Topical skin preparations

Abstract

The present invention aims to find a topical skin preparation that enhances the skincare effects of cannabidiol, and to provide a topical skin preparation that enhances the skincare effects of cannabidiol by containing (a) cannabidiol, (b) 20-80% by mass of an oil, and (c) a surfactant. [Solution] In a topical skin preparation containing (a) cannabidiol, (b) an oil, and (c) a surfactant, the skin care effect of cannabidiol can be enhanced by incorporating the oil in an amount of 20 to 80% by mass.

Description

Technical Field

[0001] The present invention relates to a topical skin preparation containing cannabidiol, a specific amount of an oily agent, and a surfactant. Specifically, it relates to a topical skin preparation characterized by enhancing the skin care effect of cannabidiol. More specifically, in a topical skin preparation characterized by containing cannabidiol, 20 to 80% by mass of an oily agent, and a surfactant, it relates to a topical skin preparation characterized by blending a nonionic surfactant as the surfactant for the purpose of enhancing the skin care effect of cannabidiol.

Background Art

[0002] Cannabidiol (CBD) has attracted attention as a component expected to have new pharmacological effects. Cannabidiol is one of the cannabinoids contained in hemp, and for example, therapeutic drugs for epilepsy, therapeutic compositions for tuberous sclerosis and inflammatory diseases, etc. have been developed (Patent Documents 1 to 3). In addition, its use as a topical preparation has also been developed.

[0003] However, since cannabidiol is a highly lipophilic compound and is difficult to be absorbed from the skin or the like, its skin care effect has not been fully exerted. Therefore, a topical skin preparation with an improved skin care effect of cannabidiol is desired.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0005] Therefore, the present invention aims to provide a topical skin preparation that enhances the skincare effects of cannabidiol. [Means for solving the problem]

[0006] The present inventors investigated the skin care effects of various substances in a topical skin preparation containing cannabidiol in order to find a topical skin preparation that enhances the skin care effects of cannabidiol. As a result, they found that a specific combination of oil and surfactant enhances the skin care effects of cannabidiol, leading to the completion of the present invention. Specifically, the present invention relates to a topical skin preparation characterized by containing cannabidiol, 20-80% by mass of oil, and a surfactant, and relates to the aforementioned topical skin preparation that has an excellent effect of improving the skin care effects of cannabidiol. Furthermore, the present invention relates to a topical skin preparation characterized by containing cannabidiol, 20-80% by mass of oil, and a surfactant, and relates not only to an excellent effect of improving the skin care effects of cannabidiol, but also to a topical skin preparation that is excellent in terms of usability, formulation stability, and ease of use.

[0007] The outline of the present invention is as follows: [1] A topical skin preparation comprising (a) cannabidiol, (b) an oil, and (c) a surfactant, in an amount of 20-80% by mass. [2](c) The topical skin preparation according to claim 1, characterized in that component is a nonionic surfactant. [3](c) The topical skin preparation according to [1], wherein component (c) is one or more selected from sorbitan fatty acid esters to which polyoxyethylene chains are not attached and polyoxyethylene polyhydric alcohol fatty acid esters in which the fatty acid is oleic acid. [4] Furthermore, the topical skin preparation according to [1], characterized in that it contains (d) a polyhydric alcohol. [5] The topical skin preparation according to [1], further characterized by containing (e) a fragrance. [6] The topical skin preparation according to [1], characterized in that it is a bath additive. [7] The topical skin preparation according to [1], characterized in that it is for skin care. [8] The topical skin preparation according to [7], characterized in that the skin care is for the prevention and / or improvement of rough skin. [9] The topical skin preparation according to [7], characterized in that skin care is moisturizing of the skin.

