KR102508704B1 - Complex formulation for preventing hair loss with a core-shell structure and health functional food having the same - Google Patents

Abstract

The present invention relates to a complex formulation for preventing hair loss with a core-shell structure and health functional food thereof. The complex formulation for preventing hair loss comprises a core forming composition and a shell forming composition as active ingredients. The complex formulation includes: a core layer having the core-forming composition containing a Canna generalis Bailey extract and a celery extract; and a shell layer formed on the entire surface of the core layer.

Description

Complex preparation for preventing hair loss with core-shell structure and health functional food

The present invention relates to a complex preparation for preventing hair loss having a core-shell structure and a health functional food.

In general, the causes of hair loss in humans include genetic factors, progress of aging, drug intake, radiation treatment, and stress after serious illness. From a biochemical and physiological point of view, hair loss is known to be due to three main causes: hyperactivity, scalp blood circulation problems, and deficiency of essential nutrients for hair metabolism.

Although the above three factors alone can cause hair loss, when the hair loss factors are combined to cause a synergistic effect, alopecia is accelerated and the symptoms become severe. In particular, if the generation, change, recognition, and signal transmission process of male hormones are excessively activated due to genetic factors or acquired special conditions, and the hair follicle tissue tends to age prematurely, there is a high probability of baldness earlier than normal people. . In addition, if the tension of the scalp is easily increased due to genetic factors, aging, Western high-fat diet, and other external factors, or if there are symptoms such as arteriosclerosis, blood circulation disorders easily occur, resulting in problems in smooth hair metabolism. In recent years, not only male pattern baldness, but also hair loss in young people, including obesity-related hair loss in women, is gradually spreading, and many types of hair loss treatments, hair growth agents, etc. are commercially available to improve such hair loss phenomenon.

Minoxidil, a commercially available representative hair loss treatment, was originally developed to lower blood pressure and was a treatment for hypertension, but as a side effect of use, hair growth appeared, making it a drug that has become more famous as a hair growth agent. However, excessive use of minoxidil preparations is known to cause side effects such as contact dermatitis such as scalp itching, erythema, and keratin, or hirsutism (J Korean Med Assoc 2013 January; 56(1): 45-54).

Another representative hair loss treatment drug, Propesia, inhibits the conversion of testosterone to dihydrotestosterone (DHT) by blocking 5-alpha-reductase type 2 enzyme, which plays an important role in the onset of androgenetic alopecia, thereby preventing hair loss. known to inhibit progression. Propecia is known to have an excellent hair loss prevention effect, but the reagents used in manufacturing it are expensive and toxic, and since it works by artificially blocking the production of steroid hormones itself, various side effects may occur. There is a risk. Accordingly, there is still a need for the development of a safe therapeutic agent with excellent hair loss prevention and hair growth promoting efficacy and no side effects.

In addition, brewer's yeast and biotin, which are used as nutrients rather than as therapeutic agents, are recently used as nutrients for preventing hair loss. L-cysteine contained in brewer's yeast and biotin can provide a vitamin B-rich anti-hair loss agent, but side effects such as gout, which is a problem of brewer's yeast itself, occur when taken in excess and for a long period of time.

Accordingly, there is still a need for the development of a safe therapeutic agent with excellent hair loss prevention and hair growth promoting efficacy and no side effects.

Korean Patent Publication No. 10-2012-0069407

One object of the present invention is a composite formulation for preventing hair loss comprising a core-forming composition and a shell-forming composition as active ingredients, wherein the composite formulation includes a red plant extract; and a core layer comprising the core-forming composition comprising a celery extract; and a shell layer formed on the entire surface of the core layer, wherein the shell layer includes a biotin extract; and the shell-forming composition comprising effective dry yeast, wherein the effective dry yeast includes dry brewer's yeast and dry yeast chromium, and based on 100 parts by weight of the dry brewer's yeast, the dry yeast chromium is 0.1 parts by weight or more 5 parts by weight. It is intended to provide a combination preparation for preventing hair loss that is included in a part or less, and the ratio of the outer diameter: the outer diameter of the core of the combination preparation satisfies 1:0.3 to 1:0.65.

Another object of the present invention is to provide a health functional food for preventing or treating hair loss comprising the above complex formulation.

However, the technical problem to be achieved by the present invention is not limited to the above-mentioned problems, and other problems not mentioned will be clearly understood by those skilled in the art from the following description.

