JP2006045181A - External composition for skin - Google Patents
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Abstract
Description
本発明は、極めて優れた薬効と持続性とを有する皮膚外用組成物に関する。 The present invention relates to an external composition for skin having extremely excellent medicinal properties and durability.
皮膚外用組成物とは、皮膚疾患の治療や予防のために皮膚に適用するものであり、例えば、有効成分として抗炎症成分や保湿成分等を含有する軟膏やクリーム又はローション等が用いられてきた（非特許文献１）。
しかしながら、従来の皮膚外用組成物の多くは、作用が弱く、充分な薬効の持続性も得られないことから、何度も塗布を繰り返さなくてはならないという問題があった。
The external composition for skin is applied to the skin for the treatment and prevention of skin diseases. For example, an ointment, cream or lotion containing an anti-inflammatory component or a moisturizing component as an active ingredient has been used. (Non-Patent Document 1).
However, many of the conventional external compositions for skin have a problem that the action is weak and sufficient medicinal sustainability cannot be obtained, so that the application must be repeated many times.
本発明は、上記現状に鑑み、極めて優れた薬効と持続性とを有する皮膚外用組成物を提供することを目的とする。 An object of this invention is to provide the external composition for skin which has the very outstanding medicinal effect and sustainability in view of the said present condition.
本発明者らは、鋭意検討した結果、有効成分に対し、一定のキトサン又はキトサンの誘導体を組み合わせて用いることにより、優れた薬効と持続性とを有する皮膚外用組成物が得られることを見出し、本発明を完成するに至った。
即ち、本発明によれば、抗炎症成分或いは保湿成分である有効成分に対し、一定のキトサン又はキトサンの誘導体を組み合わせて用いることにより、有効成分のみからでは通常予想し得ないような、非常に優れた薬効と持続性とを有する皮膚外用組成物が得られる。
本発明は、有効成分と一定のキトサン又はキトサンの誘導体とを含有する皮膚外用組成物である。
以下に本発明を詳述する。
As a result of intensive studies, the present inventors have found that an external composition having excellent medicinal properties and durability can be obtained by using a certain chitosan or a derivative of chitosan in combination with an active ingredient, The present invention has been completed.
That is, according to the present invention, by using a certain chitosan or chitosan derivative in combination with an active ingredient that is an anti-inflammatory component or a moisturizing component, it is very difficult to expect from the active component alone. A composition for external use on skin having excellent medicinal properties and durability can be obtained.
The present invention is an external composition for skin containing an active ingredient and certain chitosan or a chitosan derivative.
The present invention is described in detail below.
本発明の皮膚外用組成物は、キトサン又はキトサンの誘導体を含有するものである。
上記キトサンとは、キチンを濃アルカリ溶液等と加熱する等して、４０ｍｏｌ／ｍｏｌ％以上の脱アセチル化をすることにより得られるポリ−Ｎ−アセチル−Ｄ−グルコサミンのことをいう。使用する原料キチンの種類、キトサンの製造方法としては特に限定されない。
The skin external composition of the present invention contains chitosan or a chitosan derivative.
The chitosan refers to poly-N-acetyl-D-glucosamine obtained by deacetylation of 40 mol / mol% or more by heating chitin with a concentrated alkaline solution or the like. There are no particular limitations on the type of raw material chitin used and the method for producing chitosan.
本発明では、キトサンの誘導体も好適に用いられる。上記キトサンの誘導体としては、例えば、キトサンのグルコサミン残基のアミノ基、−ＯＨ基又は−ＣＨ2ＯＨ基がアルキル化、サクシニル化、ヒドロキシアルキル化、アルキルカルボニル化、ヒドロキシアルキルカルボニル化されたもの等が挙げられる。更に、キチンの脱アセチル化されたアミノ基が有機酸や無機酸と塩を形成しているもの等も挙げられる。 In the present invention, a chitosan derivative is also preferably used. Examples of the chitosan derivative include, for example, those in which the amino group, —OH group or —CH 2 OH group of the glucosamine residue of chitosan is alkylated, succinylated, hydroxyalkylated, alkylcarbonylated, hydroxyalkylcarbonylated, etc. Is mentioned. Furthermore, there may be mentioned those in which the deacetylated amino group of chitin forms a salt with an organic acid or inorganic acid.
本発明で用いられるキトサンは、平均重合度が５〜３０００のものである。この範囲外であると、充分な薬効と持続効果とが得られないことがある。好ましい平均重合度の上限は１０００である。また、キトサンの誘導体を用いる場合も平均重合度が５〜３０００のものであり、平均重合度の上限は１０００が好ましい。
なお、上記平均重合度は、キトサンのＣ6Ｈ11ＮＯ4を１単位として（ｎ＝１）、粘度から求められた数値を意味する。
The chitosan used in the present invention has an average degree of polymerization of 5 to 3000. If it is out of this range, sufficient medicinal effect and sustained effect may not be obtained. A preferable upper limit of the average degree of polymerization is 1000. Further, when a chitosan derivative is used, the average degree of polymerization is 5 to 3000, and the upper limit of the average degree of polymerization is preferably 1000.
