Filipendula glaberrima extract effective in preventing, improving and treating respiratory diseases
Patent Information
- Authority / Receiving Office
- KR · KR
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-02-05
- Publication Date
- 2026-08-12
Smart Images
Figure PAT00003_ABST
Abstract
Description
Technology Field
[0001] The present invention relates to a turkeytail extract having effects of preventing, improving, and treating respiratory diseases; a food composition for enhancing respiratory function and improving respiratory diseases comprising the turkeytail extract as an active ingredient; a health functional food comprising the food composition; and a pharmaceutical composition for preventing or treating respiratory diseases comprising the turkeytail as an active ingredient. Background Technology
[0003] Filipendula glaberrima Nakai is a plant belonging to the Rosaceae family that inhabits mountainous regions north of central Korea. As an endemic plant found only in Korea, it is a biological resource subject to approval for export. Its leaves are 16 cm long and 25 cm wide, characterized by being divided into five lobes like maple leaves; it grows to a height of approximately 1 meter and thrives in humid, semi-shaded areas. The roots are hard like wood, and the short roots spread in all directions. The stems are entirely hairless, slender, long, and stand upright. White flowers bloom from June to August, appearing in corymbs at the tips of the main stem or branches. There are 4 to 5 petals, each about 0.3 cm long, arranged in a rounded shape, while the stamens are longer than the petals. The fruit ripens as a capsule around September or October; it is ovate-elliptical with hairs along the edges. There are approximately 10 species of the genus Filipendula worldwide, with 4 species distributed in Korea. Propagation is done by seeds, and continuous research is necessary as it has value for edible and ornamental purposes.
[0005] The entire plant of *Toripul*, including the rhizomes, can be used for medicinal purposes. Its herbal names are Munjacho or Miryeohapyeopja; it has a bitter and pungent taste, a warm nature, and is non-toxic. Its medicinal effects include dispelling wind and dampness, relieving pain, and antispasmodic properties. It also has sedative and stabilizing effects and is used to treat neuralgia, rheumatism, arthritis, epilepsy, and gout. For external use, the entire plant can be crushed and applied to burns and frostbite. Young shoots are eaten as a vegetable, and the flowers are used medicinally. It has become known to the general public, primarily through wildflower clubs, due to its vibrant flowers. Despite its diverse and excellent efficacy, *Toripul* is not yet mass-produced domestically or internationally, nor are there any products utilizing it. In particular, while some *Toripul* seedlings are sold for ornamental purposes, they are not commercially available as food or raw materials. Given the lack of extensive research and material development despite its superior efficacy, it could serve as a valuable natural resource for developing domestic materials in compliance with the Nagoya Protocol. As an edible raw material, *Turipul* can be developed not only as a cosmetic ingredient but also as a health functional food ingredient, making it highly commercially viable. In particular, since *Turipul* inhabits hard-to-access areas such as alpine regions and the Demilitarized Zone, it is a highly rare material that is difficult to obtain from nature.
[0007] The respiratory system is largely composed of mucosa and muscles known as bronchial smooth muscle. The mucosa contains numerous glands that continuously secrete necessary substances, and when the bronchial smooth muscle contracts, the airway narrows. When an inflammatory response occurs due to a wide variety of factors—such as exhaust fumes, allergens, cold wind, exercise, and respiratory infections—secretions from the glands increase. These secretions block the airway, causing the mucosa to swell inward and further narrow the airway. Consequently, severe paroxysmal coughing accompanied by wheezing (a rough, rattling sound during breathing) and shortness of breath occur; during an attack, a dry cough develops and a sensation of chest tightness is felt. There are also many cases of asthma characterized solely by chronic coughing and chest tightness without wheezing, with symptoms of unknown cause; these symptoms tend to appear suddenly and paroxysmal during daily life.
[0009] Asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis, cough, phlegm, acute and chronic bronchitis, bronchiolitis, pharyngitis, tonsillitis, and laryngitis are representative inflammatory respiratory diseases. Asthma, a representative respiratory disease, is characterized by non-specific airway hyperresponsiveness and reversible airway obstruction caused by chronic airway inflammation. It is a pathological condition in which symptoms such as shortness of breath, cough, and wheezing appear repeatedly and paroxysmally. Approximately 30% of asthma patients develop their first symptoms within the first year of life, while about 80% show symptoms between the ages of 4 and 5; in Korea, the incidence rate is around 10%. Pathophysiologically, asthma is a disease involving airway inflammation, airway hyperresponsiveness, and excessive mucosal protein secretion; immunologically, it is a chronic inflammatory airway disease characterized by eosinophil infiltration, an increase in Th2 cell counts, and an increase in activated mast cell counts. Asthma can be summarized by four pathological symptoms: a significant increase in the influx of eosinophils into the airways, excessive mucus secretion, and the observation of edema; above all, it is characterized by airway narrowing. Currently, the concept of asthma has been redefined from bronchial stenosis to a chronic bronchial inflammatory disease; while alleviating symptoms when present is important, fundamental treatment methods that manage inflammation over the long term are crucial. Antigens that cause asthma induce the differentiation of T cells into Th2 cells. Th2 cells secrete cytokines such as IL-5 (interleukin), GMCSF (granulocyte-macrophage stimulating factor), IL-3, IL-13, and IL-4. IL-4 acts on B cells to promote the production of IgE and activates mast cells. Activated mast cells secrete histamine, along with β-hexosaminidase. This enzymatic activity can be used as a measure of mast cell degranulation and can therefore be used in experiments.When mast cells degranulate, they release various inflammatory mediators, causing acute inflammatory responses in the airways such as bronchoconstriction, vasodilation, sensory nerve sensitization, and cholinergic bronchoconstriction. While most asthma is reversible, in some patients, as asthma progresses, remodeling occurs due to structural changes in the airways caused by fibrosis of subepithelial cells, an increase in the number of blood vessels and mucus-secreting cells, and hypertrophy of airway smooth muscle; airway obstruction, which is seen in chronic obstructive pulmonary disease (COPD), may also occur.
