JP2009126813A - Agent for treating oral mucosal disease - Google Patents
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- JP2009126813A JP2009126813A JP2007302765A JP2007302765A JP2009126813A JP 2009126813 A JP2009126813 A JP 2009126813A JP 2007302765 A JP2007302765 A JP 2007302765A JP 2007302765 A JP2007302765 A JP 2007302765A JP 2009126813 A JP2009126813 A JP 2009126813A
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title claims abstract description 31
- 201000010099 disease Diseases 0.000 title claims abstract description 30
- 239000003814 drug Substances 0.000 claims abstract description 16
- 239000004480 active ingredient Substances 0.000 claims abstract description 5
- 229940124597 therapeutic agent Drugs 0.000 claims description 7
- 238000002360 preparation method Methods 0.000 claims description 5
- 230000000069 prophylactic effect Effects 0.000 claims description 3
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- GFWRVVCDTLRWPK-KPKJPENVSA-N sofalcone Chemical compound C1=CC(OCC=C(C)C)=CC=C1\C=C\C(=O)C1=CC=C(OCC=C(C)C)C=C1OCC(O)=O GFWRVVCDTLRWPK-KPKJPENVSA-N 0.000 abstract description 10
- 229950004782 sofalcone Drugs 0.000 abstract description 10
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- 230000000306 recurrent effect Effects 0.000 abstract description 4
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- 230000004054 inflammatory process Effects 0.000 description 11
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- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 4
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- 239000008187 granular material Substances 0.000 description 4
- 206010002091 Anaesthesia Diseases 0.000 description 3
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- WEXRUCMBJFQVBZ-UHFFFAOYSA-N pentobarbital Chemical compound CCCC(C)C1(CC)C(=O)NC(=O)NC1=O WEXRUCMBJFQVBZ-UHFFFAOYSA-N 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
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- LRFVTYWOQMYALW-UHFFFAOYSA-N 9H-xanthine Chemical class O=C1NC(=O)NC2=C1NC=N2 LRFVTYWOQMYALW-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
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- 208000005232 Glossitis Diseases 0.000 description 1
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
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- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 206010013781 dry mouth Diseases 0.000 description 1
- 229950003246 ecabet Drugs 0.000 description 1
- IWCWQNVIUXZOMJ-MISYRCLQSA-N ecabet Chemical compound OC(=O)[C@@](C)([C@@H]1CC2)CCC[C@]1(C)C1=C2C=C(C(C)C)C(S(O)(=O)=O)=C1 IWCWQNVIUXZOMJ-MISYRCLQSA-N 0.000 description 1
- 231100000321 erythema Toxicity 0.000 description 1
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- 210000004195 gingiva Anatomy 0.000 description 1
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- -1 isoprenyl chalcone compound Chemical class 0.000 description 1
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- 230000007170 pathology Effects 0.000 description 1
- 229960001412 pentobarbital Drugs 0.000 description 1
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- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
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- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
Description
本発明は、医薬品の分野におけるソファルコンを有効成分とした口腔粘膜疾患の予防又は治療剤に関する。 The present invention relates to a prophylactic or therapeutic agent for oral mucosal disease comprising sofalcone as an active ingredient in the field of pharmaceuticals.
口腔粘膜とは、舌、歯肉、頬、口唇、口蓋などを覆っている軟組織であり、この粘膜上に生じる病変を総称して口腔粘膜疾患と呼ぶ。口腔粘膜疾患の中では粘膜の滲出性炎が多く、この口腔粘膜の炎症は口内炎と称される。口内炎はそれぞれの病態によりアフタ性、カタル性、紅斑あるいはびらん性、潰瘍性、偽膜性などに分類される。口内炎のうち歯肉、舌、口唇に限局しているものを特に歯肉炎、舌炎、口唇炎ということもある（非特許文献１参照）。 The oral mucosa is a soft tissue covering the tongue, gums, cheeks, lips, palate and the like, and lesions occurring on the mucous membrane are collectively referred to as oral mucosal diseases. Among oral mucosal diseases, there are many mucosal exuditis, and this inflammation of the oral mucosa is called stomatitis. Stomatitis is classified into aphthous, catarrhal, erythema or erosive, ulcerative, pseudomembranous, etc., depending on the pathology. Of the stomatitis, those limited to the gingiva, tongue and lips are sometimes referred to as gingivitis, glossitis and cheilitis (see Non-Patent Document 1).
