Emulsion composition

Abstract

[Problem] To provide an emulsion composition that can increase the absorbability of various carotenoids in the body, that is compatible with soft capsules and can be formulated into soft capsules, and that uniformly disperses raw materials including carotenoids and emulsifiers within the soft capsule formulation. [Solution] An emulsion composition containing a carotenoid and two or more predetermined emulsifiers selected from the group consisting of tetraglycerin monooleate, decaglycerin monolaurate, sucrose stearate, and sucrose laurate.

Description

Technical Field

[0001] The present invention relates to an emulsified composition, and more particularly to an emulsified composition containing carotenoids and two or more predetermined emulsifiers selected from the group consisting of tetraglycerin monooleate, decaglycerin monolaurate (decaglyceryl monolaurate), sucrose stearate, and sucrose laurate.

Background Art

[0002] Many poorly soluble bioactive components handled in the fields of health foods, pharmaceuticals, and quasi-drugs have problems in terms of in vivo absorbability. In recent years, carotenoids, which have attracted attention for their high functionality, are also poorly soluble bioactive components with problems in terms of in vivo absorbability, and in order to enhance their in vivo absorbability, they are usually handled in the form of an emulsified composition. Emulsified compositions include an emulsion type in which water and an emulsifier are added to an oil component, a self-emulsifying type or a pre-emulsified type in which an emulsifier is added to an oil component. Generally, since the emulsion type has the property of quickly dissolving in water, it is used in beverages, cosmetics, etc., and the self-emulsifying type and the pre-emulsified type are used in soft capsule preparations (soft gelatin capsule preparations) with limited amounts of water and glycerin.

[0003] A soft capsule preparation is a preparation in which pharmaceuticals, supplements, etc. in the form of powder, liquid, etc. are encapsulated and molded with a capsule film. It is a dosage form suitable for oral ingestion of poorly soluble, peculiarly odorous or bitter, and oxygen- or light-sensitive bioactive components. However, when formulating into a soft capsule preparation, there may be a bias in the raw materials containing the component, and particularly when using a powdery substance such as sucrose fatty acid ester as a raw material, there is a tendency not to disperse uniformly. On the other hand, for carotenoids, although it is possible to formulate into a soft capsule preparation when using a self-emulsifying type or a pre-emulsified type emulsified composition, since the in vivo absorbability is low, the development of an emulsion type emulsified composition that enables soft capsule formulation and has high in vivo absorbability has been desired.

[0004] Conventionally, emulsion compositions have been developed that enhance the absorbability of carotenoids in the body and can be formulated into soft capsules. One example is a fat-reducing agent (Patent Document 1) that contains as an active ingredient a carotenoid-containing composition that includes a crystalline carotenoid, 90% by mass of which is amorphous, and a (poly)glycerin fatty acid ester having 1 to 6 glycerin units, 1 to 6 fatty acid units, and at least one hydroxyl group on the glycerin unit. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent Publication No. 2012-206972 Summary of the Invention [Problem to be solved by the invention]

[0006] However, the emulsion composition of Patent Document 1 is an emulsion composition that enhances the body absorbability of lycopene, a carotenoid, and can be formulated into soft capsules, but is not an emulsion composition that is versatile enough to be used with various carotenoids and that can enhance the body absorbability of various carotenoids and can be formulated into soft capsules.

[0007] The present invention has been made to solve the above-mentioned problems, and aims to provide an emulsion composition that can increase the in vivo absorbability of various carotenoids, is compatible with soft capsules so as to be capable of being formulated into soft capsules, and uniformly disperses raw materials including carotenoids and emulsifiers within the soft capsule formulation. [Means for solving the problem]

[0008] As a result of intensive research, the present inventors have found that an emulsion composition containing a carotenoid and two or more specified emulsifiers selected from the group consisting of tetraglycerol monooleate, decaglycerol monolaurate, sucrose stearate and sucrose laurate can increase the body absorbency of various carotenoids, is compatible with soft capsules and can be formulated into soft capsules, and can uniformly disperse raw materials including carotenoids and emulsifiers within the soft capsule formulation, and have completed the following inventions.

[0009] (1) An emulsion composition containing a carotenoid and any combination of emulsifiers selected from the following (a), (b), (c), (d), (e), (f), (g), (h), (i) and (j); (a) tetraglycerol monooleate and decaglycerol monolaurate, (b) tetraglycerol monooleate and sucrose stearate, (c) tetraglycerol monooleate and sucrose laurate, (d) decaglycerol monolaurate and sucrose laurate, (e) sucrose stearate and sucrose laurate, (f) tetraglycerol monooleate, decaglycerol monolaurate and sucrose stearate, (g) tetraglycerol monooleate, decaglycerol monolaurate and sucrose laurate, (h) tetraglycerol monooleate, sucrose stearate and sucrose laurate, (i) Decaglycerol monolaurate, sucrose stearate and sucrose laurate, (j) Tetraglycerol monooleate, decaglycerol monolaurate, sucrose stearate and sucrose laurate.

[0010] (2) An emulsion composition containing a carotenoid, as well as decaglycerol monolaurate and sucrose stearate, and not containing lecithin.

[0011] (3) The emulsion composition according to (1) or (2), which contains an alcohol; the alcohol here includes, but is not limited to, monohydric alcohols such as methanol and ethanol, dihydric alcohols such as propylene glycol, and (polyhydric) sugar alcohols such as xylitol, sorbitol, lactitol, and erythritol.

[0012] (4) The emulsion composition according to any one of (1) to (3), wherein the carotenoid is one or more selected from the group consisting of lutein, zeaxanthin, astaxanthin, lycopene, β-carotene, γ-carotene, phytofluene, phytoene, canthaxanthin, β-cryptoxanthin, capsanthin, fucoxanthin, and fatty acid esters thereof.

[0013] (5) The emulsion composition according to (4), wherein the astaxanthin is derived from a Haematococcus algae extract.

[0014] (6) The emulsion composition according to any one of (1) to (5), which contains minerals and / or vitamins.

[0015] (7) The emulsion composition according to any one of (1) to (6), which has self-emulsifying properties.

[0016] (8) A soft capsule formulation comprising the emulsion composition according to any one of (1) to (7).

[0017] (9) preparing an aqueous phase by mixing and dissolving at least sucrose stearate and / or sucrose laurate in water; A step of preparing an oil phase by mixing and dissolving at least a carotenoid, and tetraglycerol monooleate and / or decaglycerol monolaurate, and then mixing the aqueous phase and the oil phase to obtain an emulsion composition; The method for producing the emulsion composition according to (1), comprising the steps of:

[0018] (10) preparing an aqueous phase by mixing and dissolving at least sucrose stearate in water; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and one or more fatty acid esters selected from the group consisting of sucrose laurate, tetraglycerol monooleate, and decaglycerol monolaurate, and thereafter, mixing the aqueous phase and the oil phase to obtain an emulsion composition; The method for producing the emulsion composition according to (1), comprising the steps of:

[0019] (11) A step of mixing and dissolving at least sucrose laurate in water to prepare an aqueous phase; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and one or more fatty acid esters selected from the group consisting of sucrose stearate, tetraglycerol monooleate, and decaglycerol monolaurate, and thereafter, mixing the aqueous phase and the oil phase to obtain an emulsion composition; The method for producing the emulsion composition according to (1), comprising the steps of:

[0020] (12) preparing an aqueous phase by mixing and dissolving at least sucrose stearate and sucrose laurate in water; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and an oil and fat, and then mixing the aqueous phase and the oil phase to obtain an emulsion composition; The method for producing the emulsion composition according to (1), comprising the steps of:

[0021] (13) A step of preparing an aqueous phase by mixing and dissolving a water-soluble substance in water as necessary; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and two or more fatty acid esters selected from the group consisting of sucrose stearate, sucrose laurate, tetraglycerol monooleate and decaglycerol monolaurate, and thereafter, mixing water or the aqueous phase and the oil phase to obtain an emulsion composition; The method for producing the emulsion composition according to (1), comprising the steps of:

[0022] (14) A step of mixing and dissolving at least sucrose stearate in water to prepare an aqueous phase; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and decaglycerol monolaurate without mixing and dissolving lecithin, and thereafter mixing the aqueous phase and the oil phase to obtain an emulsion composition; The method for producing the emulsion composition according to (2), comprising the steps of:

[0023] (15) A step of preparing an aqueous phase by mixing and dissolving a water-soluble substance in water as necessary; preparing an oil phase by mixing and dissolving at least a carotenoid, sucrose stearate and decaglycerol monolaurate without mixing and dissolving lecithin; and thereafter, mixing the aqueous phase and the oil phase to obtain an emulsion composition; The method for producing the emulsion composition according to (2), comprising the steps of:

[0024] (16) The method for producing the emulsion composition according to any one of (9) to (15), comprising a step of adding and mixing an alcohol in at least any one of the steps of preparing the aqueous phase, preparing the oil phase, mixing the aqueous phase and the oil phase, and mixing the aqueous phase and the oil phase.

