JP2020200279A - Oral tablet - Google Patents

Abstract

To provide a theaflavins-containing oral tablet that causes less coloration with time and exhibits excellent melt in mouth when being taken.SOLUTION: An oral tablet comprises the following components (A) to (C): (A) theaflavins; (B) an excipient; and (C) one or more additive(s) selected from the group comprising a sucrose fatty acid ester, silicon dioxide, and a fatty acid salt. A content of the component (A) is 0.01 mass% or more and 15 mass% or less; a content of the component (C) is 0.1 mass% or more and 18 mass% or less; and a mass ratio [(A)/(C)] of the component (A) to the component (C) is 0.01 or more and 1.5 or less.SELECTED DRAWING: None

Description

The present invention relates to oral tablets.

Antibacterial substances used as natural products, especially edible natural products (foods), are being sought. As one of them, theaflavins, which are components contained in black tea, are known to have an antibacterial action against harmful bacteria (Patent Document 1).

By the way, typical diseases in the human oral cavity are caries (caries) and periodontal disease. For example, Patent Document 2 describes tea for the purpose of specifically inhibiting the formation of Streptococcus mutans plaques without affecting the indigenous bacterial flora in the oral cavity or intestine. The invention of a plaque formation inhibitor containing an adsorbed component obtained by treating a solvent extract with a synthetic adsorbing resin as an active ingredient and an anti-cariogenic composition containing the plaque formation inhibitor has been disclosed, and the anti-cariogenic composition is used for oral hygiene such as a troche. It is stated that it can be added to products for use.

Japanese Unexamined Patent Publication No. 2-276562 Japanese Unexamined Patent Publication No. 2000-344642

However, the theaflavins-containing preparation has a problem that coloring occurs over time. Therefore, it has been desired to develop a means for suppressing coloration over time when theaflavins are used in oral tablets such as chewable tablets that require long-term storage. In addition, oral tablets are also required by consumers to have good mouthfeel when taken.
The present invention relates to an oral tablet containing theaflavins, which is less colored over time and has a good texture when taken.

In the oral tablets containing theaflavins, the present inventors suppress the coloration over time derived from theaflavins by blending a predetermined additive in a specific ratio, and at the same time, the lips are injured when taken. Found to be good.
That is, in the present invention, the following components (A) to (C):
It contains one or more additives selected from the group consisting of (A) theaflabins (B) excipients (C) sucrose fatty acid esters, silicon dioxide, and fatty acid salts, and the content of component (A) is 0. 0.01% by mass or more and 15% by mass or less, the content of the component (C) is 0.1% by mass or more and 18% by mass or less, and the mass ratio of the component (A) to the component (C) [(A) / (C) )] For oral tablets of 0.01 or more and 1.5 or less.

According to the present invention, it is possible to provide an oral tablet containing theaflavins, which is less colored over time and has a good texture when taken.

[Oral tablets]
The oral tablet of the present invention contains the following components (A) to (C), the content of the component (A) is 0.01% by mass or more and 15% by mass or less, and the content of the component (C) is 0. It is 1% by mass or more and 18% by mass or less, and the mass ratio [(A) / (C)] of the component (A) to the component (C) is 0.01 or more and 1.5 or less.
(A) Theaflavins (B) Excipients (C) One or more additives selected from the group consisting of sucrose fatty acid esters, silicon dioxide, and fatty acid salts The oral tablets of the present invention are predetermined for theaflavins. By blending the additives of the above in a specific ratio, the theaflavins-derived coloration over time is suppressed, and the mouthfeel at the time of administration is improved.
Although the reason why the above effect is obtained in the oral tablet of the present invention is not clear, it consists of the group consisting of the sucrose fatty acid ester of the component (C), silicon dioxide, and the fatty acid salt with respect to theaflavins of the component (A). By containing one or more selected additives in a specific ratio, the component (C) is present on the tablet surface when the oral tablet of the present invention is prepared, and as a result, the component (A) It is considered that the contact with oxygen and water in the air is suppressed, and the coloring due to the oxidation of the component (A) is suppressed.

