Solid preparation

JP2025036048AInactive Publication Date: 2025-03-14FEILEB CO LTD
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Patent Information

Application Number
JP2024062524
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-04-09
Publication Date
2025-03-14
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Benefits of technology

【0019】 本発明によれば、豆抽出物にフラクトオリゴ糖とアカシア食物繊維を組合わせて利用したので、錠剤等への製剤化が容易となる。加えて、リンゴ食物繊維を利用することにより、錠剤等への製剤化が更に容易となる。

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Abstract

To provide a solid preparation of a bean extract which is configured to facilitate formulation into a tablet, etc.SOLUTION: A solid preparation contains a bean extract, fructo oligosaccharide, and acacia dietary fiber. A method for manufacturing a solid preparation includes: a raw material mixing step of obtaining a mixed raw material by mixing a raw material A that contains a bean extract and is prepared into a powder, and a raw material B that contains fructo oligosaccharide and acacia dietary fiber and is prepared into a granule; and a compression step of compressing the mixed raw material into a predetermined shape.SELECTED DRAWING: None
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Description

[Technical field]

[0001] The present invention relates to a solid preparation that enables nutritional components to be ingested conveniently on a daily basis. [Background technology]

[0002] In recent years, it has become known to use ferritin iron for iron supplementation. Ferritin iron is a protein-iron complex consisting of a globular protein made up of 24 subunits and iron held within its cage-like structure. Ferritin binds to iron in the body, keeping it water-soluble and non-toxic, and playing a role in concentrating and storing it. It is also thought to play a role in preventing iron deficiency or excess.

[0003] Regarding the use of ferritin iron, for example, Patent Document 1 describes the preparation of a ferritin iron-containing material from legumes, and discloses its use in nutritional supplements and the like. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent No. 5896543 Summary of the Invention [Problem to be solved by the invention]

[0005] However, according to the investigations of the present inventors, soybean extracts used as ferritin iron-containing materials have a high protein content and tend to adhere to the punches and dies of tablet presses, making it difficult to formulate them.

[0006] In view of the above circumstances, an object of the present invention is to provide a solid preparation of a bean extract which can be easily formulated into tablets or the like. [Means for solving the problem]

[0007] Means for Solving the Problems The present inventors have conducted extensive research to achieve the above object and have discovered that the above problems can be solved by using specific oligosaccharides and dietary fibers, thereby completing the present invention.

[0008] That is, in a first aspect, the present invention provides a solid preparation containing a bean extract, a fructooligosaccharide, and an acacia dietary fiber.

[0009] The solid preparation preferably contains a bean-derived protein-containing material having a protein content of 50% by mass or more as the bean extract. In this case, the bean-derived protein-containing material preferably contains 10% by mass or more of ferritin having a molecular weight of 23 to 27 kDa. In addition, the material preferably contains 3% by mass or more of bean-derived ferritin iron in terms of iron content.

[0010] The above solid preparation may further contain apple dietary fiber.

[0011] The solid preparation preferably contains 40 to 65% by mass of the bean extract, 15 to 35% by mass of the fructooligosaccharide, and 15 to 35% by mass of the acacia dietary fiber.

[0012] When the above solid preparation contains the apple dietary fiber, it is preferable that the solid preparation contains 25 to 50% by mass of the bean extract, 15 to 30% by mass of the fructooligosaccharide, 15 to 30% by mass of the acacia dietary fiber, and 10 to 20% by mass of the apple dietary fiber.

[0013] On the other hand, in a second aspect, the present invention provides a method for producing a solid formulation, comprising a raw material mixing step of mixing raw material A containing a bean extract and prepared into a powder, and raw material B containing fructooligosaccharides and acacia dietary fiber and prepared into granules to obtain a mixed raw material, and a tableting step of tableting the mixed raw material into a predetermined shape.

[0014] In the method for producing the solid preparation, it is preferable to use a bean-derived protein-containing material having a protein content of 50% by mass or more as the bean extract. In this case, it is preferable that the bean-derived protein-containing material contains 10% by mass or more of ferritin having a molecular weight of 23 to 27 kDa. It is also preferable that the material contains 3% by mass or more of bean-derived ferritin iron in terms of iron content.