[0025] (17) preparing an aqueous phase by mixing and dissolving at least sucrose stearate and / or sucrose laurate in water; A step of preparing an oil phase by mixing and dissolving at least a carotenoid, and tetraglycerol monooleate and / or decaglycerol monolaurate, and then mixing the aqueous phase and the oil phase to obtain the emulsion composition described in (1); and then A step of encapsulating the contents containing the emulsion composition in a soft capsule shell; A method for producing a soft capsule formulation comprising the steps of:

[0026] (18) A step of mixing and dissolving at least sucrose stearate in water to prepare an aqueous phase; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and one or more fatty acid esters selected from the group consisting of sucrose laurate, tetraglycerol monooleate, and decaglycerol monolaurate, and thereafter, mixing the aqueous phase and the oil phase to obtain the emulsion composition described in (1); and then A step of encapsulating the contents containing the emulsion composition in a soft capsule shell; A method for producing a soft capsule formulation comprising the steps of:

[0027] (19) A step of mixing and dissolving at least sucrose laurate in water to prepare an aqueous phase; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and one or more fatty acid esters selected from the group consisting of sucrose stearate, tetraglycerol monooleate, and decaglycerol monolaurate, and thereafter, mixing the aqueous phase and the oil phase to obtain the emulsion composition described in (1); and then A step of encapsulating the contents containing the emulsion composition in a soft capsule shell; A method for producing a soft capsule formulation comprising the steps of:

[0028] (20) preparing an aqueous phase by mixing and dissolving at least sucrose stearate and sucrose laurate in water; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and an oil and fat, and then mixing the aqueous phase and the oil phase to obtain the emulsion composition described in (1); and then A step of encapsulating the contents containing the emulsion composition in a soft capsule shell; A method for producing a soft capsule formulation comprising the steps of:

[0029] (21) A step of preparing an aqueous phase by mixing and dissolving a water-soluble substance in water as necessary; A step of preparing an oil phase by mixing and dissolving at least a carotenoid and two or more fatty acid esters selected from the group consisting of sucrose stearate, sucrose laurate, tetraglycerol monooleate and decaglycerol monolaurate, and thereafter, A step of mixing water or the aqueous phase and the oil phase to obtain the emulsion composition described in (1), and thereafter, A step of encapsulating the contents containing the emulsion composition in a soft capsule shell; A method for producing a soft capsule formulation comprising the steps of:

[0030] (22) A step of mixing and dissolving at least sucrose stearate in water to prepare an aqueous phase; preparing an oil phase by mixing and dissolving at least a carotenoid and decaglycerol monolaurate without mixing and dissolving lecithin; and thereafter, mixing the aqueous phase and the oil phase to obtain the emulsion composition described in (2); and then A step of encapsulating the contents containing the emulsion composition in a soft capsule shell; A method for producing a soft capsule formulation comprising the steps of:

[0031] (23) A step of preparing an aqueous phase by mixing and dissolving a water-soluble substance in water as necessary; preparing an oil phase by mixing and dissolving at least a carotenoid, sucrose stearate and decaglycerol monolaurate without mixing and dissolving lecithin; and thereafter, mixing the aqueous phase and the oil phase to obtain the emulsion composition described in (2); and then A step of encapsulating the contents containing the emulsion composition in a soft capsule shell; A method for producing a soft capsule formulation comprising the steps of:

[0032] (24) The method for producing a soft capsule formulation according to any one of (17) to (23), comprising a step of adding and mixing an alcohol in at least any one of the steps of preparing the aqueous phase, preparing the oily phase, mixing the aqueous phase and the oily phase, and mixing the aqueous phase and the oily phase.

[0033] (25) Use of a carotenoid and any combination of the following emulsifiers (a), (b), (c), (d), (e), (f), (g), (h), (i), and (j) as an emulsion composition; (a) tetraglycerol monooleate and decaglycerol monolaurate, (b) tetraglycerol monooleate and sucrose stearate, (c) tetraglycerol monooleate and sucrose laurate, (d) decaglycerol monolaurate and sucrose laurate, (e) sucrose stearate and sucrose laurate, (f) tetraglycerol monooleate, decaglycerol monolaurate and sucrose stearate, (g) tetraglycerol monooleate, decaglycerol monolaurate and sucrose laurate, (h) tetraglycerol monooleate, sucrose stearate and sucrose laurate, (i) Decaglycerol monolaurate, sucrose stearate and sucrose laurate, (j) Tetraglycerol monooleate, decaglycerol monolaurate, sucrose stearate and sucrose laurate.

[0034] (26) Use of a carotenoid, and an emulsifier comprising decaglycerol monolaurate and sucrose stearate as an emulsion composition, wherein the emulsion composition does not contain lecithin.

[0035] (27) Use of an emulsion composition containing a carotenoid and any combination of emulsifiers selected from the following (a), (b), (c), (d), (e), (f), (g), (h), (i) and (j) as a soft capsule formulation; (a) tetraglycerol monooleate and decaglycerol monolaurate, (b) tetraglycerol monooleate and sucrose stearate, (c) tetraglycerol monooleate and sucrose laurate, (d) decaglycerol monolaurate and sucrose laurate, (e) sucrose stearate and sucrose laurate, (f) tetraglycerol monooleate, decaglycerol monolaurate and sucrose stearate, (g) tetraglycerol monooleate, decaglycerol monolaurate and sucrose laurate, (h) tetraglycerol monooleate, sucrose stearate and sucrose laurate, (i) Decaglycerol monolaurate, sucrose stearate and sucrose laurate, (j) Tetraglycerol monooleate, decaglycerol monolaurate, sucrose stearate and sucrose laurate.

[0036] (28) Use of an emulsion composition comprising a carotenoid, decaglycerol monolaurate and sucrose stearate as a soft capsule formulation, wherein the emulsion composition does not contain lecithin. Effect of the Invention

[0037] The emulsion composition of the present invention can increase the absorbability of various carotenoids in the body, and has good compatibility with soft capsules, making it possible to formulate it into a soft capsule, and it can also uniformly disperse raw materials including carotenoids and emulsifiers within the soft capsule formulation. [Brief description of the drawings]

[0038]

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Figure 6

[0039] The emulsion composition according to the present invention and its production method are described in detail below. The emulsion composition according to the present invention contains a carotenoid and two or more predetermined emulsifiers selected from the group consisting of tetraglycerin monooleate, decaglycerin monolaurate (decaglyceryl monolaurate), sucrose stearate, and sucrose laurate.

[0040] Carotenoids are a group of compounds that are a type of terpenoid, and are a general term for aliphatic or alicyclic polyenes that are yellow to red pigments (carotenoid pigments) and contain many conjugated double bonds.

[0041] The carotenoids that can be used in the present invention can be selected within a range that does not impair the characteristics of the present invention, and are not particularly limited. Examples of such carotenoids include hydrocarbons (carotenes) and their oxidized alcohol derivatives (xanthophylls). More specifically, actinioerythrol, bixin, canthaxanthin, capsanthin, capsorubin, β-8'-apo-carotenal (apocarotenal), β-12'-apo-carotenal, α-carotene, β-carotene, carotene (mixture of α- and β-carotenes), γ-carotene, β -cryptoxanthin, lutein, lycopene, violeritrin, zeaxanthin, fucoxanthin, phytoene, phytofluene, 3,4,3',4'-tetradehydrolycopene, tolulene, diaponurosporene, diapolicopen, diapolicopen dial, staphyloxanthin, crocetin, adonirubin, adonixanthin, echinenone, asteroidenone, 3-hydroxyechinenone, etc., and in the present invention, esters (fatty acid esters) and glycosides of those containing hydroxyl or carboxyl groups are also included in the carotenoids. In addition, the carotenoids of the present invention are not limited to those of natural origin, and synthetic products obtained according to a conventional method are also included in the carotenoids of the present invention.

[0042] Of these carotenoids, one or more selected from the group consisting of lutein, zeaxanthin, astaxanthin, lycopene, β-carotene, γ-carotene, phytofluene, phytoene, canthaxanthin, β-cryptoxanthin, capsanthin, fucoxanthin, and fatty acid esters thereof are preferred, and one or more selected from lutein, zeaxanthin, astaxanthin, and fatty acid esters thereof are more preferred.

[0043] Lutein (β,ε-carotene-3,3'-diol) is known to be found in green and yellow vegetables such as spinach, kale, and Japanese mustard spinach, or in the form of lutein fatty acid esters in fruits such as oranges, peaches, papayas, prunes, and mangoes, as well as in many flowers and vegetables, especially marigold petals. It is found in large amounts in the macula of the retina and is thought to act as a defense against light, and it has been reported that it protects the macula and helps prevent age-related macular degeneration. It has also been confirmed to have antioxidant activity, including singlet oxygen scavenging activity, and cancer prevention effects.

[0044] Lutein that can be used in the present invention can be selected within a range that does not impair the characteristics of the present invention, and is not particularly limited, but examples of such lutein include those derived from natural products such as the above-mentioned green and yellow vegetables, flowers, and vegetables, as well as artificially produced lutein and lutein obtained by genetic recombination. In addition, it may be a commercially available product or may be in the form of a pharmacologically acceptable salt.

[0045] Zeaxanthin (4-[18-(4-hydroxy-2,6,6-trimethyl-1-cyclohexenyl)-3,7,12,16-tetramethyl-octadeca-1,3,5,7,9,11,13,15,17-nonenyl]-3,5,5-trimethyl-3-cyclohexen-1-ol) is a fat-soluble substance similar to β-carotene and a structural isomer of lutein. Zeaxanthin, like lutein, is found in large amounts in the macula, and is said to protect the macula in the same way as lutein.

[0046] Zeaxanthin that can be used in the present invention can be selected within a range that does not impair the characteristics of the present invention, and is not particularly limited, but examples of such zeaxanthin include those derived from natural products such as plants such as corn, egg yolk, and animal fat, as well as artificially produced products and those obtained by genetic recombination. In addition, it may be a commercially available product or may be in the form of a pharmacologically acceptable salt.

[0047] Astaxanthin (3,3'-dihydroxy-β,β-carotene-4,4'-dione) is a red pigment that is widely distributed in nature, especially in the ocean, and is widely consumed in crustaceans such as shrimp and crabs, fish such as salmon and sea bream, algae such as green algae Haematococcus, and yeasts such as red yeast Phaffia. Astaxanthin is known to have a strong antioxidant effect, about 1,000 times that of vitamin E and about 40 times that of β-carotene, and has bioactivities such as antioxidant effects, anti-inflammatory effects, skin anti-aging effects, and whitening effects, and is also known as a pigment in the yellow to red range. Astaxanthin exists in three isomers, 3S,3'S, 3S,3'R (meso), and 3R,3'R, depending on the configuration of the hydroxyl groups at the 3 (3') positions of the ring structure at both ends of the molecule. In addition, there are also geometric isomers with cis and trans conjugated double bonds in the center of the molecule. For example, there are all-trans-, 9-cis and 13-cis isomers. Furthermore, the hydroxyl group at the 3(3') position can form esters with fatty acids.

[0048] Astaxanthin is also known to be a highly safe compound with no observed mutagenicity, and is widely used as a food additive (Takahashi Jiro et al.: Toxicity test of astaxanthin from Haematococcus algae - Ames test, single-dose toxicity test in rats, 90-day repeated oral dose toxicity test in rats - Clinical Medicine, 20:867-881, 2004).

