JP7306735B2 - oral composition - Google Patents

Description

The present invention relates to oral compositions containing digestive enzymes.

Conventionally, digestive enzymes such as proteases and amylases in the digestive system have been used to absorb nutrients by decomposing carbohydrates such as dietary proteins and peptides, starch and glycogen in the digestive system, to decompose unnecessary proteins and carbohydrates, and to promote protein activity. It is known to play an important role in regulation. In recent years, the importance of enhancing the activity of these enzymes has become widely known from the viewpoint of promoting biological metabolism and maintaining health.

On the other hand, as an oral or percutaneous digestive enzyme activator, it is known to use one selected from cornflowers, banyans, raspberries, grapefruits, ivy, hawthorns, jujubes, and succulents ( See Patent Document 1).

JP 2008-081441 A

In recent years, oral ingestion of digestive enzymes themselves or compositions containing digestive enzymes has been widely practiced. Conventional oral compositions containing digestive enzymes often contain inactivated digestive enzymes. Also, digestive enzymes taken orally may be partially degraded by gastric acid. However, it is generally believed that oral ingestion of active digestive enzymes has a certain effect in aiding the digestion of food and promoting metabolism. Therefore, there is a practical benefit to orally ingesting a digestive enzyme-containing composition that has a higher enzymatic activity than simply containing the digestive enzyme alone.

However, conventional techniques for enhancing the activity of digestive enzymes, including the digestive enzyme activator described in Patent Document 1, are not sufficiently effective, and the activity of digestive enzymes whose activity should be promoted is extremely high. There was a problem that an active ingredient was required.

Accordingly, an object of the present invention is to provide a composition having high digestive enzyme activity and containing a natural product-derived component as an active ingredient.

The present invention provides an oral composition containing a digestive enzyme and at least one component different from the digestive enzyme, which is selected from processed fruit products or flavors, saccharides, and lactic acid bacteria. .

According to the present invention, an oral composition having high digestive enzyme activity can be provided.

The present invention will be described below based on its preferred embodiments.
The oral composition of the present embodiment has excellent digestive enzyme activity by containing processed fruit or flavor, sugar, or lactic acid bacteria in addition to digestive enzymes.

(digestive enzyme)
The oral composition of this embodiment has digestive enzymes.
A digestive enzyme refers to an enzyme that digests a food component, and may be an enzyme that can be produced by the subject to whom the oral composition is administered, or an enzyme that cannot be produced. The digestive enzyme contained in the composition for oral use of this embodiment is preferably in an active form. An active enzyme refers to an enzyme having enzymatic activity. Having enzymatic activity means that the activity is not completely lost. Deactivation of the enzyme activity occurs when the enzyme protein is denatured by heating, pH change, or the like, and the three-dimensional structure of the active site is changed, so that the substrate cannot bind to the enzyme.

As digestive enzymes, protease, amylase, lipase, cellulase and galactosidase are generally known.

Protease is a general term for enzymes that catalyze the hydrolysis of peptide bonds in proteins, peptides, and the like. Proteases are broadly classified into two groups according to their catalytic action. Endoproteases (proteinases) catalyze the release of peptides by hydrolyzing peptide bonds inside molecules such as proteins and peptides. Exoproteases catalyze the liberation of amino acids by hydrolyzing peptide bonds from amino or carboxyl termini.
As the protease, it is preferable to contain cysteine protease, particularly papain, because of its high enzymatic activity promoting effect when combined with processed fruit or flavor, sugar or lactic acid bacteria.

Amylase is a general term for enzymes that convert amylose and amylopectin in starch and glycogen into monosaccharide glucose and disaccharides maltose and oligosaccharides by hydrolyzing glycosidic bonds. Amylases include α-amylase, β-amylase and glucoamylase.
α-Amylase, also known as 1,4-α-D-glucan glucanohydrolase or glycogenase, irregularly cleaves α-1,4-bonds of starch and glycogen to produce polysaccharides, maltose, and oligosaccharides. is an enzyme.
β-amylase, also known as 1,4-α-D-glucan glucanomaltohydrolase, glycogenase or saccharogen amylase, decomposes starch and glycogen into maltose (maltose).
Glucoamylase is officially called glucan 1,4-α-glucosidase, and 1,4-α-D-glucan glucohydrolase is exo-1,4-α-glucosidase, γ-amylase, lysosomal α-glucosidase or amyloglucosidase. alias. It hydrolyzes the α-1,4-bond at the non-reducing end of the sugar chain to the exo-type to produce one molecule of glucose. Some are known to cleave α-1,6-bonds as well.

Lipases include triacylglyceride lipase and phospholipase. Cellulases include endoglucanases and exoglucanases. Galactosidase includes β-galactosidase and the like. Lipases include triacylglyceride lipase and phospholipase. Cellulases include endoglucanases and exoglucanases. Galactosidase includes β-galactosidase and the like.

