JP4959558B2 - ジアミノオキシダーゼ含有医薬組成物 - Google Patents
ジアミノオキシダーゼ含有医薬組成物 Download PDFInfo
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- C12Y104/00—Oxidoreductases acting on the CH-NH2 group of donors (1.4)
- C12Y104/03—Oxidoreductases acting on the CH-NH2 group of donors (1.4) with oxygen as acceptor (1.4.3)
- C12Y104/03006—Amine oxidase (copper-containing)(1.4.3.6)
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Description
1)毛細血管の希釈、毛細血管の透過性の増大および血圧の低下。
2)平滑筋、すなわち肺における気管支筋の収縮。
3)増大した胃酸分泌の誘発。
4)心拍数の増大。
5)ヒスタミンはアレルギー性即時型反応のメディエーターであり、アレルギー性鼻炎(花粉症)および気管支喘息などのアレルギー性疾患における最も重要なメディエーターである。
6)さらに、ヒスタミンはじんま疹(発疹)の古典的な誘因であり、薬物アレルギーまたは過敏症に重要な役割を果たす。
RCH2NH2+H2O+O2=>RCHO+NH3+H2O2
(ここに、R残基はアミノ基を含む)。
− ほとんどのヒトは先天性DAO欠乏を有さず、DAOも失わない。
− 腸粘膜の感染症の間、一時的なDAO欠乏が起こりうる。感染症が治癒したとき、DAO活性もまた正常に戻る。
− 種々の活性阻害物質を投与するとき、外因的にDAO活性の減少を引き起こしうる。それらの中には、主としてアルコールおよびその分解生成物、アセトアルデヒド、アミン豊富ないくつかの食品、および多くの医薬が挙げられる。
実施例1
DAOをセルロース基盤のペレットにて積極的に安定化し、ペレットを胃液耐性コーティングでコーティングした。溶出試験において、70%を超える活性が1時間以内に周囲に放出されることを示すことができた。
さらに、酵素をヒドロゲル中にて安定化した。室温および37℃における保存により、4ヶ月以内において活性の減少は見られなかった。ヒスタミンによる刺激後の肌の小水疱および掻痒の発生は、ヒドロゲルの適用後数分で消失した。
ヒドロゲルにて安定化されたDAOを、計13人の人に試験した。アンケートと称して、接触アレルギー(n=5)、神経皮膚炎/皮膚病(n=6)および昆虫刺傷(n=2)によるストレス間で区別した。接触アレルギーの患者および神経皮膚炎の患者のすべてにおいて、陽性結果が証明され;昆虫刺傷の場合には、50%のボランティアが陽性結果を報告しうる。
本発明のヒドロゲルがその時に使用されるコルチゾン軟膏よりも有効であったことを二人の神経皮膚炎の患者が述べた。
胃液耐性ペレットは、80,000 U/mlの初期活性を有するDAO3%、微結晶性セルロース40%、スクロース20%、他の結合剤、充填剤および崩壊剤22%と、胃液耐性コーティング15%により製造した。ペレットからのDAOの放出は、活性アッセイを用いて180分間観察した。ここに、ペレットが溶解した溶液において、10分後にすでに40%のDAO活性、30分後に70%の活性、60分後に80%の活性および180分後に初めに用いられたDAO量の100%の活性が検出された。DAOの活性測定はAT 411688に記載されているとおりであったが、酵素活性を測定するために知られている他の方法もまた非常によく用いることができる。
Bachrach U., in: B. Mondovi (Ed) (1985), Structure and Functions of Amine Oxidase, CRC Press, Boca Raton, pp. 5-20x
Bartholomew M.J. et al (1990), Cancer 66:1539-1543
James S.M., Palcic M.M., Scaman C.H., Smith A.J., Brown D.E., Dooley D.M., Mure M., Klinman J.P. (1992), Bio-chemistry 31:12147-12154
James S.M., Mu D., Wemmer D., Smith A.J., Kaur S., Maltby D., Burlingame A.L., Klinman J.P. (1990), Science 248:981-987
Keskinege A., Elgun S., Yilmaz E. (2001), Biochim. Bio-phys. Acta 25:76
Kitanaka J., Kitanaka N., Tsujimura T., Terada N., Takemura M. (2002), European Journal of Pharmacology 437:179-185
Kluetz M.D., Schmidt P.G. (1977), Biochem. Biophys. Res. Comm. 76:40-45
Kufner M.A., Ulrich P., Raithel M., Schwelberger H.G. (2001), Inflamm. res. 50, Supplement 2, 96-97
Kusche J., Menningen R., Leisten L., Krakamp B. (1988), Adv. Exp. Med. Biol. 250:745-52
