Oral composition

Abstract

To provide an oral composition that is excellent in improving sleep quality and alleviating mental health problems. [Solution] An oral composition characterized by containing cannabidiol and at least one component selected from (A) to (D) below: (A) Sugars (B) Flavoring components (C) Amino acids (D) Alcohols having 3 to 12 carbon atoms (E) Aroma components

Description

Technical Field

[0001] The present invention relates to an oral composition characterized by containing cannabidiol and at least one selected from the group consisting of saccharides, organic acids, amino acids, alcohols having 3 to 12 carbon atoms, and aroma components.

Background Art

[0002] As a component expected to have a new pharmacological action, cannabidiol (CBD) has attracted attention. Cannabidiol (CBD) is a kind of cannabinoid contained in hemp, and for example, therapeutic agents for epilepsy and therapeutic compositions for tuberous sclerosis have been developed (Patent Document 1, Patent Document 2). In addition, although its use as an oral composition or an external preparation has also been developed, the examination thereof is not sufficient.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] Therefore, the present inventors have made various studies with the problem of providing an oral composition that enhances the effects of cannabidiol.

Means for Solving the Problems

[0005] As a result, the present inventors have succeeded in developing an oral composition in which the effect of improving the quality of sleep and the effect of improving mental health disorders are enhanced by blending at least one selected from the group consisting of saccharides, taste components, amino acids, alcohols having 3 to 12 carbon atoms, and aroma components together with cannabidiol, and have completed the present invention.

[0006] In other words, the present invention is as follows: <1> An oral composition characterized by containing cannabidiol and at least one component selected from (A) to (D) below: (A) Sugars (B) Flavoring components (C) Amino acids (D) Alcohols having 3 to 12 carbon atoms (E) Aroma components <2> (A) The sugar is at least one selected from the group consisting of glucose, fructose, maltose, and maltotriose; (B) The flavor component is at least one selected from the group consisting of succinic acid, tartaric acid, malic acid, acetic acid, and isohumulone; (C) The amino acid is at least one selected from the group consisting of arginine, alanine, and proline; (D) The C3-C12 alcohol is at least one selected from the group consisting of n-propanol, isobutanol, and isoamyl alcohol; and (E) The aroma component is at least one selected from the group consisting of α-pinene, limonene, and citronellol. <1> The oral composition described above. <3> Furthermore, it is characterized by containing ethanol. <1> The oral composition described above. <4> Characterized by being a non-pharmaceutical preparation, <1> The oral composition described above. <5> Characterized by being a beverage, <1> The oral composition described above. <6> It is characterized by being for improving sleep quality. <1> The oral composition described above. <7> An improvement in sleep quality is defined as at least one of the following: reduced morning drowsiness, easier sleep onset, increased sleep duration, reduced dreaming, reduced fatigue upon waking, shorter periods of awakening during the night, reduced daytime sleepiness, improved sleep rhythm, increased sleep depth, and increased satisfaction with sleep. <6> The oral composition described above. <8> It is characterized as being for improving mental health problems. <1> The oral composition described above. <9> Improvement in mental health problems is an improvement in at least one of mental or social health. <8> An oral composition for improving mental health problems as described above.<10> Improvement in mental health is defined as at least one of the following: reduced anxiety, reduced depression, reduced tension, reduced fatigue, reduced irritability, reduced difficulty concentrating, reduced psychological stress, reduced confusion, increased mental stability, increased relaxation, increased vitality and energy, increased positive emotions, increased motivation, improved daily role functioning, improved concentration, and increased well-being. <9> An oral composition for improving mental health problems as described above. <11> Improvement in social health means at least one of the following: improved smooth communication with others, active participation in social activities, improved cooperation in the workplace and at home, increased satisfaction with interpersonal relationships, increased self-esteem, and reduced feelings of loneliness. <9> An oral composition for improving mental health problems as described above. [Effects of the Invention]

[0007] According to the present invention, by containing cannabidiol and at least one selected from the group consisting of sugars, flavoring components, amino acids, alcohols having 3 to 12 carbon atoms, and aroma components, an oral composition with excellent effects in improving sleep quality and alleviating mental health problems can be obtained. [Modes for carrying out the invention]

[0008] The oral compositions of the present invention will be described in detail below. However, the present invention is not limited to the embodiments shown below, and can be modified, added, altered, or deleted to the extent that a person skilled in the art can conceive of it. Any embodiment that achieves the effects and functions of the present invention is included within the scope of the present invention.

[0009] The oral composition of the present invention is characterized by containing cannabidiol, as well as sugars, flavoring components, amino acids, C3-C12 alcohols, and aroma components.

