JP2019097436A - Oral composition - Google Patents

Abstract

To provide an oral composition which contains a processed Terminalia product, has high stability during storage, and can suppress bitterness.SOLUTION: The oral composition contains (A) a processed Terminalia product, (B) a lubricant and/or (C) an excipient, where the total amount of (B) and/or (C) based on the total amount of (A), (B) and (C) is 7 mass% or more.SELECTED DRAWING: None

Description

The present invention relates to an oral composition containing a terminalia processed product.

In recent years, interest in preventing adult diseases, diabetes control, lowering blood sugar levels, obesity elimination and the like is increasing, and various health foods are being developed. In health food, development of functional materials having these effects is required. For example, indigestible dextrin is known to have an effect of improving intestinal regulation and hypercholesterolemia. Nowadays, the demand for health food that brings multiple effects with one product is rapidly increasing (Non-Patent Document 1).

Asahi Beverage Co., Ltd. News Release "New proposal! Two health claims W (double) Tokuho '16 Asahi tea with Asahi meal W (double) 'April 15 (Tue) new release" website (URL: https : //www.asahiinryo.co.jp/company/newsrelease/2014/pick_0205-2.html)

Applicants have focused on terminaria workpieces as components that produce multiple effects with one component. However, the terminaria processed product is highly hygroscopic, has a problem in storage stability when formulated, and has a unique bitter taste, and it has been necessary to study its solution.

As a result of intensive investigations in light of the above problems, the applicant of the present application contains a processed product of terminalia and a lubricant and / or an excipient, and adjusts the blending amount of the lubricant and / or the excipient. By doing this, it was found that an oral composition having high storage stability and capable of suppressing bitter taste can be produced, and the present invention has been made.

The summary of the present invention is as follows.
<1> (A) Terminaliaria processed product and (B) lubricant and / or (C) excipient are contained, and the total amount of (B) and / or (C) is (A), (B) And 7% by mass or more based on the total amount of (C) and (C).
<2> (A) Terminaliaria processed product and (B) lubricant and / or (C) excipient are contained, and the total amount of (B) and / or (C) is (A), (B) And an oral composition characterized by 7% by mass or more based on the total amount of (C) (except when simultaneously containing sucrose fatty acid ester and reduced maltose).
The <3> (A) terminaliaria processed material is 10 mass% or more with respect to the total amount of (A), (B), and (C), It is characterized by either of <1> or <2> Oral composition as described.
The <4> (B) lubricant is at least one or more selected from stearic acid or a salt thereof, a fatty acid ester, and a rapeseed oil, according to any one of <1> to <3>. Oral composition.
The <5> (C) excipient is at least one or more selected from starch or derivatives thereof, cellulose or derivatives thereof, sugar alcohols, disaccharides, and any one of <1> to <4>. The oral composition as described in-.
<6> The composition for oral use according to any one of <1> to <5>, further comprising (D) a fluidizing agent.
The total amount of <7> (B) lubricant and (D) fluidizing agent is 1% by mass or more based on the total amount of (A), (B), (C) and (D) The oral composition as described in any one of <1>-<6> characterized by the above-mentioned.
The oral composition according to any one of <1> to <7>, wherein the content of gallic acid or a salt thereof contained in the composition is 0.1% by mass or more.
The composition for oral administration in any one of <1>-<8> characterized by being a <9> tablet.

According to the present invention, the product of terminaria processed product, lubricant and / or excipient, and the total amount of lubricant and / or excipient is added to the product of terminaria processed product, lubricant and excipient By setting the content to 7% by mass or more based on the total amount, an oral composition having high storage stability and suppressing bitter taste can be provided.

Photographs of Comparative Example 1 and Example 3 after the storage stability test are shown.

Hereinafter, the oral composition of the present invention will be described. The present invention is not limited to the following embodiment.