一方、アフタを形成するが周囲に炎症像を伴わず、口腔内にアフタが定期的あるいは不定期的に再発する疾患を再発性アフタと呼ぶ。この疾患は、口内炎の一つとして認識されている場合が多いが、炎症像を伴わないものが多いことから、口内炎とは異なる疾患として分類する説もある。口腔粘膜における境界明瞭な類円形の小さな潰瘍で表面を白色ないし黄色の偽膜で覆われ発赤を認める病変であり、それらは痛みを伴う。また、発生頻度が高く、全人口の２０％程度が罹患すると考えられている。 On the other hand, a disease that forms after but does not have an inflammation image around it and recurs regularly or irregularly in the oral cavity is called recurrent after. Although this disease is often recognized as one of stomatitis, there are many theories that are not accompanied by an image of inflammation, so there is a theory that it is classified as a disease different from stomatitis. These are small circular ulcers with well-defined borders in the oral mucosa, which are covered with white or yellow pseudomembrane and are red. They are painful. In addition, the frequency of occurrence is high, and it is thought that about 20% of the entire population is affected.
これら口腔粘膜疾患発症の原因は不明であるが、免疫系のバランス異常が関与すると推測されており、その他の原因としては疲労、ストレス、女性の性周期などの関与が示唆されている（非特許文献２参照）。本症は疼痛あるいは接触痛を伴うことから食物の摂取障害や発語障害など患者にとって深刻な問題となっており、早期に治療することが望まれる。 The cause of these oral mucosal diseases is unknown, but it is presumed that abnormal balance of the immune system is involved, and other causes are suggested, such as fatigue, stress, and female sexual cycle (non-patented) Reference 2). Since this disease is accompanied by pain or contact pain, it is a serious problem for patients such as food intake disorder and speech disorder, and early treatment is desired.
口腔粘膜疾患の治療薬としては、デキサメタゾン、トリアムシノロンアセトニド等のステロイド系抗炎症剤が軟膏、局所用錠剤、局所噴霧剤等の形態で用いられる（特許文献１参照）。しかし、ステロイド系抗炎症剤を配合した軟膏、局所用錠剤などの局所適用は口腔粘膜疾患が細菌性の場合や口腔内細菌等による症状の悪化を引き起こす場合もあり問題であった。ステロイド系抗炎症剤以外にも、ビタミンB群が内服剤として用いられている（特許文献２参照）。一方、胃潰瘍、胃炎治療薬を口腔粘膜疾患に使用することに関してはエカベトナトリウムの局所適用があげられる（特許文献３参照）が、実用化には至っていない。 As therapeutic agents for oral mucosal diseases, steroidal anti-inflammatory agents such as dexamethasone and triamcinolone acetonide are used in the form of ointments, topical tablets, topical sprays and the like (see Patent Document 1). However, topical applications such as ointments and topical tablets containing steroidal anti-inflammatory agents have been problematic because oral mucosal diseases may be bacterial or cause deterioration of symptoms due to oral bacteria. In addition to steroidal anti-inflammatory agents, vitamin B group is used as an internal medicine (see Patent Document 2). On the other hand, regarding the use of therapeutic agents for gastric ulcer and gastritis for oral mucosal diseases, topical application of ecabet sodium can be mentioned (see Patent Document 3), but it has not been put into practical use.
上記のような薬剤は主に軟膏、局所用錠剤、噴霧などの局所適用を対象としていたが、薬剤が口腔内に残存することによる口腔内の異物感、違和感や苦みの持続などが使用上の問題となっていた。 The above drugs were mainly intended for topical application such as ointments, topical tablets, sprays, etc., but the presence of foreign substances in the oral cavity due to the drug remaining in the oral cavity, discomfort and sustained bitterness, etc. It was a problem.
ソファルコンは胃炎、胃潰瘍治療効果を有する公知の化合物であり、急性胃炎、慢性胃炎の急性増悪期の胃粘膜病変（びらん、出血、発赤、浮腫）の改善、胃潰瘍に適用されるが、ソファルコンを口腔粘膜疾患の治療に使用することについては知られていない。 Sofalcon is a known compound that has a therapeutic effect on gastritis and gastric ulcer. It is applied to gastric ulcers, improving gastric mucosal lesions (erosion, bleeding, redness, edema) during acute gastritis and acute exacerbation of chronic gastritis. Is not known for use in the treatment of oral mucosal diseases.
本発明の目的は、安全でより効果的な口腔粘膜疾患の治療に有用な経口用薬剤を提供することである。 An object of the present invention is to provide an oral drug useful for safe and more effective treatment of oral mucosal diseases.
本発明者らは、鋭意検討した結果、ソファルコンが経口投与により口腔粘膜疾患の治療に優れた効果を発揮することを見出し、本発明を完成させた。 As a result of intensive studies, the present inventors have found that sofalcone exerts an excellent effect on the treatment of oral mucosal diseases by oral administration, and has completed the present invention.
