Composition for treating respiratory diseases comprising perilla leaf extract

Abstract

The present invention relates to a pharmaceutical composition for treating and preventing allergic bronchitis, comprising a perilla leaf extract as an active ingredient, and a preparation method therefor, and can be used as functional health food and feed compositions for preventing and alleviating allergic bronchitis.

Description

Composition for treating respiratory diseases containing perilla leaf extract

[0001] The present invention relates to a composition exhibiting respiratory disease treatment activity, and more specifically, to a pharmaceutical composition and a health functional food composition having respiratory disease treatment or prevention efficacy, which contain a perilla leaf extract as an active ingredient.

[0002]

[0003] Perilla is emerging as a high-income crop, with demand rivaling sesame oil, as its previously unknown benefits—anti-anemia, vascular health, improved cholesterol levels, and enhanced immunity—are gaining recognition. Perilla is not only environmentally friendly and pest-free, allowing for pesticide-free cultivation, but also virtually free of damage to crops. Furthermore, its relatively low cost and ease of cultivation in aging rural areas are contributing to increased farm income.

[0004] Perilla oil exports are currently diversifying to the US, Singapore, Taiwan, and beyond Japan, contributing to continued domestic production expansion. Perilla oil contains over 60% alpha-linolenic acid, an omega-3. In addition to its unique vegetable oil flavor, it boasts health benefits and is emerging as a globally exportable food ingredient. In 2021, perilla oil received approval for a functional food claim in Japan, and studies have shown that consuming 4.7 grams per day is beneficial for high blood pressure.

[0005] Perilla and Purslane Extract (No. 2021-11) has been certified for its ability to help boost immune function. Despite the proven usefulness of perilla leaves in traditional Korean medicine over a long period of time, the respiratory disease-treating activity of perilla leaves themselves has not been utilized in various compositions.

[0006] Accordingly, the inventors of the present invention conducted experiments on the respiratory disease suppression effect using perilla leaf extract as an active ingredient and verified its effectiveness through data. Through this, the inventors of the present invention seek to provide an invention relating to a pharmaceutical composition for the treatment or prevention of respiratory diseases containing perilla leaf extract as an active ingredient.

[0007]

[0008] The main purpose of the present invention is to provide a pharmaceutical composition and a health functional food composition containing perilla leaf extract as an active ingredient, which exhibits an effect in treating or preventing respiratory diseases.

[0009]

[0010] The terminology used herein is for the purpose of description only and should not be construed as limiting. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this specification, the terms "comprises" or "has" and the like are intended to specify the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but should be understood to not preclude the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0011] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the art to which the embodiments pertain. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and shall not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0012] The present invention provides a pharmaceutical composition for treating or preventing respiratory diseases, comprising a perilla leaf extract as an active ingredient.

[0013] Preferably, the extract may be an ethanol extract, but is not limited thereto.

[0014] The pharmaceutical composition according to the present invention may further comprise suitable carriers, excipients, and diluents commonly used in the manufacture of pharmaceutical compositions. The excipients may be, for example, one or more selected from the group consisting of diluents, binders, disintegrants, lubricants, adsorbents, moisturizers, film-coating materials, and controlled-release additives.

[0015] The pharmaceutical composition according to the present invention may be formulated and used in the form of external preparations such as powders, granules, sustained-release granules, enteric-coated granules, liquids, eye drops, ellipsoids, emulsions, suspensions, alcohols, troches, aromatic waters, limonades, tablets, sustained-release tablets, enteric-coated tablets, sublingual tablets, hard capsules, soft capsules, sustained-release capsules, enteric capsules, pills, tinctures, soft extracts, dry extracts, fluid extracts, injections, capsules, irrigation solutions, ointments, lotions, pastes, sprays, inhalants, patches, sterile injection solutions, or aerosols, according to a conventional method, and the external preparations may have formulations such as creams, gels, patches, sprays, ointments, ointments, lotions, liniments, pastes, or cataplasmas.

[0016] Carriers, excipients and diluents that may be included in the pharmaceutical composition according to the present invention include lactose, dextrose, sucrose, oligosaccharides, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

[0017] When formulating, it is usually prepared using diluents or excipients such as fillers, bulking agents, binders, wetting agents, disintegrants, and surfactants.

