JP2022042517A - Topical composition for scalp - Google Patents
Topical composition for scalp Download PDFInfo
- Publication number
- JP2022042517A JP2022042517A JP2021210974A JP2021210974A JP2022042517A JP 2022042517 A JP2022042517 A JP 2022042517A JP 2021210974 A JP2021210974 A JP 2021210974A JP 2021210974 A JP2021210974 A JP 2021210974A JP 2022042517 A JP2022042517 A JP 2022042517A
- Authority
- JP
- Japan
- Prior art keywords
- scalp
- external composition
- hair
- acid
- composition
- 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
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- 229940074404 sodium succinate Drugs 0.000 description 1
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- 229910052938 sodium sulfate Inorganic materials 0.000 description 1
- 235000011152 sodium sulphate Nutrition 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- DSOWAKKSGYUMTF-GZOLSCHFSA-M sodium;(1e)-1-(6-methyl-2,4-dioxopyran-3-ylidene)ethanolate Chemical compound [Na+].C\C([O-])=C1/C(=O)OC(C)=CC1=O DSOWAKKSGYUMTF-GZOLSCHFSA-M 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 229940057429 sorbitan isostearate Drugs 0.000 description 1
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- 230000007480 spreading Effects 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 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 description 1
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- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 description 1
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- 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
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Images
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- Cosmetics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
本発明は、頭皮用外用組成物に関する。より具体的には、軟質多孔性材料で形成された塗布部を備える容器に収容されてなる頭皮用外用組成物に関する。 The present invention relates to an external composition for the scalp. More specifically, the present invention relates to an external composition for scalp, which is contained in a container having a coating portion made of a soft porous material.
ヒトを始めとする哺乳動物の皮膚は、表皮、真皮及び皮下組織から構成され、そこに毛包、汗腺及び脂腺等の皮膚付属器官が存在する構造をしている。 The skin of mammals including humans is composed of epidermis, dermis and subcutaneous tissue, and has a structure in which skin appendages such as hair follicles, sweat glands and sebaceous glands are present.
ヒトの皮膚には多数の毛包が存在するが、部位によって毛包の密度及び深さは大きく異なる(非特許文献1)。ヒトの皮膚の大部分を占める腹部、腕及び下腿大腿の毛包は、毛包密度が60~80個/cm2と低く、深度は浅い傾向があることが知られている。一方、ヒトの頭皮の毛包は、毛包密度が350~500個/cm2と非常に高くて深度が深い。また、腹部等の毛包は表面に対してやや大きく傾斜した構造をしているのに対して、頭皮の毛包は、皮膚の表面から下に向かって比較的まっすぐ長い構造をしていることが知られている。 There are many hair follicles on human skin, but the density and depth of the hair follicles vary greatly depending on the site (Non-Patent Document 1). It is known that the hair follicles of the abdomen, arms and lower thighs, which occupy most of the human skin, tend to have a low hair follicle density of 60 to 80 hair follicles / cm 2 and a shallow depth. On the other hand, the hair follicles of the human scalp have a very high hair follicle density of 350 to 500 hair follicles / cm 2 and a deep depth. In addition, the hair follicles such as the abdomen have a structure that is slightly inclined with respect to the surface, whereas the hair follicles on the scalp have a relatively straight and long structure from the surface of the skin to the bottom. It has been known.
経皮的に薬物等の有効成分を投与・適用する場合、皮膚を介した有効成分の透過経路としては、表皮の角層を透過するルートと、毛包等の皮膚付属器官を介したルートが知られている。角層は皮膚表面積の大部分を占めるため適用部位は広いが、大きな成分は透過しにくいなどの問題がある。一方で、毛包等の皮膚付属器官は皮膚表面積に占める割合自体は低いものの、角層ルートよりも透過抵抗が低い場合が多いというメリットがある。 When the active ingredient such as a drug is administered and applied percutaneously, the route through which the active ingredient penetrates through the skin includes the route through the stratum corneum of the epidermis and the route through the skin appendages such as hair follicles. Are known. Since the stratum corneum occupies most of the surface area of the skin, the application site is wide, but there are problems such as difficulty in permeating large components. On the other hand, although the ratio of skin appendages such as hair follicles to the surface area of the skin is low, there is an advantage that the permeation resistance is often lower than that of the stratum corneum root.
頭皮に適用される外用組成物として、頭皮で痒み等の症状を引き起こす頭皮湿疹の治療剤及び改善剤、養毛剤並びに育毛剤等がある。頭皮湿疹は、その原因の一つとして、頭皮の毛包等におけるマラセチア属真菌(Malassezia)の過剰増殖が指摘されている。育毛剤及び養毛剤は、毛包深部に存在する毛母細胞、並びにその下を通る真皮及び皮下組織の毛細血管の血流まで充分な量の有効成分を送達させることが望まれる製剤である。また、頭皮の乾燥及びバリア機能低下は頭皮環境を悪化させ、フケ及び痒み、並びに薄毛等の原因となるため、早期に予防又は改善することが望まれる状態である。このような外用組成物はいずれも、頭皮そしてその毛包深部まで有効成分を送達させることが有益であると期待される。 As an external composition applied to the scalp, there are a therapeutic agent and an ameliorating agent for scalp eczema that cause symptoms such as itching in the scalp, a hair nourishing agent, a hair growth agent and the like. It has been pointed out that one of the causes of scalp eczema is the overgrowth of Malassezia fungus in the hair follicles of the scalp. Hair growth agents and hair nourishing agents are formulations that are desired to deliver a sufficient amount of the active ingredient to the blood flow of the hair matrix cells existing in the deep part of the hair follicle and the capillaries of the dermis and the subcutaneous tissue passing under the hair follicle cells. In addition, dryness of the scalp and deterioration of the barrier function worsen the scalp environment and cause dandruff, itchiness, thinning hair, etc., and therefore, it is desired to prevent or improve the scalp at an early stage. Any such external composition is expected to benefit from delivering the active ingredient to the scalp and deep into its hair follicles.
しかしながら、頭皮に外用組成物を適用する場合、毛髪が邪魔をして、充分な量の外用組成物を頭皮そしてその毛包深部まで送達し難くなることが懸念される。そこで毛髪を避けて外用組成物を頭皮に適用するために、噴霧状に外用組成物を吐出するスプレータイプの容器を採用すること、及び開口部を押し当てた部位にピンポイントで外用組成物を吐出するタイプの容器(いわゆる液体用細口容器。図4参照)を採用することが主流となっている。 However, when applying the external composition to the scalp, there is a concern that the hair may interfere and it may be difficult to deliver a sufficient amount of the external composition to the scalp and the deep part of the hair follicle. Therefore, in order to avoid hair and apply the external composition to the scalp, a spray-type container that discharges the external composition in the form of a spray should be adopted, and the external composition should be pinpointed to the site where the opening is pressed. It is the mainstream to adopt a discharge type container (so-called narrow mouth container for liquid, see FIG. 4).
本発明は、頭皮そしてその毛包深部への送達効率が向上した頭皮用外用組成物の提供を目的とする。 An object of the present invention is to provide an external composition for scalp with improved delivery efficiency to the scalp and the deep part of the hair follicle.
本発明者等は、低級アルコールを含有する外用組成物を収容する容器として、軟質多孔性材料で形成された塗布部を押し当てて、又は押し当てながら塗り広げて外用組成物を面状に吐出するタイプの容器を採用することで、意外にも頭皮の毛包深部への当該外用組成物の送達効率が向上することを見出した。本発明はこの新規な知見に基づく。 The present inventors, as a container for accommodating an external composition containing a lower alcohol, press or spread a coating portion made of a soft porous material while pressing the coating portion, and discharge the external composition in a planar manner. It has been found that the efficiency of delivery of the external composition to the deep part of the hair follicle of the scalp is unexpectedly improved by adopting the container of the type. The present invention is based on this novel finding.
本発明は、例えば、以下の各発明に関する。
[1]低級アルコールを含有し、軟質多孔性材料で形成された塗布部を備える容器に収容されてなる頭皮用外用組成物。
[2]発毛部位に対して用いられる、[1]に記載の頭皮用外用組成物。
[3]上記低級アルコールの含有量が、外用組成物全量を基準として5~70w/w%である、[1]又は[2]に記載の頭皮用外用組成物。
[4]頭皮における湿疹、皮膚炎、抜け毛、薄毛、フケ、痒み、乾燥及びバリア機能低下からなる群より選択される少なくとも1つの症状の予防、治療、及び/又は改善用である、[1]~[3]のいずれかに記載の頭皮用外用組成物。
[5]上記低級アルコールが、エタノールである、[1]~[4]のいずれかに記載の頭皮用外用組成物。
[6]可溶化系の組成物である、[1]~[5]のいずれかに記載の頭皮用外用組成物。
[7]ステロイド、モノテルペン、及び抗ヒスタミン成分からなる群より選択される少なくとも1種を更に含有する、[1]~[6]のいずれかに記載の頭皮用外用組成物。
[8]増粘剤を更に含有する、[1]~[7]のいずれかに記載の頭皮用外用組成物。
[9]低級アルコールを含有する頭皮用外用組成物が、軟質多孔性材料で形成された塗布部を備える容器に収容された、容器入り頭皮用外用組成物。
The present invention relates to, for example, the following inventions.
[1] An external composition for the scalp, which contains a lower alcohol and is contained in a container having a coating portion formed of a soft porous material.
[2] The external composition for scalp according to [1], which is used for a hair growth site.
[3] The external composition for scalp according to [1] or [2], wherein the content of the lower alcohol is 5 to 70 w / w% based on the total amount of the external composition.
[4] For prevention, treatment, and / or improvement of at least one symptom selected from the group consisting of eczema, dermatitis, hair loss, thinning hair, dandruff, itching, dryness, and decreased barrier function in the scalp, [1]. The composition for external use for the scalp according to any one of [3].
[5] The composition for external use on the scalp according to any one of [1] to [4], wherein the lower alcohol is ethanol.
[6] The external composition for scalp according to any one of [1] to [5], which is a solubilizing composition.
[7] The external composition for scalp according to any one of [1] to [6], further containing at least one selected from the group consisting of steroids, monoterpenes, and antihistamine components.
[8] The external composition for scalp according to any one of [1] to [7], which further contains a thickener.
[9] A container-containing external composition for scalp, wherein the external composition for scalp containing a lower alcohol is housed in a container having a coating portion formed of a soft porous material.
本発明によれば、低級アルコールを含有する外用組成物を収容する容器として、軟質多孔性材料で形成された塗布部を備える容器を採用しているため、頭皮の毛包深部への当該外用組成物の送達効率が向上する。当該容器は、塗布部を適用部位に押し当てて、又は押し当てながら塗り広げて容器内の外用組成物を面状に吐出するタイプの容器であることから、毛髪を避けて頭皮に直接外用組成物を適用することが難しく、頭皮用外用組成物を収容する容器としては適していないと考えられていた。すなわち、頭皮の毛包深部への外用組成物の送達効率が向上するという本発明による効果は、全く意外なものである。 According to the present invention, as a container for accommodating an external composition containing a lower alcohol, a container having a coating portion formed of a soft porous material is adopted, so that the external composition for the deep part of the hair follicle of the scalp is adopted. The delivery efficiency of goods is improved. Since the container is a type of container in which the applied portion is pressed against the application site or spread while being pressed to discharge the external composition in the container in a planar manner, the external composition is directly applied to the scalp while avoiding hair. It was considered difficult to apply the substance and it was not suitable as a container for containing an external composition for scalp. That is, the effect of the present invention on improving the delivery efficiency of the external composition to the deep part of the hair follicle of the scalp is completely surprising.
以下、本発明を実施するための形態について詳細に説明する。ただし、本発明は以下の実施形態に限定されるものではない。 Hereinafter, embodiments for carrying out the present invention will be described in detail. However, the present invention is not limited to the following embodiments.
本発明の頭皮用外用組成物は、低級アルコールを含有する。また、本発明の頭皮用外用組成物は、軟質多孔性材料で形成された塗布部を備える容器に収容されてなる。 The external composition for scalp of the present invention contains a lower alcohol. Further, the external composition for scalp of the present invention is contained in a container provided with a coating portion made of a soft porous material.
