KR20230103027A - Composition for prevention of hair loss or improvement of hair growth - Google Patents

Abstract

The present invention relates to a composition for preventing hair loss or stimulating hair growth. It has an excellent effect of promoting the activity of the wind/beta-catenin signaling pathway, and thus can be usefully used as a composition for preventing hair loss or promoting hair growth.

Description

Composition for prevention of hair loss or improvement of hair growth}

The present invention relates to a composition for preventing hair loss or stimulating hair growth, and specifically, contains whey protein containing sialic acid as an active ingredient, thereby inducing proliferation of dermal papilla cells to promote hair growth and inhibiting the activity of 5-alpha-reductase. The present invention relates to a composition for preventing hair loss or stimulating hair growth, which has an excellent effect of inhibiting the production of dihydrotestosterone and promoting the activity of the wint/beta-catenin signaling pathway.

In addition to the simple function of biologically protecting the scalp, hair has been considered important as a means of expressing beauty and individuality in terms of beauty. In particular, in a modern society that values beauty, hair occupies the most important part in satisfying the desire for individual expression regardless of age or gender.

In recent years, not only male pattern baldness, but also a change in dietary habits and an increase in stress caused by social environments have led to an increase in the number of female hair loss populations, and their age is also decreasing regardless of age or gender. Moreover, in recent years, as the regulation or restriction of internal and external activities has been followed by the prolonged corona pandemic, the number of hair loss population due to increased stress, lack of exercise, irregular lifestyle, etc. is rapidly increasing.

There are about 100,000 to 150,000 hairs in the human body, and each hair has a different cycle and repeats growth and shedding through anagen, catagen, and telogen. This hair growth cycle is repeated over 3 to 6 years. As a result, it is a natural phenomenon that about 50 to 70 hairs fall out per day, but if the number of hairs that fall out exceeds 100, it is likely to be a symptom of hair loss.

In general, 'alopecia' refers to an increase in the number of abnormally falling hairs due to a decrease in the proportion of hair in the growth phase and an increase in hair in the catagen or telogen phase during this cycle. Alopecia, in which hair is lost from the scalp, is caused by various factors, and is usually divided into congenital genetic predisposition and acquired alopecia formed by receiving other environments. Currently, the causes of hair loss include internal factors such as the action of male hormones or external factors such as mental stress in daily life and accumulation of lipid peroxide in the scalp. there is.

Specifically, in terms of the hair growth cycle, alopecia refers to an increase in the number of hairs that fall out abnormally due to a shortened hair growth rate in the hair growth cycle and an increased number of hairs in the catagen or telogen phase. Hair loss is a normal phenomenon, but normal people have a lot of hair in the growth phase, whereas people with alopecia have a lot of hair in the resting phase. In other words, the characteristic of people exhibiting alopecia is miniaturization of the hair. As hair loss progresses, the period of the growth phase is shortened, the transition to the catagen phase and the telogen phase is promoted, and the volume of the subsequent hair dermal papilla is reduced, so the hair follicles are gradually miniaturized. Therefore, for the treatment of hair loss, it is more preferable to make hair follicles in the telogen phase go quickly to the anagen phase and to increase the shortened anagen phase.

Hair loss prevention agents that can improve or treat alopecia that are currently widely used include minoxidil and oral finasteride, which are external skin preparations approved by the US Food and Drug Administration (FDA), and approved by the Ministry of Food and Drug Safety (MFDS) in Korea. There is an oral dutasteride that has been received. Minoxidil, which has been used as a treatment for hypertension, has been known to promote hair growth through a mechanism that expands blood vessels through hyperpolarization of cell membranes and supplies nutrients to hair follicles, but recent studies have shown that minoxidil promotes hair growth by acting directly on hair follicle cells. It has been reported to activate the signaling pathway of Wnt/β-catenin, which is a mechanism. Finasteride is the ingredient name of Propecia, which was developed as a treatment for benign prostatic hyperplasia and then introduced to the treatment of alopecia. ) is known to inhibit the production of DHT, which causes hair loss. However, hair loss inhibitors such as minoxidil, finasteride, dutasteride, etc. show a temporary great effect in terms of efficacy, but the fact is that the effect varies greatly between individuals, and the effect disappears immediately when discontinued, and various dermatitis or As many side effects, such as loss of sexual desire and induction of gynecomastia, are concerned, it is difficult to maintain these effects for a long period of time.

Sialic acid is a generic term for N-acyl and O-acyl derivatives of neuraminic acid. It is an acidic sugar composed of 9 carbons and having a COOH group. However, sugars with biological diversity are unknown in nature. Twenty-three types of sialic acids have been reported in the animal kingdom due to differences in substituents, and these show specific distributions in species or tissues.

Sialic acid does not exist in a free state in nature except for some metabolic processes, and is widely present as a component of oligosaccharides, polysaccharides, glycoproteins, and glycolipids in animal organs, tissues, blood, mucus, and milk. Although not found, it is relatively widely distributed in the microbial kingdom. Particularly, in higher animals, sialic acid is linked by an α-glycosidic linkage by Gal, GlcNAc, GalNAc of glycoproteins, glycolipids, oligosaccharide sugar chains, and sialytransferase specific for sialic acid, respectively. In other words, it only temporarily exists in a free form during the metabolic process, and most of it exists in the form of an oligosaccharide attached to the non-reducing end of the sugar chain as a glycoside.

Sialic acid is a component of glycoproteins or glycolipids on the cell surface of cell membranes and can perform various biological functions by being located at the terminal. Sialic acid is a component of ganglioside or glycoprotein in the brain and is particularly abundant in the brain or central nervous system, and its amount increases rapidly during infancy, so sialic acid is known to play an important role in the function expression or development of these tissues. . And as an indispensable component of mucoprotein, antiviral function to block the hemolysis of influenza virus, anticancer function, neutralization of toxin component, anti-inflammatory function, defense function in case of bacterial infection, immune regulation function, suppression of pigmentation Functions, various functions such as nerve cell signaling functions have been reported.

Whey is a liquid product remaining after coagulation of milk and separation of curd during the general cheese manufacturing process, and accounts for about 90% of milk. As a result, various R&D efforts are being conducted on whey.

Milk contains two major proteins, 80% casein and 20% whey, and whey is found in the water content of milk. Whey is a liquid by-product separated during cheese manufacturing or casein production. It has excellent nutritional values such as protein, lactose, minerals, vitamins, and inorganic ingredients, as well as physical functional characteristics such as improved physical properties and increased flavor, and is currently used as a food additive as well as a nutritional food ingredient. is widely used as

Types of whey products include whey powder, dried whey, reduced-lactose whey, deminerlized whey and lactose, and whey. There are whey protein (WP), etc., from which non-protein components have been removed. In other words, whey protein refers to the protein contained in whey from which casein, etc. have been removed from milk, and the types of whey protein are further divided into whey protein concentration (WPC) and whey protein isolate (Whey Protein Isolate) depending on the processing and purification methods. , WPI), and hydrolyzed whey protein (Whey Protein Hydrodysate (WPH)).

Whey protein contains β-lactoglobulin, α-lactoglobulin and trace amounts of branched-chain amino acids (BCAA), immunoglobulins, phospholipoproteins, lactoferrin, and enzymes, which are protein factors with various physiological activities. It consists of In particular, whey protein has recently been in the limelight as a protein supplement material for muscle development because it has a higher content of leucine, a type of BCAA, and is absorbed faster than other proteins. It is known to have various functions such as improving recovery speed after recovery, preventing muscle fatigue, controlling satiety and weight, and strengthening immunity.

