JP6864970B2 - Gastrointestinal drug composition - Google Patents
Gastrointestinal drug composition Download PDFInfo
- Publication number
- JP6864970B2 JP6864970B2 JP2019034365A JP2019034365A JP6864970B2 JP 6864970 B2 JP6864970 B2 JP 6864970B2 JP 2019034365 A JP2019034365 A JP 2019034365A JP 2019034365 A JP2019034365 A JP 2019034365A JP 6864970 B2 JP6864970 B2 JP 6864970B2
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- Prior art keywords
- extract
- gastrointestinal
- mass
- perilla
- drug composition
- Prior art date
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Description
本発明は、ソヨウ及びモッコウ並びにそれらの抽出物から選ばれる１種以上を含む胃腸薬組成物に関する。 The present invention relates to a gastrointestinal drug composition containing one or more selected from perilla and costus and extracts thereof.
胃腸薬とは一般に、食べ過ぎ、胸やけ、もたれ、胃痛、吐き気、嘔吐などの症状を緩和する作用を示し、胃腸を健康な状態に維持するあるいは健康な状態に回復させるために広く用いられる医薬であり、消化薬、健胃薬、制酸薬、複合胃腸薬、胃腸鎮痛鎮痙薬などに細分類される。 Gastrointestinal drugs are generally used to relieve symptoms such as overeating, heartburn, leaning, stomach pain, nausea, and vomiting, and are widely used to maintain or restore a healthy state of the gastrointestinal tract. It is subdivided into digestive drugs, stomachic drugs, antacids, compound gastrointestinal drugs, gastrointestinal analgesic and antispasmodic drugs, etc.
ソヨウ（蘇葉）は、シソ又はチリメンジソの葉及び枝先であり、わずかに苦い味を有し、興奮性発汗、解熱、鎮咳、鎮静、鎮痛、利尿などの作用を有するとされており、胃腸薬に配合される場合もある。
また、モッコウ（木香）は、Saussurea lappa Clarkeの根であり、芳香健胃薬として使用される。また、胃腸薬に配合される場合もある。
一方、センブリ、ロートコン、メチルメチオニンスルホニウムクロライドはそれぞれ胃腸薬の成分として用いられる。さらに、メチルメチオニンスルホニウムクロライドについては、消化管運動の賦活化作用についても報告されている（特許文献１）。
しかしながら、これらを組み合わせた際の効果については、これまでに知られていない。
Perilla (perilla) is a leaf and branch tip of perilla or perilla, has a slightly bitter taste, and is said to have effects such as excitatory sweating, antipyretic, antitussive, sedative, analgesic, and diuretic, and is gastrointestinal. It may be added to medicine.
Costus is the root of Saussurea lappa Clarke and is used as an aromatic stomachic. It may also be added to gastrointestinal drugs.
On the other hand, Swertia japonica, Rotocon, and methylmethionine sulfonium chloride are used as components of gastrointestinal drugs, respectively. Furthermore, regarding methylmethionine sulfonium chloride, the activation effect of gastrointestinal motility has also been reported (Patent Document 1).
However, the effect of combining these has not been known so far.
本発明の課題は、優れた消化管運動賦活化作用を示す新たな胃腸薬組成物を提供することにある。 An object of the present invention is to provide a novel gastrointestinal drug composition exhibiting an excellent gastrointestinal motility activating effect.
本発明者らは、まず、ソヨウ若しくはモッコウ又はそれらの抽出物の消化管運動賦活化作用を確認したところ、これらは単独では消化管運動賦活化作用を示さないことが判明した。
しかしながら、センブリやロートコン、メチルメチオニンスルホニウムクロライドと共に用いた場合に消化管運動賦活化作用を向上させるものについて鋭意検討したところ、全く意外にも、上記のような単独では消化管運動賦活化作用を示さないソヨウ若しくはモッコウ又はそれらの抽出物が、センブリやロートコン、メチルメチオニンスルホニウムクロライドと共に組み合わせて用いた場合に消化管運動賦活化作用を向上させることを見出し、本発明を完成した。
The present inventors first confirmed the gastrointestinal motility activating effect of perilla or Costus or their extracts, and found that they alone did not exhibit the gastrointestinal motility activating effect.
However, when a diligent study was conducted on a substance that improves the gastrointestinal motility activating effect when used in combination with assembly, rotocon, and methylmethionine sulfonium chloride, the above-mentioned alone showed a gastrointestinal motility activating effect. The present invention has been completed by finding that no soybean or mokko or an extract thereof improves the gastrointestinal motility activating effect when used in combination with sembri, rotocon, and methylmethionine sulfonium chloride.
すなわち、本発明は、次の成分（Ａ）及び（Ｂ）：
（Ａ）ソヨウ及びその抽出物（以下、成分（Ａ−１）とも称する。）、並びにモッコウ及びその抽出物（以下、成分（Ａ−２）とも称する。）から選ばれる１種以上；
（Ｂ）センブリ及びその抽出物（以下、成分（Ｂ−１）とも称する。）、ロートコン及びその抽出物（以下、成分（Ｂ−２）とも称する。）、並びにメチルメチオニンスルホニウムクロライド（以下、成分（Ｂ−３）とも称する。）から選ばれる１種以上；
を含有する、胃腸薬組成物を提供するものである。
That is, the present invention describes the following components (A) and (B):
(A) One or more selected from perilla and its extract (hereinafter, also referred to as component (A-1)), and costus and its extract (hereinafter, also referred to as component (A-2));
(B) Swertia japonica and its extract (hereinafter, also referred to as component (B-1)), rotocon and its extract (hereinafter, also referred to as component (B-2)), and methylmethionine sulfonium chloride (hereinafter, component). One or more selected from (B-3);
To provide a gastrointestinal drug composition containing.
本発明の胃腸薬組成物は、顕著に高められた消化管運動賦活化作用を有する。したがって、本発明の胃腸薬組成物は、もたれ、胃部・腹部膨満感や胃重などの症状の改善する効果を示す。 The gastrointestinal drug composition of the present invention has a significantly enhanced gastrointestinal motility activating effect. Therefore, the gastrointestinal drug composition of the present invention exhibits an effect of improving symptoms such as leaning, stomach / abdominal bloating, and stomach weight.
＜成分（Ａ−１）＞
「ソヨウ」（蘇葉）とは、第十六改正日本薬局方に記載のとおり、シソ（Perilla frutescens Britton var. acuta Kudo）又はチリメンジソ（Perilla frutescens Britton var. crispa Decaisne（Labiatae））の葉及び枝先を意味する。ソヨウは必要に応じてその形態を調節することができ、小片、小塊に切断若しくは粉砕、又は粉末に粉砕することができる。また、胃腸薬組成物の製造時の取扱の便宜等を考慮して、ソヨウに何らかの抽出処理を施したもの（以下、「ソヨウ抽出物」と称する。）を用いてもよい。
なお、上記「ソヨウ抽出物」には、抽出処理に加えて、加熱、乾燥、粉砕等の加工処理を施したものも包含される。具体的には、ソヨウを必要に応じて適当な大きさとした後に、適当な抽出溶媒を加えて浸出した液や、当該浸出液を濃縮した液（軟エキス、チンキ等）、さらにこれらを乾燥させたもの（乾燥エキス等）なども本発明の「ソヨウ抽出物」に包含される。
本発明において、ソヨウ及びその抽出物から選ばれる１種以上としては、ソヨウ乾燥エキスが好ましい。
<Ingredient (A-1)>
"Soyo" (Suha) is the leaves and branches of perilla (Perilla frutescens Britton var. Acuta Kudo) or perilla (Perilla frutescens Britton var. Crispa Decaisne (Labiatae)) as described in the 16th revised Japanese Pharmacopoeia. Means ahead. The morphology of perilla can be adjusted as needed, and it can be cut or crushed into small pieces, lumps, or crushed into powder. In addition, in consideration of convenience of handling at the time of manufacturing the gastrointestinal drug composition, a perilla that has been subjected to some kind of extraction treatment (hereinafter, referred to as "perilla extract") may be used.
The above-mentioned "perilla extract" includes those subjected to processing treatments such as heating, drying and pulverization in addition to the extraction treatment. Specifically, after making the soybean into an appropriate size as needed, a liquid leached by adding an appropriate extraction solvent, a liquid obtained by concentrating the leaching liquid (soft extract, tincture, etc.), and further dried. Things (dried extract, etc.) are also included in the "solvent extract" of the present invention.
In the present invention, a dried perilla extract is preferable as one or more selected from perilla and its extract.
ソヨウ抽出物の製造方法は特に限定されず、例えば第十六改正日本薬局方 製剤総則の「エキス剤」、「浸剤・煎剤」、「チンキ剤」、「流エキス剤」の項の記載など、公知の植物抽出物の製造方法を参考にして製造できる。具体的には例えば、ソヨウを必要に応じて切断、加熱、乾燥、粉砕等したうえ、適当な抽出溶媒を加え抽出を行うことで、製造することができる。得られた抽出物は、必要に応じさらに濃縮、乾燥等させてもよい。 The method for producing the soybean extract is not particularly limited, and for example, the description in the "extract", "immersion / decoction", "tincture", "flow extract" section of the 16th revised Japanese Pharmacopoeia General Rules for Formulation, etc. It can be produced with reference to a known method for producing a plant extract. Specifically, for example, perilla can be produced by cutting, heating, drying, pulverizing or the like as necessary, and then adding an appropriate extraction solvent for extraction. The obtained extract may be further concentrated, dried or the like, if necessary.
上記抽出溶媒としては例えば、メタノール、エタノール、イソプロパノール、ｎ−ブタノール等の低級一価アルコール；エチレングリコール、プロピレングリコール、１，３−ブチレングリコール、グリセリン等の低級多価アルコール；ジエチルエーテル等のエーテル類；アセトン、エチルメチルケトン等のケトン類；酢酸エチル等のエステル類；アセトニトリル等のニトリル類；ペンタン、ヘキサン、シクロペンタン、シクロヘキサン等のアルカン類；ジクロロメタン、クロロホルム等のハロゲノアルカン類；ベンゼン、トルエン等の芳香族炭化水素；ジメチルホルムアミド等のアミド類；ジメチルスルホキシド等のスルホキシド類；水（熱水を含む）等が挙げられる。これらは各々単独で用いてもよいし、２種以上を組み合わせて用いてもよい。本発明においては、水、エタノール、又は水とエタノールの混液が好ましい。
抽出操作は特に限定されず、植物からの抽出操作に利用される公知の方法を採用することができ、具体的には例えば、抽出溶媒への浸漬（冷浸、温浸、パーコレーション等）、超臨界流体や亜臨界流体を用いた抽出などが挙げられる。なお、抽出効率を上げるため、撹拌や抽出溶媒中でホモジナイズしてもよい。
抽出温度は特に限定されず、使用する抽出溶媒、抽出操作等により異なるが、１時間〜１４日程度とするのが好ましい。
Examples of the extraction solvent include lower monohydric alcohols such as methanol, ethanol, isopropanol and n-butanol; lower polyhydric alcohols such as ethylene glycol, propylene glycol, 1,3-butylene glycol and glycerin; ethers such as diethyl ether. Ketones such as acetone and ethyl methyl ketone; esters such as ethyl acetate; nitriles such as acetonitrile; alkanes such as pentane, hexane, cyclopentane and cyclohexane; halogenoalkanes such as dichloromethane and chloroform; benzene, toluene and the like Aromatic hydrocarbons; amides such as dimethylformamide; sulfoxides such as dimethylsulfoxide; water (including hot water) and the like. Each of these may be used alone, or two or more thereof may be used in combination. In the present invention, water, ethanol, or a mixed solution of water and ethanol is preferable.
