JP2016196419A - External preparation for skin - Google Patents
External preparation for skin Download PDFInfo
- Publication number
- JP2016196419A JP2016196419A JP2015076611A JP2015076611A JP2016196419A JP 2016196419 A JP2016196419 A JP 2016196419A JP 2015076611 A JP2015076611 A JP 2015076611A JP 2015076611 A JP2015076611 A JP 2015076611A JP 2016196419 A JP2016196419 A JP 2016196419A
- Authority
- JP
- Japan
- Prior art keywords
- skin
- tocopherol
- external preparation
- group
- diphenhydramine
- 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 23
- POJWUDADGALRAB-UHFFFAOYSA-N allantoin Chemical compound NC(=O)NC1NC(=O)NC1=O POJWUDADGALRAB-UHFFFAOYSA-N 0.000 claims abstract description 18
- 229960000520 diphenhydramine Drugs 0.000 claims abstract description 11
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 claims abstract description 11
- ZAKOWWREFLAJOT-CEFNRUSXSA-N D-alpha-tocopherylacetate Chemical compound CC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-CEFNRUSXSA-N 0.000 claims abstract description 10
- 229940042585 tocopherol acetate Drugs 0.000 claims abstract description 10
- POJWUDADGALRAB-PVQJCKRUSA-N Allantoin Natural products NC(=O)N[C@@H]1NC(=O)NC1=O POJWUDADGALRAB-PVQJCKRUSA-N 0.000 claims abstract description 9
- 229960000458 allantoin Drugs 0.000 claims abstract description 9
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229960001295 tocopherol Drugs 0.000 claims abstract description 9
- 239000011732 tocopherol Substances 0.000 claims abstract description 9
- 229930003799 tocopherol Natural products 0.000 claims abstract description 9
- 235000010384 tocopherol Nutrition 0.000 claims abstract description 9
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims abstract description 9
- MPDGHEJMBKOTSU-YKLVYJNSSA-N 18beta-glycyrrhetic acid Chemical compound C([C@H]1C2=CC(=O)[C@H]34)[C@@](C)(C(O)=O)CC[C@]1(C)CC[C@@]2(C)[C@]4(C)CC[C@@H]1[C@]3(C)CC[C@H](O)C1(C)C MPDGHEJMBKOTSU-YKLVYJNSSA-N 0.000 claims abstract description 5
- SNPLKNRPJHDVJA-ZETCQYMHSA-N D-panthenol Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCCO SNPLKNRPJHDVJA-ZETCQYMHSA-N 0.000 claims abstract description 5
- 239000003908 antipruritic agent Substances 0.000 claims abstract description 5
- 229940101267 panthenol Drugs 0.000 claims abstract description 5
- 235000020957 pantothenol Nutrition 0.000 claims abstract description 5
- 239000011619 pantothenol Substances 0.000 claims abstract description 5
- 235000019155 vitamin A Nutrition 0.000 claims abstract description 5
- 239000011719 vitamin A Substances 0.000 claims abstract description 5
- MPDGHEJMBKOTSU-UHFFFAOYSA-N Glycyrrhetinsaeure Natural products C12C(=O)C=C3C4CC(C)(C(O)=O)CCC4(C)CCC3(C)C1(C)CCC1C2(C)CCC(O)C1(C)C MPDGHEJMBKOTSU-UHFFFAOYSA-N 0.000 claims abstract description 4
- MSCCTZZBYHQMQJ-AZAGJHQNSA-N Tocopheryl nicotinate Chemical compound C([C@@](OC1=C(C)C=2C)(C)CCC[C@H](C)CCC[C@H](C)CCCC(C)C)CC1=C(C)C=2OC(=O)C1=CC=CN=C1 MSCCTZZBYHQMQJ-AZAGJHQNSA-N 0.000 claims abstract description 4
- 229940121363 anti-inflammatory agent Drugs 0.000 claims abstract description 4
- 239000002260 anti-inflammatory agent Substances 0.000 claims abstract description 4
- 229960003720 enoxolone Drugs 0.000 claims abstract description 4
- 229950009883 tocopheryl nicotinate Drugs 0.000 claims abstract description 4
- CIVCELMLGDGMKZ-UHFFFAOYSA-N 2,4-dichloro-6-methylpyridine-3-carboxylic acid Chemical compound CC1=CC(Cl)=C(C(O)=O)C(Cl)=N1 CIVCELMLGDGMKZ-UHFFFAOYSA-N 0.000 claims abstract description 3
- 229960000525 diphenhydramine hydrochloride Drugs 0.000 claims abstract description 3
- 229960004949 glycyrrhizic acid Drugs 0.000 claims abstract description 3
- 235000019410 glycyrrhizin Nutrition 0.000 claims abstract description 3
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 claims abstract description 3
- 229940040452 linolenate Drugs 0.000 claims abstract description 3
- DTOSIQBPPRVQHS-PDBXOOCHSA-M linolenate Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC([O-])=O DTOSIQBPPRVQHS-PDBXOOCHSA-M 0.000 claims abstract description 3
- 150000003839 salts Chemical class 0.000 claims abstract description 3
