JP2019214560A - Collyrium composition - Google Patents
Collyrium composition Download PDFInfo
- Publication number
- JP2019214560A JP2019214560A JP2019107104A JP2019107104A JP2019214560A JP 2019214560 A JP2019214560 A JP 2019214560A JP 2019107104 A JP2019107104 A JP 2019107104A JP 2019107104 A JP2019107104 A JP 2019107104A JP 2019214560 A JP2019214560 A JP 2019214560A
- Authority
- JP
- Japan
- Prior art keywords
- eyewash
- eyewash composition
- composition according
- poe
- castor oil
- 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.)
- Pending
Links
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Abstract
Description
本発明は、洗眼剤組成物に関する。 The present invention relates to an eyewash composition.
従来、洗眼剤を用いて眼を洗浄する際にはアイカップが用いられている(例えば、特許文献1)。しかしながら、アイカップが実質的に必須であることから洗眼剤による眼の洗浄が可能な場面が限定されてしまい、例えば外出時等における眼の洗浄について不便を強いられていた。 2. Description of the Related Art Conventionally, an eyecup has been used to wash eyes with an eyewash (for example, Patent Document 1). However, since the eyecup is substantially essential, the scenes where the eyes can be washed with the eyewash are limited, and for example, it has been inconvenient to wash the eyes when going out.
本発明は、直接点眼して眼を洗浄することのできる洗眼剤組成物を提供することを目的とする。 An object of the present invention is to provide an eyewash composition that can wash eyes by direct instillation.
本発明者は、上記課題を解決すべく鋭意検討を行った結果、1回あたり3〜12滴の点眼により、水溶性異物や固形異物が十分に除去され、眼を洗浄することができることを見出した。本発明は、この知見に基づくものであり、以下の各発明を提供するものである。 The present inventor has conducted intensive studies in order to solve the above-mentioned problems, and as a result, found that by applying 3 to 12 drops per time, water-soluble foreign matters and solid foreign matters can be sufficiently removed, and the eyes can be washed. Was. The present invention is based on this finding, and provides the following inventions.
[1]
1回3〜12滴を点眼して眼を洗浄する使用のための、洗眼剤組成物。
[2]
(A)抗ヒスタミン剤を含有し、(A)成分の含有量が洗眼剤組成物の総量を基準として0.00006〜0.05w/v%であり、pHが5.0〜8.5である、[1]に記載の洗眼剤組成物。
[3]
(B)脂溶性成分、及び(C)非イオン界面活性剤を更に含有する、[1]又は[2]に記載の洗眼剤組成物。
[4]
(B)成分が、清涼化剤、ビタミンE、ビタミンA、及び油からなる群より選択される少なくとも1種である、[3]に記載の洗眼剤組成物。
[5]
(C)成分が、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンヒマシ油、ポリオキシエチレンポリオキシプロピレングリコール、及びモノステアリン酸ポリエチレングリコールからなる群より選択される少なくとも1種である、[3]に記載の洗眼剤組成物。
[6]
清涼化剤を含有し、pHが5.0〜8.5である、[1]に記載の洗眼剤組成物。
[7]
清涼化剤が、メントール、カンフル、ボルネオール、及びゲラニオールからなる群より選択される少なくとも1種である、[6]に記載の洗眼剤組成物。
[8]
非イオン界面活性剤を更に含有する、[6]に記載の洗眼剤組成物。
[9]
非イオン界面活性剤が、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンヒマシ油、ポリオキシエチレンポリオキシプロピレングリコール、及びモノステアリン酸ポリエチレングリコールからなる群より選択される少なくとも1種である、[8]に記載の洗眼剤組成物。
[10]
粘度が1〜10mPa・sである、[1]〜[9]のいずれかに記載の洗眼剤組成物。
[11]
洗眼剤組成物と接触する部分の少なくとも一部がポリエチレンで形成された容器に収容される、[1]〜[10]のいずれかに記載の洗眼剤組成物。
[1]
An eyewash composition for use in washing eyes by applying 3 to 12 drops at a time.
[2]
(A) It contains an antihistamine, the content of the component (A) is 0.00006 to 0.05 w / v% based on the total amount of the eyewash composition, and the pH is 5.0 to 8.5. The eyewash composition according to [1].
[3]
The eyewash composition according to [1] or [2], further comprising (B) a fat-soluble component, and (C) a nonionic surfactant.
[4]
(B) The eyewash composition according to [3], wherein the component is at least one selected from the group consisting of a cooling agent, vitamin E, vitamin A, and oil.
[5]
Component (C) is at least one selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, polyoxyethylene polyoxypropylene glycol, and polyethylene glycol monostearate The eyewash composition according to [3], which is:
[6]
The eyewash composition according to [1], comprising a cooling agent and having a pH of 5.0 to 8.5.
[7]
The eyewash composition according to [6], wherein the cooling agent is at least one selected from the group consisting of menthol, camphor, borneol, and geraniol.
[8]
The eyewash composition according to [6], further comprising a nonionic surfactant.
[9]
The nonionic surfactant is at least one selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, polyoxyethylene polyoxypropylene glycol, and polyethylene glycol monostearate. The eyewash composition according to [8], which is a seed.
[10]
The eyewash composition according to any one of [1] to [9], which has a viscosity of 1 to 10 mPa · s.
[11]
The eyewash composition according to any one of [1] to [10], wherein at least a part of a portion that comes into contact with the eyewash composition is contained in a container formed of polyethylene.
本発明によれば、直接点眼して眼を洗浄することのできる洗眼剤組成物を提供することができる。 ADVANTAGE OF THE INVENTION According to this invention, the eyewash composition which can wash eyes by dropping directly can be provided.
以下、本発明を実施するための形態について詳細に説明する。ただし、本発明は以下の実施形態に限定されるものではない。 Hereinafter, embodiments for carrying out the present invention will be described in detail. However, the present invention is not limited to the following embodiments.
本明細書において、特に記載のない限り、含有量の単位「%」は「w/v%」を意味し、「g/100mL」と同義である。 In this specification, the unit “%” of the content means “w / v%” and is synonymous with “g / 100 mL” unless otherwise specified.
〔1.洗眼剤組成物〕
本実施形態に係る洗眼剤組成物は、1回3〜12滴を点眼して使用する。
[1. Eyewash composition)
The eyewash composition according to the present embodiment is used by applying 3 to 12 drops at a time.
本実施形態に係る洗眼剤組成物を点眼する際において、1回あたりの滴数は3〜12滴であればよいが、本発明による効果をより顕著に奏するという観点から、4〜12滴であることが好ましく、4〜9滴であることがより好ましく、4〜6滴であることが更に好ましい。 When instilling the eyewash composition according to the present embodiment, the number of drops per time may be 3 to 12 drops, but from the viewpoint that the effect of the present invention is more remarkably exhibited, 4 to 12 drops. Preferably, it is 4 to 9 drops, more preferably 4 to 6 drops.
本実施形態に係る洗眼剤組成物を点眼する際において、1滴あたりの滴下量は本発明による効果を奏する滴下量であれば特に限定されないが、本発明による効果をより顕著に奏するという観点から、5〜100μLでることが好ましく、10〜80μLであることがより好ましく、20〜60μLであることが更に好ましく、30〜50μLであることが更により好ましい。なお、1滴あたりの滴下量は、容器の材質、中栓(ノズル)又は注出口の開口部の面積、容器本体の厚みや周面における圧縮強度を適宜設定すること等により調整することができる。 When instilling the eyewash composition according to the present embodiment, the drop amount per drop is not particularly limited as long as the drop amount exerts the effect of the present invention, but from the viewpoint that the effect of the present invention is more remarkably exhibited. , Preferably 5 to 100 μL, more preferably 10 to 80 μL, even more preferably 20 to 60 μL, and even more preferably 30 to 50 μL. The amount of each droplet can be adjusted by appropriately setting the material of the container, the area of the opening of the inner plug (nozzle) or the spout, the thickness of the container body, and the compressive strength of the peripheral surface. .
本実施形態に係る洗眼剤組成物は、(A)抗ヒスタミン剤(単に「(A)成分」とも表記する。)を含有することが好ましい。洗眼剤組成物が(A)成分を含有することで、本発明による効果がより顕著に奏される。 The eyewash composition according to the present embodiment preferably contains (A) an antihistamine (also simply referred to as “component (A)”). When the eyewash composition contains the component (A), the effect of the present invention is more remarkably exhibited.
〔(A)成分〕
抗ヒスタミン剤は、抗ヒスタミン作用を有する化合物、及びその塩である。抗ヒスタミン剤は、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。
[Component (A)]
The antihistamine is a compound having an antihistamine action, and a salt thereof. The antihistamine is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
抗ヒスタミン剤の具体例としては、クロルフェニラミン、イプロヘプチン、ジフェンヒドラミン、ケトチフェン、オロパタジン、レボカバスチン、及びそれらの塩が挙げられる。抗ヒスタミン剤としては、クロルフェニラミン及びその塩、ジフェンヒドラミン及びその塩が好ましく、クロルフェニラミンマレイン酸塩、ジフェンヒドラミン塩酸塩がより好ましく、クロルフェニラミンマレイン酸塩が更に好ましい。 Specific examples of the antihistamine include chlorpheniramine, iproheptin, diphenhydramine, ketotifen, olopatadine, levocabastine, and salts thereof. As the antihistamine, chlorpheniramine and its salts, diphenhydramine and its salts are preferable, chlorpheniramine maleate and diphenhydramine hydrochloride are more preferable, and chlorpheniramine maleate is further preferable.
抗ヒスタミン剤は、市販されているものを使用してもよい。抗ヒスタミン剤は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 A commercially available antihistamine may be used. One kind of the antihistamine may be used alone, or two or more kinds thereof may be used in combination.
本実施形態に係る洗眼剤組成物における(A)成分の含有量は特に限定されず、(A)成分の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。(A)成分の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、(A)成分の総含有量が、0.00006〜0.05w/v%であることが好ましく、0.0001〜0.01w/v%であることがより好ましく、0.0006〜0.005w/v%であることが更に好ましい。 The content of the component (A) in the eyewash composition according to the present embodiment is not particularly limited, and the type of the component (A), the type and content of other compounding components, the use and the formulation of the eyewash composition, and the like. Is set as appropriate according to. As the content of the component (A), from the viewpoint of more remarkably exerting the effects of the present invention, for example, the total content of the component (A) is 0.00006 to 0. It is preferably 0.05 w / v%, more preferably 0.0001 to 0.01 w / v%, and still more preferably 0.0006 to 0.005 w / v%.
本実施形態に係る洗眼剤組成物のpHは、(A)成分(特にクロルフェニラミンおよびその塩)の安定性の点で、5.0〜8.5であることが好ましく、5.0〜8.0であることがより好ましく、5.0〜7.5であることが更に好ましく、5.0〜7.0であることが更により好ましく、5.0〜6.5であることが特に好ましい。 The pH of the eyewash composition according to the present embodiment is preferably 5.0 to 8.5 in view of the stability of the component (A) (particularly, chlorpheniramine and a salt thereof), and is preferably 5.0 to 8.5. It is more preferably 8.0, further preferably 5.0 to 7.5, still more preferably 5.0 to 7.0, and still more preferably 5.0 to 6.5. Particularly preferred.
