JP2023132041A - Sleep quality improver and sleep quality-improving composition, daytime productivity improver and daytime productivity-improving composition, as well as concentration improver and concentration-improving composition - Google Patents
Sleep quality improver and sleep quality-improving composition, daytime productivity improver and daytime productivity-improving composition, as well as concentration improver and concentration-improving composition Download PDFInfo
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Abstract
Description
本発明は、睡眠の質向上剤及び睡眠の質向上用組成物、日中の生産性向上剤及び日中の生産性向上用組成物、並びに集中力向上剤及び集中力向上用組成物に関する。 The present invention relates to a sleep quality improver and a composition for improving sleep quality, a daytime productivity improver and a composition for improving daytime productivity, and a concentration improver and a composition for improving concentration.
人間は人生の約3分の1を「睡眠」に費やしており、睡眠は人間にとって最も重要な行為と考えられる。しかしながら、現代社会では、生活リズムの乱れやストレス、運動不足等により睡眠不足、不眠の症状を訴える人が多く存在する。
また、睡眠の質は、加齢に伴い低下する。そのため、今後、高齢者数の増加に伴い、睡眠の質が低下した高齢者が増加すると予想される。
睡眠の質には、身体的要因の他、心理的要因、薬理学的要因、環境要因等の様々な要因が影響し、一般的に、寝つきが悪い入眠障害、夜中に何度も目が覚める中途覚醒、朝早くに目が覚めてしまう早期覚醒、よく眠った感じがしない熟眠不全等を誘発する。睡眠の質の低下は、心筋梗塞や脳梗塞等の重大な疾患に繋がるだけでなく、日中の眠気や疲労から生産性や集中力が低下し、重大な事故に繋がることから、その改善は重要な課題である。
Humans spend approximately one-third of their lives sleeping, and sleep is considered the most important act for humans. However, in modern society, many people complain of sleep deprivation and insomnia due to disturbances in their daily rhythms, stress, lack of exercise, and the like.
Additionally, the quality of sleep declines with age. Therefore, as the number of elderly people increases, it is expected that the number of elderly people with poor sleep quality will increase in the future.
The quality of sleep is affected by various factors such as physical factors, psychological factors, pharmacological factors, environmental factors, etc. Generally, people have difficulty falling asleep, have trouble falling asleep, and wake up many times during the night. It induces mid-way awakening, early awakening where you wake up early in the morning, and poor sleep where you don't feel like you slept well. Poor sleep quality not only leads to serious diseases such as myocardial infarction and cerebral infarction, but also reduces productivity and concentration due to daytime sleepiness and fatigue, which can lead to serious accidents. This is an important issue.
これまでに、睡眠の質を改善する技術として、デルフィニジン-3-ルチノシド、シアニジン-3-ルチノシド又はその組み合わせを有効成分とする睡眠の質改善剤が提案されている(例えば、特許文献1参照)。 So far, as a technique for improving sleep quality, sleep quality improving agents containing delphinidin-3-rutinoside, cyanidin-3-rutinoside, or a combination thereof as active ingredients have been proposed (for example, see Patent Document 1). .
しかしながら、睡眠の質向上作用、日中の生産性向上作用、及び集中力向上作用の少なくともいずれかの作用を有し、かつ安全性が高く、そのため、飲食品、医薬品、研究用試薬などの成分として広く利用が可能な新たな素材に対する要望は依然として強く、その速やかな開発が求められているのが現状である。 However, it has the effect of improving sleep quality, improving daytime productivity, and improving concentration, and is highly safe, so it is used as an ingredient in foods and drinks, pharmaceuticals, research reagents, etc. There is still a strong demand for new materials that can be widely used, and the current situation is that prompt development is required.
本発明は、前記従来における諸問題を解決し、以下の目的を達成することを課題とする。即ち、本発明は、優れた睡眠の質向上作用を有し、かつ安全性が高い睡眠の質向上剤及び睡眠の質向上用組成物を提供することを目的とする。
また、本発明は、優れた日中の生産性向上作用を有し、かつ安全性が高い日中の生産性向上剤及び日中の生産性向上用組成物を提供することを目的とする。
また、本発明は、優れた集中力向上作用を有し、かつ安全性が高い集中力向上剤及び集中力向上用組成物を提供することを目的とする。
An object of the present invention is to solve the problems in the conventional art and to achieve the following objects. That is, an object of the present invention is to provide a sleep quality improving agent and a sleep quality improving composition that have an excellent sleep quality improving effect and are highly safe.
Another object of the present invention is to provide a daytime productivity improving agent and a daytime productivity improving composition that have an excellent daytime productivity improving effect and are highly safe.
Another object of the present invention is to provide a concentration improving agent and a concentration improving composition that have an excellent concentration improving effect and are highly safe.
前記課題を解決するために本発明者らが鋭意検討を重ねた結果、下記構造式(1)で表される化合物が、優れた睡眠の質向上作用、日中の生産性向上作用、及び集中力向上作用を有し、かつ安全性が高く、睡眠の質向上、日中の生産性向上、及び集中力向上に有用であることを知見した。
本発明は、本発明者らの前記知見に基づくものであり、前記課題を解決するための手段としては、以下の通りである。即ち、
<1> 下記構造式(1)で表される化合物を含むことを特徴とする睡眠の質向上剤である。
<3> 下記構造式(1)で表される化合物を含むことを特徴とする日中の生産性向上剤である。
<5> 下記構造式(1)で表される化合物を含むことを特徴とする集中力向上剤である。
<1> A sleep quality improving agent characterized by containing a compound represented by the following structural formula (1).
<3> A daytime productivity improver characterized by containing a compound represented by the following structural formula (1).
<5> A concentration improver characterized by containing a compound represented by the following structural formula (1).
