JPH0774152B2 - Liquid for external use on skin - Google Patents
Liquid for external use on skinInfo
- Publication number
- JPH0774152B2 JPH0774152B2 JP19211190A JP19211190A JPH0774152B2 JP H0774152 B2 JPH0774152 B2 JP H0774152B2 JP 19211190 A JP19211190 A JP 19211190A JP 19211190 A JP19211190 A JP 19211190A JP H0774152 B2 JPH0774152 B2 JP H0774152B2
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- skin
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- external preparation
- preparation
- external
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
【発明の詳細な説明】 産業上の利用分野 本発明は皮膚外用液剤、詳しくは乾燥皮膚治療作用及び
鎮痒作用を合せ持つ新しい皮膚外用液剤に関する。TECHNICAL FIELD The present invention relates to a skin external liquid preparation, and more particularly to a new skin external liquid preparation having both a dry skin treatment effect and an antipruritic effect.
従来技術とその課題 最近医療福祉の現場において、乾燥性皮膚疾患の問題が
大きく取り沙汰されるようになってきた。2. Description of the Related Art Recently, in the field of medical welfare, the problem of dry skin disease has come to be widely discussed.
乾燥性皮膚疾患は、アトピー性皮膚炎、老人性乾燥皮膚
症等に代表されるように、皮膚が乾燥、角化するだけで
なく、常に掻痒症を伴う疾患である。特に老人性乾燥皮
膚症について詳述すれば、高齢者の皮膚は加齢と共にホ
ルモンの分泌量が減り、皮脂の分泌が少なくなることに
よって乾燥、角化しやすくなり、それら伴って、湿疹、
かゆみ等が生じ、全身に亘る皮膚炎となることもあり、
とりわけ寝たきり老人にとっては、かゆみが不眠やいら
いら、食欲不振等の二次的障害をもたらすともいわれ、
高齢化社会へと向かっている現在、上記問題はもはや一
部の人のものとはいえなくなっている。The dry skin disease is a disease not only that the skin is dried and keratinized but also always accompanied by pruritus as typified by atopic dermatitis and senile dry dermatosis. In particular, in case of senile dry dermatosis, the skin of the elderly will decrease in the amount of hormone secreted with aging, and the secretion of sebum will decrease, which makes it easier to dry and keratinize.
Itching, etc. may occur, resulting in dermatitis throughout the body,
Especially for bedridden old people, itching is said to cause secondary disorders such as insomnia, irritability, and loss of appetite.
Now that we are heading towards an aging society, the above problems are no longer for some people.
また近年環境及び衣食住のスタイルの急激な変化により
アレルギー患者が増えつつあり、それに伴いアレルギー
を引き起こすアトピー性皮膚炎の患者も急増している。
之等の患者は皮膚の乾燥や荒れによる外見上の問題と激
しいかゆみによる不快感、更に精神的な不安や苦痛に悩
まされている。In recent years, the number of allergic patients has been increasing due to a rapid change in the environment and the style of food, clothing, and shelter, and the number of patients with atopic dermatitis that causes allergies is also rapidly increasing.
These patients suffer from cosmetic problems due to dryness and rough skin, discomfort due to severe itchiness, and further mental anxiety and pain.
乾燥性皮膚疾患は、上述した病因のためにその治療が困
難であり、更に悪いことはかゆみにより掻痕や血痂を生
じ、病態が悪化する傾向がある。従ってその治療には、
皮膚の乾燥だけでなくかゆみも抑えることができる薬剤
が必要となる。Due to the above-mentioned etiologies, dry skin diseases are difficult to treat, and worse, itching tends to cause scars and blood clots, and the pathology tends to worsen. Therefore, in the treatment,
There is a need for a drug that can suppress itching as well as dry skin.
