JP5938617B2 - コンタクトレンズ用液剤組成物 - Google Patents
コンタクトレンズ用液剤組成物 Download PDFInfo
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- JP5938617B2 JP5938617B2 JP2012027796A JP2012027796A JP5938617B2 JP 5938617 B2 JP5938617 B2 JP 5938617B2 JP 2012027796 A JP2012027796 A JP 2012027796A JP 2012027796 A JP2012027796 A JP 2012027796A JP 5938617 B2 JP5938617 B2 JP 5938617B2
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- contact lens
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Images
Description
0 分から2 4 時間、好ましくは3 0 分から8 時間浸漬することにより、保存・洗浄・消毒を行う。本発明に従うコンタクトレンズ用液剤組成物に含まれる蛋白分解酵素、界面活性剤により浸漬中に蛋白除去や脂質除去などの洗浄が行われる。また、炭素数5〜6のポリオールにより本液剤の防腐および必要な場合はコンタクトレンズやコンタクトレンズケースの消毒も行うことが出来るのである。
まず、本発明の実施例1〜4及び比較例1〜4の各種コンタクトレンズ用液剤を表1に示す成分組成において均一に精製水に溶解して調製した。そして調製した各液剤のpH及び浸透圧を、それぞれpHメーター(F−21型:堀場製作所(株)製)及び浸透圧計(OM−6040型:アークレイ(株)製)を用いて測定し、その結果を表1に合わせて示した。なお、(a)成分のC5〜6のポリオールとしては、1,2−ペンタンジオール(商品名「ハイドロライト−5」:(株)感光社製)、(b)成分の蛋白分解酵素としては、微生物由来のプロテアーゼ(商品名「エスペラーゼ」:ノボザイム・ジャパン(株)製)、(c)成分の界面活性剤はアニオン性界面活性剤として、α−オレフィンスルホン酸ナトリウム(商品名「ニッコールOS−14」:日光ケミカルズ(株)製)を、ノニオン性界面活性剤としてポリオキシエチレン(40)セチルエーテル(商品名「ニッコールBC40−TX」:日光ケミカルズ(株)製)を用いた。(d)成分の保湿成分は味の素ヘルシーサプライ(株)製のピロリドンカルボン酸ナトリウム(表中ではPCAナトリウムと示す)、L−アルギニン、L−トレオニン、グリシン、DL−アラニン、L−リジン塩酸塩、セリン、L−プロリンを使用した。またその他の成分として、緩衝剤としてホウ酸及びホウ砂、浸透圧調整剤として塩化ナトリウム、多価アルコールとしてグリセリン、金属イオン封鎖剤としてエチレンジアミン四酢酸ニナトリウム(表中「エデト酸ナトリウム」と示す)、増粘剤としてポリビニルピロリドン(商品名「コリドン30」:BASF Co.製)、α−ヒドロキシ酸塩としてDL−乳酸ナトリウムを使用した。
−保湿効果試験−
保湿効果試験は、ヒトの前腕を用いて、以下のような手順で生体角膜水負荷試験により評価した。先ず室温約20℃、湿度約66%の環境下に1時間試験部位を安定化させた。次に、前腕屈側に各試験液を2箇所づつ塗布する位置を定め、2.5×2.5cmで試験範囲にしるしをした。各試験液を試験範囲全体に綿棒を用いて塗布し、1分間放置した後、精製水で30秒間試験液を洗い流した。試験範囲以外の余分な水を拭き取り、2分間自然乾燥させた。次に、精製水を試験範囲中心部に1滴のせ、10秒後に吸水紙で吸い取った。吸い取った直後から、60秒、90秒、120秒後に肌湿度計(SR−101型;ロゼンスター(株)製)を用いて、水分含量(%)を測定した。測定結果の平均値を求め、各測定ポイントの水分含量(%)と試験開始前の水分含量との差から水分含量の変化量(%)を求め、結果を図1に示した。
−酵素安定性試験−
本発明の実施例1〜4及び比較例2〜4の各種コンタクトレンズ用液剤について、当該液剤の酵素活性を下記の手法に従って測定する一方、40℃で4週間保存した後にも同様にしてそれぞれの酵素活性を測定し、下式に従って、酵素活性残存率(%)を算出した。また、残存率が90%以上を○、80〜90%を△、80%未満の場合を×と判定し、結果を表2に示した。
各液剤(サンプル)0.6mLに1%亜硫酸ナトリウム溶液0.9mLを添加し、50℃で約2分放置する。そののち0.4%DMC基質溶液(20mLの精製水をバイアルビンに入れ、ホットプレートで80〜100℃に加温し、ジメチルカゼイン(ノボザイムズ・ジャパン(株)製)を0.20g加え20分程スターラーで撹拌して完全に溶かす。溶解後、ホウ酸緩衝液(ホウ砂4.28gとリン酸2水素ナトリウム・2水和物4.15gを精製水100mLに溶解したもの)20mLを加え、さらに精製水で全容50mLとした溶液)0.6mL添加し50℃で1分後、0.1%2,4,6−トリニトロベンゼンスルホン酸ナトリウム(TNBS)溶液を0.15mL加えてさらに50℃で25分置く。反応後、1.5mLの冷水を加えて、室温で25分置き、波長425nmにて吸光度(対照としてはサンプルの代わりに1%亜硫酸ナトリウム溶液0.6mLを使用したものをおいて)を測定する。酵素濃度既知の溶液を予め前記同様の方法により測定して検量線を作成しておき前記測定結果の吸光度からサンプルの酵素濃度を決定する。