According to one embodiment of the present invention, a complex preparation for preventing hair loss comprising a core-forming composition and a shell-forming composition as active ingredients, wherein the complex preparation includes a red plant extract; and a core layer comprising the core-forming composition comprising a celery extract; and a shell layer formed on the entire surface of the core layer, wherein the shell layer includes a biotin extract; and the shell-forming composition comprising effective dry yeast, wherein the effective dry yeast includes dry brewer's yeast and dry yeast chromium, and based on 100 parts by weight of the dry brewer's yeast, the dry yeast chromium is 0.1 parts by weight or more 5 parts by weight. part or less, and the ratio of the outer diameter: the outer diameter of the core of the combination preparation satisfies 1:0.3 to 1:0.65.

In the present invention, based on 100 parts by weight of the core forming composition, 70 parts by weight or more and 90 parts by weight or less of the hongcho extract; And it provides a combination preparation for preventing hair loss comprising 10 parts by weight or more and 30 parts by weight or less of the celery extract.

In the present invention, 0.01 parts by weight or more and 0.1 parts by weight or less of the biotin extract based on 100 parts by weight of the shell-forming composition; And it provides a complex preparation for preventing hair loss comprising 80 parts by weight or more and 97 parts by weight or less of the effective dry yeast.

In the present invention, it is intended to provide a combination preparation for preventing hair loss in which the chromium content in the dry yeast chromium is 1 wt% or less.

In the present invention, the complex preparation is prepared according to the dissolution test method 2 (paddle method) of the Korean Pharmacopoeia at 37° C., pH 4.0, and the shell-forming composition contained in a water eluate containing 70 to 70% of the total weight of the active ingredient after 1 hour. 85%, to provide a combination preparation for preventing hair loss that satisfies the dissolution profile in which the core-forming composition is dissolved in the range of 5 to 10% of the total weight of the active ingredient after 1 hour.

In the present invention, the complex preparation is prepared according to the dissolution test method 2 (paddle method) of the Korean Pharmacopoeia at 37° C., pH 4.0, and the shell-forming composition contained in a water elution solution after 4 hours from 5 to 5% of the total weight of the active ingredient. 10%, to provide a combination preparation for preventing hair loss that satisfies a dissolution profile in which the core-forming composition is dissolved in the range of 80 to 90% of the total weight of the active ingredient after 4 hours.

In the present invention, the shell-forming composition is selenium, cellulose, magnesium stearate, catechin, cathinone, tryptamine, P-octopamine, P-tyramine ), synephrine (Synephrine) and ephedrine (Ephedrine) to provide a combination preparation for preventing hair loss further comprising any one or more selected from the group consisting of.

Finally, in one embodiment of the present application, it is intended to provide a health functional food containing the above-described combination preparation for preventing hair loss.

The combined preparation for preventing hair loss provided by the present invention has excellent efficacy in preventing and treating problems such as hair loss and nail breakage.

The complex preparation for preventing hair loss according to the present application includes a substance effective for hair loss as a shell-forming composition, and at the same time, in order to solve problems such as gout, which is a side effect thereof, it is characterized by including a core-forming composition as an antioxidant effective for ventilation. . Among them, the present invention has a composite formulation having the above-mentioned active ingredients, the composite formulation has a structure of a core and a shell, and the ratio of the outer diameter of the composite formulation to the outer diameter of the core satisfies 1:0.3 to 1:0.65. It is characterized by doing.

That is, as described above, the outer diameter ratio of the core satisfies a certain range (ie, by adjusting the ratio of the core and the shell) based on the entire composite formulation, so that the amount of the active ingredient eluted within a certain time can be effectively controlled. do. That is, as the core-forming composition and the shell-forming composition included as active ingredients are not eluted at once, but are provided in the form of a complex formulation to satisfy the specific structure of the core-shell, a high content of the required composition is eluted within a certain period of time, and then It is characterized by continuous elution of branched substances.

Accordingly, the hair loss prevention effect can be continuously obtained, and at the same time, the core-forming composition starts to be secreted from about 4 hours after administration of the complex preparation (ie, the time it passes through the stomach and stays in the intestine). The core-forming composition is a natural material containing an antioxidant that is good for gout, but when such a material is secreted from the stomach after administration, side effects such as heartburn may occur due to its acidity. The main feature of the composite formulation according to the present application is that it is simply formed into a core-shell structure to solve this problem, and the core-forming composition is controlled to be secreted after a certain period of time after administration.

