JP2005261237A - Visual performance-improving food and method for evaluating health food - Google Patents

Visual performance-improving food and method for evaluating health food Download PDF

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JP2005261237A
JP2005261237A JP2004075427A JP2004075427A JP2005261237A JP 2005261237 A JP2005261237 A JP 2005261237A JP 2004075427 A JP2004075427 A JP 2004075427A JP 2004075427 A JP2004075427 A JP 2004075427A JP 2005261237 A JP2005261237 A JP 2005261237A
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seed coat
soybean seed
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卓 ▲崎▼元
Taku Sakimoto
Kosuke Kojima
康資 小嶋
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KEI TWO COMMUNICATIONS KK
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a visual performance-improving food effective for improvement of asthenopia caused by VDT (video display terminal) work and visual acuity restoration. <P>SOLUTION: The visual performance-improving food has the following structure: a black soybean seed coat extract composition extracted from black soybean seed coat is used as a main ingredient; and an anti-oxidant vitamin and selenium are contained; the anti-oxidant vitamin comprises vitamin E; the vitamin E is contained at 3-150 mg in 300 mg of the black soybean seed coat extract composition; the selenium is contained at 45-250 μg in 300 mg of the black soybean seed coat extract composition; and β-carotene may be contained as the anti-oxidant vitamin. A method for evaluating health food comprises evaluating taken health food based on visual performance-improving effect on a dominant eye when evaluating the visual performance-improving effect resulted from intake of the health food. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は、黒大豆種皮から抽出された黒大豆種皮抽出組成物を主成分として含有する視機能改善食品及び健康食品の評価方法に関する。   The present invention relates to a visual function improving food containing a black soybean seed coat extract composition extracted from black soybean seed coat as a main component and a method for evaluating a health food.

IT時代を迎え、近年、いわゆるVDT(visual display terminal)作業に従事する労働者が増加し、眼の疲れや眼の奥の痛み等に代表される眼精疲労を訴える人の数も増加の一途をたどっている。そんな中、眼精疲労の改善に効果のある物質として、アントシアニンが注目されており、特に、アントシアニンの一つであり、最も強い活性酸素消去能力(抗酸化作用)を有する化合物であるシアニジン3−グルコシドが注目されている。シアニジン3−グルコシドの供給源としてはブルーベリー抽出物が知られているが、製造原料の保存条件が厳しく(−20℃以下冷凍保存)、この抽出物はシアニジンの他に夾雑物を多く含み、かつ、高価である等の問題がある。このため、シアニジン3−グルコシドの供給源として、ブルーベリーの代わりに、黒大豆種皮の抽出物を用いる方法が提案されている(例えば、特許文献1を参照。)。この発明では、黒大豆種皮を原料とし、水、水溶性有機溶媒又は含水水溶性有機溶媒のいずれかにより抽出・濃縮して黒大豆種皮抽出物を得ている。そして、この抽出物を経口摂取することで、眼精疲労と肩こりが改善するとされている。
特開2002−128689号公報
In the IT era, in recent years, the number of workers engaged in so-called VDT (visual display terminal) work has increased, and the number of people complaining of eye strain such as eye fatigue and back pain has been increasing. I'm following. Under such circumstances, anthocyanin has attracted attention as a substance effective in improving eye strain, and in particular, cyanidin 3-is a compound that is one of anthocyanins and has the strongest active oxygen scavenging ability (antioxidant action). Glucosides are drawing attention. Blueberry extract is known as a source of cyanidin 3-glucoside, but the storage conditions of the production raw material are severe (−20 ° C. or lower frozen storage), and this extract contains a lot of impurities in addition to cyanidin, and There are problems such as being expensive. For this reason, as a supply source of cyanidin 3-glucoside, a method using an extract of black soybean seed coat instead of blueberry has been proposed (see, for example, Patent Document 1). In the present invention, black soybean seed coat is obtained by using black soybean seed coat as a raw material and extracting and concentrating with water, a water-soluble organic solvent or a water-containing water-soluble organic solvent. And it is said that taking this extract orally improves eyestrain and stiff shoulders.
JP 2002-126889 A

前述のように、VDT作業に伴う眼の疲労感等を軽減する作用が黒大豆種皮抽出物に含まれるアントシアニン系化合物にあることは知られているが、単に黒大豆種皮抽出物を摂取するだけでは、眼精疲労の症状を軽減する程度にとどまり、VDT症候群の最も深刻な症状である、低下した視力を回復させる効果はなく、VDT症候群の根本的な解決方法としては不十分である。   As described above, it is known that the anthocyanin compound contained in the black soybean seed coat extract has an action to reduce the eye fatigue caused by VDT work, but only ingests the black soybean seed coat extract. However, the symptoms of eye strain are only reduced, and the most serious symptom of VDT syndrome, which is the effect of recovering the decreased visual acuity, is not sufficient as a fundamental solution for VDT syndrome.

そこで本発明はこのような従来の実情に鑑みて提案されたものであり、VDT作業による眼精疲労を改善可能であり、且つ視力回復に効果のある視機能改善食品を提供することを目的とする。また、本発明は、健康食品の視機能改善効果を的確に把握し得る健康食品の評価方法を提供することを目的とする。   Therefore, the present invention has been proposed in view of such a conventional situation, and an object of the present invention is to provide a visual function-improving food that can improve eye strain caused by VDT work and is effective in restoring visual acuity. To do. Another object of the present invention is to provide a health food evaluation method capable of accurately grasping the visual function improvement effect of health food.