しかるに現在、乾燥性皮膚疾患に対して用いられている
皮膚外用剤としては、多くの製品が市販されているが、
之等はいずいれも上記乾燥性皮膚疾患の治療に合致する
性能を具備するものではない。即ち、市販の皮膚外用剤
は乾燥皮膚又は掻痒のどちらか一方にしか作用を示さ
ず、一剤で両方を治療できるものは存在していない。従
って、市販品を乾燥性皮膚疾患の治療に用いる場合は、
二剤を併用しなければならず、患者にとって極めて不便
である。また市販の皮膚外用剤は殆どの場合それらの剤
型は軟膏剤かクリーム剤であり、之等は使用者にとり、
べたつき感等を不快感を伴い、また使用部に埃等の異物
が付着しやすくなる問題があり、乾燥性皮膚疾患に対し
ては好ましいものではない。However, at present, many products are commercially available as external skin preparations used for dry skin diseases,
None of them have the performance suitable for the treatment of the above-mentioned dry skin diseases. That is, a commercially available external preparation for skin has an effect on either dry skin or pruritus, and no single preparation can treat both. Therefore, when using a commercial product for the treatment of dry skin disease,
Two drugs must be used in combination, which is extremely inconvenient for the patient. Most of the commercially available external preparations for skin are ointments or creams, and for the user,
It is not preferable for dry skin diseases, because it causes stickiness and other unpleasant sensations and foreign matter such as dust tends to adhere to the use part.
一方、病院内処方として、クロタミン製剤やコルチコス
テロイド製剤に有効量の尿素を配合したものが知られて
いる［皮膚疾患と外用製剤（南山堂）参照］が、之等は
上記市販品を単に混合したものに過ぎず、剤型も必然的
に軟膏剤かクリーム剤に限定され、不快感や異物付着の
問題を解消され得ない。On the other hand, as an in-hospital prescription, it is known that an effective amount of urea is mixed with a crotamine preparation or a corticosteroid preparation [see Skin Diseases and Topical Preparations (Nanzandou)]. It is only a mixture, and the dosage form is necessarily limited to an ointment or a cream, and the problems of discomfort and adhesion of foreign matter cannot be solved.
以上のように、従来の皮膚外用剤はこれを乾燥性皮膚疾
患に適用するには問題があり、この問題を解決した外用
剤、即ち乾燥皮膚と掻痒との両方に効き目を示し且つ使
用感が良好で異物付着の問題のない新しい外用剤が斯界
で要望されている。As described above, the conventional external preparation for skin has a problem in applying it to dry skin diseases, and an external preparation that solves this problem, that is, it has an effect on both dry skin and pruritus and has a feeling of use. There is a need in the art for new external preparations that are good and have no foreign matter adhesion problems.
課題を解決するための手段 本発明の目的は、斯界で要望されている乾燥性皮膚疾患
患者への適用に適しており、従来の外用剤に見られる問
題を全て解消された新しい外用剤を提供することにあ
る。Means for Solving the Problem An object of the present invention is to provide a new external preparation suitable for application to patients with dry skin disease, which has been demanded in the art, and has solved all the problems found in conventional external preparations. To do.
本発明者らは、上記目的より鋭意研究を重ねた結果、下
記に示す特定組成、即ち特定の乾燥皮膚治療作用をもつ
薬剤、鎮痒剤及び保湿剤の所定量を、基剤としてのエタ
ノール及び／又はイソプロピルアルコールに配合してな
る液剤形態の外用剤を調製するに成功し、該外用剤が上
記目的に合致することを見出だし、ここに本発明を完成
するに至った。The inventors of the present invention have made extensive studies as a result of the above object, and as a result, a specific composition shown below, that is, a predetermined amount of a drug having a specific dry skin treatment action, an antipruritic agent and a moisturizing agent, was used as a base with ethanol and / or Alternatively, they succeeded in preparing a liquid preparation for external use prepared by mixing with isopropyl alcohol, and found that the external preparation meets the above purpose, and thus completed the present invention.
即ち、本発明は下記組成範囲の各成分と精製水とを必須
成分として含有することを特徴とする皮膚外用液剤に係
わる。That is, the present invention relates to a liquid preparation for external use for skin, which contains each component in the following composition range and purified water as essential components.
尿 素 8 〜23w/v％ ジフェンヒドラミン 0.3〜 4w/v％ リドカイン 0.5〜 5w/v％ エタノール及び／又はイソプロピルアルコール40 〜70
w/v％ 保湿剤 0.1〜30w/v％ 本発明の皮膚外用剤は、上記特定組成を有する液剤形態
としたことに基づき、乾燥皮膚治療作用と鎮痒作用とを
合せ有し、しかも使用感に優れ且つ異物付着の問題を伴
わない利点を有している。Urine 8 to 23 w / v% Diphenhydramine 0.3 to 4 w / v% Lidocaine 0.5 to 5 w / v% Ethanol and / or isopropyl alcohol 40 to 70
w / v% humectant 0.1 to 30 w / v% The external preparation for skin of the present invention has a dry skin treatment effect and an antipruritic effect on the basis of being in the form of a liquid having the above-mentioned specific composition, and has a feeling of use. It has the advantage of being excellent and free from the problem of foreign matter adhesion.
