KR102414431B1 - A composition for improving, preventing and treating of diabetes mellitus - Google Patents

Abstract

The present invention relates to a composition for preventing, treating or improving diabetes, comprising: a first mixed extract obtained by extracting a mixture consisting of milk thistle and dandelion; and a second mixed extract obtained by extracting a mixture consisting of pork potato, onion, currant mulberry, bitter melon, aronia and ginger; By containing it as an active ingredient, it has excellent antidiabetic effect, and since it is non-toxic, it can be consumed in the form of food, so that diabetes can be improved, prevented or treated in the long term through diet and lifestyle of daily life.

Description

Thistle, dandelion, bitter gourd, pork potato, onion, kkujippong, aronia and a composition for preventing, treating or improving diabetes comprising ginger {A composition for improving, preventing and treating of diabetes mellitus}

The present invention relates to a composition for the prevention, treatment or improvement of diabetes containing a mixture consisting of milk thistle, dandelion, bitter gourd, pork potato, onion, cucurbita, aronia and ginger as an active ingredient.

Diabetes mellitus is one of the most important adult diseases in the world. Recently, with rapid economic growth in Korea, the prevalence of diabetes has reached 10%. Currently, over 240 million people worldwide, and by 2025, it will reach 380 million people worldwide. In 2009, the American Medical Association (JAMA) announced that 60% of cases will occur in Asia. In particular, the onset of diabetes has been extended to the middle-aged, and due to the extension of lifespan, the development of complications has become an unavoidable situation.

That is, in general, after 10 to 20 years of diabetes, almost all organs in the body are damaged, resulting in diabetic retinopathy, diabetic cataract, diabetic nephropathy, and diabetic nerves. It appears as a diabetic neuropathy, heart disease, cancer, osteoporosis, etc. Chronic diabetic nephropathy is the most important cause of hemodialysis treatment and end-stage renal failure, and diabetic cataract and retinopathy cause blindness and eventually death.

Currently, in the study of insulin-dependent diabetes mellitus (type 1 diabetes), alloxan and streptozotocin are mainly used to induce diabetes in experimental animals (Lee, J.W., B.I. Seo, J.H. Park, S.S. Roh, Y.H. Kim, and M.R. Kim). Effect of Mantidis OOtheca and Mori fructus on treatment of osteoporosis in ovariectomized rats. Kor J Herbology. 2009. 24:59-71). Alloxan selectively accumulates rapidly in beta cells of the pancreas, and inhibits beta cell glucokinase to decrease insulin secretion (Lenzen, S.. Beta-cell apoptosis in type 2 diabetes: Quantitative and functional consequences. Diabetes Metab. 2008. 34:56-64.). The zebrafish (Danio rerio) is a small tropical freshwater fish native to India. After inducing diabetes to zebrafish, an experiment is known to check whether or not diabetes is recovered by measuring the size of the pancreatic islet after administering a drug (Kim, H.T., and C.H. Kim. Zebrafish as a tool for functional genomics. Dev Reprod. 2003. 7:69-80).

Natural products proposed to be effective in the treatment of diabetes include moxibustion extract (Korean Patent No. 464815), an aflanaic acid derivative compound isolated from Jannabi shiitake mushroom (Korean Patent No. 457690), and extract of Heotgae tree (Korean registered patent). No. 417287), polysaccharides isolated from Angelica larvae (International Patent Publication No. 2001-60386), bile of ruminants (US Patent No. 6451355), and the like can be exemplified.

Republic of Korea Patent No. 464815 Republic of Korea Patent No. 457690 Republic of Korea Patent No. 417287

An object of the present invention is to provide a food composition capable of preventing or improving diabetes by containing a mixture consisting of milk thistle, dandelion, bitter melon, pork potato, onion, cucurbita, aronia and ginger as an active ingredient.

Another object of the present invention is to provide a method for preparing a food composition that can prevent or improve the diabetes.

Another object of the present invention is to provide a pharmaceutical composition capable of preventing or treating diabetes by containing a mixture consisting of milk thistle, dandelion, bitter melon, pork potato, onion, cucurbita, aronia and ginger as an active ingredient.

The food composition capable of preventing or improving diabetes of the present invention for achieving the above object is a first mixed extract obtained by extracting a mixture consisting of milk thistle and dandelion; and a second mixed extract obtained by extracting a mixture consisting of pork potato, onion, currant mulberry, bitter melon, aronia and ginger; It may contain as an active ingredient.

The first mixed extract may be an extract extracted at 80 to 100° C. by mixing 25 to 55 parts by weight of dandelion with respect to 100 parts by weight of thistle.

The second mixed extract is 80 to 100 by mixing pork potato, onion, currant mulberry, bitter gourd, aronia and ginger in a weight ratio of 1: 0.8-1.2: 0.1-0.8: 0.1-0.8: 0.1-0.8: 0.01-0.05 It may be an extract extracted at ℃.

The thistle may be a mixture of flowers, stems and leaves, and roots of thistles in a weight ratio of 1:14-25:0.1-0.9.

The composition capable of preventing, treating or ameliorating diabetes of the present invention for achieving the above other object comprises the steps of (A) obtaining a first mixed extract by mixing and extracting milk thistle and dandelion; (B) obtaining a second mixed extract by mixing and extracting pork potato, onion, mulberry tree, bitter melon, aronia and ginger; and (C) mixing the first mixed extract and the second mixed extract.