(A) Terminaria processed product Terminaria is a broad-leaved tree of the family Agronomidae. In the present invention, for example, Terminalia bellirica (belerica), Terminalia catappa, Terminalia tomentosa, Terminalia citrina, Terminalia phellocarpa, Terminalia copelandii, Terminalia brassi, Terminalia ivorensis, Terminalia superba, Terminalia arjuna, Terminalia chebula etc. can be mentioned. Among them, Terminalia bellirica (belerica) and Terminalia chebula are preferable, and Terminaria belliricca which exerts an effect of suppressing an increase in blood sugar level and an increase in triglyceride level is particularly preferable. Moreover, in the present invention, it is preferable to use a fruit of terminalia. The content of the terminal product in the oral composition of the present invention is not particularly limited, but is preferably 5% by mass to 95% by mass, and more preferably 10% by mass to 90% by mass.

The processed product of the terminalia of the present invention can be processed products such as crushed products, squeezed juices and extracts. As a ground material, powder, granules and the like can be mentioned. The squeezed juice and the extract may be liquid, but can also be used as a paste or dry powder. The extract can be obtained by extraction using a suitable solvent, and as a solvent that can be used, for example, water, methanol, ethanol, isopropanol, acetone, 1,3-butylene glycol, ethylene glycol, propylene glycol, Glycerin, acetic acid, ethyl acetate, ether, hexane, or a mixed solvent thereof can be mentioned. In the present invention, it is preferable to use water, methanol, ethanol, or a mixed solvent thereof from the viewpoint of effectively exerting the blood glucose level elevation suppression effect and the neutral fat elevation suppression effect. The temperature at the time of extraction can be suitably adjusted from room temperature to a temperature equal to or lower than the boiling point of the extraction solvent. In the present invention, commercially available products can be used.

(B) Lubricant A lubricant is used to reduce friction between a tablet press mill and a tablet when compressing a powder for tablets, and to prevent tableting problems such as sticking. It is. The lubricant which can be used in the present invention is not particularly limited as long as it is a component capable of achieving the above object, for example, stearic acid, calcium stearate, stearic acid such as magnesium stearate or a salt thereof, fumaric acid Examples thereof include fatty acid esters such as stearyl sodium, polyethylene glycol and sucrose fatty acid esters, vegetable oils and fats, hydrogenated oils, and talc. These may be used alone or in combination of two or more. A commercially available product can be used as the lubricant. In the present invention, stearic acid or a salt thereof, fatty acid ester, rapeseed oil is preferable from the viewpoint of improving storage stability of the composition to be obtained and bitter taste improvement, calcium stearate, sucrose fatty acid ester, rapeseed oil is more preferable .

The content of the lubricant in the present invention is not particularly limited, but is preferably 0.1% by mass or more, and more preferably 0.5% by mass or more.

(C) Excipient An excipient is added to improve the handling or molding of the composition and to make it easier to take. The excipient which can be used in the present invention is not particularly limited. For example, starch such as starch, pregelatinized starch, partially pregelatinized starch, starch decomposition product such as starch decomposition product, dextrin, reduced palatinose, sugar alcohol such as reduced maltose, Lactose, disaccharides such as maltose, brewer's yeast, crystalline cellulose, low substituted hydroxypropyl cellulose, cellulose such as hydroxypropyl cellulose, hydroxypropyl methylcellulose or derivatives thereof, refined sucrose, light anhydrous silicic acid, calcium silicate, titanium oxide, And precipitated calcium carbonate and the like. These may be used alone or in combination of two or more. As the excipient, commercially available products can be used. In the present invention, starch or derivatives thereof, cellulose or derivatives thereof, saccharides such as sugar alcohols and disaccharides are preferable from the viewpoints of improvement of the productivity and improvement of storage stability of the composition and improvement of bitter taste, pregelatinized starch and crystals Cellulose, hydroxypropyl cellulose, dextrin, reduced palatinose, reduced maltose, lactose, maltose are more preferred.

In the present invention, the content of (B) lubricant and / or (C) excipient is relative to the total amount of (A) terminalia processed product, (B) lubricant and (C) excipient, It may be 7% by mass or more, preferably 10% by mass or more. Moreover, 95 mass% or less is preferable, More preferably, it is 90 mass% or less. By setting it as the said compounding ratio, the composition for oral cavity obtained has high stability at the time of storage, and can suppress bitterness.

