KR20210074865A - Pharmaceutical composition for preventing or treating diabetes, including extract of fermented tea leaves - Google Patents

Abstract

The present invention relates to a pharmaceutical composition for preventing or treating diabetes, comprising an extract of fermented tea leaves of Camellia sinensis or a fraction thereof. It was confirmed that an alcohol extract of fermented tea leaves of Camellia sinensis has superior DPPH radical scavenging activity compared to an extract of unfermented Camellia sinensis so as to provide an excellent antioxidant effect, and also has an excellent inhibitory activity of alpha-glucosidase enzyme so as to provide an effect of preventing or treating diabetes. In addition, it was confirmed that an ethyl acetate fraction of the alcohol extract of fermented tea leaves of Camellia sinensis has superior inhibitory activity of the alpha-glucosidase enzyme compared to other fractions thereof. Thus, the extract of fermented tea leaves of Camellia sinensis or a fraction thereof can be used for preventing or treating diabetes.

Description

A pharmaceutical composition for preventing or treating diabetes, comprising an extract of fermented tea leaves {Pharmaceutical composition for preventing or treating diabetes, including extract of fermented tea leaves}

The present invention relates to a pharmaceutical composition for preventing or treating diabetes, comprising an extract of fermented tea leaves.

Diabetes mellitus is a type of metabolic disease such as insufficient insulin secretion or failure to function normally. It is characterized by high blood sugar in which the concentration of glucose in the blood rises. High blood sugar causes various symptoms and signs and excretes glucose in the urine. .

Insulin is made by beta cells of the islets of Langerhans in the pancreas, and is a substance necessary for most cells in the body to use glucose, that is, glucose. In the case of diabetic patients, the ability of body cells to use glucose normally is impaired, blood sugar level increases, and as glucose accumulates in the blood more and more, excess sugar is excreted in the urine.

Diabetes is divided into insulin-dependent diabetes and non-insulin-dependent diabetes according to the secretion and action of insulin. Insulin-dependent diabetes mellitus (type 1 diabetes) is a condition of severe insulin deficiency because the beta cells of the pancreas are destroyed and cannot secrete insulin. In order to prevent ketosis and death, insulin must be supplied regularly from the outside, mainly before adolescence. Because of this, it is called juvenile diabetes. On the other hand, non-insulin-dependent diabetes mellitus (type 2 diabetes), which accounts for more than 90% of all diabetic patients, is a disease induced by abnormal insulin function although the pancreatic beta cells have the ability to secrete insulin.

People with diabetic disease should prevent a sudden rise in blood sugar by allowing the carbohydrates in the food they eat to be absorbed slowly. Alpha-glucosidase enzyme is an enzyme that hydrolyzes oligosaccharides digested with meals in the small intestine into monosaccharides, and this enzyme inhibitor acts to alleviate postprandial blood glucose rise by delaying carbohydrate absorption. Representative examples of such α-glucosidase inhibitors include acarbos and miglitol developed by Bayer in Germany in 1977, and these are developed and marketed as a treatment for diabetes and obesity. is becoming However, if these commercially available blood sugar regulators are continuously used, the effect of suppressing blood sugar rise is strong, but continuous use of these drugs causes hypoglycemic shock, gas generation, and abnormal fermentation of starch-degrading bacteria in the large intestine due to the inflow of undigested starch directly into the large intestine. Side effects such as abdominal distension and diarrhea have been reported.

Therefore, there is a need for a method that can control blood sugar in a safe way with fewer side effects.

Republic of Korea Patent Publication No. 10-2010-0078830

One object of the present invention is to provide a pharmaceutical composition for preventing or treating diabetes comprising an extract of fermented tea leaves of Camellia sinensis or a fraction thereof.

Another object of the present invention is to provide a food composition for preventing or improving diabetes, comprising an extract of fermented tea leaves of Camellia sinensis or a fraction thereof.

As one aspect for achieving the above object, the present invention provides a pharmaceutical composition for preventing or treating diabetes comprising an extract of fermented tea leaves of Camellia sinensis or a fraction thereof.

