Oral composition

Abstract

To provide an oral composition excellent in improving sleep quality and enhancing relaxation effect.SOLUTION: The oral composition comprises (A) cannabidiol, and at least one component selected from the group consisting of (B) polyphenols, (C) proteins, (D) carbohydrates, and (E) plant-derived components.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an oral composition characterized by containing cannabidiol and a specific ingredient. [Background technology]

[0002] Cannabidiol (CBD) is attracting attention as a component expected to have new pharmacological effects. Cannabidiol (CBD) is a type of cannabinoid found in hemp, and has been developed as a therapeutic agent for epilepsy and a composition for treating tuberous sclerosis (Patent Document 1, Patent Document 2). Its use as an oral composition and topical agent has also been developed, but has not been fully explored. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2013-523708 [Patent Document 2] Special Publication No. 2017-537064 Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, the present inventors have conducted various studies with the objective of providing an oral composition that enhances the effects of cannabidiol. [Means for solving the problem]

[0005] As a result, the inventors have succeeded in developing an oral composition that enhances the effects of improving sleep quality and relaxation by combining specific ingredients with cannabidiol, thereby completing the present invention.

[0006] That is, the present invention is as follows. <1> (A) An oral composition comprising cannabidiol and at least one component selected from the following (B) to (E): (B) Polyphenols (C) Proteins (D) Carbohydrates (E) Plant-derived ingredients <2> (B) The polyphenol is at least one selected from the group consisting of saponarin, procyanidin, caffeine, chlorogenic acid, and catechins. <1> The oral composition according to claim 1. <3> (C) The protein is at least one selected from the group consisting of protein and gelatin. <1> The oral composition according to claim 1. <4> (D) The carbohydrate contains at least one selected from the group consisting of indigestible dextrin, polydextrose, erythritol, and trehalose. <1> The oral composition according to claim 1. <5> (E) The plant-derived component contains at least one selected from the group consisting of chlorophyll and fruit juice. <1> The oral composition according to claim 1. <6> Characterized by its use for improving sleep quality and / or relaxation <1> The oral composition according to claim 1. [Effects of the Invention]

[0007] According to the present invention, by containing specific ingredients together with cannabidiol, the protective effect against oxidative stress is enhanced, and therefore an oral composition having excellent effects of improving sleep quality and relaxation can be obtained. DETAILED DESCRIPTION OF THE INVENTION

[0008] The oral composition of the present invention will be described in detail below. The present invention is not limited to the following embodiments, and may be modified, added, modified, deleted, or otherwise altered within the scope of what one skilled in the art can conceive. Any embodiment is within the scope of the present invention as long as it exhibits the functions and effects of the present invention.

[0009] The oral composition of the present invention is characterized by containing (A) cannabidiol and at least one selected from the group consisting of (B) polyphenols, (C) proteins, (D) carbohydrates, and (E) plant-derived components (sometimes referred to as components (A) to (E)). Components (A) to (E) are described in detail below.

[0010] <(A) Cannabidiol> The oral composition of the present invention is characterized by containing cannabidiol. Cannabidiol is a type of cannabinoid known to be contained in hemp. Cannabidiol is known to have a different pharmacological effect from tetrahydrocannabinol, another cannabinoid. In the present invention, cannabidiol extracted and purified from plants such as hemp or citrus peel, or synthesized cannabidiol can be used. However, from the viewpoints of safety and enhancing the effects of improving sleep quality and relaxation, it is preferable to use cannabidiol extracted and purified from natural products.

[0011] The cannabidiol content in the oral composition of the present invention is not particularly limited, and is, for example, 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 effects of improving sleep quality and relaxing effects. It is also 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 effects of improving sleep quality and relaxing effects.

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

[0013] [Table A]

[0014] <(B) Polyphenols> The oral composition of the present invention may contain, together with cannabidiol, one or more of saponarin, procyanidins, chlorogenic acid, and catechins as component (B), either singly or in combination. The inclusion of these components can enhance the effects of improving sleep quality and relaxation.