After all, the combination preparation according to the present invention is characterized in that it includes a core-forming composition that can continuously have the existing hair loss prevention effect and solve problems such as gout, which is a side effect thereof, and each of them It is characterized in that it exhibits a more excellent effect by adjusting the administration rate of the composition.

However, it should be understood that it is not limited to the above effects, and includes all effects that can be inferred from the configuration of the invention described in the detailed description or claims.

1 is a diagram schematically showing a combination preparation according to an exemplary embodiment of the present invention.

Hereinafter, examples will be described in detail to aid understanding of the present invention. However, the following examples are merely illustrative of the contents of the present invention, and the scope of the present invention is not limited to the following examples. The embodiments of the present invention are provided to more completely explain the present invention to those skilled in the art. The present invention may be embodied in other forms without being limited only to the embodiments presented here.

In the present invention, the term "extracted material" or "extract" refers to an extract obtained by extraction treatment, a diluted or concentrated solution of the extract, a dried product obtained by drying the extract, a crude or purified product of the extract, or a mixture thereof. Etc., the extract itself and extracts of all formulations that can be formed using the extract.

The extract of the present specification follows the dictionary definition, and is obtained by concentrating a specific component in the extract, separating a specific active component with a suitable solvent, completely or mostly evaporating the solvent, and adjusting the remaining lump or powder according to the standard. It can mean one, and in the present specification, the extract is meant to include all three types, namely semi-fluid or syrup-like, pill-like or solid, dried powder, etc. can be used

The extract of the present specification follows the dictionary definition, and may mean a substance in a liquid state extracted from a specific substance or state.

According to one embodiment of the present invention, a complex preparation for preventing hair loss comprising a core-forming composition and a shell-forming composition as active ingredients, wherein the complex preparation includes a red plant extract; and a core layer comprising the core-forming composition comprising a celery extract; and a shell layer formed on the entire surface of the core layer, wherein the shell layer includes a biotin extract; and the shell-forming composition comprising effective dry yeast, wherein the effective dry yeast includes dry brewer's yeast and dry yeast chromium, and based on 100 parts by weight of the dry brewer's yeast, the dry yeast chromium is 0.1 parts by weight or more 5 parts by weight. part or less, and the ratio of the outer diameter: the outer diameter of the core of the combination preparation satisfies 1:0.3 to 1:0.65.

The combination preparation according to the present invention is characterized in that it includes a core-forming composition that can continuously have the existing hair loss prevention effect and solve problems such as gout, which is a side effect thereof. It is characterized in that it shows a better effect by adjusting the administration rate.

In the present invention, the drying of the extract may be carried out by a known method within the range of not destroying useful components from the collected natural material, and may be carried out, for example, by natural drying in the shade. In addition, crushing or pulverization may be pulverized by crushing or pulverizing to the extent that useful components of the plant can be sufficiently extracted in the subsequent extraction process. The drying and crushing or crushing process may be carried out in reverse order or repeatedly if necessary.

In the extraction of the present invention, the extraction method is not particularly limited, and may be extracted according to a method commonly used in the art. Non-limiting examples of the extraction method include a hot water extraction method, an ultrasonic extraction method, a filtration method, a reflux extraction method, and the like, which may be performed alone or in combination of two or more methods.

In particular, the type of extraction solvent used to extract natural substances in the present invention is not particularly limited, and any solvent known in the art may be used.

In this application, biotin is a vitamin containing sulfur and is involved in fat and carbohydrate metabolism. Biotin acts as an essential cofactor for four decarboxylase enzymes, three of which are involved in energy and amino acid metabolism and one is involved in making fatty acids. Biotin is called 'vitamin H' because it has a good effect on the skin and hair. In addition, 　Biotin is involved in the production of blood cells and the secretion of male hormones, and together with other B vitamins, it facilitates the function of the nervous system and bone marrow.

In this application, pomegranate, Schisandra chinensis, raspberry, red ginseng, grape, mulberry, and baengnyeoncho are used for the preparation of the hongcho extract. Preparation of the hongcho extract is as follows.

First, pomegranate, Schisandra chinensis, raspberry, red ginseng, grape, mulberry, and white lotus root are cleaned with pure purified water to remove foreign substances such as fine dust. If each natural product has a wound, it is cut out and the skin and seeds of each natural product are used as they are. Then, these natural products are taken out and finely pulverized, and the pulverized natural products are put into respective brewing vessels. At this time, fill only up to about 70% of the container and leave about 30% of the top empty. Then, add dry yeast and mix so that it penetrates well throughout the ingredients. Next, the lid of the brewing vessel for fermentation is covered with a double layer of Korean paper to allow air to pass through and tied with a string. It is fermented for more than 3 months in a place where there is no direct sunlight, relatively constant temperature and good air circulation. In this way, the matured ingredients are squeezed or filtered to prepare pomegranate vinegar, Schisandra chinensis, bokbunja vinegar, red ginseng vinegar, grape vinegar, odocho, and white lotus vinegar, respectively, and mixed to form a hongcho extract, which is then dried to obtain a hongcho extract. formed. The hongcho extract is known to have excellent antioxidant performance.