[0018] The additives of the tablets, powders, granules, capsules, pills, and troches according to the present invention include excipients such as corn starch, potato starch, wheat starch, lactose, sucrose, glucose, fructose, D-mannitol, precipitated calcium carbonate, synthetic aluminum silicate, calcium hydrogen phosphate, calcium sulfate, sodium chloride, sodium bicarbonate, purified lanolin, microcrystalline cellulose, dextrin, sodium alginate, methylcellulose, sodium carboxymethylcellulose, kaolin, urea, colloidal silica gel, hydroxypropyl starch, hydroxypropyl methylcellulose (HPMC) 1928, HPMC 2208, HPMC 2906, HPMC 2910, propylene glycol, casein, calcium lactate, and Primogel; Gelatin, gum arabic, ethanol, agar powder, cellulose acetate phthalate, carboxymethylcellulose, calcium carboxymethylcellulose, glucose, purified water, sodium caseinate, glycerin, stearic acid, sodium carboxymethylcellulose, sodium methylcellulose, methylcellulose, microcrystalline cellulose, dextrin, hydroxycellulose, hydroxypropyl starch, hydroxymethylcellulose, refined shellac, starch starch, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, polyvinyl pyrrolidone, and binders such as hydroxypropyl methylcellulose, corn starch, agar powder, methylcellulose, bentonite, hydroxypropyl starch, sodium carboxymethylcellulose, sodium alginate, Disintegrants such as carboxymethylcellulose calcium, calcium citrate, sodium lauryl sulfate, anhydrous silicic acid, 1-hydroxypropyl cellulose, dextran, ion exchange resin, polyvinyl acetate, formaldehyde-treated casein and gelatin, alginic acid, amylose, guar gum, baking soda, polyvinylpyrrolidone, calcium phosphate, gelling starch, gum arabic, amylopectin, pectin, sodium polyphosphate, ethyl cellulose, sucrose, magnesium aluminum silicate, di-sorbitol solution, and light anhydrous silicic acid;Lubricants such as calcium stearate, magnesium stearate, stearic acid, hydrogenated vegetable oil, talc, lycopodium dentata, kaolin, petrolatum, sodium stearate, cacao butter, sodium salicylate, magnesium salicylate, polyethylene glycol 4000, polyethylene glycol 6000, liquid paraffin, hydrogenated soybean oil (Lubri wax), aluminum stearate, zinc stearate, sodium lauryl sulfate, magnesium oxide, macrogol, synthetic aluminum silicate, anhydrous silicic acid, higher fatty acids, higher alcohols, silicone oil, paraffin oil, polyethylene glycol fatty acid ether, starch, sodium chloride, sodium acetate, sodium oleate, dl-leucine, and light anhydrous silicic acid can be used.;

[0019] As additives of the liquid formulation according to the present invention, water, dilute hydrochloric acid, dilute sulfuric acid, sodium citrate, monostearate sucrose, polyoxyethylene sorbitol fatty acid esters (twin esters), polyoxyethylene monoalkyl ethers, lanolin ethers, lanolin esters, acetic acid, hydrochloric acid, ammonia water, ammonium carbonate, potassium hydroxide, sodium hydroxide, prolamine, polyvinylpyrrolidone, ethyl cellulose, sodium carboxymethyl cellulose, etc. can be used.

[0020] The syrup according to the present invention may include a solution of white sugar, other sugars, or sweeteners, and may also include a fragrance, a coloring agent, a preservative, a stabilizer, a suspending agent, an emulsifier, a viscosity modifier, and the like, as needed.

[0021] Purified water may be used in the emulsion according to the present invention, and emulsifiers, preservatives, stabilizers, fragrances, etc. may be used as needed.

[0022] The suspension according to the present invention may include suspending agents such as acacia, tragacanth, methylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, microcrystalline cellulose, sodium alginate, hydroxypropylmethylcellulose (HPMC), HPMC 1828, HPMC 2906, and HPMC 2910, and, if necessary, surfactants, preservatives, stabilizers, colorants, and fragrances may be used.

