Bone density improving agent

Abstract

The purpose of this disclosure is to provide novel health applications for compositions containing black ginger components. [Solution] A composition containing (A) black ginger and / or its extract, and (B) B vitamins, is useful as a bone density improving agent.

Description

Technical Field

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[0007] In other words, this disclosure provides inventions in the following embodiments. Item 1. A bone density improving agent containing (A) black ginger and / or its extract, and (B) B vitamins. Item 2. The bone density improving agent described in Item 1, applicable to individuals with a BMI of 30 or higher. Item 3. The bone density improving agent according to item 1 or 2, wherein the (B) component is selected from the group consisting of vitamin B2 and vitamin B5. Item 4. A bone mass improving agent according to any one of items 1 to 3, comprising 0.05 to 1 part by weight of component (B) per 1 part by weight of component (A). [Effects of the Invention]

[0008] According to the bone density improving agent of this disclosure, bone density can be improved by combining black ginger and / or its extract with B vitamins. [Modes for carrying out the invention]

[0009] The bone density improving agent of this disclosure is characterized by containing (A) black ginger and / or its extract (hereinafter also referred to as "component (A)") and (B) vitamin B (hereinafter also referred to as "component (B)"). The bone density improving agent of this disclosure will be described in detail below. In this disclosure, the numerical range "X~Y" refers to a range of X or more and Y or less.

[0010] (A) Black ginger and / or its extract In the bone density improving agent disclosed herein, black ginger is also known as black ginger and is a plant (Kaempferia parviflora) belonging to the genus Kaempferia in the family Zingiberaceae.

[0011] In the bone density improving agent of this disclosure, component (A) may be black ginger itself (typically dried black ginger powder) or an extract of black ginger. In either case, there are no particular restrictions on the part used, but the rhizome is preferred. Among these, an extract of black ginger is preferred from the viewpoint of further enhancing the bone density improving effect.

[0012] For the extraction process to obtain black ginger extract, any common extraction method used in the production of plant extracts is acceptable, such as solvent extraction, supercritical fluid extraction, or steam distillation. Among these, solvent extraction is preferred.

[0013] Examples of extraction solvents used in solvent extraction processes include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; hydrophilic solvents such as acetone; and mixed solvents thereof. Among these extraction solvents, water, lower 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. In the mixed solvent of water and lower alcohol, the ratio of water to lower alcohol is not particularly limited, but for example, the lower alcohol content should be about 5 to 90% by weight, preferably about 20 to 80% by weight, and even more preferably about 40 to 80% by weight.

[0014] The solvent extraction process involves immersing the target part of black ginger (preferably the rhizome), which has been dried, cut, or crushed as necessary to improve extraction efficiency, in an extraction solvent and stirring as needed. For example, immersion in approximately 0.3 to 20 L of extraction solvent, preferably 0.5 to 1.5 L, per 100 g of the target part of black ginger can be performed for approximately 0.5 to 24 hours. The temperature conditions for the solvent extraction process are not particularly limited, but for example, 40 to 95°C is acceptable.

[0015] After the extraction process, solid matter is removed by solid-liquid separation to obtain an extract (extract solution) of black ginger. The extract solution obtained from the extraction process may be purified by filtration or adsorption treatment using various chromatography methods such as polystyrene gel (polystyrene-divinylbenzene copolymer, etc.), ion exchange resin, or activated carbon columns packed with carriers. The obtained extract solution may be used as is as a non-concentrated extract, or it may be subjected to a concentration process to be used as a soft extract, or further dried to be used as an extract powder.

[0016] In the bone mass improving agent of this disclosure, component (A) typically contains polymethoxyflavones. The amount of polymethoxyflavones contained in component (A) is, for example, 1 to 15 parts by weight, preferably 5 to 13 parts by weight, and more preferably 6 to 10 parts by weight per 100 parts by weight (dry weight) of component (A).

[0017] In the bone mass improving agent of this disclosure, the content of component (A) can be appropriately set depending on the form of the bone mass improving agent, but for example, on a dry weight basis, it can be 5 to 70% by weight, preferably 10 to 50% by weight, more preferably 15 to 30% by weight, and even more preferably 17 to 25% by weight.

[0018] In the bone mass improving agent of this disclosure, the content of polymethoxyflavones in component (A) is determined according to the content of component (A) and the content of polymethoxyflavones in component (A), but for example, it can be 0.4 to 6% by weight, preferably 0.9 to 4.5% by weight, more preferably 1.3 to 2.5% by weight, and even more preferably 1.5 to 2.2% by weight.

[0019] (B) Vitamin B In the bone mass improving agent of the present disclosure, examples of vitamin Bs include vitamin B1s, vitamin B2s, vitamin B3s, vitamin B5s, vitamin B6s, vitamin B7, vitamin B9s, and vitamin B12s. These vitamin Bs may be used alone or in combination of two or more.