[0049] Astaxanthin in the present invention includes free astaxanthin and / or its ester derivatives. In addition, astaxanthin esters include monoesters and / or diesters. For example, astaxanthin obtained from Haematococcus pluvialis is known to be a 3S,3'S form, and contains a large amount of monoesters with one fatty acid bonded (Renstrom, B. et.al., Fatty acids of some esterified carotenols, Comp. Biochem. Physiol. B, Comp. Biochem., 1981, 69, p. 625-627). On the other hand, astaxanthin obtained from krill is known to contain a large amount of diesters in which two fatty acids are bonded (Yamaguchi, K. et. al., The composition of carotenoid pigments in the Antarctic krill Euphausia superba, Bull. Jap. Sos. Sci. Fish., 1983, 49, p. 1411-1415).

[0050] Astaxanthin obtained from Phaffia rhodozyma is known to be a 3R,3'R form (Andrewes, A. Get. al., (3R,3'R)-Astaxanthin from the yeast Phaffia rhodozyma, Phytochem., 1976, 15, p.1009-1011), which has the opposite structure to the 3S,3'S form usually found in nature. It is a non-esterified form that does not form an ester with fatty acids, that is, it exists as a free form (Andrewes, A. Get. al., Carotenids of Phaffia rhodozyma, a red pigmented fermenting yeast, Phytochem., 1976, 15, p.1003-1007).

[0051] The astaxanthin that can be used in the present invention can be selected within a range that does not impair the characteristics of the present invention, and is not particularly limited. Examples of such astaxanthin include natural astaxanthin and synthetic astaxanthin. Examples of natural astaxanthin include astaxanthin-containing extracts obtained from algae such as Haematococcus; yeasts such as Phaffia; crustaceans such as shrimp, krill, and crab; cephalopods such as squid and octopus; various seafood; plants such as Adonis; bacteria such as Paracoccus sp.N81106, Brevundimonas sp.SD212, and Erythrobacter sp.PC6; actinomycetes such as Gordonia sp.KANMONKAZ-1129; labyrinthulae such as Schizochytriuym sp.KH105; and genetically modified organisms that produce astaxanthin. Examples of natural astaxanthin include astaxanthin-containing extracts obtained from microal ... Examples of synthetic astaxanthin include AstaSana (manufactured by DSM), Lucantin Pink (registered trademark; manufactured by BASF), etc. Examples of synthetic astaxanthin obtained by chemically converting other naturally occurring carotenoids include AstaMarine (manufactured by PIVEG), etc.

[0052] Examples of Haematococcus algae from which natural astaxanthin can be obtained include Haematococcus pluvialis, Haematococcus lacustris, Haematococcus capensis, Haematococcus deroebakensis, and Haematococcus zimbabwiensis.

[0053] As a method for culturing these Haematococcus green algae, a closed culture method is preferred in which there is no contamination or growth of heterologous microorganisms and there is little contamination of other impurities. Such culture methods include, for example, a culture method using a culture medium having a partially open dome shape, conical shape, or cylindrical shape culture device and a gas discharge device movable within the device (International Publication No. 1999 / 050384 pamphlet), a method of applying a drying stress to Haematococcus algae to induce cyst formation of the algae and collecting astaxanthin from the culture of the cyst-formed algae (Japanese Patent Laid-Open No. 8-103288), a method of culturing by placing a light source in a closed culture device and irradiating light from the inside, and a method using a flat culture tank or a tube-shaped culture layer.

[0054] Also, the astaxanthin that can be used in the present invention is, for example, the above-mentioned Haematococcus algae, and if necessary, the cell wall is disrupted according to the method disclosed in Japanese Patent Laid-Open No. 5-068585 and the like, and an organic solvent such as acetone, ether, chloroform, and alcohol (ethanol, methanol, etc.) or an extraction solvent / solvent such as supercritical carbon dioxide is added for extraction to obtain an astaxanthin-containing extract, or the astaxanthin-containing extract may be appropriately purified if necessary. The astaxanthin content of the astaxanthin-containing extract is preferably 3 to 40% (w / w), more preferably 3 to 12% (w / w), and even more preferably 5 to 10% (w / w).

[0055] Astaxanthin that can be used in the present invention includes commercially available products. Examples of such commercially available products include the AstaReal, Astavita, and Astamate series, such as AstaReal Oil 200SS, AstaReal L10, AstaReal Oil 50F, AstaReal Oil 50FC, AstaReal Oil 5F, AstaReal P2AF, AstaTROL-X, AstaReal Oil 50FC, AstaReal Powder 20F, Water-soluble AstaReal Liquid, AstaReal WS Liquid, AstaReal 10WS Liquid, AstaReal ACT, Astavita e, Astavita Sports, and Astamate (all registered trademarks; manufactured by AstaReal Co., Ltd. and Fuji Chemical Industry Co., Ltd.); the ASTOTS series, such as ASTOTS-S, ASTOTS-10O, ASTOTS-ECS, ASTPTS-2.0PW, and ASTOTS-3.0MB (all registered trademarks; manufactured by Fuji Film Co., Ltd.); BioAstin (registered trademark; manufactured by Cyanotec Corporation); and Astazine TM (manufactured by BGG Japan); astaxanthin powder 1.5%, astaxanthin powder 2.5%, astaxanthin oil 5%, astaxanthin oil 10% (manufactured by Bioactives Japan); astaxanthin (manufactured by Oryza Oil & Fat Chemical Co., Ltd.); Sunactive AX (registered trademark; manufactured by Taiyo Kagaku Co., Ltd.); Haematococcus WS30 (manufactured by Yaegaki Fermentation Engineering Co., Ltd.); AstaMarine (manufactured by PIVEG), etc.

[0056] AstaReal Oil 200SS, AstaReal Oil 50FC, AstaReal P2AF, AstaTROL-X, AstaReal Oil 50FC and AstaReal Powder 20F manufactured by AstaReal and Fuji Chemical Industry Co., Ltd. are each "Halal certified," and AstaReal Oil 50FC, AstaReal P2AF, AstaTROL-X, AstaReal Oil 50FC and AstaReal Powder 20F manufactured by AstaReal and Fuji Chemical Industry Co., Ltd. are each "Kosher" certified. Furthermore, AstaReal L10 is Non-GMO (non-genetically modified) certified.

[0057] Next, the emulsion composition according to the present invention contains any combination of emulsifiers (polyglycerol fatty acid ester and / or sucrose fatty acid ester) selected from the following (a), (b), (c), (d), (e), (f), (g), (h), (i) and (j); (a) tetraglycerol monooleate and decaglycerol monolaurate (decaglyceryl monolaurate), (b) tetraglycerol monooleate and sucrose stearate, (c) tetraglycerol monooleate and sucrose laurate, (d) decaglycerol monolaurate and sucrose laurate, (e) sucrose stearate and sucrose laurate, (f) tetraglycerol monooleate, decaglycerol monolaurate and sucrose stearate, (g) tetraglycerol monooleate, decaglycerol monolaurate and sucrose laurate, (h) tetraglycerol monooleate, sucrose stearate and sucrose laurate, (i) Decaglycerol monolaurate, sucrose stearate and sucrose laurate, (j) Tetraglycerol monooleate, decaglycerol monolaurate, sucrose stearate and sucrose laurate.

[0058] The tetraglycerol monooleate, decaglycerol monolaurate, sucrose stearate and sucrose laurate that can be used in the present invention are commercially available products. Examples of such commercially available products include SY Glyster FMO-3S (manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) for tetraglycerol monooleate, NIKKOL DECAGLYN 1-L (manufactured by Nikko Chemicals Co., Ltd.) and Ryoto Polyglycerol L-10D (manufactured by Mitsubishi Chemical Foods Co., Ltd.) for decaglycerol monolaurate, and SY Glyster FMO-3S (manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) for decaglycerol monolaurate. Examples of sucrose stearate esters include Ryoto Sugar Esters (S-070, S-170, S-270, S-370, S-370F, S-570, S-770, S-970, S-1170, S-1170F, S-1570, S-1670; manufactured by Mitsubishi Chemical Foods Corporation) and DK Ester SS (manufactured by Daiichi Kogyo Seiyaku Co., Ltd.); and examples of sucrose laurate esters include Ryoto Sugar Esters (L-195, L-595, L-1695, LWA-1570; manufactured by Mitsubishi Chemical Foods Corporation) and DK Ester S-L18A (manufactured by Daiichi Kogyo Seiyaku Co., Ltd.).

[0059] The emulsion composition according to the present invention may contain polyglycerol fatty acid esters other than tetraglycerol monooleate and / or decaglycerol monolaurate. Such polyglycerol fatty acid esters can be selected within a range that does not impair the characteristics of the present invention, and are not particularly limited. Examples of such polyglycerol fatty acid esters include esters of polyglycerol having an average polymerization degree of 2 or more with, for example, citric acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, pentastearic acid, monoisostearic acid, diisostearic acid, pentaisostearic acid, and pentaoleic acid, and more specifically, hexaglycerol monooleate. Glycerin, hexaglycerin monostearate, hexaglycerin monopalmitate, hexaglycerin monomyristate, hexaglycerin monolaurate, decaglycerin monooleate, decaglycerin monostearate, decaglycerin monopalmitate, decaglycerin monomyristate, decaglycerin monolaurate, glycerin stearate citrate, decaglycerin distearate, tetraglycerin monostearate, tetraglycerin tristearate Examples of the polyglycerol fatty acid ester include hexaglycerol monooleate, hexaglycerol monolaurate, hexaglycerol monomyristate, hexaglycerol monostearate, hexaglycerol tristearate, hexaglycerol monopalmitate, decaglycerol monomyristate, decaglycerol monostearate, decaglycerol monolaurate, decaglycerol monopalmitate, decaglycerol distearate, decaglycerol trioleate, decaglycerol tristearate, decaglycerol pentastearate, decaglycerol monoisostearate, decaglycerol diisostearate, decaglycerol pentaisostearate, and decaglycerol pentaoleate. The polyglycerol fatty acid ester may include one or more polyglycerol fatty acid esters selected from the group consisting of these polyglycerol fatty acid esters.

[0060] The emulsion composition according to the present invention may contain sucrose fatty acid esters other than sucrose stearate and / or sucrose laurate. Such sucrose fatty acid esters can be selected within the scope of the present invention without impairing the characteristics of the present invention, and are not particularly limited, but are preferably those with high hydrophilicity and excellent water dispersibility, and examples thereof include those in which a fatty acid having 6 to 22 carbon atoms is ester-bonded to one or more hydroxyl groups of sucrose, more specifically, sucrose myristic acid ester, sucrose palmitic acid ester, sucrose oleic acid ester, sucrose erucic acid ester, etc., and one or more sucrose fatty acid esters selected from the group consisting of these sucrose fatty acid esters may be included.

