JP2019099520A - Blood pressure lowering composition - Google Patents
Blood pressure lowering composition Download PDFInfo
- Publication number
- JP2019099520A JP2019099520A JP2017233616A JP2017233616A JP2019099520A JP 2019099520 A JP2019099520 A JP 2019099520A JP 2017233616 A JP2017233616 A JP 2017233616A JP 2017233616 A JP2017233616 A JP 2017233616A JP 2019099520 A JP2019099520 A JP 2019099520A
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- JP
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- Prior art keywords
- blood pressure
- composition
- mumefural
- weeks
- lowering
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Abstract
Description
本発明は、血圧降下用組成物に関するものであり、より詳細にはムメフラール高含有梅エキスを含有する血圧降下用組成物に関するものである。 The present invention relates to a blood pressure lowering composition, and more particularly to a blood pressure lowering composition containing mumefural-rich plum extract.
ムメフラール高含有梅エキス粒状製品が知られている(特許文献1)。しかし、ムメフラール高含有梅エキスが、血圧を降下させること、又は血圧降下作用持続時間を改善することについて、一切知られておらず、示唆さえされていない。 BACKGROUND ART [0002] An ume extract high-plum extract granular product is known (Patent Document 1). However, nothing is known or even suggested that mumefural-rich plum extract lowers blood pressure or improves the duration of blood pressure lowering action.
本発明の目的は、血圧降下用組成物を提供することである。 An object of the present invention is to provide a blood pressure lowering composition.
本発明者らは、ムメフラール高含有梅エキスを含有する組成物が、血圧を降下させること及び血圧降下作用持続時間を改善することを見出し、さらに検討を重ねて本発明を完成するに至った。 The present inventors have found that a composition containing a mumefural-rich plum extract lowers blood pressure and improves the duration of blood pressure-lowering action, and has conducted further studies to complete the present invention.
すなわち、本発明は以下のとおりである。
[1]ムメフラール高含有梅エキスを含有することを特徴とする血圧降下用組成物。
[2]梅エキス中のムメフラール含有割合が、0.2〜2質量%であることを特徴とする前記[1]に記載の組成物。
[3]ムメフラール高含有梅エキス投与期間中又は投与停止後2週間、血圧降下作用が持続することを特徴とする前記[1]又は[2]に記載の組成物。
[4]適用対象が、I度高血圧のヒトであることを特徴とする前記[1]〜[3]のいずれかに記載の組成物。
[5]前記[1]〜[4]のいずれかに記載の組成物を含有し、血圧を降下させる旨の表示、血圧降下作用持続時間を改善する旨の表示又は血圧高めのヒト若しくはI度高血圧のヒトに適している旨の表示を付した血圧降下用飲食品。
[6]前記[1]〜[4]のいずれかに記載の組成物を、前記組成物が血圧を降下させること、血圧降下作用持続時間を改善すること、又は血圧高めのヒト若しくはI度高血圧のヒトに適していることを記載した説明書と共にパッケージした血圧降下用製品。
That is, the present invention is as follows.
[1] A composition for lowering blood pressure, characterized by containing a mumefural-rich plum extract.
[2] The composition according to the above [1], wherein the content of mumefural in the ume extract is 0.2 to 2% by mass.
[3] The composition according to the above [1] or [2], wherein the blood pressure lowering action is sustained during the administration period of the high mumefural plum extract administration or for 2 weeks after the administration is stopped.
[4] The composition according to any one of the above [1] to [3], wherein the subject to be applied is a human with I-degree hypertension.
[5] A display showing that the blood pressure is lowered, a display showing that the blood pressure lowering action duration is improved, or a blood pressure-enhancing human or I containing the composition according to any one of the above [1] to [4] Food and drink for lowering blood pressure with an indication that it is suitable for humans with high blood pressure.
[6] The composition according to any one of the above [1] to [4], wherein the composition lowers blood pressure, improves the duration of blood pressure lowering action, or increases blood pressure or a human with I-degree hypertension An antihypertensive product packaged with instructions describing that it is suitable for humans.
