JP2010100576A - Constipation-improving agent - Google Patents

Constipation-improving agent Download PDF

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JP2010100576A
JP2010100576A JP2008274406A JP2008274406A JP2010100576A JP 2010100576 A JP2010100576 A JP 2010100576A JP 2008274406 A JP2008274406 A JP 2008274406A JP 2008274406 A JP2008274406 A JP 2008274406A JP 2010100576 A JP2010100576 A JP 2010100576A
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constipation
improving agent
improving
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Mamiko Hashimoto
麻美子 橋本
Toshiaki Inose
利明 井ノ瀬
Takashi Kimura
隆 木村
Takeo Sakai
健雄 酒井
Toshiyuki Koori
俊之 郡
Atsushi Chuma
淳 中馬
Shoichi Tsujiyama
彰一 辻山
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Unitika Ltd
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Unitika Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a constipation-improving agent effective for the improvement of the constipation and accompanying various disorders over the both sides of mental and body by promoting the normalization of intestinal functions and having high safety. <P>SOLUTION: This constipation-improving agent is characterized in that it comprises the extract of Sparassis crispa having a thick half gel state and prepared by extracting the dried powder of a fruit of the S. crispa with hot water under pressure, as an active ingredient; a liquid state medicinal composition containing the above constipation-improving agent and having the constipation-improving effect; a drink type beverage or food containing the constipation-improving agent and having the constipation-improving effect. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

本発明は、便秘改善剤に関するものであり、さらに詳しくは、腸機能の正常化を促すことにより便秘およびそれに付随する、心身両面に渡る種々の障害の改善に有効な便秘改善剤並びに該改善剤を含んでなる薬学的組成物及び飲食品に関するものである。   The present invention relates to a constipation-improving agent, and more specifically, the constipation-improving agent effective for improving constipation and various disorders related to both mind and body by promoting normalization of intestinal function and the ameliorating agent. The present invention relates to a pharmaceutical composition comprising

便秘とは、日本内科学会の定義では「三日以上排便がない状態。または毎日排便があっても残便感がある状態」となっており、症状の軽重はあれ、日常生活において便秘を経験したことのない人はいないといわれている。   Constipation is defined by the Japan Society of Internal Medicine as “no stool for more than three days. Or even if there is a stool every day, there is a feeling of residual stool.” It is said that no one has ever done it.

便秘の原因は、器質性便秘と機能性便秘の二つに大別され、前者は、便の経路である消化管自体の狭窄、癒着、他臓器の病変による圧迫等の物理的障害が原因となって生じるものである。器質性便秘の改善には、原因となっている物理的障害を取り除くことが必要となる。   The causes of constipation are roughly divided into organic constipation and functional constipation. The former is caused by physical disorders such as stenosis of the digestive tract itself, adhesion, and compression due to lesions of other organs. This is what happens. In order to improve organic constipation, it is necessary to remove the physical disorder that causes it.

一方、機能性便秘は、腸管の機能低下または機能異常により生じる便秘で、さらに一過性便秘と慢性便秘に大別される。一過性便秘は、急性かつ一過性の便秘であり、ダイエットなどによる急激な食生活の変化や生活環境の変化、精神的要因等が原因となることが多いと考えられている。また、利尿剤などの薬剤の長期連用による薬剤性便秘なども一過性便秘に分類される。   On the other hand, functional constipation is constipation caused by a decrease in function or abnormal function of the intestinal tract, and is broadly divided into transient constipation and chronic constipation. Transient constipation is acute and transient constipation, and is considered to be often caused by sudden changes in dietary habits, changes in living environment, mental factors, and the like due to diet. In addition, drug constipation due to long-term continuous use of drugs such as diuretics is also classified as transient constipation.

