KR102233672B1 - A composition for improving, preventing and treating of diabetes mellitus comprising Milk thistle and Helianthus tuberosus - Google Patents

Abstract

The present invention relates to a composition for preventing, treating or improving diabetes. By containing a mixture containing thistle, pork potato, onion and bitter gourd as an active ingredient, it has excellent antidiabetic effect and is not toxic, so it can be ingested in the form of food. In the long term, diabetes can be improved, prevented, or treated through daily diet and lifestyle.

Description

A composition for improving, preventing and treating of diabetes mellitus comprising Milk thistle and Helianthus tuberosus}

The present invention relates to a composition for preventing, treating or improving diabetes containing a mixture comprising thistle, pork potato, onion and bitter gourd as an active ingredient.

Diabetes mellitus is a disease in which hyperglycemia occurs because the cells in the body cannot use sugar due to decreased insulin secretion or decreased insulin function. In the case of diabetes, due to an imbalance of hormones including insulin, it exhibits characteristic symptoms of hyperglycemia due to abnormal physiological metabolic control functions such as metabolism of proteins, lipids and electrolytes including carbohydrates.If such symptoms of hyperglycemia persist, blood circulation disorders, retinal damage, nerve cell damage, It causes poor kidney function and vascular complications, and leads to serious chronic complications.

The diabetes is usually divided into insulin-dependent diabetes (type I diabetes) and insulin-independent diabetes (type II diabetes). Insulin-dependent diabetes mellitus is caused by viral infection, and as a result of destruction of pancreatic beta cells, insulin is not secreted. It is named because it is difficult to maintain life.

Insulin-independent diabetes mellitus is also called adult-type diabetes because insulin is secreted from beta cells of the pancreas due to obesity and the like. It is called insulin-independent diabetes because it is not necessary to supply insulin from the outside in order to maintain life, but this does not mean that insulin treatment is not necessary for the treatment of hyperglycemia.

Diabetes treatment includes biguanides, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and α-glucosidase inhibitors. Diabetes treatment with drugs has many side effects, and the World Health Organization (WHO) strongly recommends the use of natural products with fewer side effects for diabetes (Grover JK, Vats. V., Rathi. SS, Journal of Ethnopharmacology, 73 , pp461-470, 2000).

Natural products suggested to be effective in treating diabetes include Coxibustion extract (Republic of Korea Registration Patent No. 464815), aplanaic acid derivative compound isolated from the chinensis mushroom (Republic of Korea Registration Patent No. 457690), and extract of dulcis (Korean registered patent). No. 417287), polysaccharides isolated from Angelica Angelica (International Patent Publication No. 2001-60386), and bile of ruminants (US Patent No. 6451355) may be exemplified.

Korean Patent Registration No. 464815 Korean Patent Registration No. 457690

An object of the present invention is to provide a pharmaceutical composition capable of preventing or treating diabetes by containing a mixture comprising thistle, pork potato, onion and bitter gourd as an active ingredient.

Another object of the present invention is to provide a food composition capable of preventing or improving diabetes by containing a mixture containing thistle, pork potato, onion and bitter gourd as an active ingredient.

The pharmaceutical composition capable of preventing or treating diabetes according to the present invention for achieving the above object may contain a mixture including thistle, pork potato, onion and bitter gourd as an active ingredient.

The mixture may be included in 50 to 80 parts by weight of pork potato, 50 to 80 parts by weight of onion, and 10 to 50 parts by weight of bitter gourd based on 100 parts by weight of thistle.

The pork potatoes and onions may be mixed in a weight ratio of 1: 1-2.

The thistle may be a mixture of flowers of thistle, a mixture of stems and leaves, and a mixed extract in which the roots are mixed in a weight ratio of 1: 14-25: 0.1-0.9, and the mixture of stems and leaves has a stem and leaves of 1:1. It may be mixed at a weight ratio of -4.