However, research and development using sialic acid-containing whey proteins based on their respective functional properties, such as the various functional, nutritional and bioactive properties of sialic acid and whey proteins, is virtually non-existent. In particular, as a result of the cytotoxicity test on the sialic acid-containing whey protein, no specific lesions were observed in the cells, and it was confirmed that there was no cytotoxicity (Registration Patent No. 10-1119148). It is judged that development for the purpose of improvement can be done in various ways.

Regarding the efficacy of the sialic acid-containing whey protein, Korean Patent Registration Nos. 10-1119148, 10-1119538, and 10-1355018 disclose the influenza virus inhibitory effect of sialic acid-containing whey proteins, but hair loss has not yet been achieved. There are no known examples of use with respect to prevention or hair growth promoting efficacy.

The inventors of the present invention have made intensive efforts to develop a composition that can prevent hair loss, induce hair growth, and effectively act on safe hair loss prevention or hair growth promotion without side effects even when used on the human body for a long time. It was confirmed that it had efficacy, and it came to complete the present invention.

Accordingly, the technical problem to be achieved by the present invention relates to a composition for preventing hair loss or stimulating hair growth, which contains sialic acid-containing whey protein as an active ingredient to promote hair growth by inducing proliferation of dermal papilla cells and 5 alpha-reductase It is an object of the present invention to provide a composition for preventing hair loss or stimulating hair growth, which has an excellent effect of suppressing the production of dihydrotestosterone by inhibiting the activity of and promoting the activity of the wint/beta-catenin signaling pathway.

In order to achieve the above object, the present invention provides a composition for preventing hair loss or promoting hair growth containing sialic acid-containing whey protein as an active ingredient,

In order to achieve the above object, the present invention contains sialic acid-containing whey protein as an active ingredient to promote hair growth by inducing proliferation of dermal papilla cells and inhibiting the activity of 5-alpha-reductase to produce dihydrotestosterone. Provided is a composition for preventing hair loss or promoting hair growth that promotes the activity of the wint/beta-catenin signaling pathway.

By containing the sialic acid-containing whey protein of the present invention as an active ingredient, there is no skin irritation or cytotoxicity, so it has excellent safety to the human body, promotes hair growth by inducing proliferation of dermal papilla cells, and inhibits the activity of 5-alpha-reductase to dehydrogenate. Since it is very effective in inhibiting the production of testosterone as well as promoting the activity of the wint/beta-catenin signaling pathway, it can be usefully used as an active ingredient in cosmetic and pharmaceutical compositions for preventing hair loss or promoting hair growth.

1 is a graph showing the analysis results of the activity promoting effect of the wint/beta-catenin signaling pathway by the sialic acid-containing whey protein of the present invention.

The present invention relates to a composition for preventing hair loss or promoting hair growth, containing whey protein containing sialic acid as an active ingredient.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In general, the nomenclature used herein is one well known and commonly used in the art.

Hereinafter, the present invention will be described in more detail.

In the present invention, sialic acid (Sia, NeuAc, NeuGc) collectively refers to several types of neuraminic acid (NANA), specifically neuraminic acid or 5-amino-3,5-didi Oxy-D-glycero-D-galacto-non-2-ulosonic acid (5-amino-3,5-dideoxy-D-glycero-D-galacto-non-2-ulosonic acid) is N-acyl and It is a general term for O-acyl derivatives and is a 9-carbon monosaccharide acidic sugar, and is an aldol condensation product of pyruvic acid and D-mannosamine (2-amino-2-deoxymannose). Although such neuraminic acid is not produced in nature, many neuraminic acid derivatives are widely distributed in animal tissues and bacteria, and are particularly found in glycoproteins and gangliosides. The N- or O-substituted derivatives of neuraminic acid are known collectively as sialic acid, the predominant form in mammalian cells being N-acetylneuraminic acid. The amino group has an acetyl group or a glycoyl group. Hydroxy substituents can vary considerably; acetyl, lactyl, methyl, sulfate and phosphate groups have been found. Twenty-three types of sialic acids have been reported in the animal kingdom due to differences in substituents, and they are known to show specific distributions in species or tissues.

In the present invention, sialic acid is a monosaccharide attached to cells or water-soluble proteins in the form of a sugar chain, and is produced from glucose in higher animal cells or microorganisms through a complex process. In addition, sialic acid is a component of mucopolysaccharide, glycoprotein, and glycolipid and acts as a signal transduction receptor on the cell surface.

In the present invention, sialic acid is a major factor determining the lifespan of glycoproteins in the body, and glycoproteins whose sugar chains do not end with sialic acid are rapidly eliminated from the body. Therefore, the physiological activity of the sugar chain of the cell surface or glycoprotein may change greatly depending on the presence or absence of terminal sialic acid. Currently, the most widely existing sialic acid is N-acetylneuraminic acid (N-acetyl neuraminic acid, Neu5Ac), N-glycosyl neuraminic acid (Neu5Gc), N-acetyl-9-O-acetyl There are three types of neuraminic acid (N-acetyl-9-O-neuraminic acid, Neu5,9Ac ₂ ), among which only N-acetylneuraminic acid is universal and the other two are not found in all species. Common sialic acids have α2-3 or α2-6 linkages, and non-sugar substances such as sulfate, phosphate, 2-aminoethyl phosphate, alkyl, and acyl groups are also linked.

Specifically, in the present invention, sialic acid is a 9-carbon acidic acid sugar that does not exist in a free state in nature except for some metabolic processes, and is an oligosaccharide, polysaccharide, glycoprotein, etc. of animal organs, tissues, blood, mucus, and milk. , It is widely present as a component of glycolipids, not found in plants, but relatively widely distributed in microorganisms.

More specifically, in the present invention, sialic acid of the above three types (N-acetylneuraminic acid, N-glycolylneuraminic acid, N-acetyl-9-O-acetylneuraminic acid) is widely distributed next to Sialic acid is Kdn, which is frequently found in microorganisms or animals, and sulfated and methylated sialic acids are limited to echinoderms.

In the present invention, sialic acid is found in the animal kingdom, but not in bacteria or healthy human tissue except for small amounts in some tumors. In addition, not all sialic acids exist in a single cell or organism, and their distribution depends on cell function as well as animal species and cell species, and is believed to be limited at the genetic level. Cattle have the largest distribution of different sialic acids. In particular, 15 types of sialic acids were found in submandibular gland mucin, and most of them have 9- It is O-lactylized. It is also known that echinoderms such as starfish, sea urchins, and sea cucumbers have a large number of sialic acid species, and several of them are N-acetylneuraminic acid, N-glycolylneuraminic acid, and O-acetyl-forms, which are well known in higher animals. It also contains known monosaccharides. In particular, among the non-specific hemagglutination inhibition factors in milk, there are sialic acid-containing oligosaccharides and gangliosides. There are more than 130 types of oligosaccharides in human milk and most mammalian milk. Among them, only sialyllactose and sialyl-N-tetraose contain sialic acid.

In the present invention, sialic acid is a component of glycoproteins or glycolipids on the cell surface of the cell membrane and can perform various biological functional roles by being located at the terminal. For example, sialic acid is synthesized in mammals from fructose-6-phosphate via N-acetylamannoseamine. Sialic acid is a component of ganglioside or glycoprotein in the brain and is particularly abundant in the brain or central nervous system, and its amount increases rapidly during infancy, so sialic acid is known to play an important role in the function expression or development of these tissues.

