Composition containing α - amylase inhibitor derived from wheat

Abstract

To provide a composition containing an α - amylase-inhibiting protein derived from wheat, easy to ingest without feeling peculiar flavor while containing a material containing the α - amylase-inhibiting protein derived from wheat, and excellent in disintegration and elution in the stomach.SOLUTION: A composition containing a wheat-derived α - amylase-inhibiting protein, comprising 40 to 95% by mass of a wheat-derived α - amylase-inhibiting protein (A) and 0.1 to 30% by mass of a bicarbonate or carbonate (B).SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to compositions containing wheat-derived α-amylase inhibitor proteins. In particular, the present invention relates to a composition containing wheat-derived α-amylase inhibitor protein, which when formulated has excellent dissolution properties in the stomach and has an immediate effect of suppressing blood sugar levels. [Background technology]

[0002] Preventing and improving diabetes is an important issue for modern people. In diabetic patients, the biological regulatory mechanism that lowers blood glucose levels does not function properly for some reason. On the other hand, increased blood glucose levels and decreased glucose tolerance are related to the onset of diabetes. Therefore, controlling blood glucose levels is important for preventing and improving diabetes.

[0003] Various proposals have been made to moderate the rise in blood glucose levels after meals. Patent Documents 1 and 2 describe that α-amylase inhibitor proteins contained in wheat inhibit the breakdown of starch into sugars and are useful for treating hyperglycemia and diabetes. Patent Document 3 describes the use of α-amylase inhibitor proteins as carbohydrate digestion enzyme inhibitors in antidiabetic foods containing carbohydrate digestion enzyme inhibitors and sugar absorption inhibitors.

[0004] Methods for extracting wheat-derived α-amylase inhibitory proteins from wheat include, for example, the methods described in Patent Documents 1 and 2. Food materials containing wheat-derived α-amylase inhibitory proteins include commercially available products such as wheat albumin NA-1 (Nissin Pharma Co., Ltd.).

[0005] When food ingredients containing α-amylase inhibitor proteins are ingested with meals, they can slow the digestion and absorption of starches and other substances contained in food, thereby suppressing the rapid rise in postprandial blood glucose levels. In particular, suppressing the "postprandial blood glucose peak" that occurs 30 minutes after eating is an important point in controlling blood glucose levels.

[0006] Therefore, it is necessary to inhibit α-amylase activity immediately after ingestion of a meal, and the faster the α-amylase inhibitor protein dissolves in digestive juices, the better.

[0007] On the other hand, food ingredients containing wheat-derived α-amylase inhibitor proteins have a distinctive flavor derived from wheat components, so they are sometimes made into capsule or tablet form to prevent the flavor from being felt in the mouth when ingested.

[0008] However, it was discovered that although food ingredients containing wheat-derived α-amylase inhibitor proteins are water-soluble, they tend to clump in water, meaning that when made into capsules or tablets, they do not disintegrate or dissolve smoothly in the stomach, meaning that they do not have a sufficiently rapid effect in the stomach.

