JP2005220128A - Prophylactic/therapeutic agent for atopic dermatitis - Google Patents
Prophylactic/therapeutic agent for atopic dermatitis Download PDFInfo
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- JP2005220128A JP2005220128A JP2005000303A JP2005000303A JP2005220128A JP 2005220128 A JP2005220128 A JP 2005220128A JP 2005000303 A JP2005000303 A JP 2005000303A JP 2005000303 A JP2005000303 A JP 2005000303A JP 2005220128 A JP2005220128 A JP 2005220128A
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Abstract
Description
本発明は、インチンコウ及びジフシを含有することを特徴とする止痒剤であり、アトピー性皮膚炎の予防または治療剤として用いられる。 The present invention is an antidiarrheal agent characterized in that it contains a ginseng and a jifushi, and is used as a preventive or therapeutic agent for atopic dermatitis.
アトピー性皮膚炎は近年の生活環境の変化により急激にその患者数の増加している慢性炎症性疾患であり、その臨床症状として極度の掻痒感と慢性皮膚病変を主とする疾患である。アトピー性皮膚炎患者に認められる多くの皮疹は掻破行動によって悪化し、さらに痒みがひどくなる。従って、痒みを抑制してこの悪循環を断つことは、大きな治療上の効果を有する。また、激しい痒みは睡眠障害などQOL(Quality of Life)の著しい低下を招くことから、痒みを抑制することはQOLの改善の点においても意義がある。 Atopic dermatitis is a chronic inflammatory disease whose number of patients is rapidly increasing due to changes in the living environment in recent years, and its clinical symptoms include extreme pruritus and chronic skin lesions. Many rashes seen in patients with atopic dermatitis are exacerbated by scratching behavior, and itching becomes even worse. Therefore, suppressing this itching and breaking this vicious circle has a great therapeutic effect. In addition, since severe itching causes a significant decrease in quality of life (QOL) such as sleep disorders, suppressing itching is also meaningful in terms of improving QOL.
アトピー性皮膚炎をはじめ蕁麻疹、接触性皮膚炎、痒疹など痒みを伴う疾患は多数あるが、痒みは致命的な症状ではないために、これまであまり研究されていない分野であった。痒み誘起物質としてはヒスタミンが古くから知られており、痒みの抑制に抗ヒスタミン剤や抗アレルギー剤が使用されてきた。しかし、アトピー性皮膚炎における痒みは抗ヒスタミン剤や抗アレルギー剤では抑制されないという報告が数多くあり（非特許文献１〜４参照）、動物試験においてもアトピー性皮膚炎様症状を十分に改善する抗アレルギー剤の報告は少ないのが現状である。現在でもアトピー性皮膚炎の治療には主にステロイド剤や免疫抑制剤が使用されているが、いずれも副作用が問題となっており、その使用が制限されている。
There are many diseases with itching such as atopic dermatitis, urticaria, contact dermatitis and prurigo, but it has not been studied so far because it is not a fatal symptom. Histamine has long been known as a stagnation-inducing substance, and antihistamines and antiallergic agents have been used to suppress itching. However, there are many reports that itching in atopic dermatitis is not suppressed by antihistamines or antiallergic agents (see Non-Patent
ところで、インチンコウやジフシといった生薬が止痒（抗掻痒）作用を有することは知られているが（特許文献１または２参照）、これらを組み合わせることにより強力な止痒作用を発揮すること、即効性と持効性を併せ持つ止痒剤が得られることについては知られていない。
By the way, it is known that herbal medicines such as Inchinkou and Gyfushi have an antipruritic action (see
本発明は、アトピー性皮膚炎様症状に伴う痒みを抑制し、即効性と持効性を併せもつ、副作用の少ないアトピー性皮膚炎の予防または治療剤を提供することを目的とする。 An object of the present invention is to provide an agent for the prevention or treatment of atopic dermatitis that suppresses itchiness associated with atopic dermatitis-like symptoms, has both immediate effects and long-acting effects and has few side effects.
