JP6831558B2 - Brain function improving composition - Google Patents

Description

The present invention relates to a brain function improving composition.

Traditionally, phosphatidylcholine has been known as a major constituent and neurotransmitter of cell membranes in vivo, and intractable cerebral diseases and symptoms for which no cure has been established, such as Parkinson's disease, autism, and Alzheimer's disease. It is attracting attention as a brain function improving substance that is effective in improving and preventing symptoms such as syndrome, hyperactivity disorder, and dementia.

Therefore, various supplements, drugs, and functional foods focusing on the efficacy and efficacy of phosphatidylcholine have been proposed so far.

For example, phosphatidylcholine is mixed with gelatin to form a jelly or gummy (see, for example, Patent Document 1), or is contained in a soluble capsule.

Japanese Unexamined Patent Publication No. 2007-28921

By the way, in recent years, the strength of swallowing muscles such as the oral cavity, pharynx, and esophagus, and those who have weaker occlusal force and inferior masticatory function (hereinafter, also referred to as masticatory difficulty) such as infants and elderly people compared to healthy people. The issue is how a person with poor swallowing function (hereinafter referred to as a person who has difficulty swallowing) ingests food.

These people who have difficulty chewing or swallowing cannot properly convert food into pieces to form a bolus due to insufficient chewing, and when swallowing, they suddenly enter the trachea instead of the esophagus and reach the lungs, so-called aspiration. There is a risk of waking up.

Such a tendency is particularly remarkable among the elderly whose brain function has deteriorated due to the above-mentioned diseases associated with aging, and in Japan, which accelerates the aging society, due to such aspiration pneumonia in the elderly. The cause of death is high, which is a serious problem.

When ingesting the capsule type described above, there is no opportunity to chew and reverberate in the oral cavity in the series of chewing and swallowing movements, and the texture of eating foods such as mouthfeel, tongue and throat is obtained. It was extremely inorganic, as long as it could be ingested depending on intestinal absorption.

Furthermore, since swallowing is a reflexive movement caused by reflexes through mastication, it is difficult to perform only swallowing movements. For example, those contained in soluble capsules cause unexpected aspiration, especially for people who have difficulty swallowing. There was a danger of causing it.

On the other hand, gummy-like or jelly-like substances allow the ingestor to chew and give a texture, but the degree of stickiness (adhesiveness) of the food pieces in the oral cavity and the ease of cohesion in the pharynx (aggregation). There was still a risk of aspiration depending on the degree of sex).

In general, the chemical form of active ingredients such as drugs and nutrients is changed by decomposition in the intestine and the first pass effect in the liver.

Therefore, it is difficult to predict whether the active ingredient ingested in the body is in a chemical form that is easily absorbed by the target tissue, etc., and even if it is absorbed in the body, only a small part of the active ingredient is absorbed. Since it is not possible to reach the target organs and tissues (brain), there is a problem that it is difficult to realize the expected effect.

The present invention has been made in view of such circumstances, and it is possible to prevent aspiration without losing the texture due to mastication, and not only intestinal absorption but also tongue, palatal mucosa, and cheeks. Of the absorption of oral mucosa such as mucosa, mainly to promote sublingual absorption that is directly absorbed into the capillaries of the tongue and to reach the active ingredient phosphatidylcholine to obtain the effect of improving brain function. To provide a composition for improving brain function.

In order to solve the above-mentioned conventional problems, in the brain function improving composition according to the present invention, (1) a brain function containing phosphatidylcholine as a main component in a gel matrix and promoting brain activation by oral ingestion. In the improved composition, the adhesiveness in the mouth during mastication was 200 J / m ³ or less, the cohesiveness in the mouth during mastication was 0.1 to 1.0, and the surface area was 5 to 85 cm ² .

In addition, the brain function improving composition according to the present invention is also characterized in the following points.
(2) The masticatory hardness was 1 to 50 according to the JIS K6253 Type A durometer, and the surface area was 5 to 15 cm ² .
(3) The time to dissolve in the non-chewed state in the oral cavity is within 3 minutes.
(4) Jelly-like masticatory hardness of 1 to 15 kN / m ² , oral adhesion of 150 J / m ³ or less, oral cohesiveness during mastication of 0.1 to 0.9, and surface area of 35 to 85 cm ^2. That was.
(5) The time to dissolve in the oral cavity in a non-chewed state is within 2 minutes.
(6) Further contains an auxiliary component that promotes the activation of the brain by the phosphatidylcholine, and the auxiliary component is 30 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight per 100 parts by weight of the brain function improving composition. Vitamin C, 0.45 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin B1, 0.5 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin B2, 0.081 × 10 ^{-6 to} 300 × 10 ^{Consists of -3} parts by weight of folic acid and 2 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight of pantothenic acid.
(7) Dysphagia Dysphagia Docosahexaenoic acid or eicosapentaenoic acid derived from fish oil is further contained as a taste component to increase the oral residence time during oral ingestion and increase the amount of phosphatidylcholine absorbed from under the tongue. What was configured to make it.

According to the brain function improving composition according to the present invention, the gel matrix contains phosphatidylcholine as a main component and is a brain function improving composition that promotes brain activation by oral ingestion, and is a composition for improving brain function during mastication. Adhesion is 200 J / m ³ or less, oral cohesiveness during mastication is 0.1 to 1.0, and surface area is 5 to 85 cm ² , so aspiration can be prevented without losing the texture due to mastication. Moreover, among not only intestinal absorption but also oral mucosal absorption such as tongue, palatal mucosa, and buccal mucosa, phos is an active ingredient for the brain by promoting sublingual absorption, which is mainly absorbed directly into the capillaries of the tongue. It is possible to provide a brain function improving composition for reaching fatidylcholine to obtain a brain function improving effect.