本発明の組成物は、血圧降下作用を有し、好ましくは血圧降下作用の持続時間を改善(好ましくは長期化又は延長)することができる。本発明の組成物は、ビーズ等の徐放化製剤技術を採用しなくても作用の持続時間を改善(好ましくは長期化又は延長)することができる点又は例えば毎日などの連続投与(服用)をし忘れていても支障なく血圧降下効果が奏される点で特に優れている。 The composition of the present invention has a blood pressure lowering action, and preferably can improve (preferably prolong or prolong) the duration of the blood pressure lowering action. The composition of the present invention can improve the duration of action (preferably prolong or prolong) without adopting a sustained release preparation technology such as beads or continuous administration (dose), for example, every day It is particularly excellent in that even if you forget to
本開示は、ムメフラール高含有梅エキスを含有する血圧降下用組成物(以下、本発明の組成物ともいう。)を包含する。 The present disclosure includes a blood pressure lowering composition (hereinafter, also referred to as a composition of the present invention) containing a mumefural-rich plum extract.
本発明の組成物は、ムメフラール高含有梅エキスを含有する。本発明の組成物は、ムメフラール高含有梅エキスに加えて、それ以外の成分を含有していてもよい。該成分は、本発明の効果を失しない限り、特に限定されず、例えば、医薬、薬学又は食品等の分野で知られる任意の成分を用いることができる。本発明のひとつの態様において、ムメフラール高含有梅エキス以外の成分として、例えばソルビトール、ステビア、サッカリン、アスパルテーム、ネオテーム、アドバンテーム、アセスルファムカリウム、スクラロース、キシリトール、エリスリトール等の甘味料;ペクチン、グアーガム、キサンタンガム、タマリンドガム、カラギーナン、プロピレングリコール、カルボキシメチルセルロース等の増粘剤;ハチミツ;クエン酸;矯味剤;香料;防腐剤;pH調整剤;梅果肉、生姜、山椒等の食品素材等の添加剤が挙げられる。 The composition of the present invention contains a mumefural-rich plum extract. The composition of the present invention may contain other components in addition to the mumefural-rich plum extract. The component is not particularly limited as long as the effect of the present invention is not lost, and any component known in the field of, for example, medicine, medicine, food and the like can be used. In one embodiment of the present invention, as components other than the mumefural-rich plum extract, for example, sweeteners such as sorbitol, stevia, saccharin, aspartame, neotame, neotame, advantame, acesulfame potassium, sucralose, xylitol, erythritol etc; pectin, guar gum, xanthan gum Thickeners such as tamarind gum, carrageenan, propylene glycol, carboxymethylcellulose, etc .; honey; citric acid; flavoring agents; flavors; preservatives; pH adjusters; additives such as food ingredients such as plum flesh, ginger, and yam Be
ムメフラール高含有梅エキスとして、市販品である梅真珠(商品名、中野BC株式会社製)を使用してもよい。また、ムメフラール高含有梅エキスは、梅果肉を搾ることにより得られた梅果汁を煮詰めて得られる梅肉エキスと、梅果肉乾燥粉末とを含む梅由来の成分を所望の割合で混合することにより製造され得る。ムメフラール高含有梅エキスの製造法は、特許第4566978号の記載を参照してもよい。
梅エキス全体に対するムメフラール含有割合は、例えば、約0.2〜2質量%であることが好ましく、1〜2質量%であることがより好ましく、1.5〜2質量%であることがさらに好ましい。上記範囲内であれば、より優れた本発明の効果が奏され得る。
さらに本発明におけるムメフラール高含有梅エキスには、クエン酸が含まれていることが好ましい。当該梅エキス全体に対するクエン酸含有割合は、例えば、約1〜80質量%であることが好ましく、10〜70質量%であることがより好ましく、20〜60質量%であることがさらに好ましい。上記範囲内であれば、より優れた本発明の効果が奏され得る。
本発明の組成物中、ムメフラール高含有梅エキスの含有量は、本発明の効果が発揮されれば、特に限定されないが、組成物100質量%中、例えば、約0.001〜100質量%の範囲であってよく、好ましくは、約10〜100質量%である。
A commercially available product, plum pearl (trade name, manufactured by Nakano BC Co., Ltd.) may be used as the mumefural-rich plum extract. In addition, the mumefural high ume extract is obtained by mixing the plum-derived extract obtained by simmering in the plum juice obtained by squeezing plum flesh and the plum-derived component including dried plum flesh in a desired ratio It can be manufactured. The method of producing the mumefural-rich plum extract may be referred to the description of Japanese Patent No. 4566978.
For example, the content of mumefural relative to the whole plum extract is preferably about 0.2 to 2% by mass, more preferably 1 to 2% by mass, and still more preferably 1.5 to 2% by mass . Within the above range, more excellent effects of the present invention can be exhibited.