一方、慢性便秘は、さらに直腸性便秘、弛緩性便秘、痙攣性便秘に分けられる。直腸性便秘は、繰り返し便意を我慢するなど、排便反射の鈍化により起こると考えられており、女性に多い。弛緩性便秘は、腹筋力の不足などによる大腸の運動能力の鈍化によって生じる便秘で、老人や長期療養者などに多く見られるものである。また痙攣性便秘は、腸管の拡張や蠕動の亢進などの痙攣によって起こる便秘で、自律神経の乱れなどに起因する過敏性腸症候群など、ストレスがその一因であると考えられている。   On the other hand, chronic constipation is further divided into rectal constipation, flaccid constipation, and spastic constipation. Rectal constipation is thought to be caused by a slowing of the bowel reflex, such as enduring constipation repeatedly, and is common in women. Loose constipation is constipation caused by slowing of the large intestine's ability to exercise the colon due to lack of abdominal muscle strength, and is often seen in the elderly and long-term caregivers. Spastic constipation is constipation caused by convulsions such as dilatation of the intestinal tract and increased peristalsis, and stress such as irritable bowel syndrome caused by disorder of autonomic nerves is considered to be one of the causes.

便秘は、数日程度で自然に回復し、正常な排便パターンに戻れば、一過性の不快症状のみで済むが、慢性化すると、様々な身体的及び精神的症状が発現する。すなわち、腹部の膨満感、圧迫感、不快感、痛みをともない、胸やけや食欲不振、肌荒れ等、又、頭痛、めまい、発熱、不眠、不安感増大や集中力低下等を誘発し、日常生活に支障をきたすことがあり、重症の場合は中毒死にまで至ることもある。また、近年、便秘と大腸癌との因果関係も指摘されており、看過できない問題である。   Constipation recovers spontaneously within a few days, and if it returns to a normal defecation pattern, only transient discomfort is required, but when it becomes chronic, various physical and mental symptoms appear. In other words, abdominal fullness, pressure, discomfort, painful, heartburn, loss of appetite, rough skin, headache, dizziness, fever, insomnia, increased anxiety and reduced concentration, etc. Can cause serious poisoning, and in severe cases it can lead to death from poisoning. In recent years, a causal relationship between constipation and colorectal cancer has been pointed out, which is a problem that cannot be overlooked.

特に高齢者では、咀嚼力の低下、摂食量の減少、長期臥床、運動不足、筋力の低下、精神的誘因(脳血管障害での便意の不感知など)などの悪条件が重なって便秘が誘発されやすく、便秘から食欲不振、低栄養へと進み、更なる体力低下を招くという悪循環が形成されてしまう危険性がある。各種疾患により、上記身体機能に障害を負った患者でも同様のことが危惧される。   Particularly in elderly people, constipation is induced by overlapping adverse conditions such as reduced masticatory power, decreased food intake, long-term bedridden, exercise deficit, weak muscle strength, and mental incentives (such as unawareness of constipation due to cerebrovascular disorders). There is a risk that a vicious circle will be formed in which constipation leads to loss of appetite and malnutrition, leading to further decline in physical fitness. The same is feared even in patients who have impaired physical function due to various diseases.

機能性便秘を改善するためには、従来から、水分補給、規則的な食事生活や排便の習慣づけ、適度な運動とストレス軽減が勧められ、食事においては、食物繊維、乳酸菌、ヨーグルト、果糖、オリゴ糖、クエン酸やリンゴ酸等の有機酸等の積極的摂取が推奨されてきた。しかしながら、これらの方策は必ずしも十分な効果を奏していなかった。   In order to improve functional constipation, hydration, regular dietary habits and defecation habits, moderate exercise and stress reduction have been recommended. In the diet, dietary fiber, lactic acid bacteria, yogurt, fructose, Active intake of oligosaccharides, organic acids such as citric acid and malic acid has been recommended. However, these measures have not always had a sufficient effect.

機能性便秘を改善する薬剤としては、一般的には、大腸粘膜を刺激して蠕動運動を促す下剤が主に用いられている。   As a drug that improves functional constipation, laxatives that stimulate the peristaltic mucosa and promote peristaltic movement are generally used.