すなわち本発明は、
（１）ソファルコンを有効成分として含有することを特徴とする口腔粘膜疾患の予防又は治療剤。
（２）経口用製剤である（１）記載の口腔粘膜疾患の予防又は治療剤。
である。
That is, the present invention
(1) A prophylactic or therapeutic agent for oral mucosal diseases, comprising sofalcone as an active ingredient.
(2) The preventive or therapeutic agent for oral mucosal disease according to (1), which is an oral preparation.
It is.
ソファルコン含有経口製剤は、口腔粘膜疾患の治癒を促進する優れた効果を示した。 Sofalcon-containing oral preparations showed an excellent effect of promoting the healing of oral mucosal diseases.
ソファルコンとは特公昭５７−４０８０６号に記載のあるイソプレニルカルコン化合物である。上記公報中に記載されている方法又はそれに準じた方法で製造することができる。 Sofalcon is an isoprenyl chalcone compound described in JP-B-57-40806. It can be produced by the method described in the above publication or a method analogous thereto.
本発明の医薬組成物の好ましい適用対象は口腔粘膜疾患であり、口腔粘膜疾患のうち、さらに好ましい適用対象は口内炎である。口内炎のうち特に好ましい適用対象はアフタ性口内炎である。口腔粘膜疾患のうち、別の好ましい適用対象は再発性アフタである。再発性アフタとはアフタが口腔粘膜に繰り返し生じる現象で、炎症像を伴わないものが多い。 A preferable application target of the pharmaceutical composition of the present invention is oral mucosal disease, and among oral mucosal diseases, a more preferable application target is stomatitis. Of the stomatitis, a particularly preferred application target is aphthous stomatitis. Among oral mucosal diseases, another preferred application target is recurrent after. Recurrent after is a phenomenon in which after occurs repeatedly in the oral mucosa, and it often has no inflammation image.
ソファルコンを口腔粘膜疾患の治療又は予防剤として使用する場合、経口剤として投与することが特に好ましい。ソファルコンを経口で投与することを想定した場合、錠剤、カプセル剤、細粒剤、微粒剤、チュアブル剤、トローチなどの固形製剤で摂取することが可能である。また、液剤、ドライシロップ剤などで摂取することも可能である。 When using Sofalcon as an agent for treating or preventing oral mucosal disease, it is particularly preferable to administer it as an oral agent. When it is assumed that Sofalcon is administered orally, it can be taken in solid preparations such as tablets, capsules, fine granules, fine granules, chewable preparations, and troches. It can also be taken in liquid form, dry syrup form and the like.
また、発明の効果を損なわない質的および量的範囲で、ビタミン、キサンチン誘導体、アミノ酸などを添加することができる。さらに必要に応じて他の公知の添加剤として、生薬、天然物、賦形剤、ｐＨ調整剤、清涼化剤、懸濁化剤、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、矯味剤、界面活性剤、可塑剤、香料などを混合することができる。 In addition, vitamins, xanthine derivatives, amino acids, and the like can be added within a qualitative and quantitative range that does not impair the effects of the invention. Further, as necessary, other known additives include crude drugs, natural products, excipients, pH adjusting agents, cooling agents, suspending agents, thickening agents, solubilizing agents, disintegrating agents, binders, lubricants. A lot of additives, antioxidants, coating agents, coloring agents, flavoring agents, surfactants, plasticizers, fragrances and the like can be mixed.
通常、成人にはソファルコンとして１回５０〜２００ｍｇを1日２〜３回経口投与することが望ましく、1回１００mgを１日３回経口投与することがさらに望ましい。また、この投与量は投与ルート、年齢、性別、症状の重症度などにより適宜増減することも可能である。 In general, for adults, it is desirable to orally administer 50 to 200 mg as a sofalcone once to 2-3 times a day, and more desirably 100 mg once orally 3 times a day. In addition, this dose can be appropriately increased or decreased depending on the route of administration, age, sex, severity of symptoms, and the like.
