Composition for preventing, improving or treating of diabetes containing Inula helenium extract

Abstract

The present invention relates to a composition for the prevention, improvement, or treatment of diabetes comprising an extract of *Inula helenium*. The composition according to the present invention has the advantage of ensuring safety as a natural extract and minimizing side effects while exhibiting excellent effects in preventing, improving, or treating diabetes. The composition according to the present invention may be used as a pharmaceutical composition useful for the prevention, improvement, or treatment of diabetes, or as a food composition useful for the prevention or improvement of diabetes.

Description

Technology Field

[0001] The present invention relates to civil engineering ( Inula helenium The present invention relates to a composition for the prevention, improvement, or treatment of diabetes comprising an extract. The composition according to the present invention has the advantage of ensuring safety as a natural extract and minimizing side effects while exhibiting excellent effects in preventing, improving, or treating diabetes. The composition according to the present invention can be used as a pharmaceutical composition useful for the prevention, improvement, or treatment of diabetes, or as a food composition useful for the prevention or improvement of diabetes. Background Technology

[0002] Due to the Westernization of dietary habits and a lack of exercise resulting from reduced physical activity, we are facing serious challenges such as obesity, cardiovascular disease, hyperlipidemia, hypertension, and diabetes. Among these, the prevalence of diabetes mellitus is showing a rapidly increasing trend globally, and the number of people suffering from the disease is rising sharply. Diabetes is a disease influenced by genetic factors as well as acquired environmental conditions, such as obesity, dietary habits, lack of exercise, and stress. Modern medicine has not yet developed a method to fundamentally cure diabetes, and maintaining blood sugar levels at a normal level is known to be the best treatment method. Dietary therapy, along with medication and exercise, is primarily attempted as a treatment method for diabetes.

[0003] Diabetes mellitus is a disease characterized by abnormal carbohydrate metabolism in the body, caused by a rapid rise in blood glucose levels due to an absolute or relative deficiency in the secretion of insulin from the β-cells of the islets of Langerhans in the pancreas. As blood glucose fails to enter cells, hyperglycemia occurs; furthermore, abnormal lipid metabolism leads to elevated concentrations of blood lipoproteins and free fatty acids, resulting in hyperlipidemia. This, in turn, promotes the generation of free radicals within blood vessels through lipid peroxidation, thereby impairing the body's defense mechanisms and causing tissue damage. Consequently, oxidative stress triggers major complications such as hypertension, coronary artery disease (including myocardial infarction), and stroke. It can also lead to various other complications, including blindness due to retinal disease and chronic renal failure, potentially resulting in severe consequences. Consequently, the need for prevention and treatment is becoming increasingly critical.

[0004] Accordingly, research and development are required for pharmaceutical or food compositions that possess excellent antidiabetic effects, ensure safety as natural extracts, and minimize side effects. The problem to be solved

[0005] The object of the present invention is to provide a pharmaceutical composition for the prevention, improvement, or treatment of diabetes comprising a Tumuxiang extract.

[0006] Another objective of the present invention is to provide a food composition for preventing or improving diabetes comprising a Tomokhyang extract.

[0007] Another objective of the present invention is to provide a method for preventing, improving, or treating diabetes by administering a therapeutically effective amount of a composition for preventing, improving, or treating diabetes to a subject in need thereof.

[0008] Another objective of the present invention is to provide a use for a Tomokhyang extract for the prevention, improvement, or treatment of diabetes. means of solving the problem

[0009] The present invention relates to a composition for the prevention, improvement, or treatment of diabetes comprising a Tomokhyang extract.

[0010] The present invention will be described in more detail below.

[0011] One aspect of the present invention is civil engineering ( Inula helenium This relates to a pharmaceutical composition for the prevention, improvement, or treatment of diabetes containing an extract of L.)

[0012] In the present invention, the root of the *Mokhyang* plant, a member of the Asteraceae family, is dried. Its outer surface is yellowish-brown to dark brown and has longitudinal wrinkles and traces of root hairs. The head portion is thick, and there is a stem scar at the upper end; sometimes leaves are attached, and there are conical side branches around it. The texture is hard and does not break easily. The broken surface is slightly flat, yellowish-white to light grayish-yellow, and has a slightly indented oil chamber. It has a distinctive aroma and a bitter and pungent taste.

[0013] In the present invention, the extract of the earthenware plant may be an extract obtained by extraction with one or more solvents selected from the group consisting of purified water, straight-chain or branched alcohols having 1 to 4 carbon atoms, acetone, ethyl acetate, butyl acetate, ethyl ether, diethyl ether, 1,3-butylene glycol, hexane, and dichloromethane, for example, ethyl alcohol, but is not limited thereto.

[0014] In the present invention, the earth incense extract may be an alcohol extract, but is not limited thereto.

