Composition containing lutein for oral administration and method for producing the same

Abstract

To provide a novel composition containing lutein.SOLUTION: A composition for oral administration comprises a material containing lutein and a dispersing agent, and the dispersing agent includes at least one selected from lecithin, sucrose fatty acid ester, and beeswax.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a lutein-containing composition for oral administration and a method for producing the same. [Background technology]

[0002] Lutein is generally known as an antioxidant present in plants. Lutein is a type of carotenoid, a yellow, orange, and red pigment. Lutein is found in large amounts in the macula and lens of the eye, and has been used in the fields of food, medicine, and the like as a preventative substance for macular degeneration, cataracts, and the like (Patent Document 1). Generally, lutein is known to be found in large amounts in fresh vegetables such as spinach, broccoli, lettuce, and green peas, and can be easily ingested by eating them. However, even if these lutein-containing ingredients are simply ingested orally, 130 g of spinach or 300 g of broccoli are required to obtain the generally required amount of 6 mg / day. Furthermore, since the lutein contained in these vegetables exists as lutein esters, the absorption rate of lutein from the digestive tract is extremely low.

[0003] Furthermore, carotenoids are poorly soluble in water and poorly absorbed by the body when orally ingested, and various techniques have been attempted to improve their availability or absorption rate in the body. As an example, Patent Document 2 uses glycerin fatty acid esters or polyglycerin fatty acid esters. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2005-287376 [Patent Document 2] Japanese Patent Application Publication No. 2020-015669 Summary of the Invention [Problem to be solved by the invention]

[0005] However, the glycerin fatty acid esters and polyglycerin fatty acid esters disclosed in Patent Document 2 are chemically synthesized surfactants, and are not recommended for large doses because they are used as agricultural chemicals and may affect the testes if administered in large doses.

[0006] An object of the present invention is to provide a novel composition containing lutein.

[0007] Another object of the present invention is to provide a lutein-containing composition having an excellent bioavailability of lutein.

[0008] Another object of the present invention is to provide a lutein-containing composition that has an excellent bioabsorbability of lutein without using a glycerin fatty acid ester or a polyglycerin fatty acid ester.

[0009] Another object of the present invention is to provide a method for producing the above composition. [Means for solving the problem]

[0010] The present inventors have found that the bioabsorption rate of lutein is improved by combining a lutein-containing material with a specific dispersant, and have also found that the bioabsorption rate of lutein is likely to be improved by using a finely divided lutein-containing material in combination with a specific dispersant. After further intensive research, they have completed the present invention.

[0011] That is, the present invention relates to the following compositions, etc. [1] A composition for oral administration containing a lutein-containing material and a dispersing agent, wherein the dispersing agent comprises at least one selected from the group consisting of lecithin, sucrose fatty acid esters, and beeswax. [2] The composition according to [1], wherein the lutein-containing material is finely divided. [3] The composition according to [1] or [2], wherein the dispersing agent comprises lecithin, sucrose fatty acid ester, and beeswax. [4] The composition according to any one of [1] to [3], wherein the lutein-containing material is subjected to high-pressure homogenization treatment using a wet-type micronization device, and at least a portion of the material is nanosized. [5] The composition according to any one of [2] to [4], wherein the median diameter of the finely divided lutein-containing material is 100 nm to 100 μm. [6] The composition according to any one of [1] to [5], wherein the lutein-containing material is at least one lutein-containing plant selected from marigold, spinach, broccoli, lettuce, green peas, kale, mulukhiyah, mugwort, komatsuna, pumpkin, prune, avocado, and carrot, or a processed product thereof. [7] The composition according to [6], wherein the lutein-containing material is marigold. [8] The composition according to any one of [1] to [7], further comprising a plant oil and / or an extract thereof. [9] [8] The composition according to [8], wherein the vegetable oil is at least one selected from soybean oil, safflower oil, chili pepper oil, rapeseed oil, corn oil, sunflower oil, and linseed oil.

