JP2020105102A - Solid composition and method for producing the same - Google Patents

Abstract

To provide a solid composition containing Aspalathus linearis extract with a wood odor reduced.SOLUTION: A solid composition contains (A) component: Aspalathus linearis extract, and (B) component: at least one selected from the group consisting of erythritol, xylitol, and sorbitol, a mass ratio between (A) component and (B) component ((A)/(B)) of 0.40 or less.SELECTED DRAWING: None

Description

The present invention relates to a solid composition containing Aspalathus linealis extract and a method for producing the same.

The Aspalathus linealis extract has muscarinic M3 receptor activity. Therefore, it is effective in reducing dry mouth, dry eye, and eye strain. Application inventions have been proposed that pay attention to such effects (for example, see Patent Documents 1 and 2).

JP, 2005-107925, A JP, 2005-107924, A

By the way, the Aspalathus linealis extract has a peculiar tree smell. The peculiar woody odor of Aspalathus linealis extract results in a reduced palatability of the consumer's continued intake.
Therefore, from the viewpoint of product development, a technique for suppressing the tree odor of the Aspalathus linealis extract is desired.

In addition, there is a problem that the content rate of eriodithiol-6-C-glucoside (E6CG), which is a functional component of the Aspalathus linealis extract, decreases when formulated. Moreover, it is preferable that the formulation has excellent disintegration property.
Furthermore, it goes without saying that discoloration of the formulation adversely affects the palatability of the consumer. Therefore, a technique for suppressing discoloration when the Aspalathus linealis extract is formulated is also desired.

An object of the present invention is to provide a solid composition containing an Aspalathus linealis extract with suppressed tree odor.
Moreover, the subject of this invention suppresses a tree smell, suppresses the fall of the content rate of eriodicthiol-6-C-glucoside (E6CG), and contains the Asparasus linearias extract excellent in disintegration property. It is also to provide a solid composition.
Furthermore, the subject of this invention is providing the solid composition containing the Aspalathus linealis extract which can prevent discoloration in addition to the above.

As a result of diligent studies on the above problems, the inventors of the present invention have contained an Aspalathus linealis extract and a predetermined sugar alcohol, and have a mass ratio (Aspalathus linealis extract/predetermined sugar alcohol) of 0.40 or less. By doing so, they have found that the above problem of suppressing tree odor can be solved, and have completed the present invention.
Further, by setting the mass ratio (Aspalathus linealis extract/predetermined sugar alcohol) to 0.02 or more, in addition to suppressing tree odor, the content rate of eriodithiol-6-C-glucoside (E6CG) The present invention has been completed by finding that the above-mentioned deterioration is suppressed and the disintegration is excellent.
Furthermore, they have found that discoloration can be prevented by containing hydroxypropyl cellulose, and have completed the present invention.

That is, the present inventors provide the following [1] to [7].
[1] The component (A): Aspalathus linealis extract, and the component (B): at least one selected from the group consisting of erythritol, xylitol, and sorbitol, and the component (A) and the above. A solid composition in which the mass ratio ((A)/(B)) of the component (B) is 0.40 or less.
[2] The solid composition according to the above [1], wherein the mass ratio ((A)/(B)) is 0.02 or more.
[3] The solid composition as described in [1] or [2] above, which further comprises (C) component: hydroxypropyl cellulose.
[4] The mass ratio ((A)/(C)) between the component (A) and the component (C) is 0.010 to 10.0, and the above [1] to [3] is described. Solid composition.
[5] The solid composition as described in any of [1] to [4] above, which is a tablet.
[6] The solid composition according to any one of [1] to [5] above, which is a food product.
[7] At least a component (A): Aspalathus linealis extract, and a component (B): at least one selected from the group consisting of erythritol, xylitol, and sorbitol, the component (A) and the above A method for producing a solid composition, comprising a step of mixing the component (B) so that the mass ratio ((A)/(B)) is 0.40 or less to obtain a mixed powder.

According to the present invention, it is possible to provide a solid composition containing an Aspalathus linealis extract with suppressed tree odor.
Moreover, according to the present invention, while suppressing tree odor, it suppresses a decrease in the content rate of eriodithiol-6-C-glucoside (E6CG), and contains an Aspalathus linealis extract having excellent disintegration properties. Can be provided.
Furthermore, according to the present invention, in addition to the above, it is possible to provide a solid composition containing an Aspalathus linealis extract capable of preventing discoloration.