The mixture mixed in step (C) may be concentrated to a volume of 1/3 to 1/7 of the volume of the mixture.

A pharmaceutical composition capable of preventing or treating diabetes of the present invention for achieving the above another object is a first mixed extract obtained by extracting a mixture consisting of milk thistle and dandelion; and a second mixed extract obtained by extracting a mixture consisting of pork potato, onion, currant mulberry, bitter melon, aronia and ginger; It may contain as an active ingredient.

Since the composition for preventing, treating or improving diabetes of the present invention has an excellent blood sugar lowering effect, it can be effectively used for the prevention and treatment of diabetes, and since it is nontoxic, it can be consumed in the form of food.

The present invention relates to a composition for preventing, treating or ameliorating diabetes containing a mixture consisting of milk thistle, dandelion, bitter gourd, pork potato, onion, cucurbiton, aronia and ginger as an active ingredient.

Hereinafter, the present invention will be described in detail.

The composition for preventing, treating or improving diabetes of the present invention includes a first mixed extract obtained by extracting a mixture consisting of milk thistle and dandelion; and a second extract obtained by extracting a mixture consisting of pork potato, onion, mulberry tree, bitter gourd, aronia and ginger; contains as an active ingredient.

first mixed extract

thistle

The thistle used in the present invention may be a white thistle (Silybum marianum (L.) Gaertn.), a spiny thistle (Cirsium japonicum Fisch ex DC. var. spinossimum Kitam.), or a mixture thereof, and preferably a white thistle. Thistle alone is used.

The white patterned thistle (Silybum marianum (L.) Gaertn.) is a deep, shiny green plant with milky white leaf veins, a wavy edge at the edge and a thorny root-leaf divided into long thin plants. It is mainly found on levee fences and abandoned lands. The useful parts of the plant are the whole herb, roots, leaves, seeds, and husks, and thistle seeds contain a flavonoid compound known as silymarin. Thistle seed extract contains 70-80% silymarin.

The thistle according to the present invention is a mixed extract containing a mixture of flowers, stems and leaves, and roots of thistle.

The flower of the thistle has a purple or red corolla and a length of 19-24 mm. It is preferable to use only those with a length of 10 to 15 mm and not use those with a length longer than that for toxicity.

In addition, the thistle stem and leaves are mixed and used in a weight ratio of 1: 1-4, preferably 1: 2-3. If the content of the leaf based on the stem is less than the lower limit, the bitter taste may be strong, and if it exceeds the upper limit, it is not preferable for the prevention, treatment or improvement of diabetes.

Also, unlike flowers, stems and leaves, which are harvested twice a year, the thistle root is harvested once every three years, so it is preferable to use it after drying.

The flower, stem and leaf mixture, and root of the thistle are mixed in a weight ratio of 1:14-25:0.1-0.9, preferably 1:16-19:0.4-0.8 by weight. If the content of the mixture of stems and leaves and roots based on the flower is less than the lower limit, the effect on the prevention, treatment or improvement of diabetes may not be excellent, and if it exceeds the upper limit, the bitter taste is strong and the prevention of diabetes; The effectiveness of treatment or improvement may be reduced.

The mixed extract of the present invention is a hot water extract extracted at 80 to 100 ℃ for 20 to 30 hours, preferably for 24 to 28 hours. If the extraction temperature and time are less than the lower limit, the active ingredient may not be extracted, and if it exceeds the upper limit, the burnt taste may be strong and the nutrients may be destroyed. In addition, when the extraction is performed by another method such as extraction with an organic solvent in addition to extraction using water bath, the effect on the prevention, treatment or improvement of diabetes is insignificant and a bitter taste may be strongly generated.

Specifically, the mixed extract is extracted by mixing flowers, and a mixture of stems and leaves, and separately extracting the roots in a bath and mixing afterwards. Unlike the present invention, in the case of extracting the hot water by mixing all of the mixture and roots of flowers, stems and leaves, the bitter taste is strong and the effect on the prevention, treatment or improvement of diabetes may be reduced.

Specifically, the method for preparing this milk thistle mixed extract includes the steps of: (a) mixing a mixture of flowers, stems, and leaves of thistle, and extracting the extract with hot water at 80 to 100° C.; (b) extracting the root of thistle at 80 to 100° C. to obtain an extract; and (c) lyophilizing the extracts obtained in steps (a) and (b), respectively, to powder them and mixing them. In addition, after step (c), (d) drying and pulverizing the residue remaining after extraction in step (b); and (e) mixing 100 parts by weight of the powder mixed in step (c) and 0.1 to 3 parts by weight of the powder of step (d); may further include.

Unlike the steps (a) and (b), when extracting in a hot water by mixing all of the flowers, stem and leaf mixture, and roots, the bitter taste is strong and the effect on the prevention, treatment or improvement of diabetes may be reduced. ; In the case of extracting flowers, a mixture of stems and leaves, and roots, respectively, in a bath, the yield may be reduced.