The mixed extract of thistle may be a mixture of an extract obtained by mixing the thistle flower, and a mixture of stems and leaves, and extracting the extract in the middle bath at 80 to 100°C, and the extract obtained by extracting the root in the bath at 80 to 100°C.

Powder obtained by drying and pulverizing the remaining residue after the roots are extracted in a bath at 80 to 100° C. may be added to the mixed extract.

In addition, the food composition capable of preventing or improving diabetes of the present invention for achieving the above-described other object may contain a mixture including thistle, pork potato, onion and bitter gourd as an active ingredient.

The composition for preventing, treating or improving diabetes of the present invention has an excellent hypoglycemic effect, so it can be effectively used for the prevention and treatment of diabetes, and because it is not toxic, it can be consumed in the form of food.

The present invention relates to a composition for preventing, treating or improving diabetes containing a mixture containing thistle, pork potato, onion and bitter gourd 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 contains a mixture including thistle, pork potato, onion and bitter gourd as an active ingredient.

Thistle

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

The white-patterned thistle (Silybum marianum (L.) Gaertn.) is a deep, shiny green plant with milky white veins, and is a long, elongated plant divided into root-leaves with wavy patterns and thorns at the edges. It is mainly found in levee fences and in abandoned land. Useful parts of plants are whole herbs, roots, leaves, seeds, and shells, and thistle seeds contain a flavonoid compound known as silymarin. Thistle seed extract contains 70-80% silymarin.

Thistle according to the present invention is a mixed extract of a thistle flower, a mixture of stems and leaves, and a mixture of roots.

The flowers of thistle are purple or red corolla and 19-24 mm in length, and it is preferable to use only those having a length of 10 to 15 mm and not use those with a length longer than that.

In addition, the thistle stem and leaves are used by mixing in a weight ratio of 1: 1-4, preferably in a weight ratio of 1: 2-3. When the content of leaves is less than the lower limit based on the stem, the bitter taste may be strong, and when the content of the leaves is greater than the upper limit, it is not preferable for preventing, treating, or improving diabetes.

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

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

The mixed extract of the present invention is an extract extracted in a bath for 20 to 30 hours, preferably 24 to 28 hours at 80 to 100 ℃. If the boiling water 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 tan taste may be strong and the nutrient component may be destroyed. In addition, when the extraction is performed by other methods such as organic solvent extraction other than the water bath extraction, the effect on preventing, treating, or improving diabetes may be insignificant and a strong bitter taste may occur.

Specifically, the mixed extract is mixed with a flower, and a mixture of stems and leaves to extract the middle bath, and the roots are separately extracted with the bath and mixed later. Unlike the present invention, in the case of extracting the water by mixing flowers, a mixture of stems and leaves, and roots, the bitter taste is strong, and the effect on preventing, treating, or improving diabetes may be lowered.

The method for preparing such a mixed thistle extract specifically includes the steps of (A) mixing a mixture of flowers of thistle, and a mixture of stems and leaves, and extracting the extract by boiling water at 80 to 100° C. to obtain an extract; (B) extracting the roots of thistle in a bath at 80 to 100° C. to obtain an extract; And (C) lyophilizing the extracts obtained in steps (A) and (B), respectively, to powder and mix them. In addition, after the step (C), (D) drying and pulverizing the residue extracted in the step (B); And (E) mixing 100 parts by weight of the powder mixed in step (C) with 0.1 to 3 parts by weight of the powder in step (D).

Unlike the above steps (A) and (B), when the bath is extracted by mixing flowers, a mixture of stems and leaves, and roots, the bitter taste is strong, and the effect on preventing, treating or improving diabetes may be lowered. ; When the flowers, the mixture of stems and leaves, and the roots are all extracted in a bath, the yield may decrease.