In addition, if the masticatory hardness is 1 to 50 according to the JIS K6253 Type A durometer and the surface area is 5 to 15 cm ^{2 in} the shape of a gummy candy, saliva is secreted while giving the predator an appropriate chewy texture. It is possible to provide a gummy-like brain function improving composition capable of promoting the elution of phosphatidylcholine in the oral cavity.

In addition, if the time to dissolve in the non-chewed state in the oral cavity is within 3 minutes, the brain function improving composition can be quickly applied without giving the predator a feeling of discomfort in the oral cavity or a foreign body sensation in the larynx. It can be eluted in the oral cavity to promote the absorption of the oral mucosa mainly in the tongue and cheeks.

In addition, the masticatory hardness is 1 to 15 kN / m ² , the mouth adhesion is 150 J / m ³ or less, the mouth cohesiveness during mastication is 0.1 to 0.9, and the surface area is 35 to 85 cm ^2. Therefore, it is possible to provide a jelly-like brain function improving composition capable of further facilitating fragmentation of the brain function improving composition and promoting elution of phosphatidylcholine.

In addition, if the time to dissolve in the non-chewed state in the oral cavity is within 2 minutes, the brain function improving composition is more rapidly eluted in the oral cavity without leaving a residue in the oral cavity, and the main component is In addition, it is possible to promote the absorption of the oral mucosa in the tongue, cheeks, etc., and it is possible to provide a jelly-like brain function improving composition having a property particularly gentle to those who have difficulty chewing.

In addition, it further contains an auxiliary component that promotes the activation of the brain by the phosphatidylcholine, and the auxiliary component is 30 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight per 100 parts by weight of the brain function improving composition. vitamin C and, vitamin B1 of 0.45 × 10 ^-6 ~300 × 10 ^-3 parts by weight, and 0.5 × 10 ^-6 ~300 × 10 ^-3 parts by weight of vitamin ^{B2, 0.081 × 10 -6 ~300 ×} 10 - If it is composed of ³ parts by weight of folic acid and 2 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of pantothenic acid, oral mucosal absorption such as sublingual absorption and buccal mucosal absorption is further improved. The effect of improving brain function of phosphatidylcholine can be further enhanced.

In addition, docosahexaenoic acid or eikosapentaenoic acid derived from fish oil is further contained as a dysphagic taste component to increase the oral residence time during oral ingestion and increase the amount of phosphatidylcholine absorbed from the tongue. If the composition is designed to improve sublingual absorption, it suppresses swallowing by people with dysphagia to prevent aspiration, etc., and is absorbed from under the tongue. It is possible to exert an effective effect of improving brain function.

The present invention is a composition for improving brain function that contains phosphatidylcholine as a main component in a gel matrix and promotes brain activation by oral ingestion, and has an oral adhesion of 200 J / m ³ or less during mastication. The present invention provides a brain function improving composition characterized in that the cohesiveness in the mouth during mastication is 0.1 to 1.0 and the surface area is 5 to 85 cm ² .

In particular, the brain function improving composition according to the present embodiment promotes the absorption of phosphatidylcholine, which is the main component thereof, even for persons with difficulty chewing or swallowing, such as infants and the elderly, and is cerebral. It also provides foods that improve or prevent intractable diseases.

As described above, the brain function improving composition according to the present embodiment has a mouth adhesiveness of 200 J / m ³ or less during mastication, a mouth cohesiveness at mastication of 0.1 to 1.0, and a surface area of 5 to 85 cm ² , and is a gel. As long as the matrix contains phosphatidylcholine as a main component, the form at the time of ingestion is not particularly limited.

The main component, phosphatidylcholine, employs lecithin, which is a composition composed of a fatty acid group and a glycerin group.

Lecithin refers to a lipid product containing phospholipids such as phosphatidylinositol, phosphatidylethanolamine, phosphatidylserine, and phosphatidic acid in addition to phosphatidylcholine.

That is, lecithin may be used as long as it contains phosphatidylcholine. For example, egg yolk lecithin made from egg yolk or soybean lecithin made from soybean can be adopted, other than phosphatidylcholine. It is also possible to use phospholipids in combination.

In addition, phosphatidylcholine is an effective component for biophysiological function as described above, but since phospholipid is an unsaturated fatty acid and has a large molecular weight, it is not properly absorbed in the living body as it is, and the expected effect is obtained. May be difficult to obtain.

In such cases, phospholipids are enzymatically decomposed (hydrolyzed) to reduce their molecular weight (resolysis), and lysophosphatidylcholine, which is a chemical form suitable for absorption in the body, is the main component of the brain function improving composition. May be adopted as. In addition, in this specification, phosphatidylcholine includes not only unrezolated phosphatidylcholine but also lysolated lysophosphatidylcholine as a concept.

In addition, by rezolation of lecithin, other phospholipids of phosphatidylcholine are also in a lysolated chemical form. Therefore, the lecithin in the present embodiment may contain rezolated phosphatidylcholine and phosphatidylserine, and phosphatidylcholine and phosphatidylserine are also rezolated respectively. It may be.