試験例
Wistar系雄性ラット（８週齢、日本ＳＬＣ）を用いた。ラットは飼育期間中、餌および水を自由に摂取させ、室温２３±１℃、湿度５０±５％、１２時間の明暗サイクルの一定環境で飼育した。
ペントバルビタール（５０ｍｇ／ｋｇ、ｉ．ｐ．）麻酔下でラットの口腔粘膜を露出させ、粘膜下に２０％酢酸生理食塩水溶液２０μＬを注入した。２４時間後エーテル麻酔下に粘膜の炎症部位について、長軸径とそれに直交する短軸径をノギスにて測定し、炎症面積を四角に近似して算出した。炎症面積が一定になるよう群分けを行い、群分け当日から薬物投与を開始した。投与サンプルには大正製薬株式会社製のソロン細粒２０％（製品１g中ソファルコン２００mg含有）を用いた。ソロン細粒２０％を水に懸濁し、２００ｍｇ／ｋｇ（ソファルコンとして）の用量で１日２回、午前と午後に経口投与した（１日あたり４００ｍｇ／ｋｇ）。対照群には水を経口投与した。上記条件で毎日経口投与を行い、投与終了翌日（投与開始後１、４、７、８、９、１０及び１１日後）にエーテル麻酔下で、炎症面積を測定した。
結果を表１に示した。ラットの口腔粘膜に酢酸を注入すると２４時間後の炎症面積は約２５mm2であった。その後、炎症面積は経日的に消退し、対照群では薬物投与開始から１１日後には炎症像がほぼ消失した。サンプル投与群では、表１から明らかなように、この口内炎の治癒を４日目以降、促進する作用が認められ、投与開始から７日目及び８日目において対照群に比較して有意な炎症面積の縮小が認められた。すなわち、ソファルコンが口腔粘膜疾患の治癒を促進することが明らかになった。
Test example
Wistar male rats (8 weeks old, Japan SLC) were used. Rats were allowed free access to food and water during the breeding period, and were kept in a constant environment with a room temperature of 23 ± 1 ° C., humidity of 50 ± 5%, and a 12-hour light-dark cycle.
Under anesthesia with pentobarbital (50 mg / kg, ip), the oral mucosa of rats was exposed, and 20 μL of 20% acetic acid saline solution was injected under the mucosa. 24 hours later, the major axis diameter and the minor axis diameter orthogonal to the inflamed area of the mucous membrane were measured with calipers under ether anesthesia, and the area of inflammation was calculated by approximating the square. Grouping was performed so that the inflammation area was constant, and drug administration was started from the day of grouping. As the administration sample, 20% solon fine granules (containing 200 mg of sofalcone in 1 g of product) manufactured by Taisho Pharmaceutical Co., Ltd. were used. Solon granules 20% were suspended in water and administered orally in the morning and afternoon (400 mg / kg per day) twice daily at a dose of 200 mg / kg (as sofalcone). Water was orally administered to the control group. Oral administration was performed every day under the above conditions, and the area of inflammation was measured under ether anesthesia on the next day after administration (1, 4, 7, 8, 9, 10 and 11 days after the start of administration).
The results are shown in Table 1. When acetic acid was injected into the oral mucosa of a rat, the inflammation area after 24 hours was about 25 mm 2 . Thereafter, the inflammation area disappeared daily, and in the control group, the inflammation image almost disappeared 11 days after the start of drug administration. As is apparent from Table 1, in the sample administration group, an effect of promoting the healing of this stomatitis was observed from the 4th day onward, and significant inflammation was observed on the 7th and 8th days from the start of the administration as compared with the control group. A reduction in area was observed. That is, it was revealed that sofalcone promotes healing of oral mucosal diseases.
本発明により、ソファルコンを有効成分として含有する口腔粘膜疾患の経口用薬剤を提供することが可能となる。 According to the present invention, it is possible to provide an oral drug for oral mucosal diseases containing sofalcone as an active ingredient.
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| JP2011057667A (en) * | 2009-08-12 | 2011-03-24 | Taisho Pharmaceutical Co Ltd | Prophylactic or therapeutic agent for keratoconjunctive disease |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JPH07179346A (en) * | 1993-11-10 | 1995-07-18 | Taisho Pharmaceut Co Ltd | Therapeutic agent for gastrointestine |
| JPH10109942A (en) * | 1996-08-13 | 1998-04-28 | Takeda Chem Ind Ltd | Medicine |
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| JPH07179346A (en) * | 1993-11-10 | 1995-07-18 | Taisho Pharmaceut Co Ltd | Therapeutic agent for gastrointestine |
| JPH10109942A (en) * | 1996-08-13 | 1998-04-28 | Takeda Chem Ind Ltd | Medicine |
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| JPN6012067389; 伊藤公訓ら: 新薬と臨床 Ｖｏｌ．５５， Ｎｏ．１０, 2006, ｐ．４６-５４ * |
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| JP2011057667A (en) * | 2009-08-12 | 2011-03-24 | Taisho Pharmaceutical Co Ltd | Prophylactic or therapeutic agent for keratoconjunctive disease |
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