Incidentally, the average degree of polymerization, a C 6 H 11 NO 4 of chitosan as one unit (n = 1), means a numerical value obtained from viscosity.
本発明の皮膚外用組成物におけるキトサン及びキトサンの誘導体の含有量は、下限が０．２重量％、上限が１０重量％である。０．２重量％未満であると、充分な薬効と持続効果とが得られないことがあり、１０重量％を超えると、それ以上の効果は期待できないことに加え、溶解しにくく、製剤化が困難となることがある。好ましい下限は０．５重量％、好ましい上限は５重量％であり、より好ましい下限は１重量％、より好ましい上限は３重量％である。 The lower limit of the content of chitosan and chitosan derivatives in the composition for external use of the present invention is 0.2% by weight, and the upper limit is 10% by weight. If it is less than 0.2% by weight, sufficient medicinal and sustained effects may not be obtained. If it exceeds 10% by weight, no further effect can be expected, and it is difficult to dissolve. It can be difficult. A preferred lower limit is 0.5% by weight, a preferred upper limit is 5% by weight, a more preferred lower limit is 1% by weight, and a more preferred upper limit is 3% by weight.
本発明の皮膚外用組成物は、上記キトサン又はその誘導体を水溶化するために酸を含有することが好ましい。
上記酸としては無機酸、有機酸のいずれも用いることができる。上記無機酸としては、例えば、塩酸、リン酸、硫酸、硝酸等が挙げられる。上記有機酸としては、例えば、酢酸、コハク酸、リンゴ酸、乳酸、酪酸、フマル酸、マロン酸、イタコン酸、グルコン酸、グリコール酸、酒石酸、クエン酸等が挙げられる。特に、カルボン酸にヒドロキシル基を有する化学構造を持つ脂肪酸であるヒドロキシ酸が好ましい。これらの酸は単独で用いられてもよいし、２種以上が併用されてもよい。
上記酸の含有量の好ましい下限は０．１重量％、好ましい上限は２０重量％である。０．１重量％未満であると、充分にキトサン又はその誘導体を水溶化できないことがあり、２０重量％を越えると、適用部位によっては皮膚刺激性を示す可能性がある。より好ましい下限は０．５重量％、より好ましい上限は１０重量％である。
The external composition for skin of the present invention preferably contains an acid in order to make the chitosan or derivative thereof water-soluble.
As the acid, either an inorganic acid or an organic acid can be used. Examples of the inorganic acid include hydrochloric acid, phosphoric acid, sulfuric acid, nitric acid, and the like. Examples of the organic acid include acetic acid, succinic acid, malic acid, lactic acid, butyric acid, fumaric acid, malonic acid, itaconic acid, gluconic acid, glycolic acid, tartaric acid, and citric acid. In particular, a hydroxy acid which is a fatty acid having a chemical structure having a hydroxyl group in the carboxylic acid is preferred. These acids may be used independently and 2 or more types may be used together.
The minimum with preferable content of the said acid is 0.1 weight%, and a preferable upper limit is 20 weight%. If it is less than 0.1% by weight, chitosan or a derivative thereof may not be sufficiently water-solubilized, and if it exceeds 20% by weight, skin irritation may be exhibited depending on the application site. A more preferred lower limit is 0.5% by weight, and a more preferred upper limit is 10% by weight.
本発明の皮膚外用組成物は、有効成分として抗炎症成分及び／又は保湿成分を含有するものである。
上記抗炎症成分としては、グリチルレチン酸、グリチルリチン酸塩、グリチルリチン酸、βーグリチルレチン酸、グリチルレチン酸グリセリン、グリチルリチン酸ステアリル、グリチルリチン酸ステアリルピリドキシン、アラントイン、アルニカエキス、オウゴンエキス、オウレンエキス、オドリコソウエキス、ガマ穂エキス、カミツレエキス、カラミン、カワラヨモギエキス、甘草エキス、クチナシエキス、クマザサエキス、ゲンチアナエキス、紅茶エキス、コンフリーエキス、酢酸トコフェロール、サリチル酸メチル、酸化亜鉛、シコンエキス、シソエキス、シナノキエキス、シモツケソウエキス、シャクヤクエキス、スイカズラエキス、セージエキス、セイヨウキズタエキス、セイヨウニワトコエキス、セイヨウノコギリソウエキス、センブリエキス、ソウハクヒエキス、トウキンセンカエキス、ピリドキシンＨＣＬ、ビワ葉エキス、モモ葉エキス、ヤグルマキクエキス、ユキノシタエキス、ヨモギエキス、レタスエキス、ローマカミツレエキス、ワレモコウエキス又はε−アミノカプロン酸が挙げられる。上記グリチルリチン酸塩として、例えば、グリチルリチン酸ジカリウム、グリチルリチン酸３ナトリウム、グリチルリチン酸２ナトリウム、グリチルリチン酸モノアンモニウム等が挙げられる。
The external composition for skin of the present invention contains an anti-inflammatory component and / or a moisturizing component as an active ingredient.