When the root residue powder prepared in step (D) is added, the effect on disease can be significantly improved compared to the case where the root residue powder is not added.

dandelion

The dandelion (Taraxacum platycarpum) is also called Geumjamcho, Jijeong, Pogongyeong, Pogongcho, and Anjilbang, and also has a nickname called Satseunbang. The leaves or stems contain proteins, carbohydrates, fats, ash, minerals, vitamins, etc. evenly. Young shoots are used as greens or soup. In oriental medicine, the roots and outposts before flowering are said to have antipyretic, anti-inflammatory, diuretic, and gastric effects, and are used as a treatment for hypothyroidism, sore throat, bronchitis, lymphadenitis, ophthalmitis, mastitis, hepatitis, cholecystitis, indigestion, indigestion, and constipation. use it

Such dandelion is mixed in an amount of 25 to 55 parts by weight, preferably 35 to 50 parts by weight, based on 100 parts by weight of thistle.

If the content of dandelion is less than the lower limit, the effect of preventing, treating or improving diabetes may be lower than when each substance is used alone, and if it exceeds the upper limit, the effect of preventing, treating or improving diabetes will be reduced. can

The first mixed extract of the present invention is obtained by mixing a mixture of milk thistle and dandelion and an extraction solvent in a weight ratio of 1: 1 to 100, preferably 1: 5 to 20, and extracting at 80 to 100 ° C. for 40 to 50 hours. Prepare the extract. When the weight ratio of the mixture and the extraction solvent is out of the above range, the active ingredient of the milk thistle and dandelion mixture may be extracted in a small amount in the extract.

The extraction solvent for extracting the extract is water, a lower alcohol having 1 to 4 carbon atoms, or a mixed solvent thereof. The extraction solvent is not particularly limited, but the extract extracted with water shows an excellent effect.

second mixed extract

The second mixed extract is pork potato, onion, mulberry tree, bitter gourd, aronia and ginger in a weight ratio of 1: 0.8-1.2: 0.1-0.8: 0.1-0.8: 0.1-0.8: 0.01-0.05, preferably 1: 0.9 -1: 0.2-0.5: 0.2-0.5: 0.2-0.5: A weight ratio of 0.02-0.01, more preferably 1:1: 0.24: 0.24: 0.24: 0.024 weight ratio of the mixed mixture is extracted. In particular, it contains pork potatoes and onions in the same content; The effect of preventing, treating, or improving diabetes can be significantly improved when Cuji mulberry, bitter gourd, and aronia are contained in the same content.

If the content of onion, currant mulberry, bitter gourd, aronia and ginger based on pork potato is less than the lower limit, the effect of preventing, treating or improving diabetes may not be improved. The effect of preventing, treating, or improving may be lower than when each substance is used alone.

The second mixed extract is obtained by mixing a mixture of pork potato, onion, currant mulberry, bitter melon, aronia and ginger and an extraction solvent in a weight ratio of 1:1 to 100, preferably 1: 3 to 20 by mixing 80 It is an extract by extraction at 100 ° C. for 5 to 20 hours.

The extraction solvent for extracting the extract is water, a lower alcohol having 1 to 4 carbon atoms, or a mixed solvent thereof. The extraction solvent is not particularly limited, but the extract extracted with water shows an excellent effect.

The pork potato (Helianthus tuberosus) is a naturalized plant that is estimated to have been introduced to Korea after the 17th century through China from Europe, and grows wild in fields or mountains. If you dig under the dry stem, you can find tubers of pork potatoes, and the flowers that bloom in the fall are very attractive.

In addition, the onion (onion) contains 'allicin', a component that gives a spicy taste, so it is spicy and sweet, and has an antioxidant action and lowering blood cholesterol level.

In addition, the Cudrania tricuspidata Bureau) is a deciduous broad-leaved small arboreous tree belonging to the family Moraceae, which is dioecious, has 1.0-3.5 cm thorns on the stem, and the root skin is yellowish and sparse, producing red fruits around October. There is a characteristic.

As a herbal medicine, the stem of the mulberry tree is called Jamok, and the leaves are used as a substitute for mulberry leaves when making silkworms, and the fruits are edible and used to make jam or to make alcohol. Donguibogam has nutritive and tonic effects, and is effective for physical weakness, stamina, yin, insomnia, and loss of vision. Studies on the antioxidant, anticancer, antidiabetic, and antibacterial effects of Cudrania were published, and in particular, various parts of Cudrania were investigated to have high antioxidant properties.

In addition, although the bitter gourd (Momordica charantia Linnaeus) is traditionally widely used for medicinal purposes, there is a risk of miscarriage if a pregnant woman takes a large amount of bitter melon. If you apply the juice extracted from the leaves to insect bites, bee stings, burns, small wounds, skin allergies, etc., itching is relieved and no scars are left. Extracts of the leaves and fruits are used for the treatment of stomach pain, fever, arthritis, diabetes, high blood pressure, cancer, and infectious diseases, and are particularly effective in lowering blood sugar.

In addition, the aronia is a fruit corresponding to the genus Rosaceae Aronia of the Rosaceae family, and has excellent antioxidant and anticancer effects due to the highest anthocyanin content among berries, and has only effects such as weight loss, prevention of liver damage, alleviation of inflammation, and alleviation of eye fatigue. It also lowers cholesterol levels and helps prevent cardiovascular disease and stroke.

