A composition for improving intestinal microflora comprising a ginseng extract or a fraction thereof

Abstract

The present invention provides a composition for improving intestinal microbial flora, the composition including: a ginseng extract or a fraction thereof; and sodium propionate. The composition for improving intestinal microbial flora of the present invention can increase the proportion of beneficial bacteria in intestinal microbial flora by promoting the growth of beneficial bacteria while inhibiting the growth of harmful bacteria, and thus, can improve the composition of intestinal microbial flora and maintain the balance thereof, ultimately contributing to improving physical health, for example, by enhancing immunity and improving skin texture.

Description

Technical Field

[0001] This invention relates to a composition for improving the gut microbiota, the composition comprising ginseng extract or fractions thereof. Background Technology

[0002] The microbiome is a compound term created by combining microbes and genomes, and can also be called a microbial community. It encompasses all microorganisms that inhabit or coexist in all environments, such as humans, animals, plants, soil, oceans, lakes, rocks, and air, along with their entire genetic information. Recently, the microbiome has also been referred to as the microbial community in various environments. Various studies have been conducted on the microbiome, such as the plant microbiome, animal microbiome, environmental microbiome, human microbiome, gut microbiome, and skin microbiome, with the majority of research focused on the human microbiome.

[0003] The human body is a complex and vibrant ecosystem, with diverse microorganisms present in areas such as the stomach and skin. In these areas, 500 to 1000 or more different microorganisms coexist and constitute the gut microbiota. Intestinal microorganisms in the stomach synthesize substances such as vitamins to supply the body and inhibit infections from pathogens introduced through contaminated food.

[0004] The gut microbiota is transplanted from the mother's body at birth and, influenced by the environment, each individual develops a unique gut microbiota. Numerous microbiota coexist and maintain a balance within the body to perform various physiological functions. Recently, due to the differences in gut microbiota between obese and normal individuals, it has been discovered that the composition of specific microorganisms may affect weight. Furthermore, transplanting gut microbiota into another gut induces weight changes, further demonstrating a close relationship between obesity and gut microbiota.

[0005] Prebiotics are indigestible food additives that exert beneficial effects on the host by limiting the growth of harmful gut microbes or selectively promoting the growth of beneficial microbes. Known prebiotics include oligosaccharides (fructooligosaccharides, galactooligosaccharides, isomaltooligosaccharides, xylooligosaccharides, chitosan oligosaccharides) and dietary fibers (dextrin, inulin). In recent years, the importance of prebiotics as food for beneficial gut bacteria and thus contributing to gut health has become increasingly prominent, and research on new materials that can be used as prebiotics is ongoing (Patent Document 1).

[0006] Ginseng (Panax ginseng CAMeyer) is a perennial herb belonging to the genus Panax in the family Araliaceae. It is one of the herbs used in Eastern medicine. It has a sweet and bitter taste, warm and nourishing energy, and herbal effects such as strengthening vital energy, protecting the spleen, and invigorating the lungs.

[0007] The main physiologically active substances in ginseng include saponins (also known as ginsenosides), essential oil components, polyacetylenes, phenolic components, glycosides, and acidic peptides, as well as various other components such as vitamins, sugars, and minerals. It has been reported that the physiological activities of ordinary ginseng include effects on the central nervous system, immune enhancement, and anti-cancer effects. In particular, to date, approximately 40 types of ginsenosides have been discovered, and their excellent effects on regulating bodily functions, i.e., normalizing physiological functions, have been demonstrated by broadly influencing the endocrine, immune, and metabolic systems, including the central nervous system. These ginsenosides have similar or opposite effects and are known to exhibit various effects individually or through several types of interactions.

[0008] The inventors discovered that red ginseng extract exhibits excellent effects in promoting the growth of beneficial intestinal bacteria and found the potential of red ginseng extract as a prebiotic. However, red ginseng extract has the problem of promoting the growth of both beneficial and harmful bacteria. Therefore, although research on prebiotic compositions that can inhibit the growth of harmful bacteria and selectively promote only beneficial bacteria is ongoing, the inventors have demonstrated that when sodium propionate is mixed with red ginseng extract, it effectively inhibits the growth of harmful bacteria while promoting the growth of beneficial bacteria, thus completing this invention. Summary of the Invention

[0009] [Technical Issues]

[0010] The purpose of this invention is to provide a composition for improving the intestinal microbiota, which can inhibit the growth of harmful bacteria while promoting the growth of beneficial bacteria in the intestinal microbiota.

[0011] [Technical Solution]

[0012] One aspect of the present invention provides a composition for improving the intestinal microbiota, comprising ginseng extract or fraction thereof; and sodium propionate.

[0013] Another aspect of the present invention provides a pharmaceutical composition for the prevention, improvement or treatment of inflammatory bowel disease or bowel motility disorder, comprising ginseng extract or fraction thereof; and sodium propionate.