As digestive enzymes, proteases and amylases are preferred because processed fruit products or flavors, sugars, or lactic acid bacteria are highly effective in improving enzymatic activity.

The digestive enzyme may be a commercially available enzyme preparation or a food product containing a digestive enzyme. For example, papain, which is a type of protease, is known to be abundant in immature papaya fruit and/or fruit juice or processed products thereof. Or those processed products can be used as papain. Papaya is not particularly limited as long as it is a plant of the genus Papaya, which is known as a fruit native to tropical America, and examples thereof include Carica papaya. Papain is particularly preferred as papaya fruit or juice extract and its dry powder.

For example, the protease and the processed foodstuff containing it preferably have a proteolytic activity of 5,000 units/g or more, preferably 10,000 units/g or more, on a dry mass basis. is more preferable, it is particularly preferable to use 20,000 units/g or more, and it is even more preferable to use 30,000 units/g or more. The proteolytic titer referred to in this specification refers to casein (dairy) as a substrate, at 37°C and pH 6.0, which increases the absorbance at a wavelength of 275 nm corresponding to 1 µg of L-tyrosine for 1 minute at the initial stage of the reaction. One unit is the activity. The proteolytic potency is sometimes called protein digestion and can be measured by the method described in Examples below. For the reasons described above, it is preferable to use papain having a proteolytic potency of 5,000 units/g or more, more preferably 10,000 units/g or more, and 50,000 units. / g or more is particularly preferred.

Further, for example, amylase and processed food products containing it preferably have a starch decomposition potency of 1 to 5,000,000 units/g, preferably 10 to 500,000 units/g, and more preferably 100 to 100,000 units/g. is more preferable.
The method for measuring the starch decomposition potency may be according to a conventional method, and the following method may be mentioned, for example. Starch decomposition titer measurement method: Starch (soluble) is used as a substrate, and 1 ml of a 1% starch solution is added to 1 ml of a 1% starch solution for 30 minutes at 40°C and a light path length of 10 nm at a wavelength of 670 nm and a transmittance of 66%. The activity to decompose to give can be measured as one unit.

In the composition for oral use of the present embodiment, the digestive enzyme may be solid, such as liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, and lotion. may be in a fluid state. Solids include powders, granules, granules, tablets, chewables, capsules, soft capsules, and the like.

(Processed fruit or flavor, sugar or lactic acid bacteria)
In the present invention, the processed fruit or flavor, sugar, and lactic acid bacteria are components different from digestive enzymes. However, as described above, the digestive enzymes may be processed foodstuffs, and the foodstuffs include fruit and lactic acid bacteria. As the processing method of the processed product, the same method as the processing method of fruit and the processing method of lactic acid bacteria in the processed fruit product can be mentioned.
Therefore, for example, the oral composition of the present embodiment contains two or more processed fruit products, one or more of which contains a processed fruit, and one or more of which contains digestive enzymes. includes those containing as

- Processed fruit or flavor The fruit in the processed fruit or flavor refers to the fruit part or flower stalk of an edible fruit or fruity vegetable. In addition, in this specification, a fruit includes a pericarp, a pulp, a fruit juice, and a seed.

Fruits include pome fruits, stone fruits and other types. Fruits include pome fruits such as Chinese quince, Chinese pear, pear, quince, medlar, and apple; Other stone fruits such as cranberries (also called bilberry), strawberries (also called strawberries, strawberries), bilberries, blackberries, blueberries, raspberries, red currants, gooseberries, cassis (also called blackcurrants); , figs, persimmons, kiwifruit (also known as kiwi), gummy (also known as gummy bears, peanuts, and shrubs), mulberries, cowberries (also known as moss peaches, rock peaches, hamanashi, and okama apples), pomegranates (also known as pomegranates and pomegranates). ), argassi (saru pear, shirakuchizuru, kokuwa), gooseberry (vinegar mass, gooseberry), jujube (also called jujube), Japanese plum (also called garden plum, koume, and ikuri), haskap (also known as black minnow) red currant), currant (also known as currant mass, red currant), grapes (also described as grapes), tomato, pineapple, melon, banana, tangerine, lemon, orange, grapefruit, acerola, passion fruit, watermelon, avocado, dragon Examples include fruits.
Among them, it is preferable to use at least one selected from pome fruits, stone fruits, berries, bananas, pineapples and melons, and in particular, at least one selected from apples, mangos, strawberries, bananas, melons and pineapples is used. is preferred.