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

Pork potato

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 wildly in fields or in wild mountains. If you dig under the dry stem, you can find tubers of pork potato, and the flowers blooming in autumn are very attractive. Recently, as it is known to be good for diabetes, more and more farmers harvest or cultivate wild produce and sell it.

In the present invention, after washing the pork potato, it is used after extracting with a hot water for 8 to 15 hours, preferably 10 to 12 hours at 80 to 100°C without removing the skin. This pork potato extract is used in an amount of 50 to 80 parts by weight, preferably 60 to 70 parts by weight, based on 100 parts by weight of thistle.

If the content of pork potato extract is less than the lower limit, the effect of preventing, treating or improving diabetes may be significantly reduced, and if it exceeds the upper limit, the organoleptic is lowered and prevents diabetes than when each substance is used alone. , Treatment or improving effect may be reduced.

onion

The onion contains'allysine', which is an ingredient that gives off a spicy taste, so it has a spicy and sweet taste, and has an antioxidant effect and an effect of lowering blood cholesterol levels.

In the present invention, after removing the outer skin of the onion, only the kernels are extracted and used in a bath for 5 to 10 hours, preferably 6 to 8 hours at 80 to 100°C. This onion extract is used in an amount of 50 to 80 parts by weight, preferably 60 to 70 parts by weight, based on 100 parts by weight of thistle.

When the content of onion extract is less than the above lower limit, the effect of preventing, treating or improving diabetes may be lower than when each substance is used alone, and when it exceeds the upper limit, the effect of preventing, treating or improving diabetes decreases. Can be.

In addition, the pork potato extract and onion extract are mixed in a weight ratio of 1: 1-2, preferably in a weight ratio of 1: 1. If the content of onion extract based on the pork potato extract is less than the lower limit, the effect of preventing, treating or improving diabetes may not be improved, and if it exceeds the upper limit, the bitter taste is strong and the effect of preventing, treating or improving diabetes. May be lower than when each substance is used alone.

Yeoju

The bitter gourd (Momordica charantia Linnaeus) is traditionally widely used for medicinal purposes, but there is a risk of miscarriage when a pregnant woman takes a large amount of bitter gourd. The juice obtained by squeezing leaves is applied to insect bites, stings, burns, small wounds, skin allergies, etc. to relieve itching and leave no scars. Leaf and fruit extracts are used to treat stomach pain, fever, arthritis, diabetes, high blood pressure, cancer, and infectious diseases, and are particularly effective in lowering blood sugar.

In the present invention, the fruit of the bitter gourd is extracted and used in a bath for 5 to 10 hours, preferably 6 to 8 hours at 80 to 100°C. This bitter gourd extract is used in an amount of 10 to 50 parts by weight, preferably 20 to 30 parts by weight, based on 100 parts by weight of thistle.

When the content of the bitter gourd extract is outside the above range, the effect of preventing, treating or improving diabetes may not be improved.

When thistle, pork potato, onion, and bitter gourd are used alone, they exhibit a low efficacy of 1.5 to 20 times compared to the case of using thistle, pork potato, onion, and bitter gourd together.

The form of the composition of the present invention may be prepared in the form of granules, pills, powders, juices, tea bags, and the like.

For example, in the case of manufacturing into granules or pills, powder obtained by lyophilizing the milk thistle extract, pig potato delivery obtained by lyophilizing the extract in the same manner, onion powder, and bitter gourd powder are mixed with water to prepare a dough, and the prepared dough It is molded into granules or rings using water.

As another example, in the case of preparing granules, powders, pills, and juice, the thistle extract, pork potato extract, onion extract, and bitter gourd extract are mixed in the proportions of the present invention, lyophilized to powder, and then the obtained powder is molded. Granules or pills can be obtained.

As another example, in the case of preparing granules, powders, pills, and greens, the milk thistle, pork potato, onion and bitter gourd can be mixed in the proportions of the present invention and then added sugars to obtain green onions, and the milk thistle extract, pork potato Extract, onion extract, and mixed extract of bitter gourd extract can be dried to obtain a powder by drying the concentrate, and the concentrate is partially dried to form granules or rings, and then dried again to obtain complete granules or rings. .