[0015] In the above-mentioned method for producing a solid preparation, in the raw material mixing step, powdered apple dietary fiber may be further mixed to obtain the mixed raw material.

[0016] In the above-mentioned method for producing a solid preparation, it is preferable that the raw material B contains 48 to 52% by mass of the fructooligosaccharide and 42 to 48% by mass of the acacia dietary fiber.

[0017] In the above-mentioned method for producing a solid preparation, it is preferable that the solid preparation contains 40 to 65% by mass of the bean extract, 15 to 35% by mass of the fructooligosaccharide, and 15 to 35% by mass of the acacia dietary fiber.

[0018] In the above-mentioned method for producing a solid preparation, when the solid preparation contains the apple dietary fiber, it is preferable that the solid preparation contains 25 to 50% by mass of the bean extract, 15 to 30% by mass of the fructooligosaccharide, 15 to 30% by mass of the acacia dietary fiber, and 10 to 20% by mass of the apple dietary fiber. Effect of the Invention

[0019] According to the present invention, the bean extract is combined with fructooligosaccharides and acacia dietary fiber, which makes it easy to formulate the product into tablets, etc. In addition, the use of apple dietary fiber makes it even easier to formulate the product into tablets, etc. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The bean extract used in the present invention may be any edible material containing nutritional components derived from beans, and is not particularly limited. For example, it may be a bean-derived protein-containing material prepared using a legume as a raw material. The bean-derived protein includes ferritin, which is an iron-binding protein. Examples of legumes include soybeans, lentils, kidney beans, chickpeas, broad beans, adzuki beans, peas, peanuts, flower beans, mung beans, peas, cowpeas, lupins, etc. In addition, the parts of legumes used as raw materials may be parts other than legumes, such as leaves, stems, vines, sheaths, roots, seeds, and flowers, or a combination of multiple parts of these parts. Furthermore, sprouts may be used as raw materials.

[0021] The bean-derived protein-containing material is preferably a material having a protein content of 50% by mass or more. It is also preferable that the material contains 10% by mass or more of ferritin having a molecular weight of 23 to 27 kDa. It is also preferable that the material contains 3% by mass or more of bean-derived ferritin iron as an iron content. In this case, the iron content may be typically 3.5 to 6.5% by mass, more typically 4 to 6% by mass, etc. In addition, since soybean-derived ferritin iron-containing materials such as "Mame-Tetsu" (product name, manufactured by SloIron Co., Ltd.) are commercially available, such commercially available products may be used.

[0022] In general, edible materials containing nutrients derived from beans may contain phospholipids and isoflavone compounds derived from beans in addition to ferritin iron and other proteins. The bean extract used in the present invention typically has a lipid content of 5% by mass or less, more typically 0.5 to 3.5% by mass. The isoflavone compound content is typically 2% by mass or less, more typically 0.5% by mass or less.

[0023] The method for obtaining the above-mentioned bean extract composition is not particularly limited, but for example, the water-soluble extract of the bean raw material may be subjected to a treatment for concentrating the protein fraction by salting out, or a treatment for decomposing carbohydrates with one or more types of glycosidase enzymes, and then subjected to a molecular weight fractionation means such as ultrafiltration. In this case, the water-soluble extract of the bean raw material may be subjected to both salting out and enzyme treatment, and the order of treatment may be either salting out or enzyme treatment. Examples of glycosidase enzymes include α-amylase, β-amylase, α-galactosidase, β-galactosidase, β-glucosidase, xylanase, cellulase, cellobiohydrolase, xylosidase, mannanase, glucuronidase, arabinanase, arabinofuranosidase, galactanase, pectin lyase, etc.

