JP5286652B2 - Agent for improving exocrine dysfunction - Google Patents
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本発明は、長期間使用しても安全で外分泌腺の分泌を促進することによる乾き眼及び口腔乾燥症の予防又は改善に有効な医薬品、医薬部外品又は食品に関する。 The present invention relates to a pharmaceutical, a quasi-drug, or a food that is safe even after long-term use and is effective in preventing or improving dry eyes and dry mouth by promoting secretion of exocrine glands.
コンピュータの急速な普及、高齢化社会、ストレス社会の到来などの社会的現象を背景に、近年、現代病の一つとしてドライシンドローム(乾燥症候群)が問題となっている。ドライシンドロームとは、体の様々な部位に生じるドライ化現象のことであり、その代表的な疾患としては、ドライアイ(乾き眼)、ドライマウス(口腔乾燥症)、ドライスキン(皮膚乾燥症)等があげられ、外分泌腺の異常が原因の一つと考えられている。外分泌腺とは、分泌物を導管を介して体外あるいは体外と直接連結している分泌する腺のことであり、代表的な外分泌腺としては、涙腺、唾液腺、汗腺等があげられる。近年、特に涙腺や唾液腺の異常によって生じるドライアイやドライマウスを訴える患者が急増しており、社会的問題となっている。 In recent years, dry syndrome (dry syndrome) has become a problem as one of the modern diseases against the backdrop of social phenomena such as the rapid spread of computers, the aging society, and the arrival of stress society. Dry syndrome is a phenomenon of dryness that occurs in various parts of the body. Typical diseases include dry eye (dry eye), dry mouse (xerostomia), and dry skin (dry skin). It is considered that one of the causes is abnormalities of the exocrine glands An exocrine gland is a gland that secretes secretions directly or externally via a conduit, and typical exocrine glands include the lacrimal glands, salivary glands, sweat glands, and the like. In recent years, the number of patients complaining of dry eyes and dry mice caused by abnormalities of the lacrimal glands and salivary glands has increased rapidly, which has become a social problem.
ドライアイとは、涙液の量的又は質的な異常により、角結膜上皮細胞が障害される疾患のことをいい、眼の乾き、眼の痛み、眼の充血、眼の不快感といった症状を伴う。また、眼精疲労患者の60%はドライアイを伴っているといわれており、ドライアイの予防及び改善は眼精疲労を改善する上でも重要である。 Dry eye refers to a disease in which keratoconjunctival epithelial cells are damaged due to quantitative or qualitative abnormalities of tears, and symptoms such as dry eyes, eye pain, redness of the eyes, and eye discomfort. Accompany. Moreover, it is said that 60% of eyestrain patients are accompanied by dry eyes, and prevention and improvement of dry eyes are important in improving eyestrain.
ドライマウスとは、口や喉の乾きを訴える口腔乾燥症のことであり、激しい運動をしたり、暑い所にいるわけでもないのに、口の中や喉の乾きを訴えるようになる。ドライマウスになると、唾液分泌能が著しく低下し、口渇、ウ蝕、歯周病、口臭、嚥下困難、睡眠障害等を引き起こし、生活者のQOLを著しく低下させる。 Dry mouth is a dry mouth that complains of dry mouth and throat. It does not work hard or is in a hot place but complains of dry mouth and throat. When it becomes a dry mouse, saliva secretion ability falls remarkably, causing dry mouth, dental caries, periodontal disease, bad breath, swallowing difficulty, sleep disorder and the like, and QOL of consumers is remarkably lowered.
ドライアイ、ドライマウスの代表的な疾患としては、シェーグレン症候群がある。シェーグレン症候群は唾液腺や涙腺等の外分泌腺の障害に基づく口腔及び眼乾燥症を主徴とする自己免疫疾患である。また、これら乾燥症はシェーグレン症候群の他にも、ストレス、加齢変化、各種薬剤(抗コリン薬、抗ヒスタミン薬、抗精神薬)の使用によっても引き起こされる。特に、ストレスや加齢変化は腺細胞の萎縮や分泌能の低下を引き起こし、現代のようなストレス社会、高齢化社会においては、重大な要因の一つである。 A typical disease of dry eye and dry mouse is Sjogren's syndrome. Sjogren's syndrome is an autoimmune disease whose main feature is oral and dry eyes based on disorders of exocrine glands such as salivary glands and lacrimal glands. In addition to Sjogren's syndrome, these dry diseases are caused by stress, changes with age, and the use of various drugs (anticholinergic drugs, antihistamines, antipsychotics). In particular, stress and age-related changes cause atrophy of glandular cells and a decrease in secretory ability, and are one of the important factors in the modern stress society and aging society.