Furthermore, it is preferable that citric acid is contained in the mumefural high content plum extract in this invention. The citric acid content ratio to the whole plum extract is, for example, preferably about 1 to 80% by mass, more preferably 10 to 70% by mass, and still more preferably 20 to 60% by mass. Within the above range, more excellent effects of the present invention can be exhibited.
The content of the mumefural-rich plum extract in the composition of the present invention is not particularly limited as long as the effects of the present invention are exhibited, but for example, about 0.001 to 100% by mass in 100% by mass of the composition It may be in the range, preferably about 10 to 100% by mass.
本発明の組成物の投与経路は、特に限定されず、例えば、経口又は非経口のいずれかの経路で哺乳動物に投与してよい。特に本発明の組成物は、ヒト(より好ましくはI度高血圧のヒト)に投与して、拡張期血圧及び/若しくは収縮期血圧が低下し得る点、又は低下時間が持続し得る点で優れている。I度高血圧は、通常、来所時収縮期血圧140以上160未満及び/又は来所時拡張期血圧90以上100未満のことをいう。また、来所時血圧(診察室血圧)は、通常、病院又は診療所等で測った血圧のことをいう。また、後述の家庭血圧は、通常、朝は起床後1時間以内、排尿後、座位1〜2分の安静後、降圧薬服用前、朝食前に測った血圧のこと、晩は就寝前、座位1〜2分の安静後に測った血圧のことをいう。
ムメフラール高含有梅エキスの摂取量は、経口又は注射投与の場合は、摂取者の年齢及び体重、症状、投与時間、剤形、投与方法、薬剤の組み合わせ等に依存して決定できる。例えば、成人1人(約60kg)1日当たり、ムメフラール高含有梅エキスを、好ましくは約0.5〜5g、より好ましくは約1〜4g摂取されるように設定するのが好ましい。当該エキスにはムメフラールが高割合で含有されているところ、成人1人(約60kg)1日当たり、ムメフラールを、好ましくは約10〜50mg、より好ましくは約20〜40mg、更に好ましくは約25〜35mg摂取されるように設定するのが好ましい。摂取回数は、1日1回又は複数回に分けて行うことができる。また、前記の投与用量を、数日(2〜3日)に1日投与又は適用することができる。
または外用塗布の場合は、適用する皮膚面積に応じて、ムメフラール高含有梅エキスの塗布量を適宜選択することができるが、通常、当該塗布量は、適用部位の面積約10cm2に対して、1日につき、好ましくは約0.01〜100mg、より好ましくは約0.02〜30mgである。前記の投与用量を、1日あたり、1回又は数回に分けて投与又は適用することができる。また、前記の投与用量を、数日(2〜3日)に1日投与又は適用することができる。
The route of administration of the composition of the present invention is not particularly limited, and may be administered to a mammal, for example, by either oral or parenteral route. In particular, the composition of the present invention is excellent in that it can be administered to humans (more preferably, humans with I-high blood pressure) and diastolic blood pressure and / or systolic blood pressure can be reduced, or the reduction time can be sustained. There is. Degree I hypertension usually refers to a systolic blood pressure at visit 140 or more and less than 160 and / or a diastolic blood pressure at visit 90 or more and less than 100. In addition, blood pressure at the time of visit (doctor's office blood pressure) usually refers to the blood pressure measured at a hospital or clinic or the like. In addition, the home blood pressure described below is usually measured within 1 hour after getting up in the morning, after urination, after sitting for 1 to 2 minutes, before taking antihypertensive drugs, before taking breakfast, before going to bed at night, sitting down Blood pressure measured after 1 to 2 minutes of rest.
In the case of oral or injection administration, the intake of the mumefural-rich plum extract can be determined depending on the age and body weight of the user, symptoms, administration time, dosage form, administration method, drug combination and the like. For example, it is preferable to set so as to be preferably ingested about 0.5 to 5 g, more preferably about 1 to 4 g of mumefural-rich plum extract per adult (about 60 kg) per day. Where the extract contains a high proportion of mumefural, preferably about 10 to 50 mg, more preferably about 20 to 40 mg, still more preferably about 25 to 35 mg of mumefural per adult (about 60 kg) per day It is preferable to set so as to be ingested. The intake frequency can be divided into one or more times a day. In addition, the above dose can be administered or applied daily for several days (2 to 3 days).
Or, in the case of application for external use, the application amount of the mumefural high ume extract can be appropriately selected according to the skin area to be applied, but generally, the application amount is about 10 cm 2 of the application area. Preferably it is about 0.01 to 100 mg, more preferably about 0.02 to 30 mg per day. The dose described above can be administered or applied once or several times a day. In addition, the above dose can be administered or applied daily for several days (2 to 3 days).
