JP7464297B2 - Intestinal regulator - Google Patents
Intestinal regulator Download PDFInfo
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- JP7464297B2 JP7464297B2 JP2022076506A JP2022076506A JP7464297B2 JP 7464297 B2 JP7464297 B2 JP 7464297B2 JP 2022076506 A JP2022076506 A JP 2022076506A JP 2022076506 A JP2022076506 A JP 2022076506A JP 7464297 B2 JP7464297 B2 JP 7464297B2
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Classifications
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Medicines Containing Plant Substances (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Medicinal Preparation (AREA)
Description
特許法第３０条第２項適用 日本農芸化学会２０１５年度大会（平成２７年３月２６～２９日 岡山大学にて開催） 日本農芸化学会２０１５年度大会要旨集（平成２７年３月５日、日本農芸化学会発行） 東洋新薬 ニュースリリース（平成２７年４月９日、株式会社東洋新薬発行） 健康産業新聞（平成２７年８月１９日、ＵＢＭメディア株式会社発行） ヘルスライフビジネス（平成２７年７月１日、株式会社ヘルスライフビジネスマガジン社発行） ヘルスライフビジネス（平成２７年６月１５日、株式会社ヘルスライフビジネスマガジン社発行） 健康産業流通新聞（平成２７年６月１１日、株式会社健康産業流通新聞社発行） 日本流通産業新聞（平成２７年６月４日、株式会社日本流通産業新聞社発行） 健康ジャーナル（平成２７年４月２１日、株式会社健康ジャーナル社発行） 食品新聞（平成２７年４月２０日、株式会社食品新聞社発行）Application of Article 30, paragraph 2 of the Patent Act 2015 Annual Meeting of the Agricultural Chemical Society of Japan (held at Okayama University from March 26 to 29, 2015) Abstracts of the 2015 Annual Meeting of the Agricultural Chemical Society of Japan (March 5, 2015, published by the Agricultural Chemical Society of Japan) Toyo Shinyaku News Release (April 9, 2015, published by Toyo Shinyaku Co., Ltd.) Health Industry News (August 19, 2015, published by UBM Media Co., Ltd.) Health Life Business (July 1, 2015, published by Health Life Business Magazine Co., Ltd.) Health Life Business (June 15, 2015, published by Health Life Business Magazine Co., Ltd.) Health Industry Distribution News (June 11, 2015, published by Health Industry Distribution Newspaper Co., Ltd.) Japan Distribution Industry News (June 4, 2015, published by Japan Distribution Industry Newspaper Co., Ltd.) Health Journal (April 21, 2015, published by Health Journal Co., Ltd.) Food News (April 20, 2015, published by Food Newspaper Co., Ltd.)
本発明は、整腸剤に関する。 The present invention relates to an intestinal regulator.
近年、食生活の変化、食事内容の偏り、ストレスなどから様々な生活習慣病が蔓延している。その一つとして便秘や下痢などの腸の不調がある。便秘は、腸内で便が長く滞留することにより生じる。また、重度の便秘は、腸内の有害細菌の増加や有害物質の吸収の増加などを引き起こし、大腸ガンの誘因となる可能性がある。そこで、腸の不調を改善する整腸作用のある物質を有効成分とする整腸剤の開発が進められている。 In recent years, various lifestyle-related diseases have become widespread due to changes in eating habits, unbalanced diet, stress, and other factors. One of these is intestinal disorders such as constipation and diarrhea. Constipation occurs when stool remains in the intestines for a long time. Severe constipation can also cause an increase in harmful bacteria in the intestines and increased absorption of harmful substances, which may lead to colon cancer. As a result, efforts are underway to develop intestinal regulators that contain active ingredients with intestinal regulating properties that improve intestinal disorders.
整腸剤の有効成分の一つとして、例えば、不溶性食物繊維を多く含む植物が知られている。不溶性食物繊維は便通改善作用を有する。このような不溶性食物繊維としては、例えば、小麦ふすまなどの植物外皮由来物質が知られている。 For example, plants that are rich in insoluble dietary fiber are known to be one of the active ingredients in intestinal regulators. Insoluble dietary fiber has the effect of improving bowel movements. Examples of such insoluble dietary fiber include substances derived from the outer skin of plants such as wheat bran.
また、植物粉末の粒度が便通改善作用に影響することが知られている。例えば、非特許文献１では、粒度の異なる小麦ふすま（小麦粒の表皮部分）を用いて排便頻度や排便量を比較し、小麦ふすまの粒度が大きくなると保水量が増すことから、排便頻度や排便量が増加することが記載されている。同様に、特許文献１には、平均粒径が５０～２００μｍと比較的大きい、トウモロコシ外皮に由来する不溶性食物繊維を１０％以上含有することを特徴とする整腸作用性食品が記載されている。 It is also known that the particle size of plant powders affects the effect of improving bowel movements. For example, Non-Patent Document 1 compares the frequency and amount of stool excreted using wheat bran (the outer layer of wheat grains) of different particle sizes, and describes that as the particle size of wheat bran increases, the amount of water it retains increases, and therefore the frequency and amount of stool excreted increases. Similarly, Patent Document 1 describes a food with an intestinal regulating effect that is characterized by containing 10% or more of insoluble dietary fiber derived from corn husks, which has a relatively large average particle size of 50 to 200 μm.
確かに、特許文献１及び非特許文献１に記載されている、粒度が比較的大きい植物外皮由来粉末を使用すれば、便通改善作用などの整腸作用を有する整腸剤が製造できる可能性がある。しかし、これらの物質は、被験体の体質によっては、下痢などの副作用が生じる場合があることから、整腸作用が見られる程度にまで摂取量を増加することが難しいという問題がある。 It is true that by using the relatively large particle size powder derived from plant husks described in Patent Document 1 and Non-Patent Document 1, it is possible to produce an intestinal regulator that has an intestinal regulating effect, such as improving bowel movements. However, these substances can cause side effects such as diarrhea depending on the constitution of the subject, and there is a problem in that it is difficult to increase the intake amount to a level where an intestinal regulating effect is observed.
そこで、本発明は、従前の整腸作用を有する物質に比べて、天然素材を用いながら、安全性が高く、かつ、優れた整腸作用を示す物質を含有する整腸剤を提供することにある。 The present invention aims to provide an intestinal regulator that uses natural materials, is safer, and contains substances that have superior intestinal regulating properties compared to conventional substances that regulate the intestines.
本発明者らは、上記課題を解決するために、種々の物質について鋭意検討を積み重ねたところ、大麦の茎葉に着眼するに至った。そして、大麦の茎葉を粉末にして粒度の違いにより整腸作用を調べてみたところ、驚くべきことに、非特許文献１に記載の小麦ふすまや特許文献１に記載のトウモロコシ外皮由来物とは真逆に、大麦の茎葉は粒度を小さくすることによって、便通改善作用、腸内環境改善作用及び腸管免疫賦活化作用といった整腸作用が高められることを見出した。かかる知見を基に、本発明者らは、粒度が比較的小さい麦類の茎葉の粉末を含有する整腸剤を創作することに成功した。本発明は、この成功例に基づき、完成された発明である。 The inventors of the present invention have conducted extensive research into various substances to solve the above problems, and have come to focus on barley stalks and leaves. They then powdered barley stalks and leaves and investigated the intestinal regulating effects depending on particle size. Surprisingly, they found that, contrary to the wheat bran described in Non-Patent Document 1 and the corn husk-derived material described in Patent Document 1, by reducing the particle size of barley stalks and leaves, the intestinal regulating effects such as improving bowel movements, improving the intestinal environment, and activating intestinal immunity were enhanced. Based on this knowledge, the inventors have succeeded in creating an intestinal regulator containing a powder of barley stalks and leaves, which have a relatively small particle size. The present invention was completed based on this successful example.
したがって、本発明によれば、麦類の葉及び／又は茎の粉末を含有する整腸剤であって、
前記粉末は、平均粒子径が２５μｍ以下である粉末である、前記整腸剤が提供される。
Therefore, according to the present invention, there is provided an intestinal regulator containing a powder of wheat leaves and/or stems, comprising:
The intestinal regulator is provided, wherein the powder has an average particle size of 25 μm or less.
本発明の別の側面によれば、麦類の葉及び／又は茎の粉末を含有する整腸剤であって、
前記粉末は、粒子径２０μｍ以下の累積頻度が２５体積％以上である累積粒度分布、粒子径３０μｍ以下の累積頻度が３７体積％以上である累積粒度分布、粒子径４０μｍ以下の累積頻度が４８体積％以上である累積粒度分布及び粒子径５０μｍ以下の累積頻度が６０体積％以上である累積粒度分布からなる群から選ばれる少なくとも１種の体積基準の累積粒度分布を有する粉末である、前記整腸剤が提供される。
According to another aspect of the present invention, there is provided an intestinal regulator comprising a powder of wheat leaves and/or stems,
The powder has at least one volume-based cumulative particle size distribution selected from the group consisting of a cumulative particle size distribution in which the cumulative frequency of particle diameters of 20 μm or less is 25 vol% or more, a cumulative particle size distribution in which the cumulative frequency of particle diameters of 30 μm or less is 37 vol% or more, a cumulative particle size distribution in which the cumulative frequency of particle diameters of 40 μm or less is 48 vol% or more, and a cumulative particle size distribution in which the cumulative frequency of particle diameters of 50 μm or less is 60 vol% or more.
本発明の別の側面によれば、麦類の葉及び／又は茎の粉末を含有する整腸剤であって、
前記粉末は、１０体積％粒子径が８μｍ以下である累積粒度分布、５０体積％粒子径が４１μｍ以下である累積粒度分布及び９０体積％粒子径が８７μｍ以下である累積粒度分布からなる群から選ばれる少なくとも１種の体積基準の累積粒度分布を有する粉末である、前記整腸剤が提供される。
According to another aspect of the present invention, there is provided an intestinal regulator comprising a powder of wheat leaves and/or stems,
The powder has at least one volume-based cumulative particle size distribution selected from the group consisting of a cumulative particle size distribution in which the 10 volume % particle size is 8 μm or less, a cumulative particle size distribution in which the 50 volume % particle size is 41 μm or less, and a cumulative particle size distribution in which the 90 volume % particle size is 87 μm or less.
好ましくは、本発明の整腸剤が、便通改善剤、腸内環境改善剤又は腸管免疫機能活性化剤である。 Preferably, the intestinal regulator of the present invention is a laxative, intestinal environment improver, or intestinal immune function activator.
好ましくは、本発明の整腸剤において、前記麦類が、大麦、小麦、えん麦及びらい麦からなる群から選ばれる少なくとも１種の麦類である。 Preferably, in the intestinal regulator of the present invention, the wheat or grain is at least one type of wheat or grain selected from the group consisting of barley, wheat, oats, and rye.
好ましくは、本発明の整腸剤において、前記粉末は、５０．５°以上である安息角を有する粉末である。 Preferably, in the intestinal regulator of the present invention, the powder has an angle of repose of 50.5° or more.
好ましくは、本発明の整腸剤において、前記粉末は、０．２２０ｇ／ｃｍ３以下である嵩密度を有する粉末である。 Preferably, in the intestinal regulator of the present invention, the powder has a bulk density of 0.220 g/ cm3 or less.
本発明によれば、粒度の小さい麦類の茎葉の粉末を含有することにより、糞便量の増加、糞中ＩｇＡ量の増加及び腸内有用細菌の増加がみられ、便通改善作用、腸内環境改善作用及び腸管免疫賦活化作用を含む整腸作用を有する整腸剤が得られる。また、麦類の茎葉を含有することを特徴とする本発明の整腸剤は安全性の高いものである。 According to the present invention, by containing a powder of barley and wheat stems and leaves with small particle size, an increase in fecal volume, an increase in fecal IgA levels, and an increase in useful intestinal bacteria are observed, and an intestinal regulator having intestinal regulating effects including improving bowel movements, improving the intestinal environment, and activating intestinal immunity is obtained. Furthermore, the intestinal regulator of the present invention, which is characterized by containing barley and wheat stems and leaves, is highly safe.
