JP4726268B2 - Pharmaceutical composition - Google Patents
Pharmaceutical composition Download PDFInfo
- Publication number
- JP4726268B2 JP4726268B2 JP11886096A JP11886096A JP4726268B2 JP 4726268 B2 JP4726268 B2 JP 4726268B2 JP 11886096 A JP11886096 A JP 11886096A JP 11886096 A JP11886096 A JP 11886096A JP 4726268 B2 JP4726268 B2 JP 4726268B2
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- stomach
- sofalcone
- sodium bicarbonate
- magnesium aluminate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
【０００１】
【発明の属する技術分野】
本発明は、医薬組成物に関する。
【０００２】
【従来の技術】
近年、社会生活におけるストレスの増加や食事習慣の変化などにより、胃炎、胃潰瘍などの上部消化管疾患の患者が増加している。その治療剤として種々の薬剤が開発されており、代表的なものとしてソファルコンをあげることができる。ソファルコンは広豆根の研究から開発されたイソプレニルカルコン誘導体であり、化学名は２’−カルボキシメトキシ−４，４’−ビス（３−メチル−２−ブテニルオキシ）カルコンと称し、その配合製剤が特開平７−１７９３４６号公報、特開平４−１１２８２４号公報などに記載されている。しかしながら、従来知られているソファルコン配合剤は疾病の治療に対して必ずしも満足できるものではなかった。
【０００３】
【発明が解決しようとする課題】
本発明は、ソファルコンを配合した製剤による、各種疾病の治療期間の短縮を目的とする。
【０００４】
【課題を解決するための手段】
本発明者らは上記事情を鑑み種々検討した結果、ソファルコン、ロートエキスおよび制酸剤を配合した医薬組成物が胃炎の治療期間を大幅に短縮することを見いだし本発明を完成した。すなわち本発明はソファルコン、ロートエキスおよび制酸剤からなる医薬組成物である。
【０００５】
【発明の実施の形態】
本発明においてロートエキスとはロートコンを常法により抽出したものもしくはその乾燥物などである。制酸剤とは炭酸水素ナトリウム、ケイ酸アルミン酸マグネシウム、リン酸水素カルシウム、メタケイ酸アルミン酸ナトリウム、合成ヒドロタルサイトなどをあげることができるが、好ましいものとして炭酸水素ナトリウムおよびケイ酸アルミン酸マグネシウムをあげることができる。制酸剤は２種以上を用いてもよく、特に速効的な胃酸中和作用を有する薬剤と持続的な胃酸中和作用を有する薬剤を併用すると胃炎の治療効果の点で好ましい。特に、炭酸水素ナトリウムおよびケイ酸アルミン酸マグネシウムを同時配合すると胃炎治療効果の点で最も好ましい。
【０００６】
各配合成分はソファルコン１重量部に対して、ロートエキスの乾燥物換算で０．０１〜５重量部、好ましくは０．０５〜２重量部、最も好ましくは０．１重量部である。また、制酸剤の量は、胃内のｐＨを３〜５に保持するのに充分な量が好ましい。制酸剤として炭酸水素ナトリウムおよびケイ酸アルミン酸マグネシウムを用いた場合の配合量は、１日３回投与の場合、１回分で炭酸水素ナトリウム５０〜２０００ｍｇ、好ましくは１００〜５００ｍｇ、最も好ましくは２００ｍｇであり、ケイ酸アルミン酸マグネシウムは５０〜１５００ｍｇ、好ましくは１５０〜５００ｍｇ、最も好ましくは３００ｍｇである。
【０００７】
本発明の医薬組成物を胃炎の治療に用いた場合、通常、成人に対して１日あたり１回〜数回に分けて経口または非経口で投与することができる。ソファルコンの投与量は１０〜１０００ｍｇ／日が好ましい。この投与量は年齢、体重、病状などにより適宜増減することができる。
【０００８】
本発明の医薬は、錠剤、顆粒剤、散剤、カプセル剤、液剤など経口投与形態または注射剤、塗布剤などの非経口投与形態の通常の製剤として用いる。
【０００９】
これらの製剤は、常法により調製することができる。製剤の調製に使用する担体としては、乳糖、デンプン、砂糖、マンニトール、結晶セルロースなどの賦形剤、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、ゼラチン、ポリビニルピロリドンなどの結合剤、カルボキシメチルセルロースカルシウム、低置換度ヒドロキシプロピルセルロースなどの崩壊剤、ステアリン酸マグネシウム、硬化ヒマシ油、タルクなどの滑択剤があり、この他必要に応じて溶解補助剤、緩衝剤、保存剤、香料、色素、矯味剤などを使用することができる。
【００１０】
【実施例】
以下に実施例および試験例により本発明をさらに詳細に説明する。
【００１１】
実施例１
ソファルコン ３００ｍｇ、ロートエキス３倍散 ９０ｍｇ、炭酸水素ナトリウム ６００ｍｇおよびケイ酸アルミン酸マグネシウム ９００ｍｇをとり、日本薬局方製剤総則、散剤の項の製法に準じ調製し、３分包して散剤を得た。
【００１２】
試験例
実施例１で調製した散剤を１６５名（男性７５例、女性９０例、平均年齢４７．１歳）の胃炎患者に１回１包、１日３回経口投与して自覚症状（胃痛、胃部不快感、胃重感、胃部膨満感、胃もたれ、はきけ、胸やけ、げっぷ、胸のつかえ）の改善度を見た。総合改善度をソファルコンのみの製剤についての文献（診療と新薬、第２３巻、２６１９−２６３１頁、１９８６年）に記載のデータと比較した。実施例、比較データともソファルコンの含有量は１包あたり１００ｍｇで同一である。