The extraction operation is not particularly limited, and a known method used for the extraction operation from a plant can be adopted. Specifically, for example, immersion in an extraction solvent (cold immersion, warm immersion, percolation, etc.), super Extraction using a critical fluid or a subcritical fluid can be mentioned. In addition, in order to improve the extraction efficiency, it may be homogenized with stirring or in an extraction solvent.
The extraction temperature is not particularly limited and varies depending on the extraction solvent used, the extraction operation and the like, but is preferably about 1 hour to 14 days.
また、本発明において、ソヨウ及びその抽出物から選ばれる１種以上としては、これらを成分として含む漢方処方を用いてもよい。このような漢方処方としては、具体的には例えば、香蘇散(コウソサン)、蘇子降気湯(ソシコウキトウ)、かっ香正気散(カッコウショウキサン)、茯苓飲合半夏厚朴湯(ブクリョウインゴウハンゲコウボクトウ)、半夏厚朴湯(ハンゲコウボクトウ)等が挙げられる。 Further, in the present invention, as one or more kinds selected from perilla and its extracts, a Chinese herbal formula containing these as ingredients may be used. Specific examples of such Chinese medicine prescriptions include Kososan, Soshikoukito, Kakkoshoxan, and Bukuryoingo Hangekobokuto. Hangekobokuto), Hangekobokuto (Hangekobokuto), etc. can be mentioned.
本発明において、ソヨウ及びその抽出物から選ばれる１種以上としては、市販品を用いることができ、具体的な市販品としては例えば、ソヨウ流エキス、蘇葉乾燥エキス（以上、日本粉末薬品(株)製）等が挙げられる。 In the present invention, a commercially available product can be used as one or more selected from perilla and its extract, and specific commercially available products include, for example, perilla-style extract and dried perilla extract (these are Japanese powdered chemicals (above, Japanese powder chemicals). Made by Co., Ltd.) and the like.
本発明において、ソヨウ及びその抽出物から選ばれる１種以上の含有量は特に限定されないが、消化管運動賦活化作用の観点から、胃腸薬組成物全質量に対して原生薬換算量で合計０．１〜１０質量％含有するのが好ましく、０．１〜５質量％含有するのがより好ましく、０．５〜２質量％含有するのが特に好ましい。 In the present invention, the content of one or more selected from perilla and its extract is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, the total mass of the gastrointestinal drug composition is 0 in terms of crude drug. It is preferably contained in an amount of 1 to 10% by mass, more preferably 0.1 to 5% by mass, and particularly preferably 0.5 to 2% by mass.
＜成分（Ａ−２）＞
「モッコウ」（木香）とは、第十六改正日本薬局方に記載のとおり、Saussurea lappa Clarke（Compositae）の根を意味する。モッコウは必要に応じてその形態を調節することができ、小片、小塊に切断若しくは粉砕、又は粉末に粉砕することができる。また、胃腸薬組成物の製造時の取扱の便宜等を考慮して、モッコウに何らかの抽出処理を施したもの（以下、「モッコウ抽出物」と称する。）を用いてもよい。
なお、上記「モッコウ抽出物」には、抽出処理に加えて、加熱、乾燥、粉砕等の加工処理を施したものも包含される。具体的には、モッコウを必要に応じて適当な大きさとした後に、適当な抽出溶媒を加えて浸出した液や、当該浸出液を濃縮した液（軟エキス、チンキ等）、さらにこれらを乾燥させたもの（乾燥エキス等）なども本発明の「モッコウ抽出物」に包含される。
本発明において、モッコウ及びその抽出物から選ばれる１種以上としては、モッコウ軟エキスが好ましい。
<Ingredient (A-2)>
"Costus" (Asteraceae) means the root of Saussurea lappa Clarke (Compositae) as described in the 16th revised Japanese Pharmacopoeia. The morphology of Costus can be adjusted as needed, and it can be cut or crushed into small pieces, lumps, or crushed into powder. Further, in consideration of convenience of handling at the time of manufacturing the gastrointestinal drug composition, those obtained by subjecting Costus to some extraction treatment (hereinafter, referred to as "Costus extract") may be used.
The above-mentioned "Costus extract" includes those subjected to processing treatments such as heating, drying and pulverization in addition to the extraction treatment. Specifically, after making the mokko into an appropriate size as needed, a liquid leached by adding an appropriate extraction solvent, a liquid obtained by concentrating the leaching liquid (soft extract, tincture, etc.), and further dried. Things (dried extract, etc.) are also included in the "mokko extract" of the present invention.
In the present invention, as one or more species selected from Costus and its extracts, Costus soft extract is preferable.
モッコウ抽出物の製造方法は特に限定されず、例えば、上記したソヨウ抽出物の製造方法と同様の方法により製造できる。 The method for producing the Costus extract is not particularly limited, and for example, it can be produced by the same method as the above-mentioned method for producing the perilla extract.
また、本発明において、モッコウ及びその抽出物から選ばれる１種以上としては、これらを成分として含む漢方処方を用いてもよい。このような漢方処方としては、具体的には例えば、烏苓通気散（ウレイツウキサン）、枳縮二陳湯（キシュクニチントウ）、帰脾湯（キヒトウ）、きゅう帰調血飲第一加減（キュウキチョウケツインダイイチカゲン）、九味檳榔湯（クミビンロウトウ）、香砂養胃湯（コウシャヨウイトウ）、牛膝散（ゴシツサン）、椒梅湯（ショウバイトウ）、参蘇飲（ジンソイン）、喘四君子湯（ゼンシクンシトウ）、銭氏白朮散（ゼンシビャクジュツサン）、丁香柿蔕湯（チョウコウシテイトウ）、女神散（ニョシンサン）、分消湯（ブンショウトウ）、帰脾湯（キヒトウ）等が挙げられる。 Further, in the present invention, as one or more kinds selected from Costus and its extracts, a Chinese medicine prescription containing these as ingredients may be used. Specific examples of such Chinese herbal prescriptions include Atractylodes aeruginosa, Achyranthes bidentata, Kihito, and Kyu Kihito. Kichoke Twin Daiichikagen, Kumibinrouto, Koshayouito, Gositsusan, Shobaito, Jinsoin ), Zenshikunshito, Zenshibyakujutsusan, Chokoushiteito, Nyoshinsan, Bunshoto, Kihito ) Etc. can be mentioned.
本発明において、モッコウ及びその抽出物から選ばれる１種以上としては、市販品を用いることができ、具体的な市販品としては例えば、木香末、木香エキス、木香乾燥エキス（以上、日本粉末薬品(株)製）、モッコウ軟エキス（小城製薬(株)製）等が挙げられる。 In the present invention, a commercially available product can be used as one or more selected from Costus and its extract, and specific commercially available products include, for example, wood scent powder, wood scent extract, and wood scent dried extract (the above, Examples include Nippon Powder Chemicals Co., Ltd.) and Lady Banks' rose soft extract (manufactured by Koshiro Pharmaceutical Co., Ltd.).
本発明において、モッコウ及びその抽出物から選ばれる１種以上の含有量は特に限定されないが、消化管運動賦活化作用の観点から、胃腸薬組成物全質量に対して原生薬換算量で合計０．１〜３０質量％含有するのが好ましく、０．５〜２０質量％含有するのがより好ましく、１〜１０質量％含有するのが特に好ましい。 In the present invention, the content of one or more selected from Costus and its extracts is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, the total mass of the gastrointestinal drug composition is 0 in terms of crude drug. .1 to 30% by mass is preferable, 0.5 to 20% by mass is more preferable, and 1 to 10% by mass is particularly preferable.
本発明において、成分（Ａ）ソヨウ及びモッコウ並びにそれらの抽出物から選ばれる１種以上としては、消化管運動賦活化作用及び苦味抑制作用の観点から、少なくともソヨウ及びその抽出物から選ばれる１種以上を含むものであるのが好ましい。 In the present invention, as one or more selected from the components (A) perilla and costus and their extracts, at least one selected from perilla and its extracts from the viewpoint of gastrointestinal motility activating action and bitterness suppressing action. It is preferable that the above is included.
＜成分（Ｂ−１）＞
「センブリ」（当薬）とは、第十六改正日本薬局方に記載のとおり、センブリ（Swertia japonica Makino（Gentianaceae））の開花期の全草を意味する。
<Ingredient (B-1)>
"Swertia japonica" (this drug) means the whole plant of Swertia japonica Makino (Gentianaceae) during the flowering period, as described in the 16th revised Japanese Pharmacopoeia.
なお、下記試験例４にて示すように、センブリは極めて強い苦味を呈し、ソヨウ及びその抽出物から選ばれる１種以上も苦味を呈するにも拘わらず、斯かるソヨウ及びその抽出物から選ばれる１種以上が、上記センブリの苦味を抑制する作用を有することが明らかとなった。
従って、成分（Ａ）として少なくともソヨウ及びその抽出物から選ばれる１種以上を含むとともに成分（Ｂ）として少なくともセンブリ及びその抽出物から選ばれる１種以上を含む本発明の胃腸薬組成物は、消化管運動賦活化作用に優れ、かつ、センブリ由来の苦味が抑制され服用し易く服用コンプライアンスにも優れる、という効果を有する。
As shown in Test Example 4 below, Swertia japonica exhibits an extremely strong bitterness, and is selected from such perilla and its extract, even though one or more species selected from the perilla and its extract also exhibit the bitterness. It was clarified that one or more kinds have an action of suppressing the bitterness of the above-mentioned Swertia japonica.
Therefore, the gastrointestinal drug composition of the present invention containing at least one selected from perilla and its extract as the component (A) and at least one selected from Swertia japonica and its extract as the component (B). It has the effect of activating gastrointestinal motility, suppressing the bitterness derived from Swertia japonica, making it easy to take, and having excellent dosing compliance.
また、別の観点から、本発明は、次の成分（Ａ−１）及び（Ｂ−１）：
（Ａ−１）ソヨウ及びその抽出物から選ばれる１種以上；
（Ｂ−１）センブリ及びその抽出物から選ばれる１種以上；
を含有する医薬組成物（好適には、胃腸薬組成物）を提供するものである。斯かる組成物はセンブリ由来の苦味が抑制され服用し易いため、ソヨウとセンブリの有する薬理作用を利用した、服用コンプライアンスの良好な医薬（例えば、胃腸薬）として好適に利用できる。なお、斯かる態様の組成物における各種成分の量、組み合わせ比率等は成分（Ａ）及び（Ｂ）を含有する胃腸薬組成物におけるものと同様である。
さらに、別の観点から、本発明は、ソヨウ及びその抽出物から選ばれる１種以上を共存せしめることを特徴とする、センブリ及びその抽出物から選ばれる１種以上由来の苦味抑制方法（好適には、ソヨウ及びその抽出物から選ばれる１種以上を配合することを特徴とする、センブリ及びその抽出物から選ばれる１種以上を含有する医薬組成物（好適には、胃腸薬組成物）の苦味抑制方法）を提供するものである。なお、斯かる態様の方法における各種成分の量、組み合わせ比率等は成分（Ａ）及び（Ｂ）を含有する胃腸薬組成物におけるものと同様である。
From another point of view, the present invention describes the following components (A-1) and (B-1):
(A-1) One or more species selected from perilla and its extracts;
(B-1) One or more selected from Swertia japonica and its extracts;
To provide a pharmaceutical composition containing the above (preferably a gastrointestinal drug composition). Since such a composition suppresses the bitterness derived from Swertia japonica and is easy to take, it can be suitably used as a drug having good dosing compliance (for example, a gastrointestinal drug) utilizing the pharmacological action of perilla and Swertia japonica. The amounts, combination ratios, etc. of various components in the composition of such an embodiment are the same as those in the gastrointestinal drug composition containing the components (A) and (B).
