JP2011037868A - シクロデキストリン、リポソーム及び生分解性ポリマー並びに/或いはそれらの混合物及び生成物を用いる、ペプチドアンギオテンシン−(1−7)並びにその類似体、作動薬及び拮抗薬の製剤の調製方法 - Google Patents
シクロデキストリン、リポソーム及び生分解性ポリマー並びに/或いはそれらの混合物及び生成物を用いる、ペプチドアンギオテンシン−(1−7)並びにその類似体、作動薬及び拮抗薬の製剤の調製方法 Download PDFInfo
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Abstract
【解決手段】親水性シクロデキストリン、リポソーム、生分解性ポリマー及びその誘導体を用いるD−Ala7−アンギオテンシン−(1−7)(A−779)及び類似体及び誘導体、D−Pro7−アンギオテンシン−(1−7)及び類似体又は誘導体、Ang−(1−7)類似体又は誘導体の製剤。
【選択図】なし
Description
1)AT1受容体上の結合を競合すること
[Bovy PR、Trapani AJ、McMahon EG、Palomo M。アンギオテンシンIIのカルボキシ末端切断型類似体[Sar1]−アンギオテンシンII−(1−7)−アミドは、新たな種類のアンギオテンシンII拮抗薬への入口を提供する(The carboxy−terminus truncated analogue of angiotensin II [Sar1]−angiotensin II−(1−7)−amide,provides an entry to the new class of angiotensin II antagonists)。J Med Chem.、32巻、520〜522ページ、1989年。−Ueda S、Masumori−Maemoto S、Ashino K、Nagahara T、Gotoh及び、Umemura S、Ishii M。アンギオテンシン−(1−7)は、ヒトにおいてアンギオテンシンIIによって引き起こされる血管収縮を軽減するが、ノルアドレナリンによって引き起こされる血管収縮は軽減しない(Angiotensin−(1−7) attenuates vasoconstriction evoked by angiotensin II but not by noradrenaline in man)。Hypertension、35巻、998〜1001ページ、2000年。Roks AJ、Van−Geel PP、Pinto YM、Buikema H、Henning RH、deZeeuw D、van−Gilst WH。アンギオテンシン−(1−7)は、ヒトのレニン−アンギオテンシン系の調節因子である(Angiotensin−(1−7) is a modulator of the human renin−angiotensin system)。Hypertension、34巻(2号)、296〜301ページ、1999年。Rowe BP、Saylor DL、Speth RC、Absher DR。ラット脳内のアンギオテンシンII受容体において結合するアンギオテンシン−(1−7)(Angiotensin−(1−7) binding at angiotensin II receptors in the rat brain)。Regul Pep。56巻(2号)、139〜146ページ、1995年。Mahon JM、Carrr RD、Nicol AK、Hendersn IW。アンギオテンシン−(1−7)は、1型アンギオテンシンII受容体における拮抗薬である(Angiotensin−(1−7) is an antagonist at the type 1 angiotensin II receptor)。J Hypertension、12巻、1377〜1381ページ、1994年]、及び
2)おそらく細胞内カルシウムの利用能を変化させることにより、Ang II作用によるシグナル伝達機序を変化させること
[Chansel D、Vandermeerch S、Andrzej T、Curat C、Ardaillou R。メサンギウム細胞における基礎的なアンギオテンシンII刺激性サイトゾルCa+2に対するアンギオテンシンIV及びアンギオテンシン−(1−7)の影響(Effects of angiotensin IV and angiotensin−(1−7) on basal angiotenin II−stimulated cytosolic Ca+2 in mesangial cells)。Eur J Pharmacol。414巻、165〜175ページ、2001年)によってAng II作用を阻害する。Ang−(1−7)が心血管系に対するAng IIの有害な作用に拮抗することができる第三の機序は、ブラジキニン作用の増強である(Paula、RD;It Rasps、CV、Khosla、MC、Santos、RAS。アンギオテンシン−(1−7)は、覚醒ラットにおいてブラジキニンの血圧低下作用を増強する(Angiotensin−(1−7) potentiates the hypotensive effect of bradykinin in concious rats)。Hypertension、26巻、1154〜1159ページ、1995年。Li P、Chappell MC、Ferrario CM、Brosnihan KB。アンギオテンシン−(1−7)は、ACEと競合して一酸化窒素を放出することにより、ブラジキニン誘発血管拡張を増強する(Angiotensin−(1−7) augments bradykinin−induced vasodilation by competing with ACE and releasing nitric oxide)。Hypertension。29巻(パート2)、394〜400ページ、1997年)。