本実施形態に係る洗眼剤組成物のpHは、必要に応じてpH調節剤を用いて調節することができる。pH調節剤としては、塩酸、硫酸、リン酸、ホウ酸の無機酸;酢酸、クエン酸等の有機酸;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等の無機塩基;トリエタノールアミン、ジイソプロパノールアミン等の有機塩基;リン酸ナトリウム、リン酸水素二ナトリウム、リン酸二水素ナトリウム、リン酸カリウム、リン酸水素二カリウム、リン酸二水素カリウム、酢酸ナトリウム、クエン酸ナトリウム、炭酸ナトリウム、炭酸水素ナトリウム、ホウ砂等の弱酸と強塩基の塩;塩化亜鉛、硫酸亜鉛等の強酸と弱塩基の塩が挙げられる。 The pH of the eyewash composition according to this embodiment can be adjusted using a pH adjuster as needed. Examples of the pH regulator include inorganic acids such as hydrochloric acid, sulfuric acid, phosphoric acid and boric acid; organic acids such as acetic acid and citric acid; inorganic bases such as sodium hydroxide, potassium hydroxide, calcium hydroxide and magnesium hydroxide; Organic bases such as amines and diisopropanolamine; sodium phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium phosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, sodium acetate, sodium citrate, carbonic acid Salts of weak acids and strong bases such as sodium, sodium bicarbonate, borax and the like; salts of strong acids and weak bases such as zinc chloride and zinc sulfate.
本実施形態に係る洗眼剤組成物は、(A)成分(特にクロルフェニラミンおよびその塩)の安定性の点で、(B)脂溶性成分(単に「(B)成分」とも表記する。)及び(C)非イオン界面活性剤(単に「(C)成分」とも表記する。)を含有することが好ましい。洗眼剤組成物が(B)成分及び(C)成分を含有することで、本発明による効果がより顕著に奏される。 The eyewash composition according to the present embodiment is (B) a fat-soluble component (also simply referred to as “(B) component”) in view of the stability of the component (A) (particularly, chlorpheniramine and a salt thereof). And (C) a nonionic surfactant (also simply referred to as “component (C)”). When the eyewash composition contains the component (B) and the component (C), the effects of the present invention are more remarkably exhibited.
なお、(B)成分及び(C)成分を含有する場合、本実施形態に係る洗眼剤組成物のpHは、(A)成分(特にクロルフェニラミンおよびその塩)の安定化効果がより顕著に奏される点で、6.5〜8.5であることが好ましく、7.0〜8.5であることがより好ましく、7.5〜8.5であることが更に好ましい。 When the component (B) and the component (C) are contained, the stabilizing effect of the component (A) (particularly chlorpheniramine and its salt) is more remarkable as the pH of the eyewash composition according to the present embodiment. From the viewpoint of performance, it is preferably from 6.5 to 8.5, more preferably from 7.0 to 8.5, and still more preferably from 7.5 to 8.5.
〔(B)成分〕
脂溶性成分は水分子との親和性が低い成分である。脂溶性成分は、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) component]
The fat-soluble component is a component having low affinity for water molecules. The fat-soluble component is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
脂溶性成分としては、清涼化剤、ビタミンE、ビタミンA、油が挙げられる。 Examples of the fat-soluble component include a cooling agent, vitamin E, vitamin A, and oil.
清涼化剤の具体例としては、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、樟脳油が挙げられる。清涼化剤としては、メントール、カンフル、ボルネオール、ゲラニオール、ユーカリ油、ペパーミント油、ハッカ油が好ましく、メントール、カンフル、ボルネオール、ゲラニオールがより好ましく、メントールが更に好ましい。 Specific examples of the cooling agent include menthol, menthol, camphor, borneol, geraniol, cineol, citronellol, carvone, anethole, eugenol, limonene, linalool, linalyl acetate, thymol, cimene, terpineol, pinene, camphene, isoborneol, phenene Chen, nerol, myrcene, myrsenol, linalool acetate, lavandulol, eucalyptus oil, bergamot oil, peppermint oil, cool mint oil, spearmint oil, peppermint oil, fennel oil, cinnamon oil, rose oil, camphor oil. As a cooling agent, menthol, camphor, borneol, geraniol, eucalyptus oil, peppermint oil and peppermint oil are preferred, menthol, camphor, borneol and geraniol are more preferred, and menthol is even more preferred.
ビタミンEとしては、トコフェロール及びその誘導体が挙げられる。トコフェロール誘導体の具体例としては、酢酸トコフェロール、コハク酸トコフェロール、ニコチン酸トコフェロールが挙げられる。ビタミンEとしては、トコフェロール誘導体が好ましく、酢酸トコフェロールがより好ましい。 Vitamin E includes tocopherol and its derivatives. Specific examples of tocopherol derivatives include tocopherol acetate, tocopherol succinate, and tocopherol nicotinate. As the vitamin E, a tocopherol derivative is preferable, and tocopherol acetate is more preferable.
ビタミンAとしては、レチノール及びその誘導体が挙げられる。レチノール誘導体の具体例としては、パルミチン酸レチノール、酢酸レチノール、レチナール、レチノイン酸が挙げられる。ビタミンAとしては、レチノール誘導体が好ましく、パルミチン酸レチノール、酢酸レチノールがより好ましく、パルミチン酸レチノールが更に好ましい。 Vitamin A includes retinol and its derivatives. Specific examples of the retinol derivative include retinol palmitate, retinol acetate, retinal, and retinoic acid. Vitamin A is preferably a retinol derivative, more preferably retinol palmitate or retinol acetate, and even more preferably retinol palmitate.
油としては、植物油、動物油、鉱物油が挙げられる。植物油の具体例としては、ゴマ油、ヒマシ油、オリブ油、ダイズ油、ラッカセイ油、アルモンド油、小麦胚芽油、ツバキ油、トウモロコシ油、ナタネ油、ヒマワリ油、綿実油、ヤシ油が挙げられる。動物油の具体例としては、スクワランが挙げられる。鉱物油としては、流動パラフィン、ワセリンが挙げられる。油としては、植物油が好ましく、ゴマ油、ヒマシ油がより好ましく、ゴマ油が更に好ましい。 Oils include vegetable oils, animal oils and mineral oils. Specific examples of vegetable oils include sesame oil, castor oil, olive oil, soybean oil, peanut oil, almond oil, wheat germ oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, and coconut oil. Specific examples of animal oils include squalane. Mineral oils include liquid paraffin and petrolatum. As the oil, vegetable oil is preferred, sesame oil and castor oil are more preferred, and sesame oil is even more preferred.
脂溶性成分は市販されているものを使用してもよい。脂溶性成分は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 A commercially available fat-soluble component may be used. One fat-soluble component may be used alone, or two or more fat-soluble components may be used in combination.
本実施形態に係る洗眼剤組成物における(B)成分の含有量は特に限定されず、(B)成分の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。(B)成分の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、(B)成分の総含有量が、0.00003〜0.5w/v%であることが好ましく、0.00006〜0.1w/v%であることがより好ましく、0.0003〜0.05w/v%であることが更に好ましい。また、(B)成分がビタミンAの場合、洗眼剤組成物の総量を基準として、ビタミンAの総含有量が、50〜50000IUであることが好ましく、100〜10000IUであることがより好ましく、500〜5000IUであることが更に好ましい。 The content of the component (B) in the eyewash composition according to the present embodiment is not particularly limited, and the type of the component (B), the type and content of other components, the use and the formulation of the eyewash composition, and the like. Is set as appropriate according to. As the content of the component (B), from the viewpoint of more remarkably exhibiting the effects of the present invention, for example, the total content of the component (B) is 0.00003 to 0. It is preferably 5 w / v%, more preferably 0.00006 to 0.1 w / v%, and even more preferably 0.0003 to 0.05 w / v%. When the component (B) is vitamin A, the total content of vitamin A is preferably from 50 to 50,000 IU, more preferably from 100 to 10,000 IU, and more preferably from 500 to 50,000 IU, based on the total amount of the eyewash composition. More preferably, it is 0005000 IU.
本実施形態に係る洗眼剤組成物における、(A)成分に対する(B)成分の含有比率は特に限定されず、(A)成分及び(B)成分の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。(A)成分に対する(B)成分の含有比率としては、本発明による効果をより一層高める観点から、例えば、本実施形態に係る洗眼剤組成物に含まれる(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、0.001〜50質量部であることが好ましく、0.01〜30質量部であることがより好ましく、0.1〜10質量部であることが更に好ましい。 In the eyewash composition according to the present embodiment, the content ratio of the component (B) to the component (A) is not particularly limited, and the types of the components (A) and (B), and the types and contents of other compounding components. It is set as appropriate according to the use and formulation of the eyewash composition. As the content ratio of the component (B) to the component (A), for example, from the viewpoint of further enhancing the effect of the present invention, for example, the total content of the component (A) contained in the eyewash composition according to the present embodiment is 1% by mass. Parts, the total content of the component (B) is preferably 0.001 to 50 parts by mass, more preferably 0.01 to 30 parts by mass, and 0.1 to 10 parts by mass. More preferably, it is.
〔(C)成分〕
非イオン界面活性剤は、界面活性剤のうち、イオンに解離する基を有しないものである。非イオン界面活性剤は、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) component]
The nonionic surfactant is a surfactant that does not have a group that dissociates into ions. The nonionic surfactant is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
非イオン界面活性剤の具体例としては、モノラウリン酸POE(20)ソルビタン(ポリソルベート20)、モノパルミチン酸POE(20)ソルビタン(ポリソルベート40)、モノステアリン酸POE(20)ソルビタン(ポリソルベート60)、トリステアリン酸POE(20)ソルビタン(ポリソルベート65)、モノオレイン酸POE(20)ソルビタン(ポリソルベート80)等のPOEソルビタン脂肪酸エステル類;POE(5)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油5)、POE(10)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油10)、POE(20)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油20)、POE(30)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油30)、POE(40)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油40)、POE(60)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油60)、POE(80)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油80)、POE(100)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油100)等のPOE硬化ヒマシ油;POE(3)ヒマシ油(ポリオキシエチレンヒマシ油3)、POE(10)ヒマシ油(ポリオキシエチレンヒマシ油10)、POE(35)ヒマシ油(ポリオキシエチレンヒマシ油35)、POE(70)ヒマシ油(ポリオキシエチレンヒマシ油70)等のPOEヒマシ油;POE(9)ラウリルエーテル等のPOEアルキルエーテル;POE(20)POP(4)セチルエーテル等のPOE−POPアルキルエーテル;POE(20)POP(20)グリコール(プルロニックL44)、POE(42)POP(67)グリコール(ポロクサマー403、プルロニックP123)、POE(54)POP(39)グリコール(ポロクサマー235、プルロニックP85)、POE(120)POP(40)グリコール(プルロニックF87)、POE(160)POP(30)グリコール(ポロクサマー188、プルロニックF68)、POE(196)POP(67)グリコール(ポロクサマー407、プルロニックF127)、POE(200)POP(70)グリコール等のPOE・POPグリコール;ステアリン酸ポリオキシル10、ステアリン酸ポリオキシル40等のモノステアリン酸ポリエチレングリコール等が挙げられる。なお、上記で例示する化合物において、括弧内の数字は付加モル数を示す。また、略号「POE」はポリオキシエチレンを意味し、略号「POP」はポリオキシプロピレンを意味する。非イオン界面活性剤としては、POEソルビタン脂肪酸エステル類、POE硬化ヒマシ油、POEヒマシ油、POE・POPグリコール、モノステアリン酸ポリエチレングリコールが好ましく、ポリソルベート80、ポリオキシエチレン硬化ヒマシ油60、ポロクサマー407がより好ましく、ポリソルベート80、ポリオキシエチレン硬化ヒマシ油60が更に好ましい。
Specific examples of the nonionic surfactant include POE (20) sorbitan monolaurate (polysorbate 20), POE (20) sorbitan monopalmitate (polysorbate 40), POE (20) monostearate sorbitan (polysorbate 60) and trisorbate. POE sorbitan fatty acid esters such as POE (20) sorbitan stearate (polysorbate 65), POE (20) sorbitan monooleate (polysorbate 80); POE (5) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 5), POE (10) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 10), POE (20) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 20), POE (30) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 30), POE (40) curing Castor oil (polyoxyethylene hydrogenated castor oil 40), POE (60) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 60), POE (80) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 80), POE (100) POE hardened castor oil such as hardened castor oil (polyoxyethylene hardened castor oil 100); POE (3) castor oil (polyoxyethylene castor oil 3), POE (10) castor oil (polyoxyethylene castor oil 10), POE (35) POE castor oil such as castor oil (polyoxyethylene castor oil 35), POE (70) castor oil (polyoxyethylene castor oil 70); POE (9) POE alkyl ether such as lauryl ether; POE (20) POE (4) POE-POP alkyl ether such as cetyl ether; POE (20) P P (20) glycol (Pluronic L44), POE (42) POP (67) glycol (Poloxamer 403, Pluronic P123), POE (54) POP (39) glycol (Poloxamer 235, Pluronic P85), POE (120) POP ( 40) Glycol (Pluronic F87), POE (160) POP (30) Glycol (Poloxamer 188, Pluronic F68), POE (196) POP (67) Glycol (Poloxamer 407, Pluronic F127), POE (200) POP (70) POE / POP glycols such as glycol; and polyethylene glycol monostearate such as polyoxyl stearate 10 and polyoxyl stearate 40. In the compounds exemplified above, the numbers in parentheses indicate the number of moles added. The abbreviation "POE" means polyoxyethylene, and the abbreviation "POP" means polyoxypropylene. As nonionic surfactants, POE sorbitan fatty acid esters, POE hydrogenated castor oil, POE castor oil, POE POP glycol, polyethylene glycol monostearate are preferred, and
非イオン界面活性剤は市販されているものを使用してもよい。非イオン界面活性剤は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 A commercially available nonionic surfactant may be used. As the nonionic surfactant, one type may be used alone, or two or more types may be used in combination.