[0014] [Beneficial Effects]

[0015] According to the present invention, the composition for improving the gut microbiota can increase the proportion of beneficial bacteria in the gut microbiota by inhibiting the growth of harmful bacteria while promoting the growth of beneficial bacteria. Therefore, the composition of the present invention can improve the morphology of the gut microbiota and maintain its balance, ultimately contributing to improved health, such as enhanced immunity and improved skin texture. Attached Figure Description

[0016] Figure 1 The results indicate the growth-promoting effects on beneficial and harmful bacteria when the red ginseng pure water extract of Example 1, the red ginseng extract / fraction mixture of Example 3, and fructooligosaccharides are concentrated and prepared respectively. Detailed Implementation

[0017] The present invention will now be described in detail.

[0018] The terms and words used in this specification and claims should not be construed as limited to their ordinary or dictionary meanings, but should be interpreted in a meaning and concept consistent with the technical spirit of the invention, based on the principle that the inventors are able to appropriately define the concepts of the terms in order to describe their invention in the best possible way.

[0019] In this invention, "microbial community" refers to a microbial community that includes all bacteria, fungi and other prokaryotes present in the human body, and mainly inhabits the stomach, skin and other areas.

[0020] In this invention, "intestinal microbiota" refers to the microbial community that exists in the intestine.

[0021] One aspect of the present invention provides a composition for improving the intestinal microbiota, comprising ginseng extract or fraction thereof; and sodium propionate.

[0022] In this invention, "improving the intestinal microbiota" refers to promoting the growth of beneficial intestinal bacteria, inhibiting the growth of harmful intestinal bacteria, or maintaining a balance between beneficial and harmful intestinal bacteria.

[0023] In this invention, "prebiotics," as food additives that are poorly digested in the body, are substances that can stimulate the growth or activity of specific beneficial bacteria without being hydrolyzed or absorbed in the upper gastrointestinal tract, thereby inducing the gut microbiota in a direction beneficial to the host's health. In this invention, "prebiotic composition" can be used with the same meaning as compositions used to improve the gut microbiota.

[0024] In this invention, "beneficial intestinal bacteria" refers to beneficial bacteria that exist in the intestines, as well as bacteria that produce beneficial effects on the intestinal environment when ingested and reaching the intestines. Beneficial intestinal bacteria may be, but are not particularly limited to, Bifidobacterium, Lactobacillus, Lactococcus, Streptococcus, Leuconostoc, Akkermansia, Clostridium, Enterococcus, Bacillus, etc.

[0025] Specifically, beneficial gut bacteria may include at least one selected from the group consisting of Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus helveticus, Lactobacillus fermentum, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus delbrueckii subsp. lactis, Lactococcus lactis subsp. lactis, Lactococcus lactis subsp. lactis, Lactococcus lactis subsp. lactis, Enterococcus faecalis, Enterococcus faecium, Streptococcus thermophilus, Leuconostoc mesenteroides, Leuconostoc pseudomesenteroides, Bifidobacterium, Bifidobacterium infantis, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium animalis subsp. lactis, and Bacillus coagulans.

[0026] In this invention, "intestinal harmful bacteria" refers to harmful bacteria present in the intestines, as well as bacteria that have a harmful effect on the intestinal environment when ingested and reaching the intestines. Intestinal harmful bacteria may be, but are not particularly limited to, Escherichia coli, Clostridium, Staphylococcus, Porphyromonas, Bacteroides, Vibrio, Salmonella, Shigella, Akkermansia, Eubacterium, Pseudomonas, Candida, Bacteroides, etc.

[0027] Specifically, harmful intestinal bacteria may include at least one of the following groups: Escherichia coli, Staphylococcus aureus, Aminobacterium spp., Enterobacteriaceae, Akkermansia myxophilus, Eubacterium rectum, Clostridium perfringens, Clostridium ivory-Marie, Clostridium histolyticum, Clostridium perfringens, Clostridium difficile, Veillonaceae, Proteus, β-Proteus, Pseudomonas aeruginosa, Candida albicans, and Bacteroides vulgaris.

[0028] In this invention, "extract" means a substance extracted from a raw material by any method, and is used in the sense of including, but not limited to, extracts extracted as described above, concentrates obtainable therefrom, and the dry matter and powder of said concentrates.

[0029] Extracts can be obtained by extraction from raw materials or their dried form, and the raw materials for extracts can be used without restriction, such as cultivated or commercially available materials.

[0030] In this invention, when extracting and obtaining "ginseng extract" from ginseng, all known conventional extraction methods, such as solvent extraction, ultrasonic extraction, filtration, and reflux extraction, can be used as extraction methods, and solvent extraction or reflux extraction is preferably used to prepare ginseng extract. The extraction process can be repeated several times, after which additional steps such as concentration or freeze-drying can be performed. Specifically, the obtained extract is concentrated under reduced pressure to obtain a concentrate, and after freeze-drying the concentrate, a high-concentration extract powder can be prepared using a grinder. The extract also contains fractions obtained by further fractionation of the extract.