本発明の整腸剤は、整腸作用によって、便秘、下痢、排便障害などの腸機能不全、腸管免疫不全、腸内の有害微生物代謝産物や有害酵素の発生、生活習慣病、アレルギーなどの腸組織の異常に関連する種々の疾病及び異常の改善、緩和、治療及び予防することが期待できる。 The intestinal regulator of the present invention is expected to improve, alleviate, treat and prevent various diseases and disorders associated with abnormalities in intestinal tissue, such as intestinal dysfunction such as constipation, diarrhea and defecation disorders, intestinal immune deficiency, production of harmful microbial metabolic products and harmful enzymes in the intestine, lifestyle-related diseases and allergies, through its intestinal regulating effect.
以下、本発明の詳細について説明する。
本発明の整腸剤は、麦類の葉の粉末、茎の粉末又はその両方の粉末、すなわち、麦類の葉及び／又は茎の粉末を含有することを特徴とする。本明細書では、「葉及び／又は茎」を総称して茎葉とよぶ場合がある。本発明の整腸剤は、麦類の茎葉の粉末を含有すればよく、これらに加えて麦類の根などの他の部位の粉末を含有してもよい。
The present invention will be described in detail below.
The intestinal regulation agent of the present invention is characterized by containing powder of wheat leaves, wheat stems, or both, i.e., powder of wheat leaves and/or wheat stems. In this specification, "leaves and/or stems" may be collectively referred to as stems and leaves. The intestinal regulation agent of the present invention may contain powder of wheat stems and leaves, and may also contain powder of other parts of wheat such as wheat roots.
麦類は通常知られているとおりのものであれば特に限定されず、例えば、大麦、小麦、えん麦、らい麦などが挙げられ、これらの１種又は２種以上の組み合わせであり得る。麦類として好ましいのは大麦である。以下では、麦類について大麦を例にとって説明する場合があるが、本発明の整腸剤の有効成分として用いられる麦類は大麦に限定されるものではない。 The wheat or barley is not particularly limited as long as it is a commonly known type, and examples thereof include barley, wheat, oats, and rye, and may be one or a combination of two or more of these. Barley is preferred as the wheat or barley. In the following, barley may be used as an example to explain wheat or barley, but the wheat or barley used as an active ingredient in the intestinal regulator of the present invention is not limited to barley.
大麦（Ｈｏｒｄｅｕｍ ｖｕｌｇａｒｅ Ｌ．）は中央アジア原産とされ、イネ科に属する一年生又は越年生草本であり、穂形により、二条大麦や六条大麦などに大別される。また、品種も様々あり、二条大麦の例として、ニシノホシ、はるか二条、ニシノチカラ、はるしずくなどが挙げられ、六条大麦の例として倍取、シュンライ、サヌキハダカ、ダイシモチ、イチバンボシ、ファイバースノウ、シルキースノウ、はがねむぎ、カシマゴール、赤神力（登録商標）、ミノリムギ、マサカドムギ、すすかぜ、カシマムギなどが挙げられる。本発明に用いられる大麦は特に限定されず、上記した品種、野生種、交雑種などのいずれであってもよい。 Barley ( Hordeum vulgare L. ) is said to be native to Central Asia, and is an annual or biennial herb belonging to the family Poaceae. It is roughly classified into two-row barley, six-row barley, etc., depending on the shape of the ear. There are also various varieties, and examples of two-row barley include Nishinohoshi, Haruka Nijo, Nishinochikara, and Harushizuku, and examples of six-row barley include Doubletori, Shunrai, Sanukihadaka, Daishimochi, Ichibanboshi, Fiber Snow, Silky Snow, Haganemugi, Kashimagoal, Akashinriki (registered trademark), Minorimugi, Masakadomugi, Susukaze, and Kashimamugi. The barley used in the present invention is not particularly limited, and may be any of the above varieties, wild species, hybrids, etc.
麦類の茎葉はいずれの収穫時期に収穫されたものであってもよく、特に限定されないが、例えば、麦類が大麦である場合、成熟期前、すなわち、分けつ開始期から出穂開始前期に収穫されたものであることが好ましい。具体的には、品種の違いによっても異なるが、一般に、背丈が１０ｃｍ以上、好ましくは１０～９０ｃｍ程度、特に好ましくは２０～８０ｃｍ程度、とりわけ３０～７０ｃｍ程度である大麦から、茎葉を収穫することが好ましいが、これらに限定されるものではない。 The stems and leaves of wheat and barley may be harvested at any harvest time, and are not particularly limited, but for example, when the wheat and barley is barley, it is preferable that they are harvested before maturity, that is, from the time when tillers begin to form until before the ear begins to emerge. Specifically, although this differs depending on the variety, it is generally preferable to harvest the stems and leaves from barley that is 10 cm or more tall, preferably about 10 to 90 cm, particularly preferably about 20 to 80 cm, and especially about 30 to 70 cm, but this is not limited to these.
麦類の茎葉は、収穫後、直ちに粉末化することが好ましい。粉末化までに時間を要する場合、麦類の茎葉の変質を防ぐために低温貯蔵などの当業者が通常用いる貯蔵手段により貯蔵することが好ましい。 It is preferable to powder the barley and wheat stems and leaves immediately after harvesting. If it takes time to powder them, it is preferable to store them by a storage method commonly used by those skilled in the art, such as low-temperature storage, to prevent deterioration of the barley and wheat stems and leaves.
麦類の茎葉は、粉末化するに際して、粉砕処理に加えて、各種の処理に供してもよい。そのような処理として、例えば、乾燥処理、ブランチング処理、殺菌処理、細片処理、搾汁処理、抽出処理などが挙げられるが、これらに限定されない。本発明の整腸剤で用いられる麦類の茎葉の粉末としては、麦類の茎葉の乾燥粉末、麦類の茎葉の細片化物の乾燥粉末、麦類の茎葉の搾汁の乾燥粉末、麦類の茎葉の抽出物の乾燥粉末などが挙げられる。なお、本発明において、粉末とは、必要に応じて賦形剤などを添加し顆粒化又は錠剤化したものを含むものとする。 When powdering the stems and leaves of wheat and barley, in addition to the grinding process, various other processes may be performed. Examples of such processes include, but are not limited to, drying, blanching, sterilization, shredding, squeezing, and extraction. Examples of powder of stems and leaves of wheat and barley used in the intestinal regulator of the present invention include dried powder of stems and leaves of wheat and barley, dried powder of shredded stems and leaves of wheat and barley, dried powder of squeezed juice of stems and leaves of wheat and barley, and dried powder of extract of stems and leaves of wheat and barley. In the present invention, powder includes granulated or tableted products to which excipients are added as necessary.
例えば、乾燥処理及び粉砕処理を組み合わせることにより、麦類の茎葉を乾燥粉末化することができる。乾燥処理及び粉砕処理は同時に行ってもよく、又はいずれを先に行ってもよいが、乾燥処理を先に行った後に粉砕処理を行うことが好ましい。麦類の茎葉を乾燥粉末化するに際して、さらに必要に応じて、ブランチング処理、殺菌処理などの処理から選ばれる１種又は２種以上の処理を組み合わせて行ってもよい。また、粉砕処理を行う回数は特に限定されず、粗粉砕処理を行った後に、より細かく粉砕する微粉砕処理を行うなどのように、１回又は２回以上の処理として実施してもよい。 For example, the barley and wheat stems and leaves can be dried and powdered by combining a drying process and a grinding process. The drying process and the grinding process may be performed simultaneously, or either may be performed first, but it is preferable to perform the drying process first and then the grinding process. When dry-powdering the barley and wheat stems and leaves, one or more treatments selected from a blanching process, a sterilization process, and the like may be further performed in combination as necessary. The number of times the grinding process is performed is not particularly limited, and the process may be performed once or twice or more times, such as performing a coarse grinding process followed by a fine grinding process to grind the barley and wheat stems and leaves more finely.
ブランチング処理は麦類の茎葉の緑色を鮮やかに保つための処理であり、ブランチング処理の方法としては、熱水処理や蒸煮処理などが挙げられる。 Blanching is a process to keep the stems and leaves of wheat and other grains bright green, and methods for blanching include hot water treatment and steaming.
熱水処理としては、例えば、７０～１００℃、好ましくは８０～１００℃の熱水又は水蒸気中で、麦類の茎葉を６０～２４０秒間、好ましくは９０～１８０秒間処理する方法などが挙げられる。また、熱水処理に際して、炭酸マグネシウムなどの炭酸塩や炭酸水素ナトリウムなどの炭酸水素塩を用いることが好ましく、炭酸水素の塩を熱水に溶解することにより、麦類の茎葉の緑色をより鮮やかにすることができる。 Examples of hot water treatment include a method in which the barley and stalks are treated in hot water or steam at 70 to 100°C, preferably 80 to 100°C, for 60 to 240 seconds, preferably 90 to 180 seconds. In addition, it is preferable to use a carbonate such as magnesium carbonate or a bicarbonate such as sodium bicarbonate during the hot water treatment, and dissolving the bicarbonate in hot water can make the green color of the barley and stalks more vivid.
蒸煮処理としては、常圧又は加圧下において、麦類の茎葉を水蒸気により蒸煮する処理と冷却する処理とを繰り返す間歇的蒸煮処理が好ましい。間歇的蒸煮処理において、水蒸気により蒸煮する処理は、例えば、２０～４０秒間、好ましくは３０秒間行われる。蒸煮処理後の冷却処理は、直ちに行われることが好ましく、その方法は特に限定されないが、冷水への浸漬、冷蔵、冷風による冷却、温風による気化冷却、温風と冷風とを組み合わせた気化冷却などが用いられる。このうち温風と冷風とを組み合わせた気化冷却が好ましい。このような冷却処理は、麦類の茎葉の品温が、好ましくは６０℃以下、より好ましくは５０℃以下、さらに好ましくは４０℃以下となるように行われる。また、ビタミン、ミネラル、葉緑素などの栄養成分に富んだ麦類の茎葉の粉末を製造するためには、間歇的蒸煮処理を２～５回繰り返すことが好ましい。 As the steaming treatment, an intermittent steaming treatment is preferred in which the barley and stalks are repeatedly steamed with steam and cooled under normal or pressurized pressure. In the intermittent steaming treatment, the steaming with steam is carried out for, for example, 20 to 40 seconds, preferably 30 seconds. The cooling treatment after the steaming treatment is preferably carried out immediately, and the method is not particularly limited, but immersion in cold water, refrigeration, cooling with cold air, evaporative cooling with hot air, evaporative cooling combining hot air and cold air, etc. are used. Of these, evaporative cooling combining hot air and cold air is preferred. Such a cooling treatment is carried out so that the product temperature of the barley and stalks is preferably 60°C or less, more preferably 50°C or less, and even more preferably 40°C or less. In order to produce powder of barley and stalks rich in nutritional components such as vitamins, minerals, and chlorophyll, it is preferable to repeat the intermittent steaming treatment 2 to 5 times.
殺菌処理は当業者に通常知られている殺菌処理であれば特に限定されないが、例えば、温度、圧力、電磁波、薬剤などを用いて物理的又は化学的に微生物を殺滅させる処理であるということができる。 The sterilization process is not particularly limited as long as it is a sterilization process generally known to those skilled in the art, but it can be said to be a process that physically or chemically kills microorganisms using, for example, temperature, pressure, electromagnetic waves, chemicals, etc.
乾燥処理及び粉砕処理に追加してブランチング処理を行う場合、ブランチング処理は乾燥処理の前に行われることが好ましい。また、乾燥処理及び粉砕処理に追加して殺菌処理を行う場合、殺菌処理は、乾燥処理の後か、粉砕処理の前又は後に行われることが好ましい。 When blanching is performed in addition to drying and grinding, it is preferable that the blanching is performed before the drying. Also, when sterilization is performed in addition to drying and grinding, it is preferable that the sterilization is performed after the drying, or before or after the grinding.
