JP2018035151A - 眼科組成物 - Google Patents
眼科組成物 Download PDFInfo
- Publication number
- JP2018035151A JP2018035151A JP2017163409A JP2017163409A JP2018035151A JP 2018035151 A JP2018035151 A JP 2018035151A JP 2017163409 A JP2017163409 A JP 2017163409A JP 2017163409 A JP2017163409 A JP 2017163409A JP 2018035151 A JP2018035151 A JP 2018035151A
- Authority
- JP
- Japan
- Prior art keywords
- ophthalmic composition
- component
- acid
- salts
- acanthamoeba
- Prior art date
- 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.)
- Granted
Links
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Abstract
Description
[1]
(A)アレキシジン及びその塩から選択される少なくとも1種と、(B)多価アルコールと、(C)ホウ酸、リン酸及び塩基性アミノ酸、並びにそれらの塩から選択される少なくとも1種とを含有する、眼科組成物。
[2]
(A)アレキシジン及びその塩から選択される少なくとも1種の含有量が、眼科組成物の全量を基準として、0.001〜2ppmである、[1]に記載の眼科組成物。
[3]
(B)多価アルコールが、プロピレングリコールである、[1]又は[2]に記載の眼科組成物。
[4]
(D)(A)成分以外の殺菌剤を更に含有する、[1]〜[3]のいずれかに記載の眼科組成物。
[5]
コンタクトレンズ用である、[1]〜[4]のいずれかに記載の眼科組成物。
[6]
眼科組成物に(A)アレキシジン及びその塩から選択される少なくとも1種、(B)多価アルコール、並びに(C)ホウ酸、リン酸及び塩基性アミノ酸、及びそれらの塩を配合することを含む、該眼科組成物のアカントアメーバのシストに対する殺菌力を高める方法。
本実施形態に係る眼科組成物は、(A)アレキシジン及びその塩から選択される少なくとも1種(「(A)成分」ともいう。)と、(B)多価アルコール(「(B)成分」ともいう。)と、(C)ホウ酸、リン酸及び塩基性アミノ酸、並びにそれらの塩から選択される少なくとも1種(「(C)成分」ともいう。)とを含有する。
(A)成分であるアレキシジン及びその塩は、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されない。
(B)成分である多価アルコールは、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されない。
(C)成分であるホウ酸、リン酸及び塩基性アミノ酸、並びにそれらの塩は、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されない。
本実施形態に係る眼科組成物は、(D)(A)成分以外の殺菌剤(「(D)成分」ともいう。)を更に含有することが好ましい。これにより、本発明による効果をより一層高めることができる。(D)成分としては、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、ミリスチン酸プロピルジメチルアミン、塩酸クロルヘキシジン、グルコン酸クロルヘキシジン、塩酸ポリヘキサメチレンビグアニド(塩酸ポリヘキサニド)及び塩化ポリドロニウムが挙げられる。(A)成分以外の殺菌剤としては、塩酸ポリヘキサメチレンビグアニド(塩酸ポリヘキサニド)、塩化ポリドロニウムが好ましく、塩酸ポリヘキサニドがより好ましい。
抗アレルギー剤:例えば、クロモグリク酸ナトリウム、トラニラスト、ペミロラストカリウム等。
抗ヒスタミン剤:例えば、塩酸ジフェンヒドラミン、イプロヘプチン、マレイン酸クロルフェニラミン、塩酸レボカバスチン、フマル酸ケトチフェン、ペミロラストカリウム、塩酸オロパタジン等。
消炎剤:例えば、グリチルリチン酸、サリチル酸メチル、サリチル酸グリコール、グリチルリチン酸二カリウム、アラントイン、トラネキサム酸、ベルベリン、塩化ベルベリン、硫酸ベルベリン、リゾチーム、塩化リゾチーム、アズレンスルホン酸、アズレンスルホン酸ナトリウム、インドメタシン、プラノプロフェン、イブプロフェン、イブプロフェンピコノール、ケトプロフェン、フェルビナク、ベンダザック、ピロキシカム、ブフェキサマク、フルフェナム酸ブチル等。
ステロイド剤:例えば、プロピオン酸フルチカゾン、フランカルボン酸フルチカゾン、フランカルボン酸モメタゾン、プロピオン酸ベクロメタゾン、フルニソリド等。
充血除去剤:例えば、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、酢酸レチノール、パルミチン酸レチノール、酢酸トコフェロール、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、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等。
(C)成分以外のアミノ酸類:例えば、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、コンドロイチン硫酸ナトリウム等。
収斂剤:例えば、亜鉛華、乳酸亜鉛、硫酸亜鉛等。
その他:例えば、スルファメトキサゾール、スルフイソキサゾール、スルフイソミジン及びそれらの塩等。
担体:例えば、水、含水エタノール等の水性溶媒。
キレート剤:例えば、エチレンジアミン二酢酸(EDDA)、エチレンジアミン三酢酸、エチレンジアミン四酢酸(EDTA)、N−(2−ヒドロキシエチル)エチレンジアミン三酢酸(HEDTA)、ジエチレントリアミン五酢酸(DTPA)等。