[10] A method for producing a lutein-containing composition for oral administration, comprising the step of blending a lutein-containing material and a dispersant, and further comprising a step of subjecting the lutein-containing material to high-pressure homogenization treatment using a wet-type micronization device to nano-size at least a portion of the lutein-containing material to obtain a finely divided lutein-containing material. [Effects of the Invention]

[0012] According to the present invention, a novel lutein-containing composition (composition for oral administration) can be provided.

[0013] According to one aspect of the present invention, a lutein-containing composition having excellent bioavailability of lutein can be provided. Such a composition can exhibit excellent bioavailability of lutein without using a glycerin fatty acid ester or a polyglycerin fatty acid ester. Furthermore, such a composition has excellent bioabsorbability of lutein (for example, absorption rate from the digestive tract), and can therefore efficiently exert the biological functions provided by lutein (for example, antioxidant effect).

[0014] The composition of one embodiment of the present invention can be safely and easily ingested because natural plant materials are used as the source of lutein, and such a composition also allows the simultaneous intake of other nutrients such as vitamins and minerals contained in the natural materials.

[0015] According to one aspect of the present invention, there can be provided a method for producing the above composition. According to one aspect of the present invention, the composition can be produced inexpensively and easily. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 shows micrographs of the lutein-containing material after each micronization treatment in Test Example 1. [Figure 2] FIG. 2 shows the particle size distribution of the lutein-containing material after each micronization treatment in Test Example 1. [Figure 3] FIG. 3 shows the calibration curve of the dissolution rate in Test Example 2. DETAILED DESCRIPTION OF THE INVENTION

[0017] [Lutein-containing composition] The composition of the present invention generally contains a lutein-containing material and a dispersing agent. The compositions of the present invention may generally be for oral administration.

[0018] Lutein-containing material As the lutein-containing material, a plant containing lutein (lutein-containing plant) may be used as it is, or a processed product of the plant may be used.

[0019] Examples of lutein-containing plants include, but are not limited to, marigold, spinach, broccoli, lettuce, green peas, kale, mulukhiyah, mugwort, Japanese mustard spinach, pumpkin, prune, avocado, and carrot. Among lutein-containing plants, plants with a high lutein content (for example, marigold, spinach, broccoli, etc.) are preferred, and marigold is more preferred.

[0020] The lutein-containing plants may be used alone or in combination of two or more kinds.

[0021] The part of the lutein-containing plant that can be used is not particularly limited, but since lutein is a pigment component, it may be, for example, fruit, seeds, leaves, flowers, etc., and it may also be preferable to use parts that contain some of the constituent components of these.

[0022] The processed product of a lutein-containing plant is not particularly limited, but examples thereof include a solution or dispersion of a lutein-containing plant, and an extract of a lutein-containing plant.

[0023] The solution or dispersion of the lutein-containing plant matter may be a solution in which the lutein-containing plant matter is dissolved or dispersed (e.g., emulsified and dispersed) in a solvent. The solvent is not particularly limited and may be, for example, water, edible oil (e.g., vegetable oil), organic solvent, etc., preferably vegetable oil. The solvent may be used alone or in combination of two or more. As the organic solvent, those exemplified below may be used.

[0024] In the solution of the lutein-containing plant body, the concentration of the lutein-containing plant body is not particularly limited, and may be, for example, 1% by weight or more, 3% by weight or more, 5% by weight or more, or 50% by weight or less, 40% by weight or less, or 30% by weight or less.

[0025] Examples of extracts from lutein-containing plants include solvent extracts. Examples of extraction solvents include water, vegetable oil, organic solvents, and acids. The extraction solvents may be used alone or in combination of two or more. The extraction solvent may be, for example, a mixture of water and an organic solvent, a mixture of water and an acid (acid solution), a mixture of vegetable oil and an acid, or the like.

[0026] The vegetable oil is not particularly limited, but examples thereof include soybean oil, safflower oil, chili pepper oil, rapeseed oil, corn oil, sunflower oil, and linseed oil, and preferably soybean oil.