また本発明皮膚外用剤は、尿素の分解及びそれにより生
成するアンモニアの量が少ない点で、より安定である利
点をも有している。Further, the external preparation for skin of the present invention has an advantage that it is more stable in that the decomposition of urea and the amount of ammonia produced thereby are small.
本発明液剤において、尿素は乾燥皮膚治療の薬効成分と
して用いられるものであり、その配合量は上記薬効を示
すのに充分な量、即ち全組成物の８〜23％（w/v％、以
下同じ）、好ましくは10〜20％の範囲から選択されるの
が重要であり、この範囲を外れる量、特に上記範囲を下
回る量で用いる場合、本発明所期の効果は奏し得なくな
る。In the liquid preparation of the present invention, urea is used as a medicinal ingredient for treating dry skin, and its compounding amount is an amount sufficient to exhibit the medicinal effect, that is, 8 to 23% (w / v%, below of the total composition). The same), preferably from 10 to 20%, is important. When used in an amount outside this range, particularly below the above range, the intended effect of the present invention cannot be obtained.
また、本発明液剤は抗ヒスタミン剤としてのジフェンヒ
ドラミン及び局所麻酔剤としてのリドカインのそれぞれ
所定量を含有することが重要である。之等はいずれも鎮
痒成分として働くものであり、該抗ヒスタミン剤として
のジフェンヒドラミンは、その塩酸塩、タンニン酸塩等
の薬理的に許容される塩の形態で利用することもでき
る。之等の配合量は、抗ヒスタミン剤としてのジフェン
ヒドラミンの場合、0.3〜４％、好ましくは0.5〜２％の
範囲、また局所麻酔剤としてのリドカインの場合、0.5
〜５％、好ましくは１〜３％の範囲とするのがよく、之
等配合量範囲において、本発明所期の効果を奏し得る。Further, it is important that the liquid preparation of the present invention contains diphenhydramine as an antihistamine and predetermined amounts of lidocaine as a local anesthetic. All of them work as an antipruritic component, and diphenhydramine as the antihistamine can be used in the form of a pharmacologically acceptable salt such as its hydrochloride or tannate. In the case of diphenhydramine as an antihistamine, the compounding amount is in the range of 0.3 to 4%, preferably 0.5 to 2%, and in the case of lidocaine as a local anesthetic, it is 0.5.
It is preferable to be in the range of ˜5%, preferably 1 to 3%, and the desired effects of the present invention can be achieved in the same range of compounding amount.
本発明の皮膚外用液剤には、上記各必須薬効成分の他
に、之等各成分の薬効を補うために、他の同様の薬効成
分を付加的に添加配合することもできる。上記他の薬効
成分としては、乾燥皮膚治療成分として例えばサリチル
酸等を、鎮痒成分として例えばクロタミトン、マレイン
酸クロルフェニラミン等を例示できる。但し之等の配合
量は本発明製剤が液剤形態を保持する量とする必要があ
る。In addition to the above-mentioned essential medicinal components, the same external medicinal components may be added to the external liquid preparation of the present invention in order to supplement the medicinal properties of each component. Examples of the other medicinal component include salicylic acid as a dry skin treating component, and crotamiton, chlorpheniramine maleate as an antipruritic component. However, it is necessary that the amount of each of them is such that the preparation of the present invention maintains the liquid form.
本発明液剤は、更に保湿剤を必須成分として含有してお
り、これは尿素の保湿及び乾燥皮膚治療作用を助長する
働きがある。該保湿剤としては、従来公知の各種のもの
のいずれでもよく、その具体例としては例えばグリセリ
ン、プロピレングリコール、1,3−ブチレングリコール
等の多価アルコール類、ポリエチレングリコール、ヒド
ロキシプロピルセルロース等の水溶性高分子物質、その
他乳酸、乳酸ナトリウム等を例示できる。之等保湿剤の
本発明液剤中への配合割合は、該保湿剤の種類により若
干異なるが、0.1〜30％の範囲から適宜選択されるのが
よく、薬効成分の作用や製剤の妨げとならない量をする
のはいうまでもない。The liquid preparation of the present invention further contains a moisturizing agent as an essential component, which has the function of promoting the moisturizing effect of urea and the therapeutic effect on dry skin. The moisturizer may be any of various conventionally known ones, and specific examples thereof include polyhydric alcohols such as glycerin, propylene glycol, and 1,3-butylene glycol, and water-soluble polyethylene glycol, hydroxypropyl cellulose and the like. Examples thereof include polymeric substances, lactic acid, sodium lactate and the like. The mixing ratio of the humectant to the liquid agent of the present invention is slightly different depending on the type of the humectant, but it is preferably appropriately selected from the range of 0.1 to 30% and does not interfere with the action of the medicinal component or the formulation. It goes without saying that the amount is used.
