JP3693657B2 - Contact lens solution - Google Patents
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- JP3693657B2 JP3693657B2 JP2003111228A JP2003111228A JP3693657B2 JP 3693657 B2 JP3693657 B2 JP 3693657B2 JP 2003111228 A JP2003111228 A JP 2003111228A JP 2003111228 A JP2003111228 A JP 2003111228A JP 3693657 B2 JP3693657 B2 JP 3693657B2
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- contact lens
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Description
【0001】
【発明の属する技術分野】
本発明はコンタクトレンズ用液剤に関する。さらに詳しくは、コンタクトレンズの保存液として短時間で十分な抗菌効果を有すると同時に、眼組織に対して十分な安全性を有するコンタクトレンズ用液剤に関する。
【0002】
【従来の技術】
一般に、コンタクトレンズは、ハードコンタクトレンズとソフトコンタクトレンズに大別される。このうち、ソフトコンタクトレンズは非含水タイプと含水ゲルタイプに分類される。
コンタクトレンズは、ハードコンタクトレンズ、ソフトコンタクトレンズにかかわらず、目に装着した場合、涙液由来の成分などによる汚れや、手指や眼組織由来の真菌・細菌などの雑菌がレンズに付着する。それゆえ、レンズ装用後、これらの汚れを除去する他、レンズに付着した雑菌を除去、消毒し、再び衛生的に装用できるようにする必要がある。
コンタクトレンズの装用が要因の一つである感染症として、潰瘍性角膜炎が挙げられ、場合によっては失明に至ることもある。この潰瘍性角膜炎という疾患は、コンタクトレンズ装用者は非装用者に対比して80倍罹患率が高くなるという報告があり(Lancet 338巻 p.650−653(1991))、このような危険な感染症を防ぐ意味からもコンタクトレンズの衛生的な装用、とりわけ、装用後の消毒処理は重要である。特に、含水ソフトコンタクトレンズは消毒が義務づけられている。
【0003】
旧来、コンタクトレンズの消毒処理は、煮沸消毒もしくは過酸化水素による化学消毒が広く用いられていた。しかしながら、前者は特別な煮沸器を必要とし、かつ、常に煮沸器を作動させるための電源を確保しなければならず、これはたとえば旅行者にとっては大きな負担であった。過酸化水素を用いればこの問題を避けることが可能であるが、今度は、過酸化水素を注意深く中和する工程を行う必要が生じ、もし、中和が不十分な場合は、過酸化水素による眼組織の薬傷を負う危険性があり、携帯性、安全性、簡便性、長期保存性にすぐれたコンタクトレンズの消毒保存液が求められている。
たとえば、特許文献1では、ポリリジンを用いたコンタクトレンズの保存消毒液が開示されている。しかしながら、上述した眼組織の感染症に関連する微生物のうち、黄色ブドウ球菌やカンジダ・アルビカンス等に対する効果が弱く、コンタクトレンズの消毒保存液として十分な殺菌効果を得るためにはポリリジンを多量に含有させるか、あるいは、液剤にコンタクトレンズを長い時間浸漬させる必要が生じ、このため、経済的な観点や簡便性の観点、あるいは、大量にポリリジンを含有させることから生じる毒性の点などから問題が多く、コンタクトレンズの消毒保存液としては実用化には至っていないのが現状である。
【0004】
【特許文献1】
国際公開第97/27879号
【0005】
【発明が解決しようとする課題】
本発明の目的は、コンタクトレンズの消毒保存用溶液に用いるためのポリリジンの有効性を高め、少量で短時間で有害な微生物を殺菌できると同時に、なおかつ眼組織に有害な作用を及ぼさない、安全なコンタクトレンズ用液剤を提供することにある。
【0006】
【課題を解決するための手段】
本発明者らは、上記の課題を解決するために鋭意検討した結果、コンタクトレンズ用液剤に構造式(1)で表される化合物とε−ポリリジンとを同時に含有させると、意外なことに抗菌効果が相乗的に高められ、その結果、含有濃度を抑えることができると同時に、消毒時間を短縮することが可能であることを見出し、本発明を完成させた。
