JP2023054255A - External preparation for skin - Google Patents
External preparation for skin Download PDFInfo
- Publication number
- JP2023054255A JP2023054255A JP2023026204A JP2023026204A JP2023054255A JP 2023054255 A JP2023054255 A JP 2023054255A JP 2023026204 A JP2023026204 A JP 2023026204A JP 2023026204 A JP2023026204 A JP 2023026204A JP 2023054255 A JP2023054255 A JP 2023054255A
- Authority
- JP
- Japan
- Prior art keywords
- skin
- perspiration
- oil
- examples
- external preparation
- 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.)
- Granted
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 38
- SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical class FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 claims abstract description 16
- 239000004480 active ingredient Substances 0.000 claims abstract description 9
- -1 patch Substances 0.000 claims description 34
- 201000004624 Dermatitis Diseases 0.000 claims description 20
- 239000006071 cream Substances 0.000 claims description 14
- 239000008309 hydrophilic cream Substances 0.000 claims description 10
- 239000002674 ointment Substances 0.000 claims description 6
- 230000001737 promoting effect Effects 0.000 claims description 6
- 208000015413 lichen amyloidosis Diseases 0.000 claims description 5
- 239000006210 lotion Substances 0.000 claims description 5
- 206010039793 Seborrhoeic dermatitis Diseases 0.000 claims description 4
- 208000010668 atopic eczema Diseases 0.000 claims description 4
- 239000006260 foam Substances 0.000 claims description 4
- 239000000499 gel Substances 0.000 claims description 4
- 208000008742 seborrheic dermatitis Diseases 0.000 claims description 4
- 239000002552 dosage form Substances 0.000 claims description 2
- 239000011505 plaster Substances 0.000 claims description 2
- 229920001287 Chondroitin sulfate Polymers 0.000 abstract description 2
- 210000003491 skin Anatomy 0.000 description 45
- 235000019271 petrolatum Nutrition 0.000 description 23
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 21
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 18
- 239000003921 oil Substances 0.000 description 17
- 235000019198 oils Nutrition 0.000 description 15
- PRAKJMSDJKAYCZ-UHFFFAOYSA-N squalane Chemical compound CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 description 15
- 230000035900 sweating Effects 0.000 description 15
- 239000003795 chemical substances by application Substances 0.000 description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
- 239000003871 white petrolatum Substances 0.000 description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 12
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 12
- 235000011187 glycerol Nutrition 0.000 description 12
- 210000000434 stratum corneum Anatomy 0.000 description 12
- 229930195733 hydrocarbon Natural products 0.000 description 11
- 150000002430 hydrocarbons Chemical class 0.000 description 11
- 239000000203 mixture Substances 0.000 description 11
- 239000002562 thickening agent Substances 0.000 description 11
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 10
- 239000004166 Lanolin Substances 0.000 description 10
- 239000004264 Petrolatum Substances 0.000 description 10
- 235000014113 dietary fatty acids Nutrition 0.000 description 10
- 239000003995 emulsifying agent Substances 0.000 description 10
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 10
- 239000000194 fatty acid Substances 0.000 description 10
- 229930195729 fatty acid Natural products 0.000 description 10
- 235000019388 lanolin Nutrition 0.000 description 10
- 229940039717 lanolin Drugs 0.000 description 10
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 10
- 229940066842 petrolatum Drugs 0.000 description 10
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 9
- 206010037083 Prurigo Diseases 0.000 description 9
- 150000001298 alcohols Chemical class 0.000 description 9
- 229940057995 liquid paraffin Drugs 0.000 description 9
- 230000003020 moisturizing effect Effects 0.000 description 9
- 229910052708 sodium Inorganic materials 0.000 description 9
- 239000011734 sodium Substances 0.000 description 9
- 238000012360 testing method Methods 0.000 description 9
- 230000000699 topical effect Effects 0.000 description 9
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 8
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 8
- 239000000654 additive Substances 0.000 description 8
- 239000002585 base Substances 0.000 description 8
- 229940082500 cetostearyl alcohol Drugs 0.000 description 8
- 230000001684 chronic effect Effects 0.000 description 8
- 238000009472 formulation Methods 0.000 description 8
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 8
- 239000003755 preservative agent Substances 0.000 description 8
- 239000000126 substance Substances 0.000 description 8
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 description 8
- MGSRCZKZVOBKFT-UHFFFAOYSA-N thymol Chemical compound CC(C)C1=CC=C(C)C=C1O MGSRCZKZVOBKFT-UHFFFAOYSA-N 0.000 description 8
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 8
- 239000001993 wax Substances 0.000 description 8
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 7
- 235000013871 bee wax Nutrition 0.000 description 7
- 239000012166 beeswax Substances 0.000 description 7
- JXTPJDDICSTXJX-UHFFFAOYSA-N n-Triacontane Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCC JXTPJDDICSTXJX-UHFFFAOYSA-N 0.000 description 7
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 7
- 229940032094 squalane Drugs 0.000 description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 6
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 description 6
- 239000004909 Moisturizer Substances 0.000 description 6
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 6
- 229920002125 Sokalan® Polymers 0.000 description 6
- 239000004359 castor oil Substances 0.000 description 6
- 235000019438 castor oil Nutrition 0.000 description 6
- 150000002148 esters Chemical class 0.000 description 6
- 150000004665 fatty acids Chemical class 0.000 description 6
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 6
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 6
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 6
- 229960002216 methylparaben Drugs 0.000 description 6
- 230000001333 moisturizer Effects 0.000 description 6
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 6
- 229940037001 sodium edetate Drugs 0.000 description 6
- HLZKNKRTKFSKGZ-UHFFFAOYSA-N tetradecan-1-ol Chemical compound CCCCCCCCCCCCCCO HLZKNKRTKFSKGZ-UHFFFAOYSA-N 0.000 description 6
- SPSPIUSUWPLVKD-UHFFFAOYSA-N 2,3-dibutyl-6-methylphenol Chemical compound CCCCC1=CC=C(C)C(O)=C1CCCC SPSPIUSUWPLVKD-UHFFFAOYSA-N 0.000 description 5
- 235000021355 Stearic acid Nutrition 0.000 description 5
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 5
- 235000010354 butylated hydroxytoluene Nutrition 0.000 description 5
- LVTYICIALWPMFW-UHFFFAOYSA-N diisopropanolamine Chemical compound CC(O)CNCC(C)O LVTYICIALWPMFW-UHFFFAOYSA-N 0.000 description 5
- 229940043276 diisopropanolamine Drugs 0.000 description 5
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 5
- 229940056211 paraffin Drugs 0.000 description 5
- 239000012188 paraffin wax Substances 0.000 description 5
- 239000011148 porous material Substances 0.000 description 5
- 235000011118 potassium hydroxide Nutrition 0.000 description 5
- 239000008117 stearic acid Substances 0.000 description 5
- DSEKYWAQQVUQTP-XEWMWGOFSA-N (2r,4r,4as,6as,6as,6br,8ar,12ar,14as,14bs)-2-hydroxy-4,4a,6a,6b,8a,11,11,14a-octamethyl-2,4,5,6,6a,7,8,9,10,12,12a,13,14,14b-tetradecahydro-1h-picen-3-one Chemical compound C([C@H]1[C@]2(C)CC[C@@]34C)C(C)(C)CC[C@]1(C)CC[C@]2(C)[C@H]4CC[C@@]1(C)[C@H]3C[C@@H](O)C(=O)[C@@H]1C DSEKYWAQQVUQTP-XEWMWGOFSA-N 0.000 description 4
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 description 4
- 229940058015 1,3-butylene glycol Drugs 0.000 description 4
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 description 4
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 description 4
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 description 4
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 description 4
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 description 4
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 4
- 206010012438 Dermatitis atopic Diseases 0.000 description 4
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 4
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 description 4
- 239000005642 Oleic acid Substances 0.000 description 4
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 description 4