〔容器〕
図1は、一実施形態に係る容器を示す斜視図である。当該容器は、軟質多孔性塗布部を備えた液体塗布用栓式容器等と呼ばれるものである。図1に示す軟質多孔性塗布部を備えた液体塗布用栓式容器100は、外用組成物20を貯える容器本体10と、容器本体10に着脱自在に螺嵌されるキャップ30とを備える。キャップ30は、断面が略逆U字形に形成され、内周面には螺子が形成されている。この螺子が容器本体10の螺子40と螺合する。容器本体10には、外用組成物20を吐出する塗布部50が形成されている。塗布部50は、容器本体10と一体に成形されていてもよいし、また着脱自在に構成されていてもよい。
〔container〕
FIG. 1 is a perspective view showing a container according to an embodiment. The container is called a liquid coating stopper type container or the like provided with a soft porous coating portion. The liquid coating plug-
塗布部50は、軟質多孔性材料で形成される。本明細書において、「軟質多孔性材料で形成される」とは、塗布部の少なくとも一部(好ましくは約70%以上、より好ましくは約80%以上、更に好ましくは約90%以上、なかでも好ましくは全体)が軟質多孔性材で構成されることをいう。軟質多孔性材料は、皮膚に適用するのに適した軟らかさを有し、多数の細孔を有する多孔質の材料であって、容器内部の外用組成物が容器外部に排出されるものであればよい。軟質多孔性材料の構造は、スポンジ構造、バルーン構造、ハニカム構造等のいずれであってもよい。細孔の孔径は、外用組成物をより効率よく塗布することができるという観点から、1mm以下であることが好ましく、0.7mm以下であることがより好ましく、0.5mm以下であることが更に好ましく、0.3mm以下であることが更により好ましい。また、細孔の孔径は0.01μm以上であることが好ましく、0.1μm以上であることがより好ましく、1μm以上であることが更に好ましい。
The
軟質多孔性材料の具体例として、例えば、連続気泡構造を有する樹脂発泡体を挙げることができる。当該樹脂発泡体は、独立気泡構造を含んでいてもよい。樹脂発泡体の具体例としては、天然ゴム発泡体;ポリウレタン発泡体、ポリスチレン発泡体、ポリプロピレン発泡体、ポリエチレン発泡体等の合成ゴム発泡体;メラミン樹脂発泡体等が挙げられる。樹脂発泡体としては、本発明による効果をより一層顕著に奏することから、天然ゴム発泡体、合成ゴム発泡体が好ましく、天然ゴム発泡体、ポリウレタン発泡体(例えば、軟質ウレタン)がより好ましく、天然ゴム発泡体が更に好ましい。塗布部50は、これら軟質多孔性材料を1種単独で使用して形成されたものであってもよく、2種以上を組み合わせて使用して形成されたものであってもよい。
Specific examples of the soft porous material include a resin foam having an open cell structure. The resin foam may contain a closed cell structure. Specific examples of the resin foam include natural rubber foam; synthetic rubber foam such as polyurethane foam, polystyrene foam, polypropylene foam, and polyethylene foam; and melamine resin foam. As the resin foam, natural rubber foam and synthetic rubber foam are preferable, natural rubber foam and polyurethane foam (for example, soft urethane) are more preferable, and natural rubber foam is preferable because the effect of the present invention is more remarkably exhibited. Rubber foam is more preferred. The
容器本体10及びキャップ30を形成する材料としては、例えば、ポリエチレンテレフタレート(PET)、ポリプロピレン(PP)、ポリエチレン(高密度ポリエチレン:HDPE、低密度ポリエチレン:LDPE)、ポリスチレン、ガラス、アルミニウム等の金属が挙げられる。これらは1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。また、容器本体10とキャップ30は、同一の材料で形成されていてもよく、また異なる材料で形成されていてもよい。
Examples of the material forming the
容器本体10の形状は、軟質多孔性材料で形成された塗布部を備えるものであれば、図1に示す形状に限定されるものではなく、例えば、塗布部が横向き、下向き、やや上方又は下方に傾斜した向きになるように曲げられた形状を有していてもよい。キャップ30は容器本体10と着脱自在であれば、螺嵌構造に限定されず、例えば、ワンタッチロック嵌合、外嵌等の任意の嵌合構造を有していてもよい。
The shape of the
〔組成物〕
本実施形態に係る頭皮用外用組成物は、低級アルコールを含有する。本明細書において、低級アルコールとは、炭素数1~6の1価のアルコールを意味する。
〔Composition〕
The external composition for scalp according to this embodiment contains a lower alcohol. As used herein, the lower alcohol means a monohydric alcohol having 1 to 6 carbon atoms.
低級アルコールは、生理学的又は薬学的に許容できるものであれば特に制限されない。低級アルコールの具体例として、例えば、エタノール、プロパノール、イソプロパノール、n-ブチルアルコール、s-ブチルアルコール、t-ブチルアルコール、イソブチルアルコール、ペンチルアルコール及びヘキシルアルコールが挙げられる。本発明による効果をより一層顕著に奏するという観点から、低級アルコールは、エタノール、プロパノール、イソプロパノール、n-ブチルアルコール、s-ブチルアルコール、t-ブチルアルコール及びイソブチルアルコールであることが好ましく、エタノール及びイソプロパノールであることがより好ましく、エタノールであることが更に好ましい。低級アルコールは、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The lower alcohol is not particularly limited as long as it is physiologically or pharmaceutically acceptable. Specific examples of the lower alcohol include ethanol, propanol, isopropanol, n-butyl alcohol, s-butyl alcohol, t-butyl alcohol, isobutyl alcohol, pentyl alcohol and hexyl alcohol. From the viewpoint of exerting the effect of the present invention more remarkably, the lower alcohol is preferably ethanol, propanol, isopropanol, n-butyl alcohol, s-butyl alcohol, t-butyl alcohol and isobutyl alcohol, and ethanol and isopropanol are preferable. Is more preferable, and ethanol is even more preferable. The lower alcohol may be used alone or in combination of two or more.
頭皮用外用組成物における低級アルコールの含有量は、本発明による効果をより一層顕著に奏することから、外用組成物全量を基準として、5~70w/w%であることが好ましく、5~50w/w%であることがより好ましく、10~50w/w%が更に好ましく、30~50w/w%であることが更により好ましい。 The content of the lower alcohol in the external composition for scalp is preferably 5 to 70 w / w% based on the total amount of the external composition, and is preferably 5 to 50 w /, because the effect of the present invention is more remarkable. It is more preferably w%, further preferably 10 to 50 w / w%, and even more preferably 30 to 50 w / w%.
本実施形態に係る頭皮用外用組成物は、医薬品、医薬部外品又は化粧品に使用される有効成分又は機能性成分を更に含んでいてもよい。有効成分又は機能性成分の具体例としては、例えば、ステロイド、保湿成分、抗炎症成分、抗ヒスタミン成分、抗菌成分、ビタミン類、鎮痒成分、局所麻酔成分、局所刺激成分、養毛・育毛成分、モノテルペン、ペプチド又はその誘導体、アミノ酸又はその誘導体、細胞賦活化成分、老化防止成分、血行促進成分、角質軟化成分、美白成分、収斂成分、紫外線防御成分(紫外線吸収成分、紫外線散乱成分)が挙げられる。これらを含有することにより、その有効成分又は機能性成分に応じた用途展開が可能となる。これらの有効成分又は機能性成分は、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The external composition for scalp according to the present embodiment may further contain an active ingredient or a functional ingredient used in pharmaceutical products, quasi-drugs or cosmetics. Specific examples of the active ingredient or functional ingredient include steroids, moisturizing ingredients, anti-inflammatory ingredients, anti-histamine ingredients, antibacterial ingredients, vitamins, antipruritic ingredients, local anesthetic ingredients, local stimulant ingredients, hair-growth / hair-growth ingredients, and the like. Monoterpen, peptide or its derivative, amino acid or its derivative, cell activation component, anti-aging component, blood circulation promoting component, keratin softening component, whitening component, convergence component, ultraviolet protection component (ultraviolet absorption component, ultraviolet scattering component) Be done. By containing these, it is possible to develop applications according to the active ingredient or the functional ingredient. These active ingredients or functional ingredients may be used alone or in combination of two or more.
本実施形態に係る頭皮用外用組成物は、上記有効成分又は機能性成分に応じて、例えば、頭皮における湿疹、皮膚炎、抜け毛、薄毛、フケ、痒み、乾燥及びバリア機能低下からなる群より選択される少なくとも1つの症状の予防、治療、及び/又は改善用として好適に用いられる。本発明の頭皮用外用組成物は、頭皮の毛包深部への有効成分又は機能性成分の送達効率が向上するので、これらの成分の所期の効果を十分に発揮させることができる。 The external composition for scalp according to the present embodiment is selected from the group consisting of, for example, eczema, dermatitis, hair loss, thinning hair, dandruff, itch, dryness and deterioration of barrier function in the scalp, depending on the above active ingredient or functional ingredient. It is suitably used for the prevention, treatment and / or amelioration of at least one symptom. Since the external composition for scalp of the present invention improves the efficiency of delivery of the active ingredient or the functional ingredient to the deep part of the hair follicle of the scalp, the desired effect of these ingredients can be fully exerted.
本実施形態に係る頭皮用外用組成物は、ステロイド、モノテルペン、及び抗ヒスタミン成分からなる群より選択される少なくとも1種を更に含有していてもよい。頭皮用外用組成物がステロイド、モノテルペン、又は抗ヒスタミン成分を含むことにより、頭皮及びその毛包深部への送達効率がより一層向上する。また、ステロイド、モノテルペン、又は抗ヒスタミン成分による作用に応じた用途展開が可能となる。 The external composition for scalp according to the present embodiment may further contain at least one selected from the group consisting of steroids, monoterpenes, and antihistamine components. When the external composition for scalp contains a steroid, a monoterpene, or an antihistamine component, the efficiency of delivery to the scalp and the deep part of the hair follicle is further improved. In addition, it is possible to develop applications according to the action of steroids, monoterpenes, or antihistamine components.
ステロイドは、ステロイド核を有するステロイドホルモン及びその誘導体、並びにこれらの塩であって、抗炎症作用、免疫抑制作用、抗アレルギー作用等を有するものである。ステロイドは、ステロイド系抗炎症薬とも称される。ステロイドは、市販のものを用いることもできる。 Steroids are steroid hormones having a steroid nucleus, derivatives thereof, and salts thereof, which have anti-inflammatory, immunosuppressive, anti-allergic, and the like. Steroids are also called steroidal anti-inflammatory drugs. Commercially available steroids can also be used.
ステロイドホルモンの誘導体としては、ステロイドホルモンの官能基の一部を化学修飾したもの、官能基の一部に保護基を付加したもの等をいい、異性体を含むものである。例えば、ステロイド核の一つ又はそれ以上の水素原子が、ヒドロキシル基、アミノ基、クロロ基、ブロモ基、ヨード基、フルオロ基、トリフルオロ基、ニトロ基、シアノ基、カルボキシル基、炭素数1~6のアルキル基、炭素数2~6のアセチル基、炭素数6~10のアリール基、炭素数2~6のアルキニル基、炭素数2~6のアルケニル基、炭素数1~6のアルコキシル基、炭素数1~6のアルキルアミノ基等に置換されたもの、有機酸(例えば、吉草酸、酢酸、酪酸、プロピオン酸、フランカルボン酸等)でエステル化されたもの、保護基が外れることによりステロイド系抗炎症薬としての活性を有するように修飾された前駆体等が挙げられる。 The derivative of the steroid hormone refers to a product obtained by chemically modifying a part of the functional group of the steroid hormone, a product having a protective group added to a part of the functional group, or the like, and includes an isomer. For example, one or more hydrogen atoms in the steroid nucleus are a hydroxyl group, an amino group, a chloro group, a bromo group, an iodine group, a fluoro group, a trifluoro group, a nitro group, a cyano group, a carboxyl group, and 1 to 1 carbon atoms. 6 alkyl groups, 2 to 6 carbon acetyl groups, 6 to 10 carbon aryl groups, 2 to 6 carbon alkynyl groups, 2 to 6 carbon alkenyl groups, 1 to 6 carbon alkoxyl groups, Those substituted with an alkylamino group having 1 to 6 carbon atoms, those esterified with an organic acid (for example, valeric acid, acetic acid, butyric acid, propionic acid, furancarboxylic acid, etc.), steroids by removing the protective group. Examples thereof include precursors modified to have activity as a system anti-inflammatory agent.
