Oral composition

Abstract

To provide an oral composition which comprises at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene and has an excellent bone resorption-inhibiting action.SOLUTION: There is provided an oral composition which comprises at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene and a black ginger (Kaempferia parviflora) extract.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present disclosure relates to an oral composition containing at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, and having an excellent bone resorption inhibitory effect. [Background technology]

[0002] Osteoporosis is an age-related disease caused by a decrease in calcium absorption and increased bone resorption by osteoclasts.

[0003] To prevent osteoporosis, it is important to consume a lot of calcium-rich dairy products and fish. In recent years, in addition to calcium, magnesium and vitamin D have been incorporated into nutritional functional foods as nutrients related to bone formation, and vitamin K, soy isoflavones, milk basic protein, and fructooligosaccharides have been incorporated into foods for specified health uses (FOSHU) for bone health.

[0004] Carotenoids are also known to have bone resorption inhibitory effects. For example, Patent Document 1 proposes a solid osteoporosis prevention composition containing a carotenoid-containing extract obtained by drying, cutting or crushing persimmon peel, and solvent-extracting it. Patent Document 2 also proposes a composition for preventing or treating bone diseases, containing lutein and a pharmaceutically acceptable carrier. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-191002 [Patent Document 2] International Publication No. 2014 / 175226 Summary of the Invention [Problem to be solved by the invention]

[0006] However, conventional carotenoid-containing compositions are not satisfactory in terms of bone resorption inhibitory activity, and there has been a demand for the development of an oral composition that has excellent bone resorption inhibitory activity.

[0007] An object of the present disclosure is to provide an oral composition that contains at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene and has excellent bone resorption inhibitory activity. [Means for solving the problem]

[0008] The present inventors have conducted extensive research to solve the above-mentioned problems and have unexpectedly found that by further incorporating black ginger extract into an oral composition containing at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, the bone resorption inhibitory effect is synergistically improved. The present disclosure was completed based on this finding and further research.

[0009] That is, the present disclosure provides the inventions of the following aspects. <1> An oral composition comprising at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, and a black ginger extract. <2> Paprika oil containing the carotenoids <1> The oral composition according to claim 1. <3> An oral composition for inhibiting bone resorption, <1> or <2> The oral composition according to claim 1. <4> It is an inhibitor of osteoclast differentiation. <1> or <2> The oral composition according to claim 1. <5> An oral composition for preventing or improving osteoporosis, <1> or <2> The oral composition according to claim 1. <6> A method for improving the bone resorption inhibitory effect of an oral composition containing at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, comprising: A method for improving bone resorption inhibitory activity, comprising further comprising adding black ginger extract to the oral composition. <7> A method for improving the bone resorption inhibitory effect of carotenoids, comprising allowing at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene to coexist with black ginger extract. [Effects of the Invention]

[0010] The oral composition of the present disclosure contains black ginger extract along with at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, and the synergistic effect of these ingredients provides significantly superior bone resorption inhibitory activity, making it expected to prevent or improve osteoporosis. DETAILED DESCRIPTION OF THE INVENTION

[0011] 1. Oral Composition The oral composition of the present disclosure is characterized by comprising at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, and a black ginger extract. The oral composition of the present disclosure is described in detail below.

[0012] [Carotenoids] The oral composition of the present disclosure contains at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene. When used in combination with black ginger extract, the carotenoid can impart an excellent bone resorption inhibitory effect to the oral composition.

[0013] The carotenoid used in the present disclosure may be an extract obtained by extraction from a plant or algae containing the carotenoid, or may be obtained by chemical synthesis, etc. The method for extracting the carotenoid from a plant or algae may be any common extraction method used in the production of plant extracts, such as solvent extraction, supercritical extraction, and steam distillation.

[0014] Examples of plants containing carotenoids include paprika, tomato, carrot, oil palm, marigold, spinach, red bell pepper, green bell pepper, pumpkin, persimmon, Satsuma mandarin, corn, saffron, chili pepper, shiso, parsley, watercress, kale, tea leaves, komatsuna, green onion, broccoli, okra, and asparagus.

[0015] Examples of the algae containing carotenoids include Dunaliella.

[0016] From the viewpoint of exhibiting a more excellent bone resorption inhibitory effect, the oral composition of the present disclosure preferably contains all of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene. Paprika oil (paprika extract), chili pepper extract, and bell pepper extract are preferably used because they contain all four carotenoids. In paprika oil, the content ratio (weight ratio) of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene is not particularly limited, but is typically 100:1 to 500:1 to 500:1 to 500, preferably 100:5 to 100:5 to 100, more preferably 100:10 to 50:10 to 50:10 to 75, and even more preferably 100:10 to 30:10 to 30:10 to 50.