ドライアイの治療には、水分の補給を目的とした人工涙液やムチン層の補給を目的とした点眼剤による対処療法が主な治療法であり、十分な治療法が確立しているとはいえない。
一方、ドライマウスの治療には、これまで、人工唾液、含嗽剤、利胆剤のアネトールトリチオン、去痰剤の塩酸ブロムヘキシン、塩酸アンブロキソールが用いられてきたが、その効果は十分なものとはいえなかった。
For the treatment of dry eye, coping therapy with eye drops for the purpose of supplementing artificial tears and mucin layers for the purpose of supplying water is the main treatment, and it is said that sufficient treatment has been established I can't say that.
On the other hand, artificial saliva, gargle, astringent anethole trithione, and expectorant bromhexine hydrochloride and ambroxol hydrochloride have been used to treat dry mice. I could not say.
近年、外分泌腺の腺分泌を促進し、ドライアイやドライマウスへの効果が期待できる新しい治療薬として、ムスカリンM3受容体の選択的なアゴニストである塩酸セビメリンが、注目されている。しかし、塩酸セビメリンは、シェーグレン症候群患者の口腔乾燥症状の改善を主な目的に使用されている。シェーグレン症候群以外のドライマウスやドライアイの予防や改善に有効な治療薬は存在しておらず、長期間服用しても安全で有効な治療薬の開発が望まれている。 In recent years, cevimeline hydrochloride, which is a selective agonist of muscarinic M3 receptor, has attracted attention as a new therapeutic agent that promotes gland secretion of exocrine glands and can be expected to have an effect on dry eyes and dry mice. However, cevimeline hydrochloride is used mainly to improve dry mouth symptoms in patients with Sjogren's syndrome. There is no therapeutic drug effective for the prevention and improvement of dry mice and dry eye other than Sjogren's syndrome, and the development of a safe and effective therapeutic drug for long-term use is desired.
生薬のビンロウジは、ヤシ科(Palmae)のビンロウジュ(ビンロウヤシ)Areca catechu L.の成熟種子を乾燥したものであり、健胃、消化、収斂、駆虫薬として、脚気、腫脹、腹痛、消化不良、便秘、條虫駆除などに利用されている。またビンロウジに関しては、ヒアルロン酸蓄積促進作用による血栓形成阻害用組成物、関節炎治療用組成物、リウマチ治療用組成物、血管柔軟化用組成物、動脈硬化治療用組成物、ドライアイ予防用組成物等、雑多な組成物が開示されている(特許文献1)。しかしながら、当該作用と組成物は何ら関連付けられていない。 The herbal betel wax is Palmaae's Areca catchu L. The dried seeds are used as a healthy stomach, digestive, astringent, and anthelmintic, and are used for beriberi, swelling, abdominal pain, indigestion, constipation, and worm control. As for betel wax, a composition for inhibiting thrombus formation by promoting hyaluronic acid accumulation, a composition for treating arthritis, a composition for treating rheumatism, a composition for softening blood vessels, a composition for treating arteriosclerosis, and a composition for preventing dry eye A miscellaneous composition is disclosed (Patent Document 1). However, the action and the composition are not associated at all.
ビンロウジの涙腺分泌や唾液腺分泌の促進作用によるドライマウスの予防又は改善作用、ドライアイの改善効果に関しては知られていない。 It is not known about the prevention or improvement effect of dry mice and the improvement effect of dry eye by promoting the secretion of lacrimal gland and salivary gland secretion.
本発明は、長期間使用しても安全で有効な外分泌腺の腺分泌促進作用によるドライアイ又はドライマウスの予防又は改善剤を提供することを目的とする。 An object of the present invention is to provide a preventive or ameliorating agent for dry eye or dry mouse by a gland secretion promoting action of an exocrine gland that is safe and effective even when used for a long period of time.