Examples of the anti-inflammatory component include glycyrrhetinic acid, glycyrrhizinate, glycyrrhizic acid, β-glycyrrhetinic acid, glyceryl retinoic acid, stearyl glycyrrhizinate, stearylpyridoxine glycyrrhizinate, allantoin, arnica extract, urgonum extract, lauren extract, licorice extract, gama Panicle extract, chamomile extract, calamine, sagebrush extract, licorice extract, gardenia extract, kumazasa extract, gentian extract, tea extract, comfrey extract, tocopherol acetate, methyl salicylate, zinc oxide, pear extract, perilla extract, linden extract, citrus extract, peonies Extract, honeysuckle extract, sage extract, Kizuta extract, elderberry extract, yarrow extract, Nburiekisu, mulberry bark extract, Toukinsenkaekisu, pyridoxine HCL, loquat leaf extract, peach leaf extract, Ya Guruma chrysanthemum extract, saxifrage extract, mugwort extract, lettuce extract, Roman chamomile extract, is burnet extract or ε- aminocaproic acid. Examples of the glycyrrhizinate include dipotassium glycyrrhizinate, trisodium glycyrrhizinate, disodium glycyrrhizinate, monoammonium glycyrrhizinate, and the like.
上記保湿成分としては、ＤＮＡ−Ｎａ、ＰＣＡ−Ｎａ（ピロリドンカルボン酸ナトリウム）、ＰＧ（プロピレングリコール）、ＲＮＡ−Ｎａ、アシタバエキス、アスパラギン酸、アマチャエキス、アラニン、アルギニン、アルギン酸Ｎａ、アルテアエキス、アロエベラエキス−２、オイスターエキス、加水分解ケラチン、加水分解コラーゲン、加水分解コンキオリン、加水分解卵殻膜、加水分解卵白、加水分解シルク、褐藻エキス、カリンエキス、キイチゴエキス、キシリトール、キュウリエキス、クインスシードエキス、グリシン、グルコース、グレープフルーツエキス、クレマティスエキス、ケープアロエエキス、ゴボウエキス、サンザシエキス、シイタケエキス、ジオウエキス、ジグリセリン、シスチン、システイン、スギナエキス、ゼニアオイエキス、セリン、ソルビトール、ダイズタンパク、トマトエキス、トレハロース、ノバラエキス、バクガエキス、ハチミツ、ブクリョウエキス、ヘチマエキス、マルチトース、マルトース、マンニトール、ユリエキス、ラクトフェリン、リシン、リンゴエキス、レンゲソウエキス、ローヤルゼリー、アーモンド油、アボガド油、オリーブ油、オレイン酸、オレンジラフィー油、カカオ脂、カロットエキス、ゴマ油、サザンカ油、サフラワー油、ジヒドロコレステロール、月見草油、ヒマシ油、ヒマワリ油、フィトスフィンゴシン、ブドウ種子油、ホホバ油、マカデミアナッツ油、ミネラルオイル、ミンク油、メドウフォーム油、ユーカリ油、ラノリン、ローズヒップ油又はワセリンが挙げられる。 Examples of the moisturizing component include DNA-Na, PCA-Na (sodium pyrrolidonecarboxylate), PG (propylene glycol), RNA-Na, ashitaba extract, aspartic acid, amateur extract, alanine, arginine, sodium alginate, altea extract, aloe vera Extract-2, oyster extract, hydrolyzed keratin, hydrolyzed collagen, hydrolyzed conchiolin, hydrolyzed egg shell membrane, hydrolyzed egg white, hydrolyzed silk, brown algae extract, karin extract, raspberry extract, xylitol, cucumber extract, quince seed extract, Glycine, glucose, grapefruit extract, clematis extract, cape aloe extract, burdock extract, hawthorn extract, shiitake extract, diou extract, diglycerin, cystine, cysteine, horsetail extract, Near Oyster Extract, Serine, Sorbitol, Soy Protein, Tomato Extract, Trehalose, Novara Extract, Bakuga Extract, Honey, Bukkuri Extract, Loofah Extract, Multitose, Maltose, Mannitol, Lily Extract, Lactoferrin, Ricin, Apple Extract, Forsythia Extract, Royal Jelly, Almond Oil, Avocado Oil, olive oil, oleic acid, orange luffy oil, cocoa butter, carrot extract, sesame oil, sasanqua oil, safflower oil, dihydrocholesterol, evening primrose oil, castor oil, sunflower oil, phytosphingosine, grape seed oil, jojoba oil, macadamia nut oil , Mineral oil, mink oil, meadow foam oil, eucalyptus oil, lanolin, rosehip oil or petrolatum.
これらの有効成分は単独で用いられてもよいし、２種以上が併用されてもよい。また、上記有効成分としては、上記で例示した有効成分の塩又は誘導体であってもよい。
上記有効成分の含有量としては特に限定されず、各々の有効成分の通常用いられる量の範囲から適宜選択することができる。
These active ingredients may be used independently and 2 or more types may be used together. Moreover, as said active ingredient, the salt or derivative | guide_body of the active ingredient illustrated above may be sufficient.