[0027] Examples of organic solvents include alcohols (e.g., methanol, ethanol, butanol, propanol, isopropanol, etc.), polar solvents (e.g., glycerin, glacial acetic acid, etc.), low-polarity solvents (e.g., hexane, ethyl acetate, etc.), and naturally occurring oils and fats. Among these organic solvents, naturally occurring oils and fats may be preferably used from the viewpoints of lutein extraction efficiency, applicability to living organisms, extraction costs, and the like. The organic solvents may be used alone or in combination of two or more kinds.

[0028] Examples of acids include inorganic acids (eg, hydrochloric acid, sulfuric acid), organic acids (eg, acetic acid, formic acid, citric acid), and the like. The acids may be used alone or in combination of two or more.

[0029] The method for producing an extract of a lutein-containing plant (or a method for extracting lutein from a lutein-containing plant (extraction treatment)) is not particularly limited, and any known method for producing a plant extract may be used. The extraction treatment can be carried out, for example, by adding the lutein-containing plant to an extraction solvent. The temperature for the extraction treatment may be room temperature (for example, 20 to 40°C) or heated (for example, 40 to 100°C). The extraction treatment may be carried out by standing or by stirring. The extraction time is not particularly limited, but is preferably 30 minutes or more in order to ensure that lutein is sufficiently transferred into the extraction solvent. After the extraction treatment, a solid-liquid separation treatment may be carried out to separate insoluble components.

[0030] The extract obtained by the above extraction treatment (and further solid-liquid separation treatment) may be used as a lutein-containing material as it is, or may be used as a lutein-containing material after treatment such as concentration, drying, dilution, etc. For concentration and drying, known methods such as reduced pressure concentration, membrane concentration, freeze concentration, vacuum drying, spray drying, and freeze drying can be used.

[0031] The extract obtained as described above may be further subjected to a process such as separation or purification of lutein. The separation or purification method is not particularly limited, and known methods can be used, for example, column chromatography. Examples of chromatography carriers include porous synthetic adsorption resins, ion exchange resins, gel filtration chromatography, etc., and these may be used in appropriate combinations. Note that porous synthetic adsorption resins can adsorb and separate various organic substances from solutions due to the physical interaction between the pore surfaces within the resin and the adsorbed substances.

[0032] The lutein-containing material obtained as described above is preferably further subjected to a micronization treatment. Examples of the micronization treatment include homogenization treatment (homogenization) to micro or nano units (micronization treatment, nano treatment, etc.).

[0033] The method for the micronization treatment is not particularly limited, and any known method may be used, for example, a commercially available wet micronization device may be used. Examples of wet pulverization devices include a high-pressure homogenizer that pulverizes an object by moving a fluid at high speed through a nozzle having one or more small diameter holes and a specific flow path under a high-pressure atmosphere, an ultrasonic pulverizer that pulverizes an object using ultrasonic waves, a high-speed rotation impact pulverizer that pulverizes an object by high-speed stirring or by impact, and a ball mill or bead mill that uses a pulverization medium. Among these, a wet atomizer is preferred, as it is easy to obtain a sharp particle size distribution, and an oblique collision type wet atomizer is more preferred.

[0034] The conditions for the micronization treatment using a wet micronization device are determined appropriately depending on the model, type of nozzle, particle size of the lutein-containing material before micronization, etc. Furthermore, the micronization treatment may be repeated one or more times as necessary so that the median diameter of the lutein-containing material after micronization falls within a predetermined range.

[0035] From the viewpoint of easily improving the bioabsorption rate of lutein, it is preferable that the finely divided lutein-containing material contains at least a portion of nano-level (e.g., particle size of 10 nm to 100 nm) to micro-level (e.g., particle size of 1 μm to 100 μm), and more preferably contains at least a portion of nano-level particles (nanoparticles) with a particle size of 1 μm or less.

[0036] The particle size of the micronized lutein-containing material is not particularly limited, but from the viewpoint of easily improving the bioabsorption rate of lutein, the median diameter (or median diameter, median value, d50) is preferably in the range of 100 nm to 100 μm, and more preferably in the range of 10 nm to 10 μm. A median diameter of 10 nm or more is more preferable from the viewpoints that the number of times of the micronization treatment can be reduced, production is easy and the components contained therein are less likely to deteriorate. Furthermore, a median diameter of 100 μm or less is preferable from the viewpoint of lutein being easily absorbed into the body.