本発明者らは、上記課題を解決するために鋭意検討を行った結果、ビンロウジエキスがラットの涙液分泌及び唾液分泌を促進することを見いだし、本発明を完成した。すなわち、本発明は、
1)ビンロウジを配合したことを特徴とする外分泌機能障害改善剤
2)ビンロウジを配合したことを特徴とするドライマウスの予防又は改善剤
3)ビンロウジを配合したことを特徴とするドライアイの予防又は改善剤
である。
As a result of intensive studies to solve the above-mentioned problems, the present inventors have found that betel nut extract promotes lacrimal secretion and salivary secretion in rats, thereby completing the present invention. That is, the present invention
1) An exocrine dysfunction ameliorating agent characterized by the inclusion of betel wax 2) A preventive or ameliorating agent for dry mouth characterized by the inclusion of betel wax 3) Prevention of dry eye characterized by the inclusion of betel wax It is an improving agent.
本発明により、涙液分泌及び唾液分泌を促進することができ、ドライアイ又はドライマウスの予防又は改善に有効で安全性の高い医薬品、医薬部外品又は食品の提供が可能になった。 According to the present invention, lacrimal secretion and salivary secretion can be promoted, and it has become possible to provide a highly safe pharmaceutical, quasi-drug, or food that is effective in preventing or improving dry eye or dry mouse.
本発明に用いるビンロウジは、そのまま生薬末として、又は水、極性溶媒、それらの混合溶媒などで抽出したエキスとして使用できるが、水とアルコールを等量混合して抽出したエキスが望ましい。またエキスは、乾燥エキス、流エキスなどを用いることもできる。 The betel wax used in the present invention can be used as a crude drug powder as it is or as an extract extracted with water, a polar solvent, a mixed solvent thereof or the like, but an extract obtained by mixing equal amounts of water and alcohol is desirable. As the extract, a dry extract, a flow extract, or the like can be used.
本発明に用いるビンロウジの投与量は、年齢、性別等を考慮して適宜増減できるが、通常成人に対し、原生薬換算量で100mg〜50gの範囲で用いることができ、好ましくは500mg〜30gである。 The dose of betel wax used in the present invention can be appropriately increased or decreased in consideration of age, sex, etc., but can be used in the range of 100 mg to 50 g, preferably 500 mg to 30 g, in terms of drug substance for normal adults. is there.
本発明においては、発明の効果を損なわない質的及び量的範囲で、ビタミン、
キサンチン誘導体、アミノ酸、賦形剤、pH調整剤、清涼化剤、懸濁化剤、消泡剤、粘稠剤、溶解補助剤、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、香料などを配合して、常法により、液剤、錠剤、顆粒剤、散剤、カプセル剤、ドライシロップ剤、チュアブル錠、経粘膜剤などの経口製剤、クリーム剤、ローション剤、ゲル剤、軟膏剤、貼付剤、パッチ剤、パップ剤、プラスター剤、点眼剤、眼軟膏剤、点鼻剤、乳剤、懸濁化剤などの非経口製剤とすることができる。
In the present invention, vitamins and qualitative and quantitative ranges that do not impair the effects of the invention,
Xanthine derivatives, amino acids, excipients, pH adjusters, cooling agents, suspending agents, antifoaming agents, thickeners, solubilizers, disintegrating agents, binders, lubricants, antioxidants, coating agents Ordinary liquids, tablets, granules, powders, capsules, dry syrups, chewable tablets, transmucosal agents, etc. by blending colorants, flavoring agents, surfactants, plasticizers, fragrances, etc. Parenteral preparations such as preparations, creams, lotions, gels, ointments, patches, patches, patches, plasters, eye drops, eye ointments, nasal drops, emulsions, suspending agents, etc. be able to.
以下に実施例及び試験例を挙げ、本発明をさらに具体的に説明する。
(実施例1)
原生薬量500gのビンロウジを細切後、10倍量の50%エタノールを加え、沸騰状態で30分間加熱抽出し、濾過後減圧下でエタノールを留去し、さらに、濃縮を行うことにより、エキスを得た。
Hereinafter, the present invention will be described more specifically with reference to examples and test examples.