[0024] The fructooligosaccharide used in the present invention may be any edible material containing fructooligosaccharide, which is a resistant oligosaccharide, and is not particularly limited. For example, it may be a fructooligosaccharide-containing material obtained by transferring fructose to sucrose by an enzymatic reaction. In this way, a material that is substantially free of inulin, which causes hygroscopicity, can be used. More specifically, the fructooligosaccharide may be a material that contains, as a main component, 1-kestose (GF2), in which 1 to 3 molecules of fructose are bound to sucrose, nystose (GF3), fructofuranosylnystose (GF4), or a mixture thereof. Note that, since "Mei Oligo P" and "Mei Oligo G" (trade names, both of which are Meiji Food Materials Co., Ltd.) are commercially available as fructooligosaccharide-containing materials, such commercially available products may be used.

[0025] The acacia dietary fiber used in the present invention may be any edible material containing a polymeric polysaccharide also called gum arabic, obtained from sap exuded from a tree of the Acacia genus of the legume family (acacia), and is not particularly limited. However, gum balls, which are dried sap, may be used without undergoing processes such as desalting and decolorization. This allows the use of materials with less unusual flavors. More specifically, the molecular weight range of the polymeric polysaccharides constituting the acacia dietary fiber may typically be 380 to 850 kDa, and more typically may be 400 to 650 kDa. In addition, since "Fiber Gum P" and "Fiber Gum TAN" (trade names, both of which are manufactured by Nexira Co., Ltd.) are commercially available as acacia dietary fiber-containing materials, such commercially available products may be used.

[0026] The apple dietary fiber used in the present invention is not particularly limited as long as it is an edible material obtained by crushing and grinding apple fruits, drying, and further powdering, but it may be one obtained by adjusting the composition ratio of soluble dietary fiber and insoluble dietary fiber by changing the utilization ratio of parts that constitute the fruit, such as the pulp, the skin, and the seeds. More specifically, the content of insoluble dietary fiber in the apple dietary fiber-containing material may be typically 30 to 50% by mass, more typically 35 to 45% by mass. The content of soluble dietary fiber may be typically 10 to 30% by mass, more typically 10 to 15% by mass. The content of pectin among the soluble dietary fibers in the apple dietary fiber-containing material may be typically 0.1 to 10% by mass, more typically 0.1 to 5% by mass. In addition, apple dietary fiber-containing materials that are high in dietary fiber are commercially available, such as "Vitacel AF401" and "Vitacel AF401 / 30" (both product names, manufactured by Rettenmeyer Japan Co., Ltd.), so such commercially available products may be used.

[0027] The present invention provides a solid preparation containing the above-described bean extract in combination with the above-described fructooligosaccharides and acacia dietary fiber. According to this solid preparation, even when the mixed raw material is fed to a tablet press, it does not stick to the punch or die and has good releasability. Therefore, it is easy to prepare the preparation. In addition, in any non-limiting embodiment, the above-described apple dietary fiber may be further contained. According to this, even when the mixed raw material is fed to a tablet press, it does not stick to the punch or die and has good releasability. Therefore, it is easy to prepare the preparation.

[0028] In general, the formulation of tablets used in supplements requires various characteristics of the raw materials used, such as the fluidity of the mixed powder, the binding property during tableting, and the releasability from the tablet press. For example, the releasability from the tablet press can be easily achieved by using lubricants such as calcium stearate and sucrose esters. On the other hand, for people with chemical sensitivity, calcium stearate, sucrose esters, and hardened rapeseed oil (hydrogenated rapeseed oil) are substances that should be avoided and cannot be used. There is also a strong demand from consumers who choose food ingredients derived from organic agricultural products, such as organic soybeans.

[0029] Therefore, the solid preparation applied in accordance with the present invention preferably does not contain a lubricant such as calcium stearate or a sucrose ester.

[0030] On the other hand, from the viewpoint of blending as much bean extract as possible, it is preferable that the product contains 40 to 65% by mass of bean extract, 15 to 35% by mass of fructooligosaccharides, and 15 to 35% by mass of acacia dietary fiber.When apple dietary fiber is contained, it is preferable that the product contains 25 to 50% by mass of bean extract, 15 to 30% by mass of fructooligosaccharides, 15 to 30% by mass of acacia dietary fiber, and 10 to 20% by mass of apple dietary fiber.