- 239000002628 heparin derivative Substances 0.000 claims description 12
- 239000006071 cream Substances 0.000 claims description 4
- 239000000839 emulsion Substances 0.000 claims description 4
- 239000000499 gel Substances 0.000 claims description 4
- 239000002674 ointment Substances 0.000 claims description 4
- IELOKBJPULMYRW-NJQVLOCASA-N D-alpha-Tocopheryl Acid Succinate Chemical compound OC(=O)CCC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C IELOKBJPULMYRW-NJQVLOCASA-N 0.000 claims description 3
- 229940099418 d- alpha-tocopherol succinate Drugs 0.000 claims description 3
- LPLVUJXQOOQHMX-UHFFFAOYSA-N glycyrrhetinic acid glycoside Natural products C1CC(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2=O)C(O)=O)C)(C)CC2)(C)C2C(C)(C)C1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O LPLVUJXQOOQHMX-UHFFFAOYSA-N 0.000 claims description 2
- UYRUBYNTXSDKQT-UHFFFAOYSA-N glycyrrhizic acid Natural products CC1(C)C(CCC2(C)C1CCC3(C)C2C(=O)C=C4C5CC(C)(CCC5(C)CCC34C)C(=O)O)OC6OC(C(O)C(O)C6OC7OC(O)C(O)C(O)C7C(=O)O)C(=O)O UYRUBYNTXSDKQT-UHFFFAOYSA-N 0.000 claims description 2
- WNIFXKPDILJURQ-JKPOUOEOSA-N octadecyl (2s,4as,6ar,6as,6br,8ar,10s,12as,14br)-10-hydroxy-2,4a,6a,6b,9,9,12a-heptamethyl-13-oxo-3,4,5,6,6a,7,8,8a,10,11,12,14b-dodecahydro-1h-picene-2-carboxylate Chemical compound C1C[C@H](O)C(C)(C)[C@@H]2CC[C@@]3(C)[C@]4(C)CC[C@@]5(C)CC[C@@](C(=O)OCCCCCCCCCCCCCCCCCC)(C)C[C@H]5C4=CC(=O)[C@@H]3[C@]21C WNIFXKPDILJURQ-JKPOUOEOSA-N 0.000 claims description 2
- WNIFXKPDILJURQ-UHFFFAOYSA-N stearyl glycyrrhizinate Natural products C1CC(O)C(C)(C)C2CCC3(C)C4(C)CCC5(C)CCC(C(=O)OCCCCCCCCCCCCCCCCCC)(C)CC5C4=CC(=O)C3C21C WNIFXKPDILJURQ-UHFFFAOYSA-N 0.000 claims description 2
- 239000004378 Glycyrrhizin Substances 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 150000007513 acids Chemical class 0.000 claims 1
- 208000003251 Pruritus Diseases 0.000 abstract description 23
- 206010013786 Dry skin Diseases 0.000 abstract description 16
- 230000037336 dry skin Effects 0.000 abstract description 15
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 8
- 229920001499 Heparinoid Polymers 0.000 abstract 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 abstract 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 abstract 1
- 239000002554 heparinoid Substances 0.000 abstract 1
- 210000003491 skin Anatomy 0.000 description 28
- 230000007803 itching Effects 0.000 description 19
- 239000000203 mixture Substances 0.000 description 15
- 230000000694 effects Effects 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 7
- 210000001519 tissue Anatomy 0.000 description 7
- 208000017520 skin disease Diseases 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 230000009471 action Effects 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 229920000669 heparin Polymers 0.000 description 4
- 229960002897 heparin Drugs 0.000 description 4
- 230000006872 improvement Effects 0.000 description 4
- 208000024891 symptom Diseases 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 3
- 230000032683 aging Effects 0.000 description 3
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 230000001953 sensory effect Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 description 2
- 201000004624 Dermatitis Diseases 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 229920002683 Glycosaminoglycan Polymers 0.000 description 2
- 206010020649 Hyperkeratosis Diseases 0.000 description 2
- 208000001126 Keratosis Diseases 0.000 description 2
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 description 2
- 230000001387 anti-histamine Effects 0.000 description 2
- 239000000739 antihistaminic agent Substances 0.000 description 2
- 208000010668 atopic eczema Diseases 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 208000009190 disseminated intravascular coagulation Diseases 0.000 description 2
- 230000003020 moisturizing effect Effects 0.000 description 2
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 2
- 230000002688 persistence Effects 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 210000000434 stratum corneum Anatomy 0.000 description 2