[0031] Ginseng extract can be extracted using water, organic solvents, or mixtures thereof as extraction solvents. The organic solvent may be any one of the group consisting of alcohols, preferably C1–C4 lower alcohols, hexane (n-hexane), ethers, glycerol, propylene glycol, butanediol, ethyl acetate, methyl acetate, dichloromethane, chloroform, ethyl acetate, benzene, and mixtures thereof, with ethanol being preferred. For example, when a mixture of water and an organic solvent is used as the extraction solvent, the mixture of water and the organic solvent may preferably be a mixture of water and C1–C4 lower alcohols, more preferably a mixture of water and ethanol.

[0032] The mixture of water and ethanol can be an aqueous solution of 3% (v / v) or more and less than 100% (v / v), such as an aqueous solution of 5% (v / v) to 99% (v / v), preferably an aqueous solution of 10% (v / v) to 95% (v / v), more preferably an aqueous solution of 15% (v / v) to 90% (v / v), and even more preferably an aqueous solution of 20% (v / v) to 80% (v / v), but is not limited thereto.

[0033] When preparing ginseng extract, the extraction can be carried out at 10°C to 100°C or 50°C to 100°C, preferably 60°C to 90°C, and more preferably 70°C to 80°C, but is not limited thereto. The extraction can be carried out for 2 hours to 12 hours, preferably 5 hours to 10 hours, and more preferably 6 hours to 8 hours. The extraction can be performed 1 to 7 times, preferably 1 to 4 times, and more preferably 1 to 2 times, but is not limited thereto.

[0034] Packing materials, such as silica gel, activated alumina, synthetic polymers, magnesium silicate, activated carbon, cellulose, and ion exchange resins, can be used in columns for preparing purified fractions. Aromatic synthetic resins are preferred as packing materials; that is, the column can be an aromatic synthetic adsorption column, and Diaion HP-20 synthetic adsorbent is more preferred, but the invention is not limited thereto. Separation using the column can be performed one to several times until a fraction with the desired purity is obtained, and concentration and recrystallization can be performed as needed.

[0035] When preparing the purified fraction, the elution solvent may be any one selected from the group consisting of water, organic solvents, and mixtures thereof. The organic solvent may be any one selected from the group consisting of alcohols, hexane (n-hexane), ethers, glycerol, propylene glycol, butanediol, ethyl acetate, methyl acetate, dichloromethane, chloroform, ethyl acetate, benzene, acetone, acetonitrile, and mixtures thereof. Preferably, the organic solvent may be any one selected from the group consisting of acetone, acetonitrile, C1 to C4 alcohols, and mixtures thereof, and the organic solvent may be at least one of ethanol or methanol, more preferably ethanol, but is not limited thereto.

[0036] When ethanol is used as the eluent in the preparation of the purified fraction, the eluent can be ethanol or an aqueous solution of ethanol, and the aqueous solution of ethanol can be, for example, a 30% (v / v) to 100% (v / v) aqueous solution of ethanol, a 50% (v / v) to 100% (v / v) aqueous solution of ethanol, or a 70% (v / v) to 100% (v / v) aqueous solution of ethanol, but is not particularly limited thereto. When the concentration of the aqueous solution of ethanol used as the eluent is below the lower limit, the activity of the fraction obtained by adding the obtained fraction may be insufficient.

[0037] When preparing purified fractions, the addition of elution solvent involves allowing the elution solvent to flow into the column, for example, by allowing the elution solvent to flow under pressure. Specifically, column purification fractions can be obtained by comprising the following steps: 1) passing ginseng extract through a column; and 2) adding an aqueous ethanol solution to the column containing the ginseng extract to obtain the fraction.

[0038] In addition to ginseng extract, the composition of the present invention for improving intestinal microbiota can also use purified fractions obtained by column purification of ginseng extract to enhance the effect of promoting the growth of beneficial intestinal bacteria or inhibiting the growth of harmful intestinal bacteria. In other words, in the present invention, ginseng extract or its fractions can be used to refer to both ginseng extract and fractions of ginseng extract.

[0039] In one embodiment, the composition of the present invention for improving gut microbiota may comprise ginseng extract; fractions of the ginseng extract; and sodium propionate. For specific details regarding the fractions, the same amounts as those for the purified fractions described above may be applied.

[0040] The composition for improving gut microbiota may comprise ginseng extract and ginseng extract fractions in a weight ratio of 1:0.01 to 1:1, 1:0.05 to 1:0.5, or 1:0.07 to 1:0.3. Preferably, the composition for improving gut microbiota may comprise ginseng extract and ginseng extract fractions in a weight ratio of about 1:0.1. When this range is met, the composition for improving gut microbiota can increase the effect of promoting the growth of beneficial gut bacteria or inhibiting the growth of harmful gut bacteria.

