Composition for producing capsule film, method for producing material for producing capsule film, and capsule film

Abstract

The present invention addresses the problem of improving the moldability of a capsule film material (e.g., a soft capsule film material) containing a vegetable protein so as to impart a new function to a capsule preparation. Examples of the new function include: a function to make the capsule film exhibit various biological activities; a function to achieve a system (DDS; drug delivery system) for delivering an active ingredient of a capsule preparation to the intestines, particularly the large intestine; and a function to enable the use of a highly active drug as a content. As a solution for the problem, a composition for the production of a capsule film is provided, the composition comprising a vegetable-derived protein and at least one component selected from the group consisting of a polyol, a triester and a trialkylamino acid. The composition for the production of a capsule film is subjected to pressure heating treatment to provide a material for the production of a capsule film, and the material for the production of a capsule film can be formed as a capsule for a capsule preparation (preferably a soft capsule preparation).

Description

Composition for producing capsule shell, method for producing material for producing capsule shell, and capsule shell

[0001] The present invention relates to a composition for producing a capsule shell, a method for producing a material for producing a capsule shell, and a capsule shell.

[0002] It has been reported that the underlying pathology of age-related diseases such as malignant neoplasms and COPD, as well as non-communicable diseases (NCDs), is related to chronic inflammation, as evidenced by increases in blood inflammatory markers such as inflammatory cytokines. From the perspective of extending healthy lifespan and preventing the need for nursing care, the importance of preventing and improving chronic inflammation is increasing, and nutritional intake that focuses on anti-inflammatory effects, based on the intake of sufficient energy, high-quality protein, vitamins, and minerals, is required.

[0003] In this situation, Non-Patent Document 1 reports that elderly people aged 70 or over who were residing in low-cost nursing homes took soy protein, a vegetable protein, for a certain period of time, and as a result, an anti-inflammatory effect due to the TNF-α lowering effect was observed.In addition to this, various other physiological activities have been observed in vegetable proteins.

[0004] It is also known that proteins can be made resistant to digestion by hydrolysis. Protein hydrolysis is carried out by heat treatment (including heat treatment under pressure), enzyme treatment, acid treatment, etc. Techniques for making proteins resistant to digestion have also been reported. For example, Patent Document 1 describes treating a plant-derived raw material containing protein with a protease to produce a material with a high content of resistant components.

[0005] Resistant proteins are sometimes called resistant proteins and are sometimes classified as a type of luminacoid (fermentable dietary fiber). Resistant proteins are difficult to break down by digestive enzymes in the stomach and small intestine and can be delivered to the large intestine. Therefore, resistant proteins are known to exhibit physiological functions similar to dietary fiber, and have been reported to have cholesterol-lowering effects, bowel movement-improving effects, etc. (Patent Document 2).

[0006] JP 2008-189625 A JP 2019-129737 A

[0007] Japan Plant Protein Association, Research Report, "Nutritional Effects of Plant Protein Intake on Extending Healthy Lifespan in the Elderly," [Online], November 2020, [Retrieved June 2, 2023], Internet <URL: https: / / www.protein.or.jp / wp-content / themes / protein.or.jp / pdf / study3.pdf>

[0008] For these reasons, plant proteins are expected to be used in a variety of applications, such as in foods, beverages, and pharmaceuticals that have health-promoting effects.

[0009] However, compositions containing vegetable proteins generally have poor moldability, making them difficult to formulate. Therefore, the present invention aims to impart new functions to capsule formulations by improving the moldability of capsule shell materials (e.g., soft capsule shell materials) containing vegetable proteins. For example, by incorporating vegetable proteins into the capsule shell of a capsule formulation, the capsule shell itself is expected to exert various biological effects. Furthermore, by making the vegetable proteins contained in the capsule shell material indigestible, it is expected to realize a system (DDS / Drug Delivery System) that delivers the active ingredients of the capsule formulation to the intestine, particularly the large intestine. Furthermore, by making the vegetable proteins contained in the capsule shell material indigestible, it is expected to provide capsule formulations in which highly reactive ingredients (highly active substances) are encapsulated in the capsule shell.

[0010] The present invention relates to, for example, a composition for producing a capsule shell. [1] A composition for producing a capsule shell, comprising at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (collectively referred to as a "formability-imparting component") and a plant-derived protein. [2] The composition according to [1] above, wherein the mass ratio of the formability-imparting component to the plant-derived protein is 25:75 to 80:20. [3] The composition according to [1] or [2] above, wherein the water content is less than 20 mass%. [4] The composition according to any one of [1] to [3] above, wherein the plant-derived protein comprises at least one selected from the group consisting of soybean-derived protein, adzuki bean-derived protein, kidney bean-derived protein, cocoa bean-derived protein, wheat-derived protein, buckwheat-derived protein, and rice-derived protein. [5] The composition according to any one of [1] to [4] above, wherein the formability-imparting component comprises glycerin.