[0015] In the present invention, the pharmaceutical composition may further comprise a plant mixed extract containing at least one extract selected from the group consisting of Jerusalem artichoke, malt, bamboo leaf, Fructus Amomi, Lithospermum erythrorhizon root, Morus alba root bark, Hovenia dulcis, Houttuynia cordata, Crataegus pinnatifida, Rehmannia glutinosa preparata, Lycium chinense fruit, corn silk, soybean sprout, tangerine peel, Momordica charantia, Cornus officinalis fruit, Eucommia ulmoides, Ulmus macrocarpa bark, Dimocarpus longan aril, Poria cocos, jujube, Astragalus membranaceus, Raphani Semen, Atractylodes japonica rhizome, Glycyrrhiza uralensis, Angelica gigas, Paeonia lactiflora and Cnidium officinale.

[0016] In the present invention, Jerusalem artichoke has various shapes ranging from elongated to bumpy, as well as different sizes and weights, so it is also nicknamed 'ddungddanji'. In autumn, yellow flowers that look like small sunflowers bloom; the flowers are ornamental, and the tubers that grow underground like potatoes are used for food. Jerusalem artichoke contains about 75 times more inulin than ordinary potatoes. Inulin acts as natural insulin, helping to lower blood sugar, and is good for improving cholesterol, facilitating smooth bowel movements, and inhibiting postprandial blood sugar rise. It also contains carbohydrates (15.1%), protein (1.9%), and minerals such as vitamin C and potassium, and is rich in iron, which is good for boosting immunity and relieving fatigue. In addition, it has low calories and is rich in dietary fiber, which helps intestinal health and facilitates smooth toxin excretion.

[0017] In the present invention, malt is Hordeum vulgare ( Hordeum vulgare Linne:大麥), which is a herbal medicine made by germinating, drying, and slightly roasting hulled barley. It has a sweet smell, a slightly sweet taste, and a warm property. Malt has a firm texture, sprouts of 2 cm or less, and is yellow. It has a young sprout at one end and one or more young roots at the other end; its outer surface is light yellow, and the endosperm is milky white. The aliases of malt include barley malt, barley coat, barley awn, light malt sprout, and grain malt.

[0018] In the present invention, bamboo is a general term for perennial plants belonging to the bamboo subfamily (Bambusoideae) of the grass family (Poaceae) in the order Poales of the monocotyledonous plants, and in some cases, only the tall species of the genus Phyllostachys are referred to as bamboo. There are a great number of species worldwide, with 1,250 species distributed across 120 genera. 19 species are distributed in Korea, and most bamboo varieties are distributed in China and Japan, with about 500 species native to China and about 650 species native to Japan.

[0019] In the present invention, amomum fruit is a medicinal material made from the fruit of Amomum villosum (陽春砂, Amomum villosum LOUR.), Amomum villosum var. xanthioides (綠殼砂, Amomum villosum Lour.) or Amomum longiligulare (海南砂, Amomum longiligulare T.L.Wu), which is a perennial herbaceous plant belonging to the ginger family, and its origin is Vietnam, Thailand, Cambodia and other regions. Its active pharmaceutical ingredients contain about 1.7 to 3% of aromatic essential oil components, and the main components include d-camphor, d-borneol, Bornyl acetate, Linalool, Nerolidol and the like.

[0020] In the present invention, gromwell root ( Lithospermum erythrorhizon S. et Z) is a perennial herbaceous plant belonging to the borage family, and is called Zhicao (芝草), Zicao (紫草) or Zigen (紫根) in Chinese characters. Its roots are split in the shape of ginseng. They are thick and fleshy, with purple pigment formed around the outer skin, resulting in a strong purple color. Therefore, the color of the soil around where gromwell root grows is also purple. The roots are used as dyes or medicinal materials.

[0021] In the present invention, Mori Cortex is the root bark of the mulberry tree of the mulberry family ( Morus albaIt is a medicinal material made from the root bark of *Sangbaekpi* (*Sangbaekpi*) or plants of the same genus; it has a slightly peculiar odor, a sweet taste, and a cold nature. Sangbaekpi treats coughs and asthma caused by lung heat and has diuretic effects. It is used for acute pyelonephritis and weakness-induced edema, has a blood pressure-lowering effect, and is also used for nosebleeds and hemoptysis. Other names include Sanggeunbaekpi and Baeksangpi, and the fruit is called *sim*.

[0022] In the present invention, the hackberry tree ( Hovenia dulcis Thunb.) is a deciduous broad-leaved tree belonging to the Rhamnaceae family. It grows to a height of 10 to 17 meters with a trunk that is straight yet slightly curved. In September and October, small, jar-shaped fruits about 8 mm in diameter ripen to a dark red color on plump, bumpy fruit stalks. The fruits contain seeds enclosed in a hard pit and are sweet. The bark of young trees is brown or grayish-brown and smooth.

[0023] In the present invention, the hackberry tree may be one or more selected from the group consisting of the roots, stems, fruits, and leaves of the hackberry tree, for example, it may be a stem or a fruit.

[0024] In this invention, Eoseongcho refers to the above-ground parts of *Houttuynia cordata Thunberg* of the *Sauricaceae* family during the flowering period. In Japan, the same plant is used and is called *Jyaku*. In China, the same plant is used, but it is referred to as the whole plant or above-ground parts.