- 206010012438 Dermatitis atopic Diseases 0.000 description 1
- 206010048768 Dermatosis Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 description 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 102000011782 Keratins Human genes 0.000 description 1
- 108010076876 Keratins Proteins 0.000 description 1
- VTAJIXDZFCRWBR-UHFFFAOYSA-N Licoricesaponin B2 Natural products C1C(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2)C(O)=O)C)(C)CC2)(C)C2C(C)(C)CC1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O VTAJIXDZFCRWBR-UHFFFAOYSA-N 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 description 1
- 229930002945 all-trans-retinaldehyde Natural products 0.000 description 1
- SHGAZHPCJJPHSC-YCNIQYBTSA-N all-trans-retinoic acid Chemical compound OC(=O)\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C SHGAZHPCJJPHSC-YCNIQYBTSA-N 0.000 description 1
- DTOSIQBPPRVQHS-PDBXOOCHSA-N alpha-linolenic acid Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC(O)=O DTOSIQBPPRVQHS-PDBXOOCHSA-N 0.000 description 1
- 235000020661 alpha-linolenic acid Nutrition 0.000 description 1
- 210000003423 ankle Anatomy 0.000 description 1
- 230000002429 anti-coagulating effect Effects 0.000 description 1
- 230000001139 anti-pruritic effect Effects 0.000 description 1
- 201000008937 atopic dermatitis Diseases 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
- 229960000541 cetyl alcohol Drugs 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- DNTGGZPQPQTDQF-XBXARRHUSA-N crotamiton Chemical compound C/C=C/C(=O)N(CC)C1=CC=CC=C1C DNTGGZPQPQTDQF-XBXARRHUSA-N 0.000 description 1
- 229960003338 crotamiton Drugs 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 210000001513 elbow Anatomy 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 210000003414 extremity Anatomy 0.000 description 1
- 239000001685 glycyrrhizic acid Substances 0.000 description 1
- 210000000474 heel Anatomy 0.000 description 1
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 229960003943 hypromellose Drugs 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 230000005722 itchiness Effects 0.000 description 1
- 210000003127 knee Anatomy 0.000 description 1
- 229960004488 linolenic acid Drugs 0.000 description 1
- KQQKGWQCNNTQJW-UHFFFAOYSA-N linolenic acid Natural products CC=CCCC=CCC=CCCCCCCCC(O)=O KQQKGWQCNNTQJW-UHFFFAOYSA-N 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 1
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 description 1
- 239000000820 nonprescription drug Substances 0.000 description 1
- 235000019271 petrolatum Nutrition 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 150000003254 radicals Chemical class 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000002207 retinal effect Effects 0.000 description 1
- NCYCYZXNIZJOKI-OVSJKPMPSA-N retinal group Chemical group C\C(=C/C=O)\C=C\C=C(\C=C\C1=C(CCCC1(C)C)C)/C NCYCYZXNIZJOKI-OVSJKPMPSA-N 0.000 description 1
- 229930002330 retinoic acid Natural products 0.000 description 1
- 229960003471 retinol Drugs 0.000 description 1
- 235000020944 retinol Nutrition 0.000 description 1
- 239000011607 retinol Substances 0.000 description 1
- 238000006748 scratching Methods 0.000 description 1
- 230000002393 scratching effect Effects 0.000 description 1
- 210000002374 sebum Anatomy 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 230000037307 sensitive skin Effects 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 230000035882 stress Effects 0.000 description 1
- QAOWNCQODCNURD-UHFFFAOYSA-L sulfate group Chemical group S(=O)(=O)([O-])[O-] QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 229960001727 tretinoin Drugs 0.000 description 1
- 230000007306 turnover Effects 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- NCYCYZXNIZJOKI-UHFFFAOYSA-N vitamin A aldehyde Natural products O=CC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C NCYCYZXNIZJOKI-UHFFFAOYSA-N 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- 239000003871 white petrolatum Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
本発明は、皮膚外用製剤に関する。 The present invention relates to an external preparation for skin.