【００１３】
結果
自覚症状の中等度以上の改善度は実施例１記載の散剤は２週間投与で８８．４％であった。文献記載データでは４週間投与でも８０．５％である。このことから本発明の医薬組成物は従来技術と比較し、胃炎治療期間の短縮を図っていることが明らかに解る。
【００１４】
【発明の効果】
上記試験例から明らかなように、本発明によりソファルコンを投与した胃炎患者の治療期間を短縮することが可能になった。また、ソファルコンが有効なその他の疾病の治療期間を短縮することが可能になった。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a pharmaceutical composition.
[0002]
[Prior art]
In recent years, patients with upper gastrointestinal diseases such as gastritis and gastric ulcers are increasing due to increased stress in social life and changes in dietary habits. Various drugs have been developed as therapeutic agents, and a typical example is sofalcone. Sofalcon is an isoprenyl chalcone derivative developed from the study of Hiroma Root, and its chemical name is 2′-carboxymethoxy-4,4′-bis (3-methyl-2-butenyloxy) chalcone, and its formulation Are described in JP-A-7-179346, JP-A-4-112824, and the like. However, conventionally known sofalcone combination drugs are not always satisfactory for treatment of diseases.
[0003]
[Problems to be solved by the invention]
An object of the present invention is to shorten the treatment period of various diseases by a preparation containing sofalcone.
[0004]
[Means for Solving the Problems]
As a result of various studies in view of the above circumstances, the present inventors have found that a pharmaceutical composition containing sofalcone, a funnel extract and an antacid agent significantly shortens the treatment period for gastritis, and has completed the present invention. That is, the present invention is a pharmaceutical composition comprising sofalcone, funnel extract and an antacid.
[0005]
DETAILED DESCRIPTION OF THE INVENTION
In the present invention, the funnel extract is a product obtained by extracting rotocon by a conventional method or a dried product thereof. Examples of the antacid include sodium hydrogen carbonate, magnesium aluminate silicate, calcium hydrogen phosphate, sodium aluminate metasilicate, and synthetic hydrotalcite. Sodium bicarbonate and magnesium aluminate silicate are preferable. Can give. Two or more kinds of antacids may be used, and it is particularly preferable from the viewpoint of the therapeutic effect of gastritis when a drug having a rapid gastric acid neutralizing action and a drug having a continuous gastric acid neutralizing action are used in combination. Particularly, sodium bicarbonate and magnesium aluminate silicate are most preferably combined in view of gastritis treatment effect.