In the present application, the celery extract refers to an extract of finely minced commercially available celery and dried in a powder form, and is known to have excellent antioxidant performance like the hongcho extract.

In one embodiment of the present application, a complex preparation for preventing hair loss comprising a core-forming composition and a shell-forming composition as active ingredients, wherein the complex preparation includes a red plant extract; and a core layer comprising the core-forming composition comprising a celery extract; and a shell layer formed on the entire surface of the core layer.

The composite formulation according to the present application is a physically simple core-shell structure, and rather than controlling the secretion of components according to the pH of a substance such as a medical double tablet or triple tablet, by adjusting the outer diameter ratio of the core and shell layers, It is characterized by simply adjusting the amount of ejection.

Hereinafter, each of the core layer and the shell layer will be described.

In one embodiment of the present application, the shell layer is a biotin extract; and the shell-forming composition comprising effective dry yeast.

At this time, the shell layer may contain an active ingredient that has effects such as preventing hair loss and nail breakage.

In one embodiment of the present application, 0.01 parts by weight or more and 0.1 parts by weight or less of the biotin extract based on 100 parts by weight of the shell-forming composition; And it provides a complex preparation for preventing hair loss comprising 80 parts by weight or more and 97 parts by weight or less of the effective dry yeast.

In another embodiment, 0.01 parts by weight or more and 0.1 parts by weight or less of the biotin extract based on 100 parts by weight of the shell-forming composition; Preferably it may be 0.01 parts by weight or more and 0.05 parts by weight or less, and may include more specifically 0.02 parts by weight.

In one embodiment of the present application, the effective dry yeast may be 80 parts by weight or more and 97 parts by weight or less, preferably 85 parts by weight or more and 96 parts by weight or less, more preferably 90 parts by weight or more and 95 parts by weight or less. Specifically, it may include 94 parts by weight.

In one embodiment of the present application, the effective dry yeast includes dry brewer's yeast and dry yeast chromium, and based on 100 parts by weight of the dry brewer's yeast, the dry yeast chromium may be included in an amount of 0.1 part by weight or more and 5 parts by weight or less. .

In another embodiment, the effective dry yeast includes dry brewer's yeast and dry yeast chromium, and based on 100 parts by weight of the dry brewer's yeast, the dry yeast chromium is 0.1 parts by weight or more and 5 parts by weight or less, preferably 0.2 parts by weight or more. Part by weight or more and 3 parts by weight or less, more preferably 0.3 parts by weight or more and 1 part by weight or less, may be specifically 0.48 parts by weight.

In the present application, the shell-forming composition as described above may include a biotin extract and effective dry yeast, and may specifically include the above weight parts. In the case of including the weight part, it is possible to show a special effect in preventing and preventing hair loss at the same time as supplying vitamin b. In addition, by including the dry yeast chromium in the weight part, nutrition and vitamins are added compared to the case of containing only the existing dry brewer's yeast. It has features that can be supplied.

In one embodiment of the present application, a combination preparation for preventing hair loss in which the chromium content in the dry yeast chromium is 1 wt% or less is provided.

At this time, the content of chromium may mean the amount of atoms included, and the chromium content may be 1 wt% or less, specifically 0.5 wt% or less, 0.1 wt% or more, and specifically 0.3 wt%.

In the present application, the shell forming composition is selenium, cellulose, magnesium stearate, catechin, cathinone, tryptamine, P-octopamine, P-tyramine Tyramine), synephrine (Synephrine) and ephedrine (Ephedrine) to provide a combination preparation for preventing hair loss further comprising any one or more selected from the group consisting of.

The selenium, cellulose, magnesium stearate, catechin, cathinone, tryptamine, P-octopamine, P-tyramine, synephrine and The group consisting of ephedrine can be classified into other compositions, and based on 100 parts by weight of the shell forming composition, 1 part by weight or more and 10 parts by weight or less, more specifically 3 parts by weight or more and 5 parts by weight or less, more specifically 5.9 parts by weight wealth may be included.