When this method is used, since raw material powder is used, it is not necessary to use substances such as excipients, and an active ingredient can be obtained in a larger amount.

As another example, in the case of manufacturing a tea bag, the powder obtained by lyophilizing the mixed extract of the milk thistle extract, pork potato extract, onion extract, and bitter gourd extract is roasted at 80 to 120° C. in a tea bag.

The mixture containing thistle, pork potato, onion and bitter gourd of the present invention is formulated to administer a mixture containing thistle, pork potato, onion and bitter gourd to animals in a broad sense. Mixed processed products, such as mixed powders of thistle, pork potato, onion and bitter gourd are also meant to be included. Although the experiment was conducted with a mixture of thistle, pork potato, onion, and gourd in the present invention, it is expected to those skilled in the art that the desired effect can be achieved even in the form of a mixed processed product of thistle, pork potato, onion and gourd. will be.

Meanwhile, in the present specification, the term "containing as an active ingredient" means including an amount sufficient to achieve the efficacy or activity of a mixture including thistle, pork potato, onion and bitter gourd. For example, the mixture containing thistle, pork potato, onion and bitter gourd is used at a concentration of 10 to 1500 µg/ml, preferably 100 to 1000 µg/ml. The mixture containing thistle, pork potato, onion, and bitter gourd is a natural product and does not have side effects on the human body even if it is administered in an excessive amount. Therefore, the quantitative upper limit of the mixture containing thistle, pork potato, onion and bitter gourd contained in the composition of the present invention is appropriate for those skilled in the art. It can be carried out by selecting within the 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 adjuvants include excipients, disintegrants, sweeteners, binders, coating agents, expanding agents, lubricants, Lubricating agents or flavoring agents can be used.

For administration, the pharmaceutical composition may contain one or more pharmaceutically acceptable carriers in addition to the above-described active ingredients, and may be preferably formulated into a pharmaceutical composition.

The formulation form of the pharmaceutical composition may be granules, powders, tablets, coated tablets, capsules, suppositories, solutions, syrups, juices, suspensions, emulsions, drops, or injectable solutions. For example, for formulation in the form of tablets or capsules, the active ingredient may be combined with an oral, non-toxic pharmaceutically acceptable inert carrier such as ethanol, glycerol, water, and the like. In addition, if desired or necessary, suitable binders, lubricants, disintegrants and coloring agents may also be included in the mixture. Suitable binders are, but are not limited to, natural sugars such as starch, gelatin, glucose or beta-lactose, corn sweeteners, natural and synthetic gums such as acacia, trackcacanth 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.

Acceptable pharmaceutical carriers for compositions formulated as liquid solutions are sterilized and biocompatible, and include saline, sterile water, Ringer's solution, buffered saline, albumin injection solution, 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 bacteriostatic agents may be added as necessary. In addition, diluents, dispersants, surfactants, binders, and lubricants may be additionally added to prepare injection formulations such as aqueous solutions, suspensions, emulsions, etc., pills, capsules, granules, or tablets.

Further, it can be preferably formulated according to each disease or ingredient using a method disclosed in Remington's Pharmaceutical Science, Mack Publishing Company, Easton PA as an appropriate method in the field.

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, mode of administration, age, weight, sex, pathological condition, food, administration time, route of administration, excretion rate and response sensitivity of the patient, Usually the skilled practitioner 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 dosage 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 carried out by a person skilled in the art. Or it can be prepared by incorporating it into a multi-dose container. In this case, the formulation may be in the form of a solution, suspension or emulsion in an 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 a stabilizer.

In addition, the present invention provides a food composition for preventing, treating or improving diabetes containing a mixture containing thistle, pork potato, onion and bitter gourd 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, confectionery, diet bars, dairy products, meat, chocolate, pizza, ramen, other noodles, gums, ice creams, vitamin complexes, health supplements. Etc.