[0023] The injection according to the present invention includes: a solvent such as distilled water for injection, 0.9% sodium chloride injection, Ringer's injection, dextrose injection, dextrose + sodium chloride injection, PEG, lactated Ringer's injection, ethanol, propylene glycol, non-volatile oils - sesame oil, cottonseed oil, peanut oil, soybean oil, corn oil, ethyl oleate, isopropyl myristate, and benzene benzoate; a solubilizing agent such as sodium benzoate, sodium salicylate, sodium acetate, urea, urethane, monoethylacetamide, butazolidine, propylene glycol, tween, nitrile acid amide, hexamine, and dimethylacetamide; a buffer such as weak acids and their salts (acetic acid and sodium acetate), weak bases and their salts (ammonia and ammonium acetate), organic compounds, proteins, albumin, peptone, and gums; an isotonic agent such as sodium chloride; It may contain stabilizers such as sodium bisulfite (NaHSO3), carbon dioxide, sodium metabisulfite (Na2S2O5), sodium sulfite (Na2SO3), nitrogen (N2), and ethylenediaminetetraacetic acid; oxidizing agents such as sodium bisulfite 0.1%, sodium formaldehyde sulfoxylate, thiourea, disodium ethylenediaminetetraacetic acid disodium, and acetone sodium bisulfite; analgesics such as benzyl alcohol, chlorobutanol, procaine hydrochloride, glucose, and calcium gluconate; and suspending agents such as sodium citric acid, sodium alginate, Tween 80, and aluminum monostearate.

[0024] The suppository according to the present invention comprises cocoa butter, lanolin, withepsol, polyethylene glycol, glycerogelatin, methylcellulose, carboxymethylcellulose, a mixture of stearic acid and oleic acid, Subanal, cottonseed oil, peanut oil, palm oil, cocoa butter + cholesterol, lecithin, ranet wax, glycerol monostearate, Tween or Span, Imhausen, monolene (propylene glycol monostearate), glycerin, Adeps solidus, Buytyrum Tego-G, Cebes Pharma 16, hexalide base 95, Cotomar, Hydroxocote SP, S-70-XXA, S-70-XX75 (S-70-XX95), Mechanisms such as Hydrokote 25, Hydrokote 711, Idropostal, Massa estrarium (A, AS, B, C, D, E, I, T), Massa-MF, Masupol, Masupol-15, Neosupostal-N, Paramound-B, Suposiro (OSI, OSIX, A, B, C, D, H, L), Suppository type IV (AB, B, A, BC, BBG, E, BGF, C, D, 299), Supostal (N, Es), Wecovi (W, R, S, M, Fs), and Tezester triglyceride basis (TG-95, MA, 57) can be used.

[0025] Solid dosage forms for oral administration include tablets, pills, powders, granules, capsules, etc., and these solid dosage forms are prepared by mixing the extract with at least one excipient, such as starch, calcium carbonate, sucrose or lactose, gelatin, etc. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used.

[0026] Liquid preparations for oral administration include suspensions, solutions, emulsions, and syrups. In addition to commonly used simple diluents such as water and liquid paraffin, they may contain various excipients such as wetting agents, sweeteners, flavoring agents, and preservatives. Preparations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, and suppositories. Non-aqueous solvents and suspensions can include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate.

[0027] The pharmaceutical composition according to the present invention is administered in a pharmaceutically effective amount. In the present invention, "pharmaceutically effective amount" means an amount sufficient to treat a disease with a reasonable benefit / risk ratio applicable to medical treatment. The effective dosage level can be determined based on factors including the type and severity of the patient's disease, drug activity, drug sensitivity, administration time, administration route and excretion rate, treatment period, concurrently used drugs, and other factors well known in the medical field.

[0028] The pharmaceutical composition according to the present invention can be administered as an individual therapeutic agent or in combination with other therapeutic agents. It can be administered sequentially or simultaneously with conventional therapeutic agents, or in single or multiple doses. Taking all of the above factors into account, it is important to administer an amount that achieves maximum efficacy with minimal side effects. This amount can be readily determined by those skilled in the art to which the present invention pertains.

[0029] The pharmaceutical composition of the present invention can be administered to a subject via various routes. All modes of administration are conceivable, including oral ingestion, subcutaneous injection, intraperitoneal administration, intravenous injection, intramuscular injection, intrathecal injection, sublingual administration, buccal mucosal administration, rectal insertion, vaginal insertion, ocular administration, otic administration, nasal administration, inhalation, oral or nasal spraying, dermal administration, and transdermal administration.

[0030] The pharmaceutical composition of the present invention is determined according to the type of drug as an active ingredient along with various related factors such as the disease to be treated, route of administration, age, sex, weight of the patient, and severity of the disease.