The other composition corresponds to substances that may be included in a complex formulation, such as inorganic substances and solvents.

In one embodiment of the present application, the shell layer may be formed on the entire surface of the core layer. At this time, the composite formulation can be specifically identified in FIG. 1 . Specifically, FIG. 1 schematically shows a combination preparation according to an exemplary embodiment of the present invention, and it can be seen that a shell layer is formed on the front surface of the core layer of the combination preparation. As described above, when the shell layer is formed on the front part, the core-forming composition is not extracted in high content at the beginning of administration, so it has a feature that can solve gastrointestinal problems such as heartburn.

In one embodiment of the present application, the core layer is hongcho extract; And it may include the core forming composition comprising a celery extract.

The core layer corresponds to a composition for solving problems such as ventilation, which is a problem during long-term administration of the shell-forming composition included in the above-described shell layer. That is, the core layer corresponds to a layer used to alleviate the side effects of the complex preparation for preventing hair loss rather than the effect of preventing hair loss.

In an exemplary embodiment of the present application, 70 parts by weight or more and 90 parts by weight or less of the red plant extract based on 100 parts by weight of the core-forming composition; And it provides a combination preparation for preventing hair loss comprising 10 parts by weight or more and 30 parts by weight or less of the celery extract.

In another embodiment, 70 parts by weight or more and 90 parts by weight or less of the red herb extract based on 100 parts by weight of the core-forming composition; Preferably, it may be 75 parts by weight or more and 85 parts by weight or less, and may specifically include 80 parts by weight.

In another embodiment, the core-forming composition may contain 10 parts by weight or more and 30 parts by weight or less, preferably 15 parts by weight or more and 25 parts by weight or less, specifically 20 parts by weight based on 100 parts by weight of the core-forming composition. there is.

In this case, the core-forming composition includes a solvent for dissolving the hongcho extract and the celery extract, and the solvent may include water. At this time, the solid content of the core-forming composition may be 80wt%.

In the present application, the core-forming composition may satisfy the above composition and content. It is possible to maximize the antioxidant effect by satisfying the above composition and content, and also has excellent sensory characteristics by including the above content of celery extract having an antioxidant effect. That is, when only the hongcho extract is included, the antioxidant effect may be the best, but the complex preparation itself may contain an excessive amount of sour fragrance, which may cause problems in intake.

In an exemplary embodiment of the present application, a combination preparation for preventing hair loss is provided in which the ratio of the outer diameter of the combination preparation to the outer diameter of the core satisfies 1:0.3 to 1:0.65.

In another embodiment, the ratio of the outer diameter of the composite formulation to the outer diameter of the core is 1:0.3 to 1:0.65, preferably 1:0.35 to 1:0.6, more preferably 1:0.4 to 1:0.5 ratio can be satisfied.

In one embodiment of the present application, the outer diameter of the composite formulation may be 5 mm or more and 40 mm or less.

In another exemplary embodiment, the outer diameter of the composite formulation may be 5 mm or more and 40 mm or less, preferably 7 mm or more and 30 mm or less, and more preferably 10 mm or more and 20 mm or less.

Only when the outer diameter as described above is satisfied can the effective material according to the present application be included in a desired amount, and also can be formed in a size suitable for swallowing.

In general, complex preparations for preventing hair loss contain only biotin and yeast. However, in this case, side effects such as ventilation may occur, and the present application is characterized by including a core forming composition for antioxidant effect.

Among them, the present application can have a hair loss prevention effect continuously, and at the same time, the core-forming composition starts to be secreted from about 4 hours after administration of the complex preparation (ie, the time it passes through the stomach and stays in the intestines).

The core-forming composition is a natural material containing an antioxidant that is good for gout, but when such a material is secreted from the stomach after administration, side effects such as heartburn may occur due to its acidity. In order to solve this problem, the composite formulation according to the present application was simply formed in a core-shell structure and the ratio of the outer diameter was adjusted as described above to solve the problem.

At this time, the outer diameter of the composite formulation and the outer diameter of the core can be confirmed in detail in FIG. 1 . Specifically, FIG. 1 is a diagram schematically illustrating a composite formulation according to an exemplary embodiment of the present invention, and the outer diameter of the composite formulation may be indicated by B, and in this case, the outer diameter of the core may be indicated by A. That is, the outer diameter can be expressed as a radius in a sphere or circle.

