KR20140040183A - Pharmaceutical, cosmetic, and functional food compositions comprising smilacis chinae rhizoma of smilax china l. for allergic diseases - Google Patents

Abstract

The present invention relates to a pharmaceutical composition, a cosmetic composition and a functional food composition including Smilacis chinae rhizoma of Smilax china L. for allergic diseases, and more particularly, to a pharmaceutical composition, a cosmetic composition and a functional food composition including Smilacis chinae rhizome of Smilax china L., that may dissolve in a polar solvent for allergic diseases including an atopic dermatitis of which occurrence increases globally. According to the present invention, the pharmaceutical composition, the cosmetic composition and the functional food composition including the single extract of Smilacis chinae rhizome as an active ingredient are provided. The side effects of, the tolerance to and the toxicity of the compositions are not shown for the long-term administration, and the generation of allergic inflammatory reaction and chronic inflammatory state may be decreased through the decrease of the cytokine concentration of IgE, Th2 and Th1 in blood serum, that play an important role in causing immunological diseases, the restraining of the secretion of histamine of mast cells and an inflammation inducing active material, and the decrease of the permeation and activation of the mast cell of skin tissue. [Reference numerals] (AA) Extract of Smilacis chinae rhizoma (10mg/kg, P.O.); (BB) Extract of Smilacis chinae rhizoma (30 mg/kg,P.O)

Description

[0001] PHARMACEUTICAL, COSMETIC, AND FUNCTIONAL FOOD COMPOSITIONS [0002] COMPRISING SMILACIS CHINAE RHIZOMA OF SMILAX CHINA L. FOR ALLERGIC DISEASES FOR ALLERGIC DISEASE CONTAINING SOUTHERN EXTRACT,

The present invention relates to a pharmaceutical composition, a cosmetic composition and a functional food composition which are effective for an allergic disease containing an extract of Toyohaku, which is the root stem of a Cyperaceae, as an active ingredient. More specifically, A cosmetic composition and a functional food composition which are effective for allergic diseases including atopic dermatitis in which the incidence is increasing worldwide.

Allergic diseases are also known as atopic diseases, including anaphylaxis, allergic rhinitis, hay fever, atopic dermatitis, eczema, allergic or atopic asthma, Food allergy and urticaria. Globally, about 25% of people in developing countries are suffering from the disease, and the prevalence is increasing every year due to environmental degradation due to industrialization (SJ Galli et al., Nature. 454: 445-454, 2008). Recently, allergic diseases have been increasing rapidly and many studies have been conducted.

Among the atopic inflammatory diseases, atopic dermatitis has a prevalence rate of 10 to 20% of children and 1 to 3% of adults worldwide, and the incidence is gradually increasing, and it is uncomfortable and painful due to severe pruritus and unsightly skin lesions. ≪ / RTI > is a chronic inflammatory skin disease. This disease is a genetic disease, a mild skin irritation is recognized as an itch, scratching or scratching causes an increased immune response. The increased immune response is due to itching, skin tone, bovine sponges, skin exfoliation, skin scaling, Inflammatory skin dermatitis with various characteristics such as skin rash, skin wrinkle, skin exfoliation, dry skin, dry skin, papillary skin pigmentation, white skin rejuvenation, etc. (Abramovits WJ Am Acad Dermatol 53: S86-93, 2005).

Various allergic inflammatory diseases, including atopic dermatitis, begin with three consecutive, time-delayed, or early-phase, reactions that occur after sensitization to the first-exposed allergen and occur after the second exposure to the same allergen. Late-phase reactions, and chronic allergic inflammatory conditions. In the sensitizer, a Th2-cell response is induced by allergen, immunoglobulin-type recombination from B lymphocytes under the condition that humoral immunity mediated by cytokines such as IL-4 and IL-13 produced by Th2- IgE is produced by one of many immunoglobulin isotypes (Coffman RL et al., J. Immunol. 136, 949-64, 1986) by the mechanism (Maggi E., Immunotechnology, 3, 233-244, 1998). Factors such as the patient's genotype, allergenic type and concentration, and the types of contact between allergens and the immune system (quantity, frequency, route) affect the intensity and diversity of Th2-cell responses (eg, antibody type, immunological resistance) Stephen J., Nature 454: 445-454, 2008).

The initial response is called type 1 immediate hypersensitivity reaction, which occurs within several minutes after the second exposure to allergen and is mainly caused by various inflammatory mediators secreted by mast cells. In other words, in patients with sensitization, allergen-specific IgE already produced by sensitization is bound to FcεRI, which is a high affinity IgE receptor in the cell membrane of mast cells, and these IgE bind to re- Receptor agglutination activates intricate intracellular signal transduction pathways to produce intracellular granule storage materials such as histamine, cytokines, proteases, lipid-derived substances such as prostaglandins, leukotrines, and PAF, cytokines, chemokines, growth factors And secretes various biologically active substances of the same gene expression product group 3. Acute symptoms associated with the initial response can lead to acute non-conjunctivitis, acute asthma attacks, urticaria, gastrointestinal reactions in food allergies, vasodilation, skin or conjunctival erythema, increased vascular permeability, tissue It causes a variety of inflammatory reactions such as edema, bronchial smooth muscle contraction, pain caused by pain sensory nerve stimulation, itching, coughing, and acute functional changes (airway mucus secretion, urticaria, vomiting, diarrhea, etc.). In addition, the systemic secretion of a variety of biologically active substances in group 3 leads to anaphylaxyis (systemic hypersensitivity).

The delayed response occurs 2 to 6 hours after the second exposure to allergen and reaches its peak at 6 to 9 hours. The initial reaction is necessarily accompanied and disappears after 1 to 2 days. Delayed responses were observed in a variety of physiologically active substances secreted from T cells that recognize IgE and allergen-activated resident mast cells or allergen-derived peptides. Th2 cells, eosinophils, (TNF-α, IL-5) and activated (TNF-α, IL-5) directly or indirectly by neutrophils, basophils, neutrophils, monocytes and other leukocytes To generate physiologically active substances. The clinical features of the delayed response are the activation of these circulating white blood cells attracted to the residential and allergen exposed areas, and the leukocytes induced by the delayed response to the lower airways of the atopic skin and asthma, Th2 cells in the early stage of the reaction and Th1 cells in the later stage contribute to the change of the cytokine environment), granulocyte eosinophils, neutrophils and basophils, and monocytes, all of which contribute to the development of allergic inflammation. Delayed response causes skin edema, pain, burning sensation, and erythema, and causes airway constriction and mucus hypersecretion in the lungs. This delayed response may be caused by bone marrow cells activated by immunoconjugates, including antigen-specific T cells and antigens, rather than IgE in patients who develop without a detectable initial response .