The oral tablet of the present invention is a tablet-type oral preparation in a solid state at 20 ° C. ± 15 ° C. The oral tablet of the present invention may further contain a carbonic acid effervescent component described later, in which case the oral tablet is carbonated effervescent.
The form of the oral tablet is not particularly limited as long as it can be taken by mouth, but from the viewpoint of expressing good sensation, and an oral hygiene agent such as an anti-cariogenic agent and a periodontal disease inhibitor of the component (A). From the viewpoint of making the above-mentioned effect more effective, chewable tablets or troche tablets are preferable, and troche tablets are more preferable.

<Component (A): Theaflavins>
Theaflavins are known as red-colored polyphenols produced in the process of fermentation that processes tea leaves into black tea. By containing theaflavins, the oral tablet of the present invention has an effect as an oral hygiene agent such as an anti-cariogenic agent and a periodontal disease inhibitor. The oral tablet of the present invention is also useful as a functional food having an oral hygiene effect.
Examples of theaflavins used in the present invention include theaflavin, theaflavin-3-O-gallate, theaflavin-3'-O-gallate, theaflavin-3,3'-O-digalate, and one or two of these. More than a seed can be used. In the present invention, the above compounds are collectively referred to as "theaflavins".
The theaflavins used in the present invention may be chemically synthesized products, or may be extracted, purified, or the like from a material derived from a natural product such as tea. In addition, commercially available theaflavins or theaflavins-containing substances can also be used. Specific examples thereof include "Theaflavin TF40" by YAIZU SUISAN CHEMICAL INDUSTRIES CO., LTD., "Polyphenon PF" by Mitsui Norin Co., Ltd., and "Polyphenon-TF35" series.

The content of the component (A) in the oral tablet of the present invention is 0.01% by mass or more, preferably 0.05% by mass or more, more preferably 0.05% by mass or more, from the viewpoint of exhibiting the efficacy as an oral hygiene agent or the like. Is 0.1% by mass or more, more preferably 0.15% by mass or more. Further, from the viewpoint of suppressing coloring over time, it is 15% by mass or less, preferably 6% by mass or less, more preferably 2.5% by mass or less, and further preferably 0.8% by mass or less. The specific range of the content of the component (A) in the oral tablet of the present invention is 0.01 to 15% by mass, preferably 0.05 to 6% by mass, and more preferably 0.1 to 2. It is 5% by mass, more preferably 0.15 to 0.8% by mass.
When the theaflavin-containing substance is blended in the oral tablet of the present invention, the theaflavin may be blended so that the effective amount of theaflavin in the oral tablet is within the above range.

<Component (B): Excipient>
The oral tablet of the present invention contains an excipient as a component (B) from the viewpoint of molding the tablet. Examples of the excipient include known excipients that can be used orally, such as monosaccharides such as glucose, galactose and fructose; disaccharides such as sucrose, lactose, maltulose, trehalose and palatinose; maltitol, xylitol and erythritol. , Sorbitol, sugar alcohols such as reduced palatinose; and the like, and one or more of these can be used.
Among the above, the component (B) is from the viewpoint of expressing the goodness of the mouthfeel when taking tablets and from the viewpoint of not impairing the efficacy of the component (A) as an oral hygiene agent such as an anti-cariogenic agent and a periodontal disease inhibitor. It is preferable to contain a sugar alcohol, and maltitol is more preferable among the sugar alcohols. The sugar alcohol may be either anhydrous or hydrated.

From the viewpoint of tableting property, the content of the component (B) in the oral tablet of the present invention is preferably 5% by mass or more, more preferably 10% by mass or more, still more preferably 35% by mass or more, and the like. From the viewpoint of containing an effective amount of the component of, it is 99.89% by mass or less, preferably 99% by mass or less, still more preferably 98% by mass or less, and even more preferably 97.5% by mass or less. The specific range of the content of the component (B) in the oral tablet of the present invention is preferably 5 to 99.89% by mass, more preferably 10 to 99% by mass, still more preferably 35 to 98% by mass, and more. More preferably, it is 35 to 97.5% by mass.

<Component (C): One or more additives selected from the group consisting of sucrose fatty acid ester, silicon dioxide, and fatty acid salt>
The oral tablet of the present invention contains one or more additives selected as the component (C) from the group consisting of sucrose fatty acid ester, silicon dioxide, and fatty acid salt. By containing a predetermined amount of the component (C) in the oral tablet of the present invention, it is possible to suppress the coloration of the component (A) over time and to improve the mouthfeel when taken.

