JP2020033310A - Skin external composition - Google Patents
Skin external composition Download PDFInfo
- Publication number
- JP2020033310A JP2020033310A JP2018161882A JP2018161882A JP2020033310A JP 2020033310 A JP2020033310 A JP 2020033310A JP 2018161882 A JP2018161882 A JP 2018161882A JP 2018161882 A JP2018161882 A JP 2018161882A JP 2020033310 A JP2020033310 A JP 2020033310A
- Authority
- JP
- Japan
- Prior art keywords
- skin
- composition
- external
- acid
- ufenamate
- 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
- 239000000203 mixture Substances 0.000 title claims abstract description 70
- 230000001139 anti-pruritic effect Effects 0.000 claims abstract description 42
- JDLSRXWHEBFHNC-UHFFFAOYSA-N Ufenamate Chemical compound CCCCOC(=O)C1=CC=CC=C1NC1=CC=CC(C(F)(F)F)=C1 JDLSRXWHEBFHNC-UHFFFAOYSA-N 0.000 claims abstract description 23
- 229950010121 ufenamate Drugs 0.000 claims abstract description 23
- 229960000520 diphenhydramine Drugs 0.000 claims abstract description 21
- 150000003839 salts Chemical class 0.000 claims abstract description 17
- 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 3
- 238000000034 method Methods 0.000 claims description 14
- 239000003908 antipruritic agent Substances 0.000 claims description 5
- 208000003251 Pruritus Diseases 0.000 description 32
- SPCKHVPPRJWQRZ-UHFFFAOYSA-N 2-benzhydryloxy-n,n-dimethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O.C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 SPCKHVPPRJWQRZ-UHFFFAOYSA-N 0.000 description 19
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 18
- -1 diphenyldisulfonate Chemical class 0.000 description 16
- 239000003814 drug Substances 0.000 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 description 8
- 239000002202 Polyethylene glycol Substances 0.000 description 8
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- 238000007790 scraping Methods 0.000 description 8
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- 229940079593 drug Drugs 0.000 description 7
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- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 4
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- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 description 4
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- 230000001387 anti-histamine Effects 0.000 description 4
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 description 4
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- 229960004194 lidocaine Drugs 0.000 description 4
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- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 239000004166 Lanolin Substances 0.000 description 3
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- 239000000654 additive Substances 0.000 description 3
- 210000001217 buttock Anatomy 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 201000005884 exanthem Diseases 0.000 description 3
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 3
- 235000019388 lanolin Nutrition 0.000 description 3
- 229940039717 lanolin Drugs 0.000 description 3
- 239000003589 local anesthetic agent Substances 0.000 description 3
- 210000003141 lower extremity Anatomy 0.000 description 3
- 239000003921 oil Substances 0.000 description 3
- 230000000144 pharmacologic effect Effects 0.000 description 3
- 229920001451 polypropylene glycol Polymers 0.000 description 3
- 229920001296 polysiloxane Polymers 0.000 description 3
- 230000001823 pruritic effect Effects 0.000 description 3
- 206010037844 rash Diseases 0.000 description 3
- 210000000689 upper leg Anatomy 0.000 description 3
- 239000001993 wax Substances 0.000 description 3
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 2
- DSSYKIVIOFKYAU-XCBNKYQSSA-N (R)-camphor Chemical compound C1C[C@@]2(C)C(=O)C[C@@H]1C2(C)C DSSYKIVIOFKYAU-XCBNKYQSSA-N 0.000 description 2
- FDCJDKXCCYFOCV-UHFFFAOYSA-N 1-hexadecoxyhexadecane Chemical compound CCCCCCCCCCCCCCCCOCCCCCCCCCCCCCCCC FDCJDKXCCYFOCV-UHFFFAOYSA-N 0.000 description 2
- ASKIVFGGGGIGKH-UHFFFAOYSA-N 2,3-dihydroxypropyl 16-methylheptadecanoate Chemical compound CC(C)CCCCCCCCCCCCCCC(=O)OCC(O)CO ASKIVFGGGGIGKH-UHFFFAOYSA-N 0.000 description 2
- FLPJVCMIKUWSDR-UHFFFAOYSA-N 2-(4-formylphenoxy)acetamide Chemical compound NC(=O)COC1=CC=C(C=O)C=C1 FLPJVCMIKUWSDR-UHFFFAOYSA-N 0.000 description 2
- LVYLCBNXHHHPSB-UHFFFAOYSA-N 2-hydroxyethyl salicylate Chemical compound OCCOC(=O)C1=CC=CC=C1O LVYLCBNXHHHPSB-UHFFFAOYSA-N 0.000 description 2
- QNAYBMKLOCPYGJ-UHFFFAOYSA-N Alanine Chemical compound CC([NH3+])C([O-])=O QNAYBMKLOCPYGJ-UHFFFAOYSA-N 0.000 description 2
- 239000005711 Benzoic acid Substances 0.000 description 2
- 241000723346 Cinnamomum camphora Species 0.000 description 2
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 2
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 description 2
- RAHZWNYVWXNFOC-UHFFFAOYSA-N Sulphur dioxide Chemical compound O=S=O RAHZWNYVWXNFOC-UHFFFAOYSA-N 0.000 description 2
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 description 2
- 150000001298 alcohols Chemical class 0.000 description 2
- POJWUDADGALRAB-UHFFFAOYSA-N allantoin Chemical compound NC(=O)NC1NC(=O)NC1=O POJWUDADGALRAB-UHFFFAOYSA-N 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
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- KVYGGMBOZFWZBQ-UHFFFAOYSA-N benzyl nicotinate Chemical compound C=1C=CN=CC=1C(=O)OCC1=CC=CC=C1 KVYGGMBOZFWZBQ-UHFFFAOYSA-N 0.000 description 2
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- YKPUWZUDDOIDPM-SOFGYWHQSA-N capsaicin Chemical compound COC1=CC(CNC(=O)CCCC\C=C\C(C)C)=CC=C1O YKPUWZUDDOIDPM-SOFGYWHQSA-N 0.000 description 2
- 239000004359 castor oil Substances 0.000 description 2
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- 229940074979 cetyl palmitate Drugs 0.000 description 2
- 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
- NEHNMFOYXAPHSD-UHFFFAOYSA-N citronellal Chemical compound O=CCC(C)CCC=C(C)C NEHNMFOYXAPHSD-UHFFFAOYSA-N 0.000 description 2
