JP7645780B2 - Food tablets, method for improving disintegrability of food tablets, and agent for improving disintegrability of food tablets - Google Patents

Description

The present invention relates to a food tablet that has excellent disintegrability while maintaining the hardness required for tablets, a method for improving the disintegrability of a food tablet that contains a functional ingredient, and an agent for improving the disintegrability of a food tablet.

In recent years, with the rise in awareness of irregular eating habits and beauty, there has been an increasing demand for dietary tablets such as nutritional supplements and supplements that contain functional ingredients such as amino acids, vitamins, minerals, and other nutrients, as well as extracts derived from plants and animal materials that contain various nutrients, in order to efficiently replenish necessary nutrients.

Disintegrants that can be used in the food tablets include sodium starch glycolate and croscarmellose sodium, which are food additives. Although there are no standards for the use of these disintegrants in pharmaceuticals, there are standards for their use in foods that state that they should be used at no more than 2% by weight. There is a problem in that some products do not exhibit sufficient disintegration properties when mixed at less than this standard of 2% by weight.

Although partially pregelatinized starch and agar can be used as food ingredients without any usage standards, there is a problem that it is difficult to increase the blending amount to 10% or 20% by mass because the ingredients themselves have poor binding properties, and increasing the blending amount reduces tablet hardness. There is also the problem that at a certain blending amount, the function reaches a plateau and the effect corresponding to the blending ratio cannot be achieved.

Meanwhile, in the pharmaceutical industry, excipient raw materials combining D-mannitol, sugar alcohols, crystalline cellulose, corn starch, lactose, etc. have been developed to provide tablets with excellent disintegration properties as orally disintegrating tablets, but there is a problem that the tablet hardness is low and they are unsuitable for distribution in food. Also, some raw materials, such as D-mannitol, cannot be used in general food products. Furthermore, there are problems with the technology being difficult to deploy in the food industry, as it is necessary to use special granulators or to have a granulation process divided into several stages in order to manufacture the excipient raw materials.

In addition, a solid oral composition containing insoluble natural plant fiber has been proposed as a solid oral composition that has the effect of removing tongue coating and strong breath odor removal effects and is highly portable, but it does not relate to a technology for improving the disintegration of food tablets (see, for example, Patent Document 1).

JP 2005-281230 A

Food tablets such as nutritional supplements and dietary supplements are commercially available, and if the tablets could be formulated with a large number of functional ingredients or the amounts of the functional ingredients could be increased, it would be possible to easily ingest nutrients that tend to be lacking. However, the present inventors have discovered that some functional ingredients reduce the disintegration properties of tablets, and that the disintegration properties of tablets can also be reduced when multiple functional ingredients are formulated or when the amounts of the functional ingredients are increased.

The present invention aims to solve the above-mentioned problems in the past and to achieve the following objectives. That is, the present invention aims to provide a food tablet that has excellent disintegrability while maintaining the hardness required for tablets, a method for improving the disintegrability of a food tablet containing a functional ingredient, and an agent for improving the disintegrability of a food tablet.

In order to solve the above problems, the present inventors conducted extensive research and discovered that by adding insoluble dietary fiber to a tablet, it is possible to obtain a tablet with good disintegrability while maintaining tablet hardness, even when the tablet contains a difficult-to-disintegrate component, or when a large number of functional components are added, or when the amount of functional components added is large.

The present invention is based on the findings of the present inventors, and the means for solving the above problems are as follows.
<1> A composition comprising a functional ingredient and a disintegration improver,
The food tablet is characterized in that the disintegration improver is an insoluble dietary fiber.
<2> The food tablet according to <1>, wherein the insoluble dietary fiber includes at least one selected from the group consisting of citrus-derived dietary fiber, apple-derived dietary fiber, locust bean gum, gellan gum, and carrageenan.
<3> The food tablet according to any one of <1> to <2>, wherein the functional ingredient contains a hardly disintegrating ingredient.
<4> The food tablet according to any one of <1> to <3>, which contains five or more kinds of the functional ingredients.
<5> The food tablet according to any one of <1> to <4>, containing 5% by mass or more of the functional ingredient.
<6> The food tablet according to any one of <3> to <5>, wherein the non-disintegrating component is contained in an amount of 5% by mass or more.
<7> A method for improving the disintegration property of a food tablet containing a functional ingredient, comprising:
The method includes mixing the functional ingredient with a disintegration enhancer,
The method for improving the disintegration property of a food tablet is characterized in that the disintegration property improver is an insoluble dietary fiber.
<8> Used to improve the disintegration property of food tablets containing functional ingredients,
The disintegration improver for food tablets is characterized by containing insoluble dietary fiber.

The present invention can solve the above-mentioned problems in the past and achieve the above-mentioned objective, and can provide a food tablet that has excellent disintegrability while maintaining the hardness required for tablets, a method for improving the disintegrability of a food tablet containing a functional ingredient, and an agent for improving the disintegrability of a food tablet.

