KR20150145440A - a composition comprising an extract of fermented Sword Bean as an active ingredient for preventing or treating inflammation, or allergy - Google Patents

Abstract

The present invention relates to a composition for preventing or treating inflammatory or allergic diseases, which contains a sword bean extract as an active ingredient. The sword bean extract according to the present invention has been confirmed to have strong effects in treating and alleviating atopic skin through: an experiment (experimental example 1) of an impact on diet efficiency and organ weight in an atopy induced animal; an experiment (experimental example 2) of an observation on a morphological change in skin of an atopy induced animal; an experiment (experimental example 3) of a behavioral analysis about itching in an atopy induced animal; and an experiment (experimental example 4) of an impact on the amount of the moisture evaporation of epidermis of an atopy induced animal. The composition has been confirmed to have excellent effects with respect to inflammatory and allergic diseases, specifically, such as atopic dermatitis and allergic dermatitis, through animal model experiments such as: an experiment (experimental example 5) of an impact on spleen cell culturing and T cell and B cell proliferating functions in an atopy induced animal; an experiment (experimental example 6) of an impact on a generation level of cytokines such as IFN-γ or IL-2 which is a Th1 type cytokine in an atopy induced animal; an experiment (experimental example 7) of an impact on levels of IgG2a, IgG1, and IgE which are blood immunoglobulins in an atopy induced animal; and an experiment (experimental example 8) of an impact on a blood histamine level in an atopy induced animal. Accordingly, the composition may be usefully used as a pharmaceutical composition, health functional food, or health supplementary food for preventing or treating inflammatory or allergic diseases.

Description

[0001] The present invention relates to a composition for preventing and treating inflammation or allergy diseases, which contains fermented soybean extract as an active ingredient,

The present invention relates to a composition for the prevention and treatment of an inflammatory or allergic disease containing fermented soybean extract as an active ingredient.

[Literature 1] Robert C. & Kupper T. S Inflammatory skin disease, T cells, and immune surveillance. N Engl. J. Med. 341, 1817-1828, 1999

[Document 2] Hwang, S. T. Mechanisms of T cell homing to skin. Adv. Dermatol. 17, 211-241, 2001

[3] Akidis, C. A et al., T cell and T cell derived cytokines as pathologic factors in the non-allergic form of atopic dermatitis J Invest Dermatol 113, 628-634, 1999

[Literature 4] Leung D. Y. & Bieber, T. Atopic dermatitis Lancet 361, 151-160, 2003

[Literature 5] Dillon S. R et al., Interleukin 31, a cytokine produced by activated T cells, induces dermatitis in mice. Nat Immunol. 5: 752-759, 2004

[Literature 6] Dieveu C. et al., GPL, a novel cytokine receptor related GP130 and leukemia inhibitory factor receptor. J boil Chem. 278, 49850-49859, 2003

IL-31 and IL-31 in atopic and allergic contact dermatitis, J Allergy Clin Immunol 118: 930-937, 2006

[Literature 8] Matsuda, H et al., Development of atopic dermatitis like skin lesions with IgE hyperproduction in NC / Nga mice. Int Immunol. 9, 461-466, 1997

[9] Takaoka, A., Arai, I., et al., Involvement of IL-31 on scratching behavior in NC / Nga mice with atopic like dermatitis. Exp Dermatol 15: 161, 2006

[Literature 10] Cheung P. F et al., Activation of human eosinophil and epidermal keratinocytes by Th2 cytokine IL-31: Implication for the immunopathogenesis of atopic dermatitis. Int Immunol 22 (6); 453-467, 2010

[Literature 11] Asnis L. A et al., Cutaneous reaction to recombinant cytokine therapy J Am Acad Dermatol 24; 915-926, 1995

[Literature 12] Matsuda H et al., Development of atopic dermatitis-like skin lesions with IgE hyperproduction in NC / Nga mice. Int Immunol. 9 (3): 461-466, 1997

[Art 13] Ha H et al., Artemisia capillaris inhibits atopic dermatitis-like skin lesions in dermatophagoides farinae-sensitized Nc / Nga mice. BMC Complement Altern. Med. 14; 14: 100, 2014

[14] Kim JP et al., Chemical Properties and DPPH Radical Scavenging Ability of Sword Bean ( Canavalia gladiata ) Extract, Korean J. Food sci. Technol. 44: 441-446, 2012

[15] Joo SJ et al., Characteristics of yougurt prepared with 'Jinpum' bean and sword bean ( Canavalin gladiata ), Korean J. Postharv. Sci. Technol., 8: 308-312, 2001

[16] Cho YS et al., Chemical components in different parts of Korean sword bean ( Canavalia gladiata ). Korean J. Postharv. Sci. Technol., 6: 475-480, 1999

[Patent Document 17] Korean Patent Registration No. 10-0563329

[18] Seino S et al., Atopic dermatitis causes lipid accumulation in the liver of NC / Nga mice. J Clin Biochem Nutr. 50 (2): 152-7, 2012;

[19] Nam Y et al., Inhibitory effects of polysaccharide-rich extracts of Phragmites rhizoma on atopic dermatitis-like skin lesions in NC / Nga mice. Life Sci. 2; 92 (14-16): 866-872, 2013

[Literature 20] Rittie L et al., UV-light-induced signal cascades and skin aging. Ageing research reviews 1: 705-720, 2002;

[21] Yanaba K et al., CD19 expression in B cells regulates atopic dermatitis in a mouse model. Am J Pathol. 182 (6): 2214-2222, 2013;

[22] Grewe M et al., A role for Th1 and Th2 cells in the immunopathogenesis of atopic dermatitis. Immunol Today. 19 (8): 359-61,1998;

Sumimoto S et al., Increased plasma tumor necrosis factor-alpha concentration in atopic dermatitis. Arch Dis Child. 67 (3): 277-279, 1992

[24] Yanaba Ket al., CD19 expression in B cells regulates atopic dermatitis in a mouse model. Am J Pathol. 182 (6): 2214-2222, 2013

[Literature 25] Lee TY et al., Oral administration of poly-γ-glutamate ameliorates atopic dermatitis in Nc / Nga mice by suppressing Th2-biased immune response and production of IL-17A. J Invest Dermatol. 134 (3): 704-701, 2014

[26] Lee TY et al., Oral administration of poly-γ-glutamate ameliorates atopic dermatitis in Nc / Nga mice by suppressing Th2-biased immune response and production of IL-17A. J Invest Dermatol. 134 (3): 704-701, 2014

The present invention relates to a pharmaceutical composition and a health functional food for the prevention and treatment of an allergic disease containing fermented soybean extract as an active ingredient.

In general, an inflammatory reaction is a defensive reaction process of a living body that attempts to repair and regenerate a damaged region when an invasion of biological changes occurs in the cell or tissue of the living body. Thus, these series of reactions include localized blood vessels, various tissue cells of body fluids, and immune-mediated cells. With the recent development of molecular biology, inflammatory diseases have been attempted to be understood at the molecular level of cytokine, and the factors affecting these diseases are also being clarified one by one.

Allergic reactions can be classified into four types according to the type of reaction: type I, type II, type III, and type IV, or type I, type II according to the time until onset after re- Type III and Type III allergies are called immediate allergies and Type IV allergies can be classified as delayed allergies.