In the present invention, the content of the (A) terminaliaria processed material is sufficient for the effect of the terminalarialy processed material to the total amount of (A) terminaliaria processed material, (B) lubricant and (C) excipient. In order to exhibit, 5 mass% or more is preferable, More preferably, it is 10 mass% or more. Moreover, it is sufficient if it is 93 mass% or less, preferably 90 mass% or less.

(D) Fluidizing agent In the present invention, it is preferable to use (D) a fluidizing agent in addition to (A) terminalia processed product, (B) lubricant, and (C) excipient. . The fluidizing agent in the present invention is used to improve the fluidity of mixed powder and granules. The fluidizing agent that can be used in the present invention is not particularly limited, and examples thereof include silicon dioxide, aluminum silicate, magnesium aluminosilicate, calcium phosphate, magnesium carbonate, magnesium oxide and the like. These may be used alone or in combination of two or more. As the fluidizing agent, commercially available products can be used. In the present invention, silicon dioxide, aluminum silicate, magnesium aluminosilicate and calcium phosphate are preferable, and silicon dioxide and calcium phosphate are more preferable, from the viewpoints of the improvement of the manufacturability, the storage stability of the composition and the bitter taste improvement.

In the present invention, when the fluidizing agent (D) is contained, the content is preferably 0.01% by mass or more, more preferably 0.1% by mass or more, and particularly preferably 0.5% by mass or more. Moreover, 0.01 mass% or more is preferable with respect to the total amount of (A) terminaliaria processed material, (B) lubricant, (C) excipient, and (D) fluidizer, 0.1 mass% or more Is more preferable, and 0.5% by mass or more is particularly preferable.

In the present invention, the total amount of (A) terminalia processed product, (B) lubricant, (C) excipient and (D) fluidizing agent from the viewpoint of improving storage stability and improving bitterness. It is preferable to contain 0.5 mass% or more in total of (B) lubricant and (D) fluidizing agent, it is more preferable to contain 1 mass% or more, and 1.5 mass% or more to contain Particularly preferred.

The oral composition of the present invention preferably contains gallic acid or a salt thereof. The gallic acid or salt thereof is not particularly limited, such as synthetically obtained, extracted from natural products, and extracts treated with an enzyme or the like. From the viewpoint of the effect, it is preferable to contain gallic acid or a salt thereof derived from a processed product of terminalia. The content of gallic acid or a salt thereof in the present invention is preferably 0.001% by mass or more, more preferably 0.01% by mass or more, and particularly preferably 0.1% by mass in the composition. Further, 30% by mass or less of gallic acid or a salt thereof is preferably contained in the composition, more preferably 20% by mass or less, and particularly preferably 10% by mass or less.

The content of gallic acid or a salt thereof in the oral composition of the present invention can be measured by a commonly known method of analysis of gallic acid or a salt thereof according to the condition of the measurement sample. For example, it is possible to analyze by liquid chromatography. In addition, in the case of a measurement, in order to make it adapt to the separability of an apparatus, you may give a process suitably, such as removing the contaminant in a sample.

In the present invention, in addition to the (A) terminaliaria processed material, (B) lubricant, and (C) excipients, components usable for an oral composition can be used. For example, components derived from animals and plants other than processed terminaria, binders, disintegrants, various carriers, stabilizers, agents, surfactants, plasticizers, solubilizers, reducing agents, buffers, sweeteners, groups Agents, adsorbents, flavoring agents, antioxidants, brighteners, coatings, skins, wetting agents, wetting regulators, fillers, refreshing agents, coloring agents, flavoring agents, perfumes, sugar coating agents, isotonicity Agents, softeners, emulsifiers, thickeners, thickeners, foaming agents, pH adjusters, diluents, dispersants, disintegrants, disintegrators, fragrances, moisture proofing agents, preservatives, preservatives, Examples thereof include solubilizers, solubilizers, solvents, antistatic agents, moisturizers, moisturizers and the like.