In addition, the ginger is a rhizome, which grows sideways, is fleshy, has a lumpy shape, is yellow, and has a pungent taste and a fragrant smell. Ginger treats chills, fever, headache, vomiting, seawater, and phlegm caused by a cold. As pharmacological action, gastric juice secretion promotion, digestive power enhancement, cardiac excitatory action, blood circulation promotion, and antibacterial action have been reported.

In addition, the present invention provides a method for preparing a composition for preventing, treating or improving diabetes.

The method for preparing a composition for preventing, treating or improving diabetes of the present invention comprises the steps of (A) obtaining a first mixed extract by mixing and extracting milk thistle and dandelion; (B) obtaining a second mixed extract by mixing and extracting pork potato, onion, mulberry tree, bitter melon, aronia and ginger; and (C) mixing the first mixed extract and the second mixed extract. A step of adding stevia may be added after step (C).

First, in step (A), a mixture of milk thistle and dandelion is extracted with an extraction solvent to obtain a first mixed extract.

The mixing conditions, extraction solvent and extraction conditions of the mixture are the same as those mentioned above.

Next, in step (B), a mixture of pork potato, onion, mulberry tree, bitter melon, aronia and ginger is extracted with an extraction solvent to obtain a second mixed extract.

The mixing conditions, extraction solvent and extraction conditions of the mixture are the same as those mentioned above.

When the first mixed extract is prepared by mixing milk thistle and dandelion in step (A), pork potato, onion, cucurbiton, bitter melon, aronia and ginger are also added and extracted together, and the bitter taste is strong and prevents, treats, or treats diabetes. Since the improving effect may be significantly reduced, it is preferable to add a second mixed extract extracted by mixing thistle and dandelion to the first mixed extract separately by mixing pork potato, onion, currant mulberry, bitter gourd, aronia and ginger. .

Next, in step (C), the first mixed extract and the second mixed extract are mixed in a weight ratio of 1:1-5, preferably 1:1-2 by weight.

If the content of the second mixed extract based on the first mixed extract is less than the lower limit, the sensory properties may be reduced and the effect of preventing, treating or improving diabetes may be significantly reduced, and if it exceeds the upper limit, the prevention of diabetes; The therapeutic or ameliorating effect is not improved, and an effect similar to the case of using each of the above substances is shown.

Stevia ( Stevia rebaudiana ) grows around rivers or wetlands, and stevia leaves have been used as a sweetener since ancient times. The leaves contain stevioside, a sweetener, about 6-7% by weight, and the content varies greatly depending on the individual. The sweetening ingredient is 300 times that of sugar, and it is used as a sweetener in soft drinks, as a substitute for making tea or chewing gum.

In the present invention, stevia is used to increase the functionality.

The stevia is mixed in an amount of 0.1 to 5 parts by weight, preferably 0.5 to 1 parts by weight, based on 100 parts by weight of milk thistle.

If the content of stevia is out of the above range, the functionality may be reduced.

The form of the composition of the present invention may be prepared in the form of gel, puree, juice, pills, large pills and granules.

For example, in the case of being prepared in the form of gel and puree, the mixture of the first mixed extract and the second mixed extract is concentrated to 1/3 to 1/5 of the volume of the mixture with a concentrator, and then the agar It is added, stirred, and then sterilized to prepare gels and purees.

As another example, when it is prepared in the form of juice, the mixture of the first mixed extract and the second mixed extract is sterilized and used as it is.

As another example, when it is prepared in the form of rings, large rings and granules, the mixture of the first mixed extract and the second mixed extract is concentrated to a volume of 1/5 to 1/7 compared to the volume of the mixture with a concentrator. Then, it is aged for 40 to 50 hours in a water bath at 60 to 70 ° C., then dried and molded to prepare rings, large rings and granules.

A mixture of the first mixed extract and the second mixed extract of the present invention is broadly defined as a mixed processed product formulated so that a mixture of the first mixed extract and the second mixed extract can be administered to an animal, such as the first It has a meaning including a mixed powder obtained by mixing the mixed extract and the second mixed extract. Although the experiment was conducted with a mixture of the first mixed extract and the second mixed extract in the present invention, the desired effect can be achieved even in the same form as a mixed product in which the first mixed extract and the second mixed extract are mixed. It will be foreseeable by those skilled in the art.

Meanwhile, in the present specification, the term 'contained as an active ingredient' means including an amount sufficient to achieve the efficacy or activity of a mixture of the first mixed extract and the second mixed extract. For example, a mixture of the first mixed extract and the second mixed extract is used at a concentration of 10 to 1500 μg/ml, preferably 100 to 1000 μg/ml. Since the mixture of the first mixed extract and the second mixed extract is a natural product and there is no side effect to the human body even when administered in excess, the upper limit of the quantity of the mixture containing the first mixed extract and the second mixed extract included in the composition of the present invention is determined by those skilled in the art. can be selected and implemented within an appropriate range.

The pharmaceutical composition of the present invention may be prepared using a pharmaceutically suitable and physiologically acceptable adjuvant in addition to the active ingredient, and the adjuvant includes an excipient, a disintegrant, a sweetener, a binder, a coating agent, an expanding agent, a lubricant, A lubricant or flavoring agent may be used.

The pharmaceutical composition may be preferably formulated as a pharmaceutical composition by including one or more pharmaceutically acceptable carriers in addition to the active ingredients described above for administration.

