JP2024026804A - Improvement agent of fatigue, reduced motivation, or drowsiness - Google Patents
Improvement agent of fatigue, reduced motivation, or drowsiness Download PDFInfo
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- JP2024026804A JP2024026804A JP2024004964A JP2024004964A JP2024026804A JP 2024026804 A JP2024026804 A JP 2024026804A JP 2024004964 A JP2024004964 A JP 2024004964A JP 2024004964 A JP2024004964 A JP 2024004964A JP 2024026804 A JP2024026804 A JP 2024026804A
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- fatigue
- black soybean
- extract
- motivation
- seed coat
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Abstract
Description
本発明は、精神性疲労を予防または改善するために好適に使用される経口組成物に関する。また、本発明は、意欲低下または眠気を予防または改善させるために好適に使用される経口組成物に関する。 The present invention relates to an oral composition suitably used for preventing or ameliorating mental fatigue. The present invention also relates to an oral composition suitably used for preventing or ameliorating loss of appetite or sleepiness.
疲労とは、単なる肉体的な運動性疲労に留まらず、免疫疾患や機能低下に伴う感染性疲労や精神的・環境的ストレス、睡眠・リズム障害による疲労などの精神性疲労が知られている。近年においては、人間関係の精神的な緊張などによるストレスだけでなく、デスクワークによる長時間労働、特にコンピュータのディスプレイなど表示機器を使用したVDT(Visual Display Terminal)作業を長時間続けたことにより生じる精神性疲労が増加している。この精神性疲労が慢性化すると、気力、意欲、集中力の低下や精神不安や眠気を引き起こし、日常生活にも支障をきたすだけでなく、うつ病を発症させるリスクを高めるため、精神性疲労を効果的に改善させる薬剤や飲食物に対する需要が高まっている。 Fatigue is not just physical fatigue due to exercise, but also mental fatigue such as infectious fatigue associated with immune diseases or functional decline, mental/environmental stress, and fatigue due to sleep/rhythm disorders. In recent years, not only stress caused by mental tension in interpersonal relationships, but also mental stress caused by long desk work, especially VDT (Visual Display Terminal) work that uses display devices such as computer displays, has become more prevalent. Sexual fatigue is increasing. When this mental fatigue becomes chronic, it causes a decline in energy, motivation, concentration, mental anxiety, and drowsiness, which not only interferes with daily life but also increases the risk of developing depression. There is a growing demand for drugs, foods and drinks that can effectively improve symptoms.
精神性疲労を改善する方法として、精神安定剤、抗不安剤、睡眠薬等の化学合成薬剤などの医薬品の服用が知られているが、一般的に医薬品は抵抗感が根強く、また習慣性や副作用の危険性を排除することができないという問題がある。そこで天然由来の成分であって、特に安全性の観点から食経験のある植物等の天然素材由来であり、精神性疲労の改善効果を奏する成分を見いだすことが望まれている。精神性疲労の改善作用を有するとされる成分を含有する飲料や健康食品として、例えば、γ-アミノ酪酸(GABA)(特許文献1)やカフェイン、テアニン及びアルギニン(特許文献2)、フラボノイド及び/または糖転移フラボノイド(特許文献3)を経口摂取する方法も提案されている。 Taking pharmaceuticals such as tranquilizers, anti-anxiety agents, and chemically synthesized drugs such as sleeping pills is known as a way to improve mental fatigue, but there is generally a deep-rooted resistance to pharmaceuticals, and they can also be addictive and cause side effects. The problem is that it is not possible to eliminate the risk of Therefore, it is desired to find a naturally derived ingredient, especially from a safety perspective, a natural material such as a plant that has been eaten, and which has the effect of improving mental fatigue. Beverages and health foods that contain ingredients that are said to improve mental fatigue include, for example, γ-aminobutyric acid (GABA) (Patent Document 1), caffeine, theanine and arginine (Patent Document 2), flavonoids, and A method of orally ingesting a transglycosylated flavonoid (Patent Document 3) has also been proposed.
また、精神性疲労は集中力・思考力の低下や感情の不安定化等を引き起こすだけでなく、身体的にも影響を及ぼすことが知られており、精神的な疲労が身体的な疲労と複合化した状態となっている場合には、眠気、全体倦怠感、だるさ、脱力感等の身体の活動意欲の低下として自覚することができる。このような症状に対して改善作用を有するとされる成分を含有する飲料や健康食品として、例えば、眠気を抑制し集中力を高めるためのトウガラシ抽出物及び/またはショウガ抽出物とテアニンを含有する組成物(特許文献4)や、疲労時もしくはストレス時の意欲低減を改善するためのマテエキスを含有する改善剤(特許文献5)を経口摂取する方法も提案されている。 Furthermore, it is known that mental fatigue not only causes a decline in concentration and thinking ability and emotional instability, but also has physical effects, and that mental fatigue can lead to physical fatigue. When the condition is complex, it can be perceived as a decrease in the desire for physical activity, such as drowsiness, general malaise, malaise, and a feeling of weakness. Beverages and health foods that contain ingredients that are said to have an ameliorating effect on such symptoms include, for example, those containing chili pepper extract and/or ginger extract and theanine to suppress drowsiness and improve concentration. A method of orally ingesting a composition (Patent Document 4) or an improving agent containing Yerba mate extract (Patent Document 5) for improving motivation reduction during fatigue or stress has also been proposed.
ところで、疲労改善効果を有する成分の多くは、抗酸化能が高いことが知られている。黒大豆種皮抽出物には、プロアントシアニジン、アントシアニンなどのポリフェノールが多量に含まれ、これらの成分は高い抗酸化能を有することから、黒大豆種皮抽出物についても疲労改善効果を有することが期待され研究が進められている。例えば、運動負荷後の疲労マーカーを低減させる黒生姜、黒胡椒、黒大豆種皮、黒ゴマおよび発酵黒タマネギを含有する肉体的疲労改善組成物(特許文献6)や、アスタキサンチン、ルテイン、黒大豆種皮エキス、ビルベリーエキスおよびDHAを含有する肩こり及び/または眼の充血改善剤(特許文献7)が提案されている。 By the way, many of the ingredients that have a fatigue-improving effect are known to have high antioxidant ability. Black soybean seed coat extract contains large amounts of polyphenols such as proanthocyanidins and anthocyanins, and these components have high antioxidant capacity, so black soybean seed coat extract is also expected to have a fatigue-improving effect. Research is underway. For example, a physical fatigue-improving composition containing black ginger, black pepper, black soybean seed coat, black sesame, and fermented black onion (Patent Document 6), which reduces fatigue markers after exercise load, and astaxanthin, lutein, and black soybean seed coat. An agent for improving stiff shoulders and/or eye congestion (Patent Document 7) containing bilberry extract, bilberry extract, and DHA has been proposed.
しかし、黒大豆種皮抽出物が、精神性疲労、意欲低下または眠気を予防または改善する効果を有することは知られていない。 However, it is not known that black soybean hull extract has the effect of preventing or improving mental fatigue, loss of motivation, or sleepiness.
本発明は、精神性疲労、意欲低下または眠気を予防または改善するために好適に使用される経口組成物を提供することを課題とする。より詳細には、VDT(Visual Display Terminal)作業負荷に起因して生じる精神性疲労、意欲低下または眠気を予防または改善することができる、経口組成物を提供することを課題とする。 An object of the present invention is to provide an oral composition suitably used to prevent or improve mental fatigue, loss of motivation, or sleepiness. More specifically, it is an object of the present invention to provide an oral composition that can prevent or improve mental fatigue, loss of motivation, or sleepiness caused by VDT (Visual Display Terminal) workload.