[0031] In the present invention, the term "subject" means a subject requiring treatment for a disease, and more specifically, a mammal such as a human or non-human primate, mouse, rat, dog, cat, horse, and cow.

[0032] In the present invention, "administration" means providing a predetermined composition of the present invention to a subject by any suitable method. In the present invention, "prevention" means any action that inhibits or delays the onset of a target disease, "treatment" means any action that improves or beneficially changes a target disease and its resulting metabolic abnormality symptoms by administering a pharmaceutical composition according to the present invention, and "improvement" means any action that reduces a parameter related to a target disease, for example, the severity of a symptom, by administering a composition according to the present invention.

[0033] In the present invention, the perilla leaf extract may exhibit an effect through a mechanism of inhibiting lymphocyte production or immunoglobulin expression, and the immunoglobulin may be IgE, but is not limited thereto.

[0034] The present invention also provides a health functional food composition for preventing or improving respiratory diseases, comprising the perilla leaf extract.

[0035] In the present invention, "food" means a natural product or processed product containing one or more nutrients, preferably a product that has gone through a certain degree of processing to become directly edible, and in its usual sense, includes all health functional foods, beverages, food additives, and beverage additives.

[0036] In the present invention, the term "functional food" is the same as food for special health use (FoSHU), and refers to a food with high medical or healthcare effects that is processed to efficiently exhibit a bioregulatory function in addition to providing nutrition, and may be manufactured in the form of tablets, capsules, pills, granules, powders, liquids, flakes, pastes, syrups, gels, jellies, bars, or films. Here, "function" means regulating nutrients for the structure and functions of the human body or obtaining a useful effect for health purposes such as physiological actions.

[0037] When the perilla leaf extract of the present invention is used as a food additive, it can be added as is or used together with other foods or food ingredients, and can be used appropriately according to a conventional method. The mixing amount of the active ingredient can be appropriately determined depending on the purpose of use (prevention, health, or therapeutic treatment). Generally, when manufacturing a food or beverage, the perilla leaf extract of the present invention can be added in an amount of 15% by weight or less, or 10% by weight or less, based on the raw material. However, in the case of long-term intake for the purpose of health and hygiene or health control, the amount can be below the above range, and since there is no problem in terms of safety, the active ingredient can also be used in an amount above the above range.

[0038] There are no specific restrictions on the types of the above foods. Examples of foods to which the above substances can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages, and vitamin complexes, and all health functional foods in the conventional sense are included.

[0039] The health beverage composition according to the present invention may contain various flavoring agents or natural carbohydrates as additional ingredients, similar to conventional beverages. The natural carbohydrates mentioned above include monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As a sweetener, natural sweeteners such as thaumatin and stevia extract, or synthetic sweeteners such as saccharin and aspartame may be used. The proportion of the natural carbohydrate is generally about 0.01-0.20 g, or about 0.04-0.10 g, per 100 mL of the composition of the present invention.

[0040] In addition to the above, the composition of the present invention may contain various nutrients, vitamins, electrolytes, flavoring agents, coloring agents, pectic acid and its salts, alginic acid and its salts, organic acids, protective colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohol, carbonating agents used in carbonated beverages, etc. In addition, the composition of the present invention may contain fruit pulp for the production of natural fruit juice, fruit juice drinks, and vegetable drinks. These ingredients may be used independently or in combination. The proportion of these additives is not particularly critical, but is typically selected within the range of 0.01 to 0.20 parts by weight per 100 parts by weight of the composition of the present invention.

[0041] The present invention also provides a feed composition for treating and improving respiratory diseases, comprising the perilla leaf extract.

[0042] The term "feed" in the present invention means any natural or artificial diet, meal, etc. or a component of said meal for eating, ingesting, and digesting by an animal or suitable therefor.

[0043] The type of the above feed is not particularly limited, and feed commonly used in the relevant technical field can be used. Non-limiting examples of the above feed include plant-based feed such as grains, roots, food processing by-products, algae, fiber, pharmaceutical by-products, oils, starches, meal, or grain by-products; and animal-based feed such as proteins, inorganic substances, oils, minerals, oils, single-cell proteins, zooplankton, or food. These may be used alone or in combination of two or more.

[0044]

[0045] The perilla leaf extract according to the present invention exhibits efficacy in treating respiratory diseases, and can be used as an effective ingredient in a pharmaceutical composition for treating or preventing respiratory diseases and a health functional food composition.