In addition, the degree of stickiness of food pieces generated when the brain function improving composition is chewed, that is, the adhesiveness to the mouth during mastication is 200 J / m ³ or less. If this intraoral adhesion exceeds 200 J / m ³ , there is a risk that food pieces of the brain function improving composition will stick to the oral cavity, pharynx, etc. and elute due to the flow of saliva, etc., causing aspiration. By setting the adhesion to the mouth to 200 J / m ³ or less, it is possible to obtain a brain function improving composition that avoids aspiration and allows the pharynx to pass smoothly.

In addition, the ease of cohesion of food pieces in the oral cavity of the brain function improving composition, that is, the cohesiveness in the mouth during mastication is set to 0.1 to 1.0. If the cohesiveness in the mouth is less than 0.1, it becomes difficult to form a bolus, which not only makes swallowing difficult but also causes aspiration. By setting the oral cohesiveness to 0.1 to 1.0, even a person with severe dysphagia can form a bolus by reaggregating the food pieces, and swallowing can be facilitated.

In addition, the surface area of the brain function improving composition is formed to be 5 to 85 cm ² . The surface area of this brain function improving composition affects the contact area with the tongue and cheeks, palatal mucosa and saliva in the oral cavity, and the ease of chewing, the dissolution rate of the improving composition in the oral cavity, the mouthfeel, and the texture of the tongue. It is deeply related to the texture such as over the throat.

If the surface area is less than 5 cm ² , the size of the dosage form of the brain function improving composition becomes too small, which not only makes chewing difficult but also impairs the texture and delays the dissolution rate.

On the other hand, if the surface area exceeds 85 cm ² , the size of the formulation of the brain function improving composition becomes too large, which makes it difficult to chew, especially for those who have difficulty chewing, and even if it is chewed into pieces, it is relative to the oral volume. An excessive amount of food pieces are formed, which not only promotes the inhibition of mastication but also gives an unpleasant texture.

Furthermore, the risk of aspiration increases because some of the food pieces cannot form a bolus and pass through the pharynx because the excessive amount of food pieces in the oral cavity is swallowed too quickly.

Therefore, by forming the surface area of the brain function improving composition to be 5 to 85 cm ² , it can be formed into an improved composition that is easy to ingest for food consumers, especially those who have difficulty chewing or swallowing, which is excellent. It is possible to realize a smooth texture and a rapid elution rate of the improved composition.

Further, among the base materials mixed when the brain function improving composition is formed into a gummy shape or a jelly shape, the following thickeners can be adopted.

For example, tamarind seed polysaccharides, glucomannan, carrageenan, agar, locust bean gum, guagam, xanthan gum, gellan gum, native gellan gum, pectin, collagen, sodium alginate, carboxymethyl cellulose, arabic gum, microcrystalline cellulose, gelatin, etc. Alternatively, a mixture thereof may be blended and used.

In addition, when the brain function improving composition is made into a gummy shape, the rubber hardness value is set to 1 to 50 to promote saliva secretion by chewing and promote elution of the brain function improving composition, and at the time of chewing. By stimulating the muscle movement of the head, the blood flow in the head can be increased, and phosphatidylcholine eluted from the brain function improving composition and absorbed sublingually can reach the brain efficiently.

In particular, when forming a gummy-shaped brain function improving composition to be ingested by a person who has difficulty chewing, the chewing hardness is set within the range of 1 to 50 in the rubber hardness value by the JIS K6253 Type A durometer, so that it is relatively relatively. It is possible to obtain a brain function improving composition which has a weak occlusal force and can be easily sharded without impairing an appropriate texture.

The shape of the gummy-shaped brain function improving composition is not particularly limited, and can be formed into any three-dimensional shape such as a substantially triangular columnar shape, a substantially dice shape, or a substantially hemispherical shape, but the surface area is 5 It is desirable to keep it at ~ 15 cm ² . By setting such a surface area, the size can be chewed off, and a sufficient elution rate of the components can be ensured even when the predator does not chew off.

In addition, the dissolution rate of phosphatidylcholine in the oral cavity in the gummy-like brain function improving composition in a non-chewed state, that is, the time during which the brain function improving composition is completely dissolved in the oral cavity (hereinafter, simply referred to as the oral dissolution time). It is desirable that it is within about 3 minutes. This elution rate (time) can be appropriately adjusted mainly by the mixing ratio of the mixture of the brain function improving composition and lecithin.

In the present specification, the non-chewing state means a state in which the surface of the oral cavity is constantly moistened with saliva and the brain function improving composition is not chewed into pieces. .. Therefore, when saliva is insufficient in the oral cavity, if the brain function improving composition is not eclipsed by chewing, saliva is secreted into the oral cavity by chewing movement or tongue movement to lubricate the saliva. May be good.

In addition, when the brain function improving composition is jelly-like, that is, jelly-type, the masticatory hardness is 1 to 15 kN / m ² , the oral adhesion is 150 J / m ³ or less, and the oral cohesiveness at the time of mastication. May be 0.1-0.9 and the surface area may be 35-85 cm ² .

If the masticatory hardness is less than 1 kN / m ² , the brain function improving composition cannot be gelled to form a jelly, while if it exceeds 15 kN / m ² , not only the texture due to the elasticity peculiar to the jelly is impaired, but also mastication. The repulsive force of time becomes too high and it becomes difficult to make it into a piece of food.