本発明者らは、上記課題を解決すべく鋭意検討を重ねていたところ、黒大豆種皮抽出物を摂取すると、精神性疲労、意欲低下または眠気を予防または改善することを見出した。さらにVDT(Visual Display Terminal)作業に伴って生じる精神性疲労、意欲低下または眠気を予防または改善することを見出し、これらの知見に基づいて本発明を完成したものである。このことから、黒大豆種皮抽出物を摂取することで、精神性疲労、意欲低下または眠気が予防または改善されて、健康増進を図ることができると考えられる。 The present inventors have conducted extensive studies to solve the above problems, and have discovered that ingesting a black soybean seed coat extract prevents or improves mental fatigue, loss of motivation, or drowsiness. Furthermore, it was discovered that mental fatigue, loss of motivation, or drowsiness caused by VDT (Visual Display Terminal) work can be prevented or improved, and the present invention was completed based on these findings. From this, it is thought that by ingesting black soybean hull extract, mental fatigue, loss of motivation, or sleepiness can be prevented or improved, and health can be improved.
本発明はこれらの知見に基づいて完成したものであり、下記の実施形態を包含するものである。
(1)精神性疲労、意欲低下および眠気の改善剤
(1-1)黒大豆種皮抽出物を有効成分として含有する、精神性疲労、意欲低下または眠気の少なくともいずれかを予防または改善する目的で使用される改善剤。
(1-2)前記精神性疲労、意欲低下または眠気がVDT(Visual Display Terminal)作業負荷に起因するものである、1-1記載の改善剤。
(1-3)黒大豆種皮抽出物が黒大豆種皮の酸性抽出物である、1-1または1-2に記載の改善剤。
(1-4))医薬品、医薬部外品または飲食物である、1-1~1-3のいずれか一項に記載の改善剤。
The present invention was completed based on these findings, and includes the following embodiments.
(1) Agents for improving mental fatigue, loss of motivation and sleepiness
(1-1) An improving agent used for the purpose of preventing or improving at least one of mental fatigue, loss of motivation, and sleepiness, which contains black soybean hull extract as an active ingredient.
(1-2) The improving agent according to 1-1, wherein the mental fatigue, decreased motivation, or sleepiness is caused by VDT (Visual Display Terminal) workload.
(1-3) The improving agent according to 1-1 or 1-2, wherein the black soybean seed coat extract is an acidic extract of black soybean seed coats.
(1-4)) The improving agent according to any one of 1-1 to 1-3, which is a drug, a quasi-drug, or a food or drink.
(2)黒大豆種皮抽出物の使用方法
(2-1)黒大豆種皮抽出物を経口組成物に配合して、当該経口組成物に対して精神性疲労、意欲低下または眠気の少なくともいずれかを予防または改善する作用を付与するための、黒大豆種皮抽出物の使用方法。
(2) Method of using black soybean seed coat extract (2-1) Black soybean seed coat extract is blended into an oral composition to cause at least one of mental fatigue, loss of motivation, and drowsiness to the oral composition. A method of using black soybean seed coat extract to impart preventive or ameliorative effects.
本発明の精神性疲労、意欲低下または眠気の改善剤によれば、黒大豆種皮抽出物を有効成分として含有する本発明の改善剤を経口摂取することにおり、精神性疲労、意欲低下または眠気の少なくともいずれかを予防するかまたは改善することができる。特に、VDT(Visual Display Terminal)作業負荷に起因して生じる精神性疲労、意欲低下または眠気の少なくともいずれかを予防するかまたは改善することができる。また本発明の黒大豆種皮抽出物の使用方法によれば、経口組成物に対して精神性疲労、意欲低下または眠気の少なくともいずれかを予防または改善する作用を付与するために用いることができる。つまり、本発明の使用方法は、精神性疲労、意欲低下または眠気を予防または改善する用途の経口組成物の調製に使用することができ、斯くして、精神性疲労、意欲低下または眠気の少なくともいずれかを予防するかまたは改善する効果に優れた経口組成物(経口医薬品、経口医薬部外品、飲食品)を調製し、提供することができる。 According to the agent for improving mental fatigue, decreased motivation, or drowsiness of the present invention, the improving agent of the present invention containing black soybean seed coat extract as an active ingredient is orally ingested. can be prevented or ameliorated. In particular, it is possible to prevent or improve at least one of mental fatigue, loss of motivation, and sleepiness caused by VDT (Visual Display Terminal) workload. Further, according to the method of using the black soybean hull extract of the present invention, it can be used to impart an effect of preventing or improving at least one of mental fatigue, loss of motivation, and drowsiness to an oral composition. That is, the method of use of the present invention can be used to prepare an oral composition for preventing or ameliorating mental fatigue, decreased motivation, or sleepiness, and thus prevents at least one of mental fatigue, decreased motivation, or sleepiness. It is possible to prepare and provide oral compositions (oral pharmaceuticals, oral quasi-drugs, food and drink products) that are highly effective in preventing or improving any of the following.
以下、本発明の精神性疲労、意欲低下または眠気の改善剤、及び、黒大豆種皮抽出物の使用方法、製造方法について、実施形態を示して説明する。ただし、本発明は以下に説明する実施形態に限定されるものではない。
また、本発明においては、「予防」とは、疲労やストレスの負荷が生じる前の平常時における精神性疲労、眠気を軽減する、意欲を向上する効果(予防効果)を意味し、「改善」とは、疲労やストレスの負荷が生じた後(直後)における精神性疲労、眠気を抑制する、意欲を維持または低下抑制する効果(改善効果)を意味するものとする。
EMBODIMENT OF THE INVENTION Hereinafter, embodiments will be shown and explained about the method for using and producing the agent for improving mental fatigue, decreased motivation, or sleepiness, and the black soybean seed coat extract of the present invention. However, the present invention is not limited to the embodiments described below.
In addition, in the present invention, "prevention" means the effect of reducing mental fatigue and sleepiness and improving motivation (preventive effect) in normal times before fatigue and stress loads occur, and "improvement" means the effect (improving effect) of suppressing mental fatigue and drowsiness and maintaining or suppressing the decline of motivation after (immediately after) fatigue and stress loads occur.
(1)精神性疲労、意欲低下または眠気の改善剤
本発明の精神性疲労、意欲低下または眠気の改善剤(以下、単に「本改善剤」とも称する)は、黒大豆種皮の抽出物を有効成分とすることを特徴とする。
(1) Agent for improving mental fatigue, decreased motivation, or drowsiness The agent for improving mental fatigue, decreased motivation, or drowsiness of the present invention (hereinafter also simply referred to as "this improving agent") is an effective agent for improving mental fatigue, decreased motivation, or drowsiness (hereinafter also simply referred to as "this improving agent"). It is characterized by being an ingredient.
本発明において用いられる黒大豆とは、マメ科ダイズ属Glycine max(L.)Merrillに属する短日性の一年生草木の黒い種子(子実)(黒大豆)である。黒大豆には、例えば中生光黒、トカチクロ、いわいくろ、玉大黒、丹波黒、信濃黒及び雁喰などの品種があるが、黒大豆であればどの品種の種子を使用しても良い。 The black soybean used in the present invention is the black seed (grain) (black soybean) of a short-day annual plant belonging to the family Fabaceae, genus Glycine max (L.) Merrill. There are varieties of black soybeans, such as Nakasei Kokuro, Tokachikuro, Iwaikuro, Tamadaikoku, Tambaguro, Shinanoguro, and Gankui, but seeds of any black soybean variety may be used.
黒大豆を、例えば分別機等に供することで種皮と胚(子葉および胚軸)とに分別することができる。本発明では当該分別により得られる黒大豆の種皮を加工原料として使用することができる。加工処理に際して、黒大豆の種皮は、分別したそのままの状態(生または乾燥物)のものであっても、またそれを破砕若しくは粉砕した状態のもの(破砕物、粉砕物、及び粉末状物を含む)であってもよい。 Black soybeans can be separated into seed coats and embryos (cotyledons and hypocotyls) by, for example, using a sorting machine. In the present invention, the seed coat of black soybean obtained by the separation can be used as a processing raw material. During processing, black soybean seed coats may be separated and left as they are (raw or dried), or they may be crushed or ground (crushed, pulverized, or powdered). ).