Among them, type I allergy is a reaction involving IgE antibody, which is called anaphylactoid type allergy, and includes allergic rhinitis such as bronchial asthma, atopic diseases (dermatitis, enteritis), hay fever, allergic conjunctivitis, .

To counteract external stimuli and antigens, various immune cells are present in the skin, forming a complex network of them and maintaining homeostasis (Robert C. & Kupper T. S Inflammatory skin disease, T cells, and immune surveillance. J. Med 341, 1817-1828, 1999). The epithelial tissues are mainly composed of keratinocytes, and there are Langerhans cells, T cells and macrophages (Hwang, S. T. Mechanisms of T cell homing to skin, Adv. Dermatol. Most skin diseases are characterized by inflammatory responses by immune cells and are accompanied by clinical symptoms such as itching, edema, erythema, eczema, and scaling. When the antigen presenting cell recognizes an antigen that enters from the outside, the chemoattractant factor is secreted, eosinophils and mast cells are introduced, and T cells are activated and collected into damaged tissue. It is known that overexpression of specific cytokines secreted from activated T cells act as pathologic factors of dermatitis (Akidis, CA et al., T cell and T cell derived cytokines as pathologic factors in the non-allergic form of atopic dermatitis J Invest Dermatol 113, 628-634, 1999). They cause itching and increase the inflow of inflammatory cells, resulting in allergic or non-allergic skin diseases such as psoriasis as well as atopic dermatitis and contact dermatitis (Leung DY et al., Atopic dermatitis Lancet 361, 151-160, 2003). IL-31 is produced in activated T cells (more expressed in Th2 cells) and belongs to the IL-6 cytokine family (Dillon S. R et al., Interleukin 31, a cytokine produced by activated T cells , induces dermatitis in mice, Nat Immunol. 5: 752-759, 2004). The IL-31 receptor is composed of the gp-130 receptor (GPL, or IL-31RA) and the oncostatin M receptor (OSMR) and is constantly present in epithelial cells and keratinocytes (Dieveu C. et al., GPL, a novel cytokine receptor related GP130 and leukemia inhibitory factor receptor (J Boil Chem., 278, 49850-49859, 2003). The expression of IL-31 is markedly elevated in skin tissue of atopic dermatitis patients and is thought to induce an increase in Th2 cytokines such as IL-4 and IL-13 (Neis MM et al., Enhanced expression levels of IL-31 correlated with IL These Th2 cytokines act on B cells and can increase the production of IgE, and IgE is present in mast cells. (Matsuda, H et al., Development of atopic dermatitis like skin lesions with IgE hyperproduction in NC / Nga mice. Int Immunol. 9, 461-466 , 1997). In addition, IL-31 receptor expression was increased in epithelial and keratinocytes from patients with atopic dermatitis, and in macrophages isolated from patients. In addition, transgenic mice that inject IL-31 into the skin of mice or continue to express IL-31 exhibit severe itching, and significant inflow of eosinophils and mast cells into skin tissue is observed, Exp Dermatol 15: 161, 2006; Cheung PF et al., Activation of human eosinophil and epidermal keratinocytes by IL-31 on scratching behavior in NC / Nga mice with atopic dermatitis Th2 cytokine IL-31: Implication for the immunopathogenesis of atopic dermatitis. Int Immunol 22 (6); 453-467, 2010). Meanwhile, IL-2 secreted from T cells stimulates and activates the proliferation of T cells. It is known that cancer patients treated with IL-2 exhibit severe skin pruritus and form swelling, erythema, necrosis, urticaria and blistering of the skin tissue (Asnis LA et al., Cutaneous reaction to recombinant cytokine therapy J Am Acad Dermatol 24; 915-926, 1995).

Atopic dermatitis is a complex, chronic inflammatory disease involving both environmental and genetic factors. It is also called skin sensitization eczema. Itching, erythema, skin cracking, and inflammation progression are chronic wasting diseases in which recovery and recurrence are repeated for a long time. It is a chronic inflammatory skin disease that usually lasts from one year of age or less to last for a long time and tends to heal ninety percent, but may persist even after adulthood.

In the past, the incidence of atopic dermatitis was reported to be 3% in children under 6 years of age in the past. It is known that atopic dermatitis is increasing in adults as well as in infants and children. These factors include air pollution, nuclear family, reduction of breastfeeding, changes in housing environment, emergence of new antigenic substances, and Westernized diet. have. In atopic dermatitis, allergic reactions are caused by the complex mechanism of various immune cells. In particular, it has been reported that a delayed immune response due to T-cell abnormality is involved rather than an immediate immune response to a specific allergen, which is caused by an immune mechanism associated with IgE (Grewe M et al., A role for Th1 and Th2 cells in the immunopathogenesis of atopic dermatitis. Immunol Today. 19 (8): 359-61, 1998).

The cytokine secretion by Th1 and Th2 cells causes an abnormal immune response. Th1 cytokine secretion decreases such as IL-2 and IFN-γ and Th2 IL-4, IL-5 and IL-10 Increased secretion of cytokines leads to isotype switching of B cells and increases IgE expression. It activates mast cells by IgE, secretes histamine and other chemicals, and stimulates blood vessels and skin to worsen symptoms. It is known that serum IgE is increased in over 80% of patients with atopic dermatitis and it is known to be correlated with the degree of disease (Matsuda H et al., Development of atopic dermatitis-like skin lesion with NC / Nga mice. 9 (3): 461-466,1997).

However, the exact cause of atopic dermatitis has not been clarified yet. Treatment with topical steroids, antihistamines, immunomodulators, and other medications is a temporary treatment, and the long-term use of these drugs is a risk of side effects and is unlikely to provide fundamental treatment. Therefore, there is an increasing interest in alternative medical therapies, and studies have been actively conducted to find functionalities from natural products with low side effects (Ha H et al., Artemisia capillaris inhibits atopic dermatitis-like skin lesions in dermatophagoides farinae-sensitized Nc / Nga mice, BMC Complement Altern. 14; 14: 100, 2014).

Soybean is a perennial plant of soybean and grows well in the southern region. It is called 豆豆 (豆豆) or 두 두 (Kim JP et al., Chemical Properties and DPPH Radical Scavenging Ability of Sword Bean Canavalia gladiata ) Extract, Korean J. Food sci. Technol. 44: 441-446, 2012). It is reported that medical books such as Chinese Primory Gangmu and Hanbo Biyo are medicinal effects that help to see the stomach, stomach, warm the inside, and help the kidney function and refresh the stomach (Joo SJ et al., Characteristics of yougurt prepared with 'Jinpum' bean and sword bean ( Canavalin gladiata ), Korean J. Postharv. Sci. Technol., 8: 308-312, 2001; Cho YS et al., Chemical components in different parts of Korean sword bean ( Canavalia gladiata ). Korean J. Postharv. Sci. Technol., 6: 475-480, 1999).

Korean Patent Registration No. 10-0563329 discloses a composition for treating allergy and inflammation comprising soybean koji as an active ingredient, but it is known that soybean protein present in soybean koji has a problem that can induce an immune response (Akaogi J et al., Role of non-protein amino acid L-canavanine in autoimmunity. Autoimmun Rev. 5 (6): 429-35, 2005).