本発明者は、上述の目的を達成するために、長期に亘り鋭意研究を重ねてきた。その結果、黒大豆の種皮から抽出した黒大豆種皮抽出組成物とともに、抗酸化性ビタミンとセレンとを組み合わせることで、これまで知られていた眼精疲労の改善効果に加えて、驚くべきことに視機能回復効果を発現することを見出した。   In order to achieve the above-mentioned object, the present inventor has intensively studied for a long time. As a result, in combination with the black soybean seed coat extract composition extracted from black soybean seed coat, the combination of antioxidant vitamins and selenium has surprisingly improved the previously known eye strain improvement effect. It was found that the visual function recovery effect was expressed.

本発明はこのような知見に基づいて完成されたものである。すなわち、本発明に係る視機能改善食品は、黒大豆種皮から抽出された黒大豆種皮抽出組成物を主成分とし、抗酸化性ビタミン及びセレンを含有することを特徴とする。   The present invention has been completed based on such findings. That is, the visual function-improving food according to the present invention is characterized in that the main component is a black soybean seed coat extract composition extracted from black soybean seed coat and contains an antioxidant vitamin and selenium.

黒大豆種皮抽出組成物は、植物性色素であるアントシアニン系化合物を多く含み、中でも活性が高いと言われるシアニジン3−グルコシドを多く含有し、眼の疲れ、眼の乾燥感、頭痛や肩こりといった全身症状等に代表される眼精疲労の改善作用を持つ。   Black soybean seed coat extract composition contains a lot of anthocyanin compounds, which are plant pigments, and contains a lot of cyanidin 3-glucoside, which is said to be highly active, and it causes eye fatigue, dry eyes, headache and stiff shoulders. It has the effect of improving eye strain represented by symptoms.

また、本発明の視機能改善食品は、主成分である黒大豆種皮抽出物に加えて抗酸化性ビタミン及びセレンを組み合わせることで、詳細は不明であるが、視機能の改善作用を発揮することが実験的に確かめられている。視機能の改善作用は、黒大豆種皮抽出物の単独摂取、黒大豆種皮抽出物とビタミンE又はセレンとを組み合わせた摂取では発揮されず、黒大豆種皮抽出物と抗酸化性ビタミンとセレンとの3種類を組み合わせた場合に特有の効果である。   In addition, the visual function improving food of the present invention combines the antioxidant vitamin and selenium in addition to the black soybean seed coat extract, which is the main component, to show the visual function improving action, although details are unknown. Has been confirmed experimentally. The visual function improvement effect is not exhibited by black soybean seed coat extract alone or in combination with black soybean seed coat extract and vitamin E or selenium, but the combination of black soybean seed coat extract, antioxidant vitamins and selenium. This effect is unique when the three types are combined.

一方、本発明に係る健康食品の評価方法は、健康食品の摂取による視機能改善効果を確認するに際し、利き目における視機能改善効果に基づいて、摂取した健康食品を評価することを特徴とする。利き目を意識しないで健康食品の視機能改善効果を評価しても、必ずしも有意差が顕著になるとは限らず、実効的な評価が難しい。利き目を対象として視力改善効果を評価すれば、視機能改善に実効を有する健康食品が確実に選別される。   On the other hand, the health food evaluation method according to the present invention is characterized in that, when confirming the visual function improvement effect by ingestion of the health food, the ingested health food is evaluated based on the visual function improvement effect in the dominant eye. . Even if the visual function improvement effect of health food is evaluated without being conscious of the dominant eye, the significant difference is not always significant, and effective evaluation is difficult. If the visual acuity improvement effect is evaluated for the dominant eye, health foods that are effective in improving visual function are reliably selected.

本発明の視機能改善食品によれば、黒大豆種皮抽出物を主成分として用いるので、目の疲れ、眼の乾燥感、頭痛や肩こりといった全身症状等の眼精疲労症状を緩和し、特に眼を酷使する傾向にあるVDT作業従事者の眼の健康の維持に貢献することができる。また、本発明の視機能改善食品は、黒大豆種皮抽出物に加えて抗酸化性ビタミン及びセレンを含有するので、これまでの健康食品では改善が困難であった視力の改善が可能である。   According to the visual function improving food of the present invention, the black soybean seed coat extract is used as a main component, so that eye fatigue symptoms such as tired eyes, dryness of eyes, systemic symptoms such as headache and stiff shoulders are alleviated, especially the eyes. Can contribute to the maintenance of eye health of VDT workers who tend to overuse. Moreover, since the visual function improving food of the present invention contains an antioxidant vitamin and selenium in addition to the black soybean seed coat extract, it is possible to improve visual acuity that has been difficult to improve with conventional health foods.

また、本発明の健康食品の評価方法によれば、健康食品における視機能改善効果を的確に把握し、その有効性について実効に即した評価を行うことができる。   Further, according to the health food evaluation method of the present invention, it is possible to accurately grasp the visual function improvement effect in the health food, and to perform an evaluation in accordance with the effectiveness thereof.

以下、本発明に係る視機能改善食品及び健康食品の評価方法について、図面を参照しながら説明する。   Hereinafter, the visual function improving food and health food evaluation method according to the present invention will be described with reference to the drawings.

本発明の視機能改善食品は、黒大豆種皮から抽出された黒大豆種皮抽出組成物を主成分とし、抗酸化性ビタミン及びセレンを含有するものである。   The visual function-improving food of the present invention is mainly composed of a black soybean seed coat extract composition extracted from black soybean seed coat, and contains an antioxidant vitamin and selenium.