[0020] Vitamin B1s include thiamine, its derivatives (e.g., thiamine disulfide, octothiamine, ciclotiamine, bisibuthiamine, bisbentiamine, dicitiamine, bisthiamine, furfurylthiamine, prosultiamine, benfotiamine, etc.), and their salts [e.g., inorganic acid salts (hydrochloride salts such as thiamine hydrochloride, furfurylthiamine hydrochloride, dicitiamine hydrochloride, etc., nitrate salts such as thiamine nitrate, bisthiamine nitrate, etc., sulfate salts such as thiamine dicityl sulfate ester salt, etc.)]. These vitamin B1s may be used alone or in combination of two or more.

[0021] Vitamin B2s include riboflavin, its esters (e.g., riboflavin phosphate ester, riboflavin butyrate ester, etc.), and their salts [e.g., alkali metal salts (sodium salts such as sodium riboflavin phosphate, sodium flavin adenine dinucleotide, etc.)]. These vitamin Bs may be used alone or in combination of two or more.

[0022] Vitamin B3s include niacin (a general term for nicotinic acid and nicotinamide), and their salts. These vitamin B3s may be used alone or in combination of two or more.

[0023] Vitamin B5 compounds include pantothenic acid, its derivatives (pantothenyl alcohol (panthenol), D-panthesine, D-pantethine, coenzyme A, pantothenyl ethyl ether, etc.), and their salts [for example, alkaline earth metal salts (calcium salts such as calcium pantothenate, etc.), alkali metal salts (sodium salts such as sodium pantothenate, etc.)]. These vitamin B5 compounds may be used individually or in combination of two or more.

[0024] Vitamin B6 compounds include pyridoxine, its derivatives (e.g., pyridoxal, pyridoxamine, and their 5'-phosphate esters), and their salts (e.g., inorganic salts (e.g., pyridoxine hydrochloride salts, pyridoxal phosphate salts, etc.)). These vitamin B6 compounds may be used individually or in combination of two or more.

[0025] Vitamin B7 refers to biotin.

[0026] Vitamin B9s include folic acid (horacin) and its pharmaceutically acceptable salts. These vitamin B9s may be used individually or in combination of two or more types.

[0027] Vitamin B12s include cobalamin, its pharmaceutically acceptable derivatives (e.g., adenosylcobalamin, methylcobalamin, sulfitocobalamin, hydroxocobalamin, cyanocobalamin, etc.), and their pharmaceutically acceptable salts [(e.g., inorganic salts (e.g., hydrochloride salts of hydroxocobalamin hydrochloride, etc.), organic salts (e.g., acetate salts of hydroxocobalamin acetate, etc.)]. These vitamin B12s may be used individually or in combination of two or more.

[0028] Among these B vitamins, vitamin B2 and vitamin B5 are preferred from the viewpoint of further enhancing the bone density improvement effect, and vitamin B2 and pantothenic acid are preferred.

[0029] In the bone mass improving agent of this disclosure, the content of component (B) may be set appropriately depending on the form of the bone mass improving agent, but the content (total amount) of component (B) per 1 part by weight (dry weight equivalent) of component (A) is, for example, 0.05 to 1 part by weight, preferably 0.1 to 0.6 parts by weight, and more preferably 0.2 to 0.4 parts by weight.

[0030] Furthermore, the content (total amount) of component (B) per 1 part by weight of polymethoxyflavone can be, for example, 0.6 to 13 parts by weight, preferably 1.2 to 7.5 parts by weight, and more preferably 2.5 to 5 parts by weight.

[0031] When the bone mass improving agent of this disclosure contains vitamin B2 and / or vitamin B5 as component (B), the content of vitamin B2 and vitamin B5 is not particularly limited, but the content of vitamin B2 (total amount) per 1 part by weight (dry weight equivalent) of component (A) is, for example, 0.01 to 0.3 parts by weight, preferably 0.03 to 0.17 parts by weight, more preferably 0.06 to 0.1 parts by weight; and the content of vitamin B5 (total amount) per 1 part by weight (dry weight equivalent) of component (A) is, for example, 0.035 to 0.7 parts by weight, preferably 0.07 to 0.4 parts by weight, more preferably 0.15 to 0.3 parts by weight.

[0032] Furthermore, if the bone density improving agent of this disclosure contains vitamin B2 and / or vitamin B5 as component (B), the content of vitamin B2 (total amount) per 1 part by weight of polymethoxyflavone may be, for example, 0.1 to 4 parts by weight, preferably 0.4 to 2 parts by weight, and more preferably 0.7 to 1.2 parts by weight; and the content of vitamin B5 (total amount) per 1 part by weight of polymethoxyflavone may be, for example, 0.05 to 0.8 parts by weight, preferably 1 to 5 parts by weight, and more preferably 2 to 3.5 parts by weight.