安定化剤:例えば、ジブチルヒドロキシトルエン、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。
基剤:例えば、オクチルドデカノール、酸化チタン、臭化カリウム、プラスチベース等。
pH調節剤:例えば、塩酸、酢酸、水酸化ナトリウム、水酸化カリウム、水酸化カルシウム、水酸化マグネシウム、トリエタノールアミン、ジイソプロパノールアミン等。
安定化剤:例えば、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)、亜硫酸水素ナトリウム、ピロ亜硫酸ナトリウム、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、シクロデキストリン、モノエタノールアミン等。
(C)成分以外の緩衝剤:例えば、炭酸緩衝剤、クエン酸緩衝剤、酢酸緩衝剤、トリス緩衝剤、アスパラギン酸、アスパラギン酸塩等。
陰イオン界面活性剤:例えば、ポリオキシエチレンアルキルエーテルリン酸塩、ポリオキシエチレンアルキルエーテル硫酸塩、アルキルベンゼンスルホン酸塩、アルキル硫酸塩、N−アシルタウリン塩等。
両性界面活性剤:例えば、ラウリルジメチルアミノ酢酸ベタイン等。
増粘剤:例えば、ヒドロキシプロピルメチルセルロース、ヒドロキシエチルセルロース、メチルセルロース、カルボキシメチルセルロースナトリウム、ヒアルロン酸ナトリウム、ジェランガム、マクロゴール、アルギン酸、アルギン酸ナトリウム等。
清涼化剤:例えば、メントール、メントン、カンフル、ボルネオール、ゲラニオール、シネオール、シトロネロール、カルボン、アネトール、オイゲノール、リモネン、リナロール、酢酸リナリル、チモール、シメン、テルピネオール、ピネン、カンフェン、イソボルネオール、フェンチェン、ネロール、ミルセン、ミルセノール、酢酸リナロール、ラバンジュロール、ユーカリ油、ベルガモット油、ペパーミント油、クールミント油、スペアミント油、ハッカ油、ウイキョウ油、ケイヒ油、ローズ油、樟脳油等。
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体又はdl体のいずれでもよい。
油類:例えば、ゴマ油、ヒマシ油、ダイズ油、オリーブ油等の植物油、スクワラン等の動物油、流動パラフィン、ワセリン等の鉱物油等。
本発明に係る眼科組成物は、(A)成分、(B)成分及び(C)成分を組み合わせて含有することにより、アカントアメーバのシストに対する殺菌力が向上している。したがって、本発明は、眼科組成物に(A)アレキシジン及びその塩から選択される少なくとも1種、(B)多価アルコール、並びに(C)ホウ酸、リン酸及び塩基性アミノ酸、及びそれらの塩から選択される少なくとも1種を配合することを含む、該眼科組成物のアカントアメーバのシストに対する殺菌力を高める方法又は向上させる方法と捉えることもできる。
表1に記載の処方に従い、各試験液を調製した。調製直後の各試験液について、アカントアメーバのシストに対する殺菌力を評価した。
(式)殺菌力改善率(%)=(各実施例のLog reduction−比較例のLog reduction)/比較例のLog reduction×100
算出した値を表1に示す。
表2に記載の処方に従い、各試験液を調製した。調製直後の各試験液について、微生物液含有試験液の静置時間を1時間としたこと以外は試験例1と同様の方法で、比較例2−1に対する各実施例の殺菌力改善率(%)を算出し、アカントアメーバのシストに対する殺菌力を評価した。
算出した値を表2に示す。
表3に記載の処方に従い、各試験液を調製した。調製直後の各試験液について、試験例2と同様の方法で、比較例3−1に対する実施例3−1の殺菌力改善率(%)を算出し、アカントアメーバのシストに対する殺菌力を評価した。
算出した値を表3に示す。
表4に記載の処方に従い、各試験液を調製した。調製直後の各試験液について、試験液に添加する微生物液を、約2.0×107cells/mLとなるように調整し、最終的な試験液中のアカントアメーバの濃度を約2.0×105cells/mLとしたこと以外は、試験例1と同様の方法で、比較例4−1に対する各実施例の殺菌力改善率(%)を算出し、アカントアメーバのシストに対する殺菌力を評価した。
算出した値を表4に示す。
表5に記載の処方に従い、各試験液を調製した。調製直後の各試験液について、試験液に添加する微生物液を、約2.0×107cells/mLとなるように調整し、最終的な試験液中のアカントアメーバの濃度を約2.0×105cells/mLとしたこと、微生物液含有試験液の静置時間を1時間としたこと以外は、試験例1と同様の方法で、比較例5−1に対する実施例5−1の殺菌力改善率(%)を算出し、アカントアメーバのシストに対する殺菌力を評価した。
算出した値を表5に示す。
Claims (6)
- (A)アレキシジン及びその塩から選択される少なくとも1種と、(B)多価アルコールと、(C)ホウ酸、リン酸及び塩基性アミノ酸、並びにそれらの塩から選択される少なくとも1種とを含有する、眼科組成物。
- (A)アレキシジン及びその塩から選択される少なくとも1種の含有量が、眼科組成物の全量を基準として、0.001〜2ppmである、請求項1に記載の眼科組成物。
- (B)多価アルコールが、プロピレングリコールである、請求項1又は2に記載の眼科組成物。
- (D)(A)成分以外の殺菌剤を更に含有する、請求項1〜3のいずれか一項に記載の眼科組成物。
- コンタクトレンズ用である、請求項1〜4のいずれか一項に記載の眼科組成物。
- 眼科組成物に(A)アレキシジン及びその塩から選択される少なくとも1種、(B)多価アルコール、並びに(C)ホウ酸、リン酸及び塩基性アミノ酸、及びそれらの塩から選択される少なくとも1種を配合することを含む、該眼科組成物のアカントアメーバのシストに対する殺菌力を高める方法。
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