In the present invention, sialic acid is an indispensable component of mucoprotein, and has antiviral function to block the hemolysis of influenza virus, anticancer function, neutralization of toxin component, anti-inflammatory function, defense function in case of bacterial infection, and immunomodulatory function. It has various functions such as , pigmentation suppression function, and nerve cell signal transmission function.

In the present invention, the production of sialic acid can be synthesized from recombinant Escherichia coli ( E. coli ) or synthesized from N-acetyl-D-glucosamine using enzymes produced therefrom, including those produced by some chemical synthesis methods. do. It also includes sialic acid prepared by hydrolyzing casein-derived glycomacropeptide isolated from whey protein, which has recently been applied to the food industry.

Therefore, sialic acid used in the present invention refers to human milk or colostrum, cow's milk and colostrum, goat's milk and colostrum, bird eggs (eggs, duck eggs, quail eggs, ostrich eggs, turkey eggs, etc.) and fish Sialic acid that can be directly extracted from eggs, other bird's nests, deer antlers or antlers, insects, sea cucumbers, starfish, sea urchins, etc., separated and purified, or produced by enzymatic synthesis derived from microorganisms, and chemical synthesis can be interpreted

In the present invention, whey is a liquid product remaining after milk is coagulated and curd is separated in the general cheese manufacturing process, and accounts for about 90% of milk, and is an essential amino acid having a very high protein efficiency ratio (3 or more). contains Whey is also rich in vitamins such as thiamine, riboflavin, pantothenic acid, vitamins A, B (vitamins B6 and B12) and C, as well as minerals such as iron, potassium, magnesium, calcium and phosphorus.

In the present invention, whey protein refers to soluble protein from which casein is removed when skim milk is precipitated, and the liquid separated as milk coagulates when making cheese is also called whey protein. Most of the whey proteins are alpha-lactalbumin and beta-lactoglobulin (70-80%), and other protein components include serum albumin, lactoperoxidase, immunoglobulins, growth factors, numerous physiologically active factors, and enzymes. It consists of In particular, beta-lactoglobulin is a major component that accounts for about 50% of whey protein and 7-12% of milk protein. acid), and an opaque and hard gel is formed in the pH range of 4-6, and an elastic gel can be formed at pH 4 or less or pH 6 or higher.

Types of whey in the present invention include whey powder dried as it is, reduced-lactose whey partially separated and dried, demineralized whey and lactose, and whey. It means that it includes all whey proteins from which non-protein components have been removed.

In the present invention, whey protein refers to soluble protein from which casein is removed when skim milk is precipitated, and the liquid separated as milk coagulates when making cheese is also called whey protein. Most of the whey proteins are alpha-lactalbumin and beta-lactoglobulin (70-80%), and other protein components include serum albumin, lactoperoxidase, immunoglobulins, growth factors, numerous physiologically active factors, and enzymes. It consists of In particular, beta-lactoglobulin is a major component that accounts for about 50% of whey protein and 7-12% of milk protein. acid), an opaque and hard gel is formed in the pH range of 4-6, and an elastic gel can be formed at pH 4 or less or pH 6 or higher.

In the present invention, the types of whey protein are concentrated and dried whey protein of good quality, such as whey protein concentration (WPC), whey protein isolate (WPI), and hydrolyzed whey protein (Whey Protein Hydrodysate, WPH). can include

The above-mentioned whey protein concentrate refers to various products (WPC35, WPC50, WPC60, WPC75, WPC87) in which the protein content is concentrated in the range of 34 to 80% by varying the purity as a protein made by concentrating whey. Its availability varies depending on the protein concentration. The above-mentioned whey protein concentrate has an average protein purity of 80%, and 35% concentrated whey protein is used as a substitute for skim milk, and 50% concentrated whey protein can be used as a protein supplement in food. The above 87% concentrated whey protein refers to a whey protein product that is concentrated to a protein content of 65% by ultrafiltration and then concentrated and dried to a high concentration by diafiltration.

The above whey protein isolate is a product in which the protein content is concentrated by more than 90%, and in particular, the physicochemical functions of protein that affect the quality of food, such as foaming, emulsifying, solubility, and dispersibility ( It can be used as a protein supplement or substitute because it has dispersibility, water-binding, and viscosity.

The above hydrolyzed whey protein is a product obtained by adding digestive enzymes to concentrated whey protein as a raw material and hydrolyzing it once more. exists as

In the present invention, whey protein has the ability to cure diseases caused by metabolic imbalance, and has been known to have antioxidant, anticancer, antidiabetic, antiobesity, and heart protecting functions.

As mentioned above, whey protein in the present invention means whey protein including all proteins except for non-proteins such as lactose separated from by-products produced when cheese or casein is produced. It can be manufactured or produced as whey protein with different functional, nutritional and physiologically active properties according to processing methods from various raw milks such as goat's milk, breast milk, and colostrum. For example, decompression by carbon dioxide, extraction by supercritical extraction by high temperature, separation using ultrafiltration membrane, separation method by various chromatography (made for separation according to size, charge, hydrophobicity or affinity), etc. additionally Whey protein fractions obtained through various purification and enzymatic extraction methods that can be performed are also included in the whey protein of the present invention.

In the present invention, the whey protein produced from the above methods may contain 1-5% of natural sialic acid.

Therefore, the term "whey protein" used in the present invention refers to a whey protein that can be separated and purified by various methods from various raw milk sources according to raw milk such as milk, goat milk, breast milk, and colostrum. The type of protein can be comprehensively interpreted to include whey protein concentrate, whey protein isolate, and hydrolyzed whey protein.

The whey protein containing sialic acid used in the present invention is a mixture made by mixing different contents of sialic acid and whey protein, and the sialic acid and whey protein are purified by extraction and separation by methods known in the art, or enzymatic synthesis, etc. It can be prepared and by a method, and the method is not particularly limited.

The sialic acid-containing whey protein used in the present invention is a complex of sialic acid and whey protein, and can be prepared by an extraction and purification method known in the art by adjusting the content ratio of each sialic acid and whey protein. Not particularly limited. It also includes those commercially available, such as whey protein products containing sialic acid from Japan, China, Europe, and Australia that are currently on the market.

The content of sialic acid in the sialic acid-containing whey protein used in the present invention refers to a complex of sialic acid and each whey protein without considering the content of sialic acid naturally bound to the whey protein.

Therefore, whey protein containing sialic acid promotes hair growth by inducing the proliferation of dermal papilla cells, which is the object of the present invention, and suppresses the production of dihydrotestosterone by inhibiting the activity of 5-alpha-reductase, as well as wint/beta- It is not particularly limited as long as it is sufficient to exhibit the characteristics of the effect of promoting the activity of the catenin signaling pathway.

In one embodiment of the present invention, the content of sialic acid in the sialic acid-containing whey protein is preferably 1 to 30% by weight based on the total weight of the glycomacropeptide.

In one embodiment, when sialic acid is 1 to 10.0% by weight based on the total weight of the whey protein, it has been shown to have an effect of preventing hair loss or promoting hair growth in a human application experiment. However, when the amount of sialic acid is less than 1% by weight based on the total weight of the glycomacropeptide, the effect is insignificant, and when it exceeds 30.0% by weight, stability of the formulation is impaired and skin irritation may occur. Even more preferably, the amount of sialic acid may be 2.0 to 20.0% by weight, most preferably 5.0 to 10.0% by weight, based on the total weight of the whey protein.

Therefore, in the present invention, it was confirmed through test examples that the sialic acid content in the sialic acid-containing whey protein was excellent in preventing hair loss or stimulating hair growth when the content of sialic acid was within the above range with respect to the total weight percent of the whey protein.