即ち本発明は、(a)微生物学的に有効量のε−ポリリジン、及び下記構造式(1)で表される化合物を含有することを特徴とするコンタクトレンズ用液剤、である。
【化2】
(但し式中、Rはアルキル基。)
【0007】
以下、本発明を詳細に説明する。
本発明のコンタクトレンズ用液剤とは、(a)ε−ポリリジンと、(b)上記構造式(1)で表される化合物とを含有することを特徴とするコンタクトレンズ用液剤である。
本発明で用いられるε−ポリリジンは微生物に対して、幅広い抗菌活性が知られている。しかしながら、カンジダ・アルビカンスなどの真菌類や黄色ブドウ球菌等に対しては効果が弱く、コンタクトレンズの消毒保存液として十分な殺菌効果を得るためにはε−ポリリジンを多量に含有させるか、あるいは、液剤にコンタクトレンズを長い時間浸漬させなくてはならない。しかしながら、構造式(1)で表される化合物とε−ポリリジンとを同時に含有させると、意外なことに抗菌効果が相乗的に高められ、その結果、含有濃度を抑えることができると同時に、消毒時間を短縮することが可能であることが判明した。
【0008】
ε−ポリリジンの含有量は0.1ppm〜10%であることが好ましく、1ppm〜1%がさらに好ましく、10ppm〜0.1%であることがとりわけ好ましく、20〜100ppmが最も好ましい。あまり高濃度で添加すると毒性の観点、あるいは、経済的な観点から好ましくなく、低濃度で添加しても所定の抗菌効果が得られない。
構造式(1)で表される化合物化合物としては、ステアリン酸スクロース、ミリスチン酸スクロース、ラウリン酸スクロース、オレイン酸スクロース、トリベヘン酸スクロース、ヘキサエルカ酸スクロース、ペンタエルカ酸スクロースなどが挙げられるが、眼刺激性の観点、毒性の観点、抗菌効果の観点などからラウリン酸スクロースや、ステアリン酸スクロース、ミリスチン酸スクロース、オレイン酸スクロースなどが好ましい。これらの化合物の含有量については、1ppm〜5%が好ましく、10ppm〜0.5%がさらに好ましく、100ppm〜0.1%がとりわけ好ましい。1ppmを下回った濃度では所望の効果が得られず、5%を越えると毒性の観点や経済的な観点から好ましくない。
【0009】
本発明でいうところのコンタクトレンズ用液剤とは、日本コンタクトレンズ協会の定めたコンタクトレンズ用洗浄剤、保存剤、洗浄保存剤に関する安全自主基準第2条に定められた各種ケア用品、すなわち、コンタクトレンズ用洗浄剤、保存剤、洗浄保存剤、溶解水および医薬部外品であるソフトコンタクトレンズ用消毒剤等を指すが、用時調整用の顆粒、粉末、タブレット等にあらかじめこれら化合物を含有させておいたものも本発明に含まれることは上記自主基準に示されている通りである。
また、本発明の溶液には、本発明を逸脱しない範囲で、キレート剤、緩衝剤等を配合することも可能である。キレート剤としては、エチレンジアミン四酢酸二ナトリウム(EDTA-2Na)、ヘキサメタリン酸ナトリウム等が例示でき、通常0.005〜1%の範囲で使用する。緩衝剤としては、重炭酸ナトリウム、リン酸ナトリウム、リン酸水素ナトリウム、ホウ酸、ホウ砂、クエン酸、クエン酸ナトリウムまたはカリウム、トリスヒドロキシメチルアミノメタン等が例示でき、通常0.01〜1%の範囲で使用する。
【0010】
また、同様に、本発明の目的を逸脱しない範囲で、界面活性剤、酵素、増粘剤を単独もしくは併用で共存させることができる。界面活性剤としては、アニオン性界面活性剤、カチオン性界面活性剤、非イオン性界面活性剤、両性界面活性剤等が単独または併用で使用でき、アニオン性界面活性剤としては、アルキルベンゼンスルホン酸ナトリウム、アルキル硫酸ナトリウム、α−オレフィンスルホン酸ナトリウム、ポリオキシエチレンアルキルエーテル硫酸ナトリウム、アルキロイルメチルタウリンナトリウム、アルキロイルベンザルコシンナトリウム等、非イオン性界面活性剤としては、ポリ(オキシエチレン)−ポリ(オキシプロピレン)ブロック共重合体、ポリオキシエチレンソルビタンアルキルエステル、ポリオキシエチレン硬化ヒマシ油、ポリオキエチレンラウリルエーテル等、両性界面活性剤としては、N−ラウロイルアミノプロピル−N,N−ジメチルグリシン、N−ココイルアミノプロピル−N,N−ジメチルグリシン、アルキルジアミノエチルグリシン、ヤシ油脂肪酸アミドプロピルベタイン、ラウリン酸アミドプロピルベタイン、ラウリルジメチルアミノ酢酸ベタイン等が例示できる。