[0010] <Cannabidiol> The oral composition of the present invention is characterized by containing cannabidiol. Cannabidiol is a type of cannabinoid and is known to be found in hemp. Cannabidiol is known to have different pharmacological effects from tetrahydrocannabinol, which is also a type of cannabinoid. In the present invention, cannabidiol can be extracted and purified from plants such as hemp or citrus peels, or synthesized, but it is preferable to use cannabidiol extracted and purified from natural products in order to enhance safety, improve sleep quality, and improve mental health problems.

[0011] The cannabidiol content in the oral composition of the present invention is not particularly limited, but is preferably 0.0001% by mass or more, more preferably 0.0005% by mass or more, and particularly preferably 0.001% by mass or more in terms of its excellent effect on improving sleep quality. Furthermore, it is preferably 80% by mass or less, more preferably 70% by mass or less, and particularly preferably 50% by mass or less in terms of its excellent effect on improving sleep quality and improving mental health problems.

[0012] In the present invention, the cannabidiol content in the oral composition can be quantified, for example, by high-performance liquid chromatography (HPLC). For HPLC, for example, an Intact Co., Ltd. Unison UK-C18HT column (particle size 3 μm) φ4.6 × 150 mm is used, a water / acetonitrile mixture is used as the mobile phase, the gradient conditions are as shown in Table A below, the column temperature is 55°C and the flow rate is 1.0 ml / min.

[0013] [Table A]

[0014] <(A) Sugars> The oral composition of the present invention contains sugars together with cannabidiol. By including these components, the effects of improving sleep quality and alleviating mental health problems can be enhanced. In the present invention, the sugars are preferably monosaccharides with one carbon atom or oligosaccharides with disaccharides to decasaccharides, more preferably oligosaccharides with monosaccharides to heptasaccharides, and particularly preferably oligosaccharides with monosaccharides to tetrasaccharides from the viewpoint of enhancing the effects of the present invention.

[0015] In the present invention, component (A) may be selected from glucose, fructose, maltose, and maltotriose and used alone, or two or more of these may be used in combination.

[0016] The sugar content in the oral composition of the present invention is not particularly limited, but is preferably 0.0001% by mass or more, more preferably 0.001% by mass or more, and particularly preferably 0.01% by mass or more from the viewpoint of enhancing the effects of the present invention. Furthermore, it is preferably 20% by mass or less, more preferably 15% by mass or less, and particularly preferably 10% by mass or less from the viewpoint of enhancing the effects of the present invention. Note that if multiple types of sugars are contained, the total amount is used.

[0017] <(B) Flavoring Components> The oral composition of the present invention contains flavoring components along with cannabidiol. By including these components, the effects of improving sleep quality and alleviating mental health problems can be enhanced. Flavoring components are chemical substances that produce the unique flavor of food, and organic acids that exhibit sourness and polyphenols that exhibit bitterness are preferred in order to enhance the effects of the present invention.

[0018] In the present invention, as component (B), one may be selected from succinic acid, tartaric acid, malic acid, acetic acid, and isohumulone and used alone, or two or more may be used in combination from these. Succinic acid is a carboxylic acid represented by HOOC-(CH2)2-COOH. Tartaric acid is a hydroxy acid represented by (CH(OH)COOH)2. Malic acid is a hydroxy acid represented by HOOC-CH(OH)-CH2-COOH. Acetic acid is a carboxylic acid represented by CH3COOH. Isohumulone is a type of polyphenol represented by R=CH2CH(CH3)2, and is also called iso-α acid or 3,4-dihydroxy-5-(3-methyl-2-butenyl)-2-(3-methyl-1-oxobutyl)-4-(4-methyl-1-oxo-3-pentenyl)-2-cyclopenten-1-one. Isohumulone may be a so-called derivative in which one or more hydrogen atoms in its structure are substituted with other substituents, but isohumulone itself is preferred in order to enhance the effects of the present invention. Isohumulone may also be a pharmaceutically acceptable salt thereof. Examples of pharmaceutically acceptable salts include inorganic acid salts such as hydrochloride, hydrobromide, sulfate, hydroiodide, nitrate, and phosphate; organic acid salts such as citrate, oxalate, acetate, formate, propionate, benzoate, trifluoroacetate, maleate, tartrate, methanesulfonate, benzenesulfonate, or p-toluenesulfonate; inorganic base salts such as sodium salt, potassium salt, calcium salt, magnesium salt, and ammonium salt; organic base salts such as triethylammonium salt, triethanolammonium salt, pyridinium salt, and diisopropylammonium salt; and amino acid salts such as arginine, aspartic acid, and glutamic acid. Isohumulone or a pharmaceutically acceptable salt thereof can be obtained, for example, by isomerizing hop extract. Hop extract is derived from hops (scientific name Humulus lupulus), a perennial plant belonging to the Cannabaceae family and native to Europe. The components are extracted from all or part of (preferably the cones or the part containing the cones) by solvent extraction or supercritical carbon dioxide extraction. Examples of solvents include water, alcohol (lower alcohols with 1 to 4 carbon atoms such as methanol, ethanol, propanol, and butanol), lower alkyl esters such as ethyl acetate, glycols such as ethylene glycol, butylene glycol, propylene glycol, and glycerin, polar solvents such as acetone and acetic acid, hydrocarbons such as benzene and hexane, and ethers such as ethyl ether and petroleum ether. After solvent extraction or supercritical carbon dioxide extraction, filtration, concentration under reduced pressure, purification, etc. may be performed as needed. In the present invention, any of the components of (B) may be artificially synthesized by chemical synthesis, or commercially available products that are normally available as food ingredients can be used as acidulants and bitter components.