本発明の睡眠の質向上剤及び睡眠の質向上用組成物によると、従来における前記諸問題を解決し、前記目的を達成することができ、優れた睡眠の質向上作用を有し、かつ安全性が高い睡眠の質向上剤及び睡眠の質向上用組成物を提供することができる。
本発明の日中の生産性向上剤及び日中の生産性向上用組成物によると、従来における前記諸問題を解決し、前記目的を達成することができ、優れた日中の生産性向上作用を有し、かつ安全性が高い日中の生産性向上剤及び日中の生産性向上用組成物を提供することができる。
本発明の集中力向上剤及び集中力向上用組成物によると、従来における前記諸問題を解決し、前記目的を達成することができ、優れた集中力向上作用を有し、かつ安全性が高い集中力向上剤及び集中力向上用組成物を提供することができる。
According to the sleep quality improving agent and sleep quality improving composition of the present invention, it is possible to solve the above-mentioned problems in the past, achieve the above-mentioned objectives, have an excellent sleep quality-improving effect, and be safe. A sleep quality improving agent and a sleep quality improving composition with high performance can be provided.
According to the daytime productivity improving agent and the daytime productivity improving composition of the present invention, the above-mentioned problems in the past can be solved and the above-mentioned objectives can be achieved, and the daytime productivity improving effect is excellent. It is possible to provide a daytime productivity improving agent and a daytime productivity improving composition that have the following properties and are highly safe.
According to the concentration improver and composition for improving concentration of the present invention, it is possible to solve the above-mentioned problems in the past, achieve the above-mentioned objectives, have an excellent concentration-enhancing effect, and be highly safe. Concentration improvers and compositions for improving concentration can be provided.
(睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤)
本発明の睡眠の質向上剤は、下記構造式(1)で表される化合物を有効成分として含有し、更に必要に応じてその他の成分を含有する。
本発明の日中の生産性向上剤は、下記構造式(1)で表される化合物を有効成分として含有し、更に必要に応じてその他の成分を含有する。
本発明の集中力向上剤は、下記構造式(1)で表される化合物を有効成分として含有し、更に必要に応じてその他の成分を含有する。
The sleep quality improving agent of the present invention contains a compound represented by the following structural formula (1) as an active ingredient, and further contains other ingredients as necessary.
The daytime productivity improver of the present invention contains a compound represented by the following structural formula (1) as an active ingredient, and further contains other ingredients as necessary.
The concentration improver of the present invention contains a compound represented by the following structural formula (1) as an active ingredient, and further contains other ingredients as necessary.
本明細書において、睡眠の質向上とは、寝起きが悪い(目覚めた直後の気分が悪い)状態を良い状態にする又は良い状態に近づけること、寝起きの熟眠感がない状態を寝起きの熟眠感がある状態又はある状態に近づけること、夜中に何度も目が覚める中途覚醒時間を短くすることをいう。 In this specification, improving the quality of sleep refers to improving the state of having difficulty waking up (feeling unwell immediately after waking up) to a good state or approaching a good state, and improving the state of not feeling well-drowsed upon waking up to the state of not feeling well-drowsed upon waking up. It means to be in a certain state or to get close to a certain state, and to shorten the period of waking up during the night.
本明細書において、日中の生産性の向上とは、日中の総合的なパフォーマンスを高めること、日中の集中力を持続することができない状態を長時間持続できる状態にする又はより長い時間持続できる状態にすること、日中の自律神経機能全体の働きを多くする又は自律神経活動を高めることをいう。 In this specification, improving daytime productivity refers to increasing overall performance during the day, changing the state of being unable to maintain concentration during the day to being able to maintain it for a longer period of time, or increasing the ability to concentrate for a longer period of time. It refers to creating a state that can be sustained, increasing the overall function of the autonomic nervous system during the day, or increasing autonomic nervous activity.
本明細書において、集中力の向上とは、集中力を持続することができない状態を長時間持続できる状態にする又はより長い時間持続できる状態にすることをいう。 As used herein, improving concentration refers to changing a state in which concentration cannot be sustained to a state in which it can be sustained for a long time, or a state in which it can be sustained for a longer period of time.
前記構造式(1)で表される化合物が、睡眠の質向上作用、日中の生産性向上作用、及び集中力向上作用の少なくともいずれかの優れた作用を有し、睡眠の質向上剤、日中の生産性向上剤、又は集中力向上剤として有用であることは、従来は全く知られておらず、本発明者らによる新たな知見である。 The compound represented by the structural formula (1) has an excellent effect of improving sleep quality, improving daytime productivity, and improving concentration, and a sleep quality improving agent; It has not been previously known that it is useful as a daytime productivity improver or a concentration improver, and this is a new finding by the present inventors.
<構造式(1)で表される化合物>
下記構造式(1)で表される化合物の名称は、3-(4-ヒドロキシ-3-メトキシフェニル)プロピオン酸(英名:3-(4-Hydroxy-3-methoxyphenyl)propionic acid)(以下、「HMPA」と称することがある。)である。
The name of the compound represented by the following structural formula (1) is 3-(4-hydroxy-3-methoxyphenyl)propionic acid (English name: 3-(4-Hydroxy-3-methoxyphenyl)propionic acid) (hereinafter referred to as " (sometimes referred to as HMPA).
前記構造式(1)で表される化合物は、公知の化合物であり、市販品を用いてもよいし、植物等から抽出したものを用いることもできる。 The compound represented by the structural formula (1) is a known compound, and a commercially available product may be used, or one extracted from a plant or the like may be used.
本発明の睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤における前記構造式(1)で表される化合物の含有量としては、特に制限はなく、目的に応じて適宜選択することができる。
前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤は、前記構造式(1)で表される化合物のみからなるものであってもよい。
The content of the compound represented by the structural formula (1) in the sleep quality improving agent, daytime productivity improving agent, and concentration improving agent of the present invention is not particularly limited, and may be determined as appropriate depending on the purpose. You can choose.