Formulations of the pharmaceutical composition may be granules, powders, tablets, coated tablets, capsules, suppositories, solutions, syrups, juices, suspensions, emulsions, drops or injectables. For example, for formulation in the form of a tablet or capsule, the active ingredient may be combined with an orally, non-toxic, pharmaceutically acceptable inert carrier such as ethanol, glycerol, water, and the like. In addition, if desired or required, suitable binders, lubricants, disintegrants and color-developers may also be included in the mixture. Suitable binders include, but are not limited to, starch, gelatin, natural sugars such as glucose or beta-lactose, corn sweeteners, natural and synthetic gums such as acacia, tracacanth or sodium oleate, sodium stearate, magnesium stearate, sodium benzoate, sodium acetate, sodium chloride, and the like. Disintegrants include, but are not limited to, starch, methyl cellulose, agar, bentonite, xanthan gum, and the like.

In the composition formulated as a liquid solution, acceptable pharmaceutical carriers are sterile and biocompatible, and include saline, sterile water, Ringer's solution, buffered saline, albumin injection, dextrose solution, maltodextrin solution, glycerol, ethanol and One or more of these components may be mixed and used, and other conventional additives such as antioxidants, buffers, and bacteriostats may be added as needed. In addition, diluents, dispersants, surfactants, binders and lubricants may be additionally added to form an injectable formulation such as an aqueous solution, suspension, emulsion, etc., pills, capsules, granules or tablets.

Furthermore, by using the method disclosed in Remington's Pharmaceutical Science, Mack Publishing Company, Easton PA by an appropriate method in the art, it can be preferably formulated according to each disease or component.

The pharmaceutical composition of the present invention may be administered orally or parenterally, and in the case of parenteral administration, it may be administered by intravenous injection, subcutaneous injection, intramuscular injection, intraperitoneal injection, transdermal administration, etc., preferably oral administration. .

A suitable dosage of the pharmaceutical composition of the present invention varies depending on factors such as formulation method, administration mode, age, weight, sex, pathological condition, food, administration time, administration route, excretion rate and response sensitivity of the patient, An ordinarily skilled physician can readily determine and prescribe a dosage effective for the desired treatment or prophylaxis. According to a preferred embodiment of the present invention, the daily dose of the pharmaceutical composition of the present invention is 0.001-10 g/kg.

The pharmaceutical composition of the present invention is prepared in unit dosage form by formulating using a pharmaceutically acceptable carrier and/or excipient according to a method that can be easily performed by a person of ordinary skill in the art to which the present invention pertains. or it may be prepared by incorporation into a multi-dose container. At this time, the formulation may be in the form of a solution, suspension, or emulsion in oil or aqueous medium, or may be in the form of an extract, powder, granule, tablet or capsule, and may additionally include a dispersant or stabilizer.

In addition, the present invention provides a food composition for preventing, treating or improving diabetes containing a mixture of the first mixed extract and the second mixed extract as an active ingredient.

The food composition according to the present invention may be formulated in the same manner as the pharmaceutical composition and used as a functional food or added to various foods. Foods to which the composition of the present invention can be added include, for example, beverages, alcoholic beverages, sweets, diet bars, dairy products, meat, chocolate, pizza, ramen, other noodles, gums, ice cream, vitamin complexes, health supplements etc.

The food composition of the present invention may include a mixture of the first mixed extract and the second mixed extract as an active ingredient, as well as ingredients commonly added during food production, for example, protein, carbohydrate, fat, Contains nutrients, seasonings and flavoring agents. Examples of the above-mentioned carbohydrates include monosaccharides such as glucose, fructose and the like; disaccharides such as maltose, sucrose, oligosaccharides and the like; and polysaccharides, for example, conventional sugars such as dextrin, cyclodextrin, and the like, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents, natural flavoring agents [taumatine, stevia extract (eg, rebaudioside A, glycyrrhizin, etc.)) and synthetic flavoring agents (saccharin, aspartame, etc.) can be used. For example, when the food composition of the present invention is prepared as a drink and beverages, in addition to the mixture of the first mixed extract and the second mixed extract of the present invention, citric acid, high fructose, sugar, glucose, acetic acid, malic acid, fruit juice, and various Plant extracts and the like may be further included.

The present invention provides a health functional food comprising a food composition for the prevention, treatment or improvement of diabetes comprising a mixture of the first mixed extract and the second mixed extract as an active ingredient. Health functional food is a food prepared by adding a mixture of the first mixed extract and the second mixed extract to food materials such as beverages, teas, spices, gum, and confectionery, or encapsulating, powdering, suspension, etc. When ingested, it means that a specific effect is brought on health, but unlike general drugs, it has the advantage that there are no side effects that may occur when taking the drug for a long period of time by using food as a raw material. The health functional food of the present invention obtained in this way is very useful because it can be ingested on a daily basis. The addition amount of the mixture of the first mixed extract and the second mixed extract in such a health functional food varies depending on the type of health functional food and cannot be uniformly defined, but within a range that does not impair the original taste of the food. It may be added in the range of 0.01 to 50% by weight, preferably 0.1 to 20% by weight, based on the target food. In addition, in the case of a health functional food in the form of pills, granules, tablets or capsules, it is usually added in an amount of 0.1 to 100% by weight, preferably 0.5 to 80% by weight. In one embodiment, the health functional food of the present invention may be in the form of a pill, tablet, capsule or beverage.

