Pharmaceutical composition comprising the extract of acer pseudosieboldianum as an effective component for prevention or treatment of diabetes and health functional food comprising the same

Abstract

The present invention relates to an antidiabetic composition containing an extract of Acer pseudosieboldianum, and more specifically, to a pharmaceutical composition and a health functional food for the prevention, treatment, or improvement of diabetes containing, as an active ingredient, a hot water extract or an ethanol extract of Acer pseudosieboldianum leaves having potent α-glucosidase inhibitory activity. As demonstrated by the examples in this specification, the hot water extract and ethanol extract of Acer pseudosieboldianum leaves having antidiabetic activity of the present invention have excellent effects that allow them to be used as pharmaceuticals and health functional foods for the prevention, treatment, or improvement of diabetes. Furthermore, the Acer pseudosieboldianum leaf extract of the present invention has excellent thermal stability and does not exhibit loss of starch-degrading enzyme inhibitory activity even under acidic conditions of pH 2, so it can be easily processed into various forms such as liquid, cream, powder, pills, and tablets, making it highly useful for the pharmaceutical and food industries.

Description

Technology Field

[0001] The present invention relates to a Japanese maple tree ( Acer pseudosieboldianum The present invention relates to an antidiabetic composition containing an extract, and more specifically, to a pharmaceutical composition and health functional food for the prevention or treatment / improvement of diabetes containing a hot water extract or ethanol extract of Japanese maple leaves having strong α-glucosidase inhibitory activity as an active ingredient. Background Technology

[0002] Diabetes mellitus, one of the most common diseases among modern people, is a type of metabolic disease characterized by high blood glucose levels, such as insufficient insulin secretion or failure to function normally, and causes various symptoms and signs due to hyperglycemia.

[0003] Diabetes is classified into Type 1 and Type 2. Type 1 diabetes is caused by the inability to produce any insulin due to genetic factors, while Type 2 diabetes is known to be caused by insulin resistance resulting from impaired insulin function. In particular, environmental factors such as high-calorie, high-fat, and high-protein diets resulting from the Westernization of eating habits, lack of exercise, and stress are known to play a significant role in Type 2 diabetes.

[0004] For the treatment of diabetes, insulin injections are essential for Type 1 diabetes, while lifestyle modifications and drug therapy are necessary for Type 2 diabetes; representative medications used include insulin secretagogues (e.g., repaglinide, mitiglinide) and carbohydrate absorption delayers in the small intestine [Glucobay: active ingredient - acarbose; Basen: active ingredient - voglibose].

[0005] Meanwhile, the Japanese maple ( Acer pseudosieboldianumAcer palmatum is a deciduous broad-leaved tree belonging to the genus Acer in the family Aceraceae, and its origin is known to be Korea, China, and Russia. In Korea, it is the most commonly seen tree among maple species and is also called the mountain maple. It is highly resistant to cold and shows good growth in areas with moderate moisture rather than dry places, and is widely distributed in mountainous areas between 100 and 1,700 meters above sea level.

[0006] Studies related to the Japanese maple include the activity in improving benign prostatic hyperplasia (Son Se-yeon, 2024, Master's thesis, Chung-Ang University), the cancer cell growth inhibitory activity of ellagitannins derived from the Japanese maple (Yin, Jun, 2020, Ph.D. thesis, Chung-Ang University), and antibacterial activity by inhibition of quorum sensing (Niu K et al., 2017, Indian J Microbiol. 57: 329-338), but to date, no potent α-glucosidase inhibitory activity of the Japanese maple has been reported.