(Food tablets)
The edible tablet of the present invention contains at least a functional ingredient and a disintegration enhancer, and further contains other ingredients as necessary.

<Functional ingredients>
The functional ingredient is not particularly limited, and ingredients used in dietary supplements and the like can be appropriately selected depending on the purpose. Examples of the functional ingredient include vitamins such as vitamin A, vitamin B group, vitamin C, vitamin D, vitamin E, vitamin K, hesperidin, and inositol; amino acids or salts thereof; peptide-containing substances containing milk-derived peptides such as casein hydrolysates, peptide-containing substances containing animal-derived peptides such as chicken cartilage-derived extracts, peptide-containing substances containing plant-derived peptides such as maca extract and sesame extract, peptide-containing substances containing seaweed-derived peptides such as wakame extract and kombu extract, shark cartilage extract, and salmon nasal cartilage extract. peptide-containing substances such as peptide-containing substances containing peptides derived from fish, such as tuna extract and tuna extract; animal extracts, such as placenta extract and collagen-containing extract; minerals, such as calcium, magnesium, zinc, iron, manganese, copper, selenium, chromium, and molybdenum; coenzyme Q10, α-lipoic acid, L-carnitine, collagen, hyaluronic acid, elastin, turmeric, glucosamine hydrochloride, chondroitin sulfate, silymarin, lutein, fermented soybean germ extract powder, pomegranate extract powder, and the like; components containing various polyphenols, such as those derived from ginkgo leaves, apples, guava, tea, pine, grapes, and salacia; etc. These may be used alone or in combination of two or more.
As the functional component, commercially available products can be appropriately used.

The food tablet can be suitably used when it contains a hardly disintegrating component as the functional component.
In the present invention, the term "difficult to disintegrate" refers to a tablet having a long disintegration time. For example, in the case of a tablet having a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet, the tablet can be said to be difficult to disintegrate if the disintegration time is 10 minutes or more when the tablet hardness is set to 70 N.
The aforementioned difficult-to-disintegrate component refers to a component that, when formed into a tablet containing the component, takes a long time to disintegrate.

The non-disintegrating component is not particularly limited and can be appropriately selected depending on the purpose. Examples of the non-disintegrating component include ginkgo leaf extract, bilberry extract, blueberry extract, salacia extract, polyphenol-containing components such as apple polyphenol, turmeric extract, silymarin, hyaluronic acid, chondroitin sulfate, lutein, heme iron, collagen, vitamins, etc. These may be used alone or in combination of two or more.

The functional ingredients can be appropriately selected from commercially available products.

The number of types of functional ingredients in the food tablet may be one or two or more, but the food tablet of the present invention has an excellent disintegration time even when it contains two or more functional ingredients, so that it is possible to blend many types of functional ingredients, for example, five or more types.

The functional component may or may not contain a non-disintegrating component. When two or more types of functional components are contained, the content ratio of each functional component is not particularly limited and can be appropriately selected depending on the purpose.

The content of the functional ingredient in the food tablet is not particularly limited and can be appropriately selected depending on the purpose, but is preferably 5% by mass or more, more preferably 10% by mass or more, even more preferably 20% by mass to 80% by mass, and particularly preferably 30% by mass to 70% by mass. According to the food tablet of the present invention, even if a large amount of the functional ingredient is blended, the tablet can have an excellent disintegration time.

The content of the non-disintegrating component in the food tablet is not particularly limited and can be appropriately selected depending on the purpose, but is preferably 5% by mass or more, more preferably 10% by mass or more, even more preferably 20% by mass to 80% by mass, and particularly preferably 30% by mass to 70% by mass. According to the food tablet of the present invention, even if the amount of the non-disintegrating component is large, the tablet can have an excellent disintegration time.

<Disintegration improver>
The disintegration enhancer is an insoluble dietary fiber.
In the present invention, improving disintegrability means shortening the disintegration time of a tablet. The disintegration improver can be used as a supplement or a substitute for a known disintegrant.

In the present invention, the insoluble dietary fiber may be composed of only insoluble dietary fiber, or may be a mixture of insoluble dietary fiber and soluble dietary fiber. In the case of a mixture of insoluble dietary fiber and soluble dietary fiber, the insoluble dietary fiber content relative to the total amount of insoluble dietary fiber and soluble dietary fiber is 50% by mass or more and is referred to as insoluble dietary fiber.
The insoluble dietary fiber refers to dietary fiber that is insoluble in water at 37°C.