[0015] Component (B) will be described in detail below.

[0016] (Saponarin) Saponarin (CAS number: 20310-89-8) refers to the 7-O-glucoside of isovitexin (saponaretin) and is known to be contained in plants such as Rose of Sharon, Jade Vine, Pomegranate, Passionflower, Saponaria (Soapwort), Barley, Sugarcane, and Hibiscus. The saponarin used in the present invention is not particularly limited, and may be produced by methods commonly known to those skilled in the art or may be a commercially available product. Saponarin may be directly obtained from saponarin-containing plants, such as flowers, leaves, or stems, or processed products thereof that have been crushed, pulverized, or the like, or may be obtained by separation, extraction, or artificial synthesis.

[0017] The crushing and grinding method for obtaining saponarin from raw materials is not particularly limited; either wet or dry crushing may be used. The crushing conditions and processing equipment are also not particularly limited; commercially available equipment can be used as appropriate. Examples of equipment that can be used include high-pressure homogenizers, ultrasonic grinders, airflow grinders, high-speed impact grinders, ball mills, and bead mills. These processes may be repeated multiple times or multiple processes may be combined as necessary to achieve desired physical properties, such as particle size, within the desired range. Furthermore, the methods for extracting, isolating, and synthesizing saponarin from raw materials are not particularly limited and can be selected appropriately depending on the purpose. Examples of extraction methods include adding an extraction solvent commonly used by those skilled in the art, such as ethanol, water, or aqueous ethanol, and extracting by heating, if necessary.

[0018] (procyanidins) Procyanidins are a group of compounds consisting of condensation polymers with a degree of polymerization of 2 or more, with flavan-3-ol as the basic structural unit. Preferably, the proanthocyanidin contains a condensation polymer with a degree of polymerization of 2 or more. Examples of procyanidins include procyanidin B1, procyanidin B2, procyanidin B3, and procyanidin C1, with procyanidin B1, procyanidin B3, and procyanidin C1 being preferred, and procyanidin B1 and procyanidin B3 being particularly preferred.

[0019] Procyanidins are components contained in pine bark, which is the bark of trees of the genus Pinus in the family Pinaceae, as well as in apples, grapes, cacao, etc. Procyanidins contained in the composition of the present invention may be those purified from plants, those obtained by chemical synthesis, commercially available reagents, or plants containing procyanidins.

[0020] (chlorogenic acid) Chlorogenic acid is a type of polyphenol found in coffee beans and the like. Chlorogenic acid is also called 3-caffeoylquinic acid. The chlorogenic acid used in the present invention is not particularly limited as long as it is edible, and examples thereof include ground products and extracts of food materials containing chlorogenic acid, such as coffee beans. Examples of ground products include dried powders, shredded products, and dried products thereof (dried shredded products). The extract may be in liquid form, but can also be used as a paste or dry powder (extract powder). The extract can be obtained by extraction using a suitable solvent, such as water, ethanol, or aqueous ethanol. The temperature of each solvent can be appropriately set between room temperature and the boiling point or below.

[0021] (Catechins) In this specification, catechins is a collective term for epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), epigallocatechin gallate (EGCg), catechin (C), gallocatechin (GC), catechin gallate (Cg), and gallocatechin gallate (GCg).

[0022] The method for obtaining catechins is not particularly limited. Examples of catechins include synthetic products synthesized by methods commonly known to those skilled in the art, natural products containing catechins, extracts extracted from such natural products and processed products thereof, commercially available catechin products, and processed products obtained by subjecting such commercially available products to chemical treatment, enzyme treatment, purification treatment, etc. Catechins may be, for example, tea extracts and concentrates thereof.