更に、本発明液剤は基剤としてエタノール及び又はイソ
プロピルアルコールを40〜70％用いることを特徴とす
る。該エタノールは前記した本発明に必須の各成分の溶
解力に優れ、また水ともよく混和するので、薬剤及び水
分を皮膚から吸収し易くする作用があると共に、殺菌消
毒作用をも有し、更に使用後は皮膚から速やかに蒸発す
るので、軟膏剤やクリーム剤のような基剤によるべとつ
き感を与えず、加えて蒸発熱を奪うことで皮膚に清涼感
をもたらす利点がある。Further, the liquid preparation of the present invention is characterized by using 40 to 70% of ethanol and / or isopropyl alcohol as a base. The ethanol has excellent dissolving power for each of the above-mentioned essential components of the present invention and also mixes well with water, so that it has an action of facilitating absorption of the drug and water from the skin, and also has a bactericidal / disinfecting action. Since it evaporates quickly from the skin after use, it has the advantage that it does not give a sticky feeling due to a base such as an ointment or a cream, and in addition, it gives a refreshing feeling to the skin by removing the heat of evaporation.
本発明の皮膚外用液剤は、上記各成分を含有する限り、
この製法は特に限定されるものではないが、一般には前
記必須薬効成分を混合してエタノール及び／又はイソプ
ロピルアルコールに溶解させた後、該溶液に保湿剤を添
加し、これに適量の水を追加して均一な液剤形態とする
ことにより調製される。The external preparation for skin of the present invention, as long as it contains the above components,
This production method is not particularly limited, but generally, after mixing the above-mentioned essential drug components and dissolving them in ethanol and / or isopropyl alcohol, a humectant is added to the solution, and an appropriate amount of water is added thereto. To prepare a uniform liquid drug form.
また本発明液剤には、上記各成分以外に、必要に応じて
他の薬効成分等、例えばカンフル、グリチルレチン酸、
サリチル酸メチル等の消炎剤、メントール、ハッカ油等
の清涼剤、ユーカリ油等の香料、トコフェロール等のビ
タミン類、消臭剤、安定化剤等を適宜添加配合すること
も可能である。Further, the liquid preparation of the present invention, in addition to the above components, if necessary, other medicinal components such as camphor, glycyrrhetinic acid,
An anti-inflammatory agent such as methyl salicylate, a cooling agent such as menthol and peppermint oil, a fragrance such as eucalyptus oil, vitamins such as tocopherol, a deodorant, a stabilizer and the like can be appropriately added and blended.
かくして調製される本発明の皮膚外用液剤は、これを適
当な容器に充填して製品とされ、これは、一回にその適
当量を患部に滴下又は塗布具等により塗布することによ
り適用される。また、スプレー容器に充填して噴霧方式
により適用可能な製品形態とすることも可能である。The thus-prepared external preparation for skin of the present invention is made into a product by filling it in a suitable container, and this is applied by dripping or applying an appropriate amount thereof onto the affected area at once by an applicator or the like. . It is also possible to fill a spray container and make it a product form applicable by a spraying method.
発明の効果 本発明の皮膚外用液剤は、一剤で乾燥皮膚治療と掻痒治
療効果とを奏することができ、特に乾燥性皮膚疾患の治
療に好適であり、また使用感が非常に良好で、その適用
時に異物付着等の問題もほとんど起らない利点がある。Effects of the Invention The external preparation for skin of the present invention can exhibit dry skin treatment and pruritus treatment effect by one agent, is particularly suitable for treatment of dry skin disease, and has a very good usability, There is an advantage that problems such as adhesion of foreign matter hardly occur when applied.
実施例 以下、本発明を更に詳しく説明するため、本発明皮膚外
用液剤の製造例を実施例として挙げ、次いで本発明液剤
の有効性を明らかにする臨床試験例及び性能試験例を挙
げる。EXAMPLES Hereinafter, in order to explain the present invention in more detail, production examples of the external preparation for skin of the present invention will be given as examples, and then clinical test examples and performance test examples for clarifying the effectiveness of the liquid preparation of the present invention will be given.