近年、我が国では生活環境の変化、急激な高齢化、様々なストレスなどによって、痒みを伴う皮膚疾患（特にアトピー性皮膚炎、乾燥性皮膚症、敏感肌など）を患う人が増加している。これらの皮膚疾患には、強い痒み・肌荒れが伴う。その治療には、クロタミトン・抗ヒスタミン剤などの鎮痒成分、ヘパリン類似物質などの保湿成分を有効成分とする外用剤が用いられている。
このうち、ヘパリン類似物質は、血行促進作用を持つムコ多糖類の多硫酸化エステルで、その構造中に硫酸基、カルボキシル基、水酸基などを多く含むことから、高い保湿能を有し、既に乾燥性皮膚疾患等の治療を目的として一般用医薬品としても利用されている。
乾燥性皮膚（老人・成人の乾皮症、小児の乾燥性皮膚）は、乾燥性皮膚疾患の代表的な症状であり、老人・成人においては皮膚の老化（加齢に伴う生理的変化）によって発生し、小児においては成人に比べて角質層が薄く、皮脂の分泌量が不安定でバリア機能がまだ安定していないことによって発生する。いずれの場合も、皮膚が乾燥して粗ぞうとなり、多くの場合に自覚症状として掻痒（かゆみ）を伴う。痒みの程度は強いことが多く、患者は常時しきりに激しく患部を掻くので痒みは増し、さらに掻きむしることによって皮膚に炎症が生じて症状が悪化し、二次的に湿疹化が進むことがある。
In recent years, an increasing number of people suffer from itching skin diseases (especially atopic dermatitis, dry dermatosis, sensitive skin, etc.) due to changes in living environment, rapid aging, various stresses, and the like. These skin diseases are accompanied by strong itching and rough skin. For the treatment, an external preparation containing an antipruritic component such as crotamiton / antihistamine and a moisturizing component such as heparin-like substance as an active ingredient is used.
Among these, heparin-like substances are polysulfated esters of mucopolysaccharides that have a blood circulation promoting action, and since they contain a large amount of sulfate groups, carboxyl groups, hydroxyl groups, etc., they have high moisturizing ability and are already dried. It is also used as an over-the-counter drug for the treatment of sexual skin diseases.
Dry skin (dry skin of the elderly and adults, dry skin of children) is a typical symptom of dry skin disease. In the elderly and adults, aging of the skin (physiological changes associated with aging) It occurs in children because the stratum corneum is thinner than adults, the amount of sebum secretion is unstable, and the barrier function is not yet stable. In either case, the skin becomes dry and rough, and in many cases itching is a subjective symptom. The degree of itching is often strong, and the patient constantly violently scratches the affected area, increasing itching, and further scratching may cause inflammation in the skin, worsening symptoms, and secondary eczema.
このような悪循環を断ち切り、不快症状である痒みを緩和するとともに湿疹化を防止する目的として、多くの研究開発が行われている（特許文献１および２を参照）。
特許文献１には、外用抗ヒスタミン剤であるジフェンヒドラミンとヘパリン類似物質とを配合し、痒みを伴う乾燥性皮ふ疾患の効能・効果を持ち合わせた外用製剤が開示されている。しかし、ヘパリン類似物質の作用は不足した水分を補うことであり、ジフェンヒドラミンの作用は痒みを緩和することであり、いずれも対症療法的なものに過ぎないため、皮膚疾患を根本的に治療させることは難しかった。
すなわち、乾燥性皮膚疾患を部位別又は疾患別に記すと、手指の荒れ、ひじ・ひざ・かかと・くるぶしの角化症、手足のひび・あかぎれ、乾皮症、小児の乾燥性皮膚などが例示される。このうち、手指の荒れ、乾皮症、角化症においては病状を呈した皮膚組織が正常な状態までに置き換わるいわゆるターンオーバーを促進する作用が、ひび・あかぎれにおいては割れた皮膚組織の治療を促進する作用が、それぞれ必要であると考えられた。そこで、皮膚組織を正常な状態に回復するのを助けるビタミン（トコフェロール酢酸エステル）及び皮膚組織の修復作用を持つアラントインを添加するという工夫がなされた（特許文献２）。
Many researches and developments have been carried out for the purpose of breaking such a vicious circle, relieving itching which is an unpleasant symptom, and preventing eczema from occurring (see Patent Documents 1 and 2).