[0025] In this invention, Sansa is a medicinal herb made from the dried ripe fruit of the hawthorn tree and other plants of the same genus of the Rosaceae family. The name Sansa was given because the fruit tastes like an apple and is red in color, resembling a small apple. Sansa warms the spleen and stomach to promote digestion and is effective for indigestion after eating meat. It is also used for abdominal pain, vomiting, diarrhea, hyperacidity, and chronic enteritis. Furthermore, it acts on blood vessels to aid blood flow and eliminate blood stasis.

[0026] In the present invention, Sukjihwang is a medicinal herb made by steaming and drying the root of Rehmannia glutinosa. Rehmannia glutinosa is a perennial medicinal plant belonging to the Scrophulariaceae family, and its root is used as a medicinal herb in Korean medicine; the raw form is called Saengjihwang, and the dried form is called Geonjihwang. Sukjihwang is a key medicinal herb in Samultang and is used for symptoms such as internal heat, dry throat, and thirst that appear due to physical weakness in various chronic diseases.

[0027] In the present invention, goji berries ( Lycium chinense *Millet* (*Millet*) is a deciduous broad-leaved shrub belonging to the Solanaceae family. Its ridged stems are typically 1 to 1.5 meters tall, and it has thorns in the leaf axils and at the tips of the branches. The fruit is a round or oval berry that ripens red in August and September. It is about 10 mm long and 5 mm in diameter. It is initially sweet but later develops a bitter taste. When dried, the surface becomes wrinkled, and the inside contains many seeds. The seeds are flat and kidney-shaped, about 2 mm in diameter, and yellowish-white.

[0028] In the present invention, the goji berry may be one or more selected from the group consisting of the roots, stems, fruits, and leaves of the goji berry plant, and, for example, may be a fruit.

[0029] In the present invention, corn silk refers to a silk-like pistil connected from the ovary of the corn, and is widely used as a tea because it has a diuretic effect and reduces swelling. In addition to water (about 64%), corn contains carbohydrates (29.4%), protein (8.9%), lipids, minerals, and vitamins.

[0030] In this invention, soybean sprouts are produced by germinating soybeans and have been used for a long time as a unique traditional food of Korea. Furthermore, the *Hyangyak Gugupbang*, a medical text published during the Goryeo Dynasty, describes dried soybean sprouts as being used for medicinal purposes. Soybean sprouts can be considered a popular traditional food because they have a short growth period, are relatively easy to cultivate, and are inexpensive. They are also widely known as a source of protein, vitamins, and minerals. However, the soybean sprouts used in this invention were cultivated by supplying water containing mineral components such as vanadium during cultivation.

[0031] In the present invention, Jinpi refers to the mature fruit peel of the tangerine (Citrus unshiu Markovich) of the Rutaceae family or closely related plants of the same genus. It is said that the older the Jinpi, the better, and because the redder the color, the better, the names Hongpi and Jinpi were given. The fruit is called Gyul, the leaves are called Gyulyeop, the yellow part of the fruit peel with the inside removed is called Gyulhong, the seeds are called Gyulhaek, and the unripe fruit peel is called Cheongpi.

[0032] In the present invention, bitter melon ( Momordica charantia Linnaeus is a climbing annual plant belonging to the Cucurbitaceae family of the order Cucurbitales, and is a vegetable with an elongated and bumpy shape resembling a goblin's club. Although it is not in high demand as a food ingredient in Korea, it is widely used in Southeast Asian cuisine, such as in Thailand.

[0033] In the present invention, Cornus fruit ( Cornus officinalis Cornus officinalis is the fruit of the Cornus controversa of the Cornaceae family. It is an oval drupe that is initially green and ripens red from August to October. The seeds are elongated oval-shaped with ridges. It has a slightly sweet taste along with an astringent and strong sour flavor. It is harvested after the first frost in mid-October; the flesh and seeds are separated, and the flesh is used as an ingredient for alcohol, tea, and traditional Korean medicine.

[0034] In the present invention, Eucommia ulmoides ( Eucommia ulmoides Oliver) is Eucommia ulmoides (E.) belonging to the genus Eucommia of the family Eucommiaaceae. ulmoides It is the stem bark of Oliv.) with the periderm removed.

[0035] In the present invention, king elm ( Ulmus macrocarpa It is a deciduous tree belonging to the family Ulmaceae, order Urticales, class Dicotyledonous plants, and grows at the foot of mountains. Cork develops on the small branches, and they are covered with fine hairs when young. The leaves are alternate, inverted egg-shaped to broadly or oblong, tapering abruptly to a point; they are 3.5–15.5 cm long and 2–9 cm wide. Both surfaces of the leaves are rough, and the margins are serrated. The petioles are 3–6 mm long and hairy.

[0036] In the present invention, the longan fruit is a longan of the Sapindus family ( Dimocarpus longan It refers to the aril of the longan. The name literally means "dragon's eye" because the fruit resembles an animal's eye and the aril, which acts as the outer shell, is thick. It has a soft yet sticky texture, a sweet taste, and a unique aroma, making it suitable as a snack to accompany alcoholic beverages. It grows wild or is cultivated in subtropical regions such as China, Japan, Taiwan, and India.