Although many studies on the cause of hair loss or promoting hair growth are continuously and actively conducted, the exact biological mechanism related to hair loss is still very complicated.

Hair repeats the hair cycle of growth, catagen, rest, and growth, and alopecia refers to a state in which the resting period is long and the growth period is short. It has been believed that hair regeneration is almost impossible until now because hair follicles atrophy when the resting period is long, and most of the hair loss prevention agents currently on the market expect only the hair loss prevention effect of growing hair.

Hereinafter, the invention for preventing hair loss or promoting hair growth of the present invention will be described in detail.

In the present invention, "hair loss" refers to a state in which there is no hair in an area where hair should normally exist, and specifically means that the terminal hair (thick and black hair) of the scalp is lost, and various forms from slight thinning of hair to complete baldness appears as The cause of hair loss is not limited, but examples include hereditary androgenetic alopecia (baldness), alopecia areata, ringworm of the head (tinea capitis) caused by fungal infection, telogen effluvium, hair growth, hair production disorders, etc. Scarring alopecia may mean that it appears in various forms due to various causes, such as hair loss caused by lupus, idiopathic folliculitis, lichen planus pilaris, hair loss caused by burns and trauma.

In the present invention, the types of hair loss include scarring alopecia in which hair is not regenerated due to the destruction of hair follicles due to scarring, and non-scarring alopecia in which hair is regenerated after the symptomatic site is razed by maintaining hair follicles without forming scars. Scarring alopecia is caused by trauma, burns, leprosy or bacterial infection, and non-scarring hair loss includes alopecia areata, hair growth, telogen effluvium, drug-induced alopecia, secondary syphilis, dermatophytosis, endocrine disorders, and dermatomyositis. which is caused by, etc.

The term "prevention" of the present invention refers to preventing something or a phenomenon from occurring, that is, preventing hair loss from occurring, and a product that prevents hair loss along with hair growth is called an anti-hair loss agent. In addition, it is divided into a hair growth agent that nourishes the hair roots to grow hair, a hair growth agent that promotes blood circulation in the scalp to help prevent hair loss, and a hair growth agent that turns thinned vellus hair into healthy terminal hair.

In the present invention, the target of application of the anti-hair loss agent means that the focus is on scarring hair loss. Among scarring alopecia, androgenetic alopecia, in which male hormones act as an important etiology, accounts for about 80% of all hair loss symptoms. Genetic factors, the concentration of androgen, a male hormone in the blood, and a high concentration of dihydrotestosterone (DHT: dihydrotestosterone), which binds to androgen receptors present in scalp hair follicles, are known to be the main causes. DHT regulates hair growth by binding to the androgen receptor in the scalp dermal papilla. At this time, the binding of DHT transmits a cell destruction signal to the genes of keratinocyte cells to produce apoptosis factors, DKK-1 and TGF-β. This means that hair loss occurs due to the destruction of hair cells.

In addition, in the present invention, 5 alpha-reductase (5α-reductase), an enzyme that catalyzes the irreversible reduction of testosterone to DHT, together with nicotinamide adenine dinucleotide phosphate (NADPH) as a hydrogen donor. reductase) is associated with hair loss. That is, DHT produced in this way inhibits protein synthesis around the hair follicle, thereby reducing cell proliferation of hair cells, shrinking scalp hair follicles, and converting thick and long healthy hair into thin and short hair to progress hair loss.

In the present invention, "hair growth" means that hair grows in a hair follicle, and the hair includes hair roots and hair follicles of the head, hair, eyelashes, eyebrows, beard, armpits, pubic hair, and all parts of the body with hair roots and hair follicles do.

In the present invention, "acceleration" means supplying nutrients to the root of the hair so that the hair grows quickly, thereby controlling the growth cycle of the hair. At this time, the activity of outer root sheath cells, including dermal papilla cells and hair follicle stem cells constituting hair follicles, and various cytokines and growth factors produced by these cells play an important role. In particular, regeneration of hair follicles and activation of stem cells are followed for periodic hair growth, which is achieved through activation of the Wnt/β-catenin signaling pathway. In addition, growth factors such as vascular endothelial growth factor (VEGF), insulin-like growth factor-1 (IGF-1), and fibroblast growth factor (FGF) promote the growth phase of hair, and transforming growth factor (TGFβ-1) , Epidermal growth factor (EGF), etc. means to regulate the hair growth cycle by inducing the catagen phase of the hair follicle.

Therefore, in the present invention, the hair loss prevention or hair growth promotion effect promotes dermal papilla cell proliferation by the sialic acid-containing whey protein, inhibits the activity of 5 alpha-reductase, and activates the wint/beta-catenin signaling pathway. It may be achieved by stimulating

In an embodiment of the present invention, the composition for preventing hair loss or promoting hair growth (or promoting hair growth) of the present invention may be used as a cosmetic composition, a pharmaceutical composition (for pharmaceutical composition, quasi-drug), or a health functional food composition. The composition of the present invention may be formulated in any form that can be applied to the skin in general, but may be formulated in the form of an external preparation for skin. The composition of the present invention may be formulated into a formulation that can be applied to the skin, such as, for example, liquid, cream, paste, or solid.

The sialic acid-containing whey protein of the present invention may be included in the composition or formulation as an anti-hair loss agent or a hair growth promoter.

In one embodiment of the present invention, in the cosmetic composition for preventing hair loss or stimulating hair growth, the content of sialic acid is preferably 0.001 to 30.0% by weight based on the total weight of the whey protein composition containing 5% or more sialic acid. More preferably, it is contained in an amount of 0.1 to 10% by weight based on the total weight of the composition, and may be more preferably 1.0 to 5% by weight. However, when the sialic acid-containing whey protein is less than 0.001% by weight, the hair growth promoting effect is insignificant, and when it exceeds 30% by weight, stability of the formulation is impaired and skin irritation may occur.

In the present invention, when the content of sialic acid is 0.1 to 5% by weight based on the total weight of the whey protein composition containing 5% or more sialic acid, it has been clinically shown to have an effect of preventing hair loss or stimulating hair growth. More preferably, the sialic acid-containing whey protein having a sialic acid content of 5% or more may be 1 to 5.0% by weight, most preferably 2 to 5% by weight, based on the total weight of the composition. In the present invention, it was confirmed through test examples that the whey protein containing sialic acid having a sialic acid content of 5% or more was excellent in preventing hair loss or stimulating hair growth when the content was within the above range.

The formulation of the cosmetic composition containing the sialic acid-containing whey protein of the present invention is not particularly limited and may be appropriately selected according to the purpose. For example, softening lotion (skin lotion and milk lotion), nourishing lotion, essence, nourishing cream, massage cream, pack, gel, essence, eye cream, eye essence, cleansing cream, cleansing foam, cleansing water, pack, powder, Body lotion, body cream, body oil, body essence, hair tonic, hair conditioner, hair essence, hair lotion, hair nutrition lotion, hair shampoo, hair conditioner, hair treatment, hair cream, hair nutrition cream, hair moisture cream, hair Massage cream, hair wax, hair aerosol, hair pack, hair nutrition pack, hair soap, hair cleansing foam, hair oil, hair drying agent, hair preservative, hair dye, hair waving agent, hair bleach, hair gel, hair glaze, hair dressing , hair lacquer, hair moisturizer, hair mousse and hair spray, but may be prepared in any one or more formulations selected from the group consisting of, but not limited thereto, preferably hair tonic, hair conditioner, hair essence, hair lotion, hair Nutrition lotion, hair shampoo, hair rinse, hair treatment, hair cream, hair nutrition cream, hair moisture cream, hair massage cream, hair wax, hair aerosol, hair pack, hair nutrition pack, hair soap, hair cleansing foam, hair oil, hair It can be formulated as a drying agent, hair preservative, hair dye, hair waving agent, hair bleach, hair gel, hair glaze, hair dresser, hair lacquer, hair moisturizer, hair mousse or hair spray.