上記薬剤としては、例えば、古くからはフェノールフタレイン系の下剤がよく用いられてきた。これらの薬剤は結腸粘膜を刺激して、蠕動運動を亢進することが知られている。またジフェニルメタン系化合物を有効成分とする合成薬下剤は、比較的最近開発された下剤であり、例えば、ピコスルファートナトリウムは、胃や小腸では分解されず、大腸で加水分解されて大腸の蠕動運動を亢進するとともに水分吸収抑制作用により大便を軟化させる。またアントラキノン系下剤としては、センナ、大黄、アロエ、カスカラサグラダ等の植物成分を有効成分とする生薬系下剤が挙げられる(例えば、特許文献1、2参照)。これらの中でも特にセンナは、加水分解されやすい配糖体センノシドAと加水分解されにくいセンノシドBのアントラキノン誘導体があり、これが大腸の細菌によって活性型のアントラキノンとなり、大腸の蠕動運動を亢進すると考えられている。   As the drug, for example, phenolphthalein laxatives have long been used. These drugs are known to stimulate the colonic mucosa and enhance peristaltic movement. Synthetic laxatives containing diphenylmethane compounds as active ingredients are laxatives developed relatively recently. For example, picosulfate sodium is not degraded in the stomach and small intestine, but is hydrolyzed in the large intestine and peristalsis of the large intestine. Stool is softened by water absorption suppression action. In addition, examples of the anthraquinone laxative include herbal physic laxatives containing plant components such as senna, large yellow, aloe, and cascara sagrada (see, for example, Patent Documents 1 and 2). Among these, senna is an anthraquinone derivative of glycoside sennoside A which is easily hydrolyzed and sennoside B which is difficult to be hydrolyzed, and this is considered to be an active anthraquinone by colonic bacteria and enhance peristaltic movement of the large intestine. Yes.

しかしながら、フェノールフタレインには発ガン性のおそれがあるとの指摘があり、現在は使用されない方向にある。一方、ジフェニルメタン系の合成薬下剤は、悪心、嘔吐、腹部の不快感などの副作用を伴うことがあるため、慎重に使用されなければならないなど、使用に際しては注意を要するという問題点がある。   However, it has been pointed out that phenolphthalein has a carcinogenic potential, and is currently not used. On the other hand, diphenylmethane-based synthetic laxatives may have side effects such as nausea, vomiting, and abdominal discomfort, and thus must be used with caution, such as being used carefully.

アントラキノン系の生薬系下剤は、植物由来ということから安心感が大きく、緩下剤として広く用いられているが、大腸刺激性の薬剤であり、作用が強力で、腹痛や下痢を伴うことがある。また、連用すると耐性が増大し、有効性を減ずる可能性があることから、長期連用は好ましくない。   Anthraquinone-based herbal remedies have great reassurance because they are derived from plants and are widely used as laxatives. However, they are large intestine-stimulating agents, have strong action, and may be accompanied by abdominal pain and diarrhea. Further, long-term continuous use is not preferable because continuous use increases resistance and may reduce the effectiveness.

一方、セルロース、カンテン等の不溶性食物繊維を摂取することにより緩下作用が誘発されることが知られており、各種便秘改善薬として用いられている。   On the other hand, ingestion of insoluble dietary fibers such as cellulose and agar is known to induce a laxative action, and is used as various constipation-improving drugs.

しかしながら、不溶性食物繊維は大腸刺激による便通効果の改善が知られているものの(非特許文献1参照)、痙攣性便秘には逆効果になる可能性が指摘されている。
特開平4−154728号公報 特開平8−310960号公報 「図説薬理学」、朝倉書店、1977年12月発行、249頁
However, although insoluble dietary fiber has been known to improve the bowel movement effect by stimulation of the large intestine (see Non-Patent Document 1), it has been pointed out that it may have an adverse effect on convulsive constipation.
JP-A-4-154728 JP-A-8-310960 "Illustrated Pharmacology", Asakura Shoten, published December 1977, p.249

本発明は、従来用いられてきた前記下剤のように、悪心、嘔吐、腹部の不快感、腹痛、下痢などの副作用を伴うことなく、安全性が高く、自然に近いおだやかな便通効果を得ることのできる便秘改善剤を提供することを目的とする。   The present invention has a high safety and a gentle bowel effect that is close to nature without side effects such as nausea, vomiting, abdominal discomfort, abdominal pain, and diarrhea, as in the case of the laxatives conventionally used. An object of the present invention is to provide an agent for improving constipation.

本発明者らは、上記課題を解決するために種々検討した結果、ハナビラタケの抽出物に便秘改善作用があることを見出し、本発明を完成するに至った。   As a result of various studies to solve the above-mentioned problems, the present inventors have found that the extract of Hanabiratake has an effect of improving constipation, and have completed the present invention.