本発明の組成物を経口投与する場合は、散剤、顆粒剤、丸剤、錠剤、カプセル剤等の固形製剤であってもよく、シロップ剤等の液剤であってもよい。これらの製剤を製造する場合には、その製剤形態に応じた担体もしくは添加剤を使用することができる。これらの製剤の製造は従来充分に確立されているので、本発明においてもそれに従ってよい。そのような製剤の製造に使用される担体もしくは添加剤としては、例えば、賦形剤(ポリアクリル酸ナトリウム、ポリアクリル酸カルシウム、カルボキシメチルセルロース、乳糖、デキストリン、コーンスターチ、結晶セルロース、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、リン酸カリウム等)、滑沢剤(ステアリン酸マグネシウム、ショ糖脂肪酸エステル、グリセリン脂肪酸エステル、精製タルク、ポリエチレングリコール等)、崩壊剤(カルボキシメチルセルロースカルシウム、無水リン酸水素カルシウム、カルボキシメチルセルロースナトリウム、低置換度ヒドロキシプロピルセルロース、乾燥デンプン、アルギン酸ナトリウム、カンテン末、炭酸水素ナトリウム、炭酸カルシウム等)、結合剤(ヒドロキシプロピルセルロース、アラビアゴム液、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、メチルセルロース、ポリビニルピロリドン等)、溶解補助剤(アラビアゴム、ポリソルベート80等)、吸収促進剤(ラウリル硫酸ナトリウム等)、緩衝剤(リン酸緩衝液、酢酸緩衝液、ホウ酸緩衝液、炭酸緩衝液、クエン酸緩衝液、トリス緩衝液等)、保存剤(パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、クロロブタノール、ベンジルアルコール、塩化ベンザルコニウム、デヒドロ酢酸ナトリウム、エデト酸ナトリウム等)、増粘剤(プロピレングリコール、グリセリン、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ポリビニルアルコール、ポリエチレングリコール等)、安定化剤(亜硫酸水素ナトリウム、チオ硫酸ナトリウム、エデト酸ナトリウム、クエン酸ナトリウム、アスコルビン酸、ジブチルヒドロキシトルエン等)又はpH調整剤(塩酸、水酸化ナトリウム、リン酸、酢酸等)を挙げることができる。必要に応じて、コーティング剤(白糖、ゼラチン、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロースフタレート等)で被覆していてもよいし、また2以上の層で被覆していてもよい。 When the composition of the present invention is orally administered, it may be a solid preparation such as powder, granule, pill, tablet, capsule and the like, or may be liquid such as syrup. When these formulations are produced, carriers or additives can be used according to the formulation form. The preparation of these formulations is well established in the art and may be followed according to the invention. Examples of carriers or additives used for producing such a preparation include excipients (sodium polyacrylate, calcium polyacrylate, carboxymethylcellulose, lactose, dextrin, corn starch, crystalline cellulose, sucrose, sodium chloride, Glucose, urea, starch, calcium carbonate, kaolin, silicic acid, potassium phosphate etc., lubricant (magnesium stearate, sucrose fatty acid ester, glycerin fatty acid ester, purified talc, polyethylene glycol etc), disintegrant (carboxymethyl cellulose Calcium, anhydrous calcium hydrogen phosphate, sodium carboxymethylcellulose, low substituted hydroxypropyl cellulose, dry starch, sodium alginate, agar powder, sodium hydrogen carbonate, calcium carbonate etc.) Binder (hydroxypropylcellulose, gum arabic solution, water, ethanol, propanol, simple syrup, glucose solution, starch solution, gelatin solution, carboxymethylcellulose, methylcellulose, polyvinylpyrrolidone etc.), solubilizer (eg gum arabic, polysorbate 80 etc.) Absorption accelerator (sodium lauryl sulfate etc.), buffer (phosphate buffer, acetate buffer, borate buffer, carbonate buffer, citrate buffer, tris buffer etc), preservative (methyl parahydroxybenzoate) , Ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, chlorobutanol, benzyl alcohol, benzalkonium chloride, sodium dehydroacetate, sodium edetate etc., thickeners (propylene glycol, glycerin, hydroxy Chill cellulose, hydroxypropyl cellulose, polyvinyl alcohol, polyethylene glycol etc., stabilizers (sodium bisulfite, sodium thiosulfate, sodium edetate, sodium citrate, ascorbic acid, dibutylhydroxytoluene etc.) or pH adjusters (hydrochloric acid, Sodium hydroxide, phosphoric acid, acetic acid etc. can be mentioned. If necessary, it may be coated with a coating agent (sucrose, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate or the like) or may be coated with two or more layers.