本実施形態に係る洗眼剤組成物における(C)成分の含有量は特に限定されず、(C)成分の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。(C)成分の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、(C)成分の総含有量が、0.01〜10w/v%であることが好ましく、0.01〜5w/v%であることがより好ましく、0.01〜1w/v%であることが更に好ましい。 The content of the component (C) in the eyewash composition according to the present embodiment is not particularly limited, and the type of the component (C), the type and content of other compounding components, the use and the formulation of the eyewash composition, and the like. Is set as appropriate according to. As the content of the component (C), from the viewpoint of more remarkably exerting the effects of the present invention, for example, the total content of the component (C) is 0.01 to 10 w /, based on the total amount of the eyewash composition. v%, more preferably 0.01 to 5 w / v%, even more preferably 0.01 to 1 w / v%.
本実施形態に係る洗眼剤組成物における、(B)成分に対する(C)成分の含有比率は特に限定されず、(B)成分及び(C)成分の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。(B)成分に対する(C)成分の含有比率としては、本発明による効果をより一層高める観点から、例えば、本実施形態に係る洗眼剤組成物に含まれる(B)成分の総含有量1質量部に対して、(C)成分の総含有量が、0.1〜100質量部であることが好ましく、1〜80質量部であることがより好ましく、5〜50質量部であることが更に好ましい。 In the eyewash composition according to the present embodiment, the content ratio of the component (C) to the component (B) is not particularly limited, and the types of the components (B) and (C), and the types and contents of other compound components. It is set as appropriate according to the use and formulation of the eyewash composition. As the content ratio of the component (C) to the component (B), for example, from the viewpoint of further enhancing the effect of the present invention, the total content of the component (B) contained in the eyewash composition according to the present embodiment is 1% by mass. Parts, the total content of the component (C) is preferably 0.1 to 100 parts by mass, more preferably 1 to 80 parts by mass, and further preferably 5 to 50 parts by mass. preferable.
また、別の態様として、本実施形態に係る洗眼剤組成物は、清涼化剤を含有することが好ましい。洗眼剤組成物が清涼化剤を含有することで、洗眼時の洗浄感を高める効果がより顕著に奏される。 In another aspect, the eyewash composition according to the present embodiment preferably contains a cooling agent. When the eyewash composition contains a cooling agent, the effect of enhancing the feeling of washing during eyewashing is more remarkably exhibited.
清涼化剤の具体例としては、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、樟脳油が挙げられる。清涼化剤としては、メントール、カンフル、ボルネオール、ゲラニオール、ユーカリ油、ペパーミント油、ハッカ油が好ましく、メントール、カンフル、ボルネオール、ゲラニオールがより好ましく、メントールが更に好ましい。 Specific examples of the cooling agent include menthol, menthol, camphor, borneol, geraniol, cineol, citronellol, carvone, anethole, eugenol, limonene, linalool, linalyl acetate, thymol, cimene, terpineol, pinene, camphene, isoborneol, phenene Chen, nerol, myrcene, myrsenol, linalool acetate, lavandulol, eucalyptus oil, bergamot oil, peppermint oil, cool mint oil, spearmint oil, peppermint oil, fennel oil, cinnamon oil, rose oil, camphor oil. As a cooling agent, menthol, camphor, borneol, geraniol, eucalyptus oil, peppermint oil and peppermint oil are preferred, menthol, camphor, borneol and geraniol are more preferred, and menthol is even more preferred.
清涼化剤は市販されているものを使用してもよい。清涼化剤は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 A commercially available cooling agent may be used. One type of cooling agent may be used alone, or two or more types may be used in combination.
本実施形態に係る、清涼化剤を含有する洗眼剤組成物における清涼化剤の含有量は特に限定されず、清涼化剤の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。清涼化剤の含有量としては、洗眼時の洗浄感を高める効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、清涼化剤の総含有量が、0.0001〜0.1w/v%であることが好ましく、0.005〜0.05w/v%であることがより好ましく、0.001〜0.03w/v%であることが更に好ましい。 The content of the cooling agent in the eyewash composition containing a cooling agent according to the present embodiment is not particularly limited, and the type of the cooling agent, the type and the content of other components, and the content of the eyewash composition It is set appropriately according to the use and the form of the preparation. As the content of the refreshing agent, from the viewpoint of more remarkably enhancing the effect of enhancing the feeling of washing during eye washing, for example, the total content of the cooling agent is 0.0001 to, based on the total amount of the eyewash composition. It is preferably 0.1 w / v%, more preferably 0.005 to 0.05 w / v%, even more preferably 0.001 to 0.03 w / v%.
本実施形態に係る、清涼化剤を含有する洗眼剤組成物のpHは、洗眼時の洗浄感をより高める観点から、5.0〜8.5であることが好ましく、5.5〜8.0であることがより好ましく、5.0〜7.5であることが更に好ましく、5.0〜7.0であることが更により好ましく、5.0〜6.5であることが特に好ましい。 The pH of the eyewash composition containing a refreshing agent according to this embodiment is preferably from 5.0 to 8.5, and more preferably from 5.5 to 8.5, from the viewpoint of further enhancing the feeling of washing during eyewashing. 0, more preferably 5.0 to 7.5, still more preferably 5.0 to 7.0, particularly preferably 5.0 to 6.5. .
本実施形態に係る、清涼化剤を含有する洗眼剤組成物は、清涼化剤の安定性の点で、非イオン界面活性剤を含有することが好ましい。清涼化剤を含有する洗眼剤組成物が非イオン界面活性剤を含有することで、本発明による効果がより顕著に奏される。 The eyewash composition containing a cooling agent according to the present embodiment preferably contains a nonionic surfactant from the viewpoint of the stability of the cooling agent. When the eyewash composition containing a refreshing agent contains a nonionic surfactant, the effect of the present invention is more remarkably exhibited.
非イオン界面活性剤の具体例としては、モノラウリン酸POE(20)ソルビタン(ポリソルベート20)、モノパルミチン酸POE(20)ソルビタン(ポリソルベート40)、モノステアリン酸POE(20)ソルビタン(ポリソルベート60)、トリステアリン酸POE(20)ソルビタン(ポリソルベート65)、モノオレイン酸POE(20)ソルビタン(ポリソルベート80)等のPOEソルビタン脂肪酸エステル類;POE(5)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油5)、POE(10)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油10)、POE(20)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油20)、POE(30)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油30)、POE(40)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油40)、POE(60)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油60)、POE(80)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油80)、POE(100)硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油100)等のPOE硬化ヒマシ油;POE(3)ヒマシ油(ポリオキシエチレンヒマシ油3)、POE(10)ヒマシ油(ポリオキシエチレンヒマシ油10)、POE(35)ヒマシ油(ポリオキシエチレンヒマシ油35)、POE(70)ヒマシ油(ポリオキシエチレンヒマシ油70)等のPOEヒマシ油;POE(9)ラウリルエーテル等のPOEアルキルエーテル;POE(20)POP(4)セチルエーテル等のPOE−POPアルキルエーテル;POE(20)POP(20)グリコール(プルロニックL44)、POE(42)POP(67)グリコール(ポロクサマー403、プルロニックP123)、POE(54)POP(39)グリコール(ポロクサマー235、プルロニックP85)、POE(120)POP(40)グリコール(プルロニックF87)、POE(160)POP(30)グリコール(ポロクサマー188、プルロニックF68)、POE(196)POP(67)グリコール(ポロクサマー407、プルロニックF127)、POE(200)POP(70)グリコール等のPOE・POPグリコール;ステアリン酸ポリオキシル10、ステアリン酸ポリオキシル40等のモノステアリン酸ポリエチレングリコール等が挙げられる。なお、上記で例示する化合物において、括弧内の数字は付加モル数を示す。また、略号「POE」はポリオキシエチレンを意味し、略号「POP」はポリオキシプロピレンを意味する。非イオン界面活性剤としては、POEソルビタン脂肪酸エステル類、POE硬化ヒマシ油、POEヒマシ油、POE・POPグリコール、モノステアリン酸ポリエチレングリコールが好ましく、ポリソルベート80、ポリオキシエチレン硬化ヒマシ油60、ポロクサマー407がより好ましく、ポリソルベート80、ポリオキシエチレン硬化ヒマシ油60が更に好ましい。
Specific examples of the nonionic surfactant include POE (20) sorbitan monolaurate (polysorbate 20), POE (20) sorbitan monopalmitate (polysorbate 40), POE (20) monostearate sorbitan (polysorbate 60) and trisorbate. POE sorbitan fatty acid esters such as POE (20) sorbitan stearate (polysorbate 65), POE (20) sorbitan monooleate (polysorbate 80); POE (5) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 5), POE (10) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 10), POE (20) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 20), POE (30) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 30), POE (40) curing Castor oil (polyoxyethylene hydrogenated castor oil 40), POE (60) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 60), POE (80) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 80), POE (100) POE hardened castor oil such as hardened castor oil (polyoxyethylene hardened castor oil 100); POE (3) castor oil (polyoxyethylene castor oil 3), POE (10) castor oil (polyoxyethylene castor oil 10), POE (35) POE castor oil such as castor oil (polyoxyethylene castor oil 35), POE (70) castor oil (polyoxyethylene castor oil 70); POE (9) POE alkyl ether such as lauryl ether; POE (20) POE (4) POE-POP alkyl ether such as cetyl ether; POE (20) P P (20) glycol (Pluronic L44), POE (42) POP (67) glycol (Poloxamer 403, Pluronic P123), POE (54) POP (39) glycol (Poloxamer 235, Pluronic P85), POE (120) POP ( 40) Glycol (Pluronic F87), POE (160) POP (30) Glycol (Poloxamer 188, Pluronic F68), POE (196) POP (67) Glycol (Poloxamer 407, Pluronic F127), POE (200) POP (70) POE / POP glycols such as glycol; and polyethylene glycol monostearate such as polyoxyl stearate 10 and polyoxyl stearate 40. In the compounds exemplified above, the numbers in parentheses indicate the number of moles added. The abbreviation "POE" means polyoxyethylene, and the abbreviation "POP" means polyoxypropylene. As nonionic surfactants, POE sorbitan fatty acid esters, POE hydrogenated castor oil, POE castor oil, POE POP glycol, polyethylene glycol monostearate are preferred, and
非イオン界面活性剤は市販されているものを使用してもよい。非イオン界面活性剤は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 A commercially available nonionic surfactant may be used. As the nonionic surfactant, one type may be used alone, or two or more types may be used in combination.