[0033] Other ingredients The bone density improving agent of this disclosure may contain other nutritional components and / or pharmacological components in addition to the components (A) and (B) described above. Such nutritional components and pharmacological components are not particularly limited as long as they can be used in food and / or oral medicines, but examples include vitamins (other than the above component (B)), amino acids, minerals, carbohydrates, fatty acids, flavorings, seasonings, plant extracts (other than extracts of the above component (A)), hypoglycemic agents, anticholinergic agents, immunostimulants, etc. These components may be used individually or in combination of two or more. The content of these components will be appropriately determined depending on the type of additive used and / or the intended use of the bone density improving agent.

[0034] The bone density improving agent of this disclosure may contain a base and / or additives as necessary to prepare it into a desired formulation. Such bases and additives are not particularly limited as long as they can be used in food and / or oral pharmaceuticals, but examples include water, lower (1-5 carbon) monohydric alcohols, polyhydric alcohols, oily bases [solid oils, higher (6 or more carbon) alcohols, higher (6 or more carbon) fatty acids, etc.], surfactants, excipients, disintegrants, lubricants, binders, thickeners, pH adjusters, buffers, antioxidants, preservatives, chelating agents, etc. These may be used individually or in combination of two or more.

[0035] Dosage form / form The dosage form of the bone density improving agent disclosed herein is not particularly limited and may be a solid preparation (specifically, a powder, granules, tablets, capsules, etc.), a semi-solid preparation (specifically, a paste, gel, etc.), or a liquid preparation.

[0036] The formulation of the bone density improving agent described herein is typically any form that can be taken orally, and may be either a food product or an oral pharmaceutical product.

[0037] When the bone density improving agent of this disclosure is put into food formulation form, the aforementioned components (A) and (B), and other components added as needed, should be prepared in the desired form. Such foods can be classified as general foods and beverages, as well as foods for specified health uses, nutritional supplements, foods with functional claims, foods for sick people, etc.

[0038] Purpose The bone mass improving agent disclosed herein is used for the purpose of improving bone mass. Bone mass refers to the total amount of minerals contained in the bone (i.e., estimated bone mass, also more accurately called bone mineral content).

[0039] The bone density improving agent described herein is not particularly limited in terms of BMI (Body Mass Index), but from the viewpoint of further enhancing the effect of improving exercise habits, it is preferably applied to individuals with a BMI of 30 or higher, and more preferably to individuals with a BMI of 30 or higher but less than 40.

[0040] The bone mass improving agent of this disclosure can increase bone mass independently of exercise. Therefore, preferred applications of the bone mass improving agent of this disclosure include those who do not require an increase in exercise frequency.

[0041] Dosage / Usage Examples of the daily dose of the bone density improving agent of this disclosure include, for example, 50 to 300 mg of component (A), preferably 80 to 250 mg, more preferably 100 to 200 mg, and even more preferably 130 to 170 mg; and for example, 4.5 to 27 mg of polymethoxyflavone, preferably 7 to 23 mg, more preferably 10 to 20 mg, and even more preferably 12 to 15 mg.

[0042] The bone density improving agent of this disclosure is typically taken orally.

[0043] The duration of administration of the bone density improving agent of this disclosure is not particularly limited, but examples include 2 weeks or more, preferably 3 weeks or more, and more preferably 4 weeks or more. [Examples]

[0044] The present disclosure will be explained in more detail below with reference to examples, but the present disclosure is not limited to these examples.

[0045] Test foods (tablets) with the composition shown in Table 1 were prepared. The black ginger extract was a dried powder of an extract obtained by extracting the rhizome of black ginger (Kaempferia parviflora) with an aqueous ethanol solution, and it contains 8% by weight of polymethoxyflavones.

[0046] [Table 1]

[0047] Nine male and female subjects with a BMI of 30 or higher (more specifically, the BMI of these subjects was in the range of 30 to less than 40) were given the test food at the doses shown in Table 1 for four weeks. The subjects were not informed that they were taking the test food for the purpose of improving bone density. No lifestyle guidance was provided to the subjects during the study period.

[0048] Estimated bone mass was measured using the Tanita "InnerScan Dual RD-803L / 804L" body composition analyzer before intake and 4 weeks after intake, and the measured values ​​were averaged. As a result, the average bone mass before intake was 2.9 kg, while the average bone mass after 4 weeks of intake was 3.0 kg, indicating an improvement in bone mass. Among these subjects, some showed an increase in bone mass despite a decrease in the frequency of exercise (light exercise that causes sweating) during the study period, confirming that the test food can increase bone mass independently of exercise.

Claims

1. A bone density improving agent containing (A) black ginger and / or its extract, and (B) B vitamins.

2. A bone density improving agent according to claim 1, applicable to persons with a BMI of 30 or higher.

3. The bone density improving agent according to claim 1, wherein the (B) component is selected from the group consisting of vitamin B2 and vitamin B5.

4. The bone mass improving agent according to claim 1, wherein the agent contains 0.05 to 1 part by weight of component (B) per 1 part by weight of component (A).

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