KR20240127428A - Oral compositions and soft capsules - Google Patents

Abstract

The object of the present invention is to provide an oral composition comprising ergothioneine or a salt thereof and a fat, which is difficult to separate and is uniform. The present invention is an oral composition comprising ergothioneine or a salt thereof, a fat, and an emulsifier having HLB of 10 or less, wherein the emulsifier comprises a polyhydric alcohol fatty acid ester containing a saturated fatty acid having 12 to 22 carbon atoms as a constituent fatty acid, and wherein the fat contains 10 wt% or more.

Description

Oral compositions and soft capsules

The present invention relates to an oral composition containing ergothioneine or a salt thereof, a fat and an emulsifier. The present invention also relates to a soft capsule containing the oral composition.

Soft capsules containing a non-oily soluble active ingredient are generally manufactured by dispersing the active ingredient in an edible fat and filling the dispersion prepared by dispersing the active ingredient in the edible fat and filling it into a capsule using gelatin as a shell. In order to uniformly disperse the active ingredient in the edible fat and fat, a liquid composition for filling a soft capsule has been proposed in which a non-oily soluble active ingredient is dispersed in the edible fat and fat by combining a plurality of types of emulsifiers such as a reactive monoglyceride or a distilled monoglyceride (see Patent Document 1).

Patent Document 1: Japanese Patent No. 5405242

Ergothioneine is a sulfur-containing amino acid that is poorly oil-soluble and has various physiological activities including antioxidant action, so food such as supplements containing ergothioneine or its salts are useful for maintaining or improving health. However, since ergothioneine is poorly oil-soluble, there is a problem that separation easily occurs in a composition containing oil and ergothioneine, and there is room for improvement. If a composition containing an effective ingredient is separated, the appearance of the product is undesirable, and there is a problem that it is difficult to precisely mix a desired amount of the effective ingredient into the product.

An object of the present invention is to provide an oral composition comprising ergothioneine or a salt and fat thereof, which is difficult to separate and is uniform.

The present invention includes the following oral compositions.

〔1〕 An oral composition comprising ergothioneine or a salt thereof, fat and an emulsifier having an HLB of 10 or less, wherein the emulsifier comprises a polyhydric alcohol fatty acid ester containing a saturated fatty acid having 12 to 22 carbon atoms as a constituent fatty acid, and wherein the fat content is 10 wt% or more.

〔2〕 The oral composition described in 〔1〕, wherein the polyhydric alcohol fatty acid ester is at least one selected from the group consisting of glycerin fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, and sucrose fatty acid ester.

〔3〕 An oral composition as described in 〔1〕 or 〔2〕, wherein the saturated fatty acid has 12 to 18 carbon atoms.

〔4〕 An oral composition according to any one of 〔1〕 to 〔3〕, wherein the content of the emulsifier is 1 to 30 wt%.

〔5〕 An oral composition according to any one of the above 〔1〕 to 〔4〕 for filling soft capsules.

〔6〕 A soft capsule having a capsule film and a content including the oral composition described in any one of 〔1〕 to 〔5〕 above.

According to the present invention, an oral composition comprising ergothioneine or a salt and fat thereof, which is difficult to separate and is uniform can be provided.

The oral composition of the present invention contains ergothioneine or a salt thereof, fat and oil, and an emulsifier having HLB of 10 or less.

Ergothioneine is a type of sulfur-containing amino acid. In the present invention, ergothioneine is preferably L-ergothioneine.

The salt of ergothioneine is not particularly limited as long as it is a pharmacologically acceptable salt or a salt acceptable for foodstuffs, and may be either an acidic salt or a basic salt. As the acidic salt, for example, inorganic salts such as hydrochloride, sulfate, nitrate, and phosphate; organic salts such as acetate, citrate, maleate, malate, oxalate, lactate, succinate, fumarate, and propionate; and the like. As the basic salt, for example, alkali metal salts such as sodium salt and potassium salt; alkaline earth metal salts such as calcium salt and magnesium salt; and the like.

