Composition for improving unpleasant sensation in mouth and throat

Abstract

To provide a composition for improving unpleasant sensation in the mouth or throat.SOLUTION: Provided is a composition for improving unpleasant sensation in the mouth and / or throat, the composition comprising lactoferrin.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a composition for relieving discomfort in the mouth and throat. [Background technology]

[0002] Dryness in the mouth and throat is an unpleasant sensation caused by the dryness of the mucous membranes of the mouth and throat, and is often perceived as a thirst sensation. In addition, dryness in the mouth and throat can also cause other sensations such as difficulty in speaking and swallowing.

[0003] To alleviate the discomfort associated with dry mouth and throat, methods that involve spraying artificial saliva that has a composition similar to that of human saliva into the oral cavity, as well as the use of drugs that protect the mucous membrane or promote saliva secretion, are known.

[0004] Patent Document 1 discloses an upper respiratory tract protecting agent, which contains lactoferrin, lactoperoxidase, glucose oxidase, glucose source and pH adjusting component as active ingredients.It is described that this upper respiratory tract protecting agent has the effect of suppressing the discomfort such as dry upper respiratory tract mucosa, thirst and irritated throat during smoking, and suppressing the onset of cold symptoms.

[0005] Furthermore, Patent Document 2 discloses a bioadhesive patch for treating xerostomia. It is described that this agent treats xerostomia by increasing the amount of saliva.

[0006] However, there remains a need for further means for alleviating the discomfort associated with dry mouth and throat. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] WO2017 / 033616 [Patent Document 2] US20100247644A1 Summary of the Invention [Problem to be solved by the invention]

[0008] In view of the above circumstances, an object of the present invention is to provide a composition for relieving discomfort in the mouth and throat. [Means for solving the problem]

[0009] The present inventors have conducted extensive research to obtain a composition for improving discomfort in the mouth and throat. As a result, they have found that lactoferrin can improve discomfort in the mouth and throat. Based on this finding, they have completed the present invention.

[0010] That is, the gist of the present invention relates to the following. [1] A composition for improving discomfort in the mouth and / or throat, comprising lactoferrin. [2] The composition described in [1], wherein the lactoferrin content in the composition is 0.01% by mass or more. [3] The composition described in [1] or [2], wherein the composition does not contain lactoperoxidase. [4] The composition according to any one of [1] to [3] for improving discomfort in the mouth and / or throat in an environment with a relative humidity of 40% or less. [5] The composition described in any of [1] to [4], wherein the discomfort in the mouth and / or throat is a feeling of dry throat. [6] The composition according to any one of [1] to [5], wherein the throat is at least one selected from the group consisting of the pharynx, the larynx, the trachea, and the esophagus. [7] The composition according to any one of [1] to [6], wherein the improvement of the discomfort is achieved by increasing the wettability of saliva. Another aspect of the present invention relates to a composition for increasing the wettability of saliva, comprising lactoferrin. [8] The composition according to any one of [1] to [6], wherein the improvement of the discomfort is achieved by preventing evaporation of saliva. Another aspect of the present invention relates to a composition for preventing evaporation of saliva, comprising lactoferrin. [9] The composition according to any one of [1] to [8], which is a food or drink.

[0011] The present invention can also have the following aspects.

[10] A method for improving mouth and / or throat discomfort, comprising administering lactoferrin to a subject.

[11] The use of lactoferrin in improving mouth and / or throat discomfort.

[12] Use of lactoferrin in the manufacture of a composition for improving mouth and / or throat discomfort. Effect of the Invention

[0012] The present invention provides a safe and economical means for improving discomfort in the mouth and throat, using lactoferrin as an active ingredient. Lactoferrin has the effect of improving the wettability of saliva and inhibiting the evaporation of saliva, and is particularly effective in improving discomfort in the mouth and throat even in low humidity environments where secreted saliva evaporates quickly and is difficult to diffuse into the oral cavity. Lactoferrin is a type of milk protein and can be ingested as a food. In other words, the present invention has few side effects and is highly safe, so the amount and frequency of intake can be freely set, and it can be taken daily for a long period of time. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Hereinafter, the preferred embodiments of the present invention will be described. However, the present invention is not limited to the following preferred embodiments, and can be freely modified within the scope of the present invention.