Further, from another viewpoint, the present invention is characterized in that one or more selected from Swertia japonica and its extract coexist, and a method for suppressing bitterness derived from one or more selected from Swertia japonica and its extract (preferably). Is a pharmaceutical composition (preferably a gastrointestinal drug composition) containing one or more selected from Swertia japonica and its extract, which comprises blending one or more selected from Swertia japonica and its extract. A method for suppressing bitterness) is provided. The amounts, combination ratios, etc. of various components in the method of such an embodiment are the same as those in the gastrointestinal drug composition containing the components (A) and (B).
センブリは必要に応じてその形態を調節することができ、小片、小塊に切断若しくは粉砕、又は粉末に粉砕することができ、例えば、センブリを粉末とした「センブリ末」も本発明に用いることができる。また、胃腸薬組成物の製造時の取扱の便宜等を考慮して、センブリに何らかの抽出処理を施したもの（以下、「センブリ抽出物」と称する。）を用いてもよい。
なお、上記「センブリ抽出物」には、抽出処理に加えて、加熱、乾燥、粉砕等の加工処理を施したものも包含される。具体的には、センブリを必要に応じて適当な大きさとした後に、適当な抽出溶媒を加えて浸出した液や、当該浸出液を濃縮した液（軟エキス、チンキ等）、さらにこれらを乾燥させたもの（乾燥エキス等）なども本発明の「センブリ抽出物」に包含される。
本発明において、センブリ及びその抽出物から選ばれる１種以上としては、センブリ末が好ましい。
The form of Swertia japonica can be adjusted as needed, and it can be cut or crushed into small pieces or lumps, or crushed into powder. For example, "Swertia japonica powder" obtained by powdering Swertia japonica is also used in the present invention. Can be done. Further, in consideration of convenience of handling at the time of manufacturing the gastrointestinal drug composition, a Swertia japonica subjected to some extraction treatment (hereinafter, referred to as "Swertia japonica extract") may be used.
The above-mentioned "Swertia japonica extract" includes those subjected to processing treatments such as heating, drying, and pulverization in addition to the extraction treatment. Specifically, after the assembly was made into an appropriate size as needed, a liquid leached by adding an appropriate extraction solvent, a liquid obtained by concentrating the leaching liquid (soft extract, tincture, etc.), and further dried. Things (dried extract, etc.) are also included in the "assembly extract" of the present invention.
In the present invention, Swertia japonica powder is preferable as one or more selected from Swertia japonica and its extract.
センブリ抽出物の製造方法は特に限定されず、例えば、上記したソヨウ抽出物の製造方法と同様の方法により製造できる。 The method for producing the Swertia japonica extract is not particularly limited, and for example, it can be produced by the same method as the above-mentioned method for producing the perilla extract.
本発明において、センブリ及びその抽出物から選ばれる１種以上としては、市販品を用いることができ、具体的な市販品としては例えば、センブリ末、日粉センブリ重曹散（以上、日本粉末薬品(株)製）等が挙げられる。 In the present invention, a commercially available product can be used as one or more selected from Swertia japonica and its extract, and specific commercially available products include, for example, Swertia japonica powder and Swertia japonica sodium bicarbonate powder (above, Nippon Powder Chemicals Co., Ltd. Co., Ltd.) and the like.
本発明において、センブリ及びその抽出物から選ばれる１種以上の含有量は特に限定されないが、消化管運動賦活化作用の観点から、胃腸薬組成物全質量に対して原生薬換算量で合計０．００１〜１０質量％含有するのが好ましく、０．０１〜７．５質量％含有するのがより好ましく、０．０５〜５質量％含有するのがさらに好ましく、０．１〜４質量％含有するのがさらに好ましく、０．２５〜３質量％含有するのがさらに好ましく、０．５〜２質量％含有するのが特に好ましい。
また、ソヨウ及びその抽出物から選ばれる１種以上と、センブリ及びその抽出物から選ばれる１種以上との組み合わせ比率は特に限定されないが、消化管運動賦活化作用、苦味抑制作用の観点から、ソヨウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、センブリ及びその抽出物から選ばれる１種以上を原生薬換算量で０．１〜１０質量部、より好ましくは０．１〜５質量部、特に好ましくは０．５〜２質量部の割合で組み合わせることが好ましい。
さらに、モッコウ及びその抽出物から選ばれる１種以上と、センブリ及びその抽出物から選ばれる１種以上との組み合わせ比率は特に限定されないが、消化管運動賦活化作用の観点から、モッコウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、センブリ及びその抽出物から選ばれる１種以上を原生薬換算量で０．０１〜５質量部、より好ましくは０．０５〜２質量部、特に好ましくは０．１〜１．５質量部の割合で組み合わせることが好ましい。
In the present invention, the content of one or more selected from the assembly and its extract is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, the total mass of the gastrointestinal drug composition is 0 in terms of protozoan. It is preferably contained in an amount of .001 to 10% by mass, more preferably 0.01 to 7.5% by mass, further preferably 0.05 to 5% by mass, and 0.1 to 4% by mass. It is more preferable to contain 0.25 to 3% by mass, and it is particularly preferable to contain 0.5 to 2% by mass.
The combination ratio of one or more selected from Soyo and its extract and one or more selected from Swertia japonica and its extract is not particularly limited, but from the viewpoint of gastrointestinal motility activating action and bitterness suppressing action, One or more selected from Swertia japonica and its extract is 1 part by mass in terms of crude drug equivalent, and one or more selected from Swertia japonica and its extract is 0.1 to 10 parts by mass in terms of crude drug, more preferably. Is preferably combined in a ratio of 0.1 to 5 parts by mass, particularly preferably 0.5 to 2 parts by mass.
Further, the combination ratio of one or more selected from Costus and its extract and one or more selected from Swertia japonica and its extract is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, Costus and its extraction One or more kinds selected from the substances are 1 part by mass in terms of crude drug equivalent, and one or more kinds selected from Swertia japonica and its extracts are 0.01 to 5 parts by mass in terms of crude drug equivalent, more preferably 0.05. It is preferable to combine them in a ratio of ~ 2 parts by mass, particularly preferably 0.1 to 1.5 parts by mass.
＜成分（Ｂ−２）＞
「ロートコン」とは、第十六改正日本薬局方に記載のとおり、ハシリドコロ（Scopolia japonica Maximowicz、Scopolia carniolica Jacquin又はScopolia parviflora Nakai（Solanaceae））の根茎及び根である。ロートコンは必要に応じてその形態を調節することができ、小片、小塊に切断若しくは粉砕、又は粉末に粉砕することができる。また、胃腸薬組成物の製造時の取扱の便宜等を考慮して、ロートコンに何らかの抽出処理を施したもの（以下、「ロートコン抽出物」と称する。）を用いてもよい。
なお、上記「ロートコン抽出物」には、抽出処理に加えて、加熱、乾燥、粉砕等の加工処理を施したものも包含される。具体的には、ロートコンを必要に応じて適当な大きさとした後に、適当な抽出溶媒を加えて浸出した液や、当該浸出液を濃縮した液（軟エキス、チンキ等）、さらにこれらを乾燥させたもの（乾燥エキス等）なども本発明の「ロートコン抽出物」に包含される。このようなロートコン抽出物としては、具体的には例えば、第十六改正日本薬局方に記載の「ロートエキス」（「ロートコン」の粗末をとり、３５vol％エタノール、「常水」、「精製水」又は「精製水（容器入り）」を浸出剤として、エキス剤の製法により軟エキスとしたもの）が挙げられる。
本発明において、ロートコン及びその抽出物から選ばれる１種以上としては、ロートエキスが好ましい。
<Ingredient (B-2)>
"Rotocon" is the rhizome and root of Scopolia japonica Maximowicz, Scopolia carniolica Jacquin or Scopolia parviflora Nakai (Solanaceae), as described in the 16th revised Japanese Pharmacy. The form of the rotocon can be adjusted as needed, and it can be cut or crushed into small pieces or lumps, or crushed into powder. Further, in consideration of convenience of handling at the time of manufacturing the gastrointestinal drug composition, a rotocon subjected to some extraction treatment (hereinafter, referred to as "rotocon extract") may be used.
The above-mentioned "Rotocon extract" includes those subjected to processing treatments such as heating, drying and pulverization in addition to the extraction treatment. Specifically, after making the rotocon into an appropriate size as needed, a liquid leached by adding an appropriate extraction solvent, a liquid obtained by concentrating the leaching liquid (soft extract, tincture, etc.), and further dried. Things (dried extract, etc.) are also included in the "rotocon extract" of the present invention. Specific examples of such a rotocon extract include "roto extract" (take the crude of "rotocon", 35 vol% ethanol, "normal water", and "purified water" described in the 16th revised Japanese Pharmacopoeia. "Or" purified water (in a container) "as a leachate, which is a soft extract produced by an extract agent).
In the present invention, Scopolia extract is preferable as one or more selected from Scopolia japonica and its extract.
ロートコン抽出物の製造方法は特に限定されず、例えば、上記したソヨウ抽出物の製造方法と同様の方法により製造できる。 The method for producing the rotocon extract is not particularly limited, and for example, it can be produced by the same method as the above-mentioned method for producing the perilla extract.
本発明において、ロートコン及びその抽出物から選ばれる１種以上としては、市販品を用いることができ、具体的な市販品としては例えば、ロートエキス３倍散（アルプス薬品工業(株)製）等が挙げられる。 In the present invention, a commercially available product can be used as one or more selected from the scopolia japonica and its extract, and as a specific commercially available product, for example, Scopolia extract triple powder (manufactured by Alps Pharmaceutical Industry Co., Ltd.) and the like can be used. Can be mentioned.
本発明において、ロートコン及びその抽出物から選ばれる１種以上の含有量は特に限定されないが、消化管運動賦活化作用の観点から、胃腸薬組成物全質量に対して合計０．１〜１０質量％含有するのが好ましい。特に、ロートコン及びその抽出物から選ばれる１種以上としてロートエキスを用いる場合、胃腸薬組成物全質量に対して合計で０．１〜１０質量％含有するのが好ましく、０．１〜５質量％含有するのがより好ましく、０．５〜３質量％含有するのがさらに好ましく、０．５〜２質量％含有するのが特に好ましい。
また、ソヨウ及びその抽出物から選ばれる１種以上と、ロートコン及びその抽出物から選ばれる１種以上との組み合わせ比率は特に限定されないが、消化管運動賦活化作用の観点から、ソヨウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、ロートコン及びその抽出物から選ばれる１種以上を０．１〜１０質量部の割合で組み合わせることが好ましい。特に、ロートコン及びその抽出物から選ばれる１種以上としてロートエキスを用いる場合、ソヨウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、ロートエキスを０．１〜１０質量部の割合、より好ましくは０．１〜５質量部の割合、特に好ましくは０．５〜２質量部の割合で組み合わせることが好ましい。
さらに、モッコウ及びその抽出物から選ばれる１種以上と、ロートコン及びその抽出物から選ばれる１種以上との組み合わせ比率は特に限定されないが、消化管運動賦活化作用の観点から、モッコウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、ロートコン及びその抽出物から選ばれる１種以上を０．５〜５質量部の割合で組み合わせることが好ましい。特に、ロートコン及びその抽出物から選ばれる１種以上としてロートエキスを用いる場合、モッコウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、ロートエキスを０．０５〜１５質量部の割合、より好ましくは０．１〜１０質量部の割合、特に好ましくは０．５〜５質量部の割合で組み合わせることが好ましい。
In the present invention, the content of one or more selected from rotocon and its extract is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, a total of 0.1 to 10 mass with respect to the total mass of the gastrointestinal drug composition. % Is preferably contained. In particular, when Scopolia extract is used as one or more selected from Scopolia japonica and its extract, it is preferably contained in an amount of 0.1 to 10% by mass in total, preferably 0.1 to 5% by mass, based on the total mass of the gastrointestinal drug composition. % Is more preferable, 0.5 to 3% by mass is more preferable, and 0.5 to 2% by mass is particularly preferable.