Therefore, if the masticatory hardness is 1 to 15 kN / m ² , the brain function improving composition can be eclipsed without applying an extra reaction force to the upper and lower jaws at the time of mastication, which is particularly preferable for people with masticatory difficulty. ..

In addition, if the jelly-type oral adhesion exceeds 150 J / m ³ , there is a risk that the brain function improving composition will stick to the pharynx and clog when swallowing, causing choking due to airway obstruction. Such a risk can be avoided by setting it to ³ or less.

In addition, if the mouth cohesiveness during mastication of the jelly type is less than 0.1, it becomes difficult to form bolus as described above, and if it exceeds 0.9, the edible pieces of the brain function improving composition immediately aggregate with each other, resulting in mastication. It hinders the progress and causes aspiration.

Therefore, by setting the oral cohesiveness to 0.1 to 0.9, it is easy to form a bolus of an appropriate size to prevent aspiration when swallowing the brain function improving composition that has been chewed into pieces.

The shape of the jelly-type brain function improving composition is not particularly limited as long as the surface area when ingested into the oral cavity is 35 to 85 cm ² . For example, the jelly-type brain function improving composition may be squeezed into the oral cavity in an appropriate amount from a storage container such as a tube, or may be molded and stored in a storage container partitioned so as to have the above-mentioned surface area.

Further, it is desirable that the dissolution rate of phosphatidylcholine in the oral cavity in the jelly-like brain function improving composition in a non-chewed state, that is, the dissolution time in the oral cavity is approximately 2 minutes or less. This elution rate (time) can also be appropriately adjusted mainly by the mixing ratio of the mixture of the brain function improving composition and lecithin.

Further, the brain function improving composition according to the present embodiment may contain a functional auxiliary component, a seasoning component, a sublingual absorption promoter, a dysphagia taste component, an excipient, water and the like. ..

The functional auxiliary component is a component added to impart further functionality such as a vitamin supplement function to the brain function improving composition. Examples of such functional auxiliary components include vitamin A, vitamin D, vitamin E, vitamin B6, vitamin B12, phosphatidylserine, niacin and the like.

The seasoning component is a component for flavoring the brain function improving composition. As the seasoning component, for example, fruit juice, flavor, acidulant (citric acid, etc.) can be used.

The sublingual absorption promoter is an agent for promoting sublingual absorption of phosphatidylcholine and lecithin contained as main components in the brain function improving composition according to the present embodiment. This sublingual absorption enhancer is composed of vitamin C, vitamin B2, folic acid, pantothenate, and vitamin B1.

The present inventor has found in many years of research using phosphatidylcholine that phosphatidylcholine alone is difficult to be taken into the living body from the measurement results of the brain function improving effect.

Under such circumstances, the present inventor dramatically increases the sublingual absorption efficiency of phosphatidylcholine by using a sublingual absorption promoter consisting of vitamin C, vitamin B2, folic acid, pantothenate, and vitamin B1 in combination. I found that it would increase.

In particular, this sublingual absorption enhancer contains 30 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin C and 0.45 × 10 ^{-6 to} 300 × 10 ^{-3 by} weight per 100 parts by weight of the brain function improving composition. Vitamin B1 and 0.5 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight Vitamin B2 and 0.081 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight folic acid and 2 × 10 ^{-6 to} 300 × 10 ^It is desirable to compose with ^-3 parts by weight of pantothenic acid. With such a configuration, the sublingual absorption efficiency of phosphatidylcholine can be enhanced, and the brain function is improved more effectively and promptly than when phosphatidylcholine is absorbed via the digestive tract. It can be effective.

The dysphagia taste component is one of the further features of the brain function improving composition according to the present embodiment, and in the brain function improving composition according to the present embodiment, which aims to prevent aspiration during swallowing by texture. Furthermore, in order to make the prevention of aspiration more solid, the idea is to add a component that has a taste that avoids swallowing as a dysphagia taste component, making swallowing itself difficult and further avoiding aspiration. It is based on.

The dysphagic taste component is not particularly limited as long as it is a component that exhibits a taste that makes swallowing difficult, but the inclusion of a brain function improving composition such as bitterness or pungent taste in the mouth itself is inhibited. Ingredients that exhibit such irritation are not preferred. Further, it is not preferable to use a component that cancels the taste seasoned by the seasoning component.

As an example of the taste exhibited by the dysphagia taste component, it can be preferably a taste that can be perceived as a kind of fishy odor, such as a fish odor or a seaweed odor.

In particular, examples of the dysphagic taste component exhibiting such a taste include DHA and EPA derived from marine products such as fish, and oils containing these, and more preferably, sardines. It can be DHA or EPA derived from blue fish such as mackerel or mackerel, or an oil containing these.

By including such a component in the brain function improving composition as a dysphagia taste component, swallowing becomes difficult while retaining the taste of the brain function improving composition itself seasoned with the seasoning component. As a result, the occurrence of aspiration can be prevented, and even when swallowed, the aspiration can be steadily prevented by having a predetermined texture.

Further, in the brain function improving composition in which the dysphagia taste component is used in combination with the above-mentioned sublingual absorption promoter, the retention time of the brain function improving composition in the oral cavity is long due to the dysphagia taste component. Therefore, in combination with the effect of the sublingual absorption promoter, further sublingual absorption can be expected, and a more efficient and prompt effect of improving brain function can be produced.

In particular, by adding a dysphagic taste component within the range of at least 3 × 10 ^-3 parts by weight to 2 parts by weight per 100 parts by weight of the brain function improving composition, the brain function improving composition is reflexive. Swallowing is suppressed and the residence time in the oral cavity can be secured.