[0014] As used herein, "amelioration" refers to the improvement of a disease, symptom or condition, the prevention, inhibition or delay of the worsening of a disease, symptom or condition, or the reversal, prevention, inhibition or delay of the progression of a disease, symptom or condition. Furthermore, as used herein, "prevention" refers to preventing, suppressing, or delaying the onset of a disease, symptom, or condition in an individual, or reducing the risk of an individual developing a disease, symptom, or condition.

[0015] Composition for relieving mouth and / or throat discomfort One aspect of the present invention relates to a composition for improving discomfort in the mouth and / or throat, comprising lactoferrin (hereinafter, may be referred to as "the composition of the present invention"). In another aspect, the present invention may be a composition for preventing or improving discomfort in the mouth and / or throat, comprising lactoferrin. Here, "discomfort in the mouth and / or throat" refers more specifically to, for example, discomfort caused by dryness of the mouth and / or throat.

[0016] <Lactoferrin> The composition of the present invention contains lactoferrin as an active ingredient. Lactoferrin is a type of milk protein that is a harmless, natural iron-binding protein (capable of binding two iron ions per molecule) that is also found in mammalian secretions such as milk, saliva, tears, and airway mucus.

[0017] The lactoferrin used in the present invention can be obtained from the milk of mammals such as humans, cows, horses, sheep, and goats, and may be produced by a conventional method. For example, lactoferrin produced by the following method using skim milk obtained by removing fat from cow's milk as a raw material is used, but is not limited thereto. That is, an ion exchanger (e.g., product name: CM-Sepharose FF) is packed in a column, and the ion exchanger is equilibrated by washing with water, and then skim milk cooled to 4°C is passed through the column, and the permeate is recovered and passed through the column again in the same manner. Next, distilled water and saline are passed through the column to obtain an eluate of basic proteins adsorbed to the ion exchanger. The resulting eluate is ultrafiltered using an ultrafiltration membrane module, after which water is added, diafiltered using the same device, desalted, and freeze-dried to obtain powdered bovine lactoferrin.

[0018] According to the above method, bovine lactoferrin with a purity of 95% by mass or more can be obtained. The purity of lactoferrin can be measured by known methods such as liquid chromatography and electrophoresis. In addition, lactoferrin-containing liquids in each purification step before freeze-drying can also be used in the present invention.

[0019] ≪Composition≫ The composition of the present invention may consist of lactoferrin alone, or may be in a form that also contains ingredients such as raw materials to be contained in foods, beverages, etc. In addition, one aspect of the composition of the present invention is a composition that does not contain lactoperoxidase.Lactoperoxidase is a kind of milk protein, and is an oxidoreductase that is also contained in secretions such as mammalian milk, saliva, tears, and airway mucus.The composition of the present invention does not contain lactoperoxidase, and in addition to the advantages of production cost and simplification of production process, it also has the advantage of being easily mixed into fermented products (such as yogurt).Lactoperoxidase produces a component that acts bacteriostatically, and when applied to fermented products, it may suppress the activity of the bacteria that are responsible for fermentation.

[0020] The content of lactoferrin in the composition of the present invention is not particularly limited as long as it has the effect of improving discomfort in the mouth and / or throat of the present invention, but the content of lactoferrin relative to the total amount of the composition may be 0.01 to 100 mass%, 0.05 to 90 mass%, 0.1 to 50 mass%, 1 to 30 mass%, or 2 to 10 mass%, or the content of lactoferrin in the composition may be 0.01 to 1000 mg, 0.1 to 500 mg, 1 to 300 mg, or 1 to 200 mg.