Patent Document 1 discloses a preparation for external use that combines diphenhydramine, which is an antihistamine for external use, and a heparin-like substance, and has the effects and effects of dry skin disease accompanied by itchiness. However, the action of heparin-like substances is to supplement deficient water, and the action of diphenhydramine is to relieve itching, both of which are only symptomatic, so that skin diseases can be treated fundamentally. Was difficult.
In other words, when desiccating skin diseases are classified by region or disease, examples include rough fingers, keratosis of the elbows, knees, heels, and ankles, cracks and scratches on the limbs, dry skin, and dry skin of children. The Among these, in the case of rough hands, dry skin, and keratosis, the action that promotes the so-called turnover that replaces the diseased skin tissue to a normal state is effective in treating cracked skin tissue. Each promoting action was considered necessary. Therefore, a device has been devised in which vitamin (tocopherol acetate) that helps to restore the skin tissue to a normal state and allantoin having a skin tissue repairing action are added (Patent Document 2).
上記の工夫にも拘わらず、痒みを伴う乾燥性皮膚疾患について、根本的な治療を促し得る皮膚外用製剤は、十分に提供されているとは言い難い状況であった。
本発明は、上記した事情に鑑みてなされたものであり、その目的は、痒みを抑えると共に皮膚組織を正常な状態に回復することにより、痒みを伴う乾燥性皮膚疾患を根本的に治療し得る皮膚外用製剤を提供することである。
In spite of the above-described devices, it has been difficult to say that a preparation for external use for skin that can promote radical treatment for dry skin disease accompanied with itching is not sufficiently provided.
The present invention has been made in view of the above-described circumstances, and an object of the present invention is to fundamentally treat dry skin diseases accompanied by itching by suppressing itching and restoring skin tissue to a normal state. It is to provide an external preparation for skin.
上記目的を達成するための発明に係る皮膚外用製剤は、（Ａ）ヘパリン類似物質と、（Ｂ）トコフェロール、トコフェロール酢酸エステル、ニコチン酸トコフェロール、リノレン酸トコフェロール、コハク酸トコフェロール、パンテノール及びビタミンＡ類からなる群より選択される少なくとも一種と、（Ｃ）グリチルリチン酸、グリチルレチン酸、グリチルレチン酸ステアリル、アラントイン、及びそれらの塩からなる群より選択される少なくとも一種の抗炎症剤と、（Ｄ）ジフェンヒドラミン及び塩酸ジフェンヒドラミンからなる群から選択される少なくとも一種の鎮痒剤とを含むことを特徴とする。
本発明において、（Ａ）ヘパリン類似物質の含量は、全体の０.２〜０.４質量％（好ましくは０.３質量％）、（Ｂ）トコフェロール、トコフェロール酢酸エステル、ニコチン酸トコフェロール、リノレン酸トコフェロール、コハク酸トコフェロール、パンテノール及びビタミンＡ類からなる群より選択される少なくとも一種の含量は、全体の０.００１〜１質量％（好ましくは０.０１〜０.８質量％、更に好ましくは０.１〜０.７質量％、更に好ましくは０.４〜０.６質量％）、（Ｃ）抗炎症剤の含量は、全体の０.０１〜５質量％（好ましくは０.０５〜１質量％、更に好ましくは０.１〜０.５質量％）、（Ｄ）鎮痒剤の含量は、全体の０.１〜２質量％（好ましくは０.５〜１.５質量％）である。
The external preparation for skin according to the invention for achieving the above object comprises: (A) a heparin-like substance, (B) tocopherol, tocopherol acetate, tocopherol nicotinate, tocopherol linolenate, tocopherol succinate, panthenol and vitamins A At least one selected from the group consisting of: (C) at least one anti-inflammatory agent selected from the group consisting of glycyrrhizic acid, glycyrrhetinic acid, stearyl glycyrrhetinate, allantoin, and salts thereof; and (D) diphenhydramine and And at least one antipruritic agent selected from the group consisting of diphenhydramine hydrochloride.