[0011] Chronic obstructive pulmonary disease (COPD) refers to a group of diseases characterized by reduced airflow velocity due to airway obstruction, without underlying lung or heart conditions. Clinically, when it is difficult to distinguish between chronic bronchitis—characterized by a chronic cough accompanied by sputum—and emphysema—in which alveoli below the terminal bronchioles are abnormally enlarged and alveolar septa are destroyed—the term COPD is used to collectively refer to these conditions. COPD manifests airway symptoms similar to asthma, such as shortness of breath, coughing, and phlegm, before deteriorating lung function and eventually leading to death. The primary cause of the disease is smoking; however, pollution, congenital diseases, and respiratory infections also contribute to its development, and it is known to be induced by neutrophils and macrophages. Neutrophils are representative inflammatory cells that secrete various types of proteolytic enzymes, causing destruction of lung parenchyma and chronic mucus secretion, while macrophages have recently emerged as important inflammatory cells with overexpression of IFN-γ (interferon-gamma), IL-13, TNF-α (Tumor necrosis factor-alpha), IL-6, MCP-1 (Monocyte chemoattactant protein-1, CCL-2), and NO (Nitric oxide). These cells are major causes of chronic inflammation, as they not only secrete mediators that cause tissue damage (reactive oxygen species, ROS metabolites, etc.) but also mediators involved in wound healing (transforming growth factor, TGF-β; fibroblast growth factor, FGF2; endothelial growth factor, VEGF, etc.). Irreversible airway obstruction includes emphysema, which occurs when surrounding airways are blocked due to the destruction of alveoli, and chronic obstructive bronchiolitis (small airway fibrosis, obstructive bronchiolitis), which is characterized by fibrosis caused by inflammation of the bronchioles and subsequent repeated damage.In most patients with these diseases, inflammation and fibrosis of the small airways occur along with emphysema.
[0013] Allergic rhinitis is a condition characterized by symptoms such as runny nose, sneezing, and itching of the nose and eyes due to an allergic inflammatory response, which worsens the quality of life. In most industrialized nations, it is one of the most common chronic diseases among adults and children, affecting 8–24% of the population. While rhinitis can occur due to mechanisms other than allergies, allergies are a significant factor in its development, accounting for approximately two-thirds of all cases. Allergic rhinitis is frequently associated with asthma and shares many genetic predispositions and pathophysiological characteristics.
[0015] Antitussive refers to stopping a cough, while expectorant refers to eliminating phlegm. Coughing and phlegm can be caused by physicochemical factors such as cold air, external foreign substances including pathogenic microorganisms, air pollutants, and allergens. Coughing is a defense mechanism that occurs reflexively in response to irritation of the airway mucosa; if persistent coughing is triggered by excessive irritation, it reduces and worsens the patient's quality of life. Furthermore, following the same principle as coughing, when dust or irritants enter the body, the bronchi expel them outward through muscular movements accompanied by saliva; this is the cause of sputum formation, and thick purulent sputum is produced due to inflammation of the bronchi, such as in the lungs.
[0017] Acute bronchitis is acute inflammation of the trachea and bronchi, usually associated with respiratory infections. Depending on the cause, acute bronchitis can be classified into acute infectious bronchitis and acute irritant bronchitis; the causes of infectious bronchitis mostly involve upper respiratory tract infections caused by viruses or bacteria. Acute irritant bronchitis may be caused by irritation from various metallic substances, volatile solvents, substances such as nitrogen dioxide or tobacco, or allergic reactions resulting from the inhalation of allergens. Chronic bronchitis is generally defined as chronic inflammation of the bronchial mucosa characterized by coughing and excessive sputum production almost daily for at least three months a year for two consecutive years. Patients with chronic bronchitis frequently experience acute exacerbations, including increased coughing, increased volume and purulence of sputum, and shortness of breath. Mortality rates associated with chronic bronchitis and its exacerbations are increasing in many countries.
[0019] Currently, there is no fundamental cure for such respiratory diseases, and while various methods and medications are used to prevent attacks and complications, satisfactory results are not being achieved. Treatments primarily utilize inhaled bronchodilators, oral or injectable bronchodilators (sympathomimetic agents and theophylline-based drugs), steroids (inhaled, oral, injectable, etc.), leukotriene antagonists (montelukast, tranlukast, ziluron, etc.), and anti-allergic agents (disodium chloroglycate, cromolyn sodium, ketotifen). Since airway difficiles such as anticholinergics and beta-2 receptor agonists are ineffective against inflammation that exacerbates the disease and only alleviate simple symptoms, there is a concern that long-term use may lead to drug resistance and worsening of the condition. Steroids, known to be effective against inflammation, can cause serious side effects, posing a problem with long-term use. Therefore, while these two are frequently prescribed in combination, there is a problem of poor patient compliance because they are developed in inhaled form rather than oral form due to the side effects of steroids, making them difficult to take. Consequently, there is a need to develop a new treatment that can overcome these limitations of current drug therapies, fundamentally treat the cause, and effectively improve symptoms.
[0021] Pneumonia, which accounts for the leading cause of death from respiratory diseases in Korea, is highly contagious and can be easily transmitted to others through coughing. Pneumonia is an infectious disease in which inflammation occurs in the lung tissue below the bronchioles due to bacteria or viruses. Causes of pneumonia include bacteria, viruses, and fungi; rarely, inflammation can occur in the lungs by inhaling substances such as chemicals or vomit. Bacterial pneumonia is the most common type, with Streptococcus pneumoniae being particularly closely associated with its development. Infections with Staphylococcus aureus or Mycoplasma are also causes of pneumonia. Among viruses, influenza is the primary cause. When pneumonia develops, symptoms such as coughing, phlegm, and shortness of breath appear, and fever and chills are frequently present. Nowadays, thanks to effective antibiotics, many cases of pneumonia are cured; however, as the antibiotic resistance of the causative bacteria gradually increases, pneumonia is becoming more difficult to treat than in the past. The problem to be solved
[0023] The objective of the present invention is to provide a turkeytail extract having effects of preventing, improving, and treating respiratory diseases; a food composition for strengthening respiratory function and improving respiratory diseases comprising the turkeytail extract as an active ingredient; and a health functional food comprising said composition.
[0024] Another objective of the present invention is to provide a pharmaceutical composition for the prevention or treatment of respiratory diseases comprising a turkeytail extract as an active ingredient. means of solving the problem
[0026] This is explained in detail as follows. Meanwhile, each description and embodiment disclosed in this application may also be applied to other descriptions and embodiments. That is, all combinations of the various elements disclosed in this application fall within the scope of this application. Furthermore, the scope of this application should not be considered limited by the specific descriptions provided below.
[0028] As confirmed in the examples and experimental examples below, the inventors have completed the present invention by confirming the superior efficacy of the extract of *Turipul* of the present invention, which contains previously unreported active ingredients, inhibits the secretion of inflammatory substances such as TNF-α, IL-6, CCL-2, and NO in human mononuclear cell line THP-1 cells and mouse macrophage cell line RAW264.7 cells, inhibits lung tissue damage in a mouse model of respiratory disease induced by nasal infection of Staphylococcus aureus, inhibits macrophage infiltration and Staphylococcus aureus infection in the bronchoalveolar lavage fluid (BALF), restores the thickness of alveolar cells, septa, and alveolar sac and alveolar duct structures to normal, and inhibits cough and sputum production in animal models of cough and expectoration.