すなわち、本発明は、ハナビラタケの抽出物を有効成分とすることを特徴とする便秘改善剤を要旨とするものである。また別の本発明は、該便秘改善剤を含有し、便秘改善作用を有することを特徴とする薬学的組成物を要旨とするものである。さらに別の本発明は、該便秘改善剤を含有し、便秘改善作用を有することを特徴とする飲食品を要旨とするものである。   That is, the gist of the present invention is a constipation-improving agent characterized by using an extract of agaric bamboo as an active ingredient. Another gist of the present invention is a pharmaceutical composition comprising the constipation-improving agent and having a constipation-improving action. Yet another aspect of the present invention is to provide a food or beverage product containing the constipation-improving agent and having a constipation-improving action.

本発明によれば、食経験の豊富なハナビラタケから抽出されたハナビラタケ由来の成分を有効成分とするものであるため、日常生活における摂取による効果が期待できる安全かつ効果的な便秘改善用の薬学的組成物や飲食品を提供することができ、その摂取は、便秘症状の改善を安全かつ効果的に進めるために極めて有用なものとなる。   According to the present invention, since the active ingredient is a component derived from the agaric bamboo extracted from abundant food habitat, a pharmaceutical for improving constipation safely and effectively that can be expected to have an effect by ingestion in daily life Compositions and foods and drinks can be provided, and their intake is extremely useful for safely and effectively improving constipation symptoms.

以下、本発明を詳細に説明する。   Hereinafter, the present invention will be described in detail.

ハナビラタケ(Sparassis crispa)は、カラマツやアカマツ等の針葉樹に発生する、生物学上、ハナビラタケ科に分類される食用きのこである。これまで、その栽培は難しく、一般にはあまり知られていなかったが、近年、人工栽培方法が確立され、量産されるに至った。   Hanabira bamboo (Sparassis crispa) is an edible mushroom that occurs in conifers such as larch and Japanese red pine and is classified biologically as the family Hanabiratake. Until now, its cultivation has been difficult and generally not well known, but in recent years, an artificial cultivation method has been established and has been mass-produced.

本発明においてはハナビラタケの子実体又は菌糸体が用いられるが、ハナビラタケ子実体としては、天然のものでも人工栽培されたものでもよい。人工栽培の方法としては、従来から知られている人工栽培用の菌床を作製することにより行うことができる(詳細は、例えば、特開平11−56098号公報、特開2002−369621号公報参照)。   In the present invention, the fruit body or mycelium of the bamboo shoot is used. The fruit body of the flower bud may be natural or artificially cultivated. As a method of artificial cultivation, it can be performed by preparing a conventionally known fungal bed for artificial cultivation (for details, see, for example, JP-A Nos. 11-56098 and 2002-369621). ).

このようにして得られたハナビラタケの子実体は、生のままで次の抽出工程に移してもよいし、乾燥し、必要により粉末化などの加工をしてから抽出工程に移してもよい。   The fruit body of the bamboo shoot obtained in this manner may be transferred to the next extraction step as it is, or may be dried and processed into powder if necessary before being transferred to the extraction step.

本発明における便秘改善剤は、ハナビラタケより抽出されるものを有効成分とするものであるが、その際、極性溶剤又は非極性溶剤による抽出操作によって活性物質を得ることができる。極性溶剤としては、エタノール等のアルコール類または純水、酸水溶液、アルカリ水溶液、塩溶液などを用いることができる。また、抽出にはこれら溶剤を単独で又は2種類以上を混合して用いることができる。   The constipation-improving agent in the present invention has an active ingredient that is extracted from Hanabira bamboo, and at that time, an active substance can be obtained by an extraction operation with a polar solvent or a nonpolar solvent. As the polar solvent, alcohols such as ethanol, pure water, acid aqueous solution, alkaline aqueous solution, salt solution, or the like can be used. In addition, these solvents can be used alone or in admixture of two or more for extraction.

抽出に用いる溶剤の量に特に制限はないが、ハナビラタケの質量に対して2〜100倍量を用いることが好ましい。2倍量以下では操作性が、100倍量以上では作業効率が悪い。   Although there is no restriction | limiting in particular in the quantity of the solvent used for extraction, It is preferable to use 2-100 times amount with respect to the mass of Hanabiratake. The operability is less than twice the amount, and the work efficiency is poor if the amount is more than 100 times.