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- 229940075507 glyceryl monostearate Drugs 0.000 description 2
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- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 description 2
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- 125000000913 palmityl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
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- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
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- 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
- 235000005713 safflower oil Nutrition 0.000 description 1
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- YGSDEFSMJLZEOE-UHFFFAOYSA-M salicylate Chemical compound OC1=CC=CC=C1C([O-])=O YGSDEFSMJLZEOE-UHFFFAOYSA-M 0.000 description 1
- 229960004889 salicylic acid Drugs 0.000 description 1
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- 229920002545 silicone oil Polymers 0.000 description 1
- 239000003009 skin protective agent Substances 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
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- 235000010234 sodium benzoate Nutrition 0.000 description 1
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- 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
- CRPCXAMJWCDHFM-UHFFFAOYSA-M sodium;5-oxopyrrolidine-2-carboxylate Chemical compound [Na+].[O-]C(=O)C1CCC(=O)N1 CRPCXAMJWCDHFM-UHFFFAOYSA-M 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
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- 239000003381 stabilizer Substances 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
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- 230000000638 stimulation Effects 0.000 description 1
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- 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
- 230000001629 suppression Effects 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 229940095064 tartrate Drugs 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
- 230000001225 therapeutic effect Effects 0.000 description 1
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- 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
- 239000006097 ultraviolet radiation absorber Substances 0.000 description 1
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- 239000011782 vitamin Substances 0.000 description 1
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- 235000019155 vitamin A Nutrition 0.000 description 1
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- 238000010792 warming Methods 0.000 description 1
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- 239000011787 zinc oxide 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
本発明は、ジフェンヒドラミン及び／又はその塩を含有し、鎮痒効果が向上した皮膚外用組成物に関する。 The present invention relates to an external skin composition containing diphenhydramine and / or a salt thereof and having an improved antipruritic effect.
ジフェンヒドラミン塩酸塩等のジフェンヒドラミン類は、皮膚の痒みなどのアレルギー症状を引き起こすヒスタミンの作用を抑制し得ることが知られ、抗ヒスタミン剤として医薬品又は医薬部外品の皮膚外用剤に配合して用いられている。例えば、特許文献１には、有効成分として、吉草酸酢酸プレドニゾロンと、ジフェンヒドラミン及びその塩類等の抗ヒスタミン剤とを含む、湿疹、皮膚炎、虫さされ、かゆみ、あせも、かぶれ及びじんましん等に対する治療効果を有する皮膚外用剤が開示されている。 Diphenhydramines such as diphenhydramine hydrochloride are known to be able to suppress the action of histamine causing allergic symptoms such as itching of the skin, and are used as an antihistamine in a drug or a quasi-drug skin external preparation. . For example, Patent Document 1 discloses that as an active ingredient, prednisolone acetate valerate and an antihistamine such as diphenhydramine and salts thereof are used, and the therapeutic effects on eczema, dermatitis, insect bites, itching, rash, rash and urticaria are described. A skin external preparation having the same is disclosed.
ウフェナマートは、非ステロイド系抗炎症剤として、医薬品又は医薬部外品の皮膚外用剤に配合して用いられている。例えば、特許文献２には、ウフェナマートにヘパリンを配合した乳化状態の皮膚外用組成物が、優れた抗炎症作用を発揮させることが開示されている。 Ufenamate is used as a nonsteroidal anti-inflammatory agent in skin or external preparations of drugs or quasi-drugs. For example, Patent Literature 2 discloses that an emulsified skin external composition obtained by mixing heparin with ufenamate exhibits an excellent anti-inflammatory effect.
ジフェンヒドラミン類が配合された皮膚外用剤は、その抗ヒスタミン効果により皮膚掻痒に対する効果（以下、単に「鎮痒効果」とも記載し、鎮痒効果を生じさせる性質を「鎮痒性」とも記載する。）が得られるが、鎮痒効果がより一層高められた更なる有用な他の手段の開発が求められている。 An external preparation for skin containing diphenhydramines has an effect on skin pruritus due to its antihistamine effect (hereinafter simply referred to as "pruritic effect", and the property of producing an antipruritic effect is also referred to as "pruritic"). However, there is a need for the development of further useful other means with further enhanced antipruritic effect.
本発明は鎮痒効果がより一層高められた皮膚外用組成物を提供することを目的とする。 An object of the present invention is to provide a composition for external use on the skin in which the antipruritic effect is further enhanced.
本発明者は、鋭意検討を行ったところ、ジフェンヒドラミン及び／又はその塩（以下において、「ジフェンヒドラミン類」とも記載する。）を含む皮膚外用組成物にウフェナマートを配合したところ、ウフェナマートが皮膚掻痒に対する有効成分でないにも関わらず、鎮痒効果が向上するという驚くべき知見を見出した。本発明は、この知見に基づいて更に検討を重ねることにより完成したものである。 The present inventors have conducted intensive studies and have found that when ufenamate is added to a skin external composition containing diphenhydramine and / or a salt thereof (hereinafter, also referred to as “diphenhydramines”), ufenamate is effective against skin pruritus The present inventors have found a surprising finding that the antipruritic effect is improved despite not being a component. The present invention has been completed by further study based on this finding.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項１． （Ａ）ジフェンヒドラミン及び／又はその塩、並びに（Ｂ）ウフェナマートを含有する皮膚外用組成物。
項２． 鎮痒用途で使用される、項１に記載の皮膚外用組成物。
項３． （Ａ）ジフェンヒドラミン及び／又はその塩を含む皮膚外用組成物において、鎮痒効果を向上させる方法であって、
皮膚外用組成物に、前記（Ａ）成分とともに（Ｂ）ウフェナマートを配合する、鎮痒効果向上方法。
That is, the present invention provides the following aspects of the invention.