Hereinafter, the present invention will be described in detail with reference to its preferred embodiments.
In addition, in the present specification, unless otherwise specified, the description “AA to BB” indicates AA or more and BB or less.

The solid composition of the present invention contains (A) component: Aspalathus linealis extract, and (B) component: at least one selected from the group consisting of erythritol, xylitol, and sorbitol, (A) The mass ratio ((A)/(B)) of the () component and the (B) component is 0.40 or less.
The solid composition of the present invention contains the component (B), and by setting the mass ratio ((A)/(B)) of the component (A) and the component (B) to 0.40 or less, (A) The tree odor derived from the components can be suppressed.

[1. Dosage form]
The dosage form of the solid composition includes, for example, granules (powder, granules, enteric-coated granules, etc.), tablets (plain tablets, sugar-coated tablets, coated tablets, enteric-coated tablets, orally disintegrating tablets, chewable tablets, effervescent tablets). Etc.), capsules, pills, troches, granules, and powders. Of these, tablets are preferable because the effects of the present invention can be more easily enjoyed.

When the dosage form of the solid composition of the present invention is a tablet, the size of the tablet is not particularly limited. From the viewpoint of easy handling of the tablet and swallowability, the diameter of the tablet is preferably 5 to 14 mmφ, more preferably 6 to 13 mmφ, and further preferably 7 to 12 mmφ.
The mass of each tablet is preferably 200 to 800 mg.
Further, the hardness of the tablet is preferably 5 to 15 kgf. When the hardness is 5 kgf or more, it is easy to suppress tree odor. When the hardness is 15 kgf or less, the disintegration property can be improved.

[2. Structural component]
Hereinafter, the details of the constituent components of the solid composition of the present invention will be described.
The content and mass ratio of each component can be calculated from the amount of raw materials used when using the solid composition. However, in the present invention, the content and mass ratio of each component is not limited to the value calculated from the amount used, the peak area ratio by high performance liquid chromatography using a known compound of high purity was used. It can also be calculated as a value.

[(A) component]
The component (A) is an Aspalathus linealis extract, and Aspalathus linealis is known as Rooibos. The Aspalathus linealis extract is preferably a tea leaf extract. The tea leaves of Aspalathus linealis may be fermented or non-fermented, and fermented tea leaves are preferable. The tea leaves are preferably young leaves, branches and the like. As the pretreatment of tea leaves, pulverization treatment, drying treatment, or a combination of these treatments may be performed.
As the component (A), one type of extract may be used alone, or two or more types of extract may be used in combination.

Examples of the extraction solvent include water, lower alcohol, lower aliphatic ketone, polyhydric alcohol and the like. Among these, the extraction solvent is preferably water or ethanol, or a mixed solution thereof. For example, the mixed solution of water and ethanol may be a mixed solution having a mass ratio (water/ethanol) of 0.1 or more. The extraction solvent is more preferably water.

The extraction condition is not particularly limited. The following conditions may be mentioned as an example.
The temperature of the extraction solvent is preferably 20 to 100°C, more preferably 80 to 100°C.
The extraction time is preferably 0.5 to 12 hours, more preferably 0.5 to 4 hours.
The amount of the extraction solvent is preferably 5 to 20 times, more preferably 7 to 15 times, in terms of mass.

The step of producing the extract may include a step of dissolving the extract in water or an adsorbent treatment solvent which is a mixture of water and an organic solvent, and bringing the extract into contact with the porous adsorbent.
Examples of the porous adsorbents include activated carbon, activated clay, acid clay, activated alumina, zeolite, silica gel, and synthetic adsorbents.

In the solid composition of the present invention, the content of the component (A) is preferably 1.0 to 25.0 mass% (w/w%), and 5.0 to 20.0 mass% (w/w%). Is more preferable and 10.0-18.0 mass% (w/w%) is still more preferable. When the content of the component (A) is 1.0% by mass (w/w%) or more, it is easy to suppress the decrease in eriodictyol-6-C-glucoside (E6CG). Therefore, it can be a solid composition exhibiting an effect on dry mouth, dry eye and the like. On the other hand, when the content is 25.0% by mass (w/w%) or less, the component (B) easily suppresses the tree odor.