本発明の組成物は、特に限定されないが、例えば、飲食品、飼料、食品添加剤、飼料添加剤、医薬品、又は化粧品等であってよく、好ましくは、飲食品等である。すなわち、本開示は、本発明の組成物を含有し、血圧降下作用持続時間を改善する旨の表示又は血圧高めのヒト若しくはI度高血圧のヒトに適している旨の表示を付した血圧降下作用持続時間改善用飲食品を包含する。 The composition of the present invention is not particularly limited, and may be, for example, food and drink, feed, food additive, feed additive, medicine, cosmetic, etc., preferably food and the like. That is, the present disclosure contains a composition of the present invention, and displays an indication that the blood pressure lowering action duration is improved, or displays an indication that the blood pressure is elevated or that it is suitable for humans with degree I hypertension. Include food and drink for improving the duration.
本発明の組成物が飲食品である場合、飲食品には、一般的に飲食品に用いられる食品添加剤、例えば甘味料、着色料、保存料、増粘安定剤、酸化防止剤、発色料、漂白料、防かび剤、ガムベース、苦味料、酵素、光沢剤、酸味料、調味料、乳化剤、強化剤、製造用剤、香料、香辛料抽出物等が添加されてもよい。なお、飲食品には、機能性表示食品、特定保健用食品、健康食品、病者用食品が含まれる。当該飲食品は、飲食品中にムメフラール高含有梅エキスを添加する工程も含めて、一般的な飲食品の製造方法を用いて加工製造することができる。 When the composition of the present invention is a food or drink, food additives generally used for food and drink, such as sweeteners, colorants, preservatives, thickeners, thickeners, antioxidants, color formers Bleaching agents, fungicides, gum bases, bitter agents, enzymes, brighteners, acidulants, seasonings, emulsifiers, enhancers, manufacturing agents, flavors, spice extracts and the like may be added. The food and drink include functional indication food, food for specified health use, health food, food for sick people. The said food-drinks can be processed and manufactured using the manufacturing method of a general food-drinks including the process of adding a mumefural high content plum extract in food-drinks.
本発明に好適な飲食品として、具体的には例えば、いわゆる栄養補助食品(サプリメント)としての錠剤、顆粒剤、散剤、ドリンク剤等を挙げることができる。これ以外には、例えば茶飲料、清涼飲料、炭酸飲料、栄養飲料、果実飲料、乳酸飲料等の飲料、そば、うどん、中華麺、即席麺等の麺類、飴、キャンディー、ガム、チョコレート、スナック菓子、ビスケット、ゼリー、ジャム、クリーム、焼き菓子、パン等の菓子及びパン類、かまぼこ、ハム、ソーセージ等の水産・畜産加工食品、加工乳、発酵乳等の乳製品、サラダ油、てんぷら油、マーガリン、マヨネーズ、ショートニング、ホイップクリーム、ドレッシング等の油脂及び油脂加工食品、ソース、たれ等の調味料、カレー、シチュー、丼、お粥、雑炊等のレトルトパウチ食品、アイスクリーム、シャーベット、かき氷等の冷菓等を挙げることができる。 Specific examples of the food and drink suitable for the present invention include tablets, granules, powders, drinks and the like as so-called nutraceuticals (supplements). Other than this, for example, beverages such as tea beverages, soft drinks, carbonated beverages, nutritional beverages, fruit beverages, lactic acid beverages, soba noodles, udon noodles, Chinese noodles, instant noodles etc., candy, candies, gums, chocolates, snacks, Biscuits, jellies, jams, creams, baked goods, pastries such as bread, breads, fish and fish processed foods such as kamabo, ham, sausages, dairy products such as processed milk and fermented milk, salad oil, tempura oil, margarine, mayonnaise , Shortening, whipped cream, fats and oils such as dressings and processed foods, sauces, seasonings such as sauce, curry, stew, chopsticks, rice cakes, retort pouch food such as risotto, ice cream, sherbet, frozen desserts such as shaved ice It can be mentioned.