The food composition of the present invention may include not only a mixture including thistle, pork potato, onion and bitter gourd as an active ingredient, but also ingredients commonly added during food production, for example, proteins, carbohydrates, fats, nutrients. , Seasoning and flavoring agents. Examples of the aforementioned carbohydrates include monosaccharides such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose, oligosaccharides, and the like; And polysaccharides, for example, common sugars such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents, natural flavoring agents [taumatin, 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 made of drinks and beverages, citric acid, liquid fructose, sugar, glucose, acetic acid, malic acid, fruit juice, and various plants in addition to the mixture containing thistle, pork potato, onion and bitter gourd of the present invention It may further include an extract or the like.

The present invention provides a health functional food comprising a food composition for preventing, treating or improving diabetes comprising a mixture comprising the thistle, pork potato, onion and bitter gourd as an active ingredient. Health functional foods are foods prepared by adding a mixture containing thistle, pork potato, onion, and bitter gourd to food ingredients such as beverages, teas, spices, gums, confectionery, etc., or prepared by encapsulation, powdering, suspension, etc. If it does, it means that it has a specific effect on health, but unlike general drugs, it has the advantage of not having side effects that may occur when taking the drug for a long 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 consumed on a daily basis. The amount of the mixture containing thistle, pork potato, onion and bitter gourd in such a health functional food cannot be uniformly regulated depending on the type of health functional food to be targeted, but within the range that does not impair the original taste of the food. It may be added, and is usually 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 health functional foods in the form of pills, granules, tablets or capsules, it is usually added in the range 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 comprising milk thistle, pork potato, onion and bitter gourd for the manufacture of a drug or food for the prevention, treatment or improvement of diabetes. As described above, a mixture containing thistle, pork potato, onion and bitter gourd 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 comprising milk thistle, pork potato, onion and bitter gourd.

The term "mammal" as used herein refers to a mammal that is an object of treatment, observation or experiment, and preferably refers to a human.

The term "effective amount" as used herein 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, which is considered by a researcher, veterinarian, doctor or other clinician, which Includes an amount that induces relief of symptoms of the disease or disorder. It is apparent to those skilled in the art that the effective amount and the number of administrations 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 ingredients 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 condition, sex and diet, time of administration, route of administration and rate of secretion of the composition, duration of treatment, and drugs used concurrently. In the prevention, treatment or improvement method of the present invention, in the case of adults, it is preferable to administer thistle and onion at a dose of 0.001 g/kg to 10 g/kg when administered once to several times a day.

In the treatment method of the present invention, a composition comprising a mixture containing thistle, pork potato, onion and bitter gourd as an active ingredient is oral, rectal, intravenous, intraarterial, intraperitoneal, intramuscular, intrasternal, transdermal, topical, ocular It can be administered in a conventional manner via an intradermal or intradermal route.

Hereinafter, a preferred embodiment is presented to aid in the understanding of the present invention, but it is obvious to those skilled in the art that various changes and modifications are possible within the scope of the present invention and the scope of the technical idea, but the following examples are only illustrative of the present invention, It is natural that such modifications and modifications fall within the scope of the appended claims.

Example 1. Thistle + Pork Potato + Onion + Litchi

Manufacture of thistle

Thistle flower 1 part by weight, a mixture of stem and leaf (stem: leaf = 1:2 weight ratio) 18.6 parts by weight and 45 parts by weight of water were mixed and extracted with water at 95° C. for 24 hours to obtain extract A, and then thistle root 0.4 Part by weight and 45 parts by weight of water were extracted in a bath at 95° C. for 24 hours to obtain extract B, and then freeze-dried to prepare and mix powder A and powder B to prepare a mixed extract powder.