The combination ratio of one or more selected from soybean and its extract and one or more selected from rotocon and its extract is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, soybean and its extraction It is preferable to combine one or more selected from the substances in a ratio of 0.1 to 10 parts by mass with respect to 1 part by mass in terms of crude drug equivalent, and one or more selected from the rotocon and its extract. In particular, when scopolia extract is used as one or more selected from scopolia japonica and its extract, 0.1 or more scopolia extract is added to 1 part by mass in terms of crude drug equivalent of one or more selected from scopolia japonica and its extract. It is preferable to combine them in a proportion of 10 parts by mass, more preferably 0.1 to 5 parts by mass, and particularly preferably 0.5 to 2 parts by mass.
Further, the combination ratio of one or more selected from Costus and its extract and one or more selected from Rotocon and its extract is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, Costus and its extraction It is preferable to combine one or more selected from the substances in a ratio of 0.5 to 5 parts by mass with respect to 1 part by mass in terms of crude drug equivalent, and one or more selected from the rotocon and its extract. In particular, when scopolia extract is used as one or more selected from scopolia japonica and its extract, the amount of scopolia extract is 0.05 to 1 part by mass in terms of crude drug equivalent of one or more selected from scopolia japonica and its extract. It is preferable to combine them in a proportion of 15 parts by mass, more preferably 0.1 to 10 parts by mass, and particularly preferably 0.5 to 5 parts by mass.
＜成分（Ｂ−３）＞
「メチルメチオニンスルホニウムクロライド」（以下、本明細書においてＭＭＳＣと表記する。）は、ビタミンＵとしても知られる成分である。本発明においては、ＭＭＳＣとして市販品を用いることができ、具体的な市販品としては例えば、Ｕビット「ハマリワイ」（米沢浜理薬品工業(株)製）等が挙げられる。
<Ingredient (B-3)>
"Methylmethionine sulfonium chloride" (hereinafter referred to as MMSC in the present specification) is a component also known as vitamin U. In the present invention, a commercially available product can be used as the MMSC, and specific commercial products include, for example, U-bit "Hamariwai" (manufactured by Yonezawa Hamari Chemical Industry Co., Ltd.).
本発明において、ＭＭＳＣの含有量は特に限定されないが、消化管運動賦活化作用の観点から、胃腸薬組成物全質量に対して０．１〜１０質量％含有するのが好ましく、１〜７．５質量％含有するのがより好ましく、２．５〜５質量％含有するのが特に好ましい。
また、ソヨウ及びその抽出物から選ばれる１種以上と、ＭＭＳＣとの組み合わせ比率は特に限定されないが、消化管運動賦活化作用の観点から、ソヨウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、ＭＭＳＣを０．１〜１５質量部、より好ましくは１〜１０質量部、特に好ましくは２．５〜７．５質量部の割合で組み合わせることが好ましい。
さらに、モッコウ及びその抽出物から選ばれる１種以上と、ＭＭＳＣとの組み合わせ比率は特に限定されないが、消化管運動賦活化作用の観点から、モッコウ及びその抽出物から選ばれる１種以上を原生薬換算量で１質量部に対し、ＭＭＳＣを０．５〜７０質量部、より好ましくは１〜５０質量部、さらに好ましくは３〜３０質量部、特に好ましくは５〜２０質量部の割合で組み合わせることが好ましい。
In the present invention, the content of MMSC is not particularly limited, but from the viewpoint of activating gastrointestinal motility, it is preferably 0.1 to 10% by mass with respect to the total mass of the gastrointestinal drug composition, and 1 to 7. It is more preferably contained in an amount of 5% by mass, and particularly preferably contained in an amount of 2.5 to 5% by mass.
The combination ratio of one or more selected from Soyo and its extract and MMSC is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, one or more selected from Soyo and its extract are crude drugs. It is preferable to combine MMSC in a ratio of 0.1 to 15 parts by mass, more preferably 1 to 10 parts by mass, and particularly preferably 2.5 to 7.5 parts by mass with respect to 1 part by mass in terms of converted amount.
Further, the combination ratio of one or more selected from Costus and its extract and MMSC is not particularly limited, but from the viewpoint of gastrointestinal motility activating action, one or more selected from Costus and its extract is a crude drug. Combine MMSC in a ratio of 0.5 to 70 parts by mass, more preferably 1 to 50 parts by mass, further preferably 3 to 30 parts by mass, and particularly preferably 5 to 20 parts by mass with respect to 1 part by mass in terms of conversion amount. Is preferable.
本発明において、成分（Ｂ）センブリ及びその抽出物、ロートコン及びその抽出物、並びにメチルメチオニンスルホニウムクロライドから選ばれる１種以上としては、消化管運動賦活化作用及び苦味抑制作用の観点から、少なくともセンブリ及びその抽出物から選ばれる１種以上を含むものであるのが好ましく、センブリ及びその抽出物から選ばれる１種以上と、ロートコン及びその抽出物又はメチルメチオニンスルホニウムクロライドとの組み合わせであるのがより好ましく、センブリ及びその抽出物から選ばれる１種以上と、ロートコン及びその抽出物から選ばれる１種以上と、メチルメチオニンスルホニウムクロライドとの組み合わせであるのが特に好ましい。 In the present invention, at least one assembly selected from the component (B) assembly and its extract, rotocon and its extract, and methylmethionine sulfonium chloride from the viewpoint of gastrointestinal motility activating action and bitterness suppressing action. And one or more selected from the extract thereof, and more preferably one or more selected from the assembly and its extract, and a combination of rotocon and its extract or methylmethionine sulfonium chloride. A combination of one or more selected from the assembly and its extract, one or more selected from the rotocon and its extract, and methylmethionine sulfonium chloride is particularly preferable.
本発明の胃腸薬組成物は、下記試験例において示されるように、優れた消化管運動賦活化作用を有している。従って、本発明の胃腸薬組成物は、消化管運動の賦活化のために用いるのに適し、消化管内容物の滞留を原因とする、もたれ、胃部・腹部膨満感、胃重などの症状、特に飲み過ぎ若しくは食べ過ぎによって生じるこれらの症状の改善のために用いるのに特別適する。 The gastrointestinal drug composition of the present invention has an excellent gastrointestinal motility activating effect as shown in the following test examples. Therefore, the gastrointestinal drug composition of the present invention is suitable for use for activating gastrointestinal motility, and causes symptoms such as leaning, stomach / abdominal bloating, and stomach weight caused by retention of gastrointestinal contents. Especially suitable for use in the amelioration of these symptoms caused by overdrinking or overeating.
本発明の胃腸薬組成物の投与方法としては特に制限されず、経口投与及び非経口投与が挙げられるが、消化管運動賦活化作用の観点から、経口投与が好ましい。
本発明の胃腸薬組成物の剤形としては特に制限されず、上記の投与方法に応じて適宜第十六改正日本薬局方等に記載の剤形として製剤化すればよい。このような剤形としては、具体的には例えば、散剤、顆粒剤、錠剤、丸剤、軟カプセル剤、硬カプセル剤等の固形の形態の胃腸薬組成物；ドリンク剤等の液状の形態の胃腸薬組成物；ゼリー剤等の半固形の形態の胃腸薬組成物等が挙げられる。本発明においては、服用の容易性の観点から、固形の形態の胃腸薬組成物とするのが好ましく、散剤、顆粒剤又は錠剤の形態とするのが特に好ましい。
The method for administering the gastrointestinal drug composition of the present invention is not particularly limited, and examples thereof include oral administration and parenteral administration, but oral administration is preferable from the viewpoint of gastrointestinal motility activating action.
The dosage form of the gastrointestinal drug composition of the present invention is not particularly limited, and it may be appropriately formulated as the dosage form described in the 16th revised Japanese Pharmacopoeia or the like according to the above-mentioned administration method. Specific examples of such a dosage form include a gastrointestinal drug composition in a solid form such as a powder, a granule, a tablet, a pill, a soft capsule, and a hard capsule; and a liquid form such as a drink. Gastrointestinal drug composition; Examples thereof include a semi-solid form of a gastrointestinal drug composition such as a jelly agent. In the present invention, from the viewpoint of ease of administration, the gastrointestinal drug composition in the solid form is preferable, and the powder, granules or tablets are particularly preferable.
本発明の胃腸薬組成物においては、上記した成分の他に、上記した剤形に応じて医薬上許容される担体（賦形剤、結合剤、崩壊剤、滑沢剤、着色剤、矯味剤、コーティング剤等）の１種又は２種以上を配合してもよい。 In the gastrointestinal drug composition of the present invention, in addition to the above-mentioned components, a pharmaceutically acceptable carrier (excipient, binder, disintegrant, lubricant, colorant, flavoring agent) according to the above-mentioned dosage form. , Coating agent, etc.) 1 type or 2 or more types may be blended.
賦形剤としては、乳糖、デンプン類、結晶セルロース、ショ糖、マンニトール、軽質無水ケイ酸等が挙げられる。結合剤としては、ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロース、ゼラチン、アルファー化デンプン、ポリビニルピロリドン、ポリビニルアルコール、プルラン等が挙げられる。崩壊剤としては、カルボキシメチルスターチナトリウム、カルメロース、カルメロースカルシウム、クロスカルメロースナトリウム、クロスポビドン、トウモロコシデンプン、低置換度ヒドロキシプロピルセルロース等が挙げられる。滑沢剤としては、ステアリン酸マグネシウム、タルク等が挙げられる。着色剤としては、タール色素、三二酸化鉄等が挙げられる。矯味剤としては、ステビア、アスパルテーム等が挙げられる。コーティング剤としては、カルボキシメチルエチルセルロース、酢酸フタル酸セルロース、メタアクリル酸コポリマーＳ、メタアクリル酸コポリマーＬ、メタアクリル酸コポリマーＬＤ、ヒドロキシプロピルメチルセルロースフタレート、ヒドロキシプロピルメチルセルロースアセテートサクシネート等のフィルム形成高分子が挙げられる。なお、フィルム形成させる際に、クエン酸トリエチル、トリアセチン、ポリエチレングリコール等の可塑剤、タルク、酸化チタン、黄色三二酸化鉄、三二酸化鉄、法定色素、軽質無水ケイ酸、含水二酸化ケイ素等の紛体を配合することもできる。本発明においては、これらの１種又は２種以上を適宜組み合わせて配合することができる。 Examples of the excipient include lactose, starches, crystalline cellulose, sucrose, mannitol, light silicic acid anhydride and the like. Examples of the binder include hydroxypropyl methylcellulose, hydroxypropyl cellulose, gelatin, pregelatinized starch, polyvinylpyrrolidone, polyvinyl alcohol, pullulan and the like. Examples of the disintegrant include carboxymethyl starch sodium, carmellose, carmellose calcium, croscarmellose sodium, crospovidone, corn starch, low-degree-of-substitution hydroxypropyl cellulose and the like. Examples of the lubricant include magnesium stearate and talc. Examples of the colorant include tar pigments and iron sesquioxides. Examples of the flavoring agent include stevia and aspartame. As the coating agent, film-forming polymers such as carboxymethyl ethyl cellulose, cellulose acetate phthalate, methacrylic acid copolymer S, methacrylic acid copolymer L, methacrylic acid copolymer LD, hydroxypropylmethylcellulose phthalate, and hydroxypropylmethylcellulose acetate succinate are used. Can be mentioned. When forming the film, plasticizers such as triethyl citrate, triacetin, and polyethylene glycol, and powders such as talc, titanium oxide, yellow iron sesquioxide, iron sesquioxide, legal pigments, light anhydrous silicic acid, and hydrous silicon dioxide are used. It can also be blended. In the present invention, one or more of these can be blended as appropriate.