Kusche J., Bieganski T., Hesterberg R., Stahlknecht C.D., Feussner K.D., Stahlenberg I., Lorenz W. (1980), Agents Actions 10:110-3
Mennigen R, Bieganski T, Elbers A, Kusche J (1989), J. Chromatogr. B Biomed. Sci. Appl. 27:221
Mizuguchi H., Imamura I., Takemura M., Fukui H. (1994), J. Biochem. 116:631-635
Mu D., James S. M., Smith A.J., Brown D.E., Dooley D.M., Klinman J.P. (1992), J. Biol. Chem. 267:7979-7982
Nilsson B.O., Kockum I., Rosengren E. (1996), Inflamma-tion Res. 45:513-518
Rinaldi A., Vecchini P., Floris G. (1982), Prep. Bio-chem. 12:11-28
Shah M. A., Ali R. (1988), Biochem. J. 253:103-107
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Claims (12)
- 組成物が胃液耐性ペレットまたは胃液耐性カプセルとしての、口腔投与または経口投与に適用される形態にて提供されることを特徴とする、ジアミンオキシダーゼを含有するヒスタミン誘発性疾患の治療のための医薬組成物であって、該ジアミンオキシダーゼが外因性ヒスタミンを胃腸管から除去または軽減する、医薬組成物。
- ジアミンオキシダーゼが非植物由来であることを特徴とする、請求項1記載の組成物。
- 組成物が動物由来のジアミンオキシダーゼを含有することを特徴とする、請求項2記載の組成物。
- ジアミンオキシダーゼがブタ腎臓に由来することを特徴とする、請求項3記載の組成物。
- 組成物が組換え型由来のジアミンオキシダーゼを含有することを特徴とする、請求項1〜4のいずれかに記載の組成物。
- 組成物が原核生物または真核生物の細胞培養から回収された組換えジアミンオキシダーゼを含有することを特徴とする、請求項5記載の組成物。
- 原核生物が細菌であり、真核生物が動物または酵母である、請求項6記載の組成物。
- 医薬が胃液耐性ペレットまたは胃液耐性カプセルとしての、口腔投与または経口投与に適用される形態にて提供されることを特徴とする、ヒスタミン誘発性疾患の治療のための医薬の製造のためのジアミンオキシダーゼの使用であって、該ジアミンオキシダーゼが外因性ヒスタミンを胃腸管から除去または軽減する、使用。
- 医薬が胃液耐性ペレットまたは胃液耐性カプセルとしての、口腔投与または経口投与に適用される形態にて提供されることを特徴とする、慢性および急性のじんま疹からなる群から選択されるじんま疹の治療のための医薬の製造のためのジアミンオキシダーゼの使用であって、該ジアミンオキシダーゼが外因性ヒスタミンを胃腸管から除去または軽減する、使用。
- 医薬が胃液耐性ペレットまたは胃液耐性カプセルとしての、口腔投与または経口投与に適用される形態にて提供されることを特徴とする、アトピー性皮膚炎の治療のための医薬の製造のためのジアミンオキシダーゼの使用であって、該ジアミンオキシダーゼが外因性ヒスタミンを胃腸管から除去または軽減する、使用。
- 医薬が胃液耐性ペレットまたは胃液耐性カプセルとしての、口腔投与または経口投与に適用される形態にて提供されることを特徴とする、サバ中毒の治療のための医薬の製造のためのジアミンオキシダーゼの使用であって、該ジアミンオキシダーゼが外因性ヒスタミンを胃腸管から除去または軽減する、使用。
- 医薬が胃液耐性ペレットまたは胃液耐性カプセルとしての、口腔投与または経口投与に適用される形態にて提供されることを特徴とする、胃腸管から外因性ヒスタミンを除去するための医薬の製造のためのジアミンオキシダーゼの使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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AT1150/2004 | 2004-07-07 | ||
AT0115004A AT502098B8 (de) | 2004-07-07 | 2004-07-07 | Diaminooxidase-hältige zusammensetzung |
PCT/EP2005/053234 WO2006003213A1 (de) | 2004-07-07 | 2005-07-06 | Pharmazeutische zusammensetzungen, die diaminooxidase enthalten |
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Publication Number | Publication Date |
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JP2008505869A JP2008505869A (ja) | 2008-02-28 |
JP2008505869A6 JP2008505869A6 (ja) | 2008-07-03 |
JP4959558B2 true JP4959558B2 (ja) | 2012-06-27 |
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Application Number | Title | Priority Date | Filing Date |