[0061] Furthermore, the emulsion composition according to the present invention may contain an emulsifier other than the polyglycerol fatty acid ester and / or sucrose fatty acid ester described above. Such an emulsifier can be selected within a range that does not impair the characteristics of the present invention, and is not particularly limited. For example, various emulsifiers that have been used in foods and beverages can be mentioned, and specifically, fatty acid monoglycerides, fatty acid diglycerides, fatty acid triglycerides, propylene glycol fatty acid esters, lecithin, chemically modified starch, sorbitan fatty acid esters, succinic acid fatty acid esters, Quillaja extract, gum arabic, tragacanth gum, guar gum, karaya gum, xanthan gum, pectin, alginic acid and its salts, carrageenan, gelatin, casein, saponin, sterol, etc. can be mentioned, and one or more emulsifiers selected from the group consisting of these emulsifiers can be included.

[0062] However, when the emulsion composition according to the present invention contains decaglycerol monolaurate and sucrose stearate, it does not contain lecithin.

[0063] Next, the emulsion composition according to the present invention may contain alcohol. Such alcohol can be selected within a range that does not impair the characteristics of the present invention, and is not particularly limited, but examples thereof include lower alcohols, higher alcohols, and polyhydric alcohols. More specifically, monohydric alcohols include ethanol, propanol, isopropanol, isobutyl alcohol, and t-butyl alcohol; dihydric alcohols include ethylene glycol, propylene glycol, trimethylene glycol, 1,2-butylene glycol, 1,3-butylene glycol, tetramethylene glycol, 2,3-butylene glycol, pentamethylene glycol, 2-butene-1,4-diol, hexylene glycol, and octylene glycol; trihydric alcohols include glycerin and trimethylolpropane; tetrahydric alcohols include pentaerythritol such as 1,2,6-hexanetriol; and pentahydric alcohols include glycerin and trimethylolpropane. As hexahydric alcohols, sorbitol, mannitol, etc.; as polyhydric alcohol polymers, diethylene glycol, dipropylene glycol, triethylene glycol, polypropylene glycol, tetraethylene glycol, diglycerin, polyethylene glycol, triglycerin, tetraglycerin, polyglycerin, etc.; as higher alcohols, batyl alcohol, cetanol, palmitoleic alcohol, heptadecanol, 1-heptadecanol, stearyl alcohol, isostearyl alcohol, elaidyl alcohol, oleyl alcohol, linoleyl alcohol, elaidyl linoleyl alcohol, linolenyl alcohol, elaidyl linoleyl alcohol, ricinoleyl alcohol, nonadecyl alcohol, arachidyl alcohol, heneicosanol, behenyl alcohol, erucyl alcohol, etc.;As dihydric alcohol alkyl ethers, ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, ethylene glycol monophenyl ether, ethylene glycol monohexyl ether, ethylene glycol mono-2-methylhexyl ether, ethylene glycol isoamyl ether, ethylene glycol benzyl ether, ethylene glycol isopropyl ether, ethylene glycol dimethyl ether, ethylene glycol diethyl ether, ethylene glycol dibutyl ether, diethylene glycol monomethyl ether, diethylene glycol monoethyl ether, diethylene glycol monobutyl ether, diethylene glycol dimethyl ether, diethylene glycol diethyl ether, diethylene glycol butyl ether, diethylene glycol methyl ethyl ether, triethylene glycol monomethyl ether, triethylene glycol monoethyl ether, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol monobutyl ether, propylene glycol isopropyl ether, dipropylene glycol methyl ether, dipropylene glycol ethyl ether, dipropylene glycol butyl ether, etc.; as dihydric alcohol ether esters, ethylene glycol monomethyl ether acetate, ethylene glycol monoethyl ether acetate, ethylene glycol monobutyl ether acetate, ethylene glycol monophenyl ether acetate, ethylene glycol diadipate, ethylene glycol disuccinate, diethylene glycol monoethyl ether acetate, diethylene glycol monobutyl ether acetate, propylene glycol monomethyl ether acetate, propylene glycol monoethyl ether acetate, propylene glycol monopropyl ether acetate, propylene glycol monophenyl ether acetate, etc.; glycerin monoalkyl ether; as sugar alcohols, sorbitol, maltitol, maltotriose, mannitol, sucrose, erythritol, glucose, fructose, starch hydrolyzate, maltose, xylitol, starch hydrolyzate reduced alcohol, etc.;Glysolid; As other alcohols such as tetrahydrofurfuryl alcohol, POE-tetrahydrofurfuryl alcohol, POP-butyl ether, POP·POE-butyl ether, tripolyoxypropylene glycerin ether, POP-glycerin ether, POP-glycerin ether phosphate, POP·POE-pentaerythritol ether, etc. can be mentioned, and one or more alcohols selected from the group consisting of these alcohols can be included, but those that enhance the uniformity of the emulsifier are preferred. Specifically, monohydric alcohols such as methanol and ethanol, dihydric alcohols such as propylene glycol, and sugar alcohols such as xylitol, sorbitol, lactitol, and erythritol are more preferred.;

[0064] Next, the emulsified composition according to the present invention may contain minerals. Such minerals can be selected within a range that does not impair the characteristics of the present invention and are not particularly limited. For example, as food additives represented by organic acid salts, inorganic acid salts, chemically synthesized products, etc., minerals derived from food materials such as various food extracts and yeasts can be mentioned. More specifically, calcium, phosphorus, copper, zinc, manganese, chromium, molybdenum, selenium, iron, sodium, potassium, magnesium, iodine, sodium phosphate, sodium hydrogen phosphate, sodium citrate, potassium phosphate, etc. can be mentioned, and one or more minerals selected from the group consisting of these minerals can be included, but minerals derived from yeasts such as zinc yeast and the same yeast are preferred.

[0065] Next, the emulsion composition according to the present invention may contain vitamins. Such vitamins can be selected within a range that does not impair the characteristics of the present invention, and are not particularly limited, but can include various fat-soluble vitamins and water-soluble vitamins, specifically, vitamin A such as retinol, retinal, retinoic acid, and its derivatives; vitamin D such as ergocalciferol, cholecalciferol; vitamin E such as tocopherol, tocotrienol; vitamin K such as phylloquinone, menaquinone; vitamin B1 such as thiamine hydrochloride; vitamin B2 such as riboflavin, flavin adenine dinucleotide; niacins such as nicotinic acid and nicotinamide; pantothenic acid, calcium pantothenate, pantothenyl alcohol (panthenol). pantothenic acids such as; vitamin B6s such as pyridoxine, pyridoxal, and pyridoxamine; biotins such as biotin and biocytin; folates such as folic acid; vitamin B12s such as cyanocobalamin; vitamin Cs (ascorbic acid and its derivatives) such as sodium ascorbyl phosphate, magnesium ascorbyl phosphate, ascorbyl glucoside, and ascorbyl tetra-2-hexyldecanoate; and other vitamin-like factors such as carnitine, ferulic acid, orotic acid, and γ-oryzanol. One or more vitamins selected from the group consisting of these vitamins may be included, but vitamin C and vitamin E are preferred.

[0066] Next, the emulsion composition according to the present invention may contain fats and oils as fat-soluble components. Such fats and oils can be selected within a range that does not impair the characteristics of the present invention, and are not particularly limited, but examples thereof include fats and oils that are liquid at room temperature, solid fats and oils, and mixtures thereof. Examples of liquid fats and oils include olive oil, camellia oil, macadamia nut oil, castor oil, avocado oil, evening primrose oil, turtle oil, corn oil, mink oil, rapeseed oil, egg yolk oil, sesame oil, persic oil, wheat germ oil, sasanqua oil, linseed oil, safflower oil, cottonseed oil, perilla oil, soybean oil, peanut oil, tea seed oil, kaya oil, rice bran oil, Chinese giri oil, Japanese tung oil, jojoba oil, germ oil, glycerin trioctanoate, glycerin triisopalmiate, salad oil, safflower oil (vegetable oil, sesame oil, perilla oil, wheat germ oil, sasanqua oil, linseed oil, safflower oil (vegetable oil, sesame oil, perilla oil, wheat germ oil, sesame ... Examples of the solid fats and oils include beef tallow, hardened beef tallow, beef leg fat, beef bone fat, mink oil, egg yolk oil, lard, horse fat, mutton tallow, hardened oil, cacao butter, coconut oil, hardened coconut oil, palm oil, hardened palm oil, Japan wax, Japan wax kernel oil, and hardened castor oil, and the oil and oil mixture may include one or more fats and oils selected from the group consisting of these fats and oils.

[0067] Furthermore, as the fat, a medium-chain fatty acid triglyceride is preferably used. A medium-chain fatty acid glyceride refers to a lipid formed by esterifying glycerol with a saturated fatty acid having 6 to 12 carbon atoms, specifically, any one of caproic acid, caprylic acid, capric acid, and lauric acid. The number of these fatty acids esterified with glycerol may be any one of 1 to 3, or a mixture of these. That is, any one of monoglycerides, diglycerides, and triglycerides may be used, or a mixture of these. Oils containing a large amount of unsaturated fatty acids (such as olive oil and safflower oil) are liquid at room temperature, while oils containing a large amount of saturated fatty acids (such as coconut oil and palm oil) are solid. Since medium-chain fatty acid glycerides are contained in, for example, the palm oil and coconut oil, these are also preferably used. When using a Haematococcus algae extract containing 18% by weight or more of astaxanthin, stable micelles can be formed by blending the above-mentioned fat.

[0068] Next, the emulsion composition according to the present invention may contain a radical scavenger. A radical scavenger is an additive that suppresses the generation of radicals and captures the generated radicals as quickly as possible to break the chain reaction (source: "Oil Chemistry Handbook, 4th Edition," edited by Japan Oil Chemists' Society, 2001). A known direct method for confirming the function as a radical scavenger is to mix it with a reagent and measure the radical scavenging state using a spectrophotometer or ESR (electron spin resonance).