本発明者は自然発症的にアトピー性皮膚炎様の皮膚疾患を発症するNC/Ngaマウスを用いて、その掻破行動を長時間測定することにより、自然発症的に惹起される掻破行動に対する数種生薬の止痒効果について評価を行った。その結果、止痒作用においてインチンコウは持続性を有し、ジフシは即効性を有することを見出した（図２及び３参照）。また、驚くべきことにインチンコウとジフシの併用は止痒作用の即効性と持効性に止まらず、止痒効果を増強させることをも見出した。 The present inventor uses NC / Nga mice that spontaneously develop atopic dermatitis-like skin diseases, and measures several kinds of scratching behavior for a long time by measuring the scratching behavior for a long time. The antipruritic effect of crude drugs was evaluated. As a result, it was found that Inchinkou has persistence in antipruritic action, and jifushi has immediate effect (see FIGS. 2 and 3). Surprisingly, it has also been found that the combined use of ginseng and jifushi enhances the antipruritic effect as well as the immediate and sustained effects of the antipruritic action.
かかる知見に基づき完成した本発明の態様の一つは、インチンコウ及びジフシを含有することを特徴とする止痒剤である。 One of the aspects of the present invention completed based on this finding is an antidiarrheal agent characterized by containing a ginseng and a jifushi.
本発明の他の態様は、インチンコウ及びジフシを含有することを特徴とするアレルギー性疾患に起因する掻痒感に対する止痒剤である。 Another aspect of the present invention is an antipruritic agent for pruritus caused by an allergic disease, characterized in that it contains intincho and jifushi.
本発明の他の態様は、インチンコウ及びジフシを含有することを特徴とするアトピー性皮膚炎に起因する掻痒感に対する止痒剤である。 Another aspect of the present invention is an antipruritic agent for pruritus caused by atopic dermatitis, characterized in that it contains a ginseng and a jifushi.
本発明の他の態様は、インチンコウ及びジフシを含有することを特徴とするアトピー性皮膚炎の予防または治療剤である。 Another aspect of the present invention is a prophylactic or therapeutic agent for atopic dermatitis, characterized by containing a ginseng and a jifushi.
本発明により、アトピー性皮膚炎様症状により惹起される掻痒感を低減させることが可能となった。 According to the present invention, itching can be reduced due to atopic dermatitis-like symptoms.
「インチンコウ（茵陳萵）」は、キク科カワラヨモギまたはその類縁植物より得られる生薬で、本発明においては、乾燥物でも抽出物でもよい。水、エタノール、プロピレングリコール、１，３−ブチレングリコールまたはこれらの混液を抽出溶媒として、インチンコウ抽出物を得ることができる。
「ジフシ（地膚子）」は、アカザ科のホウキギの乾燥果実であり、本発明においては乾燥物でも抽出物でもよい。水、エタノール、プロピレングリコール、１，３−ブチレングリコールまたはこれらの混液を抽出溶媒として、ジフシ抽出物を得ることができる。
“Inchinkou” is a herbal medicine obtained from Asteraceae or its related plants. In the present invention, it may be a dried product or an extract. Inchinkou extract can be obtained using water, ethanol, propylene glycol, 1,3-butylene glycol or a mixture thereof as an extraction solvent.
“Difushi” is a dried fruit of a red squirrel family, and may be a dried product or an extract in the present invention. A difushi extract can be obtained using water, ethanol, propylene glycol, 1,3-butylene glycol or a mixture thereof as an extraction solvent.
ジフシの配合量は、インチンコウ１質量部に対して0.01〜100質量部であり、好ましくは0.1〜10質量部である。インチンコウの配合量を増すと止痒作用が持続し、ジフシの配合量を増すと止痒作用の立ち上がりが早くなるという傾向がある。 The amount of jifusi is 0.01 to 100 parts by mass, preferably 0.1 to 10 parts by mass, with respect to 1 part by mass of the ginseng. Increasing the compounding amount of the ginseng tends to maintain the antipruritic action, and increasing the compounding amount of jifushi tends to accelerate the rise of the antipruritic action.