[0007] Patents related to the Japanese maple include Korean registered patent No. 10-2479869, which discloses a composition for the prevention, treatment, or improvement of prostate cancer containing a Japanese maple extract or a fraction thereof; Korean registered patent No. 10-2697085, which discloses an anti-obesity composition using a Japanese maple extract; and Korean registered patent No. 10-1656875, which discloses a quorum detection inhibitor for inhibiting Gram-negative bacteria using a maple extract, a Japanese maple extract, and a Japanese quince extract. Additionally, Korean published patent No. 10-2009-0089951 discloses a method for producing a lactic acid bacteria fermented beverage using the sap of a Japanese maple and the lactic acid bacteria fermented beverage produced therefrom, and Korean published patent No. 10-2017-0091238 discloses an antioxidant composition containing a complex extract of a sugar maple, a Japanese maple, and a Styrax japonica. However, to date, no potent α-glucosidase inhibitory activity of the Japanese maple has been reported. Prior art literature

[0008] Benign prostate hypertrophy improvement effects of phenolic compounds isolated from Acer pseudosieboldianum (Pax) Komarov leaves. Son, Se-yeon, 2024. Master's thesis, Chung-Ang University. The problem to be solved

[0009] The present invention has been devised to solve the problems of the prior art as described above, and the problem to be solved by the present invention is the Japanese maple ( Acer pseudosieboldianum The present invention provides an antidiabetic composition containing a leaf extract as an active ingredient. means of solving the problem

[0010] In order to solve the above problems, the present invention relates to a Japanese maple tree ( Acer pseudosieboldianum Provides a pharmaceutical composition for the prevention or treatment of diabetes containing an extract as an active ingredient.

[0011] The above Japanese maple tree ( Acer pseudosieboldianum ) extract is Japanese maple ( Acer pseudosieboldianum It is preferable that the extract be a hot water extract or an ethanol extract of the leaf.

[0012] In addition, the present invention relates to a Japanese maple tree ( Acer pseudosieboldianum Provides a health functional food for the prevention or improvement of diabetes containing ) extract as an active ingredient.

[0013] The above Japanese maple tree ( Acer pseudosieboldianum ) extract is Japanese maple ( Acer pseudosieboldianum It is preferable that the extract be a hot water extract or an ethanol extract of the leaf. Effects of the invention

[0014] As demonstrated by the examples in this specification, the hot water extract and ethanol extract of the leaves of the Japanese maple tree having antidiabetic activity according to the present invention have excellent effects that allow them to be used as pharmaceuticals and health functional foods for the prevention or treatment / improvement of diabetes. Furthermore, the Japanese maple leaf extract of the present invention has excellent thermal stability and does not exhibit loss of starch-degrading enzyme inhibitory activity even under acidic conditions of pH 2, so it can be easily processed into various forms such as liquid, cream, powder, pills, and tablets, making it very useful for the pharmaceutical and food industries. Specific details for implementing the invention

[0015] The present invention will be described in detail below.

[0016] In order to verify the antidiabetic efficacy of native Korean plants, the inventors of the present invention prepared various plant extracts by a specific method and evaluated their α-glucosidase inhibitory activity and antioxidant activity, thereby confirming strong antidiabetic activity in the extract of the Japanese maple tree. They recovered the hot water extract and 70% ethanol extract of the leaves of the Japanese maple tree as antidiabetic active components, and by confirming that the extracts exhibited excellent thermal stability and acid stability while showing no hemolytic activity against human red blood cells, they intended to utilize the extracts as an antidiabetic composition.

[0017] Specifically, in order to develop an antidiabetic active ingredient from the Japanese maple tree, the inventors prepared a hot water extract and a 70% ethanol extract from the leaves and evaluated their inhibitory activity against α-glucosidase. As a result, they confirmed a strong α-glucosidase inhibitory activity of 15.6–21.2% at a concentration of 2 mg / ml.

[0018] Therefore, the present invention relates to a Japanese maple tree ( Acer pseudosieboldianum Provides a pharmaceutical composition for the prevention or treatment of diabetes containing an extract as an active ingredient.

[0019] The above-mentioned Japanese maple extract is preferably a hot water extract or an ethanol extract of Japanese maple leaves.