[10] The topical skin preparation described in [7], characterized in that the skin care is anti-inflammatory. [Effects of the Invention]

[0008] According to the present invention, it is possible to provide a topical skin preparation that has excellent skincare effects, excellent usability, excellent stability of the formulation, and excellent usability of the formulation. [Modes for carrying out the invention]

[0009] The present invention will now be described in terms of preferred embodiments. The present invention relates to a topical skin preparation characterized by containing cannabidiol, an oily agent in an amount of 20-80% by mass, and a surfactant. In this specification, skin care effects include the prevention and / or improvement of rough skin, anti-inflammatory effects, and moisturizing of the skin. The feeling of use includes the feeling of moisture on the skin after use. Furthermore, the feeling of moisture on the skin after use includes a rapid improvement effect, such as 5 minutes after adding it to bathwater and bathing. The feeling of use also includes the ease of use as a bath additive, such as spreading uniformly when the topical skin preparation is added to bathwater and stirred. The inventors have found that by combining (a) cannabidiol, (b) an oily agent in an amount of 20-80% by mass, and (c) a surfactant with components such as (d) polyhydric alcohols and (e) fragrances, it is possible to obtain excellent skin care effects, enhance the feeling of use effectively, and improve the stability and usability of the formulation.

[0010] (a) Cannabidiol The topical skin preparation 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 that has been purified from natural products or synthesized from natural products in order to enhance safety and the skin care effects of cannabidiol.

[0011] The cannabidiol content in the topical skin preparation 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 obtaining a high skin care effect. Furthermore, 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 obtaining a high skin care effect.

[0012] (b) Oils The topical skin preparation of the present invention is characterized by containing cannabidiol along with 20-80% by mass of an oil and a surfactant. The oil used in the present invention may be any oil that can be applied to the skin, and can be either polar or nonpolar. Furthermore, it may be either a liquid or a solid at room temperature (20°C), and is not particularly limited, but a liquid oil at room temperature is preferred from the viewpoint of improving the skin care effect of cannabidiol, providing excellent usability, stability, and ease of use. Specifically, for example, hydrocarbon oils such as liquid paraffin, squalane, squalene, and mineral oil; fatty acids such as isostearic acid, oleic acid, and polyhydroxystearic acid; higher alcohols such as octyldodecanol and tetradecyldecanol; isopropyl palmitate, isopropyl myristate, isopropyl stearate, isobutyl stearate, 2-ethylhexyl stearate, isopropyl isostearate, butyl isostearate, decyl isostearate, lauryl isostearate, isodecyl isodecanoate, isodecyl isononanoate, isotridecyl isononanoate, isononyl isononanoate, diisostearyl malate, neopentyl glycoside dioctanoate, propylene glycoside dicaprate, propylene glycoside dicaprylate, glyceryl tri-2-ethylhexanoate, monoisosulfate Examples include ester oils such as polyglyceryl thearate, polyglyceryl diisostearate, diglyceryl triisostearate, diglyceryl tetraisostearate, diethyl sebacate, cetyl 2-ethylhexanoate, ethylhexyl palmitate, octyldodecyl myristate, oleyl oleate, ethyl oleate, triethylhexanoin, ester oils such as N-lauroyl glutamate di(phytosteryl / 2-octyldodecyl), N-lauroyl glutamate di(phytosteryl / behenyl / 2-octyldodecyl), N-lauroyl glutamate di(cholesteryl / 2-octyldodecyl), and N-lauroyl sarcosinate isopropyl; silicone oils such as dimethylpolysiloxane, cyclopentasiloxane, and alkoxy-modified polysiloxane; and one or more of these can be used.

[0013] When (b) an oil is incorporated into the topical skin preparation of the present invention, its content is not particularly limited, but is preferably 20% by mass or more, more preferably 30% by mass or more, and particularly preferably 40% by mass or more from the viewpoint of obtaining a topical skin preparation with high skincare effects, excellent feel, stability and usability. Furthermore, is preferably 80% by mass or less, more preferably 77.5% by mass or less, and particularly preferably 75% by mass or less from the viewpoint of obtaining a topical skin preparation with high skincare effects, excellent feel, stability and usability.

[0014] The oil content relative to cannabidiol in the topical skin preparation of the present invention is not particularly limited. When the cannabidiol content is set to 1, a ratio of 1:0.005 to 1,000,000 is preferred, more preferably 1:0.01 to 500,000, and particularly preferred from the viewpoint of improving solubility, enhancing the skincare effect of cannabidiol, providing excellent usability, stability, and ease of use. When two or more oils are used, the oil content relative to cannabidiol is the total amount.