インチンコウ及びジフシの有効投与量は、患者の体重、年齢、性別などにより適宜に増減できるが、１日あたり原生薬量として0.1〜10ｇであり、１日に１乃至数回投与できる。 The effective doses of ginseng and jifushi can be appropriately increased or decreased depending on the weight, age, sex, etc. of the patient, but the amount of the drug substance per day is 0.1 to 10 g, and can be administered once to several times a day.
本発明の止痒剤により予防または治療効果が発現する皮膚疾患としてはアトピー性皮膚炎、アレルギー性皮膚炎を挙げることができるが、特に有効なのはアトピー性皮膚炎である。 Examples of skin diseases that exhibit a preventive or therapeutic effect with the antidiarrheal agent of the present invention include atopic dermatitis and allergic dermatitis. Atopic dermatitis is particularly effective.
本発明の止痒剤は、公知の添加剤、例えば、賦形剤、崩壊剤、結合剤、滑沢剤、抗酸化剤、コーティング剤、着色剤、矯味矯臭剤、界面活性剤、可塑剤を配合して常法により、顆粒剤、散剤、カプセル剤、錠剤、チュアブル錠、ドライシロップ剤、液剤、軟膏剤、クリーム剤、貼付剤とすることができる。 The antidiarrheal agent of the present invention contains known additives such as excipients, disintegrants, binders, lubricants, antioxidants, coating agents, coloring agents, flavoring agents, surfactants, and plasticizers. It can be formulated into granules, powders, capsules, tablets, chewable tablets, dry syrups, liquids, ointments, creams and patches by conventional methods.
なお、本発明の止痒剤は、全身性の掻痒感に対しては経口投与が好ましいが、局所的な掻痒感に対しては外用剤として患部に塗布することも有効である。 The antipruritic agent of the present invention is preferably administered orally for systemic pruritus, but it is also effective to apply it to the affected area as an external preparation for local pruritus.
本発明の止痒剤には、本発明の効果を損なわない範囲で、ビタミン類、他の生薬等を配合することもできる。 The antidiarrheal agent of the present invention can also contain vitamins, other herbal medicines and the like as long as the effects of the present invention are not impaired.
以下に実施例及び試験例を挙げて、本発明をさらに詳細に説明する。なお、インチンコウ及びジフシはエキスとして配合しており、配合量は原生薬換算量である。 Hereinafter, the present invention will be described in more detail with reference to examples and test examples. Inchinkou and jifushi are blended as extracts, and the blending amount is the amount in terms of the active ingredient.
実施例１
インチンコウ １００ｇ
ジフシ １００ｇ
乳糖 １７００ｇ
微結晶セルロース ５００ｇ
低置換ヒドロキシプロピルセルロース ５００ｇ
タルク ５０ｇ
硬化ヒマシ油 ５０ｇ
上記の各成分及び分量を秤量し均一に混合した後、得られた混合粉末を直打法により１錠重量３００ｍｇになるように打錠して錠剤を得た。
Example 1
Inchinkou 100g
Gifushi 100g
Lactose 1700g
500g microcrystalline cellulose
Low substituted hydroxypropylcellulose 500g
Talc 50g
Hardened castor oil 50g
Each of the above components and amounts were weighed and mixed uniformly, and then the obtained mixed powder was tableted by a direct compression method so that the weight of one tablet was 300 mg to obtain a tablet.