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 4
- 239000005844 Thymol Substances 0.000 description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 4
- 239000003945 anionic surfactant Substances 0.000 description 4
- 201000008937 atopic dermatitis Diseases 0.000 description 4
- VXOWJCTXWVWLLC-REGDIAEZSA-N betamethasone butyrate propionate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CCC)[C@@]1(C)C[C@@H]2O VXOWJCTXWVWLLC-REGDIAEZSA-N 0.000 description 4
- 229950008408 betamethasone butyrate propionate Drugs 0.000 description 4
- 230000036760 body temperature Effects 0.000 description 4
- 235000019437 butane-1,3-diol Nutrition 0.000 description 4
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- 239000008112 carboxymethyl-cellulose Substances 0.000 description 4
- 239000001087 glyceryl triacetate Substances 0.000 description 4
- 235000013773 glyceryl triacetate Nutrition 0.000 description 4
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 description 4
- 239000004310 lactic acid Substances 0.000 description 4
- 235000014655 lactic acid Nutrition 0.000 description 4
- BJEPYKJPYRNKOW-UHFFFAOYSA-N malic acid Chemical compound OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 4
- 239000002736 nonionic surfactant Substances 0.000 description 4
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 4
- 239000004006 olive oil Substances 0.000 description 4
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- 235000011007 phosphoric acid Nutrition 0.000 description 4
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 4
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- 235000010234 sodium benzoate Nutrition 0.000 description 4
- 229960003885 sodium benzoate Drugs 0.000 description 4
- 239000001509 sodium citrate Substances 0.000 description 4
- 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 4
- 235000011083 sodium citrates Nutrition 0.000 description 4
- 239000004402 sodium ethyl p-hydroxybenzoate Substances 0.000 description 4
- 235000010226 sodium ethyl p-hydroxybenzoate Nutrition 0.000 description 4
- 239000001540 sodium lactate Substances 0.000 description 4
- 229940005581 sodium lactate Drugs 0.000 description 4
- 235000011088 sodium lactate Nutrition 0.000 description 4
- 239000004290 sodium methyl p-hydroxybenzoate Substances 0.000 description 4
- 235000010268 sodium methyl p-hydroxybenzoate Nutrition 0.000 description 4
- 239000004404 sodium propyl p-hydroxybenzoate Substances 0.000 description 4
- 235000010230 sodium propyl p-hydroxybenzoate Nutrition 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
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- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 3
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- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 3
- 241000287828 Gallus gallus Species 0.000 description 3
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- 244000299461 Theobroma cacao Species 0.000 description 3
- 235000005764 Theobroma cacao ssp. cacao Nutrition 0.000 description 3
- 235000005767 Theobroma cacao ssp. sphaerocarpum Nutrition 0.000 description 3
- SLINHMUFWFWBMU-UHFFFAOYSA-N Triisopropanolamine Chemical compound CC(O)CN(CC(C)O)CC(C)O SLINHMUFWFWBMU-UHFFFAOYSA-N 0.000 description 3
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- 239000002280 amphoteric surfactant Substances 0.000 description 3
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- 235000015278 beef Nutrition 0.000 description 3
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- DLGJWSVWTWEWBJ-HGGSSLSASA-N chondroitin Chemical compound CC(O)=N[C@@H]1[C@H](O)O[C@H](CO)[C@H](O)[C@@H]1OC1[C@H](O)[C@H](O)C=C(C(O)=O)O1 DLGJWSVWTWEWBJ-HGGSSLSASA-N 0.000 description 3
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- 229940043348 myristyl alcohol Drugs 0.000 description 3
- IEDOGKKOPNRRKW-UHFFFAOYSA-N octadecyl tetradecanoate Chemical compound CCCCCCCCCCCCCCCCCCOC(=O)CCCCCCCCCCCCC IEDOGKKOPNRRKW-UHFFFAOYSA-N 0.000 description 3
- 235000014593 oils and fats Nutrition 0.000 description 3
- 239000000312 peanut oil Substances 0.000 description 3
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- 150000003431 steroids Chemical class 0.000 description 3
- WNWHHMBRJJOGFJ-UHFFFAOYSA-N 16-methylheptadecan-1-ol Chemical compound CC(C)CCCCCCCCCCCCCCCO WNWHHMBRJJOGFJ-UHFFFAOYSA-N 0.000 description 2
- XDOFQFKRPWOURC-UHFFFAOYSA-N 16-methylheptadecanoic acid Chemical compound CC(C)CCCCCCCCCCCCCCC(O)=O XDOFQFKRPWOURC-UHFFFAOYSA-N 0.000 description 2
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- 201000004681 Psoriasis Diseases 0.000 description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
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- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 208000010247 contact dermatitis Diseases 0.000 description 2
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- 230000007423 decrease Effects 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 239000004088 foaming agent Substances 0.000 description 2
- KWIUHFFTVRNATP-UHFFFAOYSA-N glycine betaine Chemical compound C[N+](C)(C)CC([O-])=O KWIUHFFTVRNATP-UHFFFAOYSA-N 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 239000008308 lipophilic cream Substances 0.000 description 2
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 2
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- 208000017940 prurigo nodularis Diseases 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 238000006748 scratching Methods 0.000 description 2
- 230000002393 scratching effect Effects 0.000 description 2
- 230000008591 skin barrier function Effects 0.000 description 2
- 208000017520 skin disease Diseases 0.000 description 2
- CLBALUNQCMWJSU-UHFFFAOYSA-L sodium;hexadecyl sulfate;octadecyl sulfate Chemical compound [Na+].CCCCCCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCCCCCCCOS([O-])(=O)=O CLBALUNQCMWJSU-UHFFFAOYSA-L 0.000 description 2
- 239000000600 sorbitol Substances 0.000 description 2
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- A61P17/00—Drugs for dermatological disorders
- A61P17/04—Antipruritics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/08—Antiseborrheics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/16—Emollients or protectives, e.g. against radiation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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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
Abstract
Description
特許法第３０条第２項適用申請有り 一般社団法人日本アレルギー学会より平成２９年５月１５日に発行されたアレルギー 第６６巻，第４・５号の第４３７頁に青山裕美が第６６回日本アレルギー学会学術大会の予稿を掲載したことにより公開されたThere is an application for the application of Article 30, Paragraph 2 of the Patent Act. Published by posting a draft of the Annual Meeting of the Japanese Society of Allergology
本発明は、皮膚外用剤に関する。 The present invention relates to an external preparation for skin.
汗は、汗腺を通り汗孔から分泌される液体で、体温調節や皮膚の保湿に関与している。 Sweat is a fluid that is secreted from sweat pores through sweat glands and is involved in temperature regulation and skin moisturization.
汗孔は、皮膚の皮丘及び皮溝に分布しているが、運動や入浴などによる温熱負荷による体温上昇に対する体温調節のための発汗（温熱性発汗）は、主に皮丘の汗孔から分泌される。
一方、皮膚の保湿を目的とする発汗は、室温での安静時など体温上昇が起きない状態において皮溝の汗孔から微量に分泌されており、不感発汗と呼ばれている。不感発汗は、発汗量が微量であることから、べたつき等、温熱性発汗により生じる不快感はなく、発汗していることを感じないが角層への水分供給に寄与しており、皮膚の保湿に重要である。
Sweat pores are distributed in the dermis and sulcus cutis of the skin, but sweating (thermal perspiration) for controlling body temperature against the increase in body temperature due to thermal load due to exercise and bathing is mainly from the cranium of the skin. secreted.
On the other hand, sweating for the purpose of moisturizing the skin is secreted in minute amounts from perspiration pores in the cutaneous grooves when the body temperature does not rise, such as when the body is at rest at room temperature, and is called insensible sweating. Insensible perspiration is a small amount of perspiration, so there is no stickiness or other discomfort caused by thermal perspiration. important to
不感発汗が不足すると、皮膚角層の水分量が減少し皮膚の乾燥を来し、掻破行動につながる。掻破行動は皮膚バリア機能を低下させ、炎症性皮膚疾患を引き起こす要因の一つであることが知られている。発汗障害を伴う炎症性皮膚疾患であるアミロイド苔癬や痒疹では、発汗促進による治療が報告されている（非特許文献１、２）。 When insensible perspiration is insufficient, the moisture content of the stratum corneum of the skin decreases, causing dryness of the skin and leading to scratching behavior. It is known that scratching behavior lowers the skin barrier function and is one of the factors that cause inflammatory skin diseases. Amyloid lichen and prurigo, which are inflammatory skin diseases accompanied by sweating disorders, have been reported to be treated by promoting sweating (Non-Patent Documents 1 and 2).