[0015] (b) Surfactants The emulsifier of the present invention is characterized by containing cannabidiol along with 20-80% by mass of an oil and a surfactant. The surfactant used in the present invention may be any surfactant that can be applied to the skin, and may be a liquid, or a solid such as a powder, fine granules, granules, flakes, or solid form, and is not particularly limited. From the viewpoint of improving solubility, storage stability, ease of handling, and the effect of improving the skin care action of cannabidiol, it is preferable that it dissolves uniformly in water at room temperature (20°C).

[0016] The emulsifier of the present invention may be any surfactant that can be applied to the skin, and is not particularly limited as long as it is water-soluble and can be dispersed or dissolved in water. For example, emulsifiers with an HLB of 3 to 20 can be mentioned. From the perspective of facilitating phase inversion emulsification and obtaining a stable oil-in-water type topical skin preparation, an emulsifier with an HLB of 3 to 18 is preferred, and more preferably an anionic surfactant, cationic surfactant, amphoteric surfactant, and nonionic surfactant with an HLB of 3 to 16, and even more preferably a nonionic surfactant with an HLB of 3 to 16.

[0017] The HLB value of the nonionic surfactant used in the present invention is not particularly limited. From the perspective of improving the skin care effect of cannabidiol, excellent usability, stability, usability, and ease of handling, it is preferably greater than 3, more preferably greater, even more preferably 3.5 or more, preferably 3.8 or more, preferably less than 20, preferably less than 18, and particularly preferably less than 16. The HLB value is an index indicating the hydrophilic-lipophilic balance (Hydrophilic-Lypophilic Balance), and indicates the molecular weight of the hydrophilic group portion in the total molecular weight of the surfactant, and is obtained, for example, by the Griffin formula.

[0018] Examples of nonionic surfactants with an HLB value greater than 3 include sorbitan sesquioleate, sorbeth-30 tetraoleate, polysorbate 60, glyceryl PEG-20 isostearate, PEG-40 stearate, polyoxyethylene (12) lauryl ether, polyoxyethylene (14) lauryl ether, and polyoxyethylene tridecyl ether. Among these, sorbitan sesquioleate, sorbeth-30 tetraoleate, polysorbate 60, and glyceryl PEG-20 isostearate are preferred from the perspective of improving the skin care effect of cannabidiol, excellent usability, stability, usability, and ease of handling, and sorbitan sesquioleate and sorbeth-30 tetraoleate with an HLB value of 4.0 to less than 12 are particularly preferred.

[0019] When two or more nonionic surfactants are used in the present invention, the HLB value is the weighted average of the HLB values of each nonionic surfactant based on its blending ratio. Therefore, even if the HLB value of an individual nonionic surfactant is 3 or less or greater than 16, as long as the mixed HLB value is greater than 3 and 16 or less, it is a nonionic surfactant with an HLB value greater than 3 and 16 or less in the present invention.

[0020] As the nonionic surfactant, any nonionic surfactant such as ester type, ether type, ester-ether type, polyethylene glycol type, alkyl polyglycoside, etc. may be used without particular limitation. From the viewpoints of solubility, storage stability, ease of handling, the effect of improving the skin care effect of cannabidiol, excellent usability, stability and usability, ester type, ether type, and ester-ether type are preferred, and ester type and ester-ether type are particularly preferred.

[0021] Examples of ester-type nonionic surfactants include sucrose fatty acid esters such as sucrose polystearate and sucrose tetrastearate triacetate; glycerin fatty acid esters such as glyceryl stearate and glyceryl diisostearate; polyglycerin fatty acid esters such as polyglyceryl-2 oleate, polyglyceryl-2 isostearate, and polyglyceryl-6 polyricinoleate; fatty acid sorbitan esters such as sorbitan isostearate, sorbitan sesquiisostearate, sorbitan oleate, and sorbitan sesquioleate; polyoxyethylene sorbitan fatty acid esters such as PEG-4 sorbitan triisostearate; polyoxyethylene glycerin fatty acid esters such as PEG-5 glyceryl stearate; polyoxyethylene fatty acid esters such as PEG-3 isostearate and PEG-2 stearate; and polyoxyethylene hydrogenated castor oil such as PEG-5 hydrogenated castor oil and PEG-7 hydrogenated castor oil. Of these, fatty acid sorbitan esters are preferred from the viewpoint of improving the skincare effect of cannabidiol, providing excellent usability, stability and usability, and ease of handling. Sorbitan fatty acid esters in which the fatty acid is oleic acid are more preferred, and sorbitan sesquioleate is particularly preferred.

