Sleep aids

Abstract

The purpose of this disclosure is to provide novel health applications for compositions containing black ginger components. [Solution] A composition containing (A) black ginger and / or its extract, and (B) B vitamins, is useful as a sleep aid.

Description

Technical Field

[0001] The present invention relates to a sleep improving agent.

Background Art

[0002] It is known that black ginger contains active ingredients having effects such as antioxidant action, anti-aging action, anti-inflammatory action (Patent Document 1), and fat decomposition promoting action (Patent Document 2). Therefore, black ginger is used in various health foods in order to utilize these useful physiological actions.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] Since a composition containing a black ginger component can be used as a food or the like, if a useful physiological action is newly found in the composition, it can be expected to more widely utilize the health promotion function of the composition.

[0005] Therefore, an object of the present disclosure is to provide a new health use of a composition containing a black ginger component.

Means for Solving the Problems

[0006] The inventor of the present invention conducted intensive studies to solve the above problems, and found that an effect of improving sleep can be obtained by combining black ginger and / or its extract with vitamins B. The present disclosure was completed by further studies based on these findings.

[0007] In other words, this disclosure provides inventions in the following embodiments. Item 1. A sleep aid containing (A) black ginger and / or its extract, and (B) B vitamins. Item 2. A sleep aid as described in Item 1, applicable to people in their 20s and 30s. Item 3. The sleep aid according to item 1 or 2, wherein the (B) component is selected from the group consisting of vitamin B2 and vitamin B5. Item 4. A sleep aid according to any one of items 1 to 3, comprising 0.05 to 1 part by weight of component (B) per 1 part by weight of component (A). [Effects of the Invention]

[0008] According to the sleep aid of this disclosure, sleep can be improved by combining black ginger and / or its extract with B vitamins. [Modes for carrying out the invention]

[0009] The sleep aid of this disclosure is characterized by containing (A) black ginger and / or its extract (hereinafter also referred to as "(A) component") and (B) vitamin B compounds (hereinafter also referred to as "(B) component"). The sleep aid of this disclosure will be described in detail below. In this disclosure, the numerical range "X~Y" refers to a range of X or more and Y or less.

[0010] (A) Black ginger and / or its extract In the sleep aids disclosed herein, black ginger is also known as black ginger and is a plant (Kaempferia parviflora) belonging to the genus Kaempferia in the family Zingiberaceae.

[0011] In the sleep aid of this disclosure, component (A) may be black ginger itself (typically dried black ginger powder) or an extract of black ginger. In either case, there are no particular restrictions on the part used, but the rhizome is preferred. Among these, a black ginger extract is preferred from the viewpoint of further enhancing the sleep-improving effect.

[0012] For the extraction process to obtain black ginger extract, any common extraction method used in the production of plant extracts is acceptable, such as solvent extraction, supercritical fluid extraction, or steam distillation. Among these, solvent extraction is preferred.

[0013] Examples of extraction solvents used in solvent extraction processes include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; hydrophilic solvents such as acetone; and mixed solvents thereof. Among these extraction solvents, water, lower alcohols, and mixed solvents thereof are preferred, more preferably water, ethanol, and mixed solvents thereof, and even more preferably a mixed solvent of water and ethanol. In the mixed solvent of water and lower alcohol, the ratio of water to lower alcohol is not particularly limited, but for example, the lower alcohol content should be about 5 to 90% by weight, preferably about 20 to 80% by weight, and even more preferably about 40 to 80% by weight.

[0014] The solvent extraction process involves immersing the target part of black ginger (preferably the rhizome), which has been dried, cut, or crushed as necessary to improve extraction efficiency, in an extraction solvent and stirring as needed. For example, immersion in approximately 0.3 to 20 L of extraction solvent, preferably 0.5 to 1.5 L, per 100 g of the target part of black ginger can be performed for approximately 0.5 to 24 hours. The temperature conditions for the solvent extraction process are not particularly limited, but for example, 40 to 95°C is acceptable.

[0015] After the extraction process, solid matter is removed by solid-liquid separation to obtain an extract (extract solution) of black ginger. The extract solution obtained from the extraction process may be purified by filtration or adsorption treatment using various chromatography methods such as polystyrene gel (polystyrene-divinylbenzene copolymer, etc.), ion exchange resin, or activated carbon columns packed with carriers. The obtained extract solution may be used as is as a non-concentrated extract, or it may be subjected to a concentration process to be used as a soft extract, or further dried to be used as an extract powder.

[0016] In the sleep aid of this disclosure, component (A) typically comprises polymethoxyflavones. The amount of polymethoxyflavones contained in component (A) is, for example, 1 to 15 parts by weight, preferably 5 to 13 parts by weight, and more preferably 6 to 10 parts by weight per 100 parts by weight (dry weight) of component (A).

[0017] In the sleep aid of this disclosure, the content of component (A) can be appropriately set depending on the form of the sleep aid, etc., but for example, on a dry weight basis, it can be 5 to 70% by weight, preferably 10 to 50% by weight, more preferably 15 to 30% by weight, and even more preferably 17 to 25% by weight.