[0030] One aspect of the present invention for achieving the above objective provides a food composition for enhancing respiratory function and improving respiratory diseases comprising a turkeytail extract as an active ingredient; and a health functional food comprising said composition.
[0032] In this invention, the term "respiratory function enhancement" refers to any act of maintaining the original functions of respiratory organs, such as the nasal cavity, pharynx, larynx, trachea, bronchi, and lungs, in a healthy state, or improving the functions of respiratory organs that have been impaired due to symptoms caused by smoking, fine dust, activation of neutrophil netosis, bacterial or viral infection, or other respiratory diseases, back to their original healthy state.
[0034] In addition, in the present invention, the term "respiratory disease" refers to a disease occurring in an individual's respiratory organs, such as the nasal cavity, pharynx, larynx, trachea, bronchi, and lungs. Specifically, the respiratory disease refers to a respiratory disease caused by smoking or fine dust; or a lung disease accompanied by nephrosis. Inflammation occurring in lung tissue below the bronchioles may refer to pneumonia caused by bacterial or viral infection, but is not specifically limited thereto. More specifically, the respiratory disease may mean a lung disease accompanied by symptoms of sputum, dyspnea, airway hyperresponsiveness, airway obstruction, mucus overproduction, reduced expiratory flow rate and / or impaired gas exchange, and more specifically, may mean one or more selected from the group consisting of asthma, chronic obstructive pulmonary disease (COPD), tracheitis, bronchitis, diffuse interstitial lung disease (DILD), acute respiratory distress syndrome (ARDS), acute lung injury, cystic fibrosis, bronchiolitis, influenza virus infection, pneumonia, tuberculosis, and transfusion-related acute lung injury, most specifically may mean asthma, COPD, or pneumonia. In the composition of the present invention, the active ingredient may be included in any amount (effective amount) depending on the specific use, formulation, purpose of combination, etc., as long as it exhibits activity of strengthening respiratory function and improving respiratory diseases, or activity of preventing or treating respiratory diseases. The typical effective amount may be determined within the range of 0.001 weight % to 20.0 weight % based on the total weight of the composition.The term "effective amount" above refers to the amount of an active ingredient included in the composition of the present invention that, when administered to an individual subject to the composition of the present invention during an administration period suggested by a person skilled in the art, can produce intended functional and pharmacological effects, such as strengthening respiratory function and improving respiratory diseases, preventive or therapeutic effects, or improvement of asthma, COPD, or pneumonia. Such effective amount may be experimentally determined by a person skilled in the art within the scope of ordinary ability.
[0036] The subject to which the composition of the present invention can be applied may be mammals such as dogs, cats, cows, horses, pigs, and humans, and it may be preferable for humans.
[0038] The food composition of the present invention may include 1 μg to 10 g of extract, preferably 100 μg to 1 g of turkeygrass extract, as an active ingredient.
[0040] In addition, the composition of the present invention may further include any compound or natural extract that has already been verified for safety and is known in the art to possess such activity, in addition to the active ingredient, in order to enhance the convenience of taking or consuming by adding similar activities such as anti-inflammatory activity or anti-allergic activity.
[0042] These compounds or extracts may include compounds or extracts listed in pharmacopoeias of various countries (such as the 'Korean Pharmacopoeia' in Korea) or health functional food codes of various countries (such as the 'Standards and Specifications for Health Functional Foods' notified by the Ministry of Food and Drug Safety in Korea); compounds or extracts that have received product approval in accordance with the laws of various countries governing the manufacture and sale of pharmaceuticals (such as the 'Pharmaceutical Affairs Act' in Korea); and compounds or extracts whose functionality has been recognized in accordance with the laws of various countries governing the manufacture and sale of health functional foods (such as the 'Act on Health Functional Foods' in Korea). For example, MSM (dimethylsulfonylmethane) and N-acetylglucosamine, which have been recognized for anti-inflammatory functionality in accordance with the Korean 'Act on Health Functional Foods', and those recognized for anti-allergic functionality Enterococcus faecalis Complexes such as heat-treated dried powder, guava leaf extract, kiwi extract, perilla leaf extract, picao pretto powder, etc., and PLAG (1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol) may be examples of such compounds or extracts, but are not particularly limited thereto. One or more of such compounds or natural extracts may be included in the composition of the present invention together with the active ingredients.
[0044] The composition of the present invention can be understood as a food composition in specific embodiments, and said food may include a health functional food.
[0046] In the present invention, the term "health functional food" refers to a food manufactured and processed in the form of tablets, capsules, powders, granules, liquids, pills, etc., using raw materials or ingredients that possess functional properties useful to the human body. The term "functional properties" means obtaining effects useful for health purposes, such as regulating nutrients or physiological actions regarding the structure and function of the human body. The health functional food of the present invention can be manufactured by methods commonly used in the industry, and can be manufactured by adding raw materials and ingredients commonly added in the industry. Furthermore, the formulation of the health functional food can be manufactured without restriction as long as it is a formulation recognized as a health functional food. The food composition of the present invention can be manufactured in various forms of formulations. Unlike general pharmaceuticals, it has the advantage of being made from food ingredients and thus avoiding side effects that may occur with long-term use of pharmaceuticals. Additionally, due to its excellent portability, the health functional food of the present invention can be consumed as an adjuvant to enhance the effects of improving asthma or COPD, and furthermore, to strengthen respiratory function and improve respiratory diseases.
[0048] The food composition of the present invention may be manufactured in any form, for example, as beverages such as tea, juice, carbonated beverages, and isotonic drinks; processed dairy products such as milk and yogurt; food products such as chewing gum, rice cakes, Korean confectionery, bread, confectionery, and noodles; and health functional food preparations such as tablets, capsules, pills, granules, liquids, powders, flakes, pastes, syrups, gels, jellies, and bars. Furthermore, the food composition of the present invention may take on any product classification in terms of legal and functional classification, as long as it complies with the regulations in effect at the time of manufacture and distribution. For example, it may be a health functional food under the Korean 'Act on Health Functional Foods', or confectionery, legumes, teas, beverages, special dietary foods, etc., according to each food type in the Food Code of the Korean 'Food Sanitation Act' (Notification of the Ministry of Food and Drug Safety 'Standards and Specifications for Food').