[0037] The 90% cumulative frequency diameter (or d90) of the finely divided lutein-containing material is not particularly limited, but from the viewpoint of easily improving the bioabsorption rate of lutein, it is preferably in the range of 70 nm to 70 μm, and more preferably in the range of 7 nm to 7 μm. The 90% cumulative frequency diameter is usually the particle diameter at which 90% of the particles are equal to or smaller than that diameter.

[0038] The method for measuring particle size (e.g., median diameter, 90% cumulative frequency diameter, etc.) is not particularly limited, and any known method can be used. For example, measurement can be performed using a commercially available laser diffraction / scattering particle size distribution analyzer.

[0039] The content of lutein in the lutein-containing material may be, for example, 5 to 50% by weight, preferably 10 to 30% by weight, and more preferably 15 to 25% by weight, from the viewpoint of the stability of the microparticulated lutein particles.

[0040] The content of the lutein-containing material in the composition may be, for example, 1 to 80% by weight, preferably 30 to 50% by weight, and more preferably 20 to 30% by weight.

[0041] Dispersants Examples of dispersants include surfactant-type dispersants (e.g., sucrose fatty acid esters, etc.), polymer-type dispersants (e.g., lecithin, etc.), and thickening-type dispersants (or thickeners) (e.g., beeswax, acrylic polymer sorbitan fatty acid esters, etc.). From the viewpoint of high absorption rate of lutein from the digestive tract, lecithin, sucrose fatty acid esters, beeswax, etc. are preferred, and lecithin is more preferred. The dispersant may be a protective agent or an emulsifier used as a food additive.

[0042] The dispersants may be used alone or in combination of two or more.

[0043] The content of the dispersant in the composition is preferably 0.01 to 99% by weight, more preferably 0.1 to 10% by weight. When the content of the dispersant is 0.01% by weight or more, re-aggregation of the finely divided lutein-containing material can be easily suppressed. Furthermore, when the content of the dispersant in the composition is 99% by weight or less, the effects of lutein are easily exhibited.

[0044] The ratio of lutein to dispersant in the composition may be, for example, lutein / dispersant (weight ratio) of 20 / 1 to 1 / 1, preferably 10 / 1 to 2 / 1, and more preferably 7 / 1 to 3 / 1, from the viewpoint of formulation processing and the like.

[0045] The composition preferably does not contain glycerin fatty acid esters and polyglycerin fatty acid esters as dispersants. Even when the composition contains glycerin fatty acid esters and / or polyglycerin fatty acid esters, it is preferable that the composition is substantially free of them, and the proportion of glycerin fatty acid esters and / or polyglycerin fatty acid esters relative to the total weight of the dispersant is preferably 0.1% by weight or less.

[0046] Other ingredients The composition of the present invention may contain one or more other components in addition to the lutein-containing material and the dispersing agent. Examples of other ingredients include vegetable oils (e.g., soybean oil, safflower oil, chili pepper oil, rapeseed oil, corn oil, sunflower oil, linseed oil, etc.) and extracts thereof, which can easily improve the bioabsorption rate of lutein (particularly the absorption rate from the digestive tract). Safflower oil, soybean oil, etc. may be preferably used, which can easily improve the absorption rate of lutein from the digestive tract. These vegetable oils or extracts thereof may be used singly or in combination of two or more.

[0047] Lutein is a type of carotenoid present in plants, and exists in plants as an ester in which one or two fatty acids are bound to two hydroxyl groups. Since lutein is a fat-soluble molecule, vegetable oil, which is a fat, may be preferably contained in the composition from the viewpoint of efficient absorption in the digestive tract, such as the small intestine.

[0048] The proportion of other components in the composition is not particularly limited, but may be, for example, about 1 to 99% by weight.

[0049] When the composition contains a vegetable oil or an extract thereof, the proportion of the vegetable oil or an extract thereof in the composition is not particularly limited, but may be, for example, 1 to 99% by weight, preferably 20 to 80% by weight.