通常これらの界面活性剤は、0.01〜2%の範囲で使用されるが、非イオン性界面活性剤が眼組織への刺激が少ないことから好んで用いられる。
【0011】
酵素としては、蛋白分解酵素、脂質分解酵素、多糖類分解酵素が単独または併用で使用でき、蛋白分解酵素としては、植物由来のパパイン、パンクレアチン等、サブチリシン、ストレプトマイセス属等の微生物由来のプロテアーゼやペプチダーゼ、動物由来のトリプシン、ペプシン等、脂質分解酵素としては、ヘパリナーゼ、ヒアルノニナーゼ、アミラーゼ、デキストラナーゼ等が例示でき、通常0.005〜5%の範囲で使用する。増粘剤としては、ヒアルロン酸ナトリウム等のムコ多糖類、ポリビニルアルコール、ヒドロキシプロピルメチルセルロース等のメチルセルロース及びその誘導体、ポリエチレングリコール等が例示でき、通常、0.1〜5%の範囲で使用する。本発明では、その他の物質、例えば、香料、色素などとの併用を制限するものではなく、必要に応じてこれらの物質を共存させることも自由である。
【0012】
【発明の実施の形態】
以下、実施例などにより本発明を具体的に説明するが、本発明はこれら実施例などにより何ら限定されるものではない。
【実施例1〜3】
各成分を表1に示した配合で精製水に溶解し、1N水酸化ナトリウム水溶液もしくは、1N塩酸でpHを7.2に調整し、各種液剤を作成した。すべての液剤で黄色ブドウ球菌とカンジダ・アルビカンスに対する抗菌力試験とV79細胞を用いた細胞毒性試験を行った。
【表1】
【0013】
【比較例1〜4】
各成分を表2に示した配合で精製水に溶解し、1N水酸化ナトリウム水溶液もしくは1N塩酸でpHを7.2に調整し各種液剤を作成した。すべての液剤で黄色ブドウ球菌とカンジダ・アルビカンスに対する抗菌力試験とV79細胞を用いた細胞毒性試験を行った。
【表2】
【0014】
抗菌力試験
基本的な操作方法はISO14729に従った。すなわち、Staphylococcus aureus ATCC 6538もしくはCandida albicans ATCC 10231は斜面寒天培地にて前培養を行った後、緩衝液に懸濁し、試験菌液を調整した。実施例もしくは比較例に示した各液剤に試験菌液の一定量を無菌的に加え、室温下に放置した。初発の生菌数と4時間処理後の生菌数を測定し、下式で抗菌力を表示した。
生菌数の対数減少量=log(初発の生菌数)−log(4時間処理後の生菌数)
【0015】
細胞毒性試験
「医療用具及び医用材料の基礎的な生物学的試験のガイドライン」(平成7年6月27日、薬機第99号)、「医薬品の安全性に関する非臨床試験の実施の基準に関する省令」(平成9年3月26日、厚生省令第21号)および「医薬品の安全性に関する非臨床試験の実施の基準に関する省令の施行について」(平成9年3月27日、薬発第424号)に準拠して行った。すなわち、V79細胞を6ウェルプレートに一定数播種し、10%添加を最大濃度として段階希釈した被験液を添加して培養した。培養終了後、固定し、染色液で染色した。ウェルあたりのコロニー数を計測し、陰性対照(注射用蒸留水)と比較して、相対コロニー形成率を算出した。最大濃度でコロニー形成率が陰性対照の50%を下回るものを細胞毒性陽性と判定し、50%以上のものは細胞毒性陰性と判定した。
【0016】
結果は表3〜5に示した通りである。実施例1〜11は良好な抗菌力を示したが、比較例1、3、4は抗菌力はほとんど認められないか、僅かであった。実施例1〜3は細胞毒性を示さないのに対し、比較例2は細胞毒性が認められた。
【表3】
【0017】
【表4】
【0018】
【表5】
【0019】
【発明の効果】
本発明によるコンタクトレンズ用液剤は、短時間で有害な微生物を殺菌できると同時に、なおかつ眼組織に有害な作用を及ぼさない、コンタクトレンズ用液剤の安全性・有効性を改良せしめる効果がある。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a contact lens solution. More specifically, the present invention relates to a contact lens solution that has a sufficient antibacterial effect in a short time as a storage solution for contact lenses and at the same time has sufficient safety for ocular tissues.