[0023] Examples of tea extracts include green teas such as sencha, bancha, gyokuro, tencha, and kamairicha, which are produced from tea leaves of the tea plant (Camellia sinensis); semi-fermented teas such as Tieguanyin and Huangguangxi, collectively known as Bird Dragon Tea, which are fermented to a semi-ripe state; and teas extracted from fermented teas such as Darjeeling, Assam, and Sri Lanka, known as black tea, using water or hot water, and in some cases, an extraction aid. Specific examples of tea extracts include extracts made with hot water or a water-soluble organic solvent. Examples of tea extract concentrates include those obtained by concentrating tea extracts using organic solvents, columns, membranes, etc. The form of the tea extract concentrate may be a solid, an aqueous solution, a slurry, or the like.

[0024] The tea extract and concentrate thereof may be commercially available. In the present invention, the tea extract and concentrate thereof are preferably fermented tea or semi-fermented tea extract and concentrate thereof, which are commercially available in the form of flavorings, extract powders, etc. For example, as flavorings and extract powders derived from semi-fermented tea, oolong tea flavorings and oolong tea extract powders are commercially available. Furthermore, as flavorings and extract powders derived from fermented tea, black tea flavorings and black tea extract powders are commercially available.

[0025] In the present invention, as component (C), one of protein and gelatin may be selected and used alone, or two or more of them may be used in combination.

[0026] (protein) Proteins are extracted and purified from proteins contained in animals or plants, and commercially available products can be used. Examples of animal-derived proteins include milk protein, whey protein (whey protein isolate), casein protein, egg protein, and beef protein, while examples of plant-derived proteins include soy protein, pea protein, and rice protein. In the present invention, it is preferable to use milk protein, whey protein, or soy protein.

[0027] (gelatin) Gelatin is obtained by applying heat to collagen, a main component of animal skin, bones, tendons, etc., and extracting it. In the present invention, gelatin obtained by a known production method can be used, for example, gelatin produced by treating the skin, bones, tendons, etc. of cows, pigs, chickens, fish, etc., as raw materials with acid or alkali to obtain crude collagen, and then heat-extracting the resulting collagen. In addition, the gelatin used in the present invention may be a hydrolysate, an oxygen decomposition product, a gelatin derivative (e.g., acylated gelatin, etc.), etc.

[0028] In the present invention, as component (D), one selected from indigestible dextrin, polydextrose, erythritol, and trehalose may be used alone, or two or more may be used in combination.

[0029] (Indigestible dextrin) Resistant dextrin is a polysaccharide that is resistant to hydrolysis by human digestive enzymes (amylases). For example, it can be obtained by hydrolyzing starch by heating, followed by amylase hydrolysis, and purifying the resistant component. Resistant dextrin is commercially available in the form of powder, fine granules, granules, etc., and these commercially available products can be used. Furthermore, since resistant dextrin is water-soluble, it may also be used in the form of an aqueous solution.

[0030] (Polydextrose) Polydextrose is a water-soluble, indigestible polysaccharide consisting of a branched polymer structure of glucose units in α- or β-forms with 1-2, 1-3, 1-4, or 1-6 bonds. A portion of polydextrose functions as dietary fiber. Polydextrose can be produced, for example, by mixing glucose, sorbitol, and citric acid in a weight ratio of 89:10:1 or glucose, sorbitol, and phosphoric acid in a weight ratio of 90:10:0.1, followed by polymerization at high temperatures. Polydextrose is commercially available in various forms, and any form can be used.

[0031] The polydextrose may be polydextrose produced by the above-mentioned method or a derivative of polydextrose. Examples of polydextrose derivatives include hydrogenated polydextrose and reduced polydextrose. Polydextrose may also be neutralized with a base such as potassium hydroxide.

[0032] (erythritol) Erythritol is a sugar alcohol found in fruits and fermented foods, and fruits and fermented foods containing erythritol, as well as products extracted from these, can be used. Erythritol can also be synthesized by fermentation using glucose as a raw material, and such synthetic products can also be used.