The tea tree (C amellia sinensis ) is an evergreen shrub belonging to the tea family, which grows to 2-3 m in height and has dense branches from the root tree. The leaves are alternate phyllotaxis with short leaf stems, long oval lanceolates, 2.5-5cm long and 2-3cm wide. Tea leaves contain caffeine, tannins, nitrogen, protein, vitamins A and C, and inorganic salts, which have beneficial pharmacological effects on the human body such as arousal, diuresis, strong heart, detoxification, and recovery from fatigue.

The present invention uses the leaves of the tea tree (C amellia sinensis). Specifically, tea leaves harvested from June to July are used, and fermented tea leaves obtained by fermenting the tea leaves are used. The tea leaves harvested from June to July had high total phenol content and excellent antioxidant activity due to high DPPH radical scavenging activity. Catechin content such as (EC) and epigallocatechin (EGC) is high.

The fermented tea leaves are withered; rubbing step; fermentation step; and a drying step. By the withering step, the moisture content of the tea leaves is reduced to a level of 50 to 70%. The withering step proceeds for 10 to 15 hours. Next, the rubbing step is a process of destroying cell membranes so that various water-soluble components of tea can easily come out in water. The rubbing step is carried out for 20 to 40 minutes. Next, the fermentation step is fermented at 25±2℃ for 100~150 minutes. Next, the drying step is carried out by drying at 90 to 120° C. for 20 to 40 minutes.

As used herein, the term "extract" refers to an extract obtained by extraction treatment, a diluted or concentrated liquid of the extract, a dried product obtained by drying the extract, a prepared or purified product of the extract, or a mixture thereof, such as the extract itself and the extract Contains extracts of all formulations that can be formed using

In the extraction of the present invention, the extraction method is not particularly limited, and extraction may be performed according to a method commonly used in the art.

In the present invention, the extract of fermented tea leaves of the tea tree ( Camellia sinensis _{) is water, C 1} to It can be obtained by extraction with a C _{4 lower alcohol or a mixed solvent thereof.} In addition, the lower alcohol may be ethanol or methanol. More specifically, it may be a 20 to 80% alcoholic extract of fermented tea leaves of the tea tree (Camellia sinensis), and more specifically, a 50% alcoholic extract.

As used herein, the term "fraction" refers to a result obtained by performing fractionation in order to separate a specific component or a specific component group from a mixture including various components.

The fractionation method for obtaining the fraction in the present invention is not particularly limited, and may be performed according to a method commonly used in the art. Non-limiting examples of the fractionation method include a method of obtaining a fraction from the extract by treating an extract of fermented tea leaves of the tea tree (Camellia sinensis) with a predetermined solvent.

The kind of solvent used to obtain the fraction in the present invention is not particularly limited, and any solvent known in the art may be used. Non-limiting examples of the fractionation solvent include water, alcohol having 1 to 4 carbon atoms, hexane, ethyl acetate, butanol, or a mixed solvent thereof.

In an embodiment of the present invention extracts the fermented tea leaves of the tea plant (Camellia sinensis) in 50% (w / v) ethanol was obtained the alcoholic extract of the fermented tea leaves of the tea plant (Camellia sinensis), this n- hexane (n-hexane , Hex), ethyl acetate (ethyl acetate, EtOAc), n-butanol (n-butanol, BuOH), and water (water, H ₂ O) were sequentially fractionated in this order to form a total of four solvent fraction layers, n-hexane and ethyl acetate. , normal butanol, and a fraction of the residual water layer were prepared.

In the present invention, the fraction is a hexane fraction, an ethyl acetate fraction, a butanol fraction or a water fraction.