Item 1. An external skin composition comprising (A) diphenhydramine and / or a salt thereof, and (B) ufenamate.
Item 2. Item 2. The external composition for skin according to Item 1, which is used for antipruritic use.
Item 3. (A) A method for improving an antipruritic effect in a skin external composition containing diphenhydramine and / or a salt thereof,
A method for improving an antipruritic effect, comprising mixing (B) ufenamate with the above-mentioned component (A) in a composition for external use on the skin.
本発明の皮膚外用組成物は、ジフェンヒドラミン類にウフェナマートを配合することによって、鎮痒効果を向上させることができる。 The composition for external use on the skin of the present invention can improve the antipruritic effect by adding ufenamate to diphenhydramines.
１．皮膚外用組成物
本発明の皮膚外用組成物は、（Ａ）ジフェンヒドラミン類（以下、「（Ａ）成分」とも記載する。）及び（Ｂ）ウフェナマート（以下「（Ｂ）成分」とも記載する。）を含有することを特徴とする。以下、本発明の皮膚外用組成物について詳述する。
1. External composition for skin The external composition for skin of the present invention comprises (A) diphenhydramines (hereinafter, also referred to as "(A) component") and (B) ufenamate (hereinafter, also referred to as "(B) component"). It is characterized by containing. Hereinafter, the skin external composition of the present invention will be described in detail.
（Ａ）ジフェンヒドラミン及び／又はその塩
本発明の皮膚外用組成物は、（Ａ）成分としてジフェンヒドラミン及び／又はその塩を含有する。ジフェンヒドラミンは、抗ヒスタミン作用があることが知られている公知の薬剤である。（Ａ）成分は単独では鎮痒効果を発現するまでに時間がかかるため、皮膚外用組成物適用後の初期段階では有効な鎮痒性を生じさせず、却って掻痒を悪化させる作用すらあるが、本発明の皮膚外用組成物は、速やかに有効な掻痒性を発揮することが可能である。
(A) Diphenhydramine and / or a salt thereof The external composition for skin of the present invention contains diphenhydramine and / or a salt thereof as the component (A). Diphenhydramine is a known drug that is known to have antihistamine action. Since the component (A) alone takes a long time to exhibit an antipruritic effect, it does not produce an effective antipruritic property at the initial stage after application of the composition for external use on the skin, and may even have an effect of exacerbating pruritus. The composition for external use on the skin can quickly exhibit effective pruritus.
ジフェンヒドラミンの塩としては、薬学的に許容されるものである限り特に制限されないが、具体的には、塩酸塩、クエン酸塩、コハク酸塩、酒石酸塩、フマル酸塩、マレイン酸塩、サリチル酸塩、ジフェニルジスルホン酸塩、タンニン酸塩、ラウリル硫酸塩、硫酸塩等の酸付加塩が挙げられる。これらの塩は、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。 The diphenhydramine salt is not particularly limited as long as it is pharmaceutically acceptable. Specifically, hydrochloride, citrate, succinate, tartrate, fumarate, maleate, salicylate And acid addition salts such as diphenyldisulfonate, tannate, lauryl sulfate and sulfate. These salts may be used alone or in a combination of two or more.
本発明の皮膚外用組成物において、ジフェンヒドラミン及びその塩の中から１種を選択して使用してもよく、また２種以上を組み合わせて使用してもよい。 In the composition for external use on the skin of the present invention, one of diphenhydramine and a salt thereof may be selected and used, or two or more thereof may be used in combination.
本発明の皮膚外用組成物における（Ａ）成分の含有量については、付与すべき薬効等に応じて適宜設定すればよいが、例えば、総量で０．０１〜５重量％、好ましくは０．１〜３重量％、より好ましくは０．１〜２重量％が挙げられる。 The content of the component (A) in the composition for external use on the skin of the present invention may be appropriately set according to the medicinal effect to be imparted, for example, 0.01 to 5% by weight in total, preferably 0.1 to 5% by weight. To 3% by weight, more preferably 0.1 to 2% by weight.
（Ｂ）ウフェナマート
本発明の皮膚外用組成物は、（Ｂ）成分としてウフェナマートを含有する。ウフェナマートは、フルフェナム酸ブチルとも呼ばれ、脂溶性の非ステロイド性抗炎症薬として公知の成分である。ウフェナマートは、それ自体は有効な鎮痒性を発揮せず、むしろ単独では適用後の初期段階で鎮痒性を悪化させる作用すらあるが、本発明の皮膚外用組成物においては、（Ａ）成分に組み合わされることによって、（Ａ）成分の単独配合による欠点（つまり、鎮痒効果を発現するまでに時間がかかるため、皮膚外用組成物適用の初期段階では有効な鎮痒性を生じさせず、却って掻痒を悪化させる作用すらあること）さえも解消し、速やかに有効な掻痒性を発揮することが可能である。
(B) Ufenamate The external composition for skin of the present invention contains ufenamate as the component (B). Ufenamate, also called butyl flufenamic acid, is a component known as a fat-soluble non-steroidal anti-inflammatory drug. Ufenamate itself does not exhibit an effective antipruritic effect, but rather has an effect of even worsening the antipruritic effect at an early stage after application. However, in the external composition for skin of the present invention, ufenamate is combined with the component (A). As a result, the disadvantages caused by the single combination of the component (A) (that is, it takes a long time to develop the antipruritic effect, so that at the initial stage of application of the composition for external use on the skin, no effective antipruritic property is produced, but rather itching is worsened) Even if it has an effect of causing pruritus), and it is possible to quickly exert effective pruritus.