[0033] (Trehalose) Trehalose is a non-reducing disaccharide in which two molecules of D-glucose are linked via their reducing groups. Trehalose is known to be produced by various methods, such as by extraction from yeast or by treating starch with an enzyme, but the method for producing the trehalose used in the present invention is not limited.

[0034] In the present invention, one of chlorophyll and fruit juice may be selected and used alone as component (E), or two or more of these may be used in combination.

[0035] (chlorophyll) Chlorophyll, also known as chlorophyll, is a porphyrin pigment found in plants and is a chemical substance involved in photosynthesis. Examples of chlorophyll include chlorophyll a, chlorophyll b, and chlorophyll c1. Although there are no limitations on the type, chlorophyll a or chlorophyll b is preferably used, and chlorophyll a is more preferably used.

[0036] The chlorophyll used in the present invention is not particularly limited, and may be one produced by a method commonly known to those skilled in the art or may be a commercially available product. Chlorophyll may be directly obtained from chlorophyll-containing plants, such as flowers, leaves, stems, or processed products thereof that have been crushed or pulverized, or may be obtained by separation, extraction, or artificial synthesis.

[0037] The crushing and grinding method for obtaining chlorophyll from raw materials is not particularly limited; either wet or dry crushing methods are acceptable. The crushing conditions and processing equipment are also not particularly limited; commercially available equipment can be used as appropriate. Examples of equipment that can be used include high-pressure homogenizers, ultrasonic grinders, airflow grinders, high-speed impact grinders, ball mills, and bead mills. These processes may be repeated multiple times or multiple processes may be combined as necessary to achieve desired physical properties, such as particle size, within the desired range. Furthermore, the methods for extracting, separating, and synthesizing chlorophyll from raw materials are not particularly limited and can be selected appropriately depending on the purpose. Examples of extraction methods include adding an extraction solvent commonly used by those skilled in the art, such as ethanol, water, or aqueous ethanol, and extracting by heating, if necessary.

[0038] (fruit juice) Fruit juice refers to juice or processed products obtained by squeezing plants such as fruits and vegetables. The method for producing fruit juice is not particularly limited, and it can be produced by conventionally known methods, such as squeezing the plant itself or its shredded material, or centrifuging or filtering the shredded material. A specific example of a method for producing juice includes squeezing the juice using a mechanical crushing device such as a mixer or juicer, and optionally removing coarse solids by sieving or filtration to obtain a squeezed juice. The obtained juice may be concentrated as needed, or may be subjected to processes such as freeze-drying, hot air drying, or spray drying to produce a dried powder (fruit juice powder). When obtaining fruit juice powder, an excipient such as dextrin can be used as needed. In the present invention, it is preferable to use a fruit juice concentrate or fruit juice powder, and fruit juice powder is particularly preferred.

[0039] The type of fruit juice that can be used in the present invention is not particularly limited, and examples include citrus juices (sweet orange juice, mandarin orange juice, grapefruit juice, lemon juice, lime juice, etc.), apple juice, grape juice, peach juice, tropical fruit juices (pineapple, guava, banana, mango, acerola, papaya, passion fruit, etc.), other fruit juices (plum juice, pear juice, apricot juice, plum juice, berry juice, kiwi fruit juice, etc.), tomato juice, carrot juice, strawberry juice, melon juice, etc., but citrus juice, apple juice, peach juice, grape juice, blueberry juice, plum juice, and blackcurrant juice are preferably used, and orange juice, sweet orange juice, mandarin orange juice, grapefruit juice, lemon juice, lime juice, grape juice, blueberry juice, and blackcurrant juice are particularly preferred. One or more fruit juices may be appropriately selected from these and used.

[0040] The contents of components (B) to (E) in the oral composition of the present invention are not particularly limited, and are, for example, 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 their excellent effects of improving sleep quality and relaxing. Furthermore, the contents are preferably 95% by mass or less, more preferably 90% by mass or less, and particularly preferably 80% by mass or less in terms of their excellent effects of improving sleep quality and relaxing. When a plurality of components (B) to (E) are contained, the contents of components (B) to (E) refer to the total amount.