ステロイドホルモン及びその誘導体の塩としては、生理学的又は薬学的に許容できるものであれば特に制限されない。具体的には、アルカリ金属塩、アルカリ土類金属塩、有機塩基等との塩が例示され、ナトリウム、カリウム、カルシウム、マグネシウム、アンモニウム、ジエタノールアミン、エチレンジアミン等との塩が挙げられる。さらには、アンモニア、メチルアミン、ジメチルアミン、トリメチルアミン、ジシクロヘキシルアミン、トリス(ヒドロキシメチル)アミノメタン、N,N-ビス(ヒドロキシエチル)ピペラジン、2-アミノ-2-メチル-1-プロパノール、エタノールアミン、N-メチルグルカミン、L-グルカミン等のアミンとの塩;リジン、δ-ヒドロキシリジン、アルギニン等の塩基性アミノ酸との塩が挙げられる。また、例えば、塩酸、臭化水素酸、硫酸、硝酸、リン酸等の鉱酸との塩;メタンスルホン酸、ベンゼンスルホン酸、パラトルエンスルホン酸、酢酸、プロピオン酸、酒石酸、フマル酸、マレイン酸、リンゴ酸、シュウ酸、コハク酸、吉草酸、クエン酸、安息香酸、マンデル酸、ケイ皮酸、乳酸、グリコール酸、グルクロン酸、アスコルビン酸、ニコチン酸、サリチル酸等の有機酸との塩;アスパラギン酸、グルタミン酸等の酸性アミノ酸との塩も挙げられる。ステロイドホルモン及びその誘導体の塩は、溶媒和物又は水和物であってもよい。 The salt of the steroid hormone and its derivative is not particularly limited as long as it is physiologically or pharmaceutically acceptable. Specific examples thereof include salts with alkali metal salts, alkaline earth metal salts, organic bases and the like, and examples thereof include salts with sodium, potassium, calcium, magnesium, ammonium, diethanolamine, ethylenediamine and the like. Furthermore, ammonia, methylamine, dimethylamine, trimethylamine, dicyclohexylamine, tris (hydroxymethyl) aminomethane, N, N-bis (hydroxyethyl) piperazine, 2-amino-2-methyl-1-propanol, ethanolamine, Salts with amines such as N-methylglucamine and L-glucamine; salts with basic amino acids such as lysine, δ-hydroxylysine and arginine can be mentioned. Also, for example, salts with mineral acids such as hydrochloric acid, hydrobromic acid, sulfuric acid, nitrate, phosphoric acid; methanesulfonic acid, benzenesulfonic acid, paratoluenesulfonic acid, acetic acid, propionic acid, tartrate acid, fumaric acid, maleic acid. , Salts with organic acids such as malic acid, oxalic acid, succinic acid, valeric acid, citric acid, benzoic acid, mandelic acid, silicic acid, lactic acid, glycolic acid, glucuronic acid, ascorbic acid, nicotinic acid, salicylic acid; asparagine Examples thereof include salts with acidic amino acids such as acids and glutamates. The salt of the steroid hormone and its derivative may be a solvate or a hydrate.
ステロイドの具体例としては、例えば、プレドニゾロン、ヒドロコルチゾン、コルチゾン、デキサメタゾン、ベタメタゾン、トリアムシノロン、トリアムシノロンアセトニド、ジフルプレドナード、モメタゾン、ジフルコルトロン、フルオニシド、ベクロムタゾン、デプロドン、クロベタゾン、アルクロメタゾン、フルメタゾン及びこれらの誘導体、並びにこれらの塩が挙げられ、より具体的には、プロピオン酸クロベタゾール、プロピオン酸ハロベタゾール、酢酸ジフロラゾン、ジプロピオン酸ベタメタゾン、吉草酸ジフルコルトロン、フランカルボン酸モメタゾン、ジプロピオン酸ベタメタゾン、アムシノニド、プロピオン酸デキサメタゾン、ジフルプレドナート、フルオニシド、酪酸プロピオン酸ヒドロコルチゾン、吉草酸酢酸プレドニゾロン(プレドニゾロン吉草酸エステル酢酸エステル)、ジプロピオン酸ベタメタゾン、プレドニゾロン、ベクロメタゾンジプロピオネート、プロピオン酸ベクロメタゾン、吉草酸デキサメタゾン、吉草酸ベタメタゾン、フルオシノロンアセトニド、トリアムシノロンアセトニド、酪酸ヒドロコルチゾン、酢酸ヒドロコルチゾン、酢酸クロベタゾン、プロピオン酸アルクロメタゾン、デキサメタゾン、ヒドロコルチゾン、ベタメタゾン、酢酸デキサメタゾン、ヒドロコルチゾン、酢酸コルチゾン、酢酸プレドニゾロンが挙げられる。 Specific examples of steroids include, for example, prednisolone, hydrocortisone, cortisone, dexamethasone, betamethasone, triamsinolone, triamcinolone acetonide, diflupredonado, mometazone, diflucortron, fluoniside, betamethasone, deprodon, clobetazone, alchrometamethasone, flumethasone and derivatives thereof. , As well as these salts, more specifically clobetazole propionate, halobetazole propionate, diflorazone acetate, betamethasone dipropionate, diflucortron valerate, momemethasone furancarboxylate, betamethasone dipropionate, amcinonide, propion. Dexamethasone acid, diflupredonato, fluoricid, hydrocortisone butyrate propionate, prednisolone valerate acetate (prednisolone valerate acetate), betamethasone dipropionate, prednisolone, becromethasone dipropionate, becromethasone propionate, dexamethasone valerate. , Fluosinolone acetonide, triamcinolone acetonide, hydrocortisone butyrate, hydrocortisone acetate, clobetazone acetate, alcromethasone propionate, dexamethasone, hydrocortisone, betamethasone, dexamethasone acetate, hydrocortisone, cortisone acetate, prednisolone acetate.
ステロイドとしては、本発明による効果をより一層顕著に奏することから、吉草酸酢酸プレドニゾロン、酪酸ヒドロコルチゾン、酪酸プロピオン酸ヒドロコルチゾン、ジフルプレドナート、プロピオン酸ベクロメタゾンが好ましく、吉草酸酢酸プレドニゾロンがより好ましい。 As the steroid, prednisolone valerate acetate, hydrocortisone butyrate, hydrocortisone butyrate propionate, difluprednisolone, and bechrometazone propionate are preferable, and prednisolone valerate acetate is more preferable, because the effect of the present invention is more remarkably exhibited.
ステロイドは、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The steroid may be used alone or in combination of two or more.
本実施形態に係る頭皮用外用組成物におけるステロイドの含有量は特に限定されず、ステロイドの種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。ステロイドの含有量としては、本発明による効果をより顕著に奏する観点から、例えば、外用組成物の総量を基準として、ステロイドの総含有量が、0.01~2w/w%であることが好ましく、0.02~1w/w%であることがより好ましく、0.025~0.5w/w%であることが更に好ましく、0.05~0.25w/w%であることが特に好ましい。 The content of the steroid in the external composition for scalp according to the present embodiment is not particularly limited, and is appropriately set according to the type of steroid, the type and content of other compounding ingredients, the use of the external composition, the formulation form, and the like. To. As for the steroid content, for example, the total steroid content is preferably 0.01 to 2 w / w% based on the total amount of the external composition, from the viewpoint of exerting the effect of the present invention more remarkably. , 0.02 to 1 w / w%, more preferably 0.025 to 0.5 w / w%, and particularly preferably 0.05 to 0.25 w / w%.
本実施形態に係る頭皮用外用組成物における、低級アルコールに対するステロイドの含有比率は特に限定されず、低級アルコール及びステロイドの種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。低級アルコールに対するステロイドの含有比率としては、本発明による効果をより一層高める観点から、例えば、本実施形態に係る頭皮用外用組成物に含まれる低級アルコールの総含有量1重量部に対して、ステロイドの総含有量が、0.0001~0.05重量部であることが好ましく、0.0002~0.03重量部であることがより好ましく、0.0003~0.02重量部であることが更に好ましく、0.0005~0.01重量部であることが特に好ましい。 The content ratio of steroid to lower alcohol in the external composition for scalp according to the present embodiment is not particularly limited, and the types of lower alcohol and steroid, the types and contents of other compounding ingredients, the uses and formulation forms of the external composition. It is set appropriately according to the above. Regarding the content ratio of the steroid to the lower alcohol, from the viewpoint of further enhancing the effect of the present invention, for example, the steroid is based on 1 part by weight of the total content of the lower alcohol contained in the external composition for scalp according to the present embodiment. The total content of steroids is preferably 0.0001 to 0.05 parts by weight, more preferably 0.0002 to 0.03 parts by weight, and preferably 0.0003 to 0.02 parts by weight. It is more preferably 0.0005 to 0.01 parts by weight, and particularly preferably 0.0005 to 0.01 parts by weight.
本実施形態に係る頭皮用外用組成物がステロイドを含有する場合、例えば、頭皮における湿疹、皮膚炎、フケ、痒み、及び乾燥からなる群より選択される少なくとも1つの症状の予防、治療、及び/又は改善用として好適に用いられる。 When the external composition for scalp according to the present embodiment contains steroids, for example, prevention, treatment, and / of at least one symptom selected from the group consisting of eczema, dermatitis, dandruff, itch, and dryness in the scalp. Alternatively, it is preferably used for improvement.
モノテルペンは、二個のイソプレン単位からなる構造を有し、清涼化剤等として公知の化合物である。モノテルペンとしては、生理学的又は薬学的に許容できるものであれば特に制限されない。また、モノテルペンは、d体、l体又はdl体の何れであってもよい。 The monoterpene has a structure consisting of two isoprene units and is a compound known as a refreshing agent or the like. The monoterpene is not particularly limited as long as it is physiologically or pharmaceutically acceptable. Further, the monoterpene may be d-form, l-form or dl-form.
モノテルペンの具体例としては、例えば、メントール、オイゲノール、チモール、リモネン、アネトール、シメン及びテルピネオール等の単環式モノテルペン、カンフル、ボルネオール、シネオール、ピネン、カンフェン、イソボルネオール及びフェンチェン等の二環式モノテルペン、並びにゲラニオール、ネロール、ミルセン、ミルセノール、リナロール、酢酸リナロール及びラバンジュロール等の非環式モノテルペンが挙げられる。 Specific examples of the monoterpene include monoterpenes such as menthol, eugenol, timole, linalool, anator, simene and terpineol, and dicyclics such as camphor, borneol, cineole, pinen, camfen, isobornole and fenchen. Examples include formal monoterpenes and acyclic monoterpenes such as geraniol, nerol, milsen, milsenol, linalool, linalool acetate and lavandulone.
モノテルペンとしては、本発明による効果をより一層顕著に奏することから、メントール、オイゲノール、チモール、リモネン、アネトール、シメン及びテルピネオール等の単環式モノテルペン、カンフル、ボルネオール、シネオール、ピネン、カンフェン、イソボルネオール及びフェンチェン等の二環式モノテルペンが好ましく、メントール、カンフル及びボルネオールがより好ましく、メントールが更に好ましい。 As a monoterpene, since the effect of the present invention is more remarkable, monoterpene such as menthol, eugenol, timole, limonene, anator, simene and terpineol, camphor, borneol, cineole, pinen, camphen, iso Bicyclic monoterpenes such as borneol and fenchen are preferred, menthol, camphor and borneol are more preferred, and menthol is even more preferred.
モノテルペンは、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The monoterpene may be used alone or in combination of two or more.