[0021] The composition of the present invention may be in the form of a food or beverage by itself, or may be in the form of an additive contained in a food or beverage (this form can also be referred to as an "agent for improving discomfort in the mouth and / or throat"). The composition of the present invention may be administered orally or parenterally, but is usually administered orally. Parenteral administration includes transdermal, intravenous, rectal, and inhalation routes.

[0022] The content of lactoferrin when the composition of the present invention is orally ingested (administered) may be the content in the entire composition as described above, or may be appropriately diluted. The lactoferrin content relative to the total mass of the composition at the time of ingestion (administration) may be 0.01 to 100 mass %, 0.05 to 90 mass %, 0.1 to 50 mass %, 1 to 30 mass %, or 2 to 10 mass %. These contents may be within the range generally used when distributed as oral compositions.

[0023] The timing of taking the composition of the present invention is not particularly limited, and may be, for example, before a meal, after a meal, between meals, or before going to bed.

[0024] There are no particular limitations on the subject to which the composition of the present invention is administered (ingested) as long as it is an animal, but it is usually a mammal, and preferably a human.

[0025] Incidentally, "administering a composition to a subject" may be synonymous with "allowing a subject to ingest the composition." Ingestion may be voluntary (free intake) or forced (forced intake). That is, the administration step may specifically be, for example, a step of supplying the composition of the present invention to a subject as food, drink, or feed, thereby allowing the subject to ingest the composition freely.

[0026] The timing and duration of ingestion (administration) of the composition of the present invention are not particularly limited and can be appropriately selected depending on the condition of the subject to be administered.

[0027] The intake (administration) amount of the composition of the present invention is appropriately selected depending on the age (months), sex, condition, other conditions, etc. of the subject to be ingested (administered). The intake (administration) amount of the composition of the present invention is preferably set to an amount in the range of, for example, 0.01 to 1000 mg / kg / day, 0.1 to 500 mg / kg / day, 1 to 300 mg / kg / day, or 1 to 200 mg / kg / day in terms of lactoferrin intake. Regardless of the amount or period of intake (administration), the composition of the present invention can be administered once a day or in divided doses.

[0028] The composition of the present invention has the effect of relieving discomfort in the mouth and / or throat. Here, in the present invention, "amelioration of discomfort in the mouth and / or throat" may mean amelioration of discomfort caused by dryness of the mouth and / or throat, and more specifically, for example, amelioration of dryness of the mouth and / or throat. More preferably, it may mean amelioration of dryness of the throat.

[0029] In the present invention, the term "mouth" refers to the area from the lips to the pharynx, and can also be referred to as the oral cavity. For example, the tongue, floor of the oral cavity, gums, buccal mucosa, hard palate, etc. are included as parts contained in the mouth. In the present invention, the term "throat" refers to the part including the pharynx, larynx, trachea, and esophagus. In the present invention, the object is to improve discomfort in at least one selected from the pharynx, larynx, trachea, and esophagus, and in one embodiment, the object is to improve discomfort in at least one selected from the trachea and esophagus.

[0030] The effect of the present invention can be evaluated by referring to the method described in the Examples below. Specifically, for example, the improvement of discomfort can be evaluated using a "Visual Analogue Scale (VAS)". Examples of controls include subjects at the time of administration of a placebo or before administration of a test sample. In addition, the relative humidity and / or temperature may be appropriately set. For example, when the effect of the present invention is measured in a low humidity environment, the relative humidity may be set to 20 to 40% (preferably 20%), and the temperature may be set to 20 to 30°C (preferably 20°C).

[0031] The composition of the present invention also has an effect of changing the properties of saliva, such as an effect of increasing the wettability of saliva, due to lactoferrin. That is, in one embodiment, the composition of the present invention is a composition containing lactoferrin, and is a composition for improving discomfort in the mouth and / or throat by increasing the wettability of saliva.

[0032] Here, the wettability of saliva can be confirmed qualitatively or quantitatively by a known method, for example, by measuring the contact angle of saliva on a solid by a standard method, etc. For example, the method described in the Examples can be referred to.

