ミリグラム
L−アルギニン・HCl 50ミリグラム
L−システイン・HCl 50ミリグラム
L−カルニチン酒石酸塩 50ミリグラム
パントテン酸 50ミリグラム
ビオチン 100マイクログラム
葉酸 150マイクログラム
リン(リン酸ナトリウムとして) 50ミリグラム
鉄(グルコン酸第一鉄として) 18ミリグラム
マグネシウム(塩化マグネシウムとして) 80ミリグラム
亜鉛(塩化亜鉛として) 10ミリグラム
セレン(亜セレン酸ナトリウムとして) 50−200マイクログラム
銅(グルコン酸銅として) 1ミリグラム
マンガン(クエン酸マンガンとして) 2ミリグラム
モリブデン(モリブデン酸アンモニウムとして) 10マイクログラム
カリウム(塩化カリウムとして) 50ミリグラム
ビタミンA(β−カロテン) 5,000I.U.
ビタミンC(アスコルビン酸) 50ミリグラム
ビタミンE(d−α−トコフェロール) 400I.U.
ビタミンB1(チアミン) 10ミリグラム
ビタミンB2(リボフラビン) 10ミリグラム
ビタミンB6(ピリドキシン・HCl) 15ミリグラム
ビタミンB12(シアノコバラミン) 50ミリグラム
ビタミンD 400ミリグラム
*分子量≧3000ダルトン
抗酸化剤の増強
コエンザイムQ10 50ミリグラム
リコピン 1−5ミリグラム
ルテイン 1−3ミリグラム
シリコン(ケイ酸として) 2ミリグラム
バナジウム(硫酸バナジルとして) 10マイクログラム
ニッケル(硫酸ニッケルとして) 5マイクログラム
ホウ素(ホウ酸として) 150−1000マイクログラム
*分子量≧3000ダルトン
糖尿病及び肥満の治療に非常に適したドリンクミックス粉末が、下表6に記されている。
凍結乾燥されたG.シルベスタの画分* 2グラム
S.ウレンスの浸出物 3.5グラム
グアーガム 2.5グラム
コミフォラ・ムクル 100ミリグラム
クエン酸カルシウム 500ミリグラム
ニコチン酸クロム 120マイクログラム
ナイアシン(ニコチン酸) 150ミリグラム
*分子量≧3000ダルトン
Claims (23)
- 分子量カットオフ濾過によって測定された場合に少なくとも約3000ダルトンの分子量を有する、ギムネマ・シルベスタ(Gymnema sylvestre)の葉から得られる凍結乾燥されたエタノール抽出物と、
非代謝性、水膨潤性の多糖と、および
水溶性多糖とを含み、
前記水溶性多糖が、経口組成物中の総多糖含量の少なくとも約10重量%を占める、
血糖降下薬として適切な経口組成物。 - カルシウム源をさらに含む、請求項1に記載の経口組成物。
- 前記カルシウム源がクエン酸カルシウムである、請求項2に記載の経口組成物。
- 生理的に許容される金属炭酸塩をさらに含む、請求項1に記載の経口組成物。
- 前記炭酸金属塩が、炭酸カルシウム、炭酸マグネシウム、炭酸カリウム、炭酸ナトリウム、炭酸水素カリウム、炭酸水素ナトリウム及びこれらの混合物からなる群の要素である、請求項4に記載の経口組成物。
- 生理的に許容されるクロム塩をさらに含む、請求項1に記載の経口組成物。
- 前記クロム塩が、ニコチン酸クロム、ピコリン酸クロム、バナジン酸クロム及びこれらの混合物からなる群の要素である、請求項6に記載の経口組成物。
- 生理的に許容されるバナジウム化合物をさらに含む、請求項1に記載の経口組成物。
- 前記バナジウム化合物が硫酸バナジルである、請求項8に記載の経口組成物。
- 前記非代謝性、水膨潤性多糖が、ステルキュリア・ウレンス(Sterculia urens)の浸出物である、請求項1に記載の経口組成物。
- 前記水溶性多糖がグアーガムである、請求項1に記載の経口組成物。
- 前記水膨潤性多糖がステルキュリア・ウレンスの浸出物であり、前記水溶性多糖がグアーガムであり、前記水膨潤性多糖及び前記水溶性多糖が、それぞれ約1:1ないし約1:3の範囲の重量比で組成物中に存在する、請求項1に記載の経口組成物。
- 前記水膨潤性多糖がステルキュリア・ウレンスの浸出物であり、前記水溶性多糖がグアーガムであり、前記水膨潤性多糖及び前記水溶性多糖が約1:1の重量比で組成物中に存在する、請求項1に記載の経口組成物。