モノテルペンとしては、モノテルペンを含む精油を用いてもよい。このような精油としては、例えば、クールミント油、ペパーミント油、ハッカ油、ユーカリ油、ベルガモット油、スペアミント油、ローズ油及び樟脳油が挙げられる。メントール及びカンフルを含む精油としては、例えば、クールミント油、ペパーミント油、ハッカ油及び樟脳油を挙げることができる。 As the monoterpene, an essential oil containing a monoterpene may be used. Examples of such essential oils include cool mint oil, peppermint oil, peppermint oil, eucalyptus oil, bergamot oil, spare mint oil, rose oil and cypress oil. Essential oils containing menthol and camphor include, for example, cool mint oil, peppermint oil, peppermint oil and camphor oil.
本実施形態に係る頭皮用外用組成物におけるモノテルペンの含有量は特に限定されず、モノテルペンの種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。モノテルペンの含有量としては、本発明による効果をより顕著に奏する観点から、例えば、外用組成物の総量を基準として、モノテルペンの総含有量が、0.01~5.0w/w%であることが好ましく、0.05~4.0w/w%であることがより好ましく、0.1~3.5w/w%であることが更に好ましく、0.5~3.5w/w%であることが更により好ましく、1.0~3.5w/w%であることが特に好ましい。本実施形態に係る頭皮用外用組成物が、モノテルペンとして精油を含む場合には、精油中のモノテルペン含量が上記範囲内となるように設定することが好ましい。 The content of monoterpene in the external composition for scalp according to the present embodiment is not particularly limited, and is appropriately depending on the type of monoterpene, the type and content of other compounding ingredients, the use of the external composition, the formulation form, and the like. Set. Regarding the content of monoterpene, from the viewpoint of exerting the effect of the present invention more remarkably, for example, the total content of monoterpene is 0.01 to 5.0 w / w% based on the total amount of the external composition. It is preferably 0.05 to 4.0 w / w%, more preferably 0.1 to 3.5 w / w%, and 0.5 to 3.5 w / w%. It is even more preferably 1.0 to 3.5 w / w%, and particularly preferably 1.0 to 3.5 w / w%. When the external composition for scalp according to the present embodiment contains an essential oil as a monoterpene, it is preferable to set the monoterpene content in the essential oil within the above range.
本実施形態に係る頭皮用外用組成物における、低級アルコールに対するモノテルペンの含有比率は特に限定されず、低級アルコール及びモノテルペンの種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。低級アルコールに対するモノテルペンの含有比率としては、本発明による効果をより一層高める観点から、例えば、本実施形態に係る頭皮用外用組成物に含まれる低級アルコールの総含有量1重量部に対して、モノテルペンの総含有量が、0.0001~1重量部であることが好ましく、0.0005~0.8重量部であることがより好ましく、0.001~0.7重量部であることが更に好ましく、0.005~0.5重量部であることが更により好ましく、0.01~0.1重量部であることが特に好ましい。本実施形態に係る頭皮用外用組成物が、モノテルペンとして精油を含む場合には、精油中のモノテルペン含量の比率が上記範囲内となるように設定することが好ましい。 The content ratio of monoterpene to lower alcohol in the external composition for scalp according to the present embodiment is not particularly limited, and the types of lower alcohol and monoterpene, the types and contents of other compounding components, the uses of the external composition and the use of the external composition It is appropriately set according to the formulation form and the like. Regarding the content ratio of monoterpene to lower alcohol, from the viewpoint of further enhancing the effect of the present invention, for example, with respect to 1 part by weight of the total content of lower alcohol contained in the external composition for scalp according to the present embodiment. The total content of the monoterpene is preferably 0.0001 to 1 part by weight, more preferably 0.0005 to 0.8 part by weight, and preferably 0.001 to 0.7 part by weight. It is even more preferably 0.005 to 0.5 parts by weight, and particularly preferably 0.01 to 0.1 parts by weight. When the external composition for scalp according to the present embodiment contains an essential oil as a monoterpene, it is preferable to set the ratio of the monoterpene content in the essential oil within the above range.
本実施形態に係る頭皮用外用組成物がモノテルペンを含有する場合、例えば、頭皮における湿疹、皮膚炎、フケ、及び痒みからなる群より選択される少なくとも1つの症状の予防、治療、及び/又は改善用として好適に用いられる。 When the external composition for scalp according to the present embodiment contains monoterpenes, for example, prevention, treatment, and / or prevention of at least one symptom selected from the group consisting of eczema, dermatitis, dandruff, and itching in the scalp. It is suitably used for improvement.
抗ヒスタミン成分としては、生理学的又は薬学的に許容できるものであれば特に制限されない。抗ヒスタミン成分としては、例えば、ジフェンヒドラミン、クロルフェニラミン、イソチペンジル、ケトチフェン、ベポタスチン、ジメンヒドリナート、シプロヘプタジン、ジフェニルピラリン、プロメタジン、イプロヘプチン、エメダスチン、クレマスチン、アゼラスチン、レボカバスチン、ヒドロキシジン、メキタジン、ロラタジン、フェキソフェナジン、セチリジン、オキサトミド、テルフェナジン、エピナスチン、アステミゾール、エバスチン、及びこれらの化合物の塩が挙げられる。上記化合物の塩としては、生理学的又は薬学的に許容されることを限度として、特に制限されず、例えば、上記でステロイドホルモン及びその誘導体の塩について例示したような各種の塩が挙げられる。抗ヒスタミン成分の塩は、溶媒和物又は水和物であってもよい。 The antihistamine component is not particularly limited as long as it is physiologically or pharmaceutically acceptable. Examples of the antihistamine component include diphenhydramine, chlorpheniramine, isotipendyl, ketotifen, bepotastin, dimenhydrinate, cyproheptazine, diphenylpyraline, promethazine, iproheptin, emedastin, clemastine, azelastin, levocabastine, hydroxyzine, and mekitadin. Examples include phenazine, cetirizine, oxatomid, terfenadine, epinastine, astemizole, evastin, and salts of these compounds. The salt of the above compound is not particularly limited as long as it is physiologically or pharmaceutically acceptable, and examples thereof include various salts as exemplified above for salts of steroid hormones and derivatives thereof. The salt of the antihistamine component may be a solvate or a hydrate.
抗ヒスタミン成分の具体例としては、塩酸ジフェンヒドラミン、ジフェンヒドラミン、ジメンヒドリナート等のエタノールアミン系化合物;マレイン酸クロルフェニラミン、クロルフェニラミン等のプロピルアミン系化合物;塩酸プロメタジン、塩酸イソチペンジル等のフェノチアジン系化合物;ヒドロキシジン等のピペラジン系化合物;塩酸シプロヘプタジン等のピペリジン系化合物;エピナスチン塩酸塩、ロラタジン、及び塩酸フェキソフェナジン等が挙げられる。 Specific examples of the antihistamine component include ethanolamine-based compounds such as diphenhydramine hydrochloride, diphenhydramine, and dimenhydrinate; propylamine-based compounds such as chlorpheniramine maleate and chlorpheniramine; and phenothiazine-based compounds such as promethazine hydrochloride and isotipendyl hydrochloride. ; Piperazine-based compounds such as hydroxyzine; Piperidine-based compounds such as diphenhydramine hydrochloride; epinastin hydrochloride, loratadine, fexofenadine hydrochloride and the like can be mentioned.
抗ヒスタミン成分としては、本発明による効果をより一層顕著に奏することから、エタノールアミン系化合物、プロピルアミン系化合物、フェノチアジン系化合物が好ましく、塩酸ジフェンヒドラミン、ジフェンヒドラミン、マレイン酸クロルフェニラミン、クロルフェニラミン、塩酸イソチペンジルがより好ましく、塩酸ジフェンヒドラミン、ジフェンヒドラミンが更に好ましい。 As the antihistamine component, an ethanolamine-based compound, a propylamine-based compound, and a phenothiazine-based compound are preferable because the effect of the present invention is more remarkable, and diphenhydramine hydrochloride, diphenhydramine, chlorpheniramine maleate, chlorpheniramine, etc. Isothipendyl hydrochloride is more preferable, and diphenhydramine hydrochloride and diphenhydramine are even more preferable.
抗ヒスタミン成分は、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The antihistamine component may be used alone or in combination of two or more.
本実施形態に係る頭皮用外用組成物における抗ヒスタミン成分の含有量は特に限定されず、抗ヒスタミン成分の種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。抗ヒスタミン成分の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、外用組成物の総量を基準として、抗ヒスタミン成分の総含有量が、0.1~5.0w/w%であることが好ましく、0.15~4.5w/w%であることがより好ましく、0.2~4.0w/w%であることが更に好ましく、0.3~3.0w/w%であることが特に好ましい。 The content of the antihistamine component in the external composition for scalp according to the present embodiment is not particularly limited, and depends on the type of antihistamine component, the type and content of other compounding components, the use and formulation form of the external composition, and the like. Is set as appropriate. Regarding the content of the antihistamine component, from the viewpoint of exerting the effect of the present invention more remarkably, for example, the total content of the antihistamine component is 0.1 to 5.0 w / w based on the total amount of the external composition. %, More preferably 0.15 to 4.5 w / w%, further preferably 0.2 to 4.0 w / w%, and even more preferably 0.3 to 3.0 w / w. % Is particularly preferable.
本実施形態に係る頭皮用外用組成物における、低級アルコールに対する抗ヒスタミン成分の含有比率は特に限定されず、低級アルコール及び抗ヒスタミン成分の種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。低級アルコールに対する抗ヒスタミン成分の含有比率としては、本発明による効果をより一層高める観点から、例えば、本実施形態に係る頭皮用外用組成物に含まれる低級アルコールの総含有量1重量部に対して、抗ヒスタミン成分の総含有量が、0.001~1重量部であることが好ましく、0.002~0.9重量部であることがより好ましく、0.003~0.8重量部であることが更に好ましく、0.004~0.6重量部であることが特に好ましい。 The content ratio of the antihistamine component to the lower alcohol in the external composition for scalp according to the present embodiment is not particularly limited, and the types of the lower alcohol and the antihistamine component, the types and contents of other compounding components, and the external composition. It is appropriately set according to the intended use, the form of the formulation, and the like. The content ratio of the antihistamine component to the lower alcohol is, for example, from the viewpoint of further enhancing the effect of the present invention, for example, with respect to 1 part by weight of the total content of the lower alcohol contained in the external composition for scalp according to the present embodiment. The total content of the antihistamine component is preferably 0.001 to 1 part by weight, more preferably 0.002 to 0.9 part by weight, and 0.003 to 0.8 part by weight. It is more preferably 0.004 to 0.6 parts by weight, and particularly preferably 0.004 to 0.6 parts by weight.
本実施形態に係る頭皮用外用組成物が抗ヒスタミン成分を含有する場合、例えば、頭皮における湿疹、皮膚炎、フケ、及び痒みからなる群より選択される少なくとも1つの症状の予防、治療、及び/又は改善用として好適に用いられる。 When the external composition for scalp according to the present embodiment contains an antihistamine component, for example, prevention, treatment, and / of at least one symptom selected from the group consisting of eczema, dermatitis, dandruff, and itching in the scalp. Alternatively, it is preferably used for improvement.