乾燥処理は特に限定されないが、例えば、麦類の茎葉の水分含量が１０ｗｔ％以下、好ましくは５ｗｔ％以下となるように乾燥する処理が挙げられる。乾燥処理は、例えば、熱風乾燥、高圧蒸気乾燥、電磁波乾燥、凍結乾燥などの当業者に公知の任意の方法により行われ得る。加熱による乾燥は、例えば、４０℃～１４０℃、好ましくは８０～１３０℃にて加温により麦類の茎葉が変色しない温度及び時間で行われ得る。 The drying process is not particularly limited, but examples include a process of drying the barley and wheat stems and leaves so that their moisture content is 10 wt% or less, preferably 5 wt% or less. The drying process can be carried out by any method known to those skilled in the art, such as hot air drying, high-pressure steam drying, electromagnetic wave drying, and freeze drying. Drying by heating can be carried out at a temperature and time such that the barley and wheat stems and leaves do not discolor due to heating, for example, at 40°C to 140°C, preferably 80°C to 130°C.
粉砕処理は特に限定されないが、例えば、当業者が通常使用する任意の方法により植物体を粉砕する処理が挙げられる。麦類の茎葉の粉末は、必要に応じて篩にかけてもよく、例えば、１００～１５０メッシュを通過するものを麦類の茎葉の粉末として用いることができる。粉砕処理に際して、粒度の均一化、粉砕時間の短縮など、粉砕効率を上げる観点から、粗粉砕及び微粉砕を組み合わせて行うことが好ましい。 The grinding process is not particularly limited, but examples include grinding the plant body by any method commonly used by those skilled in the art. The powder of barley and wheat stems and leaves may be sieved as necessary, and for example, sieves passing through a 100 to 150 mesh can be used as the powder of barley and wheat stems and leaves. In terms of increasing the grinding efficiency, such as achieving uniform particle size and shortening the grinding time, it is preferable to combine coarse grinding and fine grinding during the grinding process.
粉砕処理において、粗粉砕工程では、麦類の茎葉をカッター、スライサー、ダイサーなどの当業者が通常用いる任意の粗粉砕用の機器又は器具を用いて、例えば、麦類の茎葉の長径が約２０ｍｍ以下、好ましくは約０．１～１０ｍｍとなるように破砕する。微粉砕工程では、クラッシャー、ミル、ブレンダー、石臼などの当業者が通常用いる任意の微粉採用の機器や器具を用いて、９０ｗｔ％以上が２００メッシュ区分を通過するように麦類の茎葉を微粉砕することが好ましい。 In the coarse grinding process, the wheat and barley stems and leaves are crushed using any equipment or tool for coarse grinding commonly used by those skilled in the art, such as a cutter, slicer, or dicer, so that the major axis of the wheat and barley stems and leaves is, for example, about 20 mm or less, preferably about 0.1 to 10 mm. In the fine grinding process, the wheat and barley stems and leaves are preferably finely ground using any equipment or tool for fine powder commonly used by those skilled in the art, such as a crusher, mill, blender, or stone mill, so that 90 wt% or more pass through a 200 mesh section.
麦類の茎葉を乾燥粉末化する方法としては、当業者が通常用いる方法により乾燥粉末化すればよく、従来公知の方法を用いてもよい。例えば、麦類の茎葉を切断した後、ブランチング処理を行い、次いで乾燥及び粉砕する方法（特開２００４－０００２１０号公報を参照）、麦類の茎葉を切断した後、ブランチング処理を行い、次いで揉捻し、その後、乾燥し、粉砕する方法（特開２００２－０６５２０４号公報を参照）、麦類の茎葉を乾燥し、粗粉砕した後、１１０℃以上で加熱し、更に微粉砕する方法（特開２００３－０３３１５１号公報を参照）などが挙げられる。 The method for drying and powdering the barley and wheat stems and leaves may be a method commonly used by those skilled in the art, and may be a conventionally known method. For example, there may be mentioned a method in which the barley and wheat stems and leaves are cut, then blanched, then dried and pulverized (see JP 2004-000210 A), a method in which the barley and wheat stems and leaves are cut, then blanched, then rolled, then dried and pulverized (see JP 2002-065204 A), a method in which the barley and wheat stems and leaves are dried, coarsely pulverized, heated at 110°C or higher, and further finely pulverized (see JP 2003-033151 A), etc.
麦類の茎葉を細片化する方法としては、当業者が通常用いる方法により細片化すればよく、従来公知の方法を用いてもよい。例えば、植物体をスライス、細断などにより細片化する方法が挙げられる。細片化の一例として、スラリー化してもよい。スラリー化は、麦類の茎葉をミキサー、ジューサー、ブレンダー、マスコロイダーなどにかけ、麦類の茎葉をどろどろした粥状（液体と固体の懸濁液）にする方法により行ってもよい。 The method for shredding the barley and wheat stems and leaves may be a method commonly used by those skilled in the art, and any conventionally known method may be used. For example, the plant body may be shredded by slicing or chopping. One example of shredding is slurrying. Slurrying may be performed by putting the barley and wheat stems and leaves in a mixer, juicer, blender, mass colloider, or the like to make the barley and wheat stems and leaves into a mushy gruel-like mixture (a suspension of liquid and solids).
麦類の茎葉の細片化物を乾燥する方法としては、当業者が通常用いる方法により乾燥すればよく、従来公知の方法を用いてもよい。例えば、天日で乾燥する方法、乾燥機を用いて噴霧乾燥、凍結乾燥、減圧乾燥、流動乾燥などにより乾燥する方法などが挙げられる。 The method for drying the shredded barley and wheat stems and leaves may be a method commonly used by those skilled in the art, and may be a conventionally known method. Examples of the method include drying in the sun, and drying using a dryer by spray drying, freeze drying, vacuum drying, fluidized drying, etc.
麦類の茎葉を搾汁する方法としては、当業者が通常用いる方法により搾汁すればよく、従来公知の方法を用いてもよい。例えば、麦類の茎葉又はその細片化物を圧搾する方法、麦類の茎葉の細片化物を遠心又はろ過する方法などが挙げられる。なお、搾汁物は必要に応じて濃縮してもよい。また、麦類の茎葉から搾汁処理を行った後に残る搾汁残渣を乾燥したものを麦類の茎葉の粉末として用いてもよい。 The method for squeezing the barley and wheat stems and leaves may be a method commonly used by those skilled in the art, and may be a conventionally known method. For example, a method of squeezing barley and wheat stems and leaves or shredded barley and wheat stems and leaves, a method of centrifuging or filtering shredded barley and wheat stems and leaves, etc. The squeezed juice may be concentrated as necessary. In addition, the squeezed residue remaining after squeezing the barley and wheat stems and leaves may be dried and used as barley and wheat stem and leaf powder.
麦類の茎葉の搾汁物を乾燥粉末化する方法としては、当業者が通常用いる方法により搾汁物を乾燥粉末化すればよく、従来公知の方法を用いてもよい。例えば、搾汁物をそのまま乾燥して粉末化してもよく、搾汁物に適切な結合剤や賦形剤などを添加してから乾燥して粉末化してもよい。また、搾汁物又は搾汁物の乾燥粉末に必要に応じて賦形剤などを添加して、公知の湿式、乾式などの顆粒造粒法によって顆粒に成形して粉末化してもよい。 The method for drying and powdering the squeezed juice of barley and wheat stems and leaves may be a method commonly used by those skilled in the art, and may be a conventionally known method. For example, the squeezed juice may be dried and powdered as is, or an appropriate binder, excipient, etc. may be added to the squeezed juice and then dried and powdered. Alternatively, an excipient, etc. may be added to the squeezed juice or dried powder of the squeezed juice as necessary, and the mixture may be formed into granules by a known wet or dry granulation method, and then powdered.
麦類の茎葉を抽出する方法としては、当業者が通常用いる方法により抽出すればよく、従来公知の方法を用いてもよい。例えば、麦類の茎葉又はその細片化物に、エタノール、水、含水エタノールなどの当業者が通常用いる抽出溶媒を加え、必要に応じて加温して抽出する方法などが挙げられる。なお、抽出物は必要に応じて濃縮してもよい。また、特定成分の濃度を高めるため、当業者が通常用いる方法により抽出物を分画してもよく、当業者が通常用いる方法により特定成分を精製してもよい。また、麦類の茎葉から抽出処理を行った後に残る抽出残渣を乾燥したものを麦類の茎葉の粉末として用いてもよい。 The method for extracting barley and wheat stems and leaves may be a method commonly used by those skilled in the art, and may be a conventionally known method. For example, an extraction solvent commonly used by those skilled in the art, such as ethanol, water, or aqueous ethanol, may be added to barley and wheat stems and leaves or shredded barley and wheat stems and leaves, and the extraction may be performed by heating as necessary. The extract may be concentrated as necessary. In order to increase the concentration of a specific component, the extract may be fractionated by a method commonly used by those skilled in the art, or the specific component may be purified by a method commonly used by those skilled in the art. The extraction residue remaining after the extraction process from barley and wheat stems and leaves may be dried and used as barley and wheat stem and leaf powder.
麦類の茎葉の抽出物を乾燥粉末化する方法としては、当業者が通常用いる方法により抽出物を乾燥粉末化すればよく、従来公知の方法を用いてもよい。例えば、抽出物を乾燥して粉末化してもよく、抽出物に適切な結合剤や賦形剤などを添加してから乾燥して粉末化してもよい。また、抽出物又は抽出物の乾燥粉末に必要に応じて賦形剤などを添加して、公知の湿式、乾式などの顆粒造粒法によって顆粒に成形して粉末化してもよい。 The method for drying and powdering the extract of barley and wheat stems and leaves may be a method commonly used by those skilled in the art, and may be a conventionally known method. For example, the extract may be dried and powdered, or an appropriate binder, excipient, etc. may be added to the extract and then dried and powdered. Alternatively, excipients, etc. may be added to the extract or dried powder of the extract as necessary, and the extract may be formed into granules by a known wet or dry granulation method, and then powdered.
本発明の整腸剤は、上記した麦類の茎葉の粉末を含有するものである。ただし、該麦類の茎葉の粉末は、比較的粒度が小さいものであり、そのことによって、本発明の整腸剤は、腸管免疫賦活化作用及び腸内環境改善作用を含む整腸作用を有することができる。 The intestinal regulator of the present invention contains the above-mentioned powder of barley and wheat stems and leaves. However, the powder of barley and wheat stems and leaves has a relatively small particle size, which allows the intestinal regulator of the present invention to have an intestinal regulating effect, including an intestinal immunity activating effect and an intestinal environment improving effect.
麦類の茎葉の粉末は、比較的粒度が小さいものとして、次の三つの態様に分けることができる：
（１）平均粒子径が２５μｍ以下である粉末；
（２）粒子径２０μｍ以下の累積頻度が２５体積％以上である累積粒度分布、粒子径３０μｍ以下の累積頻度が３７体積％以上である累積粒度分布、粒子径４０μｍ以下の累積頻度が４８体積％以上である累積粒度分布及び粒子径５０μｍ以下の累積頻度が６０体積％以上である累積粒度分布からなる群から選ばれる少なくとも１種の体積基準の累積粒度分布を有する粉末；及び／又は、
（３）１０体積％粒子径が８μｍ以下である累積粒度分布、５０体積％粒子径が４１μｍ以下である累積粒度分布及び９０体積％粒子径が８７μｍ以下である累積粒度分布からなる群から選ばれる少なくとも１種の体積基準の累積粒度分布を有する粉末。
The powder of wheat and barley stems and leaves has a relatively small particle size and can be divided into the following three types:
(1) A powder having an average particle size of 25 μm or less;
(2) A powder having at least one volume-based cumulative particle size distribution selected from the group consisting of a cumulative particle size distribution in which the cumulative frequency of particle diameters of 20 μm or less is 25% by volume or more, a cumulative particle size distribution in which the cumulative frequency of particle diameters of 30 μm or less is 37% by volume or more, a cumulative particle size distribution in which the cumulative frequency of particle diameters of 40 μm or less is 48% by volume or more, and a cumulative particle size distribution in which the cumulative frequency of particle diameters of 50 μm or less is 60% by volume or more; and/or
(3) A powder having at least one volume-based cumulative particle size distribution selected from the group consisting of a cumulative particle size distribution in which the 10 volume% particle size is 8 μm or less, a cumulative particle size distribution in which the 50 volume% particle size is 41 μm or less, and a cumulative particle size distribution in which the 90 volume% particle size is 87 μm or less.