In addition, the present invention provides the use of a mixture of the first mixed extract and the second mixed extract for the manufacture of a medicament or food for the prevention, treatment or improvement of diabetes. As described above, a mixture of the first mixed extract and the second mixed extract may be used for diabetes.

In addition, the present invention provides a method for improving, preventing, or treating diabetes, comprising administering to a mammal an effective amount of a mixture of the first mixed extract and the second mixed extract.

As used herein, the term "mammal" refers to a mammal that is the subject of treatment, observation or experimentation, preferably a human.

As used herein, the term "effective amount" refers to the amount of an active ingredient or pharmaceutical composition that induces a biological or medical response in a tissue system, animal or human as conceived by a researcher, veterinarian, physician or other clinician, which an amount that induces alleviation of the symptoms of a disease or disorder. It is apparent to those skilled in the art that the effective amount and frequency of administration for the active ingredient of the present invention will vary depending on the desired effect. Therefore, the optimal dosage to be administered can be easily determined by those skilled in the art, and the type of disease, the severity of the disease, the content of active ingredients and other components contained in the composition, the type of formulation, and the age, weight, and general health of the patient It can be adjusted according to various factors including state, sex and diet, administration time, administration route and secretion rate of the composition, treatment period, and concurrently used drugs. In the prevention, treatment or improvement method of the present invention, in the case of adults, when the mixture of the first mixed extract and the second mixed extract is administered once to several times a day, a dose of 0.001 g/kg to 10 g/kg It is preferable to administer

In the treatment method of the present invention, the composition comprising a mixture of the first mixed extract and the second mixed extract as an active ingredient is oral, rectal, intravenous, intraarterial, intraperitoneal, intramuscular, intrasternal, transdermal, topical, Administration may be carried out in a conventional manner via intraocular or intradermal routes.

Hereinafter, preferred examples are presented to help the understanding of the present invention, but the following examples are merely illustrative of the present invention, and it will be apparent to those skilled in the art that various changes and modifications are possible within the scope and spirit of the present invention, It goes without saying that such variations and modifications fall within the scope of the appended claims.

production example 1 Preparation of thistle

1 part by weight of the flower of thistle, 18.6 parts by weight of a mixture of stem and leaf (stem:leaf=1:2 weight ratio), and 45 parts by weight of water were mixed and extracted at 95° C. for 24 hours to obtain an extract A, followed by 0.4 parts by weight of thistle root. Extract B was obtained by extracting parts by weight and 45 parts by weight of water at 95° C. for 24 hours, and then lyophilized to prepare powder A and powder B, respectively, to prepare a mixed thistle extract powder.

Example One.

Preparation of the first mixed extract

After mixing 100 parts by weight of thistle and 41 parts by weight of dandelion prepared in Preparation Example 1, the mixture and water were mixed in a weight ratio of 1: 9 and extracted at 90° C. for 48 hours to obtain a first mixed extract.

Preparation of the second mixed extract

Pig potato, onion, mulberry tree, bitter gourd, aronia and ginger were mixed in a weight ratio of 1: 1: 0.24: 0.24: 0.24: 0.024, and extracted at 90 ° C. for 10 hours to obtain a second mixed extract. .

Preparation of the final mixed extract

The first mixed extract and the second mixed extract were mixed in a weight ratio of 1: 1.26 and mixed at room temperature for 10 minutes to obtain a final mixed extract.

Comparative Example 1. Using only the first mixed extract

It was carried out in the same manner as in Example 1, except that only the first mixed extract was used without using the second mixed extract.

Comparative Example 2. Using only the second mixed extract

It was carried out in the same manner as in Example 1, except that the first mixed extract was not used and only the second mixed extract was used.

Comparative Example 3. First mixed extract: second mixed extract = 1: 0.5 weight ratio

The same procedure as in Example 1, except that the first mixed extract and the second mixed extract were mixed in a weight ratio of 1:0.5 and mixed at room temperature for 10 minutes to obtain a final mixed extract.

<Test Example>

laboratory animal

Obese, 6-week-old male db/db mice exhibiting symptoms of diabetes were artificially genetically mutated to block leptin feedback signal transduction to induce type 2 diabetes along with overweight as they grow. As a result, the drug was orally administered to this mouse model, and the same amount of physiological saline was administered to the control group. For the experimental group, 7 mice were randomly assigned to each group, one group received vehicle (saline, negative control group), banaba leaf extract (Wellis banana) 100 mg/kg to the positive control group, and 100 mg/kg to the experimental group. 2 g/kg of the sample prepared above was orally administered (each sample was suspended in saline) by 0.4 ml at 10 am and 18 pm, respectively, every day. The rearing conditions of each group were maintained in an SPF environment controlled by temperature 22±2 ℃, humidity 55±10%, and light and dark at 12 hour intervals, as in the preliminary animal experiment, and body weight and blood sugar at 0, 7, 14, and 21 days of administration. A portable blood glucose meter (OneTouch TM, Johnson & Johnson, USA) was used for changes, and the average value for each experimental group is shown.

blood analysis

After each sample was administered to db/db mice for 21 days, blood was collected from animals in each group, centrifuged at 3,000 rpm for 10 minutes, and the supernatant plasma was separated and analyzed for glucose, etc. to determine the difference from the control group. Statistical method (student t-test)

Significance analysis was performed using

Statistical processing

Results obtained from various experiments were recorded as meanw standard error, and significance was determined using Student's T-test analysis method.