When the composition containing the sialic acid-containing whey protein of the present invention is formulated into a cosmetic formulation, the composition of the present invention may contain all ingredients commonly used in cosmetics in addition to the extract, such as water-soluble vitamins, oil-soluble vitamins, It may contain a component selected from the group consisting of polymeric peptides, polymeric polysaccharides, sphingolipids, and seaweed extracts.

In the present invention, any polymeric peptide can be selected as long as it can be incorporated into cosmetics, but preferably collagen, hydrolyzed collagen, gelatin, elastin, hydrolyzed elastin, keratin and the like can be selected. Polymer peptides can be purified and obtained by conventional methods such as a purification method from a culture medium of microorganisms, an enzyme method, or a chemical synthesis method, or can be used after being purified from natural products such as pig or cow dermis or silkworm silk fibers.

In the present invention, as the polymeric polysaccharide, any polysaccharide that can be blended with cosmetics can be selected, but hydroxyethyl cellulose, xanthan gum, sodium hyaluronate, chondroitin sulfate or a salt thereof (sodium salt, etc.) is preferably selected. can For example, chondroitin sulfate or a salt thereof can be used after being purified from mammals or fish.

In the present invention, any sphingolipid can be selected as long as it can be blended with cosmetics, but ceramide, phytosphingosine, sphingoglycolipid and the like can be preferably selected. Sphingolipids can be purified by conventional methods or obtained by chemical synthesis from mammals, fish, shellfish, yeast, or plants.

In the cosmetic composition of the present invention, in addition to the above essential ingredients, other ingredients commonly used in cosmetic preparations may be incorporated as needed. In this case, the ingredients include oil and fat components, moisturizers, emollients, surfactants, organic and inorganic pigments, organic powders, ultraviolet absorbers, preservatives, bactericides, antioxidants, plant extracts, pH adjusters, alcohols, pigments, fragrances, and blood circulation promoters. , cooling agents, antiperspirants, purified water and the like can be used.

Ingredients included in the composition formulated as a cosmetic formulation of the present invention may include ingredients commonly used in cosmetics in addition to the extract as an active ingredient, for example, stabilizers, solubilizers, vitamins, pigments, and fragrances Such conventional adjuvants and carriers are included.

The pharmaceutical composition in the present invention means prepared for the purpose of preventing or treating a disease, and the pharmaceutical composition containing the sialic acid-containing whey protein of the present invention can be prepared by using suitable carriers, excipients and A diluent may be further included.

The pharmaceutical composition containing sialic acid-containing whey protein according to the present invention can be formulated according to conventional methods, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, sprays, external preparations, suppositories and sterile injection solutions. It can be formulated and used in the form of a powder, preferably in the form of a powder, granule, tablet or spray, more preferably in the form of a nasal spray, and may be used as a lubricant, wetting agent, flavoring agent, emulsifying agent, suspending agent, preservative, surfactant, etc. It may be formulated into a parenteral formulation using a diluent or excipient of and used.

In addition, it may be formulated and used in the form of external preparations, suppositories, external preparations for the skin, and sterile injection solutions. Specifically, the composition of the present invention can be used by a method such as directly applying or spreading to the hair or scalp. The hair to which the composition of the present invention is applied includes hair roots and hair follicles of the head, hair, eyelashes and eyelashes, beard, armpits, pubic hair, hair roots throughout the body, and all parts with hair follicles.

The pharmaceutical composition containing the sialic acid-containing whey protein of the present invention can be administered in a pharmaceutically effective amount. The pharmacologically effective amount means an amount that is sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment and does not cause side effects. It may be determined according to the activity of the drug, sensitivity to the drug, method of administration, time of administration, route of administration and excretion rate, duration of treatment, factors including drugs used in combination or concurrently, and other factors well known in the medical field.

Specifically, it is generally 0.01 mg to 5000 mg per day per 1 kg of body weight of the subject to be administered, and may be administered once or several times a day at regular time intervals according to the judgment of a doctor or pharmacist, but is not limited thereto. That is, the preferred dosage of the pharmaceutical composition containing the sialic acid-containing whey protein of the present invention varies depending on the condition and body weight of the patient, the severity of the disease, the type of drug, the route and duration of administration, but can be appropriately selected by those skilled in the art. . However, for desirable effects, the complex of the present invention is preferably administered at 0.2 to 200 mg per day, preferably 2 to 100 mg.

Administration may be administered once a day, or may be administered in several divided doses. The dosage is not intended to limit the scope of the present invention in any way.

The sialic acid-containing whey protein of the present invention can be administered to mammals such as rats, mice, livestock, and humans by various routes. All modes of administration are contemplated, eg oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine intrathecal or intracerebrovascular injection.

In addition, the pharmaceutical composition of the present invention may be used alone or in combination with other pharmaceutically active compounds exhibiting an effect of preventing or improving hair loss-related diseases or in a suitable set.

The pharmaceutical composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with conventional therapeutic agents. And it can be single or multiple administrations. It is important to administer the amount that can obtain the maximum effect with the minimum amount without causing side effects in consideration of all of the above factors, and can be easily determined by those skilled in the art.

For example, but not limited thereto, in addition to the pharmaceutical composition containing the sialic acid-containing whey protein of the present invention as an active ingredient, minoxidil, finasteride, spironolactone, or dutasteride, which are conventional anti-hair loss agents (dutasteride) can be selected and administered additionally.

As used herein, the term "administration" means introducing the pharmaceutical composition of the present invention to a subject by any suitable method, and the route of administration of the composition of the present invention can be various oral or parenteral routes as long as it can reach the target tissue. can be administered through

The administration method of the pharmaceutical composition according to the present invention is not particularly limited, and may follow a method commonly used in the art. As a non-limiting example of the administration method, the composition may be administered by oral administration or parenteral administration. Specifically, the composition of the present invention can be used by a method such as directly applying or spreading to the hair or scalp.

The pharmaceutical composition according to the present invention may be prepared in various formulations depending on the desired administration method.

The frequency of administration of the composition of the present invention is not particularly limited thereto, but may be administered once a day or administered several times by dividing the dose.

As another aspect, the present invention provides a method for preventing or treating hair loss-related diseases comprising administering a pharmaceutical composition containing whey protein containing sialic acid.

In the present invention, diseases related to causes of hair loss include Alopecia Areata, Androgenetic Alopecia, Telogen Efffluvium, Traumatic, Trichoti lomania, Pressure Alopecia, etc. It may include, but is not limited to, nasal congestion, syphilitic (Alopecia syphlltiac), seborrheic alopecia (Alopecia seborrhecia), symptomatic, scarring, congenital alopecia, etc., and may refer to all diseases caused by hair loss from the hair follicle. there is

In the present invention, the subject of hair loss may refer to all animals, including humans, having or are likely to have a hair loss-related disease. The animal may be not only humans but also mammals such as cattle, horses, sheep, pigs, goats, camels, antelopes, dogs, and cats that require treatment for similar symptoms, but are not limited thereto.

Specifically, the preventive or therapeutic method of the present invention may include administering the composition in a pharmaceutically effective amount to a subject having or at risk of developing a hair loss-related disease. The administration method is as described above.