[0041] In the composition of the present invention for improving intestinal microbiota, the concentration of ginseng extract or its fraction may be 0.1 to 100 mg / ml, 0.5 to 50 mg / ml, or 1 to 25 mg / ml, and is particularly preferred to be 1.25 to 10 mg / ml.

[0042] In this invention, "sodium propionate" is a white crystalline solid, a sodium salt of propionic acid, and deliquesces in moist air.

[0043] The composition of the present invention for improving intestinal microbiota may comprise ginseng extract or fractions thereof and sodium propionate in a weight ratio of about 8:1 to 1:8, 7:1 to 1:7, 6:1 to 1:6, 5:1 to 1:5, 4:1 to 1:4, 3:1 to 1:3, or 2:1 to 1:2. When these numerical ranges are met, the composition can be excellent in promoting the growth of beneficial intestinal bacteria or inhibiting the growth of harmful intestinal bacteria.

[0044] Furthermore, the compositions of the present invention for improving gut microbiota may further comprise plant extracts or portions thereof. Plant extracts may include Scutellaria baicalensis extract, Glycyrrhiza uralensis extract, Ziziphus jujuba extract, and Astragalus membranaceus extract.

[0045] When preparing various extracts contained in plant extracts, all known conventional extraction methods, such as solvent extraction, ultrasonic extraction, filtration, and reflux extraction, can be used, and solvent extraction or reflux extraction is preferred for preparing various extracts. The extraction process can be repeated several times, after which additional steps such as concentration or freeze-drying can be performed. Specifically, the obtained extract is concentrated under reduced pressure to obtain a concentrate, and after freeze-drying the concentrate, a high-concentration extract powder can be prepared using a grinder.

[0046] When preparing various extracts contained in plant extracts, water, organic solvents, or mixtures thereof can be used as extraction solvents to extract the extracts. Organic solvents can be any one selected from, but are not limited to, alcohols preferably C1–C4 alcohols, hexane (n-hexane), ethers, glycerol, propylene glycol, butanediol, ethyl acetate, methyl acetate, dichloromethane, chloroform, ethyl acetate, benzene, and mixtures thereof. Preferably, water can be used as the extraction solvent.

[0047] When preparing various extracts, extraction can be carried out at temperatures ranging from 15°C to 120°C, 20°C to 32°C, 22°C to 30°C, 23°C to 27°C, 40°C to 120°C, 45°C to 110°C, 50°C to 100°C, or 60°C to 100°C, but is not limited thereto. Extraction can be carried out for 2 hours to 24 hours, preferably 4 hours to 18 hours, and more preferably 6 hours to 16 hours. Extraction can be performed 1 to 7 times, preferably 1 to 4 times, and more preferably 1 to 2 times, but is not limited thereto.

[0048] In a plant extract comprising Scutellaria baicalensis extract, Glycyrrhiza uralensis extract, Ziziphus jujuba extract and Astragalus membranaceus extract, as a mixing ratio of the various plant extracts relative to the total weight of the mixed plant extracts, Scutellaria baicalensis extract may comprise 20 to 60 parts by weight, Glycyrrhiza uralensis extract may comprise 10 to 50 parts by weight, Ziziphus jujuba extract may comprise 1 to 30 parts by weight and Astragalus membranaceus extract may comprise 1 to 30 parts by weight, but the invention is not limited thereto.

[0049] Preferably, the Scutellaria baicalensis extract may comprise 25 to 55 parts by weight, the Glycyrrhiza uralensis extract may comprise 15 to 45 parts by weight, the Ziziphus jujuba extract may comprise 3 to 25 parts by weight, and the Astragalus membranaceus extract may comprise 3 to 25 parts by weight. More preferably, the Scutellaria baicalensis extract may comprise 30 to 50 parts by weight, the Glycyrrhiza uralensis extract may comprise 20 to 40 parts by weight, the Ziziphus jujuba extract may comprise 5 to 20 parts by weight, and the Astragalus membranaceus extract may comprise 5 to 20 parts by weight. When each of the Scutellaria baicalensis extract, Glycyrrhiza uralensis extract, Ziziphus jujuba extract, and Astragalus membranaceus extract is included outside the aforementioned ranges, the effect of promoting the growth of beneficial intestinal bacteria or inhibiting the growth of harmful intestinal bacteria may be reduced.

[0050] The composition of the present invention for improving intestinal microbiota may comprise ginseng extract or fractions thereof in a weight ratio of about 7:1 to 1:7, 6:1 to 1:6, 5:1 to 1:5, or 4:1 to 1:4. When these numerical ranges are met, the composition may be excellent in promoting the growth of beneficial intestinal bacteria or inhibiting the growth of harmful intestinal bacteria.