[0011] The present invention also relates to, for example, a method for producing a composition for producing a capsule shell. [6] A method for producing a material for producing a capsule shell, comprising a step of pressurizing and heating a composition containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-imparting component") and a plant-derived protein. [7] The method for producing a material for producing a capsule shell, comprising the step of pressurizing and heating a composition containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-imparting component") and a plant-derived protein. [8] The method for producing a material for producing a capsule shell, comprising the step of pressurizing and heating a composition containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-imparting component") and a plant-derived protein. [9] The method for producing a material for producing a capsule shell, comprising the step of pressurizing and heating a composition containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-imparting component") and a plant-derived protein.

[10] The method for producing a material for producing a capsule shell, comprising the step of pressurizing and heating a composition containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-imparting component") and a plant-derived protein.

[11] The method for producing a material for producing a capsule shell, comprising the step of pressurizing and heating a composition containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-imparting component") and a plant-derived protein.

[12] The method for producing a material for producing a capsule shell, comprising the step of pressurizing and heating a composition containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as a "formability-im

[11] The method according to any one of [6] to

[10] above, wherein the heating temperature is 50 to 200°C.

[0012] The present invention further relates to, for example, a capsule shell and a capsule formulation comprising the same.

[12] A capsule shell containing at least one selected from the group consisting of polyols, triesters, and trialkylamino acids (also referred to as "formability-imparting components") and a plant-derived protein.

[13] The capsule shell according to

[12] above, wherein the mass ratio of the formability-imparting component to the plant-derived protein is 25:75 to 80:20.

[14] The capsule shell according to

[12] or

[13] above, wherein the plant-derived protein comprises at least one selected from the group consisting of soybean-derived protein, adzuki bean-derived protein, kidney bean-derived protein, cocoa bean-derived protein, wheat-derived protein, buckwheat-derived protein, and rice-derived protein.

[15] The capsule shell according to any of

[12] to

[14] above, wherein the formability-imparting component comprises glycerin.

[16] The capsule shell according to any of

[12] to

[15] above, wherein the plant-derived protein is a protein that has been subjected to pressure and heat treatment.

[17] A capsule preparation comprising the capsule shell according to any one of

[12] to

[16] above and a content encapsulated in the capsule shell.

[0013]

[18] A method for reducing digestibility of a protein, comprising the steps of pressurizing and heating a composition containing the protein.

[19] The method according to

[18] above, wherein the composition further contains a polyol.

[0014] According to the present invention, a new use of plant-derived proteins as capsule shells is provided. Also, according to the present invention, indigestible capsule shells are obtained. Furthermore, according to the present invention, a capsule formulation having new functions is provided.

[0015] Hereinafter, embodiments of the present invention will be described in detail.

[0016] [1. Composition for producing capsule shell] The composition for producing capsule shell according to one embodiment of the present invention is a composition that is processed or treated (typically, but not limited to, pressure and heat treatment) to form a material for producing a capsule shell. The composition for producing capsule shell contains at least one selected from the group consisting of triol, triester, and trialkylamino acid (collectively referred to as "formability-imparting component") and a plant-derived protein; it may also contain any other component. Each component of the composition for producing capsule shell will be described below.

[0017] [1-1. Plant-derived protein] The plant-derived protein contained in the composition for producing a capsule shell of the present invention is not particularly limited as long as it is a protein derived from a plant. Examples of plants from which proteins are derived include grains, beans, nuts and seeds, potatoes, vegetables, fruits, mushrooms, algae, etc. Examples of grains include wheat, barley, oats, rice, corn, buckwheat, etc.; examples of beans include soybeans, peas, adzuki beans, chickpeas, lentils, broad beans, mung beans, lupins, kidney beans, cacao beans, etc.; examples of nuts and seeds include almonds, peanuts, cashew nuts, pistachios, hazelnuts, macadamia nuts, flaxseed, sesame, rapeseed, cottonseed, safflower, sunflower, etc.; examples of potatoes include potato, sweet potato, mountain yam, Jerusalem artichoke, kikui, etc. Examples of vegetables include asparagus, artichoke, cauliflower, broccoli, edamame, etc.; examples of fruits include banana, jackfruit, kiwi fruit, coconut, avocado, olive, etc.; examples of mushrooms include mushroom, king oyster mushroom, shiitake mushroom, shimeji mushroom, maitake mushroom, etc.; examples of algae include chlorella, spirulina, euglena, nori, kelp, wakame seaweed, hijiki seaweed, tengusa, mozuku seaweed, etc.

[0018] Plant-derived proteins in the present invention include proteins contained in fermented products made from plants (for example, rice-derived proteins such as proteins contained in sake lees made from rice) and denatured proteins extracted from plants.