The insoluble dietary fiber is not particularly limited and may be appropriately selected depending on the purpose, and examples thereof include citrus-derived dietary fiber, apple-derived dietary fiber, sugarcane-derived dietary fiber, locust bean gum, gellan gum, carrageenan, yeast-derived dietary fiber, etc. These may be used alone or in combination of two or more.
Among the insoluble dietary fibers, at least one selected from the group consisting of citrus-derived dietary fiber, apple-derived dietary fiber, locust bean gum, gellan gum, and carrageenan is preferred, in terms of better tablet hardness and disintegration properties, and citrus-derived dietary fiber is more preferred.

The citrus refers to plants of the Rutaceae family, and examples of the Rutaceae family include lemon, lime, orange, iyokan, Uchimurasaki, Satsuma mandarin, Oobenimaki mandarin, kabosu, Kishu mandarin, grapefruit, Sanbokan, Shikashya, citron, Sudachi, Tachibana, Bitter orange, Natsumikan, Navel orange, Hassaku, Hyuganatsu, bergamot, Ponkan, Yuzu, and kumquat. These may be used alone or in combination of two or more. Among these, lemon, lime, and orange are preferred in terms of superior tablet hardness and disintegration.

The apple tree refers to a plant of the genus Malus in the family Rosaceae. Examples of the plant of the genus Malus in the family Rosaceae include Apple, Apple Tree, and Apple Tree. These may be used alone or in combination of two or more kinds.

The insoluble dietary fiber can be any commercially available product.

The content of the disintegration improver in the food tablet is not particularly limited and can be appropriately selected depending on the purpose, but is preferably 1% by mass to 50% by mass, more preferably 3% by mass to 30% by mass, and particularly preferably 5% by mass to 20% by mass. When the content of the disintegration improver is within the preferred range, a tablet with excellent disintegration properties can be obtained while suppressing a decrease in tablet hardness.

When the food tablet contains two or more types of disintegration improvers, the content ratio of each disintegration improver is not particularly limited and can be appropriately selected depending on the purpose.

The form of the disintegration enhancer is not particularly limited and can be appropriately selected depending on the purpose. Examples include powder and granules (sometimes called granulated material). Among these, granules are preferred because they can further improve disintegration.

The particle size (D50) of the insoluble dietary fiber is not particularly limited and can be selected appropriately depending on the purpose, but is preferably 10 μm to 300 μm. If it is within the above preferred range, it is advantageous in that the mixing uniformity with other ingredients is good, and the ingredients are not crushed during the compression process when processing into tablets, resulting in excellent disintegration properties.

The mass ratio of the functional ingredient to the disintegration enhancer (disintegration enhancer/functional ingredient) is not particularly limited and can be appropriately selected depending on the purpose, but is preferably 0.01 or more, more preferably 0.05 or more, and particularly preferably 0.1 or more. If the mass ratio is within the preferred range, it is advantageous in that the disintegration properties are more excellent.

<Other ingredients>
The other components in the food tablet are not particularly limited as long as they do not impair the effects of the present invention, and can be appropriately selected depending on the purpose. Examples of the other components include lubricants such as stearic acid, calcium stearate, magnesium stearate, sodium stearyl fumarate, sucrose fatty acid esters, talc, vegetable oils and fats, and hardened oils; disintegrants such as partially pregelatinized starch, sodium starch glycolate, and sodium croscarmellose; excipients such as starch, lactose, brewer's yeast, dextrin, and corn starch; powdered cellulose; crystalline cellulose; and cellulose derivatives such as hydroxypropyl cellulose and hydroxypropyl methylcellulose. Examples of the additives include water-soluble polymers such as polyvinylpyrrolidone and polyvinyl alcohol, sugar alcohols such as reduced maltose syrup, xylitol, sorbitol, mannitol, and maltitol, disaccharides such as trehalose, palatinose, and isomalt, soybean polysaccharides, binders such as corn protein, silicon such as anhydrous silicic acid, calcium silicate, light anhydrous silicic acid, hydrous silicon dioxide, and silicon dioxide, or a salt or oxide thereof, adhesives, colorants such as titanium oxide and iron oxide, pH adjusters or buffers such as phytic acid, citric acid, succinic acid, sodium citrate, sodium acetate, DL-malic acid, phosphoric acid, and disodium phosphate, and antioxidants. These may be used alone or in combination of two or more.
As the other components, commercially available products can be appropriately used.
The content of other ingredients in the food tablet is not particularly limited and can be appropriately selected depending on the purpose.

There are no particular limitations on the shape, structure, and size of the food tablets, and they can be selected appropriately depending on the purpose.

The food tablets can be suitably used as dietary supplements or dietary supplements.

<Method of manufacturing food tablets>
The method for producing the food tablets is not particularly limited and can be appropriately selected depending on the purpose, but it is preferable to produce them by a method that includes at least a mixing step and further includes other steps as necessary.

<<Mixing process>>
The mixing step is a step of mixing a functional component and a disintegration enhancer. In the mixing step, other components may be further mixed, if necessary.