[0019] The content of flavoring components in the oral composition of the present invention is not particularly limited. For example, it is preferably 0.00001% by mass or more, more preferably 0.0001% by mass or more, and particularly preferably 0.001% by mass or more from the viewpoint of enhancing the effects of the present invention. Furthermore, it is preferably 5% by mass or less, more preferably 3% by mass or less, and particularly preferably 1% by mass or less from the viewpoint of enhancing the effects of the present invention. Note that if multiple types of flavoring components are included, the total amount is used.

[0020] <(C) Amino Acid>The oral composition of the present invention contains an amino acid together with cannabidiol. By including these components, the effect of improving the quality of sleep and the effect of improving mental health disorders can be enhanced. An amino acid is a general term for organic compounds having both functional groups of an amino group and a carboxyl group. Depending on the position of the amino group, there are α-amino acids, β-amino acids, γ-amino acids, and δ-amino acids. The amino acids that can be used in the present invention are not particularly limited, but α-amino acids, β-amino acids, and γ-amino acids are preferred, and α-amino acids and γ-amino acids are particularly preferred. The amino acids of the present invention can be used not only in the free form but also in the form of salts. Examples of the form of salts include acid addition salts and salts with bases, etc., and it is preferable to select pharmacologically acceptable salts. Specific examples of the salts include salts with inorganic bases, organic bases, inorganic acids, organic acids, etc. In the present invention, from the viewpoint of enhancing the effects of the present invention, the free form or organic acid salts are preferred, the free form or hydrochloride is more preferred, and the free form is particularly preferred. In the present invention, commercially available products that can be obtained as ordinary food raw materials can be used.

[0021] In the present invention, as the (C) component, one kind may be selected from arginine, alanine, and proline and used alone, or two or more kinds may be used in combination. The arginine used in the present invention may be any of L-arginine, D-arginine, and the racemic form DL-arginine, but L-arginine is desirable from the viewpoint of enhancing the effects of the present invention. The alanine used in the present invention may be any of L-alanine, D-alanine, and the racemic form DL-alanine, but L-alanine is desirable from the viewpoint of enhancing the effects of the present invention. The proline used in the present invention may be any of L-proline, D-proline, and the racemic form DL-proline, but L-proline is desirable from the viewpoint of enhancing the effects of the present invention.

[0022] The content of amino acids in the oral composition of the present invention is not particularly limited. For example, it is preferably 0.00001% by mass or more, more preferably 0.0001% by mass or more, and particularly preferably 0.001% by mass or more from the viewpoint of enhancing the effects of the present invention. Also, it is preferably 10% by mass or less, more preferably 5% by mass or less, and particularly preferably 3% by mass or less from the viewpoint of enhancing the effects of the present invention. When containing multiple types of amino acids, it is the total amount thereof.

[0023] <(D) Alcohols having 3 to 12 carbon atoms>The oral composition of the present invention contains alcohols having 3 to 12 carbon atoms together with cannabidiol. By including these components, the effect of improving the quality of sleep and the effect of improving mental health disorders can be enhanced. Preferred examples of the alcohols having 3 to 12 carbon atoms include propanol, butanol, isobutanol, 1-methylbutanol, amyl alcohol, isoamyl alcohol, 2-ethylhexanol, decanol, and dodecanol. In the present invention, from the viewpoint of enhancing the effects of the invention, alcohols having 3 to 10 carbon atoms are more preferred, and alcohols having 3 to 8 carbon atoms are particularly preferred.

[0024] In the present invention, as the (D) component, one kind may be selected from propanol, isobutanol, and isoamyl alcohol and used alone, or two or more kinds may be combined and used. Propanol, isobutanol, and isoamyl alcohol in the present invention may be synthetic products, may be commercially available products, or may be food and beverages or extracts containing propanol, isobutanol, or isoamyl alcohol in part thereof.