本発明の皮膚外用組成物において、ウフェナマートの含有量については、付与すべき薬効等に応じて適宜設定されるが、例えば１〜２０重量％が挙げられ、（Ａ）成分との組み合わせによる鎮痒性をより効果的に発揮させる観点から、好ましくは２〜１０重量％、更に好ましくは３〜７重量％が挙げられる。 In the composition for external use on the skin of the present invention, the content of ufenamate is appropriately set according to the medicinal effect to be imparted, for example, 1 to 20% by weight, and antipruritic by combination with the component (A). Is more preferably 2 to 10% by weight, and still more preferably 3 to 7% by weight.
本発明の皮膚外用組成物において、（Ａ）成分に対する（Ｂ）成分の比率については、（Ａ）成分及び（Ｂ）成分の各含有量に応じて定まるが、例えば、（Ａ）成分の１重量部当たり、（Ｂ）成分が例えば０．５〜３０重量部が挙げられる。鎮痒性をより効果的に発揮させる観点から、（Ａ）成分の１重量部当たり、好ましくは０．８〜２０重量部、より好ましくは１〜１５重量部が挙げられる。 In the composition for external use on skin of the present invention, the ratio of the component (B) to the component (A) is determined according to the content of each of the components (A) and (B). The component (B) is, for example, 0.5 to 30 parts by weight per part by weight. From the viewpoint of more effectively exhibiting antipruritic properties, the amount is preferably 0.8 to 20 parts by weight, more preferably 1 to 15 parts by weight, per part by weight of the component (A).
その他の成分
本発明の皮膚外用組成物は、前述する成分の他に、必要に応じて、他の薬理成分を含んでもよい。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（リドカイン、ジブカイン、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、安息香酸アルキルエステル（例えばアミノ安息香酸エチル、塩酸パラブチルアミノ安息香酸ジエチルアミノエチル）、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（グリチルレチン酸、グリチルレチン酸塩、アラントイン、サリチル酸、サリチル酸グリコール、サリチル酸メチル、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等）、殺菌剤（酸化亜鉛、塩化ベンザルコニウム、塩化デカリニウム、塩化ベンゼトニウム、塩化セチルピリジニウム、イソプロピルメチルフェノール、塩酸クロルヘキシジン、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）、鎮痒剤（クロタミトン、チアントール等）、皮膚保護剤（コロジオン、ヒマシ油等）、血行促進成分（ノニル酸ワニリルアミド、ニコチン酸ベンジルエステル、カプサイシン、トウガラシエキス等）、清涼化剤（メントール、カンフル等）、ビタミン類（ビタミンＡ，Ｂ，Ｃ，Ｄ等）、ムコ多糖類（コンドロイチン硫酸ナトリウム、ヒアルロン酸等）等が挙げられる。
Other Ingredients The external composition for skin of the present invention may contain other pharmacological ingredients, if necessary, in addition to the components described above. Such pharmacological components include, for example, antihistamines (such as chlorpheniramine maleate), local anesthetics (lidocaine, dibucaine, procaine, tetracaine, bupivacaine, mepivacaine, chloroprocaine, proparacaine, meprilcaine or salts thereof, benzoic acid) Alkyl esters (e.g. ethyl aminobenzoate, diethylaminoethyl parabutylaminobenzoate hydrochloride), orthocaine, oxesazein, oxypolyentoxydecane, funnel extract, percaminepase, tesit decithin, etc., anti-inflammatory agents (glycyrrhetinic acid, glycyrrhetinic acid, allantoin, Salicylic acid, glycol salicylate, methyl salicylate, indomethacin, felbinac, sodium diclofenac, sodium loxoprofen), fungicide Zinc oxide, benzalkonium chloride, decalinium chloride, benzethonium chloride, cetylpyridinium chloride, isopropylmethylphenol, chlorhexidine hydrochloride, chlorhexidine gluconate, aqueous ammonia, sulfadiazine, lactic acid, phenol, etc., antipruritics (crotamiton, thiantol, etc.), skin Protective agents (collodion, castor oil, etc.), blood circulation promoting components (nonylate varnishylamide, nicotinic acid benzyl ester, capsaicin, capsicum extract, etc.), fresheners (menthol, camphor, etc.), vitamins (vitamin A, B, C, D) and mucopolysaccharides (such as sodium chondroitin sulfate and hyaluronic acid).
これらの他の薬理成分の中でも、かぶれを防止する観点、及び／又は適用時の軽い灼熱感（温感）により却って掻痒を悪化させることを防止する観点から、クロタミトンを含まないことが好ましく、（Ｂ）成分による鎮痒向上効果を効果的に得る等の観点から、グリチルレチン酸及びグリチルレチン酸塩を含まないことが好ましい。 Among these other pharmacological components, from the viewpoint of preventing rash and / or preventing pruritus from worsening due to a slight burning sensation (warming sensation) at the time of application, it is preferable that crotamiton is not contained, It is preferable that glycyrrhetinic acid and glycyrrhetinic acid be not contained from the viewpoint of effectively obtaining the antipruritic effect of the component (B).