実施例２
インチンコウ ５０ｇ
ジフシ ５０ｇ
乳糖 ４００ｇ
微結晶セルロース ４５０ｇ
タルク ５０ｇ
上記の各成分及び分量を秤量し均一に混合した後、得られた混合粉末を１号硬カプセルに２５０ｍｇずつ充填し、カプセル剤を得た。
Example 2
Inchinkou 50g
Gifushi 50g
Lactose 400g
450g microcrystalline cellulose
Talc 50g
After weighing and mixing the above components and amounts uniformly, the obtained mixed powder was filled into No. 1 hard capsules in an amount of 250 mg to obtain capsules.
実施例３
インチンコウ １０ｇ
ジフシ １０ｇ
エラグ酸ナトリウム ５ｇ
ヒアルロン酸ナトリウム ３ｇ
メチルパラベン ２ｇ
精製水 ２０４ｇ
流動パラフィン（＃７０） ５０ｇ
スクワラン １００ｇ
セトステアリルアルコール ６０ｇ
蜜蝋 ２０ｇ
モノステアリン酸グリセリン １５ｇ
ソルビタンモノラウレート ２０ｇ
プロピルパラベン １ｇ
上記の成分をそれぞれ混合し均一に乳化し、更に香料を適量加えクリーム剤５００ｇを得た。
Example 3
Inchinkou 10g
Gifushi 10g
5g sodium ellamate
Sodium hyaluronate 3g
Methyl paraben 2g
204g of purified water
Liquid paraffin (# 70) 50g
Squalane 100g
Setostearyl alcohol 60g
20g of beeswax
15g glyceryl monostearate
Sorbitan monolaurate 20g
1g propylparaben
Each of the above components was mixed and uniformly emulsified, and an appropriate amount of a fragrance was added to obtain 500 g of a cream.
試験例１：NC/Ngaマウス自発性掻破行動に対する作用
（試験方法）
試験動物は体重約30ｇのNC/Nga系雄性マウス、１群８匹を用いた。マウスは発症している動物と1週間同居させ、掻破行動を誘起させた。
自発性掻破行動数はニューロサイエンス社製の掻痒測定システム（NS-SCT16）を用いて測定した。上記動物の後肢にスクラッチ測定用マグネットを挿入し、１匹ずつ測定用ケージに入れ、溶媒（0.2％CMC溶液）経口投与後掻破行動数を24時間測定した（pre値）。その後、各薬剤を経口投与し、再び掻破行動数を24時間測定した（post値）。各生薬エキスは50％エタノール抽出物を用い、0.2％CMC溶液に用時懸濁した。得られた波形は、スクラッチ計測・解析用ソフトウェアにより1.5秒以上の足の動きを１回の掻破行動として数値化し、統計解析処理を行い、pre値、post値間の有意差検定を行った。
なお、デキサメタゾンはステロイド剤であり、本発明の止痒剤と比較するために投与した。
Test Example 1: Effects on spontaneous scratching behavior of NC / Nga mice (test method)
As test animals, NC / Nga male mice weighing about 30 g, 8 per group were used. Mice were allowed to live with the affected animal for a week to induce scratching behavior.
The number of spontaneous scratching behaviors was measured using a neuroscience pruritus measurement system (NS-SCT16). Scratch measurement magnets were inserted into the hind limbs of the animals, one animal was placed in a measurement cage, and the number of scratching behavior was measured for 24 hours after oral administration of a solvent (0.2% CMC solution) (pre value). Thereafter, each drug was orally administered, and the number of scratching behaviors was again measured for 24 hours (post value). Each crude drug extract was 50% ethanol extract and suspended in 0.2% CMC solution at the time of use. The obtained waveform was digitized as a scratching action of 1.5 seconds or more by scratch measurement / analysis software, subjected to statistical analysis processing, and a significant difference test between the pre value and the post value was performed.
Dexamethasone is a steroid and was administered for comparison with the antidiarrheal agent of the present invention.
（実験結果）
結果を表１及び図１〜５に示した。
(Experimental result)
The results are shown in Table 1 and FIGS.