When the solid composition of the present invention is a tablet, the content of the component (A) per tablet is preferably 3 to 83 mg/tablet, more preferably 16 to 66 mg/tablet, and even more preferably 33 to 60 mg/tablet. ..
When the solid composition of the present invention is a tablet, the single dose is not particularly limited and may be, for example, 2 tablets. Therefore, the intake amount of the component (A) per dose is preferably 6 to 166 mg/dose, more preferably 32 to 132 mg/dose, and even more preferably 66 to 120 mg/dose.

The content of eriodithiol-6-C-glucoside (E6CG) in the rooibos extract is usually about 0.04 to 0.5 g per 100 g of the rooibos extract.
In the solid composition of the present invention, the compounding amount of eriodithiol-6-C-glucoside (E6CG) is preferably 0.0004 to 0.125 mass% (w/w%), and 0.002 to 0.100. Mass% (w/w%) is more preferable, and 0.003-0.090 mass% (w/w%) is still more preferable.

[(B) component]
The component (B) is at least one selected from the group consisting of erythritol, xylitol, and sorbitol. Among these, erythritol and xylitol are preferable, and erythritol is more preferable, from the viewpoint of suppressing tree odor.
Commercially available products of erythritol, xylitol, and sorbitol can be used.

In the solid composition of the present invention, the content of the component (B) is preferably 2.5 to 95.0 mass% (w/w%), and 20.0 to 85.0 mass% (w/w%). Is more preferable and 55.0 to 70.0 mass% (w/w%) is still more preferable. When the content of the component (B) is in such a range, the tree odor derived from the component (A) is suppressed, the reduction of eriodictyol-6-C-glucoside (E6CG) is suppressed, and further the disintegration property is obtained. Excellent in

When the solid composition of the present invention is a tablet, the content of the component (B) per tablet is preferably 8 to 600 mg/tablet, more preferably 66 to 280 mg/tablet, and further preferably 181 to 231 mg/tablet. ..

[Mass ratio ((A)/(B))]
In the solid composition of the present invention, the upper limit of the mass ratio ((A)/(B)) of the component (A) and the component (B) is 0.40 or less, preferably 0.38 or less, and 0.1. 30 or less is more preferable. When the mass ratio ((A)/(B)) is 0.40 or less, the tree odor derived from the component (A) can be suppressed. The lower limit is preferably 0.02 or more, more preferably 0.10 or more. When the mass ratio ((A)/(B)) is 0.02 or more, it is presumed that a stable state is created by interacting with eriodithiol-6-C-glucoside (E6CG). Therefore, the reduction of eriodictyol-6-C-glucoside (E6CG) can be suppressed. In addition, it is assumed that the presence of the component (B) changes the dissolved state in water. Therefore, it is excellent in disintegration.
Therefore, in the solid composition of the present invention, the mass ratio ((A)/(B)) is 0.40 or less, preferably 0.02 to 0.40, and more preferably 0.10 to 0.38. , 0.10 to 0.30 are more preferable.

[Mass ratio (eriodithiol-6-C-glucoside (E6CG)/(B))]
In the solid composition of the present invention, the mass ratio of eriodithiol-6-C-glucoside (E6CG) and component (B) (eriodithiol-6-C-glucoside (E6CG)/(B)) is 0. 00006 to 0.00120 is preferable, 0.00030 to 0.00110 is more preferable, and 0.00030 to 0.0010 is further preferable. When the mass ratio (eriodithiol-6-C-glucoside (E6CG)/(B)) is within such a range, the tree odor derived from the component (A) is suppressed, and eriodithiol-6-C-glucoside is suppressed. It suppresses the decrease of (E6CG) and is also excellent in disintegration.

[(C) component]
The component (C) is hydroxypropyl cellulose. A commercial item can be used for hydroxypropyl cellulose.
Hydroxypropyl cellulose has isomers having various degrees of substitution. Among these, the hydroxypropoxy group substitution degree of hydroxypropyl cellulose is preferably 53.4 to 80.5% by mass. The degree of substitution of the hydroxypropoxy group is a value converted from the value measured by the substitution degree analysis method of hypromellose (hydroxypropylmethylcellulose) described in the 17th revised Japanese Pharmacopoeia.

In the solid composition of the present invention, the content of the component (C) is preferably 1.5 to 85.0 mass% (w/w%), and 2.0 to 70.0 mass% (w/w%). Is more preferable, 4.0-65.0 mass% (w/w%) is still more preferable, and 10.0-40.0 mass% (w/w%) is still more preferable. When the content of the component (C) is within such a range, it is easy to suppress discoloration during formulation.