[0019] When the capsule shell production composition of the present invention is used as a material for producing a capsule shell, the plant-derived protein contained in the capsule shell production composition is preferably made indigestible by, for example, heat treatment under pressure (thereby imparting indigestibility to the capsule shell). Examples of plant-derived proteins that are easily made indigestible include soybean-derived protein, adzuki bean-derived protein, kidney bean-derived protein, cocoa bean-derived protein, wheat-derived protein, buckwheat-derived protein, rice-derived protein, etc. The plant-derived proteins can be used alone or in combination of two or more.

[0020] The lower limit of the content of the plant-derived protein in the composition for producing a capsule shell of the present invention is preferably 10% by mass, more preferably 15% by mass, and particularly preferably 20% by mass, based on the total amount of the composition. By incorporating the plant-derived protein, it is possible to impart predetermined functions (including physiologically active functions and indigestibility due to the plant-derived protein) to the resulting capsule shell. The upper limit of the content of the plant-derived protein in the composition for producing a capsule shell is not particularly limited, but, taking into consideration its formability, it is preferably 85% by mass, more preferably 80% by mass, and particularly preferably 75% by mass, based on the total amount of the composition.

[0021] [1-2. Moldability-imparting component] The capsule shell production composition of the present invention is processed into a capsule shell production material; the moldability-imparting component contained in the capsule shell production composition can impart good moldability to the capsule shell production material. The moldability-imparting component can be at least one selected from polyols, triesters, and trialkylamino acids.

[0022] [1-2-1. Polyol] The polyol among the moldability-imparting components is not particularly limited as long as it is an organic compound having multiple hydroxyl groups, and may be a diol, triol, or a polyol having 4 or more hydroxyl groups. The polyols may be used alone or in combination of two or more.

[0023] The diol may be, for example, a (poly)alkylene glycol, a monoester of a fatty acid and glycerin, etc. Examples of the (poly)alkylene glycol include ethylene glycol, propylene glycol, polyethylene glycol, polypropylene glycol, etc. Examples of the monoester of a fatty acid and glycerin include glyceryl monocaprylate, glyceryl monobehenate, glyceryl monopalmitate, glyceryl monostearate, glyceryl monobehenate, etc.

[0024] The triol may be, for example, glycerin, a monoester of a fatty acid and diglycerin, etc. Examples of the monoester of a fatty acid and diglycerin include a monoester of stearic acid and diglycerin, etc.

[0025] Examples of polyols having four or more hydroxyl groups include chain sugar alcohols such as erythritol, xylitol, sorbitol, and mannitol; chain compounds having four or more hydroxyl groups such as polyglycerin; sugar alcohols containing a ring structure such as isomalt, lactitol, and maltitol; and polysaccharides such as trehalose, cellulose derivatives, and chitosan. Examples of cellulose derivatives include methyl cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, and ethyl cellulose with a low ethoxylation rate (preferably an ethoxylation rate of 40% by mass or less).

[0026] [1-2-2. Triester] The moldability-imparting component may be a triester. Examples of triesters include triesters of glycerin and carboxylic acids such as triacetin, glycerol tripropionate, glycerol tributyrate, and glycerol trihexanoate; citric acid triesters such as triethyl citrate, acetyl triethyl citrate, tributyl citrate, acetyl triethyl citrate, and acetyl tris(2-ethylhexyl) citrate; and trimellitic acid triesters such as tributyl trimellitate and tris(2-ethylhexyl) trimellitate. These triesters can be used alone or in combination of two or more.

[0027] [1-2-3. Trialkylamino acid] The moldability-imparting component may be a trialkylamino acid. Trialkylamino acid is a compound having an N,N,N-trialkylammonio group and a —COO － or a compound containing a carboxy group or a salt thereof. Examples of trialkylamino acids include betaine (trimethylglycine), triethylglycine, tripropylglycine, triisopropylglycine, trimethyl-γ-aminobutyric acid, N,N,N-trimethylalanine, N,N,N-triethylalanine, N,N,N-triisopropylalanine, N,N,N-trimethylmethylalanine, carnitine, acetylcarnitine, and salts thereof (e.g., hydrochloride salts, organic acid salts). Trialkylamino acids can be used alone or in combination of two or more types.

[0028] The capsule shell production composition of the present invention preferably contains a polyol as a moldability-imparting component. Furthermore, the capsule shell production composition preferably contains glycerin as a moldability-imparting component in order to enhance the moldability of the capsule shell production material. The content of glycerin in the capsule shell production composition is preferably 30% by mass or more, particularly preferably 50% by mass or more, based on the total amount of the moldability-imparting components.