また、抽出は1種又は複数種の溶剤を用いて、複数回行うこともできる。複数回行う場合は、ハナビラタケからの抽出でもよいし、ハナビラタケから得られた抽出画分をさらに抽出もしくは分画してもよい。また、それらを組み合わせて行うことができる。   The extraction can also be performed multiple times using one or more solvents. In the case of performing multiple times, the extraction may be performed from Hanabiratake, or the extracted fraction obtained from Hanabiratake may be further extracted or fractionated. Moreover, it can carry out combining them.

抽出操作の際の温度に特に制限はなく、溶剤の種類等により、適宜、−20〜200℃程度まで適用することができる。抽出時間にも特に制限はないが、20分〜3日間程度が好ましい。抽出は静置のまま行うこともできるが、撹拌又は振盪、加圧などすることによって抽出効率を高めることができる。   There is no restriction | limiting in particular in the temperature in the case of extraction operation, According to the kind etc. of solvent, it can apply to about -20-200 degreeC suitably. The extraction time is not particularly limited, but is preferably about 20 minutes to 3 days. Extraction can be performed while standing, but the extraction efficiency can be increased by stirring, shaking, pressurizing, or the like.

本発明の便秘改善剤は、以上のようにして得られた、ハナビラタケ抽出物を含有するものである。本発明においては、得られた抽出画分をさらに分画、濃縮して含ませることも可能である。分画、濃縮の方法としては、アルコール沈殿、乾燥などの周知の手段を用いることができる。   The constipation-improving agent of the present invention contains an extract of Hanabiratake obtained as described above. In the present invention, the obtained extracted fraction can be further fractionated and concentrated for inclusion. As a method of fractionation and concentration, known means such as alcohol precipitation and drying can be used.

本発明の便秘改善剤の形態は、適用の仕方に応じて、ゲル化剤、錠剤、カプセル剤、散剤、顆粒剤、丸剤、液剤、乳剤、懸濁剤、溶液剤、酒精剤、シロップ剤、エキス剤、エリキシル剤等、種々の形態にすることができる。   The form of the constipation improving agent of the present invention is gelling agent, tablet, capsule, powder, granule, pill, liquid, emulsion, suspension, solution, alcoholic beverage, syrup according to the application method. , Extract, elixir and the like.

本発明の便秘改善剤の有効成分は、ハナビラタケに由来するものであり、ハナビラタケ子実体は食経験を有する極めて安全な食品である。この点から、本発明の便秘改善剤の服用量は厳しく制限されるものではないと考えられるが、概ね、下限は予防又は治療という目的に応じた効果を発揮しうる量を、上限は服用のしやすさ、経済性等の観点から実際的な量を基準とし、通常、ハナビラタケ子実体乾燥物に換算して成人1日あたり約50mg〜約20g、好ましくは約100mg〜約10gを服用すればよい。もちろん、服用する者の年齢、体重、症状、服用期間、治療経過等に応じて変化させることもできる。1日あたりの量を数回に分けて投与することもできる。   The active ingredient of the constipation-improving agent of the present invention is derived from Hanabiratake, which is a very safe food with a food experience. From this point, it is considered that the dose of the constipation improving agent of the present invention is not strictly limited, but generally the lower limit is an amount that can exert an effect according to the purpose of prevention or treatment, and the upper limit is the dose of In terms of ease of use, economics, etc., based on a practical amount, it is usually about 50 mg to about 20 g, preferably about 100 mg to about 10 g per day for an adult when converted to dried dried fruit. Good. Of course, it can be changed according to the age, weight, symptom, duration of treatment, course of treatment, etc. of the person taking the medicine. The daily dose can be administered in several divided doses.