The sleep quality improving agent, daytime productivity improving agent, and concentration improving agent may consist only of the compound represented by the structural formula (1).
<その他の成分>
前記その他の成分としては、本発明の効果を損なわない限り、特に制限はなく、前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤の利用形態に応じて適宜選択することができ、例えば、賦形剤、防湿剤、防腐剤、強化剤、増粘剤、乳化剤、酸化防止剤、甘味料、酸味料、調味料、着色料、香料、美白剤、保湿剤、油性成分、紫外線吸収剤、界面活性剤、増粘剤、アルコール類、粉末成分、色剤、水性成分、水、皮膚栄養剤などが挙げられる。これらは、1種単独で使用してもよいし、2種以上を併用してもよい。
<Other ingredients>
The other ingredients are not particularly limited as long as they do not impair the effects of the present invention, and are appropriately selected depending on the usage form of the sleep quality improver, daytime productivity improver, and concentration improver. For example, excipients, moisture-proofing agents, preservatives, fortifying agents, thickeners, emulsifiers, antioxidants, sweeteners, acidulants, seasonings, colorants, fragrances, whitening agents, humectants, oil-based ingredients, ultraviolet absorbers, surfactants, thickeners, alcohols, powder ingredients, coloring agents, aqueous ingredients, water, skin nutrients, etc. These may be used alone or in combination of two or more.
前記その他の成分の前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤における含有量としては、特に制限はなく、目的に応じて適宜選択することができる。 The content of the other components in the sleep quality improving agent, daytime productivity improving agent, and concentration improving agent is not particularly limited and can be appropriately selected depending on the purpose.
<用途>
前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤の用途としては、特に制限はなく、目的に応じて適宜選択することができ、例えば、医薬品、医薬部外品、飲食品などが挙げられる。
前記睡眠の質向上剤は、優れた睡眠の質向上作用を有し、安全性が高いので、例えば、後述する睡眠の質向上用組成物の有効成分として好適に用いることができる。
前記日中の生産性向上剤は、優れた日中の生産性向上作用を有し、安全性が高いので、例えば、後述する日中の生産性向上用組成物の有効成分として好適に用いることができる。
前記集中力向上剤は、優れた集中力向上作用を有し、安全性が高いので、例えば、後述する集中力向上用組成物の有効成分として好適に用いることができる。
<Application>
The use of the sleep quality improving agent, daytime productivity improving agent, and concentration improving agent is not particularly limited and can be appropriately selected depending on the purpose, such as pharmaceuticals, quasi-drugs, Examples include food and drink.
The sleep quality improving agent has an excellent sleep quality improving effect and is highly safe, so it can be suitably used, for example, as an active ingredient of the sleep quality improving composition described below.
The daytime productivity improving agent has an excellent daytime productivity improving effect and is highly safe, so it can be suitably used, for example, as an active ingredient in a composition for improving daytime productivity described below. I can do it.
The concentration improving agent has an excellent concentration improving effect and is highly safe, so it can be suitably used, for example, as an active ingredient in a composition for improving concentration described below.
本発明の睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤は、ヒトに対して好適に適用されるものであるが、その作用効果が奏される限り、ヒト以外の動物(例えば、マウス、ラット、ハムスター、イヌ、ネコ、ウシ、ブタ、サルなど)に対して適用することもできる。 The sleep quality improving agent, daytime productivity improving agent, and concentration improving agent of the present invention are preferably applied to humans, but as long as the effects are exerted, they may also be applied to non-humans. It can also be applied to animals (eg, mice, rats, hamsters, dogs, cats, cows, pigs, monkeys, etc.).
前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤の用法としては、特に制限はなく、目的に応じて適宜選択することができ、例えば、経口、非経口、外用などの用法が挙げられる。 The usage of the sleep quality improving agent, daytime productivity improving agent, and concentration improving agent is not particularly limited and can be appropriately selected depending on the purpose, such as oral, parenteral, external use, etc. Examples include the usage of
前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤の使用部位、用法、及び剤型としては、その使用目的に応じて適宜選択することができる。 The use site, usage method, and dosage form of the sleep quality improving agent, daytime productivity improving agent, and concentration improving agent can be appropriately selected depending on the purpose of use.
前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤は、デキストリン、シクロデキストリン等の薬学的に許容し得るキャリアーその他任意の助剤を用いて、常法に従い、粉末状、顆粒状、錠剤状、液状等の任意の剤型に製剤化することができる。この際、助剤としては、例えば、賦形剤、結合剤、崩壊剤、滑沢剤、安定剤、矯味・矯臭剤等を用いることができる。
前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤は、他の組成物(例えば、後述する睡眠の質向上用組成物、日中の生産性向上用組成物、集中力向上用組成物等)に配合して使用することができるほか、注射剤、点滴剤、坐剤等の非経口投与剤や、軟膏剤、点眼剤、外用液剤、貼付剤などとして使用することもできる。
The sleep quality improving agent, daytime productivity improving agent, and concentration improving agent are prepared in powder form according to a conventional method using a pharmaceutically acceptable carrier such as dextrin or cyclodextrin, or any other auxiliary agent. It can be formulated into any dosage form such as granules, tablets, and liquids. In this case, as the auxiliary agent, for example, an excipient, a binder, a disintegrant, a lubricant, a stabilizer, a flavoring agent, etc. can be used.
The sleep quality improving agent, the daytime productivity improving agent, and the concentration improving agent may be used in combination with other compositions (e.g., a composition for improving sleep quality, a composition for improving daytime productivity, and a concentration improving agent described below). In addition to being used in parenteral preparations such as injections, drops, and suppositories, ointments, eye drops, external liquids, and patches, etc. You can also do it.