[0020] In addition, the present invention relates to a Japanese maple tree ( Acer pseudosieboldianum Provides a health functional food for the prevention or improvement of diabetes containing ) extract as an active ingredient.

[0021] The above-mentioned Japanese maple extract is preferably a hot water extract or an ethanol extract of Japanese maple leaves.

[0022] Below, the method for preparing the Japanese maple extract of the present invention and efficacy experiments are described in more detail.

[0023] The present invention comprises the steps of: preparing a Japanese maple leaf sample; preparing a hot water extract and a 70% ethanol extract from the sample; evaluating the antidiabetic activity of the extracts; and evaluating the stability and human erythrocyte hemolytic activity of the active extracts.

[0024] The "Japanese maple" extract included in the composition of the present invention can be obtained by the steps of: recovering a mature Japanese maple leaf sample; removing foreign substances from the recovered sample and extracting with a solvent; and filtering the extract using a filter mesh of 0.06 mm or less and concentrating it under reduced pressure.

[0025] The solvent used in the present invention may be water (cold water, hot water), ethanol, anhydrous or hydrated lower alcohols having 1 to 4 carbon atoms (methanol, ethanol, ethanol, propanol, butanol, etc.), a mixed solvent of the lower alcohol and water, and hot water and 70% ethanol extraction are most preferred.

[0026] In addition, the above hot water or ethanol extract can be fractionated sequentially or separately with organic solvents of hexene, ethyl acetate, and butanol to additionally obtain a hexene fraction, an ethyl acetate fraction, a butanol fraction, and a water residue.

[0027] The Japanese maple extract of the present invention can be prepared into a powder through conventional pulverization processes such as vacuum drying, freeze-drying, or spray drying. These are not degraded by various degrading enzymes in plasma and maintain their activity even under heat treatment at 100°C and at a pH of 2 in the human stomach.

[0028] The Japanese maple extract of the present invention exhibits strong enzyme inhibitory activity against α-glucosidase, and can be used as a material for pharmaceutical compositions and health functional foods related to the prevention, treatment, or improvement of diabetes complications such as type 1 diabetes, type 2 diabetes, diabetic retinopathy, and diabetic nephropathy.

[0029] As a preferred embodiment, the antidiabetic composition of the present invention can be applied as a pharmaceutical composition.

[0030] A pharmaceutical composition containing the active ingredient of the present invention can be formulated into various forms according to conventional methods to suit each intended use, such as oral formulations like powders, granules, tablets, capsules, suspensions, emulsions, syrups, and aerosols, and injectable formulations like sterile injectable solutions, and can be administered orally or through various routes including intravenous, intraperitoneal, subcutaneous, rectal, and local administration.

[0031] These pharmaceutical compositions may additionally include carriers, excipients, or diluents, and examples of suitable carriers, excipients, or diluents that may be included include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, amorphous cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil. Additionally, the pharmaceutical compositions of the present invention may additionally include fillers, anticoagulants, lubricants, wetting agents, fragrances, emulsifiers, preservatives, etc.

[0032] As a preferred embodiment, solid formulations for oral administration include tablets, pills, powders, granules, capsules, etc., and these solid formulations are formulated by mixing at least one excipient, such as starch, calcium carbonate, sucrose, lactose, gelatin, etc., with the above pharmaceutical composition. In addition, in addition to simple excipients, lubricants such as magnesium stearate, talc, etc. may be used.

[0033] As a preferred embodiment, oral liquid formulations may be exemplified as suspensions, liquid formulations, emulsions, syrups, etc., and may include various excipients in addition to commonly used simple diluents such as water and liquid paraffin, such as humectants, sweeteners, flavorings, preservatives, etc.

[0034] As a preferred embodiment, formulations for parenteral administration may be exemplified as sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized agents, suppositories, etc. Non-aqueous solvents and suspensions may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters such as ethyl oleate, etc. Injectables may include conventional additives such as solubilizers, isotonic agents, suspending agents, emulsifiers, stabilizers, preservatives, etc.