However, none of the above documents discloses or teaches the efficacy of treating inflammation, allergic diseases, or atopy using fermented soybean extract.

Therefore, the present inventors have solved the problem of side effects such as existing immune function by using the fermented soybean koji obtained by digesting the soybean proteins present in soybean curd instead of the soybean curd extract which is likely to cause an immune reaction through fermentation, (Experimental Example 1), experiment for observing changes in skin morphology in atopic animals (Experimental Example 2), behavioral studies on itching in atopic animals (Experimental Example 3), and experiment (Example 4), which was conducted to examine the effect of the present invention on the amount of water vapor evaporation in the atopic skin, and the like. In addition, T cell and B cell proliferation (Experimental Example 5), IL-2 and IFN, which are Th1 type cytokines in atopy-induced animals, (Experimental Example 6), experiments on the levels of IgG2a, IgG1 and IgE, which are serum immunoglobulins in an atopy-induced animal (Experimental Example 7), and the effects of serum (Experimental Example 8) The present inventors completed the present invention by confirming that they have excellent efficacy against inflammation and allergic diseases, especially, atopic dermatitis and allergic dermatitis through animal model experiments such as Experimental Example 8.

According to one aspect of the present invention, there is provided a pharmaceutical composition for preventing or treating an inflammatory or allergic disease comprising fermented soybean extract as an active ingredient.

The fermented soybean koji as defined herein is prepared by mixing dry koji (Aspergillus genus fungus), preferably Aspergillus oryzae , in a dried soybean koji sample subjected to a drying and sterilization step, in an amount of 0.1 to 20%, preferably 1 Preferably 10 to 40%, more preferably 20 to 30%, at a fermentation temperature of 1 to 50 DEG C, preferably 10 to 40%, more preferably 20 to 30% Containing relative humidity of 20 to 90%, preferably 40 to 80%, more preferably 50 to 70%, for a fermentation time of 1 hour to 1 week, preferably 2 days to 5 days, Fermenting soybean fermented soybeans obtained through a process comprising fermenting and sterilizing for about 30 to 50 hours, followed by drying and pulverizing.

The fermented soybean koji as defined herein includes imported products such as Korean, Myanmar, Philippine, Thai, Indonesian, Indian, Japanese, and Chinese, preferably Korean or Chinese.

The extracts as defined herein include extracts which are soluble in water, alcohol, lower alcohols such as methanol, ethanol, butanol or a mixed solvent thereof, preferably water or water and a mixed solvent of ethanol or alcohol.

As used herein, the term "inflammation" as used herein refers to an inflammatory disease such as dermatitis, atopy, conjunctivitis, periodontitis, rhinitis, otitis, sore throat, tonsillitis, pneumonia, gastric ulcer, gastritis, Crohn's disease, colitis, hemorrhoids, ), Rheumatoid arthritis, osteoarthritis, rheumatoid arthritis, periarthritis, tendonitis, hay fever, tendinitis, myositis, hepatitis, cystitis, nephritis, sjogren's syndrome, multiple sclerosis and acute and chronic inflammatory diseases But is not limited thereto.

As used herein, the term " allergy " refers to allergic rhinitis, allergic rhinitis, allergic rhinitis, allergic rhinitis, atopic dermatitis, contact dermatitis, urticaria, insect allergies, food allergies or drug allergies, Asthma, allergic dermatitis, atopic dermatitis, contact dermatitis, urticaria, food allergies or drug allergies, more preferably atopic dermatitis or contact dermatitis.

Hereinafter, a production method for obtaining the extract of the present invention will be described in detail.

For example, the extract of the present invention is washed and dried fermentation jakdukong, about 1 times to 30 times the sample volume, preferably from about 5-fold to 25-fold (v / v) the volume of water, alcohol, C ₁ to the lower alcohol or a mixed solvent of the C _4, preferably with water or water and ethanol, or ethanol mixed yongmaeeul extraction solvent, from about 10 to 120 ℃, preferably about 30 minutes at a reaction temperature of 20 to 110 ℃ Preferably from 2 to 10 times, more preferably from 2 to 10 times, by conventional extraction methods such as room temperature extraction method, heat extraction method, ultrasonic extraction method and reflux extraction method, preferably room temperature extraction method or reflux extraction method, A second step of repeating extraction seven times; A third step of filtrating and concentrating the extract obtained in the above step under reduced pressure; And a fourth step of lyophilizing the concentrated extract at about -50 ° C to -30 ° C for about 24 to 72 hours to obtain a fermented extract of the present invention.

Accordingly, the present invention provides a pharmaceutical composition and a health functional food for the prevention and treatment of inflammation or allergic diseases containing the fermented soybean extract obtained by the above production method and the above-mentioned method as an active ingredient.

(Experimental Example 1), Experimental Example 2 for observing changes in skin morphology in atopic animals (Experimental Example 2), Experimental Example 2 for the evaluation of atopic effect (Experimental Example 3), Experimental Example 3, Experimental Example 3, Experimental Example 4, Experimental Example 4, Experimental Example 4, Experimental Example 4, Atopic Dermatitis, (Experimental Example 5), Influence on cytokine production level of IL-2 and IFN-γ, which are Th1 type cytokines in atopy-induced animals, on experiment of effect on spleen cell culture and T cell and B cell proliferation in induced animals (Experimental Example 6), experiments on the effects of IgG2a, IgG1 and IgE on serum immunoglobulins in atopic animals (Experimental Example 7), and histamine levels in atopic animals (Experimental Example 8), and the like, it was confirmed that it is effective for the treatment and prevention of inflammation or allergic diseases by confirming the excellent efficacy against inflammation and allergic diseases, especially atopic dermatitis and allergic dermatitis .

The composition of the present invention contains the herbal extract in an amount of 0.1 to 50% by weight based on the total weight of the composition.

However, the composition is not limited thereto, and may vary depending on the condition of the patient, the type of disease, and the progress of the disease.

Compositions comprising the extract of the present invention may further comprise suitable carriers, excipients and diluents conventionally used in the manufacture of pharmaceutical compositions.

The composition containing the extract according to the present invention may be formulated in the form of powders, granules, tablets, capsules, oral preparations such as suspensions, emulsions, syrups and aerosols, external preparations, suppositories and sterilized injection solutions, Examples of carriers, excipients and diluents that can be included in the composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium Silicates, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, magnesium stearate and mineral oil. In the case of formulation, a diluent or excipient such as a filler, an extender, a binder, a wetting agent, a disintegrant, or a surfactant is usually used. Solid formulations for oral administration include tablets, pills, powders, granules, capsules and the like, which may contain at least one excipient such as starch, calcium carbonate, sucrose ), Lactose, gelatin and the like. In addition to simple excipients, lubricants such as magnesium stearate talc are also used. Examples of the liquid preparation for oral use include suspensions, solutions, emulsions, and syrups. In addition to water and liquid paraffin, simple diluents commonly used, various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included . Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. Examples of the suppository base include witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin and the like.