Manufacture of pork potato

10 parts by weight of the washed pork potato was mixed with 40 parts by weight of water without removing the skin, followed by extraction in a boiling water bath at 95° C. for 11 hours to obtain an extract, and then freeze-dried to prepare a porcine potato extract powder.

Manufacture of onions

After mixing 10 parts by weight of the peeled onion and 40 parts by weight of water, the extract was extracted by boiling water at 95° C. for 8 hours, and then freeze-dried to prepare an onion extract powder.

Production of litchi

After mixing 10 parts by weight of the fruit of the washed gourd and 40 parts by weight of water, extract was obtained by extracting in a bath at 95° C. for 7 hours, and then freeze-dried to prepare a gourd extract powder.

Thistle + Pork Potato + Onion + Yeoju

A composition was prepared by mixing 100 parts by weight of the prepared thistle powder, 62.5 parts by weight of pork potato powder, 62.5 parts by weight of onion powder, and 25 parts by weight of bitter gourd powder. At this time, pork potato powder and onion powder were mixed in a weight ratio of 1:1.

Example 2. Addition of thistle root residue

It was carried out in the same manner as in Example 1, but when the thistle powder was prepared, the thistle root was extracted in a bath, and the remaining residue was dried and pulverized to obtain C powder (root residue powder), and the A powder, B powder, and C powder were prepared. Mixing (0.3 parts by weight of C powder based on 100 parts by weight of A powder + B powder) to prepare a mixed thistle extract powder, and then to prepare a composition using this.

Comparative Example 1. Omission of thistle

In the same manner as in Example 1, but omitting thistle and using only pork potato, onion, and bitter gourd, a Jungtang extract was obtained.

Comparative Example 2. Pork potato omission

It was carried out in the same manner as in Example 1, except that pork potatoes were omitted and only thistle, onion, and bitter gourd were used to obtain a Jungtang extract.

Comparative Example 3. Omission of onion

In the same manner as in Example 1, but omitting the onion and using only thistle, pork potato, and bitter gourd, a Jungtang extract was obtained.

Comparative Example 4. Litchi Omit

In the same manner as in Example 1, but omitting the bitter gourd and using only thistle, pork potato and onion to obtain a Jungtang extract.

Comparative Example 5. Weight ratio of pork potato: onion 1:4

In the same manner as in Example 1, a composition was prepared by mixing 100 parts by weight of the prepared thistle powder, 62.5 parts by weight of pork potato powder, 250 parts by weight of onion powder, and 25 parts by weight of bitter gourd powder. At this time, pork potato powder and onion powder were mixed in a weight ratio of 1:4.

<Test Example>

Experimental animals

6-week-old male db/db mice, which are obese and show diabetic symptoms, artificially cause genetic mutations to block the feedback signaling of leptin, thereby causing type 2 diabetes along with excess weight 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. The experimental group db/db mice were randomly assigned 7 mice per each group, one group was given a vehicle (saline), the positive control group was banaba leaf extract (wellis banana) 100 mg/kg, and the experimental group was prepared above. Samples were orally administered at a rate of 2 g/kg at 10 am and 18:00 pm each day (each sample was suspended in saline and added). The breeding conditions of each group are the same as in the preliminary animal experiments, while maintaining in an SPF environment controlled by temperature 22±2 ℃, humidity 55±10%, and contrast at 12 hour intervals, weight and blood sugar at 0, 7, 14, 21 days of administration. A portable blood glucose meter (OneTouch TM, Johnson & Johnson, USA) was used for the change, and the average value was shown for each experimental group.

Blood analysis

After administering each sample to db/db mice for 21 days, blood was collected from animals of each group, centrifuged at 3,000 rpm for 10 minutes, and then 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 mean± standard error, and significance verification was determined using Student's T-test analysis method.