[0037] In the present invention, Poria cocos is formed by the symbiotic relationship of ectomycorrhizals on pine tree roots and has an irregular shape. The surface is dark brown, and the interior is grayish-white, fleshy granular in shape, emitting a fresh scent. The outer shell is called Poria cocos peel, and the fungal body that grows enveloping the pine root is called Poria cocos (Fúshēn); the one with a white interior is called Poria cocos (Báibólíng), and the one with a red interior is called Poria cocos (Zhèfólíng); all are used as medicine. Its medicinal properties are ordinary, and its taste is sweet and mild.

[0038] In the present invention, jujube ( Ziziphus jujuba var. inermisJujubes are the fruit of the jujube tree, also known as *jo* or *mokmil*. They have a reddish-brown surface, are oval-shaped, and reach a length of 1.5 to 2.5 cm; they are sweet when ripe and red. The fruit is consumed fresh, and after harvesting, it is thoroughly dried and used as a dried fruit for confectionery, cooking, and medicinal purposes. Jujubes are also processed in daily life to make jujube wine, jujube tea, jujube vinegar, and jujube porridge. Honey jujubes, as a processed product, are well-received in China, Japan, and Europe. In traditional Korean medicine, they are used as a diuretic, tonic, and laxative.

[0039] In the present invention, astragalus ( Astragalus membranaceus It is a plant belonging to the legume family and is one of the herbs widely used in traditional Korean medicine. Its history of medicinal use is very long, spanning over 2,000 years, and it is listed in the *Shen Nong Ben Cao Jing*, the first herbal text.

[0040] In the present invention, the inner part is a radish of the Cruciferous family ( Raphanus sativus It is a medicinal material made using the seeds of L. or plants of the same genus. The root of the Naebokja is called Naebok, and the leaves are called Naebokyeop.

[0041] In the present invention, Atractylodes ( Atractylodes japonica Atractylodes is a perennial herb belonging to the Asteraceae family, order Campanulales, and class Dicotyledon. The rhizome of Atractylodes is thick, long, node-bearing, and fragrant. The stem stands upright, branches out into several parts at the top, and reaches a height of 30 to 100 cm. The leaves emerging from the root wither and disappear when the flowers bloom.

[0042] In the present invention, licorice ( Glycyrrhiza uralensis It is a perennial herb belonging to the Fabaceae family in the Rosales order of dicotyledonous plants, and is used as a medicinal plant. The roots are reddish-brown and penetrate deep into the ground, while the stem is angular and grows upright to about 1 meter in height. It is also densely covered with white hairs, giving it a grayish-white appearance, and has scattered glandular dots. The leaves are alternate and odd-pinnately compound. There are 7 to 17 leaflets, which are egg-shaped and pointed at the tip. The leaflets are 2 to 5 cm long and 1 to 3 cm wide, with white hairs and glandular dots on both sides, and lack serrations.

[0043] In the present invention, the Angelica is a medicinal material obtained by drying the root of *Angelica gigas*, which belongs to the Apiaceae family. It grows to a height of 1 to 1.5 m, and its stem is purplish. The leaves are pinnately compound, and the margins are serrated. The dried root is used as a medicinal material, and the young leaves are also eaten as a vegetable.

[0044] In the present invention, the peony is a perennial herbaceous plant belonging to the Ranunculaceae family, and in traditional Korean medicine, the root is used as a medicinal material. Its components include paeoniflorin as a glycoside and paeonine as an alkaloid, as well as tannins, resins, and benzoic acid.

[0045] In the present invention, the heavenly palace ( Cnidium officinale It is a perennial herb belonging to the Apiaceae family, order Apiaceae, class Dicotyledon. Native to China, it is cultivated as a medicinal plant. It grows to a height of 30–60 cm, is hollow, and has somewhat branched stems. The leaves are alternate and bipinnately compound; the leaflets are ovate-lanceolate with somewhat deep serrations. The basal leaves and lower leaves have long petioles, and the base forms a leaf sheath that wraps around the stem.

[0046] In the present invention, the plant mixed extract may be an extract obtained by extraction with one or more solvents selected from the group consisting of water, straight-chain or branched alcohols having 1 to 4 carbon atoms, acetone, ethyl acetate, butyl acetate, ethyl ether, diethyl ether, 1,3-butylene glycol, hexane, and dichloromethane, for example, purified water, but is not limited thereto.

[0047] In the present invention, the plant mixed extract may be a hot water extract obtained by extracting with hot water at 70 to 130 ℃, 70 to 120 ℃, or 70 to 100 ℃, for example, 70 ℃, but is not limited thereto.

[0048] In the present invention, the pharmaceutical composition may additionally include one or more selected from the group consisting of banaba leaf extract, allulose, zinc sulfate, magnesium sulfate, potassium carbonate, calcium chloride, deer antler extract, manganese sulfate, grapefruit seed extract, vitamin D3, and aminomix.