In the present invention, the content of (A) heparin-like substance is 0.2 to 0.4% by mass (preferably 0.3% by mass), (B) tocopherol, tocopherol acetate, tocopherol nicotinate, linolenic acid The content of at least one selected from the group consisting of tocopherol, tocopherol succinate, panthenol and vitamins A is 0.001 to 1% by mass (preferably 0.01 to 0.8% by mass, more preferably 0.1 to 0.7% by mass, more preferably 0.4 to 0.6% by mass), and (C) the content of the anti-inflammatory agent is 0.01 to 5% by mass (preferably 0.05 to 0.55%). 1% by mass, more preferably 0.1 to 0.5% by mass), and (D) the content of the antipruritic agent is 0.1 to 2% by mass (preferably 0.5 to 1.5% by mass). is there.
ヘパリンとは、生体内では主として肝臓において生成されるグリコサミノグリカンの一種である。抗凝固作用を有しており、血栓塞栓症・播種性血管内凝固症候群（ＤＩＣ）の治療薬、人工透析・体外循環における血液の凝固防止などの用途がある。ヘパリン類似物質とは、ヘパリン、及びヘパリンが修飾・一部分解されたものであって、ヘパリンと同様の生理活性を備えたものを意味する。
ビタミンＡ類とは、レチノール、レチナール、レチノイン酸及びこれらの3-デヒドロ体並びにこれらの誘導体を総称したものを意味する。
皮膚外用製剤の剤形としては、例えばクリーム、乳液、軟膏、ゲル剤などが含まれる。
Heparin is a type of glycosaminoglycan produced mainly in the liver in the living body. It has anticoagulant action and has uses such as a therapeutic agent for thromboembolism and disseminated intravascular coagulation syndrome (DIC), and prevention of blood coagulation in artificial dialysis and extracorporeal circulation. The heparin-like substance means heparin and a substance obtained by modifying and partially decomposing heparin and having physiological activity similar to that of heparin.
Vitamin A means a general term for retinol, retinal, retinoic acid and their 3-dehydro compounds and their derivatives.
Examples of the dosage form of the external preparation for skin include creams, emulsions, ointments, gels and the like.
本発明によれば、痒みを抑えると共に、皮膚組織を正常な状態に回復することにより、痒みを伴う乾燥性皮膚疾患を根本的に治療し得る皮膚外用製剤を提供できる。 ADVANTAGE OF THE INVENTION According to this invention, while suppressing itching, the external preparation for skin which can fundamentally treat the dry skin disease which accompanies itching can be provided by restoring skin tissue to a normal state.
次に、本発明の実施形態について、図表を参照しつつ説明するが、本発明の技術的範囲は、これらの実施形態によって限定されるものではなく、発明の要旨を変更することなく様々な形態で実施することができる。
＜試験方法＞
１．各組成物の調製
有効成分として、ヘパリン類似物質、トコフェロール酢酸エステル、アラントイン及びジフェンヒドラミン含む皮膚外用製剤（試験組成物）としてのクリームを調製した。
一方、有効成分として、ヘパリン類似物質及びジフェンヒドラミンを含む皮膚外用製剤（比較組成物１）、及びヘパリン類似物質、パンテノール、トコフェロール酢酸エステル、アラントイン及びジフェンヒドラミンを含む皮膚外用製剤（比較組成物２）を調製した。なお、各組成物において、他の配合成分は同一に調製した。
各組成物の用量は、表１に記載の通りとした。
Next, embodiments of the present invention will be described with reference to the drawings. However, the technical scope of the present invention is not limited by these embodiments, and various forms can be made without changing the gist of the invention. Can be implemented.
<Test method>
1. Preparation of each composition As an active ingredient, a cream as an external preparation for skin (test composition) containing a heparin analog, tocopherol acetate, allantoin and diphenhydramine was prepared.
On the other hand, as an active ingredient, an external preparation for skin containing a heparin analog and diphenhydramine (Comparative Composition 1), and an external preparation for skin containing a heparin analog, panthenol, tocopherol acetate, allantoin and diphenhydramine (Comparative Composition 2) Prepared. In addition, in each composition, the other compounding component was prepared identically.
The dose of each composition was as described in Table 1.