In addition, it was confirmed that the extract of fermented tea leaves of the tea tree ( Camellia sinensis ) and the hexane fraction, ethyl acetate fraction, butanol fraction, or water fraction of the extract inhibited the activity of the alpha-glucosidase enzyme. In particular, the alcohol extract of fermented tea leaves of Camellia sinensis has superior DPPH radical scavenging activity compared to the extract of unfermented tea tree, and thus has excellent antioxidant effect, and has excellent inhibitory activity of alpha-glucosidase enzyme to prevent diabetes or It was confirmed that the treatment was effective. In addition, it was confirmed that the ethyl acetate fraction of the alcohol extract of fermented tea leaves of Camellia sinensis had superior inhibitory activity of the alpha-glucosidase enzyme compared to the fractions of other solvents. Therefore, the extract of fermented tea leaves of the tea tree ( Camellia sinensis ) or a fraction thereof can be used for preventing or treating diabetes.

In the present invention, the term "diabetes" refers to a type of metabolic disease such as insufficient insulin secretion or failure to function normally, characterized by high blood sugar in which the concentration of blood glucose increases, and various symptoms and signs due to high blood sugar. A disease that causes the excretion of glucose in the urine.

As used herein, the term “prevention” refers to any action that inhibits or delays diabetes. In the present invention, "prevention" means that the sugar concentration in the blood is well controlled to a normal level by administering the extract or a fraction thereof of fermented tea leaves of the tea tree (Camellia sinensis) of the present invention, thereby inhibiting or delaying the progression to diabetes. .

As used herein, the term “treatment” refers to any action for alleviating, ameliorating, or alleviating the symptoms of diabetes. In the present invention, "treatment" means that the sugar concentration in the blood is stably maintained at a normal level by administering the extract or a fraction thereof of fermented tea leaves of the tea tree (Camellia sinensis) of the present invention, thereby alleviating, improving or alleviating the symptoms of diabetes. means that

The pharmaceutical composition comprising the extract or fraction thereof of fermented tea leaves of the tea tree (Camellia sinensis ) of the present invention may further include a suitable carrier, excipient or diluent commonly used in the preparation of the pharmaceutical composition. In this case, the peptide included in the composition is not particularly limited thereto, but may be included in an amount of 0.001 wt% to 99 wt%, preferably 0.01 wt% to 50 wt%, based on the total weight of the composition.

The pharmaceutical composition may have any one formulation selected from the group consisting of tablets, pills, powders, granules, capsules, suspensions, internal solutions, emulsions, syrups, sterile aqueous solutions, non-aqueous solutions, freeze-drying agents, and suppositories, , oral or parenteral formulations may be used. In the case of formulation, it is prepared using diluents or excipients, such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants.

Solid preparations for oral administration include tablets, pills, powders, granules, capsules, etc., and these solid preparations include at least one excipient, for example, starch, calcium carbonate, dextrin or lactose, gelatin. , may be prepared by mixing agar and the like. In addition to simple excipients, lubricants such as magnesium stearate, talc and the like may also be used. Liquid formulations for oral administration include suspensions, internal solutions, emulsions, syrups, etc. In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, lyophilized formulations, and suppositories. Non-aqueous solvents and suspensions may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin, and the like can be used.

The pharmaceutical composition of the present invention may be administered in a pharmaceutically effective amount. As used herein, the term "pharmaceutically effective amount" means an amount sufficient to treat a disease with a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is dependent on the subject's type and severity, age, sex, and disease. It can be determined according to the type, drug activity, drug sensitivity, administration time, administration route and excretion rate, treatment period, factors including concurrent drugs, and other factors well known in the medical field. The composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with conventional therapeutic agents. and may be administered single or multiple. In consideration of all of the above factors, it is important to administer an amount that can obtain the maximum effect with a minimum amount without side effects, and can be easily determined by those skilled in the art.

The pharmaceutical composition of the present invention is not particularly limited as long as it is an individual for the purpose of treating diabetes, and any one is applicable. For example, any of non-human animals such as monkey, dog, cat, rabbit, guinea pig, rat, mouse, cow, sheep, pig, goat, human, bird and fish can be used, and the pharmaceutical composition is parenterally, subcutaneously , intraperitoneal, intrapulmonary and intranasal, and for local treatment, if necessary, by any suitable method including intralesional administration. The preferred dosage of the pharmaceutical composition of the present invention varies depending on the condition and weight of the individual, the degree of disease, the drug form, the route of administration, and the duration, but may be appropriately selected by those skilled in the art. For example, it may be administered by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebrovascular injection, but is not limited thereto.