[0041] The blending ratio of cannabidiol to components (B) to (E) in the oral composition of the present invention is not particularly limited, and for example, cannabidiol:components (B) to (E)=1:0.01 to 10,000,000 is preferred, and cannabidiol:components (B) to (E)=1:0.1 to 1,000,000 is more preferred, with a cannabidiol:components (B) to (E)=1:0.1 to 100,000 being particularly preferred from the standpoint of excellent effects in improving sleep quality and relaxation. When a plurality of components (B) to (E) are contained, the amount of components (B) to (E) is the total amount thereof.

[0042] The content of cannabidiol in the oral composition of the present invention relative to the total amount of cannabidiol and components (B) to (E) is, for example, 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 effects of improving sleep quality and relaxing. It is also 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 effects of improving sleep quality and relaxing. When a plurality of components (B) to (E) are contained, the amount of components (B) to (E) is the total amount of those components.

[0043] The daily dosage of the oral composition of the present invention is not particularly limited and can be appropriately set depending on the mode of use, the content of use by the user, etc. 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, converted to solid content based on the body weight of the user, and even more preferably 2 to 100 mg / kg from the viewpoint of exerting the effects of the oral composition of the present invention.

[0044] Similarly, the dosage of the oral composition of the present invention per administration is not particularly limited. For example, the dosage of the oral composition of the present invention per administration is preferably 0.01 to 2000 mg / kg, more preferably 0.1 to 1000 mg / kg, calculated as solid content based on the body weight of the user, 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.

[0045] Furthermore, the daily usage amount of the oral composition of the present invention is not particularly limited, and for example, in terms of solid content, it is preferably 0.001 to 20 g, more preferably 0.01 to 10 g, and from the viewpoint of exerting the effects of the oral composition of the present invention, it is particularly preferably 0.1 to 5 g.

[0046] The amount of the oral composition of the present invention used at one time is not particularly limited, and is, for example, preferably 0.0001 to 20 g, more preferably 0.001 to 10 g, in terms of solid content, and particularly preferably 0.01 to 5 g, from the viewpoint of exerting the effects of the oral composition of the present invention.

[0047] Furthermore, the amount of cannabidiol contained in the oral composition of the present invention per day is not particularly limited, and is preferably 0.00001 to 1 g, more preferably 0.00005 to 0.5 g, and from the viewpoint of exerting the effects of the oral composition of the present invention, particularly preferably 0.0001 to 0.1 g.

[0048] The amount of cannabidiol contained in a single dose of the oral composition of the present invention is not particularly limited, and can be, for example, 0.000001 to 1 g, more preferably 0.000005 to 0.5 g, in terms of solid content, and from the viewpoint of exerting the effects of the oral composition of the present invention, particularly preferably 0.00001 to 0.1 g.

[0049] <Other ingredients> In addition to the above components, other components can be blended into the oral composition of the present invention as needed. Examples of other components include various vitamins and minerals, and microorganisms such as lactic acid bacteria and yeast. Furthermore, if needed, ingredients commonly used in the food industry, such as sugars (e.g., dextrin and starch), oligosaccharides, sweeteners, acidulants, nutritional supplements, stabilizers, lubricants, binders, glossing agents, thickeners, colorants, excipients, diluents, bulking agents, emulsifiers, food additives, and seasonings, can be included. The content of these other components can be appropriately selected depending on the form of the composition of the present invention.

[0050] <Oral Composition> The form of the oral composition of the present invention is not particularly limited and may be any form, for example, a form suitable for oral use, specifically, powder, granules, tablets, liquid, paste, capsules such as hard capsules and soft capsules, caplets, etc., and from the viewpoint of ease of ingestion, granules, tablets, liquid, and capsules are preferred.