Chronic allergic inflammatory conditions are characterized by an antigen-induced initial response and a delayed < RTI ID = 0.0 > It is a reaction that causes persistent inflammation. A large number of congenital and adaptive immune cells (leukocyte form) are present in allergen exposed areas, and the number of cells, phenotypes and functions of tissues constituting a significant change in the extracellular matrix of the site tissues are changed. Chronic allergic inflammatory conditions include tissue remodeling such as long-term changes in tissue components (such as increased angiogenesis) and severe changes in epithelial barriers such as atopic dermatitis, allergic rhinitis, asthma, , 2004, Pawankar, R. et al., Immunol. Allergy Clin. North Am. 24: 75-85, 2004, Stephen J Galli & Mindy Tsai, Nature Medicine, 18: 693-704, 2012). That is, the risk of chronic infection due to the generation of nasal polyps in the allergic rhinitis, the damage of the barrier is increased, and the risk of bacterial infection in the skin due to the damage of the skin barrier in atopic dermatitis is increased (Galli Stephen J., Nature 454: 445-454, 2008). Since most allergic disease patients are chronic exposed to allergens, a more detailed study of the development and maintenance of chronic allergic inflammatory conditions is needed.

As described above, allergic diseases are mediated by activation of type 2 T helper (Th2) cells and IgE produced by cytokines such as IL-4, 5, and 13 secreted therefrom. , Delayed response, and chronic inflammatory state due to the action of various secreted three types of physiologically active substances, resulting in various allergic diseases including atopic dermatitis. In this process, eosinophils, neutrophils, and basophils Leukocytes are attracted and secreted by a variety of different substances (Maggi E., Immunotechnology, 3: 233-244, 1998; Vercelli D., Clin. Allergy Immunol., 16: 179-196, 2002; Pawankar R , Curr. Opin. Allergy Clin. Immunol., 1: 3-6, 2001).

The incidence and aggravation of allergic inflammatory diseases contribute to the occurrence of acute and chronic allergic inflammation in an interdependent or mutually independent manner of IgE and mast cells above those mentioned above.

Many patients who have only a single allergic disease, such as atopic dermatitis, eventually develop a combination of allergic diseases, including allergic asthma and allergic rhinitis, which are allergic or atopic marches do. This allergic process is a process in which allergic inflammation reduces epithelial barrier function to increase the exposure of the immune system to the initial allergens and additional allergens and to prevent allergen-specific IgE, Because it contributes to the sensitization of Antigen-presenting cells (APCs, antigen-presenting cells: Langerhans cells, dendritic cells, B cells, etc.) expressing IgE high affinity cell membrane receptor FcεRI and low affinity receptor CD23 are allergen-specific IgE , It is possible to introduce allergen at the time of initial sensitization into cells or to simultaneously treat new allergens to produce various allergen epitopes and new allergen-specific Th2 cell production, proliferation and activation, (epitope spreading). This increased local or circulating IgE enhances the expression of FcεRI receptors in mast cells and basophil cell membranes, thereby enhancing the effector function that causes the development and aggravation of IgE-dependent allergic diseases, and ultimately, , Delayed response, chronic allergic inflammation is repeated with the vicious cycle, and allergic inflammatory diseases are further aggravated (Stephen J. Galli et al., Nature 454: 445-454; 2008, Stephen J Galli & Mindy Tsai, Nature Medicine, 18: 693-704, 2012).

In addition, some IgE antibody molecules may bind to high affinity receptors, secrete physiologically active substances from mast cells in the absence of antigen through antigen-independent aggregation, and exacerbate the inflammatory state of allergic diseases. IgE-independent, antigen-independent activation of basophils occurs in the airways of asthmatic patients independent of mast cells, contributing to allergic inflammation.

On the other hand, mast cells are associated with mechanisms that induce chronic allergic inflammation and tissue remodeling independent of IgE irrespective of mast cell signaling through the conventional IgE-FcεRI pathway, Contributing. For example, cells in diseased areas such as soluble factors such as IFN-γ, S1P, adenosine, and IL-33, and Th2 cells and regulatory T cells (T _reg cells: interactions with OX40L in mast cells) Some of the pathogen-associated molecules (PAMPs) and cytokines (TSLP, IL-33) regulate IgE-independent mast cell activation and control the activation of various classes of cytokines and chemokines May lead to chronic allergic inflammatory diseases and tissue remodeling and functional changes (Stephen J Galli & Mindy Tsai, Nature Medicine, 18: 693-704, 2012).

(IL-4, IL-5, IL-12, IL-12, IL-12, and IL-12) and chronic allergic inflammatory diseases (T cells, eosinophils, basophils, neutrophils, monocytes, macrophages, natural killer T cells) IL-15, IL-25, IL-3, etc.) act as effector cells or effector factors, and their complex interactions contribute to the control of chronic allergic inflammation, And patient individual.

Patients with atopic dermatitis due to allergic marching or atopic marching can develop various types of atopic diseases in a timely manner. Usually, atopic asthma, allergic rhinitis, non-purulent otitis media, eustachian tube disease, conjunctivitis, At least 50% of children with atopic dermatitis develop first and clinically first, and atopic dermatitis is progressively improved or maintained, and then experiences other forms of atopic disease (Sehra S et al., Crit. Rev. Immunol., 28: 15-43, 2008). This phenomenon indicates that the pathophysiology of atopic diseases has a common mechanism, and thus it is desirable to prevent the development of atopic diseases by effective prevention and treatment of atopic dermatitis.

Although the development of atopic dermatitis has not been fully elucidated, it has a common mechanism most commonly associated with the development of allergic inflammatory diseases. In other words, cells such as T lymphocytes, Langerhans cells, eosinophils, and keratinocytes of the skin are associated with factors such as cytokines and immunoglobulins.

Antigen presenting cells (APCs), such as dendritic cells that ingest and treat allergen, an allergen that infiltrates the body, have differentiated CD4 ⁺ T cells into Th1 or Th2 cells. Th0 cells were differentiated into Th2 lymphocytes rather than Th1 lymphocytes and increased Th2 lymphocytes according to cytokine environment and common stimulus signals at the time of interaction between CD4 ⁺ T-helper lymphocytes (Th0 cells) and antigen presenting cells (APCs) Allergic reactions. Th1 lymphocytes produce IL-2, IFN-γ, and TNF and promote macrophage activation and delayed hypersensitivity. However, Th2 lymphocytes express IL-4, IL-5, IL- These cytokines produce IgE from B lymphocytes, activate mast cells and eosinophils, promote type 1 hypersensitivity, stimulate the proliferation and differentiation of B lymphocytes, inhibit Th1 cell activation . Th1 / Th2 equilibrium models, such as allergic inflammatory diseases, contribute to the development of atopic dermatitis Th2 response, but the actual mechanism is more complex biphasic helper T-cell type of atopic dermatitis patients in the early acute phase Th2 immune response (Leung DYM, J. Allergy Clin. Immunol 105: 860-76, 2000). In chronic inflammation maintenance, IL-5 and IL-12 expression and eosinophil infiltration are more involved than acute lesions. IL-12 is induced by Th2 cell immune response and cytokines generated from it, To activate Th1 and Tho cells and increase IFN-y production to inhibit the Th2 response and enhance the Th1 response, leading to long-lasting atopic dermatitis lesions.