[0035] The active ingredient of the present invention is administered in a pharmaceutically effective amount. In the present invention, "pharmaceutically effective amount" refers to an amount sufficient to treat a disease with a reasonable benefit / risk ratio applicable to medical treatment, and the effective dose level may be determined based on factors including the type and severity of the patient's disease, drug activity, sensitivity to the drug, time of administration, route of administration and elimination rate, duration of treatment, concurrently used drugs, and other factors well known in the medical field. The pharmaceutical composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, may be administered sequentially or simultaneously with conventional therapeutic agents, and may be administered as a single or multiple doses. It is important to administer an amount that obtains maximum effect with a minimum amount without side effects, taking all of the above-mentioned factors into consideration, and this can be easily determined by a person skilled in the art.

[0036] As a preferred embodiment, the effective amount of the active ingredient in the pharmaceutical composition of the present invention may vary depending on the patient's age, gender, and body weight, and generally, 1 to 5,000 mg, preferably 100 to 3,000 mg per kg of body weight, may be administered daily or every other day, or divided into 1 to 3 doses per day. However, since the dosage may be increased or decreased depending on the route of administration, severity of the disease, gender, body weight, age, etc., the above dosage does not limit the scope of the present invention in any way.

[0037] The pharmaceutical composition of the present invention may be administered to a subject via various routes. Any mode of administration may be anticipated, for example, by oral, rectal or intravenous, intramuscular, subcutaneous, intradural, or intracerebroventricular injection.

[0038] In the present invention, "administration" means providing a specific substance to a patient by any appropriate method, and the route of administration of the pharmaceutical composition of the present invention may be oral or parenteral through any general route capable of reaching the target tissue. Additionally, the composition of the present invention may be administered using any device capable of delivering the active ingredient to target cells.

[0039] In the present invention, "object" includes, but is not specifically limited to, humans, monkeys, cattle, horses, sheep, pigs, chickens, turkeys, quails, cats, dogs, mice, rats, rabbits, or guinea pigs, and preferably means mammals, more preferably humans.

[0040] As another preferred embodiment, the antidiabetic composition of the present invention can be applied for use in health functional foods.

[0041] The health functional food of the present invention can be used in various ways, such as in foods and beverages, that are effective in preventing or improving diabetes. Foods containing the active ingredients of the present invention include, for example, various types of food, beverages, chewing gum, tea, vitamin complexes, health supplements, etc., and can be used in the form of powder, granules, tablets, capsules, or beverages.

[0042] The active ingredient of the present invention can generally be added in an amount of 0.01 to 15% by weight of the total food weight, and the health drink composition can be added in a ratio of 0.02 to 10g, preferably 0.3 to 1g, based on 100ml.

[0043] In addition to containing the above compound as an essential component in the indicated proportions, the health functional food of the present invention may contain food-grade acceptable food additives, such as natural carbohydrates and various flavoring agents, as additional components.

[0044] Examples of the above natural carbohydrates include monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, and polysaccharides such as dextrin and cyclodextrin, as well as common sugars and sugar alcohols such as xylitol, sorbitol, and erythritol.

[0045] As the above flavoring agents, natural flavoring agents such as stevia, thaumatin, rebaudioside A, or glycyrrhizin, and synthetic flavoring agents such as saccharin and aspartame may be used. The ratio of the above natural carbohydrates is generally about 1 to 20g, preferably about 5 to 12g, per 100ml of the health functional food of the present invention. In addition to the above, the health functional food of the present invention may contain various nutritional supplements, vitamins, minerals, flavoring agents such as synthetic and natural flavoring agents, coloring agents and thickening agents, pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohol, carbonating agents used in carbonated beverages, etc. Furthermore, the health functional food of the present invention may contain fruit pulp for the production of natural fruit juices, fruit juice beverages, vegetable beverages, etc. These ingredients may be used independently or in combination. The proportion of such additives is generally selected in the range of 0.01 to about 20 parts by weight per 100 parts by weight of the active ingredient of the present invention.