Test Example 1. Measurement of anti-diabetic effect in mice, an animal model of type 2 diabetes

In order to confirm the hypoglycemic effect of the sample of the above example, an experiment was performed with the following procedure by modifying the method disclosed in the literature [Am J Physiol Endocrinol Metab. 288: E510-E518 (2005); Diabetologia 49: 1647-1655 (2006); J. Ethnopharmacol. 103: 491-495 (2006); J. Med. Chem. 43: 3487-3494 (2003); Metabolism 50:1049-1053 (2001); Nutrition & Metabolism 53: 488-499 (2004)].

1-1. Effect on blood sugar changes

Each sample was orally administered twice a day in the morning and afternoon for 3 weeks to a 6-week-old db/db mouse model, and blood glucose was measured by collecting blood from the tail of the mice once a week with a portable blood glucose meter, and on the day before the measurement, all mice of the diet was removed (about 12 hours).

Category (unit: blood sugar mg/dL) 0 days 7 days 14 days 21 days negative control 350.8 396.7 574.9 598.2 positive control 361.7 409.6 392.8 372.8 Example 1 359.0 385.7 375.1 364.8 Comparative Example 1 362.4 461.3 465.2 467.0 Comparative Example 2 361.9 443.9 448.7 440.1 Comparative Example 3 362.5 438.9 441.7 433.9

As shown in Table 1 above, it was confirmed that the mixture prepared according to Example 1 of the present invention was excellently suppressed in blood sugar from day 0 to day 21.

On the other hand, in the negative control group and Comparative Example 1, blood sugar was not suppressed and increased continuously, and it was confirmed that Comparative Examples 2 and 3 were not inhibited in blood sugar compared to Example 1.

1-2. Measurement of changes in blood glucose (glucose)

After the end of the experiment on the 21st, the diet was removed the day before, anesthetized with ethyl ether in a fasting state (about 12 hours), blood was collected from the heart with a 3 ml syringe, left at room temperature for 1 hour, and centrifuged at 3000 rpm for 10 minutes After separation, the serum was separated, and the change in glucose in the serum was measured with an automatic serum meter.

division Glucose measurement (mg/dL) negative control 631.9 positive control 462.1 Example 1 474.5 Comparative Example 1 546.9 Comparative Example 2 536.9 Comparative Example 3 531.4

As shown in Table 2 above, it was confirmed that the mixture prepared according to Example 1 of the present invention had a decrease in glucose compared to the negative control group and Comparative Examples 1 to 3.

As a result of Table 1 and Table 2, it was confirmed that the composition of Example 1 had antidiabetic effect.

Test Example 2. Effect on weight and dietary changes

The change in body weight was measured twice a week with 7 mice in each experimental group, and the average daily food intake of each experimental group (7 mice) was observed by measuring the dietary intake at 3-day intervals.

weight change

division
(Unit: g) 0 days 0.5 days 7 days 7.5 days 14 days 14.5 days 21 days negative control 29.1 29.4 29.9 30.8 31.8 32.6 33.9 positive control 28.7 29.0 29.4 29.7 29.8 30.5 30.8 Example 1 28.9 29.2 29.6 29.9 30.2 30.4 30.6 Comparative Example 1 29.2 29.6 30.0 30.3 30.7 31.1 31.7 Comparative Example 2 28.5 29.0 29.5 30.0 30.4 30.9 31.4 Comparative Example 3 28.7 29.3 29.7 30.2 30.8 31.2 31.6

dietary intake

division
(Unit: g) 7 days 14 days 21 days negative control 33.3 38.1 38.6 positive control 33.5 38.4 38.1 Example 1 33.3 38.3 38.7 Comparative Example 1 33.2 38.5 38.5 Comparative Example 2 33.5 38.8 38.7 Comparative Example 3 33.4 38.7 38.4

As shown in Tables 3 and 4 above, the compound prepared according to Example 1 of the present invention showed a slight decrease in body weight compared to the negative control group and Comparative Examples 1 to 3 even though the intake was similar to the negative control group and Comparative Examples 1 to 3 Confirmed.

Test Example 3. Acute toxicity test

An acute toxicity test was conducted using 6-week-old Specific pathogen-free (SPF) SD rats. The compositions of Examples and Comparative Examples were orally administered once at a dose of 100 mg/kg to two animals in each group. After administration of the test substance, the animal's mortality, clinical symptoms, and weight change were observed, and hematological and blood biochemical tests were performed. After an autopsy, the tonic and thoracic organs were visually observed for abnormalities.

As a result, there were no remarkable clinical symptoms or mortality in all the animals to which the test substance was administered, and no toxic changes were observed in body weight changes, blood tests, blood biochemical tests, and autopsy findings.

Hereinafter, formulation examples of the composition containing the powder of the present invention will be described, but the present invention is not intended to limit the present invention, but merely to describe it in detail.

Formulation Example 1. Preparation of powder

500 mg of the mixture powder obtained in Example 1

Lactose 100 mg

talc 10 mg

The above ingredients are mixed and filled in an airtight bag to prepare a powder.