ここで、黒大豆種皮抽出組成物とは、黒大豆の種皮から水抽出により溶出させた水溶性の抽出組成物を構成成分として含むものである。黒大豆は、中国等において大量に栽培されており、その種皮は大豆加工の製造工程で剥がれ落ち、副産物として例えば家畜の飼料に利用されている。この副産物種皮には、アントシアニン(特にシアニジン−3−グルコシド)が多く含まれる。本発明では、その有効成分を抽出、精製し、機能性に富む新素材として活用する。   Here, the black soybean seed coat extract composition includes a water-soluble extract composition eluted from the black soybean seed coat by water extraction as a constituent component. Black soybeans are cultivated in large quantities in China and the like, and the seed coats are peeled off in the manufacturing process of soybean processing, and are used as a by-product in, for example, livestock feed. This by-product seed coat is rich in anthocyanins (particularly cyanidin-3-glucoside). In the present invention, the active ingredient is extracted and purified, and used as a new material rich in functionality.

黒大豆種皮抽出組成物を得るには、例えば特開2002−128689号公報に記載される方法を採用することができる。この方法では、先ず、黒大豆種皮を抽出溶媒でpH1〜5で抽出する。pH1〜5に調整する酸としては、無機酸(塩酸、硫酸等)又は有機酸(蟻酸、酢酸、クエン酸、アスコルビン酸等)があり、抽出溶媒は、水、メタノール、エタノール、アセトン等の水溶性有機溶媒又は含水有機溶媒を用いることができ、室温から抽出溶媒の沸点までの温度範囲内で抽出し、有機溶媒の水含量は、メタノール、エタノールでは75%以下、アセトンでは65%以下である。   In order to obtain a black soybean seed coat extract composition, for example, a method described in JP-A No. 2002-126889 can be employed. In this method, first, black soybean seed coat is extracted with an extraction solvent at pH 1-5. Acids to be adjusted to pH 1 to 5 include inorganic acids (hydrochloric acid, sulfuric acid, etc.) or organic acids (formic acid, acetic acid, citric acid, ascorbic acid, etc.), and extraction solvents are water, methanol, ethanol, acetone, and other water-soluble solvents. An organic solvent or a hydrous organic solvent can be used, and extraction is performed within a temperature range from room temperature to the boiling point of the extraction solvent. The water content of the organic solvent is 75% or less for methanol and ethanol, and 65% or less for acetone. .

次に、得られた黒大豆種皮抽出液から有機溶媒を留去して、合成吸着樹脂にシアニジン3−グルコシドを吸着させ、次いで水で不純物を洗浄し、有機溶媒又は有機溶媒と水との混合溶媒を用いて該当する合成樹脂から溶出させ、濃縮、乾燥し、黒大豆種皮有効成分を含む抽出固形物を得る。該当する合成吸着樹脂の具体例としては、「ダイヤイオンHP樹脂、SP樹脂」(三菱化学社製)、「アンパーライトXAD樹脂」(ロームアンドハ−ス社製)、「デュオライトS樹脂」(ダイヤモンドシャムロック社製)等が挙げられる。   Next, the organic solvent is distilled off from the obtained black soybean seed coat extract, the cyanidin 3-glucoside is adsorbed on the synthetic adsorption resin, the impurities are then washed with water, and the organic solvent or the organic solvent and water are mixed. It is eluted from the corresponding synthetic resin using a solvent, concentrated and dried to obtain an extract solid containing black soybean seed coat active ingredients. Specific examples of the corresponding synthetic adsorption resin include “Diaion HP resin, SP resin” (manufactured by Mitsubishi Chemical), “Amperite XAD resin” (manufactured by Rohm and Haas), “Duolite S resin” (Diamond Sham). Lock).

黒大豆種皮有効成分の吸着は、通常カラム法で行われ、室温下、ダイヤイオンHP20の場合、space velocityが0.5から2になるように調節して行う。ダイヤイオンHP20の場合、溶出に用いる有機溶媒はメタノール、エタノール、アセトンが望ましく、含水で用いる場合は、メタノール、エタノールは水分を20%以下、アセトンの場合は水分を30%以下とする。濃縮は減圧下又は常圧下で行い、室温から抽出溶媒の沸点までの温度範囲内で行う。乾燥は固形分が20%〜30%程度まで濃縮した液を噴霧乾燥するか、濃縮液を蒸発面の大きい容器に広げ、乾燥機又は減圧乾燥機下で蒸発乾固することにより行う。この方法により黒大豆種皮抽出物は、その乾燥物においてシアニジン3−グルコシドを5%〜35%含む。   The adsorption of the black soybean seed coat active ingredient is usually carried out by a column method, and at room temperature, in the case of Diaion HP20, the space velocity is adjusted so as to be 0.5 to 2. In the case of Diaion HP20, the organic solvents used for elution are preferably methanol, ethanol, and acetone. When used in water, methanol and ethanol have a water content of 20% or less, and in the case of acetone, the water content is 30% or less. Concentration is performed under reduced pressure or normal pressure, and is performed within a temperature range from room temperature to the boiling point of the extraction solvent. Drying is performed by spray-drying a liquid concentrated to a solid content of about 20% to 30% or by spreading the concentrated liquid in a container having a large evaporation surface and evaporating to dryness in a dryer or a vacuum dryer. By this method, the black soybean seed coat extract contains 5% to 35% cyanidin 3-glucoside in the dried product.