本発明の薬学的組成物は、前記の便秘改善剤を含有するものであり、さらに製剤に必要な薬剤的に許容できる種々の担体を加えることができる。例えば、賦形剤、結合剤、崩壊剤、滑沢剤、着香剤、着色剤、甘味剤、矯味剤、溶解補助剤、懸濁化剤、乳化剤、コーティング剤を含むことができるが、これらに限定されない。   The pharmaceutical composition of the present invention contains the aforementioned constipation-improving agent, and various pharmaceutically acceptable carriers necessary for the preparation can be further added. For example, excipients, binders, disintegrants, lubricants, flavoring agents, coloring agents, sweeteners, corrigents, solubilizers, suspending agents, emulsifiers, coating agents can be included. It is not limited to.

また、液状品を作製する場合には、必要に応じて種々の濃度の溶液に濃縮または希釈され、そのまま、あるいは、界面活性剤、油剤、アルコール、乳化剤、pH調整剤、防腐剤、酸化防止剤、増粘剤、色素、香料等の1種または2種以上を必要に応じて適宜混合することができる。また、そのようにして調製した液状品をソフトカプセルに封入してもよい。   In the case of preparing a liquid product, it is concentrated or diluted to a solution of various concentrations as necessary, or as it is, or a surfactant, an oil agent, an alcohol, an emulsifier, a pH adjuster, an antiseptic, an antioxidant. In addition, one or more of thickeners, pigments, fragrances and the like can be appropriately mixed as necessary. The liquid product thus prepared may be enclosed in a soft capsule.

本発明の飲食品は、本発明の便秘改善剤を飲食品の原材料に前記の配合量となるよう配合することにより、例えば、麺類、パン、キャンディー、ゼリー、クッキー、スープ等を便秘改善飲料の形態とすることができる。本発明の飲食品には、さらに、鉄、カルシウム等の無機成分、種々のビタミン類、大豆抽出物等のタンパク質、レシチンなどの脂質、オリゴ糖、ショ糖、乳糖等の糖類、各種調味料等を加えることができるが、これらに限定されない。   The food / beverage product of the present invention is prepared by blending the constipation improving agent of the present invention into the raw material of the food / beverage product so as to have the above-mentioned blending amount, for example, noodles, bread, candy, jelly, cookies, soup, etc. It can be in the form. The food and drink of the present invention further includes inorganic components such as iron and calcium, various vitamins, proteins such as soybean extract, lipids such as lecithin, saccharides such as oligosaccharides, sucrose and lactose, various seasonings, etc. However, it is not limited to these.

以下、本発明の実施例およびその効果を説明するための試験例を挙げるが、これらは本発明を何ら限定するものではない。   Examples of the present invention and test examples for explaining the effects thereof will be given below, but these do not limit the present invention.

実施例1〔便秘改善剤および対照剤の調製〕
ハナビラタケの子実体を60℃で6時間熱風乾燥して得られた乾燥品を、ミルで粉末化した。この400gを8Lの飲料水に懸濁し、加圧下、121℃で2時間加熱した。これを室温まで放冷した後、遠心分離(8500rpm×20min)にて沈殿物を取り除き上清約5Lを得た。得られた上清は、とろみのある半ゲル状で、冷蔵(5℃)することにより容易にゲル化するものであった。
Example 1 (Preparation of constipation improving agent and control agent)
A dried product obtained by drying the fruit body of Hanabiratake with hot air at 60 ° C. for 6 hours was pulverized with a mill. 400 g of this was suspended in 8 L of drinking water and heated at 121 ° C. for 2 hours under pressure. After allowing to cool to room temperature, the precipitate was removed by centrifugation (8500 rpm × 20 min) to obtain about 5 L of supernatant. The obtained supernatant was thick and semi-gelled and easily gelled by refrigeration (5 ° C.).

対照剤として、市販されているシイタケ(Lentinula edodes)子実体を同様に熱風乾燥、粉末化した後に加圧熱水抽出し、上清を得た。   As a control agent, commercially available shiitake mushroom (Lentinula edodes) fruit bodies were similarly dried with hot air and powdered, followed by extraction with pressurized hot water to obtain a supernatant.

実施例2〔健康ボランティア服用試験〕
軽度便秘の自覚症状を有する健常成人ボランティア10名(34〜93才、男性2名、女性8名)に実施例1の便秘改善剤5mLを1日1回夕食後に服用させた。
Example 2 [Health volunteer test]
Ten healthy adult volunteers (34-93 years old, 2 men, 8 women) with subjective symptoms of mild constipation were given 5 ml of the constipation improving agent of Example 1 once a day after dinner.