前述する成分の他に、必要に応じて、皮膚外用剤等に通常使用される他の基剤や添加剤を含んでもよい。このような基材や添加剤としては、薬学的に許容されることを限度として特に制限されないが、例えば、水、低級アルコール（例えば、イソプロパノール）、多価アルコール（グリセリン、プロピレングリコール、ジプロピレングリコール、１，３−ブチレングリコール等）等の水性基剤；油類（オリーブ油、サフラワー油、大豆油、つばき油、とうもろこし油、なたね油、ひまわり油、綿実油、落花生油、ラード、スクワラン、魚油等）、鉱物油（流動パラフィン、パラフィン、ゲル化炭化水素、ワセリン等）、ワックス類・ロウ類（ミツロウ、カルナウバロウ、キャンデリラロウ、セレシン、ライスワックス、マイクロクリスタリンワックス等）、エステル油（ミリスチン酸イソプロピル、アジピン酸イソプロピル、セバシン酸ジエチル、セバシン酸イソプロピル、パルミチン酸イソプロピル、パルミチン酸セチル、オレイン酸エチル等）、脂肪酸アルキルエステル、脂肪酸（ステアリン酸、オレイン酸、パルミチン酸、ベヘン酸、リノール酸、ラノリン等）、脂肪酸エステル（パルミチン酸セチル、パルミチン酸イソプロピル、リノール酸エチル等）、高級アルコール（ステアリルアルコール、セタノール、ベヘニルアルコール、ミリスチルアルコール、オレイルアルコール、ヘキサデシルアルコール、ラノリンアルコール等）、コレステロール、トリ２−エチルヘキサン酸グリセリル、２−エチルヘキサン酸セチル、シリコーンオイル（ジメチルポリシロキサン、環状シリコーン等）等の油性基剤；ＰＯＥ（１０〜５０モル）フィトステロールエーテル、ＰＯＥ（１０〜５０モル）ジヒドロコレステロールエーテル、ＰＯＥ（１０〜５０モル）２−オクチルドデシルエーテル、ＰＯＥ（１０〜５０モル）デシルテトラデシルエーテル、ＰＯＥ（１０〜５０モル）オレイルエーテル、ＰＯＥ（２〜５０モル）セチルエーテル、ＰＯＥ（５〜５０モル）ベヘニルエーテル、ＰＯＥ（５〜３０モル）ポリオキシプロピレン（５〜３０モル）２−デシルテトラデシルエーテル、ＰＯＥ（１０〜５０モル）ポリオキシプロピレン（２〜３０モル）セチルエーテルなどのポリオキシエチレンアルキルエーテル、これらのリン酸・リン酸塩（ＰＯＥセチルエーテルリン酸ナトリウムなど）、ＰＯＥ（２０〜６０モル）ソルビタンモノオレート、ＰＯＥ（１０〜６０モル）ソルビタンモノイソステアレート、ＰＯＥ（１０〜８０モル）グリセリルモノイソステアレート、ＰＯＥ（１０〜３０モル）グリセリルモノステアレート、ＰＯＥ（２０〜１００モル）・ポリオキシプロピレン変性シリコーン、ＰＯＥ・アルキル変性シリコーン、モノラウリン酸ポリエチレングリコール、モノパルミチン酸ポリエチレングリコール、モノステアリン酸ポリエチレングリコール、ジラウリン酸ポリエチレングリコール、ジパルミチン酸ポリエチレングリコール、ジステアリン酸ポリエチレングリコール、ジオレイン酸ポリエチレングリコール、ジリシノレイン酸ポリエチレングリコール、ポリオキシエチレン硬化ヒマシ油（５〜１００）、ポリソルベート（２０〜８５）、グリセリン脂肪酸エステル（モノステアリン酸グリセリン等）、水素添加大豆リン脂質、水素添加ラノリンアルコール等の界面活性剤；清涼化剤（メントール、カンフル、ボルネオール、ハッカ水、ハッカ油等）、防腐剤（メチルパラベン、プロピルパラベン、安息香酸、安息香酸ナトリウム、ソルビン酸等）、着香剤（シトラール、１，８−シオネール、シトロネラール、ファルネソール等）、着色剤（タール色素（褐色２０１号、青色２０１号、黄色４号、黄色４０３号等）、カカオ色素、クロロフィル、酸化アルミニウム等）、粘稠剤（カルボキシビニルポリマー、ヒプロメロース、ポリビニルピロリドン、アルギン酸ナトリウム、エチルセルロース、ヒドロキシエチルセルロース、カルボキシメチルセルロースナトリウム、キサンタンガム、カラギーナン等）、ｐＨ調整剤（リン酸、塩酸、クエン酸、クエン酸ナトリウム、コハク酸、酒石酸、水酸化ナトリウム、水酸化カリウム、トリエタノールアミン、トリイソプロパノールアミン等）、湿潤剤（ｄｌ−ピロリドンカルボン酸ナトリウム液、Ｄ−ソルビトール液、マクロゴール等）、安定化剤（ジブチルヒドロキシトルエン、ブチルヒドロキシアニソール、エデト酸ナトリウム、メタリン酸ナトリウム、Ｌ−アルギニン、Ｌ−アスパラギン酸、ＤＬ−アラニン、グリシン、エリソルビン酸ナトリウム、没食子酸プロピル、亜硫酸ナトリウム、二酸化硫黄、クロロゲン酸、カテキン、ローズマリー抽出物等）、酸化防止剤、紫外線吸収剤、キレート剤、粘着剤、緩衝剤、溶解補助剤、可溶化剤、保存剤等の添加剤が挙げられる。 In addition to the above-mentioned components, other bases and additives usually used for external preparations for skin and the like may be contained as necessary. Such base materials and additives are not particularly limited as long as they are pharmaceutically acceptable. For example, water, lower alcohols (eg, isopropanol), polyhydric alcohols (glycerin, propylene glycol, dipropylene glycol) , Oils (olive oil, safflower oil, soybean oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, lard, squalane, fish oil, etc.) , Mineral oils (liquid paraffin, paraffin, gelled hydrocarbons, petrolatum, etc.), waxes / waxes (bee wax, carnauba wax, candelilla wax, ceresin, rice wax, microcrystalline wax, etc.), ester oils (isopropyl myristate, Isopropyl adipate, diethyl sebacate Isopropyl sebacate, isopropyl palmitate, cetyl palmitate, ethyl oleate, etc.), fatty acid alkyl esters, fatty acids (stearic acid, oleic acid, palmitic acid, behenic acid, linoleic acid, lanolin, etc.), fatty acid esters (cetyl palmitate, Isopropyl palmitate, ethyl linoleate, etc., higher alcohols (stearyl alcohol, cetanol, behenyl alcohol, myristyl alcohol, oleyl alcohol, hexadecyl alcohol, lanolin alcohol, etc.), cholesterol, glyceryl tri-2-ethylhexanoate, 2-ethylhexanoic acid Oil bases such as cetyl and silicone oil (dimethylpolysiloxane, cyclic silicone, etc.); POE (10 to 50 mol) phytosterol ether, POE (10 to 5 mol) Mol) dihydrocholesterol ether, POE (10 to 50 mol) 2-octyldodecyl ether, POE (10 to 50 mol) decyltetradecyl ether, POE (10 to 50 mol) oleyl ether, POE (2 to 50 mol) cetyl ether POE (5-50 mol) behenyl ether, POE (5-30 mol) polyoxypropylene (5-30 mol) 2-decyltetradecyl ether, POE (10-50 mol) polyoxypropylene (2-30 mol) Polyoxyethylene alkyl ethers such as cetyl ether, their phosphoric acid / phosphates (eg, POE cetyl ether sodium phosphate), POE (20 to 60 mol) sorbitan monooleate, POE (10 to 60 mol) sorbitan monoisostea Rate, POE (10-80 mol ) Glyceryl monoisostearate, POE (10 to 30 mol) glyceryl monostearate, POE (20 to 100 mol) polyoxypropylene modified silicone, POE alkyl modified silicone, polyethylene glycol monolaurate, polyethylene glycol monopalmitate, Polyethylene glycol monostearate, polyethylene glycol dilaurate, polyethylene glycol dipalmitate, polyethylene glycol distearate, polyethylene glycol dioleate, polyethylene glycol diricinoleate, polyoxyethylene hydrogenated castor oil (5-100), polysorbate (20-85) ), Glycerin fatty acid esters (such as glyceryl monostearate), hydrogenated soybean phospholipids, hydrogenated lanolin alcohol Surfactants such as menthol, camphor, borneol, peppermint water, peppermint oil, etc., preservatives (methylparaben, propylparaben, benzoic acid, sodium benzoate, sorbic acid, etc.), flavoring agents (citral) , 1,8-sionone, citronellal, farnesol, etc.), coloring agents (tar dyes (brown 201, blue 201, yellow 4, yellow 403, etc.), cocoa dyes, chlorophyll, aluminum oxide, etc.), thickeners (Carboxyvinyl polymer, hypromellose, polyvinylpyrrolidone, sodium alginate, ethylcellulose, hydroxyethylcellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, etc.), pH adjuster (phosphoric acid, hydrochloric acid, citric acid, sodium citrate, succinic acid, tartaric acid, water) Sodium hydroxide, potassium hydroxide, triethanolamine, triisopropanolamine, etc.), wetting agents (sodium dl-pyrrolidonecarboxylate solution, D-sorbitol solution, macrogol, etc.), stabilizers (dibutylhydroxytoluene, butylhydroxyanisole, Sodium edetate, sodium metaphosphate, L-arginine, L-aspartic acid, DL-alanine, glycine, sodium erysorbate, propyl gallate, sodium sulfite, sulfur dioxide, chlorogenic acid, catechin, rosemary extract, etc.), oxidation Additives such as an inhibitor, an ultraviolet absorber, a chelating agent, a pressure-sensitive adhesive, a buffer, a solubilizer, a solubilizing agent, and a preservative.
性状・製剤形態等
本発明の皮膚外用組成物の性状としては特に限定されず、水性液状組成物、水性ゲル状組成物、油性ゲル状組成物、乳化組成物等が挙げられる。この中でも、製剤安定性の観点から、好ましくは、水性ゲル状組成物、油性ゲル状組成物、乳化組成物が挙げられ、より好ましくは、乳化組成物が挙げられる。乳化組成物の乳化状態については、水中油型又は油中水型のいずれであってもよいが、ベタツキ抑制等の使用感の観点から、好ましくは水中油型が挙げられる。
The properties of the composition for external use on the skin, such as properties and formulation , are not particularly limited, and examples thereof include an aqueous liquid composition, an aqueous gel composition, an oily gel composition, and an emulsified composition. Among them, from the viewpoint of formulation stability, preferably, an aqueous gel composition, an oily gel composition, and an emulsified composition are used, and more preferably, an emulsified composition is used. The emulsified state of the emulsified composition may be either an oil-in-water type or a water-in-oil type, but is preferably an oil-in-water type from the viewpoint of feeling of use such as suppression of stickiness.
本発明の皮膚外用組成物の製剤形態については特に制限されず、例えば、ローション剤、乳液剤、軟膏剤、クリーム剤等が挙げられる。この中でも、製剤安定性の観点から、好ましくは、乳液剤、クリーム剤が挙げられる。 The formulation of the composition for external use on skin of the present invention is not particularly limited, and examples thereof include lotions, emulsions, ointments, creams and the like. Among them, from the viewpoint of formulation stability, preferably, an emulsion or a cream is used.
本発明の皮膚外用組成物としては、具体的には、医薬品、医薬部外品、化粧品等が挙げられる。これらの製剤形態の中でも、好ましくは医薬品、医薬部外品が挙げられる。 Specific examples of the composition for external use on the skin of the present invention include pharmaceuticals, quasi-drugs, and cosmetics. Among these formulation forms, pharmaceuticals and quasi-drugs are preferred.
使用方法
本発明の皮膚外用組成物は、鎮痒用途に使用することができ、痒みを感じる皮膚の部位又は掻痒を防止すべき皮膚の部位に塗布することにより使用される。本発明の皮膚外用組成物が適用される皮膚の部位における皮膚症状としては、痒みが惹起される症状であれば特に限定されないが、赤みや湿疹に対して好ましく適用される。このような赤みや湿疹は、好ましくは、蒸れ；摩擦・刺激；体重負荷等により生じる皮膚症状である。
Method of Use The composition for external use on the skin of the present invention can be used for antipruritic use, and is used by applying it to a part of the skin where itching is felt or a part of the skin where pruritus is to be prevented. The skin condition at the site of the skin to which the composition for external use of the skin of the present invention is applied is not particularly limited as long as it is a condition in which itch is induced, but is preferably applied to redness and eczema. Such redness or eczema is preferably a skin condition caused by stuffiness; friction / stimulation;
本発明の皮膚外用組成物が適用される皮膚の部位については、痒みを伴う部位、好ましくは上述の赤みや湿疹が生じやすい部位であれば特に限定されない。具体的には、蒸れ；摩擦・刺激；体重負荷等を繰り返し受けやすい、臀部及び大腿部、より好ましくは臀部と大腿部との境界近傍が挙げられる。 The skin site to which the composition for external use of the skin of the present invention is applied is not particularly limited as long as it is a site with itch, preferably a site where the above-mentioned redness or eczema is likely to occur. Specific examples include a gluteal region and a thigh region, and more preferably a region near the boundary between the gluteal region and the thigh region, which is susceptible to repeated heat, friction, irritation, and weight load.