本発明の組成物を飲食品の形態に調製した場合、当該飲食品、添付説明書又は包装箱等には、本発明の組成物の作用に鑑みて、(1)血圧降下作用持続時間を改善(好ましくは長期化又は延長)する旨、(2)血圧を降下させる旨、(3)血圧高めのヒト又はI度高血圧のヒトに適している旨、(4)メタボリックシンドロームを予防又は改善する旨、(5)肥満を抑制する旨、及び(6)ダイエット効果を有する旨から選択される1つ以上を表示することができる。 When the composition of the present invention is prepared in the form of a food or drink, the food or drink, the attached instruction or the packaging box, etc., improves the duration of blood pressure lowering action in view of the action of the composition of the present invention. (Preferably to prolong or prolong) (2) to lower blood pressure, (3) to be suitable for human with high blood pressure or a person with I high blood pressure, and (4) to prevent or improve metabolic syndrome , (5) to suppress obesity, and (6) to display one or more selected from the effect of having a diet effect.
飼料としては、例えば、ウシ、ウマ、ブタ等の家畜用飼料、ニワトリ等の家禽用飼料、イヌ、ネコ等のペット用飼料などが挙げられる。飼料は、飼料中にムメフラール高含有梅エキスを添加する工程も含めて、一般的な飼料の製造方法を用いて加工製造することができる。 Examples of feeds include feeds for livestock such as cattle, horses and pigs, feeds for poultry such as chicken, and feeds for pets such as dogs and cats. The feed can be processed and manufactured using a general feed production method, including the step of adding a mumefural-rich plum extract to the feed.
医薬品はムメフラール高含有梅エキスと公知の医薬品添加剤等を配合して製造され得る。 The pharmaceutical preparation can be prepared by combining mumefural-rich plum extract with known pharmaceutical additives and the like.
化粧品としては、例えば、ボディ洗浄料、ハンド洗浄料、洗顔料等の洗浄料類や化粧水、乳液、クリーム等の基礎化粧料、ファンデーション、アンダーメークアップ、白粉等のメークアップ料等の化粧料剤形等が挙げられる。化粧品は、化粧品中にムメフラール高含有梅エキスを添加する工程も含めて、一般的な化粧品の製造方法を用いて加工製造することができる。 Examples of cosmetics include body cleansers, hand cleansers, cleansers such as face cleansers, basic cosmetics such as lotions, emulsions and creams, and cosmetics such as foundations, under make-up, makeups such as white powder. A dosage form etc. are mentioned. Cosmetics can be processed and manufactured using the manufacturing method of a general cosmetics including the process of adding a mumefural high content plum extract in cosmetics.
本発明の組成物は、(1)血圧降下作用持続時間を改善(好ましくは長期化又は延長)する効果、(2)血圧を降下させる効果、(3)血圧高めのヒト又はI度高血圧のヒトに適している効果、(4)メタボリックシンドロームを予防又は改善する効果、(5)肥満を抑制する効果、及び(6)ダイエット効果を有する効果から選択される1つ以上効果を奏し得る。 The composition of the present invention has (1) an effect of improving (preferably prolonging or prolonging) the blood pressure lowering action duration, (2) an effect of lowering blood pressure, (3) a human with high blood pressure or a human with I high blood pressure One or more effects selected from the effects of (4) effects of preventing or improving metabolic syndrome, (5) effects of suppressing obesity, and (6) effects of diet may be exhibited.