[0017] In the oral composition of the present disclosure, the content of the carotenoid may be appropriately set depending on the form of the oral composition, the daily intake / administration amount, etc., but is, for example, 0.01 to 20% by weight, and from the viewpoint of exhibiting a more excellent bone resorption inhibitory effect, is preferably 0.05 to 15% by weight, more preferably 0.1 to 10% by weight, even more preferably 0.1 to 5% by weight, and even more preferably 0.1 to 3% by weight. However, when an extract of a plant or the like containing the carotenoid is used, the description of the content of the carotenoid in this specification refers to a value converted into the amount of the carotenoid contained in the extract.

[0018] The oral composition of the present disclosure may contain carotenoids other than the four carotenoids mentioned above.

[0019] [Black ginger extract] The oral composition of the present disclosure contains black ginger extract, and by using the carotenoid in combination with the black ginger extract, the oral composition can be endowed with an excellent bone resorption inhibitory effect.

[0020] Black ginger extract is a component obtained by performing an extraction process using black ginger as an extraction raw material. Black ginger, also known as black ginger, is a plant (Kaempferia parviflora) of the Zingiberaceae family.

[0021] The part of black ginger used as the raw material for extraction is not particularly limited, but preferably the rhizome. The rhizome of black ginger to be subjected to extraction treatment may be subjected to treatment such as drying, cutting, or crushing as necessary to increase the extraction efficiency.

[0022] The extraction treatment may be any common extraction method used in the production of plant extracts, such as solvent extraction treatment, supercritical extraction treatment, steam distillation treatment, etc. Among these, solvent extraction treatment is preferred.

[0023] Examples of extraction solvents used in solvent extraction include water; lower monohydric alcohols having 1 to 4 carbon atoms, such as methanol, ethanol, n-propanol, isopropanol, and n-butanol; polyhydric alcohols, such as propylene glycol and 1,3-butylene glycol; and mixed solvents thereof. Among these extraction solvents, water, lower monohydric alcohols, and mixed solvents thereof are preferred, more preferably water, ethanol, and mixed solvents thereof, and even more preferably a mixed solvent of water and ethanol. When a mixed solvent of water and lower monohydric alcohol is used as the extraction solvent, the ratio of water to lower monohydric alcohol is not particularly limited, but the weight ratio of water to lower monohydric alcohol is, for example, 1:99 to 90:10, preferably 5:95 to 70:30, more preferably 5:95 to 60:40, and even more preferably 5:95 to 50:50.

[0024] The solvent extraction process can be carried out by immersing or refluxing the raw material part of black ginger in the extraction solvent. After the extraction process, solid matter is removed by solid-liquid separation to obtain a plant extract. The obtained black ginger extract can be used as is as a black ginger extract, or, if necessary, a part or all of the solvent can be removed and the product can be used as a concentrate or dried product.

[0025] In the oral composition of the present disclosure, the content of black ginger extract may be appropriately determined depending on the content of the carotenoid, the form of the oral composition, the daily intake / administration amount, etc., but is, for example, 1 to 70 wt % in terms of the dry weight of the black ginger extract, and from the viewpoint of exhibiting a more excellent bone resorption inhibitory effect, is preferably 3 to 60 wt %, more preferably 5 to 55 wt %, and even more preferably 10 to 50 wt %.

[0026] In the oral composition of the present disclosure, the content ratio of the carotenoid to the black ginger extract is not particularly limited, but the content of the black ginger extract per 1 part by weight of the carotenoid, calculated as dry weight, is, for example, 1 to 1,000 parts by weight, and from the viewpoint of exhibiting a more excellent bone resorption inhibitory effect, is preferably 2 to 700 parts by weight, more preferably 3 to 500 parts by weight, even more preferably 3 to 300 parts by weight, and even more preferably 4 to 200 parts by weight.

[0027] [Other ingredients] The oral composition of the present disclosure may contain other nutritional components and pharmacological components in addition to the components described above. Such nutritional components and pharmacological components are not particularly limited as long as they are usable in foods and oral pharmaceuticals, and examples thereof include vitamins, amino acids, minerals, carbohydrates, vegetable oils and fats, fatty acids, flavorings, seasonings, plant extracts (other than the carotenoid-containing extract and black ginger extract), antioxidants, hypoglycemic agents, anticholesterol agents, immunostimulants, and the like. These components may be used alone or in combination of two or more. The content of these components is appropriately determined depending on the type of additives used and the intended use of the oral composition.