The preferred dosage of the extract of the present invention varies depending on the condition and the weight of the patient, the degree of disease, the type of drug, the administration route and the period of time, but can be appropriately selected by those skilled in the art. However, for the desired effect, the extract is preferably administered at a dose of 0.01 mg / kg to 10 g / kg per day, preferably 1 mg / kg to 1 g / kg per day. The administration may be carried out once a day or divided into several doses. Therefore, the dose is not intended to limit the scope of the present invention in any aspect.

The composition of the present invention may be administered to mammals such as rats, mice, livestock, humans, and the like in various routes. All modes of administration may be expected, including, for example, oral and rectal, or intravenous.

The present invention also provides a health functional food for preventing or ameliorating an inflammatory or allergic disease comprising fermented soybean extract as an active ingredient.

The health functional food containing the extract of the present invention can be used variously for medicines, foods and beverages for prevention and improvement of inflammation or allergic diseases. Examples of the foods to which the extract of the present invention can be added include various foods, beverages, gums, tea, vitamin complexes, health supplements and the like, and they can be used as powders, granules, tablets, capsules or beverages have.

&Quot; Health functional food "as defined herein means food prepared and processed using raw materials or ingredients having functionality useful to the human body in accordance with Law No. 6727 on Health Functional Foods." Functional " Structure and function of the nutrient to control or physiological effects, such as to obtain a beneficial effect for health is intended to eat.

The health functional food for preventing or ameliorating the inflammatory or allergic diseases of the present invention contains 0.01 to 95% by weight, preferably 1 to 80% by weight, of the above purified product with respect to the total weight of the composition.

For the purpose of preventing or ameliorating an inflammatory or allergic disease, it is also possible to use pharmaceutical dosage forms such as powders, granules, tablets, capsules, pills, suspensions, emulsions and syrups or healthful functional foods such as tea bags, Can be manufactured and processed.

The present invention also provides a health supplement containing, as an active ingredient, a fermented soybean extract having an effect of preventing or ameliorating an inflammatory or allergic disease.

The present invention also provides a food or food additive containing as an active ingredient a fermented soybean extract having an effect of preventing or ameliorating inflammation or allergic diseases.

In addition, the above health functional foods may further include food additives, and whether or not they are suitable as "food additives" may be added to the relevant items in accordance with the general provisions of the Food Additives Ordinance approved by the Food and Drug Administration Shall be determined according to the relevant standards and standards.

Examples of the products listed in the above-mentioned "food additives" include natural products such as ketones, chemical products such as glycine, potassium citrate, nicotinic acid and cinnamic acid, coloring matter, licorice extract, crystalline cellulose, guar gum, Sodium laurate, sodium glutamate preparation, noodles-added alkaline agent, preservative agent, tar pigment preparation and the like.

Examples of the functional food containing the extract of the present invention include confectionery ice cream such as bread, rice cakes, dried fruits, candy, chocolate, chewing gum and confectionery, ice cream products such as ice cream, ice cream powder, low fat milk, Processed products such as processed oil, goat milk, fermented oil, butter oil, concentrated oil, yogurt cream, butter oil, natural cheese, processed cheese, milk powder, milk products, meat products such as hamburger meat products, ham , Fish oil products such as sausages, bacon, etc. Fish products such as noodles, noodles, noodles, noodles, noodles, luxury noodles, improved noodles, noodles such as frozen noodles, pasta, vegetable beverages, Seasonings such as beverages such as soy sauce, miso, kochujang, chunchu, chonggukjang, mixed berries, vinegar, sauce, tomato ketchup, curry, dressing, Lean, shortening, and pizza.

The health functional beverage composition of the present invention has no particular limitation on the other ingredients other than the above-mentioned extract as an essential ingredient in the indicated ratio, and may contain various flavors or natural carbohydrates as an additional ingredient such as ordinary beverages. Examples of the above-mentioned natural carbohydrates include monosaccharides (e.g., glucose, fructose, etc.); Disaccharide, (e.g., maltose, sucrose, etc.); And polysaccharides (for example, dextrin, cyclodextrin and the like), and sugar alcohols such as xylitol, sorbitol and erythritol. As natural flavors other than those described above, natural flavors (such as tau martin, stevia extract (e.g., rebaudioside A, glycyrrhizin)) and synthetic flavors (saccharin, aspartame, etc.) have. The ratio of the natural carbohydrate is generally about 1 to 20 g, preferably about 5 to 12 g per 100 ml of the composition of the present invention.

In addition to the above-mentioned composition, the composition of the present invention can be used as a flavoring agent such as various nutrients, vitamins, minerals (electrolytes), synthetic flavors and natural flavors, coloring agents and intermediates (cheese, chocolate etc.), pectic acid and its salts, Salts, organic acids, protective colloid thickening agents, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated beverages and the like. In addition, the compositions of the present invention may contain flesh for the production of natural fruit juices and fruit juice drinks and vegetable drinks. These components may be used independently or in combination. The proportion of such additives is not so critical, but is generally selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.

In addition, the extract of the present invention can be added to food or beverage for the purpose of preventing the objective disease. At this time, the amount of the extract in the food or beverage may be 0.01 to 15% by weight of the total food, and the health beverage composition may be added in a proportion of 0.02 to 5 g, preferably 0.3 to 1 g, based on 100 ml .

The extract according to the present invention, which is added to foods containing beverages in the course of manufacturing the health functional food, can be appropriately added or decreased as needed.

The fermented soybean extract according to the present invention was tested for its effects on dietary efficiency and organ weight in an atopy-induced animal (Experimental Example 1), observation of skin morphological changes in an atopy-induced animal (Experimental Example 2) (Experimental Example 3) for the itching test, experiment for the effect on the moisture content of the skin of the atopy in the atopic animal (Experimental Example 4), and the like. (Experimental Example 5), Experiments on the Effect of Th1 Type Cytokines, IL-2 and IFN-γ, on the Level of Cytokine Production in Atopy-induced Animals (Experimental Example 6), the effects of IgG2a, IgG1 and IgE levels on blood serum immunoglobulins in atopy-induced animals (Experimental Example 7), and on histamine levels in atopic animals (Experimental Example 8), and the like, it has been confirmed that it has excellent efficacy against inflammation and allergic diseases, especially atopic dermatitis and allergic dermatitis, and thus it can be used for the treatment and prevention of inflammation or allergic diseases.