[0051] The composition of the present invention for improving gut microbiota can be a health functional food composition or a food additive composition. When the composition of the present invention for improving gut microbiota is used as a health functional food composition or a food additive composition, preferably, in addition to the ginseng extract or its fraction and sodium propionate of the present invention, the composition may also contain other components that can synergistically enhance the effects of the ginseng extract or its fraction and sodium propionate, without impairing the effects of the present invention. For example, the composition may contain conventional adjuvants, such as stabilizers, solubilizers, vitamins, etc., or carriers.

[0052] Furthermore, the composition may contain ingredients typically added during food preparation, including, for example, proteins, carbohydrates, fats, nutrients, flavorings, and seasonings. Examples of carbohydrates may include monosaccharides such as glucose and fructose; disaccharides such as maltose, sucrose, and oligosaccharides; and polysaccharides such as common sugars like dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As seasonings, natural seasonings, taurine, stevia extract, and synthetic seasonings may be used. For example, when the composition of the present invention is prepared into a beverage, in addition to the ginseng extract or its fractions of the present invention and sodium propionate, it may also contain citric acid, high-fructose corn syrup, sugar, glucose, acetic acid, malic acid, fruit juice, natural extracts, etc.

[0053] There are no particular restrictions on the types of foods that use the health functional food composition or food additive composition. Examples of foods that can contain a composition of ginseng extract or its fractions and sodium propionate of the present invention include meat, sausage, bread, chocolate, candy, pasta, pizza, ramen, other noodles, chewing gum, dairy products containing ice cream, various soups, beverages, tea, drinks, alcoholic beverages, vitamin complexes, etc., and include all foods in the general sense.

[0054] To improve gut microbiota, food can be prepared and processed into tablets, capsules, powders, granules, liquids, pills, and other forms.

[0055] For example, tablet-form foods can be manufactured by granulating a mixture obtained by mixing a health functional food composition or food additive composition with excipients, binders, disintegrants, and other additives using conventional known methods, and then compressing the mixture with lubricants or directly. Additionally, tablet-form foods may contain sweeteners, etc., as needed.

[0056] In food, hard capsules are prepared by filling a mixture of a health functional food composition or food additive composition with additives (such as excipients) into conventional hard capsules. Soft capsules are prepared by filling a mixture of a health functional food composition or food additive composition with additives (such as excipients) into a capsule matrix (such as gelatin). If desired, soft capsules may contain plasticizers, such as glycerin or sorbitol, colorants, preservatives, etc.

[0057] Foods in pellet form can be prepared by shaping a mixture of health functional food composition or food additive composition with excipients, binders, disintegrants, etc., using conventional known methods. If desired, the mixture can also be coated with sugar or other coating agents or with materials such as starch and talc.

[0058] Foods in granule form can be prepared by granulating a mixture of a health functional food composition or a food additive composition with excipients, binders, disintegrants, etc., using conventional and known methods, and may contain flavorings, sweeteners, etc., if desired.

[0059] Another aspect of the present invention provides a pharmaceutical composition for the prevention, improvement or treatment of inflammatory bowel disease or bowel motility disorder, comprising ginseng extract or fraction thereof; and sodium propionate.

[0060] In this invention, "intestinal inflammatory disease" can be one or more selected from intestinal Behcet's disease, Crohn's disease, ulcerative colitis, acute enteritis, and chronic enteritis.

[0061] In this invention, "intestinal motility disorder" can be one or more selected from the group consisting of functional dyspepsia, irritable bowel syndrome, intestinal obstruction, constipation and diarrhea.

[0062] Without impairing the effects of the present invention, in addition to the ginseng extract or its fractions and sodium propionate of the present invention, preferably, the pharmaceutical composition of the present invention may also contain other components that can synergistically enhance the effects of the ginseng extract or its fractions and sodium propionate. For example, the pharmaceutical composition of the present invention may contain conventional adjuvants, such as antioxidants, stabilizers, solubilizers, vitamins, etc., or carriers.

[0063] The routes of administration of the pharmaceutical composition include oral, intravenous, intramuscular, intra-arterial, transdermal, subcutaneous, intraperitoneal, intranasal, intraenteral, local, sublingual, or rectal administration. For example, local application by means of administration can be used, but preferably, the pharmaceutical composition can be administered orally.

[0064] The pharmaceutical compositions of the present invention can be administered in pharmaceutically effective amounts. In this invention, the term "pharmaceutically effective amount" refers to an amount sufficient to treat a disease with a reasonable benefit / risk ratio suitable for medical treatment, and the level of the effective dose can be determined based on factors including patient type, severity, age, sex, type of disease, drug activity, drug sensitivity, time of administration, route of administration, and excretion rate, duration of treatment, concurrent drugs, and other factors known in the medical field. The compositions of the present invention can be administered as a single therapeutic agent or in combination with other therapeutic agents, and sequentially or simultaneously with conventional therapeutic agents. Furthermore, the pharmaceutical compositions can be administered alone or multiple times. Taking all factors into account, it is important to administer an amount that achieves maximum effect with minimal dosage and without side effects, and this amount can be readily determined by those skilled in the art.