本実施形態に係る、清涼化剤及び非イオン界面活性剤を含有する洗眼剤組成物における非イオン界面活性剤の含有量は特に限定されず、非イオン界面活性剤の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。非イオン界面活性剤の含有量としては、洗眼時の洗浄感を高める効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、非イオン界面活性剤の総含有量が、0.01〜10w/v%であることが好ましく、0.01〜5w/v%であることがより好ましく、0.01〜1w/v%であることが更に好ましい。 According to the present embodiment, the content of the nonionic surfactant in the eyewash composition containing a cooling agent and a nonionic surfactant is not particularly limited, the type of the nonionic surfactant, the other components It is appropriately set according to the type and content, the use of the eyewash composition, the formulation form, and the like. As the content of the nonionic surfactant, from the viewpoint of more remarkably improving the feeling of washing during eyewash, for example, based on the total amount of the eyewash composition, the total content of the nonionic surfactant is It is preferably from 0.01 to 10 w / v%, more preferably from 0.01 to 5 w / v%, even more preferably from 0.01 to 1 w / v%.
本実施形態に係る、清涼化剤及び非イオン界面活性剤を含有する洗眼剤組成物における、清涼化剤に対する非イオン界面活性剤の含有比率は特に限定されず、清涼化剤及び非イオン界面活性剤の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。清涼化剤に対する非イオン界面活性剤の含有比率の含有比率としては、本発明による効果をより一層高める観点から、例えば、本実施形態に係る洗眼剤組成物に含まれる清涼化剤の総含有量1質量部に対して、非イオン界面活性剤の総含有量が、0.1〜100質量部であることが好ましく、1〜80質量部であることがより好ましく、5〜50質量部であることが更に好ましい。 In the eyewash composition containing a cooling agent and a nonionic surfactant according to this embodiment, the content ratio of the nonionic surfactant to the cooling agent is not particularly limited, and the cooling agent and the nonionic surfactant are used. It is appropriately set according to the type of agent, the type and content of other compounding components, the use of the eyewash composition and the form of formulation. As the content ratio of the content ratio of the nonionic surfactant to the cooling agent, from the viewpoint of further enhancing the effect of the present invention, for example, the total content of the cooling agent contained in the eyewash composition according to the present embodiment The total content of the nonionic surfactant is preferably 0.1 to 100 parts by mass, more preferably 1 to 80 parts by mass, and more preferably 5 to 50 parts by mass with respect to 1 part by mass. Is more preferable.
〔抗炎症剤〕
本実施形態に係る洗眼剤組成物は、更に抗炎症剤を含有することが好ましい。洗眼剤組成物が抗炎症剤を更に含有することで、本発明による効果がより顕著に奏される。抗炎症剤は、抗炎症作用又は消炎作用を有する化合物、及びその塩である。抗炎症剤は、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。
(Anti-inflammatory agent)
The eyewash composition according to the present embodiment preferably further contains an anti-inflammatory agent. When the eyewash composition further contains an anti-inflammatory agent, the effects of the present invention are more remarkably exhibited. Anti-inflammatory agents are compounds having an anti-inflammatory or anti-inflammatory effect, and salts thereof. The anti-inflammatory agent is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
抗炎症剤の具体例としては、イプシロン−アミノカプロン酸、アラントイン、ベルベリン、アズレン類(アズレン、アズレンスルホン酸、カマアズレン、グアイアズレン等)、グリチルリチン酸、亜鉛塩(硫酸亜鉛、乳酸亜鉛等)、リゾチーム、セレコキシブ、ロフェコキシブ、インドメタシン、ジクロフェナク、ブロムフェナク、ピロキシカム、メロキシカム、サリチル酸メチル、イブプロフェン、イブプロフェンピコノール、ブフェキサマク、フルフェナム酸ブチル、ベンダザック、ケトプロフェン、フェルビナク、プラノプロフェン及びそれらの塩が挙げられる。抗炎症剤としては、イプシロン−アミノカプロン酸及びその塩、アラントイン、ベルベリン及びその塩、アズレンスルホン酸及びその塩、グリチルリチン酸及びその塩、亜鉛塩が好ましく、イプシロン−アミノカプロン酸、アラントイン、塩化ベルベリン、硫酸ベルベリン、アズレンスルホン酸ナトリウム、グリチルリチン酸二カリウム、硫酸亜鉛、乳酸亜鉛がより好ましく、イプシロン−アミノカプロン酸、アラントイン、グリチルリチン酸二カリウムが更に好ましい。 Specific examples of anti-inflammatory agents include epsilon-aminocaproic acid, allantoin, berberine, azulene (azulene, azulene sulfonic acid, kama azulene, guaiazulene, etc.), glycyrrhizic acid, zinc salts (zinc sulfate, zinc lactate, etc.), lysozyme, celecoxib , Rofecoxib, indomethacin, diclofenac, bromfenac, piroxicam, meloxicam, methyl salicylate, ibuprofen, ibuprofen piconol, bufexamac, butyl flufenamic acid, bendazac, ketoprofen, felbinac, pranoprofen and salts thereof. As the anti-inflammatory agent, epsilon-aminocaproic acid and its salts, allantoin, berberine and its salts, azulene sulfonic acid and its salts, glycyrrhizic acid and its salts, and zinc salts are preferable, and epsilon-aminocaproic acid, allantoin, berberine chloride, and sulfuric acid Berberine, sodium azulene sulfonate, dipotassium glycyrrhizinate, zinc sulfate and zinc lactate are more preferred, and epsilon-aminocaproic acid, allantoin and dipotassium glycyrrhizinate are more preferred.
抗炎症剤は、市販されているものを使用してもよい。抗炎症剤は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 A commercially available anti-inflammatory agent may be used. One type of anti-inflammatory agent may be used alone, or two or more types may be used in combination.
本実施形態に係る洗眼剤組成物における抗炎症剤の含有量は特に限定されず、抗炎症剤の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。抗炎症剤の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、抗炎症剤の総含有量が、0.00005〜0.2w/v%であることが好ましく、0.0001〜0.1w/v%であることがより好ましく、0.0004〜0.55w/v%であることが更に好ましい。 The content of the anti-inflammatory agent in the eyewash composition according to the present embodiment is not particularly limited, and depends on the type of the anti-inflammatory agent, the type and content of the other components, the use of the eyewash composition, the formulation, and the like. Is set as appropriate. As the content of the anti-inflammatory agent, from the viewpoint of more remarkably exerting the effects of the present invention, for example, the total content of the anti-inflammatory agent is 0.00005 to 0.2 w / v%, more preferably 0.0001 to 0.1 w / v%, even more preferably 0.0004 to 0.55 w / v%.
〔水溶性ビタミン〕
本実施形態に係る洗眼剤組成物は、更に水溶性ビタミンを含有することが好ましい。洗眼剤組成物が水溶性ビタミンを更に含有することで、本発明による効果がより顕著に奏される。水溶性ビタミンは、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。
(Water-soluble vitamin)
It is preferable that the eyewash composition according to the present embodiment further contains a water-soluble vitamin. When the eyewash composition further contains a water-soluble vitamin, the effect of the present invention is more remarkably exhibited. The water-soluble vitamin is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
水溶性ビタミンの具体例としては、フラビンアデニンジヌクレオチド及びその塩(フラビンアデニンジヌクレオチドナトリウム等)、コバラミン類(シアノコバラミン、メチルコバラミン等)、ピリドキシン又はその塩(塩酸ピリドキシン等)、パンテノール、パントテン酸及びその塩(例えば、パントテン酸ナトリウム、パントテン酸カリウム、パントテン酸カルシウム、パントテン酸マグネシウム等)、ピリドキサール及びその塩(リン酸ピリドキサール等)、アスコルビン酸及びその塩(アスコルビン酸ナトリウム、アスコルビン酸カルシウム等)が挙げられる。水溶性ビタミンとしては、フラビンアデニンジヌクレオチド及びその塩、コバラミン類、ピリドキシン又はその塩、パンテノール、パントテン酸及びその塩が好ましく、ピリドキシン又はその塩、パンテノールが更に好ましい。 Specific examples of the water-soluble vitamin include flavin adenine dinucleotide and salts thereof (flavin adenine dinucleotide sodium and the like), cobalamins (cyanocobalamin, methylcobalamin and the like), pyridoxine or a salt thereof (pyridoxine hydrochloride and the like), panthenol, pantothenic acid And salts thereof (eg, sodium pantothenate, potassium pantothenate, calcium pantothenate, magnesium pantothenate, etc.), pyridoxal and its salts (pyridoxal phosphate, etc.), ascorbic acid and its salts (sodium ascorbate, calcium ascorbate, etc.) Is mentioned. As the water-soluble vitamin, flavin adenine dinucleotide and its salt, cobalamin, pyridoxine or its salt, panthenol, pantothenic acid and its salt are preferable, and pyridoxine or its salt and panthenol are more preferable.
水溶性ビタミンは、市販されているものを使用してもよい。水溶性ビタミンは、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 Commercially available water-soluble vitamins may be used. One type of water-soluble vitamin may be used alone, or two or more types may be used in combination.
本実施形態に係る洗眼剤組成物における水溶性ビタミンの含有量は特に限定されず、水溶性ビタミンの種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。水溶性ビタミンの含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、水溶性ビタミンの総含有量が、0.0001〜0.1w/v%であることが好ましく、0.0005〜0.05w/v%であることがより好ましく、0.0002〜0.02w/v%であることが更に好ましい。 The content of the water-soluble vitamin in the eyewash composition according to the present embodiment is not particularly limited, and depends on the type of the water-soluble vitamin, the type and content of other components, the use of the eyewash composition, the formulation, and the like. Is set as appropriate. As the content of the water-soluble vitamin, from the viewpoint of more remarkably exerting the effects of the present invention, for example, the total content of the water-soluble vitamin is 0.0001 to 0.1 w /, based on the total amount of the eyewash composition. v%, more preferably 0.0005 to 0.05 w / v%, even more preferably 0.0002 to 0.02 w / v%.
〔アミノ酸〕
本実施形態に係る洗眼剤組成物は、更にアミノ酸を含有することが好ましい。洗眼剤組成物がアミノ酸を更に含有することで、本発明による効果がより顕著に奏される。アミノ酸は、分子内にアミノ基とカルボキシル基を有する化合物、及びその誘導体、並びにそれらの塩である。アミノ酸は、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、特に制限されず、公知のアミノ酸から適宜選択して使用することができる。
〔amino acid〕
The eyewash composition according to the present embodiment preferably further contains an amino acid. When the eyewash composition further contains an amino acid, the effect of the present invention is more remarkably exhibited. Amino acids are compounds having an amino group and a carboxyl group in the molecule, derivatives thereof, and salts thereof. The amino acid is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable, and can be appropriately selected from known amino acids and used.