Ergothioneine or its salt is not limited at all by its form or manufacturing method, etc. Ergothioneine or its salt may be a chemically synthesized product or may be extracted and purified from a natural product. L-ergothioneine is contained in large quantities in the Golden/Yellow Oyster Mushroom (scientific name: Pleurotus cornucopiae var. citrinopileatus ), a mushroom of the Oyster genus in the Oyster family. L-Ergothioneine is found in many mushrooms, including button mushrooms, cremini mushrooms, and portabella mushrooms ( Agaricus bisporus ), grey oyster mushrooms ( Pleurotus ostreatus ), shiitake mushrooms ( Lentinula edodes ), maitake mushrooms ( Grifola frondosa ), reishi mushrooms ( Ganoderma lucidum ), truffles ( Hericium erinaceus ), and truffles ( Agrocybe aegerita ). ), chanterelle (scientific name: Cantharellus cibarius ), porcini (scientific name: Boletus edulis ), and morel (scientific name: Morchella esculenta ). When obtaining L-ergothioneine from natural products, extraction from yellow oyster mushrooms, etc. is preferable. Ergothioneine or a salt thereof can also be produced by microbial fermentation. Ergothioneine or a salt thereof may be isolated.

The content of ergothioneine or its salt included in the oral composition of the present invention is not particularly limited and can be set depending on its form, etc.

The content of ergothioneine or a salt thereof in the oral composition of the present invention is, in terms of ergothioneine, preferably 0.01 wt% or more, more preferably 0.1 wt% or more, and further preferably 10 wt% or less, and still more preferably 5 wt% or less. In one embodiment, the content of ergothioneine or a salt thereof is, in terms of ergothioneine, preferably 0.01 to 10 wt%, more preferably 0.1 to 10 wt%, and still more preferably 0.1 to 5 wt%. When the content of ergothioneine or a salt thereof is in the above range, separation of the oral composition of the present invention is suppressed. Furthermore, the oral composition of the present invention can efficiently exhibit the physiological function of ergothioneine or a salt thereof.

In this specification, the expression “the amount of ergothioneine equivalent” or a similar expression means, in the case of ergothioneine, the amount, and, in the case of a salt of ergothioneine, the value obtained by multiplying the number of moles of the salt by the molecular weight of ergothioneine.

The content of ergothioneine can be measured by high-performance liquid chromatography (HPLC).

The fat included in the oral composition of the present invention is not particularly limited as long as it is fat that can be orally consumed by humans, and examples thereof include edible fats and oils that are liquid at room temperature (25°C). Such edible fats and oils include, for example, vegetable fats and oils such as olive oil, sesame oil, rice germ oil, safflower oil, soybean oil, corn oil, rapeseed oil, palm oil, palm olein, palm kernel oil, sunflower oil, grape oil, cottonseed oil, coconut oil, and peanut oil; medium-chain fatty acid triglycerides, squalene, and fish oil. Fish oil contains many compounds such as triglycerides (fat and oil) that include omega-3 fatty acids such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) as constituent fatty acids. For example, as fish oil, a DHA-containing fat that is concentrated so that the content of a compound that includes DHA as a constituent fatty acid is 40 wt% or more, or 50 wt% or more, in terms of DHA, may be used.

The amount of docosahexaenoic acid equivalent or a similar expression means the amount converted to free DHA by liberating DHA from a compound containing DHA as a constituent fatty acid through saponification or enzymatic treatment.

In the oral composition of the present invention, one type of these maintenance agents may be used, or two or more types may be used in any combination.

