JP6628488B2 - ゲル状外用組成物 - Google Patents
ゲル状外用組成物 Download PDFInfo
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- JP6628488B2 JP6628488B2 JP2015074068A JP2015074068A JP6628488B2 JP 6628488 B2 JP6628488 B2 JP 6628488B2 JP 2015074068 A JP2015074068 A JP 2015074068A JP 2015074068 A JP2015074068 A JP 2015074068A JP 6628488 B2 JP6628488 B2 JP 6628488B2
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- WTEVQBCEXWBHNA-JXMROGBWSA-N geranial Chemical compound CC(C)=CCC\C(C)=C\C=O WTEVQBCEXWBHNA-JXMROGBWSA-N 0.000 description 1
- 229960002442 glucosamine Drugs 0.000 description 1
- 125000003976 glyceryl group Chemical group [H]C([*])([H])C(O[H])([H])C(O[H])([H])[H] 0.000 description 1
- 229940075507 glyceryl monostearate Drugs 0.000 description 1
- 229960002449 glycine Drugs 0.000 description 1
- 229940100608 glycol distearate Drugs 0.000 description 1
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- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 1
- BBEJNBLSSWFDSN-UHFFFAOYSA-N methylamino benzoate Chemical compound CNOC(=O)C1=CC=CC=C1 BBEJNBLSSWFDSN-UHFFFAOYSA-N 0.000 description 1
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- KSCKTBJJRVPGKM-UHFFFAOYSA-N octan-1-olate;titanium(4+) Chemical compound [Ti+4].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-] KSCKTBJJRVPGKM-UHFFFAOYSA-N 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 1
- 235000021313 oleic acid Nutrition 0.000 description 1
- 229940055577 oleyl alcohol Drugs 0.000 description 1
- XMLQWXUVTXCDDL-UHFFFAOYSA-N oleyl alcohol Natural products CCCCCCC=CCCCCCCCCCCO XMLQWXUVTXCDDL-UHFFFAOYSA-N 0.000 description 1
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- 235000008390 olive oil Nutrition 0.000 description 1
- 229950006098 orthocaine Drugs 0.000 description 1
- TWNQGVIAIRXVLR-UHFFFAOYSA-N oxo(oxoalumanyloxy)alumane Chemical compound O=[Al]O[Al]=O TWNQGVIAIRXVLR-UHFFFAOYSA-N 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 239000000312 peanut oil Substances 0.000 description 1
- 235000019477 peppermint oil Nutrition 0.000 description 1
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 1
- 239000004584 polyacrylic acid Substances 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
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- 229960004919 procaine Drugs 0.000 description 1
- MFDFERRIHVXMIY-UHFFFAOYSA-N procaine Chemical compound CCN(CC)CCOC(=O)C1=CC=C(N)C=C1 MFDFERRIHVXMIY-UHFFFAOYSA-N 0.000 description 1