As in allergic inflammatory diseases, IgE production from B lymphocytes is increased by the sensitization by Th2 cell reaction activated to atopic dermatitis, and IgE-induced immediate responses of type 1 immediate hypersensitivity and delayed response, chronic persistent inflammation (Abramovits W., J. Am. Acad. Dermatol. 53: S86-93, 2005). Eosinophils and macrophages are infiltrated into the skin by IL-5, IL-3, GM-CSF produced from Th2 cells and mast cells by TNF-α produced from Langerhans cells by the initial reaction, The resulting IL-12, ECP (eosinophil cationic protein), etc. play an important role in the development and progression of the delayed and chronic inflammatory reaction.

In atopic dermatitis, the role of keratinocyte, which forms the stratum corneum, which is a permeation barrier, and corneocytes, which differentiate these cells, is important. Damage to the stratum corneum, proliferation of these cells, and overexpression of GM-CSF by keratinocyte initiate and maintain chronic inflammatory processes through the induction of Langerhans cell production and maturation, and antigen presentation. In addition, various cytokines are secreted to induce inflammatory cells such as eosinophils and induce Th2 cell reaction. In case of keratinocyte damage, skin barrier deficiency causes penetration of various bacteria into the skin, thereby worsening atopic dermatitis. Secrete cytokines or secrete cytosolic molecules to reactivate memory T cells or act as antigen presenting cells (APCs) through T cell regulatory functions to maintain persistent skin inflammatory responses (Abramovits W., J. Am. Acad Dermatol 53: S86-93, 2005; Werfel TJ Invest Dermatol., 129: 1878-1891, 2009; Kamsteeg M. et al., Am. J. Pathol., 178: 2091-2099, 2011).

In general, medicines such as antihistamines, steroidal or nonsteroidal anti-inflammatory drugs, leukotriene antagonists, beta-sympathicotics, and the like that block H1 histamine receptors are used for the treatment of allergic diseases. These drugs are mainly useful for symptom improvement and have various effects depending on the type of allergic diseases. However, as described above, it is possible to inhibit IgE production, inhibit mast cell function, inhibit effector cell activation, inhibit FcεRI- Lt; RTI ID = 0.0 > inhibiting < / RTI > dependent signaling, and the like.

Atopic dermatitis The global drug market is expected to continue growing through 2017. The annual average growth rate of 3.3% in the US $ 728 million market in 2009 is expected to be as high as $ 942 million in 2017, so that the extract of Toyohaku gum extract according to the present invention will enter the world market as a preventive and therapeutic agent for atopic dermatitis , It is expected that economic and industrial effects will be great through export and technology transfer (Source: Global Information, Source: GlobalData).

Korean Patent No. 10-1156636 (pharmaceutical composition for prevention or treatment of vascular diseases containing Cheongmyeongnae extract), Korean Patent No. 10-0521845 (growth hormone secretagogue containing diphosin) 10-1086669 (Preparation method of Cheongmyeongnae extract and cosmetic composition for skin whitening containing Cheongyirae japonica extract) and Korean Patent No. 10-0593511 (Anti acne cosmetic composition using natural material) disclose Cheongmyeonga vine, It is not disclosed that the extract has excellent efficacy in the prevention and treatment of allergic diseases.

Therefore, the present inventors have sought to provide a fundamental solution by using the root bark of the blue-white flounder, which has an excellent effect on allergic diseases including atopic dermatitis.

It is an object of the present invention to provide a new method of use for a tobacco roots which is rootstock of Cheongmaea crane and to provide a pharmaceutical composition, a cosmetic composition and a functional food composition containing hot water or a lower alcohol extract of Tohoku Kogyo Kogyo as an active ingredient, We aim to fundamentally address allergic and inflammatory diseases including atopic dermatitis through inhibition of mast cell function, inhibition of effector-cell activation, and inhibition of FcεRI-dependent signaling. In addition, it replaces the treatment of inflammation of adrenocorticotropic hormone such as dexamethasone which shows severe side effects due to the influence of protein and sugar metabolism, and to compensate for weakness such as pharmacological reaction durability and resistance development do.

In order to achieve the above object, the present invention provides a pharmaceutical composition for preventing or treating an allergic disease, which contains Smilacis chinense Rhizoma (Root Stem) of Smilax China L. as an active ingredient.

The soil extract is an extract which is soluble in water, a lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof.

The above-mentioned allergic diseases include atopic dermatitis, allergic dermatitis, hypersensitivity, systemic hypersensitivity, allergic rhinitis, asthma, allergic conjunctivitis, urticaria, contact dermatitis, skin pruritus, non-purulent otitis media, eustachian tube disease, food allergy, insect allergy Or drug allergies.

The pharmaceutical composition may be in the form of tablets, capsules, pills, granules, powders, extensions, suspensions, emulsions, syrups, oral forms of aerosols, ointments, ointments, external preparations of infusions or intravenous, In a sterile injectable solution or suppository form.

In addition, the present invention provides a cosmetic composition for preventing or alleviating allergic symptom comprising Smiracis Chinae Rhizoma (Smilax China Rhizoma) as a active ingredient.

The soil extract is an extract which is soluble in water, a lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof.

The allergic symptom is characterized by atopic dermatitis, allergic dermatitis, urticaria, contact dermatitis, skin pruritus, food allergy, insect allergy or drug allergy.

The cosmetic composition is characterized in that the cosmetic composition is made of a gel, a lotion, a fat-soluble powder, a water-soluble powder, a water-soluble liquid, a lotion, a shampoo, a rinse, a cleanser, a cream, an essence or a hair conditioner.

The present invention also provides a functional food composition for preventing or ameliorating an allergic symptom containing Smyracis chinense Rhizoma root extract of Smilax China L. as an active ingredient.

The soil extract is an extract which is soluble in water, a lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof.

The allergic symptom may be atopic dermatitis, allergic dermatitis, hypersensitivity, systemic hypersensitivity, allergic rhinitis, asthma, allergic conjunctivitis, urticaria, contact dermatitis, skin pruritus, nonpulmonary otitis media, eustachian tube disease, food allergy, insect allergy Or drug allergies.

The functional food composition is characterized by being made of powder, granule, tablet, capsule, syrup, beverage, chewing gum, tea, candy, vitamin / mineral combination, caramil product, food, beverage, ice confection or confection.