A suitable total daily amount may be determined by a treating physician within the scope of sound medical judgment, and is generally in an amount of 0.001 to 1000 mg/kg, preferably 0.05 to 200 mg/kg, more preferably 0.1 to 100 mg/kg. The amount of kg can be administered in divided doses from once to several times a day.

In another aspect, the present invention provides a food composition for preventing or improving diabetes, comprising an extract of fermented tea leaves of a tea tree ( Camellia sinensis ) or a fraction thereof.

In the present invention, the terms " Camellia sinensis ", "fermented tea leaves", "extracts", "fractions", and "diabetes" are the same as described above.

The food composition of the present invention may include the form of pills, powders, granules, needles, tablets, capsules or liquids, jellies, liquid jellies, and the like, and extracts of fermented tea leaves of Camellia sinensis of the present invention or fractions thereof There is no particular limitation on the type of food that can be added, and for example, there are various beverages, gum, tea, vitamin complexes, health supplements, and the like.

In the food composition, other ingredients may be added in addition to the extract of fermented tea leaves of Camellia sinensis or a fraction thereof, and the type thereof is not particularly limited. For example, it may contain, as an additional component, various herbal extracts, food-logically acceptable food supplements or natural carbohydrates, such as conventional food, but is not limited thereto.

As used herein, the term "food supplement additive" refers to a component that can be supplementally added to food, and is added to prepare food of each formulation, and those skilled in the art can appropriately select and use it. Examples of food supplement additives include various nutrients, vitamins, minerals (electrolytes), synthetic flavoring agents and flavoring agents such as natural flavoring agents, coloring agents and fillers, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners , pH adjusters, stabilizers, preservatives, glycerin, alcohol, carbonation agents used in carbonated beverages, etc., but the above examples are not limited to the types of food supplement additives of the present invention.

Examples of the natural carbohydrate include monosaccharides such as glucose and fructose; disaccharides such as maltose and sucrose; and polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. Hygin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) may be advantageously used.

The food composition of the present invention may include a health functional food. The term "health functional food" used in the present invention refers to food manufactured and processed in the form of tablets, capsules, powders, granules, liquids, liquid jellies and pills, etc. using raw materials or ingredients useful in the human body. Here, the term "functionality" refers to obtaining useful effects for health purposes, such as regulating nutrients or physiological effects with respect to the structure and function of the human body. The health functional food of the present invention can be prepared by a method commonly used in the art, and at the time of manufacture, it can be prepared by adding raw materials and components commonly added in the art. In addition, unlike general drugs, food is used as a raw material, so there are no side effects that may occur when taking the drug for a long time, and it can be excellent in portability.

The mixed amount of the active ingredient may be appropriately determined according to the purpose of use (prevention, health or therapeutic treatment). In general, when preparing food, the active ingredient of the present invention may be added in an amount of 1 to 50% by weight, preferably 3 to 10% by weight, and more preferably 5% by weight of the raw material composition, but is not limited thereto. However, in the case of long-term ingestion for health and hygiene purposes or for health control, the above amount may be used below the above range.

There is no particular limitation on the type of the food. Examples of foods to which the above substances can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages, tea, drinks, There are alcoholic beverages, liquid jelly, and vitamin complexes, and includes all health functional foods in the ordinary sense.

The present invention relates to a pharmaceutical composition for preventing or treating diabetes, comprising an extract of fermented tea leaves of Camellia sinensis or a fraction thereof.