来所時血圧(診察室血圧)又は家庭血圧を、例えば血圧計HEM−7080−IC(オムロン ヘルスケア株式会社製)、テルモ電子血圧計W300(テルモ株式会社製)等の血圧測定器で測定した結果、収縮期血圧又は拡張期血圧(好ましくは拡張期血圧)が本発明の組成物投与前と比較して減少している場合に、本発明の組成物は血圧を降下させる効果を有すると判断することができる。本開示において、ムメフラール高含有梅エキス投与期間中に(例えば、投与開始より一定期間後から又は投与期間中ずっと)血圧降下作用を示してもよく、ムメフラール高含有梅エキス投与停止後に血圧降下作用を示してもよく、ムメフラール高含有梅エキス投与期間中(例えば、投与開始より一定期間後から又は投与期間中ずっと)及び投与停止後に血圧降下作用を示してもよい。上記の場合において、投与期間中は、毎日、好ましくは、朝、昼及び夜の毎食前に本発明の組成物を投与することが好ましい。
血圧降下作用を示す期間は、1日間であってもよく、2日間であってもよく、3日間であってもよく、1週間であってもよく、2週間であってもよく、3週間であってもよく、4週間であってもよく、6週間であってもよく、8週間であってもよく、10週間であってもよく、12週間であってもよく、14週間であってもよい。
上記「投与開始より一定期間後から」における、一定期間は、1日であってもよく、2日であってもよく、3日であってもよく、1週間であってもよく、2週間であってもよく、3週間であってもよく、4週間であってもよく、6週間であってもよく、8週間であってもよく、10週間であってもよく、12週間であってもよく、14週間であってもよい。
また、ムメフラール高含有梅エキス投与停止後に血圧降下作用を示す場合、投与停止日は、本発明の組成物投与開始日であってもよく、本発明の組成物投与開始から1日後であってもよく、2日後であってもよく、3日後であってもよく、1週間後であってもよく、2週間後であってもよく、3週間後であってもよく、4週間後であってもよく、6週間後であってもよく、8週間後であってもよく、10週間後であってもよく、12週間後であってもよく、14週間後であってもよい。
例えば、ムメフラール高含有梅エキス投与停止後に血圧降下作用を示す場合に、血圧降下作用を示す期間が上記期間である場合、本発明の組成物は血圧降下作用持続時間を改善する効果を有すると判断することができ、また、血圧降下作用持続時間改善用組成物として有用である。
好ましくは、例えばムメフラールを20〜40mg含有する本発明の組成物を1日服用すると、効果がその後数日間(例えば2〜3日)持続し得る。
The blood pressure at the time of visit (medical office blood pressure) or home blood pressure was measured with a blood pressure measurement device such as, for example, a sphygmomanometer HEM-7080-IC (manufactured by Omron Healthcare Co., Ltd.) or Terumo Electronic Sphygmomanometer W300 (manufactured by Terumo Corporation). As a result, when the systolic blood pressure or the diastolic blood pressure (preferably, the diastolic blood pressure) is decreased compared to before administration of the composition of the present invention, it is determined that the composition of the present invention has an effect of lowering blood pressure. can do. In the present disclosure, the blood pressure lowering action may be exhibited during the mumefural high content plum extract administration period (for example, after a fixed period after administration start or throughout the administration period), It may also be shown, and it may exhibit an antihypertensive effect during the period of high mumefural plum extract-containing plum extract administration (for example, after a fixed period of time from the start of administration or throughout the period of administration) and after the administration is stopped. In the above case, it is preferred to administer the composition of the present invention daily, preferably every morning, day and night before meals, during the administration period.
The blood pressure lowering period may be one day, two days, three days, one week, two weeks, or three weeks. It may be 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks. May be
The fixed period in the above “after a fixed period from the start of administration” may be 1 day, 2 days, 3 days, 1 week, 2 weeks May be, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12
In addition, when the blood pressure lowering action is shown after cessation of administration of ume extract containing high mumefural, the cessation date of administration may be the day of administration of the composition of the present invention, even one day after the administration of the composition of the present invention Well, after two days, after three days, after one week, after two weeks, after three weeks, after four weeks It may be after 6 weeks, after 8 weeks, after 10 weeks, after 12 weeks or after 14 weeks.
For example, when the blood pressure lowering action is shown after cessation of administration of the mumefural-rich plum extract administration, the composition of the present invention is judged to have the effect of improving the blood pressure lowering action duration when the period showing the blood pressure lowering action is the above period. It is also useful as a composition for improving blood pressure lowering action duration.
Preferably, for example, if the composition of the present invention containing 20 to 40 mg of mumefural is taken for 1 day, the effect may last for several days thereafter (for example 2 to 3 days).
本開示は、本発明の組成物を、前記組成物が血圧を降下させること、血圧降下作用持続時間を改善すること、又は血圧高めのヒト若しくはI度高血圧のヒトに適していることを記載した説明書と共にパッケージした血圧降下作用持続時間改善用製品を包含する。 The present disclosure describes the composition of the present invention as said composition lowering blood pressure, improving blood pressure lowering duration, or being suitable for high blood pressure humans or people with I high blood pressure. It includes a product for improving the duration of blood pressure lowering action packaged with the instructions.
以下に実施例をあげて本発明をさらに具体的に説明するが、本発明はこれらに限定されるものではない。 EXAMPLES The present invention will be more specifically described below with reference to examples, but the present invention is not limited to these.
下記の通り、ムメフラール高含有梅エキスの摂取による血圧改善作用に関するプラセボ対照二重盲検並行群間比較試験を行った。 As described below, a placebo-controlled, double-blind, parallel-group comparative study was conducted on the blood pressure ameliorating effect of intake of a mumefural-rich plum extract.