黒大豆種皮からの抽出方法としては、一般に用いられる方法を利用することができる。制限はされないが、例えば水溶性溶媒中に生または乾燥処理した黒大豆種皮(そのままの形状、若しくは粗末、細切、破砕、粉砕状)を浸漬する方法;必要に応じて攪拌しながら抽出する方法;またはパーコレーション法等を挙げることができる。抽出に使用する温度条件は、特に制限されず、低温、常温、加温条件(高温を含む)のいずれの条件でもよいが、好ましくは抽出効率が高まる加温条件(高温を含む)である。より具体的には、後述の含水低級アルコールで抽出する場合は30℃以上、好ましくは40℃~60℃の範囲であり、制限されないものの、かかる温度条件での抽出を60分以上、好ましくは90分~120分程度行なうことで目的とする黒大豆種皮成分(抽出物)を十分に抽出することができる。また、酸性水溶液で抽出する場合は、50℃以上、好ましくは50~80℃の範囲であり、制限されないものの、かかる温度条件での抽出を10分以上、好ましくは20分~120分程度行う。 As a method for extraction from black soybean seed coat, commonly used methods can be used. Examples include, but are not limited to, a method of immersing raw or dried black soybean seed coat (as is, or in coarse, finely chopped, crushed, or pulverized form) in a water-soluble solvent; a method of extraction with stirring as necessary; ; or a percolation method. The temperature conditions used for extraction are not particularly limited, and may be any of low temperature, room temperature, and heating conditions (including high temperatures), but preferably heating conditions (including high temperatures) that increase extraction efficiency. More specifically, in the case of extraction with a water-containing lower alcohol described below, the temperature is 30°C or higher, preferably in the range of 40°C to 60°C, and although not limited, extraction at such temperature conditions is carried out for 60 minutes or more, preferably 90°C. The desired black soybean seed coat component (extract) can be sufficiently extracted by performing this for about 120 minutes. In addition, when extracting with an acidic aqueous solution, the temperature is 50° C. or higher, preferably in the range of 50 to 80° C., and although not limited, extraction is carried out at such temperature conditions for 10 minutes or more, preferably about 20 minutes to 120 minutes.
抽出に使用する水溶性溶媒としては、特に制限されないが、水、低級アルコール、またはこれらの混合物を挙げることができる。低級アルコールとしては、メタノール、エタノール、プロパノール及びイソプロピルアルコール、ブタノール等の炭素数1~4の低級アルコールを例示することができる。低級アルコールとして好ましくはエタノールを挙げることができる。水溶性溶媒として好ましくは、水、または含水低級アルコール(特に含水エタノール)であり、より好ましくは抽出時または精製時の作業容易性が高い水である。尚、含水低級アルコールを溶媒として使用する場合、それに含まれる低級アルコール量は80容量%以下であることが好ましい。 The water-soluble solvent used for extraction includes, but is not particularly limited to, water, lower alcohols, or mixtures thereof. Examples of the lower alcohol include lower alcohols having 1 to 4 carbon atoms such as methanol, ethanol, propanol, isopropyl alcohol, and butanol. Ethanol can be preferably mentioned as the lower alcohol. The water-soluble solvent is preferably water or a water-containing lower alcohol (especially water-containing ethanol), and more preferably water because of its ease of extraction or purification. In addition, when using a water-containing lower alcohol as a solvent, it is preferable that the amount of lower alcohol contained therein is 80% by volume or less.
抽出に使用する水溶性溶媒は黒大豆種皮成分(抽出物)の安定性等を高める目的で酸性に調整されていることが好ましい。特に制限されないが、水溶性溶媒のpH範囲は、好ましくはpH1~4程度の範囲であり、特にpH1~2の範囲であることが好ましい。水溶性溶媒のpHを、かかる範囲になるように調整するため、通常、有機酸や無機酸などの適当な酸性物質を用いることができる。 The water-soluble solvent used for extraction is preferably adjusted to be acidic for the purpose of increasing the stability of the black soybean seed coat component (extract). Although not particularly limited, the pH range of the water-soluble solvent is preferably about 1 to 4, particularly preferably about 1 to 2. In order to adjust the pH of the water-soluble solvent to fall within this range, an appropriate acidic substance such as an organic acid or an inorganic acid can usually be used.
酸性物質として、具体的には、塩酸、硫酸、硝酸、リン酸、ホウ酸などの無機酸;並びにメタンスルホン酸、ベンゼンスルホン酸、p-トルエンスルホン酸、10-カンファースルホン酸、フルオロスルホン酸(以上、スルホン酸)、ギ酸、酢酸、クエン酸、シュウ酸(以上、カルボン酸)などの有機酸を挙げることができる。好ましくはスルホ基を有する酸であり、具体的には硫酸、メタンスルホン酸、ベンゼンスルホン酸、p-トルエンスルホン酸、10-カンファースルホン酸、及びフルオロスルホン酸を挙げることができる。中でも好ましくは硫酸である。なお、水溶性溶媒における酸の規定度は、水溶性溶媒が上記pH範囲になるような範囲であれば特に制限されないものの、好ましくは0.01~0.5Nの範囲、より好ましくは0.03~0.5Nの範囲である。 Examples of acidic substances include inorganic acids such as hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, and boric acid; as well as methanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, 10-camphorsulfonic acid, and fluorosulfonic acid ( Examples include organic acids such as sulfonic acid), formic acid, acetic acid, citric acid, and oxalic acid (carboxylic acid). Acids having a sulfo group are preferred, and specific examples include sulfuric acid, methanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, 10-camphorsulfonic acid, and fluorosulfonic acid. Among them, sulfuric acid is preferred. Note that the normality of the acid in the water-soluble solvent is not particularly limited as long as the pH of the water-soluble solvent is within the above pH range, but is preferably in the range of 0.01 to 0.5N, more preferably 0.03N. ~0.5N.
得られた抽出液は、そのままでも本改善剤として使用することができるが、必要に応じて、さらにろ過、共沈または遠心分離による固形物の除去、活性炭処理、吸着処理等の精製処理を行ってもよい。 The obtained extract can be used as it is as this improving agent, but if necessary, it can be further purified by filtration, coprecipitation or centrifugation to remove solids, activated carbon treatment, adsorption treatment, etc. It's okay.
斯くして調製される黒大豆種皮抽出物は、そのままでも本改善剤として使用することができるが、服用の観点や飲食物製造の観点から、濃縮処理または/及び乾燥処理してもよい。さらに必要に応じて、該抽出液の細菌数の低減や保存性を高める目的で、本発明の効果を損なわない範囲において、前記加工処理の前または後にUHT殺菌、レトルト殺菌処理といった公知の方法による殺菌処理を行ってもよい。なお、本発明における黒大豆種皮抽出物とは、抽出液、該抽出液の希釈液もしくは濃縮液、または該抽出物を乾燥して得られる乾燥物のいずれかを意味するものとする。 The black soybean seed coat extract prepared in this manner can be used as it is as the present improving agent, but from the viewpoint of administration and food and drink production, it may be subjected to concentration treatment and/or drying treatment. Furthermore, if necessary, for the purpose of reducing the number of bacteria and improving the preservability of the extract, a known method such as UHT sterilization or retort sterilization may be applied before or after the processing to the extent that the effects of the present invention are not impaired. Sterilization treatment may also be performed. In addition, the black soybean seed coat extract in the present invention shall mean either an extract, a diluted or concentrated solution of the extract, or a dried product obtained by drying the extract.