また、黒大豆種皮抽出組成物を得る方法としては、前記の方法の他、樹脂及び有機溶媒を使わず、酸水による抽出を採用することもできる。この抽出法では、先ず、黒大豆種皮から酸水により水溶性成分を溶出させる。酸水に含まれる酸としては、任意の酸を用いることができるが、入手が容易で安価な塩酸が好適である。酸水のpHは1.0〜2.0に設定する。酸水のpHが2.0を越えると、抽出効率が低下する虞れがある。   Moreover, as a method for obtaining a black soybean seed coat extract composition, extraction with acid water can be employed without using a resin and an organic solvent in addition to the above-described method. In this extraction method, first, a water-soluble component is eluted from black soybean seed coat with acid water. Although any acid can be used as the acid contained in the acid water, hydrochloric acid that is easily available and inexpensive is preferable. The pH of the acid water is set to 1.0 to 2.0. If the pH of the acid water exceeds 2.0, the extraction efficiency may be reduced.

前記抽出後、酸水を中和し、その後通常の濾過を行う。中和に際しては、pHが3.0〜4.0(例えばpH3.8)になるように中和を行うが、これは黒大豆種皮抽出物の自然のpH値という理由による。中和に際しては任意のアルカリを使用することが可能であるが、入手が容易で安価なこと等からNaOHが好適である。濾過の後、限外濾過により脱塩濃縮、精製を行うが、ここで、限外濾過は、市販のUF膜を用いて行えばよい。   After the extraction, the acid water is neutralized, followed by normal filtration. Neutralization is performed so that the pH is 3.0 to 4.0 (for example, pH 3.8), because of the natural pH value of the black soybean seed coat extract. Although any alkali can be used for neutralization, NaOH is preferred because it is easily available and inexpensive. After the filtration, desalination concentration and purification are performed by ultrafiltration. Here, ultrafiltration may be performed using a commercially available UF membrane.

本発明の視機能改善食品に含まれる抗酸化性ビタミンとしては、ビタミンEが好適である。黒大豆種皮抽出組成物300mgあたりのビタミンEの含有量は、栄養機能食品としての基準に適合する3mg〜150mgであることが好ましい。ビタミンEの含有量を前記範囲内とすることで、ビタミンEの摂取量を適量とすることができる。   Vitamin E is suitable as the antioxidant vitamin contained in the visual function improving food of the present invention. The content of vitamin E per 300 mg of black soybean seed coat extract composition is preferably 3 mg to 150 mg which meets the standards as a nutritional functional food. By making the content of vitamin E within the above range, the intake amount of vitamin E can be made appropriate.

抗酸化性ビタミンとしては、ビタミンEに加え、さらにβ−カロテンを含むことが好ましい。黒大豆種皮抽出組成物300mgあたりのβ−カロテンの含有量は、栄養機能食品としての基準に適合する1080μg〜3600μgであることが好ましい。前記範囲内であることで、β−カロテンの摂取量を適量とすることができる。   In addition to vitamin E, the antioxidant vitamin preferably further contains β-carotene. It is preferable that the content of β-carotene per 300 mg of black soybean seed coat extract composition is 1080 μg to 3600 μg which meets the standard as a nutritional functional food. By being within the above range, the intake amount of β-carotene can be made an appropriate amount.

また、黒大豆種皮抽出組成物300mgあたりのセレンの含有量は、45μg〜250μgであることが好ましい。前記範囲を下回ると所定の効果が得られくなるおそれがあり、逆に前記範囲を上回ると、セレンの過剰摂取となり、第六次改定日本人栄養所要量において食事摂取基準として定められた許容上限摂取量を上回るおそれがある。   Moreover, it is preferable that content of selenium per 300 mg of black soybean seed coat extract compositions is 45 μg to 250 μg. If the above range is not reached, the prescribed effect may not be obtained. If the above range is exceeded, excessive intake of selenium will occur, and the allowable upper limit set as the dietary intake standard in the 6th revised Japanese nutritional requirements May exceed intake.

本発明の視機能改善食品を製剤化する場合、剤形としては、粉末状、顆粒状、錠剤状等、任意の剤形を採用することができる。あるいは、飲料やドリンク剤とすることもできる。その際、保存や取り扱いを容易にするために、デキストリン、シクロデキストリン等のキャリヤ、保存料、その他任意の助剤を必要に応じて配合することができる。   When formulating the visual function improving food of the present invention, any dosage form such as powder, granule, tablet and the like can be adopted as the dosage form. Or it can also be set as a drink or a drink agent. At that time, in order to facilitate storage and handling, carriers such as dextrin and cyclodextrin, preservatives and other optional auxiliaries can be blended as necessary.

以下、本発明を適用した具体的な実施例について、実験結果に基づいて説明する。なお、本発明は以下の実施例の記載に限定されるものではない。   Hereinafter, specific examples to which the present invention is applied will be described based on experimental results. In addition, this invention is not limited to description of a following example.

カプセルの調製
実施例の被験食として、黒大豆種皮抽出組成物主成分とし、その他の原材料としてアボガドオイル、ぶどう種子オイル、ビタミンE含有植物油、ビール酵母(セレン含有)、ミツロウ、海藻カロテンを含有するフットボール型のソフトカプセルを製剤した。本被験食のソフトカプセルは、1カプセル350mgあたり、黒大豆種皮抽出物を120mg含有する。なお、本被験食の栄養成分分析値は、1.0gあたり熱量5.9kcal、たんぱく質0.3g、脂質0.4g、炭水化物0.3g、ナトリウム0.9g、β−カロテン(ビタミンA換算35%)1140μg、ビタミンE33.5mg、セレン80μgであった。
The preparation food of the capsule preparation example contains black soybean seed coat extract as a main component, and other ingredients include avocado oil, grape seed oil, vegetable oil containing vitamin E, brewer's yeast (containing selenium), beeswax, seaweed carotene A football-type soft capsule was formulated. The soft capsule of this test meal contains 120 mg of black soybean seed coat extract per 350 mg of capsule. In addition, the nutritional component analysis value of this test food is: calorie 5.9 kcal per 1.0 g, protein 0.3 g, lipid 0.4 g, carbohydrate 0.3 g, sodium 0.9 g, β-carotene (35% in terms of vitamin A) 1140 μg, vitamin E 33.5 mg, selenium 80 μg.