麦類の茎葉の粉末は、上記した三つの態様のうちいずれか一つの態様に該当するものであればよいが、二つの態様を兼ね備えたものであってもよく、三つの態様全てを兼ね備えたものであってもよい。 The powder of barley and wheat stems and leaves may be any one of the three aspects described above, but may also be two or all three aspects.
麦類の茎葉の粉末は、平均粒子径が２５μｍ以下であることが好ましい。後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末の平均粒子径は、１８．０μｍ以下がより好ましく、１４．０μｍ以下がさらに好ましい。麦類の茎葉の粉末の平均粒子径の下限は特に限定されないが、例えば、１．０μ以上であり、好ましくは５．０μｍ以上であり、より好ましくは１０．０μｍ以上である。 The average particle size of the powder of barley and wheat stems and leaves is preferably 25 μm or less. In view of the description of the Examples and Production Examples described later, in order to obtain a smaller particle size, the average particle size of the powder of barley and wheat stems and leaves is more preferably 18.0 μm or less, and even more preferably 14.0 μm or less. There is no particular lower limit to the average particle size of the powder of barley and wheat stems and leaves, but it is, for example, 1.0 μm or more, preferably 5.0 μm or more, and more preferably 10.0 μm or more.
麦類の茎葉の粉末は、粒子径２０μｍ以下の累積頻度が２５体積％以上である累積粒度分布、粒子径３０μｍ以下の累積頻度が３７体積％以上である累積粒度分布、粒子径４０μｍ以下の累積頻度が４８体積％以上である累積粒度分布、粒子径５０μｍ以下の累積頻度が６０体積％以上である累積粒度分布又はこれらのいずれか２種、３種若しくは４種の体積基準の累積粒度分布を有することが好ましい。なお、例えば、粒子径２０μｍ以下の累積頻度が２５体積％以上である累積粒度分布を有する粉末とは、全粒子を粒子径の小さいものから大きいものへと並べたときに、粒子径が２０μｍ以下である粒子が全粒子の２５体積％以上を占めている粉末をいう。 The powder of barley and wheat stems and leaves preferably has a cumulative particle size distribution in which the cumulative frequency of particles with a diameter of 20 μm or less is 25% by volume or more, a cumulative particle size distribution in which the cumulative frequency of particles with a diameter of 30 μm or less is 37% by volume or more, a cumulative particle size distribution in which the cumulative frequency of particles with a diameter of 40 μm or less is 48% by volume or more, a cumulative particle size distribution in which the cumulative frequency of particles with a diameter of 50 μm or less is 60% by volume or more, or any two, three or four of these cumulative particle size distributions based on volume. For example, a powder having a cumulative particle size distribution in which the cumulative frequency of particles with a diameter of 20 μm or less is 25% by volume or more of the total particles when all particles are arranged from smallest to largest particle size is a powder in which particles with a diameter of 20 μm or less account for 25% by volume or more of the total particles.
後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末が有する累積粒度分布は、粒子径２０μｍ以下の累積頻度が４４．０体積％以上であることがより好ましく、６０．０体積％以上であることがさらに好ましい。また、麦類の茎葉の粉末が有する累積粒度分布について、粒子径２０μｍ以下の累積頻度の上限は特に限定されないが、例えば、９０．０体積％以下であり、好ましくは８０．０体積％以下であり、より好ましくは７５．０体積％以下である。 In light of the description of the examples and manufacturing examples described below, in order to achieve a smaller particle size, the cumulative particle size distribution of the powder of barley and wheat stems and leaves has a cumulative frequency of 44.0 volume % or more, and even more preferably 60.0 volume % or more, for particle sizes of 20 μm or less. In addition, the upper limit of the cumulative frequency of particle sizes of 20 μm or less for the cumulative particle size distribution of the powder of barley and wheat stems and leaves is not particularly limited, but is, for example, 90.0 volume % or less, preferably 80.0 volume % or less, and more preferably 75.0 volume % or less.
後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末が有する累積粒度分布は、粒子径３０μｍ以下の累積頻度が６０．０体積％以上であることがより好ましく、８０．０体積％以上であることがさらに好ましい。また、麦類の茎葉の粉末が有する累積粒度分布について、粒子径３０μｍ以下の累積頻度の上限は特に限定されないが、例えば、９９．０体積％以下であり、好ましくは９５．０体積％以下であり、より好ましくは９０．０体積％以下である。 In light of the description of the examples and manufacturing examples described below, in order to achieve a smaller particle size, the cumulative particle size distribution of the powder of barley and wheat stems and leaves has a cumulative frequency of 60.0 volume % or more, and even more preferably 80.0 volume % or more, for particle sizes of 30 μm or less. In addition, the upper limit of the cumulative frequency of particle sizes of 30 μm or less for the cumulative particle size distribution of the powder of barley and wheat stems and leaves is not particularly limited, but is, for example, 99.0 volume % or less, preferably 95.0 volume % or less, and more preferably 90.0 volume % or less.
後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末が有する累積粒度分布は、粒子径４０μｍ以下の累積頻度が７２．０体積％以上であることがより好ましく、８８．０体積％以上であることがさらに好ましい。また、麦類の茎葉の粉末が有する累積粒度分布について、粒子径４０μｍ以下の累積頻度の上限は特に限定されないが、例えば、９９．０体積％以下であり、好ましくは９８．０体積％以下であり、より好ましくは９７．０体積％以下である。 In light of the description of the examples and manufacturing examples described below, in order to achieve a smaller particle size, the cumulative particle size distribution of the powder of barley and wheat stems and leaves has a cumulative frequency of 72.0 volume % or more, and even more preferably 88.0 volume % or more, for particle sizes of 40 μm or less. In addition, the upper limit of the cumulative frequency of particle sizes of 40 μm or less for the cumulative particle size distribution of the powder of barley and wheat stems and leaves is not particularly limited, but is, for example, 99.0 volume % or less, preferably 98.0 volume % or less, and more preferably 97.0 volume % or less.
後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末が有する累積粒度分布は、粒子径５０μｍ以下の累積頻度が８２．０体積％以上であることがより好ましく、９３．０体積％以上であることがさらに好ましい。また、麦類の茎葉の粉末が有する累積粒度分布について、粒子径５０μｍ以下の累積頻度の上限は特に限定されないが、例えば、９９．９体積％以下であり、好ましくは９９．５体積％以下であり、より好ましくは９９．２体積％以下である。 In consideration of the description of the examples and manufacturing examples described below, in order to achieve a smaller particle size, the cumulative particle size distribution of the powder of barley and wheat stems and leaves has a cumulative frequency of 82.0 volume % or more, and even more preferably 93.0 volume % or more, for particle sizes of 50 μm or less. In addition, the upper limit of the cumulative frequency of particle sizes of 50 μm or less for the cumulative particle size distribution of the powder of barley and wheat stems and leaves is not particularly limited, but is, for example, 99.9 volume % or less, preferably 99.5 volume % or less, and more preferably 99.2 volume % or less.
麦類の茎葉の粉末は、１０体積％粒子径が８μｍ以下である累積粒度分布、５０体積％粒子径が４１μｍ以下である累積粒度分布、９０体積％粒子径が８７μｍ以下である累積粒度分布又はこれらのいずれか２種若しくは３種の体積基準の累積粒度分布を有することが好ましい。なお、例えば、１０体積％粒子径が８μｍ以下である累積粒度分布を有する粉末とは、全粒子を粒子径が小さいものから大きいものへと並べたときに、全粒子の１０体積％を占める粒子の粒子径が８μｍ以下である粉末をいう。 The powder of barley and wheat stems and leaves preferably has a cumulative particle size distribution in which the 10% by volume particle size is 8 μm or less, a cumulative particle size distribution in which the 50% by volume particle size is 41 μm or less, a cumulative particle size distribution in which the 90% by volume particle size is 87 μm or less, or any two or three of these cumulative particle size distributions based on volume. For example, a powder having a cumulative particle size distribution in which the 10% by volume particle size is 8 μm or less refers to a powder in which, when all particles are arranged from smallest to largest in particle size, the particle size of particles that make up 10% by volume of all particles is 8 μm or less.
後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末が有する累積粒度分布は、１０体積％粒子径が５．０μｍ以下であることがより好ましく、４．０μｍ以下であることがさらに好ましい。また、麦類の茎葉の粉末が有する累積粒度分布について、１０体積％粒子径の下限は特に限定されないが、例えば、１．０μｍ以上であり、好ましくは２．０μｍ以上であり、より好ましくは３．０μｍ以上である。 In light of the description of the examples and production examples described below, in order to achieve a smaller particle size, the cumulative particle size distribution of the powder of barley and wheat stems and leaves is more preferably 10 volume % particle size of 5.0 μm or less, and even more preferably 4.0 μm or less. In addition, the lower limit of the 10 volume % particle size of the cumulative particle size distribution of the powder of barley and wheat stems and leaves is not particularly limited, but is, for example, 1.0 μm or more, preferably 2.0 μm or more, and more preferably 3.0 μm or more.
後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末が有する累積粒度分布は、５０体積％粒子径が２３．０μｍ以下であることがより好ましく、２０．０μｍ以下であることがさらに好ましい。また、麦類の茎葉の粉末が有する累積粒度分布について、５０体積％粒子径の下限は特に限定されないが、例えば、５．０μｍ以上であり、好ましくは８．０μｍ以上であり、より好ましくは１２．０μｍ以上である。なお、５０体積％粒子径は、一般に、メディアン径とよばれる粒子径である。 In view of the description of the examples and manufacturing examples described later, in order to obtain a smaller particle size, the cumulative particle size distribution of the powder of barley and wheat stems and leaves is more preferably such that the 50 volume % particle size is 23.0 μm or less, and even more preferably 20.0 μm or less. In addition, the lower limit of the 50 volume % particle size of the cumulative particle size distribution of the powder of barley and wheat stems and leaves is not particularly limited, but is, for example, 5.0 μm or more, preferably 8.0 μm or more, and more preferably 12.0 μm or more. The 50 volume % particle size is generally the particle size called the median size.
後述する実施例及び製造例の記載を鑑みて、粒度がより小さいものとするために、麦類の茎葉の粉末が有する累積粒度分布は、９０体積％粒子径が６２．０μｍ以下であることがより好ましく、５０．０μｍ以下であることがさらに好ましい。また、麦類の茎葉の粉末が有する累積粒度分布について、９０体積％粒子径の下限は特に限定されないが、例えば、１０．０μｍ以上であり、好ましくは２０．０μｍ以上であり、より好ましくは２５．０μｍ以上である。 In light of the description of the Examples and Production Examples described below, in order to achieve a smaller particle size, the cumulative particle size distribution of the powder of barley and wheat stems and leaves is more preferably 62.0 μm or less, and even more preferably 50.0 μm or less, in terms of the 90 volume% particle size. In addition, the lower limit of the cumulative particle size distribution of the powder of barley and wheat stems and leaves is not particularly limited, but is, for example, 10.0 μm or more, preferably 20.0 μm or more, and more preferably 25.0 μm or more.
麦類の茎葉の粉末の平均粒子径や累積粒度分布などの粒度の測定は、例えば、レーザー回析散乱光式粒度分布測定装置、具体的には株式会社セイシン企業製のＬＭＳ－３００やＬＭＳ－３０００を用いて測定することができる。 The particle size of wheat stem and leaf powder, such as the average particle size and cumulative particle size distribution, can be measured using, for example, a laser diffraction/scattered light type particle size distribution measuring device, specifically the LMS-300 or LMS-3000 manufactured by Seishin Enterprise Co., Ltd.