It does not specifically limit as content of the said active ingredient, It can select suitably from the range of the quantity normally used of each active ingredient.
本発明の皮膚外用組成物は、本発明の目的を阻害しない範囲で、粉末、油分、界面活性剤、増粘剤、有機溶剤、可塑剤、色素、顔料、香料、防腐剤、抗酸化剤等を含有していても良い。 The composition for external use of the skin of the present invention is a powder, oil, surfactant, thickener, organic solvent, plasticizer, dye, pigment, fragrance, preservative, antioxidant, etc., as long as the object of the present invention is not impaired. It may contain.
本発明の皮膚外用組成物の剤形としては特に限定されず、例えば、軟膏剤、クリーム剤、液剤等が挙げられ、上記液剤には、例えば、ゲル剤、ゾル剤、水溶液剤、アルコール剤、グリセリン・グリコール剤、油剤、懸濁型ローション剤、乳剤型ローション剤、ニス剤、湿布剤、噴霧剤等が含まれる。
本発明の皮膚外用組成物の製造方法としては特に限定されず、従来公知の方法により製造することができる。
The dosage form of the external composition for skin of the present invention is not particularly limited, and examples thereof include ointments, creams, liquids, etc. Examples of the liquids include gels, sols, aqueous solutions, alcohols, Examples include glycerin glycol agent, oil agent, suspension type lotion agent, emulsion type lotion agent, varnish agent, poultice agent, spray agent and the like.
It does not specifically limit as a manufacturing method of the external composition for skin of this invention, It can manufacture by a conventionally well-known method.
本発明の皮膚外用組成物の適用量は、有効成分の種類や濃度、塗布する部位の状態等により適宜調整され、特に限定されないが、通常は１日に１〜数回、０．０１〜１０ｇ／１回程度を適用することが好ましい。また本発明の皮膚外用組成物の適用方法としても特に限定されず、手指により塗布する方法やへら等の器具を用いた通常の塗布方法の他、ポンプ式、スプレー式、チューブ式容器から直接塗布する方法、湿布する方法等が挙げられる。 The application amount of the external composition for skin of the present invention is appropriately adjusted depending on the type and concentration of the active ingredient, the state of the site to be applied, etc., but is not particularly limited, but is usually 0.01 to 10 g once to several times a day. / It is preferable to apply about once. Also, the application method of the external composition for skin of the present invention is not particularly limited, and it is applied directly from a pump type, spray type, tube type container in addition to a normal application method using a finger or a spatula. And a method of compressing.
本発明の皮膚外用組成物は、抗炎症成分或いは保湿成分である有効成分に対し、一定のキトサン又はキトサンの誘導体を組み合わせて用いるので、有効成分のみからでは通常予想し得ないような、非常に優れた薬効と持続性とを有している。
これにより、何度も塗布を繰り返す必要がなく、効率よい治療を行うことができる。
The external composition for skin of the present invention uses a certain chitosan or chitosan derivative in combination with an active ingredient that is an anti-inflammatory component or a moisturizing component. It has excellent medicinal properties and sustainability.
Thereby, it is not necessary to repeat application | coating many times, and an efficient treatment can be performed.
以下に実施例を掲げて本発明を更に詳しく説明するが、本発明はこれら実施例のみに限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to examples. However, the present invention is not limited to these examples.
（実施例１〜６０）
平均重合度３０又は３００のキトサン（和光純薬社製）と、表１及び表２に示した有効成分とを、表１及び表２に示した含有量になるように、乳酸２重量％とともに注射用水に添加して攪拌、溶解・分散して、皮膚外用組成物サンプルを得た。
尚、有効成分としては、グリチルレチン酸（ナカライテスク社製）、グリチルリチン酸（和光純薬社製）、アラントイン（和光純薬社製）、ＰＣＡ−Ｎａ（和光純薬社製）、加水分解コラーゲン（和光純薬社製）、ヨモギエキス（丸善製薬社製）、カミツレエキス（丸善製薬社製）、ε−アミノカプロン酸（武蔵野化学研究所製）、グアイアズレン（和光純薬社製）、シソエキス（丸善製薬社製）を使用した。
(Examples 1 to 60)
Chitosan having an average polymerization degree of 30 or 300 (manufactured by Wako Pure Chemical Industries, Ltd.) and the active ingredients shown in Tables 1 and 2 together with 2% by weight of lactic acid so as to have the contents shown in Tables 1 and 2 It was added to water for injection, stirred, dissolved and dispersed to obtain a composition sample for external use on the skin.