[0025] The content of C3-C12 alcohols in the oral composition of the present invention is not particularly limited, but is preferably 0.00001% by mass or more, more preferably 0.0001% by mass or more, and particularly preferably 0.001% by mass or more from the viewpoint of enhancing the effects of the present invention. Furthermore, it is preferably 60% by mass or less, more preferably 50% by mass or less, and particularly preferably 40% by mass or less from the viewpoint of enhancing the effects of the present invention. Note that if multiple types of C3-C12 alcohols are included, the total amount is used.

[0026] <(E) Aromatic Components> The oral composition of the present invention contains aromatic components along with cannabidiol. By including these components, the effects of improving sleep quality and alleviating mental health problems can be enhanced.

[0027] In the present invention, (E) as an aroma component, one can be selected from α-pinene, limonene, and citronellol and used alone, or two or more can be used in combination. The α-pinene, limonene, and citronellol in the present invention may be synthetic products, commercially available products, or food and beverages or extracts that contain α-pinene, limonene, or citronellol as part of the product.

[0028] The content of aroma components in the oral composition of the present invention is not particularly limited. For example, it is preferably 0.000001% by mass or more, more preferably 0.00001% by mass or more, and particularly preferably 0.0001% by mass or more from the viewpoint of enhancing the effects of the present invention. Furthermore, it is preferably 1% by mass or less, more preferably 0.5% by mass or less, and particularly preferably 0.1% by mass or less from the viewpoint of enhancing the effects of the present invention. Note that if multiple types of aroma components are included, the total amount is used.

[0029] <Ethanol> The oral composition of the present invention more preferably contains ethanol in addition to cannabidiol and at least one selected from the group consisting of sugars, flavoring components, amino acids, C3-C12 alcohols, and aroma components. The inclusion of ethanol can further enhance the effect of improving sleep quality and alleviating mental health problems, as well as increasing the stability of cannabidiol.

[0030] The ethanol content in the oral composition of the present invention is not particularly limited, but is preferably 0.0001% by mass or more, more preferably 0.001% by mass or more, and particularly preferably 0.01% by mass or more from the viewpoint of enhancing the effects of the present invention. Furthermore, it is preferably 60% by mass or less, more preferably 50% by mass or less, and particularly preferably 40% by mass or less from the viewpoint of enhancing the effects of the present invention.

[0031] The ratio of cannabidiol to components (A) to (E) in the oral composition of the present invention is not particularly limited. For example, cannabidiol:components (A) to (E) = 1:0.01 to 10,000,000 is preferred, and cannabidiol:components (A) to (E) = 1:0.1 to 1,000,000 is more preferred, as it is excellent in improving sleep quality and alleviating mental health problems. When multiple components (A) to (E) are included, the ratio of components (A) to (E) refers to their total amount.

[0032] Furthermore, the content of cannabidiol in the oral composition of the present invention relative to the total amount of cannabidiol and components (A) to (E) is preferably 0.0001% by mass or more, more preferably 0.0005% by mass or more, and particularly preferably 0.001% by mass or more, from the viewpoint of excellent sleep quality improvement effects. Also, 80% by mass or less is preferred, 70% by mass or less is more preferred, and 50% by mass or less is particularly preferred, from the viewpoint of excellent sleep quality improvement effects and mental health disorder improvement effects. Note that if multiple components (A) to (E) are contained, the total amount of components (A) to (E) is the sum of those amounts.

[0033] The daily dosage of the oral composition of the present invention is not particularly limited and can be set as appropriate depending on the mode of use and the user's usage. For example, the daily dosage of the oral composition of the present invention is preferably 0.1 to 1000 mg / kg, more preferably 1 to 500 mg / kg, and even more preferably 2 to 100 mg / kg, based on the user's body weight and in terms of solid content.

[0034] Similarly, there are no particular limitations on the amount of the oral composition of the present invention used in a single dose. For example, the amount of the oral composition of the present invention used in a single dose is preferably 0.01 to 2000 mg / kg, more preferably 0.1 to 1000 mg / kg, based on the user's body weight in terms of solid content, and even more preferably 0.2 to 50 mg / kg, from the viewpoint of exerting the effects of the oral composition of the present invention.

[0035] Furthermore, the daily amount of the oral composition of the present invention is not particularly limited. For example, in terms of solid content, it is preferably 0.001 to 20 g, more preferably 0.01 to 10 g, and particularly preferably 0.1 to 5 g, from the viewpoint of exhibiting the effects of the oral composition of the present invention.

[0036] The amount of the oral composition of the present invention used in a single dose is not particularly limited. For example, in terms of solid content, it is preferably 0.0001 to 20 g, more preferably 0.001 to 10 g, and particularly preferably 0.01 to 5 g, from the viewpoint of exhibiting the effects of the oral composition of the present invention.