Apple is the fruit of a deciduous tall tree belonging to the genus Malus of the Rosaceae family.
Mango is the fruit of a fruit tree belonging to the genus Mango of the Anacardiaceae family.
Strawberry is a perennial plant belonging to the family Rosaceae, and is a general term for raspberry, raspberry, raspberry, etc., and it is preferable to use the flowers and/or fruits of these. In particular, florets and/or fruits of Dutch strawberry are preferred.
Banana is a general term for a group of cultivars whose fruit is edible among the genus Musaceae of the Musaceae family, and refers to the fruit of the group of cultivars.
Melon is the fruit of an annual herbaceous plant belonging to Cucurbitaceae whose fruit is edible, and its scientific name is called Cucumis melo.
Pineapple is a perennial fruit belonging to the family Bromeliaceae, and its scientific name is called Ananas comosus.

The processed fruit or flavor may be a processed fruit or flavor of immature fruit, but is preferably a processed fruit or flavor of ripe fruit.

A processed fruit product is obtained by subjecting a fruit to fermentation, drying, pulverization, extraction, heating, filtration, juicing, slurrying, or the like.

If the processed fruit or flavor is to be obtained from the fruit, the fruit is preferably freshly harvested or processed immediately after harvesting. If it takes a long time to process, it is preferable to store the fruit by a storage means commonly used by those skilled in the art, such as cold storage, in order to prevent deterioration of the fruit.

Processed fruits or flavors include, for example, dry powder obtained by drying and pulverizing fruits (hereinafter also referred to as "dried pulverized powder"), fruit pieces and their dried products, and fruit juices. (sometimes referred to as fruit juice) and its dry powder, fruit extracts and its dry powder, etc., but are not limited thereto. However, from the viewpoint of easiness of processing, storage, transportation, etc. and versatility of use form, it is preferable that the powder is finally in the form of powder. In the present specification, the term "powder" generally includes any of dry pulverized powder, dry powder of minced material, dry powder of squeezed juice, and dry powder of extract.
Also, the processed fruit or flavor may be a fermented fruit or a dry powder thereof. Fermented fruits include those obtained by fermenting fruits or their pulverized products, juices, extracts or shredded products.

In particular, the processed fruit is preferably a fruit extract or its dry powder, or a fruit juice or its dry powder.

For example, a conventionally known method can be used to dry and pulverize a specific plant body. As such a method, a method combining drying treatment and crushing treatment can be used for the plant body. A sterilization treatment may be performed in addition to the drying treatment and the pulverization treatment.

The drying treatment is not particularly limited, but includes, for example, drying such that the moisture content of the plant is 10% or less, preferably 5% or less. The drying treatment can be performed by any method known to those skilled in the art, such as hot air drying, high-pressure steam drying, electromagnetic wave drying, and freeze drying. Drying by heating can be carried out, for example, at 40° C. to 140° C., preferably 80° C. to 130° C., at a temperature and for a time that does not cause discoloration of the plant body.

The pulverization treatment is not particularly limited, but includes, for example, a treatment of pulverizing the plant by any method commonly used by those skilled in the art using a crusher, mill, blender, millstone or other crushing equipment or instrument. The pulverized plant body is sieved as necessary, and it is preferable to use, for example, a sieve that passes through 30 to 250 mesh as the plant powder. By setting the particle size to be 250 mesh or less, the plant powder can be easily handled during further processing, and by setting the particle size to be 30 mesh or more, the plant powder can be easily mixed with other materials. Uniform mixing is facilitated.

A specific method of dry pulverization includes, for example, a method of cutting a plant, drying it to a moisture content of 10% by mass or less, preferably 5% by mass or less, and then pulverizing it. In addition to this, for example, a method of cutting a plant body, kneading it, then drying and pulverizing it; a method of drying the plant body, coarsely pulverizing it, heating it at 110° C. or higher, and further finely pulverizing it, and the like. is mentioned.

In addition, although the method for shredding the plant is not particularly limited, methods commonly used by those skilled in the art to shred the plant can be used, such as slicing, crushing, and shredding. As an example of comminution, it may be slurried. Slurrying is carried out by subjecting the plant body to a mixer, juicer, blender, masscolloider, or the like to form a mushy gruel (suspension of liquid and solid).

The method of squeezing the plant body is not particularly limited, but examples thereof include a method of squeezing the plant body or its fragmented material, and a method of centrifuging or filtering the plant fragmented material. As an example of a specific squeezing method, the juice is squeezed by a mechanical crushing means such as a mixer or a juicer, and if necessary, a sieved liquid is obtained by removing coarse solids by means such as sieving or filtering. method.

The method of obtaining a plant extract (extract) is not particularly limited. A method of extracting by stirring and/or heating as necessary can be mentioned. Subsequent sieving, filtering or other means may remove crude solids to obtain an extract.

Furthermore, the method of fermenting a plant body can be carried out by adding lactic acid bacteria, yeast, koji mold, natto bacteria, acetic acid bacteria, etc. to the plant body or its pulverized product, squeezed juice, extract or shredded product. These may be used alone or in combination of two or more. The lactic acid bacteria referred to herein may be bifidobacteria, or general lactic acid bacteria other than bifidobacteria.