As active ingredients, glycyrrhetinic acid (manufactured by Nacalai Tesque), glycyrrhizic acid (manufactured by Wako Pure Chemical Industries, Ltd.), allantoin (manufactured by Wako Pure Chemical Industries, Ltd.), PCA-Na (manufactured by Wako Pure Chemical Industries, Ltd.), hydrolyzed collagen ( Wako Pure Chemical Industries), Artemisia extract (Maruzen Pharmaceutical Co., Ltd.), Chamomile extract (Maruzen Pharmaceutical Co., Ltd.), ε-aminocaproic acid (Musashino Chemical Research Laboratory), Guaiazulene (Wako Pure Chemical Industries, Ltd.), Perilla extract (Maruzen Pharmaceutical Co., Ltd.) Used).
（比較例１〜１１）
表３に示したように、グリチルレチン酸（ナカライテスク社製）、グリチルリチン酸（和光純薬社製）、アラントイン（和光純薬社製）、ＰＣＡ−Ｎａ（和光純薬社製）、加水分解コラーゲン（和光純薬社製）、グアイアズレン（和光純薬社製）、ヨモギエキス（丸善製薬社製）、カミツレエキス（丸善製薬社製）、シソエキス（丸善製薬社製）、ε−アミノカプロン酸（武蔵野化学研究所製）又はキトサン（平均重合度３００、和光純薬社製）を注射用水に１重量％となるように溶解又は乳鉢で懸濁して、比較用の皮膚外用組成物サンプルを得た。なお、キトサンを用いた比較例６のみ、乳酸を２重量％となるように配合した。
(Comparative Examples 1-11)
As shown in Table 3, glycyrrhetinic acid (manufactured by Nacalai Tesque), glycyrrhizic acid (manufactured by Wako Pure Chemical Industries, Ltd.), allantoin (manufactured by Wako Pure Chemical Industries, Ltd.), PCA-Na (manufactured by Wako Pure Chemical Industries, Ltd.), hydrolyzed collagen (Manufactured by Wako Pure Chemical Industries, Ltd.), guaiazulene (manufactured by Wako Pure Chemical Industries, Ltd.), mugwort extract (manufactured by Maruzen Pharmaceutical Co., Ltd.), chamomile extract (manufactured by Maruzen Pharmaceutical Co., Ltd.), perilla extract (manufactured by Maruzen Pharmaceutical Co., Ltd.), ε-aminocaproic acid (Musashino Chemicals) Laboratories) or chitosan (average polymerization degree 300, manufactured by Wako Pure Chemical Industries, Ltd.) was dissolved or suspended in water for injection at 1% by weight to obtain a composition sample for external use for comparison. In addition, only the comparative example 6 using chitosan mix | blended lactic acid so that it might become 2 weight%.
（評価１）モルモット紫外線紅斑に対する評価
４週齢ハートレー系雄性モルモットの背部を剃毛し、上記実施例１、７〜１１及び１３〜１７、並びに、比較例１、２、３及び６で得られた皮膚外用組成物０．１ｇを予め定めた背部正中寄り２．５ｃｍ角全体に行き渡るよう塗布した。塗布４時間後及び２４時間後に、それぞれ、紫外線紅斑装置（ユニコム社製、商品名「ＴＫ−１５１」）を用いて、モルモット照射部位（塗布部位及びコントロール部位）に孔あき遮光布をかぶせ、ルックスメーターの読みで１６５０−１６７０になるように紫外線を３０秒間照射した。２時間後に各照射部位の紅斑強度を色彩色差計（ミノルタ社製、商品名「ＣＲ２００」）で測定し、皮膚外用組成物の薬効とその持続性を評価した。結果は表４に示した。
なお、各測定値は、健常部位の測定値を差し引いた値で、それぞれ３匹のモルモットを用いた平均値を示しており、表４の紅斑強度の数値が低いほど薬効が高いことを示している。
(Evaluation 1) Evaluation for guinea pig ultraviolet erythema The back of a 4-week-old Hartley male guinea pig was shaved and obtained in Examples 1, 7-11 and 13-17, and Comparative Examples 1, 2, 3 and 6. Further, 0.1 g of the composition for external use on the skin was applied so as to spread over the entire 2.5 cm square near the center of the back. After 4 hours and 24 hours after application, using a UV erythema apparatus (trade name “TK-151”, manufactured by Unicom), cover the guinea pig irradiation site (application site and control site) with a perforated shading cloth, and looks. Ultraviolet rays were irradiated for 30 seconds so that the meter reading would be 1650-1670. After 2 hours, the erythema intensity at each irradiated site was measured with a color difference meter (trade name “CR200”, manufactured by Minolta Co., Ltd.) to evaluate the efficacy and durability of the external composition for skin. The results are shown in Table 4.
In addition, each measured value is a value obtained by subtracting the measured value of the healthy site, and shows an average value using three guinea pigs. The lower the numerical value of erythema intensity in Table 4, the higher the medicinal effect. Yes.
表４より、一定のキトサンと有効成分とを含有する皮膚外用組成物は、それぞれの成分を単独で含有する比較用の皮膚外用組成物の効果の和より、強い紫外線紅斑抑制作用と持続性とを示した。なお、コントロール部位とは背部正中反対側であり、コントロール部位における紅斑強度の平均値は、４時間後で５．３、２４時間後で５．５であった。 From Table 4, the composition for external use of skin containing a certain chitosan and an active ingredient has a stronger UV erythema inhibitory action and sustainability than the sum of the effects of a comparative composition for external use of skin containing each ingredient alone. showed that. The control site was on the opposite side of the back midline, and the average value of erythema intensity at the control site was 5.3 after 4 hours and 5.5 after 24 hours.