[0046]

[0047] [Correction pursuant to Rule 91, February 18, 2025][Deleted]

[0048] [Revised 18.02.2025 under Article 91 of the Rules] Figure 1 shows the changes in the total number of white blood cells, lymphocytes, and eosinophils in experimental animals following administration of perilla leaf extract.

[0049] [Correction under Rule 91 18.02.2025] Figure 2 shows the change in serum IgE of experimental animals following administration of perilla leaf extract.

[0050]

[0051] Hereinafter, preferred examples are presented to aid in understanding the present invention. However, the following examples are provided solely to facilitate a better understanding of the present invention, and the scope of the present invention is not limited by the following examples.

[0052]

[0053] Perilla leaf extract manufacturing

[0054] After washing the raw material, the perilla leaves were blanched in hot water at 100℃ for 1-2 minutes and then dried in low-temperature hot air at 45℃ for 5 days. The leaves were then selected, the stems removed, and ground. 1,900 g of 70% ethanol was used as a solvent to extract 100 g of dried perilla leaves by stirring at 100 rpm for 24 hours at room temperature. The extract was filtered through a 5-8 μm filter, concentrated to about 80%, centrifuged at 11,000 rpm for 30 minutes, the supernatant was discarded, suspended in 400 g of distilled water, and vortexed. After that, the leaves were sonicated at 65℃ for 30 minutes, filtered through a 5-8 μm filter, and dried in hot air at 82℃ for 3 days before being finely ground.

[0055]

[0056] Preparation of animal models for respiratory disease

[0057] This experiment was approved by the Animal Care and Use Committee of the Non-Clinical Research Institute of Corestem ChemOn Co., Ltd. in accordance with the Animal Protection Act and the Laboratory Animals Act (Review No.: 2023-0535).

[0058] Ten-week-old female specific pathogen-free (SPF) BALB / c mice (BALB / cAnNCrljOri) (Orient Bio, Daejeon, South Korea) were housed in polycarbonate cages and given free access to solid rodent diet (Teklad certified irradiated global 18% protein rodent diet, 2918C, Inotiv, USA) and tap water sterilized with a UV sterilizer and microfiltration device. After acclimatization for approximately 7 days in a laboratory environment with a temperature of 22±3℃, a humidity of 55±15%, and a 12-h day-night cycle (lights on: 8:00 AM), the general health status was observed, and healthy individuals were selected. The selected experimental animals were then divided into four groups: G1, G2, G3, and G4.

[0059] G1 and G2 were randomly distributed as in the experimental group composition by measuring and ranking the body weights of animals judged as healthy among the experimental animals so that the average body weights of each group were evenly distributed. G3 and G4 were randomly distributed as in the experimental group composition by measuring and ranking the body weights of animals judged as healthy among the remaining animals that had been sensitized (ovalbumin 10 μg / 0.1 mL / head, twice in total) so that the average body weights of each group were evenly distributed.

[0060] Perilla leaf extract was administered to experimental animals at a dose of 10 mL / kg / day, and PBS as a control was administered at a dose of 20 mL / kg / day, once daily for 30 days. The animals' lumbar region was manually corrected, and the medication was administered directly into the stomach using a syringe tube equipped with a zonde. The dosage and conditions for each experimental group are listed in Table 1.

[0061] One hour after administration of perilla leaf extract, one or two mice from each experimental group were placed in the same chamber, the lid was closed, and 10 mL (10 mg / mL) of 1% ovalbumin was sprayed into the chamber through a silicone hose connected to a nebulizer to induce allergic bronchitis. Ovalbumin spray was administered three times a week for 60 minutes for four weeks, and administration and ovalbumin spray were performed together during the four weeks when perilla leaf extract and PBS were administered.

[0062]

[0063] Number of individuals administered (mg / kg) Dosage (mL / kg) Dosage substance G15-20PBS G25-20G3330010Perilla leaf extract G43100010

[0064]

[0065] Analysis of immune cell counts in bronchial lavage fluid

[0066] To collect bronchoalveolar lavage fluid (BALF) from all experimental groups, the animals were euthanized, and the thoracic cavity was opened to expose the lungs. Cold phosphate buffered saline (PBS) was prepared in a 1 mL syringe connected to a 3-way cock, a needle was inserted into the upper airway, and the airway and the needle were tied with thread to secure them. 700 μL of cold PBS was injected into the syringe, 500 μL of the lavage fluid was withdrawn through the opposite valve, and transferred to a tube. Then, 500 μL of cold PBS was added and 300 μL of the lavage fluid was withdrawn. This process was repeated twice to obtain approximately 1 mL of bronchial lavage fluid. The obtained lavage fluid was centrifuged at 1,000 rpm at 4°C for 10 minutes to separate the pellet and supernatant. The pellet was resuspended in 500 μL of PBS, and the number of immune cells was analyzed using an ADVIA 2120i (SEMENS, USA).