In the present application, the complex formulation is prepared according to the dissolution test method 2 (paddle method) of the Korean Pharmacopoeia at 37° C., pH 4.0, and the shell-forming composition contained in a water eluate containing 70% of the total weight of the active ingredient after 1 hour. to 85%, and the core-forming composition satisfies a dissolution profile in which 5 to 10% of the total weight of the active ingredient is dissolved after 1 hour.

In the present application, the complex formulation is prepared according to the dissolution test method 2 (paddle method) of the Korean Pharmacopoeia at 37° C., pH 4.0, and the shell-forming composition contained in a water eluate after 4 hours at 5% of the total weight of the active ingredient. to 10%, and the core-forming composition satisfies a dissolution profile in which 80 to 90% of the total weight of the active ingredient is dissolved after 4 hours.

The preferred dosage of the combination preparation 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 a desired effect, the combination preparation of the present invention may vary the content of the active ingredient according to the severity of the disease. Preferably, a preferred total dose of the composition of the present invention may be about 0.01 μg to 1,000 mg, most preferably 0.1 μg to 100 mg per kg of patient body weight per day. However, the dosage of the combination formulation is determined by considering various factors such as the patient's age, weight, health condition, sex, severity of disease, diet and excretion rate, as well as the route of administration of the pharmaceutical composition and the number of treatments. Since it is determined, considering this point, those skilled in the art will be able to determine an appropriate effective dosage according to the specific use of the combination preparation as a hair loss prevention or treatment agent.

The combination preparation according to the present invention is not particularly limited in its formulation, administration route and administration method as long as it exhibits the effects of the present invention. When formulating the complex preparation, it is prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants.

According to another embodiment of the present invention, there is provided a health functional food containing the complex preparation for preventing hair loss according to the present application.

The health functional food may be formulated with one selected from the group consisting of tablets, pills, powders, granules, powders, capsules and liquid formulations by further including one or more of carriers, diluents, excipients and additives. Foods to which the acteoside or its food-acceptable salt can be added include various foods, powders, granules, tablets, capsules, syrups, beverages, gums, teas, vitamin complexes, nutritional supplements, health functional foods, and food additives, etc.

Additives that may be further included in the health functional food include natural carbohydrates, flavors, nutrients, vitamins, minerals (electrolytes), flavors (synthetic flavors, natural flavors, etc.), coloring agents, fillers (cheese, chocolate, etc.) , pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, antioxidants, glycerin, alcohols, carbonation agents and at least one component selected from the group consisting of fruit flesh may be used. there is.

Examples of the natural carbohydrates include monosaccharides such as glucose, fructose, and the like; disaccharides such as maltose, sucrose and the like; and polysaccharides such as conventional sugars such as dextrins, cyclodextrins, and the like, and sugar alcohols such as xylitol, sorbitol, and erythritol. As the flavoring agent, natural flavoring agents (thaumatin, stevia extract (eg, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. In addition, various Nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, colorants and enhancers (cheese, chocolate, etc.), pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, It may contain a pH adjusting agent, a stabilizer, a preservative, glycerin, alcohol, a carbonating agent used in carbonated beverages, etc. In addition, the health functional food may contain fruit flesh for the production of natural fruit juice and vegetable beverages. These components may be used independently or in combination.

Specific examples of the carrier, excipient, diluent, and additive include, but are not limited to, lactose, dextrose, sucrose, sorbitol, mannitol, erythritol, starch, gum acacia, calcium phosphate, alginate, gelatin, calcium phosphate, calcium Silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, polyvinylpyrrolidone, methylcellulose, water, sugar syrup, methylcellulose, methyl hydroxy benzoate, propylhydroxy benzoate, talc, magnesium stearate And at least one selected from the group consisting of mineral oil is preferably used.

When the health functional food is formulated, it is prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants.

Hereinafter, examples will be described in detail for more detailed description.

manufacturing example

<Example>

<Core Forming Composition>

They are pomegranate, Schisandra chinensis, raspberry, red ginseng, grape, mulberry, and white lotus plant used in the manufacture of hongcho extract. Preparation of the hongcho extract is as follows.