（評価２）モルモットストリッピング皮膚紅斑に対する評価
４週齢ハートレー系雄性モルモットの背部を剃毛し、セロハンテープを用いて、予め定めた背部正中寄り２．５ｃｍ角を３回ストリッピングし、上記実施例１、７〜１１及び１３〜１７、並びに、比較例１、２、３及び６で得られた皮膚外用組成物０．１ｇをストリッピング部位全体に行き渡るよう塗布した。なお、背部正中反対側はストリッピングのみを行い、コントロール部位とした。塗布４時間後及び２４時間後に皮膚外用組成物塗布部位の紅斑強度を色彩色差計（ミノルタ社製、ＣＲ２００）で測定し、皮膚外用組成物の薬効とその持続性を評価した。結果は表５に示した。
なお、各測定値は、健常部位の測定値を差し引いた値で、それぞれ３匹のモルモットを用いた平均値を示しており、表５の紅斑強度の数値が低いほど薬効が高いことを示している。
(Evaluation 2) Evaluation on guinea pig stripping cutaneous erythema The back of a 4-week-old Hartley male guinea pig was shaved, and a cellophane tape was used to strip a 2.5 cm square of a predetermined midline of the back three times. 0.1 g of the external composition for skin obtained in Examples 1, 7 to 11 and 13 to 17 and Comparative Examples 1, 2, 3 and 6 was applied over the entire stripping site. In addition, only the stripping was performed on the opposite side of the back midline as a control site. After 4 hours and 24 hours after application, the erythema intensity at the site of application of the external composition for skin was measured with a color difference meter (CR200, manufactured by Minolta Co., Ltd.) to evaluate the efficacy and durability of the external composition for skin. The results are shown in Table 5.
In addition, each measured value is a value obtained by subtracting the measured value of the healthy site, and shows an average value using three guinea pigs. The lower the numerical value of erythema intensity in Table 5, the higher the medicinal effect. Yes.
表５より、一定のキトサンと有効成分とを含有する皮膚外用組成物は、それぞれの成分を単独で含有する比較用の皮膚外用組成物の効果の和より、強い紅斑抑制作用と持続性とを示した。なおコントロール部位における紅斑強度の平均値は、４時間後で１０．６、２４時間後で７．６であった。
従って、評価１及び２より、本発明の皮膚外用組成物は肌荒れ等に対する高い効果が期待できることが判明した。
From Table 5, the skin external composition containing a certain chitosan and an active ingredient has a stronger erythema inhibitory action and sustainability than the sum of the effects of the comparative skin external composition containing each component alone. Indicated. The average value of erythema intensity at the control site was 10.6 after 4 hours and 7.6 after 24 hours.
Therefore, from the evaluations 1 and 2, it was found that the external composition for skin of the present invention can be expected to have a high effect on rough skin.
（評価２−２）
上記（評価２）において、皮膚外用組成物塗布部位の紅斑強度の測定を塗布後２４時間のみとした以外は（評価２）と同様にし、実施例３１、３７、４３、４９及び５５、並びに、比較例６〜１１で得られた皮膚外用組成物の薬効とその持続性を評価した。結果は表６に示した。
(Evaluation 2-2)
In the above (Evaluation 2), Examples 31, 37, 43, 49 and 55, and Examples 31, 37, 43, 49 and 55, and The efficacy and durability of the external composition for skin obtained in Comparative Examples 6 to 11 were evaluated. The results are shown in Table 6.
(評価３)モルモット皮膚による角質水分保持性の評価
４週齢ハートレー系雄性モルモットの背部を剃毛し、背部正中寄り２．５ｃｍ角内にある部位の皮膚角質水分量を測定した。その後すぐに、上記実施例１９〜２３及び２５、並びに、比較例４〜６で得られた皮膚外用組成物０．１ｇを上記背部正中寄り２．５ｃｍ角部分全体に行き渡るよう塗布した。塗布後３時間後、塗布後２４時間後に、皮膚外用剤塗布前に皮膚角質水分量を測定したのと同じ部位において皮膚角質水分量を測定した。得られた皮膚外用剤塗布前、塗布後３時間後及び塗布後２４時間後の皮膚角質水分量の値を表７に示した。
なお、皮膚角質水分量（単位：μＳ）は、皮膚表層の水分量を測定できる測定器（ＩＢＳ社製、商品名「スキコン２００」）を用いて測定した値であり、表７の皮膚角質水分量は数値が高いほど角質水分保持性が高いことを示している。
また、各測定にはそれぞれ３匹のモルモットを用い、皮膚角質水分量は、３匹の平均値を示した。
(Evaluation 3) Evaluation of keratin moisture retention by guinea pig skin The back of a 4-week-old Hartley male guinea pig was shaved, and the skin keratin moisture content at a site within 2.5 cm square near the midline of the back was measured. Immediately thereafter, 0.1 g of the external composition for skin obtained in Examples 19 to 23 and 25 and Comparative Examples 4 to 6 was applied over the entire 2.5 cm square portion of the back midline. After 3 hours from the application, 24 hours after the application, the skin keratin water content was measured at the same site where the skin keratin water content was measured before applying the skin external preparation. Table 7 shows the values of skin keratin water content before application of the obtained skin external preparation, 3 hours after application, and 24 hours after application.