[0049] In the present invention, the extract comprises a solvent crude extract and may be in the form of a solution, concentrate, or powder.

[0050] In the present invention, the pharmaceutical composition can prevent, improve, or treat diabetes by suppressing a rapid rise in blood sugar levels after a meal.

[0051] In the present invention, diabetes may be type 2 diabetes.

[0052] The pharmaceutical composition of the present invention may be used as a pharmaceutical composition comprising a pharmaceutically effective amount of a Tomokhyang extract and / or a pharmaceutically acceptable carrier.

[0053] The term "pharmaceutical effective amount" in this specification means an amount sufficient to achieve the efficacy or activity of the Tumuxiang extract.

[0054] Pharmaceutically acceptable carriers included in the pharmaceutical composition of the present invention are those commonly used in formulations and include, but are not limited to, lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia gum, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methylcellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil. In addition to the above components, the pharmaceutical composition of the present invention may additionally include lubricants, wetting agents, sweeteners, flavoring agents, emulsifiers, suspending agents, preservatives, etc.

[0055] The pharmaceutical composition according to the present invention may be administered to mammals, including humans, by various routes. The mode of administration may be any commonly used mode, and may be administered by routes such as oral, skin, intravenous, intramuscular, subcutaneous, etc., and may be administered orally, for example.

[0056] The suitable dosage of the pharmaceutical composition of the present invention varies depending on factors such as the formulation method, mode of administration, patient's age, body weight, gender, pathological condition, food, time of administration, route of administration, rate of excretion, and response sensitivity, and a physician who is normally skilled can easily determine and prescribe a dosage effective for the desired treatment or prevention.

[0057] Another aspect of the present invention is civil engineering ( Inula helenium This relates to a food composition for preventing or improving diabetes containing an extract.

[0058] In the present invention, the extract of the earthenware plant may be an extract obtained by extraction with one or more solvents selected from the group consisting of purified water, straight-chain or branched alcohols having 1 to 4 carbon atoms, acetone, ethyl acetate, butyl acetate, ethyl ether, diethyl ether, 1,3-butylene glycol, hexane, and dichloromethane, for example, ethyl alcohol, but is not limited thereto.

[0059] In the present invention, the earth incense extract may be an alcohol extract, but is not limited thereto.

[0060] In the present invention, the food composition may additionally include a mixed plant extract comprising one or more extracts selected from the group consisting of Jerusalem artichoke, malt, bamboo leaf, Amomum xanthioides, Lithospermum erythrorhizon root, mulberry bark, Hovenia dulcis, Houttuynia cordata, Crataegus pinnatifida, Rehmannia glutinosa, Lycium barbarum, corn silk, soybean sprout, dried tangerine peel, bitter melon, Cornus fruit, Eucommia ulmoides, king elm bark, longan fruit, Poria cocos, jujube, Astragalus membranaceus, Atractylodes japonica, Atractylodes rhizome, licorice, Angelica gigas, peony, and Cnidium officinale.

[0061] In the present invention, the hackberry tree may be one or more selected from the group consisting of the roots, stems, fruits, and leaves of the hackberry tree, for example, it may be a stem or a fruit.

[0062] In the present invention, the goji berry may be one or more selected from the group consisting of the roots, stems, fruits, and leaves of the goji berry plant, and, for example, may be a fruit.

[0063] In the present invention, the plant mixed extract may be an extract obtained by extraction with one or more solvents selected from the group consisting of water, straight-chain or branched alcohols having 1 to 4 carbon atoms, acetone, ethyl acetate, butyl acetate, ethyl ether, diethyl ether, 1,3-butylene glycol, hexane, and dichloromethane, for example, purified water, but is not limited thereto.

[0064] In the present invention, the plant mixed extract may be a hot water extract obtained by extracting with hot water at 70 to 130 ℃, 70 to 120 ℃, or 70 to 100 ℃, for example, 70 ℃, but is not limited thereto.

[0065] In the present invention, the pharmaceutical composition may additionally include one or more selected from the group consisting of banaba leaf extract, allulose, zinc sulfate, magnesium sulfate, potassium carbonate, calcium chloride, deer antler extract, manganese sulfate, grapefruit seed extract, vitamin D3, and aminomix.

[0066] In the present invention, "aminomix" refers to a composition in which several amino acids are mixed, and may refer to a composition in which two or more amino acids selected from the group consisting of tryptophan, lysine, phenylalanine, valine, leucine, isoleucine, threonine, methionine, histidine, arginine, alanine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, and tyrosine are mixed.

[0067] In the present invention, the extract comprises a solvent crude extract and may be in the form of a solution, concentrate, or powder.

[0068] In the present invention, the food composition can prevent or improve diabetes by suppressing a rapid rise in blood sugar after a meal.

[0069] In the present invention, diabetes may be type 2 diabetes.

[0070] In the present invention, the food composition can be manufactured and processed in the form of tablets, capsules, powder, granules, liquid, pills, etc.