心臓におけるブラジキニンの有益な作用についても記載されている[Linz W、Wohlfart P、Scholkens BA、Malinski T、Wiemer G。ACE、キニンとNO間の相互作用(Interactions among ACE、 kinins and NO)。Cardiovasc Res。43巻、549〜561ページ、1999年]。Ang−(1−7)は、血管内[Paula、R.D.;Lima、C.V.;Khosla、M.C.;Santos、R.A.S.。アンギオテンシン−(1−7)は、覚醒ラットにおいてブラジキニンの血圧低下作用を増強する(Angiotensin−(1−7) potentiates the hypotensive ffect of bradykinin in concious rats)。Hypertension、26巻、1154〜1159ページ、1995年。Li P、Chappell MC、Ferrario CM、Brosnihan KB。アンギオテンシン−(1−7)は、ACEと競合して一酸化窒素を放出することにより、ブラジキニン誘発血管拡張を増強する(Angiotensin−(1−7) augments bradykinin−induced vasodilation by competing with ACE and releasing nitric oxide)。Hypertension。29巻(パート2)、394〜400ページ、1997年]、及び心臓内[Almeida、AP、Frabregas、BC、Madureira、MM、Santos、RJ S、Campagnole−Santos、MJ、Santos、RAS。アンギオテンシン−(1−7)は、摘出ラット心臓におけるブラジキニンの冠拡張作用を増強する(Angiotensin−(1−7) potentiates the coronary vasodilatory effect of bradykinin in the isolated rat heart)。Braz.J.of Medical and Biological Research、33巻、709〜713ページ、2000年]でブラジキニンの作用を増強する。
調製は、等モルのシクロデキストリンとAng−(1−7)で行う。手短に言えば、β−シクロデキストリン及び/又はその誘導体を、撹拌及び加熱を用いて水に溶かす。次いで、それぞれの量のアンギオテンシン−(1−7)を水溶液に加える。溶解後、液体窒素中で混合物を凍結し、凍結乾燥工程にかけて乾燥した固体を得る。次いで、得られた固体を、FT赤外分光法、熱分析(TG/DTG及びDSC)、X線回折並びに1H及び13C NMR分光法及びT1緩和時間を用いて物理化学的特徴を測定した。
Claims (20)
- 親水性シクロデキストリンと複合化された、Sar1−アンギオテンシン(1−7)、D−Ala7−アンギオテンシン(1−7)、D−Pro7−アンギオテンシン(1−7)及び生物学的に活性なそれらの誘導体からなる群から選択されるアンギオテンシン−(1−7)又はその類似体若しくは誘導体を含む、医薬製剤。
- 前記複合体が、リポソームに包まれている、請求項1に記載の医薬製剤。
- 前記複合体が、合成生分解性ポリマー又はその誘導体に包まれている、請求項1に記載の医薬製剤。
- 前記親水性シクロデキストリンは、α−、β−、又はγ−シクロデキストリンである、請求項1から3の何れか1項に記載の医薬製剤。
- 前記親水性シクロデキストリンは、6−O−マルトシルシクロデキストリン、スルフォブチルシクロデキストリン、2−ヒドロキシエチルシクロデキストリン、2−ヒドロキシプロピルシクロデキストリン、3−ヒドロキシプロピルシクロデキストリン、2,3−ジヒドロキシプロピルシクロデキストリンからなる群から選択される、請求項1から4の何れか1項に記載の医薬製剤。
- 生分解性ポリマーと複合化された、Sar1−アンギオテンシン(1−7)、D−Ala7−アンギオテンシン(1−7)、D−Pro7−アンギオテンシン(1−7)及び生物学的に活性なそれらの誘導体からなる群から選択されるアンギオテンシン−(1−7)又はその類似体若しくは誘導体を含む、医薬製剤。
- リポソームに包まれた、Sar1−アンギオテンシン(1−7)、D−Ala7−アンギオテンシン(1−7)、D−Pro7−アンギオテンシン(1−7)及び生物学的に活性なそれらの誘導体からなる群から選択されるアンギオテンシン−(1−7)又はその類似体若しくは誘導体を含む、医薬製剤。
- 前記リポソームは、ホスファチジルコリン、ホスファチジルセリン、ホスファチジルグリセロール、カルジオリピン、コレステロール、ホスファチジン酸、スフィンゴ脂質、糖脂質、脂肪酸、ステロール、ホスファチジルエタノールアミン、重合又は非重合形態の重合可能な脂質、及びこれらの脂質の組合せからなる群から選択される1以上の脂質を含む、請求項2又は7に記載の医薬製剤。