ジフシは70mg/kgでは抑制作用は認められなかった（表１及び図１）。200mg/kgでも有意な抑制作用は認められなかったが（表１及び図１）、インチンコウに比べてその抑制作用の立ち上がりが早いこと（即効性）が確認された（図２及び３）。 Gifushi had no inhibitory effect at 70 mg / kg (Table 1 and FIG. 1). Although no significant inhibitory action was observed even at 200 mg / kg (Table 1 and FIG. 1), it was confirmed that the rise of the inhibitory action was earlier (immediate effect) than that of Inchinkou (FIGS. 2 and 3).
これらに対して、インチンコウ及びジフシを併用した群では、70mg/kgずつ及び200mg/kgずつのいずれにおいても強力な抑制作用を示し、その抑制作用はデキサメタゾンの１mg/kg投与より強かった（表１及び図１）。また、その抑制作用は投与直後から発現し（即効性）、長時間にわたって持続すること（持効性）が確認された（図４及び５）。 On the other hand, in the group using Inchinkou and Difushi, both 70 mg / kg and 200 mg / kg showed a strong inhibitory action, and the inhibitory action was stronger than that of dexamethasone administered at 1 mg / kg (Table 1). And FIG. 1). In addition, it was confirmed that the inhibitory action was manifested immediately after administration (immediate effect) and persisted for a long time (sustained effect) (FIGS. 4 and 5).
重度のアトピー性皮膚炎の場合、治療の初期段階では副作用はあるが治療効果の大きいステロイド剤を投与し、治療が進んだ段階で副作用の少ない本発明の止痒剤に切り替えるという治療法が考えられる。 In the case of severe atopic dermatitis, a treatment method may be considered in which a steroid agent that has side effects at the initial stage of treatment but is administered with a large therapeutic effect and is switched to the antidiarrheal agent of the present invention with few side effects at the advanced stage It is done.
また、アトピー性皮膚炎は一旦治癒してもすぐに再発することが多い疾患であり、予防剤の投与が有効であるが、副作用の強いステロイド剤を予防剤として投与するのは患者に対する負担が大きい。これに対して、本発明の止痒剤であれば、副作用が少なく、長期間の投与が可能であるので、再発防止用の予防剤としては極めて有効である。 In addition, atopic dermatitis is a disease that often recurs soon after being cured, and administration of prophylactic agents is effective. However, administration of steroids with strong side effects as prophylactic agents has a burden on patients. large. In contrast, the antidiarrheal agent of the present invention is extremely effective as a prophylactic agent for preventing recurrence because it has few side effects and can be administered for a long time.
本発明により、アトピー性皮膚炎の予防及び治療に極めて有効な医薬品の供給が期待される。 According to the present invention, it is expected to supply a drug that is extremely effective for the prevention and treatment of atopic dermatitis.
Claims (4)
A prophylactic or therapeutic agent for atopic dermatitis, characterized by containing intincho and jifushi.
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| JPH10245395A (en) * | 1997-03-03 | 1998-09-14 | Dainippon Pharmaceut Co Ltd | Antipruritic derived from kochiae fructus |
| JP2000103718A (en) * | 1998-09-28 | 2000-04-11 | Pola Chem Ind Inc | Composition for improving activity of living body |
| JP2002029990A (en) * | 2000-07-12 | 2002-01-29 | Kanebo Ltd | Anti-itching agent for external use |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JPH10245395A (en) * | 1997-03-03 | 1998-09-14 | Dainippon Pharmaceut Co Ltd | Antipruritic derived from kochiae fructus |
| JP2000103718A (en) * | 1998-09-28 | 2000-04-11 | Pola Chem Ind Inc | Composition for improving activity of living body |
| JP2002029990A (en) * | 2000-07-12 | 2002-01-29 | Kanebo Ltd | Anti-itching agent for external use |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102670736A (en) * | 2012-05-23 | 2012-09-19 | 成肃龙 | External ointment for treating various skin diseases |
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