The skin keratin water content (unit: μS) is a value measured using a measuring instrument (trade name “Skicon 200” manufactured by IBS Co., Ltd.) capable of measuring the water content of the skin surface layer. The higher the value, the higher the keratin moisture retention.
In addition, three guinea pigs were used for each measurement, and the skin keratin water content showed an average value of three.
表７より、一定のキトサンと有効成分とを含有する皮膚外用組成物は、それぞれの成分を単独で含有する比較用の皮膚外用組成物の効果の和より、強い皮膚角質水分増加作用と持続性とを示した。なおコントロール部位の皮膚角質水分量の平均値は、塗布後３時間後及び２４時間後とも２４であった。
このことから、本発明の皮膚外用組成物は、皮膚乾燥に対し、高い効果が期待できることが判明した。
From Table 7, the skin external composition containing a certain chitosan and an active ingredient has stronger skin keratin moisture increasing action and durability than the sum of the effects of the comparative skin external composition containing each ingredient alone. And showed. In addition, the average value of the amount of skin keratin in the control site was 24 at 3 hours and 24 hours after application.
From this, it was found that the external composition for skin of the present invention can be expected to have a high effect on dry skin.
(評価４)しわ改善効果の評価
６０歳代の女性１０名に、実施例２５〜２９及び比較例５、６で得られた皮膚外用組成物を、前腕のしわの多い部分に、１日２回、連続２週間塗布してもらい、塗布部分の肌の状態について、以下の基準により評価点を付けてもらった。
評価点２：しわが明らかに改善した
評価点１：しわがやや改善した
評価点０：変化なし
１０名の評価点について、各人の評価点及びこれら評価点の平均値、並びに評価点２又は１を付けた人の割合（有効率）を算出し、表８に示した。有効率が高いほど、しわ改善効果が高いことを表す。
(Evaluation 4) Evaluation of wrinkle improvement effect For 10 women in their 60s, the skin external compositions obtained in Examples 25 to 29 and Comparative Examples 5 and 6 were applied to the wrinkled part of the forearm 2 times a day. The skin was applied twice a week for two consecutive weeks, and the skin condition of the applied part was evaluated according to the following criteria.
Evaluation point 2: Wrinkles are clearly improved Evaluation point 1: Wrinkles are slightly improved Evaluation point 0: No change For 10 evaluation points, the evaluation points of each person, the average value of these evaluation points, and the evaluation point 2 or The ratio (effective rate) of persons given 1 was calculated and shown in Table 8. The higher the effective rate, the higher the wrinkle improvement effect.
表８より、一定のキトサンと有効成分とを含有する皮膚外用組成物は、それぞれの成分を単独で含有する比較用の皮膚外用組成物の効果からの予想をはるかに上回る、優れたしわ改善効果を示した。
このことから、本発明の皮膚外用組成物は、しわ改善効果に対し、高い効果が期待できることが判明した。
From Table 8, the skin external composition containing a certain chitosan and an active ingredient has an excellent wrinkle improvement effect far exceeding the expectation from the effect of the comparative skin external composition containing each ingredient alone. showed that.
From this, it was found that the external composition for skin of the present invention can be expected to have a high effect on the wrinkle improving effect.
本発明によれば、極めて優れた薬効と持続性とを有する皮膚外用組成物を提供できる。 ADVANTAGE OF THE INVENTION According to this invention, the composition for skin external application which has the very outstanding medicinal effect and durability can be provided.