The prevention may mean any act of suppressing or delaying the onset of hair loss-related diseases by administering the composition for preventing hair loss or stimulating hair growth according to the present invention to a subject.

In addition, the treatment may refer to any action that improves or benefits the symptoms of a hair loss-related disease by administering the composition of the present invention to a subject suspected of having a hair loss-related disease.

For administration, the composition of the present invention may contain pharmaceutically acceptable carriers, excipients or diluents in addition to the above-described active ingredients. The carriers, excipients and diluents include lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia gum, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methyl cellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

An appropriate dosage of the composition of the present invention varies depending on the condition and weight of the patient, the severity of the disease, the type of drug, and the time, but can be appropriately selected by those skilled in the art. Specifically, the dosage of the sialic acid-containing whey protein may be 50 to 500 mg.

The amount of the composition of the present invention can be appropriately adjusted according to individual differences such as age, severity of lesions, etc., or formulation, and it is preferable to apply an appropriate amount to the scalp once or several times a day and use it for one week to several months. In an embodiment of the present invention, the composition for preventing hair loss or stimulating hair growth was used 7 times a week for 3 months, and as a result, it was confirmed that an excellent effect of preventing hair loss or stimulating hair growth appeared (Formulation Example 2 and Test Example 5).

In the present invention, the term "food" refers to the food that people consume on a daily basis, and is a concept including health functional food.

The health functional food refers to food having bioregulatory functions such as disease prevention and improvement, biodefense, immunity, recovery after illness, and aging suppression, and should be harmless to the human body when taken for a long period of time.

The sialic acid-containing whey protein of the present invention may be added to a food composition for the purpose of preventing hair loss or promoting hair growth. When the sialic acid-containing whey protein of the present invention is used as a food additive, the compound may be added as it is or used together with other foods or food ingredients, and may be appropriately used according to a conventional method. The mixing amount of the active ingredient may be appropriately determined depending on the purpose of use (prevention, health or therapeutic treatment). In general, when preparing food or beverage, the compound of the present invention is added in an amount of 0.01 to 10% by weight, preferably 0.05 to 1% by weight of the raw material composition. However, in the case of long-term intake for the purpose of health and hygiene or health control, the amount below the above range may be used.

The food of the present invention can be prepared in all forms, such as functional food, nutritional supplement, health food and food additives, and there are no particular restrictions on the type of food. there is no Examples of foods to which the above substances can be added include meat, sausages, bread, chocolates, candies, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice creams, various soups, beverages, tea, drinks, There are alcoholic beverages, vitamin complexes, and the like, and includes all foods in a conventional sense.

The beverage composition of the present invention may contain various flavoring agents or natural carbohydrates as additional components. The aforementioned natural carbohydrates include monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As the sweetener, natural sweeteners such as thaumatin and stevia extract, or synthetic sweeteners such as saccharin and aspartame may be used.

The proportion of the natural carbohydrate is generally about 0.01 to 0.04 g, preferably about 0.02 to 0.03 g per 100 ml of the composition of the present invention.

In addition to the above, the composition of the present invention contains various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, A carbonation agent used in carbonated beverages and the like may be contained. The ratio of these additives is not very important, but is generally selected in the range of 0.01 to 0.1 parts by weight per 100 parts by weight of the composition of the present invention. In addition, the composition of the present invention may contain fruit flesh for preparing natural fruit juice, fruit juice beverages and vegetable beverages. The ratio of such flesh is not very important, but is generally selected in the range of 0.01 to 10 parts by weight per 100 parts by weight of the composition of the present invention. These components may be used independently or in combination.

Hereinafter, preferred preparation examples, formulation examples, examples and test examples will be described in detail to aid understanding of the present invention. However, the following preparation examples, formulation examples, examples, and test examples are only for exemplifying the present invention and may be modified in various other forms, and the scope of the present invention is not limited only to the following examples, and equivalent It includes all variations of technological ideas. Preparation examples, formulation examples, examples and test examples of the present invention are provided to more completely explain the present invention to those skilled in the art.

[Production Example 1] Preparation of sialic acid-containing whey protein

In general, in the production method of whey protein containing sialic acid, sialic acid and whey protein have a large difference in content or components depending on the type of raw material and processing method, respectively, and thus their functional, nutritional and physiologically active characteristics can be different. In the present invention, commercially available more refined sialic acid and whey protein were purchased and used. Sialic acid was purchased with a purity of over 99% from Huacheng, China, and whey protein wasolate from Australia was purchased and used with a purity of over 99%. In the preparation of the whey protein containing sialic acid, the purchased sialic acid content was 0.1% by weight, 0.5% by weight, 1.0% by weight, 2.5% by weight, 5.0% by weight, 7.5% by weight, and 10.0% by weight based on the total weight of whey protein. A total of 7 types of sialic acid-containing whey proteins, including as much as possible, were prepared, and are shown in Table 1 below.

Table 1

[Test Example 1] Proliferative effect of dermal papilla cells

To investigate the effect of sialic acid-containing whey protein on the proliferation of human hair follicle dermal papilla cells (hereinafter referred to as HHFDPC), which are the main cells of hair growth, the proliferation capacity of dermal papilla cells was measured. Human dermal papilla cells were purchased from PromoCell, and the HHFDPC was supplemented with a culture medium additive (Supplement Mix; PromoCell, Heidelberg, Germany), 100 units/mL of penicillin, and 100 μg of streptomycin. Cell Growth Medium; PromoCell, Heidelberg, Germany) was cultured at 37°C and 5% CO ₂ conditions. Specifically, after culturing HFDPC, it was inoculated into a 96-well plate (1.5 x 10 ⁴ cells/well), and incubated in a 5% CO ₂ incubator at 37° C. for 24 hours. HFDPC cells were used in this test.

Dimethylsulfoxide (DMSO) diluted 1:1000 in Dulbecco's modified Eagle's medium (DMEM) containing 1% fetal bovine serum (FBS), 100 units/mL of penicillin, 100 μg of streptomycin, and 1 ng/mL βFGF to the cultured cells. ) as a control, 0.1 μg of minoxidil as a positive control, and 0.1, 0.5, and 1 μg concentrations for each concentration for a total of 7 types of Examples 1 to 7, respectively, and then treated at 37 ° C. and 5% CO ₂ conditions. Incubated again for 48 hours. After 72 hours, the cell culture supernatant was removed by centrifugation, washed once with PBS (Phosphate Buffer Saline) solution, and MTT (3-[4,5-dimethylthiazol-2-yl]-2 dissolved in 1 mg/mL ,5-diphenyltetrazolium bromide) reagent (Sigma, USA) was diluted 10 times, mixed with the medium, treated, and incubated for 1-2 hours, after which the MTT reagent was removed. When formazan crystals are observed in each well, 200 μl of DMSO per well is added and gently shaken for 30 minutes in a light-shielded state to dissolve the formazan crystals. The degree of cell proliferation was evaluated. CCK-8 was treated in a culture solution at a ratio of 1:10 and incubated for 1 hour, and then the absorbance at 450 nm was repeatedly measured three times using a spectrophotometer for each well, and the average of the absorbance values was calculated.

Table 2

The measurement results of the dermal papilla cell proliferation rate are shown in Table 2, and the results show the dermal papilla cell proliferation effect in all of the treatments at concentrations of 0.1, 0.5, and 1 μg, respectively, for Examples 1 to 7 of the preparation example. Confirmed. Even at the same 0.1 μg treatment concentration as minoxidil, which is a positive control, Examples 1 to 3 showed a relatively low dermal papilla cell proliferation rate compared to Minoxidil, Example 4 showed a level almost similar to that of Minoxidil, and Examples 5 to 7 showed a relatively lower proliferation rate than Minoxidil. It showed a high dermal papilla cell proliferation rate. In particular, the difference in dermal papilla cell proliferation rate in Examples 5 to 7 was almost similar and did not show a significant difference. In addition, even at the treatment concentrations of 0.5 and 1 μg for Examples 1 to 7, the pattern of dermal papilla cell proliferation was not significantly different from that of the treatment concentration of 0.1 μg.