本改善剤は、経口投与形態であれば、その形態を特に問わない。また経口投与(経口摂取)形態を有するものである限り、その用途の別(医薬品、医薬部外品、飲食物[特定保健用食品、機能性表示食品、栄養機能性食品などの保健機能性食品やサプリメントを含む])は、特に制限されるものではない。また、本改善剤は、ヒト以外の動物(家畜や家禽、ペットを含む)を対象とした飼料やペットフードに適用されるものであってもよい。さらに本改善剤は、医薬品、医薬部外品、飲食物、飼料またはペットフードに対して添加される添加剤であってもよい。 The form of the improving agent is not particularly limited as long as it is in an oral administration form. In addition, as long as it has an oral administration (oral ingestion) form, it can be classified according to its use (drugs, quasi-drugs, food and drink [foods with health functions such as foods for specified health uses, foods with functional claims, and foods with nutritional functions)]. and supplements]) are not particularly limited. Further, the present improving agent may be applied to feed or pet food for animals other than humans (including livestock, poultry, and pets). Furthermore, the improving agent may be an additive added to pharmaceuticals, quasi-drugs, foods and drinks, feed, or pet food.
経口投与形態として、具体的には、上記抽出方法により調製される抽出液を液剤(エキス形態やシロップを含む)またはゼリー剤の形態に調製したもの;抽出液を常法により粉末状または顆粒状に製剤化した散剤、細粒剤、または顆粒剤;液剤や散剤または顆粒剤をカプセルに充填したカプセル剤(硬質カプセル剤、軟質カプセル剤);または粉末または顆粒をさらに打錠して錠剤形態としたものなどを挙げることができる(固形製剤)。 Specifically, the oral dosage form includes the extract prepared by the above extraction method in the form of a liquid (including extract form and syrup) or jelly; Powders, fine granules, or granules formulated into capsules; capsules (hard capsules, soft capsules) filled with liquids, powders, or granules; or powders or granules that are further compressed to form tablets. (solid preparations).
本改善剤は、上記黒大豆種皮抽出物と薬学的に、または食品や飼料として許容される従来公知の可食性の担体、賦形剤等を組み合わせて各種剤型(経口投与形態)に調製することもできる。 The present improving agent is prepared into various dosage forms (oral dosage forms) by combining the black soybean seed coat extract with conventionally known edible carriers, excipients, etc. that are pharmaceutically acceptable or acceptable as food or feed. You can also do that.
本改善剤を液状製剤の形態とする場合、担体として当該分野で従来公知のものを広く使用できる。その例としては、例えば液剤及びシロップ剤の製造に適切な添加物は、例えば、水、エタノール、ショ糖、転化糖、ブドウ糖、マルトース、還元水あめ等を使用できる。 When the present improving agent is in the form of a liquid preparation, a wide variety of carriers conventionally known in the art can be used as carriers. By way of example, suitable additives for the production of solutions and syrups can be used, such as water, ethanol, sucrose, invert sugar, glucose, maltose, reduced starch syrup, and the like.
本改善剤を固形剤の形態とする場合、例えば、錠剤の場合であれば、担体として当該分野で従来公知のものを広く使用することができる。このような担体としては、例えば乳糖、白糖、塩化ナトリウム、ブドウ糖、尿素、デンプン、炭酸カルシウム、カオリン、ケイ酸等の賦形剤;水、エタノール、プロパノール、単シロップ、ブドウ糖液、デンプン液、ゼラチン溶液、カルボキシメチルセルロース、セラック、メチルセルロース、リン酸カリウム、ポリビニルピロリドン、結晶セルロース、ヒドロキシプロピルセルロース、ヒプロメロース、アルギン酸ナトリウム等の結合剤;乾燥デンプン、カンテン末、ラミナラン末、炭酸水素ナトリウム、ポリオキシエチレンソルビタン脂肪酸エステル類、ラウリル硫酸ナトリウム、ステアリン酸モノグリセリド、デンプン、クロスポビドン、ポビドン、低置換度ヒドロキシプロピルセルロース等の崩壊剤;ステアリン、カカオバター、水素添加油等の崩壊抑制剤;第4級アンモニウム塩、ラウリル硫酸ナトリウム等の吸収促進剤;グリセリン等の保湿剤;デンプン、乳糖、カオリン、ベントナイト、コロイド状ケイ酸等の吸着剤;精製タルク、ステアリン酸塩、ホウ酸末、ポリエチレングリコール等の滑沢剤等を使用できる。さらに錠剤は、必要に応じ通常の剤皮を施した錠剤、例えば糖衣錠、ゼラチン被包錠、腸溶被錠、フィルムコーティング錠あるいは二重錠、多層錠とすることができる。また、前記有効成分を含有する組成物を、ゼラチン、プルラン、デンプン、アラビアガム、ヒドロキシプロピルメチルセルロース(HPMC)等を原料とする従来公知のカプセルに充填して、カプセル剤とすることができる。 When the present improving agent is in the form of a solid preparation, for example, in the case of a tablet, a wide variety of carriers conventionally known in the art can be used as the carrier. Such carriers include, for example, excipients such as lactose, sucrose, sodium chloride, glucose, urea, starch, calcium carbonate, kaolin, and silicic acid; water, ethanol, propanol, simple syrup, glucose solution, starch solution, and gelatin. Solution, binder such as carboxymethylcellulose, shellac, methylcellulose, potassium phosphate, polyvinylpyrrolidone, crystalline cellulose, hydroxypropylcellulose, hypromellose, sodium alginate; dried starch, agar powder, laminaran powder, sodium bicarbonate, polyoxyethylene sorbitan fatty acid Disintegrants such as esters, sodium lauryl sulfate, stearic acid monoglyceride, starch, crospovidone, povidone, and low-substituted hydroxypropylcellulose; disintegration inhibitors such as stearin, cocoa butter, and hydrogenated oil; quaternary ammonium salts, lauryl Absorption enhancers such as sodium sulfate; humectants such as glycerin; adsorbents such as starch, lactose, kaolin, bentonite, colloidal silicic acid; lubricants such as purified talc, stearate, boric acid powder, polyethylene glycol, etc. can be used. Furthermore, the tablets may be coated with a conventional coating if necessary, such as sugar-coated tablets, gelatin-encapsulated tablets, enteric-coated tablets, film-coated tablets, double tablets, or multilayer tablets. Furthermore, the composition containing the active ingredient can be filled into conventionally known capsules made from gelatin, pullulan, starch, gum arabic, hydroxypropyl methylcellulose (HPMC), etc., to form capsules.
また、丸剤の形態とする場合、担体として当該分野で従来公知のものを広く使用できる。その例としては、例えばブドウ糖、乳糖、デンプン、カカオ脂、硬化植物油、カオリン、タルク等の賦形剤、アラビアゴム末、トラガント末、ゼラチン、エタノール等の結合剤、ラミナラン、カンテン等の崩壊剤等を使用できる。 In addition, when it is in the form of a pill, a wide variety of carriers conventionally known in the art can be used as carriers. Examples include excipients such as glucose, lactose, starch, cocoa butter, hydrogenated vegetable oil, kaolin, and talc, binders such as gum arabic powder, tragacanth powder, gelatin, and ethanol, and disintegrants such as laminaran and agar. can be used.
上記以外に、添加剤として、例えば、界面活性剤、吸収促進剤、吸着剤、充填剤、防腐剤、安定剤、乳化剤、可溶化剤など、製剤の形態に応じて適宜選択し使用することができる。 In addition to the above, additives such as surfactants, absorption enhancers, adsorbents, fillers, preservatives, stabilizers, emulsifiers, and solubilizers may be selected and used as appropriate depending on the form of the formulation. can.