本発明の皮膚外用組成物は、皮膚部位１００ｃｍ2当たり、例えば０．１〜０．５ｇを、１日に１〜２回塗布することで適用することができる。 The composition for external use on skin of the present invention can be applied by applying, for example, 0.1 to 0.5 g per 100 cm 2 of the skin site once or twice a day.
本発明の皮膚外用組成物を塗布した皮膚部位では、速やかに鎮痒効果を生じ、さらに、掻痒刺激を防止するとともにウフェナマートが本来有する消炎効果も相まって、痒みを生じていた皮膚症状も改善することができる。 In the skin site to which the composition for external use of the skin of the present invention is applied, an antipruritic effect is promptly generated, and further, it is possible to prevent the stimulus of pruritus and to improve the skin symptom that has caused itching, in combination with the anti-inflammatory effect inherent to ufenamate. it can.
２．鎮痒効果向上方法
更に、本発明はジフェンヒドラミン類を含む皮膚外用組成物の鎮痒効果を向上させる方法を提供する。鎮痒効果の向上とは、ジフェンヒドラミン及び／又はその塩を単独で含む場合に比べて、より早い段階で鎮痒効果が発現すること、並びに／若しくは、少なくとも、皮膚外用組成物の適用後の適用後の初期段階（例えば１５分以内、好ましくは１０分以内、より好ましくは５分以内）において、ジフェンヒドラミン及び／又はその塩を単独で含む場合に比べて鎮痒効果が増強されていることをいう。
2. Method for Improving Antipruritic Effect Further, the present invention provides a method for improving the antipruritic effect of an external composition for skin containing diphenhydramines. The improvement of the antipruritic effect means that the antipruritic effect is expressed at an earlier stage as compared with the case where diphenhydramine and / or a salt thereof is solely contained, and / or at least after application after application of the skin external composition. In the initial stage (for example, within 15 minutes, preferably within 10 minutes, more preferably within 5 minutes), it means that the antipruritic effect is enhanced as compared with the case where diphenhydramine and / or a salt thereof are contained alone.
具体的には、本発明の鎮痒効果向上方法は、皮膚外用組成物に、（Ａ）ジフェンヒドラミン及び／又はその塩とともに（Ｂ）ウフェナマートを配合することを特徴とする。本発明の鎮痒効果向上方法において、使用される成分の種類や配合量、皮膚外用組成物の性状・製剤形態、使用方法等については、前記「１．皮膚外用組成物」の欄に記載の通りである。 Specifically, the method for improving the antipruritic effect of the present invention is characterized in that (B) ufenamate is blended with (A) diphenhydramine and / or a salt thereof in a composition for external use on the skin. In the method for improving the antipruritic effect of the present invention, the type and amount of the components used, the properties and formulation of the composition for external use on the skin, the method of use, and the like are as described in the above-mentioned “1. Composition for external use on the skin”. It is.
以下に実施例を示して本発明をより具体的に説明するが、本発明はこれらに限定されるものではない。 Hereinafter, the present invention will be described more specifically with reference to Examples, but the present invention is not limited thereto.
試験例１
表１に示す組成の皮膚外用組成物を調製し、掻痒惹起物質を投与して作製した掻痒モデルマウスに適用し、掻痒試験を行った。掻痒試験では、マウスの掻き動作の回数をカウントすることで鎮痒効果を評価した。掻痒モデルマウス、適用方法及び掻き動作回数のカウント方法の詳細は以下の通りである。
Test example 1
A skin external composition having the composition shown in Table 1 was prepared, applied to a pruritus model mouse prepared by administering a pruritus-inducing substance, and subjected to a pruritus test. In the pruritus test, the antipruritic effect was evaluated by counting the number of times of scratching of the mouse. The details of the pruritus model mouse, the application method, and the method of counting the number of times of the scratching operation are as follows.
・掻痒モデルマウス
使用動物
種 マウス
系統 Slc：ＩＣＲ
週齢 ５週齢
入手元 日本エスエルシー（株）
掻痒惹起物質の投与
掻痒惹起物質 Ｃｏｍｐｏｕｎｄ ４８／８０
入手元 Ｓｉｇｍａ−Ａｌｄｒｉｃｈ Ｃｏ．
投与経路 皮内投与
投与用量 ５０μｇ／ｓｉｔｅ
投与方法 ガラス製注射筒（（株）トップ）及び３０Ｇニードル（（株）デントロニクス）を用いて、剃毛し皮膚外用組成物を塗布した直後の背部に投与した。
投与回数 １回
-Pruritus model mouse Animal species Mouse strain Slc: ICR
5 weeks of age Source: Japan SLC, Inc.
Administration of pruritus-inducing substance Pruritic-inducing compound Compound 48/80
Source Sigma-Aldrich Co.
Administration route Intradermal administration Administration dose 50μg / site
Administration method Using a glass syringe (Top Co., Ltd.) and a 30G needle (Dentronix Co., Ltd.), the composition was shaved and administered to the back immediately after the skin external composition was applied.
1 dose
・皮膚外用組成物の適用
投与経路 塗布
投与用量 １００ｍｇ／マウス
投与方法 掻痒惹起物質投与直前に、ゴム手袋をした指で、剃毛した背部全体に塗り広げた。
投与回数 １回
-Application of the composition for external use on the skin Administration route Application Application dose 100 mg / mouse Administration method Immediately before administration of the pruritus-inducing substance, it was spread over the shaved back with a finger wearing a rubber glove.