The alcohol extract of fermented tea leaves of the tea tree ( Camellia sinensis ) has excellent antioxidant effect due to superior DPPH radical scavenging activity compared to the extract of unfermented tea tree, and has excellent inhibitory activity of alpha-glucosidase enzyme to prevent or treat diabetes was confirmed to be effective. In addition, it was confirmed that the ethyl acetate fraction of the alcohol extract of fermented tea leaves of Camellia sinensis had superior inhibitory activity of the alpha-glucosidase enzyme compared to the fractions of other solvents. Therefore, the extract of fermented tea leaves of the tea tree ( Camellia sinensis ) or a fraction thereof can be used for preventing or treating diabetes.

1 shows changes in the total phenol content of tea leaves by harvest time.
Figure 2 shows the antioxidant (DPPH radical scavenging ability) change of tea leaves by harvest time. Antioxidant activity was analyzed by DPPH radical scavenging ability, and the degree was expressed as Vit C eq.mg/g.
3 shows the changes in the content of four catechins in tea leaves by harvest time.
4 shows the α-glucosidase activity inhibitory ability (%) of tea extracts by alcohol content of non-fermented tea and fermented tea.
Figure 5 shows the DPPH radical scavenging ability for each solvent extraction of fermented tea and non-fermented tea. Antioxidant activity was analyzed by DPPH radical scavenging ability, and the degree was expressed as Vit C eq.mg/g.
6 shows the redness a value of the tea extract according to the alcohol content of fermented tea (black tea) and unfermented tea (green tea).
Figure 7 shows the total phenol and flavonoid content of the tea extract according to the alcohol content of the fermented tea.
8 shows the antidiabetic effect (inhibition of α-glucosidase activity) of 50% alcohol extract, silkworm freeze-dried powder, Banaba extract, and acarbose of fermented tea and non-fermented tea.
9 shows the antidiabetic effect of each solvent fraction of the 50% fermented tea extract.
10 shows the antidiabetic efficacy of a fraction obtained by separating an ethyl acetate fraction from a solvent fraction of a 50% alcohol extract of fermented tea into a single substance using HPLC.
11 shows a black tea extract manufacturing process for preparing anti-diabetic liquid jelly in Experimental Example 12.
12 shows the manufacturing process of anti-diabetic liquid jelly in Experimental Example 12.
13 shows the manufacturing process of a liquid jelly prototype in an industry.
14 shows the prepared liquid jelly prototype.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those of ordinary skill in the art can easily carry out the present invention. However, the present invention may be embodied in many different forms and is not limited to the embodiments described herein.

<Example 1> Preparation of fermented tea and preparation of fermented tea extract

Fermented tea leaves were prepared by drying the tea leaves of the tea tree ( Camellia sinensis ) with a wilting moisture content of 60%, rubbing for 30 minutes, fermentation at 25° C. for 120 minutes, and at 120° C. for 25 minutes. Here, water or a solvent with different alcohol content was extracted to prepare fermented tea water extract or fermented tea (black tea) 25%, 50%, 75%, and 100% alcohol extract. As a control, an extract of unfermented unfermented tea (green tea) was prepared in the same manner.

Next, the 50% alcohol extract of the fermented tea was suspended in distilled water and fractionated sequentially according to the polarity order to obtain a total of four solvent fraction layers in the order of hexane, ethyl acetate, butanol and water.

<Experimental Example 1> Comparison of changes in total phenol content in tea leaves by harvest period

The total phenol content of tea leaves by harvest time was high in summer tea leaves harvested from June to July, and was highest in tea leaves in July in particular (Fig. 1).

<Experimental Example 2> Comparison of changes in antioxidant properties (DPPH radical scavenging ability) of tea leaves by harvest period

The antioxidant activity investigated by the DPPH radical scavenging ability of tea leaves by harvest time was high in the summer tea leaves harvested in June-July, and the highest in the tea leaves in July in particular (FIG. 2).

<Experimental Example 3> Comparison of changes in the content of 4 types of catechins in tea leaves by harvest time

As a result of analyzing the catechin content of tea leaves by harvest time using HPLC equipment, the contents of single catechins ECG, EGCG, EC, and EGC were highest in tea leaves harvested in July (FIG. 3).