アミノ酸の具体例としては、アミノ酸及びその塩、アミノ酸誘導体及びその塩、並びにムコ多糖及びその誘導体及びそれらの塩が挙げられる。アミノ酸及びその塩の具体例としては、例えば、グリシン、アラニン、アミノ酪酸、及びアミノ吉草酸等のモノアミノモノカルボン酸、アスパラギン酸、及びグルタミン酸等のモノアミノジカルボン酸、アルギニン、及びリジン等のジアミノモノカルボン酸、並びにそれらの塩が挙げられる。アミノ酸誘導体及びその塩の具体例としては、例えば、アミノエチルスルホン酸等のアミノ酸誘導体及びその塩が挙げられる。ムコ多糖及びその誘導体並びにそれらの塩としては、コンドロイチン硫酸及びその塩が挙げられる。アミノ酸は、D体、L体、DL体のいずれでもよい。アミノ酸としては、モノアミノジカルボン酸及びその塩、アミノ酸誘導体及びその塩、ムコ多糖及びその塩が好ましく、アスパラギン酸及びその塩、アミノエチルスルホン酸及びその塩、コンドロイチン硫酸及びその塩がより好ましく、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(等量混合物)、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が更に好ましく、アスパラギン酸カリウム、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が更により好ましい。 Specific examples of amino acids include amino acids and their salts, amino acid derivatives and their salts, and mucopolysaccharides and their derivatives and their salts. Specific examples of amino acids and salts thereof include, for example, monoaminomonocarboxylic acids such as glycine, alanine, aminobutyric acid, and aminovaleric acid, monoaminodicarboxylic acids such as aspartic acid, and glutamic acid, diamino acids such as arginine, and lysine. Monocarboxylic acids, and salts thereof. Specific examples of amino acid derivatives and salts thereof include, for example, amino acid derivatives such as aminoethylsulfonic acid and salts thereof. Mucopolysaccharides and derivatives thereof and salts thereof include chondroitin sulfate and salts thereof. The amino acid may be any of D-form, L-form and DL-form. As the amino acid, monoaminodicarboxylic acid and its salt, amino acid derivative and its salt, mucopolysaccharide and its salt are preferable, aspartic acid and its salt, aminoethylsulfonic acid and its salt, chondroitin sulfate and its salt are more preferable, and asparagine Potassium acid, magnesium aspartate, magnesium / potassium aspartate (equivalent mixture), aminoethylsulfonic acid, and sodium chondroitin sulfate are more preferred, and potassium aspartate, aminoethylsulfonic acid, and sodium chondroitin sulfate are even more preferred.
アミノ酸は、市販されているものを使用してもよい。アミノ酸は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 As the amino acid, a commercially available amino acid may be used. One amino acid may be used alone, or two or more amino acids may be used in combination.
本実施形態に係る洗眼剤組成物におけるアミノ酸の含有量は特に限定されず、アミノ酸の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。アミノ酸の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、アミノ酸の総含有量が、0.0005〜1w/v%であることが好ましく、0.001〜0.5w/v%であることがより好ましく、0.005〜0.3w/v%であることが更に好ましい。 The content of the amino acid in the eyewash composition according to the present embodiment is not particularly limited, and is appropriately set according to the type of amino acid, the type and content of other components, the use of the eyewash composition, the formulation, and the like. You. From the viewpoint of more remarkably exerting the effects of the present invention, the content of the amino acid may be, for example, 0.0005 to 1 w / v% based on the total amount of the eyewash composition. Preferably, it is 0.001 to 0.5 w / v%, more preferably 0.005 to 0.3 w / v%.
〔緩衝剤〕
本実施形態に係る洗眼剤組成物は、更に緩衝剤を含有することが好ましい。洗眼剤組成物が緩衝剤を更に含有することで、本発明による効果がより顕著に奏される。緩衝剤は、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。
(Buffer)
The eyewash composition according to the present embodiment preferably further contains a buffer. When the eyewash composition further contains a buffer, the effect of the present invention is more remarkably exhibited. The buffer is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
緩衝剤としては、例えば、無機酸由来の緩衝剤である無機緩衝剤、及び有機酸又は有機塩基由来の緩衝剤である有機緩衝剤が挙げられる。 Examples of the buffer include an inorganic buffer which is a buffer derived from an inorganic acid, and an organic buffer which is a buffer derived from an organic acid or an organic base.
無機緩衝剤としては、例えば、ホウ酸緩衝剤、リン酸緩衝剤、炭酸緩衝剤等が挙げられる。ホウ酸緩衝剤としては、ホウ酸又はその塩(ホウ酸アルカリ金属塩、ホウ酸アルカリ土類金属塩等)が挙げられる。リン酸緩衝剤としては、リン酸又はその塩(リン酸アルカリ金属塩、リン酸アルカリ土類金属塩等)が挙げられる。炭酸緩衝剤としては、炭酸又はその塩(炭酸アルカリ金属塩、炭酸アルカリ土類金属塩等)が挙げられる。また、ホウ酸緩衝剤、リン酸緩衝剤又は炭酸緩衝剤として、ホウ酸塩、リン酸塩又は炭酸塩の水和物を用いてもよい。より具体的な例として、ホウ酸緩衝剤として、ホウ酸又はその塩(ホウ酸ナトリウム、テトラホウ酸カリウム、メタホウ酸カリウム、ホウ酸アンモニウム、ホウ砂等);リン酸緩衝剤として、リン酸又はその塩(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、リン酸三ナトリウム、リン酸三カリウム、リン酸一水素カルシウム、リン酸二水素カルシウム等);炭酸緩衝剤として、炭酸又はその塩(炭酸水素ナトリウム、炭酸ナトリウム、炭酸アンモニウム、炭酸カリウム、炭酸カルシウム、炭酸水素カリウム、炭酸マグネシウム等)などが例示できる。 Examples of the inorganic buffer include a borate buffer, a phosphate buffer, and a carbonate buffer. Examples of the borate buffer include boric acid or a salt thereof (such as an alkali metal borate and an alkaline earth metal borate). Examples of the phosphate buffer include phosphoric acid and salts thereof (eg, alkali metal phosphate and alkaline earth metal phosphate). Examples of the carbonate buffer include carbonic acid and salts thereof (eg, alkali metal carbonate and alkaline earth metal carbonate). Further, a borate, a phosphate or a carbonate hydrate may be used as the borate buffer, the phosphate buffer or the carbonate buffer. As more specific examples, boric acid or a salt thereof (sodium borate, potassium tetraborate, potassium metaborate, ammonium borate, borax, etc.) as a borate buffer; phosphoric acid or a salt thereof as a phosphate buffer Salts (disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, trisodium phosphate, tripotassium phosphate, calcium monohydrogen phosphate, calcium dihydrogen phosphate, etc.); Or salts thereof (sodium hydrogen carbonate, sodium carbonate, ammonium carbonate, potassium carbonate, calcium carbonate, potassium hydrogen carbonate, magnesium carbonate and the like).
有機緩衝剤としては、例えば、クエン酸緩衝剤、酢酸緩衝剤、乳酸緩衝剤、コハク酸緩衝剤、トリス緩衝剤、AMPD緩衝剤等が挙げられる。クエン酸緩衝剤としては、クエン酸又はその塩(クエン酸アルカリ金属塩、クエン酸アルカリ土類金属塩等)が挙げられる。酢酸緩衝剤としては、酢酸又はその塩(酢酸アルカリ金属塩、酢酸アルカリ土類金属塩等)が挙げられる。乳酸緩衝剤としては、乳酸又はその塩(乳酸アルカリ金属塩、乳酸アルカリ土類金属塩等)が挙げられる。コハク酸緩衝剤としては、コハク酸又はその塩(コハク酸アルカリ金属塩等)が挙げられる。また、クエン酸緩衝剤、酢酸緩衝剤、乳酸緩衝剤又はコハク酸緩衝剤として、クエン酸塩、酢酸塩、乳酸塩又はコハク酸塩の水和物を用いてもよい。より具体的な例として、クエン酸緩衝剤として、クエン酸又はその塩(クエン酸ナトリウム、クエン酸カリウム、クエン酸カルシウム、クエン酸二水素ナトリウム、クエン酸二ナトリウム等);酢酸緩衝剤として、酢酸又はその塩(酢酸アンモニウム、酢酸ナトリウム、酢酸カリウム、酢酸カルシウム等);乳酸緩衝剤として、乳酸又はその塩(乳酸ナトリウム、乳酸カリウム、乳酸カルシウム等);コハク酸緩衝剤としてコハク酸又はその塩(コハク酸一ナトリウム、コハク酸二ナトリウム等)などが例示できる。トリス緩衝剤としては、例えば、トロメタモール又はその塩(トロメタモール塩酸塩等)が挙げられる。AMPD緩衝剤としては、例えば、2−アミノ−2−メチル−1,3−プロパンジオール又はその塩が挙げられる。 Examples of the organic buffer include a citrate buffer, an acetate buffer, a lactate buffer, a succinate buffer, a Tris buffer, an AMPD buffer and the like. Examples of the citrate buffer include citric acid and salts thereof (eg, alkali metal citrate and alkaline earth metal citrate). Examples of the acetic acid buffer include acetic acid or a salt thereof (eg, an alkali metal acetate, an alkaline earth metal acetate). Examples of the lactic acid buffer include lactic acid or a salt thereof (an alkali metal lactate, an alkaline earth metal lactate, and the like). Examples of the succinic acid buffer include succinic acid or a salt thereof (such as an alkali metal succinate). In addition, citrate, acetate, lactate or hydrate of succinate may be used as the citrate buffer, acetate buffer, lactate buffer or succinate buffer. As a more specific example, citric acid or a salt thereof (sodium citrate, potassium citrate, calcium citrate, sodium dihydrogen citrate, disodium citrate, etc.) as a citrate buffer; acetic acid as an acetate buffer Or a salt thereof (ammonium acetate, sodium acetate, potassium acetate, calcium acetate, etc.); lactic acid or a salt thereof (sodium lactate, potassium lactate, calcium lactate, etc.) as a lactic acid buffer; succinic acid or a salt thereof as a succinic acid buffer ( Monosodium succinate, disodium succinate, etc.). Examples of the Tris buffer include tromethamol or a salt thereof (tromethamol hydrochloride or the like). Examples of the AMPD buffer include 2-amino-2-methyl-1,3-propanediol or a salt thereof.
緩衝剤としては、ホウ酸緩衝剤(例えば、ホウ酸とホウ砂の組み合わせ等)、リン酸緩衝剤(例えば、リン酸水素二ナトリウムとリン酸二水素ナトリウムの組み合わせ等)、トリス緩衝剤(例えば、トロメタモール)が好ましく、ホウ酸緩衝剤がより好ましく、ホウ酸及びその塩が更に好ましく、ホウ酸とホウ砂の組み合わせが更により好ましい。 Examples of the buffer include a borate buffer (for example, a combination of boric acid and borax), a phosphate buffer (for example, a combination of disodium hydrogen phosphate and sodium dihydrogen phosphate), and a tris buffer (for example, , Trometamol) are preferred, borate buffers are more preferred, boric acid and its salts are more preferred, and a combination of boric acid and borax is even more preferred.
緩衝剤は、市販されているものを使用してもよい。緩衝剤は、1種を単独で使用してもよく、又は2種以上を組み合わせて使用してもよい。 A commercially available buffer may be used. One type of buffer may be used alone, or two or more types may be used in combination.
本実施形態に係る洗眼剤組成物における緩衝剤の含有量は特に限定されず、緩衝剤の種類、他の配合成分の種類及び含有量、洗眼剤組成物の用途及び製剤形態等に応じて適宜設定される。緩衝剤の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、緩衝剤の総含有量が、0.001〜10w/v%であることが好ましく、0.1〜5w/v%であることがより好ましく、0.5〜3w/v%であることが更に好ましい。 The content of the buffer in the eyewash composition according to the present embodiment is not particularly limited, and may be appropriately determined depending on the type of the buffer, the type and content of other components, the use of the eyewash composition, the formulation, and the like. Is set. As the content of the buffer, from the viewpoint of more remarkably exerting the effect of the present invention, for example, the total content of the buffer is 0.001 to 10 w / v% based on the total amount of the eyewash composition. Is preferably 0.1 to 5 w / v%, more preferably 0.5 to 3 w / v%.
