JP2014111588A - 眼の異物感改善剤 - Google Patents
眼の異物感改善剤 Download PDFInfo
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- JP2014111588A JP2014111588A JP2013229428A JP2013229428A JP2014111588A JP 2014111588 A JP2014111588 A JP 2014111588A JP 2013229428 A JP2013229428 A JP 2013229428A JP 2013229428 A JP2013229428 A JP 2013229428A JP 2014111588 A JP2014111588 A JP 2014111588A
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- Prior art keywords
- eye
- foreign body
- improving agent
- ophthalmic composition
- acid
- Prior art date
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Abstract
【解決手段】ピリドキシン及びその塩からなる群から選択される少なくとも一種を有効成分として含有する、眼の異物感改善剤。
【選択図】なし
Description
[1]ピリドキシン及びその塩からなる群から選択される少なくとも一種を有効成分として含有する、眼の異物感改善剤。
[2]さらにアミノ酸類を有効成分として含有する、[1]に記載の眼の異物感改善剤。
[3]アミノ酸類がアミノエチルスルホン酸、コンドロイチン硫酸及びそれらの塩からなる群から選択される少なくとも一種である、[2]に記載の眼の異物感改善剤。
[4](A)成分の総含有量が、0.0005〜0.5w/v%である、[1]〜[3]に記載の眼の異物感改善剤。
[5](B)成分の総含有量が、0.001〜5w/v%である、[2]〜[4]に記載の眼の異物感改善剤。
[6](A)成分の総含有量1質量部に対して、(B)成分の総含有量が、0.01〜10000質量部である、[2]〜[5]に記載の眼の異物感改善剤。
[7]点眼剤又は洗眼剤である、[1]〜[6]に記載の眼の異物感改善剤。
[8]眼科用組成物に眼の異物感改善作用を付与する方法であって、ピリドキシン及びその塩からなる群から選択される少なくとも一種を有効成分として眼科用組成物に配合することを特徴とする、方法。
[9]さらにアミノ酸類を有効成分として眼科用組成物に配合することを特徴とする、[8]に記載の方法。
[10]アミノ酸類がアミノエチルスルホン酸、コンドロイチン硫酸及びそれらの塩からなる群から選択される少なくとも一種である、[9]に記載の方法。
上記(A)成分の含有量は、眼の異物感を改善するという観点から好適である。
なかでも、眼の異物感を顕著に改善するという観点から、(B)成分としては、アミノエチルスルホン酸、コンドロイチン硫酸又はそれらの塩が好ましい。
本実施形態に使用されるコンドロイチン硫酸としては、医薬上、薬理学的に(製薬上)又は生理学的に許容される限り、その由来については、特に制限されず、例えば、哺乳動物や魚類の軟骨(サケ軟骨等)などに由来するものなどが使用され得る。
点眼剤、洗眼剤等の眼科用組成物として使用するという観点から、アミノ酸類の総含有量は、0.002〜7.5w/v%であることが好ましく、0.01〜4w/v%であることがより好ましく、0.02〜1.5w/v%であることが更に好ましい。
また、本実施形態に係る眼の異物感改善剤及び眼科用組成物が含有することができる陰イオン性界面活性剤として、具体的には、アルキルベンゼンスルホン酸塩、アルキル硫酸塩、ポリオキシエチレンアルキル硫酸塩、α−スルホ脂肪酸エステル塩、α−オレフィンスルホン酸等が例示できる。
そして、本実施形態に係る眼の異物感改善剤及び眼科用組成物が含有することができる陽イオン性界面活性剤として、具体的には、塩化ベンザルコニウム、塩化ベンゼトニウム等が例示される。
等張化剤としては、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。等張化剤としては、例えば、リン酸水素二ナトリウム、リン酸二水素ナトリウム、リン酸二水素カリウム、亜硫酸水素ナトリウム、亜硫酸ナトリウム、塩化カリウム、塩化カルシウム、塩化ナトリウム、塩化マグネシウム、酢酸カリウム、酢酸ナトリウム、炭酸水素ナトリウム、炭酸ナトリウム、チオ硫酸ナトリウム、硫酸マグネシウム、グリセリン、プロピレングリコール、ポリエチレングリコール、ブドウ糖、マンニトール、ソルビトール等が挙げられる。これらの等張化剤の中でも、グリセリン、プロピレングリコール、ポリエチレングリコール、ブドウ糖、塩化ナトリウム、塩化カリウム、塩化カルシウム又は塩化マグネシウムが好ましく、塩化ナトリウム、塩化カリウム又はプロピレングリコールがさらに好ましく、塩化ナトリウムが特に好ましい。これらの等張化剤は、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。
これらの粘稠剤は、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。
抗ヒスタミン剤又は抗アレルギー剤:例えば、フマル酸ケトチフェン、塩酸ジフェンヒドラミン、マレイン酸クロルフェニラミン、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、オロパタジン塩酸塩等。
充血除去剤:塩酸テトラヒドロゾリン、塩酸ナファゾリン、硫酸ナファゾリン、塩酸エピネフリン、塩酸エフェドリン、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、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、酢酸レチノール、パルミチン酸レチノール、パンテノール、パントテン酸カルシウム、酢酸トコフェロール等。
消炎剤:例えば、グリチルリチン酸、アズレンスルホン酸、アラントイン、ベルベリン、リゾチーム等。
収斂剤:例えば、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、アルギン酸等。