また、本発明の胃腸薬組成物には、上記した成分の他に、他の医薬成分（例えば、局所麻酔剤、消化剤（利胆剤）、消化酵素、胃粘膜修復剤（粘膜保護成分）、生薬成分、制酸剤等）の１種又は２種以上を配合してもよい。 Further, in the gastrointestinal drug composition of the present invention, in addition to the above-mentioned components, other pharmaceutical components (for example, local anesthetic, digestive agent (antacid), digestive enzyme, gastric mucosa repair agent (mucosal protective component)) , Crude drug ingredients, antacids, etc.) may be blended in one or more.
局所麻酔剤としては、アミノ安息香酸エチル、オキセサゼイン等が挙げられる。消化剤（利胆剤）としては、ウルソデオキシコール酸、動物胆（熊胆、牛胆）等が挙げられる。消化酵素としては、でんぷん消化酵素（ビオジアスターゼ、タカジアスターゼ）、脂肪消化酵素（リパーゼ）等が挙げられる。胃粘膜修復剤（粘膜保護成分）としては、銅クロロフィンナトリウム、銅クロロフィンカリウム、アルジオキサ、スクラルファート、塩酸セトラキサート、ソファルコン、ゲファルナート、マレイン酸トリメブチン、アズレンスルホン酸ナトリウム等が挙げられる。生薬成分としては、アセンヤク、アニス実、アロエ、ウイキョウ、ウコン、ウバイ、ウヤク、エンゴサク、延命草、オウゴン、オウバク、オウレン、加工大蒜、ガジュツ、カッコウ、カラムス根、カンキョウ、カンゾウ、キジツ、クジン、ケイヒ、ケツメイシ、ゲンチアナ、ゲンノショウコ、コウジン、コウボク、ゴシュユ、胡椒、五倍子、コロンボ、コンズランゴ、サンザシ、サンショウ、山奈、シソシ、シャクヤク、シュクシャ、ショウキョウ、ショウズク、青皮、赤芽柏、石菖根、センタウリウム草、ソウジュツ、大茴香、ダイオウ、チクセツニンジン、チョウジ、チンピ、トウガラシ、トウヒ、ニガキ、ニクズク、ニンジン、ハッカ、セイヨウハッカ、ヒハツ、ビャクジュツ、ホップ、ホミカ、睡菜葉、ヤクチ、ヨウバイヒ、リュウタンおよびリョウキョウ等の生薬やその抽出物が挙げられる。制酸剤としては、オメプラゾール、ランソプラゾール、ラベプラゾールナトリウム等のプロトンポンプ阻害薬；シメチジン、塩酸ラニチジン、及びファモチジン等のＨ２受容体拮抗薬；乾燥水酸化アルミニウムゲル、ケイ酸アルミン酸マグネシウム、メタケイ酸アルミン酸マグネシウム、ケイ酸マグネシウム、合成ケイ酸アルミニウム、合成ヒドロタルサイト、酸化マグネシウム、水酸化アルミナマグネシウム、水酸化アルミニウムゲル、水酸化アルミニウム・炭酸水素ナトリウム共沈生成物、水酸化アルミニウム・炭酸マグネシウム混合乾燥ゲル、水酸化アルミニウム・炭酸マグネシウム・炭酸カルシウム共沈生成物、水酸化マグネシウム、炭酸水素ナトリウム、炭酸マグネシウム、沈降炭酸カルシウム、メタケイ酸アルミン酸マグネシウム、無水リン酸水素カルシウム、リン酸水素カルシウム等の無機塩類；烏賊骨、石決明、ボレイ、アミノ酢酸、ジヒドロキシアルミニウムアミノアセテート等が挙げられる。本発明においては、これらの１種又は２種以上を適宜組み合わせて配合することができる。 Examples of the local anesthetic include ethyl aminobenzoate, oxesazein and the like. Examples of the digestive agent (biliary agent) include ursodeoxycholic acid, animal gall bladder (bear gall bladder, bovine gall bladder) and the like. Examples of digestive enzymes include starch digestive enzymes (biodiastase, takadiastase), fat digestive enzymes (lipase) and the like. Examples of the gastric mucosa repair agent (mucosal protective component) include copper chlorofin sodium, copper chlorofin potassium, aldioxa, sucralfate, cetraxate hydrochloride, sofalcone, gefarnate, trimebutine maleate, sodium azulene sulfonate and the like. Crude drug ingredients include Asenyaku, Anise fruit, Aloe, Uikyo, Ukon, Ubai, Uyaku, Engosaku, Enmeisou, Ogon, Oubaku, Ouren, Processed mint, Gajutsu, Kakko, Columns root, Kankyo, Kanzo, Kijitsu, Kujin , Ketsumeishi, Gentiana, Gennoshoko, Kojin, Koboku, Goshuyu, Kosho, Peppermint, Colombo, Konzlango, Sanzashi, Sansho, Yamana, Shisoshi, Shakuyaku, Shuksha, Shokyo, Shozuku, Aoki , Oka, Daiou, Chikusetsu carrot, Chow, Chinpi, Star anise, Tohi, Nigaki, Nutmeg, Carrot, Peppermint, Peppermint, Hihatsu, Byakujutsu, Hop, Homika, Crude drug, Yakuchi, Youbaihi, Ryutan and Ryokyo, etc. Examples include herbal medicines and extracts thereof. Antioxidants include proton pump inhibitors such as omeprazole, lansoprazole, and labeprazole sodium; H2 receptor antagonists such as simethidine, lanitidine hydrochloride, and famotidine; dry aluminum hydroxide gel, magnesium aluminate silicate, aluminometasilicate. Magnesium, magnesium silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, magnesium hydroxide, aluminum hydroxide gel, aluminum hydroxide / sodium hydrogen carbonate co-precipitated product, aluminum hydroxide / magnesium carbonate mixed dry gel , Aluminum hydroxide / magnesium carbonate / calcium carbonate co-precipitated product, magnesium hydroxide, sodium hydrogen carbonate, magnesium carbonate, precipitated calcium carbonate, magnesium aluminometasilicate, anhydrous calcium hydrogen phosphate, calcium hydrogen phosphate and other inorganic salts Includes pirate bones, stone determination, volley, aminoacetic acid, dihydroxyaluminum aminoacetate and the like. In the present invention, one or more of these can be appropriately combined and blended.
本発明の胃腸薬組成物のヒトに対する投与量としては、剤形、疾患の程度、患者の年齢等に応じて適宜調整すればよいが、例えば、ソヨウ及びその抽出物から選ばれる１種以上を含有する場合は、これを基本として、通常成人に対して原生薬換算量で５０〜３０００ｍｇ／日程度、特に１００〜２０００ｍｇ／日程度を投与すればよく、斯かる投与量に合わせて、上記した組み合わせ比率を参考にして他の成分の投与量も決定することができる。また、例えば、モッコウ及びその抽出物から選ばれる１種以上を含有する場合は、これを基本として、通常成人に対して原生薬換算量で１００〜５０００ｍｇ／ｋｇ程度が好ましく、特に５００〜３０００ｍｇ／ｋｇ程度がより好ましい。斯かる投与量に合わせて、上記した組み合わせ比率を参考にして他の成分の投与量も決定することができる。 The dose of the gastrointestinal drug composition of the present invention to humans may be appropriately adjusted according to the dosage form, the degree of disease, the age of the patient, etc., and for example, one or more selected from perilla and its extracts may be used. When it is contained, it is usually sufficient to administer about 50 to 3000 mg / day, particularly about 100 to 2000 mg / day in terms of crude drug to an adult based on this, and the above-mentioned is adjusted according to such a dose. The dose of other components can also be determined with reference to the combination ratio. In addition, for example, when one or more species selected from Costus and its extracts are contained, based on this, usually about 100 to 5000 mg / kg in terms of crude drug is preferable for adults, and particularly 500 to 3000 mg / kg. About kg is more preferable. In accordance with such a dose, the dose of other components can also be determined with reference to the above-mentioned combination ratio.
以下に実施例を挙げて本発明を詳細に説明するが、本発明はこれら実施例に何ら限定されるものではない。 Hereinafter, the present invention will be described in detail with reference to examples, but the present invention is not limited to these examples.
［試験例１］ソヨウ抽出物単独の消化管運動賦活化作用の確認
試験前日より絶食させた６〜７週齢のｄｄＹ系雄性マウスを、平均体重が均等になるように各群６匹ずつ２群に分け、それぞれ被験薬物投与群及びコントロール群とした。
[Test Example 1] Confirmation of gastrointestinal motility activating effect of perilla extract alone 6 male ddY mice aged 6 to 7 weeks aged from the day before the test were 2 in each group so that the average body weight was even. The group was divided into a test drug administration group and a control group, respectively.
被験薬物投与群のマウスには０．５％メチルセルロース水溶液に溶解したソヨウ抽出物（蘇葉乾燥エキス：日本粉末薬品（株）製）３０ｍｇ／ｋｇ体重（原生薬換算量：２７０ｍｇ／ｋｇ体重）を、コントロール群のマウスには０．５％メチルセルロース水溶液をそれぞれ経口投与し、その１０分後に５％ 活性炭素末懸濁液を０．１ｍＬ／１０ｇ体重の用量で経口投与した。 Mice in the test drug-administered group received 30 mg / kg body weight (crude drug equivalent amount: 270 mg / kg body weight) of Soyo extract (dried Suspension extract: manufactured by Nippon Powder Chemicals Co., Ltd.) dissolved in a 0.5% methylcellulose solution. , 0.5% methylcellulose solution was orally administered to the mice in the control group, and 10 minutes later, 5% activated carbon powder suspension was orally administered at a dose of 0.1 mL / 10 g body weight.
活性炭素末懸濁液投与から２０分後にマウスを頸椎脱臼にてと殺し、胃幽門部から回腸末端までの腸管を摘出した。被験薬物投与群、コントロール群それぞれ各群について、炭素末の移動率（幽門部からの移動距離の、摘出腸管全長に対する割合）の平均値を算出し、さらに、コントロール群の移動率の平均値を１とした場合の被験薬物投与群の移動率の平均値の相対指数を算出することにより、被験薬物の投与による消化管運動の賦活化の有無を確認した。
結果を表１に示す。
Twenty minutes after the administration of the active carbon powder suspension, the mice were killed by cervical dislocation, and the intestinal tract from the gastric pylorus to the terminal ileum was removed. For each of the test drug administration group and the control group, the average value of the carbon powder migration rate (the ratio of the migration distance from the pylorus to the total length of the excised intestinal tract) was calculated, and the average value of the migration rate of the control group was calculated. By calculating the relative index of the average value of the migration rate of the test drug-administered group when the value was 1, it was confirmed whether or not the gastrointestinal motility was activated by the administration of the test drug.
The results are shown in Table 1.
被験薬物投与群の移動率の相対指数が１より小さいことから、ソヨウを２７０ｍｇ／ｋｇ体重（原生薬換算量）の用量で単独投与した場合は、消化管運動が賦活化されないことが確認された。 Since the relative index of the migration rate of the test drug-administered group was smaller than 1, it was confirmed that gastrointestinal motility was not activated when perilla was administered alone at a dose of 270 mg / kg body weight (crude drug equivalent). ..
［試験例２］ソヨウ抽出物と他の薬物との併用投与による消化管運動賦活化作用の評価
試験前日より絶食させた６〜７週齢のｄｄＹ系雄性マウスを、平均体重が均等になるように各群６匹ずつ２群に分け、それぞれ被験薬物Ａ投与群（Ａ群）及び被験薬物Ｂ投与群（Ｂ群）とした。
[Test Example 2] Evaluation of gastrointestinal motility activating effect by combined administration of soybean extract and other drugs 6 to 7 week-old male ddY mice fasted from the day before the test so that the average weight is equal. Each group was divided into 2 groups of 6 animals each, and the test drug A administration group (A group) and the test drug B administration group (B group) were used.