[0050] In addition, the food composition of the present invention may include food additives in addition to its active ingredients. Food additives can generally be understood as substances added to, mixed with, or permeated into food during the manufacture, processing, or preservation of food; since they are consumed daily and over a long period of time along with food, their safety must be guaranteed. Food additive codes based on national laws governing the manufacture and distribution of food (such as the 'Food Sanitation Act' in Korea) restrictively define food additives with guaranteed safety in terms of composition or function. The Korean Food Additive Code (Notification of the Ministry of Food and Drug Safety, 'Standards and Specifications for Food Additives') classifies food additives into chemically synthesized products, natural additives, and mixed preparations in terms of composition, while these food additives are classified into sweeteners, flavoring agents, preservatives, emulsifiers, acidulants, and thickeners in terms of function.
[0052] The above sweetener is used to impart a suitable sweetness to food, and may be natural or synthetic. Preferably, natural sweeteners are used, and examples of natural sweeteners include corn syrup solids, honey, sucrose, fructose, lactose, maltose, etc.
[0054] The above-mentioned flavoring agent may be used to improve taste or aroma, and both natural and synthetic types may be used. Preferably, natural types are used. When natural types are used, nutritional enhancement can be achieved in addition to flavor. Natural flavoring agents may be obtained from apples, lemons, citrus fruits, grapes, strawberries, peaches, etc., or from green tea leaves, Solomon's seal, bamboo leaves, cinnamon, chrysanthemum leaves, jasmine, etc. Additionally, those obtained from ginseng (red ginseng), bamboo shoots, aloe vera, ginkgo, etc. may be used. Natural flavoring agents may be liquid concentrates or solid extracts. In some cases, synthetic flavoring agents may be used, and synthetic flavoring agents may include esters, alcohols, aldehydes, terpenes, etc.
[0056] Calcium sorbate, sodium sorbate, potassium sorbate, calcium benzoate, sodium benzoate, potassium benzoate, EDTA (ethylenediaminetetraacetic acid), etc. may be used as the above preservatives, and acacia gum, carboxymethylcellulose, xanthan gum, pectin, etc. may be used as emulsifiers, and acetic acid, malic acid, fumaric acid, adipic acid, phosphoric acid, gluconic acid, tartaric acid, ascorbic acid, acetic acid, phosphoric acid, etc. may be used as acidifiers. Acidifiers may be added to the food composition to achieve an appropriate acidity for the purpose of inhibiting the growth of microorganisms in addition to enhancing the taste.
[0058] As the above-mentioned thickening agent, a suspending agent, a settling agent, a gel-forming agent, a puffing agent, etc. may be used.
[0060] In addition to the food additives described above, the food composition of the present invention may include physiologically active substances or minerals known in the art and guaranteed to be safe as food additives for the purpose of supplementing and reinforcing functionality and nutritional value. Examples of such physiologically active substances include catechins contained in green tea, vitamins such as vitamin B1, vitamin C, vitamin E, and vitamin B12, tocopherol, dibenzoylthiamine, etc. Examples of such minerals include calcium preparations such as calcium citrate, magnesium preparations such as magnesium stearate, iron preparations such as iron citrate, chromium chloride, potassium iodide, selenium, germanium, vanadium, zinc, etc.
[0062] The food composition of the present invention may include the aforementioned food additives in an appropriate amount to achieve the purpose depending on the product type, and regarding other food additives that may be included in the food composition of the present invention, reference may be made to the food codes or food additive codes of each country.
[0064] The term "prevention" in this invention refers to any act of suppressing or delaying symptoms associated with respiratory diseases in an individual through the administration of a composition containing a turkeytail extract according to this invention.
[0066] The term "treatment" in this invention refers to any act in which symptoms of a respiratory disease in an individual are improved or completely cured by the administration of a composition containing a turkeytail extract according to this invention.
[0068] The pharmaceutical composition of the present invention may include 1 μg to 10 g of extract, preferably 100 μg to 1 g of turkeygrass extract, as an active ingredient.
[0070] The pharmaceutical composition of the present invention may be prepared as an oral or parenteral formulation according to the route of administration by conventional methods known in the art, including pharmaceutically acceptable additives in addition to the active ingredient. Specifically, the route of administration may be any suitable route including a local route, an oral route, an intravenous route, an intramuscular route, and direct absorption through mucosal tissue, and may be used in combination of two or more routes. An example of a combination of two or more routes is a case where two or more drug formulations according to the route of administration are combined, for example, one drug is administered intravenously as a first and another drug is administered locally as a second.
[0072] Pharmaceutically acceptable additives are known in the industry according to the route of administration or dosage form, and specifically, one may refer to the pharmacopoeias of each country, including the 'Korean Pharmacopoeia'.
[0074] When the pharmaceutical composition of the present invention is prepared as an oral formulation, it may be prepared in the form of powder, granules, tablets, pills, coated tablets, capsules, liquids, gels, syrups, suspensions, wafers, etc., in accordance with methods known in the art with suitable additives. Examples of suitable additives include sugars such as lactose, glucose, sucrose, dextrose, sorbitol, mannitol, and xylitol; starches such as corn starch, potato starch, and wheat starch; celluloses such as cellulose, methylcellulose, ethylcellulose, sodium carboxymethylcellulose, and hydroxypropylmethylcellulose; polyvinylpyrrolidone; water; methylhydroxybenzoate; propylhydroxybenzoate; magnesium stearate; mineral oil; malt; gelatin; talc; polyols; vegetable oils; ethanol; glycerol; etc. In the case of formulation, appropriate binders, lubricants, disintegrants, coloring agents, diluents, etc. may be included as needed. Suitable binders include starch, magnesium aluminum silicate, starch ferrite, gelatin, methylcellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone, glucose, corn sweetener, sodium alginate, polyethylene glycol, wax, etc. Suitable lubricants include sodium oleate, sodium stearate, magnesium stearate, sodium benzoate, sodium acetate, sodium chloride, silica, talcum, stearic acid, its magnesium and calcium salts, polyethylene glycol, etc. Examples of disintegrants include starch, methylcellulose, agar, bentonite, xanthan gum, starch, alginic acid, or its sodium salt, etc. Other diluents include lactose, dextrose, sucrose, mannitol, sorbitol, cellulose, glycine, etc.
[0076] When the pharmaceutical composition of the present invention is prepared as a parenteral formulation, it may be formulated in the form of an injectable, transdermal, nasal inhalant, and suppository according to methods known in the art with a suitable additive. When formulated as an injectable, an aqueous isotonic solution or suspension may be used as a suitable additive; specifically, isotonic solutions such as PBS (phosphate buffered saline) containing triethanolamine, sterile water for injection, or 5% dextrose may be used. When formulated as a transdermal formulation, it may be formulated in the form of an ointment, cream, lotion, gel, topical solution, paste, liniment, aerosol, etc. In the case of nasal inhalers, they can be formulated in the form of an aerosol spray using suitable propellants such as dichlorofluoromethane, trichlorofluoromethane, dichlorotetrafluoroethane, and carbon dioxide, and when formulated as suppositories, the carriers may include Witepsol, Tween 61, polyethylene glycols, cocoa starch, laurin starch, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearate, and sorbitan fatty acid esters.