[0050] [Method of producing the composition] The composition of the present invention can be produced by mixing (or blending) the lutein-containing material and the dispersing agent (and other ingredients). That is, the present invention also encompasses a method for producing a composition, which includes the step of blending a lutein-containing material and a dispersing agent. The manufacturing method of the present invention preferably includes a step of subjecting a lutein-containing material to high-pressure homogenization treatment using a wet micronization device, thereby nano-sizing at least a portion of the lutein-containing material to obtain a micronized lutein-containing material. The dispersant may be added before or after the high-pressure homogenization treatment of the lutein-containing material. The vegetable oil or extract thereof may be blended before or after the high-pressure homogenization treatment.

[0051] [Uses of the composition] The composition of the present invention can be used in a variety of applications.

[0052] Lutein has excellent antioxidant properties and is known to play an important role in the normal functioning of the lens and macula of the eye as a major carotenoid. Therefore, the composition of the present invention may be applied to health foods, supplements, pharmaceuticals, and quasi-drugs.

[0053] The composition of the present invention may be used in foods and beverages. When applied to foods and beverages, it can be used by adding it to various food or beverage ingredients. The form of the food and beverage is not particularly limited, and may be any of liquid, powder, gel, and solid, and the dosage form may be any of tablets, capsules, granules, and drinks. Among these, capsules are preferred, which allow a large amount of the composition to be ingested at once. The food and beverage may also contain other ingredients such as gelling agent-containing foods, sugars, flavorings, sweeteners, oils and fats, base materials, excipients, food additives, secondary ingredients, and bulking agents, as appropriate.

[0054] When the composition of the present invention is used as a pharmaceutical, it is preferably administered by oral ingestion. The dosage form is not particularly limited, but examples thereof include powders, powders, granules, tablets, capsules, pills, suppositories, liquids, injections, etc. In addition, excipients, bases, emulsifiers, solvents, stabilizers, etc. may be added as additives.

[0055] The composition of the present invention can be applied not only to foods and beverages and medicines for human consumption, but also to feed for domestic animals such as livestock and pets as a supplement, nutritional supplement, medicine, etc. [Example]

[0056] The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples.

[0057] <Test Example 1: Production of finely divided lutein-containing material and measurement of particle size distribution> A marigold pigment preparation (trade name: Lutein Fi-Fil20, safflower oil solution from Omnica Co., Ltd.) standardized to a marigold pigment content of 30% (lutein content of 20%) was used as the lutein-containing material.

[0058] Next, the lutein-containing material (0 pass) was treated once (1 pass) and twice (2 passes) at a high pressure of 150 MPa using a wet pulverization device (Starburst, manufactured by Sugino Machine Co., Ltd.). Figure 1 shows photographs of each lutein-containing material after 0, 1, and 2 passes, observed under a microscope (Shimadzu Corporation BOTIC BA210, 100x magnification). As shown in Figure 1, we confirmed that the size of the device increases with each processing step.

[0059] Next, the particle size distribution of each lutein-containing material was determined using a laser scattering particle size distribution analyzer (LA-960, Horiba, Ltd.). The 90% cumulative frequency diameters were 110.5636 μm (0th pass), 3.8618 μm (1st pass), and 3.2550 μm (2nd pass). The particle size distribution graphs for each are shown in Figures 2A-C.

[0060] As shown in Figures 2A to 2C, the results of measuring the particle size distribution showed that the median diameter was 24.77411 μm for 0 passes, 2.07825 μm for 1 pass, and 1.66131 μm for 2 passes, confirming that the particle size distribution shifted to a smaller size (nano level) with increasing number of passes.