Fig. 1: Diagram showing the morphological changes of the skin of an atopy-induced animal of a sample;
Figure 2: a graph showing the effect of the scratching frequency of atopic induced animal of the sample is (here, the result is the mean (means) ± expressed in SD of different sign from each other is measured by the test method (Duncan's multiple range test) p <0.05);&lt; / RTI &gt;
FIG. 3 is a graph showing the effect of the sample on the amount of water vapor evaporation of the atopic skin of the atopic animal (Here, the results are expressed as mean (SD), and the different symbols are measured by Duncan's multiple range test p < 0.05);
FIG. 4 is a graph showing the effect of the sample on the T cell and B cell proliferative capacity of the atopy-induced animal (wherein the results are denoted by mean SD), and symbols different from each other are tested by Duncan's multiple range test Gt; p < 0.05, &lt; / RTI &gt;
Figure 5: a graph showing the effects of Th1 cytokines produce in atopic induced animal of the sample is (here, the result is the mean (means) ± expressed in SD of different sign from each other are test (Duncan's multiple range test) as measured in p &Lt;0.05);
Figure 6: a graph showing the effects of Th2 cytokines produce in atopic induced animal of the sample is (here, the result is the mean (means) ± expressed in SD of different sign from each other are test (Duncan's multiple range test) as measured in p &Lt;0.05);
Figure 7 is a graph showing the effect of the samples on the proinflammatory cytokine production of the atopy-induced animals (where the meanings are denoted by means SD and the different symbols are measured by Duncan's multiple range test) 0.0 &gt; p &lt; 0.05; &lt; / RTI &gt;
FIG. 8 is a graph showing the effect of the sample on the blood immunoglobulin concentration of the atopy-induced animal (wherein the results are expressed as mean (SD) and different symbols are measured by Duncan's multiple range test p &lt; 0.05);
Figure 9: atopic induced animal sample is a graph showing the effect on blood histamine levels (here, the result is the mean (means) ± expressed in SD of different sign from each other are test (Duncan's multiple range test) as measured in p &Lt; 0.05).

Hereinafter, preferred embodiments of the present invention will be described in order to facilitate understanding of the present invention. However, the following examples are provided to further understand the present invention, and the present invention is not limited by the examples.

< Example  1> Fermented soybean extract preparation

Powdered soybeans cultivated in Gwangju Metropolitan City were added to 500 g of powdered Aspergillus oryzae , Chungmu fermentation Co., Ulsan, Korea) was inoculated at 15 g and fermented at 25 ± 2 ° C and humidity 50 ± 5% for 36 hours in a fermenter (Ino Biotech, Korea).

(30% ethanol and 80% ethanol) were added to the fermented powdery samples, and the hot water extract was extracted at 100 ° C for 4 hours. The 30% ethanol extract and the 80% After extracting the time, it was filtered in a vacuum filtration apparatus, and then the extract solvent was removed using a vacuum concentrator and then freeze-dried to be used in the experiment.

As a result of the above experiment, 10.2% of water extract (hereinafter referred to as FCGH), 6.1% of a 30% alcohol extract (hereinafter referred to as FCG30) and 80% ) Was 3.0%.

< Experimental Example  1> Atopy induction  In animals Dietary efficiency  And long-term weight

In order to confirm the effect of the above-mentioned examples on the diet efficiency in atopic animals and on the organ weights such as spleen and liver, which are atopy related organs, the method described in the literature was applied as follows (Seino S et al. , Atopic dermatitis causes lipid accumulation in the liver of NC / Nga mouse. J Clin Biochem Nutr. 50 (2): 152-7, 2012).

1.1. Preparation for experiment

Balb / c mice (20 ± 3 g), which were used for male and male NC / Nga mice (20 ± 3 g) and normal control group, were fed from the central laboratory animal (seoul, korea) The specimens were adapted to the surrounding environment for 1 week under constant conditions (temperature: 23 ± 2 ° C, relative humidity: 50 ± 5%, darkness: 12 hours light / dark cycle)

For the animals that were determined to be healthy during the adaptation period, individuals close to the average weight were selected and grouped using a random method using 8 mice per group.

(FCGH), fermented soybean 30%, 300 mg / kg bw diet (FCG30), fermented soybean 80%, 300 mg (normal control), atopic control (AD control), fermented soybean hydrothermal 300 mg / kg bw diet / kg bw diet group (FCG80), and mice of all groups except normal control group induced atopic dermatitis.

All diets were made on the basis of AIN93G, and diet and negative water were supplied free. NC / Nga mice, an atopic animal model, are normal in specific pathogen free (SPF) conditions, but they are pruritic at 3-4 weeks in the general environment and cause atopic dermatitis. Therefore, in order to induce atopic dermatitis, NC / Nga mice were exposed to general environment without filtration, and all animals were sacrificed after 10 weeks.

As shown in Table 1, it was confirmed that there was no significant difference in dietary efficiency among all groups. Immunohistochemical staining of the spleen, the most important lymphoid organs in the immune system, resulted in significant weight gain ( p <0.05) in the atopic control compared to the normal control. The spleen showed increased immunity ( P <0.05) by confirming that the weight was increased by atopic induction because the size increased and the spleen enlargement was induced when the antigen was presented or the immune reaction progressed rapidly. . On the other hand, FCG30 and FCG80 were significantly decreased compared with the atopic control ( P <0.05). In addition, weights of the liver were significantly increased in the atopic control compared to the normal control ( P <0.05). In this study, we investigated the effects of atopic dermatitis on the oxidative stress induced by atopic dermatitis. In this study, we investigated the effects of atopic dermatitis on the development of oxidative stress. J Clin Biochem Nutr. 50 (2): 152-7, 2012). ( P <0.05) (Table 1). It was found that the increase of liver weight by atopy induction was significantly decreased in FCG30 compared to the atopic control group (Table 1).

Dietary efficiency and long-term weight change Groups Normal
control NC / Nga mice AD control FCGH FCG30 FCG80 FER ^One) 0.037 ± 0.009 ^NS 0.035 0.006 0.036 + 0.003 0.034 0.002 0.033 0.005 Spleen (g) 0.13 0.03 ^b 0.18 + 0.01 ^a 0.16 ± 0.05 ^ab 0.12 0.03 ^b 0.13 0.03 ^b Kidney (g) 0.49 + 0.04 ^NS 0.48 ± 0.09 0.52 ± 0.05 0.53 + 0.08 0.49 + 0.04 Liver (g) 1.33 ± 0.09 ^c 1.62 + - 0.11 ^a 1.49 ± 0.06 ^ab 1.47 ± 0.11 ^bc 1.49 ± 0.09 ^{ab 1)} FER = weight gain (g) / food intake calories (g)
The results were presented means ± SD. Different letters show a significant difference at p <0.05 as determined by Duncan's multiple range test.

< Experimental Example  2> Atopy induction  Observation of skin morphological changes in animals

In order to confirm the morphological changes of the skin of the above-mentioned examples in the atopic animal, the following method was applied to the method described in the literature (Ha H et al., Artemisia capillaris inhibits atopic dermatitis-like skin lesions in Dermatophagoides farinae -sensitized Nc / Nga mice. BMC Complement Altern. 14; 14: 100, 2014)

The skin morphological changes in the atopy-induced animals of Experimental Example 1 were examined. As a result, when the skin of NC / Nga mice in which atopy induction naturally progressed was examined in comparison with normal group, erythema, edema, dryness, hematoma, , And rash. The morphological changes of atopic dermatitis were visualized, and the dietary treatment of soybean fermented soybeans alleviated symptoms of atopic dermatitis. In particular, symptoms of atopic dermatitis were attenuated in FCG30 and FCG80 (Fig. 1).

< Experimental Example  3> Atopy induction  Behavioral analysis of itching in animals

In order to confirm the behavioral changes of the samples of the above-mentioned examples in the atopic animals, the method described in the literature was applied as follows (Ha H et al., Artemisia capillaris inhibits atopic dermatitis-like skin lesions in Dermatophagoides farinae-sensitized Nc / Nga mice. BMC Complement Altern. Med. 14; 14: 100, 2014).