Test Example 1. Measurement of anti-diabetic effect in a type 2 diabetic animal model mouse

In order to confirm the blood glucose lowering effect of the samples of the above example, an experiment was performed in 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. Effects on blood sugar changes

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

Category (Unit: blood sugar mg/dL) 0 days 7 days 14 days 21 days Negative control 351.2 397.4 575.4 599.6 Positive control 363.4 410.5 394.1 372.1 Example 1 360.7 407.4 392.3 375.3 Example 2 358.1 384.5 371.6 361.7 Comparative Example 1 360.4 456.1 463.1 481.1 Comparative Example 2 363.7 448.7 443.6 433.4 Comparative Example 3 362.8 433.8 431.6 431.7 Comparative Example 4 363.5 437.5 432.3 429.9 Comparative Example 5 360.5 421.8 415.6 411.1

As shown in Table 1 above, it was confirmed that the compositions prepared according to Examples 1 and 2 of the present invention exhibited excellent inhibition of blood sugar from 0 to 21 days. In particular, it was confirmed that Example 2 further suppressed blood sugar compared to Example 1.

On the other hand, in the negative control group and Comparative Example 1, blood glucose was not suppressed and increased continuously, and it was confirmed that the blood glucose was not suppressed in Comparative Examples 2 to 5 compared to Examples 1 and 2.

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

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

division Glucose measurement (mg/dL) Negative control 632.1 Positive control 462.5 Example 1 483.4 Example 2 436.9 Comparative Example 1 532.5 Comparative Example 2 520.4 Comparative Example 3 509.8 Comparative Example 4 518.5 Comparative Example 5 502.7

As shown in Table 2 above, it was confirmed that the composition prepared according to Examples 1 and 2 of the present invention reduced glucose compared to the negative control group and Comparative Examples 1 to 5.

As a result of Table 1 and Table 2, the antidiabetic efficacy of the compositions of Examples 1 and 2 could be confirmed.

Test Example 2. Effect on body weight and diet change

The change in body weight was measured twice a week with 7 mice of each experimental group, and the average dietary intake of each experimental group (7 mice) was observed by measuring the dietary intake at 3 days 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 28.4 28.9 29.6 30.2 30.8 31.5 32.1 Positive control 28.3 28.5 29.2 29.9 30.7 31.4 32.2 Example 1 28.3 28.9 29.4 30.0 30.6 31.4 32.2 Example 2 28.5 29.2 30.0 30.8 31.4 32.1 32.6 Comparative Example 1 28.4 29.1 29.8 30.6 31.1 31.8 32.3 Comparative Example 2 28.1 28.7 29.5 30.1 30.9 31.3 32.0 Comparative Example 3 28.3 29.1 29.6 30.2 30.8 31.6 32.1 Comparative Example 4 28.2 28.8 29.6 30.1 30.9 31.4 31.9 Comparative Example 5 28.6 29.1 29.7 30.3 31.0 31.7 32.4

Dietary intake

division
(Unit: g) 7 days 14 days 21 days Negative control 33.4 38.4 38.7 Positive control 33.0 38.3 38.9 Example 1 33.2 38.2 38.3 Example 2 33.3 38.3 38.4 Comparative Example 1 33.0 38.4 38.2 Comparative Example 2 33.1 38.1 38.1 Comparative Example 3 33.4 38.2 38.4 Comparative Example 4 33.2 38.5 38.6 Comparative Example 5 33.1 38.2 38.3

As shown in Tables 3 and 4 above, it was confirmed that the compositions prepared according to Examples 1 and 2 of the present invention gained weight similarly to the negative control group, the positive control group, and Comparative Example 1 endoscopy 5, and the intake amount was similar.

Test Example 3. Acute toxicity test

Acute toxicity experiments were conducted using 6-week-old specific pathogen-free (SPF) SD rats. The compositions of Examples and Comparative Examples were administered orally once at a dose of 100 mg/kg to 2 animals for each group. After administration of the test substance, the animals were observed for mortality, clinical symptoms, and body weight changes, hematological and blood biochemical tests were performed, and autopsies were performed to visually observe the abnormalities of tonic organs and thoracic organs.

