JP6345492B2 - 点眼剤 - Google Patents
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- JP6345492B2 JP6345492B2 JP2014114676A JP2014114676A JP6345492B2 JP 6345492 B2 JP6345492 B2 JP 6345492B2 JP 2014114676 A JP2014114676 A JP 2014114676A JP 2014114676 A JP2014114676 A JP 2014114676A JP 6345492 B2 JP6345492 B2 JP 6345492B2
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- Prior art keywords
- acid
- eye drop
- agent
- eyes
- content
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 claims description 23
- 230000002265 prevention Effects 0.000 claims description 16
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 claims description 14
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- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 1
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- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
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- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
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- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
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- 230000001105 regulatory effect Effects 0.000 description 1
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- QGNJRVVDBSJHIZ-QHLGVNSISA-N retinyl acetate Chemical compound CC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C QGNJRVVDBSJHIZ-QHLGVNSISA-N 0.000 description 1
- 235000019173 retinyl acetate Nutrition 0.000 description 1
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- 229940108325 retinyl palmitate Drugs 0.000 description 1
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- XWGJFPHUCFXLBL-UHFFFAOYSA-M rongalite Chemical compound [Na+].OCS([O-])=O XWGJFPHUCFXLBL-UHFFFAOYSA-M 0.000 description 1
- 239000010666 rose oil Substances 0.000 description 1
- 235000019719 rose oil Nutrition 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
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- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 description 1
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- 235000010262 sodium metabisulphite Nutrition 0.000 description 1
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- 239000001488 sodium phosphate Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
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- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