[0046] The present invention will be explained in more detail below through specific embodiments. The details described in the following embodiments describe a preferred embodiment of the present invention, and the scope of the present invention is not to be interpreted as being limited by the details described in the following embodiments.

[0047] [Example]

[0048] Example 1: Preparation of extract of Japanese maple leaves

[0049] The hot water extract and 70% ethanol extract of the leaves of the Japanese maple used in the present invention were obtained from the Freshwater Biological Resources Bank (FBCC) of the Resource Banking Department at the National Nakdong River Biological Resources Center, and sample information is shown in Table 1. To prepare the extracts, the leaves of the Japanese maple were collected, foreign substances were removed, and they were dried. The dried powder was extracted twice with 10 times its weight in 70% by weight ethanol at room temperature for 24 hours, and the filtrate filtered through a Whatman No. 2 was concentrated using a rotary vacuum evaporator (EYELA, Japan) and freeze-dried to produce the ethanol extract. Meanwhile, 20 times its weight in distilled water was added to the dried powder of the leaves, extracted at 100°C for 1 hour, and the filtrate filtered through a Whatman No. 2 was concentrated using a rotary vacuum evaporator (EYELA, Japan) and freeze-dried to produce the hot water extract. The prepared extract was dissolved in DMSO to a concentration of 20 mg / ml. The sample used is disclosed in the Freshwater Biological Resources Bank.

[0050] [Table 1] Information on the Japanese maple extract used in the present invention

[0051]

[0052] Example 2: Analysis of Total Polyphenol Content in Japanese Maple Leaf Extract

[0053] The total polyphenol content of the Acer palmatum extract prepared in Example 1 was measured, and the results are shown in Table 2. The hot water and ethanol extracts of Acer palmatum leaves exhibited very high total polyphenol content ranging from 59.8 to 60.2 mg / g. Since polyphenol components in plants are associated with various beneficial physiological activities such as antioxidant, anti-diabetic, and anti-inflammatory effects, this high total polyphenol content of Acer palmatum leaves suggests the beneficial physiological activities of Acer palmatum. The total polyphenol content was analyzed by adding 50 μl of Folin-Ciocalteau and 100 μl of saturated Na2CO3 solution to 400 μl of the extract solution, leaving it at room temperature for 1 hour, and measuring the absorbance at 725 nm. Tannic acid was used as the standard reagent.

[0054] [Table 2] Analysis of total polyphenol content of the Japanese maple extract used in the present invention

[0055]

[0056] Example 3: Evaluation of Antidiabetic Activity of Various Maple Extracts

[0057] The antidiabetic activity of the Acer palmatum extract prepared in Example 1 was evaluated, and the α-glucosidase inhibitory activity was evaluated and presented. The α-glucosidase inhibitory activity was evaluated using pNPG (p-nitrophenol glucoside; Sigma Co., USA). 2.5 μl of the Acer palmatum leaf extract sample was mixed with 25 μl of α-glucosidase (0.25 U / ml) diluted with 50 mM Sodium acetate buffer (pH 5.6) and subjected to a first reaction at 37°C for 10 minutes. Then, 25 μl of a 1 mM pNPG solution was added and subjected to a second reaction at 60°C for 10 minutes. Afterward, the reaction was stopped by adding 25 μl of 1 M NaOH, and the inhibition rate was calculated by measuring the absorbance at 405 nm.