The functional ingredient, the disintegration enhancer, and the other ingredients in the mixing step are the same as those described in the section (food tablets) of the present invention above, and the preferred embodiments are also the same.

In the mixing step, the functional ingredient, the disintegration enhancer, and, if necessary, the other ingredients may be mixed together in one batch, or any desired ingredient may be mixed in multiple batches.

The mixture obtained in the mixing step may be in the form of a powder or granules.

The mixing can be carried out using a known device, such as a container tumbler, a V-type mixer, or a Bohley container mixer.
The mixing conditions such as temperature and time are not particularly limited and can be appropriately selected.

The granulation method is not particularly limited and may be appropriately selected from known methods, such as fluidized bed granulation, stirring granulation, dry granulation, and spray drying.
Specific examples of the granulation method include a method in which the components are mixed, kneaded, kneaded, and/or stirred, and an appropriately selected binder is sprayed and/or added.

The binder is not particularly limited and can be appropriately selected depending on the purpose, and examples thereof include cellulose derivatives such as hydroxypropylmethylcellulose, hydroxypropylcellulose, and methylcellulose, thickening polysaccharides such as pullulan and guar gum, and sugar alcohols such as isomaltose, xylitol, maltitol, and sorbitol. These may be used alone or in combination of two or more.
As the binder, commercially available products can be appropriately used.

The binder may be in the form of a solution or dispersion (hereinafter sometimes referred to as a "spray liquid") for spraying.
The solvent used to dissolve or disperse the binder is not particularly limited and can be appropriately selected depending on the type of binder used, and examples thereof include water, ethanol, and a mixture thereof.

The viscosity of the spray liquid and the concentration of the binder in the spray liquid (solids concentration) are not particularly limited and can be appropriately selected depending on the purpose.
The method for spraying the spray liquid is not particularly limited and can be appropriately selected depending on the purpose. For example, the spray liquid can be sprayed from a spraying means provided in the granulation device used, such as a spray gun or a spray nozzle.
The spray conditions (spray amount, size of mist particles to be sprayed, spray time, spray interval, etc.) are not particularly limited, and known conditions can be appropriately selected.

The granulation can be carried out using a known device, and examples of the device include a spray granulator, a fluidized bed granulator, and an agitation granulator.
The conditions of the granulation, such as temperature and time, are not particularly limited and can be appropriately selected depending on the purpose.

<<Other processes>>
The other steps are not particularly limited as long as they do not impair the effects of the present invention, and can be appropriately selected depending on the purpose. For example, a tableting step can be included.

The tableting process is a process of tableting the powder or granules obtained in the mixing process and, if necessary, the other ingredients, to produce a tablet.

The tableting can be carried out using known equipment, such as tablet presses (e.g., HT-APSS type, HT-AP-MS type, HT-X-SS type, HT-X-MS type (all manufactured by Hata Iron Works Co., Ltd.); VEL5, VIRGO, AQUARIUS, LIBRA (all manufactured by Kikusui Seisakusho Co., Ltd.)).

There are no particular limitations on the conditions for the tableting, such as the tableting pressure, and these can be selected appropriately depending on the purpose.

The food tablet of the present invention has good disintegration properties while maintaining the hardness required for tablets. In addition, the food tablet of the present invention can be efficiently manufactured using a simple method, and is therefore also excellent in terms of manufacturing costs.

(Method for improving disintegration property of food tablets containing functional ingredients)
The method for improving the disintegrability of a food tablet containing a functional ingredient according to the present invention (hereinafter sometimes referred to as the "method for improving disintegrability") includes at least a mixing step, and may further include other steps as necessary.

<Mixing step>
The mixing step is a step of mixing a functional ingredient with a disintegration enhancer, and can be carried out in the same manner as described in the <<Mixing step>> section of <Method for manufacturing food tablets>> of the (Food tablets) of the present invention described above, and the preferred aspects can also be the same.

<Other processes>
The other steps are not particularly limited as long as they do not impair the effects of the present invention, and can be appropriately selected depending on the purpose. For example, they may be similar to those described in the <<Other steps>> section of <<Method for manufacturing food tablets>> of (Food tablets) of the present invention described above.

The method for improving disintegrability of the present invention makes it possible to improve disintegrability while maintaining the hardness required for tablets.

(Disintegration improver for food tablets)
The disintegration improver for food tablets of the present invention is used to improve the disintegration property of food tablets containing functional ingredients, and contains at least insoluble dietary fiber, and further contains other ingredients as necessary.

<Insoluble dietary fiber>
The insoluble dietary fiber is the same as that described in the section <Disintegrability improver> of the above-mentioned (edible tablet) of the present invention, and preferred embodiments are also the same.

The content of the insoluble dietary fiber in the disintegration improver is not particularly limited and can be appropriately selected depending on the purpose. The disintegration improver may consist only of the insoluble dietary fiber.