[0009] Several techniques have been proposed for producing compositions such as capsules and tablets that have good disintegration and dissolution properties. Patent Document 4 discloses a non-effervescent tablet composition for oral administration characterized by improving the dissolution of a herbal extract by blending sodium bicarbonate in an amount of 3% by weight or more relative to the herbal extract in a tablet composition containing 56% by weight or more of the herbal extract. Patent Document 5 discloses a non-effervescent tablet composition for oral administration containing a poorly soluble drug, hydroxypropyl methylcellulose, a gel-forming water-soluble polymer, and sodium bicarbonate and / or potassium bicarbonate, and wherein the poorly soluble drug is hydrophilic. Patent Document 6 discloses a rapidly disintegrating pharmaceutical composition in the form of a tablet or capsule, in which a poorly water-soluble drug is supported as a solid dispersion in hydroxypropylmethylcellulose. Patent Document 6 discloses an oral solid tablet containing granulated particles (A) containing a poorly water-soluble drug, a water-swellable polymer compound (a1), one or more polymer compounds (a2) selected from water-soluble polymer compounds, and a water-soluble powder (a3), and particles (B) consisting of one or more compounds selected from the group consisting of bicarbonates (b1) and carbonates (b2). Patent Document 7 discloses a solid composition containing (A) wheat albumin, (B) a carbonate, and (C) an organic acid, in which the mass ratio of component (A) to component (B) "(A) / (B)" is 1.5 to 16.5 and the equivalent ratio of component (C) to component (B) is 0.7 to 1.9, and which generates carbon dioxide gas, thereby improving adhesion in the mouth and reducing unpleasant tastes despite containing a high concentration of wheat albumin. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] Patent No. 2757404 [Patent Document 2] Japanese Patent Application Laid-Open No. 2003-286296 [Patent Document 3] Japanese Patent Application Laid-Open No. 2001-103928 [Patent Document 4] Patent No. 4122544 [Patent Document 5] Patent No. 3988193 [Patent Document 6] Japanese Patent Application Laid-Open No. 2015-212258 [Patent Document 7] Japanese Patent Application Laid-Open No. 2013-87062 Summary of the Invention [Problem to be solved by the invention]

[0011] The object of the present invention is to provide a wheat-derived α-amylase inhibitor protein-containing composition that contains a wheat-derived α-amylase inhibitor protein-containing material, yet is easy to ingest without any distinctive flavor, and has excellent disintegration and dissolution properties in the stomach. [Means for solving the problem]

[0012] As a result of extensive research to solve the above problems, the inventors discovered that by incorporating a certain amount of bicarbonate or carbonate, a wheat-derived α-amylase inhibitor protein-containing composition can be obtained that is easy to ingest and has excellent dissolution properties of the wheat-derived α-amylase inhibitor protein in the stomach, and thus completed the present invention.

[0013] Therefore, the above problems can be solved by the following formulation. (1) A wheat-derived α-amylase inhibitor protein-containing composition comprising 40 to 95% by mass of wheat-derived α-amylase inhibitor protein (A) and 0.1 to 30% by mass of bicarbonate or carbonate (B). (2) The composition according to (1), wherein the blending ratio (B / A) of component (A) to component (B) is 0.1 to 50%. (3) The composition according to (1) or (2), wherein the bicarbonate or carbonate is at least one selected from the group consisting of sodium bicarbonate, ammonium bicarbonate, potassium bicarbonate, sodium carbonate, and calcium carbonate. (4) The composition according to any one of (1) to (3), which is a capsule or a tablet. (5) The composition according to any one of (1) to (4), which is a capsule or tablet that disintegrates in the stomach. [Effects of the Invention]

[0014] The present invention provides a wheat-derived α-amylase inhibitor protein-containing material that is easy to ingest without any distinctive flavor and has excellent disintegration and dissolution properties in the stomach. The present invention provides a composition containing the α-amylase inhibitor protein derived from the fungus, which has a rapid-acting effect of suppressing elevation of blood glucose levels and is therefore capable of providing a more effective agent for suppressing elevation of blood glucose levels. DETAILED DESCRIPTION OF THE INVENTION

[0015] The wheat-derived α-amylase inhibitor protein-containing composition of the present invention contains a wheat-derived α-amylase inhibitor protein and a bicarbonate or carbonate.

[0016] (Wheat-derived α-amylase inhibitor protein) The wheat-derived α-amylase inhibitor protein used in the present invention is a heat-resistant protein found in large amounts in wheat plants, particularly in the endosperm of wheat seeds. Examples of the wheat-derived α-amylase inhibitor protein include α-amylase inhibitor 0.19 (or 0.19α-AI) "Swiss Prot: ID=IAA1_WHEAT"; α-amylase inhibitor 0.28 "Swiss Prot: ID=IAA2_WHEAT"; and α-amylase inhibitor 0.53 "Swiss Prot: ID=IAA3_WHEAT". Prot: ID=IAA5_WHEAT"; 0.26AIa and 0.26AIb disclosed in JP-A-9-194390, among which α-amylase inhibitor 0.19 is preferred.