[0071] In the present invention, the food composition may be a "health functional food composition," and a health functional food composition refers to a food manufactured and processed using raw materials or ingredients having functional properties useful to the human body, and means consuming it for the purpose of obtaining effects useful for health uses, such as regulating nutrients or physiological actions on the structure and function of the human body.

[0072] In the present invention, health functional foods may include conventional food additives, and unless otherwise specified, suitability as a food additive is determined by the specifications and standards for the relevant items in accordance with the general provisions and general test methods of the Food Additives Codex approved by the Ministry of Food and Drug Safety. Items listed in the above 'Food Additives Codex' may include, for example, chemically synthesized compounds such as ketones, glycine, calcium citrate, nicotinic acid, and cinnamon acid; natural additives such as persimmon dye, licorice extract, crystalline cellulose, sorghum dye, and guar gum; and mixed preparations such as L-sodium glutamate preparations, alkaline noodle additives, preservative preparations, and tar dye preparations. For example, a health functional food in tablet form may be produced by granulating a mixture of the active ingredient of the present invention with an excipient, a binder, a disintegrant, and other additives using a conventional method, and then adding a lubricant and compression molding, or by directly compression molding the mixture. In addition, the above-mentioned tablet-form health functional food may contain binders, etc., as necessary. Among the capsule-form health functional foods, hard capsules may be manufactured by filling a conventional hard capsule with a mixture in which the active ingredient of the present invention is mixed with additives such as excipients, and soft capsules may be manufactured by filling a capsule base such as gelatin with a mixture in which the active ingredient of the present invention is mixed with additives such as excipients. The above-mentioned soft capsules may contain plasticizers such as glycerin or sorbitol, coloring agents, preservatives, etc., as necessary. The pill-form health functional food may be prepared by molding a mixture in which the active ingredient of the present invention is mixed with excipients, binders, disintegrants, etc., using a previously known method, and may be coated with sucrose or other coating agents as necessary, or the surface may be coated with a substance such as starch or talc. A health functional food in granular form can be manufactured into a granular form by a previously known method of mixing a mixture of the active ingredients of the present invention, such as excipients, binders, and disintegrants, and may contain flavoring agents, stimulants, etc. as needed. Effects of the invention

[0073] The present invention relates to civil engineering ( Inula helenium The present invention relates to a composition for the prevention, improvement, or treatment of diabetes comprising an extract. The composition according to the present invention has the advantage of ensuring safety as a natural extract and minimizing side effects while exhibiting excellent effects in preventing, improving, or treating diabetes. The composition according to the present invention can be used as a pharmaceutical composition useful for the prevention, improvement, or treatment of diabetes, or as a food composition useful for the prevention or improvement of diabetes. Brief explanation of the drawing

[0074] FIG. 1a is a graph showing the results of a glucose tolerance test performed by administering a composition according to one embodiment of the present invention to a type 2 diabetic mouse for 9 weeks, administering glucose at the 10th week, and collecting blood at time intervals. Figure 1b is a graph showing the area under the blood glucose curve of Figure 1. Specific details for implementing the invention

[0075] The present invention will be explained in more detail below through the following examples. However, these examples are merely illustrative of the invention, and the scope of the invention is not limited by these examples.

[0077] Preparation Example 1. Preparation of HDI

[0078] 1-1. Preparation of Tumuxiang Extract

[0079] 70% ethanol at 8 times (v / w) the weight of the dry earthenware root was added for a first extraction at 25°C and 50 rpm for 24 hours and filtered, and then 70% ethanol at 5 times (v / w) was added for a second extraction at 25°C and 50 rpm for 8 hours. The extract was filtered through filter paper (Whatman No. 3, Little Chalfont, England), and the filtrate was concentrated (solid content 18.0%) using a rotary vacuum concentrator over a 45°C water bath and used in the experiment.

[0081] 1-2. Preparation of Plant Mixed Extracts

[0082] Jerusalem artichoke 13.0%, malt 8.0 wt%, bamboo leaves 6.50 wt%, Amomum xanthioides 6.00 wt%, Lithospermum erythrorhizon 6.00 wt%, mulberry bark 6.00 wt%, Hovenia dulcis 5.00 wt%, Dioscorea japonica 5.00 wt%, Houttuynia cordata 5.00 wt%, Crataegus pinnatifida 4.00 wt%, Rehmannia glutinosa 4.00 wt%, Lycium chinense 4.00 wt%, corn silk 4.00 wt%, soybean sprouts 4.00 wt%, dried tangerine peel 6.00 wt%, bitter melon 2.00 wt%, Cornus fruit 2.00 wt%, Eucommia ulmoides 1.00 wt%, Ulmus davidiana bark 1.00 wt%, Longan fruit 1.00 wt%, Prunus mume 1.00 wt%, Jujube 1.00 wt%, Astragalus membranaceus 1.00 wt%, Polygonum multiflorum A plant mixture was prepared by mixing 1.00 wt% of Atractylodes rhizome, 0.50 wt% of licorice, 0.50 wt% of Angelica gigas, 0.50 wt% of Paeonia lactiflora, and 0.50 wt% of Cnidium officinale, adding 8 times (w / v) the weight of the plant mixture in purified water, performing a first extraction at 70°C for 6 hours, filtering, then adding 5 times the amount of purified water for a second extraction, filtering, and then mixing the first and second extracts.