[0078] A preferred dosage of the pharmaceutical composition of the present invention may be in the range of 0.001 mg / kg to 10 g / kg per day, preferably 0.001 mg / kg to 1 g / kg, depending on the patient's condition, body weight, gender, age, severity of the patient, and route of administration. Administration may be administered once a day or divided into several doses. Such dosages shall not be construed as limiting the scope of the present invention in any aspect. Effects of the invention
[0080] The present invention inhibits inflammatory responses such as TNF-α, IL-6, CCL-2, and NO in human mononuclear cell line THP-1 cells and mouse macrophage cell line RAW264.7 cells, inhibits lung tissue damage in a mouse model of respiratory disease induced by nasal infection with Staphylococcus aureus, inhibits macrophage infiltration and Staphylococcus aureus infection within the BALF, restores the thickness of alveolar cells, septa, and alveolar sac and alveolar duct structures to normal, and has the effect of suppressing cough and removing phlegm. Brief explanation of the drawing
[0082] Figure 1 shows the main components of the turkeytail extract according to the present invention, identified through UHPLC-MS / MS analysis. Figure 2 shows the results of evaluating the cytotoxicity, mucilage (MUC5AC) secretion inhibitory activity, and beta-hexosaminidase inhibitory activity of three types of turmeric extracts in NCI-H292 cells stimulated with PMA. Figure 3 shows the results of inhibition of inflammatory cytokines (TNF-α, IL-6, CCL-2) by terebinth extract in human mononuclear cell line THP-1 cells stimulated with endotoxin (LPS). Figure 4 shows the results of inhibition of the expression of inflammatory inducers (TNF-α, IL-6, CCL-2, NO) by terebinth extract in LAW264.7 mouse macrophages stimulated with LPS. Figure 5 shows the results of staining lung tissue with Hematoxylin and Eosin (H&E) after administering the turkeyleaf extract of the present invention to a mouse model of respiratory disease induced by nasal infection with Staphylococcus aureus. Figure 6 shows the results of immune cell infiltration in lung tissue extracted after administering the turkeyleaf extract of the present invention to a mouse model of respiratory disease induced by nasal infection with Staphylococcus aureus. Figure 7 shows the results of Staphylococcus aureus infection in lung tissue extracted after administering the turfgrass extract of the present invention to a mouse model of respiratory disease induced by nasal infection with Staphylococcus aureus. Figure 8 shows the results of evaluating the hBD3 mRNA expression induction efficiency of three types of turkeytail extracts in HaCaT cells and the results of evaluating the antibacterial efficacy of turkeytail extracts against Staphylococcus aureus (Disk assay). Figure 9 shows the results of the antibacterial efficacy evaluation using a fermented turkeytail product fermented with lactic acid bacteria L. plantarum K8. Figure 10 shows the results of the antibacterial efficacy evaluation of a turkeytail extract fermented with a representative probiotic strain. Figure 11 shows the results of an animal experiment on the antitussive efficacy of turkey-leaf extract. Figure 12 shows the results of an animal experiment on the expectorant efficacy of turkeytail extract. Specific details for implementing the invention
[0083] The present invention will be explained in more detail below through the following examples. However, these examples are intended to illustrate the invention and the scope of the invention is not limited to these examples.
[0085] Example 1: Method for preparing turkeytail extract
[0086] Dried turban grass (above-ground parts or leaves) was sliced and then powdered using a grinder, the turban grass powder was steamed by heating with steam for 20 to 60 minutes at a temperature of 120 to 160°C and a pressure of 0.3 to 0.5 MPa, then dried for 24 to 72 hours at a temperature of 16 to 25°C and a humidity of 40 to 65%, the dried turban grass powder was extracted for 24 to 72 hours at a temperature of 16 to 25°C and a humidity of 40 to 65% after adding 5 times the amount of 70% ethanol, and the supernatant of the extract was filtered and then freeze-dried for 24 to 72 hours. 0.01 to 100,000 mg of freeze-dried turmeric extract was dissolved in sterile distilled water, then ultrasonically ground under conditions of 700 watt 20 kHz 25% amplitude, and an appropriate amount was collected and used for biological activity testing or UHPLC-MS / MS analysis.
[0088] Example 2: UHPLC-MS / MS analysis of turkeytail extract
[0089] The turkeytail extract prepared by the above method was analyzed under the following conditions at a concentration of 1000 ppm.
[0090]
[0091]
[0092] UHPLC-MS / MS has higher sensitivity than conventional LC-MS / MS, making it advantageous for detecting substances at low concentrations within plant extracts. As a result, new components of the *Turipul* extract that were not detected in previous analyses can be identified through this development. As a result of UHPLC-MS / MS analysis, the *Turipul* sample of the present invention was found to contain previously reported (+)-catechin and Kaempferol, as well as previously unreported biflavonoid, tormentic acid, ceanothic acid, and 3-epi-corosolic acid at concentrations of 8.96, 0.17, 1.74, and 1.22 mg / g, respectively (Fig. 1).
[0094] Example 3: Evaluation of Respiratory Health Activity of Trichosanthes Extract
[0095] 3-1. Evaluation of Cytotoxicity Against Bronchial Cells
[0096] The extracts of *Turi-pul*, *Maebeung-turi-pul*, and *Jiri-turi-pul* of the present invention were treated to bronchial cells NCI-H292 cultured in a 96-well plate at concentrations of 6.25 μg / mL, 12.5 μg / mL, 25 μg / mL, and 100 μg / mL. As controls, a group treated with phorbol 12-myristate 13-acetate (PMA) alone was compared with a group treated with Dexamethasone 1 or 10 μg / mL. As a result, none of the samples used in the experiment exhibited significant cytotoxicity (Fig. 2A).
[0098] 3-2. Evaluation of Inhibitory Activity on Mucus Secretion and Production
[0099] To evaluate the inhibitory activity on the secretion and production of mucus, which is a major symptom of bronchitis or respiratory diseases, NCI-H292 bronchial epithelial cells were treated with PMA to induce MUC5AC production, and then the extracts of *Turi-pul*, *Maebeung-turi-pul*, and *Jiri-turi-pul* of the present invention were treated at indicated concentrations to evaluate the degree of mucus secretion inhibition.