According to the present invention, it is possible to provide a pharmaceutical composition, a cosmetic composition and a functional food composition containing a soil extract as an active ingredient without any side effects, tolerance and toxicity in long-term administration, and play an important role in the development of immune diseases , Decrease of cytokine concentration of IgE, Th2 and Th1 in serum, inhibition of secretion of histamine and inflammation-inducing activity of mast cells, inhibition of immunosuppression mediated by them, decrease of dermatitis index, (Mast cell) infiltration and activation, thereby reducing the occurrence of the allergic inflammatory reaction and the chronic inflammatory state.

1 is a graph showing the results of experiments in which the extract of Toyohaku (10, 30, 100 μg / ml) according to the present invention inhibits the degranulation of histamine-containing granules induced by an antigen-antibody reaction from an RBL-2H3 cell line. In the results of the present invention, NS means a native group that has not been treated with antigen, and PP2 is added as a standard control substance of Src family kinase inhibitor, which is known to strongly inhibit the secretion of allergen-inducing substances in mast cells.
FIG. 2 shows experimental results of passive skin anaphylaxis observed after a single administration of the extract of Toyohaku (100, 300 mg / kg) according to the present invention to mice. DPH was added as a representative antihistamine 50 mg / kg.
FIG. 3 is a graph showing the results of manual skin anaphylaxis observed after administration to a mouse once a day for 7 days according to the present invention.
FIG. 4 is a graph showing the results of skin irritation test observed after administering the extract of Toyohakuji according to the present invention to atopic dermatitis-producing Nc / Nga mice once a day for 9 weeks.
FIG. 5 is a graph showing the results of skin irritation index test, which was observed over time for nine weeks, once a day, in the atopic dermatitis-induced Nc / Nga mouse according to the present invention.
FIG. 6 is a graph showing the results of measuring the IgE concentration in the serum when the extract of Toyohakuwoong according to the present invention was administered to Nc / Nga mice with atopic dermatitis once a day for 9 weeks.
FIG. 7 is a graph showing the results of cytokine IL-5 concentration measurement in serum when the extract of Toyocho extract according to the present invention was administered to Nc / Nga mice with atopic dermatitis once a day for 9 weeks.
FIG. 8 is a graph showing the results of the cytokine INF-γ concentration measurement in serum when the extract of Toyohakuchi according to the present invention was administered to Nc / Nga mice with atopic dermatitis once a day for 9 weeks.
FIG. 9 shows results of skin and dermis examination of skin tissues stained with Hematoxylin / Eosin after 9 weeks of once-a-day administration to Nerf / Nga mice with atopic dermatitis according to the present invention.
FIG. 10 is a graph showing changes in mast cell infiltration and activation at low magnification and high magnification of dermal tissue stained with Toluidine blue after 9 weeks of once-a-day administration to Nc / Nga mice with atopic dermatitis The results are shown.
FIG. 11 is a graph showing the results of measurement of leukocyte, neutrophil, lymphocyte and eosinophil counts in blood after 9 weeks of once-a-day administration to Noc / Nga mice suffering from atopic dermatitis according to the present invention.
FIG. 12 is a photograph of inflammation of the lesion before and after application of the extract of Toyohakuchi according to the present invention to a patient suffering from atopic dermatitis three times a day for drinking and affected part for 12 weeks.

Hereinafter, the present invention will be described in detail.

The soil used in the present invention is Smilacis Chinae Rhizoma (rootstock) of Smilax China L. distributed in Korea, China, and Japan, and has been widely used in traditional oriental medicinal materials or folk remedies. It is known to have a therapeutic effect on detoxification and dehumidification, joint pain, muscle paralysis, diarrhea, dysentery, species, disease, poisoning, leprosy, hemorrhoids, gastric cancer and esophageal cancer.

It is a vine deciduous shrub with lily lily. Its rhizome extends sideways, it is irregularly curved, thick and hard, and rarely has beard roots. Stems are hard and up to 2m high and thorns are grayed. Leaves are circular or broad oval, with a slightly protruding or blunt circular end. The dry rootstock is slightly curved and irregularly recessed into the nodular phase.

The present invention provides a pharmaceutical composition for the prevention or treatment of allergic diseases, which contains Smyracis chinense Rhizoma (Root Stem Extract) of Smilax China L. as an active ingredient. This has the effect of increasing the efficiency of the current allergic immunotherapy which targets serum IgE reduction.

The soil extract preferably is an extract which is soluble in water, a lower alcohol having 1 to 4 carbon atoms, or a polar solvent in which the water is mixed. The soil extract is dried and pulverized to a volume of about 5 to 20 times, preferably about 5 to 15 times the dry weight of soil soil, a lower alcohol such as methanol, ethanol, propanol and butanol or In a mixed solvent having a mixing ratio of about 1: 0.1 to 1: 10, preferably water or 70 to 100 v / v% ethanol, at an extraction temperature of 30 to 100 캜, preferably 50 to 100 캜, Preferably 1 to 10 times, preferably 2 to 3 times, by an extraction method such as hot water extraction, reflux cooling extraction or ultrasonic extraction for 3 days, preferably 30 minutes to 1 day, and then filtered with a filter paper The filtrate is concentrated under reduced pressure at 30 to 100 ° C, preferably 50 to 70 ° C with a rotary vacuum concentrator, and then the residue is dissolved in water, a lower alcohol or a mixed solvent thereof by vacuum freeze drying can do. In the case of the hot-water extract, the extract may be extracted as described above, and then filtered to extract in a dissolved state.

The allergic diseases include atopic dermatitis, allergic dermatitis, hypersensitivity, anaphylaxis, allergic rhinitis, asthma, allergic conjunctivitis, allergic conjunctivitis, Urticaria, contact dermatitis, skin itching, non-purulent otitis media, eustachian tube disease, food allergies, insect allergies or drug allergies.

The pharmaceutical composition may be in the form of tablets, capsules, pills, granules, powders, extensions, suspensions, emulsions, syrups, oral forms of aerosols, ointments, ointments, external preparations of infusions or intravenous, In the form of a sterile injectable solution or suppository. The pharmaceutical dosage form of the extract of the present invention may contain, alone or in combination with other carriers therapeutically useful pharmaceutical active substances which are conventionally acceptable for the production of pharmaceutical compositions, . ≪ / RTI >

Examples of carriers, excipients and diluents that can be included in the pharmaceutical composition of the present invention include Dextrose, Lactose, Sucrose, Starch, Sorbitol, Mannitol, Xylitol, Acacia Rubber, Calcium Silicate, Calcium Phosphate, Alginate, Gelatin, Cellulose, methylcellulose, microcrystalline cellulose, water, propylhydroxybenzoate, mineral oil, methylhydroxybenzoate, talc, magnesium stearate and the like. In the case of formulation, it may be prepared by using diluents or excipients such as binders, disintegrants, fillers, extenders, surfactants, humectants and the like which are usually used.