[0069] Compounds that can be used as radical scavengers can be selected within the scope of the present invention without impairing the characteristics of the present invention, and are not particularly limited. Examples of compounds that can be used as radical scavengers include those described in "Theory and Practice of Antioxidants (by Kajimoto, Sanshobo, 1984)" and "Antioxidant Handbook (by Saruwatari et al., Taiseisha, 2002)." Among the various antioxidants described in "Antioxidants for Chemical Substances, Vol. 1, No. 1976," any antioxidant that functions as a radical scavenger may be used. Specific examples of the antioxidant include compounds having a phenolic hydroxyl group; amine compounds such as phenylenediamines, such as diphenyl-p-phenylenediamine and 4-amino-p-diphenylamine; ascorbic acid; and oil-soluble derivatives of erythorbic acid. Examples of the compound having a phenolic hydroxyl group include guaiac oil; nordihydroguaiaretic acid (NDGA); gallic acid esters, such as propyl gallate, butyl gallate, and octyl gallate; BHT (butylhydroxytoluene); BHA (butylhydroxyanisole); tocopherols, such as mixed tocopherol; and bisphenols. The antioxidant may include one or more compounds selected from the group consisting of these compounds that can be used as radical scavengers, and tocopherols are preferred.

[0070] Next, the emulsion composition according to the present invention may contain a polyol. Such a polyol can be selected within a range that does not impair the characteristics of the present invention, and is not particularly limited. Examples of the polyol include polyols that have a viscosity adjusting function, as well as polyols that reduce the interfacial tension between water and oil and fat components, making the interface easier to spread and facilitating the formation of a stable emulsion composition. More specifically, the polyols include glycerin, diglycerin, triglycerin, polyglycerin, 3-methyl-1,3-butanediol, 1,3-butylene glycol, isoprene glycol, polyethylene glycol, 1,2-pentanediol, 1,2-hexanediol, propylene glycol, dipropylene glycol, polypropylene glycol, ethylene glycol, diethylene glycol, pentaerythritol, neopentyl glycol, maltitol, reduced starch syrup, fructose, glucose, sucrose, lactose, and the like. Examples of polyols include dihydric or higher alcohols such as maltose, palatinite, erythritol, sorbitol, mannitol, xylitol, xylose, glucose, lactose, mannose, maltose, galactose, fructose, inositol, pentaerythritol, maltotriose, sorbitol, sorbitan, trehalose, starch hydrolysis sugar, and starch hydrolysis sugar reduced alcohol. These polyols may be used alone or in combination of two or more types, but one or more types selected from glycerin, diglycerin, propylene glycol, ethylene glycol, 1,3-butylene glycol, polyethylene glycol, sorbitol, mannitol, dipropylene glycol, and sorbitan are preferred, and it is more preferred that the polyol contains at least glycerin.

[0071] Next, the emulsion composition of the present invention may contain water. The water is not particularly limited as long as it is used in foods, medicines, and cosmetics, and for example, purified water, pure water, ion-exchanged water, alkaline ionized water, deep sea water, vibration water, natural water, etc. can be used.

[0072] Furthermore, the emulsion composition according to the present invention may contain any substance within a range that does not impair the characteristics of the present invention, and examples of such substances include glycerophospholipids such as phosphatidic acid, bisphosphatidic acid, lecithin (phosphatidylcholine), phosphatidylethanolamine, phosphatidylmethylethanolamine, phosphatidylserine, phosphatidylinositol, phosphatidylglycerin, and diphosphatidylglycerin (cardiolipin), as well as hydrogenated or hydroxylated versions of these; lysolecithin, ... Lyso compounds such as lysophosphatidic acid, lysophosphatidylglycerin, lysophosphatidylinositol, lysophosphatidylethanolamine, lysophosphatidylmethylethanolamine, lysophosphatidylcholine (lysolecithin), and lysophosphatidylserine; various lecithins derived from plants such as soybeans, corn, peanuts, rapeseed, and wheat, from animals such as egg yolk and cows, and from microorganisms such as E. coli; sphingophospholipids such as sphingomyelin (phospholipids); L-ascorbic acid, L-ascorbic acid, and Ascorbic acid or ascorbic acid derivatives or their salts, such as sodium ascorbate, potassium L-ascorbate, calcium L-ascorbate, L-ascorbic acid phosphate, magnesium L-ascorbic acid phosphate, L-ascorbic acid sulfate, disodium L-ascorbic acid sulfate, and L-ascorbic acid 2-glucoside; erythorbic acid, sodium erythorbate, potassium erythorbate, calcium erythorbate, erythorbic acid phosphate, and erythorbic acid sulfate It may contain erythorbic acid or erythorbic acid derivatives or salts thereof, such as esters; flavonoids (catechin, anthocyanin, flavones, isoflavones, flavans, flavanones, rutin, glycosides thereof, etc.), phenolic acids (chlorogenic acid, ellagic acid, gallic acid, propyl gallate, etc.), lignans, curcumins, coumarins and other polyphenols (all of the above, antioxidants); and other various flavorings, sweeteners, acidulants or coloring agents, which may be used alone or in combination of multiple types.

[0073] Next, the emulsion composition of the present invention may have self-emulsifying properties. In the present invention, self-emulsifying is also called natural emulsifying, and means that an emulsion is naturally formed by contacting with an aqueous medium or digestive fluid without the need for external force. When the emulsion composition of the present invention has self-emulsifying properties, it can form a stable emulsion in a solution containing more than 40%, 50%, 60%, 70%, 75%, 80%, 85%, or 90% (w / w) of water. In a preferred embodiment of the present invention, the content of water is about 0.01 to 7 parts by weight relative to 100 parts by weight of the entire emulsion composition.

[0074] The method for producing the emulsion composition according to the present invention includes the steps of (i) mixing and dissolving at least a sucrose fatty acid ester, and, if necessary, other water-soluble emulsifiers, and water-soluble substances such as polyols, water-soluble minerals, and water-soluble vitamins in water to obtain an aqueous phase (aqueous phase preparation step), (ii) mixing and dissolving at least a carotenoid, a sucrose fatty acid ester and / or a polyglycerin fatty acid ester, and, if necessary, other fat-soluble emulsifiers, oils and fats, compounds that can be used as radical scavengers, fat-soluble minerals, and fat-soluble vitamins to obtain an oil phase (oil phase preparation step), and then (iii) mixing the aqueous phase and the oil phase to obtain a mixed liquid, and emulsifying and dispersing the obtained mixed liquid to obtain an emulsion composition (emulsion composition preparation step).

[0075] (i) When a sucrose fatty acid ester is not used (not mixed / dissolved) in the aqueous phase preparation step, (i) the aqueous phase preparation step is a step of mixing and dissolving water and, as necessary, other water-soluble substances such as water-soluble emulsifiers, polyols, water-soluble minerals, and water-soluble vitamins to obtain an aqueous phase, and (iii) the emulsion composition preparation step is a step of mixing water or the aqueous phase and the oil phase to obtain an emulsion composition.

[0076] On the other hand, when the polyglycerol fatty acid ester is not used (not mixed / dissolved) in (ii) the oil phase preparation step, (ii) the oil phase preparation step is a step of mixing and dissolving at least the carotenoid and fats and oils, and, if necessary, fat-soluble substances such as sucrose fatty acid esters and other fat-soluble emulsifiers, compounds that can be used as radical scavengers, fat-soluble minerals, and fat-soluble vitamins to obtain an oil phase.

[0077] In addition, in the case where (i) in the aqueous phase preparation step, at least sucrose stearate is mixed / dissolved in water, and (ii) in the oil phase preparation step, at least a carotenoid and decaglycerol monolaurate are mixed / dissolved, or in the case where water is mixed with other water-soluble substances such as other water-soluble emulsifiers, polyols, water-soluble minerals, water-soluble vitamins, etc., as necessary, and (ii) in the oil phase preparation step, at least a carotenoid, sucrose stearate, and decaglycerol monolaurate are mixed, lecithin is not mixed / dissolved in the oil phase preparation step.

[0078] In this specification, the HLB (Hydrophile-Lipophile Balance) value can be used as an indicator of whether a sucrose fatty acid ester is used (mixed / dissolved) in the aqueous phase preparation step or used (mixed / dissolved) in the oil phase preparation step.

[0079] In such cases, if the ingredient being used is a commercially available product, the commercially available product should be used, and if the HLB value of the commercially available product is clearly indicated in the catalog or other literature of the commercially available product, the value indicated in the catalog or other literature should be used.

[0080] On the other hand, when the component used is not a commercially available product, or when the HLB value is not clearly indicated in a catalog or other document even if it is commercially available, the value calculated by the Griffin formula is adopted as the HLB value in this specification. In the Griffin formula, the HLB value is calculated using the value of S (the saponification value of the ester) and the value of N (the neutralization value of the fatty acid that constitutes the ester). The formula is as follows:

[0081] HLB value = 20(1-S / N)

[0082] The closer the HLB value is to 20, the more hydrophilic it is, and the closer it is to 0, the more lipophilic it is. Furthermore, emulsifiers are generally defined as lipophilic when their HLB value is less than 7, and hydrophilic when their HLB value is 7 or more.

[0083] In addition, in the emulsification and dispersion in the (iii) emulsion composition preparation step, the emulsion and dispersion can be carried out using a conventional emulsification device such as a stirrer, an impeller stirrer, a homomixer, or a continuous flow type shear device.

[0084] Next, a soft capsule formulation can be selected as the dosage form of the emulsion composition of the present invention, and the soft capsule formulation can be obtained by encapsulating contents containing the emulsion composition of the present invention in a soft capsule shell.

[0085] In the present invention, the soft capsule formulation can be selected within a range that does not impair the characteristics of the present invention, and is not particularly limited. Examples of such soft capsule formulations include, for example, a capsule formed into a single container carrying a liquid payload or semisolid containing a drug, one or more additives, and, optionally, an excipient (including, for example, a self-emulsifying formulation and a non-emulsifying formulation).

[0086] The method for producing a soft capsule formulation according to the present invention further includes, after obtaining the emulsion composition described in (1) or (2) as described above, (iv) a step of encapsulating contents containing the obtained emulsion composition in a soft capsule shell (soft capsule encapsulation step).

[0087] In the present invention, the (iv) soft capsule encapsulation step can include, for example, an embodiment including the steps (1) to (3) of (1) preparing the capsule contents and the base material that forms the soft capsule shell (contents, etc. preparation step), (2) encapsulating the contents into the obtained base material that forms the soft capsule shell, molding and drying to obtain an intermediate formulation (molding step), and (3) drying the obtained intermediate formulation (drying step).

[0088] The "step of preparing the contents, etc." in (1) is a step of preparing the contents containing the emulsion composition according to the present invention and the base material that forms the soft capsule shell, as described above.