Formulation Example 2. Preparation of tablets

300 mg of the mixture powder obtained in Example 1

100 mg cornstarch

Lactose 100 mg

2 mg magnesium stearate

After mixing the above ingredients, tablets are prepared by tableting according to a conventional manufacturing method of tablets.

Formulation Example 3. Preparation of capsules

200 mg of the mixture powder obtained in Example 1

3 mg of crystalline cellulose

Lactose 14.8 mg

0.2 mg magnesium stearate

According to a conventional capsule preparation method, the above ingredients are mixed and filled in a gelatin capsule to prepare a capsule.

Formulation Example 4. Preparation of injection

600 mg of the mixture powder obtained in Example 1

mannitol 180 mg

2974 mg of sterile distilled water for injection

Na ₂ HPO _4, 12H ₂ O 26 mg

According to a conventional method for preparing injections, the content of the above ingredients per 1 ampoule is prepared.

Formulation Example 5. Preparation of liquid formulation

4 g of the mixture powder obtained in Example 1

10 g isomerized sugar

5 g of mannitol

Purified water appropriate amount

According to a conventional liquid preparation method, each component is added to purified water to dissolve, an appropriate amount of lemon flavor is added, the above components are mixed, purified water is added, the whole is adjusted to 100 g by adding purified water, and then filled in a brown bottle to sterilize to prepare a liquid.

Formulation Example 6. Preparation of granules

1,000 mg of the mixture powder obtained in Example 1

appropriate amount of vitamin mixture

70 μg vitamin A acetate

Vitamin E 1.0 mg

Vitamin B1 0.13 mg

Vitamin B2 0.15 mg

0.5 mg of vitamin B6

0.2 μg of vitamin B12

Vitamin C 10 mg

Biotin 10 μg

Nicotinamide 1.7 mg

50 μg of folic acid

Calcium pantothenate 0.5 mg

Mineral mixture appropriate amount

ferrous sulfate 1.75 mg

Zinc Oxide 0.82 mg

Magnesium carbonate 25.3 mg

potassium phosphate monobasic 15 mg

Dibasic calcium phosphate 55 mg

Potassium citrate 90 mg

100 mg of calcium carbonate

Magnesium chloride 24.8 mg

The composition ratio of the vitamin and mineral mixture is relatively suitable for granules in a preferred embodiment, but the mixing ratio may be arbitrarily modified. It can be prepared and used in the preparation of a health functional food composition according to a conventional method.

Formulation Example 7. Preparation of functional beverage

1,000 mg of the mixture powder obtained in Example 1

1,000 mg citric acid

100 g of oligosaccharides

2 g of plum concentrate

1 g taurine

Add purified water to total 900 mL

After mixing the above ingredients according to the usual health drink manufacturing method, after stirring and heating at 85 ° C for about 1 hour, the resulting solution is filtered and obtained in a sterilized 2 L container, sealed and sterilized, then refrigerated. It is used to prepare the functional beverage composition of the present invention.

Although the composition ratio is prepared by mixing ingredients suitable for relatively favorite beverages in a preferred embodiment, the mixing ratio may be arbitrarily modified according to regional and national preferences such as demand class, demanding country, and use.

Claims (7)

a first mixed extract obtained by extracting a mixture consisting of thistle and dandelion; and a second mixed extract obtained by extracting a mixture consisting of pork potato, onion, currant mulberry, bitter melon, aronia and ginger; As an active ingredient,
The first mixed extract and the second mixed extract is a food composition for preventing or improving diabetes, characterized in that it is mixed in a weight ratio of 1:1-5. The food composition for preventing or improving diabetes according to claim 1, wherein the first mixed extract is an extract extracted at 80 to 100°C by mixing 25 to 55 parts by weight of dandelion with respect to 100 parts by weight of milk thistle. According to claim 1, wherein the second mixed extract is pork potato, onion, mulberry tree, bitter gourd, aronia and ginger in a weight ratio of 1: 0.8-1.2: 0.1-0.8: 0.1-0.8: 0.1-0.8: 0.01-0.05 A food composition for preventing or improving diabetes, characterized in that the extract is mixed with and extracted at 80 to 100 °C. delete The food composition for preventing or improving diabetes according to claim 1, wherein the milk thistle is a mixture of flowers, stems and leaves, and roots of thistle in a weight ratio of 1:14-25:0.1-0.9. (A) obtaining a first mixed extract by mixing and extracting milk thistle and dandelion;
(B) obtaining a second mixed extract by mixing and extracting pork potato, onion, mulberry tree, bitter gourd, aronia and ginger; and
(C) mixing the first mixed extract and the second mixed extract;
The first mixed extract and the second mixed extract is a method of manufacturing a food composition for preventing or improving diabetes, characterized in that it is mixed in a weight ratio of 1:1-5. a first mixed extract obtained by extracting a mixture consisting of thistle and dandelion; and a second mixed extract obtained by extracting a mixture consisting of pork potato, onion, currant mulberry, bitter melon, aronia and ginger; As an active ingredient,
The first mixed extract and the second mixed extract is a pharmaceutical composition for preventing or treating diabetes, characterized in that it is mixed in a weight ratio of 1:1-5.