実験
主にVDT(visual display terminal)作業に従事し、年齢20歳〜55歳の男女で健康な日常生活を営むもので、かつ眼精疲労の訴えのある者を被験者とし、4週間にわたって、前記実施例の被験食を1日2回(朝1カプセル 午後3時ごろ2カプセル)合計3カプセルを水にて摂取させた。実験期間中、被験者には他のサプリメントの摂取を禁じたが、特に食事制限は行わなかった。同意を得た被験者32名(男性10名、女性22名)について、下記表1に示すスケジュールで実験を行った。
The tester is mainly engaged in VDT (visual display terminal) work, is a male and female aged 20 to 55 years old, and has a healthy daily life. A total of 3 capsules were ingested in water twice a day (1 capsule in the morning and 2 capsules around 3 pm) in the example. During the experiment, subjects were prohibited from taking other supplements, but were not specifically restricted. Experiments were conducted on 32 subjects (10 males and 22 females) who obtained consent according to the schedule shown in Table 1 below.

Figure 2005261237
Figure 2005261237

実験は、各被験者のスケジュール表にしたがい摂取開始前日に検査を行い、翌日より前記の方法に基づいて被験食の摂取を開始し、摂取開始より2週間後、摂取開始より4週間後、中止時、自覚症状の経過観察時を含め、検査および調査を実施した。なお、スクリーニング検査日より被験者の都合により中止した例を除き、32例64眼(右眼・左眼)について調査または眼科機能検査を実施した。   The experiment was conducted on the day before the start of ingestion according to the schedule of each subject, and the intake of the test food was started from the following day based on the above method, 2 weeks after the start of ingestion, 4 weeks after the start of ingestion, Examinations and investigations were conducted, including during follow-up of subjective symptoms. In addition, except for the case that was canceled due to the convenience of the subject from the screening examination date, 64 eyes (right eye / left eye) were examined or ophthalmic function examination was performed.

検査項目・調査項目および方法
摂取開始前日に、被験者の年齢、性別、眼鏡使用の有無、利き目について確認するとともに、下記表2に示す自覚症状調査表の提出を受け、医師の問診を行った。上記表1に示した眼科的機能検査について摂取開始前日、摂取開始日より2週間後、摂取開始より4週間後に検査を実施した。なお、下記表2に示す眼に関する訴えを中心とする24項目の自覚症状については、医師による問診時に評価を実施した。評価基準は、3:高度、2:中度、1:軽度、0:症状なし、とした。また、摂取開始4週間後も医師による評価を実施し、摂取前と摂取開始4週間後との結果を比較して改善度を求めた。なお、症状別の改善度は、−3:著明改善、−2:中等度改善、−1:軽度改善、0:不変、1:軽度悪化、2:中等度悪化、3:著明悪化とし、改善率は中等度以上とした。また、自覚症状の調査において、下記表3に示す生活状況を背景因子として検討した。
Examination item / survey item and method The day before the start of ingestion, the subject's age, gender, presence / absence of eyeglass use, and dominant eye were confirmed, and the subjective symptom survey table shown in Table 2 below was submitted, and doctors were interviewed. . About the ophthalmic function test | inspection shown in the said Table 1, the test was implemented on the day before the start of ingestion, 2 weeks after the start of ingestion, and 4 weeks after the start of ingestion. In addition, 24 subjective symptoms centered on eye complaints shown in Table 2 below were evaluated at the time of medical inquiry. The evaluation criteria were 3: high, 2: moderate, 1: mild, 0: no symptoms. In addition, evaluation by a doctor was also conducted 4 weeks after the start of intake, and the degree of improvement was determined by comparing the results before intake and 4 weeks after start of intake. The degree of improvement for each symptom is -3: marked improvement, -2: moderate improvement, -1: mild improvement, 0: unchanged, 1: mild deterioration, 2: moderate deterioration, 3: significant deterioration. The improvement rate was moderate or higher. In the investigation of subjective symptoms, the living conditions shown in Table 3 below were examined as background factors.

Figure 2005261237
Figure 2005261237

Figure 2005261237
Figure 2005261237

眼科機能検査
眼科機能検査については、摂取前、摂取開始より2週間後、摂取開始より4週間後にそれぞれ以下のようにして実施した。
Ophthalmic Function Test The ophthalmic function test was performed as follows before ingestion, 2 weeks after the start of ingestion, and 4 weeks after the start of ingestion.

(1)フリッカーテスト
小型携帯用最小中心C.F.Fフリッカー測定器として日点フリッカーミニ(日本点眼研究所社製)を用い、15分間の暗順応の後に、右眼及び左眼について赤色(波長66nm)について4回測定し、中心C.F.Fの平均値を算出した。
(1) Flicker test Smallest portable center F. A day-point flicker mini (manufactured by Nippon Ophthalmology Laboratories) was used as an F flicker measuring instrument, and after red adaptation for 15 minutes, red (wavelength: 66 nm) was measured four times for the right and left eyes. F. The average value of F was calculated.

(2)視力
万国式日本試視力表(61級)を用い、右眼及び左眼について、30cm視力及び5m視力の裸眼並びに矯正視力を測定した。
(2) Visual Acuity Using the universal Japanese visual acuity table (grade 61), the right eye and the left eye were measured for 30 cm visual acuity and 5 m visual acuity and corrected visual acuity.