The squeezed juice (fruit juice) obtained by the above-mentioned shredding process, the liquid extract obtained by the extraction process, and the liquid and slurry after fermentation are all dried with hot air, high-pressure steam, electromagnetic waves, freeze-dried, etc. can be dry powdered by any method known to those skilled in the art. At this time, an excipient such as dextrin may be added.

Fruit flavors include either reclaimed fruit flavors, semi-synthetic products, or synthetic products. The recovered incense may be extracted with an aqueous solvent such as water, a polar solvent such as ethanol, or a mixture thereof, or may be extracted with a non-polar solvent. A fruit flavor means a substance having a fruit-specific flavor, and is generally available as a fruit flavor or a fruit essence. Moreover, generally, what is marketed as a fruit flavor can be mentioned. Specific examples of these flavors include flavors described in [Patent Office Gazette, Collection of Well-Known and Commonly Used Techniques (Fragrance) Part 2, Flavors for Foods].

Commercially available processed fruits or flavors may be used as active ingredients. Examples of commercially available products include those described in Examples described later.

- Carbohydrates Carbohydrates are preferably sugars or sugar alcohols, and more preferably monosaccharides or oligosaccharides or sugar alcohols thereof. As the oligosaccharides referred to herein, the number of constituent sugars is preferably 2 or more and 50 or less, more preferably 2 or more and 40 or less, and particularly preferably 2 or more and 30 or less. Monosaccharides include glucose, fructose, mannose, galactose, xylose, arabinose and the like. Oligosaccharides include disaccharides such as lactose, sucrose, and maltose, trisaccharides such as maltotriose, fructooligosaccharides, xylooligosaccharides, galactooligosaccharides, xylooligosaccharides, and cyclic oligosaccharides. oligosaccharides. Examples of sugar alcohols include sugar alcohols corresponding to sugars. Specifically, monosaccharide alcohols include, for example, tetritols such as erythritol, D-threitol, L-threitol, D-arabinitol, and xylitol. pentitol such as pentitol, D-iditol, galactitol (dulcitol), hexitol such as D-glucitol (sorbitol), cyclitol such as inositol, mannitol, boremitol, ribitol, perseitol, D-erythro-D-galacto-octitol and the like. be done. Examples of disaccharide alcohols include reduced maltose (maltitol), lactitol, and reduced palatinose (isomalt). Examples of trisaccharide or higher alcohols include maltotriitol, isomaltotriitol, and panitol.
Among them, the number of constituent sugars is preferably 2 or more and 50 or less, more preferably 2 or more and 30 or less, and even more preferably 2 or more and 15 or less. Sugars or sugar alcohols thereof are preferred as constituent sugars.

- Lactic acid bacteria Lactic acid bacteria may be viable or dead, and in the case of dead bacteria, disrupted cells may be used. Lactic acid bacteria powder can be obtained, for example, by removing unnecessary components such as medium from cultured lactic acid bacteria or lactic acid bacteria culture used for fermentation, and then pulverizing the cells of lactic acid bacteria by a known method. The type of lactic acid bacteria is not particularly limited as long as it produces lactic acid as a metabolite, and includes those conventionally orally ingested by animals such as humans. genera Pediococcus, Staphylococcus, Tetragenococcus, Bacillus.
The genus Bifidobacterium includes Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium adolescentis, and Bifidobacterium mongoliense.
Lactobacillus brevis, Lactbacillus gasseri, Lactobacillus acidophilus, Lactobacillus buchneri, Lactobacillus bulgaricus, Lactobacillus delburvecki, Lactobacillus casei, Lactobacillus crispatus, Lactobacillus curvatus, Lactobacillus halivaticus, Lactobacillus pentosus, Lactobacillus plantarum , Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus sporogenes, Lactobacillus sakei, Lactobacillus fructivorans, Lactobacillus hilgardii, Lactobacillus reuteri, Lactobacillus fermentum.
Enterococcus includes Enterococcus faecalis (sometimes called Streptococcus faecalis), Enterococcus faesium (sometimes called Streptococcus faesium), Streptococcus thermophilus, and Lactococcus lactis (sometimes called Streptococcus lactis). be done.
The genus Leuconostoc includes Leuconostoc mesenteroides and Leuconostoc oenos.
The genus Pediococcus includes Pediococcus acidilactici and Pediococcus pentosaceus.
The genus Staphylococcus includes Staphylococcus carnosus and Staphylococcus xylosus.
Tetragenococcus genus includes Tetragenococcus halophilus. The Bacillus genus includes Bacillus coagulans, Bacillus mesentericus, and the like.
Especially preferred are Bacillus coagulans, Enterococcus faecalis and Bifidobacterium bifidum. These may be used individually by 1 type, and may use 2 or more types together.

In the oral composition of the present embodiment, the saccharide and lactic acid bacteria are usually in the form of powder, but liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse and lotion can be used. It may be in a fluid state such as. The solid state may be in the form of powder, granules, granules, tablets, chewables, capsules, soft capsules, and the like.