[0061] <Test Example 2: Evaluation of lutein absorbability in lutein-containing oral administration composition> In recent years, from the perspective of animal welfare, in vitro alternative testing has been recommended in place of animal testing, and dissolution tests are used to measure the absorption rate of pharmaceuticals and supplements as a bioequivalence confirmation test. Furthermore, after water-soluble nutrients are absorbed from the intestinal tract, they are transferred to the liver where they undergo processes such as detoxification and decomposition before being transferred into the bloodstream. As a result, the processing process in the liver becomes rate-limiting and the results of dissolution tests do not necessarily reflect the absorption rate in some cases. However, fat-soluble nutrients such as lutein are absorbed through the lymphatic vessels and enter the bloodstream directly, so it is known that the results of dissolution tests more accurately reflect the absorption rate than water-soluble components. Dissolution tests specified in the Japanese Pharmacopoeia include the paddle method, basket method, and flow-through cell method, but these dissolution tests generally involve forced agitation of the solvent to measure dissolution rates in a relatively short period of time. In addition, differences in dissolution rates immediately after the start of the test tend to be noticeable, and although this is not thought to have a significant impact on bioequivalence when administered to humans, it is not suitable for measuring absorption rates over time. Furthermore, when the sample is an oil-based formulation, a sinker is used to fix the sample to the bottom to prevent floating, which limits the contact area with the solvent. Therefore, in order to increase accuracy, in this test, a dissolution test was conducted using a disintegration tester specified in the Japanese Pharmacopoeia, which does not involve forced agitation of the solvent, without fixing the sample and using an auxiliary plate to prevent floating.

[0062] A marigold pigment preparation standardized to a lutein content of 20% (product name: Lutein Fi-Fil20, Omnica Co., Ltd., or product name: Flora GLO Lutein 20% Suspension, SAF DMS Co., Ltd.) and its micronized product were used to prepare these preparations and use them as samples for the absorbability test. To investigate the absorption-promoting effect of these, polysorbate 80 was used as a dissolution aid, and a dissolution test was conducted using a disintegration tester with an auxiliary plate. After 30 minutes, the liquid was collected and the amount of carotenoid was measured by absorbance to determine the dissolution rate. The calibration curve for the dissolution rate is shown in Figure 3.

[0063] (Test Example 2-1) First, a lutein-containing composition for oral administration was prepared for use in the absorption test. Three raw materials were prepared: a marigold pigment preparation (product name: Lutein Fi-Fil20, Omnica Corporation) standardized to a marigold pigment content of 30% (lutein content of 20%) itself (0 pass); the pigment preparation was subjected to a wet micronization device (Starburst, manufactured by Sugino Machine Co., Ltd.) and treated once (1 pass) at 150 MPa; and another product was treated twice more (2 passes). The samples were as follows, and six capsules of each were prepared. Sample 1: HPMC No. 1 capsule filled with lutein Hi-Fil 20 (0 pass) 150 mg and glycerin fatty acid ester 30 mg Sample 2: HPMC No. 1 capsule filled with 150 mg of lutein Hi-Fil 20 (0 pass) and 30 mg of an equal mixture of beeswax and glycerin sugar fatty acid ester Sample 3: HPMC No. 1 capsule filled with 150 mg of lutein Hi-Fil 20 (0 pass) and 30 mg of an equal mixture of lecithin and glycerin sugar fatty acid ester Sample 4: HPMC No. 1 capsule filled with 150 mg of lutein Hi-Fil 20 treated once (1 pass) and 30 mg of an equal mixture of lecithin, sucrose fatty acid ester, and beeswax. Sample 5: HPMC No. 1 capsule filled with 150 mg of twice-processed (2-pass) lutein Hi-Fil 20 and 30 mg of an equal mixture of lecithin, sucrose fatty acid ester, and beeswax. Sample 6: HPMC No. 1 capsule filled with 150 mg of lutein Hi-Fil 20 (0 pass) and 30 mg of an equal mixture of sucrose fatty acid ester and glycerin sugar fatty acid ester

[0064] A dissolution test was carried out using a disintegration tester with a polysorbate 80 solution (0.7%). After 30 minutes, the liquid was collected and carotenoids were extracted using an organic solvent (hexane:ethyl acetate (75:25)). After diluting 100 times with ethanol, the absorbance at a wavelength of 446 nm was measured using a spectrophotometer. The total amount of lutein extracted from each of the six capsules was compared, and the results shown in Table 1 below were obtained.