各群のマウスに、０．５％メチルセルロースに溶解又は懸濁させた下記被験薬物を経口投与し、その１０分後に５％ 活性炭素末懸濁液を０．１ｍＬ／１０ｇ体重の用量で経口投与した。 The following test drug dissolved or suspended in 0.5% methylcellulose was orally administered to each group of mice, and 10 minutes later, a 5% active carbon powder suspension was orally administered at a dose of 0.1 mL / 10 g body weight. did.
活性炭素末懸濁液投与から２０分後にマウスを頸椎脱臼にてと殺し、胃幽門部から回腸末端までの腸管を摘出した後、各群それぞれについて炭素末の移動率（幽門部からの移動距離の、摘出腸管全長に対する割合）を算出した。 Twenty minutes after the administration of the active carbon powder suspension, the mice were killed by cervical dislocation, and the intestinal tract from the gastric pylorus to the terminal ileum was removed. (Ratio to the total length of the excised intestinal tract) was calculated.
なお、被験薬物は、以下の通りとした。
Ａ群：センブリ（センブリ末：日本粉末薬品（株）製）３０ｍｇ／ｋｇ体重、ロートコン抽出物（ロートエキス３倍散：アルプス薬品工業（株）製）９０ｍｇ／ｋｇ体重（ロートエキスとして３０ｍｇ／ｋｇ体重）及びメチルメチオニンスルホニウムクロライド（米沢浜理薬品工業（株）製）１５０ｍｇ／ｋｇ体重の組み合わせ
Ｂ群：ソヨウ抽出物（蘇葉乾燥エキス：日本粉末薬品（株）製）３０ｍｇ／ｋｇ体重（原生薬換算量として２７０ｍｇ／ｋｇ体重）とＡ群の組み合わせの併用
結果を表２に示す。なお、炭素末の移動率は、平均値で表示した。
The test drugs were as follows.
Group A: Assembly (assembly powder: manufactured by Nippon Powder Chemicals Co., Ltd.) 30 mg / kg body weight, Rotocon extract (Roto extract triple powder: manufactured by Alps Pharmaceutical Industry Co., Ltd.) 90 mg / kg body weight (30 mg / kg as funnel extract) Body weight) and methylmethionine sulfonium chloride (manufactured by Yonezawahama Pharmaceutical Co., Ltd.) 150 mg / kg Weight combination Group B: Soyo extract (dried soybean extract: manufactured by Nippon Powder Chemicals Co., Ltd.) 30 mg / kg body weight (original) Table 2 shows the results of the combined use of the combination of 270 mg / kg body weight as a crude drug equivalent and group A. The carbon powder migration rate is shown as an average value.
表２の結果から、ソヨウ単独では消化管運動が賦活化されない投与量においても、センブリ、ロートエキス及びメチルメチオニンスルホニウムクロライドと組み合わせることによって優れた消化管運動賦活化作用が発揮されることが明らかとなった。
以上の試験結果から、ソヨウ及びその抽出物から選ばれる１種以上と、センブリ及びその抽出物、ロートコン及びその抽出物、並びにメチルメチオニンスルホニウムクロライドから選ばれる１種以上との組み合わせは、優れた消化管運動賦活化作用を示すことが明らかとなった。
From the results in Table 2, it is clear that even at a dose in which gastrointestinal motility is not activated by perilla alone, an excellent gastrointestinal motility activating effect is exhibited by combining with Swertia japonica, Scopolia japonica extract and methylmethionine sulfonium chloride. became.
From the above test results, the combination of one or more selected from perilla and its extract and one or more selected from Swertia japonica and its extract, rotocon and its extract, and methylmethionine sulfonium chloride is excellent in digestion. It was clarified that it exhibits a tube motility activating effect.
［試験例３］胃腸薬組成物の腹部不定愁訴に対する効果の評価
腹部の不定愁訴（もたれ、胃部・腹部膨満感及び胃重）を訴える男性ボランティア（４１歳）に、同意のうえ、以下の成分及び汎用の賦形剤を含有する錠剤を１回２錠、１日３回毎食後の用法で２日間投薬した。
＜錠剤成分：６錠中＞
ソヨウ乾燥エキス ２７０ｍｇ（原生薬換算量）
センブリ末 ３０ｍｇ
ロートエキス ９０ｍｇ
メチルメチオニンスルホニウムクロライド １５０ｍｇ
[Test Example 3] Evaluation of the effect of the gastrointestinal drug composition on abdominal indefinite complaints With the consent of a male volunteer (41 years old) who complains of abdominal indefinite complaints (stomach / abdominal bloating and stomach weight), the following Two tablets containing the ingredients and general-purpose excipients were administered three times a day for 2 days in a postprandial manner.
<Tablet ingredients: out of 6 tablets>
Perilla dried extract 270 mg (equivalent amount of crude drug)
Swertia japonica powder 30 mg
Scopolia extract 90 mg
Methylmethionine sulfonium chloride 150 mg
投薬後、上記不定愁訴に関しヒアリングしたところ、いずれの症状についても緩和された旨の回答を得た。
以上の試験結果から、本発明の胃腸薬組成物は、もたれ、胃部・腹部膨満感及び胃重を含む腹部の不定愁訴に対して有効であることが明らかとなった。なお、斯かる作用は、上記試験例１及び２で確認された消化管運動賦活化作用により、消化管内容物の滞留が解消されたことに基づくものと推察された。
After hearing about the above indefinite complaints after the medication, we received a reply that all the symptoms were alleviated.
From the above test results, it was clarified that the gastrointestinal drug composition of the present invention is effective for indefinite complaints of the abdomen including leaning, stomach / abdominal bloating and stomach weight. It is presumed that such an action is based on the elimination of the retention of the gastrointestinal contents by the gastrointestinal motility activating action confirmed in Test Examples 1 and 2 above.
［試験例４］ソヨウ抽出物による苦味抑制作用の評価
センブリ末単独、及びセンブリ末とソヨウ乾燥エキスの等量混合物それぞれ５ｍｇを５秒間舌先に乗せた際の服用感（苦味）を１０名のパネラーに時間を十分に空けて評価してもらった。
服用感（苦味）の評価は、以下の評価基準に従いスコア化することにより行った。
（評価基準）
「苦味が殆ど気にならない」：２点
「苦味がやや気になる」：１点
「苦くて舌が痺れる感じがする」：０点
[Test Example 4] Evaluation of bitterness-suppressing effect of perilla extract 10 panelists gave a feeling of taking (bitterness) when 5 mg of each of Swertia japonica powder alone and an equal amount mixture of Swertia japonica powder and dried perilla extract were placed on the tip of the tongue for 5 seconds. I had enough time to evaluate it.
The feeling of taking (bitter taste) was evaluated by scoring according to the following evaluation criteria.
(Evaluation criteria)
"I don't really care about bitterness": 2 points "I'm a little worried about bitterness": 1 point "I feel bitter and numb tongue": 0 points
官能試験結果（全パネラーのスコア合計）を表３に示す。 Table 3 shows the sensory test results (total scores of all panelists).
表３の結果から、ソヨウがセンブリの苦味を抑制する作用を有することが明らかとなった。
以上の試験結果から、少なくともソヨウ及びその抽出物から選ばれる１種以上と、少なくともセンブリ及びその抽出物から選ばれる１種以上を含有する胃腸薬組成物は、センブリ由来の苦味が抑制されて服用感に優れることが明らかとなった。
From the results in Table 3, it was clarified that perilla has an effect of suppressing the bitter taste of Swertia japonica.
From the above test results, a gastrointestinal drug composition containing at least one selected from perilla and its extract and at least one selected from Swertia japonica and its extract is taken with the bitterness derived from Swertia japonica suppressed. It became clear that the feeling was excellent.
［試験例５］モッコウ抽出物単独の消化管運動賦活化作用の確認
試験前日より絶食させた６〜７週齢のｄｄＹ系雄性マウスを、平均体重が均等になるように各群５匹ずつ２群に分け、それぞれ被験薬物投与群及びコントロール群とした。
[Test Example 5] Confirmation of gastrointestinal motility activating effect of Costus extract alone 5 male ddY mice aged 6 to 7 weeks aged from the day before the test were 2 in each group so that the average body weight was even. The group was divided into a test drug administration group and a control group, respectively.
被験薬物投与群のマウスには０．５％メチルセルロース水溶液に溶解したモッコウ抽出物（モッコウ軟エキス：小城製薬（株）製）１０５ｍｇ／ｋｇ体重（原生薬換算量：８０８．５ｍｇ／ｋｇ体重）を、コントロール群のマウスには０．５％メチルセルロース水溶液をそれぞれ経口投与し、その３０分後にフェノールレッド溶液（２０％ショ糖溶液）を０．２５ｍＬの投与容量で両群のマウスに経口投与した。 Mocco extract (Mocco soft extract: manufactured by Koshiro Pharmaceutical Co., Ltd.) 105 mg / kg body weight (protozoan equivalent: 808.5 mg / kg body weight) dissolved in a 0.5% aqueous solution of methylcellulose was applied to the mice in the test drug administration group. A 0.5% aqueous solution of methyl cellulose was orally administered to the mice in the control group, and 30 minutes later, a phenol red solution (20% sucrose solution) was orally administered to the mice in both groups in a dose volume of 0.25 mL.
フェノールレッド溶液投与から１５分後にマウスを頸椎脱臼にてと殺し、胃噴門部及び幽門部を結紮後、胃を摘出した。摘出した胃を細切し、これに０．１Ｍ ＮａＯＨ水溶液を１０ｍＬ加えて撹拌し、３０分間静置した後、上清を３ｍＬ分取した。得られた上清に２０％トリクロロ酢酸水溶液を０．３ｍＬ加えて撹拌した後、遠心分離（３０００ｒｐｍ、２０分）し、得られた遠心上清に０．５Ｍ ＮａＯＨ水溶液を等量加え、５６０ｎｍの吸光度を測定し、胃内の色素量の指標とした。
別途、同様の手法にて色素溶液投与直後における胃内の色素量（５６０ｎｍの吸光度）を測定し、被験薬物投与群、コントロール群それぞれ各群について、色素溶液投与直後における胃内の色素量を１００％とした場合の、色素の胃排出率の平均値を算出し、さらに、コントロール群の胃排出率の平均値を１とした場合の被験薬物投与群の胃排出率の平均値の相対指数を算出することにより、被験薬物の投与による消化管運動の賦活化の有無を確認した。
結果を表４に示す。
Fifteen minutes after the administration of the phenol red solution, the mice were killed by cervical dislocation, the gastric cardia and pylorus were ligated, and then the stomach was removed. The excised stomach was cut into small pieces, 10 mL of a 0.1 M NaOH aqueous solution was added thereto, the mixture was stirred, and the mixture was allowed to stand for 30 minutes, and then 3 mL of the supernatant was taken. 0.3 mL of a 20% trichloroacetic acid aqueous solution was added to the obtained supernatant, and the mixture was stirred and then centrifuged (3000 rpm, 20 minutes). An equal amount of 0.5 M NaOH aqueous solution was added to the obtained centrifugal supernatant to 560 nm. The absorbance was measured and used as an index of the amount of pigment in the stomach.
Separately, the amount of pigment in the stomach (absorbency at 560 nm) immediately after administration of the dye solution was measured by the same method, and the amount of pigment in the stomach immediately after administration of the dye solution was 100 for each of the test drug administration group and the control group. The average value of the gastric emptying rate of the pigment when% is calculated, and the relative index of the average value of the gastric emptying rate of the test drug-administered group when the average value of the gastric emptying rate of the control group is 1. By calculation, it was confirmed whether or not the gastrointestinal motility was activated by the administration of the test drug.