しかし、非特許文献１及び２では、外用剤の塗布部位に密封療法が行われており、温熱負荷により発汗が促進している。温熱負荷により促進される発汗は体温調節を目的とした温熱性発汗であり、皮膚の保湿を目的とした不感発汗に比べ多量の汗が分泌され不快感を伴うことがある。 However, in Non-Patent Documents 1 and 2, occlusion therapy is performed on the application site of the topical agent, and the hyperthermia load promotes perspiration. Sweating promoted by thermal load is thermal sweating for the purpose of regulating body temperature, and a large amount of sweat is secreted compared to insensible sweating for the purpose of moisturizing the skin, which may cause discomfort.
本発明の目的は、皮膚の保湿を目的とした皮溝からの発汗である不感発汗のみを促進するための皮膚外用剤を提供することにある。 An object of the present invention is to provide an external skin preparation for promoting only insensible perspiration, which is perspiration from the sulcus cutis for the purpose of moisturizing the skin.
本発明者らは、鋭意検討した結果、多硫酸化コンドロイチン硫酸を含有する皮膚用外用剤により上記の課題が解決できることを見出し、本発明を完成した。 As a result of intensive studies, the present inventors have found that the above problems can be solved by an external preparation for skin containing polysulfated chondroitin sulfate, and completed the present invention.
本発明としては、例えば、以下のものを挙げることができる。
（１）多硫酸化コンドロイチン硫酸を有効成分として含有する、不感発汗促進のための皮膚外用剤（以下、「本発明皮膚外用剤」という）。
（２）温熱負荷をかけることなく発汗が促進される、上記（１）記載の皮膚外用剤。
（３）剤形がクリーム剤、軟膏剤、硬膏剤、貼付剤、ローション剤、ゲル剤又はフォーム剤である、上記（１）又は（２）記載の皮膚外用剤。
（４）クリーム剤が水中油型クリーム剤である、上記（３）記載の皮膚外用剤。
（５）炎症性皮膚疾患を予防するための、上記（１）～（４）のいずれかに記載の皮膚外用剤。
（６）炎症性皮膚疾患の予防が再発予防である、上記（５）記載の皮膚外用剤。
（７）炎症性皮膚疾患が、慢性痒疹、皮膚炎、アミロイド苔癬及び／又は乾癬である、上記（５）又は（６）に記載の皮膚外用剤。
（８）慢性痒疹が、結節性痒疹、多形慢性痒疹、及び／又は慢性単純性痒疹である、上記（７）記載の皮膚外用剤。
（９）皮膚炎が、アトピー性皮膚炎、皮脂欠乏性皮膚炎、接触性皮膚炎、脂漏性皮膚炎、ビダール苔癬及び／又は尋常性湿疹である、上記（７）記載の皮膚外用剤。
Examples of the present invention include the following.
(1) An external preparation for skin containing polysulfated chondroitin sulfate as an active ingredient for promoting insensible perspiration (hereinafter referred to as "the external preparation for skin of the present invention").
(2) The external preparation for skin according to (1) above, which promotes perspiration without thermal load.
(3) The external preparation for skin according to (1) or (2) above, which is in the form of a cream, ointment, plaster, patch, lotion, gel or foam.
(4) The external preparation for skin according to (3) above, wherein the cream is an oil-in-water cream.
(5) The external preparation for skin according to any one of (1) to (4) above for preventing inflammatory skin diseases.
(6) The topical preparation for skin according to (5) above, wherein the prevention of inflammatory skin disease is prevention of recurrence.
(7) The external preparation for skin according to (5) or (6) above, wherein the inflammatory skin disease is chronic prurigo, dermatitis, amyloid lichen and/or psoriasis.
(8) The external preparation for skin according to (7) above, wherein the chronic prurigo is prurigo nodularis, chronic prurigo multiforme, and/or chronic simple prurigo.
(9) The external preparation for skin according to (7) above, wherein the dermatitis is atopic dermatitis, sebaceous dermatitis, contact dermatitis, seborrheic dermatitis, Bidar's lichen and/or eczema vulgaris. .
本発明に係る皮膚外用剤は、多硫酸化コンドロイチン硫酸を有効成分とする。
多硫酸化コンドロイチン硫酸とは、Ｎ－アセチル－Ｄ－ガラクトサミンとＤ－グルクロン酸からなる二糖単位あたり、硫酸エステル残基が２～４個程度、好ましくは２～３個程度含まれるポリマーである。
The external preparation for skin according to the present invention contains polysulfated chondroitin sulfate as an active ingredient.
Polysulfated chondroitin sulfate is a polymer containing about 2 to 4, preferably about 2 to 3 sulfate ester residues per disaccharide unit composed of N-acetyl-D-galactosamine and D-glucuronic acid. .
多硫酸化コンドロイチン硫酸は、コンドロイチン、コンドロイチン硫酸（Ａ、Ｃ、Ｄ、Ｅ）等のコンドロイチン成分とクロロ硫酸、濃硫酸、三酸化硫黄－ピリジン錯体等の硫酸化剤を反応させる公知の方法により容易に製造できる。 Polysulfated chondroitin sulfate can be easily obtained by a known method of reacting a chondroitin component such as chondroitin, chondroitin sulfate (A, C, D, E) with a sulfating agent such as chlorosulfuric acid, concentrated sulfuric acid, sulfur trioxide-pyridine complex. can be manufactured to
好ましい多硫酸化コンドロイチン硫酸としては、日本薬局方外医薬品規格に収載されているヘパリン類似物質が例示される。
物理化学的性質として次の値を示す。
ａ）硫酸基含量：２５．８～３７．３％
ｂ）極限粘度：０．０９～０．１８
Preferred polysulfated chondroitin sulfates are exemplified by heparin analogues listed in the Japanese Non-Pharmacopoeia Pharmaceutical Standards.
The following values are shown as physicochemical properties.
a) Sulfate group content: 25.8-37.3%
b) Intrinsic viscosity: 0.09-0.18
多硫酸化コンドロイチン硫酸は、硫酸残基に由来する遊離の酸の形態で用いてもよいが、通常は、塩基塩を用いる。 A polysulfated chondroitin sulfate may be used in the form of a free acid derived from a sulfate residue, but a base salt is usually used.
該塩基塩としては、ナトリウム、カリウム等のアルカリ金属塩、カルシウム等のアルカリ土類金属塩等が挙げられる。 Examples of the base salt include alkali metal salts such as sodium and potassium, alkaline earth metal salts such as calcium, and the like.
本発明に係る皮膚外用剤は、上述した多硫酸化コンドロイチン硫酸を有効成分として含み、不感発汗を促進することで皮膚角層の水分量が増加し皮膚が正常な状態に保たれるため、炎症性皮膚疾患の予防に有効である。
炎症性皮膚疾患としては、皮膚バリア機能の低下により引き起こされる炎症を伴う皮膚疾患であれば特に限定されないが、例えば、慢性痒疹、皮膚炎、アミロイド苔癬及び乾癬を挙げることができる。
The external preparation for skin according to the present invention contains the above-described polysulfated chondroitin sulfate as an active ingredient, and promotes insensible sweating, thereby increasing the moisture content of the stratum corneum of the skin and maintaining the skin in a normal state, thereby reducing inflammation. It is effective in preventing sexual skin diseases.
Inflammatory skin diseases are not particularly limited as long as they are skin diseases accompanied by inflammation caused by a decrease in skin barrier function. Examples include chronic prurigo, dermatitis, amyloid lichen and psoriasis.