Example 1
After shredding 500 g of beet loin in the amount of the drug substance, add 10 times the amount of 50% ethanol, extract by heating for 30 minutes in a boil, filter and distill off the ethanol under reduced pressure. Got.
(実施例2)
原生薬量500gのビンロウジを細切後、10倍量の水を加え、100℃で30分間加熱抽出し、濾過後減圧下で濃縮を行うことにより、エキスを得た。
(Example 2)
After shredding 500 g of a crude drug amount in a crude drug amount, 10 times the amount of water was added, extracted by heating at 100 ° C. for 30 minutes, filtered and concentrated under reduced pressure to obtain an extract.
(実施例3)
実施例1で得られたエキスを2g秤量し、精製水を加え、全量100mLとし、エキス濃度が原生薬換算15g/100mLとなる液剤を調整した。
(Example 3)
2 g of the extract obtained in Example 1 was weighed, purified water was added to make a total volume of 100 mL, and a liquid preparation having an extract concentration of 15 g / 100 mL in terms of drug substance was prepared.
(実施例4)
実施例2で得られたエキスを2g、ポリオキシエチレン硬化ヒマシ油60を1g秤量し、精製水を加え、全量100mLとし、エキス濃度が原生薬換算15g/100mLとなる液剤を調整した。
Example 4
2 g of the extract obtained in Example 2 and 1 g of polyoxyethylene hydrogenated
(試験例)
試験にはWistar系雄性ラット10週齢オス(日本チャールスリバー)を用いた。ラットに実施例1にて得られたビンロウジエキスを1.5g/kg(原生薬換算)の用量で十二指腸内に投与し、投与15分後、30分後、45分後、60分後に涙液分泌量及び唾液分泌量を測定した。なお対照群には水を投与した。
(Test example)
For the test, a 10-week-old male male Wistar strain (Charles River Japan) was used. Rats were treated with the beloW extract obtained in Example 1 at a dose of 1.5 g / kg (in terms of crude drug) into the duodenum, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration. The amount of secretion and the amount of saliva secretion were measured. In addition, water was administered to the control group.
涙液分泌量の測定には、フェノールレッド糸(ゾーンクィック、(株)メニコン)を使用し、1分間のラットの結膜嚢に挿入し、糸にしみ込んだ涙液の長さをノギスを用いて測定し、その累積値を求めた。 For measurement of lacrimal secretion, phenol red thread (Zonquick, Menicon Co., Ltd.) was used, inserted into the conjunctival sac of rat for 1 minute, and the length of tears soaked into the thread was measured using calipers. Measurement was made and the cumulative value was obtained.
唾液分泌量の測定は、コットンボールをラットの口腔内に15分間挿入し、その重量を測定し、その累積値を求めた。すべての群の例数は10とした。
涙液分泌量の結果を図1に、唾液分泌量の結果を図2に示した。
The amount of saliva secretion was measured by inserting a cotton ball into the oral cavity of a rat for 15 minutes, measuring its weight, and determining its cumulative value. The number of cases in all groups was 10.
The results of tear secretion are shown in FIG. 1, and the results of saliva secretion are shown in FIG.
図1及び図2で示したように、対照群と比較して、ビンロウジエキス投与群では、投与30分後から有意な涙液分泌量及び唾液分泌量の増加が確認された。
以上の結果、ビンロウジエキスは、唾液腺及び涙腺の腺分泌を促進することにより、ドライアイ又はドライマウスを予防あるいは改善することが明らかになった。
As shown in FIGS. 1 and 2, compared with the control group, a significant increase in the amount of lacrimal secretion and saliva secretion was confirmed in the beloW extract
As a result, it has been clarified that betel nut extract prevents or improves dry eyes or dry mice by promoting gland secretion of salivary and lacrimal glands.
ビンロウジエキスは、唾液腺及び涙腺の水分泌を促進することから、本発明の外分泌機能障害改善剤はドライアイ又はドライマウスの予防又は改善するための医薬品、医薬部外品又は食品に有用である。 Since betel nut extract promotes water secretion of salivary glands and lacrimal glands, the exocrine dysfunction-improving agent of the present invention is useful for pharmaceuticals, quasi drugs or foods for preventing or improving dry eye or dry mice.
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