(3)アコモドグラム
アコモドポリレコーダーHs−9E(興和オプチド社製)を用いて指標位置を確認し、右眼、左眼それぞれ片眼ずつ測定を行い、一定の速度で(約2〜3cm/秒)で指標を遠方より近づけて、被験者の眼のピントがぼけはじめた点で答える方法により、調節弛緩距離を10回繰り返して測定した。アコモドグラムについては、被験者ごとに10回目の測定値より2回目の測定値を引いた値を評価尺度とした。
(3) Accomodogram The index position is confirmed using the Acomodo poly recorder Hs-9E (manufactured by Kowa Optic Co., Ltd.), the right eye and the left eye are measured one eye at a time, and at a constant speed (approximately 2 to 3 cm / second) ), The adjustment relaxation distance was measured 10 times by the method in which the index was moved closer to the distance and the answer was made when the subject's eyes started to be out of focus. For the accomodogram, a value obtained by subtracting the second measurement value from the tenth measurement value for each subject was used as an evaluation scale.

解析方法
1)背景因子
被験者の背景因子に関して、計量値に対しては記述統計量(平均、標準偏差)を算出し、計数値に対しては度数表を作成して要約した。また、各背景因子と自覚症状の初診時のスコア及び他覚所見の初診時の検査値との相関についてSpearmanの相関係数を算出し検討した。
Analysis method 1) Background factors For the background factors of the subjects, descriptive statistics (average, standard deviation) were calculated for the measured values, and a frequency table was created and summarized for the count values. In addition, Spearman's correlation coefficient was calculated and examined for the correlation between each background factor and the score at the first visit of subjective symptoms and the test value at the first visit of objective findings.

2)自覚症状
自覚症状に関して、スコアを計量値として扱い、最終診断時の初診時からの変動を、対応のある差のt検定により検討した。症状別改善度について度数表を作成し、「中等度改善」以上を改善率として算出した。
2) Subjective symptoms Regarding subjective symptoms, the score was treated as a measured value, and the change from the first visit at the time of the final diagnosis was examined by the t-test of the corresponding difference. A frequency table was prepared for the degree of improvement for each symptom, and “moderate improvement” or higher was calculated as the improvement rate.

3)他覚所見
視力、フリッカーテスト、アコモドグラムについて、初診時、摂取開始より2週間後及び摂取開始より4週間後の記述統計量を算出するとともに、摂取開始より2週間後及び摂取開始より4週間後の初診時からの変動差を対応のある差のt検定を用い検討した。なお、これらの解析は、左目、右目及び利き目に層別して実施した。
3) Objective findings For visual acuity, flicker test, and accomodogram, descriptive statistics were calculated at the first visit, 2 weeks after the start of intake and 4 weeks after the start of intake, and 2 weeks after the start of intake and 4 weeks after the start of intake. Differences from the first visit later were examined using a paired difference t-test. These analyzes were performed by stratifying the left eye, right eye, and dominant eye.

4)安全性評価
概括安全度について度数表を作成し、「安全」としたものの割合を安全率として算出した。
なお、検定の有意水準は両側5%とした。
4) Safety evaluation A frequency table was created for the general safety level, and the percentage of those rated as “safe” was calculated as the safety rate.
The significance level of the test was 5% on both sides.

結果
被験者の背景因子要約を表4に示す。
Results Table 4 summarizes the background factors of the subjects.

Figure 2005261237
Figure 2005261237

自覚症状
自覚症状について被験者の調査結果を表5に示す。表5から明らかなように、実施例の被験食を摂取することで、自覚症状調査24項目のうち、眼の疲れ、眼の乾燥感、全身症状において、有意な改善が見られた。特に、「眼が疲れる」「眼の奥が痛い」では、P<0.0001であり、「眼がだるい」「眼を開けていているのが辛い」では、P<0.0002〜0.001で有意に改善した。また、眼の乾燥感、全身症状などでもP<0.0002〜0.001と有意に改善が見られた。また、自覚的な全身の疲労症状である肩こりと眼の疲れとには強い相関が見られた(p=0.02)。なお、表5中、*はP<0.0001を表し、**はP<0.0002〜0.001を表し、***はP<0.002〜0.005を表す。
Table 5 shows the investigation results of the subjects for subjective symptoms subjective symptoms. As is apparent from Table 5, by taking the test food of the example, significant improvement was observed in eye fatigue, eye dryness, and systemic symptoms among 24 items of subjective symptom survey. In particular, P <0.0001 for “eye is tired” and “back of eye is painful”, and P <0.0002 to 0.00 for “slow eye” and “spiky to open eyes”. 001 significantly improved. In addition, a significant improvement was also observed with P <0.0002 to 0.001 in terms of dryness of eyes and systemic symptoms. In addition, a strong correlation was found between stiff shoulders, which are subjective general fatigue symptoms, and eye fatigue (p = 0.02). In Table 5, * represents P <0.0001, ** represents P <0.0002 to 0.001, and *** represents P <0.002 to 0.005.

Figure 2005261237
Figure 2005261237

検査項目
1)視力
裸眼での視力0.2以上の差を改善ありと測定した。被験者32名中、右眼、左眼ともに10例は測定できず、測定者は22名であった。この結果、右眼では22人中9人(40%)、左眼では22人中7人(31%)が改善ありであった。また、本被験食摂取前後の裸眼視力の変動について、平均値±標準偏差を求めた。結果を表6に示した。表6から明らかなように、左目、右目及び利き目のいずれにおいても有意な変動が認められた。
Test item 1) Visual acuity The difference of visual acuity of 0.2 or more with the naked eye was measured as improved. Of the 32 subjects, 10 cases for both the right eye and the left eye could not be measured, and there were 22 measurers. As a result, 9 out of 22 (40%) in the right eye and 7 out of 22 (31%) in the left eye were improved. In addition, an average value ± standard deviation was determined for changes in the naked eye vision before and after the intake of the test food. The results are shown in Table 6. As is clear from Table 6, significant changes were observed in any of the left eye, right eye, and dominant eye.