The content of the fat in the oral composition of the present invention is 10 wt% or more with respect to the total amount of the composition. When the content of the fat is in the above range, the oral composition of the present invention is difficult to separate, and the composition becomes uniform. The content of the fat in the oral composition can be appropriately set depending on the use and form, and may be, for example, 30 wt% or more, or 50 wt% or more. Furthermore, it may be, for example, 99 wt% or less, 98 wt% or less, or 90 wt% or less. In one embodiment, the content of the fat in the oral composition of the present invention may be 10 to 99 wt%, 30 to 98 wt%, or 50 to 90 wt%. When the oral composition of the present invention is liquid, the content of the fat may be, for example, 40 wt% or more, or 50 wt% or more. In addition, for example, it may be 99 wt% or less, 98 wt% or less, or 90 wt% or less. When the oral composition of the present invention is liquid, in one embodiment, the content of the oil may be 40 to 99 wt%, or 50 to 98 wt% in the oral composition of the present invention.

The composition and content of oil can be measured by gas chromatography (GC).

The emulsifier included in the oral composition of the present invention has an HLB of 10 or less. When the HLB of the emulsifier is 10 or less, the oral composition of the present invention is difficult to separate and becomes uniform. Here, HLB is an index indicating the degree of hydrophilicity and lipophilicity of the emulsifier calculated by the Griffin method, and the lower the HLB, the higher the lipophilicity, and the higher the HLB, the higher the hydrophilicity. The HLB of the emulsifier is preferably 3 or more and 10 or less.

The above emulsifier contains a polyhydric alcohol fatty acid ester having a saturated fatty acid having 12 to 22 carbon atoms as a constituent fatty acid. When the emulsifier contains a polyhydric alcohol fatty acid ester having a saturated fatty acid having 12 to 22 carbon atoms as a constituent fatty acid, the oral composition is less likely to separate, becomes uniform, and the solubility of ergothioneine or a salt thereof contained in the oral composition in water increases. When the solubility of ergothioneine or a salt thereof contained in the oral composition in water increases, it is thought that the solubility of ergothioneine or a salt thereof in the body is good when the oral composition is ingested.

It is preferable that the emulsifier used in the oral composition of the present invention is not a polyhydric alcohol fatty acid ester whose main component includes an unsaturated fatty acid as a constituent fatty acid.

As the polyhydric alcohol fatty acid ester, at least one selected from the group consisting of glycerin fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, and sucrose fatty acid ester is preferable. As the polyhydric alcohol fatty acid ester, any compound having a monoester, diester, or higher ester bond may be used.

Glycerin fatty acid esters include monoglycerides in which one fatty acid is bonded to glycerin, diglycerides in which two fatty acids are bonded to glycerin, and may also be organic acid monoglycerides in which an organic acid is further bonded to the hydroxyl group of the monoglyceride. Examples of the organic acids include acetic acid, lactic acid, citric acid, succinic acid, diacetyltartaric acid, etc. Glycerin fatty acid esters may contain a small amount of triglycerides in which three fatty acids are bonded to glycerin, but in this specification, triglycerides in which three fatty acids are bonded to glycerin are treated as fats and oils when calculating the content.

The average degree of polymerization of glycerin constituting the polyglycerin fatty acid ester is not particularly limited, and is usually 2 or more and 10 or less.

Since the oral composition of the present invention is difficult to separate, glycerin fatty acid ester and polyglycerin fatty acid ester are preferable as the emulsifier.

As saturated fatty acids having 12 to 22 carbon atoms, examples thereof include lauric acid, myristic acid, pentadecyl acid, palmitic acid, margaric acid, stearic acid, arachidic acid, and behenic acid. It is preferable that the emulsifier contains a polyhydric alcohol fatty acid ester containing a saturated fatty acid having 12 to 18 carbon atoms as a constituent fatty acid. The saturated fatty acid having 12 to 22 carbon atoms is preferably lauric acid and stearic acid.