When the solid composition of the present invention is a tablet, the content of the component (C) per tablet is preferably 5 to 600 mg/tablet, more preferably 6 to 231 mg/tablet, and further preferably 13 to 215 mg/tablet. Even more preferably, 45-125 mg/tablet.

[Mass ratio (A)/(C)]
In the solid composition of the present invention, the mass ratio ((A)/(C)) of the component (A) and the component (C) is preferably 0.010 to 10.0, and more preferably 0.010 to 8.0. It is preferably 0.050 to 3.0 and more preferably 0.050 to 3.0. When the mass ratio ((A)/(C)) is 0.010 or more, it is easy to suppress tree odor. When the mass ratio ((A)/(C)) is 10.0 or less, discoloration is easily suppressed.

[Arbitrary ingredients]
The solid composition of the present invention may contain other components (optional components) as long as the effects of the present invention and the physical properties such as storage stability are not impaired. Examples of the optional components include physiologically active components other than the component (A) and additives other than the component (B).
Examples of the physiologically active ingredient include crude drugs such as eleuthero or its extract, royal jelly, taurine, and glucosamine.
Examples of the additives include binders, excipients, disintegrants, flavors, lubricants, sweeteners, superplasticizers, and colorants. The additives may be used alone or in combination of two or more.

Examples of the binder include crystalline cellulose, starch, sucrose, pregelatinized starch, gelatin, gum arabic powder, polyvinylpyrrolidone, pullulan, dextrin, cyclodextrin, methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol, polyethylene. Examples include glycol.

Examples of the excipient include lactose, lactose granules, mannitol, corn starch, L-cysteine, methylethyl cellulose, trehalose, maltitol, and lactitol.
Examples of the disintegrant include crospovidone, carmellose, carmellose sodium, carmellose calcium, hydroxypropyl starch, croscarmellose sodium, partially pregelatinized starch, carboxymethyl cellulose, and carboxymethyl cellulose sodium.

Examples of the fragrance include menthol, monomenthyl succinate, limonene, and plant essential oils (mint oil, mint oil, lychee oil, orange oil, lemon oil, jasmine oil, etc.).
Examples of the lubricant include calcium stearate, magnesium stearate, sodium stearyl fumarate, sucrose fatty acid ester, light anhydrous silicic acid, talc, and finely divided silicon dioxide.
Examples of the sweetener include aspartame, sodium saccharin, stevia, dipotassium glycyrrhizinate, acesulfame potassium, thaumatin, sucralose and the like.

Examples of the coloring agent include food coloring agents, organic and inorganic pigments other than food coloring agents, and animal and plant extracts.
Examples of the food coloring agent include orange essence, caramel, carmine, β-carotene, food blue No. 1, food yellow No. 4, food yellow No. 4 aluminum lake, food yellow No. 5, food red No. 2, food red No. 3. , Edible Red No. 102 can be mentioned.
Examples of the organic pigment include copper chlorophyllin sodium, copper chlorophyll, and riboflavin.
Examples of the inorganic pigment include iron sesquioxide, yellow iron sesquioxide, black iron oxide, zinc oxide, titanium oxide, black iron oxide, brown iron oxide, zinc oxide, gold foil, and medicinal charcoal.
Examples of animal and plant extracts include licorice extract, Acacia catechu ninnin powder, turmeric extract, green tea powder and the like.
Among these, inorganic pigments are preferable, because the solid preparation is less likely to fade even after storage and the adhesion to the manufacturing machine can be reduced, and iron sesquioxide, yellow iron sesquioxide, iron such as black iron oxide as the main component is used. Inorganic pigments, zinc oxide, and titanium oxide are more preferable, iron sesquioxide, yellow iron sesquioxide, zinc oxide, and titanium oxide are more preferable, and iron sesquioxide and yellow iron sesquioxide are even more preferable.

[3. Production method]
In the method for producing a solid composition of the present invention, at least the component (A) and the component (B) have a mass ratio ((A)/(B)) of the components (A) and (B) of 0. There is a step of obtaining a mixed powder by mixing so as to be 40 or less. The mixed powder may contain the component (C) and an optional component. Further, the method for producing a solid composition of the present invention preferably further has a step of granulating the mixed powder. The granulating step is preferably a wet granulating step.
Each component may be one obtained by a known production method, or may be a commercially available product. Further, as each component, powder may be used as it is, or granulated one may be used.