(Sucrose fatty acid ester)
The component derived from the fatty acid structure constituting the sucrose fatty acid ester used as the component (C) is derived from the component (A) from the viewpoint of suppressing coloration over time and from the viewpoint of improving the sensation when taking tablets. It is preferably a saturated or unsaturated fatty acid having 12 or more and 24 or less carbon atoms.
Specific examples of the fatty acid include lauric acid, myristic acid, pentadecic acid, palmitic acid, palmitoleic acid, margaderic acid, stearic acid, oleic acid, erucic acid, arachidic acid, behenic acid, tetracosanoic acid and the like. One or more of these can be used. Among them, saturated or unsaturated fatty acids having 14 or more and 24 or less carbon atoms are preferable, and specifically, from the viewpoint of suppressing the coloration derived from the component (A) over time and improving the mouthfeel when taking tablets. Is preferably one or more selected from the group consisting of myristic acid, pentadecylic acid, palmitic acid, palmitoleic acid, margaderic acid, stearic acid, oleic acid, arachidic acid, erucic acid, and behenic acid, preferably myristic acid, palmitic acid, One or more selected from the group consisting of stearic acid and behenic acid is more preferable, and behenic acid is further preferable.
That is, as the sucrose fatty acid ester, an ester of sucrose and a saturated or unsaturated fatty acid having 14 or more and 24 or less carbon atoms is preferable, and sucrose myristinate, sucrose pentadecylate, sucrose palmitate, and sucrose palmitrain. One or more selected from the group consisting of acid esters, sucrose margaderic acid esters, sucrose stearic acid esters, sucrose oleic acid esters, sucrose arachidic acid esters, sucrose erucic acid esters, and sucrose behenic acid esters. Preferably, one or more selected from the group consisting of sucrose myristic acid ester, sucrose palmitate ester, sucrose stearate ester, and sucrose behenic acid ester is more preferable, and sucrose behenic acid ester is even more preferable.

Commercially available products can also be used as the sucrose fatty acid ester. Specific examples thereof include the "Ryoto Sugar Ester" series manufactured by Mitsubishi Chemical Foods Co., Ltd. and the "DK Ester" series manufactured by Dai-ichi Kogyo Seiyaku Co., Ltd.

(Silicon dioxide)
The form of silicon dioxide used as the component (C) is preferably powder from the viewpoint of tablet moldability. The shape of the silicon dioxide powder is not particularly limited, and for example, spherical, plate-shaped, or columnar powder can be used. The silicon dioxide powder may be porous.

The average particle size of the silicon dioxide powder is preferably 0.5 μm or more, more preferably 1.0 μm, from the viewpoint of suppressing coloration derived from the component (A) over time and improving the texture when taking tablets. As described above, it is more preferably 1.5 μm or more, preferably 30 μm or less, more preferably 20 μm or less, and further preferably 10 μm or less. The specific range of the average particle size of the silicon dioxide powder is preferably 0.5 to 30 μm, more preferably 1.0 to 20 μm, and even more preferably 1.5 to 10 μm.
The average particle size is a value defined in 7.3.2 of JIS Z2320-2: 2017, and can be measured by the Coulter method.

The specific surface area of the silicon dioxide powder, component (A) in view of suppressing the temporal coloration derived, from the viewpoint of improving the meltability in the mouth during tablet dosage, preferably 100 m 2 / ^g or more, more preferably 120 m ² / It is g or more, more preferably 150 m ² / g or more, preferably 600 m ² / g or less, more preferably 500 m ² / g or less, still more preferably 400 m ² / g or less. The specific range of the specific surface area of the silicon dioxide powder is preferably 100 to 600 m ² / g, more preferably 120 to 500 m ² / g, and even more preferably 150 to 400 m ² / g. The specific surface area can be measured by the BET method in accordance with JIS Z8830: 2013.