[0002]
[Prior art]
In general, contact lenses are roughly classified into hard contact lenses and soft contact lenses. Among these, soft contact lenses are classified into a non-hydrous type and a hydrogel type.
Regardless of whether the contact lens is a hard contact lens or a soft contact lens, when it is attached to the eye, dirt due to components derived from tears, and bacteria such as fungi and bacteria derived from fingers and eye tissues adhere to the lens. Therefore, after the lens is worn, it is necessary to remove these stains and to remove and disinfect the germs attached to the lens so that they can be worn again hygienically.
Infectious diseases in which wearing contact lenses is one of the factors include ulcerative keratitis, which can lead to blindness in some cases. There is a report that this disease called ulcerative keratitis is 80 times more prevalent in contact lens wearers than non-wearers (Lancet 338, pp.650-653 (1991)). From the viewpoint of preventing various infectious diseases, sanitary wearing of contact lenses, in particular, disinfection treatment after wearing is important. In particular, disinfection of water-containing soft contact lenses is obligatory.
[0003]
Traditionally, bactericidal or chemical disinfection with hydrogen peroxide has been widely used to disinfect contact lenses. However, the former requires a special boiling machine and always has to secure a power source for operating the boiling machine, which has been a heavy burden for travelers, for example. This problem can be avoided by using hydrogen peroxide, but this time, it becomes necessary to carry out a process of carefully neutralizing hydrogen peroxide. There is a need for a disinfecting preservation solution for contact lenses that has a risk of causing chemical damage to eye tissue and is excellent in portability, safety, convenience, and long-term preservation.
For example, Patent Document 1 discloses a storage antiseptic solution for contact lenses using polylysine. However, among the above-mentioned microorganisms related to infection of the eye tissue, the effect on Staphylococcus aureus and Candida albicans is weak, and in order to obtain a sufficient bactericidal effect as a disinfecting preservation solution for contact lenses, a large amount of polylysine is contained. Or contact lenses need to be immersed in the liquid solution for a long time. Therefore, there are many problems from the viewpoints of economy and convenience, or toxicity caused by containing a large amount of polylysine. As a disinfectant preservation solution for contact lenses, it has not been put into practical use.
[0004]
[Patent Document 1]
International Publication No. 97/27879 [0005]
[Problems to be solved by the invention]
The object of the present invention is to increase the effectiveness of polylysine for use in a solution for disinfecting and preserving contact lenses, to disinfect harmful microorganisms in a short time in a small amount, and at the same time, has no harmful effect on the eye tissue. It is to provide a liquid agent for contact lenses.
[0006]
[Means for Solving the Problems]
As a result of intensive studies to solve the above-mentioned problems, the present inventors have surprisingly found that when the contact lens solution contains the compound represented by the structural formula (1) and ε-polylysine at the same time, antibacterial activity is achieved. The effect has been enhanced synergistically, and as a result, it has been found that the concentration can be suppressed and at the same time the disinfection time can be shortened, and the present invention has been completed.