The results are shown in Table 4.
被験薬物投与群の移動率の相対指数が１より小さいことから、モッコウを８０８．５ｍｇ／ｋｇ体重（原生薬換算量）の用量で単独投与した場合は、消化管運動が賦活化されないことが確認された。 Since the relative index of the migration rate of the test drug-administered group was smaller than 1, it was confirmed that gastrointestinal motility was not activated when Costus was administered alone at a dose of 808.5 mg / kg body weight (herbal drug equivalent). Was done.
［試験例６］モッコウ抽出物と他の薬物との併用投与による消化管運動賦活化作用の評価
試験前日より絶食させた６〜７週齢のｄｄＹ系雄性マウスを、平均体重が均等になるように各群６匹ずつ２群に分け、それぞれ被験薬物Ａ投与群（Ａ群）及び被験薬物Ｂ投与群（Ｂ群）とした。
[Test Example 6] Evaluation of gastrointestinal motility activating effect by combined administration of mokko extract and other drugs 6 to 7 week-old male ddY mice fasted from the day before the test so that the average weight is equal. Each group was divided into 2 groups of 6 animals each, and the test drug A administration group (A group) and the test drug B administration group (B group) were used.
各群のマウスに、０．５％メチルセルロースに溶解又は懸濁させた下記被験薬物を経口投与し、その１０分後に５％活性炭素末懸濁液を０．１ｍＬ／１０ｇ体重の用量で経口投与した。 The following test drug dissolved or suspended in 0.5% methylcellulose was orally administered to each group of mice, and 10 minutes later, a 5% active carbon powder suspension was orally administered at a dose of 0.1 mL / 10 g body weight. did.
活性炭素末懸濁液投与から２０分後にマウスを頸椎脱臼にてと殺し、胃幽門部から回腸末端までの腸管を摘出した後、各群それぞれについて炭素末の移動率（幽門部からの移動距離の、摘出腸管全長に対する割合）を算出した。 Twenty minutes after the administration of the active carbon powder suspension, the mice were killed by cervical dislocation, and the intestinal tract from the gastric pylorus to the terminal ileum was removed. (Ratio to the total length of the excised intestinal tract) was calculated.
なお、被験薬物は、以下の通りとした。
Ａ群：センブリ（センブリ末：日本粉末薬品（株）製）９０ｍｇ／ｋｇ体重、ロートコン抽出物（ロートエキス３倍散：アルプス薬品工業（株）製）２７０ｍｇ／ｋｇ体重（ロートエキスとして９０ｍｇ／ｋｇ体重）及びメチルメチオニンスルホニウムクロライド（米沢浜理薬品工業（株）製）４５０ｍｇ／ｋｇ体重の組み合わせ
Ｂ群：モッコウ抽出物（モッコウ軟エキス：小城製薬（株）製）１０５ｍｇ／ｋｇ体重（原生薬換算量として８０８．５ｍｇ／ｋｇ体重）とＡ群の組み合わせの併用
結果を表５に示す。なお、炭素末の移動率は、平均値で表示した。
The test drugs were as follows.
Group A: Assembly (assembly powder: manufactured by Nippon Powder Chemicals Co., Ltd.) 90 mg / kg body weight, Rotocon extract (Roto extract triple powder: manufactured by Alps Pharmaceutical Industry Co., Ltd.) 270 mg / kg body weight (90 mg / kg as funnel extract) Body weight) and methylmethionine sulfonium chloride (manufactured by Yonezawahama Pharmaceutical Co., Ltd.) 450 mg / kg body weight combination Group B: mokko extract (mokko soft extract: manufactured by Koshiro Pharmaceutical Co., Ltd.) 105 mg / kg body weight (crude drug equivalent) Table 5 shows the results of the combined use of the combination of 808.5 mg / kg body weight) and Group A. The carbon powder migration rate is shown as an average value.
表５の結果から、モッコウ単独では消化管運動が賦活化されない投与量においても、センブリ、ロートエキス及びメチルメチオニンスルホニウムクロライドと組み合わせることによって優れた消化管運動賦活化作用が発揮されることが明らかとなった。
以上の試験結果から、モッコウ及びその抽出物から選ばれる１種以上と、センブリ及びその抽出物、ロートコン及びその抽出物、並びにメチルメチオニンスルホニウムクロライドから選ばれる１種以上との組み合わせは、優れた消化管運動賦活化作用を示すことが明らかとなった。
From the results in Table 5, it is clear that even at a dose in which costus alone does not activate gastrointestinal motility, an excellent gastrointestinal motility activating effect is exhibited by combining with Swertia japonica, Scopolia japonica extract and methylmethionine sulfonium chloride. became.
From the above test results, the combination of one or more selected from Costus and its extract and one or more selected from Swertia japonica and its extract, rotocon and its extract, and methylmethionine sulfonium chloride is excellent in digestion. It was clarified that it exhibits a tube motility activating effect.
［試験例７］胃腸薬組成物の腹部不定愁訴に対する効果の評価
腹部の不定愁訴（もたれ、及び胃部・腹部膨満感）を訴える男性ボランティア（４２歳）に、同意のうえ、以下の成分及び汎用の賦形剤を含有する錠剤を１回２錠、１日３回毎食後の用法で２日間投薬した。
＜錠剤成分：６錠中＞
モッコウ軟エキス ２７０ｍｇ（原生薬換算量）
センブリ末 ３０ｍｇ
ロートエキス ９０ｍｇ
メチルメチオニンスルホニウムクロライド １５０ｍｇ
投薬後、上記不定愁訴に関しヒアリングしたところ、いずれの症状についても緩和された旨の回答を得た。
以上の試験結果から、本発明の胃腸薬組成物は、もたれ、及び胃部・腹部膨満感を含む腹部の不定愁訴に対して有効であることが明らかとなった。なお、斯かる作用は、上記試験例５及び６で確認された消化管運動賦活化作用により、消化管内容物の滞留が解消されたことに基づくものと推察された。
[Test Example 7] Evaluation of the effect of the gastrointestinal drug composition on abdominal indefinite complaints With the consent of a male volunteer (42 years old) who complains of abdominal indefinite complaints (leanness and abdominal / abdominal bloating), the following ingredients and Two tablets containing a general-purpose excipient were administered three times a day for 2 days in a postprandial manner.
<Tablet ingredients: out of 6 tablets>
Costus soft extract 270 mg (herbal medicine equivalent)
Swertia japonica powder 30 mg
Scopolia extract 90 mg
Methylmethionine sulfonium chloride 150 mg
After hearing about the above indefinite complaints after the medication, we received a reply that all the symptoms were alleviated.
From the above test results, it was clarified that the gastrointestinal drug composition of the present invention is effective for indefinite complaints of the abdomen including leaning and abdominal / abdominal bloating. It is presumed that such an action is based on the elimination of the retention of the gastrointestinal contents by the gastrointestinal motility activating action confirmed in Test Examples 5 and 6 above.
［製造例１］
６錠中に以下の成分を含有する錠剤を、常法により製造した。
タカヂアスターゼＴ １５０ｍｇ
メチルメチオニンスルホニウムクロライド １５０ｍｇ
ソヨウ乾燥エキス ２７０ｍｇ（原生薬換算量）
ウルソデオキシコール酸 １６ｍｇ
ロートエキス ３０ｍｇ
炭酸水素ナトリウム １５００ｍｇ
メタケイ酸アルミン酸マグネシウム ７５０ｍｇ
ショウキョウ ２０ｍｇ
ケイヒ ２０．５ｍｇ
ニクズク ２０ｍｇ
ｌ−メントール ３．５ｍｇ
乳糖水和物 ２７０ｍｇ
トウモロコシデンプン １００ｍｇ
結晶セルロース ２７５ｍｇ
ヒドロキシプロピルセルロース ２４ｍｇ
カルメロースカルシウム ７０ｍｇ
炭酸マグネシウム ２５０ｍｇ
メチルセルロース ５０ｍｇ
タルク ２６ｍｇ
マクロゴール ５０ｍｇ
ステアリン酸マグネシウム ５ｍｇ
香料 適量
[Manufacturing Example 1]
Tablets containing the following components in 6 tablets were produced by a conventional method.
Takadiastase T 150mg
Methylmethionine sulfonium chloride 150 mg
Perilla dried extract 270 mg (equivalent amount of crude drug)
Ursodeoxycholic acid 16 mg
Scopolia extract 30 mg
Sodium bicarbonate 1500mg
Magnesium aluminate metasilicate 750 mg
Ginger 20 mg
Chinese cinnamon 20.5 mg
Nutmeg 20 mg
l-menthol 3.5 mg
Lactose hydrate 270 mg
Corn starch 100 mg
Crystalline cellulose 275 mg
Hydroxypropyl cellulose 24 mg
Carmellose Calcium 70mg
Magnesium carbonate 250 mg
Methyl cellulose 50 mg
Talc 26 mg
Macrogol 50 mg
Magnesium stearate 5 mg
Appropriate amount of fragrance
［製造例２］
６錠中に以下の成分を含有する錠剤を、常法により製造した。
メチルメチオニンスルホニウムクロライド １５０ｍｇ
ソヨウ乾燥エキス ２７０ｍｇ（原生薬換算量）
ロートエキス ９０ｍｇ
センブリ末 ３０ｍｇ
ケイヒ末 ２０．５ｍｇ
ビオジアスターゼ２０００ ２４ｍｇ
リパーゼＡＰ１２ １５ｍｇ
炭酸水素ナトリウム ７００ｍｇ
沈降炭酸カルシウム １２００ｍｇ
炭酸マグネシウム ２５０ｍｇ
ヒドロキシプロピルセルロース ２４ｍｇ
硬化油 ２０６ｍｇ
ポリビニルアルコール １０６ｍｇ
カルメロースカルシウム １４２．５ｍｇ
トウモロコシデンプン ２４ｍｇ
結晶セルロース ２７４ｍｇ
低置換度ヒドロキシプロピルセルロース １３３ｍｇ
含水二酸化ケイ素 ２９．５ｍｇ
モノステアリン酸グリセリン １０ｍｇ
ステアリン酸ポリオキシル ３ｍｇ
精製セラック ４ｍｇ
タルク ２６．５ｍｇ
ｌ-メントール ４ｍｇ
ステアリン酸マグネシウム １４．５ｍｇ
[Manufacturing Example 2]
Tablets containing the following components in 6 tablets were produced by a conventional method.
Methylmethionine sulfonium chloride 150 mg
Perilla dried extract 270 mg (equivalent amount of crude drug)
Scopolia extract 90 mg
Swertia japonica powder 30 mg
Cinnamon powder 20.5 mg
Biodiastase 2000 24 mg
Lipase AP12 15 mg
Sodium bicarbonate 700 mg
Precipitated calcium carbonate 1200 mg
Magnesium carbonate 250 mg
Hydroxypropyl cellulose 24 mg
Hydrogenated oil 206mg
Polyvinyl alcohol 106 mg
Carmellose calcium 142.5 mg
Corn starch 24 mg
Crystalline cellulose 274 mg
Low degree of substitution hydroxypropyl cellulose 133 mg
Hydrous silicon dioxide 29.5 mg
Glycerin monostearate 10 mg
Polyoxyl stearate 3 mg
Purified shellac 4 mg
Talc 26.5 mg
l-menthol 4 mg
Magnesium stearate 14.5 mg
［製造例３］
３包中に以下の成分を含有する細粒剤を、常法により製造した。
Ｌ−グルタミン ４０５ｍｇ
ソヨウ末 ２００ｍｇ
桂皮（ケイヒ） １５０ｍｇ
桂皮油（ケイヒ油） ６ｍｇ
縮砂（シュクシャ） ９０ｍｇ
当薬（センブリ） ３ｍｇ
炭酸水素ナトリウム １９５０ｍｇ
重質炭酸マグネシウム ６００ｍｇ
沈降炭酸カルシウム ３００ｍｇ
サナルミン ３９９ｍｇ
ロートエキス ３０ｍｇ
ジアスメンＳＳ ２４０ｍｇ
プロザイム ５１ｍｇ
ｌ−メントール ５ｍｇ
結晶セルロース ２００ｍｇ
ケイ酸Ａｌ ５０ｍｇ
ステアリン酸Ｍｇ ５０ｍｇ
[Manufacturing Example 3]
A fine granule containing the following components in 3 packets was produced by a conventional method.