[0058] Inhibition rate (%) = [1 - (Enzyme activity of sample group / Enzyme activity of control group)] x 100

[0059] [Table 3] Antidiabetic activity of Japanese maple extract

[0060]

[0061] As a result, as shown in Table 3, acarbose, which is used as a treatment for diabetes in clinical practice, exhibited potent α-glucosidase inhibitory activity in a concentration-dependent manner. The Japanese maple leaf extract of the present invention showed excellent α-glucosidase inhibitory activity at a concentration of 2 mg / ml, and the 70% ethanol extract showed stronger inhibition (21.2%) than the hot water extract. Since α-glucosidase inhibitory activity plays a key role in antidiabetic activity, it was confirmed that the Japanese maple leaf extract can be used for the prevention and treatment of type 2 diabetes.

[0062] Example 4: Evaluation of the antioxidant activity of Japanese maple extract

[0063] Since polyphenol components of natural products are closely related to antioxidant activity and diabetes and oxidative stress are also closely related (Lim, 1998. Diabetes 22: 249-252, Diabetes and Oxidative Stress; Kim, 2008, Diabetes and Oxidative Stress: Generation and Role of ROS by Mitochondria and NAD(P)HOxidase Korean Diabetes 32: 389-398), the antioxidant activity of Acer palmatum extracts was evaluated, and the results are shown in Table 4. At this time, the extracts were dissolved in DMSO (dimethylsulfoxide) and diluted to an appropriate concentration to measure DPPH (1,1-diphenyl-2-picryl hydrazyl) anion radical scavenging activity, ABTS [2,2-azobis(3-ethylbenzo thiazoline-6-sulfonate)] cation radical scavenging activity, nitrite scavenging activity, and reducing power. First, for DPPH scavenging activity, 2 x 10⁶ dissolved in 99.5% ethanol were added to 20 μl of samples diluted to various concentrations. -4380 μl of M DPPH solution was added and mixed, and the mixture was reacted at 37°C for 30 minutes. Subsequently, the absorbance was measured at 516 nm using a microplate reader (Asys Hitech, Expert96, Asys Co., Austria). DPPH radical scavenging activity was expressed as a percentage of the sample-added group versus the sample-free group. For ABTS scavenging activity, 5 ml of 7 mM ABTS (Sigma Co., USA) and 88 ml of 140 mM potassium persulfate were mixed and exposed to light at room temperature for 16 hours to form ABTS cations. The solution was then diluted with ethanol until the absorbance value at 414 nm was 1.5. 190 ml of the prepared diluted solution was mixed with 10 ml of samples prepared at various concentrations, reacted at room temperature for 6 minutes, and the absorbance was measured at 734 nm. The ABTS radical scavenging activity was then calculated using the following formula.

[0064]

[0065] Meanwhile, for the measurement of nitrite scavenging activity, the sample solution was added to a nitrite solution (1 mM), and 0.1 N HCl was added to adjust the pH to 1.2. After reacting at 37°C for 1 hour, Griess reagent (Sigma Co., USA) was added and mixed. Subsequently, the amount of residual nitrite was determined by measuring the absorbance at 520 nm after leaving the solution at room temperature for 15 minutes. The nitrite scavenging activity (%) was calculated using the following formula.

[0066]

[0067] For the evaluation of reducing power, a modified method of Oyaizu et al. (Ahn et al., 2011. J. Life Sci. 21: 576-583) was used. To 2.5 ml of the sample dissolved in ethanol, 2.5 ml of 0.2 M sodium phosphate buffer (pH 6.6) and 2.5 ml of 10% potassium ferricyanide were added and reacted at 50°C for 20 minutes. Afterward, 2.5 ml of 10% trichloroacetic acid was added to terminate the reaction, and the supernatant was collected by centrifuging at 4000 rpm for 10 minutes. The collected supernatant was diluted twofold with distilled water, mixed with a freshly prepared 0.1% ferric chloride solution at a ratio of 5:1 (v / v), and evaluated by measuring the absorbance at 700 nm.