[0065] [Table 1]

[0066] As shown in Table 1, it was confirmed that the dissolution rate was higher when beeswax, lecithin, and sucrose fatty acid ester were used as dispersants than when glycerin fatty acid ester was used alone (comparison of Sample 1 with Samples 2-3 and 6). It was also confirmed that the use of finely divided lutein-containing material increased the dissolution rate (comparison of sample 4 and sample 5).

[0067] (Test Example 2-2) A marigold pigment preparation standardized to a lutein content of 20% (Flora GLO Lutein 20% Suspension SAF Lot. UE02106008 DSM K.K.) was used as the raw material, and the same was treated once (one pass) at 150 MPa using a wet micronization device (Starburst: manufactured by Sugino Machine Co., Ltd.) and then used as the raw material. Each was filled into a soft capsule (coated with pork gelatin) with a content of 220 mg containing 150 mg of lutein and 40 mg of soybean oil, and the dissolution rates after 20 minutes were measured using the same method as in Test Example 2-1, and compared. That is, sample 6-1 was made using 0-pass raw materials and 30 mg of lecithin as a dispersant, sample 7-1 was made using 30 mg of sucrose fatty acid ester, sample 8-1 was made using 30 mg of beeswax, and sample 9-1 was made using glycerin fatty acid ester. Furthermore, samples 6-2, 7-2, 8-2, and 9-2 were prepared in the same manner using the first-pass raw material, and the marigold pigment components dissolved in the solvent after 20 minutes were confirmed by absorbance, and the dissolution rates were measured. In the measurement, the absorbance was measured at a wavelength of 446 nm, and the amount of lutein dissolved was calculated using the calibration curve in Figure 3 and converted into the dissolution rate. Table 2 shows the ratio of the 1-pass dissolution rate to the 0-pass dissolution rate when each dispersant was used.

[0068] [Table 2]

[0069] As shown in Table 2, when glycerin fatty acid ester was used as a dispersant, the dissolution rate hardly changed even when the lutein-containing material was micronized (samples 9-1 and 9-2), whereas when lecithin, sucrose fatty acid ester, or beeswax was used as a dispersant, it was confirmed that the dissolution rate increased due to the micronization of the lutein-containing material. [Industrial Applicability]

[0070] The composition of the present invention has excellent bioavailability of lutein and can therefore be suitably used to improve the biological functions (for example, antioxidant activity) provided by lutein.

Claims

1. A composition for oral administration containing a lutein-containing material and a dispersing agent, wherein the dispersing agent comprises at least one selected from the group consisting of lecithin, sucrose fatty acid esters, and beeswax.

2. 2. The composition according to claim 1, wherein the lutein-containing material is finely divided.

3. 3. The composition according to claim 1, wherein the dispersing agent comprises lecithin, a sucrose fatty acid ester, and beeswax.

4. 3. The composition according to claim 1, wherein the lutein-containing material is subjected to high-pressure homogenization using a wet-type micronization device, and at least a portion of the lutein-containing material is nanosized.

5. 3. The composition according to claim 2, wherein the median diameter of the finely divided lutein-containing material is 100 nm to 100 μm.

6. 3. The composition according to claim 1 or 2, wherein the lutein-containing material is at least one lutein-containing plant selected from marigold, spinach, broccoli, lettuce, green peas, kale, mulukhiyah, mugwort, komatsuna, pumpkin, prune, avocado, and carrot, or a processed product thereof.

7. 7. The composition according to claim 6, wherein the lutein-containing material is marigold.

8. The composition according to claim 1 or 2, further comprising a vegetable oil and / or an extract thereof.

9. 9. The composition according to claim 8, wherein the vegetable oil is at least one selected from the group consisting of soybean oil, safflower oil, chili pepper oil, rapeseed oil, corn oil, sunflower oil and linseed oil.

10. A method for producing a lutein-containing composition for oral administration, comprising the step of blending a lutein-containing material and a dispersant, and further comprising a step of subjecting the lutein-containing material to high-pressure homogenization treatment using a wet-type micronization device to nano-size at least a portion of the lutein-containing material to obtain a finely divided lutein-containing material.

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