The solid preparation for oral administration includes tablets, capsules, pills, granules, powders and the like. Such solid preparations are prepared by mixing at least one excipient such as starch, sucrose or lactose, gelatin, etc., do. In addition to simple excipients, lubricants such as talc and magnesium stearate may also be used. Liquid preparations for oral administration include suspensions, solutions, emulsions, syrups and the like. Various excipients such as fragrances, preservatives, wetting agents, sweeteners and the like may be included in addition to water and liquid paraffin which are frequently used simple diluents .

Injections in the form of solutions or suspensions for parenteral administration may be administered subcutaneously, intravenously, intramuscularly, or intraperitoneally. In general, injectable solutions or suspensions may be formulated in pharmaceutically acceptable liquid carriers such as water, saline, aqueous textol and related sugar solutions, glycols such as non-volatile oils, ethanol, glycerin, polyethylene glycols and propylene glycol, The extract can be prepared by homogeneously mixing the extract. In addition, auxiliaries such as solubilizing agents, antibacterial agents, chelating agents, buffering agents and preservatives may be included if necessary.

The coating agent can be easily prepared in various forms such as cream, ointment, suspension, emulsion and the like according to a conventional production method. In case of producing ointment or cream, it is possible to use the soil extract of the present invention in the base of a general water-in-water type or water-in-oil type and to use the fragrance, chelating agent, pigment, antioxidant, preservative, Vitamins, proteins, and minerals can be used together for the purpose.

The dose of the soil extract of the present invention may vary depending on the weight of the patient, the severity of the disease, the drug formulation, the health condition, the administration route and the administration period. For a desired effect, the daily dose is preferably 0.001 to 10 g / kg, preferably 0.01 to 0.1 g / kg, and is not limited thereto. The administration can be administered once a day or divided into several times.

In addition, the present invention provides a cosmetic composition for preventing or alleviating allergic symptom comprising Smiracis Chinae Rhizoma (Smilax China Rhizoma) as a active ingredient.

The soil extract preferably is an extract which is soluble in water, a lower alcohol having 1 to 4 carbon atoms, or a polar solvent in which the water is mixed.

The allergic symptoms include atopic dermatitis, allergic dermatitis, urticaria, contact dermatitis, skin pruritus, food allergies, insect allergies or drug allergies.

The cosmetic composition may be prepared as a gel, a lotion, a fat-soluble powder, a water-soluble powder, a water-soluble liquid, a lotion, a shampoo, a rinse, a cleanser, a cream, an essence or a hair conditioner. An emulsifier, an antiseptic, a pH adjusting agent, a perfume, and the like may be added as needed to formulate the composition according to a conventional cosmetic preparation method.

The present invention also provides a functional food composition for preventing or ameliorating an allergic symptom containing Smyracis chinense Rhizoma root extract of Smilax China L. as an active ingredient.

The soil extract preferably is an extract which is soluble in water, a lower alcohol having 1 to 4 carbon atoms, or a polar solvent in which the water is mixed.

The allergic symptom includes atopic dermatitis, allergic dermatitis, hypersensitivity, systemic hypersensitivity, allergic rhinitis, asthma, allergic conjunctivitis, urticaria, contact dermatitis, skin pruritus, nonpulmonary otitis media, eustachian tube disease, food allergy, insect allergy Or drug allergies.

The functional food composition may be prepared from powder, granule, tablet, capsule, syrup, beverage, chewing gum, tea, candy, vitamin / mineral combination, caramel product, food, beverage, A health functional food or a food supplement containing soil extract can be produced by adding the kind and content of the other ingredients according to a usual production method.

Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are merely illustrative of the present invention and that the scope of the present invention is not construed as being limited by these embodiments.

Example 1: Preparation of soil extracts using a water solvent

We purchased and used the soil bogyeong, which was constructed on the oriental medicinal materials of Kyungdong market, in Seoul. 2 L of tertiary distilled water was added to 100 g of ground soil, and the mixture was extracted with hot water for 150 minutes at an extraction temperature maintained at 100 캜, cooled slowly and filtered. The filtrate was separated, concentrated under reduced pressure at 55 to 65 ° C, and lyophilized to obtain about 10 g (yield: about 10 w / w%) of extract powder.

The dried extract of Toyohaku extract was dissolved in distilled water or dimethylsulfoxide (DMSO) at a proper concentration or dissolved in a proper concentration of Carboxymethyl cellulose (CMC) or Hydroxypropyl-methylcellulose (HPMC) at a constant concentration or in the form of hot water extract.

Example 2: Preparation of soil extracts using ethanol solvent

1 L of a 90.0 to 95.5 v / v% aqueous ethanol solution was added to 100 g of ground soil as in Example 1, followed by sonication at an extraction temperature of 50 캜 for 2 to 3 weeks, The filtrate was separated and concentrated under reduced pressure. Finally, it was lyophilized at 40 캜 for 24 hours to obtain about 10 g (yield: about 10 w / w%) of powdery extract of the red ginseng powder (cold trap, -70 캜).

Experimental Example 1. Inhibition of secretion of allergen-inducing substances of RBL-2H3 cell line (mast cell) by tobacco extract

The inhibitory effect of the extract of Toyohaku strain prepared from Example 1 on the secretion (degranulation) of the allergen inducing substance induced by the antigen-antibody reaction from the mast cell (RBL-2H3 cell line) inducing allergy in the body was examined .

RBL-2H3 cells were cultured in minimal medium supplemented with glutamine, antibiotics and 10% bovine serume albumin. For secretion experiments, cells were harvested by trypsin-EDTA and 200,000 cells per well were incubated overnight in a 24-well plate with 25ng / ml DNP-specific IgE on complete medium. The cultured cells were washed with PIPES buffer (25 mM PIPES, pH 7.2, 159 mM NaCl, 5 mM KCl, 0.4 mM MgCl 2, 1 mM CaCl 2, 5.6 mM glucose, and 0.1% BSA) The dissolved solvent was added to the medium and pre-cultured for 30 minutes. After preincubation, DNP-BSA antigen was added at a final concentration of 20 ng / ml to induce stimulation for 10 min.

The degree of secretion of allergen inducers was determined from the amount of p-nitrophenol liberated from p-nitrophenyl-acetyl- beta -D-glucosaminide, the activity of hexosaminidase, a marker of degranulation secreted in the medium. The hexosaminidase activity was measured by using p-nitrophenyl-acetyl-β-D-glucosaminide as a substrate. The degranulation degree was determined by measuring the p-nitrophenol concentration liberated from the p-nitrophenyl-acetyl- And measured at a wavelength of 400 nm.