[0083] No. Ingredient Name Mixing Ratio (Weight%) 1 Jerusalem artichoke 13 2 malt 8 3 bamboo leaves 6.5 4 sine 6 5 Lithospermum root 6 6 mulberry bark 6 7 Hovenia dulcis stem 5 8 Hovenia dulcis fruit 5 9 Houttuynia cordata 5 10 mountain temple 4 11 Rehmannia glutinosa 4 12 Goji berry fruit 4 13 corn silk 4 14 bean sprout 4 15 dermis 6 16 Yeoju 2 17 Cornelian cherry fruit 2 18 Eucommia ulmoides 1 19 King elm bark 1 20 Longan fruit 1 21 Poria 1 22 jujube 1 23 Astragalus 1 24 inner garment 1 25 Atractylodes rhizome 0.5 26 licorice 0.5 27 Angelica 0.5 28 Peony 0.5 29 Heavenly Palace 0.5 total 100.00

[0085] 1-3. Preparation of a mixed composition (HDI) of each extract

[0086] Banaba leaf extract powder (India, corsolic acid content 1%), allulose, zinc sulfate (7-hydrate 23%), magnesium sulfate (7-hydrate 10%), potassium carbonate, calcium chloride, deer antler extract powder, manganese sulfate, grapefruit seed extract, vitamin D3 mixed preparation powder, and aminomix were purchased and used from an ibt food ingredient and additive supplier located in Gunpo-si, Gyeonggi-do, which is a raw material that meets the standard specifications according to the Food Code.

[0087] As shown in Table 2 below, a mixed composition was prepared by mixing 0.086 wt% of banaba leaf extract powder, 96.0845 wt% of the plant mixed extract prepared in Preparation Example 1-2, 0.5 wt% of allulose, 0.006 wt% of zinc sulfate, 0.107 wt% of magnesium sulfate, 0.1 wt% of potassium carbonate, 0.05 wt% of calcium chloride, 0.005 wt% of deer antler extract powder, 0.001 wt% of manganese sulfate, 0.05 wt% of grapefruit seed extract, 0.0005 wt% of vitamin D3 mixed preparation powder, 0.01 wt% of aminomix, and 3.0 wt% of the Tumoxiang extract prepared in Preparation Example 1-1, and named HDI.

[0088] No. Ingredient Name Mixing ratio (weight%) 1 Banaba leaf extract powder 0.086 2 Plant mixed extract 96.0845 3 allulose 0.5000 4 zinc sulfate 0.0060 5 magnesium sulfate 0.1070 6 potassium carbonate 0.1000 7 calcium chloride 0.0500 8 Deer antler extract powder 0.0050 9 Manganese sulfate 0.0010 10 grapefruit seed extract 0.0500 11 Vitamin D3 mixed powder 0.0005 12 Aminomix 0.0100 13 Earthwood extract 3.0000 total 100.000 brix 5.3

[0090] Experimental Example 1. Test of blood glucose elevation inhibition ability

[0091] 1-1. Experimental Method

[0092] Six male C57BLKS / J-db / m+ and six male C57BLKS / J-db / db mice were designated as the normal and control groups, respectively. Male C57BLKS / J (Orient Bio Co., Ltd., Korea) 5-week-old mice weighing 20–22 g were purchased for the normal group (db / m+ mice) and 26–31 g were purchased for the control group (db / db mice). The mice were housed in dedicated cages in a barrier facility maintaining a temperature of 23±3℃, humidity of 50±20%, and a lighting cycle (12 hours of light, 12 hours of darkness), and underwent a one-week acclimatization period. Gamma-irradiated laboratory solid feed (Lab Diet #5053 PMI Nutrition International, USA) was provided free of charge.

[0093] The experimental group was administered HDI at a dose of 10 mL / kg / day for 9 weeks to db / db (control) mice. It was administered intragastrically once a day, 5 days a week, for a total of 9 weeks using a disposable syringe (1 mL) with an oral administration sonde attached.

[0094] The oral glucose tolerance test was performed using the following method. At week 10 of the experiment, each mouse was fasted for 15 hours, blood was collected, and fasting blood glucose was measured. Then, 1.5 g / kg of glucose dissolved in distilled water was orally administered, and blood was collected from the tail vein of the mice at 30, 60, 120, and 180 minutes later to measure blood glucose levels. Blood glucose was measured using the G400 blood glucose meter kit (GC Green Cross, Korea). Normalized blood glucose was defined as the value measured before glucose administration as the initial value, and the value obtained by subtracting the initial value from the blood glucose measured at each time interval was used. The results are shown in Figure 1a and Table 3 below. The numerical values ​​of the data represent the mean ± standard deviation (n=6). * indicates a result of p < 0.05 compared to the db / db control group.