[0018] In the sleep aid of this disclosure, the amount of polymethoxyflavone in component (A) is determined according to the amount of component (A) and the amount of polymethoxyflavone in component (A), but for example, it can be 0.4 to 6% by weight, preferably 0.9 to 4.5% by weight, more preferably 1.3 to 2.5% by weight, and even more preferably 1.5 to 2.2% by weight.

[0019] (B) Vitamin B In the sleep improvement agent of the present disclosure, examples of vitamin Bs include vitamin B1s, vitamin B2s, vitamin B3s, vitamin B5s, vitamin B6s, vitamin B7, vitamin B9s, and vitamin B12s. These vitamin Bs may be used alone or in combination of two or more kinds.

[0020] Vitamin B1s include thiamine, its derivatives (e.g., thiamine disulfide, octothiamine, ciclotiamine, bisibuthiamine, bisbentiamine, disetiamine, bisthiamine, furfurylthiamine, prosultiamine, benfotiamine, etc.), and their salts [e.g., inorganic acid salts (hydrochloride salts such as thiamine hydrochloride, furfurylthiamine hydrochloride, disetiamine hydrochloride, etc., sulfate salts such as thiamine nitrate, bisthiamine nitrate, etc., sulfate salts such as thiamine disetyl sulfate ester salt, etc.)]. These vitamin B1s may be used alone or in combination of two or more kinds.

[0021] Vitamin B2s include riboflavin, its esters (e.g., riboflavin phosphate ester, riboflavin butyrate ester, etc.), and their salts [e.g., alkali metal salts (sodium salts such as sodium riboflavin phosphate, flavin adenine dinucleotide sodium, etc.)]. These vitamin B2s may be used alone or in combination of two or more kinds.

[0022] Vitamin B3s include niacin (a general term for nicotinic acid and nicotinamide), and their salts. These vitamin B3s may be used alone or in combination of two or more kinds.

[0023] Vitamin B5 compounds include pantothenic acid, its derivatives (pantothenyl alcohol (panthenol), D-panthesine, D-pantethine, coenzyme A, pantothenyl ethyl ether, etc.), and their salts [for example, alkaline earth metal salts (calcium salts such as calcium pantothenate, etc.), alkali metal salts (sodium salts such as sodium pantothenate, etc.)]. These vitamin B5 compounds may be used individually or in combination of two or more.

[0024] Vitamin B6 compounds include pyridoxine, its derivatives (e.g., pyridoxal, pyridoxamine, and their 5'-phosphate esters), and their salts (e.g., inorganic salts (e.g., pyridoxine hydrochloride salts, pyridoxal phosphate salts, etc.)). These vitamin B6 compounds may be used individually or in combination of two or more.

[0025] Vitamin B7 refers to biotin.

[0026] Vitamin B9s include folic acid (horacin) and its pharmaceutically acceptable salts. These vitamin B9s may be used individually or in combination of two or more types.

[0027] Vitamin B12s include cobalamin, its pharmaceutically acceptable derivatives (e.g., adenosylcobalamin, methylcobalamin, sulfitocobalamin, hydroxocobalamin, cyanocobalamin, etc.), and their pharmaceutically acceptable salts [(e.g., inorganic salts (e.g., hydrochloride salts of hydroxocobalamin hydrochloride, etc.), organic salts (e.g., acetate salts of hydroxocobalamin acetate, etc.)]. These vitamin B12s may be used individually or in combination of two or more.

[0028] Among these B vitamins, vitamin B2 and vitamin B5 are preferred from the viewpoint of further enhancing the sleep-improving effect, and vitamin B2 and pantothenic acid are preferred.

[0029] In the sleep aid of this disclosure, the content of component (B) may be set appropriately depending on the form of the sleep aid, etc., but the content (total amount) of component (B) per 1 part by weight (dry weight equivalent) of component (A) is, for example, 0.05 to 1 part by weight, preferably 0.1 to 0.6 parts by weight, and more preferably 0.2 to 0.4 parts by weight.

[0030] Furthermore, the content (total amount) of component (B) per 1 part by weight of polymethoxyflavone can be, for example, 0.6 to 13 parts by weight, preferably 1.2 to 7.5 parts by weight, and more preferably 2.5 to 5 parts by weight.

[0031] If the sleep aid of this disclosure contains vitamin B2 and / or vitamin B5 as component (B), the content of vitamin B2 and vitamin B5 is not particularly limited, but the content of vitamin B2 (total amount) per 1 part by weight (dry weight equivalent) of component (A) may be, for example, 0.01 to 0.3 parts by weight, preferably 0.03 to 0.17 parts by weight, more preferably 0.06 to 0.1 parts by weight; and the content of vitamin B5 (total amount) per 1 part by weight (dry weight equivalent) of component (A) may be, for example, 0.035 to 0.7 parts by weight, preferably 0.07 to 0.4 parts by weight, more preferably 0.15 to 0.3 parts by weight.