[0033] The composition of the present invention also has the effect of preventing (or suppressing) the evaporation of saliva by lactoferrin. That is, in one embodiment, the composition of the present invention is a composition containing lactoferrin, and is a composition for improving discomfort in the mouth and / or throat caused by preventing (or suppressing) the evaporation of saliva.

[0034] The amount of evaporation of saliva can be confirmed qualitatively or quantitatively by a known method, for example, by measuring the amount of saliva before and after a predetermined time by a standard method. For example, the method described in the Examples can be referred to.

[0035] Thus, the composition of the present invention has the effect of improving the wettability of saliva, the effect of inhibiting the evaporation of saliva, etc., and can improve the discomfort associated with dryness by inhibiting the dryness of the mouth and throat. Here, in a low humidity environment, etc., the rapid evaporation of saliva may cause the saliva secreted in tissues distal to the saliva secretion tissue to not reach all areas, and it is possible that the effect of inhibiting the dryness of the oral cavity and improving the discomfort caused by the secretion of saliva may not be fully obtained. However, even in a low humidity environment, etc., the composition of the present invention has the effect of improving the wettability of saliva, the effect of inhibiting the evaporation of saliva, etc., to promote the diffusion of saliva in the oral cavity and inhibit the evaporation of saliva, thereby improving the discomfort of the mouth and throat, and can be suitably used in a low humidity environment.

[0036] Here, the low humidity environment in the present invention is not limited, but may be, for example, a relative humidity of 40% or less, 35% or less, 30% or less, or 20% or less. The lower limit is not particularly limited, but may be 10% or more, or 15% or more. It may also be a range of a consistent combination of the above numerical values, specifically, 10 to 40%, 10 to 35%, 15 to 30%, or 15 to 20%.

[0037] The uses of the present invention may be therapeutic or non-therapeutic. "Non-therapeutic purposes" is a concept that does not include medical procedures, i.e., treatment of the human body through therapy. Examples include health promotion and cosmetic procedures.

[0038] When the composition of the present invention is used for non-therapeutic purposes, it can be administered to healthy subjects. Healthy subjects may refer to those who do not suffer from diseases that cause dry mouth or throat and discomfort associated with dryness. When the composition of the present invention is used for non-therapeutic purposes, it can be used to further improve the condition of the mouth or throat of healthy subjects, and in particular, it can be used to reduce the dryness of the mouth or throat of healthy subjects and the discomfort associated with dryness. When the composition of the present invention is used for non-therapeutic purposes, it may be possible to prevent diseases and symptoms that cause dryness of the mouth and throat in healthy individuals and cause discomfort associated with dryness, such as xerostomia (dry mouth).

[0039] When the composition of the present invention is used for therapeutic purposes, it may be administered to non-healthy subjects. Non-healthy subjects include those who exhibit symptoms that can be effectively prevented, improved, and / or treated by administration of lactoferrin, such as those who suffer from dry mouth or throat and discomfort associated with dryness. Such diseases include those suffering from xerostomia (dry mouth) and the like. When the composition of the present invention is used for therapeutic purposes, it may be possible to improve, prevent, or treat diseases and symptoms that cause dry mouth or throat in unhealthy individuals and cause discomfort associated with dryness. When the composition of the present invention is used for therapeutic purposes, it can be used to improve dryness of the mouth and throat and the discomfort associated with dryness in unhealthy individuals.

[0040] <Food and drink> When the composition of the present invention is intended to be orally ingested, it is preferably in the form of a food or drink (hereinafter sometimes referred to as "the food or drink of the present invention").

[0041] The food and drink of the present invention can be, for example, a food and drink for improving discomfort in the mouth and / or throat. More specifically, the food and drink of the present invention can be a food and drink for improving dryness in the mouth and / or throat.

[0042] There are no particular limitations on the form or properties of the food and beverage products as long as they do not impair the effects of the present invention and can be taken orally. Other than containing lactoferrin, the food and beverage products can be produced by conventional methods using raw materials normally used for food and beverage products.