1.被験対象
年齢30〜69歳、I度高血圧(来所時収縮期血圧140以上160未満)で、高血圧治療の必要がない男女80名を性別、年齢及び収縮期血圧を調整してランダムに、実施例1の試験食摂取群と、プラセボの試験食摂取群の2群に分けた。
1. Test subject Age: 30 to 69 years, I high blood pressure (systolic blood pressure at visit 140 or more and less than 160), 80 men and women who do not need high blood pressure treatment are adjusted randomly by adjusting sex, age and systolic blood pressure The test food intake group of Example 1 and the test food intake group of placebo were divided into two groups.
2.試験食
下記表に記載の原料を混合し、90℃で加熱殺菌して、実施例1又はプラセボの試験食を製造した。
2. Test food The raw materials described in the following table were mixed and heat-sterilized at 90 ° C. to produce a test food of Example 1 or placebo.
3.試験
各群の被験対象は、実施例1又はプラセボの試験食10gを、12週間毎日、朝、昼及び夜の毎食前に経口摂取した。試験食摂取開始から12週間経過後から試験食摂取開始後14週間までは試験食の摂取をしていない。
1日の試験食摂取量は30gである。30gの試験食に含まれる栄養組成は下記表2の通りである。
3. The test subjects in each group orally ingested 10 g of the test food of Example 1 or placebo daily for 12 weeks every morning, day and night. The test food is not taken from 12 weeks after the start of test food intake until 14 weeks after the start of test food intake.
The daily test food intake is 30 g. The nutritional composition contained in the 30 g test food is as shown in Table 2 below.
試験食摂取開始後0日目、4週間後、8週間後、12週間後及び14週間後に来所時収縮期血圧及び拡張期血圧を測定し、評価時点毎に、独立2標本のt検定の統計処理を行い、群間比較を行った。
Test systolic blood pressure and diastolic blood pressure were measured on the
4.結果
平均来所時拡張期血圧の結果を図1に示した。図1において、実施例1の試験食摂取群の試験食摂取開始後0日目の平均来所時拡張期血圧値84.27mmHg、及びプラセボの試験食摂取群の試験食摂取開始後0日目の平均来所時拡張期血圧値80.07mmHgを、各群の基準値0とし、試験食摂取開始から4週間後、8週間後、12週間後及び14週間後における来所時拡張期血圧平均値の上記試験食摂取開始後0日目の値に対する変化量を示した。
I度高血圧群において、実施例1の試験食摂取群は、プラセボの試験食摂取群と比較して、試験食摂取開始から14週間継続して、来所時拡張期血圧が低いことが示された。特に試験食摂取開始から12週間後及び14週間後において、実施例1の試験食摂取群は、プラセボの試験食摂取群と比較して、来所時拡張期血圧が有意に低下した。
4. Results The average visit diastolic blood pressure results are shown in FIG. In FIG. 1, the average visit diastolic blood pressure value 84.27 mmHg on
In the group I high blood pressure group, the test food intake group of Example 1 was shown to have a lower diastolic blood pressure at the time of visit for 14 weeks from the start of test food intake compared with the test food intake group of placebo. The In particular, at 12 weeks and 14 weeks after the start of the test food intake, the test food intake group of Example 1 had a significant reduction in visiting diastolic blood pressure as compared with the placebo test food intake group.
平均来所時収縮期血圧の結果を表3に示した。試験食摂取開始から8週間後及び14週間後において、実施例1の試験食摂取群は、プラセボの試験食摂取群と比較して、来所時収縮期血圧が低かった。また、実施例1の試験食摂取群において、試験食摂取開始から8週間後及び14週間後の来所時収縮期血圧は、試験食摂取開始後0日目のそれと比較して低下した。
The mean visit systolic blood pressure results are shown in Table 3. At 8 weeks and 14 weeks after the start of the test food intake, the test food intake group of Example 1 had a lower systolic blood pressure at the time of visit as compared with the test food intake group of the placebo. In addition, in the test food intake group of Example 1, the visit systolic blood pressure at 8 weeks and 14 weeks after the start of the test food intake was lower than that at
これらの結果から、ムメフラール高含有梅エキスが、ヒトに対して、血圧降下作用を示し、その作用は長期にわたって持続することが示された。 From these results, it has been shown that mumefural-rich plum extract has an antihypertensive action on humans, and the action lasts for a long time.
本発明の組成物は、血圧降下を目的とした飲食品、医薬品、及び飼料等として有用である。 The composition of the present invention is useful as food and drink, medicine, feed and the like for the purpose of lowering blood pressure.
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