本実施形態に係る洗眼剤組成物は、必要に応じて、生体に許容される範囲内の浸透圧比に調節することができる。適切な浸透圧比は、洗眼剤組成物の用途、製剤形態、使用方法等に応じて適宜設定され得るが、例えば、0.5〜5.0とすることができ、0.6〜3.0とすることが好ましく、0.7〜2.0とすることがより好ましく、0.8〜1.55とすることが更に好ましい。浸透圧比は、第十七改正日本薬局方に基づき、286mOsm(0.9w/v%塩化ナトリウム水溶液の浸透圧)に対する試料の浸透圧の比とし、浸透圧は日本薬局方記載の浸透圧測定法(凝固点降下法)を参考にして測定する。なお、浸透圧比測定用標準液(0.9w/v%塩化ナトリウム水溶液)は、塩化ナトリウム(日本薬局方標準試薬)を500〜650℃で40〜50分間乾燥した後、デシケーター(シリカゲル)中で放冷し、その0.900gを正確に量り、精製水に溶かし正確に100mLとして調製するか、市販の浸透圧比測定用標準液(0.9w/v%塩化ナトリウム水溶液)を用いることができる。 The eyewash composition according to the present embodiment can be adjusted to an osmotic pressure ratio within a range acceptable to a living body, if necessary. The appropriate osmotic pressure ratio can be appropriately set according to the use, formulation form, method of use, etc., of the eyewash composition, and can be, for example, 0.5 to 5.0, and 0.6 to 3.0. Is preferably set to 0.7 to 2.0, more preferably to 0.8 to 1.55. The osmotic pressure ratio is the ratio of the osmotic pressure of the sample to 286 mOsm (the osmotic pressure of a 0.9 w / v% aqueous sodium chloride solution) based on the 17th revised Japanese Pharmacopoeia. (Freezing point descent method). The standard solution for osmotic pressure ratio measurement (0.9 w / v% aqueous sodium chloride solution) was prepared by drying sodium chloride (Japanese Pharmacopoeia standard reagent) at 500 to 650 ° C. for 40 to 50 minutes and then in a desiccator (silica gel). After allowing to cool, 0.900 g thereof is accurately weighed and dissolved in purified water to prepare exactly 100 mL, or a commercially available standard solution for measuring osmotic pressure ratio (0.9 w / v% aqueous sodium chloride solution) can be used.
本実施形態に係る洗眼剤組成物の粘度は、医薬上、薬理学的に(製薬上)又は生理学的に許容される範囲内であれば、特に限定されるものではない。本実施形態に係る洗眼剤組成物の粘度としては、例えば、回転粘度計(RE550型粘度計、東機産業社製、ローター;1°34‘×R24)で測定した20℃における粘度が1〜1000mPa・sであることが好ましく、1〜100mPa・sであることがより好ましく、1〜50mPa・sであることが更に好ましく、1〜30mPa・sであることが更により好ましく、1〜10mPa・sであることが特に好ましく、1〜5mPa・sであることが最も好ましい。 The viscosity of the eyewash composition according to the present embodiment is not particularly limited as long as it is within a pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable range. As the viscosity of the eyewash composition according to the present embodiment, for example, the viscosity at 20 ° C. measured with a rotational viscometer (RE550 type viscometer, manufactured by Toki Sangyo Co., Ltd .; rotor: 1 ° 34 ′ × R24) is 1 to 3. It is preferably 1,000 mPa · s, more preferably 1 to 100 mPa · s, still more preferably 1 to 50 mPa · s, still more preferably 1 to 30 mPa · s, and 1 to 10 mPa · s. s, particularly preferably 1 to 5 mPa · s.
本実施形態に係る洗眼剤組成物は、本発明の効果を損なわない範囲であれば、上記成分の他に種々の薬理活性成分及び生理活性成分から選択される成分を組み合わせて適当量含有していてもよい。当該成分は特に制限されず、例えば、一般用医薬品製造販売承認基準2012年版(一般社団法人 レギュラトリーサイエンス学会 監修)に記載された眼科用薬における有効成分が例示できる。眼科用薬において用いられる成分として、具体的には、例えば、次のような成分が挙げられる。
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。
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。
無機塩類:例えば、塩化カルシウム、塩化マグネシウム、塩化ナトリウム、塩化カリウム等の金属の塩化物;塩化アンモニウム;硫酸カルシウム、硫酸マグネシウム、硫酸ナトリウム、硫酸カリウム、硫酸アンモニウム等の金属の硫酸塩等。
収斂剤:例えば、亜鉛華等。
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。
The eyewash composition according to the present embodiment contains an appropriate amount of a combination of components selected from various pharmacologically active components and physiologically active components in addition to the above components as long as the effects of the present invention are not impaired. You may. The component is not particularly limited, and examples thereof include an active component in an ophthalmic drug described in the OTC Pharmaceutical Manufacturing and Marketing Approval Standards 2012 edition (supervised by the Society of Regulatory Science). Specific examples of the components used in ophthalmic drugs include the following components.
Antiallergic agents: for example, sodium cromoglycate, tranilast, potassium pemirolast and the like.
Steroids: For example, fluticasone propionate, fluticasone furoate, mometasone furoate, beclomethasone propionate, flunisolide and the like.
Decongestant: For example, tetrahydrozoline hydrochloride, tetrahydrozoline nitrate, naphazoline hydrochloride, naphazoline nitrate, epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, phenylephrine hydrochloride, dl-methylephedrine hydrochloride and the like.
Ocular muscle modulators: for example, cholinesterase inhibitors having an active center similar to acetylcholine, such as neostigmine methyl sulfate, tropicamide, helenien, atropine sulfate and the like.
Inorganic salts: for example, chlorides of metals such as calcium chloride, magnesium chloride, sodium chloride, and potassium chloride; ammonium chloride; sulfates of metals such as calcium sulfate, magnesium sulfate, sodium sulfate, potassium sulfate, and ammonium sulfate.
Astringent: For example, zinc white.
Others: For example, sulfamethoxazole, sulfisoxazole, sulfisomidine, and salts thereof.
本実施形態に係る洗顔剤組成物には、本発明の効果を損なわない範囲であれば、その用途及び製剤形態に応じて、常法に従い、様々な添加物を適宜選択し、1種又はそれ以上を併用して適当量含有させてもよい。このような添加物として、例えば、医薬品添加物事典2007(日本医薬品添加剤協会編集)に記載された各種添加物が例示できる。代表的な成分として次の添加物が挙げられる。
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。
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。
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。
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、ジブチルヒドロキシトルエン等。
防腐剤、殺菌剤又は抗菌剤:例えば、塩化亜鉛、安息香酸ナトリウム、エタノール、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、塩酸ポリヘキサニド(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)、亜塩素酸塩等。
等張化剤:例えば、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等。
増粘剤:例えば、セルロース系高分子化合物(例えば、メチルセルロース、エチルセルロース、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、カルボキシメチルセルロースナトリウム等)、ポリビニル系高分子化合物(ポリビニルピロリドン、ポリビニルアルコール等)、カルボキシビニルポリマー、グアーガム、ヒドロキシプロピルグアーガム、アラビアゴム、カラヤガム、キサンタンガム、寒天、アルギン酸及びその塩(ナトリウム塩等)、ムコ多糖類(例えば、ヘパリン類似物質、ヘパリン、ヘパリン硫酸、ヘパラン硫酸、ヘパリノイド、ヒアルロン酸及びその塩(ナトリウム塩等))、デンプン、キチン及びその誘導体、キトサン及びその誘導体、カラギーナン等。
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、グリセリン等。これらはd体、l体又はdl体のいずれでもよい。
In the facial cleansing composition according to the present embodiment, various additives are appropriately selected according to a usual method, depending on the use and the form of the preparation, as long as the effects of the present invention are not impaired. An appropriate amount may be contained in combination with the above. Examples of such additives include various additives described in the Pharmaceutical Excipients Dictionary 2007 (edited by the Japan Pharmaceutical Excipients Association). Representative additives include the following additives.
Carrier: for example, an aqueous solvent such as water or hydrous ethanol.
Chelating agents: for example, ethylenediaminediacetic acid (EDDA), ethylenediaminetriacetic acid, ethylenediaminetetraacetic acid (EDTA), N- (2-hydroxyethyl) ethylenediaminetriacetic acid (HEDTA), diethylenetriaminepentaacetic acid (DTPA) and the like.
Base: for example, octyldodecanol, titanium oxide, potassium bromide, plastibase and the like.
Anionic surfactants: for example, polyoxyethylene alkyl ether phosphate, polyoxyethylene alkyl ether sulfate, alkylbenzene sulfonate, alkyl sulfate, N-acyl taurate and the like.
Amphoteric surfactants: for example, betaine lauryldimethylaminoacetate and the like.
Stabilizers: For example, sodium formaldehyde sulfoxylate (Rongalit), sodium bisulfite, sodium pyrosulfite, aluminum monostearate, glyceryl monostearate, cyclodextrin, monoethanolamine, dibutylhydroxytoluene, and the like.
Preservatives, bactericides or antibacterials: for example, zinc chloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid, potassium sorbate, sodium dehydroacetate, methyl parahydroxybenzoate, ethyl paraoxybenzoate, propyl paraoxybenzoate, paraoxyl Butyl benzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, biguanide compounds (specifically, polyhexanide hydrochloride (polyhexamethylene biguanide), etc.), Gloquil (trade name, manufactured by Rhodia), chlorite, and the like.
Isotonizing agents: for example, sodium bisulfite, sodium sulfite, potassium chloride, calcium chloride, sodium chloride, magnesium chloride, potassium acetate, sodium acetate, sodium hydrogen carbonate, sodium carbonate, sodium thiosulfate, magnesium sulfate, glycerin, propylene glycol etc.
Thickeners: For example, cellulose-based polymer compounds (eg, methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, sodium carboxymethylcellulose, etc.), polyvinyl-based polymer compounds (polyvinylpyrrolidone, polyvinylalcohol, etc.), carboxyvinyl polymer, guar gum , Hydroxypropyl guar gum, gum arabic, gum karaya, xanthan gum, agar, alginic acid and its salts (such as sodium salt), mucopolysaccharides (for example, heparin-like substances, heparin, heparin sulfate, heparan sulfate, heparinoid, hyaluronic acid and its salts ( Sodium salts, etc.)), starch, chitin and its derivatives, chitosan and its derivatives, carrageenan and the like.
Saccharides: for example, glucose, cyclodextrin and the like.
Sugar alcohols: for example, xylitol, sorbitol, mannitol, glycerin and the like. These may be d-form, l-form or dl-form.
本実施形態に係る洗眼剤組成物が水を含有する場合、水の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、洗眼剤組成物の総量を基準として、水の含有量が、80w/v%以上100w/v%未満であることが好ましく、85w/v%以上99.5w/v%以下であることがより好ましく、90w/v%以上99.2w/v%以下であることが更に好ましい。 When the eyewash composition according to the present embodiment contains water, as the content of water, from the viewpoint of more remarkably exerting the effects of the present invention, for example, based on the total amount of the eyewash composition, the water content The amount is preferably 80 w / v% or more and less than 100 w / v%, more preferably 85 w / v% or more and 99.5 w / v% or less, and 90 w / v% or more and 99.2 w / v% or less. Is more preferable.