[0043] Food and drink products include, regardless of their form, liquid, paste, gel, solid, powder, etc., such as tablet confectionery; liquid food (nutritional food for tube feeding); wheat flour products such as bread, macaroni, spaghetti, noodles, cake mix, fried chicken powder, breadcrumbs, etc.; instant noodles, cup noodles, retort / prepared foods, pre-cooked canned foods, microwave foods, instant soups / stews, instant miso soup / cleansing soups, canned soups, freeze-dried foods, other instant foods, etc.; canned agricultural products, canned fruit, jams, etc. Agricultural processed products such as marmalades, pickles, boiled beans, dried agricultural goods, cereals (processed grain products), etc.; marine processed products such as canned seafood, fish ham and sausage, seafood paste products, seafood delicacies, tsukudani (fried fish dishes), etc.; livestock processed products such as canned livestock pastes, livestock ham and sausage, etc.; dairy products such as processed milk, milk drinks, yogurt (fermented milk), lactic acid bacteria drinks, cheese, ice cream, cream, other dairy products, etc.; fats and oils such as butter, margarines, vegetable oils, etc.; soy sauce, miso, sauces Basic seasonings such as tomato processed seasonings, mirin, vinegar, etc.; complex seasonings and foods such as cooking mixes, curry bases, sauces, dressings, noodle soups, spices, and other complex seasonings; frozen foods such as ingredient frozen foods, semi-cooked frozen foods, and cooked frozen foods; confectioneries such as caramel, candy, chewing gum, chocolate, cookies, biscuits, cakes, pies, snacks, crackers, Japanese sweets, rice sweets, bean sweets, dessert sweets, jellies, and other sweets. ; carbonated drinks, natural fruit juice, fruit juice drinks, soft drinks with fruit juice, fruit pulp drinks, fruit drinks with fruit particles, vegetable drinks, soy milk, soy milk drinks, coffee drinks, tea drinks, powdered drinks, concentrated drinks, sports drinks, nutritional drinks, alcoholic drinks, other beverages, and other commercially available foods such as baby food, furikake, and ochazuke nori; nutritional compositions such as supplements and prepared milk (including powdered milk, liquid milk, etc.); enteral nutritional foods; functional foods (foods for specified health uses, foods with nutritional functions), etc.

[0044] When the food or drink is in the form of a supplement, it can be formulated into solid preparations such as powders, granules, tablets, capsules, etc., which may be enteric-coated, etc.; liquid preparations such as solutions, syrups, suspensions, emulsions, etc. Such formulations can be made in accordance with the explanation of the ingredients, carriers, and methods for the formulation of pharmaceuticals described below.

[0045] In addition, one aspect of the food and drink may be feed, such as pet food, livestock feed, and fish feed. The form of the feed is not particularly limited, and in addition to lactoferrin, examples of the feed include grains such as corn, wheat, barley, rye, and milo; soybean oil cake, rapeseed oil cake, palm oil cake, and linseed oil cake. These may contain vegetable oil cakes; bran such as wheat bran, wheat bran, rice bran, and defatted rice bran; manufacturing residues such as corn gluten meal and corn jam meal; animal feeds such as fish meal, skim milk powder, whey, yellow grease, and tallow; yeasts such as torula yeast and brewer's yeast; mineral feeds such as calcium phosphate and calcium carbonate; oils and fats; simple amino acids; sugars, etc.

[0046] When the composition of the present invention is in the form of a food or drink (including feed), it can be a food or drink for improving discomfort in the mouth and / or throat, or dryness in the mouth and / or throat. More specifically, the food or drink of the present invention can be provided and sold as a food or drink labeled with the purpose of improving discomfort in the mouth and / or throat, or dryness in the mouth and / or throat, etc. Furthermore, the lactoferrin according to the present specification can be used for the production of such food or drink.