In Figure 1, allergen-inducing mast cells, RBL-2H3 (Funaba, M. et al., Cell Biol. Int., 27: 879-85, 2003; Jeong, HJ et al., Cytokine, 18: 9, 2002), secretion of various allergenic substances of mast cells including histamine was inhibited by 6.7, 25.7, 35.8% at 10, 30, and 100 μg / Dependent inhibitory effect. The concentration of the extract of Toyohaku (IC50) inhibiting 50% of the maximal secretion was calculated to be about 273 μg / ml. 10 μM of PP2, a standard control substance of the Src family kinase inhibitor, which is known to strongly inhibit the secretion of allergen-inducing substances in mast cells, completely inhibits secretion. From the results, it was confirmed that the extract of Toyohakuchi extract of the present invention has an allergic inhibitory effect by inhibiting the activation of mast cells and the secretion of allergenic substances.

Experimental Example 2 Anti-allergic efficacy of Toyohaku Extract in an antigen-sensitized mouse model

The mice were tested for passive cutaneous anaphylaxis (PCA) to confirm the antiallergic efficacy of Toyohaku extract. The passive skin anaphylactic reaction is caused by the action of chemicals such as histamine, prostaglandins, leukotrienes, etc. leaking from the mast cell by the IgE-related functional group, and the permeability of the blood vessel wall is increased, blue is leaked, and it is a useful experiment to measure the degree of hypersensitivity by measuring a small amount of the leaked color.

(1) Anti-allergic activity test with single oral administration

Five-week-old male ICR mice were received from Orient Bio and were allowed to consume the feed and water ad libitum during the first week of the experiment. The temperature of the breeding room was maintained at 22 ± 1 ℃ and the humidity was maintained at 55 ± 10%. PCA experiments were performed by dividing into 5 experimental groups (Lim BO, et al., Polygoni cuspidata radix inhibits the activation of Syk kinase for antiallergic activity. Exp Biol Med 232: 1425-1431, 2007; Kabu K et al. Zinc is required for FcεRI-mediated mast cell activation. J Immunol 177: 1296-1305, 2006).

After intradermal injection of 0.5 μg of anti-DNP-BSA-specific IgE antibody into the ear of one mouse, 24 hours after the injection, the extract of Toyohaku (100, 300 mg / kg) and diphenylhydramine (DPH, 50 mg / kg) Were dissolved in 30% DMSO (dimethyl sulfoxide) and administered orally. One hour later, 250 μl of phosphate-buffered saline (PBS) dissolved in 250 μg of DNP-BSA and 4% of Evans blue dye was intravenously injected into the tail of the mouse to induce a passive skin hypersensitivity reaction . One hour later, mice were sacrificed by cervical dislocation, and then ears were extracted to measure the amount of evans blue color leaked from the blood vessels by the immune response. The pigments were extracted by overnight culture (700 ° C) in 700 μl formamide solution Absorbance was measured at 620 nm.

In FIG. 2, when a single oral dose of the extract (100, 300 mg / kg) was administered, the amount of evans blue leaked to one ear of the mouse decreased dose-dependently. Especially, 300mg / kg oral extract of Toyohaku extract inhibited the hypersensitivity reaction to a similar degree as the representative antihistamine DPH 50mg / kg.

(2) Anti-allergic effect of oral administration for 1 week

(50 mg / kg) of diphenylhydramine (DPH) were dissolved in 10% DMSO (dimethyl sulfoxide) and administered orally once a day for 6 days at the same time. After oral administration on day 6, anti-DNP-BSA-specific IgE antibody (0.5 μg) was intradermally injected into the mouse ear and 24 hours later, the mice were orally administered on day 7. One hour later, 250 쨉 l of PBS dissolved with 250 항 antigen (DNP-BSA) and 4% Evans blue was intravenously injected into the tail of the mouse to induce a passive skin hypersensitivity reaction. One hour later, the mice were sacrificed by cervical dislocation. The ears were then extracted to determine the amount of Evans blue leaking from the blood vessels. The pigments were extracted from the ears by incubation in 700 μl formamide solution (63 ° C) overnight and then absorbed at 620 nm Respectively.

In FIG. 3, evans blue emitted from one ear of the mouse inhibited the PCA response in a dose-dependent manner, as in the case of the single-dose experiment of (1) above, The administration group showed an inhibitory effect similar to the typical antihistamine drug DPH 50 mg / kg.

From the above results, it was confirmed that the extract of Toyohaku can inhibit the secretion of various allergenic substances including histamine and mast cell activation and prevent and treat allergic diseases from mast cells.

In particular, the repeated administration of Sophorae extracts once a day for 7 days resulted in an equivalent or better effect of inhibiting the passive skin hypersensitivity reaction even at a concentration about 10 times lower than that of a single administration. Considering that most of the drugs have disadvantages such as pharmacological reaction durability and tolerance manifesting decreased drug efficacy at the time of repeated administration, in the prevention and treatment of immune diseases such as atopic dermatitis, in which long-term drug administration is essential, Bamboo extract is expected to have the ideal pharmacological action and efficacy.

Experimental Example 3. Anti-allergic efficacy of Toyohaku Extract in a mouse model of atopic dermatitis

(1) Preparation of hapten-sensitized Nc / Nga mouse atopic dermatitis animal model

Various experiments were conducted using Nc / Nga mouse, which is widely used as an animal model of atopic dermatitis, in order to confirm the antiallergic effect from an animal having an allergic disease.

Nc / Nga mice, which have been used in many atopic dermatitis experiments, remain healthy in the SPF (specific pathogen-free) environment, but atopic dermatitis occurs naturally at 6-7 weeks of age in the nonsterile general environment, IgE also increases with age and reaches the apex at 16-18 weeks of age. In this period, it develops typical atopic dermatitis accompanied by skin dryness, nodular lesion, itching, and pathological changes of skin tissue. (Vestergaard C. et al., J. Overproduction of Th2-specific chemokines in NC / Nga mice exhibiting atopic dermatitis-like lesions, Clin. Invest., 104, 1097-1105 , 1999; Matsumoto M et al., IgE hyperproduction through enhanced tyrosine (suppl 1): 70-75, 1999; Suto H. et al., NC / Nga mice: a mouse model for atopic dermatitis. Int Arch Allergy Immunol 120 phosphorylation of Janus kinase 3 in NC / Nga mice, a model for human atopic dermatitis. J Immunol., 162: 1056-63, 1999).

However, since Nc / Nga mice show a considerable change in the incidence of dermatitis in the general environment and no abnormal skin changes in the SPF environment, the hapten (picryl chloride) is repeatedly generated as a model that reproduces the occurrence of atopic dermatitis more reproducibly Sensitized and challenged to study atopic dermatitis in humans using a model that produces 100% dermatitis in Nc / Nga mice in air-controlled barrier systems (Ohmura T et al., Role of substance P in an NC / Nga mouse model of atopic dermatitis-like disease, Int Arch Allergy Immuno 133: 389-397, 2004).

In this experiment, the antiallergic effect of Toyohaku extract was investigated using Nc / Nga mouse model using picryl chloride as a hapten.