２．角質水分量の測定
肌荒れによる痒みを訴える被験者各５名（全１５名）を対象とし、肌荒れ改善効果を評価した。
具体的には、各被験組成物を手の甲に対し、就寝前及び乾燥が気になった時に適量を塗布させた。使用前と、使用開始5日後（使用後）の電気伝導度（μｓ）を表角層水分量測定装置（SKICON-200EX、アイ・ビー・エス株式会社製）により測定した。各水分値は、各被験者について、３点での測定値の平均値で示した。水分相対値として、使用後水分値／使用前水分値を算出した。
2. Measurement of horny moisture content The skin roughness improvement effect was evaluated for 5 subjects (15 subjects in total) who complain of itching due to rough skin.
Specifically, an appropriate amount of each test composition was applied to the back of the hand before going to bed and when drying was a concern. The electrical conductivity (μs) before use and 5 days after use (after use) was measured with a surface angle layer moisture measuring device (SKICON-200EX, manufactured by IBS Co., Ltd.). Each moisture value was shown by the average value of the measured values at three points for each subject. The moisture value after use / the moisture value before use was calculated as a moisture relative value.
３．官能評価試験
肌荒れによる痒みを訴える被験者各５名の患部に各被験組成物を塗布し、次の５種類のパラメータを用いて評価した。すなわち、(1)使用感（塗布しやすい場合を５点、塗布しにくい場合を１点）、(2)肌状態の改善（肌が乾燥した状態が改善された場合を５点、肌が乾燥した状態が改善しなかった場合を１点）、(3)かゆみ止め効果（かゆみが止まった場合を５点、かゆみが止まらなかった場合を１点）、(4)かゆみの再発抑制効果（塗った日に再発して患部を掻かなかった場合を５点、塗った日に再発して患部を掻いた場合を１点）、及び(5)肌改善の持続性（塗る前に肌が乾燥した状態が改善されてきたと感じた場合を５点、塗る前に肌が乾燥した状態が改善されてきていないと感じた場合を１点）とした。各パラメータについて、５段階で評価を行った。
各被験者による評点を合計し、合計点が２１〜２５点：◎、１６〜２０点：○、１１〜１５点：△、１１点未満：×とした。
3. Sensory evaluation test Each test composition was applied to the affected area of five test subjects each complaining of itching due to rough skin, and evaluated using the following five types of parameters. (1) Usability (5 points for easy application, 1 point for difficult application), (2) Improvement of skin condition (5 points for improved dry skin, dry skin 1 point when the condition does not improve), (3) anti-itching effect (5 points when itching stops, 1 point when itching does not stop), (4) anti-itching recurrence effect (painted) 5 points when the affected area did not scratch the affected area, 1 point when the affected area recurred and scratched the affected area), and (5) Persistence of skin improvement (skin dried before applying) 5 points were given when the condition was felt to be improved, and 1 point was given when it was felt that the skin was not improved before being applied. Each parameter was evaluated in five stages.
The scores by each subject were totaled, and the total score was 21-25 points: A, 16-20 points: B, 11-15 points: A, less than 11 points: X.
＜試験結果＞
表２〜表４には、角質水分量（使用前及び使用後のもの）及び官能評価の結果を示した。
<Test results>
Tables 2 to 4 show the amount of stratum corneum (before and after use) and the results of sensory evaluation.
上記結果に示すように、試験組成物は、比較組成物に比べると、水分相対値（使用後水分値／使用前水分値）に優れていた。また、官能評価においても、比較組成物よりも高値を示した。こうして、試験組成物は、角質を正常化して手荒れを改善する効果及びかゆみの再発をおさえて肌改善の持続性を上げる効果に優れていることが明らかになった。
＜その他の組成物の調製＞
次に、その他の組成物について調製を行った。
１．乳液の調製
ヘパリン類似物質0.3g、トコフェロール酢酸エステル0.5g、アラントイン0.2g及びジフェンヒドラミン1.0gに対し、セタノール1.0g、ステアリルアルコール0.5g、白色ワセリン4g、精製水適量を加えて乳液を調製した。
２．軟膏の調製
ヘパリン類似物質0.3g、トコフェロール酢酸エステル0.5g、アラントイン0.2g及びジフェンヒドラミン1.0gに対し、マクロゴール４０００ 30g、マクロゴール４００適量を加えて軟膏を調製した。
３．ゲル剤の調製
ヘパリン類似物質0.3g、トコフェロール酢酸エステル0.5g、アラントイン0.2g及びジフェンヒドラミン1.0gに対し、エタノール40g、ヒプロメロース0.5g、ヒドロキシエチルセルロース0.5g、精製水適量を加えてゲル剤を調製した。
上記各組成物についてもクリームに示した効果と同様の効果が認められた。
このように、本実施形態によれば、痒みを抑えると共に皮膚組織を正常な状態に回復することにより、痒みを伴う乾燥性皮膚疾患を根本的に治療し得る皮膚外用製剤を提供できた。
As shown in the above results, the test composition was superior in relative water value (water value after use / water value before use) compared to the comparative composition. In sensory evaluation, the value was higher than that of the comparative composition. Thus, it was revealed that the test composition is excellent in the effect of normalizing the keratin and improving the rough hand, and the effect of suppressing the recurrence of itching and increasing the persistence of the skin improvement.