Further, the excipient is not particularly limited as long as it is generally used for foods and the like, and for example, starch can be used. When starch is used as an excipient, the effect on the texture can be almost ignored if it is 3 parts by weight or less per 100 parts by weight of the brain function improving composition according to the present embodiment.

Hereinafter, examples of the brain function improving composition according to the present embodiment will be described with reference to production examples.

[1. Preparation of standard gummy preparation]
First, a basic Gu-a01 was prepared as a gummy-shaped brain function improving composition according to the present embodiment.

In a 2 L capacity stainless steel container, weigh 80 parts by weight of sugar containing a viscous sugar solution such as water candy, heat it to 75 to 90 ° C, and then add a small amount of water to make a solution at 75 to 90 ° C. 7.2 parts by weight of gelatin (gelling agent) was mixed and stirred, and 0.072 parts by weight of emulsifier and 9.375 parts by weight of lecithin were added and mixed thoroughly.

Then, 0.641 parts by weight of fruit juice, 2.152 parts by weight of citric acid, 0.092 parts by weight of fragrance, and 0.467 parts by weight of starch (excipient) were further added, and the mixture was sufficiently stirred until uniform. Gu-a01, which is the basis of the gummy-like brain function improving composition, was prepared by housing it in a hemispherical mold and cooling and solidifying it.

When the texture of Gu-a01 obtained in this way was subjected to a JIS K6253 type A durometer and the texture was confirmed, the oral adhesion was 200 J / m ³ , the oral cohesiveness was 1.0, and the rubber hardness was 50. .. The surface area was 15 cm ² .

[2. Preparation of gummy preparations with different textures]
Next, according to the above-mentioned preparation method of the standard gummy preparation, a plurality of gummy candies having different textures and surface areas are appropriately adjusted based on Gu-a01, such as the type of saccharide, the type of gelling agent, and the amount of excipient. Preparations Gu-a02 to Gu-a12 were prepared. The texture test results of each gummy preparation prepared were as follows.
・ Gu-a02 (oral adhesion 50, oral cohesiveness 1.0, rubber hardness 50, surface area 15)
・ Gu-a03 (oral adhesion 300, oral cohesiveness 1.0, rubber hardness 50, surface area 15)
・ Gu-a04 (oral adhesion 200, oral cohesiveness 0.5, rubber hardness 50, surface area 15)
・ Gu-a05 (oral adhesion 200, oral cohesiveness 0.1, rubber hardness 50, surface area 15)
・ Gu-a06 (oral adhesion 200, oral cohesiveness 0.05, rubber hardness 50, surface area 15)
・ Gu-a07 (oral adhesion 200, oral cohesiveness 1.0, rubber hardness 60, surface area 15)
・ Gu-a08 (oral adhesion 200, oral cohesiveness 1.0, rubber hardness 1, surface area 15)
・ Gu-a09 (oral adhesion 200, oral cohesiveness 1.0, rubber hardness 0.5, surface area 15)
・ Gu-a10 (oral adhesion 200, oral cohesiveness 1.0, rubber hardness 50, surface area 20)
・ Gu-a11 (oral adhesion 200, oral cohesiveness 1.0, rubber hardness 50, surface area 5)
・ Gu-a12 (oral adhesion 200, oral cohesiveness 1.0, rubber hardness 50, surface area 3)

[3. Preparation of standard jelly preparation]
Next, the basic Je-a01 was prepared as the jelly-like brain function improving composition according to the present embodiment.

Specifically, 52.55 parts by weight of water is weighed in a 2 L capacity stainless steel container, 13.8 parts by weight of sugar and 2.4 parts by weight of a gelling agent are added until the mixture becomes uniform at 75 to 90 ° C. Thoroughly stirred, heated and dissolved. Next, 0.5 parts by weight of the emulsifier and 12 parts by weight of lecithin were added and mixed with stirring while maintaining the temperature of 75 to 90 ° C., and finally 14.85 parts by weight of the fruit juice was added. Then, 0.25 parts by weight of citric acid, 1 part by weight of a fragrance and 2.65 parts by weight of an excipient were added, and the mixture was sufficiently stirred to prepare a jelly stock solution.

Then, this jelly stock solution is filled in an aluminum pouch bag of about 2 cm x 22 cm, and the opening is sealed by heat welding and cooled to obtain Je-a01, which is the basis of the jelly-like brain function improving composition. Prepared.

When the texture of Je-a01 obtained in this way was subjected to a JIS K6253 type A durometer and the texture was confirmed, the oral adhesion was 150 J / m ³ , the oral cohesiveness was 0.9, and the masticatory hardness was 15. .. The surface area was 85 cm ² .