For the experiment, 25 week old Nc / Nga female mice (Charles River, Japan) were adapted to a new SPF environment for 2 weeks. In the group with atopic dermatitis, 150 μl of 5% TNCB (2-Chloro-1,3,5-Trinitro benzene, picryl chloride) dissolved in a mixture of ethanol and acetone (volume ratio of 4: After 5 days, 150 占 퐇 of 1% TNCB dissolved in olive oil was applied to the dorsal skin and 150 占 퐇 of 1% TNCB was applied 8 times at intervals of 1 week, The challenge was to increase the index of dermatitis, including itching, erythema, swelling and bleeding, and to develop atopic dermatitis.

(10, 30 mg / kg), solvent (3% HPMC, hydroxypropyl methylcellulose) prepared as described in Example 1 and dexamethasone (2.5 mg / kg) as a positive control group were administered daily from day 8 to week 17 Five treatment groups were prepared, including four treatments administered orally for nine weeks, and one naive without sensitization and re-sensitization by TNCB. Mice were sacrificed on TNCB control (day 0), 21 days (3 weeks), 35 days (5 weeks) and 63 days (9 weeks) after sensitization in all five mice Respectively.

(2) Analysis of severity of atopic dermatitis

In order to compare the incidence of dermatitis symptoms and the suppressive effect of dermatitis extract on dermatitis, the skin severity score of mouse skin was measured once a week for 9 weeks for the five mouse test groups prepared in the above (1) Respectively. The total clinical skin severity score is divided into four types of signs: erythema, hemorrhage, edema, swelling, excoriation, erosion and dryness. The individual scores for the symptoms were summed. The four items were rated 0 for no symptoms, 1 for mild symptoms, 2 for moderate symptoms, and 3 for severe symptoms.

FIG. 4 is a representative photograph showing the clinical skin inflammation state observed in dorsal skin of five experimental groups (after 9 weeks treatment), and FIG. 5 is a total clinical skin inflammation severity index quantifying clinical skin inflammatory state.

TNCB increased skin lesions such as atopic dermatitis over time after repeated treatment for 9 weeks. Skin irritation was observed 1 week after administration, when repeated oral administration of soil extract (10, 30 mg / kg) for 9 weeks . In both doses, the dose of 30 mg / kg decreased the total clinical skin irritation severity index to the same level as that of dexamethasone group except 6 to 9 weeks after administration.

These results indicate that the extracts of Toyohaku have significantly inhibited the development of atopic dermatitis from the 3rd week after oral administration and their efficacy is maintained constant until the 9th week after administration. Which is equivalent to that of dexamethasone.

In particular, the above characteristics suggest that the extract of Toyohaku can be widely used as a treatment for atopic dermatitis by replacing the treatment of inflammation of adrenocorticotropic hormone such as dexamethasone, which has serious side effects due to the influence of protein and sugar metabolism.

(3) Analysis of serum IgE concentration

The concentration of TNCB-specific IgE from the serum collected in (1) above was measured by an ELISA method (Biolegend).

Figure 6 shows the total IgE antibody concentration in the serum of the five experimental groups.

At the time of sensitization and re-sensitization with TNCB, the total IgE antibody in the serum increased gradually with 3, 5, and 9 weeks of time, as compared with the non-TNCB treated group (naive group). This suggests that the increase in IgE is a cellular immunological mechanism for the development of atopic dermatitis caused by TNCB reflected in the increase in the total clinical skin irritation severity index described in (2) above, and the TNCB used in connection with the present invention Treated Nc / NGa mice are useful disease models that can be used in the study of human atopic dermatitis.

IgE antibody was significantly reduced in the dose-dependent manner at the oral dose of 10, 30 mg / kg once a day for 9 weeks. In the 30 mg / kg group, the IgE concentration was decreased to the same level as the dexamethasone group Week, 5 weeks). These results suggest that the extract of Toyohaku can inhibit or treat the development of atopic dermatitis by dexamethasone - like action of reducing allergen - induced IgE, as well as reduce the various adverse effects of corticosteroids.

(4) Analysis of serum cytokines concentration

The time course of IL-5 and IFN-y, cytokines known to be associated with the development of atopic dermatitis from the serum collected in (1) above, was measured using Bio-Plex Pro Mouse Cytokine assay kit (Biorad) Plex ^TM suspension array system (Biorad).

Figures 7 and 8 show the concentrations of IL-5 and IFN-y in the serum of the five experimental groups, respectively.

In the case of IL-5, TNCB control increased to 3 weeks and 5 weeks after TNCB treatment (naive group), but decreased after 9 weeks. 1 week, and 3 weeks and 5 weeks after oral administration for 9 weeks, respectively. In the case of dexamethasone, it was slightly decreased at 3 weeks, but did not decrease TNCB-induced IL-5 uptake at 5 and 9 weeks, but rather increased at 9 weeks.

In the case of IFN-γ, the TNCB control repeatedly increased and decreased over 3 weeks, 5 weeks, and 9 weeks, and increased compared to the TNCB-treated group (naive group). At the 5th and 9th weeks after the administration of the extract, the IFN-γ increased by the TNCB treatment was reduced to the same level as the TNCB non-treatment group. On the other hand, in the dexamethasone - treated group, it decreased at 3 weeks, but at the 5th and 9th weeks, the concentration was similar to the TNCB control.

These results indicate that the extracts of Toyohaku-ku, which is a strong immunosuppressive drug, reduce all of the Th1-immunity (IFN-γ) and Th2-immunity (IL-5) Can be improved and prevented.

(5) Histological analysis of skin tissue

For the histological examination, the 5 mouse experimental groups prepared in the above (1) were orally administered with the soil extract or solvent for 9 weeks (63 days), and then the skin tissue was measured in the size of 1 cm x 1 cm Collected, fixed in 10% formaldehyde solution, embedded in paraffin (pH 7.2), and 4 μm thick sections were prepared. The tissue sections were stained with hematoxylin-eosin method and then enlarged 100 times by using an optical microscope to compare the thickness of the skin layers of the representative sites. The stained sections were stained with toluidine blue method, 400 fold increase in the number of mast cells and the deagglomeration phenomena due to mast cell infiltration and activation.

FIG. 9 is a representative photograph showing epidermal / dermal thicknesses observed after staining tissue sections obtained from dorsal skin of five experimental groups by hematoxylin-eosin method, and FIG. And then enlarged to 200 times and 400 times, respectively, to compare the degranulation phenomena caused by invasion and activation of mast cells in the dermal layer.

9 weeks of sensitization and repetitive reappraisal by TNCB The epidermal thickness and keratinization were significantly increased compared to the small, non-TNCB treated group (naive group), and the soil extract (10, 30 mg / kg) When oral administration, epidermal thickness and keratinization decreased to similar state to that of TNCB non - treated group, and the thickness and keratinization of dexamethasone treated ninth week decreased to similar state as TNCB non - treated group.