実施例 １ 尿 素 10g ジフェンヒドラミン塩酸塩 1g リドカイン 2g エタノール 45g 1,3−ブチレングリコール 20g精製水 適 量 全 量 100ml 上記量の尿素、ジフェンヒドラミン塩酸塩及びリドカイ
ンの混合物に、エタノールを加えて撹拌溶解させた。更
に得られた溶液に上記量の1,3−ブチレングリコールを
加えた後、精製水を追加して全量を100mlとして、本発
明皮膚外用液剤を調製した。Example 1 Urine 10 g Diphenhydramine hydrochloride 1 g Lidocaine 2 g Ethanol 45 g 1,3-Butylene glycol 20 g Purified water Appropriate amount 100 ml To the above mixture of urea, diphenhydramine hydrochloride and lidocaine, ethanol was added and dissolved with stirring. . Further, the above-mentioned amount of 1,3-butylene glycol was added to the obtained solution, and then purified water was added to make the total amount to 100 ml to prepare a skin external preparation of the present invention.
実施例 ２ 尿 素 10g ジフェンヒドラミン塩酸塩 1g リドカイン 2g カンフル 1g 酢酸トコフェノール 0.3g エタノール 55g 1,3−ブチレングリコール 10g 乳酸ナトリウム 5g 精製水 適 量 全 量 100ml 上記各成分の所定量を用いて、実施例１と同様にして、
本発明皮膚外用液剤を調製した。Example 2 Urine 10 g Diphenhydramine hydrochloride 1 g Lidocaine 2 g Camphor 1 g Tocophenol acetate 0.3 g Ethanol 55 g 1,3-Butyrene glycol 10 g Sodium lactate 5 g Purified water 100 ml Total amount 100 ml Example Using the above prescribed components Similar to 1,
The external preparation for skin of the present invention was prepared.
実施例 ３ 尿 素 10g ジフェンヒドラミン 1g リドカイン 4g ハッカ油 0.1g エタノール 70g ヒドロキシプロピルセルロース 0.1g精製水 適 量 全 量 100ml 上記各成分の所定量を用いて、実施例１と同様にして、
本発明皮膚外用液剤を調製した。Example 3 Urine 10 g Diphenhydramine 1 g Lidocaine 4 g Mint oil 0.1 g Ethanol 70 g Hydroxypropyl cellulose 0.1 g Purified water Appropriate amount Total amount 100 ml Using the predetermined amounts of the above components, the same procedure as in Example 1 was conducted.
The external preparation for skin of the present invention was prepared.
実施例 ４ 尿 素 8g ジフェンヒドラミン塩酸塩 0.3g リドカイン 0.5g カンフル 1g メントール 0.3g β−グリチルレチン酸 0.2g エタノール 50g 1,3−ブチレングリコール 10g 乳酸ナトリウム 5g グリセリン 5g 精製水 適 量 全 量 100ml 上記各成分の所定量に用いて、実施例１と同様にして、
本発明皮膚外用液剤を調製した。Example 4 Urine 8 g Diphenhydramine hydrochloride 0.3 g Lidocaine 0.5 g Camphor 1 g Menthol 0.3 g β-Glycyrrhetinic acid 0.2 g Ethanol 50 g 1,3-Butylene glycol 10 g Sodium lactate 5 g Glycerin 5 g Purified water Appropriate amount 100 ml of each of the above components Using a predetermined amount, in the same manner as in Example 1,
The external preparation for skin of the present invention was prepared.
実施例 ５ 尿 素 20g ジフェンヒドラミン塩酸塩 3g リドカイン 0.5g エタノール 40g 1,3−ブチレングリコール 10g 乳酸ナトリウム 5g ヒドロキシプルピルセルロース 0.1g精製水 適 量 全 量 100ml 上記各成分の所定量を用いて、実施例１と同様にして、
本発明皮膚外用液剤を調製した。Example 5 Urine 20 g Diphenhydramine hydrochloride 3 g Lidocaine 0.5 g Ethanol 40 g 1,3-Butylene glycol 10 g Sodium lactate 5 g Hydroxypurpircellulose 0.1 g Purified water Appropriate total amount 100 ml Similar to 1,
The external preparation for skin of the present invention was prepared.