[0022] Examples of ether-type nonionic surfactants, which are a type of polyethylene glycol surfactant, include polyoxyethylene alkyl ethers, polyoxyethylene fatty acid esters, polyoxyethylene polyhydric alcohol fatty acid esters, and polyoxyethylene sorbitan fatty acid esters. Among these, tetraoleate sorbeth-30, PEG-20 glyceryl isostearate, laureth-9, polysorbate 60, PEG-40 stearate, polyoxyethylene lauryl ether, polyoxyethylene cetyl ether, polyoxyethylene stearyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitan monostearate, polyoxyethylene sorbitan monooleate, polyoxyethylene oleyl ether, polyoxyethylene behenyl ether, polyoxyethylene polyoxypropylene cetyl ether, and polyoxyethylene polyoxypropylene decyltetradecyl ether are preferred. From the viewpoints of improving solubility, storage stability, ease of handling, improving the skincare effect of cannabidiol, excellent usability, stability, and usability, polyoxyethylene polyhydric alcohol fatty acid esters and polyoxyethylene sorbitan fatty acid esters are preferred, polyoxyethylene polyhydric alcohol fatty acid esters in which the fatty acid is oleic acid are preferred, and tetraoleate sorbeth-30 is particularly preferred.

[0023] In this invention, only one of these nonionic surfactants may be used, or two or more may be used.

[0024] The surfactant content in the topical skin preparation of the present invention is not particularly limited, but is preferably 0.000005% by mass or more, more preferably 0.0001% by mass or more, and is particularly preferred at 0.00005% by mass or more from the viewpoint of obtaining solubility-enhancing effects, transdermal absorption-promoting effects of cannabidiol, cell-activating effects, anti-aging effects, skin roughness-improving effects, skin moisturizing effects, and whitening effects. Furthermore, is preferably 50% by mass or less, more preferably 40% by mass or less, and is particularly preferred at 30% by mass or less from the viewpoint of obtaining solubility-enhancing effects, skin care effects of cannabidiol, excellent usability, stability and usability. When two or more surfactants are used, the surfactant content is the total amount of those surfactants.

[0025] The surfactant content relative to cannabidiol in the topical skin preparation of the present invention is not particularly limited. When the cannabidiol content is set to 1, a ratio of 1:0.005 to 1,000,000 is preferred, more preferably 1:0.01 to 500,000, and particularly preferred from the viewpoint of improving solubility, enhancing the skincare effect of cannabidiol, providing excellent usability, stability, and usability. When two or more nonionic surfactants are used, the surfactant content relative to cannabidiol is the total amount of those surfactants.

[0026] (d) Polyhydric alcohols The topical skin preparation of the present invention is characterized by containing a polyhydric alcohol. The polyhydric alcohol used in the present invention is an organic compound having two or more hydroxyl groups in one molecule. The polyhydric alcohol used in the present invention is not particularly limited as long as it is a polyhydric alcohol that can be applied to the skin, but examples include glycerin; polyglycerins such as diglycerin, triglycerin, and tetraglycerin; dihydric alcohols such as ethylene glycol, 1,3-butylene glycol, 1,4-butylene glycol, propylene glycol, polyethylene glycol, and 1,3-propanediol; sugar alcohols such as erythritol, maltitol, mannitol, sorbitol, and xylitol; and sugars such as sucrose and trehalose. Of these, glycerin, diglycerin, ethylene glycol, 1,3-butylene glycol, 1,4-butylene glycol, propylene glycol, polyethylene glycol, and 1,3-propanediol are preferred from the viewpoint of improving the skincare effect of cannabidiol, providing excellent usability, stability, and ease of use, with glycerin, diglycerin, ethylene glycol, 1,3-butylene glycol, 1,4-butylene glycol, propylene glycol, polyethylene glycol, and 1,3-propanediol being particularly preferred.

[0027] In this invention, only one of these polyhydric alcohols may be used, or two or more may be used.