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- 235000008160 pyridoxine Nutrition 0.000 description 1
- 239000011677 pyridoxine Substances 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- 229940092258 rosemary extract Drugs 0.000 description 1
- 235000020748 rosemary extract Nutrition 0.000 description 1
- 239000001233 rosmarinus officinalis l. extract Substances 0.000 description 1
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- 239000003813 safflower oil Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000037387 scars Effects 0.000 description 1
- 125000002072 seryl group Chemical group 0.000 description 1
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- 230000037370 skin discoloration Effects 0.000 description 1
- 239000003009 skin protective agent Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 229960003885 sodium benzoate Drugs 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 229940037001 sodium edetate Drugs 0.000 description 1
- 235000019983 sodium metaphosphate Nutrition 0.000 description 1
- 229940001482 sodium sulfite Drugs 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- JGMJQSFLQWGYMQ-UHFFFAOYSA-M sodium;2,6-dichloro-n-phenylaniline;acetate Chemical compound [Na+].CC([O-])=O.ClC1=CC=CC(Cl)=C1NC1=CC=CC=C1 JGMJQSFLQWGYMQ-UHFFFAOYSA-M 0.000 description 1
- CRPCXAMJWCDHFM-UHFFFAOYSA-M sodium;5-oxopyrrolidine-2-carboxylate Chemical compound [Na+].[O-]C(=O)C1CCC(=O)N1 CRPCXAMJWCDHFM-UHFFFAOYSA-M 0.000 description 1
- 239000001593 sorbitan monooleate Substances 0.000 description 1
- 235000011069 sorbitan monooleate Nutrition 0.000 description 1
- 229940035049 sorbitan monooleate Drugs 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 239000008347 soybean phospholipid Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 229940032094 squalane Drugs 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
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- 239000000126 substance Substances 0.000 description 1
- 150000005846 sugar alcohols Polymers 0.000 description 1
- SEEPANYCNGTZFQ-UHFFFAOYSA-N sulfadiazine Chemical compound C1=CC(N)=CC=C1S(=O)(=O)NC1=NC=CC=N1 SEEPANYCNGTZFQ-UHFFFAOYSA-N 0.000 description 1
- 229960004306 sulfadiazine Drugs 0.000 description 1
- 229940044609 sulfur dioxide Drugs 0.000 description 1
- 235000010269 sulphur dioxide Nutrition 0.000 description 1
- 239000002600 sunflower oil Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 229960002372 tetracaine Drugs 0.000 description 1