The content of digestive enzymes and processed fruit products or flavors, carbohydrates, or lactic acid bacteria (hereinafter also referred to as specific components) in the composition of the present invention is at least an effective amount capable of exhibiting a high digestive enzyme activity, and the active ingredients Although it may consist of only, for example, it is preferable that it is the following amount because it can exhibit a higher digestive enzyme activity action. The composition of the present invention contains a processed fruit product or flavor, sugar, or lactic acid bacteria to increase the activity of a specific digestive enzyme compared to the case where the composition contains a specific digestive enzyme alone. For example, when the composition of the present embodiment contains protease, it has a higher protease activity than when it contains protease alone, and when it contains amylase, it has higher protease activity than when it contains amylase alone. It has amylase activity.

The dry mass ratio ([digestive enzyme]:[processed fruit or flavor, sugar or lactic acid bacterium]) of the digestive enzyme and processed fruit or flavor, sugar or lactic acid bacterium in the composition is 1:0.0001 or more. : 1000,000 or less, preferably 1:0.001 or more and 1:100,000 or less, more preferably 1:0.01 or more and 1:10,000 or less, particularly preferably 1:0. It is 1 or more and 1:1,000 or less. For example, when the composition contains a processed food material as a digestive enzyme, the amount of the processed food material is regarded as the amount of papain (hereinafter the same).

In the solid content of the composition, the total content of digestive enzymes, processed fruit products or flavors, sugars, or lactic acid bacteria is preferably 0.001% by mass or more and 90% by mass or less, and 0.01% by mass or more and 80% by mass. The following are more preferable, and 0.1% by mass or more and 70% by mass or less are particularly preferable.

The total amount of the content of digestive enzymes and processed fruit or flavor, sugar or lactic acid bacteria is the lower limit as the amount used per day, in terms of the dry mass of digestive enzymes and processed fruit or flavor, sugar or lactic acid bacteria, For example, it can be set to 10 mg or more, preferably 100 mg or more, more preferably 200 mg or more. In addition, the upper limit of the daily usage amount can be set to be, for example, 20,000 mg or less, preferably 15,000 mg or less, more preferably 10,000 mg or less in terms of the dry mass of the digestive enzyme and the processed plant material.

The composition of the present invention contains processed fruit products or flavors, sugars, or lactic acid bacteria, so that digestive enzyme activities such as amylase activity and protease activity are enhanced by digestive enzymes or It is much higher than when processed fruit or flavor, sugar, or lactic acid bacteria are contained alone.

The composition for oral use may be in a solid form, or may be in a fluid form such as liquid, syrup, paste, gel, jelly, cream, emulsion, spray, mousse, lotion and the like. . Solids include powders, granules, granules, tablets, chewables, capsules, soft capsules, and the like.

The packaging form of the composition of the present invention is not particularly limited, and can be appropriately selected according to the dosage form. Examples include blister packs such as PTP; strip packaging; heat sealing; aluminum pouches; packaging; glass containers such as vials; and plastic containers such as ampoules.

The method for producing the composition of the present invention is not particularly limited, and it is produced according to general production methods known to those skilled in the art depending on the mode of use. For example, granules or solids can be used as they are or mixed with the above-mentioned other ingredients or second physiologically active ingredients simultaneously or in several stages, by fluid bed granulation method, agitation granulation method, The granules are granulated according to a granulation method such as an extrusion granulation method, and further compression-molded according to a conventional method using a tableting machine or the like to form tablets.

Ingredients other than digestive enzymes and processed fruit products or flavors, sugars or lactic acid bacteria in the composition of the present invention are not particularly limited, and other ingredients such as excipients, thickeners, oils and fats, vitamins, manufacturing agents The ingredients can be combined arbitrarily.

In addition, the composition of the present invention contains digestive enzymes, digestive enzymes and processed products or flavors of fruits, sugars or lactic acid bacteria, so that the composition has high protease activity, amylase activity, and other enzymatic activity, thereby promoting nutrient absorption, Modes such as proteolytic agents, protein activity regulators, and starch degrading agents can be employed.
In general, it is said that when the body becomes deficient in enzymes, metabolic enzymes are preferentially used for food digestion, resulting in a decrease in body metabolism. It is said that when digestive enzymes are orally ingested into the body, the production of metabolic enzymes in the body is increased or the consumption thereof is suppressed, thereby increasing or improving the metabolism and thus having a dieting effect. In addition, it is said that when digestive enzymes are orally ingested into the body, the digestive power of the digestive organs is improved, which leads to regulation of the intestines, and constipation and abdominal obesity are easily eliminated.
Since the composition of the present invention has a high digestive enzyme activity, it is expected that the diet effect and the effect of relieving constipation or abdominal obesity can be enhanced by supplying the composition to the body through oral intake.