[0017] The wheat-derived α-amylase inhibitor protein can be prepared from wheat seeds, preferably from wheat endosperm, according to the procedures described in Patent Documents 1 and 2. Alternatively, the wheat-derived α-amylase inhibitor protein used in the present invention may be a commercially available product (for example, NA-1 manufactured by Nisshin Pharma Co., Ltd.; an α-amylase inhibitor protein derived from wheat endosperm, containing α-amylase inhibitor 0.19).

[0018] The blending ratio of the wheat-derived α-amylase inhibitor protein-containing material is 40 to 95% by mass, preferably 45 to 91% by mass, based on 100% by mass of the composition.

[0019] (bicarbonate, carbonate) In the present invention, sodium hydrogen carbonate, ammonium hydrogen carbonate, potassium hydrogen carbonate, sodium carbonate, and calcium carbonate can be used as the hydrogen carbonate or carbonate. Of these, sodium hydrogen carbonate is preferably used.

[0020] The blending ratio of the bicarbonate or carbonate is 0.1 to 30 mass %, preferably 0.1 to 10 mass %, more preferably 3 to 10 mass %, and even more preferably 3 to 5 mass %, based on 100 mass % of the composition. The blending ratio of bicarbonate or carbonate to the amount of the wheat-derived α-amylase inhibitor protein-containing material can be 0.1 to 50%, preferably 0.2 to 50%, more preferably 3 to 12%, even more preferably 3 to 9%, and particularly preferably 3 to 6%.

[0021] (Manufacturing method) The method for preparing the composition of the present invention is not particularly limited. For example, a powdered composition can be prepared by mixing the wheat-derived α-amylase inhibitor protein-containing material and bicarbonate or carbonate.

[0022] (Other ingredients) When preparing a powdered composition, any ingredients typically used in foods and beverages can be added within the range that does not impair the effects, such as excipients, binders, lubricants, anti-caking agents, glossing agents, stabilizers, thickeners, emulsifiers, antioxidants, pH adjusters, colorants, flavorings, additives, sweeteners, acidulants, and other active ingredients (biologically active ingredients).

[0023] (Formulation) The composition of the present invention is used in the form of, for example, tablets or capsules, and is preferably used in the form of tablets or capsules that do not disintegrate in the oral cavity and have excellent disintegration and dissolution properties in the stomach.

[0024] When the composition of the present invention is in the form of a tablet, it can be produced by compressing the powdered composition obtained as described above into tablets in a conventional manner. When the composition of the present invention is in the form of a capsule, the powdered composition obtained as described above can be filled into a capsule according to a conventional method. The base material for the capsule is not limited to a specific one, and various film-forming materials commonly used, such as gelatin, agar, cellulose, hydroxypropyl methylcellulose (HPMC), carrageenan, pullulan, etc., can be used. [Example]

[0025] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to the following examples.

[0026] (raw materials) Wheat-derived α-amylase inhibitor protein (NA-1, Nisshin Pharma Co., Ltd.) Sodium hydrogen carbonate (sodium bicarbonate, AGC Chemicals Company, Ltd.) Cellulose (Ceolas FD-101, Ceolas ST-100, Asahi Kasei Corporation) Tricalcium phosphate (Taihei Chemical Industry Co., Ltd.) Calcium stearate (Taihei Chemical Industry Co., Ltd.) Ammonium bicarbonate (Fujifilm Wako Pure Chemical Industries, Ltd.) Potassium bicarbonate (Fujifilm Wako Pure Chemical Industries, Ltd.) Sodium carbonate (Junsei Chemical Co., Ltd.) Calcium carbonate (Fujifilm Wako Pure Chemical Industries, Ltd.) Trehalose (Trehalose, Hayashibara Co., Ltd.) Sugar ester (Ryoto Sugar Ester B-370F, Mitsubishi Chemical Foods Corporation) Silicon dioxide (Silopage 720, Fuji Silysia Chemical Ltd.) HPMC capsule (QUALI-VN, No. 2, Qualicaps Co., Ltd.)