- GKCBAIGFKIBETG-UHFFFAOYSA-N tetracaine Chemical compound CCCCNC1=CC=C(C(=O)OCCN(C)C)C=C1 GKCBAIGFKIBETG-UHFFFAOYSA-N 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- CRDAMVZIKSXKFV-UHFFFAOYSA-N trans-Farnesol Natural products CC(C)=CCCC(C)=CCCC(C)=CCO CRDAMVZIKSXKFV-UHFFFAOYSA-N 0.000 description 1
- HVUCRESARJLKJG-UHFFFAOYSA-K trisodium 1-hexadecoxyhexadecane phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O.CCCCCCCCCCCCCCCCOCCCCCCCCCCCCCCCC HVUCRESARJLKJG-UHFFFAOYSA-K 0.000 description 1
- 229940099259 vaseline Drugs 0.000 description 1
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- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
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- 235000013343 vitamin Nutrition 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- 229940011671 vitamin b6 Drugs 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/727—Heparin; Heparan
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Birds (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cosmetics (AREA)
Description
項1. ヘパリン類似物質、イソプロパノール、及びゲル化剤を含み、且つ
ヘパリン類似物質1重量部当たり、イソプロパノールを77〜180重量部の比率で含む、ゲル状外用組成物。
項2. 前記ゲル化剤が、カルボキシビニルポリマーである、項1に記載のゲル状外用組成物。
項3. ヘパリン類似物質1重量部当たり、イソプロパノールを82〜140重量部の比率含む、項1又は2記載のゲル状外用組成物。
項4. ヘパリン類似物質の配合量が0.01〜5質量%である、項1〜3のいずれかに記載にゲル状外用組成物。
項5. 保湿用途で使用される、項1〜4のいずれかに記載のゲル状外用組成物。
項6. 乾燥性皮膚疾患及び/又は炎症性皮膚疾患の予防又は治療に使用される、項1〜4のいずれかに記載のゲル状外用組成物。
項7. 肥厚性瘢痕及び/又はケロイドを予防又は治療するために使用される、項1〜4のいずれかに記載のゲル状外用組成物。
項8. きず又はやけどのあとの皮ふのしこり、或いはきず又はやけどのあとの皮ふのつっぱりの改善のために使用される、項1〜4のいずれかに記載のゲル状外用組成物。
本発明のゲル状外用組成物は、有効成分としてヘパリン類似物質を含む。ヘパリン類似物質とは、コンドロイチン多硫酸等の多硫酸化ムコ多糖であり、保湿作用、抗炎症作用、血行促進作用等を有することが知られている公知の薬剤である。
本発明のゲル状外用組成物は、ヘパリン類似物質1重量部当たり、77〜180重量部の比率でイソプロパノールを含有する。このような特定の比率でイソプロパノールを含むことによって、塗布後のべたつきを抑制し、優れた使用感を備えさせることが可能になる。また、このような特定の比率でイソプロパノールを含むことによって、格段に優れた肉芽組織の形成抑制作用を発揮させることも可能になる。
本発明のゲル状外用組成物は、ゲル剤としてゲル状を呈させるために、ゲル化剤を含む
本発明のゲル状外用組成物は、ゲル化剤によってゲル化させるために、水が含まれる。本発明のゲル状外用組成物における水の含有量については、使用するゲル化剤の種類等に応じて適宜設定すればよいが、例えば5〜92.28重量%、好ましくは20〜90重量%、更に好ましくは30〜80重量%が挙げられる。
本発明のゲル状外用組成物は、前述した成分の他に、必要に応じて、他の薬理成分を含有していてもよい。このような薬理成分としては、例えば、抗ヒスタミン剤(マレイン酸クロルフェニラミン等)、局所麻酔剤(ジブカイン、アミノ安息香酸メチル、プロカイン、テトラカイン、ブピパカイン、メピパカイン、クロロプロカイン、プロパラカイン、メプリルカイン又はこれらの塩、オルソカイン、オキセサゼイン、オキシポリエントキシデカン、ロートエキス、ペルカミンパーゼ、テシットデシチン等)、抗炎症剤(アラントイン、グリチルリチン酸、グリチルリチン酸メチル、グリチルリチン酸ステアリル、グリチルリチン酸ジカリウム、グリチルリチン酸モノアンモニウム、グリチルレチン酸、グリチルレチン酸ピリドキシン、グリチルレチン酸ステアリル、グリチルレチン酸グリセリル、グリチルレチン酸モノグルクロニドインドメタシン、フェルビナク、ジクロフェナクナトリウム、ロキソプロフェンナトリウム、スプロフェン、ベンダザック、スプロフェン、ブフェキサマク等)、殺菌剤(デカリニウム塩化物、クロルヘキシジン塩化物、グルコン酸クロルヘキシジン、アンモニア水、スルファジアジン、乳酸、フェノール等)、皮膚保護剤(ヒマシ油等)、血行促進剤(ノニル酸ワニリルアミド、カプサイシン、トウガラシエキス等)、清涼化剤(カンフル等)、ビタミン類(ビタミンA、E等)、ムコ多糖類(コンドロイチン硫酸ナトリウム、グルコサミン等)等が挙げられる。これらの薬理成分は、1種単独で使用してもよく、また2種以上を組み合わせて使用してもよい。