Although the composition of the present invention is preferably applied to humans, it can be applied to animals other than humans without any particular limitation as long as the expected effects are exhibited. The user of the composition of the present invention is not particularly limited. Middle-aged and elderly people are more preferable. The frequency of use of the composition of the present invention is not particularly limited, and is, for example, once or more per week, preferably twice or more per week.

The composition of the present invention can contain, in addition to the active ingredient, digestive enzymes such as protease and amylase, or a second physiologically active ingredient that promotes these enzymes. Such a second physiologically active component is not particularly limited as long as it exhibits a known digestive enzyme activity. For example, active ingredients of compositions and agents exhibiting a protease activity-promoting action described in Patent Document 1 can be mentioned. By containing a second physiologically active ingredient in addition to the specific ingredient of the present invention, the composition of the present invention can be a composition exhibiting synergistic digestive enzyme activity. The second bioactive component can be one or more components. The blending amount of the second physiologically active ingredient is not particularly limited as long as it does not interfere with the solution of the problems of the present invention, and is adjusted as appropriate.

Although a preferred embodiment has been described above, the present invention is not limited to this embodiment. For example, the present invention may provide a composition for improving digestive enzyme activity containing processed fruit or flavor, sugar, or lactic acid bacteria. As the fruit component, sugar or lactic acid bacteria, those described above can be used. Digestive enzymes include those described above. The composition of the composition for improving digestive enzyme activity is the same as the oral composition of the present invention except that it does not necessarily contain a digestive enzyme (although it may contain a digestive enzyme). be. Therefore, the above description of the composition for oral use applies to the composition for improving digestive enzyme activity, except that the inclusion of digestive enzymes is not essential. Such a composition for improving digestive enzyme activity can effectively enhance the activity of the digestive enzyme in the food or preparation by ingesting it together with a food or oral preparation containing the digestive enzyme.

The present invention will be described in more detail below with reference to Examples, but the present invention is not limited to these Examples, and the present invention can take various aspects as long as the problems of the present invention can be solved. .

(1) Test Samples The following were used as test samples shown in Tables 1 to 3 below.
(1-1) α-amylase: A commercially available powdered enzyme preparation (starch degradation potency: ~30 units/mg) was used.
Papain: Commercially available papaya extract powder (proteolytic titer: 90,000 units/g) extracted from immature papaya seeds was used.
(1-2) The following powder was used as the fruit component.
・Pineapple: dry powder of extract obtained by extracting pineapple fruit with water-containing ethanol, containing ceramide) was used.
- Strawberry: A commercially available dry powder (spray dry) of concentrated strawberry juice was used.
- Mango: A dry powder of mango puree was used.
- Melon: A dry powder obtained by extracting a commercially available melon placenta with hot water was used.
・Apple flavor: A commercially available apple flavor (including the flavor described in the List of Natural Flavor Source Substances (Appended Additives 2-2) and the flavor described in the Ordinance for Enforcement of the Food Sanitation Act (Appended Table 1)) was used.
・Banana flavor: A commercially available banana flavor (including the flavor described in the list of natural flavor base substances (attachment Additives 2-2) and the flavor described in the Ordinance for Enforcement of the Food Sanitation Act (Appended Table 1)) was used.
・Mango flavor: A commercially available mango flavor (including the flavor described in the List of Natural Flavor Source Substances (Appended Additives 2-2) and the flavor described in the Ordinance for Enforcement of the Food Sanitation Act (Appended Table 1)) was used.
- Lactose: A commercially available dry powder was used.
- Reduced maltose: A commercially available dry powder was used.
- Spore-bearing lactic acid bacteria: A dry powder in the state of spores before germination of commercially available Bacillus coagulans was used.
- Lactic acid bacteria (killed bacteria): A commercially available dry powder of killed bacteria of the scientific name Enterococcus faecalis was used for α-amylase activity measurement. For protease activity measurement, an aqueous extract of killed bacteria of the scientific name Enterococcus faecalis (a dry powder of killed bacteria was extracted with water for 16 hours, centrifuged, and the supernatant was lyophilized to a dry powder) or ethanol extraction. (The dry powder of killed bacteria was extracted with ethanol (50% or 100%) for 16 hours, and after centrifugation, the supernatant was lyophilized to dry powder).

(2) Examples 1-11, Comparative Examples 1-12
It was demonstrated as follows that a composition in which processed fruit products or flavors, sugars or lactic acid bacteria are combined with α-amylase, which is a digestive enzyme, markedly improves amylolytic enzyme activity.