[0028] The polyhydric alcohol content in the topical skin preparation of the present invention is not particularly limited, but is preferably 0.001% by mass or more, more preferably 0.01% by mass or more, and particularly preferably 0.05% by mass or more from the viewpoint of improving the skin care effect of cannabidiol, providing excellent usability, stability and usability. 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 improving the skin care effect of cannabidiol, providing excellent usability, stability and usability. When two or more polyhydric alcohols are used, the polyhydric alcohol content is the total amount.

[0029] The polyhydric alcohol content relative to cannabidiol in the topical skin preparation of the present invention is not particularly limited. When the cannabidiol content is set to 1, a ratio of 1:0.001 to 10,000,000 is preferred, more preferably 1:0.01 to 100,000, and particularly preferred from the viewpoint of improving the skincare effect of cannabidiol, providing excellent usability, stability, and usability, a ratio of 1:0.05 to 10,000 is preferred.

[0030] (e)Fragrance The topical skin preparation of the present invention is characterized by containing a fragrance. The fragrance used in the present invention is not particularly limited as long as it is an ingredient that can be applied to the skin, but specifically, for example, essential oils extracted from the flowers, leaves, fruit peels, seeds, roots, resins, and woods of natural plants (for example, citrus oils such as orange oil, grapefruit oil, bergamot oil, lemon oil, yuzu oil, lavender oil, ylang-ylang oil, geranium oil, peppermint oil, lemongrass oil, Litsea cubeba fruit oil, spearmint oil, tea tree leaf oil, and basil). Examples of fragrances (scenting agents) include yam oil, geranium oil, bitter orange flower oil, cinnamon leaf oil, cardamom seed oil, clary sage oil, juniper oil, wild rose oil, Roman chamomile flower oil, rosemary leaf oil, etc., and chemically synthesized fragrances (fragrance oils, for example, referring to compounds that have an aromatic scent due to their chemical structure, such as hydrocarbons, alcohols, aldehydes, ketones, esters, lactones, phenols, acetals, etc.).

[0031] The fragrance content in the topical skin preparation 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 especially preferably 0.001% by mass or more. It is also preferably 10% by mass or less, more preferably 5% by mass or less, and especially preferably 2% by mass or less. If two or more fragrances are included, the total amount refers to the total amount of those fragrances.

[0032] The amount of fragrance relative to cannabidiol in the topical skin preparation of the present invention is not particularly limited. When the cannabidiol content is set to 1, a ratio of 1:0.05 to 100,000,000 is preferred, more preferably 1:0.07 to 1000,000, and particularly preferred from the viewpoint of improving the skincare effect of cannabidiol, providing excellent usability, stability, and ease of use.

[0033] The dosage form of the topical skin preparation of the present invention is not particularly limited, but from the viewpoint of enhancing the skin care effect of cannabidiol, excellent usability, stability and usability, and formulation properties, it can take any of the following forms: oily, oil-in-water, water-in-oil, water-in-oil-in-water, or oil-in-water in oil. However, from the viewpoint of enhancing the skin care effect of cannabidiol, excellent usability, stability and usability, an oily topical skin preparation is preferred.

[0034] The topical skin preparation of the present invention is a composition used by applying it to the skin, and there are no particular limitations as long as it is a topical preparation used by applying it to the skin, for example, it can be used as a cosmetic, pharmaceutical, or quasi-drug. When the topical skin preparation of the present invention is a cosmetic or quasi-drug, examples include lotions, serums, creams, emulsions, all-in-one gels, packs, cleansers, soaps, ointments, and bath additives. However, from the viewpoint of cannabidiol's skincare effect enhancement, excellent feel, stability, and usability, it is preferably a lotion, serum, cream, all-in-one gel, emulsion, bath additive, cleanser, or soap, more preferably a lotion, serum, cream, emulsion, or bath additive, and particularly preferably a bath additive.

[0035] When the topical skin preparation of the present invention is a bath additive, the average emulsion particle size when 30 mL of the bath additive is added to 150 L of 40°C bath water and stirred is preferably 0.1 μm to 10 μm, more preferably 0.5 μm to 8 μm, and particularly preferably 0.1 μm to 6 μm, from the viewpoint of exhibiting excellent storage stability. The average emulsion particle size of the bath additive used in the present invention was measured using a microscope (KEYENCE digital microscope VHX-8000; lens used: RZ lens; dual light high magnification zoom lens: VH-Z250R / VH-Z250T).