[0037] Furthermore, the cannabidiol content in the daily dose of the oral composition of the present invention is not particularly limited. For example, it is preferably 0.00001 to 1 g, more preferably 0.00005 to 0.5 g, and particularly preferably 0.0001 to 0.1 g from the viewpoint of exhibiting the effects of the oral composition of the present invention.

[0038] The cannabidiol content in a single dose of the oral composition of the present invention is not particularly limited. For example, it can be 0.000001 to 1 g, more preferably 0.000005 to 0.5 g, on a solid content basis, and particularly preferably 0.00001 to 0.1 g, from the viewpoint of exhibiting the effects of the oral composition of the present invention.

[0039] <Other Components> In addition to the components listed above, other components may be added to the oral composition of the present invention as needed. Other components may include, for example, various vitamins and minerals, microorganisms such as lactic acid bacteria and yeast. Furthermore, as needed, sugars and oligosaccharides other than the specific components of the present invention, such as dextrin and starch, which are commonly used in the food industry, sweeteners, nutritional supplements, stabilizers, lubricants, binders, glazing agents, thickeners, colorants, excipients, diluents, fillers, emulsifiers, and food additives may be added. The content of these other components can be appropriately selected depending on the form of the composition of the present invention. Also, from the viewpoint of safety, it is preferable that the oral composition of the present invention substantially does not contain cannabinoids other than cannabidiol. Cannabinoids other than cannabidiol include cannabidivarin (CBDV), cannabigerol (CBG), cannabinol (CBN), tetrahydrocannabinol (THC), hydroxyhexahydrocannabinol (HHC), tetrahydrocannabivarin (THCV), and cannabichromene. Examples include (CBC), cannabiol acid (CBDa), cannabicitran (CBT), tetrahydrocannabivarin (THCH), tetrahydrocannabutol (THCB), tetrahydrocannabiolchol (THCO), and hexahydrocannabihexol (HHCH). Substantially absent means less than 0.000001% by mass of the total composition, and more preferably 0.0000009% by mass or less.

[0040] <Oral Composition> The form of the oral composition of the present invention is not particularly limited and can be any form. For example, tablets, capsules, powders, granules, liquids, granular preparations, rod-shaped preparations, plate-shaped preparations, block-shaped preparations, solid preparations, round preparations, paste-like preparations, cream-like preparations, caplet-like preparations, gel-like preparations, chewable preparations, stick-shaped preparations, etc. Among these, the forms of tablets, capsules, powders, granules, and liquid preparations are particularly preferred. Specifically, examples include supplements, packaged beverages filled in PET bottles, cans, bottles, etc., and instant powdered beverages and instant granular beverages that are dissolved in water (hot water), milk, fruit juice, green juice, etc. and consumed. Packaged beverages, instant powdered beverages, and instant granular beverages are particularly preferred because they are easy to drink with meals, have enhanced palatability, and furthermore, alcohols with 3 to 12 carbon atoms, aroma components, ethanol, etc. are less likely to volatilize, making it easier to obtain the effects of the present invention.

[0041] The food and beverage composition of the present invention is preferably a packaged beverage. The container used is not particularly limited, but a packaged beverage filled in a bottle, can, or paper carton is preferred, with a capacity of 25 to 3000 ml, more preferably 30 to 750 ml, and even more preferably 35 to 500 ml.

[0042] As described in the examples below, the oral composition of the present invention exhibits effects that improve sleep quality and alleviate mental health problems, and can therefore be used as a composition for improving sleep quality and a composition for improving mental health problems. In this invention, "improvement of sleep quality" is a concept that includes improving (enhancing) sleep quality and / or suppressing (maintaining) the decline in sleep quality, and "improvement of mental health problems" means that a state of impaired mental health becomes a state of normal mental health, and is a concept that includes the improvement or alleviation of mental health problems, and the improvement of mental health and / or social health.

[0043] In the present invention, sleep quality is represented by at least one selected from the group consisting of, for example, morning drowsiness, falling asleep and maintaining sleep (e.g., smooth falling asleep and maintaining sleep, or falling asleep quickly and continuing sleep stably without waking up in the middle of the night), dreaming (e.g., not having frequent dreams or nightmares), feeling tired upon waking, waking up in the middle of the night, daytime sleepiness, sleep rhythm, sleep depth, and satisfaction with sleep (e.g., sleep without feeling a lack of time).

[0044] The sleep quality improving composition of the present invention has the following effects on improving sleep quality, for example, reducing morning drowsiness, promoting sleep onset, increasing sleep duration, reducing dreaming, reducing morning fatigue, shortening the time spent awake during the night, reducing daytime sleepiness, improving sleep rhythm, improving sleep depth, and improving satisfaction with sleep.