The behavioral changes of the itching in the atopic animal of Experimental Example 1 were photographed using a camera (automatic video camera: Sony TRV, Tokyo, Japan) for 20 minutes and the number of times of scratching the face, ear, Respectively. The types of pruritus in NC / Nga mice varied among individuals, so the number of scratches was measured for 20 minutes and the significance of the groups was statistically analyzed.

Representative symptoms of atopic dermatitis were assessed for the degree of atopic dermatitis induction by confirming the response to itching. The number of scratching was significantly increased (57 ± 12.5) in the atopic control group compared to the control group (1.5 ± 0.6) ( P <0.05). In the extract group, FCGH was 58.5 ± 4.5 times, FCG30 was 33 ± 10.4 times, FCG80 was 30 ± 10.7 times. ( P < 0.05) (Fig. 2), which were significantly reduced compared with the atopic control group.

< Experimental Example  4> Atopy induction  In animals Hard skin  Experiments on the effect of moisture evaporation

In order to confirm the effect of the above experimental samples on the amount of water vapor evaporation of the epidermis in an atopic animal, experiments were conducted as described below (Nam Y et al., Inhibitory effects of polysaccharide-rich extract of Phragmites 2 &apos; 92 (14-16): 866-872, 2013). &lt; / RTI &gt;

In order to confirm the effect on the amount of water vapor evaporation in the atopic skin of Experimental Example 1, skin moisture index, which changes in the condition of atopic dermatitis, was measured using CM825 (Courage & Khazaka Gmbh, Cologne, Germany) And analyzed. The skin of the ear area of the animal was sacrificed five consecutive times to obtain the average value. The measurement was performed under the condition that the room temperature was maintained at 21 to 23 ° C and the humidity was maintained at 50 to 60%.

The skin consists of three layers of epidermis, dermis and subcutaneous fat. The epidermis consists of keratinocyte, melanocyte, Langerhans cells, etc. to form the stratum corneum and protect the dermis. It plays a role. It is known that the dermis is composed of collagen fibers, elastin fibers and derma matrix, which are composed of fibroblasts, and maintain skin elasticity (Rittie L et al., UV -light-induced signal cascades and skin aging. Aging research reviews 1: 705-720, 2002).

The stratum corneum layer, the outermost layer of the epidermis, not only acts as a barrier against external invasion but also maintains adequate water content in the skin. The keratin is composed of lipid components, and the decrease of these lipid components induces skin dryness and causes keratinization. Atopic dermatitis patients have decreased skin keratin lipid content in the epidermis. As a result, skin dryness and keratinization are increased, scratching by itching causes skin layer damage, and the phenomenon worsens further. Therefore, the water content of skin is used as an index to evaluate the degree of atopic dermatitis induction (Nam Y et al., Inhibitory effects of polysaccharide-rich extracts of Phragmites rhizoma on atopic dermatitis-like skin lesions in NC / Nga mice. 2; 92 (14-16): 866-872, 2013).

As a result of this experiment, it was confirmed that the moisture content of the skin was significantly decreased to 39.3 ± 2.8 AU (arbitrary units) in the normal control group and 25.3 ± 0.4 AU in the atopic control group ( P <0.05). On the other hand, the level of total extract was significantly increased in the diet group, especially in FCG30 and FCG80, 34.0 ± 2.0 AU and 36.3 ± 0.8 AU, respectively ( P <0.05) ) .

< Experimental Example  5> Atopy induction  In animals Splenocyte  Culture and T cells and B cells In proliferation  Impact Experiment

In order to confirm the effect of the above-mentioned examples on the culture of spleen cells and the T cell and B cell proliferation in the atopy-induced animals, the method described in the literature was applied as follows (Yanaba K et al., CD 19 expression in B cells regulate atopic dermatitis in a mouse model, Am J Pathol., 182 (6): 2214-2222, 2013).

In order to confirm the effects on spleen cell culture and T cell and B cell proliferation in the atopy-induced animals of Experimental Example 1, the spleens isolated from the animals were washed with PBS and cultured in a 0.45 μm cell strainer (BD Falcon 352340, BD Biosciences , San Jose, CA, USA) was used to make a single cell suspension. L-glutamine (Hyclone Laboratories, Logan, Utah, USA), 100 mg / L penicillin-stereptomycin (Hyclone Laboratories, Logan, Utah, USA), 10% fetal bovine serum (Hyclone Laboratories, (R7757, Sigma-Aldrich Co., St. Louis, Mo., USA) with hemolysis of the red blood cells, Cell suspension was added to a 96-well plate at a rate of 1 × 10 ⁶ cells / well (200 μL) per well. To measure T cell proliferative capacity, 5 μg / mL of concanavalin A (ConA) (C0412, Sigma-Aldrich Co., St. Louis, Mo., USA) was treated with lipopolysaccharide (LPS) -Aldrich Co., St. Louis, Mo., USA) and cultured at 37 ° C for 48 hours. After 48 hours, 20 μL of EZ-Cytox (DLS1212, Deilab INC, Korea) was dispensed and incubated at 37 ° C for 4 hours. Absorbance was measured at 450 nm.

As a result, the T cell proliferation (83.0 ± 1.4%) and the B cell proliferation (121.0 ± 10.5%) of the atopic control group were significantly decreased ( P <0.05). T cell proliferative activity was significantly increased in FCG30 (91.9 ± 6.7%) compared with atopic control, but not significantly different in the other experimental groups ( P <0.05). In addition, the proliferative capacity of B cells was significantly different from that of atopic control only in FCG30 (107.9 ± 8.5%) group, but not in other experimental groups ( P <0.05) (FIG. 4).

In this study, it was predicted that the normal function of T cells was lost by confirming the decrease of T cell proliferation by atopy. The increase of IgE due to the overgrowth of immunoglobulin due to the increase of B cell mast cells It is activated and promotes histamine production, causing itching and inflammation. FCG30 seems to have weakened atopic dermatitis by inhibiting the abnormal proliferation of T cells and B cells.

< Experimental Example  6> Atopy induction  In animals Cytokine  Experiments on the production level

In order to confirm the effect of the above examples on cytokines production level in the atopy-induced animals, the method described in the literature was applied as follows (Grewe M et al., A role for Th1 and Th2 Immunol Today. 19 (8): 359-61, 1998).