[0089] The "molding step" in (2) is a step of encapsulating the contents including the emulsion composition of the present invention in a shell formed using a base material for forming the soft capsule shell, encapsulating the contents in the base material for forming the soft capsule shell, and drying the encapsulated contents to obtain an intermediate preparation. In the present invention, the encapsulation of the contents in the base material for forming the soft capsule shell can be appropriately selected from known methods for producing soft capsule preparations. Examples of such methods include the plate method and the rotary die method.

[0090] The "drying step" in (3) is a step of drying the intermediate preparation obtained in the molding step, and a soft capsule preparation is obtained through this step. The drying means used in the drying step can be appropriately selected from known drying means. Examples of such means include a means using a known dryer such as a tumbler dryer (rotary drum dryer). In addition, the conditions such as temperature and time in the drying step are not particularly limited, and can be appropriately selected depending on the capsule contents and the type of base material forming the soft capsule shell.

[0091] In the present invention, the substrate for forming the soft capsule shell can be appropriately selected within the range that does not impair the characteristics of the present invention, and examples of the substrate include gelatins such as gelatin, acidic gelatin, alkaline gelatin, peptide gelatin, low molecular weight gelatin, and gelatin derivatives; agar; gellan gum; and the like. When gelatin is used as the substrate for the soft capsule shell, it is prepared from a gelatin shell solution containing gelatin, a plasticizer, and water. In addition, the soft capsule shell may contain a plasticizer within the range that does not impair the characteristics of the present invention, and examples of such plasticizers include glycerin; sugars such as corn syrup, sucrose, fructose, sorbitol, and mannitol; glycols such as propylene glycol and polyethylene glycol; water-insoluble celluloses such as crystalline cellulose, starches, low-substituted hydroxypropyl cellulose, and ethyl cellulose; and the like. These plasticizers may be used alone or in combination.

[0092] In the present invention, the content of the soft capsule formulation may contain 0.0001% by mass to 98% by mass of the emulsion composition according to the present invention relative to the total amount of the soft capsule formulation. The shape of the soft capsule formulation is not particularly limited, but may be, for example, an oval, a rectangular, or a round shape, and methods or devices known in the art may be appropriately applied to form these shapes.

[0093] In the present invention, the soft capsule formulation (contents and / or coating) can be appropriately blended with additive components commonly used in the fields of food, beverages, and pharmaceuticals, as long as the characteristics of the present invention are not impaired. For example, additive components can be appropriately selected and blended from coloring agents such as dyes and pigments, fragrances, sweeteners, flavorings, odorants, preservatives, fruit juice, various vitamins, animal and plant extracts, amino acids, minerals, thickeners, pH adjusters, preservatives, disintegrants, surfactants, organic acids, and the like. EXAMPLES

[0094] The emulsion composition and its production method according to the present invention will be described below with reference to examples. Note that the technical scope of the present invention is not limited to the embodiments shown by these examples.

[0095] 1. Preparation of emulsion composition First, the emulsion compositions according to Examples 1 to 42 were prepared as follows. In preparing the emulsion compositions according to Examples 1 to 42, "AstaReal Oil 200SS (manufactured by AstaReal)" was used as "Haematococcus algae pigment 20% oil", "AstaReal L10 (manufactured by AstaReal)" was used as "Haematococcus algae pigment 10% oil", and "Lutemax 2020 (manufactured by OmniActive Health Technologies)" was used as "lutein and zeaxanthin". In addition, "SY Glystar FMO-3S (manufactured by Sakamoto Pharmaceutical Co., Ltd.)" was used as "tetraglycerin monooleate ester", "NIKKOL DECAGLYN 1-L (manufactured by Nikko Chemical Co., Ltd.)" was used as "decaglycerin monolaurate ester (decaglyceryl monolaurate)", "DK Ester SS (manufactured by Daiichi Kogyo Seiyaku Co., Ltd.)" and "Ryoto Sugar Ester S-570 (manufactured by Mitsubishi Chemical Foods Co., Ltd.)" were used as "sucrose stearate ester", and "Ryoto Sugar Ester L-1695 (manufactured by Mitsubishi Chemical Foods Co., Ltd.)" and "Ryoto Sugar Ester L-195 (manufactured by Mitsubishi Chemical Foods Co., Ltd.)" were used as "sucrose laurate ester". In addition, MCT oil was used as the medium chain fatty acid triglyceride.

[0096] [1-1] Preparation of emulsion composition according to Example 1 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Next, 9.8 g of sucrose laurate with an HLB value of 16, 1 g of ethanol, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 1.

[0097] [1-2] Preparation of emulsion composition according to Example 2 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 0.8 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Next, 13 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 2.

[0098] [1-3] Preparation of emulsion composition according to Example 3 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 3.8 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Next, 10 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 3.

[0099] [1-4] Preparation of emulsion composition according to Example 4 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 7.8 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Then, 6 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 4.

[0100] [1-5] Preparation of emulsion composition according to Example 5 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 11.8 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Then, 2 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 5.

[0101] [1-6] Preparation of emulsion composition according to Example 6 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 10.8 g of triglyceride, 2 g of mixed tocopherol, and 13.5 g of tetraglycerin monooleate. Next, 7.5 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 6.

[0102] [1-7] Preparation of emulsion composition according to Example 7 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 9.8 g of triglyceride, 2 g of mixed tocopherol, and 12 g of tetraglycerin monooleate. Then, 10 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 7.

[0103] [1-8] Preparation of emulsion composition according to Example 8 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 17.8 g of triglyceride, 2 g of mixed tocopherol, and 9 g of tetraglycerin monooleate. Next, 5 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 8.

[0104] [1-9] Preparation of emulsion composition according to Example 9 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 15.8 g of triglyceride, 2 g of mixed tocopherol, and 6 g of tetraglycerin monooleate. Then, 10 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 9.

[0105] [1-10] Preparation of emulsion composition according to Example 10 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 3.8 g of triglyceride, 2 g of mixed tocopherol, 18 g of tetraglycerin monooleate, and 10 g of sucrose laurate with an HLB value of 1. Next, 6 g of propylene glycol and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 10. The formulations of the emulsion compositions of Examples 1 to 10 are shown in Table 1.

[0106] [Table 1]

[0107] [1-11] Preparation of emulsion composition according to Example 11 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Next, 9.8 g of sucrose stearate with an HLB value of 19, 1 g of ethanol, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 11.

[0108] [1-12] Preparation of emulsion composition according to Example 12 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 7.8 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Then, 6 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 12.

[0109] [1-13] Preparation of emulsion composition according to Example 13 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 11.8 g of triglyceride, 2 g of mixed tocopherol, and 18 g of tetraglycerin monooleate. Then, 2 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 13.

[0110] [1-14] Preparation of emulsion composition according to Example 14 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 9.8 g of triglyceride, 2 g of mixed tocopherol, and 12 g of tetraglycerin monooleate. Then, 10 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 14.

[0111] [1-15] Preparation of emulsion composition according to Example 15 An oil phase was prepared by adding 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 15.8 g of triglyceride, 2 g of mixed tocopherol, and 6 g of tetraglycerin monooleate, mixing and dissolving them. Next, 10 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added and dissolved in 5.2 g of purified water to prepare an aqueous phase, and then the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 15. The formulations of the emulsion compositions of Examples 11 to 15 are shown in Table 2.

[0112] [Table 2]

[0113] [1-16] Preparation of emulsion composition according to Example 16 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, 18 g of tetraglycerin monooleate, and 9.8 g of decaglycerin monolaurate. Then, 1 g of ethanol and 9 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 16.

[0114] [1-17] Preparation of emulsion composition according to Example 17 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 21 g of lutein-zeaxanthin oil, 1 g of triglyceride, 3 g of mixed tocopherol, 18 g of tetraglycerin monooleate, and 9.8 g of decaglycerin monolaurate. Then, 1 g of ethanol and 9 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 17.

[0115] [1-18] Preparation of emulsion composition according to Example 18 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 21 g of lutein-zeaxanthin oil, 1 g of triglyceride, 3 g of mixed tocopherol, 18 g of tetraglycerin monooleate, and 9.8 g of decaglycerin monolaurate. Then, 1 g of propylene glycol and 9 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 18.

[0116] [1-19] Preparation of emulsion composition according to Example 19 24g of 10% Haematococcus algae pigment oil, 15.5g of lutein-zeaxanthin oil, 2.3g of triglyceride, 2g of mixed tocopherol, 27g of tetraglycerin monooleate, and 15g of decaglycerin monolaurate were mixed and dissolved to prepare an oil phase. Then, 6g of propylene glycol and 3g of glycerin were added to 5.2g of purified water and dissolved to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 19. The formulations of the emulsion compositions of Examples 16 to 19 are shown in Table 3.

[0117] [Table 3]

[0118] [1-20] Preparation of emulsion composition according to Example 20 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 6.8 g of triglyceride, 2 g of mixed tocopherol, and 15 g of decaglycerin monolaurate. Next, 10 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 20.

[0119] [1-21] Preparation of emulsion composition according to Example 21 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 10.8 g of triglyceride, 2 g of mixed tocopherol, and 15 g of decaglycerin monolaurate. Then, 6 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 21.

[0120] [1-22] Preparation of emulsion composition according to Example 22 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 14.8 g of triglyceride, 2 g of mixed tocopherol, and 15 g of decaglycerin monolaurate. Then, 2 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 22.

[0121] [1-23] Preparation of emulsion composition according to Example 23 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 11.8 g of triglyceride, 2 g of mixed tocopherol, and 10 g of decaglycerin monolaurate. Then, 10 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to 5.2 g of purified water and dissolved to prepare an aqueous phase. The oil phase and the aqueous phase were then mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 23.

[0122] [1-24] Preparation of emulsion composition according to Example 24 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 16.8 g of triglyceride, 2 g of mixed tocopherol, and 5 g of decaglycerin monolaurate. Next, 10 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and then the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 24. The formulations of the emulsion compositions of Examples 20 to 24 are shown in Table 4.

[0123] [Table 4]

[0124] [1-25] Preparation of emulsion composition according to Example 25 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 21.8 g of triglyceride, and 2 g of mixed tocopherol. Next, 5 g of sucrose stearate with an HLB value of 19, 5 g of sucrose laurate with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 25.

[0125] [1-26] Preparation of emulsion composition according to Example 26 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 11.8 g of triglyceride, 2 g of mixed tocopherol, and 10.0 g of sucrose laurate with an HLB value of 1. Next, 10.0 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 26.