[0036] When the topical skin preparation of the present invention is a bath additive, the pH when 30 mL of the bath additive is added to 150 L of 40°C bath water and stirred is between 6 and 8. This makes it possible to maintain low irritation and a good skin feel while also providing a good feel to the bath water during bathing. Furthermore, in combination with the above components, it is possible to effectively reduce the size of the emulsified particles and exhibit excellent storage stability. From the viewpoint of effectively enhancing storage stability in combination with the above components, the pH of the bath water emulsified with the liquid bath additive of the present invention at 40°C is 6 or higher, preferably 7 or higher, and more preferably 7.2 or higher.

[0037] In addition to the cannabidiol, oil (20-80% by mass), surfactant, polyhydric alcohol, and fragrance mentioned above, the topical skin preparation of the present invention may contain various active ingredients, pH adjusters, thickeners, fragrances, colorants, antioxidants, antibacterial and antifungal agents, alcohols (excluding polyhydric alcohols), inorganic salts, lubricants, solvents, and other ingredients commonly used in topical skin preparations, as long as they do not impair the effects of the present invention, depending on the application and purpose.

[0038] The following describes some representative components of the topical skin preparation according to the present invention, other than cannabidiol, oils (20-80% by mass), surfactants, polyhydric alcohols, and fragrances.

[0039] The active ingredients used in this invention are not particularly limited, and any drugs or plant extracts used in cosmetics, pharmaceuticals, quasi-drugs, etc., can be used as needed. Typical examples include glycyrrhizic acid or its derivatives, whitening agents such as placental extract, and plant components such as licorice. As for plant components, the whole plant, leaves (leaf blade, petiole, etc.), fruits (mature, immature, etc.), seeds, flowers (petals, ovary, etc.), stems, rhizomes, roots, tubers, etc., can be used after being dried or powdered, but it is common to use extracts obtained by conventional methods using solvents such as water, ethanol, or polyhydric alcohols.

[0040] The topical skin preparation according to the present invention exhibits excellent skincare effects of cannabidiol, and by applying cannabidiol to the skin, it can be used as a cosmetic, pharmaceutical, or quasi-drug for purposes such as skincare, prevention and / or improvement of rough skin, moisturizing the skin, and anti-inflammatory effects. When using the topical skin preparation of the present invention as a cosmetic, pharmaceutical, or quasi-drug, it can be used in a container suitable for storage and use. Examples of containers include plastic, glass, and metal, and are not particularly limited, but a light-shielding container is preferred from the viewpoint of maintaining the stability and shelf life of cannabidiol, and maintaining and improving the action and effects of cannabidiol. [Examples]

[0041] The present invention will be described in more detail below with reference to examples, but the scope of the present invention is not limited to these examples.

[0042] <Preparation of topical skin preparations> The oily topical skin preparation of the present invention was prepared according to the composition shown in Table 1. For Example 1, components (a), (b), and (c) were heated to 80°C while stirring to obtain a mixture. Component (e) and 1,3-butylene glycol (component (d)) were added to the mixture and stirred. After stirring, the mixture was cooled to room temperature to prepare a colorless, transparent oily topical skin preparation. For Example 2, components (a), (b), and (c) were heated to 80°C while stirring and mixing. Then, glycerin component (d) was gradually added in small amounts while stirring and dissolved. After adding component (e) and stirring and mixing, the mixture was cooled to room temperature to prepare a colorless, transparent oily topical skin preparation. For Examples 3 to 5, components (a), (b), and (c) were heated to 80°C while being stirred and mixed, then cooled to room temperature to prepare a colorless, transparent oily topical skin preparation. For Examples 6-10 and Comparative Example 1, components (a), (b), and (c) were heated and mixed at 80°C, then 1,3-butylene glycol (component (d)) was added and mixed, followed by cooling to room temperature to prepare a colorless, transparent oily topical skin preparation. For cannabidiol, we used CBD powder refined from natural sources (CBD content of 99% or more). As ester oils, ethylhexyl palmitate, which is liquid at room temperature (20°C) with an SP value of 17.0, and triethylhexanoin, which is liquid at room temperature (20°C) with an SP value of 18.5, were used. As hydrocarbon oils, mineral oil with an SP value of 22.5 and squalane with an SP value of 16.2 were used. As surfactants, we used sorbeth-30 tetraoleate with an HLB value of 11.5, sorbitan sesquioleate with an HLB value of 4, polysorbate 60 with an HLB value of 15.4, and PEG-20 glyceryl isostearate with an HLB value of 15.4. Glycerin and 1,3-butylene glycol were used as polyhydric alcohols. Synthetic fragrances were used as the flavoring agent.