[0065] The pharmaceutical compositions of the present invention are not particularly limited and are suitable for any individual to prevent, improve, or treat inflammatory bowel disease or intestinal motility disorder. For example, the pharmaceutical compositions of the present invention can be used not only in humans but also in non-human animals such as monkeys, dogs, cats, rabbits, guinea pigs, rats, mice, cattle, sheep, pigs, goats, birds, and fish.

[0066] In addition to ginseng extract or its fractions and sodium propionate, the pharmaceutical composition may also contain one or more active ingredients with the same or similar functions. The pharmaceutical composition can be formulated according to conventional methods and used in oral formulations, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, etc.

[0067] Solid dosage forms for oral administration include powders, granules, tablets, capsules, soft capsules, and pills. Liquid dosage forms for oral administration can be suspensions, oral solutions, emulsions, syrups, etc., and may contain various excipients, such as wetting agents, sweeteners, flavoring agents, and preservatives, in addition to water and liquid paraffin, which are commonly used as simple diluents.

[0068] The pharmaceutical composition may additionally contain adjuvants such as preservatives, stabilizers, hydrating agents or emulsifying agents, salts and / or buffers for controlling osmotic pressure, and other therapeutically useful materials, and may be formulated by conventional methods such as mixing, granulation or coating.

[0069] The dosage of the pharmaceutical composition can vary depending on various factors, including the subject's age, weight, general health status, and sex, as well as the time of administration, route of administration, excretion rate, drug combination, and the severity of the specific disease.

[0070] Furthermore, the pharmaceutical compositions of the present invention can be used alone or in combination with surgical procedures, radiotherapy, hormone therapy, chemotherapy, and methods using biological response modifiers. Additionally, based on adult use, the pharmaceutical compositions can be administered at doses ranging from 0.001 to 200 mg / kg, but the dosage is not limited to the range of the present invention.

[0071] Example

[0072] The present invention will now be described in detail through examples.

[0073] However, the following embodiments are merely illustrative of the present invention, and the content of the present invention is not limited to the following preparation embodiments, embodiments and experimental examples.

[0074] <Preparation Example 1> Preparation of Red Ginseng Pure Water Extract

[0075] Add 6 times the amount of pure water to 1 kg of 6-year-old red ginseng, extract for 8 hours at room temperature, and then concentrate under reduced pressure to prepare red ginseng concentrate (hereinafter referred to as "red ginseng pure water extract").

[0076] <Preparation Example 2> Preparation of Ethanol Fractions from Red Ginseng Ethanol Aqueous Solution

[0077] Add 5.5 times the volume of 70% (v / v) ethanol to 1 kg of red ginseng and extract once at 50°C for 10 hours. Pass the ethanol extract through an HP-20 column to adsorb it, and then elute the column with 70% ethanol. Freeze-dry the eluent to obtain a powder fraction of 30 g or more (hereinafter referred to as "ethanol fraction of red ginseng ethanol aqueous solution").

[0078] <Preparation Example 3> Preparation of Red Ginseng Extract / Fractional Mixture

[0079] The pure water extract of red ginseng prepared in Preparation Example 1 was mixed with the ethanol fraction of the red ginseng ethanol aqueous solution prepared in Preparation Example 2 at a weight ratio of 10:1 to prepare a mixture of red ginseng extract / fraction.

[0080] <Preparation Example 4> Preparation of Plant Extracts

[0081] Scutellaria baicalensis, licorice, astragalus membranaceus, and jujube were washed 2 to 3 times with pure water, then placed in an extractor and 5 times their volume of pure water were added. After extraction at 60°C for 8 hours, centrifugation was performed to separate the extraction residue. The filtrate was then mixed with glycerol and concentrated to 60 Brix or higher to prepare Scutellaria baicalensis concentrate, licorice concentrate, astragalus membranaceus concentrate, and jujube concentrate.

[0082] The plant extract was obtained by mixing 38g of Scutellaria baicalensis concentrate, 27g of Glycyrrhiza uralensis concentrate, 8.5g of Ziziphus jujuba concentrate, 6.5g of Astragalus membranaceus concentrate, and 20g of pure water.

[0083] <Example 1> Confirmation of the effect of promoting the growth of beneficial and harmful bacteria in the gut.