[0101] As a result of the mucus secretion inhibition test using bronchial epithelial cells, mucus secretion was inhibited in a concentration-dependent manner by all extracts used in the experiment, indicating that they have an effect in alleviating respiratory diseases. The *Turipul* extract of the present invention showed a significant difference at treatment concentrations of 25 μg / mL, 50 μg / mL, and 100 μg / mL compared to the *Danpungturipul* extract and *Jirituripul* extract (#p<0.05, ###p<0.001: *Turipul* extract of the present invention vs. *Danpungturipul* extract; &p<0.05, &&&p<0.001: *Turipul* extract of the present invention vs. *Jirituripul* extract) (Fig. 2B).
[0103] 3-3. Evaluation of Allergy Factor Inhibitory Activity
[0104] The inhibitory activity of the present invention on β-hexosaminidase, an allergen, was evaluated by treating RBL-2H3 cells, which are bronchial cells stimulated by IgE, with the extracts of *Turi-pul*, *Danpung-turi-pul*, and *Jiri-turi-pul* of the present invention at concentrations of 6.25 μg / mL, 12.5 μg / mL, 25 μg / mL, and 100 μg / mL. At treatment concentrations ranging from 50 μg / mL to 100 μg / mL, all three *Turi-pul* extracts inhibited the expression of β-hexosaminidase. However, at concentrations of 10 μg / mL and 100 μg / mL, the extract of *Turipul* of the present invention showed significantly higher β-hexosaminidase inhibitory activity compared to the extracts of *Danpungturipul* and *Jiripul* (p<0.001: extract of *Turipul* of the present invention vs. *Danpungturipul* extract; &&&p<0.001: extract of *Turipul* of the present invention vs. *Jiripul* extract) (Fig. 2C).
[0106] Asthma is one of the major causes of bronchoconstriction and acute inflammation caused by β-hexosaminidase secreted from mast cells. In particular, since allergic rhinitis is often accompanied by asthma and shares genetic predisposition and pathophysiology, inhibition of β-hexosaminidase secretion by the turmeric extract of the present invention can be expected to have excellent effects in the treatment and prevention of asthma and allergic rhinitis.
[0108] Example 4: Evaluation of Anti-inflammatory Efficacy of Trichosanthes Extract
[0109] Since systemic inflammatory responses can exacerbate respiratory diseases, properly controlling these responses is crucial for preventing or treating respiratory diseases. Accordingly, the inventors evaluated the degree of inhibition of inflammatory cytokines generated by inducing an inflammatory response with LPS after pre-treating human monocyte cell line THP-1 cells and mouse macrophage cell line RAW264.7 cells with the turmeric extract of the present invention.
[0111] As shown in Fig. 3, THP-1 cells showed concentration-dependent inhibition of TNF-α (Fig. 3A), IL-6 (Fig. 3B), and CCL-2 (Fig. 3C) expression at treatment concentrations of 12.5 μg / mL to 100 μg / mL of turkey's pear extract. Treatment with 100 μg / mL of turkey's pear showed inhibition of inflammatory cytokine expression by more than 90%. Similarly, in RAW264.7 cells, treatment concentrations of turkey's pear extract showed concentration-dependent inhibition of inflammatory cytokine expression, including TNF-α (Fig. 4A), IL-6 (Fig. 4B), CCL-2 (Fig. 4C), and NO (Fig. 4D).
[0113] Chronic obstructive pulmonary disease (COPD) is a group of diseases characterized by reduced airflow velocity due to airway obstruction. Similar to asthma, it presents with symptoms of airway disease such as shortness of breath, coughing, and phlegm. It can be caused by factors such as smoking, congenital diseases, and respiratory infections, with neutrophils and macrophages acting as key mediators. Therefore, the anti-inflammatory efficacy of the *Turipul* extract of the present invention can help treat and prevent chronic obstructive pulmonary disease.
[0115] Example 5: Lung tissue analysis (Histological examination)
[0116] BALB / C mice (male, 5 weeks old) were purchased from Nara Biotech and acclimatized for 1 week, and grouped with n=4. After 2 weeks of administration of low-concentration thaliana extract (250 μg / mice), high-concentration thaliana extract (500 μg / mice), and PBS (100 μL, control), 1 x 10 8 CFU of Staphylococcus aureus was injected nasally. 24 hours after Staphylococcus aureus infection, the animals were anesthetized with isoflurane using an inhalation anesthetic device and dissection was performed. During the experiment, feed and drinking water were provided via free feeding, and the animals were reared in an environment of 24°C and 60% humidity.
[0118] Lung tissue was excised from dissected respiratory disease model mice, and after removing the mesenchyme, it was fixed in 10% neutral buffered formalin for 3 days. The fixed tissue was dehydrated with ethyl alcohol and xylene, embedded in paraffin, trimmed, and sectioned to a thickness of 5 μm. The prepared sections were attached to slides, stained with H&E to confirm their general morphology, and observed under a microscope.
[0120] H&E staining results confirmed that the lung tissue of the PBS control group showed a decrease in the size and number of alveolar sacs and a thinning of septa compared to the lung tissue of normal mice after Staphylococcus aureus infection, indicating an overall structural deformation of the lung tissue. Additionally, Staphylococcus aureus infection increased the infiltration of immune cells within the lung tissue. In contrast, when Staphylococcus aureus was induced after consuming the terripul extract for two weeks, the structural deformation of the lung tissue recovered to a level close to that of normal mice, and a decrease in the infiltration of immune cells was observed. These efficacys for the prevention and recovery of respiratory diseases were found to be superior as the content of the consumed terripul extract increased (Fig. 5).
[0122] Lung sections were stained with F4 / 80 antibody to measure the extent of immune cells infiltrating the lung tissue. Compared to normal mice, nasal infection with Staphylococcus aureus increased macrophage infiltration in the lung tissue, whereas in mice that ingested the terebinth extract, macrophage infiltration in the lung tissue decreased in a concentration-dependent manner (Fig. 6).
[0124] The degree of infection of Staphylococcus aureus in lung tissue was compared and analyzed after staining with anti-Staphylococcus aureus-specific antibodies. In the lung tissue of mice that did not consume the turfgrass extract, the number of infected Staphylococcus aureus increased rapidly, whereas in the lung tissue of mice that consumed the turfgrass extract, the number of Staphylococcus aureus decreased significantly (Fig. 7).
[0126] The lung tissue analysis tests above confirmed that the extract of *Turipul* has an effect in preventing or alleviating respiratory diseases caused by nasal infection with Staphylococcus aureus.
[0128] Acute infectious bronchitis and pneumonia are infectious diseases in which inflammation occurs due to infection by viruses or bacteria. The turkeytail extract of the present invention is expected to be highly effective in treating and preventing acute bronchitis and pneumonia by effectively inhibiting lung infection by Staphylococcus aureus.