(Fatty acid salt)
The fatty acid salt used as the component (C) is a fatty acid from the viewpoint of suppressing the coloration derived from the component (A) over time, improving the mouthfeel when taking tablets, and using it for oral use. Alkaline earth metal salts are preferred.
As the fatty acid constituting the fatty acid salt, a saturated or unsaturated fatty acid having 12 to 24 carbon atoms is preferable. Specific examples thereof include lauric acid, myristic acid, pentadecic acid, palmitic acid, palmitoleic acid, margaderic acid, stearic acid, oleic acid, arachidic acid, erucic acid, behenic acid and the like, and one or two of them. The above can be used. Among them, saturated fatty acids having 12 or more and 18 or less carbon atoms are preferable, and specifically, lauric acid, from the viewpoint of suppressing coloration derived from the component (A) over time and improving the texture when taking tablets. , One or more selected from the group consisting of myristic acid, palmitic acid, and stearic acid, more preferably one or more selected from the group consisting of myristic acid, palmitic acid, and stearic acid, and more preferably from palmitic acid and stearic acid. One or more selected from the group consisting of
Further, as the alkaline earth metal in the alkaline earth metal salt of the fatty acid, one or more selected from the group consisting of magnesium and calcium is preferable, and calcium is more preferable.

The fatty acid salt is preferably a magnesium salt or a calcium salt of a saturated fatty acid having 12 or more and 18 or less carbon atoms, and specifically, one or more selected from the group consisting of lauric acid, myristic acid, palmitic acid, and stearic acid. Examples include magnesium salts or calcium salts of fatty acids. Among these, more preferably one or more selected from the group consisting of magnesium myristate, calcium myristate, magnesium palmitate, calcium palmitate, magnesium stearate, and calcium stearate, and even more preferably magnesium palmitate. It is one or more selected from the group consisting of calcium palmitate, magnesium stearate, and calcium stearate, and even more preferably calcium stearate.

As the component (C), one kind or two or more kinds can be used. Among the components (C), one or more selected from the group consisting of sucrose fatty acid esters and fatty acid salts is preferable, and sucrose fatty acid esters are more preferable, from the viewpoint of good texture when taking tablets.

The content of the component (C) in the oral tablet of the present invention is 0.1% by mass or more, preferably 0.5% by mass or more, from the viewpoint of suppressing the time-dependent coloring derived from the component (A). , More preferably 1.0% by mass or more, still more preferably 1.5% by mass or more. Further, from the viewpoint of improving the mouthfeel when taking tablets, it is 18% by mass or less, preferably 12% by mass or less, more preferably 5.0% by mass or less, and further preferably 3.5% by mass or less. .. The specific range of the content of the component (C) in the oral tablet of the present invention is 0.1 to 18% by mass, preferably 0.5 to 12% by mass, and more preferably 1.0 to 5. It is 0% by mass, more preferably 1.5 to 3.5% by mass.

In the oral tablet of the present invention, the mass ratio of the component (A) to the component (C) [(A) / (C)] is 0.01 or more from the viewpoint of good mouthfeel when the tablet is taken. It is preferably 0.015 or more, more preferably 0.07 or more, still more preferably 0.11 or more. Further, from the viewpoint of suppressing coloration derived from the component (A) over time, it is 1.5 or less, preferably 1.1 or less, more preferably 0.5 or less, and further preferably 0.17 or less. The specific range of the mass ratio [(A) / (C)] is 0.01 to 1.5, preferably 0.015 to 1.1, more preferably 0.07 to 0.5, and even more preferably. Is 0.11 to 0.17.

<Carbonated foam component>
The oral tablet of the present invention can contain a carbonated effervescent component. By containing the carbonic acid effervescent component, the oral tablet of the present invention gives a feeling of effervescence and gives a refreshing feeling in the oral cavity. In addition, saliva secretion is promoted, and the disintegration property of the tablet is improved, so that the tablet feels better when taken.
The carbonic acid effervescent component is preferably composed of a carbonate and an organic acid or a salt thereof from the viewpoint of obtaining a feeling of effervescence, a saliva secretion promoting effect, and a good sensation when taking tablets.

(Carbonate)
Examples of the carbonate used as the carbonic acid effervescent component include sodium carbonate, sodium hydrogencarbonate, potassium carbonate, potassium hydrogencarbonate, ammonium carbonate, sodium sesquicarbonate and the like, and these are used alone or in combination of two or more. be able to. Among these, from the viewpoint of taste when taking oral tablets, one or more selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, and potassium carbonate is preferable, and sodium hydrogen carbonate is more preferable.

When carbonate is contained, the content of carbonic acid in the oral tablet is determined by the amount of carbonic acid in terms of carbonic acid from the viewpoint of obtaining a feeling of effervescence, an effect of promoting saliva secretion, and a good feeling when taking the tablet. The amount is preferably 12 mmol / 100 g or more, more preferably 60 mmol / 100 g or more. Further, from the viewpoint of reducing harmfulness and unpleasant taste at the time of administration, the amount is preferably 720 mmol / 100 g or less, more preferably 480 mmol / 100 g or less.