The mixed powder may contain the component (A) and the component (B), and may contain the component (C) and the optional component as necessary. The mixed powder may be, for example, a powder mixture of the powder component (A) and the powder component (B), or a granulated product containing the component (A) and the component (B).

When the solid composition of the present invention is a tablet, it can be produced, for example, by tableting a mixed powder. In the tablets produced in this manner, the component (A) and the component (B) are present in the same tablet.
Examples of the method for producing a tablet include a method including a step (tabletting step) of tableting a mixed powder using a tableting machine having a die and a punch.

The mixed powder may be a premixed powder or a newly prepared powder. That is, the method for producing a tablet may include a step of mixing the powder components to prepare a mixed powder (powder preparation step).
In the powder preparation step, the powder component (A) and the powder component (B) are mixed to obtain a mixed powder. The mixing method in the powder preparation step is not particularly limited, and conventionally known powder mixing methods can be mentioned.
Each component used in the powder preparation step may be one obtained by a known production method, or may be a commercially available product. As each component, powder may be used as it is, or granulated products may be used. When the granulated product is used, a known granulation method can be adopted as the granulation method. Among them, the granulation method by wet granulation is preferable from the viewpoint of suppressing tree odor.
Examples of the wet granulation method include a fluidized bed granulation method, a stirring granulation method, an extrusion granulation method, a kneading granulation method, and a spray granulation method. When it is a granulation method other than the wet granulation, it may be difficult to suppress the tree odor.

Examples of the tableting machine used in the tableting step include a rotary tableting machine (“Libra 3L”, manufactured by Kikusui Seisakusho).
The tableting conditions such as the tableting pressure and the rotating speed of the turntable are appropriately set.

The obtained tablets may be coated with a coating agent, if necessary.
As the coating agent, it is preferable to select a coating agent that does not significantly impair the disintegration property. Of these, water-soluble polymer compounds and plasticizers are preferable.
Examples of the water-soluble polymer compound include celluloses such as carmellose, hydroxypropylmethylcellulose (hypromellose), hydroxymethylcellulose, and methylcellulose; gum arabic, carboxyvinyl polymer, povidone, polyvinyl alcohol, polyacrylic acid, monosaccharide, disaccharide or more Polysaccharides (sugar (granulated sugar, etc.), lactose, maltose, xylose, isomerized lactose, etc.), sugar alcohols (palatinit, lactitol, reduced starch saccharified products, maltitol, mannitol, etc.), starch syrup, isomerized sugars, oligosaccharides , Sucrose, trehalose, and reduced starch saccharified products (reduced starch degradation products, etc.).
Examples of the plasticizer include those described in the Japanese Pharmacopoeia (Hirokawa Shoten) such as triethyl citrate, triacetin, carnauba wax, etc., and the compendials such as the standards for pharmaceutical additives (Shin-Yakuji Nippo).
These coating agents may be used alone or in combination of two or more.

[4. Use]
The solid composition of the present invention can be used as foods, medicines, quasi drugs, and constituent materials thereof. The food may be any of health foods, functional foods, dietary supplements (supplements), foods for specified health use, foods for medical use, foods for the sick, foods for infants, foods for nursing care, and foods for the elderly. Moreover, you may add the solid composition of this invention to foodstuffs. Such foods include, for example, confectionery (cookies, cakes, gums, candies, tablets, gummi, buns, yokan, pudding, jelly, ice cream, sorbet, etc.), processed marine products (kamaboko, chikuwa, hanpen etc.), Examples include livestock products (hamburgers, hams, sausages, wieners, cheese, butter, margarine, fermented milk, etc.) and staple foods (rice, noodles (dry noodles, raw noodles), bread, cereals, etc.).

The administration form of the drug or quasi drug is not particularly limited. Oral administration (eg, buccal administration, sublingual administration) is preferred because it is less invasive.

The subject to be ingested by the solid composition of the present invention may be an animal including human, and is usually a human, but an animal other than human (for example, mouse, rat, hamster, dog, cat, sheep, goat, cow). , Mammals such as pigs and monkeys).

Hereinafter, the present invention will be described in detail with reference to Examples. The following examples are for the purpose of illustrating the present invention in a preferable manner and not for limiting the present invention. In addition, the measurement method of the physical property values and the like is the measurement method described above unless otherwise stated.