[0028] Furthermore, in order to prepare the oral composition of the present disclosure into a desired dosage form, bases and additives may be included as necessary in addition to the above-mentioned components. Such bases and additives are not particularly limited as long as they are usable in foods and oral pharmaceuticals, and examples thereof include excipients, disintegrants, lubricants, binders, thickeners, lower alcohols, solid oils, higher alcohols, water-soluble polymers, surfactants, polyhydric alcohols, pH adjusters, buffers, antioxidants, preservatives, chelating agents, and water. These may be used alone or in combination of two or more. The content of these bases and additives is appropriately determined depending on the type of ingredients used and the intended use of the oral composition.

[0029] [Dosage form / preparation type] The dosage form of the oral composition of the present disclosure is not particularly limited as long as it can be orally ingested or administered, and may be any of solid, semi-solid, or liquid, and may be appropriately selected depending on the type and use of the oral composition.

[0030] The formulation of the oral composition of the present disclosure is not particularly limited as long as it can be orally ingested or administered, and specific examples include foods and beverages and oral medicines.

[0031] When the oral composition of the present disclosure is formulated into a food or beverage, the aforementioned components may be prepared as desired, either directly or in combination with other food materials or additives. Examples of such foods and beverages include general foods and beverages, as well as foods for specified health uses, nutritional supplements, functional foods, and foods for patients. The form of these foods and beverages is not particularly limited, but specific examples include supplements such as capsules (soft capsules and hard capsules), tablets (including coated tablets), granules, powders, and jellies; beverages such as energy drinks, soft drinks, fruit juice drinks, carbonated drinks, and lactic acid drinks; and luxury items such as gummies and candies. Among these foods and beverages, supplements are preferred, capsules, tablets, granules, and powders are more preferred, and capsules are particularly preferred, with soft capsules being particularly preferred.

[0032] When the oral composition of the present disclosure is formulated into an oral pharmaceutical preparation, the aforementioned components may be prepared as desired, either directly or in combination with other additives. Specific examples of such oral pharmaceutical preparations include capsules (soft capsules, hard capsules), tablets (including coated tablets), granules, powders, jellies, syrups, and liquids. Among these oral pharmaceutical preparations, capsules, tablets, granules, and powders are preferred, capsules are more preferred, and soft capsules are even more preferred.

[0033] [Application] The use of the oral composition of the present disclosure is not particularly limited, but since it exhibits excellent bone resorption inhibitory activity, it can be suitably used as an oral composition for inhibiting bone resorption. As used herein, an oral composition for inhibiting bone resorption refers to an oral composition used for the purpose of inhibiting bone resorption by inhibiting osteoclast differentiation in a subject. Furthermore, since the oral composition of the present disclosure can effectively inhibit osteoclast differentiation in a subject, it can be suitably used as an osteoclast differentiation inhibitor. Furthermore, since the oral composition of the present disclosure has excellent bone resorption inhibitory activity, it can be used for the purpose of preventing or ameliorating osteoporosis. Preventing osteoporosis means preventing the onset of osteoporosis before it occurs. Ameliorating osteoporosis means reducing the severity of osteoporosis that has already developed.

[0034] [Intake or dosage] The intake or dosage of the oral composition of the present disclosure is not particularly limited and is set appropriately depending on the formulation, use, etc., but for example, for an adult, the intake or dosage of the carotenoid per day may be set to be approximately 0.04 to 300 mg, preferably 0.7 to 100 mg.

[0035] 2. Method for improving the bone resorption inhibitory effect of an oral composition The present disclosure provides a method for improving the bone resorption inhibitory effect of an oral composition containing at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, which method comprises further comprising adding black ginger extract to the oral composition.

[0036] 3. Method for improving the bone resorption inhibitory effect of carotenoids The method of the present disclosure for improving the bone resorption inhibitory effect of carotenoids is characterized by coexisting at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene with black ginger extract.

[0037] In the above method, the types and amounts of ingredients used, as well as embodiments, are as described in the section "1. Oral composition." [Example]

[0038] The present disclosure will be described below with reference to examples, but the present disclosure is not limited to these examples.