[0029] In the composition for producing a capsule shell of the present invention, the lower limit of the content of the formability-imparting component is preferably 10% by mass, more preferably 15% by mass, and even more preferably 25% by mass, based on the total amount of the composition. This is to impart sufficient formability to the material for producing a capsule shell. On the other hand, the upper limit of the content of the formability-imparting component in the composition for producing a capsule shell is preferably 90% by mass, more preferably 85% by mass, and even more preferably 80% by mass, based on the total amount of the composition.

[0030] In addition, in the composition for producing a capsule shell of the present invention, the mass ratio of the formability-imparting component to the plant-derived protein (total mass of the formability-imparting component:total mass of the plant-derived protein) is preferably 25:75 to 80:20, more preferably 30:70 to 80:20, even more preferably 35:65 to 80:20, and particularly preferably 40:60 to 75:25. By adjusting the content ratio of both components, a material for producing a capsule shell with excellent formability can be obtained from the composition for producing a capsule shell.

[0031] [1-3. Other Components] The composition for producing a capsule shell of the present invention may contain other base components, solvents, thickeners, pH adjusters, sequestering agents, shell colorants, flavoring agents, sweeteners, preservatives, fragrances, etc., as needed.

[0032] [1-3-1. Other base components] The composition for producing a capsule shell may contain, in addition to the plant-derived protein, base components (other base components) used in conventional capsule shells. The other base components may be animal-derived proteins such as gelatin, starch hydrolysates such as starch and dextrin, carrageenan, etc.

[0033] [1-3-2. Solvent] The capsule shell production composition may contain a solvent; the solvent is preferably water, but may also contain organic solvents such as ethanol, isopropyl alcohol, acetone, and ethyl butyrate. However, the content of the solvent (preferably water) in the capsule shell production composition of the present invention is preferably less than 20% by mass, more preferably less than 15% by mass, even more preferably less than 10% by mass, and particularly preferably less than 5% by mass, based on the total amount of the composition. Water may not be added to the capsule shell production composition, except for water incorporated with the blended material components, such as water contained in the raw materials for plant-derived proteins.

[0034] By reducing the water content in the composition for producing a capsule shell, a material for producing a capsule shell with excellent moldability can be obtained. Furthermore, by reducing the water content, there is a significant advantage in that it is possible to shorten or omit the drying step when producing a capsule shell from the material for producing a capsule shell, or when producing a capsule formulation consisting of a capsule shell and a content.

[0035] Conventionally, when a composition containing protein (e.g., a capsule shell production composition mainly composed of gelatin or polysaccharides, which are animal proteins, or a composition containing plant-derived proteins) is subjected to pressure and heat treatment, a considerable amount of water is blended into the composition (see, for example, JP 2015-8642 A). In contrast, the water content can be reduced in the composition for producing a capsule shell of the present invention.

[0036] [1-3-3. Thickener] The composition for producing a capsule shell may contain a thickener, and examples of the thickener include gelatin, iota carrageenan, kappa carrageenan, lambda carrageenan, pullulan, agar, alginic acid, sodium alginate, alginate esters, gums, etc. The thickener may be used alone or in combination of two or more types.

[0037] [1-3-4. pH Adjusting Agent] The composition for producing a capsule shell may contain a pH adjusting agent; the pH adjusting agent is not particularly limited, but examples thereof include acids such as hydrochloric acid, sulfuric acid, and nitric acid; bases such as sodium hydroxide and potassium hydroxide; and buffers such as phosphate buffers and Tris buffers. The pH adjusting agents can be used alone or in combination of two or more.

[0038] [1-3-5. Sequestering Agent] Examples of sequestering agents (also called sequestering agents or chelating agents) include citric acid, tartaric acid, lactic acid, phosphoric acid, acetic acid, gluconic acid, ethylenediaminetetraacetic acid, metaphosphoric acid, salts thereof, glycine, etc. These sequestering agents can be used alone or in combination of two or more.

[0039] As for the other components, substances that have been conventionally used as capsule coating components can also be used.

[0040] [1-4. Production of the composition for producing a capsule shell] The method for producing the composition for producing a capsule shell is not particularly limited, and the composition can be produced by known means. For example, the composition can be produced by mixing the plant-derived protein, the component for imparting formability, and other components as needed using a mixer or the like. The mixture may be mixed while heating or cooling as needed.

[0041] [2. Material for producing capsule shell] The material for producing capsule shell according to one embodiment of the present invention can be obtained from a composition for producing capsule shell. More specifically, the material for producing capsule shell can be obtained by pressurizing and heating the composition for producing capsule shell (pressure-heat treatment). By pressurizing and heating the composition for producing capsule shell, the plant-derived protein contained therein becomes indigestible, and a material for producing capsule shell with excellent moldability can be produced.