[0095] Groups 30 minutes 60 minutes 120 minutes 180 minutes db / m+ 61.67±17.10 40.33±13.94 17.17±15.24 10.33±14.14 db / db 322.00±33.34 245.33±29.73 194.00±56.59 117.83±46.70 HDI 256.80±55.84 206.80±61.04 117.80±51.24 61.20±41.78

[0097] Based on this, the area under the blood glucose curve (AUC) was calculated by determining the area under the normalized blood glucose graph using i-solution software (IM TECH Co., Ltd., Korea), and the results are shown in Fig. 1b and Table 4 below. The numerical values ​​of the data represent the mean ± standard deviation (n=6).

[0098] Groups AUC (X100) db / m+ 441.13±134.22 db / db 2933.23±373.00 HDI 2127.46±663.05

[0100] 1-2. Experimental Results

[0101] As can be seen from the results in Figure 1a and Table 3, blood glucose levels increased rapidly 30 minutes after glucose administration in the normal group (db / m+), control group (db / db), and experimental group (HDI), and the experimental group showed 20.25% lower blood glucose levels than the control group. Furthermore, blood glucose levels showed a decreasing trend starting from 60 minutes; at 60 minutes, the experimental group showed a 15.71% decrease compared to the control group, at 120 minutes a 39.28% decrease, and at 180 minutes a 48.06% decrease, indicating a significant decreasing trend in glucose load in the experimental group. P <0.05).

[0102] In addition, as can be seen from the results in Figure 1b and Table 4, the area under the blood glucose curve was calculated, and it was confirmed that the experimental group had an AUC value that was 27.47% lower than that of the control group.

[0103] Based on these results, it was confirmed that the administration of the HDI of the present invention containing the Tomokhyang extract showed preventive, improving, and therapeutic effects on type 2 diabetes.

Claims

Claim 1 Tumokhyang ( Inula helenium A pharmaceutical composition for the prevention, improvement, or treatment of diabetes comprising an extract, wherein the pharmaceutical composition additionally comprises a plant mixed extract comprising extracts of Jerusalem artichoke, malt, bamboo leaf, Amomum xanthioides, Lithospermum erythrorhizon root, Morus alba bark, Hovenia dulcis, Houttuynia cordata, Crataegus pinnatifida, Rehmannia glutinosa, Lycium barbarum, corn silk, soybean sprout, Citrus peel, Bitter melon, Cornus fruit, Eucommia ulmoides, Ulmus davidiana bark, Longan fruit, Poria cocos, Jujube, Astragalus membranaceus, Polygonum multiflorum seed, Atractylodes rhizome, Glycyrrhiza glabra, Angelica gigas, Paeonia lactiflora, and Cnidium officinale; and wherein the pharmaceutical composition additionally comprises Banaba leaf extract, allulose, zinc sulfate, magnesium sulfate, potassium carbonate, calcium chloride, deer antler extract, manganese sulfate, grapefruit seed extract, vitamin D3, and aminomix. Claim 2 A pharmaceutical composition for the prevention, improvement, or treatment of diabetes, wherein, in claim 1, the above-mentioned earth fragrant extract is an alcohol extract. Claim 3 delete Claim 4 A pharmaceutical composition for the prevention, improvement, or treatment of diabetes, wherein, in claim 1, the plant mixed extract is a hot water extract obtained by extracting with hot water at 70 to 130 ℃. Claim 5 delete Claim 6 A pharmaceutical composition for the prevention, improvement, or treatment of diabetes, wherein, in claim 1, the diabetes is type 2 diabetes. Claim 7 Tumokhyang ( Inula helenium A food composition for preventing or improving diabetes comprising an extract, wherein the food composition additionally comprises a plant mixed extract comprising extracts of Jerusalem artichoke, malt, bamboo leaf, Amomum xanthioides, Lithospermum erythrorhizon root, Morus alba bark, Hovenia dulcis, Houttuynia cordata, Crataegus pinnatifida, Rehmannia glutinosa, Lycium barbarum, corn silk, soybean sprout, dried tangerine peel, bitter melon, Cornus fruit, Eucommia ulmoides, Ulmus davidiana bark, longan fruit, Poria cocos, jujube, Astragalus membranaceus, Polygonum multiflorum seed, Atractylodes rhizome, licorice, Angelica gigas, Paeonia lactiflora, and Cnidium officinale; and wherein the food composition additionally comprises Banaba leaf extract, allulose, zinc sulfate, magnesium sulfate, potassium carbonate, calcium chloride, deer antler extract, manganese sulfate, grapefruit seed extract, vitamin D3, and aminomix. Claim 8 A food composition for preventing or improving diabetes, wherein, in claim 7, the above-mentioned earth fragrant extract is an alcohol extract. Claim 9 delete Claim 10 A food composition for preventing or improving diabetes, wherein, in claim 7, the plant mixed extract is a hot water extract obtained by extracting with hot water at 70 to 130 ℃. Claim 11 delete Claim 12 A food composition for preventing or improving diabetes, wherein, in claim 7, the diabetes is type 2 diabetes.

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