In addition, TNCB treatment increased mast cell infiltration and degranulation by mast cell activation, and it was observed that repeated oral ingestion of the extract of Bombyx mori (10, 30 mg / kg) for 9 weeks resulted in infiltration and activation of these mast cells , And the infiltration and activation of mast cells was decreased to a similar extent as that of 30 mg / kg of Dextran extract extract of dexamethasone 9 weeks.

Therefore, it is possible that the extract of Toyohaku can reduce the epidermal hyperplasia / hypertrophy as well as the total clinical skin inflammation severity index and reduce the infiltration of mast cells in the dermis, which is closely related to the development of atopic dermatitis, Respectively.

(6) Leukocyte analysis in peripheral blood

Atopic dermatitis is characterized by increased inflammatory status of the affected skin lesions, infiltration of various inflammatory cells, and increased inflammatory cells of peripheral blood. In order to analyze the effect of oral administration of the extract of Toyohaku Extract on the number of various inflammatory cells in the peripheral blood, after oral administration of a soil extract or solvent for 9 weeks (63 days) to the five mouse experimental groups prepared in the above (1) And the number of total leukocytes, neutrophils, lymphocytes, and eosinophils was measured by an automatic blood analyzer.

Fig. 11 shows the number of inflammatory cells in blood collected from five experimental groups.

As a result, TNCB control increased total leukocyte, neutrophil, lymphocyte, and eosinophil counts, leading to increased expression of atopic symptoms and inflammatory cells in peripheral blood. These results suggest that dexamethasone, an antiinflammatory agent, has been shown to be effective in reducing inflammatory cells after oral administration for 10 weeks. This indicates that the extract of Toyohaku can be used to prevent and treat atopic skin lesions through anti-inflammatory action.

Experimental Example 4. Reduction of skin inflammation in patients with atopic dermatitis

In order to observe whether or not the extract of Toyohaku-ryung improved skin lesions in patients with atopic dermatitis, the extract of Toyohaku-shoi prepared in Example 1 was applied to the affected area three times daily for 60 days, .

As a result, as shown in FIG. 12, symptoms of dermatitis occurring in various body parts of patients with atopic dermatitis were remarkably improved.

All measurements obtained in this experiment are presented as mean ㅁ standard deviation. The mean difference was statistically tested using Student's t test and the significance level was less than 5%.

The following are examples of various formulations containing the extract of the present invention, but the present invention is not intended to be limited to the specific examples.

Formulation Example 1 Preparation of Tablet

Example 1: Tobacco roasted hot water extract: 100 mg

Starch ..................... ...... 50mg

Lactose ... ...... 50mg

Magnesium Stearate ............... 5mg

The above ingredients were mixed and tablets were prepared by using wet granulation or dry granulation according to a conventional method for preparing tablets.

Formulation Example 2 Preparation of Capsule

Example 1: Tobacco roasted hot water extract: 100 mg

Starch ..................... ...... 50mg

Lactose ... ...... 50mg

Talc ........................................ ...... 1mg

Magnesium stearate ............................. 5mg

The above ingredients were mixed and capsules were prepared according to the conventional method for preparing capsules.

Formulation Example 3 Preparation of Liquid

The extract of Toyo Bokyun hot-water extract of Example 1. 500 mg

Isomerized sugar ... ..10 g

saccharose................................................. ........ 10g

Lemon flavor ..... appropriate

Purified water was added to the whole .............................. 50 ml

The above components were mixed according to a conventional method for preparing a liquid preparation, filled in a brown bottle, and sterilized to prepare a liquid preparation.

Formulation Example 4. Preparation of injection

Example 1: Tobacco roast hot water extract 50 mg

Sodium Metabisulfite ............................ 2.6㎎

Methylparaben ............................................... 0.5 Mg

Propylparaben ........................................... 0.1㎎

Sterile sterilized water for injection ................................ Appropriate amount

The above ingredients were mixed and made up to 2 ml by a conventional method, filled in an ampoule and sterilized to prepare an injection.

Formulation Example 5 Preparation of Beverage

Example 1: Tobacco roasted hot water extract: 100 mg

Vitamin B2 ... .... 5mg

Vitamin B6 ... .... 5mg

Vitamin C ................................................ ... 80 mg

Dietary fiber .............................................. 1000㎎

Liquid fructose ............................................ 10,000㎎

Emulsifier ................................................. ... 100 mg

Lemon flavor ...... 50mg

Purified water................................................. .... Appropriate amount

The above components were mixed to make a volume of 50 ml. The mixture was passed through a 3-μm filter and filtered. The resulting mixture was first sterilized at 90 to 93 ° C for 20 seconds, filled in a 50 ml bottle, The beverage products were prepared by sterilization.

Having described specific portions of the present invention in detail, it will be apparent to those skilled in the art that this specific description is only a preferred embodiment and that the scope of the present invention is not limited thereby. It will be obvious. Accordingly, the actual scope of the present invention will be defined by the appended claims and their equivalents.

Claims (9)

Mast cell activity inhibitor comprising bokbok ryeong extract as an active ingredient.
The method according to claim 1,
The Tobok Ryong extract is mast cell activity inhibitor, characterized in that extracted by boiling water extraction method or solvent extraction method.
The method of claim 2, wherein the boiling water extraction method
(1) crushing the dried soil soil;
(2) heating the bokbokyeong crushed by the step (1) in a hot water of 30 to 100 ℃ for 30 minutes to 72 hours to obtain a bokbokyeong extract;
(3) filtering and concentrating the Tobok Ryong extract obtained by step (2); And
(4) lyophilizing the Tobokyeong extract concentrate prepared in step (3) to prepare an extract powder; mast cell activity inhibitor, characterized in that it comprises a.

The method of claim 2, wherein the solvent extraction method
(1) crushing the dried soil soil;
(2) immersing the Tobok Rin pulverized in step (1) into a lower alcohol having 1 to 4 carbon atoms or a polar solvent mixed with two or more of them;
(3) refluxing for 30 minutes to 72 hours while maintaining the temperature at 30 to 100 ° C. in the state immersed in step (2), separating and concentrating the filtrate; And
(4) lyophilizing the Tobokyeong extract concentrate prepared in step (3) to prepare an extract powder; mast cell activity inhibitor comprising a.
A pharmaceutical composition for the prophylaxis or treatment of hypersensitivity allergic diseases, comprising the mast cell activity inhibitor according to any one of claims 1 to 4.
A dietary supplement for the prevention or improvement of allergic disease comprising the mast cell activity inhibitor according to any one of claims 1 to 4.
A pharmaceutical composition for preventing or treating allergic dermatitis, comprising the mast cell activity inhibitor according to any one of claims 1 to 4.
A health functional food for preventing or improving allergic dermatitis, comprising the mast cell activity inhibitor according to any one of claims 1 to 4.
A cosmetic composition for preventing or improving allergic symptoms, comprising the mast cell activity inhibitor according to any one of claims 1 to 4.

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