First, pomegranate, Schisandra chinensis, raspberry, red ginseng, grape, mulberry, and white lotus root are cleaned with pure purified water to remove foreign substances such as fine dust. If each natural product has a wound, it is cut out and the skin and seeds of each natural product are used as they are. Then, these natural products are taken out and finely pulverized, and the pulverized natural products are put into respective brewing vessels. At this time, fill only up to about 70% of the container and leave about 30% of the top empty. Then, add dry yeast and mix so that it penetrates well throughout the ingredients. Next, the lid of the brewing vessel for fermentation is covered with a double layer of Korean paper to allow air to pass through and tied with a string. It is fermented for more than 3 months in a place where there is no direct sunlight, relatively constant temperature and good air circulation. In this way, pomegranate vinegar, omija vinegar, bokbunja vinegar, red ginseng vinegar, grape vinegar, orchid vinegar, and white lotus vinegar are prepared in a weight ratio of 1:1:1:1:1:1:1 And, mixed to form a hongcho extract, and dried to form a hongcho extract.

Celery extract was used by finely chopping commercially available celery and drying it in a powder form.

Thereafter, the celery extract and hongcho extract were added in a weight ratio of 20:80 to 100 ml of water, and the solid content was 85 wt%.

<Shell Forming Composition>

A shell-forming composition was formed such that the ratio of biotin (myrrh int) extract:dried brewer's yeast:dried yeast chromium:others satisfies the ratio of 0.02:93.6:0.48:5.9. At this time, other compositions included selenium mixture, crystalline cellulose, silicon dioxide, and magnesium stearate.

<Manufacture of combination preparation>

A core-shell structure was formed from a composite preparation satisfying the outer diameter of Table 1 below.

core outer diameter Composite Formulation Outer Diameter Example 1 4mm 10mm Example 2 5mm 10mm Example 3 9mm 20mm Example 4 8.5mm 20mm Comparative Example 1 7mm 10mm Comparative Example 2 2mm 10mm Comparative Example 3 8mm 30mm

<Comparative Example 4>

In Example 1, only the shell-forming composition was formed into a circular shape with a size of 20 mm, without including the core-forming composition, to form a composite formulation.

<Comparative Example 5>

In Example 1, only the core-forming composition was formed into a circular shape with a size of 20 mm without including the shell-forming composition to form a composite formulation.

After that, according to the dissolution test method 2 (paddle method) of the Korean Pharmacopoeia, the dissolution rate of the shell and core forming composition based on the active ingredient was evaluated after 1 hour and 4 hours at 37 ° C, pH 4.0, and water eluate, The results are shown in Table 2 below.

1 hour later 4 hours later Core forming composition (%) Shell forming composition (%) Core forming composition (%) Shell forming composition (%) Example 1 5 75 85 7 Example 2 7 76 83 5 Example 3 8 85 90 8 Example 4 8 85 90 8 Comparative Example 1 25 70 70 15 Comparative Example 2 7 76 40 10 Comparative Example 3 5 75 85 7 Comparative Example 4 - 100 - 100 Comparative Example 5 100 - 100 -

The composite preparations for preventing hair loss of Examples 1 to 4 according to the present application include a substance effective for hair loss as a shell-forming composition, and at the same time, in order to solve problems such as gout, which is a side effect thereof, the core-forming composition is used as an antioxidant effective for ventilation. It can be seen that it is characterized by including. Among them, the present invention has a composite formulation having the above-mentioned active ingredients, the composite formulation has a structure of a core and a shell, and the ratio of the outer diameter of the composite formulation to the outer diameter of the core satisfies 1:0.3 to 1:0.65. It is characterized by doing.

In the case of Examples 1 to 4, about 70 to 85% of the total weight of the shell-forming composition was released at about 1 hour after administration, and at this time, only 5 to 10% of the core-forming composition was released. That is, the state after 1 hour corresponds to the time and conditions when the complex preparation stays in the stomach in the body. That is, when staying in the stomach, a lot of water-soluble shell-forming composition is released to prevent hair loss, and the core-forming composition contains an antioxidant with strong acidity, and its release is insignificant, so it can prevent gastrointestinal disorders such as heartburn. was able to confirm

After 4 hours thereafter, it corresponds to the time and conditions when the actual administration passed through the stomach and reached the intestine, and at this time, as the content of the core-forming composition was high, the antioxidant effect was exhibited and only the shell-forming composition was included. It was found that problems such as gout, a side effect of the time, could be solved.

That is, as described above, the outer diameter ratio of the core satisfies a certain range (ie, by adjusting the ratio of the core and the shell) based on the entire composite formulation, so that the amount of the active ingredient eluted within a certain time can be effectively controlled. it was known that That is, as the core-forming composition and the shell-forming composition included as active ingredients are not eluted at once, but are provided in the form of a complex formulation to satisfy the specific structure of the core-shell, a high content of the required composition is eluted within a certain period of time, and then It was found that it was characterized by continuous elution of branched substances.