Therefore, it can be confirmed that the sialic acid-containing whey protein having a sialic acid content of 5.0% by weight or more based on the total weight of whey protein has a superior effect on promoting dermal papilla cell proliferation compared to minoxidil.

[Test Example 2] Inhibitory effect of 5-alpha-reductase activity

From the results of Test Example 1, it was confirmed that Examples 5 to 7, which are sialic acid-containing whey proteins containing sialic acid content of 5.0% by weight or more with respect to the total weight of whey protein, have excellent dermal papilla cell growth promoting effects, The measurement of the ability to inhibit the activity of 5 alpha-reductase in this test was preferably carried out using Examples 5 to 7.

In order to evaluate the activity of 5 alpha-reductase in dermal papilla cells, dermal papilla cells were dispensed at 0.8 x 10 ⁶ cells/dish in a 60 mm cell culture dish. After 24 hours of culture, the existing culture medium was removed, and no additives were added (0 mg/mL) as a control for each dish, finasteride (1 mg/mL) as a positive control, Examples 5 to 7 (1 mg/mL) were treated, respectively, and exchanged again with the culture medium containing each of them, and cultured for 24 hours. After culturing, the existing culture medium was removed, washed with 1 x PBS, and treated with Trypsin/EDTA to make each single cell. After centrifugation, the cells were lysed using an extraction buffer (880 mM Sucrose, 1.5M CaCl ₂ ), and then the supernatant obtained by centrifugation was taken and used as a crude enzyme solution for the measurement test of 5-alpha-reductase activity inhibition ability. used The measurement and analysis method calculated the activity of 5-alpha-reductase by measuring the change in the amount of NADPH, a substrate used when testosterone is converted to dihydrotestosterone, by absorbance, and the crude enzyme solution (protein 35 μg), 20 μM testosterone (Sigma, USA) and 320 μM NADPH (Sigma, USA) were mixed and incubated for 30 minutes, and then the absorbance of the mixture was measured at 340 nm using a spectrophotometer to obtain 5 alpha -The activity of the reductase was analyzed.

Table 3

As shown in Table 3, when finasteride, which is known to inhibit the activity of 5-alpha-reductase, was treated at a concentration of 1 mg/mL, a relative activity of 76.18±2.81% was shown, whereas the treatment of Examples 5 to 7 The activity of 5 alpha-reductase in one test group was 56.73 ± 2.47% in Example 5, 54.81 ± 2.69% in Example 6, and 53.52 ± 2.21% in Example 7, respectively. It can be seen that all sections of Examples 5 to 7 inhibit the activity of 5-alpha-reductase more effectively than finasteride.

Therefore, it can be confirmed that the whey protein containing sialic acid having a sialic acid content of about 5.0% by weight or more relative to the total weight of whey protein is more effective than finasteride in inhibiting the activity of 5-alpha-reductase.

[Test Example 3] Wint/beta-catenin signaling pathway activation effect

From the results of Test Example 2, since the activity inhibitory effect of 5-alpha-reductase between Examples 5 to 7 was found to be almost similar, the activation of the wint/beta-catenin signaling pathway in this test is preferably measured. This was done using Example 5 only.

The method for measuring the activation level of dermal papilla cells, which are critically involved in hair follicle formation and regeneration, starts with a protein called Wnt, which is known to play an important role in maintaining and activating genes expressed during the growth of the hair cycle. Beta-catenin/TCF (T-cell factor) was measured using the TCF reporter luciferase system, which is a method for evaluating the activation of the wint/beta-catenin signaling pathway that is transferred to transcription factors.

As for human dermal papilla cells (HHFDPC), HFDPC cells cultured in the same way as in Test Example 1 were used in this experiment, and Wnt3a protein was used as a positive control to activate the wint/beta-catenin signaling pathway, and as a negative control. used DMSO. About 3 × 10 ⁴ Wnt reporter HEK293A cells were dispensed into each well in a 96-well plate, and 18 hours later, Example 5 was treated at a concentration of 5 μg, 10 μg, and 20 μg, respectively. did Then, Wint reporter analysis was performed according to the protocol using Promega's Luciferase assay kit, and Wint/beta-catenin promoter activity was measured using PerkinElmer's luminometer Victor.

As shown in FIG. 1, the whey protein containing sialic acid of Example 5, in which the sialic acid content is 5.0% by weight based on the total weight of whey protein, amplifies the wint/beta-catenin signal by 8.74 times compared to the untreated negative control group. It became. In addition, the test group including Example 5 did not show a concentration-dependent aspect, but it was confirmed that there was a repeatable effect at a concentration of around 20 μg/mL. In particular, Example 5 showed almost similar effects when compared to the positive control Wnt3a protein (8.7 times) binding to the direct receptor of wint/beta-catenin.

Therefore, whey protein containing sialic acid, which contains 5.0 wt% of sialic acid content relative to the total weight of whey protein, promotes the activity of the wint/beta-catenin signaling pathway, which is a hair growth promoting signal of hair follicle stem cells, to activate TCF transcription factors. It can be confirmed that there is an excellent hair growth promoting effect by activating.

Taken together, from the results of Test Examples 1, 2, and 3, the sialic acid-containing whey protein having a sialic acid content of preferably 5.0% by weight or more relative to the total weight of the whey protein has an effect on promoting the proliferation of dermal papilla cells. , It was confirmed that the effect of inhibiting the activity of 5-alpha-reductase and the effect of promoting activation of the beta-catenin signaling pathway were remarkably excellent.

[Formulation Example 1] Hair Essence

In this formulation example, the hair essences of Example 7 and Comparative Example 1 were prepared in a conventional manner according to the prescriptions shown in Table 4 below.

Table 4

[Test Example 4] Safety confirmation test on human skin

In order to confirm whether the whey protein-containing composition containing sialic acid according to the present invention is safe for human skin when used, a skin irritation test was performed as part of skin safety verification.

The subjects of the present invention were selected as a panel of 30 men and women composed of Catholic University students, and the hair essences of Example 7 and Comparative Example 1 in Table 4 were used for the test subjects. Specifically, after washing the back skin, the water was wiped off, and it was allowed to wait for 15 minutes in a constant temperature and humidity room (temperature 24 ± 4 ° C, relative humidity 40-45%). The same amount of the scalp essence of Example 7 was sufficiently applied to the cotton wool so that it did not flow, and it was attached to the position of the skin on the back. After 24 hours and 48 hours after attaching the test substance, the subject indicated the degree of stimulation from 0 to 4 points (0 = no stimulation, 1 = very weak, 2 = weak, 3 = moderate, 4 = severe). (measured twice in total), stimuli such as stinging and burning were evaluated.

Table 5 below shows the number of subjects who complained of irritation according to the rating for each time period, and the average value was calculated to derive a mean score for skin irritation.

table 5

From the results in Table 5, the hair essence composition containing 10% of Example 7 showed no skin irritation, the same as Comparative Example 1, which did not contain sialic acid-containing whey protein.

Therefore, even in the composition according to the present invention using sialic acid-containing whey protein containing 10.0% by weight of sialic acid content relative to the total weight of whey protein, it is safe to the human body, does not irritate the scalp, and has no side effects even when used for a long time. Confirmed.