That is, the present invention is a contact lens solution characterized by comprising (a) a microbiologically effective amount of ε-polylysine and a compound represented by the following structural formula (1).
[Chemical formula 2]
(In the formula, R is an alkyl group.)
[0007]
Hereinafter, the present invention will be described in detail.
The contact lens solution of the present invention is a contact lens solution containing (a) ε-polylysine and (b) the compound represented by the structural formula (1).
Ε-polylysine used in the present invention is known to have a wide range of antibacterial activities against microorganisms. However, it is less effective against fungi such as Candida albicans, Staphylococcus aureus, etc., and in order to obtain a sufficient bactericidal effect as a disinfecting preservation solution for contact lenses, ε-polylysine is contained in a large amount, or The contact lens must be immersed in the solution for a long time. However, when the compound represented by the structural formula (1) and ε-polylysine are contained at the same time, the antibacterial effect is surprisingly enhanced synergistically. It has been found that it is possible to reduce the time.
[0008]
The content of ε-polylysine is preferably 0.1 ppm to 10%, more preferably 1 ppm to 1%, particularly preferably 10 ppm to 0.1%, and most preferably 20 to 100 ppm. If it is added at a very high concentration, it is not preferable from the viewpoint of toxicity or economical, and even if it is added at a low concentration, a predetermined antibacterial effect cannot be obtained.
Examples of the compound represented by the structural formula (1) include sucrose stearate, sucrose myristate, sucrose laurate, sucrose oleate, sucrose tribehenate, sucrose hexaerucate, sucrose pentapentarate, and the like. From the above viewpoints, toxicity viewpoint, antibacterial effect viewpoint, sucrose laurate, sucrose stearate, sucrose myristate, sucrose oleate and the like are preferable. The content of these compounds is preferably 1 ppm to 5%, more preferably 10 ppm to 0.5%, and particularly preferably 100 ppm to 0.1%. If the concentration is less than 1 ppm, the desired effect cannot be obtained, and if it exceeds 5%, it is not preferable from the viewpoint of toxicity and economical.
[0009]
The contact lens solution referred to in the present invention is a contact lens cleaning agent, preservative, and various care products defined in Article 2 of the Voluntary Safety Standards for Cleaning Preservatives, that is, contacts. This refers to lens cleaning agents, preservatives, cleaning preservatives, dissolved water and quasi-drugs, soft contact lens disinfectants, etc. It is as shown in the above-mentioned voluntary standard that what has been described is also included in the present invention.
Moreover, a chelating agent, a buffering agent, etc. can also be mix | blended with the solution of this invention in the range which does not deviate from this invention. Examples of the chelating agent include disodium ethylenediaminetetraacetate (EDTA-2Na), sodium hexametaphosphate and the like, and they are usually used in the range of 0.005 to 1%. Examples of the buffer include sodium bicarbonate, sodium phosphate, sodium hydrogen phosphate, boric acid, borax, citric acid, sodium or potassium citrate, trishydroxymethylaminomethane, etc., usually 0.01 to 1% Use within the range.
[0010]
Similarly, surfactants, enzymes, and thickeners can be used alone or in combination within a range not departing from the object of the present invention. As the surfactant, an anionic surfactant, a cationic surfactant, a nonionic surfactant, an amphoteric surfactant, etc. can be used alone or in combination. As the anionic surfactant, sodium alkylbenzene sulfonate is used. Nonionic surfactants such as sodium alkyl sulfate, sodium α-olefin sulfonate, sodium polyoxyethylene alkyl ether sulfate, sodium alkyloxymethyl taurate, sodium alkyl yl sarcosine, etc. include poly (oxyethylene) -poly (Oxypropylene) block copolymer, polyoxyethylene sorbitan alkyl ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene lauryl ether, etc., as the amphoteric surfactant, N-lauroylaminopropyl-N, N-dimethyl Lysine, N- cocoyl aminopropyl -N, N- dimethyl glycine, alkyldiaminoethylglycine, coconut oil fatty acid amide propyl betaine, lauric acid amidopropyl betaine, lauryl betaine and the like.