実施例 ６ 尿 素 10g ジフェンヒドラミン塩酸塩 1g リドカイン 2g カンフル 1g 酢酸トコフェノール 0.3g エタノール 43g グリセリン 10g 乳酸ナトリウム 2g ヒドロキシプルピルセルロース 0.1g 乳 酸 3g 精製水 適 量 全 量 100ml 上記各成分の所定量を用いて、実施例１と同様にして、
本発明皮膚外用液剤を調製した。Example 6 Urine 10 g Diphenhydramine hydrochloride 1 g Lidocaine 2 g Camphor 1 g Acetate tocophenol 0.3 g Ethanol 43 g Glycerin 10 g Sodium lactate 2 g Hydroxypurpyrucellulose 0.1 g Lactic acid 3 g Purified water Appropriate amount 100 ml Using the prescribed amount of each of the above components Then, in the same manner as in Example 1,
The external preparation for skin of the present invention was prepared.
実施例 ７ 尿 素 10g ジフェンヒドラミン塩酸塩 1g リドカイン 2g カンフル 1g 酢酸トコフェノール 0.3g エタノール 43g ポリエチレングリコール400 10g 乳酸ナトリウム 2g ヒドロキシプルピルセルロース 0.1g 乳 酸 3g 精製水 適 量 全 量 100ml 上記各成分の所定量を用いて、実施例１と同様にして、
本発明皮膚外用液剤を調製した。Example 7 Urine 10 g Diphenhydramine hydrochloride 1 g Lidocaine 2 g Camphor 1 g Tocophenol acetate 0.3 g Ethanol 43 g Polyethylene glycol 400 10 g Sodium lactate 2 g Hydroxypropyl cellulose 0.1 g Lactic acid 3 g Purified water Suitable total amount 100 ml Predetermined amount of each component In the same manner as in Example 1,
The external preparation for skin of the present invention was prepared.
臨床試験例 １ 施設（Ａ、Ｂ及びＣの３ケ所）において、皮膚角化及び
掻痒症状の見られる患者40名に対し、実施例６で調製し
た本発明皮膚外用液剤を１日２〜３回４週間連続して単
純塗布した。４週間後、症状の改善の程度を観察し次の
基準により判定を行なった。Clinical Test Example 1 The external preparation for skin of the present invention prepared in Example 6 was applied 2 to 3 times a day to 40 patients with keratinization of the skin and pruritus in 1 facility (3 places of A, B and C). Simple application was performed for 4 consecutive weeks. After 4 weeks, the degree of symptom improvement was observed and judged according to the following criteria.
著 効…著しく改善された 有 効…かなり改善された やや有効…ある程度改善された 無 効…症状が不変である 悪 化…症状が悪化した 実施例６で調製した本発明皮膚外用液剤を用いた上記試
験において、やや有効以上の症例数を第１表に、有効以
上の症例数を第２表にそれぞれ示す。尚、この試験にお
いては悪化症例は認められなかった。Efficacy ... Significantly improved Effectiveness ... Significantly improved Slightly effective ... Improved to some extent Ineffectiveness ... Symptoms are unchanged Exacerbation ... Symptoms were worsened The external preparation for skin of the present invention prepared in Example 6 was used. In the above test, the number of cases that are slightly more than effective is shown in Table 1, and the number of cases that are more than effective is shown in Table 2. No worse case was observed in this test.
上記各表に示す通り、実施例６で得た本発明皮膚外用液
剤は、乾燥皮膚及び掻痒に対する治療効果を奏し得るこ
とが明らかである。 As shown in the above tables, it is clear that the external preparation for skin of the present invention obtained in Example 6 can exert a therapeutic effect on dry skin and pruritus.
また、実施例７で調製した本発明皮膚外用液剤を用いた
上記試験におけるやや有効以上の症例数及び有効以上の
症例数は、それぞれ第１表及び第２表と同様であり、こ
の場合も悪化症例は認められず、本発明皮膚外用液剤が
乾燥皮膚及び掻痒に対して治療効果を奏することが確認
された。The number of cases slightly more than effective and the number of cases more than effective in the above-mentioned test using the external preparation for skin of the present invention prepared in Example 7 are the same as those in Tables 1 and 2, respectively, and also in this case No cases were observed, and it was confirmed that the external preparation for skin of the present invention exerts a therapeutic effect on dry skin and pruritus.