本実施形態に係る洗眼剤組成物に用いられる水は、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よい。このような水として、例えば、蒸留水、常水、精製水、滅菌精製水、注射用水及び注射用蒸留水等を挙げることができる。これらの定義は第十七改正日本薬局方に基づく。 The water used in the eyewash composition according to the present embodiment may be pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. Examples of such water include distilled water, ordinary water, purified water, sterilized purified water, water for injection, and distilled water for injection. These definitions are based on the 17th revised Japanese Pharmacopoeia.
本実施形態に係る洗眼剤組成物は、例えば、(A)成分、及び必要に応じて他の含有成分を所望の含有量となるように添加及び混和することにより調製することができる。具体的には、例えば、精製水で上記成分を溶解又は懸濁させ、所定のpH及び浸透圧に調整し、濾過滅菌等により滅菌処理することで調製できる。 The eyewash composition according to the present embodiment can be prepared, for example, by adding and mixing the component (A) and, if necessary, other components to a desired content. Specifically, for example, it can be prepared by dissolving or suspending the above components in purified water, adjusting the pH and osmotic pressure to predetermined values, and sterilizing by filtration sterilization or the like.
本実施形態に係る洗眼剤組成物は、目的に応じて種々の剤型をとることができ、例えば、液剤、ゲル剤、半固形剤(軟膏等)等が挙げられる。これらの中でも、液剤が好ましく、水性液剤がより好ましい。 The eyewash composition according to the present embodiment can take various forms depending on the purpose, and examples thereof include a liquid preparation, a gel preparation, and a semi-solid preparation (such as an ointment). Among these, liquid preparations are preferable, and aqueous preparations are more preferable.
本実施形態に係る洗眼剤組成物は、コンタクトレンズを装用した状態で適用することが可能である。なお、「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(イオン性及び非イオン性の双方を包含し、シリコーンハイドロゲルコンタクトレンズ及び非シリコーンハイドロゲルコンタクトレンズの双方を包含する)を含む。本実施形態に係る洗眼剤組成物は、本発明による効果をより顕著に発揮できることから、コンタクトレンズ(好ましくは、ソフトコンタクトレンズ)装用中に使用されることが好ましい。 The eyewash composition according to the present embodiment can be applied while wearing a contact lens. The “contact lens” includes a hard contact lens and a soft contact lens (including both ionic and nonionic, and including both silicone hydrogel contact lenses and non-silicone hydrogel contact lenses). The eyewash composition according to the present embodiment is more preferably used while wearing a contact lens (preferably, a soft contact lens) since the effect of the present invention can be more remarkably exhibited.
本実施形態に係る洗眼剤組成物の1日あたりの投与回数は特に制限されるものではなく、例えば、1〜12回、2〜9回、3〜6回などであってもよい。 The number of times of administration of the eyewash composition according to the present embodiment per day is not particularly limited, and may be, for example, 1 to 12, 2 to 9, 3 to 6 times.
〔容器〕
本実施形態に係る洗眼剤組成物は、任意の容器に収容されて提供される。容器は、洗眼剤組成物と接触する部分(面)を有する包装体であればよく、例えば、洗眼剤組成物を収容する容器本体、容器の抽出口を含む中栓(ノズル)、キャップなどで構成されていてもよい。また、容器の材質は特に制限されず、例えば、ガラスであってもよく、またプラスチックであってもよいが、本発明による効果をより顕著に奏するという観点から、好ましくはプラスチックである。
〔container〕
The eyewash composition according to the present embodiment is provided in an arbitrary container. The container may be a package having a portion (surface) that comes into contact with the eyewash composition. For example, the container may include a container body containing the eyewash composition, an inner stopper (nozzle) including an extraction port of the container, a cap, and the like. It may be configured. The material of the container is not particularly limited, and may be, for example, glass or plastic, but is preferably plastic from the viewpoint that the effects of the present invention are more remarkably exhibited.
容器の材質がプラスチックである場合、具体的には例えば、ポリエチレンテレフタレート(PET)、ポリブチレンテレフタレート(PBT)、ポリエチレンナフタレート、ポリアリレート、ポリカーボネート、ポリエチレン(PE;高密度ポリエチレン(HDPE)、低密度ポリエチレン(LDPE))、ポリプロピレン(PP)、ポリスチレン(PS)、アクリロニトリルブタジエンスチレン(ABS)、ポリメチルペンテン(PMP)、ポリイミド、及びこれらを構成するモノマーの共重合体、並びにこれら2種以上を混合したものが挙げられる。これらの中でも、ポリエチレン(PE)が好ましい。なお、これらのプラスチックに安定化剤等の添加剤、ガラス繊維等の補強剤を含有させてもよい。 When the material of the container is plastic, specifically, for example, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene naphthalate, polyarylate, polycarbonate, polyethylene (PE; high density polyethylene (HDPE), low density Polyethylene (LDPE)), Polypropylene (PP), Polystyrene (PS), Acrylonitrile Butadiene Styrene (ABS), Polymethylpentene (PMP), Polyimide, and Copolymers of Monomers Constituting These, and Mixture of Two or More of These What was done. Among these, polyethylene (PE) is preferred. These plastics may contain additives such as stabilizers and reinforcing agents such as glass fibers.
容器は、洗眼剤組成物と接触する部分の少なくとも一部が上記材質で構成されていてもよい。ここで、容器のうち洗眼剤組成物と接触する部分は、例えば、容器本体の内面(容器が複数の層からなる構造の場合、最も内側の層)、中栓(ノズル)が挙げられる。例えば、容器が中栓(ノズル)を有する容器の場合、中栓(ノズル)のみが上記材質(好ましくはポリエチレン)で形成されていてもよく、中栓(ノズル)以外の容器本体等が上記材質(好ましくはポリエチレン)で形成されていてもよく、洗眼剤組成物と接触する部分の全部が上記材質(好ましくはポリエチレン)で形成されていてもよい。容器は、本発明による効果をより顕著に奏するという観点から、洗眼剤組成物と接触する部分の全部が上記材質(好ましくはポリエチレン)で形成されていることが好ましい。 In the container, at least a part of a portion that comes into contact with the eyewash composition may be made of the above material. Here, the portion of the container that comes into contact with the eyewash composition includes, for example, the inner surface of the container main body (the innermost layer when the container has a structure including a plurality of layers) and an inner plug (nozzle). For example, when the container is a container having an inner stopper (nozzle), only the inner stopper (nozzle) may be formed of the above material (preferably polyethylene), and the container body other than the inner stopper (nozzle) may be formed of the above material. (Preferably polyethylene), and all of the portions in contact with the eyewash composition may be formed of the above-described material (preferably polyethylene). From the viewpoint that the effects of the present invention are more remarkably exhibited, it is preferable that the entire portion of the container that comes into contact with the eyewash composition is made of the above-mentioned material (preferably polyethylene).
容器の種類は、眼科分野で一般的に使用されており、収容された洗眼剤組成物を滴下して使用することができる容器であれば特に限定されず、具体的には、例えば、中栓(ノズル)を有する容器であってよい。容器の種類は、点眼容器として用いられる容器であることが好ましい。 The type of the container is generally used in the field of ophthalmology, and is not particularly limited as long as the container can be used by dropping the contained eyewash composition.Specifically, for example, an inner stopper (Nozzle). The type of the container is preferably a container used as an ophthalmic container.
容器の形状及び容量は、特に限定されず、用途に応じて適宜設定すればよい。また、容器は、多数回(例えば、25回以上)の使用量の洗眼剤組成物が収容される容器であってもよく、少数回(例えば、2回以上25回未満)の使用量の洗眼剤組成物が収容される容器であってもよく、単回の使用量の洗眼剤組成物が収容される容器であってもよい。 The shape and capacity of the container are not particularly limited, and may be appropriately set according to the application. Further, the container may be a container in which a large number (for example, 25 times or more) of the amount of use of the eyewash composition is contained, and a small number of times (for example, 2 times or more and less than 25 times) of the use of the eyewash. It may be a container for accommodating the agent composition or a container for accommodating a single use amount of the eyewash composition.
多数回(例えば、25回以上)の使用量の洗眼剤組成物が収容される容器である場合は、例えば、容量が1mL以上200mL以下であってよく、1mL以上100mL以下であることが好ましく、1mL以上50mL以下であることがより好ましい。少数回(例えば、2回以上25回未満)又は単回の使用量の洗眼剤組成物が収容される容器である場合は、例えば、容量が0.01mL以上7mL以下であってよく、0.05mL以上6mL以下であることが好ましく、0.1mL以上5mL以下であることがより好ましく、0.1mL以上3mL以下であることが更に好ましく、0.2mL以上2mL以下であることが更により好ましく、0.2mL以上1mL以下であることが特に好ましい。また容器は、複数回の使用量が収容されるマルチドーズ型であってもよく、単回の使用量が収容されるユニットドーズ型であってもよい。 When the container contains a large number of (for example, 25 or more) usage amounts of the eyewash composition, for example, the volume may be 1 mL or more and 200 mL or less, and preferably 1 mL or more and 100 mL or less, More preferably, it is 1 mL or more and 50 mL or less. In the case where the container contains a small number of times (for example, 2 or more and less than 25 times) or a single use amount of the eyewash composition, for example, the volume may be 0.01 mL or more and 7 mL or less. It is preferably from 05 mL to 6 mL, more preferably from 0.1 mL to 5 mL, still more preferably from 0.1 mL to 3 mL, even more preferably from 0.2 mL to 2 mL, It is particularly preferable that the concentration be 0.2 mL or more and 1 mL or less. Further, the container may be a multi-dose type accommodating a plurality of usage amounts or a unit dose type accommodating a single usage amount.
容器は、容器本体と注出口が一体成形された容器であってもよい。使用回数が少数回(例えば、2回以上25回未満)又は単回の容器であって、容量が0.1mL以上3mL以下である場合は、容器本体と注出口が一体成形された容器であることが好ましい。 The container may be a container in which the container body and the spout are integrally formed. When the number of times of use is a small number (for example, 2 or more and less than 25 times) or a single container, and the capacity is 0.1 mL or more and 3 mL or less, the container is a container in which the container body and the spout are integrally formed. Is preferred.
本実施形態に係る洗眼剤組成物は、容器に洗眼剤組成物が収容された製品(洗眼剤等)としても提供され得る。 The eyewash composition according to the present embodiment can also be provided as a product (such as an eyewash) in which the eyewash composition is contained in a container.
本実施形態に係る洗眼剤組成物は、例えば、眼の洗浄、眼病予防(水泳のあと;ほこりや汗が眼に入ったときなど)のために用いることができる。 The eyewash composition according to the present embodiment can be used, for example, for washing eyes and preventing eye diseases (after swimming; when dust or sweat enters eyes).
以下、試験例に基づいて本発明を具体的に説明するが、本発明はこれらに限定されるものではない。 Hereinafter, the present invention will be specifically described based on test examples, but the present invention is not limited thereto.
〔試験例1:水溶性の異物に対する洗浄効果の評価〕
異物として2%トリパンブルー水溶液10μLを日本白色種家兎(3kg以上、16〜18週齢)に点眼し、以下に記載の方法に従い、点眼による洗眼又はアイカップを用いた洗眼を行った後、洗い出された異物の量から洗浄効果を評価した。本試験では、洗眼剤組成物として生理食塩液を用いた。
[Test Example 1: Evaluation of cleaning effect on water-soluble foreign matter]
As a foreign substance, 10 μL of a 2% aqueous solution of trypan blue was instilled into Japanese white rabbits (3 kg or more, 16 to 18 weeks of age), and after eyewashing with eye drops or eyewashing using an eyecup according to the method described below, The cleaning effect was evaluated based on the amount of foreign substances washed out. In this test, a physiological saline solution was used as the eyewash composition.