[0043] [Table 1]

[0044] <Confirmation test of skincare effects> IL-1β, an inflammatory cytokine, is known to increase in response to UV radiation exposure to the skin. By evaluating the suppression of IL-1β gene expression using UV-irradiated human cells, it is possible to assess its anti-inflammatory effects in actual skin. Furthermore, by confirming its anti-inflammatory effects, it is possible to confirm that it also has skincare effects such as preventing and / or improving rough skin and moisturizing the skin. (1) In a 37°C, 5V %CO2 incubator, 75 cm 2 Normal human epidermal keratinocytes (NHEKs) were cultured in flasks using Keratinocyte Growth Medium 2 Kit (KGM-2). (2) Cells suspended by trypsin treatment were seeded at a cell density of 1.0 × 10^4 cells / well in each well of a collagen-coated 96-well plate and pre-cultured for 48 hours in a 37°C, 5V %CO2 incubator. (3) UVB (20 mJ / cm²) into the cells 2 After irradiation with ), the culture medium was removed from each well, and 100 μL / well of culture medium containing the test substance was added. The cultures were then incubated at 37°C in a 5V %CO2 incubator for 6 hours. (4) KGM-2 was used as the culture medium for preparing the test substance, and the total concentration of the test substance in the culture medium was set to 0.01%. (5) After 6 hours of incubation, the culture medium was removed, RNA was recovered using the Rneasy Mini Kit (QIAGEN), and cDNA was synthesized using ReverTra Ace® qPCR RT Master Mix (TOYOBO). (6) The obtained cDNA was used as a template for quantitative real-time PCR using the Rotor-Gene SYBR Green PCR Kit (QIAGEN). (7) The gene expression level of IL-1β was measured using an IL-1β primer (Eurofins Genomics). In addition, as an endogenous control, the gene expression level of ACTB was measured using an ACTB primer (QIAGEN). (8) The relative expression level of IL-1β was calculated with the value of Comparative Example 1 set to 1.

[0045] <Test to confirm user experience> To evaluate the usability of the obtained topical skin preparations, three subjects aged 20-30 were randomly selected. 30 mL of each topical skin preparation was added to 150 L of bath water set at 40°C. Immediately after stirring the bath water, subjects bathed up to their shoulders for 5 or 20 minutes. The usability (moisture after bathing, usability depending on bathing time) was evaluated comprehensively, with the best usability among Comparative Example 1 and Examples 1-10 being rated at 10 points, the worst at 1 point, and the others at a graded level. The average value for each item on the questionnaire was calculated and used as the final evaluation.

[0046] Evaluation Criteria for User Experience 10: Very good (Leaves skin very moisturized after bathing) 9: Very good (Leaves skin very moisturized after bathing) 8: Good (Leaves skin feeling moisturized after bathing) 7: Fairly good (Leaves skin slightly moisturized after bathing) 6: Slightly good (Leaves skin slightly moisturized after bathing) 5: Neither (I feel a slight moisturizing effect after bathing) 4: Slightly bad (I hardly feel any moisturizing effect after bathing) 3: Poor (Doesn't feel moisturized after bathing) 2: Very bad (I don't feel any moisturizing effect after bathing) 1: Very bad (I didn't feel any moisturizing effect after bathing, making it unsuitable for use.)

[0047] Furthermore, the amount of oil transferred to the towel when wiping the skin with a towel after bathing was evaluated based on the following criteria.

[0048] Criteria for evaluating oil transfer to towels ○: No oil transfer △: Slight oil transfer present ×: Oil transfer present

[0049] <Stability confirmation test> To evaluate the stability of the obtained topical skin preparation, 30 mL of the liquid bath agent of each example was filled in a transparent container, sealed, and allowed to stand and store in a thermostat at 40°C for 28 days. The appearance was visually observed and comprehensively evaluated according to the following criteria.