[0130] Example 6: Evaluation of the antibacterial efficacy of turkeytail extract
[0131] Changes in hBD3 expression were measured by qPCR after treating HaCaT cells with the extracts of *Turipul*, *Danpungturipul*, and *Jiripul* of the present invention. The *Turipul* extract of the present invention induced approximately 51-fold higher expression of hBD3 mRNA compared to untreated (None), while *Danpungturipul* induced approximately 24-fold and *Jiripul* induced approximately 32-fold expression. In the comparison between groups, the *Turipul* extract of the present invention induced significantly higher hBD3 mRNA expression, approximately 48% higher than *Danpungturipul* and approximately 63% higher than *Jiripul* (p<0.05 for each) (Fig. 8A).
[0133] Meanwhile, as a result of performing a disk assay against Staphylococcus aureus, the antibacterial efficacy of the turfgrass extract of the present invention was confirmed (Fig. 8B).
[0135] Example 7: Evaluation of the antimicrobial efficacy of probiotic-fermented turmeric extract
[0136] To prepare a lactic acid bacteria fermented extract, 100g of finely ground Thuricaudatus was weighed and added to 1L of MRS medium for sterilization. Lactobacillus plantarum K8 strain was added, and fermentation was carried out at 37℃ for 5 days. The culture medium was recovered using centrifugation and a filter unit, and the lactic acid bacteria fermented Thuricaudatus extract was prepared by freeze-drying.
[0138] As a result of performing a disk assay against Staphylococcus aureus using lactic acid bacteria-fermented extracts, the lactic acid bacteria-fermented *Turi-pul* extract formed a clear zone approximately 22% higher than that of the 70% ethanol *Turi-pul* extract (**p<0.01) (Fig. 9). These results demonstrate that the antibacterial efficacy of *Turi-pul* extract increases when it is fermented using lactic acid bacteria. In this experiment, no clear clear zone could be observed in the L. plantarum K8, DMSO, and Media samples.
[0140] After fermenting the turkeygrass extract using various probiotics, the growth inhibition efficacy against S. aureus was evaluated. As shown in Fig. 10, the turkeygrass extract fermented using L. plantarum K8, L. casei, Streptococcus thermophilus, Bifidobacterium longum, Leuconostoc mesenteroides, Bacillus coagulans, and Saccharomyces boulardii used in the experiment showed a growth inhibition efficacy of 65–85% against S. aureus, demonstrating an antibacterial efficacy more than twice as high compared to unfermented probiotic strains (Fig. 10).
[0142] As described above, it was confirmed that the turkeygrass extract of the present invention not only induces the expression of antimicrobial substances from skin cells but also exhibits excellent antimicrobial efficacy against Staphylococcus aureus. In particular, it was confirmed that the efficacy of the fermented product obtained by fermenting the turkeygrass extract with lactic acid bacteria is significantly increased.
[0144] Example 8: Evaluation of Antitussive and Expectorant Efficacy
[0145] 8-1. Cough-relieving effect
[0146] A positive control substance and the turkeytail extract of the present invention were orally administered once a day for 10 days, and on the last day of administration, 1 hour after administration, the experimental animals were exposed to ammonia liquor and the time until the first cough was induced in 2 minutes and the number of coughs were measured.
[0148] As a result of the antitussive test, the occurrence of the first cough after 13% ammonium hydroxide spray showed a statistically significant difference in the positive control (PC) group and the turkey extract group compared to the PBS group (Fig. 11 A). In addition, when the total number of coughs was measured, the PC group and the turkey extract treatment group showed a significant decrease compared to the PBS group (Fig. 11 B). Data were expressed as mean ± SD, and one-way ANOVA statistical analysis was used (*p<0.05; **p<0.01; ***p<0.001).
[0150] 8-2. Expectorant effect
[0151] A positive control substance and the turkeytail extract of the present invention were orally administered once a day for 10 days, and 5% phenol red was injected intraperitoneally 30 minutes after administration on the last day of administration. After 30 minutes of intraperitoneal injection, the trachea was incised and immersed in 1 mL of physiological saline for 30 minutes to immerse the phenol red. After adding 0.1 mL of 1 M NaOH to the immersion solution containing phenol red, the absorbance was measured at 546 nm to quantify the amount of phenol red secreted.
[0153] In the phenol red secretion measured to confirm the mucus secretion-promoting effect, the positive control group administered ambroxol (Ambroxol 250 mg / kg) showed a significantly higher increase than the control group (PBS, phenol red IP), and the experimental group administered 200 mg / kg of terriparia extract showed a statistically significant increase compared to the control group with p=0.0147 (Fig. 12). Data were expressed as mean ± SD, and one-tailed paired t-test statistical analysis was used.
[0155] Coughing and expectoration can be caused by physicochemical factors such as cold air, external foreign substances including pathogenic microorganisms, air pollutants, and allergens. Animal experiments have shown that the turkeytail extract of the present invention has high antitussive and expectorant efficacy.
[0157] [Preparation Example 1] Turipul extract Preparation of food containing
[0158] Food Manufacturing Example A: Preparation of a prebiotic intestinal regulator containing turkeytail extract
[0159] Lactic acid bacteria were prepared by mass culturing in MRS medium containing turkeyleaf extract according to methods known in the art, followed by crushing and freeze-drying. A prebiotic intestinal regulator product was prepared by mixing a small amount of calcium and vitamin D with the prepared turkeyleaf fermented lactic acid bacteria. The specific composition is listed in Table 1 below. To enhance the intestinal regulator effect, a small amount of other lactic acid bacteria powders with intestinal regulator effects, such as Bifidobacterium powder known to exist in the large intestine and Lactobacillus plantarum, may be added.
[0160] ingredient 1 pack (%) Fermented lactic acid bacteria from turkeytail extract 70 Vitamin D 15 calcium 15 Total 100
[0162] Food Manufacturing Example B: Preparation of raw food containing turkeytail extract
[0163] A raw food product was prepared by mixing various grain powders, seaweed powders, fruit and vegetable powders, mushroom powders, and the extract of the turmeric or its lactic acid bacteria fermentation extract of the present invention with fermented soybean germ powder. The specific composition is described in Table 2 below.
[0164] ingredient 1 pack (%) Fermented soybean germ powder 25 brown rice powder 10 barley powder 5 corn powder 3 mung bean powder 3 Job's tears powder 3 sesame powder 3 red bean powder 3 seaweed powder 5 Seaweed powder 8 Kelp powder 12 Kale powder 5 aloe powder 3 Carrot powder 2 shiitake mushroom powder 4 Reishi mushroom powder 4 Turipul extract 2 Total 100
[0166] Food Manufacturing Example C: Example of preparation of a health functional food containing turkeytail extract
[0167] A health functional food composition containing turkeytail extract was prepared using a conventional liquid preparation method with the same composition as each of the following preparation examples (Table 3). The final volume is 100 ml for each liquid. The preparation examples can be prepared using conventional preparation methods, such as in the form of tablets, powders, granules, extracts, or beverages, in addition to liquids.