Specific examples of polyhydric alcohol fatty acid esters containing a saturated fatty acid having 12 to 22 carbon atoms in the constituent fatty acids include glycerin fatty acid esters such as lauric acid monoglyceride, palmitic acid monoglyceride, stearic acid monoglyceride, behenic acid monoglyceride, monostearic acid diglyceride, behenic acid diglyceride, lactic acid monostearic acid glycerin, and succinic acid monostearic acid glycerin; polyglycerin fatty acid esters such as hexastearic acid pentaglycerin, decastearic acid decaglycerin, and pentastearic acid decaglycerin; propylene glycol fatty acid esters such as monolauric acid propylene glycol, monopalmitic acid propylene glycol, monostearic acid propylene glycol, and monobehenic acid propylene glycol; sorbitan fatty acid esters such as sorbitan monostearate; Examples thereof include sucrose fatty acid esters such as sucrose stearate. Among these, since the oral composition of the present invention is difficult to separate and becomes uniform, as the polyhydric alcohol fatty acid ester, stearic acid monoglyceride, behenic acid monoglyceride, monostearic acid diglyceride, behenic acid diglyceride, lactate monostearate glycerin, succinate monostearate glycerin, decastearate decaglycerin, pentastearate decaglycerin, and sorbitan monostearate are preferable.

The above emulsifier may contain one or more types of the polyhydric alcohol fatty acid ester. When the above emulsifier contains two or more types of the polyhydric alcohol fatty acid ester, the combination is not particularly limited. However, for example, when it contains two or more types of polyhydric alcohol fatty acid esters having different carbon numbers of constituent fatty acids, the oral composition of the present invention becomes less likely to separate and more uniform.

The above emulsifier contains, as a main component, a polyhydric alcohol fatty acid ester containing a saturated fatty acid having 12 to 22 carbon atoms in the constituent fatty acids, and it is preferable that the emulsifier contains 60 wt% or more of the polyhydric alcohol fatty acid ester. The content of the polyhydric alcohol fatty acid ester in the emulsifier is more preferably 80 wt% or more, and even more preferably 90 wt% or more.

The above emulsifier may contain other components as long as the effects of the present invention are not impaired. As other components, for example, a polyhydric alcohol fatty acid ester containing a saturated fatty acid having 11 or less carbon atoms as a constituent fatty acid, a polyhydric alcohol fatty acid ester containing an unsaturated fatty acid having 12 to 22 carbon atoms as a constituent fatty acid, etc. In one embodiment, it is preferable that the above emulsifier does not contain a polyhydric alcohol fatty acid ester containing an unsaturated fatty acid as a constituent fatty acid.

The above emulsifier may be a commercial product or a synthetic product. The synthesis of a polyhydric alcohol fatty acid ester containing a saturated fatty acid having 12 to 22 carbon atoms in the constituent fatty acids can be carried out by a known method.

The content of the emulsifier having HLB 10 or less in the oral composition of the present invention is preferably 1 wt% or more, more preferably 3 wt% or more, and even more preferably 5 wt% or more, with respect to the total amount of the composition. Furthermore, it is preferably 30 wt% or less, and even more preferably 25 wt% or less. In one embodiment, the content of the emulsifier in the oral composition of the present invention is preferably 1 to 30 wt%, more preferably 3 to 25 wt%, and even more preferably 5 to 25 wt%.

The content of emulsifier can be measured by GC or HPLC.

The form of the oral composition of the present invention is not particularly limited, and may be in the form of a solid (powder, granule, tablet, etc.), a liquid, a paste, etc. The oral composition of the present invention is preferably in the form of a liquid at 25°C. The oral composition of the present invention is preferably a composition in which ergothioneine or a salt thereof is uniformly dispersed in the oil.

Ergothioneine or its salt is a compound that is contained in natural products or foods and has a history of being consumed. Therefore, from a safety perspective, ergothioneine or its salt is thought to have few problems even when consumed daily, for example. According to the present invention, an oral composition that is highly safe and easy to consume can be provided.

Ergothioneine or its salts, as described above, are known to exhibit various physiological activities or health functions, for example, antioxidant effects, brain function improvement effects, anti-aging effects, eye disease improvement effects, whitening effects, ultraviolet ray absorption effects, melanin production inhibition effects, active oxygen species scavenging effects, elastase activity inhibition effects, wrinkle formation inhibition effects, skin sagging inhibition effects, and autophagy promotion effects.