[0051] The packaging form of the oral composition of the present invention is not particularly limited and can be appropriately selected depending on the dosage form, etc., and examples thereof include blister packs such as PTPs; strip packaging; heat seals; aluminum pouches; film packaging using plastics, synthetic resins, etc.; glass containers such as vials; and plastic containers such as ampoules.

[0052] As described in the Examples below, the oral composition of the present invention has the effect of improving sleep quality, and therefore can be used as a composition for improving sleep quality. Note that, in the present invention, improving sleep quality is a concept that includes improving (improving) sleep quality and / or suppressing (maintaining) a decline in sleep quality.

[0053] In the present invention, sleep quality is indicated by at least one item selected from the group consisting of, for example, sleepiness upon waking, sleep onset and sleep maintenance (e.g., smooth sleep onset and sleep maintenance, or falling asleep quickly and continuing a stable sleep without waking up during the night), dreaminess (e.g., not having frequent dreams or nightmares), fatigue upon waking, waking up during the night, daytime sleepiness, sleep rhythm, depth of sleep, and satisfaction with sleep (e.g., not feeling short of time).

[0054] The composition for improving sleep quality of the present invention has the effect of improving sleep quality, for example, reducing sleepiness upon waking, facilitating sleep onset, increasing sleep time, reducing dreaminess, reducing fatigue upon waking, shortening the time spent awake during the night, reducing daytime sleepiness, improving sleep rhythm, increasing the depth of sleep, and improving satisfaction with sleep.

[0055] The sleep quality improving effect and the relaxation effect can be evaluated by a conventionally known method without any particular limitation, for example, by the OSA sleep questionnaire, VAS, etc.

[0056] The compositions for improving sleep quality and for relaxation are not particularly limited as long as they contain cannabidiol and component (B) and can be distinguished from other products in that they have the function of improving sleep quality and relaxation. For example, the scope of the present invention includes products that display the function of improving sleep quality and relaxation on the main body, packaging, instructions, or promotional materials (advertising media) of the product of the present invention.

[0057] Specifically, examples include health foods labeled with claims such as "improving sleep quality," "improving sleep quality (depth of sleep, satisfaction with sleep upon waking)," "improving the feeling of deep sleep," "reducing the number of awakenings during sleep," "reducing the time spent waking during sleep," "improving sleep depth," "improving satisfaction with sleep depth," "improving sleep rhythm," "improving daytime sleepiness," "relieving daytime sleepiness," "reducing sleepiness during activities," "improving satisfaction upon waking," "improving the feeling of extended sleep time," "supporting good quality sleep at night," "sleep support," "sleep improvement," "reducing sleepiness upon waking," "reducing fatigue upon waking," "supporting good quality sleep," "improving satisfaction with sleep," "satisfaction upon waking," "improving falling asleep," "providing a feeling of having slept longer," "improving dreaminess," "reducing awakenings during the night," "improving sleep rhythm," "when you want to relax," "leading to a relaxed state," "when you feel pressured," "when you feel anxious," "for those working hard in a stressful society," "stress management," "supporting physical and mental rest," etc., as well as health foods labeled with the reported functions listed above. Furthermore, functional foods also include those whose scientific evidence for their functionality is the improvement of sleep quality.

[0058] The sleep quality improving composition or relaxation composition of the present invention may be one that lists cannabidiol and / or component (B) as the active ingredient, but is not limited to those that list cannabidiol or component (B) as the active ingredient on the product packaging, etc. For example, the active ingredient may not be specified. Furthermore, even general foods that are manufactured and sold with a suggested use are within the scope of the present invention. For example, foods sold with personal testimonials from people who have consumed the product, mentioning improvements in sleep quality or relaxation, listed on a website, etc., are also within the scope of the present invention. [Example]