- WTWSHHITWMVLBX-DKWTVANSSA-M sodium;(2s)-2-aminobutanedioate;hydron Chemical compound [Na+].[O-]C(=O)[C@@H](N)CC(O)=O WTWSHHITWMVLBX-DKWTVANSSA-M 0.000 description 1
- YIOCQGHBBNGBND-UHFFFAOYSA-N sodium;3-acetyl-6-methylpyran-3-ide-2,4-dione Chemical compound [Na+].CC(=O)[C-]1C(=O)C=C(C)OC1=O YIOCQGHBBNGBND-UHFFFAOYSA-N 0.000 description 1
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- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 description 1
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- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- IYKMDRMCUIFHRA-UHFFFAOYSA-H tripotassium;trisodium;2-hydroxypropane-1,2,3-tricarboxylate;hydrate Chemical compound O.[Na+].[Na+].[Na+].[K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O IYKMDRMCUIFHRA-UHFFFAOYSA-H 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
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- 239000000811 xylitol Substances 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
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- 239000011701 zinc Substances 0.000 description 1
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
[1](A)トラニラスト又はその塩を含有する、IL−33産生抑制用点眼剤。
[2](A)トラニラスト又はその塩と、(B)抗ヒスタミン剤、抗炎症剤、アミノ酸類及び清涼化剤からなる群から選択される少なくとも1種とを含有する、IL−33産生抑制用点眼剤。
[3]アレルゲンへの接触の1〜2週間前から適用される、(A)トラニラスト又はその塩と、(B)抗ヒスタミン剤、抗炎症剤、アミノ酸類及び清涼化剤からなる群から選択される少なくとも1種とを含有する、アレルギー症状の予防用点眼剤。
[4]花粉飛散開始1〜2週間前から適用される、[3]に記載の点眼剤。
[5]アレルギー症状が、目の充血、目のかゆみ、なみだ目、目のかすみ及び目の異物感からなる群から選択される少なくとも1つである、[3]又は[4]に記載の点眼剤。
[6]シリコーンハイドロゲルコンタクトレンズを装用していない状態で適用される、[3]〜[5]のいずれかに記載の点眼剤。
[7](B)成分として、マレイン酸クロルフェニラミン、イプロヘプチン及び塩酸ジフェンヒドラミンからなる群から選択される少なくとも1種の抗ヒスタミン剤を含む、[3]〜[6]のいずれかに記載の点眼剤。
[8](B)成分として、ε−アミノカプロン酸、アラントイン、硫酸ベルベリン、塩化ベルベリン、グリチルリチン酸二カリウム、硫酸亜鉛、乳酸亜鉛、塩化リゾチーム、プラノプロフェン及びアズレンスルホン酸ナトリウムからなる群から選択される少なくとも1種の抗炎症剤を含む、[3]〜[7]のいずれかに記載の点眼剤。
[9](B)成分として、コンドロイチン硫酸ナトリウム、アスパラギン酸カリウム、アミノエチルスルホン酸及びイプシロンアミノカプロン酸からなる群から選択される少なくとも1種のアミノ酸類を含む、[3]〜[8]のいずれかに記載の点眼剤。
[10](B)成分として、メントール、カンフル、ボルネオール、ゲラニオール及びハッカ油からなる群から選択される少なくとも1種の清涼化剤を含む、[3]〜[9]のいずれかに記載の点眼剤。
トラニラストは、N−(3,4−ジメトキシシンナモイル)アントラニル酸とも称される公知化合物であり、公知の方法により合成してもよく市販品として入手することもできる。
(B)成分は、抗ヒスタミン剤、抗炎症剤、アミノ酸類及び清涼化剤からなる群から選択される少なくとも1種である。1種単独で使用してもよく、また2種以上を任意に組み合わせて使用してもよい。
本願の効果をより一層顕著に発揮させるため、点眼剤中にエタノールアミンと粘稠剤とを共に含有することがより好ましい。エタノールアミンと粘稠剤との好ましい組み合わせは、例えばモノエタノールアミンとビニル系増粘剤であり、より好ましくはモノエタノールアミンとポリビニルピロリドン、さらに好ましくはモノエタノールアミンとポリビニルピロリドンK30との組み合わせである。さらに、エタノールアミンと粘稠剤と非イオン界面活性剤とを組み合わせると、よりさらに好ましい。
抗アレルギー剤:例えば、フマル酸ケトチフェン、ペミロラストカリウム、クロモグリク酸ナトリウム等。充血除去剤:塩酸テトラヒドロゾリン、硝酸テトラヒドロゾリン、塩酸ナファゾリン、硝酸ナファゾリン、エピネフリン、塩酸エピネフリン、塩酸エフェドリン、塩酸フェニレフリン、dl−塩酸メチルエフェドリン等。