これらの形態はいずれも当該分野における通常の方法を用いて調製でき、例えば、錠剤は、上記有効成分とその他錠剤を得るために必要な賦形剤等を適宜添加し、よく混合分散させたのち打錠して得ることができる。また、散剤は、上記有効成分とその他散剤を得る為に必要な賦形剤等を適宜添加し、好適な方法にて混合、粉体化して得ることができる。 All of these forms can be prepared using methods commonly used in the field; for example, tablets can be prepared by adding the above active ingredient and other excipients necessary to obtain tablets, mixing and dispersing them thoroughly, and then It can be obtained by compressing into tablets. Further, the powder can be obtained by appropriately adding the above-mentioned active ingredient and other excipients necessary for obtaining the powder, and mixing and pulverizing the mixture by a suitable method.
本改善剤は、前述する製剤形態のほか、通常の飲食物の形態を有するものであってもよい。当該飲食物は、前述する黒大豆種皮抽出物または後述する黒大豆種皮抽出物を含有する添加剤を種々の飲食物に添加することにより製造することができる。飲食物は、溶液、懸濁液、乳濁液、ゼリー(ゲル)、ゾル、粉末、固体成形物など、経口摂取可能な形態であればよく、特に限定されない。具体的には、例えば、即席麺、レトルト食品、缶詰、電子レンジ食品、即席スープ・みそ汁類、フリーズドライ食品などの即席食品類;清涼飲料、果汁飲料、野菜飲料、豆乳飲料、コーヒー飲料、茶飲料、粉末飲料、濃縮飲料、栄養飲料、アルコール飲料などの飲料類;パン、パスタ、麺、ケーキミックス、唐揚げ粉、パン粉などの小麦粉製品;飴、キャラメル、チューイングガム、チョコレート、クッキー、ビスケット、ケーキ、パイ、スナック、クラッカー、和菓子、デザート菓子などの菓子類;ソース、トマト加工調味料、風味調味料、調理ミックス、たれ類、ドレッシング類、つゆ類、カレー・シチューの素類などの調味料;加工油脂、バター、マーガリン、マヨネーズなどの油脂類;乳飲料、ヨーグルト類、チーズ、発酵乳、乳酸菌飲料、アイスクリーム類、クリーム類などの乳製品;プリンやマヨネーズなどの卵加工品;魚肉ハム・ソーセージ、水産練り製品などの水産加工品;畜肉ハム・ソーセージなどの畜産加工品;農産缶詰、ジャム・マーマレード類、漬け物、煮豆、シリアルなどの農産加工品;冷凍食品、栄養食品などを挙げることができる。制限されないものの、黒大豆種皮抽出物由来のポリフェノールは酸性側で安定性が高いことから沈殿や色味の低下を抑制するという点からは、好ましくは酸性の食品とすることが好ましい。 In addition to the above-mentioned formulation form, the present improving agent may be in the form of a normal food or drink. The food and drink can be produced by adding an additive containing the black soybean seed coat extract described above or the black soybean seed coat extract described below to various foods and drinks. The food and drink may be in any form that can be orally ingested, such as a solution, suspension, emulsion, jelly (gel), sol, powder, or solid molded product, and is not particularly limited. Specifically, instant foods such as instant noodles, retort foods, canned foods, microwave foods, instant soups/miso soups, and freeze-dried foods; soft drinks, fruit juice drinks, vegetable drinks, soy milk drinks, coffee drinks, and tea. Beverages such as beverages, powdered drinks, concentrated drinks, nutritional drinks, and alcoholic drinks; Flour products such as bread, pasta, noodles, cake mixes, fried chicken powder, and bread crumbs; Candy, caramel, chewing gum, chocolate, cookies, biscuits, and cakes Confectionery such as pies, snacks, crackers, Japanese sweets, and desserts; Seasonings such as sauces, processed tomato seasonings, flavor seasonings, cooking mixes, sauces, dressings, soups, and curry/stew ingredients; Fats and oils such as processed oils, butter, margarine, and mayonnaise; Dairy products such as milk drinks, yogurts, cheese, fermented milk, lactic acid bacteria drinks, ice creams, and creams; Processed egg products such as puddings and mayonnaise; Fish, meat, ham, Processed seafood products such as sausages and fish paste products; Processed livestock products such as meat hams and sausages; Processed agricultural products such as canned agricultural products, jams and marmalades, pickles, boiled beans, and cereals; Frozen foods, nutritional foods, etc. . Although not limited, polyphenols derived from black soybean seed coat extract are highly stable on the acidic side, so it is preferable to use acidic foods from the viewpoint of suppressing precipitation and deterioration of color.
また本改善剤は、通常の飼料やペットフードの形態を有するものであってもよい。これらの当該飼料やペットフードも、前述する黒大豆種皮抽出物を種々の飼料やペットフードに添加することにより製造することができる。 Further, the present improving agent may be in the form of ordinary feed or pet food. These feeds and pet foods can also be produced by adding the above-mentioned black soybean husk extract to various feeds and pet foods.
本改善剤における黒大豆種皮抽出物の含有量は、100質量%を上限として、前述する形態の種類や用途の種類(医薬品、食品、飼料・ペットフード等)等に応じて適宜設定することができる。本改善剤の投与量(摂取量)は、ヒトや動物の種類、被験者の性別や年齢、被験者の状態や症状の程度によって適宜変更され得る。制限されないものの、例えば、ヒト成人一人(体重50kg)に対する1日あたりの投与量(摂取量)は、本改善剤に含まれる黒大豆種皮抽出物(乾燥量)の量に換算して通常10~500mg程度を挙げることができる。通常、一日1回または2~3回に分けて経口投与(摂取)の形態で用いられる。服用時刻は、特に限定されず、例えば朝、昼、晩の食事時のいずれか1以上の時間帯を例示することができる。また制限されないが、食事と一緒、または食前若しくは食後の30分以内であってもよい。
The content of black soybean husk extract in this improving agent can be set as appropriate depending on the type of form and type of use (medicines, foods, feed/pet food, etc.) mentioned above, with the upper limit being 100% by mass. can. The dose (intake amount) of the present improving agent may be changed as appropriate depending on the type of human or animal, the sex and age of the subject, and the condition and severity of symptoms of the subject. Although not limited, for example, the daily dose (intake) for one adult human (
本改善剤の対象者は、疲労やストレスの自覚症状を有する者であるか、そうした疲労やストレスの予防を要望する者であればよく、この限りにおいて特に制限されない。これらの者には、VDT(Visual Display Terminal)作業またはこれと類似するデスクワーク作業に従事する者や、認知機能低下、慢性疲労症候群、鬱、慢性疲労、おっくう感、意欲低下、集中力低下、記憶力低下、判断力低下などの脳機能低下の自覚症状を有する者や、これらの予防効果を享受する必要またはそれを要望する者も含まれる。 The subject of this improving agent may be a person who has subjective symptoms of fatigue or stress, or a person who desires the prevention of such fatigue or stress, and is not particularly limited in this regard. These include those who engage in VDT (Visual Display Terminal) work or similar desk work, and those who suffer from decreased cognitive function, chronic fatigue syndrome, depression, chronic fatigue, feeling of restlessness, decreased motivation, decreased concentration, and poor memory. This also includes people who have subjective symptoms of brain function decline, such as decline in brain function and impaired judgment, and people who need or desire to enjoy these preventive effects.
本改善剤を経口的に服用(投与、摂取)することにより、精神性疲労、意欲低下または眠気を予防または改善することができる。本改善剤の服用(投与、摂取)により、精神性疲労、意欲低下または眠気を予防または改善する効果は、VAS(Visual Analogue Scale)検査によって評価、確認することができる。 By orally taking (administering, ingesting) this improving agent, mental fatigue, loss of motivation, or drowsiness can be prevented or improved. The effect of preventing or improving mental fatigue, loss of motivation, or sleepiness by taking (administering, ingesting) the present improving agent can be evaluated and confirmed by a VAS (Visual Analogue Scale) test.