慢性痒疹としては、例えば、結節性痒疹、多形慢性痒疹、慢性単純性痒疹を挙げることができる。 Chronic prurigo includes, for example, prurigo nodularis, chronic prurigo multiforme, and chronic simple prurigo.
皮膚炎としては、例えば、アトピー性皮膚炎、皮脂欠乏性皮膚炎、接触性皮膚炎、脂漏性皮膚炎、ビダール苔癬、尋常性湿疹を挙げることができる。それらの中で、特にアトピー性皮膚炎及び皮脂欠乏性皮膚炎が好ましい。 Examples of dermatitis include atopic dermatitis, sebaceous dermatitis, contact dermatitis, seborrheic dermatitis, Bidar's lichen, and eczema vulgaris. Among them, atopic dermatitis and sebaceous dermatitis are particularly preferred.
本発明皮膚外用剤中の多硫酸化コンドロイチン硫酸の濃度は、０．１～２．０重量％程度が好ましく、０．２～１．５重量％程度がより好ましく、０．３～０．９重量％が最も好ましい。多硫酸化コンドロイチン硫酸は安全性が高いため、上記濃度では副作用は殆ど生じない。 The concentration of the polysulfated chondroitin sulfate in the external preparation for skin of the present invention is preferably about 0.1 to 2.0% by weight, more preferably about 0.2 to 1.5% by weight, and more preferably about 0.3 to 0.9%. Weight percent is most preferred. Since polysulfated chondroitin sulfate is highly safe, side effects hardly occur at the above concentrations.
本発明皮膚外用剤は、１日１～数回投与することにより、不感発汗を促進し皮膚が正常な状態に保たれ、炎症性皮膚疾患に対する予防効果を発揮する。特に、抗炎症剤等の投与による炎症性皮膚疾患治療後の再発予防に効果的である。例えば、アトピー性皮膚炎は、寛解状態の患者皮膚は見かけ上は正常皮膚と大きな違いは認められないが、皮膚表面の皮膚紋理が乱れ皮溝からの発汗である不感発汗が低下している。そのため、皮膚角層が慢性的に乾燥状態になっており、症状の悪化（再発）と治療剤による寛解が繰り返されるが、寛解状態において本発明皮膚外用剤を塗布することで不感発汗が促進され、再発を予防できる。 The topical preparation for skin of the present invention promotes insensible sweating, maintains the skin in a normal state, and exerts a preventive effect against inflammatory skin diseases when administered once to several times a day. In particular, it is effective in preventing recurrence after treatment of inflammatory skin diseases by administration of anti-inflammatory agents and the like. For example, in the case of atopic dermatitis, the skin of a patient in remission does not appear to be significantly different from normal skin, but the dermatoglyphs on the skin surface are disturbed and insensible perspiration, which is sweating from the cutaneous sulcus, is reduced. As a result, the stratum corneum of the skin is chronically dry, and the worsening (recurrence) of the symptoms and the remission due to the therapeutic agents are repeated. , can prevent recurrence.
本発明皮膚外用剤の投与量は、年齢、体重及び症状に応じて適宜選択されるが、通常、薬効を発揮する量として、多硫酸化コンドロイチン硫酸として１回につき１００ｃｍ２当たり０．２～４０ｍｇに該当する量を経皮投与すればよい。 The dosage of the topical skin preparation of the present invention is appropriately selected according to age, body weight and symptoms. Usually, the effective dose is 0.2 to 40 mg per 100 cm 2 of polysulfated chondroitin sulfate per 100 cm 2 . percutaneous administration.
本発明皮膚外用剤は、当業者に自明な方法により、構成成分を適宜混合し調製することができる。 The external preparation for skin of the present invention can be prepared by appropriately mixing the components by methods obvious to those skilled in the art.
本発明皮膚外用剤の剤形は、特に限定されないが、水中油型又は油中水型のクリーム剤、軟膏剤、硬膏剤、貼付剤、ローション剤、ゲル剤、フォーム剤等を挙げることができる。それらの中で、水中油型クリーム剤が好ましい。 The dosage form of the external preparation for skin of the present invention is not particularly limited, but examples include oil-in-water or water-in-oil creams, ointments, plasters, patches, lotions, gels, and foams. . Among them, oil-in-water creams are preferred.
本発明に係る水中油型又は油中水型クリーム剤に配合される添加剤としては、油溶性物質、水溶性物質、保湿剤、乳化剤等が挙げられる。油溶性物質に高級炭化水素、油脂類、ロウ類、脂肪酸、高級アルコール、エステル類等を用いることができる。高級炭化水素としては、例えば、スクワラン、合成パラフィン、流動パラフィン、形質流動パラフィン、ワセリン、白色ワセリン、黄色ワセリン、マイクロクリスタリンワックス等が挙げられ、油脂類としては、例えば、オリーブ油、ホホバ油、ゴマ油、ダイズ油、カカオ油、ツバキ油、ラッカセイ油、牛油、豚油、鶏油、トリアセチン、硬化ヒマシ油等が挙げられ、ロウ類としては、例えば、ミツロウ、サラシミツロウ、ラノリン、セレシン等が挙げられ、脂肪酸としては、例えば、ステアリン酸、オレイン酸等が挙げられ、高級アルコールとしては、例えば、ラノリンアルコール、ミリスチルアルコール、セチルアルコール、ステアリルアルコール、セトステアリルアルコール、コレステロール等が挙げられ、エステル類としては、ミリスチン酸イソプロピル、ミリスチン酸ステアリル、中鎖脂肪酸トリグリセリド等が挙げられる。 Additives to be added to the oil-in-water or water-in-oil cream according to the present invention include oil-soluble substances, water-soluble substances, moisturizers, emulsifiers and the like. Higher hydrocarbons, oils and fats, waxes, fatty acids, higher alcohols, esters and the like can be used as oil-soluble substances. Higher hydrocarbons include, for example, squalane, synthetic paraffin, liquid paraffin, liquid paraffin, petrolatum, white petrolatum, yellow petrolatum, microcrystalline wax, etc. Examples of fats and oils include olive oil, jojoba oil, sesame oil, Soybean oil, cacao oil, camellia oil, peanut oil, beef oil, pork oil, chicken oil, triacetin, hydrogenated castor oil, etc. Examples of waxes include beeswax, bleached beeswax, lanolin, ceresin, and the like. Examples of fatty acids include stearic acid and oleic acid. Examples of higher alcohols include lanolin alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, cetostearyl alcohol, and cholesterol. Esters include , isopropyl myristate, stearyl myristate, medium-chain fatty acid triglycerides, and the like.
水溶性物質としては、水、溶剤、増粘剤、ｐＨ調節剤、保存剤等を用いることができる。溶剤としては、例えば、エタノール、プロパノール、イソプロパノール等の低級アルコールが挙げられ、増粘剤としては、例えば、カルボキシビニルポリマー、カルボキシメチルセルロース等が挙げられ、ｐＨ調節剤としては、例えば、ジイソプロパノールアミン、トリイソプロパノールアミン、トリエタノールアミン、Ｌ－アルギニン、水酸化カリウム、水酸化ナトリウム、乳酸ナトリウム、クエン酸ナトリウム、リン酸、酒石酸、ｄｌ－リンゴ酸、乳酸、クエン酸、氷酢酸等が挙げられ、保存剤としては、例えば、チモール、ジブチルヒドロキシトルエン、エデト酸ナトリウム水和物、フェノキシエタノール、安息香酸ナトリウム、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等が挙げられる。 Water, solvents, thickeners, pH adjusters, preservatives and the like can be used as water-soluble substances. Examples of solvents include lower alcohols such as ethanol, propanol, and isopropanol. Examples of thickeners include carboxyvinyl polymer, carboxymethylcellulose, and the like. Examples of pH adjusters include diisopropanolamine, triisopropanolamine, triethanolamine, L-arginine, potassium hydroxide, sodium hydroxide, sodium lactate, sodium citrate, phosphoric acid, tartaric acid, dl-malic acid, lactic acid, citric acid, glacial acetic acid, etc., and storage Examples of the agent include thymol, dibutylhydroxytoluene, sodium edetate hydrate, phenoxyethanol, sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate and the like.