[0031] The solid preparation provided by the present invention can be produced by a conventional formulation technique, for example, by feeding the raw material containing the edible ingredient described above to a tablet production line.

[0032] In any non-limiting embodiment of the present invention, the manufacturing method preferably comprises a raw material mixing step of mixing raw material A containing a bean extract and prepared into a powder with raw material B containing fructooligosaccharides and acacia dietary fiber and prepared into granules to obtain a mixed raw material, and a tableting step of tableting the obtained mixed raw material into a predetermined shape. In this case, the mixed raw material may optionally contain apple dietary fiber prepared into a powder.

[0033] According to this embodiment, the raw material B prepared as granules has a relatively porous structure, so that other raw materials prepared as powders are included in the porous structure, and thus the raw materials are more easily dispersed and mixed, and the binding between the raw materials is improved, and the tableting property is also improved. In this case, the method of preparing fructooligosaccharides and acacia dietary fiber into granules is not particularly limited and can be any method, but for example, the raw material aqueous solution containing fructooligosaccharides and acacia dietary fiber can be vacuum dried or spray dried, and then appropriately crushed or pulverized after drying. The particle size of the granules of raw material B can be 18 mesh pass 40 mesh on, etc. In addition, the particle size of the powder raw material to be mixed with the granules of raw material B, such as raw material A and apple dietary fiber, can be 60 mesh pass 200 mesh on, etc.

[0034] The solid preparation provided by the present invention can be used in various product forms, such as health foods, supplements, nutritional supplements, functional foods, medicines, quasi-drugs, health foods for animals, supplements for animals, nutritional supplements for animals, functional foods for animals, medicines for animals, etc., or in combination with these products. In addition, it can be used as general food and drink products or animal feed, or in combination with general food and drink products or animal feed.

[0035] The amount of iron described in this specification can be measured by well-known analytical methods, such as atomic absorption spectrometry or ICP mass spectrometry.

[0036] In addition, when analyzing the bean extract, the bean extract is separated into a high molecular weight layer and a low molecular weight layer by a molecular weight fractionation means such as an ultrafiltration membrane, and the amount of iron is analyzed by the above-mentioned analytical method, so that the amount of iron contained as ferritin iron can be obtained from the analysis of the high molecular weight layer, and the total amount of iron including free iron and iron salts can be obtained from the analysis of the low molecular weight layer.

[0037] The amount of dietary fiber can be analyzed by a method well known in the field of food analysis. For example, the total dietary fiber excluding low molecular weight water-soluble dietary fiber can be measured by an enzymatic-gravimetric method (Prosky method) or the like. The total dietary fiber including low molecular weight water-soluble dietary fiber can be measured by an enzymatic-HPLC method (AOAC2001.03 method) or the like. The soluble dietary fiber including low molecular weight water-soluble dietary fiber can be measured by an enzymatic-HPLC method (AOAC2011.25 method) or the like. The insoluble dietary fiber can be measured by an enzymatic-HPLC method (AOAC2011.25 method) or the like. Among the water-soluble dietary fibers, pectin can be measured by an m-hydroxydiphenyl method or the like.

[0038] The amount of protein can be analyzed by a method well known in the food analysis field, such as the nitrogen quantitative conversion method, the Kjeldahl method, or the combustion method.

[0039] The amount of lipids can be measured by well-known analytical methods for food analysis, such as acid decomposition method and solvent extraction-gravimetric method.

[0040] Furthermore, the amount of isoflavone compounds can be measured by HPLC analysis using as an index a standard sample of isoflavone compounds prepared to a specific concentration.

[0041] The molecular weight of proteins and polysaccharides can be measured by the GPC method (HPLC method using a GPC column) or the like. EXAMPLES

[0042] The present invention will be described in more detail below with reference to examples, although the scope of the present invention is not limited to these examples.