In addition, the content of carbonate in the oral tablet of the present invention is preferably 1% by mass or more, preferably 1% by mass or more, from the viewpoint of obtaining a feeling of foaming, a saliva secretion promoting effect, and a good mouthfeel when taking the tablet. Is 5% by mass or more. Further, from the viewpoint of reducing harmfulness and unpleasant taste at the time of administration, it is preferably 60% by mass or less, and more preferably 40% by mass or less.

(Organic acid or salt thereof)
The organic acid or a salt thereof used as a carbonic acid foaming component may be one or more selected from hydroxycarboxylic acid, dicarboxylic acid, ascorbic acid and salts thereof from the viewpoint of reducing harmfulness and unpleasant taste when taken. preferable.
The hydroxycarboxylic acid referred to here is a compound having at least one hydroxy group and one carboxy group, and examples thereof include lactic acid, citric acid, isocitric acid, malic acid, tartaric acid, gluconic acid, and quinic acid.
The dicarboxylic acid referred to here is a dicarboxylic acid compound having no hydroxy group, and examples thereof include oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, fumaric acid, and maleic acid.
Ascorbic acid includes the three isomers L-ascorbic acid and erythorbic acid.

As the salt in the organic acid salt, an alkali metal salt is preferable from the viewpoint of reducing harmfulness and unpleasant taste at the time of administration, one or more selected from the group consisting of sodium salt and potassium salt is more preferable, and sodium salt is further preferable.
The organic acid or a salt thereof is preferably one or more selected from hydroxycarboxylic acid, ascorbic acid and salts thereof from the viewpoint of obtaining a feeling of foaming, a saliva secretion promoting effect, and a good feeling when taking tablets. More preferably, it is one or more selected from the group consisting of citric acid, tartaric acid, and L-ascorbic acid, and further preferably citric acid.

The content of the organic acid or a salt thereof in the oral tablet of the present invention is determined by the molar amount of the acid group derived from the organic acid from the viewpoint of obtaining a feeling of foaming, a saliva secretion promoting effect, and a good mouthfeel when the tablet is taken. The amount is preferably 15 mmol / 100 g or more, more preferably 50 mmol / 100 g or more. Further, from the viewpoint of reducing harmfulness and unpleasant taste when taken, the amount is preferably 700 mmol / 100 g or less, and more preferably 500 mmol / 100 g or less. The "molar amount of acid group derived from organic acid" in the organic acid salt means the molar amount of acid group of the organic acid constituting the salt.
When the organic acid is a hydroxycarboxylic acid or a carboxylic acid, the molar amount of the acid group derived from the organic acid is the molar amount of the carboxy group. Further, ascorbic acid is assumed to be an organic acid having one acid group, and the molar amount of the acid group is calculated.

When an organic acid or a salt thereof is contained, the content of the organic acid or a salt thereof in the oral tablet is preferably 1 from the viewpoint of obtaining a feeling of foaming, a saliva secretion promoting effect, and a good mouthfeel when taking the tablet. It is preferably 45% by mass or less, more preferably 3% by mass or more, and more preferably 45% by mass or less, more preferably 30% by mass or less, from the viewpoint of reducing harmfulness and unpleasant taste when taken. is there. In the present specification, the content (mass%) of the organic acid salt in the oral tablet is the mass% in terms of the organic acid constituting the salt.

When a carbonic acid effervescent component is used in the oral tablet of the present invention, carbonic acid is used from the viewpoint of obtaining a feeling of effervescence, a salivation-promoting effect, and a good mouthfeel when taking the tablet, and from the viewpoint of reducing harmfulness and unpleasant taste when taking the tablet. When the molar amount of the salt in terms of carbonic acid is d1 and the molar amount of the acid group of the organic acid or its salt is d2, the molar ratio [d1 / d2] is preferably 0.25 or more, more preferably. It is 0.5 or more. From the same viewpoint, it is preferably 3.0 or less, preferably 1.5 or less.