[0059] The present invention will be described below based on examples. <Test substance> The following substances were used as test substances. Cannabidiol: Commercially available powder Saponarin: Commercially available product Procyanidin: Commercially available procyanidin B1 was used. Chlorogenic acid: Commercially available product Catechin: A mixture of catechins derived from commercially available tea leaves (epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), epigallocatechin gallate (EGCg), catechin (C), gallocatechin (GC), catechin gallate (Cg), and gallocatechin gallate (GCg)) was used. Soy protein: Commercially available soy protein (powder) Whey protein: Commercially available whey-derived protein (powder) Gelatin: Commercially available gelatin powder (Kanto Chemical, No. 17009-01) was used. Indigestible dextrin: Commercially available product Polydextrose: Commercially available product Erythritol: Commercially available product Trehalose: Commercially available Chlorophyll: Commercially available pure chlorophyll a powder was used. Orange juice: Commercially available orange juice powder Grape juice: Commercially available grape juice powder

[0060] <Evaluation of oxidative stress protection effect> 1. Preparation of Test Substances Cannabidiol: Dissolved in surfactant (PEG40-hydrogenated castor oil) at 70°C and diluted with medium to the desired concentration. Saponarin, procyanidins, and chlorophyll were dissolved in DMSO and diluted with medium to the desired concentrations. Other test substances: Diluted with medium to the specified concentration. The test substance-containing medium was finally prepared as 0.004% PEG40-hydrogenated castor oil-0.5% DMSO-10% FBS-RPMI1640 medium.

[0061] 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 onto a collagen-coated 96-well plate at 100 μL / well in 10% FBS-RPMI1640 medium at 4 × 10^4 cells / well. The cells were pre-cultured for 24 hours in a 37°C, 5% CO2 incubator. (2) After 24 hours of incubation, 100 μL / well of the test substance-containing medium was added to the medium already in the wells, and the cells were incubated for 24 hours in a 37°C, 5% CO2 incubator. All test substances were prepared at 1 μg / mL and mixed at the ratios shown in Tables 1 and 2 below (final test substance concentration: 0.5 μg / mL in total). (3) After 24 hours of culture, 20 μL / well of 2.2 mM hydrogen peroxide solution was added to the medium already in the wells (final concentration: 200 μM). (4) 37°C, 5% CO 2 The cells were cultured in an incubator for 2 hours. (5) After removing the medium, 150 μL of Cell Counting Kit-8 (Dojindo Laboratories) diluted 30 times with serum-free DMEM was added to each well. The plate was placed in a 37°C, 5% CO2 incubator to allow for adequate color development, after which the absorbance at 450 nm was measured. The 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 and 2. % of control = (Data sample- Data blank) / (Data control- Data blank) × 100

[0062] [Table 1]

[0063] [Table 2]

[0064] Increased oxidative stress and decreased antioxidant enzyme activity have been observed in patients with insomnia, and it is believed that suppressing oxidative stress will lead to improved sleep quality. Rat adrenal pheochromocytoma cells are used as a nervous system model cell for improving sleep quality and evaluating stress and anxiety disorders. By evaluating the protective effect against oxidative stress in rat adrenal pheochromocytoma cells, it is believed that a high level of protective effect against oxidative stress will have a positive effect on improving sleep quality and relaxation. Comparative Examples 1-5 and Examples 1-4 show that the oral compositions of the present invention, which contain cannabidiol and at least one selected from the group consisting of saponarin, procyanidins, chlorogenic acid, and catechins, exhibit a higher oxidative stress protection effect than when each of these ingredients is used alone. Comparative Examples 1, 6-8, and Examples 5-7 show that the oral compositions of the present invention, which contain cannabidiol and at least one selected from soy protein, whey protein, and gelatin, exhibit a higher oxidative stress protection effect than when each of these ingredients is used alone. Comparative Examples 1, 9-12, and Examples 8-11 show that the oral compositions of the present invention, which contain cannabidiol and at least one selected from indigestible dextrin, polydextrose, erythritol, and trehalose, exhibit a higher oxidative stress protection effect than when each of these ingredients is used alone. Furthermore, Comparative Examples 1, 13-15 and Examples 12-14 show that the oral compositions of the present invention containing cannabidiol and at least one selected from chlorophyll, orange juice, and grape juice exhibited a higher oxidative stress protection effect than when each was used alone. Furthermore, Examples 15 and 16 show that when cannabidiol and two selected from saponarin, gelatin, chlorophyll, and orange juice were used, a higher oxidative stress protection effect was observed not only when these were used alone, but also when only one of them was used. Surprisingly, Comparative Examples 1, 16, and 17 show that the inclusion of cannabidiol and piperine, which is known to promote cannabidiol absorption, did not exhibit an oxidative stress protection effect. From the above results, it can be seen that the oral composition of the present invention, due to the combination of cannabidiol and specific ingredients, enhances the protective effect against oxidative stress, thereby providing excellent sleep quality improvement, anti-depressant and anti-anxiety effects, and excellent relaxing effects. It can also be seen that these effects were unexpected.