保湿剤としては、例えば、ワセリン、白色ワセリン、黄色ワセリン、グリセリン、プロピレングリコール、１，３－ブチレングリコール等が挙げられ、乳化剤としては、陽イオン性界面活性剤、陰イオン性界面活性剤、両イオン性界面活性剤、非イオン性界面活性剤等が挙げられる。 Moisturizing agents include, for example, petrolatum, white petrolatum, yellow petrolatum, glycerin, propylene glycol, 1,3-butylene glycol, etc. Emulsifiers include cationic surfactants, anionic surfactants, both Examples include ionic surfactants and nonionic surfactants.
水中油型クリーム剤としては、高級炭化水素、高級アルコール、乳化剤及び水を含有する水中油型クリーム剤が好ましく、高級炭化水素、高級アルコール、脂肪酸、溶剤、ｐＨ調節剤、保存剤、保湿剤、乳化剤及び水を含有する水中油型クリーム剤がより好ましく、白色ワセリン、ラノリンアルコール、セトステアリルアルコール、ミリスチルアルコール、ステアリン酸、イソプロパノール、水酸化カリウム、パラオキシ安息香酸メチル、パラオキシ安息香酸プロピル、グリセリン、セトステアリルアルコール・セトステアリル硫酸ナトリウム混合物及び水を含有する水中油型クリーム剤が特に好ましい。 As the oil-in-water cream agent, an oil-in-water cream agent containing a higher hydrocarbon, a higher alcohol, an emulsifier and water is preferable. More preferred are oil-in-water creams containing emulsifiers and water, white petrolatum, lanolin alcohol, cetostearyl alcohol, myristyl alcohol, stearic acid, isopropanol, potassium hydroxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerin, ceto Particularly preferred are oil-in-water creams containing a stearyl alcohol-sodium cetostearyl sulfate mixture and water.
油中水型クリーム剤としては、高級炭化水素、ロウ類、保存剤、保湿剤、乳化剤及び水を含有する油中水型クリーム剤が好ましく、スクワラン、形質流動パラフィン、白色ワセリン、セレシン、サラシミツロウ、ジブチルヒドロキシトルエン、エデト酸ナトリウム水和物、パラオキシ安息香酸メチル、パラオキシ安息香酸プロピル、グリセリン、グリセリン脂肪酸エステル及び水を含有する油中水型クリーム剤が特に好ましい。 The water-in-oil type cream agent is preferably a water-in-oil type cream agent containing higher hydrocarbons, waxes, preservatives, moisturizers, emulsifiers and water, and includes squalane, paraffin liquid paraffin, white petrolatum, ceresin, and bleached beeswax. , dibutylhydroxytoluene, sodium edetate hydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerin, glycerin fatty acid ester and water are particularly preferred.
本発明に係る軟膏剤に配合される添加剤としては、基剤、保湿剤、増粘剤等が挙げられる。基剤に高級炭化水素、油脂類、ロウ類、脂肪酸、高級アルコール、エステル類等を用いることができる。高級炭化水素としては、例えば、スクワラン、合成パラフィン、流動パラフィン、形質流動パラフィン、ワセリン、白色ワセリン、黄色ワセリン、マイクロクリスタリンワックス等が挙げられ、油脂類としては、例えば、オリーブ油、ホホバ油、ゴマ油、ダイズ油、カカオ油、ツバキ油、ラッカセイ油、牛油、豚油、鶏油、トリアセチン、硬化ヒマシ油等が挙げられ、ロウ類としては、例えば、ミツロウ、サラシミツロウ、ラノリン、セレシン等が挙げられ、脂肪酸としては、例えば、ステアリン酸、オレイン酸等が挙げられ、高級アルコールとしては、例えば、ラノリンアルコール、セトステアリルアルコール等が挙げられ、エステル類としては、例えば、ミリスチン酸イソプロピル、ミリスチン酸ステアリル、中鎖脂肪酸トリグリセリド等が挙げられる。 Examples of additives to be blended in the ointment according to the present invention include bases, moisturizers, thickeners, and the like. Higher hydrocarbons, oils and fats, waxes, fatty acids, higher alcohols, esters and the like can be used as bases. Higher hydrocarbons include, for example, squalane, synthetic paraffin, liquid paraffin, liquid paraffin, petrolatum, white petrolatum, yellow petrolatum, microcrystalline wax, etc. Examples of fats and oils include olive oil, jojoba oil, sesame oil, Soybean oil, cacao oil, camellia oil, peanut oil, beef oil, pork oil, chicken oil, triacetin, hydrogenated castor oil, etc. Examples of waxes include beeswax, bleached beeswax, lanolin, ceresin, and the like. Examples of fatty acids include stearic acid and oleic acid. Examples of higher alcohols include lanolin alcohol and cetostearyl alcohol. Examples of esters include isopropyl myristate, stearyl myristate, medium-chain fatty acid triglycerides;
保湿剤としては、例えば、グリセリン、１，３－ブチレングリコール等が挙げられ、増粘剤としては、例えば、カルボキシビニルポリマー、カルボキシメチルセルロース等が挙げられる。 Moisturizers include, for example, glycerin and 1,3-butylene glycol, and thickeners include, for example, carboxyvinyl polymer and carboxymethylcellulose.
硬膏剤ないし貼付剤に配合される添加剤としては、増粘剤、保湿剤、充填剤、架橋剤、溶解剤、乳化剤等が挙げられる。具体的には、増粘剤としては、例えば、アルギン酸ナトリウム、ゼラチン、メチルセルロース、カルボキシビニルポリマー、ポリアクリル酸ナトリウム等が挙げられ、保湿剤としては、例えば、グリセリン等が挙げられ、充填剤としては、例えば、カオリン、二酸化チタン、亜鉛華等が挙げられ、架橋剤としては、例えば、アセトアルデヒド、ジメチルケトン、硫酸アルミニウム等が挙げられ、溶解剤としては、例えば、エタノール、イソプロパノール等のアルコール類等が挙げられ、乳化剤としては、陰イオン性界面活性剤、非イオン性界面活性剤等が各々例示される。 Additives to be added to plasters or patches include thickeners, moisturizing agents, fillers, cross-linking agents, solubilizers, emulsifiers and the like. Specifically, examples of thickeners include sodium alginate, gelatin, methylcellulose, carboxyvinyl polymer, and sodium polyacrylate. Examples of humectants include glycerin, and examples of fillers include , for example, kaolin, titanium dioxide, zinc white, etc. Examples of cross-linking agents include acetaldehyde, dimethyl ketone, aluminum sulfate, etc. Examples of solubilizers include alcohols such as ethanol and isopropanol. Examples of emulsifiers include anionic surfactants and nonionic surfactants.
本発明に係るローション剤に配合される添加剤としては、油溶性物質、水溶性物質、保湿剤、乳化剤等が挙げられる。油溶性物質に高級炭化水素、油脂類、ロウ類、脂肪酸、高級アルコール、エステル類等を用いることができる。高級炭化水素としては、例えば、スクワラン、合成パラフィン、流動パラフィン、形質流動パラフィン、ワセリン、白色ワセリン、黄色ワセリン、マイクロクリスタリンワックス等が挙げられ、油脂類としては、例えば、オリーブ油、ホホバ油、ゴマ油、ダイズ油、カカオ油、ツバキ油、ラッカセイ油、牛油、豚油、鶏油、トリアセチン、硬化ヒマシ油等が挙げられ、ロウ類としては、例えば、ミツロウ、サラシミツロウ、ラノリン、還元ラノリン、セレシン等が挙げられ、脂肪酸としては、例えば、ステアリン酸、オレイン酸等が挙げられ、高級アルコールとしては、ラノリンアルコール、セチルアルコール、セトステアリルアルコール等が挙げられ、エステル類としては、例えば、ミリスチン酸イソプロピル、ミリスチン酸ステアリル等が挙げられる。 Additives blended in the lotion according to the present invention include oil-soluble substances, water-soluble substances, moisturizers, emulsifiers and the like. Higher hydrocarbons, oils and fats, waxes, fatty acids, higher alcohols, esters and the like can be used as oil-soluble substances. Higher hydrocarbons include, for example, squalane, synthetic paraffin, liquid paraffin, liquid paraffin, petrolatum, white petrolatum, yellow petrolatum, microcrystalline wax, etc. Examples of fats and oils include olive oil, jojoba oil, sesame oil, Soybean oil, cacao oil, camellia oil, peanut oil, beef oil, pork oil, chicken oil, triacetin, hydrogenated castor oil, etc. Examples of waxes include beeswax, white beeswax, lanolin, reduced lanolin, ceresin, etc. Examples of fatty acids include stearic acid, oleic acid, etc. Examples of higher alcohols include lanolin alcohol, cetyl alcohol, cetostearyl alcohol, etc. Examples of esters include isopropyl myristate, and stearyl myristate.