前記睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤の使用量、使用期間、使用間隔等の使用方法としては、特に制限はなく、目的に応じて適宜選択することができる。 There are no particular restrictions on how to use the sleep quality improver, daytime productivity improver, and concentration improver, such as the amount, period of use, and interval of use, and they can be selected as appropriate depending on the purpose. can.
また、本発明の睡眠の質向上剤は睡眠の質向上作用、本発明の日中の生産性向上剤は日中の生産性向上作用、本発明の集中力向上剤は集中力向上作用の作用機構に関する研究のための試薬としても用いることができる。 In addition, the sleep quality improving agent of the present invention has an effect of improving sleep quality, the daytime productivity improving agent of the present invention has a daytime productivity improving effect, and the concentration improving agent of the present invention has a concentration improving effect. It can also be used as a reagent for mechanistic studies.
(睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物)
本発明の睡眠の質向上用組成物は、本発明の睡眠の質向上剤を含み、更に必要に応じてその他の成分を含む。
本発明の日中の生産性向上用組成物は、本発明の日中の生産性向上剤を含み、更に必要に応じてその他の成分を含む。
本発明の集中力向上用組成物は、本発明の集中力向上剤を含み、更に必要に応じてその他の成分を含む。
(Composition for improving sleep quality, composition for improving daytime productivity, and composition for improving concentration)
The composition for improving sleep quality of the present invention contains the sleep quality improving agent of the present invention, and further contains other components as necessary.
The composition for improving daytime productivity of the present invention contains the daytime productivity improving agent of the present invention, and further contains other components as necessary.
The composition for improving concentration of the present invention contains the concentration improver of the present invention, and further contains other components as necessary.
<睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤>
前記睡眠の質向上剤は、上述した本発明の睡眠の質向上剤である。
前記日中の生産性向上剤は、上述した本発明の日中の生産性向上剤である。
前記集中力向上剤は、上述した本発明の集中力向上剤である。
<Sleep quality improver, daytime productivity improver, and concentration improver>
The sleep quality improving agent is the sleep quality improving agent of the present invention described above.
The daytime productivity improver is the daytime productivity improver of the present invention described above.
The concentration improver is the concentration improver of the present invention described above.
前記睡眠の質向上用組成物における前記睡眠の質向上剤の含有量としては、特に制限はなく、前記睡眠の質向上用組成物の形態などによって適宜調整することができるが、前記構造式(1)で表される化合物の量に換算して、0.0001質量%~20質量%が好ましく、0.0001質量%~10質量%がより好ましい。前記睡眠の質向上用組成物は、前記睡眠の質向上剤のみからなるものであってもよい。 The content of the sleep quality improving agent in the sleep quality improving composition is not particularly limited and can be adjusted as appropriate depending on the form of the sleep quality improving composition. The amount of the compound represented by 1) is preferably 0.0001% by mass to 20% by mass, more preferably 0.0001% by mass to 10% by mass. The sleep quality improving composition may consist only of the sleep quality improving agent.
前記日中の生産性向上用組成物における前記日中の生産性向上剤の含有量としては、特に制限はなく、前記日中の生産性向上用組成物の形態などによって適宜調整することができるが、前記構造式(1)で表される化合物の量に換算して、0.0001質量%~20質量%が好ましく、0.0001質量%~10質量%がより好ましい。前記日中の生産性向上用組成物は、前記日中の生産性向上剤のみからなるものであってもよい。 The content of the daytime productivity improving agent in the daytime productivity improving composition is not particularly limited, and can be adjusted as appropriate depending on the form of the daytime productivity improving composition. However, the amount of the compound represented by the structural formula (1) is preferably 0.0001% by mass to 20% by mass, more preferably 0.0001% by mass to 10% by mass. The composition for improving daytime productivity may consist only of the daytime productivity improving agent.
前記集中力向上用組成物における前記集中力向上剤の含有量としては、特に制限はなく、前記集中力向上用組成物の形態などによって適宜調整することができるが、前記構造式(1)で表される化合物の量に換算して、0.0001質量%~20質量%が好ましく、0.0001質量%~10質量%がより好ましい。前記集中力向上用組成物は、前記集中力向上剤のみからなるものであってもよい。 The content of the concentration improver in the composition for improving concentration is not particularly limited and can be adjusted as appropriate depending on the form of the composition for improving concentration. The amount of the compound expressed is preferably 0.0001% to 20% by weight, more preferably 0.0001% to 10% by weight. The composition for improving concentration may consist only of the concentration improving agent.
<その他の成分>
前記睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物におけるその他の成分としては、特に制限はなく、前記睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物の利用形態に応じて適宜選択することができ、例えば、上記した睡眠の質向上剤、日中の生産性向上剤、及び集中力向上剤の項目に記載したその他の成分と同様のものなどが挙げられる。これらは、1種単独で使用してもよいし、2種以上を併用してもよい。
<Other ingredients>
Other ingredients in the composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration are not particularly limited. The composition for improving productivity and the composition for improving concentration can be selected as appropriate depending on the usage form, for example, the above-mentioned sleep quality improving agent, daytime productivity improving agent, and concentration improving agent. Other ingredients similar to those listed in the section above may be mentioned. These may be used alone or in combination of two or more.
前記その他の成分の前記睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物における含有量としては、特に制限はなく、目的に応じて適宜選択することができる。 The content of the other components in the composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration is not particularly limited and may be appropriately selected depending on the purpose. Can be done.
<態様>
前記睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物の態様としては、特に制限はなく、目的に応じて適宜選択することができ、例えば、医薬品、医薬部外品、飲食品などが挙げられる。
本発明の睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物は、日常的に使用することが可能であり、有効成分である前記構造式(1)で表される化合物の働きによって、睡眠の質向上作用、日中の生産性向上作用、及び集中力向上作用をはじめとする様々な生理活性作用を極めて効果的に発揮させることができる。
<Aspects>
The composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration are not particularly limited and can be appropriately selected depending on the purpose. , quasi-drugs, food and beverages, etc.
The composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration of the present invention can be used on a daily basis, and the active ingredient is the structural formula (1) ) can exhibit various physiologically active effects extremely effectively, including improving sleep quality, improving daytime productivity, and improving concentration.
本発明の睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物は、ヒトに対して好適に適用されるものであるが、それぞれの作用効果が奏される限り、ヒト以外の動物(例えば、マウス、ラット、ハムスター、イヌ、ネコ、ウシ、ブタ、サルなど)に対して適用することもできる。 The composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration of the present invention are preferably applied to humans, but their respective effects are not effective. It can also be applied to animals other than humans (for example, mice, rats, hamsters, dogs, cats, cows, pigs, monkeys, etc.) as long as it is suitable.
本発明の睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物の用法としては、特に制限はなく、目的に応じて適宜選択することができ、例えば、経口、非経口、外用などの用法が挙げられるが、経口が好ましい。 The usage of the composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration of the present invention is not particularly limited and can be appropriately selected depending on the purpose, such as , oral, parenteral, and external administration, but oral administration is preferred.
前記経口用の組成物としては、例えば、上述した経口投与剤や飲食品が挙げられる。ここで、飲食品とは、人の健康に危害を加えるおそれが少なく、通常の社会生活において、経口又は消化管投与により摂取されるものをいい、行政区分上の食品、医薬品、医薬部外品などの区分に制限されるものではない。したがって、前記飲食品は、経口的に摂取される一般食品、健康食品(機能性飲食品)、保健機能食品(特定保健用食品、栄養機能食品、機能性表示食品)、医薬部外品、医薬品等を構成する飲食品を幅広く含むものを意味する。 Examples of the oral composition include the above-mentioned oral preparations and food and drink products. Here, food and beverages refer to foods that have little risk of harming human health and are ingested orally or through gastrointestinal administration in normal social life, and are administratively classified foods, drugs, and quasi-drugs. It is not limited to such categories. Therefore, the above-mentioned foods and drinks include general foods that are orally ingested, health foods (functional foods and drinks), foods with health claims (foods for specified health uses, foods with nutritional function claims, foods with functional claims), quasi-drugs, and pharmaceuticals. This term refers to a wide range of food and beverages that make up food and beverages.
前記経口用の組成物の種類としては、特に制限はなく、目的に応じて適宜選択することができ、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、アルコール飲料、コーヒー飲料、コーヒー入り清涼飲料等の飲料(これらの飲料の濃縮原液及び調整用粉末を含む);アイスクリーム、アイスシャーベット、かき氷等の冷菓;そば、うどん、はるさめ、ぎょうざの皮、しゅうまいの皮、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、錠菓、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、パン等の菓子類;カニ、サケ、アサリ、マグロ、イワシ、エビ、カツオ、サバ、クジラ、カキ、サンマ、イカ、アカガイ、ホタテ、アワビ、ウニ、イクラ、トコブシ等の水産物;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、親子丼、お粥、雑炊、中華丼、かつ丼、天丼、うな丼、ハヤシライス、おでん、マーボドーフ、牛丼、ミートソース、玉子スープ、オムライス、餃子、シューマイ、ハンバーグ、ミートボール等のレトルトパウチ食品;サラダ、漬物等の惣菜;種々の形態の健康・美容・栄養補助食品;錠剤、粉剤、カプセル剤、顆粒剤、エキス剤、シロップ剤、ドリンク剤、トローチ、うがい薬等の医薬品、医薬部外品;口中清涼剤、口臭防止剤等の口腔内で使用する口腔清涼剤、歯磨剤などが挙げられる。 The type of the composition for oral use is not particularly limited and can be appropriately selected depending on the purpose, such as tea drinks, soft drinks, carbonated drinks, nutritional drinks, fruit drinks, lactic acid drinks, alcoholic drinks, Beverages such as coffee drinks and coffee-infused soft drinks (including concentrated stock solutions and powders for preparation of these beverages); Frozen desserts such as ice cream, ice sherbet, and shaved ice; Soba, udon, Harusame, gyoza skin, shumai skin, Noodles such as Chinese noodles and instant noodles; Candy, candy, gum, chocolate, tablets, snack foods, biscuits, jelly, jam, cream, baked goods, bread and other confectionery; Crab, salmon, clams, tuna, sardines, shrimp , bonito, mackerel, whale, oyster, saury, squid, red clam, scallop, abalone, sea urchin, salmon roe, tokobushi, and other marine products; fish cake, ham, sausage, and other processed marine and livestock products; processed milk, fermented milk, and other dairy products ; Fats and fat processed foods such as salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, and dressing; Seasonings such as sauces and sauces; Curry, stew, oyakodon, rice porridge, rice porridge, Chinese rice bowl, katsudon, Retort pouch foods such as tempura bowls, eel bowls, hayashi rice, oden, marbodorf, beef bowls, meat sauce, egg soup, omelette rice, gyoza, shumai, hamburgers, and meatballs; side dishes such as salads and pickles; various forms of health, beauty, and nutrition Supplementary foods: Pharmaceuticals and quasi-drugs such as tablets, powders, capsules, granules, extracts, syrups, drinks, troches, and gargles; Oral products used in the oral cavity, such as mouth fresheners and anti-halitosis agents. Examples include refreshing agents and toothpaste.
前記睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物の製造方法としては、特に制限はなく、前記睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物の利用形態などに応じて適宜選択することができる。 There are no particular restrictions on the method for producing the composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration. It can be appropriately selected depending on the usage form of the composition for improving sexual ability and the composition for improving concentration.
前記睡眠の質向上用組成物、日中の生産性向上用組成物、及び集中力向上用組成物の使用量、使用期間、使用間隔等としては、特に制限はなく、目的に応じて適宜選択することができる。 There are no particular restrictions on the usage amount, usage period, usage interval, etc. of the composition for improving sleep quality, the composition for improving daytime productivity, and the composition for improving concentration, and they can be selected as appropriate depending on the purpose. can do.