麦類の茎葉の粉末は、他にもその安息角や嵩密度で特定することができる。麦類の茎葉の粉末の安息角は特に限定されないが、５０．５°以上であることが好ましく、５１．０°以上であることがより好ましい。また、麦類の茎葉の粉末の嵩密度（ゆるめ）は特に限定されないが、例えば、０．２２０ｇ／ｃｍ３以下であることが好ましく、０．２１０ｇ／ｃｍ３以下であることがより好ましく、０．１７０～０．２１０ｇ／ｃｍ３であることがさらに好ましい。なお、安息角及び嵩密度の測定方法は、後述する実施例の記載を参照して実施できる。 The powder of barley and wheat stems and leaves can also be specified by its angle of repose and bulk density. The angle of repose of the powder of barley and wheat stems and leaves is not particularly limited, but is preferably 50.5° or more, and more preferably 51.0° or more. The bulk density (loose) of the powder of barley and wheat stems and leaves is not particularly limited, but is preferably 0.220 g/cm 3 or less, more preferably 0.210 g/cm 3 or less, and even more preferably 0.170 to 0.210 g/cm 3. The method of measuring the angle of repose and bulk density can be carried out by referring to the description of the examples described below.
麦類の茎葉の粉末のうち麦類の茎葉の乾燥粉末は、例えば、乾燥した麦類の茎葉を、２０．０～５０．０ｋｇ／ｈｒの割合でジェットミルに供給し、ジェットミルの吐出圧力を０．６０～０．８９ＭＰａ、好ましくは０．６５～０．８５Ｍｐａとして粉砕処理に供することにより製造できる。 Among the powders of wheat and barley stems and leaves, the dried powder of wheat and barley stems and leaves can be produced, for example, by supplying dried wheat and barley stems and leaves to a jet mill at a rate of 20.0 to 50.0 kg/hr and subjecting them to a grinding process at a jet mill discharge pressure of 0.60 to 0.89 MPa, preferably 0.65 to 0.85 MPa.
本発明の整腸剤に用いられる麦類の茎葉の粉末は、優れた整腸作用を有する。本発明の技術的範囲はいかなる推論にも拘泥されるわけではないが、例えば、麦類の茎葉の粉末を摂取することにより、総糞便量（乾燥糞便量）が増大し、さらに糞便中の水分含量が増加して排便に適した便を形成するという保水効果によって湿糞便量が増大し、***がスムーズになるという便通改善作用が得られ得る。実際に、後述する実施例に記載があるとおり、本発明の整腸剤を服用することにより、湿糞便量が増大する。 The powder of barley and wheat stems and leaves used in the intestinal regulator of the present invention has an excellent intestinal regulator effect. Although the technical scope of the present invention is not limited to any speculation, for example, by ingesting powder of barley and wheat stems and leaves, the total fecal volume (dry fecal volume) increases, and furthermore, the water content in the feces increases, forming stool suitable for defecation, which has a water-retaining effect, thereby increasing the amount of wet feces and making excretion smoother, thereby improving bowel movements. In fact, as described in the examples below, by taking the intestinal regulator of the present invention, the amount of wet feces increases.
また、便通改善により、便秘による腸内悪玉細菌の増殖を抑制し、腸内環境が正常に維持及び改善され得る。腸内環境が改善されれば、腸内の有用細菌の働きにより、腸の動きの活性化がなされ、便通が改善されるようになるという腸内環境改善作用が得られ得る。実際に、後述する実施例に記載があるとおり、本発明の整腸剤を服用することにより、腸内の有用細菌であるＬａｃｔｏｂａｃｉｌｌｕｓ属、Ｐｒｅｖｏｔｅｌｌａ属及びＣｌｏｓｔｏｒｉｄｉｕｍ ｃｌｕｓｔｅｒ ＸＩＶａの細菌数を増加することができる。 In addition, by improving bowel movements, the proliferation of bad intestinal bacteria caused by constipation can be suppressed, and the intestinal environment can be maintained and improved to a normal state. If the intestinal environment is improved, the beneficial bacteria in the intestine can activate intestinal movement, improving bowel movements, thereby improving the intestinal environment. In fact, as described in the Examples below, taking the intestinal regulator of the present invention can increase the number of beneficial intestinal bacteria, such as the genera Lactobacillus, Prevotella, and Clostoridium cluster XIVa.
さらに、腸管には多くの免疫細胞が存在し、異物の排除や無毒化といった腸管免疫が働いているところ、本発明の整腸剤を服用することにより、腸管免疫を賦活化して、細菌やウイルスから感染を防ぐ作用があるＩｇＡ量が増えるという腸管免疫賦活化作用が得られ得る。 Furthermore, the intestinal tract contains many immune cells, and intestinal immunity is active in eliminating and detoxifying foreign substances. By taking the intestinal regulator of the present invention, the intestinal immunity is activated, and the amount of IgA, which has the effect of preventing infection from bacteria and viruses, is increased, resulting in an intestinal immunity activation effect.
このように、本発明の整腸剤を摂取すると、便通改善作用及び腸内環境改善作用が相互作用的に発揮され、さらに腸管免疫賦活化作用さえ得られることから、結果として整腸作用が達成できる。また、保水効果やスムーズな***は、例えば、痔の防止などとしても有効である。 In this way, when the intestinal regulator of the present invention is ingested, the bowel movement improving effect and the intestinal environment improving effect are exerted in an interactive manner, and furthermore, the intestinal immunity activating effect is obtained, so that the intestinal regulation effect is achieved as a result. In addition, the water retention effect and smooth excretion are also effective in preventing hemorrhoids, for example.
本発明の整腸剤が有する整腸作用は、例えば、後述する実施例に記載があるとおり、湿糞便量、糞中ＩｇＡ量並びに糞中のＬａｃｔｂａｃｉｌｌｕｓ属、Ｐｒｅｖｏｔｅｌｌａ属、Ｃｌｏｓｔｏｒｉｄｉｕｍ ｃｌｕｓｔｅｒ ＸＩＶａなどの細菌数によって評価できる。すなわち、本発明の整腸剤が示す整腸作用は、例えば、本発明の整腸剤の投与群の湿糞便量が本発明の整腸剤の非投与群に対して、湿糞便量が２．２倍、好ましくは２．３倍になり；糞中ＩｇＡ量が３．４倍、好ましくは３．８倍になり；糞中のＬａｃｔｂａｃｉｌｌｕｓ属の細菌数が２．５倍、好ましくは２．８倍になり；糞中のＰｒｅｖｏｔｅｌｌａ属の細菌数が６，０００倍、好ましくは７，０００倍になり；及び／又は、糞中のＣｌｏｓｔｏｒｉｄｉｕｍ ｃｌｕｓｔｅｒ ＸＩＶａの細菌数が２．２倍、好ましくは２．３倍になる整腸作用である。 The intestinal regulating effect of the intestinal regulator of the present invention can be evaluated, for example, by the amount of wet stool, the amount of IgA in the stool, and the number of bacteria such as Lactobacillus spp., Prevotella spp., and Clostoridium cluster XIVa in the stool, as described in the Examples below. That is, the intestinal regulating effect exhibited by the intestinal regulating agent of the present invention is, for example, an intestinal regulating effect in which the wet fecal mass of the group administered with the intestinal regulating agent of the present invention is 2.2 times, preferably 2.3 times, greater than that of the group not administered with the intestinal regulating agent of the present invention; the amount of IgA in the feces is 3.4 times, preferably 3.8 times, greater; the number of bacteria of the genus Lactobacillus in the feces is 2.5 times, preferably 2.8 times, greater; the number of bacteria of the genus Prevotella in the feces is 6,000 times, preferably 7,000 times, greater; and/or the number of Clostoridium cluster XIVa bacteria in the feces is 2.2 times, preferably 2.3 times, greater.
本発明の整腸剤は、便通改善作用、腸内環境改善作用及び腸管免疫賦活化作用を有することから、このようなお腹（胃腸）の調子を整える整腸作用を得ることを目的とした種々の形態で利用され得る。本発明の整腸剤は、例えば、特別な処理を加えることなく種々の目的に利用されてもよい。例えば、医薬品、医薬部外品などとして、又はこれらに配合して利用される。 The intestinal regulator of the present invention has the effects of improving bowel movements, improving the intestinal environment, and activating intestinal immunity, and therefore can be used in various forms aimed at obtaining such an intestinal regulator effect that regulates the stomach (gastrointestinal condition). The intestinal regulator of the present invention may be used for various purposes, for example, without any special processing. For example, it can be used as a medicine, quasi-drug, etc., or in combination with these.
本発明の整腸剤において、麦類の茎葉の粉末の含有量は、本発明の課題を解決し得る限り特に限定されないが、例えば、整腸剤全体の乾燥質量換算で、下限値としては、０．１質量％以上が好ましく、０．５質量％以上がより好ましく、１質量％以上がさらに好ましく、１０質量％以上がなおさらに好ましく、２０質量％以上が特に好ましい。上限値としては、１００質量％であってもよいが、例えば、９９．９質量％以下、９０質量％以下、８０質量％以下であってもよい。麦類の茎葉の粉末の含有量が０．１質量％より少ない場合、整腸作用が十分に発揮されない場合がある。 In the intestinal regulator of the present invention, the content of powder of barley and wheat stems and leaves is not particularly limited as long as the problem of the present invention can be solved, but for example, the lower limit, calculated as the dry mass of the entire intestinal regulator, is preferably 0.1% by mass or more, more preferably 0.5% by mass or more, even more preferably 1% by mass or more, even more preferably 10% by mass or more, and particularly preferably 20% by mass or more. The upper limit may be 100% by mass, but may also be, for example, 99.9% by mass or less, 90% by mass or less, or 80% by mass or less. If the content of powder of barley and wheat stems and leaves is less than 0.1% by mass, the intestinal regulating effect may not be fully exerted.
本発明の整腸剤の１日の使用量は特に限定されず、使用態様や使用者の使用内容や腸内環境などに応じて適宜設定され得るが、例えば、整腸剤に対する麦類の茎葉の粉末の質量換算で、使用者の体重を基準として、１～６０００ｍｇ／ｋｇであり、好ましくは１～４０００ｍｇ／ｋｇであり、より好ましくは１０～３０００ｍｇ／ｋｇであり、さらに好ましくは１０～２０００ｍｇ／ｋｇである。本発明の整腸剤の１回の使用量についても同様に特に限定されず、例えば、整腸剤に対する麦類の茎葉の粉末の質量換算で、使用者の体重を基準として、０．５～３０００ｍｇ／ｋｇであり、好ましくは１～２０００ｍｇ／ｋｇであり、より好ましくは５～１０００ｍｇ／ｋｇである。 The daily usage amount of the intestinal regulator of the present invention is not particularly limited and can be set appropriately depending on the usage mode, the usage content of the user, the intestinal environment, etc., but for example, the mass conversion of the powder of barley and wheat stems and leaves to the intestinal regulator based on the user's body weight is 1 to 6000 mg/kg, preferably 1 to 4000 mg/kg, more preferably 10 to 3000 mg/kg, and even more preferably 10 to 2000 mg/kg. The single usage amount of the intestinal regulator of the present invention is also not particularly limited, and for example, the mass conversion of the powder of barley and wheat stems and leaves to the intestinal regulator based on the user's body weight is 0.5 to 3000 mg/kg, preferably 1 to 2000 mg/kg, and more preferably 5 to 1000 mg/kg.