本実施形態に係る頭皮用外用組成物が含むことができる他の有効成分又は機能性成分の具体例としては、クロタミトン等の鎮痒成分;グリチルリチン酸及びその誘導体並びにそれらの塩類(例えば、グリチルリチン酸ジカリウム、グリチルリチン酸モノアンモニウム)、グリチルレチン酸及びその誘導体(例えば、グリチルレチン酸ステアリル)並びにそれらの塩類、サリチル酸及びその誘導体(例えば、サリチル酸グリコール、サリチル酸メチル)並びにそれらの塩類、アラントイン等の抗炎症成分;イソプロピルメチルフェノール、塩化ベンザルコニウム、塩化ベンゼトニウム等の抗菌成分;酸化亜鉛、カラミン等の収斂成分;アミノ安息香酸エチル、オキシポリエトキシドデカン、ジブカイン、塩酸ジブカイン、リドカイン、塩酸リドカイン等の局所麻酔成分;アンモニア水等の局所刺激成分;酢酸トコフェロール、トコフェロール、パンテノール、ビタミンA油、パルミチン酸レチノール等のビタミン類;ピロクトンオラミン、ニンジン抽出物、センブリエキス、パントテニルエチルエーテル、D-パントテニルアルコール、海藻エキス、ミノキシジル、フィナステリド、カルプロニウム塩化物、ヒノキチオール、エストラジオール安息香酸エステル、ピリドキシン塩酸塩、パントテン酸カリウム、レゾルシン、チクセツニンジンチンキ、カシュウチンキ、アルニカチンキ、dl-α-トコフェロール、2-L-アスコルビン酸リン酸ジエステルカリウム塩、6-ベンジルアミノプリン等の養毛・育毛成分等を挙げることができるが、これらに限定されない。 Specific examples of other active ingredients or functional ingredients that can be contained in the external composition for scalp according to the present embodiment are antipruritic ingredients such as crotamitone; glycyrrhizinic acid and its derivatives and salts thereof (for example, dipotassium glycyrrhizinate). , Monoammonium glycyrrhizinate), glycyrrhetinic acid and its derivatives (eg, stearyl glycyrrhetinate) and their salts, salicylic acid and its derivatives (eg, glycol salicylate, methyl salicylate) and their salts, anti-inflammatory components such as allantin; isopropyl Antibacterial components such as methylphenol, benzalkonium chloride, benzethonium chloride; astringent components such as zinc oxide and caramine; local anesthetic components such as ethyl aminobenzoate, oxypolyethoxydodecane, dibucaine, dibucaine hydrochloride, lidocaine, lidocaine hydrochloride; ammonia Local stimulant components such as water; vitamins such as tocopherol acetate, tocopherol, pantenol, vitamin A oil, retinol palmitate; pyrocton olamine, carrot extract, assembly extract, pantothenyl ethyl ether, D-pantothenyl alcohol, Seaweed extract, minoxydil, finasteride, carpronium chloride, hinokithiol, estradiol benzoate, pyridoxin hydrochloride, potassium pantothenate, resorcin, thixetsuninjin tincture, cashew tincture, arnica tincture, dl-α-tocopherol, 2-L-ascorbin Examples thereof include, but are not limited to, hair-growth and hair-growth components such as acid phosphate diester potassium salt and 6-benzylaminopurine.
本実施形態に係る頭皮用外用組成物は上記成分のほか、本発明の効果を損なわない範囲で、医薬品、医薬部外品又は化粧品に通常使用される低級アルコール以外の基剤又は担体を含有していてもよい。また、本実施形態に係る頭皮用外用組成物は、本発明の効果を損なわない範囲で、医薬品、医薬部外品又は化粧品に通常使用される添加剤を含有していてもよい。 In addition to the above components, the external composition for scalp according to the present embodiment contains a base or carrier other than lower alcohols usually used for pharmaceuticals, quasi-drugs or cosmetics, as long as the effects of the present invention are not impaired. May be. In addition, the external composition for scalp according to the present embodiment may contain additives usually used for pharmaceuticals, quasi-drugs or cosmetics as long as the effects of the present invention are not impaired.
本実施形態に係る頭皮用外用組成物が添加剤として増粘剤を含む場合、その増粘作用により外用組成物を頭皮に適用しても毛包への有効成分又は機能性成分の送達効率が抑制される傾向が懸念される。しかし、本発明によれば、外用組成物を軟質多孔性材料で形成された塗布部を備える容器に収容して用いているため、増粘剤を含む場合であっても、頭皮そしてその毛包への有効成分又は機能性成分の送達効率が高められる。 When the external composition for scalp according to the present embodiment contains a thickener as an additive, the efficiency of delivering the active ingredient or the functional ingredient to the hair follicles is high even if the external composition is applied to the scalp due to the thickening action. There is concern that it will tend to be suppressed. However, according to the present invention, since the external composition is housed in a container having a coating portion made of a soft porous material and used, the scalp and its hair follicles even if it contains a thickener. The efficiency of delivery of the active or functional ingredient to is enhanced.
増粘剤としては、例えば、セルロース、メチルセルロース、エチルセルロース、ヒドロキシエチルセルロース、ヒドロキシメチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、疎水化ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース、カルボキシエチルセルロース等のセルロース系増粘剤;ポリビニルアルコール、ポリビニルピロリドン、カルボキシビニルポリマー等のビニル系増粘剤;ヒアルロン酸、アセチル化ヒアルロン酸、オリゴヒアルロン酸、加水分解ヒアルロン酸、コンドロイチン硫酸、アルギン酸、及びそれらの塩(例えば、ヒアルロン酸ナトリウム、アセチルヒアルロン酸ナトリウム、コンドロイチン硫酸ナトリウム、アルギン酸ナトリウム)等のムコ多糖系増粘剤;グアーガム、カチオン化グアーガム、ローカストビーンガム、カラギーナン、キサンタンガム、アクリル酸メタクリル酸アルキル共重合体、ポリエチレングリコール、ベントナイト、マクロゴール、クインスシード、デキストラン、ジェランガム等が挙げられる。 Examples of the thickener include cellulosic thickeners such as cellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydrophobicized hydroxypropylmethylcellulose, carboxymethylcellulose and carboxyethylcellulose; polyvinyl alcohol, Vinyl thickeners such as polyvinylpyrrolidone and carboxyvinyl polymers; hyaluronic acid, acetylated hyaluronic acid, oligohyaluronic acid, hydrolyzed hyaluronic acid, chondroitin sulfate, alginic acid, and salts thereof (eg, sodium hyaluronate, acetylhyaluronic acid). Mucopolysaccharide thickeners such as sodium, chondroitin sodium sulfate, sodium alginate); guar gum, cationized guar gum, locust bean gum, carrageenan, xanthan gum, alkyl methacrylate copolymer, polyethylene glycol, bentonite, macrogol, quins Seeds, dextran, gellan gum and the like can be mentioned.
増粘剤としては、本発明による効果をより一層顕著に得られ易いという観点から、セルロース系増粘剤、ビニル系増粘剤、ムコ多糖系増粘剤が好ましく、メチルセルロース、エチルセルロース、ヒドロキシエチルセルロース、ヒドロキシメチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、疎水化ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース、カルボキシエチルセルロース、ポリビニルアルコール、ポリビニルピロリドン、カルボキシビニルポリマー、ヒアルロン酸、アセチル化ヒアルロン酸、オリゴヒアルロン酸、加水分解ヒアルロン酸、コンドロイチン硫酸、アルギン酸、ヒアルロン酸ナトリウム、アセチルヒアルロン酸ナトリウム、コンドロイチン硫酸ナトリウム、アルギン酸ナトリウムがより好ましく、メチルセルロース、エチルセルロース、ヒドロキシエチルセルロース、ヒドロキシメチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、疎水化ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース、カルボキシエチルセルロースが更に好ましい。 As the thickener, a cellulose-based thickener, a vinyl-based thickener, and a mucopolysaccharide-based thickener are preferable from the viewpoint that the effect of the present invention can be obtained more remarkably, and methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, etc. Hydroxymethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydrophobic hydroxypropylmethyl cellulose, carboxymethyl cellulose, carboxyethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, carboxyvinyl polymer, hyaluronic acid, acetylated hyaluronic acid, oligo hyaluronic acid, hydrolyzed hyaluronic acid, Chondroitin sulfate, alginic acid, sodium hyaluronate, sodium acetylhyaluronate, sodium chondroitin sulfate, sodium alginate are more preferable, and methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydrophobicized hydroxypropylmethylcellulose, carboxymethylcellulose , Carboxymethyl cellulose is more preferred.
増粘剤は、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The thickener may be used alone or in combination of two or more.
本実施形態に係る頭皮用外用組成物における増粘剤の含有量は特に限定されず、増粘剤の種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。増粘剤の含有量としては、本発明による効果をより顕著に奏する観点から、例えば、外用組成物の総量を基準として、増粘剤の総含有量が、0.01~3.0w/w%であることが好ましく、0.05~2.5w/w%であることがより好ましく、0.05~2.0w/w%であることが更に好ましく、0.1~1.5w/w%であることが特に好ましい。 The content of the thickener in the external composition for scalp according to the present embodiment is not particularly limited, and depends on the type of thickener, the type and content of other compounding ingredients, the use of the external composition, the formulation form, and the like. Is set as appropriate. Regarding the content of the thickener, for example, from the viewpoint of exerting the effect of the present invention more remarkably, the total content of the thickener is 0.01 to 3.0 w / w based on the total amount of the external composition, for example. %, More preferably 0.05 to 2.5 w / w%, still more preferably 0.05 to 2.0 w / w%, and 0.1 to 1.5 w / w. % Is particularly preferable.
本実施形態に係る頭皮用外用組成物における、低級アルコールに対する増粘剤の含有比率は特に限定されず、低級アルコール及び増粘剤の種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定される。低級アルコールに対する増粘剤の含有比率としては、本発明による効果をより一層高める観点から、例えば、本実施形態に係る頭皮用外用組成物に含まれる低級アルコールの総含有量1重量部に対して、増粘剤の総含有量が、0.0001~0.6重量部であることが好ましく、0.0005~0.5重量部であることがより好ましく、0.0008~0.4重量部であることが更に好ましく、0.001~0.3重量部であることが特に好ましい。 The content ratio of the thickener to the lower alcohol in the external composition for scalp according to the present embodiment is not particularly limited, and the types of the lower alcohol and the thickener, the types and contents of other compounding components, and the external composition. It is appropriately set according to the intended use, the form of the formulation, and the like. The content ratio of the thickener to the lower alcohol is, for example, from the viewpoint of further enhancing the effect of the present invention, for example, with respect to 1 part by weight of the total content of the lower alcohol contained in the external composition for scalp according to the present embodiment. The total content of the thickener is preferably 0.0001 to 0.6 parts by weight, more preferably 0.0005 to 0.5 parts by weight, and 0.0008 to 0.4 parts by weight. It is more preferably 0.001 to 0.3 parts by weight, and particularly preferably 0.001 to 0.3 parts by weight.
基剤又は担体としては、例えば、流動パラフィン、スクワラン、ワセリン、ゲル化炭化水素(プラスチベース等)、オゾケライト、α-オレフィンオリゴマー、及び軽質流動パラフィン等の炭化水素;メチルポリシロキサン、架橋型メチルポリシロキサン、高重合メチルポリシロキサン、環状シリコーン、アルキル変性シリコーン、架橋型アルキル変性シリコーン、アミノ変性シリコーン、ポリエーテル変性シリコーン、ポリグリセリン変性シリコーン、架橋型ポリエーテル変性シリコーン、架橋型アルキルポリエーテル変性シリコーン、シリコーン・アルキル鎖共変性ポリエーテル変性シリコーン、シリコーン・アルキル鎖共変性ポリグリセリン変性シリコーン、ポリエーテル変性分岐シリコーン、ポリグリセリン変性分岐シリコーン、アクリルシリコン、フェニル変性シリコーン、シリコーンレジン等のシリコーン油;セタノール、セトステアリルアルコール、ステアリルアルコール、ベヘニルアルコール等の高級アルコール;コレステロール、フィトステロール、ヒドロキシステアリン酸フィトステリル等のステロール類;ホホバ油、メドウフォーム油、ヒマワリ油、ブドウ種子油、椿油、スクワラン、シアバター、コメ胚芽油等の植物油;ラノリン、オレンジラフィー油、スクワラン、馬油等の動物油;ポリビニルブチラート;ポリエチレングリコール;ジオキサン;ブチレングリコールアジピン酸ポリエステル;ミリスチン酸イソプロピル、ミリスチン酸オクチルドデシル、パルミチン酸イソプロピル、パルミチン酸セチル、イソノナン酸イソノニル、テトラ2-エチルヘキサン酸ペンタエリスリット、ホホバ油、トリ(カプリル酸/カプリン酸)グリセリル等のエステル類;デキストリン、マルトデキストリン等の多糖類;炭素数2~6、水酸基数2~4の多価アルコール;コハク酸、グリコール酸、グルコン酸、クエン酸等の有機酸;並びに水等の水系基剤が挙げられる。 Examples of the base or carrier include hydrocarbons such as liquid paraffin, squalane, vaseline, gelled hydrocarbon (plastibase, etc.), ozokelite, α-olefin oligomer, and light liquid paraffin; methylpolysiloxane, crosslinked methylpolysiloxane. , Highly polymerized methylpolysiloxane, cyclic silicone, alkyl-modified silicone, cross-linked alkyl-modified silicone, amino-modified silicone, polyether-modified silicone, polyglycerin-modified silicone, cross-linked polyether-modified silicone, cross-linked alkyl polyether-modified silicone, silicone -Silicone oils such as alkyl chain co-modified polyether-modified silicone, silicone-alkyl chain co-modified polyglycerin-modified silicone, polyether-modified branched silicone, polyglycerin-modified branched silicone, acrylic silicon, phenyl-modified silicone, silicone resin; Higher alcohols such as stearyl alcohol, stearyl alcohol, and behenyl alcohol; sterols such as cholesterol, phytosterol, and phytosteryl hydroxystearate; jojoba oil, meadowfoam oil, sunflower oil, grape seed oil, camellia oil, squalane, shea butter, rice germ oil, etc. Vegetable oils; animal oils such as lanolin, orange raffy oil, squalane, horse oil; polyvinyl butyrate; polyethylene glycol; dioxane; polyester butylene glycol adipate; isopropyl myristate, octyldodecyl myristate, isopropyl palmitate, cetyl palmitate, isononan Esters such as isononyl acid, pentaerythrith tetra2-ethylhexanoate, jojoba oil, tri (capricyl / capric acid) glyceryl; polysaccharides such as dextrin and maltodextrin; 2-6 carbon atoms, 2-4 hydroxyl groups Polyhydric alcohols; organic acids such as succinic acid, glycolic acid, gluconic acid, and citrate; and aqueous bases such as water.