[0032] Furthermore, if the sleep aid of this disclosure contains vitamin B2 and / or vitamin B5 as component (B), the content of vitamin B2 (total amount) per 1 part by weight of polymethoxyflavone may be, for example, 0.1 to 4 parts by weight, preferably 0.4 to 2 parts by weight, and more preferably 0.7 to 1.2 parts by weight; and the content of vitamin B5 (total amount) per 1 part by weight of polymethoxyflavone may be, for example, 0.05 to 0.8 parts by weight, preferably 1 to 5 parts by weight, and more preferably 2 to 3.5 parts by weight.

[0033] Other ingredients The sleep aids disclosed herein may contain other nutritional components and / or pharmacological components in addition to the components (A) and (B) described above. Such nutritional and pharmacological components are not particularly limited as long as they can be used in food and / or oral medicines, but examples include vitamins (other than the above-mentioned component (B)), amino acids, minerals, carbohydrates, fatty acids, flavorings, seasonings, plant extracts (other than the above-mentioned extracts of component (A)), hypoglycemic agents, anticholinergic agents, immunostimulants, etc. These components may be used individually or in combination of two or more. The content of these components will be appropriately determined depending on the type of additive used and / or the intended use of the sleep aid.

[0034] The sleep aids of this disclosure may include bases and / or additives as necessary to prepare them into a desired formulation. Such bases and additives are not particularly limited as long as they can be used in food and / or oral pharmaceuticals, but examples include water, lower (1-5 carbon) monohydric alcohols, polyhydric alcohols, oily bases [solid oils, higher (6 or more carbon) alcohols, higher (6 or more carbon) fatty acids, etc.], surfactants, excipients, disintegrants, lubricants, binders, thickeners, pH adjusters, buffers, antioxidants, preservatives, chelating agents, etc. These may be used individually or in combination of two or more.

[0035] Dosage form / form The dosage form of the sleep aid disclosed herein is not particularly limited and may be a solid preparation (specifically, a powder, granules, tablet, capsule, etc.), a semi-solid preparation (specifically, a paste, gel, etc.), or a liquid preparation.

[0036] The formulation of the sleep aid described herein is typically limited to any form that can be taken orally, and may be either a food product or an oral medication.

[0037] When the sleep aid described herein is put into food formulation form, the aforementioned components (A) and (B), and other components added as needed, can be prepared in the desired form. Such foods can be classified as general foods and beverages, as well as foods for specified health uses, nutritional supplements, foods with functional claims, foods for sick people, etc.

[0038] Purpose The sleep-improving agent disclosed herein is used for the purpose of improving sleep, specifically for the purpose of increasing sleep duration. The effect of sleep improvement can be evaluated by the length of sleep duration.

[0039] The amount of sleep to which the sleep aids disclosed herein are applicable is not particularly limited, but examples include 5 to 8 hours, preferably 5.5 to 7 hours, and more preferably 6 to 6.5 hours.

[0040] The target age for application of the sleep aid described herein is not particularly limited, but from the viewpoint of further enhancing the sleep-improving effect, it is preferably for people in their 20s to 30s.

[0041] Dosage / Usage Examples of the daily dose of the sleep aid of this disclosure include, for example, 50 to 300 mg of component (A), preferably 80 to 250 mg, more preferably 100 to 200 mg, and even more preferably 130 to 170 mg; and for example, 4.5 to 27 mg of polymethoxyflavone, preferably 7 to 23 mg, more preferably 10 to 20 mg, and even more preferably 12 to 15 mg.

[0042] The sleep aids of this disclosure are typically taken orally.

[0043] The duration of use of the sleep aid described herein is not particularly limited, but examples include two weeks or more, preferably three weeks or more, and more preferably four weeks or more. [Examples]

[0044] The present disclosure will be explained in more detail below with reference to examples, but the present disclosure is not limited to these examples.

[0045] Test foods (tablets) with the composition shown in Table 1 were prepared. The black ginger extract was a dried powder of an extract obtained by extracting the rhizome of black ginger (Kaempferia parviflora) with an aqueous ethanol solution, and it contains 8% by weight of polymethoxyflavones.

[0046] [Table 1]

[0047] Ninety-nine male and female subjects aged 20-69 years were given the test food at the dosages shown in Table 1 for four weeks. The subjects were not informed that the test food was intended to improve sleep. All subjects were given questionnaires before intake (week 0), after one week, and after four weeks of intake, regarding various lifestyle information (alcohol consumption, eating habits, exercise frequency and duration, sleep duration, number of cigarettes smoked, etc.) and any physical symptoms of concern (presence or absence of symptoms, severity and frequency). No lifestyle guidance was provided to the subjects during the study period.

[0048] Table 2 shows the average daily sleep duration for the 99 subjects.

[0049] [Table 2]

[0050] As shown in Table 2, the overall sleep duration of the subjects increased, indicating that the intake of the test food improved sleep. By age group, sleep improvement was observed most frequently in those in their 20s and 30s.

Claims

1. A sleep aid containing (A) black ginger and / or its extract, and (B) B vitamins.

2. A sleep aid according to claim 1, applicable to people in their 20s to 30s.

3. The sleep aid according to claim 1, wherein the (B) component is selected from the group consisting of vitamin B2 and vitamin B5.

4. The sleep aid according to claim 1, wherein the sleep aid contains 0.05 to 1 part by weight of component (B) per 1 part by weight of component (A).

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