In order to examine the influence of cytokine production on the level of cytokine production in the atopy-induced animals of Experimental Example 1, splenocytes were dispensed in a 96-well plate at a concentration of 1 × 10 ⁶ cells / well in a volume of 200 μL per well. ConA (C0412, (L2880, Sigma-Aldrich Co., St. Louis, Mo., USA) was stimulated with IL-2, IL-4, IL-10 and IFN- IL-6 was induced by treatment with 5 μg / mL of TNF-α. The supernatant was collected after culturing for 24 hours, IFN-γ was cultured for 72 hours, and IL-2, IL-4, IL-6, IL-10 and IFN- The amount of cytokine in the supernatant was measured using a DuoSet sandwich ELISA mouse kit (R & D System, McKinley Place NE, USA). After incubation for 1 day in a 100-μL aliquot of the primary antibody specific for each cytokine in a 96-well plate for ELISA, the cells were washed three times with washing buffer (R & D System, McKinley Place NE, After washing the primary antibody with PBS (0.05% Tween 20 in PBS), the plate was washed with 1% BSA in PBS (R & D System, McKinley Place NE, IL-4, -6, -10, TNF-α) or 0.1% BSA in TBST (IL-2, IFN-γ) for 2 hours and then washed with washing buffer. After incubation for 2 hours, 100 μL of the culture solution for the standard curve and the seeded spleen cells was incubated for 2 hours. After completion of the reaction, the cells were washed with washing buffer and diluted with secondary antibody in assay buffer. 100 μL aliquots are added to each well and treated for 2 hours. After completion of this procedure, wash the plate with washing buffer and incubate with 100 μL of substrate reagent (R & D System, McKinley Place NE, MN, USA) for color development. Measure absorbance at 570 nm, The amount of cytokine produced in the mice was calculated.

CD4 ⁺ Th cells include Th1 cells that produce Th1 type cytokines and Th2 cells that produce Th2 type cytokines. Th1 type cytokines mainly stimulate phagocytosis by increasing macrophage activity and Th2 type cytokines stimulate B cell activity and increase antibody production. It is reported that Th1 type cytokines are decreased and Th2 type cytokines are increased in atopic state by complementary regulation of Th1 / Th2 type cytokines. These cytokines imbalance reduce the ability of the immune system to develop chronic atopic symptoms (Grewe M et al., A role for Th1 and Th2 cells in the immunopathogenesis of atopic dermatitis. Immunol Today. 61, 1998).

As a result, IL-2 and IFN-γ production of Th1 type cytokines were significantly decreased in the atopic control group compared to the normal control group ( P <0.05). IL-2 produced was significantly increased in the group and FCG30 FCG80 group, production of IFN-γ was significantly increased in FCG30 group, the group FCG80 (P <0.05) (Fig. 5). The IL-4 and IL-10 production of the Th2 type cytokines was significantly increased in the atopic control compared to the normal control ( P <0.05). These results indicate that atopy is associated with Th1 / Th2 type cytokines imbalance when associated with a decrease in Th1 type cytokines in the atopic control group. IL-4 production was significantly reduced in FCG30 and FCG80 as compared to the atopic control, and IL-10 production was significantly reduced ( P <0.05) in all the experimental groups compared to the atopic control (FIG. 6). This decrease in Th2 type cytokines is thought to inhibit Th1 type cytokines, and may help to maintain immune homeostasis by reducing Th1 / Th2 imbalance.

TNF-α is mainly secreted by activated macrophages and induces inflammatory responses by inducing proinflammatory cytokines, leading to apoptosis, which is an important cytokine for the regulation of immune cell activity. Increased expression of TNF-α in patients with atopic dermatitis has been reported (Sumimoto S et al., Increased plasma tumor necrosis factor-alpha concentration in atopic dermatitis. Arch Dis Child 67 (3): 277-279 , 1992).

TNF-α production was significantly increased by 7-fold in the atopic control (578.1 ± 32.4 pg / mL) compared to the normal control (84.8 ± 26.9 pg / mL). The production of TNF-α was significantly reduced (429.2 ± 44.0 pg / mL in FCGH, 398.1 ± 29.1 pg / mL in FCG30, and 372.6 ± 65.0 pg / mL in FCG80) ( P <0.05). IL-6 was about 2-fold increased in the atopic control compared with the normal control, but significantly decreased ( P < 0.05) compared to the atopic control in FCG30 and FCG80 (Fig. 7).

<Experiment 7> effect on blood levels of immunoglobulin in experimental animals causes eczema

In order to confirm the effect of the samples of the above examples on the blood immunoglobulin level in the atopic animal, the following method was applied as follows (Yanaba K et al., CD19 expression in B cells regulates atopic dermatitis in mouse model, Am J Pathol, 182 (6): 2214-2222, 2013).

In order to confirm the effect of the blood on the immunoglobulin level in the atopy-induced animal of Experimental Example 1, the blood obtained by sacrificing the animal was centrifuged at 16,000 rpm for 20 minutes to obtain serum, followed by immunization with mouse immunoglobulin E (IgE, ab157718) IgE, IgG1 and IgG2a were measured using mouse immunoglobulin G1 (IgG1, ab133045) and mouse immunoglobulin G2a (IgG2a, ab133046) ELISA kit (abcam, USA)

When exposed to allergens, IL-4 induces iso-switching of IgM to IgG1 and IgE in B cells, which is activated by stimulation with mast cells. In contrast, IFN-γ secretion decreased IgG2a isotype switching (Lee TY et al., 2004). -17 A. J Invest Dermatol, 134 (3): 704-701, 2014). In this study, allergen response was confirmed by comparing the blood levels of IgG1, IgE, and IgG2a.

As a result, the IgG2a concentration was significantly decreased 6 times in the atopic control compared to the normal control group, and the IgG1 and IgE were significantly increased, especially the IgE concentration was increased 6 times ( P <0.05). In the FCG80 group, the IgG2a concentration was significantly decreased compared with the atopic control group and there was no significant difference in the other experimental groups ( P <0.05). The IgG1 concentration was not significantly different from all the experimental groups and the atopic control group, but the IgE concentration was significantly decreased in FCG30 and FCG80 ( P <0.05) (Fig. 8).

< Experimental Example  8> Atopy induction  Effect of Histamine Levels in Serum in Animals

In order to confirm the effect of the above-mentioned examples on histamine level in blood of atopic animals, the following experiment was conducted by applying the method described in the literature (Lee TY et al., Oral administration of poly-γ-glutamate ameliorates atopic Dermatitis in Nc / Nga mice by suppressing Th2-biased immune response and production of IL-17A J Invest Dermatol 134 (3): 704-701, 2014).

In order to confirm the effect of histamine level in the atopy-induced animal of Experimental Example 1, the blood obtained by sacrificing the animal was centrifuged at 16,000 rpm for 20 minutes to obtain serum, followed by a mouse histamine ELISA kit (BA E-1000, LDN, Nordhorn, Germany).

Histamine is stored in the mast cells, and when the mast cells are stimulated and damaged, it is released and the blood vessels are relaxed and increased in permeability, so that the blood cells and various plasma proteins can rapidly move to the site where the bacteria have invaded. The excessive secretion of histamine due to excessive immune responses may cause allergic reactions and anaphylaxis. B-cell-derived excess IgE stimulates mast cells to increase the release of histamine, and thus is an important indicator of allergy symptoms with IgE (Lee TY et al., Oral administration of poly-γ-glutamate ameliorates atopic dermatitis in Nc / Nga mice by suppressing Th2-biased immune response and production of IL-17A, J Invest Dermatol, 134 (3): 704-701, 2014).

As a result, the histamine concentration in the blood was 65.2 ± 4.1 nmol / L in the normal control group and 100.6 ± 15.4 nmol / L in the atopic control group ( P <0.05). Among the experimental groups, FCG30 (77.2 ± 10.8 nmol / L) and FCG80 (82.4 ± 12.3 nmol / L) were significantly different from the atopic control group ( P <0.05) (FIG.