In addition, when a carbonated effervescent component is used in the oral tablet of the present invention, from the viewpoint of obtaining a feeling of effervescence, a saliva secretion promoting effect, and a good mouthfeel when taking the tablet, and from the viewpoint of reducing harmfulness and unpleasant taste when taking the tablet. The mass ratio [carbonate / organic acid or salt thereof] is preferably 0.2 or more, and more preferably 0.4 or more. From the same viewpoint, it is preferably 4.0 or less, and more preferably 3.0 or less.

When the carbonic acid effervescent component is used, the content of the carbonic acid effervescent component in the oral tablet of the present invention is preferably 5% by mass from the viewpoint of obtaining a feeling of effervescence, a saliva secretion promoting effect, and a good mouthfeel when taking the tablet. The above is more preferably 10% by mass or more. Further, it is preferably 80% by mass or less, more preferably 70% by mass or less, from the viewpoint of reducing harmfulness and unpleasant taste at the time of administration and from the viewpoint of moldability.

In addition to the above-mentioned ingredients, the oral tablets of the present invention include sweeteners, vitamins, minerals, epigallocatechin gallate, tea catechins such as oolong homobisflavan, extracts, and flavors as long as the effects of the present invention are not impaired. , Colorants, preservatives and other additives other than the component (C) may be appropriately blended.
In addition, the oral tablet of the present invention can contain a carrier if necessary. Examples of the carrier include binders, disintegrants, lubricants, flavoring agents, oligosaccharides, agar, powdered or crystalline cellulose, calcium hydrogen phosphate, bulking agents, surfactants, dispersants, buffers, diluents and the like. Carriers can be mentioned. The content of the carrier can be appropriately set within a range that does not impair the object of the present invention.

The oral tablet of the present invention can be produced according to a conventional method. For example, the components (A) to (C), and if necessary, a carbonic acid foaming component, an additive other than the component (C), and a carrier are mixed and mixed, and the obtained mixture is used as a raw material powder and beaten. It can be manufactured by compression molding with a tablet molding machine. The raw material powder may be directly compression-molded, or the granulated product obtained by granulating the raw material powder may be compression-molded.
As the lock molding machine, a known molding machine such as a rotary lock machine or a single-shot lock machine can be used. The pressure at the time of tableting is preferably about 10 to 30 MPa from the viewpoint of maintaining the hardness of the tablet which is a molded product.
The shape of the tablet may be a circular shape or various irregular shaped tablets having a surface shape such as an oval shape, an oval shape, or a quadrangular shape, but it is preferably circular from the viewpoint of ease of administration. In the case of a circular tablet, the diameter is preferably 3 to 30 mm, more preferably 10 to 20 mm from the viewpoint of improving the ease of taking.
The mass of the tablet is preferably 0.1 to 6 g per preparation, and more preferably 0.3 to 3 g from the viewpoint of improving the ingestibility.

The oral tablet of the present invention can be a product enclosed in a sealed container. As the sealed container, an air-impermeable container, particularly an oxygen- and steam-impermeable container, is preferable, a packaging container in which a metal foil such as aluminum is laminated on various plastics, a packaging container in which alumina, silica or the like is vapor-deposited, or a packaging container. Containers made of metal, glass, etc. can be used.

The method of using the oral tablet of the present invention can be appropriately selected depending on the form of the oral tablet and the like. For example, when the form of an oral tablet is a chewable tablet, it may be taken by chewing it in the oral cavity, and when it is a troche tablet, it may be taken until it dissolves in the oral cavity.

The oral tablets of the present invention are useful as, for example, oral hygiene agents such as anti-cariogenic agents and periodontal disease suppressants, and functional foods having an oral hygiene effect.

Hereinafter, the present invention will be described with reference to Examples, but the present invention is not limited to the scope of the Examples.

Examples 1 to 11 and Comparative Examples 1 to 8 (manufacturing and evaluation of oral tablets)
Each component was mixed according to the compounding composition shown in Table 1. Using a single-shot tableting machine (RIKEN), tablets were tableted with a ring-shaped punch having a hole diameter of 15 mm at a tableting pressure of 18 MPa to obtain a circular oral tablet having a mass of 1 g / tablet and a diameter of 15 mm.
The following evaluation was performed using the obtained oral tablets. The results are shown in Table 1.