For this reason, the oral composition of the present invention can be suitably used for antioxidation, brain function improvement, anti-aging, eye disease, whitening, ultraviolet ray absorption, inhibition of melanin production, scavenging of active oxygen species, inhibition of elastase activity, inhibition of wrinkle formation, inhibition of skin sagging, promotion of autophagy, etc.

The oral composition of the present invention can be applied to either therapeutic purposes (medical purposes) or non-therapeutic purposes (non-medical purposes). Non-therapeutic means a concept that does not include medical practices, i.e., surgery, treatment or diagnosis of a human being.

The oral composition of the present invention can be in the form of food, medicine, quasi-drug, feed, etc. The oral composition of the present invention may also be a material or preparation used by mixing it into food, medicine, quasi-drug, feed, etc.

Specific examples of the oral composition of the present invention include, for example, foods, oral pharmaceuticals, quasi-drugs, feeds, etc., preferably foods or oral pharmaceuticals, and more preferably foods.

The oral composition of the present invention may contain, in addition to ergothioneine or a salt thereof, the above-mentioned oil and emulsifier, any additives and any components, as long as the effects of the present invention are not impaired. These additives and components can be selected according to the form of the oral composition, etc., and those that can generally be used in oral compositions such as foods, drugs, quasi-drugs, and feeds can be used. When the oral composition of the present invention is used as foods, drugs, quasi-drugs, and feeds, the production method thereof is not particularly limited, and can be produced by a general method.

For example, when the oral composition of the present invention is made into a food or beverage, various foods or beverages can be made by blending ergothioneine or a salt thereof, the oil and the emulsifier, and ingredients usable in foods or beverages (e.g., food materials, food additives used as needed, etc.). The foods or beverages are not particularly limited, and examples thereof include general foods, health foods, health supplements, health drinks, foods with functional claims, foods for specific health purposes, foods for the sick, etc. The health foods, health supplements, foods with functional claims, foods for specific health purposes, etc. can be used in various formulation forms, such as granules, tablets, granules, powders, capsules, soft capsules, chewables, dry syrups, syrups, liquids, beverages, drinks, and liquids.

When the oral composition of the present invention is used as a medicine or a quasi-drug, for example, ergothioneine or a salt thereof, the oil and the emulsifier, a pharmacologically acceptable carrier, additives added as needed, etc. can be added to form various dosage forms of a medicine or a quasi-drug. Such carriers, additives, etc. may be any pharmacologically acceptable carrier that can be used in a medicine or a quasi-drug, and examples thereof include one or two or more of excipients, binders, disintegrants, lubricants, antioxidants, and colorants. Dosage forms for oral administration of a medicine or a quasi-drug include liquids, tablets, powders, granules, granules, sugar-coated tablets, capsules, soft capsules, suspensions, emulsions, and chewable agents.

When the oral composition of the present invention is used as a feed, a mixture of ergothioneine or a salt thereof, the above-mentioned oil and emulsifier may be added to the feed. The feed also includes a feed additive. Examples of the feed include livestock feed for cattle, pigs, chickens, sheep, horses, etc.; small animal feed for rabbits, rats, mice, etc.; pet food for dogs, cats, small birds, etc.

The subject to which the oral composition of the present invention is ingested or administered (may also be referred to as the administration subject) is not particularly limited. It is preferably a human or a non-human mammal, and more preferably a human.

The oral composition of the present invention preferably has an ergothioneine or salt content of 1 to 100 mg, more preferably 2 to 50 mg, still more preferably 5 to 25 mg, and particularly preferably 5 to 20 mg in terms of ergothioneine per daily intake for an adult.

The oral composition of the present invention is preferable as a product appearance because it is difficult to separate and is uniform, and it is easy to precisely mix a desired amount of ergothioneine or a salt thereof into the product.