[0047] Such "indication" acts include all acts for informing consumers of the above-mentioned uses, and any expression that can recall or infer the above-mentioned uses falls under the category of "indication" acts in this invention, regardless of the purpose of the indication, the content of the indication, the object or medium on which it is displayed, etc. Furthermore, it is preferable that the "labeling" be done in an expression that allows consumers to directly recognize the above-mentioned uses.Specific examples include the act of transferring, delivering, displaying for transfer or delivery, or importing food and beverage products or product packaging on which the above-mentioned uses are written, displaying or distributing advertisements, price lists, or transaction documents related to the products and writing the above-mentioned uses in information containing the above-mentioned uses and providing them by electromagnetic means (such as the Internet), etc.

[0048] On the other hand, the content of the labeling is preferably a labeling approved by the government etc. (for example, a labeling approved based on various systems established by the government and made in a manner based on such approval, etc.) In addition, it is preferable that such a labeling content is affixed to the packaging, containers, catalogs, pamphlets, POP and other sales site promotional materials, other documents, etc.

[0049] In addition, "labeling" also includes labeling as health food, functional food, enteral nutrition food, special purpose food, health functional food, food for specified health uses, nutrient functional food, functional food, functional labeling food, medical drug, etc. Among these, in particular, labeling approved by the Consumer Affairs Agency, for example, labeling approved under the system related to food for specified health uses, nutrient functional food, or functional labeling food, or a similar system, etc., can be mentioned. Specifically, labeling as food for specified health uses, labeling as food for conditional specified health uses, labeling that affects the structure or function of the body, labeling that reduces the risk of disease, labeling of functionality based on scientific evidence, etc., can be mentioned, and more specifically, labeling as food for specified health uses (especially labeling of health uses) and similar labeling as specified in the Cabinet Office Ordinance on the Permission of Labeling for Special Purposes Provided in the Health Promotion Act (Cabinet Office Ordinance No. 57 of August 31, 2009) are typical examples. Examples of such claims include "relieves discomfort in the mouth and throat during dry seasons or indoors" or "relieves dryness in the mouth and throat in dry places."

[0050] The food and beverage products of the present invention can be administered to any subject, including healthy and unhealthy individuals; however, when the food and beverage products are labeled with a specific use (particularly a health use) or function, they are used for the non-therapeutic purposes described above.

[0051] In addition, all of the matters explained above in the section on <Composition for improving discomfort in the mouth and / or throat> also apply to the explanation of <Food and beverages>.

[0052] <Drugs> Based on the results of the Examples described below, the active ingredients constituting the composition of the present invention can be used to prevent, improve and / or treat discomfort in the mouth and / or throat. The present invention may also be used in methods for the prevention, amelioration and / or treatment of sore throat and / or throat discomfort. That is, the composition of the present invention can also be in the form of a pharmaceutical product. The compositions of the present invention contain lactoferrin as an active ingredient and are expected to be particularly effective in improving discomfort in the mouth and / or throat. Thus, the compositions of the present invention may be, inter alia, medicinal products administered for the amelioration of mouth and / or throat discomfort.

[0053] The route of administration of pharmaceuticals may be either oral or parenteral, with oral being preferred. Parenteral intake (administration) includes transdermal, intravenous, rectal, inhalation, etc. The pharmaceutical form can be formulated into a desired dosage form depending on the administration method. For example, in the case of oral administration, it can be formulated into solid preparations such as powders, granules, tablets, and capsules; liquid preparations such as solutions, syrups, suspensions, and emulsions. It can also be made into an enteric-coated preparation by enteric coating. In the case of parenteral administration, it can be formulated into suppositories, ointments, injections, and the like. In the formulation, in addition to lactoferrin, ingredients that are usually used in formulations, such as excipients, pH adjusters, colorants, flavorings, etc., can be used in combination with other medicinal ingredients, or active ingredients that are known or will be discovered in the future. In addition, formulation can be carried out by a known method according to the dosage form. When formulating, a carrier usually used in formulation may be appropriately mixed. Such carriers include excipients, binders, disintegrants, lubricants, stabilizers, flavoring agents, etc.