(2)黒大豆種皮抽出物の使用方法
本発明はまた、黒大豆種皮抽出物の使用方法を提供する。
その使用方法の1つは、経口組成物に対して、精神性疲労、意欲低下または眠気を予防または改善する作用を付与するための黒大豆種皮抽出物の使用方法である。
(2) Method of using black soybean seed coat extract The present invention also provides a method of using black soybean seed coat extract.
One method of using the black soybean hull extract is to impart an effect of preventing or improving mental fatigue, loss of motivation, or drowsiness to an oral composition.
当該方法は、黒大豆種皮抽出物が有する精神性疲労、意欲低下または眠気を予防または改善する作用に基づいて、対象とする経口組成物を製造するための、前記抽出物の使用方法を用いることができる。なお、黒大豆種皮抽出物に代えて、黒大豆種皮抽出物を有効成分とする前述する本改善剤を用いることもできる。 The method involves using the method for using the extract to produce a target oral composition based on the effect of black soybean seed coat extract to prevent or improve mental fatigue, loss of motivation, or sleepiness. I can do it. In addition, instead of the black soybean seed coat extract, the above-mentioned present improving agent containing a black soybean seed coat extract as an active ingredient can also be used.
対象とする経口組成物には、人に対して経口的に投与する組成物または人が摂取する組成物、具体的には経口医薬品、経口医薬部外品、及び飲食物が含まれる。好ましくは飲食物である。また非ヒト動物を対象とする場合、経口組成物として、飼料やペットフードを用いることができる。 Targeted oral compositions include compositions that are orally administered to humans or compositions that are ingested by humans, specifically oral pharmaceuticals, oral quasi-drugs, and foods and drinks. Preferably it is food and drink. Furthermore, when targeting non-human animals, feed or pet food can be used as the oral composition.
本発明の方法で用いる黒大豆種皮抽出物の原料として使用する黒大豆の種類、黒大豆種皮の取得方法、黒大豆種皮抽出物、特に抽出物の好適な一態様である黒大豆種皮酸性抽出物の調製方法は、上記(1)で説明した通りであり、本欄において援用することができる。経口組成物に対する黒大豆種皮抽出物の配合量は、経口組成物に、疲労を改善する作用が付与できる量であればよく、その限りにおいて特に制限されない。その評価は、被験者に黒大豆種皮抽出物を配合した経口組成物(対象組成物)を継続的に摂取させた場合と、被験者に黒大豆種皮抽出物を配合しない経口組成物(比較組成物)を継続的に摂取させた場合とで、VAS(Visual Analogue Scale)検査によって評価、確認することができる。 The type of black soybean used as a raw material for the black soybean seed coat extract used in the method of the present invention, the method for obtaining black soybean seed coat, the black soybean seed coat extract, especially the black soybean seed coat acidic extract that is a preferred embodiment of the extract. The preparation method is as explained in (1) above, and can be cited in this section. The amount of the black soybean hull extract added to the oral composition is not particularly limited as long as it can impart an effect of improving fatigue to the oral composition. The evaluation was conducted when subjects continuously ingested an oral composition containing black soybean seed coat extract (target composition) and when subjects took an oral composition containing no black soybean coat extract (comparison composition). It can be evaluated and confirmed by VAS (Visual Analogue Scale) test.
以下に実験例を示して本発明をより詳細に説明するが、本発明はこれらに限定されない。 The present invention will be explained in more detail by showing experimental examples below, but the present invention is not limited thereto.
〔実施例1〕黒大豆種皮抽出物の精神性疲労、意欲低下、眠気の改善効果
最初に黒大豆種皮抽出物および試験食の調製方法、次いで精神性疲労、意欲低下、眠気の改善に関する試験方法とその結果について説明する。
[Example 1] Effect of black soybean hull extract on improving mental fatigue, decreased motivation, and sleepiness Firstly, a method for preparing black soybean hull extract and test food, and then a test method for improving mental fatigue, decreased motivation, and sleepiness. and the results will be explained.
〔黒大豆種皮抽出物〕
黒大豆種皮抽出物(酸性熱水抽出物)は下記の方法により調製した。
(1)黒大豆種皮(生)1kgを抽出溶媒として希硫酸(0.3%w/v)30Lに浸漬し、55~60℃に加熱しながら20分間撹拌抽出する。
(2)抽出後、黒大豆種皮と液とを固液分離し、液を回収する。
(3)回収した液を遠心分離を行ない、固液分離では取り除けない浮遊固形物を除去する。
(4)得られた抽出液を合成吸着樹脂(セパビーズSP700:三菱化学(株)製)を入れたカラムに投入し、樹脂に吸着させる。
(5)カラム内に残存する硫酸を洗い流すため、カラムに水を通液して樹脂を洗浄する。
(6)カラムに59容量%濃度のアルコ-ル水溶液を通液して、樹脂に吸着されたポリフェノールを溶出させる。
(7)回収した溶出液(アルコール溶液)を減圧下で加熱することにより蒸発させ、濃縮する。
(8)得られた濃縮液に、賦形剤としてデキストリンを添加する。
(9)加熱殺菌する。
(10)加熱殺菌後の濃縮液を噴霧乾燥して黒大豆種皮抽出物(85g、ポリフェノール含量61.1%)を得た。
[Black soybean seed coat extract]
A black soybean seed coat extract (acidic hot water extract) was prepared by the following method.
(1) Immerse 1 kg of black soybean seed coat (raw) in 30 L of dilute sulfuric acid (0.3% w/v) as an extraction solvent, and stir and extract for 20 minutes while heating to 55-60°C.
(2) After extraction, solid-liquid separation is performed between black soybean seed coat and liquid, and the liquid is collected.
(3) The collected liquid is centrifuged to remove suspended solids that cannot be removed by solid-liquid separation.
(4) The obtained extract is put into a column containing a synthetic adsorption resin (Sepabeads SP700: manufactured by Mitsubishi Chemical Corporation) and adsorbed by the resin.
(5) To wash away the sulfuric acid remaining in the column, water is passed through the column to wash the resin.
(6) Aqueous alcohol solution with a concentration of 59% by volume is passed through the column to elute polyphenols adsorbed on the resin.
(7) The collected eluate (alcohol solution) is evaporated and concentrated by heating under reduced pressure.
(8) Add dextrin as an excipient to the obtained concentrate.
(9) Heat sterilize.
(10) The concentrated solution after heat sterilization was spray-dried to obtain a black soybean hull extract (85 g, polyphenol content 61.1%).
〔試験食〕
試験食は、黒大豆種皮抽出物含有食(被検食)、及び対照食(プラセボ)を用いた。試験食の配合を以下に示す。
(被検食) 黒大豆種皮抽出物100mg(ポリフェノール含量61.1%)とデキストリン110mgを含有するカプセル剤(合計210mg)
(プラセボ) デキストリン250mgを含有するカプセル剤
なお、プラセボは、熱量等において、被験食と大きな差がないように作製された。表1に各試験食の栄養成分表を示した。
[Test meal]
The test foods used were a black soybean husk extract-containing food (test food) and a control food (placebo). The composition of the test food is shown below.
(Test food) Capsules containing 100 mg of black soybean seed coat extract (polyphenol content 61.1%) and 110 mg of dextrin (210 mg in total)
(Placebo) Capsules containing 250 mg of dextrin The placebo was prepared so that there was no significant difference from the test food in terms of calorific value, etc. Table 1 shows the nutritional information for each test meal.