眼筋調節薬剤:例えば、アセチルコリンと類似した活性中心を有するコリンエステラーゼ阻害剤、具体的にはメチル硫酸ネオスチグミン、トロピカミド、ヘレニエン、硫酸アトロピン等。
ビタミン類:例えば、フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、パルミチン酸レチノール、酢酸レチノール、塩酸ピリドキシン、パンテノール、パントテン酸カルシウム、パントテン酸ナトリウム、酢酸トコフェロール等。
アミノ酸類:アスパラギン酸カリウム、アスパラギン酸マグネシウム、アスパラギン酸マグネシウム・カリウム、アミノエチルスルホン酸等。
殺菌剤:例えば、アクリノール、セチルピリジニウム、塩化ベンザルコニウム、塩化ベンゼトニウム、クロルヘキシジン、ポリヘキサメチレンビグアニド、塩酸アルキルジアミノエチルグリシン等。
その他:例えば、スルファメトキサゾール、スルファメトキサゾールナトリウム及びこれらの塩等。
担体:例えば、水、含水エタノール等の水性担体。
糖類:例えば、グルコース、シクロデキストリン等。
糖アルコール類:例えば、キシリトール、ソルビトール、マンニトール等。これらはD体、L体及びDL体のいずれでもよい。
防腐剤、殺菌剤又は抗菌剤:例えば、塩化亜鉛、塩酸アルキルジアミノエチルグリシン、安息香酸ナトリウム、エタノール、塩化ベンザルコニウム、塩化ベンゼトニウム、グルコン酸クロルヘキシジン、クロロブタノール、ソルビン酸、ソルビン酸カリウム、デヒドロ酢酸ナトリウム、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、硫酸オキシキノリン、フェネチルアルコール、ベンジルアルコール等。
安定化剤:トロメタモール、ナトリウムホルムアルデヒドスルホキシレート(ロンガリット)、トコフェロール、ピロ亜硫酸ナトリウム、モノエタノールアミン、モノステアリン酸アルミニウム、モノステアリン酸グリセリン等。
試料調製
各試薬を培養培地に溶解した。トラニラスト(Cayman Chemical社)は、DMSOに溶解し500mMストック溶液とした後、培養培地で希釈した。TNFαはhuman recombinant TNFα(R&D Systems社)を用い、IL−4はhuman recombinant IL−4(R&D Systems社)を用い、それぞれ、最終濃度が100ng/mLとなるように調製した。マレイン酸クロルフェニラミン、グリチルリチン酸二カリウム、コンドロイチン硫酸ナトリウム及びl−メントールは第十五改正日本薬局方適合品を用いた。
結膜線維芽細胞(ScienCell Research Laboratories社)を、6 well plate(コーニング社)に1.5x105細胞/ウェルで播種し、37度、5%CO2、湿度90%の条件でコンフルエントになるまで培養した。培養培地を無血清培地に入れ替えて一晩培養した後、トラニラスト単独又はマレイン酸クロルフェニラミン、グリチルリチン酸二カリウム、コンドロイチン硫酸ナトリウム若しくはl−メントールの各成分とトラニラストを組み合わせた薬剤を添加して1時間前処理した。その後、TNFα及びIL−4を添加してアレルギー反応を惹起した。IL−33のmRNA発現量は、ABI PRISM7000 Sequence Detection System(アプライドバイオシステムズ社)を用いて、定量的リアルタイムPCR法により定量した。
試験結果を表1に示す。結膜線維芽細胞をTNFα及びIL−4で刺激してアレルギー反応を惹起することにより、IL−33の発現量が上昇するが(比較例2)、トラニラストで前処理することでIL−33の発現量が抑制された(実施例1)。また、トラニラストにさらにマレイン酸クロルフェニラミン、グリチルリチン酸二カリウム、コンドロイチン硫酸ナトリウム又はl−メントールを組み合わせて前処理することでIL−33の発現量は顕著に抑制された(実施例2〜5)。トラニラストのみならず、マレイン酸クロルフェニラミン、グリチルリチン酸二カリウム、コンドロイチン硫酸ナトリウム、l−メントールも、それぞれIL−33の産生抑制効果は知られていない。それにも拘わらず、表1のような顕著なIL−33産生抑制効果が得られたことは予想外であり、本願発明の点眼剤が、アレルギー予防に対し特に顕著な効果を有する事が明らかである。
試料調製
下記表2の組成で比較例3及び実施例6、7の点眼剤を調製した。
試薬調製
下記表5の組成で比較例4及び実施例8、9の点眼剤を調製した。
Claims (6)
- アレルゲンへの接触の1〜2週間前から適用される、(A)トラニラスト又はその塩と、(B)抗ヒスタミン剤及び清涼化剤からなる群から選択される少なくとも1種とを含有する、アレルギー症状の予防用点眼剤。
- 花粉飛散開始1〜2週間前から適用される、請求項1に記載の点眼剤。
- 前記アレルギー症状が、目の充血、目のかゆみ、なみだ目、目のかすみ及び目の異物感からなる群から選択される少なくとも1つである、請求項1又は2に記載の点眼剤。
- シリコーンハイドロゲルコンタクトレンズを装用していない状態で適用される、請求項1〜3のいずれか一項に記載の点眼剤。
- 前記(B)成分として、マレイン酸クロルフェニラミン、イプロヘプチン及び塩酸ジフェンヒドラミンからなる群から選択される少なくとも1種の抗ヒスタミン剤を含む、請求項1〜4のいずれか一項に記載の点眼剤。
- 前記(B)成分として、メントール、カンフル、ボルネオール、ゲラニオール及びハッカ油からなる群から選択される少なくとも1種の清涼化剤を含む、請求項1〜5のいずれか一項に記載の点眼剤。
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