[Evaluation method]: The sensory evaluation was performed by the following method with reference to the "new edition sensory inspection handbook" (1999, Nikka Giren Publishing Co., Ltd.). In addition, the expert panel (p.583) in the same handbook was used for the sensory evaluation. Also, the evaluation criteria were set with reference to "19.3 Preference expression terms" (p.679 to 681) in the handbook.

[Evaluation of tree odor]: A sensory evaluation of tree odor was performed using the manufactured tablets. More details are as follows. Using the tablets produced in Comparative Example 1, the evaluator was asked to confirm the tree odor peculiar to rooibos. The evaluator was asked to chew each tablet, and the tree odor from the start of chewing to the end of chewing was evaluated according to the following criteria. Then, for each tablet, the tree odor was evaluated by the average value of 10 evaluators.
A score of 3 or more was regarded as a passing level.
(Evaluation criteria)
5 points: No tree smell 4 points: Slight tree smell 3 points: Little tree smell 2 points: Tree smell quite 1 point: Tree smell very much (Comparative Example 1)

[Evaluation of disintegration]: Based on the disintegration test method described in the 17th revised Japanese Pharmacopoeia, the disintegration of tablets immediately after production was evaluated according to the following criteria. Each tablet was subjected to a disintegration test 6 times, and the disintegration property was evaluated by the average value of 6 times.
A score of 3 or more was regarded as a passing level.
(Evaluation criteria)
5 points: Disintegration time less than 20 minutes 4 points: Disintegration time 20 minutes or more, less than 25 minutes 3 points: Disintegration time 25 minutes or more, less than 30 minutes 2 points: Disintegration time 30 minutes or more, less than 35 minutes 1 point : Collapse time is 35 minutes or more

[Evaluation of discoloration]: The discoloration suppression effect was evaluated using a handy type spectral color difference meter NF333 (manufactured by Nippon Denshoku Industries Co., Ltd.). More specifically, the color difference of the tablet stored under the environment of 50° C. and 75% RH for 4 weeks and the color difference of the tablet stored under the environment of 5° C. were measured. Using the color difference of the tablets stored under the environment of 5° C. as a control, ΔE* was calculated by the following calculation formula. Each tablet was measured 6 times, and the average value of 6 times was used to evaluate the discoloration.
Calculation formula: ΔE*=tablet (example or comparative example)-control

[Evaluation of E6CG content]: The tablet before storage and the tablet stored for 4 weeks in an environment of 50° C. and 75% RH were left at room temperature (25° C.) for 24 hours. A part of the powder obtained by crushing each tablet in a mortar was used as a measurement sample. Using the measurement sample, the E6CG content was quantified by a high performance liquid chromatograph (“LC-2010”, manufactured by Shimadzu Corporation) under the following analysis conditions.
(Analysis conditions)
Column: COSMOSIL PBr (5 μm, 2.0×150 mm, manufactured by Nacalai Tesque, Inc.)
Mobile phase: 0.1 mM EDTA methanol/water=95/5 (v/v) liquid flow rate: 0.2 mL/min
Temperature: 40 ℃
Detector: UV 288 nm
The residual ratio of the content of E6CG was calculated by the following mathematical formula. A high-purity aliquot was used as the standard for quantification. It can be said that the higher the residual ratio of the content of E6CG is, the better the suppression of the decrease of the content of E6CG is, and the more stable it is.
Residual rate (%)=E6CG content after storage/E6CG content before storage×100

[Raw materials]: The following raw materials were used in manufacturing the tablets of Examples and Comparative Examples.
(A) component:
Rooibos extract: “Rooibos dry tea extract F”, manufactured by Maruzen Pharmaceutical Co., Ltd. (containing 0.3% of E6CG)
(B) component:
Erythritol: "Erythritol 50M", manufactured by Bussan Food Science Co., Ltd. Xylitol: "Xylit fine powder", manufactured by Mitsubishi Corporation Foodtec Co., Ltd. Sorbitol: "Sorbitol LTS-P50M", manufactured by Mitsubishi Corporation Foodtec Co., Ltd. (B') Ingredients:
Maltitol: "Amarti MR-50", manufactured by Mitsubishi Corporation Foodtech (C) Ingredients:
Hydroxypropyl cellulose: "Celny SSL-SFP", manufactured by Nippon Soda Co., Ltd.