[0054] Examples of excipients include sugar derivatives such as lactose, sucrose, glucose, mannitol, and sorbitol; starch derivatives such as corn starch, potato starch, α-starch, dextrin, and carboxymethyl starch; cellulose derivatives such as crystalline cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, and calcium carboxymethyl cellulose; gum arabic; dextran; pullulan; silicate derivatives such as light anhydrous silicic acid, synthetic aluminum silicate, and magnesium aluminometasilicate; phosphate derivatives such as calcium phosphate; carbonate derivatives such as calcium carbonate; and sulfate derivatives such as calcium sulfate.

[0055] Examples of binders include gelatin, polyvinylpyrrolidone, macrogol, and the like, in addition to the above-mentioned excipients.

[0056] Examples of disintegrants include the above-mentioned excipients, as well as chemically modified starch or cellulose derivatives such as croscarmellose sodium, sodium carboxymethyl starch, and crosslinked polyvinylpyrrolidone.

[0057] Examples of lubricants include talc; stearic acid; metal stearates such as calcium stearate and magnesium stearate; colloidal silica; waxes such as pea gum and geranium stearate; boric acid; glycol; carboxylic acids such as fumaric acid and adipic acid; sodium carboxylates such as sodium benzoate; sulfates such as sodium sulfate; leucine; lauryl sulfates such as sodium lauryl sulfate and magnesium lauryl sulfate; silicic acids such as silicic anhydride and silicic acid hydrate; starch derivatives, and the like.

[0058] Examples of the stabilizer include paraoxybenzoic acid esters such as methylparaben and propylparaben; alcohols such as chlorobutanol, benzyl alcohol, and phenylethyl alcohol; benzalkonium chloride; acetic anhydride; and sorbic acid.

[0059] Examples of flavoring agents include sweeteners, acidulants, and fragrances. In the case of a liquid preparation for oral administration, examples of the carrier used include solvents such as water.

[0060] The pharmaceuticals are administered to non-healthy subjects and are used for the above-mentioned therapeutic purposes.

[0061] In addition, all of the matters explained above in <Compositions for relieving discomfort in the mouth and / or throat> and <Food and beverages> also apply to the explanation of <Medicines>. EXAMPLES

[0062] The present invention will be described in more detail below with reference to examples. However, the present invention is not limited to these examples as long as it does not depart from the gist of the present invention.

[0063] Example 1: Effect of lactoferrin intake on discomfort in the mouth and throat (the purpose) To investigate the effect of lactoferrin intake on discomfort in the mouth and throat, the following study was conducted.

[0064] (Test Method) Subjects (healthy adults) were given 100 mg of lactoferrin (Morinaga Milk Industry Co., Ltd.) and then allowed to rest in a low humidity environment for 2 hours, after which the subjects were asked to evaluate the intensity of dryness in the mouth and throat felt by the subjects using a visual analogue scale (VAS). The VAS is a method of evaluating subjective sensations by indicating them on a horizontal line. In this test, the right end of a 100 mm horizontal line was defined as "very dry" and the left end as "not dry at all," and the subjects were asked to indicate the intensity of dryness felt by drawing a vertical line on the line. The length (mm) from the left end to the vertical line drawn by the subject was recorded as the intensity of dryness.

[0065] (Test Procedure) (1) Subjects were asked to rinse their mouths with water. (2) The subjects were allowed to rest for 60 minutes in a room with a temperature of 20°C and a relative humidity of 60% to stabilize the condition of their mouths and throats. (3) The sensation of dryness in the mouth and throat was evaluated using a VAS. (4) Subjects were given 100 mg of lactoferrin dissolved in water or an equal amount of water as a placebo. (5) The subjects were allowed to rest for 120 minutes in a low-humidity environment (room temperature 20°C, relative humidity 20%). (6) After resting in a low humidity environment for 60 and 120 minutes, subjects were asked to evaluate the dryness of their mouth and throat using a VAS.