〔試験方法〕
(被験者)
被験者は、年齢が20歳以上65歳未満の健常者である男女の計21名とし、また、本試験参加に際し、事前に当該試験の説明を受け、その内容が理解でき、趣旨に賛同できる者であり、被験者本人による文書同意が得られる者とした。ただし、大豆アレルギーの者、薬を常用している者、妊娠中の者など本試験を実施するのに不適当と認めたものは除外した。
(試験食の摂取)
試験食は、1日1粒を夕食後に4週間継続して摂取させた。なお、試験期間中、抗酸化物質を多く含む健康食品など抗疲労作用を有する可能性がある飲食物については摂取を禁止した。
(試験方法)
試験デザインは、ランダム化二重盲検並行群間比較試験とした。図1に試験デザインを示した。
試験方法は、摂取開始時検査日、摂取2週間後および4週間後検査日に精神作業負荷を設定した。なお、検査日と前日はアルコール、コーヒーの摂取を禁止した。
(精神作業負荷)
精神作業負荷は、VDT(Visual Display Terminal)作業による疲労負荷として、2-back課題30分間、およびATMT(Advanced Trail Making Test,ABC課題)30分間の計1時間を1セットとし、2セット(2時間)実施した。
(1)2-back課題
3秒毎にランダムにアルファベットがパソコンの画面上に表示され、現在表示されているアルファベットと2つ前に表示されたアルファベットが同じであれば右クリック、異なっていれば左クリックする短期記憶課題とした。
(2)ATMT (ABC課題)
パソコンの画面上にランダムに表示された1から25までの25個の数字を1から25まで順にすばやくクリックしていく視覚探索課題。A、B、Cの3種類の課題を順に実施した。A課題は1から25までの数字の配置が変わらない課題、B課題は1から25の配置は変わらないが、クリックした数字が消えて26以降の新たな数字が追加される課題、C課題はB課題に加えてさらに25までの数字の配置が変わる課題とした。
〔Test method〕
(subject)
The subjects were a total of 21 healthy men and women aged between 20 and under 65. Those who participated in this study were required to receive an explanation of the study in advance, understand its contents, and agree with its purpose. Subjects were required to provide written informed consent. However, those deemed unsuitable for this study, such as those with a soybean allergy, those who regularly take medicine, and those who are pregnant, were excluded.
(Intake of test food)
The test food was one tablet per day after dinner for 4 weeks. During the test period, participants were prohibited from consuming foods and drinks that may have anti-fatigue effects, such as health foods rich in antioxidants.
(Test method)
The study design was a randomized, double-blind, parallel-group comparative study. Figure 1 shows the study design.
As for the test method, mental workload was set on the test day at the start of intake, and on the
(mental workload)
The mental workload was calculated as fatigue load due to VDT (Visual Display Terminal) work, and 2 sets (2 time) was carried out.
(1) 2-back task Alphabets are displayed randomly on the computer screen every 3 seconds. If the currently displayed alphabet is the same as the alphabet displayed two places ago, right-click; if they are different, click the right button. The short-term memory task involved left-clicking.
(2) ATMT (ABC assignment)
A visual search task in which you quickly click 25 numbers from 1 to 25 in order, which are displayed randomly on a computer screen. Three types of tasks, A, B, and C, were performed in order. Task A is a task where the arrangement of numbers 1 to 25 does not change, task B is a task where the arrangement of numbers 1 to 25 does not change, but the clicked number disappears and new numbers after 26 are added, task C is a task In addition to task B, the task involved changing the arrangement of the numbers up to 25.
(検査項目)
本試験では日本疲労学会の定める抗疲労臨床評価ガイドラインをもとに、主要評価項目をVAS(Visual Analogue Scale)検査における疲労感スコア、副次評価項目を作業能率評価(ATMT(Advanced Trail Making Test,ABC課題)とした。
(1)VAS(Visual Analogue Scale)検査
摂取開始時検査日、摂取2週間後検査日、及び摂取4週間後検査日の負荷前、負荷後にVAS検査を実施した。質問項目は、疲労感、意欲、眠気とした。
VASについては疲労感の評価方法として日本疲労学会で推奨されている。VASの自己評価スコアは、長さ10.0cmの水平な直線を提示し、両端をそれぞれの左端を最も否定的(感じない)、右端をもっとも肯定的(感じる)とし、各質問項目に対する被験者自身の感覚がどの程度のレベルに位置するか、その線分上に印を記入させた。評価結果の測定は、各被験者が印した点の位置を左端からの距離として測定し、数値化した。最も否定的な端(左端)を0点、最も肯定的な端(右端)を10.0点とした。
(2)作業能率評価(ATMT(Advanced Trail Making Test,ABC課題)
検査日のVDT(Visual Display Terminal)作業2時間におけるATMT(ABC課題)の平均反応時間、試行数、エラー数により作業能率評価を行い、課題間の意向時間により意欲の客観評価を行った。
(3)生活記録日誌
試験期間中毎日、睡眠時間、就業時間、ライフイベント、試験食摂取状況について記入させた。
(4)統計学的処理
試験データを集計し、項目ごとに統計解析を行った。統計処理ソフトはSPSS Ver.22.0(日本アイ・ビー・エム(株))を使用し、試験条件間の比較においては、対応のないt検定を実施した。ただし、データが正規分布から逸脱していると考えられる場合はMann-WhitneyのU検定を実施した。有意水準は両側検定で5%とし、10%を傾向ありとした。また、対応のないデータの平均を t 検定で検定する際は、G*Power3.1.9.6を用いてα=0.05および1-β=0.8とした場合における統計学的有意差を得るためのサンプルサイズの推定を実施した。
(Inspection item)
In this study, based on the anti-fatigue clinical evaluation guidelines established by the Japan Fatigue Society, the primary endpoint was the fatigue score in the VAS (Visual Analogue Scale) test, and the secondary endpoint was the work efficiency evaluation (ATM (Advanced Trail Making Test). ABC assignment).
(1) VAS (Visual Analogue Scale) Test VAS tests were conducted before and after the test on the test day at the start of intake, on the
VAS is recommended by the Japan Fatigue Society as a method for evaluating fatigue. For the VAS self-evaluation score, a horizontal straight line with a length of 10.0 cm is presented, with the left end being the most negative (not feeling) and the right end being the most positive (feeling). The students were asked to draw a mark on the line to indicate the level of their sensation. The evaluation results were measured by measuring the position of the point marked by each subject as the distance from the left edge and converting it into a numerical value. The most negative end (left end) was given 0 points, and the most positive end (right end) was given 10.0 points.
(2) Work efficiency evaluation (ATMT (Advanced Trail Making Test, ABC task))
Work efficiency was evaluated based on the average reaction time, number of trials, and number of errors in ATMT (ABC task) during 2 hours of VDT (Visual Display Terminal) work on the test day, and motivation was objectively evaluated based on the intention time between tasks.
(3) Daily life record diary During the test period, subjects were asked to fill in their sleeping hours, working hours, life events, and test food intake status every day.
(4) Statistical processing Test data were aggregated and statistical analysis was performed for each item. SPSS Ver. 22.0 (IBM Japan, Inc.) was used as the statistical processing software, and an unpaired t-test was performed for comparisons between test conditions. However, if the data were considered to deviate from a normal distribution, a Mann-Whitney U test was performed. The significance level was 5% with a two-sided test, and 10% was considered to be a trend. In addition, when testing the mean of unpaired data using a t-test, use G*Power 3.1.9.6 to determine the statistically significant difference when α = 0.05 and 1-β = 0.8. Sample size estimation was performed to obtain the results.