Claims (1)
前記有効成分は、抗炎症成分であるグリチルレチン酸、グリチルリチン酸塩、グリチルリチン酸、βーグリチルレチン酸、グリチルレチン酸グリセリン、グリチルリチン酸ステアリル、グリチルリチン酸ステアリルピリドキシン、アラントイン、アルニカエキス、オウゴンエキス、オウレンエキス、オドリコソウエキス、ガマ穂エキス、カミツレエキス、カラミン、カワラヨモギエキス、甘草エキス、クチナシエキス、クマザサエキス、ゲンチアナエキス、紅茶エキス、コンフリーエキス、酢酸トコフェロール、サリチル酸メチル、酸化亜鉛、シコンエキス、シソエキス、シナノキエキス、シモツケソウエキス、シャクヤクエキス、スイカズラエキス、セージエキス、セイヨウキズタエキス、セイヨウニワトコエキス、セイヨウノコギリソウエキス、センブリエキス、ソウハクヒエキス、トウキンセンカエキス、ピリドキシンＨＣＬ、ビワ葉エキス、モモ葉エキス、ヤグルマキクエキス、ユキノシタエキス、ヨモギエキス、レタスエキス、ローマカミツレエキス、ワレモコウエキス及びε−アミノカプロン酸、
保湿成分であるＤＮＡ−Ｎａ、ピロリドンカルボン酸ナトリウム、プロピレングリコール、ＲＮＡ−Ｎａ、アシタバエキス、アスパラギン酸、アマチャエキス、アラニン、アルギニン、アルギン酸Ｎａ、アルテアエキス、アロエベラエキス−２、オイスターエキス、加水分解ケラチン、加水分解コラーゲン、加水分解コンキオリン、加水分解卵殻膜、加水分解卵白、加水分解シルク、褐藻エキス、カリンエキス、キイチゴエキス、キシリトール、キュウリエキス、クインスシードエキス、グリシン、グルコース、グレープフルーツエキス、クレマティスエキス、ケープアロエエキス、ゴボウエキス、サンザシエキス、シイタケエキス、ジオウエキス、ジグリセリン、シスチン、システイン、スギナエキス、ゼニアオイエキス、セリン、ソルビトール、ダイズタンパク、トマトエキス、トレハロース、ノバラエキス、バクガエキス、ハチミツ、ブクリョウエキス、ヘチマエキス、マルチトース、マルトース、マンニトール、ユリエキス、ラクトフェリン、リシン、リンゴエキス、レンゲソウエキス、ローヤルゼリー、アーモンド油、アボガド油、オリーブ油、オレイン酸、オレンジラフィー油、カカオ脂、カロットエキス、ゴマ油、サザンカ油、サフラワー油、ジヒドロコレステロール、月見草油、ヒマシ油、ヒマワリ油、フィトスフィンゴシン、ブドウ種子油、ホホバ油、マカデミアナッツ油、ミネラルオイル、ミンク油、メドウフォーム油、ユーカリ油、ラノリン、ローズヒップ油及びワセリン、
並びにこれらの塩又は誘導体からなる群より選択される少なくとも１種である
ことを特徴とする皮膚外用組成物。 An external composition for skin containing 0.2 to 10% by weight of chitosan or chitosan derivative having an average degree of polymerization of 5 to 3000, and an active ingredient,
The active ingredients are anti-inflammatory ingredients glycyrrhetinic acid, glycyrrhizinate, glycyrrhizic acid, β-glycyrrhetinic acid, glycyrrhetinic acid glycerin, glycyrrhizic acid stearyl, glycyrrhizic acid stearylpyridoxine, allantoin, arnica extract, urgonum extract, lauren extract, odorifera Extract, spikelet extract, chamomile extract, calamine, sagebrush extract, licorice extract, gardenia extract, kumazasa extract, gentian extract, tea extract, comfrey extract, tocopherol acetate, methyl salicylate, zinc oxide, sicon extract, perilla extract, linden extract, citrus Extract, Peonies extract, Honeysuckle extract, Sage extract, Kizuta extract, Elderberry extract, Achillea millefolium Kiss, assembly extract, mulberry bark extract, Toukinsenkaekisu, pyridoxine HCL, loquat leaf extract, peach leaf extract, ya Guruma chrysanthemum extract, saxifrage extract, mugwort extract, lettuce extract, Roman chamomile extract, burnet extract and ε- aminocaproic acid,
Moisturizing ingredients DNA-Na, pyrrolidone carboxylate, propylene glycol, RNA-Na, ashitaba extract, aspartic acid, amacha extract, alanine, arginine, sodium alginate, altea extract, aloe vera extract-2, oyster extract, hydrolyzed keratin , Hydrolyzed collagen, hydrolyzed conchiolin, hydrolyzed eggshell membrane, hydrolyzed egg white, hydrolyzed silk, brown algae extract, karin extract, raspberry extract, xylitol, cucumber extract, quince seed extract, glycine, glucose, grapefruit extract, clematis extract, Cape Aloe Extract, Burdock Extract, Hawthorn Extract, Shiitake Extract, Giant Extract, Diglycerin, Cystine, Cysteine, Horsetail Extract, Mallow Extract, Serine, Sorbi , Soy protein, tomato extract, trehalose, wild rose extract, bakakuga extract, honey, bukuro extract, loofah extract, maltose, maltose, mannitol, lily extract, lactoferrin, lysine, apple extract, forsythia extract, royal jelly, almond oil, avocado oil, olive oil , Oleic acid, orange luffy oil, cacao butter, carrot extract, sesame oil, sasanqua oil, safflower oil, dihydrocholesterol, evening primrose oil, castor oil, sunflower oil, phytosphingosine, grape seed oil, jojoba oil, macadamia nut oil, mineral oil , Mink oil, meadow foam oil, eucalyptus oil, lanolin, rosehip oil and petrolatum,
And at least one kind selected from the group consisting of these salts or derivatives.
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-
2004
- 2004-09-17 JP JP2004272363A patent/JP2006045181A/en active Pending
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