[Storage condition (tablet/granule)]: The details of the storage condition used for the above evaluation are described. 62 tablets were enclosed in a PET/AL/PE laminated bag (“Lamizip AL-D”, manufactured by Production Japan Co., Ltd.) and stored at 50° C. and 75% RH for 4 weeks.
20 g of the granules were enclosed in a PET/AL/PE laminated bag (“Lamizip AL-D”, manufactured by Production Japan Co., Ltd.) and stored at 50° C. and 75% RH for 4 weeks.

(Examples 1 to 7 and Comparative Examples 1 to 3)
Component (A), component (B) or component (B') described in Table 1 and a part of crystalline cellulose are mixed (however, for Comparative Example 1, component (B) or component (B') is added). No)) and a granulating apparatus (FLOW COATER FLO-5, manufactured by Freund Sangyo Co., Ltd.) was used to spray a 3% aqueous solution of hydroxypropyl cellulose for granulation.
The granulated powder was sieved and primarily mixed with other raw materials except calcium stearate, and then secondarily mixed with calcium stearate which was twice dispersed at the granulated powder. A Bohle container mixer (MC-800 type, manufactured by Hiroshima Metal & Machinery) was used for the primary mixing and the secondary mixing. A table-top rotary tableting machine ("PICCOLA", manufactured by STEC Co., Ltd.) was used for tableting at a disc rotation speed of 20 rpm using a pestle having a diameter of 9.0 mm (6.75R). The applied pressure and the main pressure were adjusted to 8 kgf.
An evaluation test was conducted using the manufactured tablets. The results are shown in Table 1 together with the evaluation results.

As can be seen from Table 1, the tablets corresponding to the solid composition of the present invention have a generally high evaluation of tree odor and can suppress tree odor (Examples 1 to 7). Further, since (A)/(B) is 0.02 or more, the residual rate of E6CG is high, the disintegration evaluation is high, and the disintegration is excellent. On the other hand, in Comparative Example 1 in which the component (B) is not used, the tree odor score is 1.4, indicating that the odor is hardly suppressed. Further, in Comparative Example 2 in which (A)/(B) is 0.5, which is more than 0.4, the tree odor is 2.6, which is clearly inferior to the tree odor control in the tablets of the Examples. Recognize. Furthermore, in Comparative Example 3 using maltol, the tree odor score was 2.0 even when sugar alcohol was used, which indicates that the tablet odor was clearly inferior to the tablets of the Examples.

(Examples 8 to 15)
A component (A), a component (B), a part of the component (C), and a part of the crystalline cellulose described in Table 2 are mixed and a granulating device (FLOW COATER FLO-5, manufactured by Freund Sangyo Co., Ltd.) is used. Then, a 3% aqueous solution of hydroxypropyl cellulose was sprayed for granulation.
The granulated powder was sieved and primarily mixed with other raw materials except calcium stearate, and then secondarily mixed with calcium stearate which was twice dispersed at the granulated powder. A Bohle container mixer (MC-800 type, manufactured by Hiroshima Metal & Machinery) was used for the primary mixing and the secondary mixing. A table-top rotary tableting machine ("PICCOLA", manufactured by STEC Co., Ltd.) was used for tableting at a disc rotation speed of 20 rpm using a pestle having a diameter of 9.0 mm (6.75R). The applied pressure and the main pressure were adjusted to 8 kgf.
An evaluation test was conducted using the manufactured tablets. The results are shown in Table 2 together with the evaluation results.

As can be seen from Table 2, even if the tablet corresponding to the solid composition of the present invention contains the component (C), the evaluation of tree odor is generally high, and it can be seen that the tree odor can be suppressed (Example 8 ~15). Further, since (A)/(B) is 0.02 or more, the residual rate of E6CG is high, the disintegration evaluation is high, and the disintegration is excellent. Furthermore, when compared with the values of the discoloration evaluation of the solid compositions of Examples 1 to 0.70 to 0.90, the values of the discoloration evaluation of the solid compositions of Examples 8 to 15 are 0.08 to 0.61. Therefore, it can be seen that discoloration can be suppressed by containing the component (C).