<Other ingredients>
The other ingredients are not particularly limited and can be selected appropriately depending on the purpose. For example, they may be the same as those described in the <Other ingredients> section of the (food tablet) of the present invention described above.

The disintegration improver for food tablets can improve disintegration while maintaining the hardness required for tablets.

The present invention will be specifically explained below with reference to test examples, but the present invention is not limited to these test examples.

(Test Example 1: Confirmation of the effect of differences in functional ingredients on disintegration properties)
The following components were selected as functional ingredients, and tablets were manufactured at the blending ratios shown in Tables 1-1 to 1-4 below, and the disintegration time was confirmed. Note that a tablet consisting of crystalline cellulose and calcium stearate was used as a control (tablet with good disintegration properties). In addition, for Test Example 1-3 (silymarin powder) and Test Example 1-4 (hyaluronic acid), the blending ratio was lower than that of the other functional ingredients, taking into account fluidity.
[Functional ingredients]
・ Ginkgo leaf extract powder (manufactured by Dr. Willmar Schwabe GmbH & Co. KG)
・ Turmeric extract powder (manufactured by Nippon Stange Co., Ltd.)
Silymarin powder (Indena S.p.A.)
・ Hyaluronic acid (manufactured by Nippon Shinyaku Co., Ltd.)
- Chondroitin sulfate (manufactured by Shanghai Huiwen Biotechnology Co., Ltd.)
Bilberry extract powder (manufactured by Ningbo Green-Health Pharmaceutical Co., Ltd.)
・ Lutein powder (manufactured by DSM Nutrition Japan Co., Ltd.)
・ Heme iron (ILS Co., Ltd.)
・ Salacia powder (manufactured by Takama Co., Ltd.)
Vitamin Mix (a mix of vitamin A, vitamin _B1 , vitamin _B2 , vitamin _B6 , vitamin _B12 , vitamin C, vitamin E, biotin, niacin, pantothenic acid, folic acid, vitamin P, and inositol)
Vitamin B Mix (a mix of vitamin _B1 , vitamin _B2 , vitamin _B6 , vitamin _B12 , biotin, niacin, pantothenic acid, and folic acid)
L-ascorbic acid (Northeast Pharmaceutical Group Co., Ltd.)
Collagen (Rousselot Angouleme SAS)
Calcium (scallop powder) (manufactured by NC Corporation)
Glucosamine hydrochloride (manufactured by Yangzhou Koen Biotechnology Co., Ltd.)

<Tablet manufacturing>
- Preparation of tablet powder -
The ingredients shown in Tables 1-1 to 1-4 below were mixed to prepare tablet powders.

-Tableting-
The powder was packed and compressed into tablets using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) at a pressure (compression pressure) of 7 kN, 11 kN, or 14 kN to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
- Tablet hardness -
The hardness (N) of the tablets was measured using a fully automatic tablet measuring device Multicheck 5.1 (manufactured by ERWEKA Co., Ltd.) The results are shown in Tables 1-1 to 1-4.

- Collapse time -
The disintegration time of the tablets was measured using a fully automatic disintegration tester ZT322 (manufactured by ERWEKA) with water as the solvent and a water temperature of 37° C. The results are shown in Tables 1-1 to 1-4.

Since a tablet weighing 200 mg is small, a raw material that takes 10 minutes or more to disintegrate when the tablet hardness is 70 N can be said to be a hardly disintegrating ingredient.
As shown in Tables 1-1 to 1-4, the control tablets had high tablet hardness but the disintegration time was about 5 minutes, confirming that crystalline cellulose is a raw material with good disintegration properties. In addition, L-ascorbic acid, calcium (scallop powder), and glucosamine hydrochloride were also confirmed to be raw materials with good disintegration properties.
On the other hand, the remaining raw materials had a long disintegration time, and were considered to be difficult to disintegrate. The tablets containing heme iron had a low hardness because they tended not to have a high tablet hardness, and the disintegration time appeared to be short, but when the tablet hardness was extrapolated to 70N and 100N, the disintegration time tended to be long, being about 30 minutes at 70N and about 48 minutes at 100N. The tablets containing turmeric extract powder had a high tablet hardness and a long disintegration time, but when the tablet hardness was extrapolated to 100N, the disintegration time was about 17 minutes, and it could be said that the disintegration time tends to be long.

(Test Example 2)
The following ingredients were selected and examined as candidates for disintegration improvers.
[Candidates for improving disintegration]
・ Citrus-derived dietary fiber A (HelbaCel, manufactured by HerbaFood Co., Ltd.)
・ Citrus-derived dietary fiber B (Citrify, Fiberstar)
・ Guar gum (manufactured by San-Ei Gen F.F.I. Co., Ltd.)
・ Dietary fiber derived from sugar cane (manufactured by JRS Pharma Gmbh & Co. KG)
・ Locust bean gum (manufactured by San-Ei Gen F.F.I. Co., Ltd.)