[0068] [Table 4] Antioxidant activity of the Japanese maple extract of the present invention

[0069]

[0070] As shown in Table 4, vitamin C used as a control exhibited very strong antioxidant activity at a concentration of 0.05 mg / ml, showing 88.4% DPPH anion scavenging activity, 89.7% ABTS cation scavenging activity, 88.9% nitrite scavenging activity, and a reducing power of 2.207. The prepared Japanese maple extract also showed excellent antioxidant activity, and in particular, the hot water extract showed excellent active radical scavenging activity and reducing power. Therefore, it is judged that the strong antioxidant activity of the hot water and ethanol extracts of Japanese maple leaves will contribute to the antidiabetic activity of the present invention.

[0071] Example 5: Human erythrocyte hemolytic activity of Japanese maple extract

[0072] To evaluate the potential for acute toxicity of the Acer palmatum extract, human erythrocyte hemolytic activity was assessed. Hemolytic activity was evaluated according to previous reports (Son Ho-yong, 2014 · Korean J. Microbiol. Biotechnol. 42: 285-292). Simply put, 100 μl of human erythrocytes washed three times with PBS were placed in a 96-well microplate, 100 μl of sample solutions of various concentrations were added, and the mixture was reacted at 37°C for 30 minutes. Afterward, the reaction mixture was centrifuged (1,500 rpm) for 10 minutes, and 100 μl of the supernatant was transferred to a new microtiter plate. The degree of hemoglobin leakage due to hemolysis was then measured at 414 nm. DMSO (2%) was used as the solvent control for the samples, and Triton X-100 (1 mg / ml) was used as the experimental control for erythrocyte hemolysis. Hemolytic activity was calculated using the following formula.

[0073]

[0074] As shown in Table 5, DMSO and water used as controls showed no hemolytic activity, and it was confirmed that Triton X-100 lysed 100% of red blood cells at a concentration of 1 mg / ml. In addition, it was confirmed that amphotericin B, which is used as an anticancer and antifungal agent, lysed more than 50% of red blood cells at a concentration of 0.025 mg / ml.

[0075] Meanwhile, the hot water and ethanol extracts of Acer palmatum leaves did not exhibit erythrocyte hemolysis up to a concentration of 1 mg / ml, confirming that there is no acute toxicity or erythrocyte hemolytic activity. These results suggest that the hot water and ethanol extracts of Acer palmatum leaves of the present invention exhibit antidiabetic activity without erythrocyte hemolytic activity, and thus can safely replace antidiabetic drugs that cause side effects, such as acarbose, in the future.

[0076] [Table 5] Human erythrocyte hemolytic activity of the Japanese maple leaf extract of the present invention

[0077]

[0078] Example 6: Evaluation of Plasma, Acid, and Thermal Stability of Japanese Maple Leaf Extract

[0079] Plasma stability, heat stability, and acid stability regarding antidiabetic activity were confirmed for the hot water extract and ethanol extract of the Japanese maple leaves obtained in Example 1 above. The hot water extract and ethanol extract of the Japanese maple leaves did not show a decrease in α-glucosidase inhibitory activity even when heat-treated at 100°C for 1 hour, treated at pH 2 (0.01M HCl) for 1 hour, or treated in plasma for 1 hour. Therefore, it was confirmed that the hot water extract and ethanol extract of the Japanese maple leaves contain antidiabetic active substances with acid and heat resistance, and thus confirmed that there is a high possibility of practical use as an antidiabetic food or pharmaceutical material in the future.

Claims

Claim 1 Japanese maple ( Acer pseudosieboldianum A pharmaceutical composition for the prevention or treatment of diabetes containing an extract as an active ingredient. Claim 2 In Article 1, the above-mentioned Japanese maple ( Acer pseudosieboldianum ) extract is Japanese maple ( Acer pseudosieboldianum A pharmaceutical composition characterized by being a hot water extract or ethanol extract of a leaf. Claim 3 A health functional food for the prevention or improvement of diabetes containing the active ingredients described in Paragraph 1 or 2.

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