[Formulation Example 2] Hair Tonic

In this formulation example, the content of the composition of Example 5 was 0.1, 0.5, 1.0, 2,.0 and 5.0% by weight of Examples 5-1, 5-2, 5-3, 5-4, and 5-5, and The hair tonic of Comparative Example 2 was prepared by a conventional method according to the prescription shown in Table 6 below.

table 6

[Test Example 5] Confirmation of the effect of promoting hair growth

From the results of Test Examples 1, 2, and 3, the sialic acid-containing whey protein having a sialic acid content of preferably 5.0% by weight or more relative to the total weight of whey protein has an effect of promoting proliferation of dermal papilla cells, 5 alpha-reduction As it was confirmed that the effect of inhibiting enzyme activity and the effect of promoting the activation of beta-catenin signaling pathway were excellent, in the present invention, the hair tonic of Examples 5-1 to 5-5 is preferably a sialic acid-containing whey protein. A hair growth promoting effect test was conducted on the composition.

For the human body application test, the Ministry of Food and Drug Safety's "Guidelines for human application test of cosmetics that help alleviate hair loss symptoms" were applied, and the test subjects for the present invention were found to have significantly less hair than normal or hair loss through a questionnaire. A total of 60 men and women in their 20s to 50s who were recognized to have symptoms were divided into two groups consisting of 50 experimental groups and 10 non-control groups, and the purpose and purpose of the present invention was explained to all of them, and After receiving the consent to participate in the application experiment, an experiment to verify the effect of the present invention on the improvement of hair growth was conducted centering on the subjects.

Specifically, the test subject was a panel consisting of 60 adult men and women, 10 students composed of Catholic University students and their direct descendants and 50 their direct descendants, and the experimental group was the hair tonic composition of Formulation Example 2, the above Example 5-1, 5- According to 2, 5-3, 5-4, and 5-5, a total of 50 people were selected by dividing into 5 groups, 10 people each, and the remaining 10 people were selected as a control group. In order to confirm the hair growth promoting effect, Examples 5-1 to 5-5 and Comparative Example 2 were used, and were used on hair and scalp 7 times a week for 3 months.

After use, it was evaluated by dividing it into three stages according to the degree of improvement or damage as an evaluation criterion for four evaluation items such as thickness of hair, degree of denseness, volume and elasticity, respectively, and for each of Examples 2-1 to 2-5 An overall evaluation was judged (degree of improvement: +5, +4, +3, +2, +1, no improvement: 0, degree of impairment: -1, -2, -3, -4, -5). After 3 months from the start of use, the evaluation of the thickness and density of hair was carried out using a hair diagnostic device IS-3000C (Besutopia, Korea) to measure the change in hair diameter and number of hairs in the phototrichogram And, together with the results, the evaluation of the thickness, density, volume and elasticity of the hair was added together with the results of the user questionnaire in the form of a questionnaire survey, and the overall evaluation was calculated and determined.

table 7

From the results in Table 7, it was evaluated that Examples 5-4 and 5-5 exhibited a very high hair growth promoting effect compared to Comparative Example 2 that did not contain sialic acid-containing whey protein.

Therefore, it was confirmed that whey protein containing sialic acid of 5.0% by weight based on the total weight of whey protein can be effectively used for hair growth promotion when preparing a hair tonic composition with a content of 2% or more of sialic acid.

In summary, containing the sialic acid-containing whey protein of the present invention as an active ingredient promotes hair growth by inducing proliferation of dermal papilla cells and inhibits the production of dihydrotestosterone by inhibiting the activity of 5-alpha-reductase. Of course, it was confirmed that the effect of promoting the activation of the wint/beta-catenin signaling pathway was excellent.

Having described specific parts of the present invention in detail above, it is clear that these specific techniques are only preferred embodiments for those skilled in the art, and the scope of the present invention is not limited thereto. Accordingly, the substantial scope of the present invention will be defined by the appended claims and equivalents thereof.

Hereinafter, formulation examples of the cosmetic composition and pharmaceutical composition for preventing hair loss and promoting hair growth containing sialic acid-containing whey protein according to the present invention are presented. It is not intended to be limiting, but merely intended to be specific.

[Formulation Example 3] Cosmetic formulation

[Formulation Example 3-1] Hair shampoo

Hair shampoo was prepared in a conventional manner according to the composition shown in Table 8 below.

Table 8

[Formulation Example 3-2] Hair Treatment

Hair treatment was prepared in a conventional manner according to the composition shown in Table 9 below.

Table 9

[Formulation Example 3-3] Hair Serum

According to the composition shown in Table 10 below, a hair serum was prepared by a conventional method.

Table 10

[Formulation Example 3-4] Hair nutrient lotion

According to the composition shown in Table 11 below, a hair nourishing lotion was prepared in a conventional manner.

Table 11

[Formulation Example 2] Pharmaceutical formulation

[Formulation Example 4-1] Preparation of powder

Powders were prepared in a conventional manner according to the compositions shown in Table 12 below.

Table 12

[Formulation Example 4-3] Preparation of capsule formulation

According to the composition shown in Table 13 below, capsules were prepared by filling gelatin capsules in a conventional manner.

Table 13

[Formulation Example 4-5] Preparation of ointment

An ointment was prepared by a conventional method according to the composition shown in Table 14 below.

Table 14

[Food Formulation]

[Formulation Example 5-1] Production of Drinking Agent

80 mg of whey protein containing sialic acid, 9 mg of vitamin E, 9 mg of vitamin C, 10 g of glucose, 0.6 g of citric acid, and 25 g of liquid oligosaccharide were mixed, and then 300 ml of purified water was added to fill each bottle to a volume of 200 ml. After filling the bottle, the beverage was prepared by sterilizing at 130 ° C. for 4 to 5 seconds.

[Formulation Example 5-2] Preparation of granules

80 mg of whey protein containing sialic acid, 9 mg of vitamin E, 9 mg of vitamin C, 250 mg of anhydrous crystalline glucose, and 550 mg of starch were mixed, molded into granules using a fluidized bed granulator, and filled into bags.

[Prior art literature]

[Patent Literature]

(Patent Document 0001) Republic of Korea Patent Registration No. 10-1119148

(Patent Document 0002) Republic of Korea Patent Registration No. 10-1119538

(Patent Document 0003) Republic of Korea Patent Registration No. 10-1355018

Claims (6)

A composition for preventing hair loss or promoting hair growth, comprising whey protein containing sialic acid as an active ingredient. According to claim 1,
The composition for preventing hair loss or stimulating hair growth, characterized in that the sialic acid content in the sialic acid-containing whey protein is 1 to 30% by weight based on the total protein weight of the sialic acid-containing whey protein. According to claim 1,
The composition promotes hair growth by inducing the proliferation of dermal papilla cells, inhibits the activity of 5-alpha-reductase to inhibit the production of dihydrotestosterone, and promotes the activity of the wint/beta-catenin signaling pathway. A composition for preventing hair loss or promoting hair growth. According to claim 1,
The composition is a composition for preventing hair loss or promoting hair growth, characterized in that for increasing the thickness, density, volume and elasticity of the hair. According to claim 1,
The content of the extract is characterized in that contained in 0.001 to 30.0% by weight relative to the total weight of the composition for preventing hair loss or hair growth promoting composition. According to any one of claims 1 to 5,
The composition is a composition for preventing hair loss or promoting hair growth, characterized in that the cosmetic composition, pharmaceutical composition and food composition.

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