[0042] Examples of the method for pressurizing the capsule shell production composition include A) a method for kneading the capsule shell production composition, and B) a method for statically pressurizing the capsule shell production composition.

[0043] Kneading as a pressurizing technique means mixing the capsule shell production composition while applying pressure, and is different from simply mixing. The capsule shell production composition can be kneaded using any kneading machine, but the kneading machine is preferably equipped with a kneading function using a screw, blade, roll, or the like, and a heating function. That is, the capsule shell production composition can be kneaded by melt kneading under heating conditions. Furthermore, the capsule shell production composition is preferably kneaded using an extruder equipped with a twin screw (twin-screw extruder). A twin-screw extruder allows for continuous kneading and molding. When kneading using a twin-screw extruder, the screw rotation speed is preferably 2 to 20 rpm, more preferably 4 to 16 rpm.

[0044] Static pressurization is a method of applying pressure to a mass (bulk) of the capsule shell production composition that is left stationary. Static pressurization of the capsule shell production composition can be performed, for example, using a heat press. In this case, the pressing pressure is preferably 5 to 50 MPa, particularly preferably 10 to 30 MPa.

[0045] The lower limit of the temperature (heating temperature) for heating the capsule shell production composition is preferably 50° C., more preferably 70° C., and particularly preferably 115° C. On the other hand, the upper limit of the temperature (heating temperature) for heating the capsule shell production composition is preferably 200° C., more preferably 190° C., and even more preferably 180° C. By setting the heating temperature within this range, a capsule shell production material with excellent moldability can be obtained.

[0046] The temperature (heating temperature) for heating the composition for producing a capsule shell can be set so as to render the plant-derived protein contained in the composition indigestible (denatured), and for this purpose, it is usually preferable to set the heating temperature at 120 to 160°C.

[0047] When the capsule shell production composition is pressurized and heated using an extruder, the heating temperature refers to the temperature of the extruder's feeder (raw material input section) or barrel (the section inside which the screw rotates and kneads the raw materials). The extruder has a feeder (raw material input section) and a barrel (the section inside which the screw rotates and kneads the raw materials); the barrel is usually divided along the direction from directly below the feeder to the extrusion outlet, and is configured so that the heating temperature can be set for each of the multiple regions. The heating temperature of the capsule shell production composition pressurized and heated using an extruder refers to the heating temperature in at least one of the multiple regions, and it is not necessarily necessary to adjust all regions to the same heating temperature.

[0048] The capsule shell manufacturing material is characterized by high moldability; for example, the moldability can be indicated by tensile strength. The capsule shell manufacturing material has a tensile strength of 2.0 N / mm2 or more as measured based on the test method specified in JIS-K7127. ２It is preferable that the strength is 3.0 N / mm or more. ２ More preferably, it is 10 N / mm or more; ２ It is also preferable that the storage modulus G' curve shows a rubber-like plateau in the range of 70 to 170°C in dynamic viscoelasticity measurement (measurement using a rotational rheometer).

[0049] [3. Capsule Shell and Capsule Formulation] The capsule shell of one embodiment of the present invention may be a molded product of a material for manufacturing a capsule shell. That is, like the capsule shell manufacturing composition and the capsule shell manufacturing material, the capsule shell contains a formability-imparting component and a plant-derived protein, and may contain other components as necessary. The components and their contents are as described above in "1. Composition for Manufacturing Capsule Shell." The plant-derived protein contained in the capsule shell of the present invention is preferably a denatured product of a protein extracted from a plant or a denatured product of a protein contained in a fermentation product made from a plant. The denatured product may be a heat-denatured product, a pressure-denatured product, or a heat-pressure-denatured product.

[0050] The capsule shell of the present invention can be used as the capsule shell of a capsule formulation, and in the capsule formulation, the capsule shell can be filled (encapsulated) with a content. The capsule formulation is preferably a soft capsule, and can be filled with a liquid or paste-like content.

[0051] The thickness of the capsule shell of the present invention is preferably 200 μm or more. This is to ensure that the contents encapsulated in the capsule shell are securely enclosed. The upper limit of the thickness is not particularly limited, but is usually several thousand μm or less. The thickness of the capsule shell can be measured using a digital microscope.

[0052] The capsule shell of the present invention can be produced by molding a capsule shell production material. For example, the capsule shell can be formed by injecting the capsule shell production material of the present invention from an extruder into a mold having a desired capsule shape and cooling it.

[0053] Alternatively, as another method for producing a capsule shell, the material for producing a capsule shell may be formed into a film, tube, pellet, or the like when extruded from an extruder; and then formed into a capsule shell by a known method. For example, when the material for producing a capsule shell of the present invention is extruded into a film, it may then be formed into a capsule shell by a punching method, and a capsule formulation may be produced using the film. Alternatively, the material for producing a capsule shell of the present invention may be extruded into pellets, and the pelletized material for producing a capsule shell may be melted to produce a capsule shell; in this case, the above-mentioned [1-3. Other ingredients] may be added to the melt.