<Method for preparing oral composition>

The oral composition of the present invention can be prepared by mixing and stirring ergothioneine or a salt thereof, the fat and the emulsifier. Preferably, for example, the fat and the emulsifier are heated to about 60 to 80° C., mixed and stirred, and then ergothioneine or a salt thereof is added and mixed and stirred. In addition, the emulsifier can be used in advance, heated or melted. There is no particular limitation on the device for mixing and stirring, but for example, a high-speed stirrer or a high-speed grinder such as a biomixer, a homogenizer, and a colloid mill can be used.

The oral composition of the present invention can be suitably used as the contents of a soft capsule. The oral composition of the present invention is suitable, for example, as a composition for filling a soft capsule.

<Soft capsule>

The present invention also provides a soft capsule having a capsule film and a content including the oral composition.

The soft capsule of the present invention is filled with contents including the oral composition in a soft capsule formed by a capsule shell. The contents may include the oral composition. As a base material forming the capsule shell (hereinafter, also simply referred to as a shell), a base material generally used for capsule shells can be employed.

<Method for manufacturing soft capsules>

The prepared oral composition can be made into a soft capsule, for example, using a known soft capsule molding machine in a heated state. There are no special restrictions on the production of the soft capsule, and it can be produced according to the production conditions of the soft capsule sealing device.

In this specification, the numerical range indicated by the lower limit and the upper limit, that is, "lower limit - upper limit" includes these lower limit and upper limit. For example, the range indicated by "1 - 2" means 1 or more and 2 or less, and includes 1 and 2. In this specification, the upper limit and the lower limit may be a range by any combination.

Example

Hereinafter, the present invention will be described more specifically based on examples. Furthermore, the present invention is not limited to these examples.

Examples 1 to 10, Comparative Examples 1 to 10

<Production and Separability of Composition>

A mixture of the emulsifier shown in Table 1 and the fat below was placed in a transparent polypropylene tube, heated to 70°C to dissolve the emulsifier, 125 mg of L-ergothioneine was added as ergothioneine, and allowed to cool while mixing and stirring so that the entire mixture became uniform, thereby obtaining a composition. The fat was any one of safflower oil, DHA-containing fat and oil, and rice germ oil. That is, in Example 1, a composition 1-1 including ergothioneine, safflower oil, and emulsifier 1, a composition 1-2 including ergothioneine, DHA-containing fat and oil, and emulsifier 1, and a composition 1-3 including ergothioneine, rice germ oil, and emulsifier 1 were prepared. For Examples 2 to 10 and Comparative Examples 1 to 10, three compositions using different types of fat were prepared in each example, similarly to Example 1. The mixing ratio of emulsifier and fat was 1050 mg of emulsifier and 9325 mg of fat when the fat was safflower oil (total of ergothioneine, emulsifier, and fat 10500 mg). When the fat was DHA-containing fat and rice germ oil, the mixing ratio of emulsifier and fat was 1575 mg of emulsifier and 8800 mg of fat (total of ergothioneine, emulsifier, and fat 10500 mg).

Ergothioneine: L-Ergothioneine (synthetic)

DHA-containing oil: Oil containing a compound containing docosahexaenoic acid as a constituent fatty acid, in an amount of 40% or more by weight in terms of docosahexaenoic acid

After cooling, the presence or absence of separation of each composition was visually confirmed for each composition in the polypropylene tube. A composition in which separation was not confirmed was marked as “○”, a composition in which separation was slightly confirmed was marked as “△”, and a composition that was completely separated was marked as “×”. The results are shown in Table 1.

The “number of unsaturated bonds” in Table 1 indicates the number of double bonds possessed by the main constituent fatty acid of the polyhydric alcohol fatty acid ester contained in the emulsifier.

In addition, “carbon number and content of main constituent fatty acids” indicates the carbon number of the fatty acid with the largest content among the constituent fatty acids of the polyhydric alcohol fatty acid ester included in the emulsifier and its content ratio.