[0126] [1-27] Preparation of emulsion composition according to Example 27 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 11.8 g of triglyceride, 2 g of mixed tocopherol, and 10 g of sucrose stearate ester with an HLB value of 5. Then, 10 g of sucrose laurate ester with an HLB value of 16, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 27. The formulations of the emulsion compositions of Examples 25 to 27 are shown in Table 5.

[0127] [Table 5]

[0128] [1-28] Preparation of emulsion composition according to Example 28 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 6.8 g of triglyceride, 2 g of mixed tocopherol, and 15 g of decaglycerin monolaurate. Next, 10 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 28.

[0129] [1-29] Preparation of emulsion composition according to Example 29 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 10.8 g of triglyceride, 2 g of mixed tocopherol, and 15 g of decaglycerin monolaurate. Next, 6 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 29.

[0130] [1-30] Preparation of emulsion composition according to Example 30 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 14.8 g of triglyceride, 2 g of mixed tocopherol, and 15 g of decaglycerin monolaurate. Then, 2 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 30.

[0131] [1-31] ​​Preparation of emulsion composition according to Example 31 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 11.8 g of triglyceride, 2 g of mixed tocopherol, and 10 g of decaglycerin monolaurate. Then, 10 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 31.

[0132] [1-32] Preparation of emulsion composition according to Example 32 An oil phase was prepared by mixing and dissolving 32 g of 10% Haematococcus algae pigment oil, 20 g of lutein-zeaxanthin oil, 16.8 g of triglyceride, 2 g of mixed tocopherol, and 5 g of decaglycerin monolaurate. Next, 10 g of sucrose stearate with an HLB value of 19, 6 g of propylene glycol, and 3 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and then the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 32. The formulations of the emulsion compositions of Examples 28 to 32 are shown in Table 6.

[0133] [Table 6]

[0134] [1-33] Preparation of emulsion composition according to Example 33 An oil phase was prepared by mixing and dissolving 21.5 g of 20% Haematococcus algae pigment oil, 37.5 g of triglyceride, 2 g of mixed tocopherol, 20 g of tetraglycerin monooleate, 6 g of decaglycerin monolaurate, and 0.4 g of ethanol. Then, 1.52 g of sucrose laurate and 9 g of glycerin were added and dissolved in 2.08 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 33.

[0135] [1-34] Preparation of emulsion composition according to Example 34 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, 18 g of tetraglycerin monooleate, and 1 g of ethanol. Then, 6 g of sucrose stearate with an HLB value of 19, 3.8 g of sucrose laurate with an HLB value of 16, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 34.

[0136] [1-35] Preparation of emulsion composition according to Example 35 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 11.8 g of triglyceride, 2 g of mixed tocopherol, 18 g of tetraglycerin monooleate, 3 g of decaglycerin monolaurate, and 1 g of ethanol. Next, 7 g of sucrose stearate having an HLB value of 19 and 9 g of glycerin were added and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase and the aqueous phase were mixed to obtain an emulsion composition, which was the emulsion composition of Example 35. The formulations of the emulsion compositions of Examples 33 to 35 are shown in Table 7.

[0137] [Table 7]

[0138] [1-36] Preparation of emulsion composition according to Example 36 An oil phase was prepared by mixing and dissolving 21.5 g of 20% Haematococcus algae pigment oil, 33.5 g of triglyceride, 2 g of mixed tocopherol, 15 g of tetraglycerin monooleate, and 3 g of decaglycerin monolaurate. Then, 6 g of sucrose stearate with an HLB value of 19, 3.8 g of sucrose laurate with an HLB value of 16, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase. The oil phase, the aqueous phase, and 1 g of ethanol were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 36.

[0139] [1-37] Preparation of emulsion composition according to Example 37 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, 15 g of tetraglycerin monooleate, and 4.5 g of decaglycerin monolaurate. Then, 4.5 g of sucrose stearate with an HLB value of 19, 3.8 g of sucrose laurate with an HLB value of 16, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase. The oil phase, the aqueous phase, and 1 g of ethanol were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 37.

[0140] [1-38] Preparation of emulsion composition according to Example 38 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, 15 g of tetraglycerin monooleate, and 6 g of decaglycerin monolaurate. Then, 3 g of sucrose stearate with an HLB value of 19, 3.8 g of sucrose laurate with an HLB value of 16, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase. The oil phase, the aqueous phase, and 1 g of ethanol were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 38.

[0141] [1-39] Preparation of emulsion composition according to Example 39 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, 16 g of tetraglycerin monooleate, and 2 g of decaglycerin monolaurate. Next, 6 g of sucrose stearate with an HLB value of 19, 3.8 g of sucrose laurate with an HLB value of 16, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and then the oil phase, the aqueous phase, and 1 g of ethanol were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 39.

[0142] [1-40] Preparation of emulsion composition according to Example 40 An oil phase was prepared by mixing and dissolving 43 g of 10% Haematococcus algae pigment oil, 12 g of triglyceride, 2 g of mixed tocopherol, 17.5 g of tetraglycerin monooleate, and 0.5 g of decaglycerin monolaurate. Then, 6 g of sucrose stearate with an HLB value of 19, 3.8 g of sucrose laurate with an HLB value of 16, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase, and the oil phase, the aqueous phase, and 1 g of ethanol were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 40.

[0143] [1-41] Preparation of emulsion composition according to Example 41 An oil phase was prepared by mixing and dissolving 21.5 g of lutein-zeaxanthin, 33.5 g of triglyceride, 2 g of mixed tocopherol, 15 g of tetraglycerin monooleate, and 3 g of decaglycerin monolaurate. Then, 6 g of sucrose stearate with an HLB value of 19, 3.8 g of sucrose laurate with an HLB value of 16, and 9 g of glycerin were added to and dissolved in 5.2 g of purified water to prepare an aqueous phase. The oil phase, the aqueous phase, and 1 g of ethanol were mixed to obtain an emulsion composition, which was used as the emulsion composition of Example 41.

[0144] [1-42] Preparation of emulsion composition according to Example 42 21.5g of 20% Haematococcus algae pigment oil, 21.5g of lutein / zeaxanthin, 12g of triglyceride, 2g of mixed tocopherol, 15g of tetraglycerin monooleate, and 3g of decaglycerin monolaurate were mixed and dissolved to prepare an oil phase. Then, 6g of sucrose stearate with an HLB value of 19, 3.8g of sucrose laurate with an HLB value of 16, and 9g of glycerin were added and dissolved in 5.2g of purified water to prepare an aqueous phase, and the oil phase, the aqueous phase, and 1g of ethanol were mixed to obtain an emulsion composition, which was the emulsion composition of Example 42. The formulations of the emulsion compositions of Examples 36 to 42 are shown in Table 8.

[0145] [Table 8]

[0146] 2. Preparation of Comparative Composition Next, comparative compositions 1 to 4 were prepared as follows. In preparing comparative compositions 1 to 4, "AstaReal Oil 200SS (manufactured by AstaReal)" was used as "Haematococcus algae pigment 20% oil", "AstaReal L10 (manufactured by AstaReal)" was used as "Haematococcus algae pigment 10% oil", and "Lutemax 2020 (manufactured by OmniActive Health Technologies)" was used as "lutein and zeaxanthin".

[0147] 20% Haematococcus algae pigment oil was used as Comparative Composition 1, 10% Haematococcus algae pigment oil was used as Comparative Composition 2, and lutein-zeaxanthin oil was used as Comparative Composition 3. In addition, 62 g of 10% Haematococcus algae pigment oil was mixed with 38 g of lutein-zeaxanthin oil to prepare Comparative Composition 4. The formulations of Comparative Compositions 1 to 4 are shown in Table 9.

[0148] [Table 9]

[0149] 3. Evaluation of affinity with soft capsule membrane For each of the prepared emulsion compositions according to Examples 1 to 42, an evaluation of affinity with the soft capsule shell was carried out based on the following method.

[0150] The vegetable-coated MCT soft capsules were precipitated in each of the prepared emulsion compositions according to Examples 1 to 42, and left to stand at room temperature for 2 days. The soft capsules were then taken out and checked for deformation or softening of the soft capsule shell. If the soft capsule shell was not deformed, dented, or softened, it was evaluated as having low affinity with the soft capsule shell (◯), and if the soft capsule shell was deformed, dented, or softened, it was evaluated as having high affinity with the soft capsule shell (×). The results are shown in Figure 1.

[0151] As shown in FIG. 1, all of the emulsion compositions of Examples 1 to 42 did not cause deformation, dents, or softening of the soft capsule shell, indicating low affinity with the soft capsule shell (○). This demonstrates that the emulsion composition of the present invention can be formulated into a soft capsule.

[0152] 4. Bioabsorption test For each of the prepared emulsion compositions of Examples 1 to 42 and Comparative Compositions 1 to 4, a test for in vivo absorbability of carotenoid was carried out based on the following method.

[0153] [3-1] Sample preparation The emulsion compositions of Examples 1 to 42 and Comparative Compositions 1 to 4 were administered via oral gavage to Wistar rats (male, 4 to 6 per group, weighing 200 to 250 g, aged 8 to 10 weeks) that had been fasted overnight. In this case, when the emulsion compositions according to Examples 1 to 42 and the comparative compositions 1 to 4 contain only astaxanthin as a carotenoid, the dosage of astaxanthin (free form equivalent) is 100 mg / kg rat weight, when they contain only lutein and zeaxanthin, the dosage of lutein is 100 mg / kg rat weight and the dosage of zeaxanthin is 20 mg / kg rat weight, and when they contain astaxanthin and lutein and zeaxanthin, the dosage of astaxanthin (free form equivalent) is 100 mg / kg rat weight, the dosage of lutein is 120 mg / kg rat weight and the dosage of zeaxanthin is 25 mg / kg rat weight. The compositions were diluted and prepared using medium-chain fatty acid triglyceride, and administered at 4.4 cc / kg rat weight. After administration, blood was collected from the jugular vein 3, 6, 9 and 24 hours after administration, and plasma was separated. The obtained plasma was stored at -80°C until quantitative analysis of each carotenoid was performed.