[4. Preparation of jelly preparations with different textures]
Next, according to the preparation method of the standard jelly preparation described above, a plurality of substances having different textures and surface areas are used while appropriately adjusting the types of saccharides, the types of gelling agents, the amount of water and excipients, etc. based on Je-a01. The jelly preparations Je-a02 to Je-a12 of the above were prepared. The texture test results of each of the prepared jelly preparations were as follows.
・ Je-a02 (oral adhesion 50, oral cohesiveness 0.9, masticatory hardness 15, surface area 85)
・ Je-a03 (oral adhesion 200, oral cohesiveness 0.9, masticatory hardness 15, surface area 85)
・ Je-a04 (oral adhesion 150, oral cohesiveness 1.1, masticatory hardness 15, surface area 85)
・ Je-a05 (oral adhesion 150, oral cohesiveness 0.1, masticatory hardness 15, surface area 85)
・ Je-a06 (oral adhesion 150, oral cohesiveness 0.05, masticatory hardness 15, surface area 85)
・ Je-a07 (oral adhesion 150, oral cohesiveness 0.9, masticatory hardness 20, surface area 85)
・ Je-a08 (oral adhesion 150, oral cohesiveness 0.9, masticatory hardness 1, surface area 85)
・ Je-a09 (oral adhesion 150, oral cohesiveness 0.9, masticatory hardness 0.05, surface area 85)
・ Je-a10 (oral adhesion 150, oral cohesiveness 0.9, masticatory hardness 15, surface area 95)
・ Je-a11 (oral adhesion 150, oral cohesiveness 0.9, masticatory hardness 15, surface area 35)
・ Je-a12 (oral adhesion 150, oral cohesiveness 0.9, masticatory hardness 15, surface area 30)

[5. Verification test of aspiration prevention effect]
Next, using the prepared gummy preparations Gu-a01 to Gu-a12 and jelly preparations Je-a01 to Je-a12, the risk of aspiration was examined. Specifically, 10 subjects (3 males and 7 females) aged 65 to 78 years were allowed to take each preparation and evaluate the ease of swallowing. I had anxiety about aspiration ... 1 point, I felt a little stuffy in my throat ... 2 points, I felt resistance to swallowing ... 3 points, usually ... 4 points, I felt relieved to swallow ... 5 points , The average of the evaluation points for each preparation was calculated. In addition, those with an average score of 4 points or more were judged to have a low possibility of aspiration. The results are shown in Table 1.

From the above test results, it is a brain function improving composition that contains phosphatidylcholine as a main component in the gel matrix and promotes brain activation by oral ingestion, and has an oral adhesion of 200 J / m ³ or less during mastication. The brain function improving composition according to the present embodiment, which has an oral cohesiveness of 0.1 to 1.0 and a surface area of 5 to 85 cm ² during mastication, that is, Gu-a01, Gu-a02, Gu-a04, Gu-a05. , Gu-a08, Gu-a11, Je-a01, Je-a02, Je-a04, Je-a05, Je-a08, Je-a11 have been shown to be capable of preventing aspiration.

Further, a gummy-shaped brain function improving composition according to the present embodiment, which has a masticatory hardness of 1 to 50 and a surface area of 5 to 15 cm ² according to a JIS K6253 type A durometer, that is, Gu-a01, Gu-a02, Gu-a04, Gu-a05, Gu-a08, and Gu-a11 have been shown to be gummy-like, aspiration-preventable brain function-improving compositions.

In addition, the masticatory hardness is 1 to 15 kN / m ² , the mouth adhesion is 150 J / m ³ or less, the mouth cohesiveness during mastication is 0.1 to 0.9, and the surface area is 35 to 85 cm ^2. The brain function improving composition according to the present embodiment, that is, Je-a01, Je-a02, Je-a04, Je-a05, Je-a08, and Je-a11 are jelly-like brains capable of preventing aspiration. It was shown to be a function-improving composition.

[6. Brain function improvement effect confirmation test]
Next, regarding the gummy-like or jelly-like brain function-improving compositions in which the aspiration-preventing effect was confirmed in the above-mentioned verification test of the aspiration-preventing effect, the brain waves of the subjects when each brain function-improving composition was ingested were examined. Measured using a topograph, brain function was improved compared to when the comparative gummy composition Gu-cont and the comparative jelly composition Je-cont, which do not contain the main component phosphatidylcholine (lecithin), were ingested. We examined whether or not it was done.

The evaluation is performed by giving a score X according to the expression level of the α wave. Specifically, there is no α wave ... 0 ≤ X <2 points, weak ... 2 ≤ X <4 points, moderate ... 4 ≤ After setting X <6 points, strong ... 6 ≤ X <8 points, and remarkably strong ... 8 ≤ X <10 points, the average score for each brain function improving composition of the subjects was calculated. In addition, the test was conducted by ingesting each preparation in 10 subjects (3 males and 7 females) aged 65 to 78 years. The results are shown in Table 2.

As a result of statistical analysis, all of the brain function improving compositions according to the present embodiment have brain function as compared with the sample compositions Gu-cont and Je-cont that do not contain the main component phosphatidylcholine (lecithin). It was shown to have the effect of improving.

In addition, it was shown that there is no difference in the effect of the brain function improving composition on improving the brain function in both the gummy-like and jelly-like forms. In addition, it was shown that there is no difference in the effect of improving brain function regardless of the texture as long as it is within a predetermined numerical range.

[7. Examination of brain function improvement effect with and without sublingual absorption promoter]
Next, we investigated the difference in the effect of improving brain function depending on the presence or absence of a sublingual absorption promoter composed of vitamin C, vitamin B2, folic acid, pantothenate, and vitamin B1.

Prior to the test, the brain function improving compositions shown in Tables 3 to 6 below were prepared according to the above-mentioned preparation method of the reference gummy preparation and the preparation method of the reference jelly.

In addition, the test was conducted in [6. Brain function improvement effect confirmation test] was performed in the same manner. Each preparation was ingested in two ways, one when it was sufficiently chewed and the other when it was swallowed. The results are shown below.