[0066] (result) The results are shown in Table 1. Taking lactoferrin reduced the intensity of dry mouth and throat sensation after 60 and 120 minutes of rest in a low humidity environment compared to taking a placebo (controlled study).

[0067] [Table 1]

[0068] Example 2: Evaluation of lactoferrin's effect on improving saliva wettability and inhibiting evaporation (the purpose) In Example 1, the ingestion of lactoferrin was shown to have an effect of alleviating discomfort in the mouth and throat (more specifically, dryness in the mouth and throat). As part of the mechanism of action, the following test was conducted to investigate lactoferrin's effect of improving the wettability (ease of spreading) of saliva and its effect of inhibiting evaporation.

[0069] (background) A liquid with high wettability (liquid that spreads easily) has a small contact angle on a solid. The wettability of a liquid can be evaluated using the contact angle as an indicator.

[0070] <Wettability evaluation> (method) (1) A 20 mg / mL aqueous lactoferrin solution was prepared. (2) Samples were prepared by adding 500 μL of water or lactoferrin aqueous solution (20 mg / mL) to 500 μL of saliva sample. (3) 40 μL of each sample and water was dropped onto the acrylic resin. (4) A photograph was taken from the side, and the contact angle was measured using contact angle calculation software. Measurements were taken three times for each sample, and statistical analysis was performed using a paired t-test.

[0071] (result) The results are shown in Table 2. The contact angle of saliva to which lactoferrin aqueous solution was added was significantly smaller than that of saliva to which water was added. In other words, the effect of lactoferrin in improving the wettability of saliva was confirmed. It is believed that the sensation of dryness is suppressed because saliva easily covers the entire oral cavity.

[0072] [Table 2]

[0073] <Evaporation suppression> (method) (1) Aqueous solutions of 10 mg / mL and 3 mg / mL lactoferrin were prepared. (2) Saliva samples and lactoferrin aqueous solution were mixed in the following ratios to prepare samples. Add 4μL of lactoferrin solution (10mg / mL) to 396μL of saliva sample (Final concentration of added lactoferrin: 100 μg / mL) Add 4μL of lactoferrin solution (3mg / mL) to 396μL of saliva sample (Final concentration of added lactoferrin: 30 μg / mL) 396μL saliva sample + 4μL water (3) 200 μL of each sample was dropped onto a pre-weighed weighing dish. (4) The specimen was kept indoors at a room temperature of 20°C and a relative humidity of 40%. (5) After dropping, the remaining weight of the sample was weighed at 30, 60, 90, and 120 minutes.

[0074] (result) The results are shown in Table 3. As the concentration of added lactoferrin increased, the evaporation of saliva was suppressed. In other words, the effect of lactoferrin in suppressing the evaporation of saliva was confirmed. It is believed that the sensation of dryness is suppressed by making it harder for saliva to evaporate.

[0075] [Table 3] [Industrial Applicability]

[0076] The present invention is useful in the fields of foods and beverages, health foods, functional foods, supplements, and the like.

Claims

1. A composition for ameliorating discomfort in the mouth and / or throat comprising lactoferrin.

2. The composition according to claim 1 , wherein the lactoferrin content in the composition is 0.01% by mass or more.

3. The composition of claim 1 , wherein the composition does not contain lactoperoxidase.

4. 10. The composition of claim 1 for improving discomfort in the mouth and / or throat in an environment with a relative humidity of 40% or less.

5. 2. The composition of claim 1, wherein the mouth and / or throat discomfort is a dry throat.

6. The composition of claim 1 , wherein the throat is at least one selected from the group consisting of the pharynx, larynx, trachea, and esophagus.

7. The composition according to claim 1 , wherein the improvement in discomfort is due to increased wettability of saliva.

8. The composition according to claim 1 , wherein the amelioration of discomfort is due to prevention of evaporation of saliva.

9. The composition according to any one of claims 1 to 8, which is a food or drink.

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