<Less coloring over time>
The tablets obtained in each example were placed in a constant temperature bath having a temperature of 60 ° C. and a humidity of 75%, and changes in appearance after 2 hours were evaluated by three specialized panelists according to the following criteria. The evaluation criteria were as follows, the average value of the scores of the specialized panelists was calculated, and the evaluation points were determined by rounding off the second digit after the decimal point. If the average value is 2.5 or more, it is passed.
4: Almost no change in appearance compared to before measurement 3: Slight red discoloration is seen 2: Slight red discoloration is seen 1: Discoloration to deep red is seen

<Goodness of lips>
Three specialist panelists evaluated the feeling of tingling when one tablet obtained in each case was put into the mouth according to the following criteria. The evaluation criteria were as follows, the average value of the scores of the specialized panelists was calculated, and the evaluation points were determined by rounding off the second digit after the decimal point. If the average value is 2.0 or more, it is passed.
4: Very good lips 3: Good lips 2: Slightly good lips 1: Bad lips

The components shown in Table 1 are as follows. The blending amount described in the table is the blending amount (mass%) in the actual state.
* 1 Polyphenon-TF35 (Mitsui Norin Co., Ltd.): Theaflavin-containing tea extract, theaflavin content 40% by mass
* 2 Maltitol: Amalti MR-50 (Mitsubishi Corporation Food Tech Co., Ltd.)
* 3 Sucrose behenic acid ester: Ryoto sugar ester B-370F (Mitsubishi Chemical Foods Co., Ltd.)
* 4 Fine silicon dioxide: Carplex FPS-500 (DSL. Japan Co., Ltd.), average particle size 2.5 μm, specific surface area 190 m ² / g
* 5 Calcium stearate: Calcium stearate (vegetable) (Taipei Chemical Industry Co., Ltd.)

Each of the oral tablets of the present invention can be prepared by a conventional method according to the formulation shown below.

[Prescription Example 1 Effervescent Oral Tablets]
Theaflavin 0.01% by mass
Sodium hydrogen carbonate 20.00% by mass
Citric acid 15.30% by mass
Maltitol 53.69% by mass
Powdered cellulose 5.00% by mass
Sucrose behenic acid ester 3.00% by mass
Calcium Stearate 2.00% by Mass
Silicon dioxide 1.00% by mass
100.00% by mass in total

[Prescription Example 2 Effervescent Oral Tablets]
Theaflavin 0.40% by mass
Sodium hydrogen carbonate 20.00% by mass
Citric acid 15.30% by mass
Maltitol 53.30% by mass
Powdered cellulose 5.00% by mass
Sucrose behenic acid ester 3.00% by mass
Calcium Stearate 2.00% by Mass
Silicon dioxide 1.00% by mass
100.00% by mass in total

[Prescription Example 3 Effervescent Oral Tablets]
Theaflavin 4.00% by mass
Sodium hydrogen carbonate 20.00% by mass
Citric acid 15.30% by mass
Maltitol 49.70% by mass
Powdered cellulose 5.00% by mass
Sucrose behenic acid ester 3.00% by mass
Calcium Stearate 2.00% by Mass
Silicon dioxide 1.00% by mass
100.00% by mass in total

[Prescription Example 4 Effervescent Oral Tablets]
Theaflavin 0.40% by mass
Sodium hydrogen carbonate 20.00% by mass
Citric acid 15.30% by mass
Maltitol 53.30% by mass
Powdered cellulose 5.00% by mass
Sucrose stearic acid ester 3.00% by mass
Calcium Stearate 2.00% by Mass
Silicon dioxide 1.00% by mass
100.00% by mass in total

According to the present invention, it is possible to provide an oral tablet containing theaflavins, which is less colored over time and has a good texture when taken.

Claims (5)

The following components (A) to (C):
It contains one or more additives selected from the group consisting of (A) theaflavins (B) excipients (C) sucrose fatty acid esters, silicon dioxide, and fatty acid salts.
The content of the component (A) is 0.01% by mass or more and 15% by mass or less, and the content of the component (C) is 0.1% by mass or more and 18% by mass or less.
An oral tablet having a mass ratio [(A) / (C)] of the component (A) to the component (C) of 0.01 or more and 1.5 or less. The oral tablet according to claim 1, which contains a sugar alcohol as the component (B). The oral tablet according to claim 2, wherein the sugar alcohol is maltitol. The oral tablet according to any one of claims 1 to 3, wherein the component (C) is at least one selected from the group consisting of sucrose fatty acid ester and fatty acid salt. The oral tablet according to any one of claims 1 to 4, which is a troche tablet.