As can be seen from the above results, according to Gu-b01 to which a sublingual absorption promoter composed of vitamin C, vitamin B2, folic acid, pantothenate, and vitamin B1 was added, one of the components was missing. Compared with Gu-b02 to Gu-b06, a remarkable effect of improving brain function was observed. In addition, since such a remarkable effect of improving brain function is not observed when swallowed without chewing, the presence of a sublingual absorption promoter enables efficient ingestion of the main component through the oral mucosa. It was shown that sublingual absorption was mainly promoted.

Similarly, according to Je-b01 to which a sublingual absorption promoter was added, a remarkable effect of improving brain function was observed as compared with Je-b02 to Je-b06 lacking any one of the components. In addition, since such a remarkable effect of improving brain function is not observed when swallowed without chewing, the presence of a sublingual absorption promoter enables efficient ingestion of the main component through the oral mucosa. It was shown that sublingual absorption was mainly promoted.

[8. Examination of the optimum amount of sublingual absorption promoter added to the gummy-like brain function improving composition]
Next, the optimum amount of sublingual absorption promoter added to the gummy-like brain function improving composition was examined based on Gu-b01.

The sublingual absorption promoter in the brain function improving composition according to the present embodiment is composed of vitamin C, vitamin B1, vitamin B2, folic acid, and pantothenic acid. In this study, these sublingual absorption promoters are promoted. The extent to which the amount of each component of the agent was reduced or increased was examined.

In conducting this study, a total of 12 types of gummy brain function improving compositions, Gu-a01, Gu-b01, and Gu-b07 to Gu-b16, were prepared. Specific formulations are as shown in Tables 8 to 10 below.

Then, using these 12 kinds of gummy-like brain function improving compositions, the above-mentioned [6. We verified whether or not the brain function improvement effect was observed in the same way as the brain function improvement effect confirmation test]. Each preparation was ingested in two ways, one when it was sufficiently chewed and the other when it was swallowed. The results are shown below.

As can be seen from the results shown in Table 11, all of Gu-b07 to Gu-b16 have an effect of improving brain function when chewed and eaten as compared with Gu-a01 which does not contain a sublingual absorption promoter. It has been shown that it can occur.

That is, 30 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin C and 0.45 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin B1 and 0.5 × per 100 parts by weight of the brain function improving composition. 10 ^{-6 to} 300 x 10 ^-3 parts by weight of vitamin B2, 0.081 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight of folic acid, 2.0 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight of pantothenate It was shown that the sublingual absorption of phosphatidylcholine and lecithin as main components is effectively promoted by containing the sublingual absorption promoter composed of.

[9. Examination of the optimum amount of sublingual absorption promoter added to the jelly-like brain function improving composition]
Next, the above-mentioned [8. Examination of the optimum amount of sublingual absorption enhancer added to the gummy-like brain function improving composition], based on Je-b01, the optimum amount of sublingual absorption promoter added to the jelly-like brain function improving composition. Was examined.

In conducting this study, a total of seven types of jelly-like brain function improving compositions, Je-a01, Je-b01, and Je-b07 to Je-b11, were prepared. Specific formulations are as shown in Tables 12 and 13 below. Since the amount of each component of the sublingual absorption promoter contained in Je-b01 is sufficiently small, in this verification, the effect is obtained no matter how much the amount of each component is increased. I confirmed if it could be done.

Next, using these seven types of gummy-like brain function improving compositions, the above-mentioned [6. Brain function improvement effect confirmation test] was verified as to whether or not the brain function improvement effect was observed. Each preparation was ingested in two ways, one when it was sufficiently chewed and the other when it was swallowed. The results are shown below.

As can be seen from the results shown in Table 14, all of Je-b07 to Je-b11 have an effect of improving brain function when chewed and eaten as compared with Je-a01 which does not contain a sublingual absorption promoter. It has been shown to be able to occur.

That is, 30 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin C and 0.45 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin B1 per 100 parts by weight of the jelly-like brain function improving composition. , 0.5 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight of vitamin B2, 0.081 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight of folic acid, 2.0 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight It was shown that the inclusion of a sublingual absorption enhancer composed of pantothenate effectively promotes the sublingual absorption of phosphatidylcholine and lecithin as main components.

[10. Examination of brain function improvement effect by the presence or absence of dysphagia taste component]
Next, using DHA and EPA as the dysphagic taste component, the difference in the brain function improving effect depending on the presence or absence of the dysphagic taste component was examined.

Prior to the test, the brain function improving compositions shown in Tables 15 to 18 below were prepared according to the above-mentioned preparation method of the reference gummy preparation and the preparation method of the reference jelly. In this test, the gummy or jelly-like brain function improving composition did not contain a sublingual absorption promoter and a dysphagia flavoring component, or contained a sublingual absorption promoter and a dysphagia flavoring component. Those that did not contain dysphagia, those that increased or decreased the amount of dysphagic taste components, etc. were examined.

Next, using the prepared gummy preparations Gu-a01, Gu-b01, Gu-c01 to Gu-c06, and jelly preparations Je-a01, Je-b01, Je-c01 to Je-c06, they are likely to swallow when eating. We examined whether or not. Specifically, 10 subjects (3 males and 7 females) aged 65 to 78 years were allowed to take each preparation, and dysphagia was added to the swallowing behavior that is generally considered to be reflexive. We evaluated how much the swallowing behavior was suppressed by the taste component. Do not hesitate to swallow ... 1 point, slightly hesitate to swallow ... 2 points, hesitate to swallow ... 3 points, feel great resistance to swallowing ... 4 points, cannot swallow ... 5 points, respectively The average of the evaluation points for each preparation was calculated. In addition, those with an average score of 2 points or more and less than 4 points were judged to have the effect of the dysphagic taste component. The results are shown in Table 19.