上述したように、本発明の睡眠の質向上剤及び睡眠の質向上用組成物は、優れた睡眠の質向上作用を有する。
したがって、本発明は、個体に前記睡眠の質向上剤及び睡眠の質向上用組成物からなる群から選択される少なくとも1種を投与することを特徴とする睡眠の質向上方法にも関する。
As described above, the sleep quality improving agent and the sleep quality improving composition of the present invention have an excellent sleep quality improving effect.
Therefore, the present invention also relates to a method for improving sleep quality, which comprises administering to an individual at least one selected from the group consisting of the sleep quality improving agent and the composition for improving sleep quality.
上述したように、本発明の日中の生産性向上剤及び日中の生産性向上用組成物は、優れた日中の生産性向上作用を有する。
したがって、本発明は、個体に前記日中の生産性向上剤及び日中の生産性向上用組成物からなる群から選択される少なくとも1種を投与することを特徴とする日中の生産性向上方法にも関する。
As described above, the daytime productivity improving agent and the daytime productivity improving composition of the present invention have an excellent daytime productivity improving effect.
Therefore, the present invention provides an improvement in daytime productivity characterized by administering to an individual at least one selected from the group consisting of the daytime productivity improving agent and a composition for improving daytime productivity. It also relates to methods.
上述したように、本発明の集中力向上剤及び集中力向上用組成物は、優れた集中力向上作用を有する。
したがって、本発明は、個体に前記集中力向上剤及び集中力向上用組成物からなる群から選択される少なくとも1種を投与することを特徴とする集中力の向上方法にも関する。
As described above, the concentration improving agent and concentration improving composition of the present invention have an excellent concentration improving effect.
Therefore, the present invention also relates to a method for improving concentration, which comprises administering to an individual at least one selected from the group consisting of the above-mentioned concentration improver and a composition for improving concentration.
以下、本発明の試験例、配合例を説明するが、本発明は、これらの試験例、配合例に何ら限定されるものではない。 Test examples and formulation examples of the present invention will be described below, but the present invention is not limited to these test examples and formulation examples.
(試験例1)
以下のようにして、前記構造式(1)で表される化合物の臨床試験を行った。
・ 試験
ランダム化二重盲検プラセボ対照比較試験
・ 対象
40歳以上65歳未満の健常な成人男女 30名(1群15名×2群)
・ 方法
アクティボディTMRB 100mg配合カプセル(丸善製薬株式会社製、前記構造式(1)で表される化合物として23mg/日摂取)(以下、「被験食品摂取群」と称することがある。)、又はプラセボ(以下、「対照食品摂取群」と称することがある。)のいずれかを4週間摂取。
・ 評価項目
(A) アンケート調査(摂取前検査、摂取4週目検査)
(B) 腕時計型活動量計(SilmeeTMW22)による睡眠の質(中途覚醒時間)の評価(摂取期間中)
摂取開始時及び摂取4週目について1週間の平均値で評価
(C) 腕時計型活動量計(SilmeeTMW22)による自律神経活動評価(摂取期間中)
摂取開始時及び摂取4週目について1週間の平均値で評価
(Test example 1)
A clinical test of the compound represented by the structural formula (1) was conducted as follows.
・Study Randomized double-blind placebo-controlled comparative study ・Subjects 30 healthy adult men and women aged 40 to under 65 (15 people per group x 2 groups)
・ Method Actibody TM RB 100 mg capsule (manufactured by Maruzen Pharmaceutical Co., Ltd., 23 mg/day intake of the compound represented by the above structural formula (1)) (hereinafter sometimes referred to as "test food intake group"), or a placebo (hereinafter sometimes referred to as the "control food intake group") for 4 weeks.
・Evaluation items (A) Questionnaire survey (pre-intake test, 4th week test)
(B) Evaluation of sleep quality (mid-way awakening time) using a wristwatch-type activity meter (Silmee TM W22) (during the intake period)
Evaluation at the start of intake and the 4th week of intake using the average value for one week (C) Autonomic nerve activity evaluation using a wristwatch-type activity meter (Silmee TM W22) (during the intake period)
Evaluation based on the weekly average value at the start of intake and 4th week of intake
<結果>
[(A) アンケート調査-1]
対象者に、「過去4週間のあなたの勤務日における、あなたの総合的なパフォーマンス」が良いか悪いかについて、「0点」を最も悪い評価、「10点」を最も良い評価として、0~10点の11段階で回答をしてもらった。
その結果、被験食品摂取群では、摂取前検査では「6.9±0.4」(「平均値±標準誤差」、以下同様)であり、摂取4週目検査では「7.3±0.4」であった。一方、対照食品摂取群では、摂取前検査では「6.5±0.4」であり、摂取4週目検査では「6.6±0.3」であった。被験食品摂取群では、摂取4週目検査において、対照食品摂取群と比較して、有意に評価点数が増加することが確認された(Mann-WhitneyのU検定)。
<Results>
[(A) Questionnaire survey-1]
The subjects were asked to rate whether their overall performance on their workdays over the past four weeks was good or bad, with 0 points being the worst and 10 points being the best. We asked them to answer on an 11-point scale with 10 points.
As a result, in the test food intake group, the test before intake was 6.9 ± 0.4 (mean ± standard error, hereinafter the same), and the test after 4 weeks of intake was 7.3 ± 0. 4". On the other hand, in the control food intake group, the test before intake was 6.5±0.4, and the test 4 weeks after intake was 6.6±0.3. In the test food intake group, it was confirmed that the evaluation score significantly increased compared to the control food intake group in the test after 4 weeks of intake (Mann-Whitney U test).