Therefore, the results of this study confirmed that the extract of Hwang Kook - Kyun fermented soybean curd suppresses atopic dermatitis. Especially, 30% ethanol extract and 80% ethanol extract showed good efficacy. These results are expected to result from the increase of amino acid which is beneficial for reducing allergen induced by fermentation, and it can be expected to be utilized as a domestic functional material having an inhibitory effect on atopic dermatitis.

The formulation of the composition containing the extract of the present invention is described above, but the present invention is not intended to be limited thereto but is specifically described.

Formulation example  One. Sanje  Produce

FCGH ------------------------------------------------- - 20 mg

Lactose ------------------------------------------------- - 100 mg

Talc ------------------------------------------------- - 10 mg

The above components are mixed and filled in airtight bags to prepare powders.

Formulation example  2. Preparation of tablets

FCG30 ------------------------------------------------- 10 mg

Corn starch ------------------------------------------- 100 mg

Lactose ------------------------------------------------- 100 mg

Magnesium stearate ------------------------------------ 2 mg

After mixing the above components, tablets are prepared by tableting according to a conventional tablet preparation method.

Formulation example  3. Preparation of capsules

FCG80 ------------------------------------------------- 10 mg

Crystalline cellulose -------------------------------------- 3 mg

Lactose -------------------------------------------- 14.8 mg

Magnesium stearate 0.2 mg &lt; RTI ID = 0.0 &gt;

The above components are mixed according to a conventional capsule preparation method and filled in gelatin capsules to prepare capsules.

Formulation example  4. Preparation of injections

FCGH ------------------------------------------------- 10 mg

Mannitol ---------------------------------------------- 180 mg

Sterile sterile distilled water for injection --------------------------------- 2974 mg

Na2HPO4, 12H2O ---------------------------------------- 26 mg

(2 ml) per 1 ampoule according to the usual injection preparation method.

Formulation example  5. Liquid  Produce

FCG30 ------------------------------------------------ 20 mg

Isolation Party ---------------------------------------------- 10 g

Mannitol ------------------------------------------------- 5 g

Purified water ------------------------------------------------

Each component was added to purified water in accordance with the usual liquid preparation method and dissolved, and the lemon flavor was added in an appropriate amount. Then, the above components were mixed, and purified water was added thereto. The whole was adjusted to 100 ml with purified water, And sterilized to prepare a liquid preparation.

Formulation example  6. Manufacture of health food

FCG80 ---------------------------------------------- 1000 mg

Vitamin mixture -----------------------------------------

Vitamin A Acetate ---------------------------------- 70 g

Vitamin E -------------------------------------------- 1.0 mg

Vitamin B1 ------------------------------------------ 0.13 mg

Vitamin B2 ------------------------------------------ 0.15 mg

Vitamin B6 ------------------------------------------- 0.5 mg

Vitamin B12 ------------------------------------------ 0.2 g

Vitamin C --------------------------------------------- 10 mg

Biotin ----------------------------------------------- 10 μg

Nicotinic acid amide 1.7 mg

Folic acid ------------------------------------------------- 50 [mu] g

Calcium pantothenate --------------------------------------- 0.5 mg

Inorganic mixture -----------------------------------------

Ferrous sulfate ------------------------------------------ 1.75 mg

Zinc oxide - 0.82 mg

Magnesium carbonate --------------------------------------- 25.3 mg

Potassium phosphate monohydrate 15 mg

Calcium Phosphate - 55 mg

Potassium citrate ------------------------------------------- 90 mg

Calcium carbonate -------------------------------------------- 100 mg

Magnesium Chloride --------------------------------------- 24.8 mg

Although the composition ratio of the above-mentioned vitamin and mineral mixture is comparatively mixed with a composition suitable for health food as a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional method for producing healthy foods , Granules can be prepared and used in the manufacture of health food compositions according to conventional methods.

Formulation example  7. Manufacture of health drinks

FCG80 ---------------------------------------------- 1000 mg

Citric acid --------------------------------------------- 1000 mg

Oligosaccharide --------------------------------------------- 100 g

Plum concentrate --------------------------------------------- 2 g

Taurine ------------------------------------------------- 1 g

Add purified water - 900 ml total

The above components were mixed according to a conventional health drink manufacturing method, and the mixture was heated for about 1 hour at 85 DEG C with stirring, and the solution thus prepared was filtered to obtain a sterilized 2-liter container, which was sealed and sterilized, &Lt; / RTI &gt;

Although the composition ratio is a mixture of the components suitable for the preferred beverage as a preferred embodiment, the blending ratio may be arbitrarily varied according to the regional and national preferences such as the demand level, the demanding country, and the intended use.

Claims (11)

A pharmaceutical composition for preventing or treating an inflammatory or allergic disease comprising fermented soybean extract as an active ingredient. The method according to claim 1,
The fermented soybean curd is inoculated into a soybean paste sample which has been dried and sterilized in a dried state of Aspergillus fungi at 0.1 to 20% (v / v%) of the powder, Wherein the fermented soybean is fermented soybean obtained through a process comprising fermenting at a fermentation time of 1 hour to 1 week at a relative humidity of 2090%, sterilization, drying and pulverization. The method according to claim 1,
Wherein the fermented soybean is an imported product from Korea, Myanmar, Philippines, Thailand, Indonesia, India, Japan, and China. The method according to claim 1,
Wherein the extract is an extract soluble in lower alcohol such as water, alcohol, methanol, ethanol, butanol or a mixed solvent thereof. The method according to claim 1,
The inflammation is selected from the group consisting of conjunctivitis, periodontitis, rhinitis, otitis, sore throat, pneumonia, gastric ulcer, gastritis, Crohn's disease, colitis, hemorrhoids, gout, ankylosing spondylitis, rheumatic fever, lupus, fibromyalgia, psoriatic arthritis, osteoarthritis, Wherein the disease is selected from the group consisting of inflammatory bowel disease, tendinitis, nephritis, neuritis, perianal inflammation, myositis, hepatitis, cystitis, nephritis, sjogren's syndrome, multiple sclerosis and acute and chronic inflammatory diseases. The method according to claim 1,
Said allergies are selected from the group consisting of hypersensitivity, allergic rhinitis, asthma, allergic conjunctivitis, allergic dermatitis, atopic dermatitis, contact dermatitis, urticaria, insect allergies, food allergies or drug allergies, preferably allergic rhinitis, , Atopic dermatitis, contact dermatitis, urticaria, food allergies or drug allergies. A functional food for preventing or ameliorating inflammation or allergic diseases comprising fermented soybean extract as an active ingredient. 8. The method of claim 7,
The health functional food may be a pharmaceutical dosage form such as a powder, granule, tablet, capsule, pill, suspension, emulsion or syrup, or a health functional food in the form of a tea bag, an oil- A health supplement containing, as an active ingredient, a fermented soybean extract having the effect of preventing or ameliorating inflammation or allergic diseases. A food containing the fermented soybean extract having the effect of preventing or improving inflammation or allergic diseases as an active ingredient. A food additive containing as an active ingredient a fermented soybean extract having the effect of preventing or improving inflammation or allergic diseases.

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