<Production of Granules>
The components were mixed and granulated to obtain the blending ratios shown in Tables 2-1 to 2-2 below, and then dried at 60° C. for 12 to 18 hours to obtain granules 2A to 2F.

<Tablet manufacturing>
- Preparation of tablet powder -
The ingredients shown in Tables 2-3 to 2-4 below were mixed to prepare tablet powders.

-Tableting-
The powder was packed and compressed into tablets using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) at a pressure (compression pressure) of 7 kN, 11 kN, or 14 kN to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The hardness and disintegration time of each tablet were evaluated in the same manner as in Test Example 1. The results are shown in Tables 2-3 to 2-4.

As shown in Tables 2-3 to 2-4, locust bean gum, a dietary fiber derived from citrus, had disintegration properties equal to or greater than those of sodium starch glycolate, and tablet hardness was also maintained. In addition, locust bean gum, a dietary fiber derived from citrus, showed superior disintegration properties to guar gum, a water-soluble dietary fiber.

(Test Example 3)
In Test Example 2, the candidate disintegration improver was tested as granules, but in this test, the test was conducted without granulation. The following ingredients were selected and examined as candidates for the disintegration improver.
[Candidates for improving disintegration]
・ Citrus-derived dietary fiber A (HelbaCel, manufactured by HerbaFood Co., Ltd.)
・ Citrus-derived dietary fiber B (Citrify, Fiberstar)
・ Guar gum (manufactured by San-Ei Gen F.F.I. Co., Ltd.)
・ Locust bean gum (manufactured by San-Ei Gen F.F.I. Co., Ltd.)

<Tablet manufacturing>
- Preparation of tablet powder -
The ingredients shown in Tables 3-1 to 3-2 below were mixed to prepare tablet powders.

-Tableting-
The powder was packed and compressed into tablets using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) at a pressure (compression pressure) of 7 kN, 11 kN, or 14 kN to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The hardness and disintegration time of each tablet were evaluated in the same manner as in Test Example 1. The results are shown in Tables 3-1 and 3-2.

As shown in Tables 3-1 and 3-2, although the disintegration was slightly inferior compared to the case of granulation (Test Example 2), it was confirmed that the disintegration of the tablet was improved by the disintegration improver of the present invention even when the tablet was mixed without granulation.

(Test Example 4)
The effect of changing the blending ratio of the disintegration improver was examined.
[Disintegration improver]
・ Citrus-derived dietary fiber A (HelbaCel, manufactured by HerbaFood Co., Ltd.)
・ Citrus-derived dietary fiber B (Citrify, Fiberstar)

<Production of Granules>
The components were mixed and granulated in the proportions shown in Table 4-1 below, and then dried at 60° C. for 12 to 18 hours to obtain granules 4A to 4B.

<Tablet manufacturing>
- Preparation of tablet powder -
The ingredients shown in Tables 4-2 to 4-3 below were mixed to prepare tablet powders.

-Tableting-
The powder was packed and compressed into tablets using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) at a pressure (compression pressure) of 7 kN, 11 kN, or 14 kN to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The hardness and disintegration time of each tablet were evaluated in the same manner as in Test Example 1. The results are shown in Tables 4-2 to 4-3.

As shown in Tables 4-2 to 4-3, it was confirmed that disintegration improves by increasing the blending ratio of the disintegration improver. In addition, when granulation is performed, the blending ratio is up to 50% by mass, and when not granulated, the blending ratio is up to 25% by mass, and there is no significant decrease in tablet hardness, and it was confirmed that these are fully acceptable products.

(Test Example 5)
The effects of changing the blending ratio of the disintegration improver in the granules and changing the thickener in the granules were investigated.
[Disintegration improver]
・ Citrus-derived dietary fiber A (HelbaCel, manufactured by HerbaFood Co., Ltd.)

<Production of Granules>
The components were mixed and granulated to obtain the blending ratios shown in Tables 5-1 and 5-2 below, and then dried at 60° C. for 12 to 18 hours to obtain granules 5A to 5F.

<Tablet manufacturing>
- Preparation of tablet powder -
The ingredients shown in Tables 5-3 to 5-7 below were mixed to prepare tablet powders.

-Tableting-
The powder was packed and compressed at a pressure (compression pressure) of 11 kN or 14 kN using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The hardness and disintegration time of each tablet were evaluated in the same manner as in Test Example 1. The disintegration time was measured for tablets obtained at a tableting pressure of 14 kN. The results are shown in Tables 5-3 to 5-7.

As shown in Tables 5-3 to 5-7, it was confirmed that disintegration tends to improve depending on the blending ratio of disintegration enhancer. It was also confirmed that changing the thickener used during granulation has little effect on improving disintegration.