Figure 2005261237
Figure 2005261237

2)フリッカーテスト
指標が赤色(波長66nm)の連続光であるとの確認のうえ、右眼及び左眼についてそれぞれ2回ずつ計4回測定した。中心C.F.Fの出現・消失の4回平均値における摂取前と4週時との比較を行った。評価方法は、正常値…35Hg以上、要精査…26〜34Hg、異常…25Hg以下とした。結果は、異常例については右眼、左眼ともなかった。右眼については、初診時に要精査(26〜34Hg)であった11例中、9例が正常35Hg以上に正常化し(81%)、2例は不変であった。また、初診時に正常35Hg〜41Hgであった21例中、さらに上がった者が7例(32%)、不変であった者が14例であった。左眼については、初診時に要精査(26〜34Hg)であった9例中、正常35Hg以上に正常化したものが4例(55%)、5例は不変であった。また、左目について、35Hg〜41Hg(正常)であった23例中、さらに上がった者が3例、3/23(13%)、不変は19例、悪化1例であった。
2) Flicker test After confirming that the index was continuous light with a red color (wavelength 66 nm), the right eye and the left eye were each measured twice for a total of 4 times. Center C. F. A comparison was made between before intake and at 4 weeks in the mean of four appearances / disappearances of F. The evaluation method was set to a normal value: 35 Hg or more, a close examination required: 26 to 34 Hg, and an abnormality: 25 Hg or less. As a result, there were no abnormalities in the right eye and the left eye. Regarding the right eye, of 11 cases that required close examination at the first visit (26 to 34 Hg), 9 cases were normalized to normal 35 Hg or more (81%), and 2 cases remained unchanged. Moreover, among 21 cases that were normal 35Hg to 41Hg at the first visit, 7 cases (32%) were further elevated and 14 cases were unchanged. As for the left eye, among 9 cases that required close examination (26-34 Hg) at the first visit, 4 cases (55%) that were normalized to normal 35 Hg or more and 5 cases remained unchanged. In addition, among the 23 cases of 35Hg to 41Hg (normal) for the left eye, 3 were further increased, 3/23 (13%), 19 were unchanged, and 1 was worse.

また、フリッカー値の推移を表7に示す。フリッカーテストは客観的疲労測定に有用であるが、本実施例の被験食の摂取によって優位にフリッカー値は高くなっており、この食品の投与が生理学的検査においても眼精疲労を改善したことが認められた。   Table 7 shows the transition of the flicker value. Although the flicker test is useful for objective fatigue measurement, the flicker value is significantly increased by ingestion of the test food of this example, and the administration of this food also improved eye strain in the physiological examination. Admitted.

Figure 2005261237
Figure 2005261237

3)アコモドグラム
アコモドグラムでは、右眼及び左眼とも、摂取前、摂取開始より2週間後、摂取開始より4週間後のグラフを作成し、図1に示すパターンで判定した。
3) Accomodogram In the accomodogram, graphs for both the right eye and the left eye were prepared before ingestion, 2 weeks after the start of ingestion, and 4 weeks after the start of ingestion, and were determined using the pattern shown in FIG.

また、アコモドグラムについては、被験者ごとに10回目の測定値より2回目の測定値を引いた値を評価尺度とし、本被験食摂取前後の平均値±標準偏差を求めた。結果を下記表8に示す。表8から明らかなように、摂取後の摂取前からの変動は、左目、右目及び利き目のいずれにおいても改善の傾向を示したが、利き目にのみ統計学的な有意差が認められた。   Further, for the accomodogram, the average value ± standard deviation before and after intake of the test meal was determined using the value obtained by subtracting the second measurement value from the tenth measurement value for each subject as an evaluation scale. The results are shown in Table 8 below. As is clear from Table 8, the change from before ingestion after ingestion tended to improve in any of the left eye, right eye and dominant eye, but a statistically significant difference was observed only in the dominant eye. .

Figure 2005261237
Figure 2005261237

また、本被験食を4週間継続して摂取した32例全例について、悪化例、不具合、副作用と思われる例はなかった。したがって、本被験食は極めて安全性の高いものであると評価できる。   In addition, there were no cases that seemed to be worsening cases, malfunctions, or side effects in all 32 cases ingesting this test food continuously for 4 weeks. Therefore, it can be evaluated that this test meal is extremely safe.

さらに、比較例1として、年齢20代〜40代の男女で健康な日常生活を営むもので、かつ眼精疲労の訴えのある者を被験者とし、4週間にわたって黒大豆種皮抽出物を含むドリンクを、4週間にわたって摂取させた。1日あたりの黒大豆種皮抽出物の摂取量は300mgである。この比較例1のドリンクは、黒大豆種皮抽出物を含むが、ビタミンE及びセレンを含まないものである。実験期間中、被験者には他のサプリメントの摂取を禁じたが、特に食事制限は行わなかった。同意を得た被験者男女7名について、視機能における自覚症状調査、視力検査、フリッカーテストを行った。   Furthermore, as a comparative example 1, a drink containing black soybean seed coat extract for 4 weeks with a healthy daily life in men and women in their 20s to 40s who are complaining of eye strain. Ingested over 4 weeks. The daily intake of black soybean seed coat extract is 300 mg. The drink of Comparative Example 1 contains black soybean seed coat extract but does not contain vitamin E and selenium. During the experiment, subjects were prohibited from taking other supplements, but were not specifically restricted. Seven subjects male and female who obtained consent were examined for subjective symptoms in visual function, visual acuity test, and flicker test.