[0084] To verify the effect of promoting the growth of beneficial and harmful intestinal bacteria, the red ginseng pure water extract of Preparation Example 1, the red ginseng extract / fraction of Preparation Example 3, and a mixture of fructooligosaccharides were dissolved in physiological saline at concentrations of 1.25, 2.5, and 10 mg / ml. Staphylococcus aureus (strain number 39149, Life Resources Center, Korea Institute of Biotechnology) and Bifidobacterium (strain number 3281, Life Resources Center, Korea Institute of Biotechnology) were added at a concentration of 1×10⁻⁶. 6 The prepared sample was inoculated with a concentration of CFU / ml and then incubated in a shaking incubator for 24 hours. The solution containing the grown strain was collected and centrifuged to remove the supernatant. An equal volume of physiological saline was added to prepare a homogenate, and the absorbance at 600 nm was measured. The increase in the amount of strain compared to the untreated group was calculated as follows: Figure 1 As shown.

[0085] from Figure 1 The results confirmed that, compared with fructooligosaccharides used as a conventional prebiotic ingredient, the pure water extract of red ginseng has a superior effect on promoting the growth of beneficial bacteria. However, the pure water extract of red ginseng prepared in Example 1 has a high promoting effect not only on beneficial bacteria but also on the growth of harmful bacteria.

[0086] Furthermore, in the case of mixtures of red ginseng extract / fractions, an effect of selectively promoting the growth of beneficial bacteria relative to harmful bacteria was observed, but the extent was determined to be insufficient. Therefore, the inventors have confirmed the need to develop compositions capable of selectively promoting the growth of beneficial bacteria relative to harmful bacteria.

[0087] <Example 2>

[0088] 2-1. Preparation of compositions for improving gut microbiota

[0089] To prepare a mixture, 5 mg / ml sodium propionate, 10 μl / ml plant extract of Example 4, 5 mg / ml sodium benzoate, and 5 mg / ml potassium sorbate were respectively mixed into a mixture of 10 mg / ml red ginseng extract / fraction.

[0090] 2-2. Confirmation of the effect of selectively promoting the growth of beneficial bacteria relative to harmful bacteria

[0091] To confirm whether the various mixtures selectively promote the growth of beneficial bacteria relative to harmful bacteria, each mixture was treated with physiological saline, and the growth of beneficial and harmful bacteria was then measured in the same manner as in Example 1. The increase in strains was calculated as a percentage compared to the untreated group and is shown in Table 1 below.

[0092] [Table 1]

[0093]

[0094] The results in Table 1 confirm that when the red ginseng extract / fraction mixture of the composition for improving gut microbiota contains sodium propionate, it exhibits excellent selective promotion of beneficial bacteria growth relative to harmful bacteria. Conversely, when the red ginseng extract / fraction mixture of the composition contains plant extracts, it is confirmed that while it effectively promotes the growth of beneficial bacteria, it also significantly promotes the growth of harmful bacteria; therefore, its selective promotion of beneficial bacteria growth relative to harmful bacteria is low.

[0095] <Example 3>

[0096] 3-1. Preparation of compositions for improving gut microbiota

[0097] In order to determine the effect of sodium propionate content on selectively promoting the growth of beneficial bacteria relative to harmful bacteria in the composition of the mixture of red ginseng extract / fraction and sodium propionate, a mixture of 10 mg / ml red ginseng extract / fraction was mixed with sodium propionate at concentrations of 0, 1.25, 2.5 and 5 mg / ml to prepare the mixture.

[0098] In cases where the mixture of red ginseng extract / fraction and sodium propionate also contains plant extracts, in order to determine the effect of selectively promoting the growth of beneficial bacteria relative to harmful bacteria based on the content of sodium propionate, a mixture of 10 mg / ml red ginseng extract / fraction was mixed with sodium propionate at concentrations of 0, 1.25, 2.5 and 5 mg / ml, respectively, and mixed with 10 μl / ml of the plant extract from Preparation Example 4 to prepare a mixture.

[0099] 3-2. Confirmation of the effect of selectively promoting the growth of beneficial bacteria relative to harmful bacteria

[0100] To confirm whether the various mixtures selectively promote the growth of beneficial bacteria relative to harmful bacteria, each mixture was treated with physiological saline, and the growth of beneficial and harmful bacteria was then measured in the same manner as in Example 1. The increase in strains was calculated as a percentage compared to the untreated group and is shown in Table 2 below.

[0101] [Table 2]

[0102]

[0103] The results in Table 2 confirm that the composition for improving gut microbiota, containing a mixture of red ginseng extract / fractions and sodium propionate, exhibits a selective promotion of beneficial bacteria growth relative to harmful bacteria. In particular, it was confirmed that the selective promotion effect was enhanced when the mixture based on red ginseng extract / fractions contained 25% by weight (i.e., the treatment group with a concentration of 2.5 mg / ml) or more of sodium propionate. Furthermore, when the mixture of red ginseng extract / fractions and sodium propionate also contained the gut microbiota improvement composition containing the plant extract of Example 4, it was confirmed that the selective promotion of beneficial bacteria growth was further maximized as the growth of harmful bacteria was significantly reduced.