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、ビグアニド化合物(具体的には、ポリヘキサメチレンビグアニド等)、グローキル(ローディア社製 商品名)等。
清涼化剤: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、ネロール、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、ユーカリ油、ベルガモット油、ペパーミント油、ウイキョウ油、ローズ油、ケイヒ油、スペアミント油、樟脳油、クールミント、ハッカ油等。
安定化剤:エデト酸ナトリウム、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。
下記表1に従い、点眼剤を調製した。これらの点眼剤を用いて、VAS(Visual Analogue Scale)法により異物感を評価した。具体的には、眼の異物感を訴える4名の者に各点眼液を点眼し、全長114mmのスケールの左端を「異物感を感じない」0点、右端を「異物感を感じる」100点とし、自覚する異物感の程度がどの程度に相当するかをチェックさせた。なお、点眼液はコンタクトレンズを装用していない状態にて点眼された。0点(左端)からチェックした点までの長さを測定し、全長を100とした際の割合を、異物感スコアとして算出した。スコアが低い程、異物感が改善されたことを表す。結果は4名の平均値にて、表1に併せて示す。
以下の表2に従って、各眼科用組成物を調製し、角膜上皮細胞への異物吸着に及ぼす影響について評価した。
ヒト角膜上皮細胞株HCE−T(理化学研究所バイオリソースセンター、No.RCB2280)を96ウェルマイクロプレート(コーニング社製)に1.0×105細胞/ウェルの割合となるように、各ウェル培養培地で200μLずつ播種を行い、37℃、5%CO2条件下で24時間培養した。培養後、培養培地を吸引除去し、FITCで蛍光標識したアルブミン0.05%をそれぞれ含有した各眼科用組成物100μLを入れ、室温下で30分間静置した。処理後、ウェル中の液を吸引除去し、200μLのリン酸緩衝液を入れ、ウェル中の液を吸引除去して洗浄した後、100μLのリン酸緩衝液を入れ、蛍光プレートリーダー(Fluoroskan Ascent CF、Labsystems社製)を用いて励起波長485nm/発光波長527nmにおける蛍光値を測定した。得られた蛍光値を、異物量と蛍光値の検量線に基づいて、異物(アルブミン)量に換算した。得られた異物量から、式(I)に基づいて、異物吸着抑制率(%)を算出した。なお、実施例4、5及び比較例2において、コントロールとは、(A)成分も(B)成分も含んでいない眼科用組成物(コントロール1)を指す。結果を表2にまとめた。
(式I)
異物吸着抑制率(%)=(1−(各比較例又は実施例の異物量)/(コントロールの異物量))×100
以下の表3に従って、培養培地中に各薬剤を調整し、角膜上皮細胞への異物吸着に及ぼす影響について評価した。
ヒト角膜上皮細胞株HCE−T(理化学研究所バイオリソースセンター、No.RCB2280)を96ウェルマイクロプレート(コーニング社製)に1.0×105細胞/ウェルの割合となるように、各ウェル培養培地で200μLずつ播種を行い、37℃、5%CO2条件下で24時間培養した。培養後、培養培地を吸引除去し、FITCで蛍光標識したアルブミン0.1%をそれぞれ含有した各薬剤100μLを入れ、室温下で60分間静置した。処理後、ウェル中の液を吸引除去し、200μLのリン酸緩衝液を入れ、ウェル中の液を吸引除去して洗浄した後、100μLのリン酸緩衝液を入れ、蛍光プレートリーダー(Fluoroskan Ascent CF、Labsystems社製)を用いて励起波長485nm/発光波長527nmにおける蛍光値を測定した。得られた蛍光値を、異物量と蛍光値の検量線に基づいて、異物(アルブミン)量に換算した。得られた異物量から、式(I)に基づいて、異物吸着抑制率(%)を算出した。なお、実施例6、7及び比較例3において、コントロールとは、(A)成分も(B)成分も含んでいない培養培地(コントロール2)を指す。結果を表3にまとめた。
表4及び表5に記載の処方で、点眼剤(製剤例1−7)、洗眼剤(製剤例8)が調製される。表4及び表5に記載の眼科用組成物は、いずれも眼の異物感改善作用を有する。
Claims (8)
- (A)ピリドキシン及びその塩からなる群から選択される少なくとも一種を有効成分として含有する、眼の異物感改善剤。
- さらに(B)アミノ酸類を有効成分として含有する、請求項1に記載の眼の異物感改善剤。
- (B)アミノ酸類がアミノエチルスルホン酸、コンドロイチン硫酸及びそれらの塩からなる群から選択される少なくとも一種である、請求項2に記載の眼の異物感改善剤。
- (A)成分の総含有量が、0.0005〜0.5w/v%である、請求項1〜3のいずれか一項に記載の眼の異物感改善剤。
- (B)成分の総含有量が、0.001〜5w/v%である、請求項2〜4のいずれか一項に記載の眼の異物感改善剤。
- (A)成分の総含有量1質量部に対して、(B)成分の総含有量が、0.01〜10000質量部である、請求項2〜5のいずれか一項に記載の眼の異物感改善剤。
- 点眼剤又は洗眼剤である、請求項1〜6のいずれか一項に記載の眼の異物感改善剤。
- 眼科用組成物に眼の異物感改善作用を付与する方法であって、ピリドキシン及びその塩からなる群から選択される少なくとも一種を有効成分として眼科用組成物に配合することを特徴とする、方法。
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JP2018150297A (ja) * | 2017-03-09 | 2018-09-27 | ロート製薬株式会社 | 眼科組成物およびそれに摩擦低減作用を付与する方法 |
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CN107260657B (zh) * | 2017-08-03 | 2019-02-05 | 广东莱恩医药研究院有限公司 | 一种缓释型连翘苷滴眼液及其制备方法 |
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