また、本発明の整腸剤の１日の使用量は、例えば、整腸剤に対する麦類の茎葉の粉末の質量換算で、０．０１～１００ｇ、好ましくは０．０５～７０ｇ、より好ましくは０．５～５０ｇ、さらに好ましくは１～３０ｇとすることができる。同様に、本発明の整腸剤の１回の使用量は、例えば、整腸剤に対する麦類の茎葉の粉末の質量換算で、０．０１～３０ｇ、好ましくは０．０５～２０ｇ、より好ましくは０．１～１０ｇ、さらに好ましくは０．３～７ｇとすることができる。 The daily dosage of the intestinal regulator of the present invention can be, for example, 0.01 to 100 g, preferably 0.05 to 70 g, more preferably 0.5 to 50 g, and even more preferably 1 to 30 g, calculated as the mass of the powder of barley and wheat stems and leaves relative to the intestinal regulator. Similarly, the single dosage of the intestinal regulator of the present invention can be, for example, 0.01 to 30 g, preferably 0.05 to 20 g, more preferably 0.1 to 10 g, and even more preferably 0.3 to 7 g, calculated as the mass of the powder of barley and wheat stems and leaves relative to the intestinal regulator.
本発明の整腸剤は、整腸作用を得ることを目的とした種々の形態で利用され得る。本発明の整腸剤は、例えば、経口用又は非経口用の整腸剤とすることができる。 The intestinal regulator of the present invention can be used in various forms for the purpose of obtaining an intestinal regulating effect. The intestinal regulator of the present invention can be, for example, an oral or parenteral intestinal regulator.
本発明の整腸剤の形態は特に限定されず、任意の形態とすることができる。経口用の整腸剤の形態としては、例えば、経口的な使用に適した形態、具体的には、粉末状、粒状、顆粒状、錠状、棒状、板状、ブロック状、固形状、丸状、液状、飴状、ペースト状、クリーム状、ハードカプセルやソフトカプセルのようなカプセル状、カプレット状、ゲル状、チュアブル状、シロップ状などの各形態が挙げられる。 The form of the intestinal regulator of the present invention is not particularly limited and can be any form. Examples of the form of the oral intestinal regulator include forms suitable for oral use, specifically, powder, granules, tablets, rods, plates, blocks, solids, rounds, liquids, candies, pastes, creams, capsules such as hard capsules and soft capsules, caplets, gels, chewable tablets, syrups, etc.
本発明の整腸剤の包装形態は特に限定されず、剤形などに応じて適宜選択できるが、例えば、ＰＴＰなどのブリスターパック；ストリップ包装；ヒートシール；アルミパウチ；プラスチックや合成樹脂などを用いるフィルム包装；バイアルなどのガラス容器；アンプルなどのプラスチック容器などが挙げられる。 The packaging form of the intestinal regulator of the present invention is not particularly limited and can be appropriately selected depending on the dosage form, etc., but examples include blister packs such as PTPs; strip packaging; heat seals; aluminum pouches; film packaging using plastics, synthetic resins, etc.; glass containers such as vials; and plastic containers such as ampoules.
本発明の整腸剤は、粉末状であって、水と混合することにより混合物として経口的に使用する形態であると、腐敗を防ぎ長期保存に適することから好ましい。また本発明の整腸剤が粉末状や錠状などの固体の形態である場合、上述したように、これを水と混合して液状体となし、経口的に使用することができるが、使用者の好みなどに応じて、固体のまま経口的に使用してもよい。 The intestinal regulator of the present invention is preferably in a powder form that is mixed with water to be taken orally as a mixture, since this prevents spoilage and is suitable for long-term storage. Also, when the intestinal regulator of the present invention is in a solid form such as a powder or tablet, as described above, it can be mixed with water to form a liquid and taken orally, but it may also be taken orally in its solid form depending on the user's preference, etc.
本発明の整腸剤は整腸作用を有することにより、これを使用することは、便秘や下痢などの腸に異常を有する者、排便障害者、さらには生活習慣病罹患者やアレルギー体質者及びそのリスクがある者に対しての健康維持に有用である。 The intestinal regulator of the present invention has an intestinal regulating effect, and using it is useful for maintaining the health of people with intestinal disorders such as constipation or diarrhea, people with bowel disorders, and even people suffering from lifestyle-related diseases, people with allergies, and people at risk of developing these conditions.
本発明の整腸剤は、麦類の茎葉の粉末のみを含むものであってもよいし、麦類の茎葉の粉末に加えて、その他の成分を含んでもよい。その他の成分としては、例えば、種々の賦形剤、結合剤、滑沢剤、安定剤、希釈剤、増量剤、増粘剤、乳化剤、着色料、香料、添加剤などを挙げることができる。その他の成分の含有量は、本発明の整腸剤の利用形態などに応じて適宜選択することができる。 The intestinal regulator of the present invention may contain only powder of barley and wheat stems and leaves, or may contain other ingredients in addition to powder of barley and wheat stems and leaves. Examples of other ingredients include various excipients, binders, lubricants, stabilizers, diluents, bulking agents, thickeners, emulsifiers, colorants, flavorings, additives, etc. The content of other ingredients can be appropriately selected depending on the usage form of the intestinal regulator of the present invention.
本発明の整腸剤に配合されるその他の成分は、麦類の茎葉の粉末が有する作用と相加的若しくは相乗的に、又は補助的に便通改善作用、腸内環境改善作用、腸管免疫賦活化作用といった整腸作用を示す成分であることが好ましい。そのようなものとして、例えば、水溶性食物繊維やオリゴ糖などの天然物由来又は合成物質；乳酸菌などの有用微生物；乳酸菌などの有用微生物を増加又は活性化する物質などが挙げられる。本発明の整腸剤は、水溶性食物繊維、オリゴ糖及び乳酸菌からなる群から選ばれる成分のうちいずれか１種又は２種以上を含むことが好ましく、水溶性食物繊維、オリゴ糖及び乳酸菌の３成分すべてを含むことがより好ましい。 The other ingredients to be incorporated in the intestinal regulator of the present invention are preferably ingredients that exhibit intestinal regulating effects such as improving bowel movements, improving the intestinal environment, and activating intestinal immunity in an additive or synergistic manner to the effects of the powder of barley and wheat stems and leaves, or in a supplementary manner. Examples of such ingredients include natural or synthetic substances such as water-soluble dietary fiber and oligosaccharides; useful microorganisms such as lactic acid bacteria; and substances that increase or activate useful microorganisms such as lactic acid bacteria. The intestinal regulator of the present invention preferably contains one or more ingredients selected from the group consisting of water-soluble dietary fiber, oligosaccharides, and lactic acid bacteria, and more preferably contains all three ingredients of water-soluble dietary fiber, oligosaccharides, and lactic acid bacteria.
水溶性食物繊維としては従来知られているものを用いることができ、特に限定されない。そのような水溶性食物繊維の例としては、アルギン酸、難消化性デキストリン、ガラクトマンナン、グアーガム、グアーガム加水分解物、グルコマンナン、ペクチン、ポリデキストロース及びカラギーナンなどが挙げられる。これらの水溶性食物繊維は１種を単独で又は２種以上を組み合わせて用いることができる。 The water-soluble dietary fiber may be any known type, and is not particularly limited. Examples of such water-soluble dietary fibers include alginic acid, resistant dextrin, galactomannan, guar gum, guar gum hydrolysate, glucomannan, pectin, polydextrose, and carrageenan. These water-soluble dietary fibers may be used alone or in combination of two or more types.
乳酸菌としては従来知られているものを用いることができ、特に限定されない。そのような乳酸菌としては、Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｂｉｆｉｄｕｍ、Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｂｒｅｖｅ、Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｉｎｆａｎｔｉｓ、Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｌａｃｔｉｓ、Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｌｏｎｇｕｍ、Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ａｄｏｌｅｓｃｅｎｔｉｓ、Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｍｏｎｇｏｌｉｅｎｓｅ、Ｌａｃｔｂａｃｉｌｌｕｓ ｂｒｅｖｉｓ、Ｌａｃｔｂａｃｉｌｌｕｓ ｇａｓｓｅｒｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ａｃｉｄｏｐｈｉｌｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｂｕｃｈｎｅｒｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｂｕｌｇａｒｉｃｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｄｅｌｂｒｕｅｃｋｉｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｃａｓｅｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｃｒｉｓｐａｔｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｃｕｒｖａｔｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｈａｌｉｖａｔｉｃｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｐｅｎｔｏｓｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｐｌａｎｔａｒｕｍ、Ｌａｃｔｏｂａｃｉｌｕｓ ｐａｒａｃａｓｅｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｒｈａｍｎｏｓｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｓａｌｉｖａｒｉｕｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｓｐｏｒｏｇｅｎｅｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｓａｋｅｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｆｒｕｃｔｉｖｏｒａｎｓ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｈｉｌｇａｒｄｉｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｒｅｕｔｅｒｉ、Ｌａｃｔｏｂａｃｉｌｌｕｓ ｆｅｒｍｅｎｔｕｍ、ストレプトコッカス・フェカリス（Ｓｔｒｅｐｔｏｃｏｃｃｕｓ ｆａｅｃａｌｉｓ（Ｅｎｔｅｒｏｃｏｃｃｕｓ ｆａｅｃａｌｉｓと称されることもある））、Ｅｎｔｅｒｏｃｏｃｃｕｓ ｆａｅｃｉｕｍ（Ｓｔｒｅｐｔｏｃｏｃｃｕｓ ｆａｅｃｉｕｍと称されることもある）、Ｓｔｒｅｐｔｏｃｏｃｃｕｓ ｔｈｅｒｍｏｐｈｉｌｕｓ、Ｌａｃｔｏｃｏｃｃｕｓ ｌａｃｔｉｓ（Ｓｔｒｅｐｔｏｃｏｃｃｕｓ ｌａｃｔｉｓと称されることもある）、Ｌｅｕｃｏｎｏｓｔｏｃ ｍｅｓｅｎｔｅｒｏｉｄｅｓ、Ｌｅｕｃｏｎｏｓｔｏｃ ｏｅｎｏｓ、Ｐｅｄｉｏｃｏｃｃｕｓ ａｃｉｄｉｌａｃｔｉｃｉ、Ｐｅｄｉｏｃｏｃｃｕｓ ｐｅｎｔｏｓａｃｅｕｓ、Ｓｔａｐｈｙｌｏｃｏｃｃｕｓ ｃａｒｎｏｓｕｓ、Ｓｔａｐｈｙｌｏｃｏｃｃｕｓ ｘｙｌｏｓｕｓ、Ｔｅｔｒａｇｅｎｏｃｏｃｃｕｓ ｈａｌｏｐｈｉｌｕｓ、Ｂａｃｉｌｌｕｓ ｃｏａｇｕｌａｎｓ、及びＢａｃｉｌｌｕｓ ｍｅｓｅｎｔｅｒｉｃｕｓなどが用いられる。これらの乳酸菌は１種を単独で又は２種以上を組み合わせて用いることができる。乳酸菌の性質は特に限定されるものではなく、本発明の整腸剤の剤形や品質に応じて適宜選択することができ、例えば、耐熱性、耐酸性、耐糖性、耐塩性、有胞子性などが挙げられる。 Lactic acid bacteria that can be used are not particularly limited and may be any known type. Such lactic acid bacteria include Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium adolescentis, Bifidobacterium mongoliense, Lactobacillus brevis, Lactobacillus gasseri, Lactobacillus acidophilus, and Lactobacillus. buchneri, Lactobacillus bulgaricus, Lactobacillus delbrueckii, Lactobacillus casei, Lactobacillus crispatus, Lactobacillus curvatus, Lactobacillus halivaticus, Lactobacillus pentosus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus sporogenes, Lactobacillus sakei, Lactobacillus fructivorans, Lactobacillus hilgardii, Lactobacillus reuteri, Lactobacillus fermentum, Streptococcus faecalis (also called Enterococcus faecalis), Enterococcus faecium (Streptococcus faecium), Streptococcus thermophilus, Lactococcus lactis (sometimes called Streptococcus lactis), Leuconostoc mesenteroides, Leuconostoc oenos, Pediococcus acidilactici, Pediococcus pentosaceus, Staphylococcus carnosus, Staphylococcus xylosus, Tetragenococcus halophilus, Bacillus Examples of lactic acid bacteria that can be used include Bacillus coagulans and Bacillus mesentericus. These lactic acid bacteria can be used alone or in combination of two or more. The properties of the lactic acid bacteria are not particularly limited and can be appropriately selected depending on the dosage form and quality of the intestinal regulator of the present invention. Examples of the properties include heat resistance, acid resistance, sugar tolerance, salt tolerance, and spore formation.