[0168] ingredient Content (weight%) Turipul extract 100mg honey 1500mg Vitamin C 50mg Vitamin B6 10mg Nicotinamide 10mg Royal Jelly 80mg Preservatives, fragrance a very small amount purified water Remaining amount total 100mg
[0170] [Preparation Example 2] Preparation of medicines containing turkeytail extract
[0171] The turmeric extract of the present invention can be used as a pharmaceutical product by mixing it with excipients or adjuvants commonly used in pharmaceuticals at a daily dose of 0.1 to 10,000 mg and formulating it into a pharmaceutical preparation that can be administered orally or parenterally by conventional pharmaceutical methods. Next, an example of the preparation of the preparation is exemplified as a preparation example.
[0173] Formulation Example A: Preparation of tablets
[0174] 5mg of turkeytail extract
[0175] 20mg lactose
[0176] 19mg starch
[0177] Magnesium stearate red
[0178] The above ingredients are mixed and compressed into 50 mg tablets according to a standard tablet manufacturing method.
[0180] Formulation Example B: Manufacture of capsules
[0181] 5mg of turmeric extract
[0182] 20mg lactose
[0183] 19mg starch
[0184] Talc 1mg
[0185] Appropriate amount of magnesium stearate
[0186] The above ingredients are mixed and filled into 50 mg gelatin capsules according to a conventional capsule manufacturing method.
[0188] Formulation Example C: Manufacturing of injectables
[0189] 5mg of turkeytail extract
[0190] Appropriate amount of solubilizing agent
[0191] Appropriate amount of sterile distilled water for injection
[0192] The above ingredients are filled into a 2ml ampoule according to the usual method for manufacturing an injectable, sealed, and then sterilized to produce an injectable.
[0194] Formulation Example D: Preparation of syrups
[0195] 5mg of turkeytail extract
[0196] Tween 80 appropriate amount
[0197] 5g sugar
[0198] 5g isomerized sugar
[0199] Appropriate amount of purified water
[0200] Total 50ml
[0201] The above ingredients are added to purified water and stirred well, then filled into a 50ml glass bottle and sterilized to prepare a syrup.
[0203] Formulation Example E: Manufacturing of ointments
[0204] 5mg of turkeytail extract
[0205] 1.5g diethanolamine
[0206] Polyvinylpyrrolidone 5g
[0207] 30g of propylene glycol
[0208] Add distilled water to make the total 100ml.
[0209] The above ingredients are used to manufacture an ointment according to the standard method for manufacturing ointments.
[0211] Formulation Example F: Manufacture of patch formulations
[0212] A circular mold of 0.3 to 0.8 mm was pressed onto a sterile Parafilm, and 6.7 U / ml of thrombin (Sigma, T4648) in a sol state was dispensed. Then, 15 μL of the terripul extract prepared in the above example was mixed with thrombin and dispensed into the mold. Afterward, the terripul patch was prepared by curing at 37°C for 30 minutes through a sol-gel phase transition.
[0214] Formulation Example G: Manufacture of inhalants
[0215] A suspension prepared by homogenizing 50 μg of turkeytail extract with an appropriate amount of HFA134A / HFA227 was transferred to a mixing container to which the remaining amount of HFA was added. The obtained suspension was mixed, recirculated, and filled into a pre-crimped aluminum can to produce an inhalant.
Claims
Claim 1 A food composition for enhancing respiratory function and improving respiratory diseases, comprising a turkeytail extract or a fermented product thereof as an active ingredient. Claim 2 A composition according to claim 1, characterized in that the above-mentioned turkey extract is an extract containing one or more of (+)-catechin, Kaempferol, Stearic acid, Erucamide, Biflavonoid, Tormentic acid, Ceanothic acid, 3-Epi-corosolic acid, and Omadacycline. Claim 3 A composition according to claim 1, wherein the fermented product is fermented with microorganisms. Claim 4 A composition according to claim 3, characterized in that the microorganism is one or more selected from Lactobacillus sp., Streptococcus sp., Bifidobacteria sp., Lactococcus sp., Leuconostocs sp., Bacillus sp., Yeast, or Aspergilli sp. Claim 5 A composition according to claim 4, characterized in that the microorganism is Lactobacillus plantarum K8 (Lactiplantibacillus plantarum K8, accession number KCTC 10887BP). Claim 6 A composition according to claim 1, characterized in that the respiratory disease is a lung disease accompanied by symptoms such as cough, sputum, dyspnea, airway hyperresponsiveness, airway obstruction, excessive mucus secretion, reduced expiratory flow rate and / or impaired gas exchange, and difficulty breathing due to inflammation and pus filling the lungs. Claim 7 A composition according to claim 1, characterized in that the respiratory disease is asthma, COPD, diffuse interstitial lung disease, acute respiratory distress syndrome (ARDS), pneumonia, or acute lung injury. Claim 8 A health functional food comprising a food composition according to any one of claims 1 to 7. Claim 9 A pharmaceutical composition for the prevention or treatment of respiratory diseases, comprising a turkeytail extract or a fermented product thereof as an active ingredient. Claim 10 A composition according to claim 9, characterized in that the above-mentioned turkey extract is an extract containing one or more of (+)-catechin, Kaempferol, Stearic acid, Erucamide, Biflavonoid, Tormentic acid, Ceanothic acid, 3-Epi-corosolic acid, and Omadacycline. Claim 11 A composition according to claim 9, wherein the fermented product is fermented with microorganisms. Claim 12 A composition according to claim 11, characterized in that the microorganism is one or more selected from Lactobacillus sp., Streptococcus sp., Bifidobacteria sp., Lactococcus sp., Leuconostocs sp., Bacillus sp., Yeast, or Aspergilli sp. Claim 13 A composition according to claim 12, characterized in that the microorganism is Lactobacillus plantarum K8 (Lactiplantibacillus plantarum K8, accession number KCTC 10887BP). Claim 14 A composition according to claim 9, characterized in that the respiratory disease is a lung disease accompanied by symptoms such as cough, sputum, dyspnea, airway hyperresponsiveness, airway obstruction, excessive mucus secretion, reduced expiratory flow rate and / or impaired gas exchange, and difficulty breathing due to inflammation and pus filling the lungs. Claim 15 A composition according to claim 9, characterized in that the respiratory disease is asthma, COPD, diffuse interstitial lung disease, acute respiratory distress syndrome (ARDS), pneumonia, or acute lung injury.