[0027] (Examples 1 to 16 and Comparative Examples 1 to 3) (Method for preparing capsules) According to the prescribed formulation, the raw materials shown in Tables 1 and 2 were mixed and stirred to prepare a homogeneous mixture, and capsules each weighing 280 mg were obtained using a hard capsule filling machine.

[0028] (Dissolution test) A dissolution test was carried out under the following conditions in accordance with Method 2 (paddle method) of the dissolution test described in the Japanese Pharmacopoeia. Test solution: Solution 1 (pH 1.2) Test liquid volume: 900 mL Liquid temperature: 37℃ Paddle rotation speed: 50 min -1 Absorbance measurement conditions: detection wavelength 230 mm, cell length 10 mm, first solution was used as a control solution.

[0029] (Evaluation criteria) Regarding the dissolution rate after 20 minutes, a ratio of 110% or more to the dissolution rate of the control (Comparative Examples 1, 2 or 3) containing no bicarbonate or carbonate, which was set at 100%, was determined to be effective.

[0030] (result) [Table 1]

[0031] [Table 2]

[0032] As shown in Table 1, the dissolution rate of capsules containing sodium bicarbonate, ammonium bicarbonate, potassium bicarbonate, sodium carbonate, or calcium carbonate was good, and the disintegration and dissolution properties were good. The dissolution rate of the capsule containing sodium bicarbonate after 20 minutes was 384% compared to the control, which was particularly good. As shown in Table 2, a good dissolution rate was obtained by adjusting the blending ratio (B / A) of wheat-derived α-amylase inhibitor protein (A) and bicarbonate (B) to 0.1 to 50%.

[0033] (Examples 17 to 19 and Comparative Example 4) (Tablet preparation method) According to the prescribed formulation, the raw materials listed in Table 3 were mixed and stirred to prepare a homogeneous mixture, and then tablets each weighing 300 mg were obtained using a tablet press.

[0034] (Dissolution test) As with the capsules, a dissolution test was conducted in accordance with Method 2 (paddle method) of the dissolution test described in the Japanese Pharmacopoeia, and the evaluation criteria were the same as those for the capsules.

[0035] [Table 3]

[0036] As shown in Table 3, even when tablets were used, the dissolution rate was 110% or more compared to the control after 20 minutes, demonstrating a good disintegration and dissolution rate.

[0037] The composition of the present invention provides a wheat-derived α-amylase inhibitor protein-containing composition that contains a wheat-derived α-amylase inhibitor protein-containing material, is easy to ingest, and has excellent disintegration and dissolution properties in the stomach, making it extremely useful in foods, health foods, etc.

Claims

1. A wheat-derived α-amylase inhibitory protein-containing composition comprising 40 to 95% by mass of a wheat-derived α-amylase inhibitory protein (A) and 0.1 to 30% by mass of a bicarbonate or carbonate (B).

2. 2. The composition according to claim 1, wherein the blending ratio (B / A) of component (A) to component (B) is 0.1 to 50%.

3. 3. The composition according to claim 1, wherein the bicarbonate or carbonate is at least one selected from the group consisting of sodium bicarbonate, ammonium bicarbonate, potassium bicarbonate, sodium carbonate, and calcium carbonate.

4. 3. The composition of claim 1 or 2, which is a capsule or tablet.

5. 5. The composition of claim 4, which is a capsule or tablet that disintegrates in the stomach.

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