オリゴ糖としては従来知られているものを用いることができ、特に限定されない。そのようなオリゴ糖としては、ラクチュロース、パラチノース、パラチノースオリゴ糖、フラクトオリゴ糖、ラフィノース、キシロオリゴ糖、マルトオリゴ糖、イソマルトオリゴ糖、トレハロース、ガラクトオリゴ糖、乳果オリゴ糖、ビートオリゴ糖、ゲンチオオリゴ糖、ニゲロオリゴ糖、スクロース、ラクトース、マルトース及びシクロデキストリンなどが挙げられる。これらのオリゴ糖は１種を単独で又は２種以上を組み合わせて用いることができる。 Oligosaccharides that are conventionally known can be used, and are not particularly limited. Examples of such oligosaccharides include lactulose, palatinose, palatinose oligosaccharides, fructooligosaccharides, raffinose, xylooligosaccharides, maltooligosaccharides, isomaltooligosaccharides, trehalose, galactooligosaccharides, lactofructose oligosaccharides, beet oligosaccharides, gentiooligosaccharides, nigerooligosaccharides, sucrose, lactose, maltose, and cyclodextrin. These oligosaccharides can be used alone or in combination of two or more.
また、本発明の整腸剤は、麦類の茎葉の粉末が有する整腸作用に加えて、やはり麦類の茎葉の粉末に由来するビタミン類、ミネラル類などを多く含むことから、これらに基づく副次的な効果を奏し、使用者の健康維持に資する。 In addition to the intestinal regulating effect of the powdered barley and wheat stems and leaves, the intestinal regulator of the present invention also contains a large amount of vitamins, minerals, etc. derived from the powdered barley and wheat stems and leaves, and therefore exerts secondary effects based on these and contributes to maintaining the health of the user.
以下、本発明を実施例によりさらに詳細に説明するが、本発明はこれら実施例に限定されるものではなく、本発明の課題を解決し得る限り、本発明は種々の態様をとることができる。 The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples, and the present invention can take various forms as long as the object of the present invention can be solved.
大麦茎葉の粒度の違いが腸内環境改善作用の活性化及び腸管免疫の賦活化に影響を与えることを以下のとおりに評価した。 The effect of different particle sizes of barley foliage on improving the intestinal environment and activating intestinal immunity was evaluated as follows.
１．被験物質
粒度の異なる３種類の大麦茎葉の乾燥粉末を用意し、これらをそれぞれ「粉砕末（粒度小）群」、「粉砕末（粒度中）群」及び「粉砕末（粒度大）群」と名付けた。
1. Three types of dried powder of barley stems and leaves with different particle sizes were prepared as the test substance, and named the "ground powder (small particle size) group," the "ground powder (medium particle size) group," and the "ground powder (large particle size) group."
２．被験飼料の調製
背丈が約３０ｃｍで刈り取った大麦茎葉を水洗いし、付着した泥などを除去し、５～１０ｃｍ程度の大きさに切断する前処理を行った。前処理した茎葉を、９０～１００℃の熱湯で９０秒間～１２０秒間、１回のみブランチング処理し、その後、冷水で冷却した。続いて、得られた茎葉を、水分含量が５質量％以下となるまで、乾燥機中で、２０分間～１８０分間、８０℃～１３０℃の温風にて乾燥させた。乾燥した茎葉を、ミキサーを用いて、約１ｍｍの大きさに粗粉砕処理した。得られた大麦の茎葉を、小型製粉機（製品名「ミクロ・パウダー ＫＧＷ－Ｇ０１５」（有限会社ウエスト製）を用いて、平均粒子径が以下の表１に示す数値になるように、製粉機のダイヤル設定の粒度調整ツマミを操作して各群の大麦茎葉乾燥粉末を製造した。
2. Preparation of test feed Barley stalks and leaves harvested at a height of about 30 cm were washed with water to remove any adhering mud, and pre-treated by cutting into pieces of about 5-10 cm in size. The pre-treated stalks and leaves were blanched once with hot water at 90-100°C for 90-120 seconds, and then cooled with cold water. The obtained stalks and leaves were then dried in a dryer with hot air at 80°C to 130°C for 20-180 minutes until the moisture content was 5% by mass or less. The dried stalks and leaves were coarsely pulverized to a size of about 1 mm using a mixer. The obtained barley stalks and leaves were milled in a small flour mill (product name: Micro Powder KGW-G015 (manufactured by West Co., Ltd.) by operating the grain size adjustment knob of the flour mill so that the average particle size was the value shown in Table 1 below, to produce barley stalk and leaf dry powder for each group.
得られた各群の大麦茎葉乾燥粉末を、以下の表２にその組成を示すＡＩＮ－７６精製飼料と混合して、以下の表３に示す試験飼料を調製した。ここで、大麦茎葉乾燥粉末（被験物質）を加えないもの、すなわち、ＡＩＮ－７６精製飼料のみのものをコントロール群とした。なお、ＡＩＮ－７６精製飼料は乳鉢、乳棒及び混餌機（ＭＴ－３０Ｈ；愛工舎製作所）を用いて作製した。また、大麦茎葉乾燥粉末とＡＩＮ－７６精製飼料との混合は、乳鉢及び乳棒を用いて各成分が均一となるように混餌した。なお、各表中の数値はｗｔ％を示す。 The obtained dry powder of barley stems and leaves for each group was mixed with AIN-76 purified feed, the composition of which is shown in Table 2 below, to prepare the test feeds shown in Table 3 below. Here, the control group was fed AIN-76 purified feed only, i.e., no dry powder of barley stems and leaves (test substance) was added. The AIN-76 purified feed was prepared using a mortar, pestle and feed mixer (MT-30H; Aikosha Seisakusho). The dry powder of barley stems and leaves was mixed with the AIN-76 purified feed using a mortar and pestle so that each component was uniform. The values in each table indicate wt%.
３．被験動物
４週齢の雄性ＩＣＲ系マウス（九動株式会社）を６日間馴化させた。飼育環境として、照明時間は１２時間とし、ケージは木材チップ（ソフトチップ；日本エスエルシー株式会社）を床じきとしたポリカーボネイト製平底ケージ（Ｗ２２０×Ｄ３２０×Ｈ１３５ｍｍ；東洋理工株式会社）又はステンレス製５連ケージ（Ｗ１５０×Ｄ２１０×Ｈ１５０ｍｍ；トキワ株式会社）を用いた。収容個体数は、平底ケージでは１ケージあたり２～３匹とし、５連ケージでは１区画に１匹とした。なお、５連ケージは、糞便回収用に用いた。
3. Test animals Four-week-old male ICR mice (Kyudou Co., Ltd.) were acclimated for six days. The light hours were set to 12 hours for the rearing environment, and the cages used were polycarbonate flat-bottom cages (W220×D320×H135 mm; Toyo Riko Co., Ltd.) or stainless steel five-section cages (W150×D210×H150 mm; Tokiwa Co., Ltd.) with wooden chips (soft chips; Japan SLC Co., Ltd.) on the floor. The number of animals housed was 2-3 per cage in the flat-bottom cages and 1 per section in the five-section cages. The five-section cages were used for collecting feces.
馴化期間において、給餌方法は原則として自由摂取とした。飼料はＭＦ固形飼料（オリエンタル酵母工業株式会社）を用い、飲水は水道水を用いた。 During the acclimation period, the animals were generally given food ad libitum. MF solid feed (Oriental Yeast Co., Ltd.) was used as feed, and tap water was used for drinking water.
馴化期間終了後に健常な被験動物を体重がほぼ均一となるように各群に分け、試験に供した。ただし、試験開始－１～０日目に回収した湿糞便重量に各群で差がみられないように考慮した。 After the acclimation period, healthy test animals were divided into groups with roughly uniform body weights and subjected to the test. However, care was taken to ensure that there were no differences in the weight of wet feces collected between days -1 and 0 from the start of the test among the groups.
４．試験手順
馴化期間終了後に群分けされた５週齢の被験動物について、試験開始日（０日目）より各被験物質を混餌した試験飼料を１４日間自由摂取させた。飼育環境として、照明時間は１２時間とし、ケージは木材チップ（ソフトチップ；日本エスエルシー株式会社）を床じきとしたステンレス製５連ケージを用いた。収容個体数は１区画に１匹とした。給餌器は摂餌量を測定しやすくするため、ローデンカフェ（オリエンタル酵母工業株式会社）を用いた。群構成をまとめたものを表４とした。
4. Test procedure After the habituation period, the 5-week-old test animals were divided into groups and given free access to the test feed containing each test substance for 14 days from the start of the test (day 0). The lighting time was 12 hours, and the cages used were stainless steel 5-row cages with wooden chips (soft chips; Japan SLC Co., Ltd.) on the floor. The number of animals housed was one per section. A Roden Cafe (Oriental Yeast Co., Ltd.) feeder was used to make it easier to measure the amount of food intake. Table 4 shows the group composition.
試験期間中は体重及び摂餌量を週２回測定した。試験開始前日（－１日目）～試験開始日（０日目）、試験開始６～７日目、１３～１４日目の２４時間の糞便を回収し、各測定日ごとに糞便個数、湿糞便重量及び乾燥糞便重量を測定した。また、１２～１３日目の糞便を回収し、－３０℃で冷凍し腸内フローラ解析サンプルとして保存した。 During the study period, body weight and food intake were measured twice a week. Feces were collected for 24 hours from the day before the study began (day -1) to the day the study began (day 0), and from days 6-7 and 13-14 of the study, and the number of feces, wet feces weight, and dry feces weight were measured on each measurement day. Feces from days 12-13 were also collected, frozen at -30°C, and stored as samples for intestinal flora analysis.
５．評価方法
（１）粒子特性
被験物質の平均粒子径及び粒度分布をレーザー回折・散乱式粒度分布測定器（ＬＭＳ－３００；株式会社セイシン企業）により測定した。
5. Evaluation Method (1) Particle Characteristics The average particle size and particle size distribution of the test substance were measured using a laser diffraction/scattering type particle size distribution measuring instrument (LMS-300; Seishin Enterprise Co., Ltd.).
（２）安息角
被験物質の安息角について、 粉体特性評価装置（パウダテスタ（Ｒ）ＰＴ－Ｘ；ホソカワミクロン株式会社）を用いて、被験物質を一定の高さの漏斗から水平な基板の上に落させ、生成した堆積物の角度を測定することにより求めた。なお、漏斗の下の部分から基板までの距離は約７ｃｍであった。
(2) Angle of repose The angle of repose of the test substance was determined by dropping the test substance from a funnel of a certain height onto a horizontal substrate using a powder property evaluation device (Powder Tester (R) PT-X; Hosokawa Micron Corporation). The distance from the bottom of the funnel to the substrate was approximately 7 cm.
（３）嵩密度
被験物質の嵩密度について、粉体特性評価装置（パウダテスタ（Ｒ）ＰＴ－Ｘ；ホソカワミクロン株式会社）を用いて、篩にある被験物質を所定の高さから落下させて１００ｃｍ２のステンレス製容器に入れ、質量を測定することにより求めた。なお、篩から容器までの距離は約２１ｃｍであった。
(3) Bulk density The bulk density of the test substance was determined by dropping the test substance on a sieve from a specified height into a 100 cm2 stainless steel container using a powder property evaluation device (Powder Tester (R) PT-X; Hosokawa Micron Corporation), and measuring the mass. The distance from the sieve to the container was approximately 21 cm.