[0045] Improving mental health includes reducing anxiety, depression, tension, fatigue, irritability, difficulty concentrating, psychological stress, and confusion, as well as improving mental stability, relaxation, vitality, positive emotions, motivation, role functioning, concentration, and well-being. Improving social health includes improving social adaptability, such as smooth communication with others, active participation in social activities, improved cooperation at work and home, increased satisfaction with interpersonal relationships, increased self-esteem, and reduced feelings of loneliness.

[0046] The evaluation of the effects on improving sleep quality and mental health problems can be carried out using conventionally known methods and are not particularly limited. For example, the effects on improving sleep quality can be evaluated using the OSA Sleep Questionnaire, VAS, etc. For example, the effects on improving mental health problems can be evaluated using the POMS2, WEMWBS, Rosenberg Self-Esteem Scale, UCLA Loneliness Scale, Subjective Well-being Scale, SF-36, VAS, etc.

[0047] The composition for improving sleep quality and the composition for improving mental health disorders are not particularly limited as long as they contain cannabidiol and components (B) to (E) and are distinguishable from other products in that they exhibit the function of improving sleep quality and improving mental health disorders. For example, the scope of the present invention includes any product in which the body, packaging, instruction manual, or promotional material (advertising media) of the product according to the present invention displays the function of improving sleep quality and improving mental health disorders.

[0048] Specifically, regarding improving sleep quality, this includes "improving sleep quality," "improving sleep quality (sleep depth, satisfaction with sleep upon waking)," "improving the feeling of deep sleep," "reducing the number of awakenings during sleep," "reducing the duration of awakenings during sleep," "improving sleep depth," "improving satisfaction with sleep depth," "improving sleep rhythm," "improving daytime sleepiness," "improving satisfaction upon waking," "improving the feeling of extended sleep duration," "supporting good quality sleep at night," "sleep support," "sleep improvement," "reducing morning sleepiness," "reducing fatigue upon waking," "supporting good quality sleep," "alleviating daytime sleepiness," and "improving satisfaction with sleep." Regarding improving mental health problems, this includes "alleviating mental health problems," "improving mental health," "alleviating mental health problems," "alleviating mental stress," "alleviating the feeling of psychological stress," "stress reduction," "reducing transient stress," "alleviating temporary stress (irritability)," "alleviating temporary psychological (mental) stress," "alleviating irritability," "alleviating tension," "relaxing effect," "improving relaxation," "alleviating anxiety," "reducing anxiety," and "alleviating depression." "Reduces feelings of depression," "Alleviates feelings of confusion," "Reduces feelings of confusion," "Reduces states of bewilderment (state of being unable to organize thoughts)," "Relieves anxiety, tension, and feelings of depression," "(Temporary) Increase in vitality and energy," "Reduces decline in vitality and energy," "Maintains vitality and energy (positive mood, lively, relaxed, full of energy, clear mind, feeling good without worries)," "Improves gloomy mood," "Maintains vitality in middle-aged and elderly people (a feeling of energy and vitality)," "Maintains mental health (being in a happy and calm mood)," "Positive mood "Maintaining," "Maintaining a lively mood," "Maintaining motivation," "Supporting positive feelings (cheerful mood, motivated and active state, etc.)," ​​"Supporting positive emotions (optimism, feeling useful, confidence, having energy)," "Supporting well-being (feeling happy, feeling that you are enjoying life)," "Improving social health," "Reducing social health problems," "Supporting positive feelings in interpersonal relationships (enjoying socializing, trusting others)," "Self-esteem (being satisfied with oneself, feeling that one has strengths,Examples of health foods that display claims such as "increasing the feeling of being a person of equal value to others," "reducing feelings of loneliness (feeling that you have close friends, someone to talk to, someone to rely on)," "improving daily role functioning," "improving social functioning," "maintaining social relationships," "maintaining social skills," "maintaining sociability," "maintaining relationship building," "maintaining communication," "enjoying social interactions," "deepening bonds with others," "maintaining cooperation with others," "no longer finding social interactions burdensome," "being able to fulfill one's role," "no health problems affecting work or life," "being able to live daily life without difficulty," "maintaining work-life balance," "being able to live a normal life as normal," and "not experiencing any discomfort in daily life" are examples of health foods, or health foods that display claims that the listed functions have been reported. Furthermore, functional foods include those that use improved sleep quality and improvement of mental health problems as the scientific basis for their functionality.