水溶性物質としては、水、増粘剤、ｐＨ調節剤、保存剤等を用いることができる。増粘剤としては、例えば、カルボキシビニルポリマー、カルボキシメチルセルロース等が挙げられ、ｐＨ調節剤としては、例えば、ジイソプロパノールアミン、トリイソプロパノールアミン、トリエタノールアミン、Ｌ－アルギニン、水酸化カリウム、水酸化ナトリウム、乳酸ナトリウム、クエン酸ナトリウム、リン酸、酒石酸、ｄｌ－リンゴ酸、乳酸、クエン酸、氷酢酸等が挙げられ、保存剤としては、例えば、チモール、ジブチルヒドロキシトルエン、エデト酸ナトリウム水和物、フェノキシエタノール、安息香酸ナトリウム、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等が挙げられる。 Water, thickeners, pH adjusters, preservatives and the like can be used as water-soluble substances. Examples of thickeners include carboxyvinyl polymer and carboxymethylcellulose, and examples of pH adjusters include diisopropanolamine, triisopropanolamine, triethanolamine, L-arginine, potassium hydroxide, and sodium hydroxide. , sodium lactate, sodium citrate, phosphoric acid, tartaric acid, dl-malic acid, lactic acid, citric acid, glacial acetic acid, etc. Examples of preservatives include thymol, dibutylhydroxytoluene, sodium edetate hydrate, Phenoxyethanol, sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate and the like.
保湿剤としては、例えば、ワセリン、白色ワセリン、黄色ワセリン、グリセリン、１，３－ブチレングリコール等が挙げられ、乳化剤としては、陽イオン性界面活性剤、陰イオン性界面活性剤、両イオン性界面活性剤、非イオン性界面活性剤等が挙げられる。 Examples of moisturizing agents include petrolatum, white petrolatum, yellow petrolatum, glycerin, 1,3-butylene glycol, etc. Examples of emulsifiers include cationic surfactants, anionic surfactants, and amphoteric surfactants. active agents, nonionic surfactants, and the like.
ローション剤としては、高級炭化水素、ロウ類、高級アルコール、増粘剤、ｐＨ調節剤、保存剤、保湿剤、乳化剤及び水を含有するローション剤が好ましく、スクワラン、白色ワセリン、還元ラノリン、セチルアルコール、カルボキシビニルポリマー、ジイソプロパノールアミン、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、グリセリン、ポリオキシエチレンセチルエーテル、グリセリン脂肪酸エステル及び水を含有するローション剤が特に好ましい。 Preferred lotions include higher hydrocarbons, waxes, higher alcohols, thickeners, pH adjusters, preservatives, moisturizing agents, emulsifiers and water, such as squalane, white petrolatum, reduced lanolin, and cetyl alcohol. , carboxyvinyl polymer, diisopropanolamine, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerin, polyoxyethylene cetyl ether, glycerin fatty acid ester and water are particularly preferred.
ゲル剤に配合される添加剤としては、基剤、増粘剤、ｐＨ調節剤、保存剤等を用いることができる。基剤には、例えば、水、イソプロパノール、プロピレングリコール等が挙げられ、増粘剤としては、例えば、カルボキシビニルポリマー、カルボキシメチルセルロース等が挙げられ、ｐＨ調節剤としては、例えば、ジイソプロパノールアミン、トリイソプロパノールアミン、トリエタノールアミン、Ｌ－アルギニン、水酸化カリウム、水酸化ナトリウム、乳酸ナトリウム、クエン酸ナトリウム、リン酸、酒石酸、ｄｌ－リンゴ酸、乳酸、クエン酸、氷酢酸等が挙げられ、保存剤としては、例えば、チモール、ジブチルヒドロキシトルエン、エデト酸ナトリウム水和物、フェノキシエタノール、安息香酸ナトリウム、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等が挙げられる。 A base, a thickener, a pH adjuster, a preservative and the like can be used as additives to be blended in the gel. Examples of bases include water, isopropanol, propylene glycol, etc. Examples of thickeners include carboxyvinyl polymer, carboxymethylcellulose, etc. Examples of pH adjusters include diisopropanolamine, trimethylcellulose and the like. Isopropanolamine, triethanolamine, L-arginine, potassium hydroxide, sodium hydroxide, sodium lactate, sodium citrate, phosphoric acid, tartaric acid, dl-malic acid, lactic acid, citric acid, glacial acetic acid, etc. Preservatives Examples thereof include thymol, dibutylhydroxytoluene, sodium edetate hydrate, phenoxyethanol, sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, and propyl parahydroxybenzoate.
フォーム剤に配合される添加剤としては、基剤、起泡剤、ｐＨ調節剤、保存剤等を用いることができる。基剤には、例えば水、グリセリン、１，３－ブチレングリコール、ジプロピレングリコール、プロピレングリコール、Ｄ－ソルビトール、ポリエチレングリコール、トリアセチン、２－エチルヘキサンジオール、イソステアリルアルコール、オレイン酸オレイル、ミリスチン酸イソプロピル、オクチルドデカノール、ミリスチン酸オクチルドデシル、ヘキシルデカノール、イソステアリン酸、トリイソオクタン酸グリセリン、ヒマシ油、オリーブ油、中鎖脂肪酸トリグリセリド、オレイルアルコール、オレイン酸、２－エチルヘキサン酸セチル、イソステアリルパルミテート、２－エチルヘキサン酸セチル、スクワラン、軽質流動パラフィン、流動パラフィン、スクワレン、白色ワセリン、ゲル化炭化水素等が挙げられ、起泡剤としては、例えば、モノステアリン酸ポリオキシエチレンソルビタン、トリステアリン酸ポリオキシエチレンソルビタン、ポリオキシエチレンポリオキシプロピレングリコール、ステアリン酸グリセリル、ポリオキシエチレン硬化ヒマシ油、トリオレイン酸デカグリセリル、ポリオキシエチレンセチルエーテル、テトラオレイン酸ポリオキシエチレンソルビット、ショ糖ステアリン酸エステル、ポリオキシエチレンポリオキシプロピレンセチルエーテル、ポリオキシエチレンソルビットミツロウ、モノステアリン酸ポリオキシエチレングリセリル、ポリオキシエチレンラウリルエーテル、自己乳化型モノステアリン酸グリセリン、モノオレイン酸ポリオキシエチレンソルビタン、モノオレイン酸デカグリセリル、モノステアリン酸デカグリセリル、モノステアリン酸ポリエチレングリコール、ポリオキシエチレンベへニルエーテル、ラウリン酸ポリオキシエチレンソルビタン、ショ糖ラウリン酸エステル、ポリオキシエチレンステアリルエーテル、ラウリン酸ナトリウム、パルミチン酸カリウム、ステアリン酸アルギニン、ラウリル硫酸ナトリウム、ラウリル硫酸カリウム、セチル硫酸ナトリウム、ポリオキシエチレンラウリル硫酸トリエタノールアミン、ラウロイルサルコシンナトリウム、Ｎ－ステアロイル－Ｎ－メチルタウリンナトリウム、Ｎ－ミリストイル－Ｎ－メチルタウリンナトリウム、モノステアリルリン酸ナトリウム、ポリオキシエチレンオレイルエーテルリン酸ナトリウム、ポリオキシエチレンステアリルエーテルリン酸ナトリウム、ポリオキシエチレンセチルエーテルリン酸ナトリウム、ジ－２－エチルヘキシルスルホコハク酸ナトリウム、Ｎ－ラウロイルグルタミン酸モノナトリウム、Ｎ－ステアロイル－Ｌ－グルタミン酸ナトリウム、Ｎ－ステアロイル－Ｌ－グルタミン酸アルギニン、Ｎ－ステアロイルグルタミン酸ナトリウム、Ｎ－ミリストイル－Ｌ－グルタミン酸ナトリウム等が挙げられ、ｐＨ調節剤としては、例えば、ジイソプロパノールアミン、トリイソプロパノールアミン、トリエタノールアミン、Ｌ－アルギニン、水酸化カリウム、水酸化ナトリウム、乳酸ナトリウム、クエン酸ナトリウム、リン酸、酒石酸、ｄｌ－リンゴ酸、乳酸、クエン酸、氷酢酸リン酸二水素カリウム、エデト酸ナトリウム等が挙げられ、保存剤としては、例えば、チモール、ジブチルヒドロキシトルエン、エデト酸ナトリウム水和物、フェノキシエタノール、安息香酸ナトリウム、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等が挙げられる。 