As can be seen from Table 19, the gummy preparations Gu-a01 and Gu-b01 and the jelly preparations Je-a01 and Je-b01, which do not contain dysphagic taste components, hardly hesitate to swallow. It was suggested that in order to promote sublingual absorption, it is necessary to be conscious of retaining the brain function improving composition eaten in the oral cavity.

On the other hand, the gummy preparations Gu-c01 to Gu-c06 and the jelly preparations Je-c01 to Je-c06, which contain dysphagic taste components, all had an average evaluation score in the range of 2.1 to 3.9 and were placed in the oral cavity. Although it is possible to keep it and swallowing is not disturbed enough to cause nausea, it has been found that swallowing needs to be done consciously.

In addition, there was no significant difference between DHA and EPA in terms of dysphagic taste components, and it was confirmed that both of them can function as dysphagic taste components.

From these results, in the brain function improving composition according to the present embodiment, the dysphagic taste component is contained in the range of at least 3 × 10 ^-3 parts by weight to 2 parts by weight per 100 parts by weight of the brain function improving composition. It was shown that by adding the composition, the reflexive swallowing of the brain function improving composition was suppressed, and the residence time in the oral cavity could be secured.

Then, using these 16 kinds of gummy-like or jelly-like brain function improving compositions, the above-mentioned [6. Brain function improvement effect confirmation test] was verified as to whether or not the brain function improvement effect was observed. In this test, the eating method (chewing or swallowing) of each preparation was not particularly instructed. The results are shown below.

As can be seen from these results, when ingested without specifying the eating method, gummy preparations Gu-c01 to Gu-c06 and jelly preparations Je-c01 to Je-c06 containing dysphagic taste components It was shown that the effect of improving brain function was significantly improved as compared with the gummy preparations Gu-a01 and Gu-b01 and the jelly preparations Je-a01 and Je-b01, which do not contain dysphagia taste components. .. It is considered that this is because the presence of the dysphagic taste component suppressed the swallowing motion and prolonged the residence time of the brain function improving composition in the oral cavity.

In addition, from these results, the use of DHA or EPA in a brain function improving composition containing phosphatidylcholine as a main component in the gel matrix and promoting brain activation by oral ingestion is a brain function. It was shown that the improved composition prolongs the oral residence time and contributes to the promotion of sublingual absorption.

As described above, the brain function improving composition according to the present embodiment is a brain function improving composition containing phosphatidylcholine as a main component in the gel matrix and promoting the activation of the brain by oral ingestion. , Sublingual adhesion during mastication was set to 200 J / m ³ or less, oral cohesiveness during mastication was set to 0.1 to 1.0, and surface area was set to 5 to 85 cm ² , preventing aspiration without losing the texture due to mastication. In addition to intestinal absorption, of the oral mucosal absorption of the tongue, palatal mucosa, buccal mucosa, etc., it promotes sublingual absorption, which is mainly absorbed directly into the capillaries of the tongue, to the brain. It is possible to provide a brain function improving composition for reaching the active ingredient phosphatidylcholine to obtain a brain function improving effect. In addition, it is possible to provide a composition capable of promoting the induction of α waves in the brain.

Finally, the description of each embodiment described above is an example of the present invention, and the present invention is not limited to the above-described embodiment. Therefore, it goes without saying that various changes can be made according to the design and the like as long as the technical idea of the present invention is not deviated from the above-described embodiments.

Claims (5)

A brain function improving composition containing phosphatidylcholine as a main component in a gel matrix and promoting brain activation by oral ingestion , and an auxiliary component that promotes brain activation by the phosphatidylcholine. It further contains a taste component that makes swallowing difficult, and the auxiliary components are 30 × 10 ^{-6 to} 300 × 10 ^-3 parts by weight of vitamin C and 0.45 × 10 ^-6 to 0.45 × 10 ^-6 to 100 parts by weight of the brain function improving composition. 300 x 10 ^-3 parts by weight of vitamin B1, 0.5 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight of vitamin B2, 0.081 x 10 ^{-6 to} 300 x 10 ^-3 parts by weight of folic acid, 2 x 10 ^{-6 to} 300 x 10 ^-3 Consists of ³ parts by weight of pantothenic acid, the mouth adhesion during chewing is 200 J / m ³ or less , the mouth cohesiveness during chewing is 0.1 to 1.0 , and the surface area is 5 to brain function improving composition characterized by a 85cm ^2. The brain function improving composition according to claim 1, wherein the masticatory hardness is 1 to 50 in terms of rubber hardness value according to JIS K6253 Type A durometer, and the surface area is 5 to 15 cm ^{2 in} a gummy shape. The brain function improving composition according to claim 2, wherein the melting time in the non-chewed state in the oral cavity is within 3 minutes. A jelly-like substance with a masticatory hardness of 1 to 15 kN / m ² , an oral adhesion of 150 J / m ³ or less, an oral cohesiveness during mastication of 0.1 to 0.9, and a surface area of 35 to 85 cm ^2. The brain function improving composition according to claim 1. The brain function improving composition according to claim 4, wherein the melting time in the non-chewed state in the oral cavity is within 2 minutes.