(Examples 16 to 20)
A granulating device (FLOW COATER FLO-5, manufactured by Freund Sangyo Co., Ltd.) (provided that the components (A), (B), part of the component (C), and part of the crystalline cellulose shown in Table 3 are mixed) Only in Example 20, dry granulation was performed, and pressure piece granulation was performed using a granulating device (ROLLER COMPACTOR, manufactured by Freund Sangyo Co., Ltd.), and a 3% aqueous solution of hydroxypropyl cellulose was sprayed. Granulation was performed.
The granulated powder was sieved and primarily mixed with other raw materials except calcium stearate, and then secondarily mixed with calcium stearate which was twice dispersed at the granulated powder. A Bohle container mixer (MC-800 type, manufactured by Hiroshima Metal & Machinery) was used for the primary mixing and the secondary mixing. A table-top rotary tableting machine ("PICCOLA", manufactured by STEC Co., Ltd.) was used for tableting at a disc rotation speed of 20 rpm using a pestle having a diameter of 9.0 mm (6.75R). The applied pressure and the main pressure were adjusted to 8 kgf.
An evaluation test was conducted using the manufactured tablets. The results are shown in Table 3 together with the evaluation results.

(Example 21)
All of the other raw materials except calcium stearate shown in Table 3 were primarily mixed, sieved, and then secondarily mixed with calcium stearate which was double-dispersed at the granulation powder. A Bohle container mixer (MC-800 type, manufactured by Hiroshima Metal & Machinery) was used for the primary mixing and the secondary mixing. A table-top rotary tableting machine ("PICCOLA", manufactured by STEC Co., Ltd.) was used for tableting at a disc rotation speed of 20 rpm using a pestle having a diameter of 9.0 mm (6.75R). The applied pressure and the main pressure were adjusted to 8 kgf.
An evaluation test was conducted using the manufactured tablets. The results are shown in Table 3 together with the evaluation results.

As can be seen from Table 3, the tablets corresponding to the solid composition of the present invention have a generally high evaluation of tree odor regardless of the content of the component (A), and can suppress tree odor (Examples). 16-21). Further, since (A)/(B) is 0.02 or more, the residual rate of E6CG is high, the disintegration evaluation is high, and the disintegration is excellent. Furthermore, when compared with the values of the discoloration evaluation of the solid compositions of Examples 1 to 0.70 to 0.90, the values of the discoloration evaluation of the solid compositions of Examples 16 to 21 are 0.08 to 0.12. Therefore, it is understood that discoloration can be suppressed because the component (C) is contained.
In addition, it turns out that the effect of the present invention is exhibited regardless of the manufacturing method.

(Example 22)
Rooibos extract 1 kg and erythritol 4 kg were mixed, and a 3% aqueous solution of hydroxypropyl cellulose was sprayed and granulated using a granulating device (FLOW COATER FLO-5, manufactured by Freund Sangyo Co., Ltd.) to produce granules. .. The content of hydroxypropyl cellulose in the solid composition was adjusted to 15.0% by mass (w/w%).
Using the manufactured granules, evaluation tests were conducted in the same manner as in Examples 1 to 21 and Comparative Examples 1 to 3 except that the storage conditions of the granules were changed. The evaluation results are shown in Table 4.

As can be seen from Table 4, the solid composition of the present invention, even in the form of granules, is highly evaluated for tree odor and can suppress tree odor. Further, since (A)/(B) is 0.25, the residual rate of E6CG is high, the disintegration evaluation is high, and the disintegration is excellent. Furthermore, the value of the discoloration evaluation of the solid composition is 0.08, and it is understood that discoloration can be suppressed because it contains the component (C).

Claims (7)

(A) component: Aspalathus linealis extract,
(B) component: at least one selected from the group consisting of erythritol, xylitol, and sorbitol,
A solid composition in which the mass ratio ((A)/(B)) of the component (A) and the component (B) is 0.40 or less. The solid composition according to claim 1, wherein the mass ratio ((A)/(B)) is 0.02 or more. The solid composition according to claim 1 or 2, further comprising (C) component: hydroxypropyl cellulose. The solid composition according to any one of claims 1 to 3, wherein a mass ratio ((A)/(C)) of the component (A) and the component (C) is 0.010 to 10.0. .. The solid composition according to claim 1, which is a tablet. The solid composition according to claim 1, which is a food product. At least (A) component: Aspalathus linealis extract, and (B) component: at least one selected from the group consisting of erythritol, xylitol, and sorbitol, the (A) component and the (B) A method for producing a solid composition, comprising a step of obtaining a mixed powder by mixing so that a mass ratio ((A)/(B)) of components becomes 0.40 or less.