（４）湿糞便重量
試験開始前（－１日目）～試験開始日（０日目）、試験開始６～７日目及び１３～１４日目の２４時間の糞便を回収した。回収した糞便は、プラスチックトレイに置き、その重量を湿糞便重量として測定した。
(4) Wet Feces Weight Feces were collected for 24 hours from before the start of the test (day -1) to the start of the test (day 0), and from days 6 to 7 and 13 to 14 of the test. The collected feces were placed on a plastic tray, and the weight was measured as the wet feces weight.
（５）糞中ＩｇＡ量
糞中ＩｇＡ量はＥＬＩＳＡ定量キット（Ｂｅｔｈｙｌ Ｌａｂｏｒａｔｏｒｉｅｓ、モンゴメリー、ＴＸ）を用いて測定した。すなわち、試験１３～１４日目の糞便を回収し、プラスチックトレイに置いて室温で一晩乾燥させた後、－３０℃で冷凍保存した。次いで、冷凍保存した糞便を室温下で吸引ポンプ及びデシケーターを用いて２日間乾燥させた。次いで、乳鉢及び乳棒を用いて乾燥糞便を粉砕した。次いで、粉砕糞便 ０．１ｇあたり１ｍＬのＰＢＳを加え、１時間、室温で抽出した。次いで、固形分を除去するために遠心分離することにより、糞抽出液を得た。この糞抽出液を用いて、上記ＥＬＩＳＡ定量キットにより、糞中ＩｇＡ量を定量した。
(5) Amount of IgA in Feces The amount of IgA in feces was measured using an ELISA quantification kit (Bethyl Laboratories, Montgomery, TX). That is, feces on days 13-14 of the test were collected, placed on a plastic tray, dried overnight at room temperature, and then frozen at -30°C. The frozen feces were then dried for 2 days at room temperature using a suction pump and a desiccator. The dried feces were then pulverized using a mortar and pestle. 1 mL of PBS was then added per 0.1 g of pulverized feces, and extraction was performed at room temperature for 1 hour. A fecal extract was then obtained by centrifugation to remove solids. Using this fecal extract, the amount of IgA in feces was quantified using the above-mentioned ELISA quantification kit.
（６）腸内フローラ
次のようにしてリアルタイム ＰＣＲ法により腸内フローラを解析した。すなわち、試験１３～１４日目の糞便を回収し、プラスチックトレイに置いて室温で一晩乾燥させた後、－３０℃で冷凍保存した。次いで、冷凍糞便を凍結乾燥機にかけた後、粉砕を行った。１検体につき１００ｍｇ量り取りＤＮＡ抽出キット（ＱＩＡａｍｐ（登録商標）ＤＮＡ Ｓｔｏｏｌ Ｍｉｎｉ Ｋｉｔ；キアゲン）の取扱説明書に従い抽出を行った。ＤＮＡ溶液を注射用水にて５０倍希釈してテンプレートとした。
(6) Intestinal flora The intestinal flora was analyzed by real-time PCR as follows. That is, feces on days 13 and 14 of the study were collected, placed on a plastic tray, dried overnight at room temperature, and then frozen and stored at -30°C. The frozen feces were then put into a freeze-dryer and crushed. 100 mg of each sample was weighed out and extracted according to the instructions of the DNA extraction kit (QIAamp (registered trademark) DNA Stool Mini Kit; Qiagen). The DNA solution was diluted 50-fold with water for injection to prepare a template.
上記テンプレートについて、リアルタイムＰＣＲ用キット（ＱｕａｎｔｉＮｏｖａ ＳＹＢＲ Ｇｒｅｅｎ ｍａｓｔｅｒ ｍｉｘ；Ｑｉａｇｅｎ）の取扱説明書に従い、ＲｏｔｅｒＧｅｎｅ Ｑ（登録商標；Ｑｉａｇｅｎ）を用いてリアルタイムＰＣＲアッセイを行った（プレインキュベーション９５℃・５分；ＰＣＲサイクル９５℃・５秒、６０℃・１０秒×４０サイクル）。解析対象は全菌種（ｔｏｔａｌ ｂａｃｔｅｒｉａ）、Ｌａｃｔｏｂａｃｉｌｌｕｓ属、Ｐｒｅｖｏｔｅｌｌａ属及びＣｌｏｓｔｏｒｉｄｉｕｍ ｃｌｕｓｔｅｒ ＸＩＶａとし、プライマー配列は下記表５に記載のとおりとした。 A real-time PCR assay was performed on the above template using RoterGene Q (registered trademark; Qiagen) according to the instruction manual for the real-time PCR kit (QuantiNova SYBR Green master mix; Qiagen) (preincubation 95°C for 5 minutes; PCR cycle 95°C for 5 seconds, 60°C for 10 seconds x 40 cycles). The subjects of analysis were all bacteria (total bacteria), the genus Lactobacillus, the genus Prevotella, and Clostoridium cluster XIVa, and the primer sequences were as shown in Table 5 below.
コントロールの一部をスタンダードとして用い、コントロールに対する相対値として計測した。 A portion of the control was used as a standard and measurements were taken relative to the control.
（７）統計処理
得られた数値は、各群で平均値（ｍｅａｎ）、標準偏差（Ｓ．Ｄ．）及び標準誤差（Ｓ．Ｅ．）を算出した。検定は、コントロール群又は粉砕末（粒度小）群との多群比較（Ｂｏｎｆｅｒｒｏｎｉ ｔｅｓｔ）により行った。有意水準は、危険率５％又は１％とした。
(7) Statistical processing The mean, standard deviation (S.D.) and standard error (S.E.) were calculated for each group. The test was performed by multi-group comparison (Bonferroni test) with the control group or the crushed powder (small particle size) group. The significance level was set at a risk level of 5% or 1%.
６．結果
（１）粒子特性
粒子特性を測定した結果を表６に示す。表中の「粒度大」、「粒度中」及び「粒度小」はそれぞれ被験物質である「大麦茎葉乾燥粉末（粒度大）」、「大麦茎葉乾燥粉末（粒度中）」及び「大麦茎葉乾燥粉末（粒度小）」を表わす。
6. Results (1) Particle characteristics The results of measuring particle characteristics are shown in Table 6. In the table, "large particle size", "medium particle size" and "small particle size" represent the test substances "barley stover and leaf dried powder (large particle size)", "barley stover and leaf dried powder (medium particle size)" and "barley stover and leaf dried powder (small particle size)", respectively.
（２）安息角及び嵩密度
安息角及び嵩密度の測定結果を表７に示す。表中の「粒度大」、「粒度中」及び「粒度小」はそれぞれ被験物質である「大麦茎葉乾燥粉末（粒度大）」、「大麦茎葉乾燥粉末（粒度中）」及び「大麦茎葉乾燥粉末（粒度小）」を表わす。
(2) Angle of repose and bulk density The measurement results of the angle of repose and bulk density are shown in Table 7. In the table, "large particle size", "medium particle size" and "small particle size" represent the test substances "dried powder of barley stover and leaves (large particle size)", "dried powder of barley stover and leaves (medium particle size)" and "dried powder of barley stover and leaves (small particle size)", respectively.
（３）湿糞便重量、糞中ＩｇＡ量及び腸内フローラ
試験開始１３～１４日目の２４時間に回収した糞便を用いて測定した湿糞便重量の測定結果を図１に；糞中ＩｇＡ量の測定結果を図２に；及び腸内フローラの測定結果を図３及び４にそれぞれ示す。なお、それぞれの測定値は各群の平均値を示す。
(3) Wet fecal weight, fecal IgA amount, and intestinal flora The results of measuring the wet fecal weight, measured using feces collected over 24 hours on the 13th and 14th days after the start of the test, are shown in Figure 1, the results of measuring the fecal IgA amount in Figure 2, and the results of measuring the intestinal flora in Figures 3 and 4. Each measurement value is the average value for each group.
湿糞便重量、糞中ＩｇＡ及び腸内フローラともに、コントロール群に対して、粉砕末（粒度小）群、粉砕末（粒度中）群及び粉砕末（粒度大）群は統計的有意に優れた値を示した。さらに、驚くべきことに、粉砕末（粒度小）群は、粉砕末（粒度中）群又は粉砕末（粒度大）群に対して、湿糞便重量、糞中ＩｇＡ及び腸内フローラのいずれにおいても優れた値を示した。粉砕末（粒度中）群についてもまた、粉砕末（粒度大）群に対して、湿糞便重量、糞中ＩｇＡ及び腸内フローラについて同等又はより優れた値を示した。 Compared to the control group, the crushed powder (small particle size), crushed powder (medium particle size) and crushed powder (large particle size) groups showed statistically significantly superior values for wet fecal weight, fecal IgA and intestinal flora. Furthermore, surprisingly, the crushed powder (small particle size) group showed superior values for wet fecal weight, fecal IgA and intestinal flora compared to the crushed powder (medium particle size) and crushed powder (large particle size) groups. The crushed powder (medium particle size) group also showed equivalent or superior values for wet fecal weight, fecal IgA and intestinal flora compared to the crushed powder (large particle size) group.
これらの結果から、大麦茎葉の乾燥粉末は、粒径がより小さく、安息角がより大きく、又は嵩密度がより小さいものほど、湿糞便重量、糞中ＩｇＡ及び腸内フローラがより大きい、すなわち、便通改善作用、腸内環境改善作用、腸管免疫機能活性化作用といった整腸作用を示すことが明らかになった。 These results show that the smaller the particle size, the larger the angle of repose, or the smaller the bulk density of dry barley stem and leaf powder, the greater the wet fecal weight, fecal IgA, and intestinal flora. In other words, it shows intestinal regulating effects such as improving bowel movements, improving the intestinal environment, and activating intestinal immune function.
７．大麦茎葉乾燥粉末（粒度小）の製造例
平均粒子径が上記表１に示す数値になる微粉砕処理条件によって、大麦茎葉乾燥粉末（粒度小）を製造した。製造して得られた粉末（製造例１～６）の粒子特性を表８に示す。製造例１～６の粉末もまた、湿糞便重量、糞中ＩｇＡ及び腸内フローラがより大きく、便通改善作用、腸内環境改善作用、腸管免疫機能活性化作用といった整腸作用を示すことが合理的に推測される。
7. Production example of dried powder of barley stover and leaves (small particle size) Dried powder of barley stover and leaves (small particle size) was produced under fine grinding conditions that gave the average particle size the values shown in Table 1 above. The particle properties of the produced powders (Production Examples 1 to 6) are shown in Table 8. The powders of Production Examples 1 to 6 also had higher wet feces weight, fecal IgA, and intestinal flora, and it is reasonably assumed that they exhibit intestinal regulating effects such as improving bowel movements, improving the intestinal environment, and activating intestinal immune function.
本発明の整腸剤は、従前の整腸作用を有する物質に比べて、天然素材を用いながら、安全性が高く、かつ、優れた整腸作用を示す物質を含有するものであり、これにより便通改善作用、腸内環境改善作用及び腸管免疫賦活化作用を含む整腸作用を有するものである。したがって、本発明の整腸剤は、便秘、下痢、排便障害などの腸機能不全、腸管免疫不全、腸内の有害微生物代謝産物や有害酵素の発生、生活習慣病、アレルギーなどの腸組織の異常に関連する種々の疾病及び異常の改善、緩和、治療及び予防することが期待できることから、これらの疾病や異常を患う者の健康と福祉に貢献できるものである。 The intestinal regulator of the present invention contains a substance that uses natural materials, is highly safe, and exhibits excellent intestinal regulating effects compared to conventional substances with intestinal regulating effects, and thus has intestinal regulating effects including improving bowel movements, improving the intestinal environment, and activating intestinal immunity. Therefore, the intestinal regulator of the present invention is expected to improve, alleviate, treat, and prevent various diseases and disorders associated with intestinal tissue abnormalities such as intestinal dysfunction such as constipation, diarrhea, and defecation disorders, intestinal immune deficiency, production of harmful microbial metabolic products and harmful enzymes in the intestine, lifestyle-related diseases, and allergies, and can contribute to the health and welfare of those suffering from these diseases and disorders.
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