更に、上記臨床試験においては、本発明皮膚外用液剤の
使用による副作用がほとんど認められず、本発明液剤の
安全性も確認された。Furthermore, in the above clinical test, almost no side effects were observed due to the use of the external preparation for skin of the present invention, and the safety of the liquid preparation of the present invention was confirmed.
性能試験例 １ 保湿能試験 実施例６で得た本発明皮膚外用液剤と、比較のため市販
の皮膚外用剤Ａ（商品名「ヒルドイド軟膏」、マルホ社
製）及び同皮膚外用剤Ｂ（商品名「ケラチナミン乳
液」、興和社製）とについて、それぞれ以下の通り保湿
能試験を行なった。Performance Test Example 1 Moisturizing Test A skin external preparation of the present invention obtained in Example 6 and a commercially available skin external preparation A (commercial name "Hirudoid ointment", manufactured by Maruho Co.) and the same skin external preparation B (commercial name) "Keratinamine emulsion" (manufactured by Kowa Co., Ltd.) was subjected to a moisturizing ability test as follows.
即ち、皮膚疾患のない健康人10名に対して、それぞれの
外用剤試料を等量ずつ１日２回２週間連続して単純塗布
した。That is, the same amount of each external preparation sample was simply applied twice a day for 2 weeks continuously to 10 healthy people without skin diseases.
上記塗布前、塗布開始７日後、同14日後及び塗布終了２
日後のそれぞれの時期に、塗布箇所の皮膚電気伝導度
を、HFインピーダンス（モデルIB−35S、IBS社製）を用
いて測定し、また経皮水分喪失量を、エバポリメーター
EPI（セルボ製）を用いて測定し、各測定値の平均値を
求めた。Before application, 7 days after application, 14 days after application, and end of application 2
At each time point after the day, the skin electrical conductivity at the application site was measured using HF impedance (model IB-35S, manufactured by IBS), and the transepidermal water loss was measured using an evaporation meter.
It measured using EPI (made by Cervo), and calculated the average value of each measured value.
得られた結果を第１図（皮膚の電気伝導度）及び第２図
（経皮水分喪失量）に示す。The obtained results are shown in FIG. 1 (electrical conductivity of skin) and FIG. 2 (transdermal water loss).
第１図は横軸に経過時間［０〜14日＝単純塗布期間（２
回／日）及び14〜16日＝塗布中止期間］を、縦軸に電気
伝導度（μ）をとり、各供試外用剤試料の結果
［（１）は実施例６で得た本発明皮膚外用液剤を、
（２）は皮膚外用剤Ａ（ヒルドイド軟膏）を、（３）は
同皮膚外用剤Ｂ（ケラチナミン乳液）を示す］を示した
グラフである。また第２図は横軸に同経過時間をとり、
縦軸に桂皮水分喪失量（g/m2h）をとり、同各供試外用
剤試料［（１）〜（３）］の結果を求めたグラフであ
る。In Fig. 1, the horizontal axis indicates elapsed time [0 to 14 days = simple application period (2
Times / day) and 14 to 16 days = application discontinuation period], and the electrical conductivity (μ) is plotted on the vertical axis, and the results of the test external preparation samples [(1) are the skin of the present invention obtained in Example 6]. External liquid medicine,
(2) shows a skin external preparation A (hirudoid ointment), and (3) shows the same skin external preparation B (keratinamine emulsion)]. In Fig. 2, the horizontal axis shows the same elapsed time,
Fig. 6 is a graph showing the results of the test external preparation samples [(1) to (3)] obtained by taking the water loss amount of cinnamon bark (g / m 2 h) on the vertical axis.
上記各図により、本発明皮膚外用液剤は、市販品Ａ及び
Ｂと比べて、皮膚電気伝導度が高く、経皮水分喪失量は
同等もしくはそれ以下であることが判る。From the above figures, it is understood that the external preparation for skin of the present invention has higher skin electrical conductivity than the commercially available products A and B and has the same or less transdermal water loss.
従って、本発明皮膚外用液剤は保湿効果においても優れ
たものであることが確認される。Therefore, it is confirmed that the external preparation for skin of the present invention has an excellent moisturizing effect.