In the compositions of Examples 1 to 10, separation of the compositions was suppressed or almost suppressed, regardless of whether safflower oil, DHA-containing fat, or rice germ oil was used. In Comparative Examples 1 and 5, the constituent fatty acids of emulsifiers 11 and 15 had less than 12 carbon atoms, in Comparative Examples 2 to 4, 6, and 10, emulsifiers 12 to 14, 16, and 20 contained unsaturated fatty acids in the constituent fatty acids, and in Comparative Examples 7 to 10, emulsifiers 17 to 20 having an HLB value exceeding 10 were used. In Comparative Examples 1 to 10, the compositions were completely separated regardless of whether any one of safflower oil, DHA-containing fat, or rice germ oil was used, or regardless of whether any fat was used.

<Solubility of the composition in water>

Next, among the compositions of Examples 1 to 10 and Comparative Examples 7 and 8, the compositions whose separation evaluation was “○” or “△” were dispersed in pure water, and the water solubility of ergothioneine was confirmed in the following order. If the water solubility is good, it is considered that the ergothioneine solubility in the body is good when the composition is taken orally.

Each composition (168 mg) was weighed into a 50 mL tube, and 40 mL of pure water was added. The composition was dispersed in the pure water by ultrasonic treatment for 60 minutes in a water bath at 30 to 40° C. After initiating the ultrasonic treatment, 1 mL of the supernatant of the dispersion was weighed and taken 60 minutes later, and centrifuged at 15,000 rpm for 3 minutes. The centrifuged supernatant was filtered through a 0.45 μm filter, and the filtrate was used as a measurement sample. The measurement sample was subjected to HPLC analysis under the following conditions. From the concentration of ergothioneine obtained by HPLC, the water dissolution rate of ergothioneine contained in the composition was calculated by using the following formula. The results are shown in Table 2. When the dissolution rate 60 minutes after initiating the ultrasonic treatment was 60% or more, the composition was said to have excellent water dissolution properties.

[HPLC analysis conditions]

HPLC device: LC-20AD (trade name), manufactured by Shimadzu Seisakusho

Analysis Column: CAPCELL PAK C18 TYPE AQ (trade name), 4.6mm I.D.×150mm, manufactured by Osaka Soda

Mobile phase: 0.1% acetic acid aqueous solution

Analysis time: 10 min

Initial pressure: 5.8 MPa

Column temperature: 30℃

Flow rate: 1.0 mL/min

Injection volume: 10 μL

Detection: 254 nm

[Formula 1]

The compositions of Examples 1 to 10 showed excellent water solubility of ergothioneine. In particular, Examples 6 and 7 in which the emulsifier was lauric acid monoglyceride showed extremely excellent water solubility of ergothioneine in any of the fats and oils, safflower oil, DHA-containing fat and oil, and rice germ oil. In addition, when the fat and oil was safflower oil, the compositions of Examples 1 and 8 using an emulsifier including two kinds of polyhydric alcohol fatty acid esters having different carbon numbers of constituent fatty acids showed extremely excellent water solubility of ergothioneine. In addition, when the fat and oil was DHA-containing fat or rice germ oil, the compositions of Examples 6, 7, 9, and 10 using an emulsifier in which the polyhydric alcohol fatty acid ester was lauric acid monoglyceride or organic acid monoglyceride showed extremely excellent water solubility of ergothioneine.

Comparative Examples 7 and 8 showed lower solubility of ergothioneine in water compared to the composition of the example.

Claims (6)

Containing ergothioneine or its salt, fat and emulsifier having HLB of 10 or less,
The above emulsifier comprises a polyhydric alcohol fatty acid ester containing a saturated fatty acid having 12 to 22 carbon atoms in the constituent fatty acids,
An oral composition having a content of the above-mentioned maintenance agent of 10 wt% or more. An oral composition in claim 1, wherein the polyhydric alcohol fatty acid ester is at least one selected from the group consisting of glycerin fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, and sucrose fatty acid ester. An oral composition in claim 1, wherein the saturated fatty acid has 12 to 18 carbon atoms. An oral composition in claim 1, wherein the content of the emulsifier is 1 to 30 wt%. An oral composition for filling soft capsules in claim 1. A soft capsule having a capsule film and a content comprising an oral composition according to any one of claims 1 to 5.