As additives to be blended in the foam agent, bases, foaming agents, pH adjusters, preservatives and the like can be used. Bases include, for example, water, glycerin, 1,3-butylene glycol, dipropylene glycol, propylene glycol, D-sorbitol, polyethylene glycol, triacetin, 2-ethylhexanediol, isostearyl alcohol, oleyl oleate, and isopropyl myristate. , octyldodecanol, octyldodecyl myristate, hexyldecanol, isostearic acid, glyceryl triisooctanoate, castor oil, olive oil, medium chain fatty acid triglyceride, oleyl alcohol, oleic acid, cetyl 2-ethylhexanoate, isostearyl palmitate, 2- cetyl ethylhexanoate, squalane, light liquid paraffin, liquid paraffin, squalene, white petrolatum, gelling hydrocarbons, etc. Examples of foaming agents include polyoxyethylene sorbitan monostearate and polyoxyethylene tristearate. Sorbitan, polyoxyethylene polyoxypropylene glycol, glyceryl stearate, polyoxyethylene hydrogenated castor oil, decaglyceryl trioleate, polyoxyethylene cetyl ether, polyoxyethylene sorbitol tetraoleate, sucrose stearate, polyoxyethylene Polyoxypropylene cetyl ether, polyoxyethylene sorbitol beeswax, polyoxyethylene glyceryl monostearate, polyoxyethylene lauryl ether, self-emulsifying glycerin monostearate, polyoxyethylene sorbitan monooleate, decaglyceryl monooleate, monostearin Decaglyceryl acid, polyethylene glycol monostearate, polyoxyethylene behenyl ether, polyoxyethylene sorbitan laurate, sucrose laurate, polyoxyethylene stearyl ether, sodium laurate, potassium palmitate, arginine stearate, lauryl sulfate sodium, potassium lauryl sulfate, sodium cetyl sulfate, triethanolamine polyoxyethylene lauryl sulfate, sodium lauroyl sarcosinate, sodium N-stearoyl-N-methyltaurate, sodium N-myristoyl-N-methyltaurate, sodium monostearyl phosphate, poly Sodium oxyethylene oleyl ether phosphate, sodium polyoxyethylene stearyl ether phosphate, sodium polyoxyethylene cetyl ether phosphate, sodium di-2-ethylhexyl sulfosuccinate, monosodium N-lauroyl glutamate, sodium N-stearoyl-L-glutamate , N-stearoyl-L-glutamic acid arginine, N-sodium stearoyl glutamate, N-myristoyl-L-sodium glutamate, etc. Examples of pH adjusters include diisopropanolamine, triisopropanolamine, triethanolamine, L - arginine, potassium hydroxide, sodium hydroxide, sodium lactate, sodium citrate, phosphoric acid, tartaric acid, dl-malic acid, lactic acid, citric acid, glacial potassium dihydrogen phosphate, sodium edetate, etc., and preserved Examples of the agent include thymol, dibutylhydroxytoluene, sodium edetate hydrate, phenoxyethanol, sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate and the like.
本発明において上記の各製剤で使用できる陽イオン性界面活性剤の具体例としては、例えば、セチルトリメチルアンモニウムクロリド、ラウリルジメチルベンジルアンモニウムクロリド、テトラブチルアンモニウムクロリド、ジオクタデシルジメチルアンモニウムクロリド等が挙げられる。 Specific examples of cationic surfactants that can be used in the formulations of the present invention include cetyltrimethylammonium chloride, lauryldimethylbenzylammonium chloride, tetrabutylammonium chloride, dioctadecyldimethylammonium chloride, and the like.
陰イオン性界面活性剤としては、例えば、アルキルベンゼンスルホン酸ナトリウム、ドデシル硫酸ナトリウム、ヤシアルコールエトキシ硫酸ナトリウム、α－オレフィンスルホン酸ナトリウム、乳化セトステアリルアルコール（セトステアリルアルコール・セトステアリル硫酸ナトリウム混合物）等が挙げられる。 Examples of anionic surfactants include sodium alkylbenzene sulfonate, sodium dodecyl sulfate, sodium coconut alcohol ethoxy sulfate, sodium α-olefin sulfonate, emulsified cetostearyl alcohol (cetostearyl alcohol/sodium cetostearyl sulfate mixture), and the like. mentioned.
非イオン性界面活性剤としては、例えば、ポリオキシエチレンアルキルエーテル、ポリオキシエチレンアルキルフェノールエーテル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンセチルエーテル、ステアリン酸ポリオキシル、グリセリン脂肪酸エステル、ジグリセリン脂肪酸エステル等が例示できる。 Examples of nonionic surfactants include polyoxyethylene alkyl ether, polyoxyethylene alkylphenol ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene cetyl ether, polyoxyl stearate, glycerin fatty acid ester, diglycerin fatty acid ester, and the like. I can give an example.
両イオン性界面活性剤としては、例えば、Ｎ－アルキル－Ｎ，Ｎ－ジメチルアンモニウムベタイン、イミダゾリン型両性界面活性剤等が挙げられる。 Amphoteric surfactants include, for example, N-alkyl-N,N-dimethylammonium betaine, imidazoline type amphoteric surfactants and the like.
上記界面活性剤は、単独又は組み合わせて使用することができる。 The above surfactants can be used alone or in combination.
本発明皮膚外用剤を皮膚に適用する場合、温熱性発汗は不要であり、密封療法や足浴等の温熱負荷は必要ない。不感発汗のみが促進されるため、発汗による不快感なく必要な水分を角層に供給し皮膚が保湿され、皮膚を正常な状態に保つことができ、炎症性皮膚疾患の再発予防や寛解状態の維持にも有効である。 When the external preparation for skin of the present invention is applied to the skin, thermal sweating is not required, and thermal stress such as occlusion therapy and foot bathing is not required. Since only insensible perspiration is promoted, the necessary moisture is supplied to the stratum corneum without discomfort due to perspiration, the skin is moisturized, and the skin is kept in a normal state, preventing the recurrence of inflammatory skin diseases and promoting remission. It is also effective for maintenance.
以下に実施例を挙げて本発明をさらに詳しく説明するが、本発明はこれらに限定されるものではない。 EXAMPLES The present invention will be described in more detail below with reference to Examples, but the present invention is not limited to these.