Comparative Examples 1 to 3 have a core-shell structure, but correspond to cases where the ratio of the outer diameter of the composite formulation and the outer diameter of the core is not satisfied. Specifically, in Comparative Example 1, it was confirmed that a large amount of the core-forming composition was released after 1 hour, accompanied by gastrointestinal disorders such as heartburn. In Comparative Example 2, it was found that the release amount of the core-forming composition was small even after 1 hour and 4 hours, so that ventilation, a side effect of the past, could not be prevented. In the case of Comparative Example 3, the ratio according to the present application was satisfied, but the outer diameter was large, so the administration itself was difficult. Comparative Example 4 and Comparative Example 5 have only one simple composition rather than a core-shell structure. Comparative Example 4 can exhibit the effect of preventing hair loss, but cannot solve side effects such as gout, and Comparative Example 5 has the effect of preventing hair loss. It could not manifest itself and could not be used as a combination formulation.

After all, the main feature of the present application is that it can continuously have an effect of preventing hair loss, and at the same time, the core-forming composition starts to be secreted in a desired amount from about 4 hours after administration of the complex preparation (ie, the time it passes through the stomach and stays in the intestine). . The core-forming composition is a natural material containing an antioxidant that is good for gout, but when such a material is secreted from the stomach after administration, side effects such as heartburn may occur due to its acidity. It was confirmed that the main feature of the complex preparation according to the present application is that it is simply formed into a core-shell structure to solve this problem, and the core-forming composition is controlled to be secreted after a certain period of time after administration.

A: outer diameter of core layer
B: outer diameter of composite formulation

Claims (8)

A complex preparation for preventing hair loss comprising a core-forming composition and a shell-forming composition as active ingredients,
The complex formulation is hongcho extract; and a core layer comprising the core-forming composition comprising a celery extract; and
It consists of; a shell layer formed on the entire surface of the core layer,
The shell layer is a biotin extract; and the shell forming composition comprising effective dry yeast;
The effective dry yeast includes dry brewer's yeast and dry yeast chromium,
Based on 100 parts by weight of the dry brewer's yeast, the dry yeast chromium is included in 0.1 parts by weight or more and 5 parts by weight or less,
The hongcho extract is a mixed and dried extract of fermented products of pomegranate, Schisandra chinensis, raspberry, red ginseng, grape, mulberry and white lotus plant,
The composite preparation for preventing hair loss, wherein the ratio of the outer diameter of the composite preparation to the outer diameter of the core satisfies 1:0.3 to 1:0.65. The method of claim 1,
Based on 100 parts by weight of the core forming composition
70 parts by weight or more and 90 parts by weight or less of the hongcho extract; And a complex preparation for preventing hair loss comprising 10 parts by weight or more and 30 parts by weight or less of the celery extract. The method of claim 1,
Based on 100 parts by weight of the shell-forming composition, 0.01 parts by weight or more and 0.1 parts by weight or less of the biotin extract; And a complex preparation for preventing hair loss comprising 80 parts by weight or more and 97 parts by weight or less of the effective dry yeast. The method of claim 1,
A complex preparation for preventing hair loss in which the chromium content is 1 wt% or less in the dry yeast chromium. The method of claim 1,
According to the dissolution test method 2 (paddle method) of the Korean Pharmacopoeia, the complex formulation contains 70 to 85% of the total weight of the active ingredient after 1 hour at 37° C., pH 4.0, and water eluate.
Combination formulation for preventing hair loss, wherein the core-forming composition satisfies a dissolution profile in which the active ingredient is dissolved in the range of 5 to 10% of the total weight of the active ingredient after 1 hour. The method of claim 1,
According to the dissolution test method 2 (paddle method) of the Korean Pharmacopoeia, the complex formulation is 5 to 10% of the total weight of the active ingredient after 4 hours of the shell-forming composition contained in a water elution solution at 37 ° C.
Combination formulation for preventing hair loss, wherein the core-forming composition satisfies a dissolution profile in which the active ingredient is dissolved in the range of 80 to 90% of the total weight of the active ingredient after 4 hours. The method of claim 1,
The shell forming composition is selenium, cellulose, magnesium stearate, catechin, cathinone, tryptamine, P-octopamine, P-tyramine, synephrine (Synephrine) and ephedrine (Ephedrine) a combination preparation for preventing hair loss further comprising any one or more selected from the group consisting of. A health functional food comprising the complex preparation for preventing hair loss according to any one of claims 1 to 7.

Images