[0039] The compositions of the components used in the following Examples, Comparative Examples, and Formulation Examples are as follows: Paprika oil: An extract obtained by solvent extraction of paprika, containing capsanthin, zeaxanthin, β-cryptoxanthin, and β-carotene. The total content of capsanthin, zeaxanthin, β-cryptoxanthin, and β-carotene is 12% by weight. The weight ratio of capsanthin, zeaxanthin, β-cryptoxanthin, and β-carotene is 5:1:1:2. · Tomato extract carotenoids: Contains beta-carotene. ·Oil palm extract carotenoids: Contains beta-carotene. Marigold extract carotenoids: Contains beta-carotene. Carrot extract carotenoids: Contains beta-carotene. · Dunaliella extract carotenoids: Contains β-carotene. Black ginger extract: A dried powder of extract obtained by extracting black ginger rhizomes with an aqueous ethanol solution.

[0040] Test Example 1 The following materials were used for the medium: MEMα medium (liquid) was prepared by adding fetal bovine serum (FBS) in an amount of 10% by weight, penicillin-streptomycin solution in an amount of 50 mg / ml, and 100x MEM non-essential amino acids (NEAA) in an amount such that the non-essential amino acid concentration was 0.5 mM. MEMα (L-glutamine, phenol red-free) (Fujifilm Wako Pharmaceuticals: Product No. 135-15175) Penicillin-streptomycin solution (100%) (Fujifilm Wako Pure Chemical Industries, Ltd.: Product No. 168-23191) 100x MEM Non-Essential Amino Acids (NEAA) (KAC Corporation) Fetal bovine serum (FBS) (HYC: Product No. SH30068.02)

[0041] Test sample solutions were prepared by mixing paprika oil dissolved in dimethyl sulfoxide, black ginger extract dissolved in a solution of equal parts ethanol and phosphate buffer, and 115 ng / ml RANKL with medium. Test sample solutions were also prepared by mixing paprika oil dissolved in dimethyl sulfoxide and 115 ng / ml RANKL with medium. Test sample solutions were also prepared by mixing black ginger extract dissolved in a solution of equal parts ethanol and phosphate buffer with 115 ng / ml RANKL with medium. Evaluation reference solutions were also prepared by mixing 115 ng / ml RANKL with medium.

[0042] 2 x 10 in medium 4 A suspension of RAW264 cells (a macrophage-like cell line derived from Balb / c mice, ECACC strain no. 85062803) adjusted to cells / ml was seeded into each well of a 96-well plate at 100 μl / well. 24 hours after seeding, the medium was replaced, and each test sample solution and the evaluation standard solution were added so that the carotenoid concentrations in paprika oil and black ginger extract were as shown in Table 1. The total volume was adjusted to 100 μl / well, and the cells were cultured at 37°C in the presence of CO for 72 hours. After culture, the absorbance at 405 nm was measured using a microplate reader with a TRAP solution kit (Oriental Yeast, product no. 47249000). The measured absorbance at 405 nm was used to calculate the osteoclast differentiation inhibition rate according to the following formula. Each test was performed in duplicate, and the average of the obtained osteoclast differentiation inhibition rates was used as the evaluation value for bone resorption inhibition. The higher the osteoclast differentiation induction inhibition rate, the stronger the bone resorption inhibitory effect. The results are shown in Table 1. Osteoclast differentiation induction inhibition rate (%)=[1-(absorbance of wells to which test sample solution was added / absorbance of wells to which evaluation reference solution was added)]×100

[0043] [Table 1]

[0044] As shown in Examples 1 to 3, it was found that when paprika oil and black ginger extract were used in combination, the bone resorption inhibitory effect was synergistically enhanced compared to when they were used alone (Comparative Examples 1 to 3).

[0045] Prescription example Soft capsules (containing 250 mg of inner liquid and 185 mg of outer capsule per capsule) were manufactured using the inner liquid with the composition shown in Table 2 and the outer capsule with the composition shown in Table 3. All of the obtained soft capsules had excellent bone resorption inhibitory effects.

[0046] [Table 2]

[0047] [Table 3]

Claims

1. An oral composition comprising at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, and a black ginger extract.

2. 10. The oral composition of claim 1, comprising paprika oil containing the carotenoid.

3. The oral composition according to claim 1, which is an oral composition for inhibiting bone resorption.

4. The oral composition according to claim 1, which is an inhibitor of osteoclast differentiation.

5. The oral composition according to claim 1, which is an oral composition for preventing or ameliorating osteoporosis.

6. A method for improving the bone resorption inhibitory effect of an oral composition containing at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene, comprising: A method for improving bone resorption inhibitory activity, comprising further comprising adding black ginger extract to the oral composition.

7. A method for improving the bone resorption inhibitory effect of carotenoids, comprising allowing at least one carotenoid selected from the group consisting of capsanthin, β-cryptoxanthin, zeaxanthin, and β-carotene to coexist with a black ginger extract.

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