Usually, these surfactants are used in the range of 0.01 to 2%, but nonionic surfactants are preferably used because they are less irritating to ocular tissues.
[0011]
As the enzyme, a proteolytic enzyme, a lipolytic enzyme, and a polysaccharide degrading enzyme can be used alone or in combination. As the proteolytic enzyme, plant-derived papain, pancreatin, etc., subtilisin, Streptomyces genus, etc. Examples of lipolytic enzymes such as protease, peptidase, animal-derived trypsin, and pepsin include heparinase, hyaluroninase, amylase, and dextranase, and are usually used in the range of 0.005 to 5%. Examples of the thickening agent include mucopolysaccharides such as sodium hyaluronate, methylcellulose such as polyvinyl alcohol and hydroxypropylmethylcellulose and derivatives thereof, polyethylene glycol, and the like, and they are usually used in the range of 0.1 to 5%. In this invention, combined use with other substances, for example, a fragrance | flavor, a pigment | dye, etc. is not restrict | limited, These substances can also coexist as needed.
[0012]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the present invention will be specifically described with reference to examples, but the present invention is not limited to these examples.
Examples 1 to 3
Each component was dissolved in purified water with the formulation shown in Table 1, and the pH was adjusted to 7.2 with 1N aqueous sodium hydroxide or 1N hydrochloric acid to prepare various solutions. All solutions were tested for antibacterial activity against Staphylococcus aureus and Candida albicans and cytotoxicity tests using V79 cells.
[Table 1]
[0013]
[Comparative Examples 1-4]
Each component was dissolved in purified water with the formulation shown in Table 2, and the pH was adjusted to 7.2 with 1N aqueous sodium hydroxide or 1N hydrochloric acid to prepare various solutions. All solutions were tested for antibacterial activity against Staphylococcus aureus and Candida albicans and cytotoxicity tests using V79 cells.
[Table 2]
[0014]
Antibacterial activity test Basic operation method followed ISO14729. That is, Staphylococcus aureus ATCC 6538 or Candida albicans ATCC 10231 was pre-cultured on a slope agar medium and then suspended in a buffer solution to prepare a test bacterial solution. A fixed amount of the test bacterial solution was aseptically added to each solution shown in Examples or Comparative Examples, and left at room temperature. The initial viable count and the viable count after 4 hours of treatment were measured, and the antibacterial activity was displayed using the following formula.
Log reduction of viable cell count = log (initial viable cell count) −log (viable cell count after 4 hours treatment)
[0015]
Cytotoxicity test “Guidelines for basic biological tests of medical devices and materials” (June 27, 1995, Drug Machine No. 99), “Standards for conducting non-clinical studies on drug safety "Ministerial Ordinance" (March 26, 1997, Ministry of Health and Welfare Ordinance No. 21) and "Enforcement of Ministerial Ordinance on Standards for Implementation of Non-clinical Studies on Drug Safety" (March 27, 1997, Yakushu No. 424) No.). That is, a fixed number of V79 cells were seeded in a 6-well plate, and a test solution diluted serially with 10% addition as the maximum concentration was added and cultured. After completion of the culture, the cells were fixed and stained with a staining solution. The number of colonies per well was counted and compared to a negative control (distilled water for injection) to calculate the relative colony formation rate. Those having a colony formation rate below 50% of the negative control at the maximum concentration were determined as positive for cytotoxicity, and those with 50% or more were determined as negative for cytotoxicity.
[0016]
The results are as shown in Tables 3-5. Examples 1 to 11 showed good antibacterial activity, but Comparative Examples 1, 3, and 4 showed little or no antibacterial activity. While Examples 1 to 3 did not show cytotoxicity, Comparative Example 2 showed cytotoxicity.
[Table 3]
[0017]
[Table 4]
[0018]
[Table 5]
[0019]
【The invention's effect】
The contact lens solution according to the present invention can sterilize harmful microorganisms in a short time, and at the same time, has an effect of improving the safety and effectiveness of the contact lens solution that does not adversely affect the eye tissue.
Claims (6)
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