[0049] The sleep quality improving composition and mental health improvement composition of the present invention may be labeled as containing cannabidiol and / or components (B) to (E) as active ingredients, but is not limited to those labeled as containing cannabidiol as an active ingredient on product packaging, etc. For example, the active ingredient may not be specified. Furthermore, even general food products are included in the scope of the present invention if they are manufactured and sold with indications of their intended use. For example, food products sold with testimonials on websites, etc., mentioning improvements in sleep quality or mental health based on the personal experiences of those who consumed them are also included in the scope of the present invention. [Examples]

[0050] The present invention will be described below based on examples. <Test substance>

[0051] • Cannabidiol: Commercially available product used • Glucose: Commercially available product used • Fructose: Commercially available product used • Maltose: Commercially available product used • Maltotriose: Commercially available product used • Succinic acid: Commercially available product used • Tartaric acid: Commercially available product used • Malic acid: Commercially available product used • Citric acid: Commercially available product used • Acetic acid: Commercially available product used • Isohumulone: ​​Commercially available product used • Arginine: Commercially available product used • Alanine: Commercially available product used • Proline: Commercially available product used • n-Propanol: Commercially available product used • Isobutanol: Commercially available product used • Isoamyl alcohol: Commercially available product used • α-Pinene: Commercially available product used • Limonene: Commercially available product used • Citronellol: Commercially available product used • β-Damascenone: Commercially available product used • Piperine: Commercially available piperine derived from black pepper was used

[0052] <Evaluation of Oxidative Stress Protection Effect> 1. Preparation of Test Substances: • Cannabidiol: Dissolved in surfactant (PEG40-hydrogenated castor oil) at 70°C and diluted in the culture medium to the specified concentration. • Isohumulone, α-pinene, limonene, citronellol, β-damascenone, piperine: Dissolved in DMSO and diluted in the culture medium to the specified concentration. • Other test substances: Diluted in the culture medium to the specified concentration. The culture medium containing the test substances was ultimately prepared as 0.004% PEG40-hydrogenated castor oil-0.5% DMSO-10% FBS-RPMI1640 medium.

[0053] 2. Evaluation of oxidative stress protection effect (1) Rat adrenal pheochromocytoma cells (PC12, JCRB cell bank) were cultured in 10% HS-5% FBS-RPMI1640 medium, and seeded in 10% FBS-RPMI1640 medium at a rate of 4 × 10^4 cells / well in a collagen-coated 96-well plate. Pre-culture was performed for 24 hours in a 37°C, 5% CO2 incubator. (2) After 24 hours of culture, 100 μL / well of the test substance-containing medium was added on top of the medium already in the wells, and cultured for 24 hours in a 37°C, 5% CO2 incubator. All test substances were prepared to 1 μg / mL and added in the ratios shown in Tables 1 and 2 below (final concentration of test substances: total 0.5 μg / mL). (3) After 24 hours of incubation, 20 μL / well of 2.2 mM hydrogen peroxide solution was added on top of the culture medium already in the wells (final concentration: 200 μM). (4) The cells were incubated at 37°C in a 5% CO2 incubator for 2 hours. (5) After removing the culture medium, 150 μL of Cell Counting Kit-8 (Dojin Chemical Co., Ltd.), diluted 30 times by volume with serum-free DMEM, was added to each well. After standing in a 37°C incubator in a 5% CO2 incubator to allow for appropriate color development, the absorbance at 450 nm was measured. Cell viability was evaluated by calculating the % of control using the following formula based on the obtained data. The results are shown in Tables 1-3. % of control = (Data sample - Data blank) / (Data control - Data blank) × 100 Note that the denominator (base) of the above formula, "Data control - Data blank," is the value obtained by subtracting the absorbance of "blank" at 450 nm from the absorbance of the sample without the test substance added (control) at 450 nm. On the other hand, the numerator, "Data sample - Data blank" This value is obtained by subtracting the absorbance of "blank" at 450 nm from the absorbance of the sample to which the test substance has been added. It is known that the value obtained by subtracting the absorbance of "blank" at 450 nm from the absorbance of the sample at 450 nm is proportional to the number of viable cells, and "% of control" represents the relative value of the number of viable cells in the culture medium with the test substance added, with the number of viable cells in the culture medium without the test substance added being set to 100.