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JP2007519799A Expired - Fee Related JP4959558B2 (ja) | 2004-07-07 | 2005-07-06 | ジアミノオキシダーゼ含有医薬組成物 |
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US (3) | US20080193491A1 (ja) |
EP (2) | EP1782824B1 (ja) |
JP (1) | JP4959558B2 (ja) |
KR (1) | KR101367232B1 (ja) |
CN (1) | CN1980689A (ja) |
AT (4) | AT502098B8 (ja) |
AU (1) | AU2005259167B2 (ja) |
BR (1) | BRPI0513133B1 (ja) |
CA (1) | CA2571463C (ja) |
CY (1) | CY1109351T1 (ja) |
DE (2) | DE502005009568D1 (ja) |
DK (1) | DK1763363T3 (ja) |
ES (1) | ES2326421T3 (ja) |
HR (1) | HRP20090447T1 (ja) |
MX (1) | MXPA06015036A (ja) |
PL (1) | PL1763363T3 (ja) |
PT (1) | PT1763363E (ja) |
RS (1) | RS51183B (ja) |
SI (1) | SI1763363T1 (ja) |
WO (1) | WO2006003213A1 (ja) |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2388166B1 (es) * | 2011-03-18 | 2013-10-01 | Dr Healthcare España, S. L. | Alimentos funcionales que contienen diaminooxidasa y sus usos. |
US20170020993A1 (en) * | 2011-03-18 | 2017-01-26 | Dr Healthcare España, S.L. | Composition comprising diamine oxidase for use in the treatment or prevention of fibromyalgia or chronic fatigue syndrome |
ES2387973B1 (es) * | 2011-03-18 | 2013-10-01 | Dr Healthcare España, S. L. | Composiciones tópicas que contienen diaminooxidasa para el tratamiento o la prevención de enfermedades asociadas a un nivel de histamina elevada que comportan un aumento del dolor. |
ES2388515B1 (es) * | 2011-03-18 | 2013-10-01 | Dr Healthcare España, S. L. | Uso de la diaminooxidasa para la prevención de los síntomas de la resaca. |
ES2388395B1 (es) * | 2011-03-18 | 2013-10-01 | Dr Healthcare España, S. L. | Uso de la diaminooxidasa para el tratamiento o la prevención de la fibromialgia o la fatiga crónica. |
US20160024481A1 (en) * | 2011-03-18 | 2016-01-28 | Dr Healthcare España, S.L. | Topical compositions comprising diaminooxidase for the treatment or prevention of diseases associated with high histamine levels which involve an increase in pain |
WO2012135951A1 (en) * | 2011-04-07 | 2012-10-11 | Histapharm Inc. | Oral enzyme compositions for intestinal delivery |
ES2426539B1 (es) * | 2012-04-18 | 2014-09-09 | Dr Healthcare España, S. L. | Uso de la diaminooxidasa para el tratamiento o la prevención del trastorno por deficit de atencion con hiperactividad (adhd) |
CA3085223A1 (en) * | 2017-12-21 | 2019-06-27 | Pepsico, Inc. | Multi-ingredient ephemeral beverage pod for making a beverage |