[0054] A capsule formulation (preferably a soft capsule formulation) having the capsule shell of the present invention can be produced by a known method. In the capsule formulation, the contents encapsulated in the capsule shell are not particularly limited, and known active ingredients and additives can be selected. The shape of the capsule formulation is also not particularly limited, and can be any shape, such as spherical or ellipsoidal.

[0055] The capsule preparation having the capsule shell of the present invention contains a plant-derived protein in the capsule shell, and therefore can be endowed with various desirable physiological activities, such as an anti-inflammatory effect, based on the plant-derived protein.

[0056] Furthermore, since the capsule formulation having the capsule shell of the present invention can contain indigestible plant-derived proteins in the capsule shell, it may be possible to deliver active ingredients contained in the contents of the capsule formulation to the large intestine or to realize a DDS that targets the large intestine. In other words, it may be preferable that the contents of the capsule formulation contain active ingredients that are to be absorbed in the large intestine. Alternatively, since the capsule formulation having the capsule shell of the present invention can contain indigestible plant-derived proteins in the capsule shell, it may be possible to encapsulate highly reactive contents.

[0057] [4. Method for Reducing Protein Digestibility] As described above, one aspect of the present invention provides a capsule shell production composition containing a plant-derived protein, and by subjecting the composition to pressure and heat treatment, a capsule shell production material that is indigestible and has good moldability can be obtained. Furthermore, the present invention also provides a method for reducing the digestibility of proteins in general (e.g., animal-derived proteins) in addition to plant-derived proteins. The reduced digestibility can be confirmed by a general artificial digestion test. This method can be carried out by subjecting a protein-containing composition to pressure and heat treatment.

[0058] In the method for reducing digestibility of a protein, the composition containing the protein may contain the same components as the formability-imparting component in the capsule shell production composition, such as water. The formability-imparting component is preferably a polyol, more preferably glycerin. The ratio of the protein to the formability-imparting component may also be set in the same manner as in the capsule shell production composition.

[0059] The pressure and heat treatment of the protein-containing composition can be carried out under the same conditions as those for the pressure and heat treatment of the capsule shell production composition, i.e., the protein-containing composition can be treated by kneading or static pressure; a kneader such as a twin-screw extruder, a heat press, or the like can be used.

[0060] The material obtained by subjecting a composition containing a protein and a moldability-imparting component to a pressure and heat treatment preferably has good moldability similar to the above-mentioned capsule shell production material, and may have, for example, a tensile strength similar to that of the capsule shell production material.

[0061] The present invention will be described in detail below with reference to examples, but the present invention should not be construed as being limited to the following examples.

[0062] Example 1 (Production of a capsule shell production composition and a capsule shell production material) 20 g of Wilpro N10 (manufactured by Wilmar, protein content 86.4% by mass, moisture content 5.6% by mass), containing soy protein, was added to 20 g of glycerin and mixed to prepare a capsule shell production composition. The resulting capsule shell production composition was then fed to a twin-screw extruder, heated and pressurized, and the kneaded mixture was extruded from the tip of the barrel under normal pressure to obtain a capsule shell production material. The barrel temperatures were set to 90°C in the feed section (directly below the raw material feed section), 130°C in the center, and 130°C at the tip. The screw rotation speed was 8 rpm. The temperature dependence of the storage modulus G' was measured using a dynamic viscoelasticity measuring device (Ares-G2 manufactured by Waters) with a 25 mm parallel plate jig at an angular velocity of 6.28 rad / sec, a gap of 1 mm, and a heating rate of 0.1°C / sec. The obtained capsule shell manufacturing material showed a rubber-like plateau in the temperature range of 70 to 170°C.

[0063] (Evaluation of moldability) The appearance of the extruded capsule shell manufacturing material was observed, and moldability was evaluated according to the following criteria. The evaluation results are shown in Table 1. Note that a long, continuous sheet-like material is more likely to be molded into a capsule shell continuously, and is evaluated as having good moldability. ◎: Long, continuous sheet-like material ○: Continuous sheet-like material, but short or thin, or in a lump shape △: Flake-like material ×: Powder-like material

[0064] (Evaluation of Digestibility) Pancreatin (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.), a digestive enzyme, was dissolved in purified water adjusted to pH 9 with 0.1 mol / L NaOH to prepare a test solution with a pancreatin concentration of 0.3% by mass. 100 mg of the capsule shell manufacturing material was added to 50 mL of the prepared test solution and allowed to stand at 45°C for 5 hours. The residue was then recovered by centrifugation and dried at 50°C for 16 hours. The dried residue was divided by the solid-equivalent mass of the sample to determine the percentage. The evaluation results are shown in Table 1. A larger value indicates greater resistance to digestion.