[(A) アンケート調査-2]
対象者に、「集中力を持続することができない」に当てはまるか当てはまらないかについて、「7点」を最も悪い評価(当てはまる)、「1点」を最も良い評価(当てはまらない)として、1~7点の7段階で回答をしてもらった。
その結果、被験食品摂取群では、摂取前検査では「2.6±0.3」(「平均値±標準誤差」、以下同様)であり、摂取4週目検査では「2.3±0.4」であった。一方、対照食品摂取群では、摂取前検査では「2.6±0.3」であり、摂取4週目検査では「3.1±0.4」であった。被験食品摂取群では、摂取4週目検査における摂取前検査からの変化値において、対照食品摂取群と比較して、有意に評価点数が減少することが確認された(Mann-WhitneyのU検定)。
[(A) Questionnaire survey-2]
The subject was asked to rate whether or not he or she was unable to maintain concentration, with 7 points being the worst (applicable) and 1 point being the best (not applicable). We asked them to answer on a 7-point scale.
As a result, in the test food intake group, the test before intake was 2.6 ± 0.3 (mean ± standard error, hereinafter the same), and the test after 4 weeks of intake was 2.3 ± 0. 4". On the other hand, in the control food intake group, the test before intake was ``2.6±0.3'', and the test after 4 weeks of intake was ``3.1±0.4''. In the test food intake group, it was confirmed that the evaluation score significantly decreased compared to the control food intake group in the change value from the pre-consumption test in the 4th week of intake test (Mann-Whitney U test). .
[(A) アンケート調査-3]
対象者に、「寝起き(目覚めた直後の気分)が悪い」と感じるか感じないかについて、「7点」を最も悪い評価(感じる)、「1点」を最も良い評価(感じない)として、1~7点の7段階で回答をしてもらった。
その結果、被験食品摂取群では、摂取前検査では「3.0±0.4」(「平均値±標準誤差」、以下同様)であり、摂取4週目検査では「2.5±0.2」であった。一方、対照食品摂取群では、摂取前検査では「2.1±0.4」であり、摂取4週目検査では「2.7±0.3」であった。被験食品摂取群では、摂取4週目検査における摂取前検査からの変化値において、対照食品摂取群と比較して、有意に評価点数が減少することが確認された(Mann-WhitneyのU検定)。
[(A) Questionnaire survey-3]
The subjects were asked whether they felt "uncomfortable after waking up" or not, with "7" being the worst rating (feeling) and "1" being the best rating (not feeling). The respondents answered on a 7-point scale ranging from 1 to 7 points.
As a result, in the test food intake group, the test before intake was "3.0 ± 0.4"("mean value ± standard error", hereinafter the same), and the test after 4 weeks of intake was "2.5 ± 0. 2”. On the other hand, in the control food intake group, the test before intake was ``2.1±0.4'', and the test after 4 weeks of intake was ``2.7±0.3''. In the test food intake group, it was confirmed that the evaluation score significantly decreased compared to the control food intake group in the change value from the pre-consumption test in the 4th week of intake test (Mann-Whitney U test). .
[(A) アンケート調査-4]
対象者に、「寝起きの熟眠感がない」と感じるか感じないかについて、「7点」を最も悪い評価(感じる)、「1点」を最も良い評価(感じない)として、1~7点の7段階で回答をしてもらった。
その結果、被験食品摂取群では、摂取前検査では「3.1±0.4」(「平均値±標準誤差」、以下同様)であり、摂取4週目検査では「2.8±0.3」であった。一方、対照食品摂取群では、摂取前検査では「3.4±0.4」であり、摂取4週目検査では「3.6±0.3」であった。被験食品摂取群では、摂取4週目検査において、対照食品摂取群と比較して、有意に評価点数が減少することが確認された(Mann-WhitneyのU検定)。
[(A) Questionnaire survey-4]
Subjects were given a score of 1 to 7, with 7 being the worst rating (feeling) and 1 being the best rating (not feeling), as to whether they felt ``I don't feel like I had a deep sleep when I woke up.'' They were asked to answer on a seven-point scale.
As a result, in the test food intake group, the test before intake was 3.1 ± 0.4 (mean ± standard error, hereinafter the same), and the test after 4 weeks of intake was 2.8 ± 0. 3". On the other hand, in the control food intake group, the test before intake was 3.4±0.4, and the test 4 weeks after intake was 3.6±0.3. In the test food intake group, it was confirmed that the evaluation score was significantly decreased compared to the control food intake group in the test after 4 weeks of intake (Mann-Whitney U test).
[(B) 腕時計型活動量計による睡眠の質(中途覚醒時間)の評価]
腕時計型活動量計により睡眠の質に関わる中途覚醒時間を計測した結果を図1に示す。
図1中、縦軸は摂取4週目における中途覚醒時間の摂取開始時からの変化値を表し、横軸は各食品摂取群を表す。また、「□」は被験食品摂取群、「■」は対照食品摂取群の結果を表す。
図1に示したように、摂取4週目において、被験食品摂取群では、対照食品摂取群と比べて、中途覚醒時間が短くなることが確認された。
[(B) Evaluation of sleep quality (mid-wake time) using a wristwatch-type activity meter]
Figure 1 shows the results of measuring mid-way awakening time, which is related to sleep quality, using a wristwatch-type activity meter.
In FIG. 1, the vertical axis represents the change in mid-way awakening time from the start of the intake in the fourth week of intake, and the horizontal axis represents each food intake group. Moreover, "□" represents the results for the test food intake group, and "■" represents the results for the control food intake group.
As shown in FIG. 1, during the fourth week of intake, it was confirmed that the mid-morning awakening time was shorter in the test food intake group compared to the control food intake group.