<Measurement of α-amylase activity>
(2-1) Sample Preparation Acetic acid and sodium acetate were dissolved in water to prepare a pH 5 20 mM acetate buffer at room temperature. 0.5 mg/ml of starch (Wako Pure Chemical Industries: 191-03985) was dissolved in the prepared 20 mM acetate buffer to prepare a starch solution.
After dissolving potassium iodide in 1M hydrochloric acid to a concentration of 1 mg/ml, iodine was dissolved to a concentration of 0.1 mg/ml to prepare an iodine solution.
A test sample solution was prepared by dispersing or dissolving the test sample shown in Table 1 below in the 20 mM acetate buffer so as to have the concentration shown in Table 1.

(2-2) Calibration curve Using 20 mM acetate buffer and 0.5 mg/ml starch solution, the starch concentration was 0 mg/ml, 0.06 mg/ml, 0.125 mg/ml, 0.25 mg/ml and 0 A starch solution adjusted to each concentration of 5 mg/ml was prepared. 125 μl of 20 mM acetate buffer and 125 μl of iodine solution were sequentially added to 1 ml of starch solution of each concentration, and absorbance at 620 nm was measured to prepare a calibration curve.

(2-3) Measurement of starch decomposition potency 1 ml of 0.5 mg/ml starch solution was kept at 30° C., 125 μl of the test substance solution prepared in (2-1) was added to initiate the reaction, and after 20 minutes the iodine solution was added. was added and mixed well to prepare a solution for 20 minutes of enzymatic reaction.
Separately, 125 μl of the iodine solution and 125 μl of the test substance solution were sequentially added to 1 ml of the 0.5 mg/ml starch solution and mixed well to obtain a solution with no enzyme reaction. Absorbance at 620 nm was measured for each of the solution after 0 minutes of enzyme reaction and the solution after 20 minutes of enzyme reaction.
Based on the calibration curve obtained in (2-2), the starch equivalent value digested by the test sample was calculated from the absorbance difference Δ between 0 minutes and 20 minutes of the enzymatic reaction.
Regarding the obtained starch equivalent value, a relative value was obtained when the value of α-amylase alone (Comparative Example 1) was taken as 100%, and the starch decomposition potency (relative value) was obtained. The results are shown in Table 1 below. In the table below, O indicates that the test sample solution prepared in (2-1) above contained the test sample described in the left column at the concentration described in the same table (in Table 2 below, as well).

As shown in Table 1 above, according to Comparative Examples 2 to 12 using only fruit components, carbohydrates or lactic acid bacteria, the starch degradation potency is significantly higher than that of Comparative Example 1 using α-amylase alone. On the other hand, in each example in which a fruit component, sugar or lactic acid bacterium and α-amylase were combined, the total starch decomposition potency of each fruit component, sugar or lactic acid bacterium alone, and α-amylase alone significantly higher amylolytic titers were obtained. Therefore, it can be seen that the oral composition of the present invention in which processed fruit or flavor, sugar or lactic acid bacteria and α-amylase are combined has an excellent effect of improving amylolytic enzyme activity.

(3) Examples 12-31, Comparative Examples 13-26
It was demonstrated as follows that specific fruit components, sugars or lactic acid bacteria significantly improve protease activity, which is a digestive enzyme.

<Measurement of protease activity>
(3-1) Preparation of tyrosine calibration curve After drying tyrosine at 105°C for 3 hours, 0.100 g was accurately weighed, dissolved by adding 0.2N hydrochloric acid, and made exactly 100 µl, and used as a tyrosine standard. solution. 100 μl of this tyrosine standard solution was accurately weighed, diluted to 5 ml with 0.2N hydrochloric acid (20 μg/ml), diluted to concentrations of 15 μg/ml, 10 μg/ml and 5 μg/ml to prepare calibration test solutions.

500 μl of 0.55 M sodium carbonate and 100 μl of Foline reagent were added to 200 μl of each solution of 0.2N hydrochloric acid and calibration test solution, and incubated at 37° C. for 30 minutes. Here, the Foline reagent was prepared by dissolving 5 g of sodium tungstate and 1 g of phosphomolybdic acid in 50 ml of pure water, adding 2.5 ml of phosphoric acid, extracting under reflux, and diluting up to 200 mL. The test was performed with 2 replicates.

200 μl each was transferred to a 96-well plate, and the respective absorbances A ₀ , A ₁ , A ₂ , A ₃ and A ₄ at 660 nm were measured. Here, the tyrosine concentrations of A ₀ , A ₁ , A ₂ , A ₃ and A ₄ are 0, 5, 10, 15 and 20 μg/ml respectively.

Regarding the measured values, a calibration curve was prepared by plotting the absorbance difference (A _n -A ₀ ) on the vertical axis and the tyrosine concentration (μg/ml) of each solution on the horizontal axis. The amount of tyrosine ([F] μg/ml) for an absorbance difference of 1.000 was calculated from the obtained calibration curve.