[0043] [Test Example 1] [1-1. Materials] Raw material A: Soy bean extract (Anti-Aging Pro Co., Ltd.) (Powder form: iron content 5% or more by weight, ferritin content 10% or more by weight, protein content 52% by weight, particle size: 160 mesh passes, 80% or more) Raw material B: Material containing fructooligosaccharides and acacia dietary fiber (product name "Oligo and Acacia", Meiji Food Materials Co., Ltd.) (granule shape: contains 45% or more by mass of fructooligosaccharides and 45% or more by mass of acacia dietary fiber, particle size standard: 18 mesh or less)

[0044] [1-2. Test group] (A) Raw material A: 60 parts by mass Raw material B: 40 parts by mass (B) Raw material A: 50 parts by mass Raw material B: 50 parts by mass (C) Raw material A: 40 parts by mass Raw material B: 60 parts by mass (D) Raw material A: 30 parts by mass Raw material B: 70 parts by mass

[0045] [1-3. Tablet compression] Raw materials A and B were mixed to obtain a mixed raw material, which was then subjected to a benchtop prototype tablet press / MMP2 (Fuji Yakuhin Kikai Co., Ltd.) to tablet the tablets with a diameter of 7 mm, a thickness of 4.5 mm ± 0.3 mm, and a weight of 250 mg per tablet. The tableting pressure was 7 to 10 kN.

[0046] [1-4. Evaluation] (A) Raw material A: 60 parts by mass Raw material B: 40 parts by mass There was no sticking to the punches and dies of the tablet press, and the tableting was good. However, there was room for improvement in hardness and adhesion. (B) Raw material A: 50 parts by mass Raw material B: 50 parts by mass As in the case of (A) above, the tableting properties were good. (C) Raw material A: 40 parts by mass Raw material B: 60 parts by mass As with (A) above, the tableting properties were good. However, tableting problems (sticking) were observed infrequently, and there was room for improvement in the peelability. (D) Raw material A: 30 parts by mass Raw material B: 70 parts by mass As with (A) above, the tableting properties were good. However, tableting problems (sticking) were observed infrequently, and there was room for improvement in the peelability.

[0047] [Test Example 2] [2-1. Materials] Raw material C: Apple dietary fiber-containing material (product name "Vitacel AF401", Rettenmeyer Japan) (powder form: contains 50% or more by weight of apple dietary fiber, particle size: less than 30 μm)

[0048] [2-2. Test group] For the mixed raw material "(D) Raw material A: 30 parts by mass and Raw material B: 70 parts by mass" which showed some room for improvement in terms of tableting properties in Test Example 1, apple dietary fiber was further added to prepare a mixed raw material to be fed into the tablet press.

[0049] (D1) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 5 parts by mass (D2) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 10 parts by mass (D3) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 15 parts by mass (D4) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 20 parts by mass (D5) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 30 parts by mass

[0050] [2-3. Tablet compression] Raw materials A, B, and C were mixed to obtain a mixed raw material, which was then subjected to a tabletop prototype tablet press / MMP2 (Fuji Yakuhin Kikai Co., Ltd.) to compress tablets with a diameter of 7 mm, a thickness of 4.5 mm ± 0.3 mm, and a weight of 250 mg per tablet. Depending on the test group, the size of the tablets was changed to tablets with a diameter of 5 mm, a thickness of 4.2 mm, and a weight of 110 mg per tablet, or tablets with a diameter of 6 mm, a thickness of 4.5 mm, and a weight of 140 mg per tablet. The compression pressure was 7 to 10 kN.

[0051] [2-4-1. Rating 1] Diameter 7mm (Thickness: 4.5mm *Thickness / Diameter = 0.64): (D1) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 5 parts by mass As in the above (D) of Test Example 1, tableting problems (sticking) were observed with a small frequency, and there was room for improvement in the peelability. (D2) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 10 parts by mass Compared to (D1) above, the peelability was improved. (D4) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 20 parts by mass Compared to (D1) above, the peelability was improved. (D5) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 30 parts by mass Compared to (D1) above, the peelability was improved, but there was room for improvement in hardness and adhesiveness.