基剤又は担体は、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The base or carrier may be used alone or in combination of two or more.
添加剤としては、例えば、酸化防止剤、界面活性剤、防腐剤、保存剤、pH調整剤、安定化剤、刺激軽減剤、着色剤、香料、パール光沢付与剤が挙げられる。 Examples of the additive include an antioxidant, a surfactant, a preservative, a preservative, a pH adjuster, a stabilizer, an irritation reducing agent, a colorant, a fragrance, and a pearl gloss imparting agent.
酸化防止剤としては、例えば、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、ソルビン酸、亜硫酸ナトリウム、ピロ亜硫酸ナトリウム、アスコルビン酸、アスコルビン酸誘導体、トコフェロール、トコフェロール誘導体、エリソルビン酸、L-システイン塩酸塩が挙げられる。 Examples of the antioxidant include dibutylhydroxytoluene, butylhydroxyanisole, sorbic acid, sodium sulfite, sodium pyrosulfite, ascorbic acid, ascorbic acid derivative, tocopherol, tocopherol derivative, erythorbic acid, and L-cysteine hydrochloride.
界面活性剤としては、例えば、ソルビタンモノイソステアレート、ソルビタンモノラウレート、ソルビタンモノパルミテート、ソルビタンモノステアレート、ペンタ-2-エチルヘキシル酸ジグリセロールソルビタン、及びテトラ-2-エチルヘキシル酸ジグリセロールソルビタン等のソルビタン脂肪酸エステル類;モノステアリン酸プロピレングリコール等のプロピレングリコール脂肪酸エステル類;ポリオキシエチレン硬化ヒマシ油40(HCO-40)、ポリオキシエチレン硬化ヒマシ油50(HCO-50)、ポリオキシエチレン硬化ヒマシ油60(HCO-60)、ポリオキシエチレン硬化ヒマシ油80等の硬化ヒマシ油誘導体;モノラウリル酸ポリオキシエチレン(20)ソルビタン(ポリソルベート20)、モノステアリン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート60)、モノオレイン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート80)、イソステアリン酸ポリオキシエチレン(20)ソルビタン等のポリオキシエチレンソルビタン脂肪酸エステル類;ポリオキシエチレンモノヤシ油脂肪酸グリセリル;グリセリンアルキルエーテル;セトステアリルグルコシド等のアルキルグルコシド;ポリオキシエチレンセチルエーテル、ポリオキシエチレンベヘニルエーテル等のポリオキシアルキレンアルキルエーテル;ステアリルアミン、オレイルアミン等のアミン類;ポリオキシエチレン・メチルポリシロキサン共重合体、ラウリルPEG-9ポリジメチルシロキシエチルジメチコン、PEG-9ポリジメチルシロキシエチルジメチコン等のシリコーン系界面活性剤;リン脂質、サーファクチン、及びサポニン等の天然界面活性剤;ステアリン酸ジエチルアミノエチルアミド、ステアリン酸ジエチルアミノプロピルアミド等の脂肪酸アミドアミン;トリラウリルアミン、ジメチルステアリルアミン、ジ-2-エチルヘキシルアミン等のアルキルアミン;ステアリン酸ジメチルアミノプロピルアミド、及びラウリルヒドロキシスルホベタイン等のベタイン系両性界面活性剤が挙げられる。 Examples of the surfactant include sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, penta-2-ethylhexyl diglycerol sorbitan, tetra-2-ethylhexyl acid diglycerol sorbitan and the like. Solbitan fatty acid esters; propylene glycol fatty acid esters such as propylene glycol monostearate; polyoxyethylene hydrogenated castor oil 40 (HCO-40), polyoxyethylene hydrogenated castor oil 50 (HCO-50), polyoxyethylene hydrogenated castor bean paste. Hardened castor oil derivatives such as oil 60 (HCO-60) and polyoxyethylene hydrogenated castor oil 80; polyoxyethylene monolaurylate (20) sorbitan (polysorbate 20), polyoxyethylene monostearate (20) sorbitan (polysorbate 60). ), Polyoxyethylene sorbitan fatty acid esters such as polyoxyethylene monooleate (20) sorbitan (polysorbate 80), polyoxyethylene (20) sorbitan isostearate; polyoxyethylene monopalm oil fatty acid glyceryl; glycerin alkyl ether; seto Alkyl glucoside such as stearyl glucoside; polyoxyalkylene alkyl ether such as polyoxyethylene cetyl ether and polyoxyethylene behenyl ether; amines such as stearyl amine and oleyl amine; polyoxyethylene / methyl polysiloxane copolymer, lauryl PEG-9 Silicone-based surfactants such as polydimethylsiloxyethyl dimethicone, PEG-9 polydimethylsiloxyethyl dimethicone; natural surfactants such as phospholipids, surfactins, and saponins; Examples thereof include fatty acid amidamines; alkylamines such as trilaurylamine, dimethylstearylamine, and di-2-ethylhexylamine; and betaine-based amphoteric surfactants such as dimethylaminopropylamide stearate and laurylhydroxysulfobetaine.
防腐剤又は保存剤としては、例えば、安息香酸、安息香酸ナトリウム、デヒドロ酢酸、デヒドロ酢酸ナトリウム、パラオキシ安息香酸イソブチル、パラオキシ安息香酸イソプロピル、パラオキシ安息香酸ブチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ベンジル、パラオキシ安息香酸メチル、フェノキシエタノール、ベンジルアルコール、クロロブタノール、ソルビン酸及びその塩、グルコン酸クロルヘキシジン、アルカンジオール、グリセリン脂肪酸エステルが挙げられる。 Examples of preservatives or preservatives include benzoic acid, sodium benzoate, dehydroacetic acid, sodium dehydroacetate, isobutyl paraoxybenzoate, isopropyl paraoxybenzoate, butyl paraoxybenzoate, ethyl paraoxybenzoate, propyl paraoxybenzoate, paraoxy. Examples thereof include benzyl benzoate, methyl paraoxybenzoate, phenoxyethanol, benzyl alcohol, chlorobutanol, sorbic acid and salts thereof, chlorhexidine gluconate, alkanediol, and glycerin fatty acid ester.
pH調整剤としては、例えば、無機酸(塩酸、硫酸等)、有機酸(乳酸、乳酸ナトリウム、クエン酸、クエン酸ナトリウム、コハク酸、コハク酸ナトリウム等)、無機塩基(水酸化カリウム、水酸化ナトリウム等)、有機塩基(トリエタノールアミン、ジイソプロパノールアミン、トリイソプロパノールアミン等)が挙げられる。 Examples of the pH adjuster include inorganic acids (hydrochloride, sulfuric acid, etc.), organic acids (lactic acid, sodium lactate, citric acid, sodium citrate, succinic acid, sodium succinate, etc.), and inorganic bases (potassium hydroxide, hydroxylation). (Sodium, etc.), organic bases (triethanolamine, diisopropanolamine, triisopropanolamine, etc.) can be mentioned.
安定化剤としては、例えば、ポリアクリル酸ナトリウム、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が挙げられる。 Examples of the stabilizer include sodium polyacrylate, dibutylhydroxytoluene, and butylhydroxyanisole.
刺激低減剤としては、例えば、甘草エキス、アルギン酸ナトリウム、2-メタクリロイルオキシエチルホスホリルコリンが挙げられる。 Examples of the irritation reducing agent include licorice extract, sodium alginate, and 2-methacryloyloxyethyl phosphorylcholine.
着色剤としては、例えば、無機顔料、天然色素が挙げられる。 Examples of the colorant include inorganic pigments and natural pigments.
パール光沢付与剤としては、例えば、ジステアリン酸エチレングリコール、モノステアリン酸エチレングリコール、ジステアリン酸トリエチレングリコールが挙げられる。 Examples of the pearl gloss imparting agent include ethylene glycol distearate, ethylene glycol monostearate, and triethylene glycol distearate.
添加剤は、1種単独で使用してもよく、2種以上を組み合わせて使用してもよい。 The additive may be used alone or in combination of two or more.
本実施形態に係る頭皮用外用組成物のpHは、生理学的又は薬学的に許容できる範囲内であれば特に制限されないが、例えば、3~9であってよく、3.5~8.5であることが好ましく、4~8であることがより好ましく、4~7であることが更に好ましい。 The pH of the external composition for scalp according to the present embodiment is not particularly limited as long as it is within a physiologically or pharmaceutically acceptable range, but may be, for example, 3 to 9, and may be 3.5 to 8.5. It is preferably present, more preferably 4 to 8, and even more preferably 4 to 7.
本実施形態に係る頭皮用外用組成物は、例えば、可溶化系、乳化系又は粉末分散系の組成物であってよい。本発明による効果をより顕著に奏する観点から、頭皮用外用組成物は、可溶化系の組成物であることが好ましい。本明細書において可溶化系とは、水と油とが相分離せずに均一で透明の外観を呈し、熱力学的にも安定な一相系の状態を指す。すなわち、可溶化系とは、乳化系又は粉末分散系を除く状態である。 The external composition for scalp according to the present embodiment may be, for example, a solubilizing system, an emulsifying system or a powder dispersion system composition. From the viewpoint of exerting the effect of the present invention more remarkably, the composition for external use on the scalp is preferably a solubilizing composition. As used herein, the solubilization system refers to a thermodynamically stable one-phase system in which water and oil do not undergo phase separation and exhibit a uniform and transparent appearance. That is, the solubilization system is a state excluding the emulsification system or the powder dispersion system.
本実施形態に係る頭皮用外用組成物の剤型は、頭皮用外用組成物の用途等に応じて任意に選択することができ、例えば、外用液剤、リニメント剤、ローション剤、軟膏剤、クリーム剤、ゲル剤等とすることができる。これらの剤型には、公知の方法に従って製剤化することができる。本実施形態に係る頭皮用外用組成物の剤型は、外用液剤、ローション剤、ゲル剤であることが好ましく、外用液剤、ローション剤であることがより好ましい。 The dosage form of the external composition for scalp according to the present embodiment can be arbitrarily selected according to the use of the external composition for scalp, for example, an external solution, a liniment, a lotion, an ointment, and a cream. , Gel agent, etc. These dosage forms can be formulated according to known methods. The dosage form of the external composition for scalp according to the present embodiment is preferably an external liquid agent, a lotion agent, or a gel agent, and more preferably an external liquid agent or a lotion agent.