[(C) 腕時計型活動量計による自律神経活動評価]
腕時計型活動量計により自律神経機能全体の働きを計測した結果を図2A(被験食品摂取群)及び図2B(対照食品摂取群)に示す。
自律神経機能全体の働きは、腕時計型活動量計の加速度センサより取得したデータをもとに周波数解析を行い、スペクトルの低周波波動成分(LF)と高周波波動成分(HF)のパワー値の総計(トータルパワー;自律神経機能全体の働きの指標)を算出した。
図2A及び図2B中、縦軸は自律神経機能全体の働きを計測した値(トータルパワー)を表し、横軸は時間帯(0-6:0~6時、6-12:6~12時、12-18:12~18時、18-24:18~24時)を表す。また、「●」は摂取開始時、「■」は摂取4週目の結果を表す。
図2A及び図2Bに示したように、被験食品摂取群では、摂取4週目において、摂取開始時と比較して日中(6~18時)における自律神経全体の働きが高くなっていた。一方、対照食品摂取群では、摂取開始時と摂取4週目において、日中(6~18時)における自律神経活動には差が認められなかった。
[(C) Autonomic nerve activity evaluation using a wristwatch-type activity meter]
The results of measuring the function of the entire autonomic nervous system using a wristwatch-type activity meter are shown in FIG. 2A (test food intake group) and FIG. 2B (control food intake group).
The overall function of the autonomic nervous system is determined by frequency analysis based on data acquired from the acceleration sensor of a wristwatch-type activity monitor, and the total power value of the low-frequency wave component (LF) and high-frequency wave component (HF) of the spectrum. (Total power; an index of the overall function of the autonomic nervous system) was calculated.
In Figures 2A and 2B, the vertical axis represents the measured value (total power) of the function of the entire autonomic nerve function, and the horizontal axis represents the time of day (0-6:0-6:00, 6-12:6:00-12:00). , 12-18: 12-18 o'clock, 18-24: 18-24 o'clock). Further, "●" indicates the results at the start of intake, and "■" indicates the results after the fourth week of intake.
As shown in FIGS. 2A and 2B, in the test food intake group, the activity of the autonomic nerves as a whole during the day (6:00 to 18:00) was higher in the 4th week of intake compared to the time when intake started. On the other hand, in the control food intake group, no difference was observed in autonomic nerve activity during the day (6:00 to 18:00) between the start of intake and the 4th week of intake.
(配合例1)
常法により、以下の組成を有する錠剤を製造した。
・ 前記構造式(1)で表される化合物 5.0mg
・ ドロマイト 83.4mg
(カルシウム20%、マグネシウム10%含有)
・ カゼインホスホペプチド 16.7mg
・ ビタミンC 33.4mg
・ マルチトール 136.8mg
・ コラーゲン 12.7mg
・ ショ糖脂肪酸エステル 12.0mg
(Combination example 1)
Tablets having the following composition were manufactured by a conventional method.
- Compound represented by the above structural formula (1) 5.0 mg
・Dolomite 83.4mg
(Contains 20% calcium and 10% magnesium)
・Casein phosphopeptide 16.7mg
・Vitamin C 33.4mg
・ Maltitol 136.8mg
・Collagen 12.7mg
・Sucrose fatty acid ester 12.0mg
(配合例2)
常法により、以下の組成を有する経口液状製剤を製造した。
<1アンプル(1本100mL)中の組成>
・ 前記構造式(1)で表される化合物 0.3質量%
・ ソルビット 12.0質量%
・ 安息香酸ナトリウム 0.1質量%
・ 香料 1.0質量%
・ 硫酸カルシウム 0.5質量%
・ 精製水 残部
(Combination example 2)
An oral liquid preparation having the following composition was produced by a conventional method.
<Composition in 1 ampoule (100 mL per bottle)>
- Compound represented by the above structural formula (1) 0.3% by mass
・Sorvit 12.0% by mass
・Sodium benzoate 0.1% by mass
・Fragrance 1.0% by mass
・Calcium sulfate 0.5% by mass
・Remaining purified water
(配合例3)
常法により、以下の組成を有するコーヒー飲料を製造した。
・ 前記構造式(1)で表される化合物 0.1質量%
・ コーヒー抽出液(L(明度)=20、Brix=3) 40.0質量%
・ マルチトール 2.0質量%
・ 香料 適量
・ 水 残部
(Combination example 3)
A coffee beverage having the following composition was produced by a conventional method.
- Compound represented by the above structural formula (1) 0.1% by mass
・Coffee extract (L (lightness) = 20, Brix = 3) 40.0% by mass
・Maltitol 2.0% by mass
- Appropriate amount of fragrance - Remaining water
(配合例4)
常法により、以下の組成を有するカプセル剤を製造した。なお、カプセルとしては、1号ハードゼラチンカプセルを使用した。
<1カプセル(1錠200mg)中の組成>
・ 前記構造式(1)で表される化合物 30.0mg
・ コーンスターチ 70.0mg
・ 乳糖 80.0mg
・ 乳酸カルシウム 10.0mg
・ ヒドロキシプロピルセルロース(HPC-L) 10.0mg
(Combination example 4)
Capsules having the following composition were manufactured by a conventional method. Note that a No. 1 hard gelatin capsule was used as the capsule.
<Composition in 1 capsule (1 tablet 200mg)>
- Compound represented by the above structural formula (1) 30.0 mg
・Corn starch 70.0mg
・Lactose 80.0mg
・Calcium lactate 10.0mg
・Hydroxypropylcellulose (HPC-L) 10.0mg
Claims (6)
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JP2022037136A JP2023132041A (en) | 2022-03-10 | 2022-03-10 | Sleep quality improver and sleep quality-improving composition, daytime productivity improver and daytime productivity-improving composition, as well as concentration improver and concentration-improving composition |
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JP2022037136A JP2023132041A (en) | 2022-03-10 | 2022-03-10 | Sleep quality improver and sleep quality-improving composition, daytime productivity improver and daytime productivity-improving composition, as well as concentration improver and concentration-improving composition |
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