L-Glutamine 405 mg
Perilla powder 200mg
Cinnamon (Cinnamon) 150mg
Cinnamon oil (Cinnamon oil) 6 mg
Shukusha 90mg
Our drug (Swertia japonica) 3 mg
Sodium bicarbonate 1950 mg
Heavy Magnesium Carbonate 600mg
Precipitated calcium carbonate 300 mg
Sanalmin 399 mg
Scopolia extract 30 mg
Diasmen SS 240mg
Prozyme 51 mg
l-menthol 5 mg
Crystalline cellulose 200 mg
Al silicate 50 mg
Mg stearate 50 mg
［製造例４］
６錠中に以下の成分を含有する錠剤を、常法により製造した。
タカヂアスターゼＴ １５０ｍｇ
メチルメチオニンスルホニウムクロライド １５０ｍｇ
モッコウ乾燥エキス １００ｍｇ（原生薬換算量）
ウルソデオキシコール酸 １６ｍｇ
ロートエキス ３０ｍｇ
炭酸水素ナトリウム １５００ｍｇ
メタケイ酸アルミン酸マグネシウム ７５０ｍｇ
ショウキョウ ２０ｍｇ
ケイヒ ２０．５ｍｇ
ニクズク ２０ｍｇ
ｌ−メントール ３．５ｍｇ
乳糖水和物 ２７０ｍｇ
トウモロコシデンプン １００ｍｇ
結晶セルロース ２７５ｍｇ
ヒドロキシプロピルセルロース ２４ｍｇ
カルメロースカルシウム ７０ｍｇ
炭酸マグネシウム ２５０ｍｇ
メチルセルロース ５０ｍｇ
タルク ２６ｍｇ
マクロゴール ５０ｍｇ
ステアリン酸マグネシウム ５ｍｇ
香料 適量
[Manufacturing Example 4]
Tablets containing the following components in 6 tablets were produced by a conventional method.
Takadiastase T 150mg
Methylmethionine sulfonium chloride 150 mg
Costus dried extract 100 mg (equivalent amount of crude drug)
Ursodeoxycholic acid 16 mg
Scopolia extract 30 mg
Sodium bicarbonate 1500mg
Magnesium aluminate metasilicate 750 mg
Ginger 20 mg
Chinese cinnamon 20.5 mg
Nutmeg 20 mg
l-menthol 3.5 mg
Lactose hydrate 270 mg
Corn starch 100 mg
Crystalline cellulose 275 mg
Hydroxypropyl cellulose 24 mg
Carmellose Calcium 70mg
Magnesium carbonate 250 mg
Methyl cellulose 50 mg
Talc 26 mg
Macrogol 50 mg
Magnesium stearate 5 mg
Appropriate amount of fragrance
［製造例５］
６錠中に以下の成分を含有する錠剤を、常法により製造した。
メチルメチオニンスルホニウムクロライド １５０ｍｇ
モッコウ乾燥エキス ３００ｍｇ（原生薬換算量）
ロートエキス ９０ｍｇ
センブリ末 ３０ｍｇ
ケイヒ末 ２０．５ｍｇ
ビオジアスターゼ２０００ ２４ｍｇ
リパーゼＡＰ１２ １５ｍｇ
炭酸水素ナトリウム ７００ｍｇ
沈降炭酸カルシウム １２００ｍｇ
炭酸マグネシウム ２５０ｍｇ
ヒドロキシプロピルセルロース ２４ｍｇ
硬化油 ２０６ｍｇ
ポリビニルアルコール １０６ｍｇ
カルメロースカルシウム １４２ｍｇ
トウモロコシデンプン ２４ｍｇ
結晶セルロース ２７４ｍｇ
低置換度ヒドロキシプロピルセルロース １３３ｍｇ
含水二酸化ケイ素 ２９．５ｍｇ
モノステアリン酸グリセリン １０ｍｇ
ステアリン酸ポリオキシル ３ｍｇ
精製セラック ４ｍｇ
タルク ２６．５ｍｇ
ｌ-メントール ４ｍｇ
ステアリン酸マグネシウム １４．５ｍｇ
[Manufacturing Example 5]
Tablets containing the following components in 6 tablets were produced by a conventional method.
Methylmethionine sulfonium chloride 150 mg
Costus dried extract 300 mg (equivalent amount of crude drug)
Scopolia extract 90 mg
Swertia japonica powder 30 mg
Cinnamon powder 20.5 mg
Biodiastase 2000 24 mg
Lipase AP12 15 mg
Sodium bicarbonate 700 mg
Precipitated calcium carbonate 1200 mg
Magnesium carbonate 250 mg
Hydroxypropyl cellulose 24 mg
Hydrogenated oil 206mg
Polyvinyl alcohol 106 mg
Carmellose Calcium 142mg
Corn starch 24 mg
Crystalline cellulose 274 mg
Low degree of substitution hydroxypropyl cellulose 133 mg
Hydrous silicon dioxide 29.5 mg
Glycerin monostearate 10 mg
Polyoxyl stearate 3 mg
Purified shellac 4 mg
Talc 26.5 mg
l-menthol 4 mg
Magnesium stearate 14.5 mg
［製造例６］
３包中に以下の成分を含有する細粒剤を、常法により製造した。
Ｌ−グルタミン ４０５ｍｇ
モッコウ末 ８０ｍｇ
ソヨウ末 ２００ｍｇ
桂皮（ケイヒ） １５０ｍｇ
桂皮油（ケイヒ油） ６ｍｇ
縮砂（シュクシャ） ９０ｍｇ
当薬（センブリ） ３ｍｇ
炭酸水素ナトリウム １９５０ｍｇ
重質炭酸マグネシウム ６００ｍｇ
沈降炭酸カルシウム ３００ｍｇ
サナルミン ３９９ｍｇ
ロートエキス ３０ｍｇ
ジアスメンＳＳ ２４０ｍｇ
プロザイム ５１ｍｇ
ｌ−メントール ５ｍｇ
結晶セルロース ２００ｍｇ
ケイ酸Ａｌ ５０ｍｇ
ステアリン酸Ｍｇ ５０ｍｇ
[Manufacturing Example 6]
A fine granule containing the following components in 3 packets was produced by a conventional method.
L-Glutamine 405 mg
Costus powder 80mg
Perilla powder 200mg
Cinnamon (Cinnamon) 150mg
Cinnamon oil (Cinnamon oil) 6 mg
Shukusha 90mg
Our drug (Swertia japonica) 3 mg
Sodium bicarbonate 1950 mg
Heavy Magnesium Carbonate 600mg
Precipitated calcium carbonate 300 mg
Sanalmin 399 mg
Scopolia extract 30 mg
Diasmen SS 240mg
Prozyme 51 mg
l-menthol 5 mg
Crystalline cellulose 200 mg
Al silicate 50 mg
Mg stearate 50 mg
［製造例７］
６錠中に以下の成分を含有する錠剤を、常法により製造した。
メチルメチオニンスルホニウムクロライド １５０ｍｇ
ソヨウ乾燥エキス ２７０ｍｇ（原生薬換算量）
ロートエキス ９０ｍｇ
センブリ末 ３０ｍｇ
ケイヒ末 ２０．５ｍｇ
ビオジアスターゼ２０００ ２４ｍｇ
プロザイム６ １８ｍｇ
リパーゼＡＰ１２ １５ｍｇ
炭酸水素ナトリウム ７００ｍｇ
沈降炭酸カルシウム １２００ｍｇ
炭酸マグネシウム ２５０ｍｇ
ヒドロキシプロピルセルロース ２４ｍｇ
硬化油 ２０６ｍｇ
ポリビニルアルコール １０６ｍｇ
カルメロースカルシウム １２４．５ｍｇ
トウモロコシデンプン ２４ｍｇ
結晶セルロース ２７４ｍｇ
低置換度ヒドロキシプロピルセルロース １３３ｍｇ
含水二酸化ケイ素 ２９．５ｍｇ
モノステアリン酸グリセリン １０ｍｇ
ステアリン酸ポリオキシル ３ｍｇ
精製セラック ４ｍｇ
タルク ２６．５ｍｇ
ｌ-メントール ４ｍｇ
ステアリン酸マグネシウム １４．５ｍｇ
[Manufacturing Example 7]
Tablets containing the following components in 6 tablets were produced by a conventional method.
Methylmethionine sulfonium chloride 150 mg
Perilla dried extract 270 mg (equivalent amount of crude drug)
Scopolia extract 90 mg
Swertia japonica powder 30 mg
Cinnamon powder 20.5 mg
Biodiastase 2000 24 mg
Prozyme 6 18 mg
Lipase AP12 15 mg
Sodium bicarbonate 700 mg
Precipitated calcium carbonate 1200 mg
Magnesium carbonate 250 mg
Hydroxypropyl cellulose 24 mg
Hydrogenated oil 206mg
Polyvinyl alcohol 106 mg
Carmellose calcium 124.5 mg
Corn starch 24 mg
Crystalline cellulose 274 mg
Low degree of substitution hydroxypropyl cellulose 133 mg
Hydrous silicon dioxide 29.5 mg
Glycerin monostearate 10 mg
Polyoxyl stearate 3 mg
Purified shellac 4 mg
Talc 26.5 mg
l-menthol 4 mg
Magnesium stearate 14.5 mg
本発明によれば、ソウジュツやその抽出物を仮に含まなくても、顕著に高められた消化管運動賦活化作用を奏し、もたれ、胃部・腹部膨満感や胃重などの症状の改善に好適に用いることができる胃腸薬組成物を提供でき、医薬品産業・医薬部外品産業等において利用できる。 According to the present invention, even if it does not contain sojutsu or its extract, it exerts a remarkably enhanced gastrointestinal motility activating effect, and is suitable for improving symptoms such as leaning, stomach / abdominal bloating and stomach weight. It is possible to provide a gastrointestinal drug composition that can be used in the pharmaceutical industry, a quasi-drug industry, and the like.
Claims (3)
（Ａ）ソヨウの水抽出物；
（Ｂ）センブリ及びその抽出物から選ばれる１種以上と、ロートコン及びその抽出物から選ばれる１種以上と、メチルメチオニンスルホニウムクロライドとの組み合わせ；
を含有する、胃腸薬組成物。 The following components (A) and (B):
(A) aqueous extract of Seo iodine;
(B) A combination of one or more selected from Swertia japonica and its extract, one or more selected from Rotocon and its extract, and methylmethionine sulfonium chloride;
A gastrointestinal drug composition containing.
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| JP2003159001A (en) * | 2001-11-29 | 2003-06-03 | Shinwa Kogyo Kk | Fourth plucked tea powder, fourth plucked tea powder tablet, fourth plucked tea drink, health promoting powder, health promoting tablet, health promoting drink, and method for producing the fourth plucked tea powder |
| JP2006115238A (en) * | 2004-10-14 | 2006-04-27 | Canon Finetech Inc | Image processing apparatus |
| KR20080003318A (en) * | 2005-04-25 | 2008-01-07 | 교와 가부시키가이샤 | Gastrointestinal motor activation regulator |
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