Claims

1. A composition for improving gut microbiota, comprising the following: A mixture of column-purified fractions of ginseng root aqueous extract and ginseng root alcoholic extract, wherein the ginseng root alcoholic extract is extracted with a 70% (v / v) to 80% (v / v) aqueous ethanol solution, and wherein the elution solvent used to prepare the column-purified fraction is a 70% (v / v) to 100% (v / v) aqueous ethanol solution; and Sodium propionate; The weight ratio of the ginseng root water extract to the column-purified fraction is 1:0.07 to 1:0.

3. The weight ratio of the mixture to sodium propionate is 8:1 to 2:1, and The gut microbiota described therein consists of Staphylococcus aureus and Bifidobacteria. The composition described herein promotes the growth of intestinal Bifidobacteria and inhibits the growth of Staphylococcus aureus, and The column is an aromatic synthetic adsorption column.

2. The composition for improving gut microbiota as claimed in claim 1, wherein the elution solvent is a 70% (v / v) aqueous ethanol solution.

3. A composition for improving gut microbiota, comprising the following: A mixture of column-purified fractions of ginseng root aqueous extract and ginseng root alcohol extract, wherein the ginseng root alcohol extract is extracted with a 70% (v / v) to 80% (v / v) aqueous ethanol solution, and wherein the elution solvent used to prepare the column-purified fraction is a 70% (v / v) to 100% (v / v) aqueous ethanol solution. Sodium propionate; as well as Plant extracts or their fractions; The weight ratio of the ginseng root water extract to the column-purified fraction is 1:0.07 to 1:0.

3. The weight ratio of the mixture to sodium propionate is 8:1 to 2:1, and The gut microbiota described therein consists of Staphylococcus aureus and Bifidobacteria. The composition described herein promotes the growth of intestinal Bifidobacteria and inhibits the growth of Staphylococcus aureus. The column is an aromatic synthetic adsorption column. The plant extracts mentioned therein are a mixture of Scutellaria baicalensis aqueous extract, Glycyrrhiza uralensis aqueous extract, Ziziphus jujuba aqueous extract, and Astragalus membranaceus aqueous extract, and The plant extracts comprise, relative to the total weight of the plant extracts, 30 to 50 parts by weight of the Scutellaria baicalensis aqueous extract, 20 to 40 parts by weight of the Glycyrrhiza uralensis aqueous extract, 5 to 20 parts by weight of the Ziziphus jujuba aqueous extract, and 5 to 20 parts by weight of the Astragalus membranaceus aqueous extract.

4. The composition for improving gut microbiota as claimed in claim 3, wherein the weight ratio of the mixture to the plant extract or fraction thereof is 4:1 to 5:

1.

5. A pharmaceutical composition for the prevention, improvement, or treatment of inflammatory bowel disease or bowel motility disorder, comprising the following: A mixture of column-purified fractions of ginseng root aqueous extract and ginseng root alcoholic extract, wherein the ginseng root alcoholic extract is extracted with a 70% (v / v) to 80% (v / v) aqueous ethanol solution, and wherein the elution solvent used to prepare the column-purified fraction is a 70% (v / v) to 100% (v / v) aqueous ethanol solution; and Sodium propionate; The weight ratio of the ginseng root water extract to the column-purified fraction is 1:0.07 to 1:0.

3. The weight ratio of the mixture to sodium propionate is 8:1 to 2:1, and The column is an aromatic synthetic adsorption column.

6. The pharmaceutical composition of claim 5, wherein the elution solvent is a 70% (v / v) aqueous ethanol solution.

7. A pharmaceutical composition for the prevention, improvement, or treatment of inflammatory bowel disease or bowel motility disorder, comprising the following: A mixture of column-purified fractions of ginseng root aqueous extract and ginseng root alcohol extract, wherein the ginseng root alcohol extract is extracted with a 70% (v / v) to 80% (v / v) aqueous ethanol solution, and wherein the elution solvent used to prepare the column-purified fraction is a 70% (v / v) to 100% (v / v) aqueous ethanol solution. Sodium propionate; as well as Plant extracts or their fractions; The weight ratio of the ginseng root water extract to the column-purified fraction is 1:0.07 to 1:0.

3. The weight ratio of the mixture to sodium propionate is 8:1 to 2:

1. The column is an aromatic synthetic adsorption column; The plant extracts mentioned therein are a mixture of Scutellaria baicalensis aqueous extract, Glycyrrhiza uralensis aqueous extract, Ziziphus jujuba aqueous extract, and Astragalus membranaceus aqueous extract, and The plant extracts comprise, relative to the total weight of the plant extracts, 30 to 50 parts by weight of the Scutellaria baicalensis aqueous extract, 20 to 40 parts by weight of the Glycyrrhiza uralensis aqueous extract, 5 to 20 parts by weight of the Ziziphus jujuba aqueous extract, and 5 to 20 parts by weight of the Astragalus membranaceus aqueous extract.

Images