本発明のゲル状外用組成物の製剤形態については、経皮適用されるものであることを限度として特に制限されず、外用医薬品、化粧料、皮膚洗浄料等のいずれであってもよいが、好ましくは外用医薬品が挙げられる。
表2〜4に示す組成の外用組成物を調製した。各外用組成物の使用感(べたつき、液だれ、乾き易さ)、外観、性状について、それぞれ下記の基準にて評価した。
各外用組成物約0.05gを前腕内側の皮膚(長径約6cm、短径約4cmの楕円状の領域)に塗布してすりこみ(すりこみ動作は約5秒間に設定)、すりこみしてから10〜20秒後に塗布した箇所を触った際のべたつきの度合いを評価した。べたつきの度合いの評価は、VAS(Visual Analog Scale)に類した手法を使用して、表1に示すように「べたつかない」を◎◎◎、「べたつく」を×××として8段階にべたつきの度合いを分類し、各外用組成物のべたつきの度合いがどれに該当するかについて、評価することにより行った。
各外用組成物約0.05gを前腕内側に載せて、90°に傾けた際に、外用組成物の状態を観察し、以下の判定基準に従って、液だれ抑制効果を評価した。
液だれ抑制効果の判定基準
○:外用組成物が塗布領域に保持され、液だれしない。
×:外用組成物が塗布領域から流れだして、液だれした。
各外用組成物約0.05gを前腕内側の皮膚(長径約6cm、短径約4cmの楕円状の領域)に塗布してすりこみ、(すりこみ動作は約5秒間に設定)、すりこみしてから外用組成物が視認できなくなるまでの時間を乾燥時間として計測した。計測した乾燥時間を以下の判定基準に従って分類し、乾き易さを評価した。
乾き易さの判定基準
◎◎:乾燥時間が30秒未満である。
◎ :乾燥時間が30秒以上45秒未満である。
○ :乾燥時間が45秒以上60秒未満である。
△ :乾燥時間が60秒以上120秒未満である。
× :乾燥時間が120秒以上180秒未満である。
××:乾燥時間が180秒以上である。
各外用組成物の外観を目視にて観察し、以下の判定基準に従って、透明性について評価した。
透明性の判定基準
○:透明である。
△:僅かに白濁している。
×:明らかに白濁している。
各外用組成物の性状を目視で確認すると共に触って、ゲル剤として使用できるゲル状を呈しているか、液状を呈しているかを判断した。
7週齢(馴化期間1週間を含む)のSlc:Wistarラットの背部正中線上に小切開を加え、約30mgとなるように調整した滅菌済みコットンペレット(「リッチモンドコットンペレット」、株式会社アグサジャパン製)を1個挿入した後に、切開部を縫合した。縫合から6時間後、コットンペレット埋植部位の皮膚上に表5に示すゲル状外用組成物約1gを塗布(初回塗布)した。初回塗布から24時間間隔で、1日1回、合計6日間、コットンペレット埋植部位に表5に示すゲル状外用組成物約1gを塗布した。最終塗布の翌日に、ラット背部から、コットンペレットを取り巻いて形成された肉芽をコットンペレットと共に摘出した。摘出した肉芽を乾燥した後に重量を測定し、これを肉芽乾燥重量とした。また、コントロールとして、ゲル状外用組成物の塗布を行わないこと以外は、前記と同様の方法で、肉芽乾燥重量を求めた。肉芽乾燥重量から埋植したコットンペレットの重量を差し引いた値を肉芽重量とした。なお、本試験では、1群当たり10匹のラットを使用して肉芽重量の平均値を算出した。また、得られた肉芽重量から、以下の式に従って、肉芽形成抑制率(%)を算出した。
表6に示す組成のゲル状外用組成物を調製した。これらのゲル状外用組成物を前記試験例1と同条件で、塗布後のべたつきを評価すると、べたつきが抑制されていることが確認できる。また、処方例2、4、5、及び7〜9のゲル状外用組成物では、透明な外観性状を備えていた。
Claims (8)
- ヘパリン類似物質、イソプロパノール、及びゲル化剤を含み、且つ
ヘパリン類似物質1重量部当たり、イソプロパノールを77〜180重量部の比率で含む、ゲル状外用組成物(但し、非ステロイド性消炎鎮痛成分及びN−メチルピロリドンを含む場合を除く)。 - 前記ゲル化剤が、カルボキシビニルポリマーである、請求項1に記載のゲル状外用組成物。
- ヘパリン類似物質1重量部当たり、イソプロパノールを82〜140重量部の比率含む、請求項1又は2記載のゲル状外用組成物。
- ヘパリン類似物質の配合量が0.01〜5質量%である、請求項1〜3のいずれかに記載にゲル状外用組成物。
- 保湿用途で使用される、請求項1〜4のいずれかに記載のゲル状外用組成物。
- 乾燥性皮膚疾患及び/又は炎症性皮膚疾患の予防又は治療に使用される、請求項1〜4のいずれかに記載のゲル状外用組成物。
- 肥厚性瘢痕及び/又はケロイドを予防又は治療するために使用される、請求項1〜4のいずれかに記載のゲル状外用組成物。
- きず又はやけどのあとの皮ふのしこり、或いはきず又はやけどのあとの皮ふのつっぱりの改善のために使用される、請求項1〜4のいずれかに記載のゲル状外用組成物。
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