<Preparation of other compositions>
Next, other compositions were prepared.
1. Preparation of emulsion To 0.3 g of heparin-like substance, 0.5 g of tocopherol acetate, 0.2 g of allantoin and 1.0 g of diphenhydramine, 1.0 g of cetanol, 0.5 g of stearyl alcohol, 4 g of white petrolatum and an appropriate amount of purified water were added to prepare an emulsion.
2. Preparation of Ointment An ointment was prepared by adding appropriate amounts of Macrogol 4000 30g and Macrogol 400 to 0.3g of heparin-like substance, 0.5g of tocopherol acetate, 0.2g of allantoin and 1.0g of diphenhydramine.
3. Preparation of Gel Agent A gel agent was prepared by adding 40 g of ethanol, 0.5 g of hypromellose, 0.5 g of hydroxyethyl cellulose, and an appropriate amount of purified water to 0.3 g of heparin-like substance, 0.5 g of tocopherol acetate, 0.2 g of allantoin and 1.0 g of diphenhydramine.
The same effects as those shown in the cream were also observed for each of the above compositions.
As described above, according to this embodiment, it was possible to provide an external preparation for skin that can fundamentally treat dry skin diseases accompanied with itching by suppressing itching and restoring the skin tissue to a normal state.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2018193329A (en) * | 2017-05-17 | 2018-12-06 | 小林製薬株式会社 | Transglutaminase expression promoter |
| JP2018203673A (en) * | 2017-06-06 | 2018-12-27 | 小林製薬株式会社 | Sebum secretion promoter |
| JP2020100576A (en) * | 2018-12-20 | 2020-07-02 | 小林製薬株式会社 | External composition for skin |
| JP2021155355A (en) * | 2020-03-26 | 2021-10-07 | ピアス株式会社 | Topical skin preparation |
| JP2022183993A (en) * | 2021-05-31 | 2022-12-13 | ホーユー株式会社 | Composition for improving or repairing skin barrier function |
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|---|---|---|---|---|
| JP2000143517A (en) * | 1998-11-12 | 2000-05-23 | Lion Corp | Preparation for external use for skin |
| JP2014141470A (en) * | 2012-12-25 | 2014-08-07 | Lion Corp | External preparation composition and skin care sheet |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000143517A (en) * | 1998-11-12 | 2000-05-23 | Lion Corp | Preparation for external use for skin |
| JP2014141470A (en) * | 2012-12-25 | 2014-08-07 | Lion Corp | External preparation composition and skin care sheet |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2018193329A (en) * | 2017-05-17 | 2018-12-06 | 小林製薬株式会社 | Transglutaminase expression promoter |
| JP7361448B2 (en) | 2017-05-17 | 2023-10-16 | 小林製薬株式会社 | Transglutaminase expression promoter |
| JP2018203673A (en) * | 2017-06-06 | 2018-12-27 | 小林製薬株式会社 | Sebum secretion promoter |
| JP2020100576A (en) * | 2018-12-20 | 2020-07-02 | 小林製薬株式会社 | External composition for skin |
| JP7446711B2 (en) | 2018-12-20 | 2024-03-11 | 小林製薬株式会社 | Skin external composition |
| JP2021155355A (en) * | 2020-03-26 | 2021-10-07 | ピアス株式会社 | Topical skin preparation |
| JP2022183993A (en) * | 2021-05-31 | 2022-12-13 | ホーユー株式会社 | Composition for improving or repairing skin barrier function |
| JP7265278B2 (en) | 2021-05-31 | 2023-04-26 | ホーユー株式会社 | COMPOSITION FOR IMPROVING SKIN BARRIER FUNCTION OR REPAIR |
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