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

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

Formulation example One. Powdery Produce

500 mg of mixed extract powder obtained in Example 1

100 mg lactose

10 mg of talc

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

Formulation Example 2. Preparation of tablets

300 mg of mixed extract powder obtained in Example 1

100 mg corn starch

100 mg lactose

2 mg of magnesium stearate

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

Formulation Example 3. Preparation of Capsule

200 mg of mixed extract powder obtained in Example 1

3 mg of crystalline cellulose

14.8 mg lactose

Magnesium stearate 0.2 mg

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

Formulation Example 4. Preparation of injection

600 mg of mixed extract 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

It is prepared with the above ingredients per ampoule according to a conventional injection preparation method.

Formulation Example 5. Preparation of liquid formulation

4 g of mixed extract powder obtained in Example 1

10 g of isomerized sugar

5 g of mannitol

Purified water appropriate amount

According to the usual preparation method of liquid formulations, add and dissolve each component in purified water, add an appropriate amount of lemon scent, mix the above ingredients, add purified water and add purified water to adjust the total to 100 g, then fill in a brown bottle for sterilization. To prepare a liquid.

Formulation Example 6. Preparation of granules

1,000 mg of mixed extract powder obtained in Example 1

The right amount of vitamin mixture

Vitamin A acetate 70 ㎍

1.0 mg of vitamin E

Vitamin B1 0.13 mg

Vitamin B2 0.15 mg

0.5 mg of vitamin B6

Vitamin B12 0.2 ㎍

10 mg of vitamin C

Biotin 10 ㎍

1.7 mg of nicotinic acid amide

Folic acid 50 ㎍

0.5 mg of calcium pantothenate

Suitable amount of inorganic mixture

Ferrous sulfate 1.75 mg

Zinc oxide 0.82 mg

Magnesium carbonate 25.3 mg

Potassium monophosphate 15 mg

Dicalcium phosphate 55 mg

90 mg of potassium citrate

100 mg of calcium carbonate

Magnesium chloride 24.8 mg

The composition ratio of the vitamin and mineral mixture is relatively suitable for granules, but it is possible to arbitrarily modify the mixing ratio. After mixing the above ingredients according to a conventional granule preparation method, the granules And can be used to prepare a health functional food composition according to a conventional method.

Formulation Example 7. Preparation of functional beverage

1,000 mg of mixed extract powder obtained in Example 1

1,000 mg citric acid

100 g oligosaccharides

2 g of plum concentrate

1 g taurine

900 mL total by adding purified water

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

The composition ratio is a mixture of ingredients suitable for a relatively preferred beverage in a preferred embodiment, but the mixing ratio may be arbitrarily modified according to regional and ethnic preferences such as the demand class, the country of demand, and the purpose of use.

Claims (5)

A pharmaceutical composition for preventing or treating diabetes, characterized in that it contains a mixture comprising 50 to 80 parts by weight of pork potato, 50 to 80 parts by weight of onion, and 10 to 50 parts by weight of bitter gourd based on 100 parts by weight of thistle. delete The pharmaceutical for preventing or treating diabetes according to claim 1, wherein the thistle is a mixed extract in which a thistle flower, a mixture of stems and leaves, and roots are mixed in a weight ratio of 1: 14-25: 0.1-0.9 Composition. [4] The pharmaceutical composition for preventing or treating diabetes according to claim 3, wherein a powder obtained by drying and pulverizing the remaining residue after the roots are extracted in a bath at 80 to 100° C. is added to the mixed extract. Food composition for preventing or improving diabetes, characterized in that it contains a mixture comprising 50 to 80 parts by weight of pork potato, 50 to 80 parts by weight of onion and 10 to 50 parts by weight of bitter gourd based on 100 parts by weight of thistle.