US20220145269A1 (en) | 2019-02-19 | 2022-05-12 | Medizinische Universität Wien | New recombinant diamine oxidase and its use for the treatment of diseases characterized by excess histamine |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
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GB479487A (en) * | 1935-08-01 | 1938-02-04 | Ig Farbenindustrie Ag | Manufacture of stable therapeutic products from intestinal mucous membrane |
NL6815177A (ja) * | 1968-10-24 | 1970-04-28 | ||
GB1318884A (en) * | 1969-07-29 | 1973-05-31 | Hydrovane Compressor | Rotary compressors |
FR2101095A1 (en) * | 1970-08-20 | 1972-03-31 | Merieux Inst | Diamine oxidase from human placenta - for treatment of hyperhistamina |
US3639579A (en) * | 1970-12-10 | 1972-02-01 | Matthew C Urbin | Pharmaceutical preparation |
FR2215944A1 (en) * | 1973-02-01 | 1974-08-30 | Bellon Labor Sa Roger | Extracts of human placenta - free of proteases, and contg. histaminase, kininases and monoamine-oxidases for treating allergies |
FR2529463B1 (fr) * | 1982-07-05 | 1986-01-10 | Centre Nat Rech Scient | Procede et dispositif pour l'encapsulation dans les erythrocytes d'au moins une substance a activite biologique, notamment des effecteurs allosteriques de l'hemoglobine et erythrocytes ainsi obtenus |
GB8319540D0 (en) * | 1983-07-20 | 1983-08-24 | Bovril Ltd | Amine removal |
US4725540A (en) * | 1984-07-09 | 1988-02-16 | Emil Underberg | Process for the preparation of amine-oxidase containing material, so produced amine-oxidase containing material |
US5270033A (en) * | 1991-11-25 | 1993-12-14 | Montgomery Robert E | Antimicrobial composition and method of making same |
CA2352389C (en) * | 1998-11-27 | 2009-01-20 | Kanji Takada | An oral formulation for gastrointestinal drug delivery |
JP4839506B2 (ja) | 2000-04-28 | 2011-12-21 | ダイキン工業株式会社 | ドライエッチング方法 |
JP4592041B2 (ja) * | 2000-11-24 | 2010-12-01 | 株式会社Nrlファーマ | 生活の質を改善する新規食品の製造法および用途 |
IT1317067B1 (it) | 2000-11-29 | 2003-05-26 | Univ Roma | Istaminasi di origine vegetale nel trattamento dello shock allergico esettico e nell'asma allergico. |
CN1488000A (zh) * | 2001-02-23 | 2004-04-07 | 比奥维特罗姆股份公司 | 纯化可溶性ssao的方法 |
JP2003212773A (ja) * | 2002-01-04 | 2003-07-30 | Oramon Arzneimittel Gmbh | セチリジン及びロラタジンの局所医薬組成物 |
DE10239029A1 (de) | 2002-08-21 | 2004-03-04 | Coty B.V. | Kosmetische und dermatologische Zubereitung mit Proteinen zur Hautaufhellung |
JP2004167178A (ja) * | 2002-11-15 | 2004-06-17 | Masashi Takahashi | タン白質の経口投与法 |
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