[0065] [Examples 2 to 20], [Reference Example], [Comparative Examples 1 to 3] Materials for producing capsule shells were produced and evaluated in the same manner as in Example 1, except that the types and amounts of each component were changed as shown in Tables 1 to 6. The evaluation results are shown in Tables 1 to 6. In Comparative Example 3, a simple mixture of Wilpro N10 and glycerin was evaluated for digestibility.

[0066] The materials used in Examples 1 to 20, Reference Examples, and Comparative Examples 1 to 3 are shown below (see Tables 1 to 5). <Plant-derived proteins> Wilpro N10: Contains 86.4% by mass of soy protein, 5.6% by mass of water, and 3.6% by mass of carbohydrates (manufactured by Wilmar) Wilpro P20: Contains 86.9% by mass of soy protein, 5.7% by mass of water, and 2.9% by mass of carbohydrates (manufactured by Wilmar) A-Glu G: Contains 74% by mass of wheat protein (manufactured by Glyco Nutrition Foods) <Animal-derived proteins> Whey protein: Daiichilacto EM-90 (manufactured by Daiichi Kasei Co., Ltd.) <Moldability-imparting components> HPC: Hydroxypropyl cellulose (Cerny SL, manufactured by Nippon Soda Co., Ltd.) Poem J-2081V: Monoester of stearic acid and diglycerin (manufactured by Riken Vitamin Co., Ltd.) Betaine: Trimethylglycine

[0067]

[0068]

[0069]

[0070]

[0071]

[0072]

[0073] As shown in Examples 1 to 5 (Table 1), when a composition containing a plant-derived protein (soy protein) and a moldability-imparting agent, glycerin, in a predetermined ratio is subjected to pressure heating in a twin-screw extruder, moldability can be controlled by the heating temperature; in particular, moldability was best when the temperatures of the extruder's feed section, center section, and tip section were 90°C, 130°C, and 130°C, respectively. It was also found that digestibility can be controlled by the heating temperature. However, it was found that digestibility was less likely to decrease (less likely to become resistant to digestion) when the temperatures of the extruder's feed section, center section, and tip section were 105°C, 170°C, and 170°C, respectively. Thus, it can be seen that excessively high heating temperatures in the pressure heating process make the composition less likely to become resistant to digestion.

[0074] On the other hand, as shown in Comparative Example 1 (Table 6), when a composition containing a plant-derived protein (soy protein) and the moldability-imparting agent glycerin in a predetermined ratio was processed without heating in a twin-screw extruder, a material with poor moldability was obtained. Furthermore, as shown in Comparative Example 3 (Table 6), a composition (untreated material) containing a plant-derived protein (soy protein) and the moldability-imparting agent glycerin in a predetermined ratio did not show a decrease in digestibility. Furthermore, as shown in Comparative Example 2 (Table 6), when a composition containing a plant-derived protein (soy protein) and water was pressurized and heated in a twin-screw extruder, a decrease in digestibility was observed, but a material with poor moldability was obtained.

[0075] As shown in Examples 6 to 12 (Tables 2 and 3), when compositions containing plant-derived protein (soy protein) and various components (triacetin, betaine, propylene glycol, trehalose, maltitol, xylitol, erythritol) as moldability-imparting components along with the main component glycerin were subjected to pressure and heat treatment in a twin-screw extruder, materials with sufficient moldability were obtained in all cases.

[0076] As shown in Examples 13 to 15 (Table 3), when compositions containing plant-derived protein (soy protein), glycerin as a moldability-imparting component, and water were subjected to pressure and heat treatment in a twin-screw extruder, materials with good moldability were obtained; however, as the amount of water added increased, moldability tended to decrease. On the other hand, it was found that as the amount of water added increased, digestibility tended to decrease (digestibility improved).

[0077] As shown in Examples 16 and 17 (Table 4), materials with good moldability were obtained even when the content ratio of the plant-derived protein (soybean protein) to the moldability-imparting component glycerin was adjusted.

[0078] As shown in Examples 18 and 19 and Reference Example (Table 4), when compositions containing various proteins (soybean protein, wheat protein, whey protein) and glycerin, a moldability-imparting component, were subjected to pressure heating treatment in a twin-screw extruder, digestibility decreased in all cases, and materials with good moldability were obtained in Examples and 19, but moldability was poor in the Reference Example. In the Reference Example, which contained whey protein (animal protein), thermal aggregation hardly occurred compared to vegetable protein, and it was thought that moldability was difficult to improve.