(3-2) Measurement of proteolytic titer A casein solution was prepared as follows. That is, about 1 g of casein (derived from bovine milk (Hammersten formulation); Wako Pure Chemical Industries, Ltd.) was precisely weighed, incubated at 105° C. for 2 hours, and then the dry mass was measured. 1.20 g of the dried casein obtained was precisely weighed, 160 ml of an aqueous solution of 0.05 M disodium monohydrogen phosphate was added, and dissolved by heating in a water bath at 40° C. for about 15 minutes. A casein solution was prepared by adjusting the pH to 7.5 using 1M hydrochloric acid and making up to 200 ml with ultrapure water.

A protein precipitation solution was prepared containing 0.11 M trichloroacetic acid, 0.22 M sodium acetate and 0.33 M acetic acid in ultrapure water as the solvent.

As an enzyme diluent solution, a solution containing 0.01 M NaCl, 0.002 M calcium acetate and 0.002 M calcium sulfate was prepared using ultrapure water as the solvent.

A test sample solution was prepared by dissolving the test sample shown in Table 2 below in 1 ml of the above diluted enzyme solution so as to have the concentration shown in Table 2.

500 μl of casein solution was incubated at 37° C. for 10 minutes, 100 μl of test sample solution was added and immediately shaken. The resulting solution was incubated at 37° C. for 10 minutes (pH in solution at incubation=6.0). After adding 500 μl of protein precipitation solution and incubating at 37° C. for 30 minutes, centrifugation was performed at 10,000 rpm for 3 minutes at room temperature.

In addition, as a blank, 500 μl of the protein precipitation solution was added to 100 μl of the test sample solution, mixed, and then 500 μl of the casein solution was added to prepare a blank. Centrifuged.

500 μl of 0.55 M sodium carbonate and 100 μl of Foline reagent were added to 200 μl of the centrifugation supernatant and incubated at 37° C. for 30 minutes. 200 μL of the incubated solution was transferred to a 96-well plate, and the absorbance (A _T ) at 660 nm was measured. Also, the absorbance in the blank was defined as A _B .

Based on the absorbance obtained, the proteolytic titer was calculated using the following formula:
Proteolytic potency (unit/g) = (A _T - A _B ) x F x (amount of reaction solution) x (1/10) x (1/W)
F: Amount of tyrosine (μg/ml) when the absorbance difference obtained from the tyrosine calibration curve is 1.000
Reaction solution: casein solution + test sample solution + protein precipitation solution W: amount of sample in reaction solution (g)

Tables 2 and 3 show relative values of the proteolytic potencies of the compositions of Examples and Comparative Examples relative to papain when the proteolytic potency of Comparative Example 13 is taken as 100%. In addition, the above water extract is used as the spore-forming lactic acid bacteria and lactic acid bacteria (dead bacteria) (1) in Table 3, and the above 50% ethanol extract is used as the lactic acid bacteria (dead bacteria) (2). Killed bacteria) As (3) to (5), the above 100% ethanol extract was used in varying amounts.

As shown in Tables 2 and 3 above, according to Comparative Examples 14 to 26 using only fruit components, carbohydrates or lactic acid bacteria, the proteolytic potency was significantly higher than that of Comparative Example 13 using papain alone. However, in each example in which the fruit component, carbohydrate or lactic acid bacterium and papain were combined, the proteolytic potency of the fruit component, carbohydrate or lactic acid bacterium alone in Comparative Examples 14 to 26, and the proteolytic potency of Comparative Example 13 A much higher proteolytic titer was obtained than the total proteolytic titer for papain alone.
Therefore, it can be seen that the protease activity-enhancing effect of the composition for oral use of the present invention in which the fruit component, sugar or lactic acid bacteria and protease are combined is excellent.

References:
(1) Activity measurement method according to Notification No. 523 of the Central Pharmaceutical Affairs Council; study of protein digestive activity measurement method for protease and papain preparations for food production Appendix 2) ~Antacid and pH test methods and digestive power test methods for gastrointestinal drugs and their explanations~

<Production Examples 1 to 11>
Powdered beverages containing α-amylase and processed fruits or flavors were produced according to the formulations shown in Table 4 below.

<Production Examples 12 to 22>
Granules containing α-amylase and processed fruit or flavor were produced according to the formulations shown in Table 5 below.

<Production Examples 23 to 33>
Powdered beverages containing proteases and processed fruits or flavors were produced according to the formulations shown in Table 6 below.

<Production Examples 34 to 44>
Powdered beverages containing proteases and processed fruits or flavors were produced according to the formulations shown in Table 7 below.

INDUSTRIAL APPLICABILITY According to the present invention, an oral composition having high digestive enzyme activity such as α-amylase and protease can be obtained. It can be used as food and drink, food and drink with health functions, food and drink for special purposes, nutritional supplement food and drink, health supplement food and drink, supplements, beauty food and drink, other health food and drink, quasi-drugs, cosmetics, and pharmaceuticals.

Claims (1)

A dietary oral composition containing amylase and Bacillus coagulans (excluding replacement diet food).