〔結果〕
(被験者)
被験者21名をランダムに2グループ(被検食群10名、プラセボ群11名)に割り付けた。2-back課題の正答率が2/3(0.666)以下またはATMT(ABC課題)の課題の移行時間5秒以上の負荷が適切にかかっていない被験者を有効性評価の対象から除外とした。その結果、有効性評価における解析対象者は13名(被検食群7名、プラセボ群6名)であった。図2に被験者のフローチャートを示した。
〔result〕
(subject)
Twenty-one subjects were randomly assigned to two groups (10 in the test food group and 11 in the placebo group). Subjects with a correct answer rate of 2/3 (0.666) or less in the 2-back task or who were not properly loaded with a transition time of 5 seconds or more in the ATMT (ABC task) were excluded from the effectiveness evaluation. As a result, the number of subjects for analysis in the efficacy evaluation was 13 (7 in the test food group, 6 in the placebo group). Figure 2 shows a flowchart for the subjects.
(1)2-back課題
被験食群、プラセボ群ともに、摂取前検査日、摂取2週間検査日および摂取4週間後検査日のすべての検査において、2-back課題の正答率が平均値で0.882と高い正答率であった。ことから本検査において適切な負荷がかかっていることが確認された。図3に結果を示した。
(1) 2-back task For both the test food group and the placebo group, the average correct answer rate for the 2-back task was 0.882 in all tests on the pre-intake test, the 2-week test, and the 4-week post-intake test. The percentage of correct answers was high. Therefore, it was confirmed that an appropriate load was applied in this test. The results are shown in Figure 3.
(2)作業能率評価[ATMT(ABC課題)]
2セットまとめたデータの摂取前検査日からの変化について、被検食群はプラセボ群と比較して、A課題誤数字押し型エラー数が摂取4週間後検査日で減少傾向、B課題誤数字押し型エラー数が摂取4週間後検査日で減少傾向、次のトライアルまでの平均反応時間トータルが摂取2週間後検査日で短縮傾向がみられた。特に、次のトライアルまでの平均反応時間C課題-A課題が摂取2週間後検査日で有意に短縮がみられた(図4)。課題間の移行時間は意欲の客観指標として認知されていることから、黒大豆種皮抽出物の意欲向上効果が確認された。表2、図4に結果を示す(数値は平均値とその標準誤差である。)。
(2) Work efficiency evaluation [AMT (ABC task)]
Regarding changes from the pre-intake test date in the two sets of data, compared to the placebo group in the test food group, the number of incorrect digit pressing errors in task A decreased on the test day 4 weeks after ingestion, and the number of incorrect digits in task B decreased on the test day 4 weeks after ingestion. There was a tendency for the number of pressing errors to decrease on the test day 4 weeks after intake, and a tendency for the total average reaction time until the next trial to shorten on the
(3)VAS(Visual Analogue Scale)検査
実測値について、被検食群はプラセボ群と比較して、精神性疲労感、眠気が摂取4週間後検査日負荷後で低値傾向(図5、図6)、意欲低下が摂取2週間後検査日負荷前で低値傾向がみられた(図7)。この結果から黒大豆種皮抽出物の精神性疲労感抑制(改善)効果、意欲向上(予防)効果、眠気抑制(改善)効果が確認された。図8にVAS実測値の結果を示す(数値は平均値とその標準誤差である。)。
(3) VAS (Visual Analogue Scale) test Regarding the actual measured values, compared to the placebo group, the test food group had lower mental fatigue and sleepiness after 4 weeks of intake and on the test day (Figure 5, 6), there was a tendency for decreased motivation to be low on the day of the test two weeks after intake (Figure 7). From these results, it was confirmed that the black soybean seed coat extract has an effect of suppressing (improving) mental fatigue, an effect of increasing motivation (prevention), and an effect of suppressing (improving) sleepiness. FIG. 8 shows the results of actual VAS measurements (the numerical values are the average value and its standard error).
この結果から、被験食(黒大豆種皮抽出物)を経口摂取することで、精神性疲労、意欲低下、眠気を予防または改善することがわかる。用量の範囲としては、少なくとも今回検討した黒大豆種皮抽出物(酸性熱水抽出物)によれば、乾燥重量として100mg以上の範囲において、本発明の所望の効果が得られることがわかる。 These results show that oral intake of the test food (black soybean seed coat extract) prevents or improves mental fatigue, loss of motivation, and sleepiness. As for the dosage range, at least according to the black soybean seed coat extract (acidic hot water extract) examined this time, it can be seen that the desired effects of the present invention can be obtained in a range of 100 mg or more in terms of dry weight.
黒大豆種皮抽出物の処方例を以下に示す。
処方例1 ソフトカプセル
下記の原料を用いて、定法に従ってソフトカプセルを調製した。なお、黒大豆種皮抽出物として、実験例1の方法に従って調製した黒大豆種皮抽出物を用いた。
植物油脂:158.6mg
ゼラチン:135.2mg
黒大豆種皮抽出物:100mg
グリセリン:30.2mg
レシチン:30mg
ミツロウ:26mg
ビタミンE:20mg。
A formulation example of black soybean seed coat extract is shown below.
Formulation Example 1 Soft Capsules Soft capsules were prepared according to a conventional method using the following raw materials. In addition, the black soybean seed coat extract prepared according to the method of Experimental Example 1 was used as the black soybean seed coat extract.
Vegetable oil: 158.6mg
Gelatin: 135.2mg
Black soybean seed coat extract: 100mg
Glycerin: 30.2mg
Lecithin: 30mg
Beeswax: 26mg
Vitamin E: 20mg.
処方例2 錠剤
下記の原料を用いて、定法に従って錠剤を調製した。なお、黒大豆種皮抽出物として、実施例1方法に従って調製した黒大豆種皮抽出物を用いた。
デキストリン:179.69mg
黒大豆種皮抽出物:100mg
還元水あめ:28.56mg
結晶セルロース:26.51mg
ステアリン酸カルシウム:5.25mg
微粒二酸化ケイ素:5.25mg
ヒドロキシプロピルセルロース:4.77mg。
Formulation Example 2 Tablets Tablets were prepared according to a standard method using the following raw materials. In addition, the black soybean seed coat extract prepared according to the method of Example 1 was used as the black soybean seed coat extract.
Dextrin: 179.69mg
Black soybean seed coat extract: 100mg
Kangen starch syrup: 28.56mg
Crystalline cellulose: 26.51mg
Calcium stearate: 5.25mg
Fine silicon dioxide: 5.25mg
Hydroxypropyl cellulose: 4.77 mg.
処方例3 個包装スティックゼリー
下記の原料を用いて、定法に従って個包装スティックゼリーを調製した。なお、黒大豆種皮抽出物として、実施例1の方法に従って調製した黒大豆種皮抽出物を用いた。
希少糖含有シロップ:1000mg
黒大豆種皮抽出物:100mg
ゲル化剤(増粘多糖類):100mg
甘味料(キシリトール、スクラロース、ソーマチン、アセスルファムカリウム):70mg
香料:20mg
水:8710mg
Formulation Example 3 Individually packaged stick jelly Individually packaged stick jelly was prepared according to a standard method using the following raw materials. In addition, the black soybean seed coat extract prepared according to the method of Example 1 was used as the black soybean seed coat extract.
Rare sugar-containing syrup: 1000mg
Black soybean seed coat extract: 100mg
Gelling agent (polysaccharide thickener): 100mg
Sweeteners (xylitol, sucralose, thaumatin, acesulfame potassium): 70mg
Fragrance: 20mg
Water: 8710mg
本発明の黒大豆種皮抽出物を有効成分として含有する改善剤は、精神性疲労、意欲低下、または眠気を予防または改善することができる。したがって、本発明の精神性疲労、意欲低下または眠気の改善剤は、医薬品、医薬部外品、機能性表示食品、サプリメントなど広い適用範囲で利用できるため有用である。 The improving agent containing the black soybean hull extract of the present invention as an active ingredient can prevent or improve mental fatigue, loss of motivation, or sleepiness. Therefore, the agent for improving mental fatigue, loss of motivation, or sleepiness of the present invention is useful because it can be used in a wide range of applications such as pharmaceuticals, quasi-drugs, foods with functional claims, and supplements.
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