- 前記リポソームは、ポリエチレングリコール−脂質で構造上安定化されている、請求項2、7及び8の何れか1項に記載の医薬製剤。
- 前記リポソームの直径は約200nm以下である、請求項2、7、8及び9の何れか1項に記載に記載の医薬製剤。
- 前記ポリマーは、ポリアンヒドリド、ポリ(ヒドロキシ酸)、ポリ(ヒドロキシ)酸、ポリウレタン、ポリシロキサン、シリコン、ポリメタクリル酸メチル、ポリビニルアルコール、ポリ(メタクリル酸2−ヒドロキシエチル)、ポリアクリルアミド、乳酸由来のポリマー(PLA)、グリコール酸由来のポリマー(PGA)、及びこれらのコポリマー(PLGA)からなる群から選択される、請求項3又は6に記載の医薬製剤。
- ポリエチレングリコール、油、ゴマ油、オレイン酸エチル、トリグリセリド、カルボキシメチルセルロースナトリウム、ソルビトール又はデキストラン、チメロサール、m−若しくはo−クレゾール、ホルマリン、ベンジルアルコール又は血清アルブミンを含む又は含まない、水、食塩溶液、緩衝溶液、ブドウ糖溶液、ハンク液、及び生体適合性の食塩溶液からなる群から選択される賦形剤をさらに含む、請求項1から11の何れか1項に記載の医薬製剤。
- 動物における心血管疾患又は腫瘍性疾患を治療又は予防するための、請求項1から12の何れか1項に記載の医薬製剤。
- 前記心血管疾患は、左心室肥大、心筋虚血、脳卒中、心不全、アテローム性動脈硬化症、冠動脈性心疾患、心筋梗塞、狭心症、及び内皮機能不全からなる群から選択される、請求項13に記載の医薬製剤。
- Gタンパク質共役型受容体MASによる作用又は刺激を低減することにより引き起こされる疾患を治療又は予防するための、請求項1から12の何れか1項に記載の医薬製剤。
- 内皮機能不全、左心室肥大、心筋虚血、脳卒中、高血圧性の網膜症、アテローム性動脈硬化症及び心不全からなる群から選択される、動脈性高血圧症及びその合併症を治療するための、請求項1から12の何れか1項に記載の医薬製剤。
- アンギオテンシン−(1−7)の産生が低減することにより引き起こされる疾患を治療又は予防するための、請求項1から12の何れか1項に記載の医薬製剤。
- 親水性シクロデキストリンと複合化された、アンギオテンシン−(1−7)又はその類似体若しくは誘導体を含む医薬製剤を製造する方法であって、
親水性シクロデキストリンを含む溶液を、アンギオテンシン−(1−7)又はその類似体若しくは誘導体の水性溶液と接触させることを含む、方法。 - ポリエチレングリコール、油、ゴマ油、オレイン酸エチル、トリグリセリド、カルボキシメチルセルロースナトリウム、ソルビトール又はデキストラン、チメロサール、m−若しくはo−クレゾール、ホルマリン、ベンジルアルコール又は血清アルブミンを含む又は含まない、水、食塩溶液、緩衝溶液、ブドウ糖溶液、ハンク液、及び生体適合性の食塩溶液からなる群から選択される賦形剤を混合する工程をさらに含む、請求項21に記載の方法。
- 請求項1から12の何れか1項に記載の医薬製剤を含む、アンギオテンシン−(1−7)又はその類似体若しくは誘導体を制御放出するための医療装置。
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JP2016519132A (ja) * | 2013-04-30 | 2016-06-30 | ユニバーシティー オブ サウザン カリフォルニア | アンジオテンシンペプチドによる眼外傷の修復促進 |
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BRPI0105509B8 (pt) | 2021-05-25 |
CN100525830C (zh) | 2009-08-12 |
US20100158995A1 (en) | 2010-06-24 |
KR20040089078A (ko) | 2004-10-20 |
KR20110042029A (ko) | 2011-04-22 |
BRPI0105509B1 (pt) | 2016-01-05 |
CA2466232C (en) | 2015-07-14 |
CA2466232A1 (en) | 2003-05-15 |
US7723304B2 (en) | 2010-05-25 |
EP1450842A2 (en) | 2004-09-01 |
MXPA04004313A (es) | 2005-03-31 |
WO2003039434A2 (en) | 2003-05-15 |
JP2005511577A (ja) | 2005-04-28 |
EP1450842B1 (en) | 2013-12-25 |
WO2003039434A3 (en) | 2004-03-18 |
EP2356995A2 (en) | 2011-08-17 |
CN1599620A (zh) | 2005-03-23 |
AU2002349190A1 (en) | 2003-05-19 |
BR0105509A (pt) | 2007-05-22 |
EP2356995A3 (en) | 2011-08-24 |
US20050069533A1 (en) | 2005-03-31 |
KR101246608B1 (ko) | 2013-03-25 |
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