第１図は性能試験例１（保湿能試験）に従って本発明皮
膚外用液剤を塗布適用後の経時的電気伝導度（μ）を
調べたグラフである。 第２図は同性能試験例１（保湿能試験）に従って本発明
皮膚外用液剤を塗布適用後の経時的経皮水分喪失量（g/
m2h）を調べたグラフである。FIG. 1 is a graph showing the electric conductivity (μ) over time after application of the external preparation for skin of the present invention according to Performance Test Example 1 (moisture retention test). FIG. 2 shows the amount of percutaneous water loss (g / g after application and application of the external preparation for skin of the present invention according to the same performance test example 1 (moisture retention test).
It is a graph which investigated m 2 h).
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.6 識別記号 庁内整理番号 ＦＩ 技術表示箇所 Ａ６１Ｋ 47/10 Ｇ (72)発明者 大野 仁嗣 徳島県鳴門市鳴門町高島字南13―１番地 (56)参考文献 高野正彦「今日の皮膚外用剤」（1981. ５．15）南山堂，Ｐ．366−373，Ｐ．389 −403─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. 6 Identification number Reference number within the agency FI Technical indication location A61K 47/10 G (72) Inventor Hitoshi Ohno 13-1 Minami Takashima, Naruto, Naruto, Tokushima Prefecture (56) References Masahiko Takano "Today's external preparation for skin" (May 15, 1981) Nanzandou, P. 366-373, P.I. 389 −403
Claims (1)
分として含有することを特徴とする皮膚外用液剤。 尿 素 8 〜23w/v％ ジフェンヒドラミン 0.3〜 4w/v％ リドカイン 0.5〜 5w/v％ エタノール及び／又はイソプロピルアルコール40 〜70
w/v％ 保湿剤 0.1〜30w/v％1. A liquid preparation for external use for skin, which comprises, as essential components, each component having the following composition range and purified water. Urine 8 to 23 w / v% Diphenhydramine 0.3 to 4 w / v% Lidocaine 0.5 to 5 w / v% Ethanol and / or isopropyl alcohol 40 to 70
w / v% Moisturizer 0.1 to 30 w / v%
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP19646189 | 1989-07-27 | ||
| JP2-9949 | 1990-01-18 | ||
| JP1-196461 | 1990-01-18 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH03291221A JPH03291221A (en) | 1991-12-20 |
| JPH0774152B2 true JPH0774152B2 (en) | 1995-08-09 |
Family
ID=16358193
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP19211190A Expired - Lifetime JPH0774152B2 (en) | 1989-07-27 | 1990-07-19 | Liquid for external use on skin |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH0774152B2 (en) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9202060D0 (en) * | 1992-01-31 | 1992-03-18 | Sandoz Ltd | Novel compositions |
| EP0660720A4 (en) * | 1992-09-14 | 1996-12-27 | Walter P Smith | Skin-conditioning composition, its application and manufacture. |
| JPH08268861A (en) * | 1995-03-29 | 1996-10-15 | Shiseido Co Ltd | Dermal preparation for external use |
| US6299902B1 (en) | 1999-05-19 | 2001-10-09 | The University Of Georgia Research Foundation, Inc. | Enhanced transdermal anesthesia of local anesthetic agents |
| JP3723728B2 (en) * | 1999-09-30 | 2005-12-07 | 富山化学工業株式会社 | Skin topical solution |
| AU2003266644B2 (en) * | 2002-09-26 | 2008-04-03 | Men-Dar Wu | Therapeutic causing contraction of mucosal tissue, method of treating diseases relating to mucosal tissues, injector and therapeutic set |
| US20060216245A1 (en) * | 2002-12-10 | 2006-09-28 | Showa Yakuhin Kako Co., Ltd. | Composition for local anesthesia |
| ES2337359T3 (en) * | 2003-04-24 | 2010-04-23 | L'oreal | EXFOLIATION PROCEDURE USED BY UREA. |
| JP2005314331A (en) * | 2004-04-30 | 2005-11-10 | Junichi Yamashita | Ointment |
| JP5761678B2 (en) * | 2008-05-20 | 2015-08-12 | 株式会社大塚製薬工場 | Anti-itching agent for external use on skin |
| JP5008162B1 (en) * | 2011-06-02 | 2012-08-22 | 株式会社 資生堂 | Scalp Kayumi improvement composition |
-
1990
- 1990-07-19 JP JP19211190A patent/JPH0774152B2/en not_active Expired - Lifetime
Non-Patent Citations (1)
| Title |
|---|
| 高野正彦「今日の皮膚外用剤」（１９８１．５．１５）南山堂，Ｐ．３６６−３７３，Ｐ．３８９−４０３ |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH03291221A (en) | 1991-12-20 |
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