(Test Example 6)
The disintegration properties of tablets containing functional ingredients were examined.
[Functional ingredients]
・ Chondroitin sulfate (food grade chondroitin-70 granulated product derived from shark cartilage, manufactured by Shanghai Huiwen Biotechnology Co., Ltd.)
・ Hyaluronic acid (Hyaluronic Acid ST, manufactured by Nippon Shinyaku Co., Ltd.)
[Disintegration improver]
・ Citrus-derived dietary fiber A (HelbaCel, manufactured by HerbaFood Co., Ltd.)

<Tablet manufacturing>
- Preparation of tablet powder -
The components shown in Table 6 below were mixed to prepare tablet powders.

-Tableting-
The tableting powder was filled and compressed into tablets using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) to obtain tablets having a tablet hardness of 240 to 260 N, a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The disintegration time of each tablet was evaluated in the same manner as in Test Example 1. The results are shown in Table 6.

As shown in Table 6, it was confirmed that the use of the disintegration improver of the present invention in tablets containing functional ingredients can shorten the disintegration time while maintaining tablet hardness.

(Test Example 7)
The disintegration properties of tablets containing functional ingredients were examined.

<Production of Granules>
The components were mixed and granulated to obtain the blending ratios shown in Table 7-1 below, and then dried at 60° C. for 12 to 18 hours to obtain Granules 7A.
[Disintegration improver]
・ Citrus-derived dietary fiber A (HelbaCel, manufactured by HerbaFood Co., Ltd.)

<Tablet manufacturing>
- Preparation of tablet powder -
The ingredients shown in Table 7-2 below were mixed to prepare tablet powders.
[Functional ingredients]
Bilberry extract powder (manufactured by Ningbo Green-Health Pharmaceutical Co., Ltd.)
Marigold (Kemin Health, L.C.)
・ Blackcurrant extract powder (manufactured by Shaanxi Yuanbang Biotechnology Co., Ltd.)

-Tableting-
The tableting powder was filled and compressed into tablets using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) to obtain tablets having a tablet hardness of 140 to 160 N, a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The disintegration time of each tablet was evaluated in the same manner as in Test Example 1. The results are shown in Table 7-2.

As shown in Table 7-2, it was confirmed that the use of the disintegration improver of the present invention can shorten the disintegration time while maintaining tablet hardness, even in tablets containing functional ingredients different from those in Test Example 6.

(Test Example 8)
The disintegration properties of tablets containing functional ingredients were examined.

<Tablet manufacturing>
- Preparation of tablet powder -
The components shown in Table 8 below were mixed to prepare tablet powders.
[Functional ingredients]
・ Salacia extract powder (manufactured by Takama Co., Ltd.)
[Disintegration improver]
・ Citrus-derived dietary fiber A (HelbaCel, manufactured by HerbaFood Co., Ltd.)
・ Citrus-derived dietary fiber B (Citrify, Fiberstar)

-Tableting-
The tablet powder was packed and compressed at a pressure (compression pressure) of 8 kN or 11 kN using a rotary tablet press (VEL5, manufactured by Kikusui Seisakusho Co., Ltd.) to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The hardness of the tablets immediately after production was measured in the same manner as in Test Example 1. The disintegration time of each tablet was evaluated in the same manner as in Test Example 1, except that the tablets evaluated were those immediately after production (initial) and those stored at 50° C. for 60 days. The results are shown in Table 8.

As shown in Table 8, it was confirmed that the use of the disintegration enhancer of the present invention improves disintegration not only immediately after production, but also over time.

(Test Example 9: Confirmation of the effect of differences in functional ingredients on disintegration property-2)
The following components were selected as functional ingredients, tablets were manufactured at the blending ratios shown in Table 9 below, and the disintegration time was confirmed. A tablet made of crystalline cellulose and calcium stearate was used as a control (tablet with good disintegrability).
[Functional ingredients]
・ Vitamin D preparations (importer: Shanghai Freeman Japan Co., Ltd.)

<Tablet manufacturing>
- Preparation of tablet powder -
The components shown in Table 9 below were mixed to prepare tablet powders.

-Tableting-
Using a single punch tablet press (fully automatic powder molding device AutoTab-200, manufactured by Ichihashi Seiki Co., Ltd.), the tablet powder was filled and compressed at a pressure (tabletting pressure) of 5 kN, 8 kN, or 11 kN to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
- Tablet hardness -
The hardness (N) of the tablets was measured using a fully automatic tablet measuring device Multicheck 5.1 (manufactured by ERWEKA). The results are shown in Table 9.

- Collapse time -
The disintegration time of the tablets was measured using a fully automatic disintegration tester ZT322 (manufactured by ERWEKA) at a water temperature of 37° C. as the solvent. The results are shown in Table 9.