[0079] As shown in Example 20 (Table 5), when a composition containing plant-derived protein (soy protein) and the main component glycerin as a moldability-imparting component, together with HPC (hydroxypropyl cellulose) and Poem J-2081V (monoester of stearic acid and diglycerin), was pressurized and heated in a twin-screw extruder, a material with good moldability was obtained. This demonstrates that a variety of moldability-imparting components can be combined.

[0080] [Example 21] (Production of a material for producing a capsule shell using a heat press) 12 g of Wilpro N10 and 8 g of glycerin were mixed to prepare a composition for producing a capsule shell. The resulting composition for producing a capsule shell was then fed to a heat press and heated and pressurized at 15 MPa and 129°C for 120 seconds to obtain a film having a thickness of approximately 0.8 mm.

[0081] (Evaluation of digestibility and tensile strength) The digestibility of the obtained film was evaluated in the same manner as in Example 1, and was found to be 70%. The tensile strength of the obtained film was measured with reference to the plastics - tensile property test method (JIS K7127), and was found to be 3.28±0.34 N / mm ２ The tensile strength of the conventional capsule shell made from carrageenan, measured by the same method, was 1.61±0.09 N / mm ２ It was.

[0082] (Production of Capsule Shell and Capsule Formulation) The film obtained above was molded into a pocket shape using a mold to obtain two capsule shells. The contents (medium-chain fatty acid triglyceride) were manually filled into one of the obtained capsule shells, and the two upper and lower capsule shells were joined using another mold. When joining, they were heated at 140°C for 10 seconds. No leakage of the contents was observed in the obtained capsule formulation.

[0083] The composition for producing a capsule shell of the present invention provides a capsule formulation with new functions, thereby broadening the applications of capsule formulations. Specifically, for example, it is possible to impart a biological effect to the capsule shell itself, to impart a drug delivery function (DDS function) to the large intestine, or to make the capsule contents into highly active drugs.

Claims

1. A composition for producing a capsule shell, comprising at least one member selected from the group consisting of polyols, triesters and trialkylamino acids, and a plant-derived protein.

2. The composition according to claim 1, wherein the mass ratio of the at least one member selected from the group consisting of polyols, triesters and trialkylamino acids to the plant-derived protein is 25:75 to 80:

20.

3. The composition according to claim 1 or 2, wherein the water content is less than 20% by mass.

4. The composition according to claim 1 or 2, wherein the plant-derived protein comprises at least one protein selected from the group consisting of soybean-derived protein, adzuki bean-derived protein, kidney bean-derived protein, cocoa bean-derived protein, wheat-derived protein, buckwheat-derived protein and rice-derived protein.

5. The composition according to claim 1 or 2, wherein the at least one member selected from the group consisting of polyols, triesters and trialkylamino acids comprises glycerin.

6. A method for producing a material for producing a capsule shell, comprising a step of pressurizing and heating a composition containing at least one member selected from the group consisting of polyols, triesters and trialkylamino acids, and a plant-derived protein.

7. The production method according to claim 6, wherein the mass ratio of the at least one member selected from the group consisting of polyols, triesters and trialkylamino acids to the plant-derived protein is 25:75 to 80:

20.

8. The method according to claim 6 or 7, wherein the water content in the composition is less than 20% by mass.

9. The production method according to claim 6 or 7, wherein the plant-derived protein comprises at least one protein selected from the group consisting of soybean-derived protein, adzuki bean-derived protein, kidney bean-derived protein, cocoa bean-derived protein, wheat-derived protein, buckwheat-derived protein and rice-derived protein.

10. The method according to claim 6 or 7, wherein the at least one member selected from the group consisting of polyols, triesters and trialkylamino acids includes glycerin.

11. The method according to claim 6 or 7, wherein the heating temperature is 50 to 200°C.

12. A capsule shell comprising at least one member selected from the group consisting of polyols, triesters and trialkylamino acids, and a plant-derived protein.

13. The capsule shell according to claim 12, wherein the mass ratio of the at least one member selected from the group consisting of polyols, triesters, and trialkylamino acids to the plant-derived protein is 25:75 to 80:

20.

14. The capsule shell according to claim 12 or 13, wherein the plant-derived protein comprises at least one protein selected from the group consisting of soybean-derived protein, adzuki bean-derived protein, kidney bean-derived protein, cacao bean-derived protein, wheat-derived protein, buckwheat-derived protein and rice-derived protein.

15. The capsule shell according to claim 12 or 13, wherein the at least one member selected from the group consisting of polyols, triesters and trialkylamino acids includes glycerin.

16. The capsule shell according to claim 12 or 13, wherein the plant-derived protein is subjected to a pressure and heat treatment.

17. A capsule preparation comprising the capsule shell according to claim 12 or 13 and an ingredient contained in the capsule shell.

18. A method for reducing digestibility of a protein, comprising the steps of pressurizing and heating a composition containing the protein.

19. The method of claim 18, wherein the composition further comprises a polyol.