本実施形態に係る頭皮用外用組成物は、軟質多孔性材料で形成された塗布部を毛髪の上から、又は直接頭皮に押し当てる、又は押し当てながら塗り広げることにより、頭皮に適用することができる。これにより、発毛部位であるか否かに関わらず、効率よく毛包深部への有効成分又は機能性成分の送達が可能となる。本実施形態に係る頭皮用外用組成物の有効投与量は、配合成分の種類及び含有量、用途及び剤型、並びに症状等に応じて適宜設定され得る。 The external composition for scalp according to the present embodiment can be applied to the scalp by applying a coating portion formed of a soft porous material over the hair or by pressing it directly against the scalp or spreading it while pressing the coating portion. can. This makes it possible to efficiently deliver the active ingredient or the functional ingredient to the deep part of the hair follicle regardless of whether or not it is a hair growth site. The effective dose of the external composition for scalp according to the present embodiment can be appropriately set according to the type and content of the compounding component, the use and dosage form, the symptom and the like.
本実施形態に係る頭皮用外用組成物は、例えば、1日数回又は症状(痒み等)が現れたときに、適量を頭皮に塗布することにより使用することができる。定期的に塗布する場合には、頭皮洗浄・洗髪後の頭皮に塗布することが好ましい。適量としては、特に限定はされないが、例えば、単位面積あたり1回、約20~60mg/cm2程度とすることができる。 The external composition for scalp according to the present embodiment can be used, for example, by applying an appropriate amount to the scalp several times a day or when symptoms (itch, etc.) appear. When applied regularly, it is preferable to apply it to the scalp after washing the scalp and washing the hair. The appropriate amount is not particularly limited, but can be, for example, about 20 to 60 mg / cm 2 once per unit area.
以下、実施例等に基づいて本発明を具体的に説明するが、本発明はこれらに限定されるものではない。 Hereinafter, the present invention will be specifically described based on Examples and the like, but the present invention is not limited thereto.
〔試験方法〕
(毛包付き頭皮モデル)
5mm(ヒト頭皮毛包における毛の深さに相当する)厚のシリコンシート(アズワン、シリコンゴムシート5t300角)を4.15cm2(1.1cm×1.1cm×3.14)の円形状に型抜きした。1mmバイオプシーパンチ(カイメディカルBP-10F,生検トレパン)を使用して、型抜きしたシートの厚み方向に25個の貫通孔を形成した。これを毛包付き頭皮モデルとした。
〔Test method〕
(Scalp model with hair follicles)
Silicone sheet (AS ONE, silicone rubber sheet 5t 300 square) with a thickness of 5 mm (corresponding to the depth of hair in human scalp hair follicles) is made into a circular shape of 4.15 cm 2 (1.1 cm x 1.1 cm x 3.14). Die-cut. A 1 mm biopsy punch (Kymedical BP-10F, biopsy trepan) was used to form 25 through holes in the thickness direction of the die-cut sheet. This was used as a scalp model with hair follicles.
(吐出量の調整)
浸透試験での吐出量を揃えるため、事前に試験製剤毎にその吐出量を測定した。試験製剤は、各表に記載の組成物(処方)が液体用細口容器(図4参照)又は軟質多孔性塗布部を備えた液体塗布用栓式容器(図1参照)に収容されたものである。まず、容器の塗布部を5回キムタオルに押し当てた前後でのキムタオルの重量変化から容器から吐出された組成物の量を測定し、これを5回繰り返して測定値の平均値を求めた。この平均値を1回の吐出量とした。このようにして求めた1回の吐出量から、比較する試験製剤間で吐出量が同じ(0.4g)になるように押し当て回数を調整した。
(Adjustment of discharge amount)
In order to make the discharge amount in the permeation test uniform, the discharge amount was measured in advance for each test product. The test product is one in which the composition (formulation) shown in each table is contained in a narrow-mouthed liquid container (see FIG. 4) or a plug-type container for liquid coating (see FIG. 1) provided with a soft porous coating portion. be. First, the amount of the composition discharged from the container was measured from the change in the weight of the Kim towel before and after pressing the coated portion of the container against the
(浸透試験-毛髪なし)
図2(a)を参照して説明する。まず、キムタオル130の上に貫通孔110を有するシリコンシート120(毛包付き頭皮モデル)を置き、毛包付き頭皮モデルのキムタオル130とは反対側の面から試験製剤(図2(a)では、軟質多孔性塗布部を備えた液体塗布用栓式容器100)をまんべんなく押し当てた。押し当て回数は、各試験製剤の吐出量が0.4gになるよう調整した。押し当て後、貫通孔110を透過した透過液140がキムタオル130に吸収された。押し当てた前後のキムタオルの重量変化から、キムタオルまで浸透した組成物の量を測定した。この測定値を毛包への浸透量(毛髪なし)とした。
(Penetration test-no hair)
This will be described with reference to FIG. 2 (a). First, a silicon sheet 120 (scalp model with hair follicles) having a through
(浸透試験-毛髪あり)
図2(b)を参照して説明する。まず、キムタオル130の上に貫通孔110を有するシリコンシート120(毛包付き頭皮モデル)を置き、毛包付き頭皮モデルのキムタオル130とは反対側の面に毛髪サンプル150(ビューラックス,BM-B15)を載置した。毛髪サンプル150が載置されている面から試験製剤(図2(b)では、軟質多孔性塗布部を備えた液体塗布用栓式容器100)をまんべんなく押し当てた。押し当て回数は、各試験製剤の吐出量が0.4gになるよう調整した。押し当て後、貫通孔110を透過した透過液140がキムタオル130に吸収された。押し当てた前後のキムタオルの重量変化から、キムタオルまで浸透した組成物の量を測定した。この測定値を毛包への浸透量(毛髪あり)とした。
(Penetration test-with hair)
This will be described with reference to FIG. 2 (b). First, a silicon sheet 120 (scalp model with hair follicles) having a through
〔試験例1:容器の比較(1)〕
表1に示す各処方を調製し、軟質多孔性の天然ゴム発泡体で形成された軟質多孔性塗布部を備えた液体塗布用栓式容器、又は液体用細口容器に収容して試験製剤とした。なお、青色1号は、処方の視認性を高めるために添加している。
Each of the formulations shown in Table 1 was prepared and placed in a liquid coating plug-type container or a liquid narrow-mouthed container equipped with a soft porous coating portion formed of a soft porous natural rubber foam to prepare a test preparation. .. Blue No. 1 is added to improve the visibility of the prescription.
〔試験方法〕に記載した方法により、各試験製剤の浸透量(毛髪なし)及び浸透量(毛髪あり)を測定した。結果を表2及び図3に示す。図3(a)は、浸透量(毛髪なし)をエタノール濃度に対してプロットしたグラフである。図3(b)は、浸透量(毛髪あり)をエタノール濃度に対してプロットしたグラフである。
表2及び図3に示すとおり、意外にも、毛髪の有無に関わらず、少なくともエタノール濃度が5~70w/w%の範囲において、軟質多孔性塗布部を備えた液体塗布用栓式容器の方が頭皮の毛包への浸透量がより多かった。特に、軟質多孔性塗布部を備えた液体塗布用栓式容器は、毛髪ありの場合、エタノール濃度が5~50w/w%の範囲において、頭皮の毛包への浸透量が顕著に多かった。 As shown in Table 2 and FIG. 3, surprisingly, the liquid coating stopper type container provided with the soft porous coating portion in the range of at least the ethanol concentration of 5 to 70 w / w% regardless of the presence or absence of hair. However, the amount of penetration of the scalp into the hair follicles was higher. In particular, in the case of the plug-type container for liquid coating provided with the soft porous coating portion, the amount of permeation of the scalp into the hair follicles was remarkably large in the ethanol concentration range of 5 to 50 w / w% in the case of hair.
〔試験例2:処方の比較(1)〕
表3に示す各処方を調製し、軟質多孔性の天然ゴム発泡体で形成された軟質多孔性塗布部を備えた液体塗布用栓式容器、又は液体用細口容器に収容して試験製剤とした。なお、青色1号は、処方の視認性を高めるために添加している。
Each of the formulations shown in Table 3 was prepared and placed in a liquid coating plug-type container or a liquid narrow-mouthed container equipped with a soft porous coating portion formed of a soft porous natural rubber foam to prepare a test preparation. .. Blue No. 1 is added to improve the visibility of the prescription.
〔試験方法〕に記載した方法により、各試験製剤の浸透量(毛髪あり)を測定した。プレドニゾロン吉草酸エステル酢酸エステル(PVA)を含まないこと以外は処方7及び処方8と同じ処方である処方4及び処方6も同様に測定した。結果を併せて表4に示す。
表4に示すとおり、容器に収容する組成物がエタノールに加えPVAを含有することで、頭皮の毛包への浸透量(毛髪あり)が顕著に増加した。この効果は、軟質多孔性塗布部を備えた液体塗布用栓式容器の場合により顕著であった。 As shown in Table 4, when the composition contained in the container contained PVA in addition to ethanol, the amount of permeation of the scalp into the hair follicles (with hair) was significantly increased. This effect was more remarkable in the case of a liquid coating stopper type container provided with a soft porous coating portion.
〔試験例3:処方の比較(2)〕
表5に示す各処方を調製し、軟質多孔性の天然ゴム発泡体で形成された軟質多孔性塗布部を備えた液体塗布用栓式容器、又は液体用細口容器に収容して試験製剤とした。なお、青色1号は、処方の視認性を高めるために添加している。
Each of the formulations shown in Table 5 was prepared and placed in a liquid coating plug-type container or a liquid narrow-mouthed container equipped with a soft porous coating portion formed of a soft porous natural rubber foam to prepare a test preparation. .. Blue No. 1 is added to improve the visibility of the prescription.
〔試験方法〕に記載した方法により、各試験製剤の浸透量(毛髪あり)を測定した。l-メントールを含まないこと以外は処方9(又は処方10)及び処方11と同じ処方である処方6及び処方5も同様に測定した。結果を表6及び表7に示す。
表6及び表7に示すとおり、容器に収容する組成物がエタノールに加えメントールを含有することで、頭皮の毛包への浸透量(毛髪あり)が顕著に増加した。この効果は、軟質多孔性塗布部を備えた液体塗布用栓式容器の場合により顕著であった。 As shown in Tables 6 and 7, the amount of permeation of the scalp into the hair follicles (with hair) was significantly increased by containing menthol in addition to ethanol in the composition contained in the container. This effect was more remarkable in the case of a liquid coating stopper type container provided with a soft porous coating portion.
〔試験例4:処方の比較(3)〕
表8に示す処方を調製し、軟質多孔性の天然ゴム発泡体で形成された軟質多孔性塗布部を備えた液体塗布用栓式容器、又は液体用細口容器に収容して試験製剤とした。なお、青色1号は、処方の視認性を高めるために添加している。
The formulations shown in Table 8 were prepared and placed in a liquid coating stopper type container provided with a soft porous coating portion formed of a soft porous natural rubber foam or a liquid narrow mouth container to prepare a test preparation. Blue No. 1 is added to improve the visibility of the prescription.
〔試験方法〕に記載した方法により、処方12の浸透量(毛髪あり)を測定した。塩酸ジフェンヒドラミンを含まないこと以外は処方12と同じ処方である処方6も同様に測定した。結果を表9に示す。
表9に示すとおり、容器に収容する組成物がエタノールに加えて塩酸ジフェンヒドラミンを含有することで、頭皮の毛包への浸透量(毛髪あり)が顕著に増加した。この効果は、軟質多孔性塗布部を備えた液体塗布用栓式容器の場合により顕著であった。 As shown in Table 9, when the composition contained in the container contained diphenhydramine hydrochloride in addition to ethanol, the amount of permeation of the scalp into the hair follicles (with hair) was significantly increased. This effect was more remarkable in the case of a liquid coating stopper type container provided with a soft porous coating portion.
〔試験例5:容器の比較(2)〕
表10に示す各処方を調製し、軟質多孔性の天然ゴム発泡体で形成された軟質多孔性塗布部を備えた液体塗布用栓式容器、又は液体用細口容器に収容して試験製剤とした。なお、青色1号は、処方の視認性を高めるために添加している。
Each of the formulations shown in Table 10 was prepared and placed in a liquid coating stopper type container provided with a soft porous coating portion formed of a soft porous natural rubber foam or a liquid narrow mouth container to prepare a test preparation. .. Blue No. 1 is added to improve the visibility of the prescription.