[0065] <Production Examples 1 to 4> Granule oral compositions were prepared according to the formulations shown in Table 3. The oral compositions obtained in the following preparation examples can be taken once a day at a dose of 2 g to provide excellent effects in improving sleep quality and relaxation.

[0066] [Table 3]

[0067] <Production Examples 5 to 8> Tablet-shaped oral compositions (250 mg per tablet) were prepared according to the formulation shown in Table 4. The oral compositions obtained in the following preparation examples provide excellent effects of improving sleep quality and relaxation when taken in two tablets once a day.

[0068] [Table 4]

[0069] <Production Examples 9-11> Granules were prepared according to the composition shown in Table 5 below and encapsulated in a pullulan hard capsule shell to produce a capsule-shaped oral composition (250 mg per capsule; 180 mg granules, 70 mg capsule). The oral composition obtained in the following production example can be taken twice a day, one capsule at a time, to provide excellent effects of improving sleep quality and relaxation.

[0070] [Table 5]

[0071] <Production Examples 12-14> According to the composition shown in Table 6 below, the soft capsule contents were prepared and enclosed in a soft capsule shell made of pork gelatin to produce a capsule-shaped oral composition (350 mg per capsule; contents 220 mg, shell 130 mg). The oral composition obtained in the following production example provides excellent effects of improving sleep quality and relaxation when taken in two capsules once a day.

[0072] [Table 6]

[0073] <Production Examples 15-17> Chocolate was produced according to the composition shown in Table 7 below. Taking 30 g of the chocolate obtained in the following production example once a day provides excellent effects of improving sleep quality and relaxation.

[0074] [Table 7]

[0075] <Production Examples 18-20> Gummy oral compositions were prepared according to the formulations shown in Table 8. The oral compositions obtained in the following preparation examples can be taken at a dose of 4 g once a day to provide excellent effects in improving sleep quality and relaxation.

[0076] [Table 8] [Industrial Applicability]

[0077] The oral composition of the present invention contains cannabidiol and specific components, and therefore can provide an oral composition that has excellent effects in improving sleep quality and relaxing effects, and has high potential for industrial applicability.

Claims

1. An oral composition comprising (A) cannabidiol and at least one component selected from the following (B) to (E): (B) Polyphenols (C) Proteins (D) carbohydrates (E) Plant-derived ingredients

2. 2. The oral composition according to claim 1, wherein the polyphenol (B) is at least one selected from the group consisting of saponarin, procyanidins, caffeine, chlorogenic acid, and catechins.

3. 2. The oral composition according to claim 1, wherein the protein (C) is at least one selected from the group consisting of protein and gelatin.

4. 2. The oral composition according to claim 1, wherein the carbohydrate (D) contains at least one selected from the group consisting of indigestible dextrin, polydextrose, erythritol, and trehalose.

5. 2. The oral composition according to claim 1, wherein the plant-derived component (E) contains at least one selected from the group consisting of chlorophyll and fruit juice.

6. 2. The oral composition according to claim 1, characterized in that it is for improving sleep quality and / or relaxation.

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