[0052] [2-4-2. Evaluation 2] Diameter 5mm (Thickness: 4.2mm *Thickness / Diameter = 0.84): (D2) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 10 parts by mass As in the evaluation of (D) above in Test Example 1, tableting problems (sticking) were observed with a small frequency, and there was room for improvement in the peelability. (D3) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 15 parts by mass Compared to (D2) above, the peelability was improved. (D4) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 20 parts by mass Compared to (D2) above, the peelability was improved.

[0053] [2-4-3. Rating 3] Diameter 6mm (Thickness: 4.5mm *Thickness / Diameter = 0.75): (D2) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 10 parts by mass The peelability was improved by increasing the size of the tablets compared to those in Evaluation 2 above, but tableting problems (sticking) were observed infrequently, and there was room for improvement in the peelability. (D3) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 15 parts by mass Compared to (D2) above, the peelability was improved. (D4) Raw material A: 30 parts by mass Raw material B: 70 parts by mass Raw material C: 20 parts by mass Compared to (D2) above, the peelability was improved.

[0054] From the above, it was revealed that by adding fructooligosaccharides and acacia dietary fiber to the bean extract, a solid formulation can be stably produced without using lubricants such as calcium stearate and sucrose esters. In addition, it was revealed that the efficiency of formulation can be further improved by adding apple dietary fiber.

Claims

1. A solid preparation containing a soybean extract, fructooligosaccharides and acacia dietary fiber.

2. 2. The solid preparation according to claim 1, comprising a bean-derived protein-containing material having a protein content of 50% by mass or more as the bean extract.

3. The solid preparation according to claim 2, wherein the bean-derived protein-containing material contains 10% by mass or more of ferritin having a molecular weight of 23 to 27 kDa.

4. 4. The solid preparation according to claim 2 or 3, wherein the bean-derived protein-containing material contains bean-derived ferritin iron in an iron content of 3% by mass or more.

5. 2. The solid formulation according to claim 1, further comprising apple dietary fiber.

6. The solid formulation according to claim 1, comprising 40 to 65% by mass of the bean extract, 15 to 35% by mass of the fructooligosaccharide, and 15 to 35% by mass of the acacia dietary fiber.

7. The solid formulation according to claim 5, comprising 25 to 50% by mass of the bean extract, 15 to 30% by mass of the fructooligosaccharide, 15 to 30% by mass of the acacia dietary fiber, and 10 to 20% by mass of the apple dietary fiber.

8. A method for producing a solid preparation, comprising: a raw material mixing step of mixing raw material A containing a bean extract and prepared into a powder with raw material B containing fructooligosaccharides and acacia dietary fiber and prepared into granules to obtain a mixed raw material; and a tableting step of tableting the mixed raw material into a predetermined shape.

9. The method for producing a solid preparation according to claim 8, wherein the bean extract is a bean-derived protein-containing material having a protein content of 50% by mass or more.

10. The method for producing a solid preparation according to claim 9, wherein the bean-derived protein-containing material contains 10% by mass or more of ferritin having a molecular weight of 23 to 27 kDa.

11. The method for producing a solid preparation according to claim 9 or 10, wherein the bean-derived protein-containing material contains bean-derived ferritin iron in an iron content of 3% by mass or more.

12. 9. The method for producing a solid preparation according to claim 8, wherein in the raw material mixing step, powdered apple dietary fiber is further mixed to obtain the mixed raw material.

13. The method for producing a solid preparation according to claim 8, wherein the raw material B contains 48 to 52% by mass of the fructooligosaccharide and 42 to 48% by mass of the acacia dietary fiber.

14. The method for producing a solid preparation according to claim 8, wherein the solid preparation contains 40 to 65% by mass of the bean extract, 15 to 35% by mass of the fructooligosaccharide, and 15 to 35% by mass of the acacia dietary fiber.

15. The method for producing a solid preparation according to claim 12, wherein the solid preparation contains 25 to 50% by mass of the bean extract, 15 to 30% by mass of the fructooligosaccharide, 15 to 30% by mass of the acacia dietary fiber, and 10 to 20% by mass of the apple dietary fiber.

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