The oral composition of the present invention may be in the form of, for example, tablets, granules, fine granules, powders, capsules such as soft capsules and hard capsules, chewables, granules, rods, plates and blocks. Agents, solid agents, pills, caplets, sticks and the like can be mentioned. Among these, the form of a tablet, a granule, a powder, a capsule and a chewable form is preferable, and a tablet and a chewable form are particularly preferable. The oral composition of the present invention is preferably used as a food, a food for specified health use, a nutritive function food, a functional display food, or a health food.

Hereinafter, the present invention will be specifically described by way of examples. The present invention is not limited to these examples.

After mixing each component shown in Table 1, a tablet having a tablet diameter of 250 mm and a tablet diameter of 8 mm was produced using a tableting machine. The processed product of Terminaliaria used an aqueous extract of Terminalia bellica fruit, and calcium stearate, reduced palatinose and silicon dioxide used commercial products. The terminalia berylica extract was analyzed by high performance liquid chromatography and contained 8.4% of gallic acid.

(1) Stability evaluation The tablets of Comparative Examples 1 to 3 and Comparative Examples 1 to 3 were placed in plastic cups and allowed to stand for 15 hours under the conditions of a temperature of 40C and a humidity of 75%. According to the items of Table 2 and the evaluation criteria, the tablet properties before and after storage were evaluated. The evaluation items are shown in Table 2 and the evaluation results are shown in Table 3.

In Table 2, "+: slightly deformed" indicates a deformation to the extent that the surface of the tablet changes, "++: changed" indicates a deformation that the corners of the tablet can be taken, "+ ++: "There is a clear deformation" means that the corners of the tablet are removed and the tablet diameter is changed. From Table 3, the tablet diameter expanded, the shape was deform | transformed large largely, and the comparative example 1-3 after storage of temperature 40 degreeC and humidity 75% 15 hours expanded, and adhesion to a container generate | occur | produced. On the other hand, in Examples 1 to 3 stored under the same conditions, there was almost no change in tablet diameter, and almost no change in shape was observed. From this, it was found that the oral composition of the present invention is a composition having high storage stability.

(2) Sensory evaluation A sensory evaluation was performed on the tablets of Comparative Example 1 and Examples 1, 2 and 4. Specifically, based on Comparative Example 1, it was judged by the following judgment whether the bitterness was improved or not. The evaluation results are shown in Table 4.
0 point: not improved 1 point: slightly improved 2 points: improved 3 points: apparently improved

From Table 4, it was found that the oral composition of the present invention is a composition having an improved bitter taste derived from the extract of Terminaria berylica.

(3) Manufacturability evaluation The manufacturability was evaluated about Comparative Examples 1-3 and Examples 1-4. In Comparative Example 1, the raw material was hard to put in a die and hard to tablet. Compared with Comparative Example 1 in Comparative Examples 2 and 3, although the mixture of the respective raw materials was easy to handle, there was friction with a die during tableting, and a partially missing tablet was obtained. On the other hand, in Examples 1 to 4, the mixture of the respective raw materials was easy to handle, and it was possible to obtain a clean tablet free from chipping.

Hereinafter, production examples of the oral composition of the present invention will be shown. All can be manufactured by the manufacturing method similar to an Example.

All of the obtained compositions can be obtained as oral compositions having high storage stability and suppressed bitter taste.

According to the present invention, it is possible to provide an oral composition having high storage stability and suppressed bitter taste by containing a product of terminalia product and a lubricant and / or an excipient. it can.

Claims (2)

(A) terminaliaria processed product, (B) lubricant and / or (C) excipient, and the total amount of (B) and / or (C) is (A), (B) and (C) The oral composition characterized by being 7 mass% or more with respect to the total amount of 2.). The composition for oral administration according to claim 1, wherein the (A) terminalia processed product is 10% by mass or more based on the total amount of (A), (B) and (C).