［実施例］
健康成人８名の前腕を対象に４か所の外用塗布部位を設定した。試験製剤は、多硫酸化コンドロイチン硫酸を含む水中油型クリーム（ヒルドイド（登録商標）クリーム０．３％；以下、単にヒルドイドクリームと称する）、白色ワセリン（保湿剤）、ステロイド外用剤（アンテベート（登録商標）軟膏０．０５％、有効成分：ベタメタゾン酪酸エステルプロピオン酸エステル）とし、ヒルドイドクリームの１回塗布量は外用剤の塗布量の目安とされる２ｍｇ／ｃｍ２又はその３倍量の６ｍｇ／ｃｍ２、白色ワセリンとステロイド外用剤の１回塗布量は外用剤の塗布量の目安とされる２ｍｇ／ｃｍ２とした。上記の規定塗布量を１日２回（午前、夜入浴後）、７日間繰り返し塗布した。試験製剤塗布前及び塗布７日目の翌日（塗布８日目の午前の塗布前）に、Ｃｌｉｎ Ａｕｔｏ Ｒｅｓ（２００２）１２：２０－２３記載の試験法（ｉｍｐｒｅｓｓｉｏｎ ｍｏｌｄ ｔｅｃｈｎｉｑｕｅ（以下、ＩＭＴ）により、皮膚からの微量発汗を観察した。また、同時に角層水分量を皮表角層水分測定装置（ＳＫＩＣＯＮ－２００ＥＸ）を用いて電気伝導度を指標に測定した。なお、発汗測定及び角層水分量測定時は、いずれも実施３０分以上前に、２２－２３℃、４０－５０％ＲＨの環境下にて馴化させ、温熱性発汗が生じない条件下にて実施した。
[Example]
Four external application sites were set on the forearms of eight healthy adults. The test formulations were an oil-in-water cream containing polysulfated chondroitin sulfate (Hildoid (registered trademark) cream 0.3%; hereinafter simply referred to as Hildoid cream), white petrolatum (moisturizer), topical steroid preparation (Antebate (registered trademark) (trademark) ointment 0.05%, active ingredient: betamethasone butyrate propionate), and the amount of Hirudoid Cream applied per application is 2 mg/ cm2 , which is the standard for the amount of topical preparations applied, or 6 mg/cm2, which is three times that amount. cm 2 , and the amount of white petrolatum and topical steroid applied at one time was set to 2 mg/cm 2 , which is a standard for the amount of topical preparations to be applied. The prescribed amount of application was repeated twice a day (after bathing in the morning and at night) for 7 days. Before application of the test formulation and on the day after the 7th day of application (before application in the morning of the 8th day of application), the test method described in Clin Auto Res (2002) 12: 20-23 (impression mold technique (hereinafter, IMT)) A small amount of perspiration from the skin was observed, and at the same time, the stratum corneum moisture content was measured using a skin surface stratum corneum moisture measuring device (SKICON-200EX) using electrical conductivity as an index. At the time of measurement, the animals were acclimatized in an environment of 22-23° C. and 40-50% RH 30 minutes or more before the measurement, and the measurement was carried out under conditions in which thermal perspiration does not occur.
ヒルドイドクリームは、製剤１ｇ中に、有効成分として多硫酸化コンドロイチン硫酸（ヘパリン類似物質）を３．０ｍｇ含む。その他の添加物は、グリセリン、ステアリン酸、水酸化カリウム、白色ワセリン、ラノリンアルコール、セトステアリルアルコール、セトステアリルアルコール・セトステアリル硫酸ナトリウム混合物、ミリスチルアルコール、パラオキシ安息香酸メチル、パラオキシ安息香酸プロピル、イソプロパノール及び水である。 Hirudoid cream contains 3.0 mg of polysulfated chondroitin sulfate (heparin-like substance) as an active ingredient per 1 g of the formulation. Other additives include glycerin, stearic acid, potassium hydroxide, white petrolatum, lanolin alcohol, cetostearyl alcohol, cetostearyl alcohol/sodium cetostearyl sulfate mixture, myristyl alcohol, methyl paraoxybenzoate, propyl paraoxybenzoate, isopropanol and is water.
ステロイド外用剤（アンテベート（登録商標）軟膏０．０５％）は、製剤１ｇ中に、有効成分としてベタメタゾン酪酸エステルプロピオン酸エステルを０．５ｍｇ含む。その他の添加物は、スクワラン、ゲル化炭化水素、パラフィン及び白色ワセリンである。 The external steroid preparation (Antebate (registered trademark) ointment 0.05%) contains 0.5 mg of betamethasone butyrate propionate as an active ingredient per 1 g of the formulation. Other additives are squalane, gelling hydrocarbons, paraffin and white petrolatum.
［試験例１］発汗滴面積
試験製剤塗布前（無塗布）及び塗布７日後の１ｃｍ２当たりの皮溝又は皮丘からの発汗滴の面積を測定した。結果を表１に示す。不感発汗部位である皮溝では、ヒルドイドクリームの塗布により発汗滴の面積に有意な増加が認められた。一方、温熱性発汗部位である皮丘では、試験製剤塗布による発汗滴の面積の増加は僅かであった。発汗滴の面積は発汗量を反映しており、発汗を感じない皮溝からの発汗量に比べても皮丘からの発汗量は微量で体温調節といった生理的な効果もなく、ヒルドイドクリームの塗布により皮膚保湿を目的とする不感発汗は促進されるが、温熱負荷がなければ温熱性発汗は実質的に促進されない。
[Test Example 1] Area of perspiration droplets The area of perspiration droplets per 1 cm 2 per 1 cm 2 before application of the test formulation (no application) and 7 days after application was measured. Table 1 shows the results. A significant increase in the area of perspiration droplets was observed in the sulcus cutis, an insensible perspiration site, due to the application of hirudoid cream. On the other hand, in the crustus, which is the site of thermal sweating, the increase in the area of perspiration droplets due to the application of the test formulation was slight. The area of perspiration droplets reflects the amount of perspiration. Compared to the amount of perspiration from the sulcus cutis, which does not perspire, the amount of perspiration from the skin crepus is very small, and there is no physiological effect such as temperature regulation. Although insensible sweating is promoted for the purpose of moisturizing the skin, thermal perspiration is not substantially promoted unless there is a thermal load.
［試験例２］角層水分量
試験製剤塗布前（無塗布）及び塗布７日後の１ｃｍ２当たりの角層水分量を測定した。結果を表２に示す。表１の皮溝からの発汗量に応じ角層水分量が変化しており、ヒルドイドクリームの塗布による不感発汗の促進が、皮膚の保湿を意味する角層水分量の増加に効果的である。
[Test Example 2] Stratum corneum moisture content The stratum corneum moisture content per 1 cm 2 before application of the test preparation (no application) and 7 days after application was measured. Table 2 shows the results. The moisture content of the stratum corneum changes according to the amount of perspiration from the sulcus cutis in Table 1, and promotion of insensible perspiration by application of Hirudoid cream is effective in increasing the moisture content of the stratum corneum, which means moisturization of the skin.
［試験例３］発汗滴数
試験製剤塗布前（無塗布）及び塗布７日後の１ｃｍ２当たりの皮溝又は皮丘からの発汗滴数を測定した。結果を表３に示す。表１で示された発汗量の増加に比例し発汗滴数も増加しており、特定の汗孔から多量の汗が発汗されているわけではなく、多くの汗孔から均一に発汗されていることが分かる。局所的な発汗量の増加は、皮膚全体の保湿に有効ではないが、ヒルドイドクリームの塗布による不感発汗の促進では皮膚全体が保湿されている。
[Test Example 3] Number of perspiration droplets The number of perspiration droplets per 1 cm 2 per 1 cm 2 before application of the test formulation (no application) and 7 days after application was measured. Table 3 shows the results. As shown in Table 1, the number of perspiration droplets increased in proportion to the increase in the amount of perspiration, indicating that a large amount of perspiration was not perspired from a specific perspiration pore, but that perspiration was uniformly distributed from many perspiration pores. I understand. An increase in local perspiration is not effective in moisturizing the entire skin, but the promotion of insensible sweating by application of hirudoid cream moisturizes the entire skin.
なお、この臨床研究期間中、ヒルドイドクリームを含めすべての外用剤において塗布による副作用は観察されなかった。 During this clinical research period, no side effects due to application were observed with any of the topical preparations including Hirudoid Cream.
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