服用開始14日後に、アンケート形式で、便秘改善剤の喉ごし、味、匂い、便通回数および便軟度に対する影響、総合満足度について調査した。   After 14 days from the start of the administration, the effect of constipation improving agents on the throat, taste, smell, number of bowel movements and stool softness, and overall satisfaction were investigated in a questionnaire format.

14日間の無投与期間をおき、実施例1の対照剤を同様に、5mLを1日1回夕食後に服用させた。   After a 14-day no administration period, 5 mL of the control agent of Example 1 was similarly taken once a day after dinner.

服用開始14日後にアンケート形式で、対照剤の喉ごし、味、匂い、便通回数および便軟度に対する影響、総合満足度について調査した。結果を、表1に示す。   After 14 days from the start of administration, a questionnaire was used to investigate the effect of the control on the throat, taste, smell, number of bowel movements and stool softness, and overall satisfaction. The results are shown in Table 1.

表1より、本発明の便秘改善剤は、対照剤と比較して、便回数の増加、便の軟化を自覚する被検者が多く、便秘改善作用を有することが示された。また、とろみを有することから、対照剤よりものどごしが良いと感じる被験者も多く、総合的に服用継続を希望する被験者数が対照剤を上回った。 From Table 1, it was shown that the constipation-improving agent of the present invention has an effect of improving constipation because many subjects are aware of an increase in the number of stools and softening of stool, compared with the control agent. In addition, because of the thickness, there were many subjects who felt that it was better than the control agent, and the total number of subjects who wished to continue taking the drug exceeded the control agent.

実施例3〔重度機能性便秘患者服用試験〕
重度の機能性便秘患者5名に、実施例2と同様に14日間、実施例1の便秘改善剤5mLを服用させ、服用前後の便秘の状態をVAS(Visual analogue scale)スケールを用いて聞き取り調査した。
Example 3 [Study for patients with severe functional constipation]
Five patients with severe functional constipation took 5 mL of the constipation-improving agent of Example 1 for 14 days in the same manner as in Example 2 and interviewed the state of constipation before and after taking it using the VAS (Visual analogue scale) scale. did.

図1に、使用したVASスケールを示す。点数を決定する目盛り付きのスケールは内側に隠されており患者の目には触れず、患者には、便秘の度合いを「笑顔(良好)」から「困惑顔(耐えられない)」間で自由に示させる。個々の患者間の比較には適さないが、一患者の便秘度合いの変化をよく反映する。スケールの点数は0点が最も良好で100点が最も不良を表す。患者5名の結果平均を、表2に示す。   FIG. 1 shows the VAS scale used. The scale with a scale that determines the score is hidden inside and does not touch the patient's eyes, and the patient can freely adjust the degree of constipation from “smile (good)” to “confused face (unbearable)” Let me show you. Although it is not suitable for comparison between individual patients, it well reflects changes in the degree of constipation in one patient. The scale score is 0 for the best and 100 for the worst. The average results of 5 patients are shown in Table 2.

次に、改善が著明だった3名につき、表3に結果を詳細に示す。 Next, the results are shown in detail in Table 3 for three people who showed significant improvement.

表2、表3より、本発明の便秘改善剤が機能性便秘の便秘症状を顕著に改善する作用を有することが明らかとなった。 From Table 2 and Table 3, it became clear that the constipation improving agent of this invention has the effect | action which remarkably improves the constipation symptom of functional constipation.

服用試験に用いたVAS(Visual analogue scale)スケールを示す図である。It is a figure which shows the VAS (Visual analogue scale) scale used for the dosing test.

Claims (3)

ハナビラタケの抽出物を有効成分とすることを特徴とする便秘改善剤。 A constipation-improving agent characterized by comprising an extract of Hanabira bamboo. 請求項1記載の便秘改善剤を含有し、便秘改善作用を有することを特徴とする薬学的組成物。 A pharmaceutical composition comprising the constipation improving agent according to claim 1 and having a constipation improving action. 請求項1記載の便秘改善剤を含有し、便秘改善作用を有することを特徴とする飲食品。
A food or drink comprising the constipation improving agent according to claim 1 and having an effect of improving constipation.
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