酵素残存率(%)=(保存後のタンパク分解酵素活性/調製時のタンパク分解酵素活性)×100
−蛋白除去効果試験−
本発明の実施例3及び比較例2〜4の各種コンタクトレンズ用液剤について、蛋白除去効果試験を以下のようにして行った。まず、かかる蛋白除去効果試験に用いるために、牛製アルブミン:0.388(w/v)%、牛製γ−グロブリン:0.161(w/v)%、卵白リゾチーム:0.12(w/v)%、塩化ナトリウム:0.9(w/v)%、塩化カルシウム二水和物:0.015(w/v)%、リン酸二水素ナトリウム二水和物:0.104(w/v)%を水に溶解して調製し、1N水酸化ナトリウムを用いてpH7.0にした人工涙液を準備した。
蛋白汚れ除去率(%)=(1−所定時間浸漬後の輝度/浸漬前の輝度)×100
(実施例8)
本発明の実施例3のコンタクトレンズ用液剤について、以下の試験によりコンタクトレンズに対する影響を確認した。実施例3のコンタクトレンズ用液剤2mLに酸素透過性ハードコンタクトレンズ(商品名「メニコンZ」:(株)メニコン製)1枚を8〜12時間浸漬した後、取り出して、同液剤を2〜3滴レンズに滴下し、指先にて5秒間こすり洗浄後、水道水にて5秒間すすぎ、再び新しい液剤2mL中に浸漬するサイクルを30サイクル繰り返した。処理後、当該レンズ(n=3)の外観、規格(ベースカーブ、パワー、サイズ)、表面の水濡れ性を測定し、試験前のレンズと比較した。なお、対照として現在市販されているコンタクトレンズ用洗浄保存液(商品名「オーツーケア」:(株)メニコン製)を使用した。その結果、本発明例、対照ともに外観、規格、水濡れ性に関し、試験前のレンズのそれとの間に差が無かった。従って、本発明例の液剤はレンズに対し、悪影響を与える物ではなく、良好な適合性を有していることが判る。
(実施例9)
本発明の実施例3のコンタクトレンズ用液剤について、以下の試験により防腐効力を調べた。まず、供試菌として黄色ブドウ球菌(S.a.:Staphylococcus aureus ATCC6538)、大腸菌(E.c.:Escherichia coli ATCC8739)、緑膿菌(P.a.:Pseudomonas aeruginosa ATCC9027)の細菌3菌種については、SCD(ソイビーン・カゼイン・ダイジェスト)寒天培地で33℃×24時間培養したものを用いて、酵母様真菌(C.a.:Candida albicans ATCC10231)についてはSGC培地(サブロー・ブドウ糖寒天培地)で33℃×24時間培養したものを用いて、それぞれ滅菌生理食塩液に懸濁し、107〜108cfu/mLの供試菌液となるように調製した。また、黒麹菌(A.n.:Aspergillus niger ATCC16404)についてはSGA培地で23℃×7日間培養したものを用い、0.05%ポリソルベート添加滅菌生理食塩液に懸濁し、107〜108cfu/mLの供試菌液となるように調製した。
菌減少量〔対数換算〕=LOG(調製直後の菌懸濁1ml中の生菌数)−LOG(処理後の菌懸濁液1ml中の生菌数)
Claims (3)
- (a)炭素数5〜6のポリオール、(b)微生物由来の蛋白分解酵素、(c)界面活性剤であるα−オレフィンスルホン酸塩及びポリオキシエチレンアルキルエーテル、(d)ピロリドンカルボン酸もしくはその塩の中から選択される少なくとも1種を含有し、前記(a)成分濃度が0.1〜15.0w/v%、前記(b)成分濃度が0.001〜5.0w/v%、前記(c)成分のうちα−オレフィンスルホン酸塩濃度が0.01〜5.0w/v%でポリオキシエチレンアルキルエーテル濃度が0.01〜3.0w/v%、前記(d)成分濃度が0.01〜0.5w/v%であることを特徴とするコンタクトレンズ用液剤組成物。
- (a)炭素数5〜6のポリオール、(b)微生物由来の蛋白分解酵素、(c)界面活性剤であるα−オレフィンスルホン酸塩及びポリオキシエチレンアルキルエーテル、(d)アミノ酸であるアルギニン、リジン、ヒスチジン、トレオニン、グリシン、セリン、アスパラギン、グルタミン、アラニン、バリン、ロイシン、イソロイシン、メチオニン、プロリン、アスパラギン酸、グルタミン酸、又はそれらの塩から選択される少なくとも2種、(e)ポリビニルピロリドン(コリドン30:BASF Co製)及び乳酸ナトリウムを含有し、前記(a)成分濃度が0.1〜15.0w/v%、前記(b)成分濃度が0.001〜5.0w/v%、前記(c)成分のうちα−オレフィンスルホン酸塩濃度が0.01〜5.0w/v%でポリオキシエチレンアルキルエーテル濃度が0.01〜3.0w/v%、前記(d)成分の1種類の濃度が0.001〜2.0w/v%であることを特徴とするコンタクトレンズ用液剤組成物。
- 前記炭素数5〜6のポリオールが、1,2−ペンタンジオール、1,3−ペンタンジオール、1,4−ペンタンジオール、1,5−ペンタンジオール、シクロペンタン1,2−ジオールまたは1,2−ヘキサンジオール、1,3−ヘキサンジオール、1,4−ヘキサンジオール、1,5−ヘキサンジオール、1,6−ヘキサンジオール、2−メチル−2,4−ペンタンジオール、シクロヘキサン−1,3−ジオール、1,2,6−ヘキサントリオール、メチルシクロヘキサン−1,2,4−トリオール、シクロヘキサン−1,2,4,5−テトロールの中から選択される少なくとも1種であることを特徴とする請求項1又は2に記載のコンタクトレンズ用液剤組成物。
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