1 dose
・掻き動作のカウント
Windows Media Player（バージョン：12.0.7601.23517）によりビデオ映像中のマウスの行動を観察し、マウス後肢によるマウスの背部への掻き動作を、掻痒惹起物質投与直後〜掻痒惹起物質投与後５分経過時の間と、掻痒惹起物質投与直後〜掻痒惹起物質投与後１５分経過時とで、何回行ったかをカウントした。掻き動作の回数は、マウスが引っ掻くために後肢を上げ、引っ掻き行動を行って再び後肢を下す一連の動作を完了した時点で１回とした。カウントには連式数取器（DS-404：高野計器（株））を使用し、映像が途中で切れていないことを映像中のタイマー表示で確認した。掻き動作のカウント結果を表１及び図１に示す。
・ Counting of scraping operation
The behavior of the mouse in the video image was observed using Windows Media Player (version: 12.0.7601.23517), and the scratching of the back of the mouse by the hind leg of the mouse was performed immediately after administration of the pruritus-inducing substance to 5 minutes after administration of the pruritus-inducing substance. The number of times was counted from immediately after administration of the pruritus-inducing substance to 15 minutes after administration of the pruritus-inducing substance. The number of times of the scratching operation was one when the mouse lifted its hind limbs to scratch, performed a scratching action, and completed a series of operations to lower the hind limbs again. A continuous tally counter (DS-404: Takano Keiki Co., Ltd.) was used for counting, and the timer display in the video confirmed that the video was not cut off halfway. Table 1 and FIG. 1 show the count results of the scraping operation.
表１及び図１に示されるように、ジフェンヒドラミン単独の場合（比較例１）では、ジフェンヒドラミン自体が鎮痒効果を生じさせる成分であるにもかかわらず、惹起後５分間という短い時間では掻き動作回数が多く、鎮痒効果を発揮できなかった。また、ウフェナマート単独の場合（比較例２）も掻き動作回数が多く、鎮痒効果を発揮できなかった。ジフェンヒドラミンに、鎮痒効果のある局所麻酔剤リドカインを組み合わせた場合（比較例３）、掻き動作回数は若干低減したものの、その程度は十分とはいえないものであった。そして、比較例１〜３のいずれも、コントロールとして皮膚外用組成物の代わりにワセリンを塗布した場合に比べて掻き動作回数が多く、却って掻痒が悪化していた。 As shown in Table 1 and FIG. 1, in the case of diphenhydramine alone (Comparative Example 1), despite the fact that diphenhydramine itself is a component producing an antipruritic effect, the number of times of the scraping operation is as short as 5 minutes after the induction. Many did not exhibit the antipruritic effect. Also, in the case of ufenamate alone (Comparative Example 2), the number of times of the scraping operation was large, and the antipruritic effect could not be exhibited. When the local anesthetic lidocaine having an antipruritic effect was combined with diphenhydramine (Comparative Example 3), the number of times of the scraping operation was slightly reduced, but the degree was not sufficient. Further, in all of Comparative Examples 1 to 3, the number of times of the scraping operation was larger than that in the case where Vaseline was applied instead of the composition for external use as a control, and the pruritus worsened.
これに対して、ジフェンヒドラミンにウフェナマートを併用した場合（実施例１）では、大幅に掻き動作回数の低減が認められた。この低減の程度は、ジフェンヒドラミンにリドカインを組み合わせた場合（比較例３）よりも顕著であった。また、実施例１における掻き動作回数は、上記コントロールの場合よりも低減されており、鎮痒効果が適用後速やかに発揮されることが確認できた。つまり、ジフェンヒドラミンにウフェナマートを組み合わせて配合した本発明の皮膚外用組成物は、ウフェナマートが単独では鎮痒効果が無いにも関わらず、鎮痒効果のある局所麻酔剤リドカインを組み合わせた場合（比較例３）よりも顕著に鎮痒効果を向上でき、しかもそのような効果を適用後速やかに発揮できるという予想外の効果を奏することが分かった。 On the other hand, in the case where diphenhydramine was used in combination with ufenamate (Example 1), the number of times of the scraping operation was significantly reduced. The degree of this reduction was more remarkable than the case where lidocaine was combined with diphenhydramine (Comparative Example 3). In addition, the number of times of the scraping operation in Example 1 was reduced as compared with the case of the control, and it was confirmed that the antipruritic effect was quickly exhibited after application. That is, the composition for external use of the skin of the present invention in which diphenhydramine is combined with ufenamate is more effective than the case where the local anesthetic lidocaine, which has an antipruritic effect, is combined, even though ufenamate alone has no antipruritic effect (Comparative Example 3). It was also found that the antipruritic effect was remarkably improved, and that such an effect was exhibited immediately after application, which was an unexpected effect.
試験例２
表２に示す組成の皮膚外用組成物を水中油型乳化組成物として調製した。調製した皮膚外用組成物を、臀部と大腿部との境界近傍に赤み及び湿疹の皮膚症状と当該部位の痒みを訴える対象者に対して適用した。塗布量としては、１００ｃｍ2当たり約０．２ｇとし、塗布頻度としては、１日に２回とした。その結果、塗布後５分くらいから痒みの低減を実感した。さらに、塗布後２時間くらいには、赤い及び湿疹の皮膚症状の改善傾向も認められた。
Test example 2
An external composition for skin having the composition shown in Table 2 was prepared as an oil-in-water emulsion composition. The prepared skin external composition was applied to a subject who complained of skin symptoms of redness and eczema near the boundary between the buttocks and the thighs and itching at the site. The application amount was about 0.2 g per 100 cm 2 , and the application frequency was twice a day. As a result, it was felt that itching was reduced about 5 minutes after application. Further, about 2 hours after the application, there was also a tendency to improve the skin symptoms of red and eczema.
Claims (3)
皮膚外用組成物に、前記（Ａ）成分とともに（Ｂ）ウフェナマートを配合する、鎮痒効果向上方法。 (A) A method for improving an antipruritic effect in a skin external composition containing diphenhydramine and / or a salt thereof,
A method for improving an antipruritic effect, comprising mixing (B) ufenamate with the above-mentioned component (A) in a composition for external use on the skin.
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