[0006]
Each compounding component is 0.01 to 5 parts by weight, preferably 0.05 to 2 parts by weight, and most preferably 0.1 parts by weight in terms of dry matter of the funnel extract with respect to 1 part by weight of sofalcone. Further, the amount of the antacid is preferably an amount sufficient to maintain the pH in the stomach at 3-5. When sodium hydrogen carbonate and magnesium aluminate silicate are used as antacids, when administered three times a day, sodium bicarbonate 50-2000 mg, preferably 100-500 mg, most preferably 200 mg per dose The magnesium aluminate silicate is 50-1500 mg, preferably 150-500 mg, most preferably 300 mg.
[0007]
When the pharmaceutical composition of the present invention is used for the treatment of gastritis, it can be orally or parenterally administered to adults once to several times per day. The dose of Sofalcon is preferably 10 to 1000 mg / day. This dosage can be appropriately increased or decreased depending on age, body weight, medical condition and the like.
[0008]
The medicament of the present invention is used as an ordinary preparation in an oral dosage form such as a tablet, granule, powder, capsule, liquid, or a parenteral dosage form such as an injection or coating.
[0009]
These preparations can be prepared by conventional methods. Carriers used in the preparation of the formulation include excipients such as lactose, starch, sugar, mannitol, crystalline cellulose, binders such as hydroxypropylcellulose, hydroxypropylmethylcellulose, gelatin, polyvinylpyrrolidone, carboxymethylcellulose calcium, low substitution degree There are disintegrants such as hydroxypropylcellulose, lubricants such as magnesium stearate, hydrogenated castor oil, and talc. In addition, solubilizers, buffers, preservatives, fragrances, pigments, and flavoring agents are used as necessary. can do.
[0010]
【Example】
Hereinafter, the present invention will be described in more detail with reference to examples and test examples.
[0011]
Example 1
300 mg of sofalcon, 90 mg of funnel extract, 90 mg of sodium bicarbonate, 600 mg of sodium bicarbonate and 900 mg of magnesium aluminate were prepared in accordance with the preparation method of the Japanese Pharmacopoeia General Formulation and Powders, and the powder was obtained by wrapping for 3 minutes. .
[0012]
Test Example Powder powder prepared in Example 1 was orally administered to 165 (75 males, 90 females, average age 47.1 years old) gastritis patients once a day, 3 times a day for subjective symptoms (stomach pain, The degree of improvement in stomach discomfort, stomach sensation, stomach fullness, stomach sag, scalding, heartburn, belching, chest gripping) was observed. The overall improvement was compared with the data described in the literature (medical care and new drugs, Vol. 23, pp. 2619-2631, 1986) for the preparation with sofalcone alone. The content of sofalcone is the same at 100 mg per package in both the examples and comparative data.
[0013]
Results The degree of improvement in subjective symptoms of moderate or higher was 88.4% when the powder described in Example 1 was administered for 2 weeks. In literature data, it is 80.5% even after 4 weeks of administration. This clearly shows that the pharmaceutical composition of the present invention shortens the gastritis treatment period as compared with the prior art.
[0014]
【The invention's effect】
As is clear from the above test examples, the present invention has made it possible to shorten the treatment period of gastritis patients who have been administered sofalcone. In addition, it has become possible to shorten the treatment period for other diseases for which sofalcone is effective.
Claims (2)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11886096A JP4726268B2 (en) | 1996-05-14 | 1996-05-14 | Pharmaceutical composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11886096A JP4726268B2 (en) | 1996-05-14 | 1996-05-14 | Pharmaceutical composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH09301879A JPH09301879A (en) | 1997-11-25 |
| JP4726268B2 true JP4726268B2 (en) | 2011-07-20 |
Family
ID=14746933
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP11886096A Expired - Lifetime JP4726268B2 (en) | 1996-05-14 | 1996-05-14 | Pharmaceutical composition |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP4726268B2 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058552B (en) * | 2010-12-22 | 2012-10-03 | 天津药物研究院药业有限责任公司 | Sofalcone sustained release tablet and preparation method thereof |
-
1996
- 1996-05-14 JP JP11886096A patent/JP4726268B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH09301879A (en) | 1997-11-25 |
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