[0054] [Table 1]

[0055] [Table 2]

[0056] [Table 3]

[0057] In insomnia patients, elevated oxidative stress and decreased antioxidant enzyme activity are observed, and it has been revealed that oxidative stress is involved in the pathogenesis of depression and anxiety disorders. Therefore, suppressing oxidative stress is thought to lead to improved sleep quality and relief of mental health problems. Rat adrenal pheochromocytoma cells are used as a nervous system model cell to evaluate improvements in sleep quality, stress, depression, and anxiety disorders. The oxidative stress protective effect in rat adrenal pheochromocytoma cells was evaluated, and it is thought that a higher oxidative stress protective effect indicates a greater effect on improving sleep quality and mental health problems. From Comparative Examples 1-5 and Examples 1-4, the oral composition of the present invention, by containing cannabidiol and at least one sugar selected from the group consisting of glucose, fructose, maltose, and maltotriose, showed a higher oxidative stress protective effect compared to when each was used alone. Furthermore, Comparative Examples 1, 6-10 and Examples 5-9 showed that the oral compositions of the present invention, by containing cannabidiol and at least one taste component selected from succinic acid, tartaric acid, malic acid, acetic acid, and isohumulone, exhibited a higher oxidative stress protective effect compared to when each was used alone. Furthermore, Comparative Examples 1, 11-13 and Examples 10-12 showed that the oral compositions of the present invention, by containing cannabidiol and at least one amino acid selected from arginine, alanine, and proline, exhibited a higher oxidative stress protective effect compared to when each was used alone. Furthermore, Comparative Examples 1, 14-16 and Examples 13-15 showed that the oral compositions of the present invention, by containing cannabidiol and at least one C3-C12 alcohol selected from n-propanol, isobutanol, and isoamyl alcohol, exhibited a higher oxidative stress protective effect compared to when each was used alone. Furthermore, Comparative Examples 1, 17-20, and Examples 16-19 show that the oral compositions of the present invention, by containing cannabidiol and at least one aroma component selected from α-pinene, limonene, citronellol, and β-damascenone, exhibited a higher oxidative stress protection effect compared to when each component was used alone.Furthermore, Examples 20-30 showed that when cannabidiol was used in combination with two or more substances selected from glucose, fructose, maltose, maltotriose, succinic acid, tartaric acid, malic acid, acetic acid, isohumulone, arginine, alanine, proline, n-propanol, isobutanol, isoamyl alcohol, α-pinene, limonene, and citronellol, the oxidative stress protective effect was higher not only when these substances were used individually, but also when only one substance was used. Surprisingly, Comparative Examples 1, 21, and 22 showed that in all examples, the oxidative stress protective effect was higher than when cannabidiol and piperine, which is known to promote the absorption of cannabidiol, were included. From these results, it can be seen that the oral composition of the present invention enhances oxidative stress protective effect through the combination of cannabidiol and specific components, resulting in excellent improvement of sleep quality, as well as effectiveness against depression and anxiety, and excellent improvement of mental health disorders. Furthermore, it becomes clear that these effects are unpredictable.

[0058] <Manufacturing Examples 1-6> Oral compositions in the form of bottled beverages were manufactured according to the compositions listed in Table 4 below. The oral compositions obtained in the manufacturing examples below provide excellent effects in improving sleep quality and alleviating mental health problems when taken once a day at a dose of 350 ml.

[0059] [Table 4]

[0060] <Manufacturing Examples 7-10> Oral compositions in the form of bottled beverages were manufactured according to the compositions listed in Table 5 below. The oral compositions obtained in the manufacturing examples below provide excellent effects in improving sleep quality and alleviating mental health problems when taken once a day at a dose of 750 ml.

[0061] [Table 5]

[0062] <Manufacturing Examples 11-15> Oral compositions in the form of bottled beverages were manufactured according to the compositions listed in Table 6 below. The oral compositions obtained in the manufacturing examples below provide excellent effects in improving sleep quality and alleviating mental health problems when taken once a day at a dose of 150 ml.

[0063] [Table 6] [Industrial applicability]

[0064] The oral composition of the present invention, by containing cannabidiol and specific components, can provide an oral composition that is excellent in improving sleep quality and alleviating mental health problems, and has high potential for industrial use.

Claims

1. An oral composition characterized by containing cannabidiol and at least one component selected from (A) to (D) below: (A) Sugars (B) Flavoring components (C) Amino acids (D) Alcohols having 3 to 12 carbon atoms (E) Aroma components

2. The oral composition according to claim 1, characterized in that (A) the sugar is at least one selected from the group consisting of glucose, fructose, maltose, and maltotriose; (B) the taste component is at least one selected from the group consisting of succinic acid, tartaric acid, malic acid, acetic acid, and isohumulone; (C) the amino acid is at least one selected from the group consisting of arginine, alanine, and proline; (D) the C3-C12 alcohol is at least one selected from the group consisting of n-propanol, isobutanol, and isoamyl alcohol; and (E) the aroma component is at least one selected from the group consisting of α-pinene, limonene, and citronellol.

3. Furthermore, the oral composition according to claim 1, characterized in that it contains ethanol.

4. The oral composition according to claim 1, characterized in that it is a non-pharmaceutical preparation.

5. The oral composition according to claim 1, characterized in that it is a beverage.

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