As described above, since a tablet weighing 200 mg is small, a raw material that takes 10 minutes or more to disintegrate when the tablet hardness is 70 N can be said to be a hardly disintegrating ingredient.
As shown in Table 9, the control tablets had a high tablet hardness, but the disintegration time was about 5 minutes, confirming that crystalline cellulose is a raw material with good disintegrability.
On the other hand, when the tablet hardness of the tablet of Test Example 9 containing vitamin D was extrapolated to 70N and 100N, the disintegration time was approximately 27 minutes at 70N and approximately 33 minutes at 100N, showing a tendency for the disintegration time to be longer, and it was considered that vitamin D is a difficult-to-disintegrate component.

(Test Example 10)
The effect of using a vitamin D preparation (similar to that used in Test Example 9) as the difficult-to-disintegrate component and citrus-derived dietary fiber A (HelbaCel, manufactured by Herba Food Co., Ltd.) as the disintegration enhancer was examined.

<Tablet manufacturing>
The ingredients shown in Tables 10-1 to 10-2 below were mixed to prepare tablet powders.

-Tableting-
Using a single punch tablet press (fully automatic powder molding device AutoTab-200, manufactured by Ichihashi Seiki Co., Ltd.), the tableting powder was filled and compressed under pressure (tabletting pressure) adjusted so that the tablet hardness was in the range of 155 N to 160 N on average, to obtain tablets with a diameter of 8 mm, a radius of curvature (R) of 6.5 mm, and a weight of 200 mg per tablet.

<Evaluation>
The hardness and disintegration time of each tablet were evaluated in the same manner as in Test Example 9. The results are shown in Tables 10-1 and 10-2.

As shown in Tables 10-1 to 10-2, by incorporating the disintegration improver of the present invention, even tablets incorporating vitamin D exhibited disintegration properties equivalent to those of sodium starch glycolate, and it was confirmed that the disintegration properties of the tablets were improved.

Claims (9)

A food tablet comprising a functional ingredient and a disintegration improver,
the functional ingredient is two or more selected from the group consisting of hyaluronic acid, chondroitin sulfate, bilberry extract , marigold, and black currant extract;
The disintegration improver is an insoluble dietary fiber,
The insoluble dietary fiber is a citrus-derived dietary fiber that is insoluble in water at 37°C;
The content of the functional ingredient in the food tablet is 5% by mass or more, and the content of the disintegration improver is 1% by mass to 50% by mass. The functional ingredient includes a hardly disintegrable ingredient,
The non-disintegrable component is at least one selected from the group consisting of hyaluronic acid , chondroitin sulfate , and bilberry extract ,
The food tablet according to claim 1, wherein the content of the non-disintegrating component in the food tablet is 5% by mass or more. The food tablet according to claim 1 or 2, wherein the disintegration improver is in the form of granules. A method for improving the disintegration property of a food tablet containing a functional ingredient, comprising the steps of:
The method includes mixing the functional ingredient with a disintegration enhancer,
The disintegration improver is an insoluble dietary fiber,
the functional ingredient is two or more selected from the group consisting of hyaluronic acid, chondroitin sulfate, bilberry extract , marigold, and black currant extract;
The insoluble dietary fiber is a citrus-derived dietary fiber that is insoluble in water at 37°C;
A method for improving the disintegration property of a food tablet, characterized in that the content of the functional ingredient in the food tablet is 5% by mass or more, and the content of the disintegration property improver in the food tablet is 1% by mass to 50% by mass. The functional ingredient includes a hardly disintegrable ingredient,
The non-disintegrable component is at least one selected from the group consisting of hyaluronic acid , chondroitin sulfate , and bilberry extract ,
The method for improving the disintegrability of a food tablet according to claim 4, wherein the content of the difficult-to-disintegrate component in the food tablet is 5% by mass or more. The method for improving the disintegration property of a food tablet according to claim 4 or 5, wherein the disintegration improver is a granule. A disintegration improver for food tablets used to improve the disintegration of food tablets containing a functional ingredient,
The disintegration improver for the food tablet contains insoluble dietary fiber,
The insoluble dietary fiber is a citrus-derived dietary fiber that is insoluble in water at 37°C;
The disintegration improver for the food tablet is used in an amount such that the content in the food tablet is 1% by mass to 50% by mass,
the functional ingredient is two or more selected from the group consisting of hyaluronic acid, chondroitin sulfate, bilberry extract , marigold, and black currant extract;
A disintegration improver for food tablets, characterized in that the content of the functional ingredient in the food tablet is 5 mass% or more. The functional ingredient includes a hardly disintegrable ingredient,
The non-disintegrable component is at least one selected from the group consisting of hyaluronic acid , chondroitin sulfate , and bilberry extract ,
The disintegrability improver for food tablets according to claim 7, wherein the content of the difficult-to-disintegrate component in the food tablet is 5% by mass or more. The disintegration improver for food tablets according to claim 7 or 8, wherein the disintegration improver for food tablets is in the form of granules.