点眼による洗眼においては、通常の点眼容器(容量12mL、ポリエチレンテレフタレート樹脂製)を用い、生理食塩液を各家兎の片眼に12滴ずつ滴下した。3滴滴下毎に下眼瞼を軽く抑え、溢れ出た生理食塩液をピペットを用いて回収した。なお、1滴あたりの滴下量は約40μLであった。
アイカップを用いた洗眼においては、通常のアイカップ(プラスチック製)を用い、生理食塩液5mLを各家兎の片眼の角膜及び球結膜に1回2秒間、合計10回接触させた後、生理食塩液を回収した。
吸光光度法により生理食塩液中に洗い出されたトリパンブルーの量を求め、回収率を算出した。試験はそれぞれ6回行い、平均値を求めた。
結果を図1に示す。
In eye washing with eye drops, a normal eye drop container (capacity: 12 mL, made of polyethylene terephthalate resin) was used to drop 12 drops of physiological saline solution into one eye of each rabbit. The lower eyelid was lightly held down for every three drops, and the overflowing saline solution was collected using a pipette. The amount of each drop was about 40 μL.
In eye washing using an eye cup, using a normal eye cup (made of plastic), 5 mL of physiological saline is brought into contact with the cornea and bulbar conjunctiva of each rabbit once for 2 seconds for a total of 10 times. The saline solution was collected.
The amount of trypan blue washed out in the physiological saline solution was determined by the absorption spectrophotometry, and the recovery rate was calculated. Each test was performed six times, and the average value was determined.
The results are shown in FIG.
図1に示されるとおり、アイカップを用いた洗眼では水溶性異物であるトリパンブルーの回収率が約90%であったのに対し、点眼による洗眼ではトリパンブルーの回収率が3滴で約75%であり、6滴で約90%であり、9滴で約95%であり、12滴で約98%であった。これらの結果は、1回あたり3〜12滴の点眼により水溶性異物を十分に除去できることを示すものである。 As shown in FIG. 1, the recovery rate of trypan blue, which is a water-soluble foreign substance, was about 90% in eyewashing using an eyecup, whereas the recovery rate of trypan blue was about 75% in three drops in eyewashing with eye drops. %, About 90% with 6 drops, about 95% with 9 drops, and about 98% with 12 drops. These results indicate that the water-soluble foreign matter can be sufficiently removed by instilling 3 to 12 drops at a time.
〔試験例2:固形の異物に対する洗浄効果の評価〕
異物として200個のポリスチレンビーズ(粒径:340〜420μm)を0.5%メチルセルロース水溶液50μLに懸濁したものを用いたこと、点眼容器として通常の点眼容器(容量13mL,ポリエチレン樹脂製)を用いたこと、1滴あたりの滴下量が約50μLであったこと以外は、試験例1と同様の方法で評価を行った。なお、ポリスチレンビーズの個数は乾燥重量から算出した。結果を図2に示す。
[Test Example 2: Evaluation of cleaning effect on solid foreign matter]
200 polystyrene beads (particle size: 340 to 420 μm) suspended in 50 μL of 0.5% methylcellulose aqueous solution were used as foreign matter, and a normal ophthalmic container (capacity: 13 mL, made of polyethylene resin) was used as an ophthalmic container. The evaluation was performed in the same manner as in Test Example 1 except that the amount of dropping was about 50 μL per drop. The number of polystyrene beads was calculated from the dry weight. The results are shown in FIG.
図2に示されるとおり、アイカップを用いた洗眼では固形異物であるポリスチレンビーズの回収率が約80%であったのに対し、点眼による洗眼ではポリスチレンビーズの回収率が3滴で約65%であり、6、9、及び12滴で約80%であった。これらの結果は、1回あたり3〜12滴の点眼により固形異物を十分に除去できることを示すものである。 As shown in FIG. 2, the recovery rate of polystyrene beads, which are solid foreign substances, was about 80% in the eyewash using the eye cup, whereas the recovery rate of the polystyrene beads was about 65% for three drops in the eyewash using eye drops. And was about 80% at 6, 9, and 12 drops. These results show that solid foreign matter can be sufficiently removed by applying 3 to 12 drops per time.
〔試験例3:ソフトコンタクトレンズ装用時における固形の異物に対する洗浄効果の評価〕
表1に示す各洗眼剤組成物を常法により調製した。
異物として50個のポリスチレンビーズ(340〜420μm)を0.5%メチルセルロース水溶液25μLに懸濁したものを日本白色種家兎(3kg以上、16〜18週齢)に点眼し、その直後にソフトコンタクトレンズを装用させた。その後、通常の点眼容器(ポリエチレン樹脂製)を用い、上記調製した洗眼剤組成物1又は2を各家兎の片眼に9滴ずつ滴下した。3滴毎に下眼瞼を軽く抑え、溢れ出た洗眼剤組成物をピペットを用いて回収した。なお、1滴あたりの滴下量は約40μLであった。また、ポリスチレンビーズの個数は乾燥重量から算出した。結果を図3に示す。
[Test Example 3: Evaluation of cleaning effect on solid foreign matter when wearing soft contact lens]
Each eyewash composition shown in Table 1 was prepared by a conventional method.
A suspension of 50 polystyrene beads (340 to 420 μm) in 25 μL of 0.5% methylcellulose aqueous solution as foreign matter was instilled into Japanese white rabbits (3 kg or more, 16 to 18 weeks of age), and immediately thereafter, soft contact was performed. The lens was worn. Thereafter, using an ordinary eye dropper (made of polyethylene resin), 9 drops of the above
図3に示されるとおり、洗眼剤組成物1及び2を用いた場合のポリスチレンビーズの回収率は、3滴でそれぞれ約75%及び約50%であり、6滴でそれぞれ約85%及び約70%であり、9滴でそれぞれ約90%及び約80%であった。これらの結果は、ソフトコンタクトレンズ装用時においても、1回あたり3〜9滴の点眼により固形異物を十分に除去できることを示すものである。
As shown in FIG. 3, the recovery of polystyrene beads when using
〔試験例4:クロルフェニラミンマレイン酸塩の安定性の評価〕
表2及び3に示す洗眼剤組成物を常法により調製した。表2及び3における各成分の単位はw/v%である。
得られた洗眼剤組成物をポリエチレン樹脂製のユニットドーズ容器にそれぞれ充填し、表2に示す洗眼剤組成物については60℃で2時間、表3に示す洗眼剤組成物については60℃で3日間静置した。その後、クロルフェニラミンマレイン酸塩を定量し、その残存率を求めた。下記式に基づき、安定性改善率を求めた。
安定性改善率(%)=[1−(100−実施例の残存率)/(100−コントロールの残存率)]×100
結果を図4及び5にそれぞれ示す。
[Test Example 4: Evaluation of stability of chlorpheniramine maleate]
The eyewash compositions shown in Tables 2 and 3 were prepared by a conventional method. The unit of each component in Tables 2 and 3 is w / v%.
Each of the obtained eyewash compositions was filled into a unit dose container made of polyethylene resin, and the eyewash compositions shown in Table 2 were kept at 60 ° C. for 2 hours, and the eyewash compositions shown in Table 3 were kept at 60 ° C. for 3 hours. Let stand for days. Thereafter, chlorpheniramine maleate was quantified, and its residual ratio was determined. The stability improvement rate was determined based on the following equation.
Stability improvement rate (%) = [1− (100−residual rate of example) / (100−residual rate of control)] × 100
The results are shown in FIGS. 4 and 5, respectively.
図4に示されるとおり、クロルフェニラミンマレイン酸塩の安定性はpHを9.2から低下させることにより改善し、その改善率はpH8.3以下で30%以上、pH8.0以下で50%以上、pH7.5以下で70%以上、pH7.0以下で85%以上、pH6.5以下で90%以上であった。 As shown in FIG. 4, the stability of chlorpheniramine maleate is improved by lowering the pH from 9.2, and the improvement rate is 30% or more at pH 8.3 or less and 50% at pH 8.0 or less. As described above, 70% or more at pH 7.5 or less, 85% or more at pH 7.0 or less, and 90% or more at pH 6.5 or less.
また、図5に示されるとおり、クロルフェニラミンマレイン酸塩の安定性はl−メントール、d−α−トコフェロール酢酸エステル、レチノールパルミチン酸エステルを配合することにより改善し、その改善率は20%以上であった。 Further, as shown in FIG. 5, the stability of chlorpheniramine maleate was improved by blending l-menthol, d-α-tocopherol acetate, and retinol palmitate, and the improvement rate was 20% or more. Met.
〔試験例5:洗眼時の洗浄感に清涼化剤が与える影響の評価〕
表4に示す各洗眼剤組成物を常法により調製した。
洗眼時の洗浄感に清涼化剤が与える影響をVAS(Visual Analogue Scale)法により評価した。具体的には、5名の被験者に上記調製した洗眼剤組成物3及び4を左右の眼にそれぞれ4滴ずつ点眼してもらい、全長100mmのスケールの左端を「洗浄感がない」0点、右端を「洗浄感がある」100点とし、被験者が感じた洗浄感の程度をチェックしてもらった。なお、被験者にはコンタクトレンズを装用していない状態にて洗眼剤組成物を点眼してもらった。0点(左端)からチェックした点までの長さを測定し、この長さ(mm)を洗浄感スコアとした。その後、各洗眼剤組成物の洗浄感スコアについてt検定を実施した。結果を図6に示す。
[Test Example 5: Evaluation of Effect of Cooling Agent on Washing Feeling During Eye Wash]
Each eyewash composition shown in Table 4 was prepared by a conventional method.
The effect of the cooling agent on the feeling of washing during eye washing was evaluated by the VAS (Visual Analog Scale) method. Specifically, five subjects instilled four drops each of the eyewash compositions 3 and 4 prepared above into the left and right eyes, and the left end of the 100-mm-long scale was evaluated as having 0 points of “no washing feeling”. The right end was designated as having a "feel of washing" of 100 points, and the degree of the feeling of washing felt by the subject was checked. In addition, the subject applied the eyewash composition in a state where the contact lens was not worn. The length from the zero point (left end) to the checked point was measured, and this length (mm) was taken as the washing feeling score. Thereafter, a t-test was performed on the washing feeling score of each eyewash composition. The results are shown in FIG.
図6に示されるとおり、清涼化剤としてl−メントールを含む洗眼剤組成物4は、清涼化剤を含まない洗眼剤組成物3と比較して、有意に洗浄感スコアが高かった。この結果は、清涼化剤が点眼による洗眼時の洗浄感を高めることを示すものである。 As shown in FIG. 6, the eyewash composition 4 containing l-menthol as a refreshing agent had a significantly higher washing feeling score than the eyewash composition 3 containing no refreshing agent. This result indicates that the cooling agent enhances the feeling of washing during eyewashing with eye drops.
〔処方例〕
以下の表5及び6に処方例を示す。表5及び6における各成分の単位はw/v%である。処方例1〜19は全て洗眼剤であり、処方例のpHは必要に応じて塩酸又は水酸化ナトリウムを用いて調整した。各処方例をポリエチレン製容器に充填したものを処方例1´〜19´とする。
(Prescription example)
Formulation examples are shown in Tables 5 and 6 below. The unit of each component in Tables 5 and 6 is w / v%. Formulation Examples 1 to 19 are all eyewashes, and the pH of Formulation Examples was adjusted with hydrochloric acid or sodium hydroxide as needed. Each of the prescription examples filled in a polyethylene container is referred to as prescription examples 1 ′ to 19 ′.
Claims (11)
The eyewash composition according to any one of claims 1 to 10, wherein at least a part of a portion that comes into contact with the eyewash composition is contained in a container formed of polyethylene.
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