[0154] To 100 μL of the plasma sample obtained, 500 μL of butylated hydroxytoluene (BHT; 50 μg / mL) ethanol solution and 100 μL of 100 ng / mL internal standard (trans-β-Apo-8'-carotenal, 10829; Sigma) acetone solution were added, and the mixture was vigorously stirred for 15 seconds with a vortex mixer, after which 5 mL of hexane was added and further vigorously stirred for 15 seconds with a vortex mixer. This stirring process was repeated three times, and the mixture was centrifuged for 10 minutes at 3500 rpm. 4 mL of the supernatant obtained by centrifugation was collected and filtered through a membrane filter with a mesh size of 0.45 μm. The filtrate obtained was concentrated with a centrifugal evaporator, and then redissolved in 150 μL of acetone to obtain a sample, which was then subjected to reverse-phase HPLC.

[0155] On the other hand, the carotenoid standard solution was prepared as follows. That is, 1 mL of 2 μg / mL astaxanthin standard reagent (460-031-M250; Astaxanthin, manufactured by ALEXIS BIOCHEMICALS) acetone solution was mixed with 2.5 mL of 800 ng / mL internal standard (trans-β-Apo-8'-carotenal, 10829; manufactured by Sigma) acetone solution, and the resulting solution was made up to 20.0 mL using acetone to prepare the astaxanthin standard solution. Also, 2 mL of 2.67 μg / mL lutein standard acetone solution was mixed with 2.5 mL of 800 ng / mL internal standard (trans-β-Apo-8'-carotenal, 10829; manufactured by Sigma) acetone solution, and the resulting solution was made up to 20.0 mL using acetone to prepare the lutein standard solution. In addition, 2 mL of 1.55 μg / mL zeaxanthin standard solution in acetone was mixed with 2.5 mL of 800 ng / mL internal standard (trans-β-Apo-8'-carotenal, 10829; Sigma) in acetone, and the resulting solution was diluted to 20.0 mL with acetone to prepare a zeaxanthin standard solution. Each of the prepared standard solutions was subjected to reversed-phase HPLC, and the concentrations of astaxanthin, lutein, and zeaxanthin were determined by comparing the peak area ratios obtained.

[0156] [3-2] HPLC conditions HPLC was performed using Shimadzu LC20A series (pump: LC-20AD, degasser: DGU-20A5R, autosampler: SIL-20AC, column oven: CTO-20AC, detector: SPD-20AV, system controller: CBM-20A) and YMC-Carotenoid (4.6 x 250 mm, particle size 5 μm) analytical column. Liquid A (methanol), liquid B (tert-butyl methyl ether), and liquid C (1% (v / v) phosphoric acid aqueous solution) were used as mobile phases. Gradient elution was performed so that the mixture ratio of liquid A and liquid B was 81:13 (% ratio) at the start, liquid B was 28% after 15 minutes, and liquid B was 78% after 27 minutes. The composition of liquid B was maintained at 78% until 31 minutes, after which the mixture ratio was returned to the starting ratio at 31.01 minutes, and elution was continued at the starting composition until 40 minutes. The composition of solution C was always 6%. The column oven was kept at 25° C., the detection wavelength of the UV / VIS detector was set to 470 nm, and the flow rate was 1 mL / min.

[0157] In the body absorption test conducted on the emulsion compositions of Examples 1 to 42 and Comparative Compositions 1 to 4, the area under the blood concentration curve (AUC 0-24hr (hereinafter abbreviated as "AUC"). The AUC ratios of the emulsion compositions according to Examples 1 to 42 and the comparative compositions 1 to 4 were calculated using the following formula and are shown in FIG.

[0158] AUC ratio = AUC value of the emulsion composition according to Examples 1 to 42 / AUC value of the corresponding comparative compositions 1 to 4

[0159] As shown in FIG. 2, the AUC ratios for astaxanthin of the comparative composition and the emulsion compositions of Examples 1 to 40 and Example 42 were 2.7, 1.5, 2.4, 1.7, 1.5, 1.3, 1.9, 1.2, 1.9, 1.2, 2.3, 1.1, 1.2, 2.0, 1.3, 1.8, 1.2, 1.1, 1.5, 1.6, 1.9, 1.4, 2.1, 1.7, 1.3, 1.2, 1.6, 2.1, 1.8, 1.4, 2.2, 2.1, 1.8, 4.6, 2.0, 1.5, 2.6, 1.8, 2.6, 2.2, and 1.8, respectively. Furthermore, the AUC ratios for lutein of the comparative composition and the emulsion compositions of Examples 2 to 10, 12 to 15, 17 to 32, 41, and 42 were 1.4, 1.7, 1.3, 1.6, 1.2, 1.3, 1.3, 1.4, 1.2, 1.0, 1.1, 1.3, 1.1, 1.4, 1.5, 1.0, 1.1, 1.4, 1.3, 1.7, 1.3, 1.3, 0.9, 1.2, 1.2, 1.1, 1.0, 1.2, 1.2, 1.3, and 1.3, respectively. In addition, the AUC ratios for zeaxanthin between the comparative composition and the emulsion compositions of Examples 2 to 10, Examples 12 to 15, Examples 17 to 32, Example 41, and Example 42 were 2.5, 10.1, 9.6, 10.8, 2.8, 4.1, 3.3, 4.7, 3.7, 3.6, 5.4, 3.6, 4.9, 1.4, 1.9, 0.6, 2.0, 4.0, 3.4, 3.7, 5.0, 5.5, 2.6, 2.5, 1.4, 0.8, 0.8, 1.9, 1.5, 13.3, and 1.8, respectively.

[0160] As a result of the above, at least any one of the AUC ratios for astaxanthin, AUC ratios for lutein, and AUC ratios for zeaxanthin between the comparative composition and each of the emulsion compositions of Examples 1 to 42 was 1.4 or more (the highest value of the AUC ratios for astaxanthin, AUC ratios for lutein, and AUC ratios for zeaxanthin between the comparative composition and each of the emulsion compositions of Examples 1 to 42 was 1.4 or more), which made it clear that the emulsion composition of the present invention has higher in vivo absorbability of carotenoids compared to conventional emulsion compositions.

[0161] 5. Uniformity assessment For each of the emulsion compositions of Examples 11, 34, and 36, the uniformity was evaluated based on the following method.

[0162] In the emulsion compositions according to Example 11, Example 34 and Example 36, the amount of ethanol added was set to 0g (0 wt%), 0.1g (0.1 wt%), 0.25g (0.25 wt%), 0.5g (0.5 wt%), 0.75g (0.75 wt%) and 1g (1 wt%), respectively, and the total amount was adjusted by adjusting the amount of triglyceride added. In addition, for the emulsion composition according to Example 36, a dihydric alcohol such as propylene glycol, and a (polyhydric) sugar alcohol such as xylitol, sorbitol, lactitol and erythritol were also added instead of ethanol (monohydric alcohol). Each of these emulsion compositions prepared was heated at 60°C for 20 minutes, and then sieved using an 80 mesh stainless steel test sieve, and the weight (g) of each test sieve after sieving was measured. Next, the weight (g) of the test sieve before sieving was subtracted from the weight (g) of the test sieve after sieving to calculate the weight (g) of the remaining emulsion composition on the test sieve after sieving for each of the emulsion compositions according to Example 11, Example 34, and Example 36. The weight (g) of the remaining emulsion composition on the test sieve after sieving was then divided by the amount of the emulsion composition sieved to calculate the residual ratio (wt%) on the test sieve after sieving. Next, for each of the emulsion compositions, if the residual ratio (wt%) on the test sieve after sieving calculated was less than 10%, it was evaluated as being highly uniform (◯), if it was 10% or more and less than 20%, it was evaluated as having general uniformity (△), and if it was 30% or more, it was evaluated as not being uniform (×). The formulation of the emulsion composition prepared and the evaluation results are shown in Figures 3 to 6.

[0163] As shown in Figures 3 to 5, when ethanol is not added, the emulsion composition prepared is not uniform, and when ethanol is added, the emulsion composition prepared has uniformity. In addition, when the amount of ethanol added is 0.5% by weight or 0.75% by weight or more, the emulsion composition prepared is highly uniform. In addition, as shown in Figure 6, even when (polyhydric) sugar alcohols such as propylene glycol (dihydric alcohol), xylitol, sorbitol, lactitol, and erythritol are added instead of ethanol (monohydric alcohol), the emulsion composition prepared has the same uniformity as when ethanol is added. From these, it is clear that the emulsion composition according to the present invention has uniformity by containing alcohol.

[0164] 5. Soft capsules 55 g of the emulsion composition prepared in Examples 1 to 42, 40 g of diglycerol laurate (Rikemal L-71-D; manufactured by Riken Vitamin Co., Ltd.), and 5 g of polyoxyethylene sorbitan fatty acid ester are mixed until homogeneous, and the mixture is filled into soft capsules using a filling machine to obtain soft capsules containing carotenoids.

Claims

1. An emulsion composition containing a carotenoid and any combination of the following emulsifiers (a), (b), (c), (d), (e), (f) and (g); (a) tetraglycerol monooleate and decaglycerol monolaurate, (b) tetraglycerol monooleate and sucrose stearate; (c) tetraglycerol monooleate and sucrose laurate; (d) tetraglycerol monooleate, decaglycerol monolaurate and sucrose stearate; (e) tetraglycerol monooleate, decaglycerol monolaurate and sucrose laurate; (f) tetraglycerol monooleate, sucrose stearate and sucrose laurate, (g) Tetraglycerol monooleate, decaglycerol monolaurate, sucrose stearate and sucrose laurate.

2. The emulsion composition described in claim 1, containing alcohol.

3. An emulsion composition comprising ethanol, a carotenoid, and any combination of the following emulsifiers (a), (b), and (c): (a) decaglycerol monolaurate and sucrose laurate, (b) sucrose stearate and sucrose laurate; (c) Decaglycerol monolaurate, sucrose stearate and sucrose laurate.

4. An emulsion composition described in any one of claims 1 to 3, wherein the carotenoid is one or more selected from the group consisting of lutein, zeaxanthin, astaxanthin, lycopene, beta-carotene, gamma-carotene, phytofluene, phytoene, canthaxanthin, beta-cryptoxanthin, capsanthin, fucoxanthin and fatty acid esters thereof.

5. The emulsion composition of claim 4, wherein the astaxanthin is derived from Haematococcus algae extract.

6. An emulsion composition described in any one of claims 1 to 5, containing minerals and / or vitamins.

7. A soft capsule formulation containing an emulsion composition described in any one of claims 1 to 6.

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