- 生理的に適合性のある抗酸化剤を含む、請求項1に記載の経口組成物。
- 請求項1に記載の経口組成物を含む、ドリンクミックス粉末。
- 請求項1に記載の経口組成物を含む、スナックバー。
- ヒト患者の血中グルコースレベルを所定の値に維持するのに十分な量及び頻度で、請求項1に記載の組成物を前記患者に経口投与することを含む、ヒト患者のグルコース代謝を調節する方法。
- 遺伝的に糖尿病に対する素因があるヒト患者の血中グルコースレベルを所定の値に維持するのに十分な量及び頻度で、請求項1に記載の組成物を前記患者に経口投与することを含む、遺伝的に糖尿病に対する素因があるヒト患者を調節する方法。
- I型糖尿病に罹患しているヒト患者の血中グルコースレベルを所定の値に維持するのに十分な量及び頻度で、請求項1に記載の組成物を、インシュリン療法に対する補助として、前記患者に経口投与することを含む、I型糖尿病に罹患し、インシュリン療法を受けているヒト患者を治療する方法。
- 請求項1に記載の組成物の治療上有効な量を、ヒト患者に経口投与することを含む、肥満に対する素因があるヒト患者を治療する方法。
- 請求項1に記載の組成物の治療上有効な量を、ヒト患者に経口投与することを含む、ヒト患者における糖尿病性網膜症を治療する方法。
- 患者の血中グルコースレベルを所定の値に維持するのに十分な量及び頻度で、請求項1に記載の組成物を哺乳動物に経口投与することを含む、哺乳動物におけるグルコース代謝を調節する方法。
- 患者の血清コレステロールレベルを減少させるのに十分な、治療上有効な量で、請求項1に記載の組成物を、コレステロール血症の治療を必要としている患者に投与することを含む、コレステロール血症を治療する方法。
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PCT/US2004/006528 WO2004078139A2 (en) | 2003-03-04 | 2004-03-04 | Therapeutic compositions |
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EP (1) | EP1608385A4 (ja) |
JP (1) | JP2006519867A (ja) |
CA (1) | CA2517172C (ja) |
MY (1) | MY126280A (ja) |
TW (1) | TWI331019B (ja) |
WO (1) | WO2004078139A2 (ja) |
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CN112707816B (zh) * | 2019-10-25 | 2022-01-18 | 华南理工大学 | 一种具有胰岛素增敏活性的多钒酸盐烷氧衍生物及其制备方法与应用 |
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Also Published As
Publication number | Publication date |
---|---|
CA2517172A1 (en) | 2004-09-16 |
TW200507866A (en) | 2005-03-01 |
US20040151783A1 (en) | 2004-08-05 |
US6946151B2 (en) | 2005-09-20 |
MY126280A (en) | 2006-09-29 |
EP1608385A4 (en) | 2010-03-03 |
EP1608385A2 (en) | 2005-12-28 |
TWI331019B (en) | 2010-10-01 |
WO2004078139A2 (en) | 2004-09-16 |
CA2517172C (en) | 2011-11-01 |
WO2004078139A3 (en) | 2005-01-20 |
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