[0050] Evaluation criteria for stability 5: Transparent and uniform 4: Slightly opaque 3: No separation, but opaque 2: Slight separation is observed 1: Separation is observed

[0051] <Confirmation test of usability> 30 mL of the topical skin preparation of each example was put into 150 L of bath water set at 40°C, and the appearance of the bath water when stirred was visually observed and evaluated according to the following criteria.

[0052] Evaluation criteria for usability 5: Emulsifies uniformly into milky white 4: Emulsifies uniformly into slightly turbid to cloudy white 3: Slightly turbid to cloudy white, with a little oil floating on the surface of the bath water 2: Slightly turbid to cloudy white, with oil floating on the surface of the bath water 1: Does not emulsify, colorless and transparent, with oil floating on the surface of the bath water

[0053] <Measurement of emulsion particle size> 30 mL of the liquid bath agent of each example was put into 150 L of bath water set at 40°C, and regarding the average emulsion particle size of the bath water when stirred, it was observed with a microscope (KEYENCE digital microscope VHX-8000. Lens used; RZ lens; Dual light high magnification zoom lens: VH-Z250R / VH-Z250T), and the average particle size of the emulsion particles was measured 3 times. Here, the particle size is the observed particle size by the microscope, the average particle size is the value expressed by the equivalent circle diameter, and it is shown as the range of the 3 measurement results.

[0054] <pH measurement> 30 mL of each liquid bath additive was added to 150 L of bath water set to 40°C, and the pH of the bath water after stirring was evaluated using a pH meter.

[0055] The results of each test are shown in Tables 2 and 3. From the results in Tables 2 and 3, when cannabidiol, 20-80% by mass of an oil, and a surfactant were included, the IL-1β gene expression level was higher compared to when cannabidiol, 19% by mass of an oil, and a surfactant were included. This resulted in superior usability when used as a bath additive, stability of the topical skin preparation, and ease of use as a bath additive. Furthermore, when the surfactants were polysorbate 60 and PEG-20 glyceryl isostearate (Example 6), although the feel of use, such as the moisturizing effect on the skin, was excellent, the entire mixture was not emulsified, some oil separated, and oil adhered to the towel when the skin was dried after bathing. In contrast, when the surfactants were sorbitan sesquioleate, a fatty acid sorbitan ester whose fatty acid is oleic acid, and sorbeth-30 tetraoleate, a polyoxyethylene polyhydric alcohol fatty acid ester whose fatty acid is oleic acid, the inhibitory effect on the gene expression level of IL-1β was high, and the feel of use when used as a bath additive, the stability of the topical skin preparation, and the ease of use as a bath additive were excellent. Therefore, it was found that the topical skin preparation according to the present invention is excellent in the inhibitory effect of cannabidiol on the gene expression of IL-1β, and thus is excellent not only in anti-inflammatory effects, prevention and / or improvement of rough skin, and skin moisturizing effects, but also in the feel of use when used as a bath additive, the stability of the topical skin preparation, and the ease of use as a bath additive.

[0056] [Table 2]

[0057] [Table 3]

[0058] As is clear from the above test results, the present invention provides a topical skin preparation with excellent skincare effects, as well as superior feel, stability, and usability.

[0059] <Manufacturing Examples 1-8> An oily topical skin preparation, specifically a bath additive, was manufactured according to the composition described in Table 4 below. Specifically, components (a), (b), and (c) were stirred and mixed at a predetermined temperature, and then the other components were gradually added and stirred to obtain an oily bath additive. The bath additive obtained using the following formulation example has high skincare efficacy, as well as excellent usability, stability, and ease of use.

[0060] [Table 4]

Claims

1. A topical skin preparation comprising (a) cannabidiol, (b) an oily agent in an amount of 20-80% by mass, and (c) a surfactant.

2. (c) The topical skin preparation according to claim 1, characterized in that the component is a nonionic surfactant.

3. (c) The topical skin preparation according to claim 1, wherein the component is one or more selected from a sorbitan fatty acid ester to which a polyoxyethylene chain is not added and a polyoxyethylene polyhydric alcohol fatty acid ester in which the fatty acid is oleic acid.

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