また、比較例2として、年齢20代〜40代の男女で健康な日常生活を営むもので、かつ眼精疲労の訴えのある者を被験者とし、4週間にわたって黒大豆種皮抽出物及びビタミンEを含むソフトカプセルを、4週間にわたって摂取させた。1日あたりの黒大豆種皮抽出物の摂取量は360mgである。この比較例2のソフトカプセルは、黒大豆種皮抽出物及びビタミンEを含むが、セレンを含まないものである。実験期間中、被験者には他のサプリメントの摂取を禁じたが、特に食事制限は行わなかった。同意を得た被験者男女7名について、視機能における自覚症状調査、視力検査、フリッカーテストを行った。   Moreover, as a comparative example 2, those who have a healthy daily life in men and women in their 20's to 40's and who are complaining of eye strain, have black soybean seed coat extract and vitamin E for 4 weeks. The containing soft capsules were ingested for 4 weeks. The intake of black soybean seed coat extract per day is 360 mg. The soft capsule of Comparative Example 2 contains black soybean seed coat extract and vitamin E, but does not contain selenium. During the experiment, subjects were prohibited from taking other supplements, but were not specifically restricted. Seven subjects male and female who obtained consent were examined for subjective symptoms in visual function, visual acuity test, and flicker test.

以上の比較例1及び比較例2について、実施例の実験と同様に、眼精疲労の自覚調査、視力検査、フリッカーテストを行った。その結果、比較例1及び比較例2については、眼精疲労の軽減はみられたが、視力の向上及びピント調節機能の改善はみられなかった。このことから、黒大豆種皮抽出物の単独摂取、又は黒大豆種皮抽出物とビタミンEとを組み合わせた摂取では視力回復に効果がなく、黒大豆種皮抽出物とビタミンEとセレンとの3つを組み合わせて摂取することで、はじめて視力の回復効果を発揮できることがわかった。   About the comparative example 1 and the comparative example 2 mentioned above, the subjective investigation of eye strain, visual acuity test, and flicker test were performed as in the experiment of the example. As a result, in Comparative Example 1 and Comparative Example 2, although eye strain was reduced, improvement in visual acuity and improvement in focus adjustment function were not observed. Therefore, ingestion of black soybean seed coat extract alone or in combination with black soybean seed coat extract and vitamin E has no effect on visual acuity recovery, and three of black soybean seed coat extract, vitamin E and selenium are used. It was found that the effect of restoring visual acuity could be demonstrated only when taken in combination.

アコモドグラムにおける判定パターンを示す図である。It is a figure which shows the determination pattern in an accomodogram.

Claims (9)

黒大豆種皮から抽出された黒大豆種皮抽出組成物を主成分とし、抗酸化性ビタミン及びセレンを含有することを特徴とする視機能改善食品。   A visual function-improving food comprising a black soybean seed coat extract composition extracted from black soybean seed coat as a main component and an antioxidant vitamin and selenium. 前記抗酸化性ビタミンがビタミンEであることを特徴とする請求項1記載の視機能改善食品。   The visual function improving food according to claim 1, wherein the antioxidant vitamin is vitamin E. 前記ビタミンEを黒大豆種皮抽出組成物300mgあたり3mg〜150mg含有することを特徴とする請求項2記載の視機能改善食品。   The visual function improving food according to claim 2, wherein the vitamin E is contained in an amount of 3 mg to 150 mg per 300 mg of the black soybean seed coat extract composition. 前記セレンを黒大豆種皮抽出組成物300mgあたり45μg〜250μg含有することを特徴とする請求項2又は3記載の視機能改善食品。   The visual function improving food according to claim 2 or 3, wherein the selenium is contained in an amount of 45 µg to 250 µg per 300 mg of black soybean seed coat extract composition. 前記抗酸化性ビタミンとして、さらにβ−カロテンを含むことを特徴とする請求項2乃至4のいずれか1項記載の視機能改善食品。   The visual function improving food according to claim 2, further comprising β-carotene as the antioxidant vitamin. 前記β−カロテンを黒大豆種皮抽出組成物300mgあたり1080μg〜3600μg含有することを特徴とする請求項6記載の視機能改善食品。   The visual function improving food according to claim 6, wherein the β-carotene is contained in an amount of 1080 μg to 3600 μg per 300 mg of black soybean seed coat extract composition. 粉末状、顆粒状、錠剤状、カプセル状、飲料、ドリンク剤のいずれかであることを特徴とする請求項1乃至6のいずれか1項記載の視機能改善食品。   The visual function-improving food according to any one of claims 1 to 6, which is any one of powder, granules, tablets, capsules, beverages and drinks. 健康食品の摂取による視機能改善効果を確認するに際し、利き目における視機能改善効果に基づいて、摂取した健康食品を評価することを特徴とする健康食品の評価方法。   A health food evaluation method, comprising: evaluating a health food intake based on a visual function improvement effect in a dominant eye when confirming a visual function improvement effect due to the intake of the health food. 前記視機能改善効果を確認するための評価項目が、視力、フリッカーテスト、アコモドグラムから選ばれる少なくとも1種であることを特徴とする請求項8記載の健康食品の評価方法。   9. The health food evaluation method according to claim 8, wherein the evaluation item for confirming the visual function improvement effect is at least one selected from visual acuity, flicker test, and accomodogram.
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