〔試験方法〕に記載した方法により、各試験製剤の浸透量(毛髪あり)を測定した。結果を併せて表11に示す。
増粘剤(疎水化ヒドロキシプロピルメチルセルロース)を含有する外用組成物は粘性がやや高まるため、頭皮の小さな毛包には一般に浸透し難い傾向がある。しかし、表11に示すように、増粘剤が配合された外用組成物であっても、軟質多孔性塗布部を備えた液体塗布用栓式容器を用いることにより頭皮の毛包への浸透量(毛髪あり)が顕著に増加した。 External compositions containing a thickener (hydrophobicized hydroxypropylmethylcellulose) tend to be less viscous and therefore generally less likely to penetrate into the small hair follicles of the scalp. However, as shown in Table 11, even in the case of an external composition containing a thickener, the amount of permeation of the scalp into the hair follicles by using a plug-type container for liquid coating provided with a soft porous coating portion. (With hair) increased significantly.
〔試験例6:容器の比較(3)〕
表1に示した処方4を、軟質多孔性のポリウレタン発泡体(軟質ウレタン)で形成された軟質多孔性塗布部を備えた液体塗布用栓式容器、又は液体用細口容器に収容して試験製剤とした。〔試験方法〕に記載した方法により、各試験製剤の浸透量(毛髪あり)を測定した。結果を併せて表12に示す。
The formulation 4 shown in Table 1 is housed in a liquid coating stopper type container provided with a soft porous coating portion made of a soft porous polyurethane foam (soft urethane) or a liquid narrow mouth container to be a test preparation. And said. The permeation amount (with hair) of each test product was measured by the method described in [Test method]. The results are also shown in Table 12.
表12に示すとおり、軟質多孔性のポリウレタン発泡体(軟質ウレタン)で形成された軟質多孔性塗布部を備えた液体塗布用栓式容器を用いた場合にも、毛包への浸透量が高められた。 As shown in Table 12, even when a liquid coating plug-type container provided with a soft porous coating portion made of a soft porous polyurethane foam (soft urethane) is used, the amount of penetration into hair follicles is high. Was done.
別途、容器に収容して用いた場合と等量(0.4g)の処方4を、図2(b)に示した毛髪サンプル150の上に滴下し、それを指で塗り広げることにより、容器を用いずに塗布した場合の評価も行った。その結果、指で塗り広げようとしても処方4の試験製剤が毛髪にはじかれて非常に浸透させ難く、その浸透量は液体用細口容器を用いる場合よりも劣る傾向があることが確認された。
Separately, the same amount (0.4 g) of the formulation 4 as that used in the container is dropped onto the
〔製剤処方例〕
以下に、本発明の製剤処方例を示す。これらのローション剤は、頭皮に適用した場合に、広範囲に塗布できるだけでなく、液ダレしにくく、毛髪があっても十分に液剤が頭皮に到達した感覚があり、実効感に優れる。
[Example of pharmaceutical prescription]
The following is an example of the pharmaceutical formulation of the present invention. When applied to the scalp, these lotions not only can be applied over a wide area, but also do not easily drip, and even if there is hair, there is a feeling that the liquid has reached the scalp sufficiently, and the effect is excellent.
<製剤処方例1:ローション剤>
(1)イオン交換水 残余
(2)プレドニゾロン吉草酸エステル酢酸エステル 0.15重量%
(3)l-メントール 3.5重量%
(4)1,3-ブチレングリコール 5重量%
(5)パラベン 0.1重量%
(6)エデト酸2ナトリウム 0.05重量%
(7)疎水化ヒドロキシプロピルメチルセルロース 0.1重量%
(8)無水エタノール 45重量%
常法に従い、上記の各成分を配合した処方を調製する。調製した処方を、軟質多孔性材料(天然ゴム発泡体)で形成された塗布部を有する容器に充填することで、本実施形態のローション剤を製造することができる。
<Formulation example 1: Lotion agent>
(1) Ion-exchanged water residue (2) Prednisolone valeric acid ester Acetic acid ester 0.15% by weight
(3) l-menthol 3.5% by weight
(4) 1,3-
(5) Paraben 0.1% by weight
(6) Disodium edetate 0.05% by weight
(7) Hydrophobicized hydroxypropylmethylcellulose 0.1% by weight
(8) 45% by weight of absolute ethanol
A formulation containing each of the above ingredients is prepared according to a conventional method. The lotion agent of the present embodiment can be produced by filling the prepared formulation in a container having a coating portion formed of a soft porous material (natural rubber foam).
<製剤処方例2:ローション剤>
(1)イオン交換水 残余
(2)ジフェンヒドラミン塩酸塩 1.0重量%
(3)l-メントール 3.5重量%
(4)1,3-ブチレングリコール 10重量%
(5)パラベン 0.1重量%
(6)エデト酸2ナトリウム 0.05重量%
(7)疎水化ヒドロキシプロピルメチルセルロース 0.2重量%
(8)無水エタノール 50重量%
常法に従い、上記の各成分を配合した処方を調製する。調製した処方を、軟質多孔性材料(天然ゴム発泡体)で形成された塗布部を有する容器に充填することで、本実施形態のローション剤を製造することができる。
<Pharmaceutical prescription example 2: Lotion agent>
(1) Ion-exchanged water residue (2) Diphenhydramine hydrochloride 1.0% by weight
(3) l-menthol 3.5% by weight
(4) 1,3-
(5) Paraben 0.1% by weight
(6) Disodium edetate 0.05% by weight
(7) Hydrophobicized hydroxypropylmethylcellulose 0.2% by weight
(8) 50% by weight of absolute ethanol
A formulation containing each of the above ingredients is prepared according to a conventional method. The lotion agent of the present embodiment can be produced by filling the prepared formulation in a container having a coating portion formed of a soft porous material (natural rubber foam).
<製剤処方例3:ローション剤>
(1)イオン交換水 残余
(2)グリチルリチン酸ジカリウム 0.1重量%
(3)酢酸トコフェロール 0.05重量%
(4)1,3-ブチレングリコール 5重量%
(5)パラベン 0.1重量%
(6)エデト酸2ナトリウム 0.05重量%
(7)カルボキシビニルポリマー 0.15重量%
(8)水酸化カリウム 0.05重量%
(9)無水エタノール 10重量%
常法に従い、上記の各成分を配合した処方を調製する。調製した処方を、軟質多孔性材料(ポリウレタン発泡体)で形成された塗布部を有する容器に充填することで、本実施形態のローション剤を製造することができる。
<Pharmaceutical prescription example 3: Lotion agent>
(1) Ion-exchanged water residue (2) Dipotassium glycyrrhizinate 0.1% by weight
(3) Tocopherol acetate 0.05% by weight
(4) 1,3-
(5) Paraben 0.1% by weight
(6) Disodium edetate 0.05% by weight
(7) Carboxyvinyl polymer 0.15% by weight
(8) Potassium hydroxide 0.05% by weight
(9)
A formulation containing each of the above ingredients is prepared according to a conventional method. The lotion agent of the present embodiment can be produced by filling the prepared formulation in a container having a coating portion formed of a soft porous material (polyurethane foam).
<製剤処方例4:乳化系ローション剤>
(1)イオン交換水 残余
(2)プレドニゾロン吉草酸エステル酢酸エステル 0.15重量%
(3)アラントイン 0.2重量%
(4)ジプロピレングリコール 3重量%
(5)ジグリセリン 1重量%
(6)軽質流動パラフィン 1.5重量%
(7)パルミチン酸イソプロピル 0.5重量%
(8)モノステアリン酸ソルビタン 0.5重量%
(9)ポリソルベート60 1.5重量%
(10)パラベン 0.2重量%
(11)エデト酸2ナトリウム 0.05重量%
(12)カルボキシビニルポリマー 0.2重量%
(13)トリエタノールアミン 0.3%重量%
(14)無水エタノール 5重量%
常法に従い、上記の各成分を配合した処方を調製する。調製した処方を、軟質多孔性材料(天然ゴム発泡体)で形成された塗布部を有する容器に充填することで、本実施形態の乳化系ローション剤を製造することができる。
<Prescription example 4: Emulsifying lotion>
(1) Ion-exchanged water residue (2) Prednisolone valeric acid ester Acetic acid ester 0.15% by weight
(3) Allantoin 0.2% by weight
(4) Dipropylene glycol 3% by weight
(5) Diglycerin 1% by weight
(6) Light liquid paraffin 1.5% by weight
(7) Isopropyl palmitate 0.5% by weight
(8) Sorbitan monostearate 0.5% by weight
(9) Polysorbate 60 1.5% by weight
(10) Paraben 0.2% by weight
(11) Disodium edetate 0.05% by weight
(12) Carboxyvinyl polymer 0.2% by weight
(13) Triethanolamine 0.3% by weight
(14)
A formulation containing each of the above ingredients is prepared according to a conventional method. The emulsified lotion of the present embodiment can be produced by filling the prepared formulation in a container having a coating portion formed of a soft porous material (natural rubber foam).
10,11…容器本体、20,21…外用組成物、30,31…キャップ、40,41…螺子、50…塗布部、51…開口部(塗布部)、100…軟質多孔性塗布部を備えた液体塗布用栓式容器、110…貫通孔、120…シリコンシート、130…キムタオル、140…浸透液、150…毛髪サンプル、200…液体用細口容器。 10, 11 ... Container body, 20, 21 ... External composition, 30, 31 ... Cap, 40, 41 ... Screw, 50 ... Coating part, 51 ... Opening (coating part), 100 ... Soft porous coating part Liquid application plug-type container, 110 ... through hole, 120 ... silicon sheet, 130 ... Kim towel, 140 ... penetrant, 150 ... hair sample, 200 ... narrow mouth container for liquid.
Claims (7)
ステロイド、モノテルペン、及び抗ヒスタミン成分からなる群より選択される少なくとも1種と、を含有し、
軟質多孔性材料で形成された塗布部を備える容器(但し、薬液を毛髪や頭皮に塗布する塗布部と、前記塗布部に供給する薬液を貯留する薬液貯蔵部を有する薬液塗布用具であり、前記塗布部は、前記薬液貯蔵部に連通し薬液を吐出させる吐出通路と、押し上げにより移動して前記吐出通路を開き薬液を吐出させる導き機能を有する中棒部材と、前記中棒部材を前記吐出通路を閉じ方向に付勢し、押し上げ力に対して負荷を与える付勢手段と、を有し、前記中棒部材は、押し上げにより移動して前記吐出通路を開き薬液を吐出させ、押し上げによる前記中棒部材の移動に応じて薬液の吐出量を変化させることを特徴とする薬液塗布用具を除く。)に収容されてなる頭皮用外用組成物(但し、ジフェンヒドラミン塩酸塩及びデキサメタゾン酢酸エステルを含有する外用組成物を除く。)。 With lower alcohol
Containing at least one selected from the group consisting of steroids, monoterpenes, and antihistamine components,
A container provided with a coating portion made of a soft porous material (provided that the chemical solution coating tool has a coating portion for applying the chemical solution to hair or the scalp and a chemical solution storage section for storing the chemical solution to be supplied to the coating portion. The coating portion includes a discharge passage that communicates with the chemical liquid storage unit to discharge the chemical liquid, a middle rod member that moves by pushing up to open the discharge passage and has a guiding function to discharge the chemical liquid, and the middle rod member is the discharge passage. It has an urging means for urging in the closing direction and applying a load to the pushing force, and the middle rod member moves by pushing up to open the discharge passage to discharge the chemical solution, and the middle rod member is pushed up. External composition for scalp contained in a chemical solution application tool (excluding a chemical solution application tool characterized by changing the discharge amount of the chemical solution according to the movement of the rod member) (provided that the external use contains diphenhydramine hydrochloride and dexamethasone acetate. Excluding the composition.).
The external composition for scalp according to any one of claims 1 to 6, further comprising a thickener.
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