[0067]

[0068] Serum separation

[0069] All experimental animals in the experimental group were anesthetized, laparotomized, and blood was collected via the abdominal vena cava. The collected blood was placed in SST tubes and left at room temperature for 15–20 minutes to coagulate. The blood was then centrifuged at 3,000 rpm for 10 minutes to separate the serum. The separated serum was placed in tubes and stored at -70°C until use for analysis.

[0070]

[0071] Statistical analysis

[0072] Statistical analysis was performed using SPSS statistics 12.0K for medical science. Parametric multiple comparison procedures were used to compare the normal group (G1) and the negative control group (G2) to determine the induction of allergic bronchitis, and Student's t-test was used for analysis. One-way analysis of variance (ANOVA) was used to compare the negative control group (G2) and the perilla leaf extract-administered groups (G3-G4). Post hoc tests included the Duncan test for equal variances and the Dunnett test for unequal variances.

[0073]

[0074] Example 1. Changes in leukocytes, lymphocytes, and eosinophils in an animal model following perilla leaf extract treatment.

[0075] On the final administration day, experimental animals were sacrificed to obtain bronchial lavage fluid, and white blood cells (WBC), lymphocytes (LYM), and eosinophils (EOS) were measured using a hematological test measuring device (Fig. 1).

[0076] As a result of BALF hematological analysis, the negative control group (G2) showed a statistically significant increase in white blood cells (WBC), lymphocytes (LYM), and eosinophils (EOS) by 56.20%, 31.96%, and 1300.00%, respectively, compared to the normal group (G1). In white blood cells (WBC), no significant change was observed in the perilla leaf extract administration group (G3-G4) compared to the negative control group (G2). In lymphocytes (LYM), the perilla leaf extract administration group (G3-G4) showed a decreasing trend of 38.80% and 29.69%, respectively, although the decrease was not significant compared to the negative control group (G2), and in eosinophils (EOS), a significant increase was observed in the perilla leaf extract administration group (G3-G4) compared to the negative control group (G2) (p<0.05).

[0077]

[0078] Example 2. Changes in serum IgE in an animal model following administration of perilla leaf extract.

[0079] On the final day of administration, blood samples were collected from all administration groups, and serum was separated from the blood and subjected to an IgE assay (Invitrogen, Cat No. EMIGHE) (Fig. 2).

[0080] As a result of measuring serum IgE, a statistically significant increase was observed in the negative control group (G2) compared to the normal group (G1) (P<0.01). Although not statistically significant, a trend toward a 38.27% and 33.82% decrease in IgE was observed in the perilla leaf extract administration groups (G3-G4) compared to the negative control group (G2).

Claims

1. A pharmaceutical composition for treating or preventing allergic bronchitis containing perilla leaf extract as an active ingredient.

2. In paragraph 1, A pharmaceutical composition characterized in that the above perilla leaf extract is extracted with 70% ethanol.

3. In paragraph 1, A pharmaceutical composition characterized in that the above perilla leaf extract is extracted including a blanching process prior to extraction.

4. In paragraph 1, A pharmaceutical composition characterized in that the above perilla leaf extract exhibits an effect through a mechanism of inhibiting lymphocyte production or immunoglobulin expression.

5. In paragraph 4, A pharmaceutical composition characterized in that the above immunoglobulin is IgE.

6. A method for treating allergic bronchitis comprising administering to a subject a pharmaceutical composition of any one of claims 1 to 5.

7. A method for inhibiting lymphocyte production or immunoglobulin expression, comprising administering to a subject a pharmaceutical composition of any one of claims 1 to 5.

8. In paragraph 7, A method characterized in that the above immunoglobulin is IgE.

9. A health functional food composition for preventing or improving allergic bronchitis containing perilla leaf extract.

10. Feed composition for preventing or improving allergic bronchitis containing perilla leaf extract.

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