<Experimental Example 4> Comparison of main characteristics of unfermented tea (green tea) and fermented tea (black tea) using tea leaves

Table 1 shows the results of analyzing the main components of tea by using NIR to manufacture unfermented and fermented teas from tea leaves harvested in May and July, and then grind the pulverized powder with tea leaves in July rather than in May. One tea had a high tannin content.

During the fermented tea manufacturing process, tannins and catechins contained in the original tea leaves are fermented by polyphenol oxidase during rubbing and fermentation to form polyphenol oxidized polymers such as theaflavin and thearubigin, which exhibit redness. , the orange-red component of fermented tea was produced, and the redness a value of tea and tea water increased. Specifically, the tea leaves harvested in July showed the highest redness of 2.5±0.09.

Comparison of main ingredients and characteristics of unfermented tea and fermented tea using summer tea leaves in May and July division tea leaves
harvest time total nitrogen
(%) total amino acids
(%) tannins
(%) chromaticity L value a value (redness) b value unfermented tea
(green tea) In May 5.24 ± 0.01 2.18±0.01 13.08±0.03 48.67±0.17 -6.60±0.05 14.79±.17 In July 4.73±0.00 1.60±0.01 14.10±0.07 47.30±0.16 -6.86±0.00 13.56±0.14 fermented tea
(black tea) In May 5.33±0.01 2.25±0.03 11.10±0.04 39.26±0.08 1.41±0.02 8.29±0.22 In July 4.90±0.02 1.93±0.04 11.44±0.06 39.42±0.09 2.50±0.09 8.53±0.17

* Mean ± standard error

<Experimental Example 5> α-glucosidase activity inhibitory ability (%) of the extract according to the alcohol extraction solvent of non-fermented tea and fermented tea

Summer tea leaves have a high content of tannins and catechins. As the catechins contained in the tea are fermented by polyphenol oxidase, they form an oxidized polymer of theaflavin, giving it an orange-red color. These oxidized polymer components show effective antidiabetic effects. it is known

As described above, it was confirmed that the redness increased due to an increase in the polyphenol oxidized polymer components of theaflavin and thearubigin in fermented tea compared to unfermented tea. As the polyphenol oxidized polymer component increases, α-glucosidase It was found that the activity inhibitory effect was increased, and thus, the antidiabetic effect was significantly greater in the fermented tea than in the unfermented tea (FIG. 4).

<Experimental Example 6> Changes in DPPH radical scavenging activity and antioxidant properties by solvent extraction of fermented and non-fermented tea

In the case of fermented tea, the initial antioxidant activity was lower than that of unfermented tea, and the highest in the 50% alcohol solvent. However, after 2 hours under the same conditions, the antioxidant activity showed higher activity in fermented tea as a result of the DPPH radical scavenging effect, and was higher in 25%, 50%, and 75% of alcohol, especially in the extract of 50% alcohol. was high (Fig. 5).

<Experimental Example 7> Redness a value of tea extract extracted with solvent for each alcohol content of fermented tea and non-fermented tea

In the redness of the fermented tea and non-fermented tea solvent extracts, 25% to 75% of alcohol was high, and in particular, it was highest in the 50% solvent extract of alcohol (FIG. 6). It is considered that this is because the aflavin of fermented tea is contained in a 50% alcohol extract a lot, and it is judged that these components show anti-diabetic efficacy and effective antioxidant and anti-diabetic effects.

<Experimental Example 8> Total phenol and flavonoid content of tea extract extracted with solvent for each alcohol content of fermented tea

The total phenol and flavonoid content of the solvent extract by alcohol content of fermented tea was highest in the solvent extract containing 50% alcohol, which showed a similar trend to the result of the antidiabetic enzyme activity (alpha-glucosidase inhibitory effect). (Fig. 7).

<Experimental Example 9> Comparison of antidiabetic effect (inhibition of α-glucosidase activity) of 50% alcohol extract, silkworm freeze-dried powder, Banaba extract, and acarbose of fermented and unfermented tea

Results of comparing the antidiabetic effect (α-glucosidase activity) of 50% alcohol extract of fermented and non-fermented tea, freeze-dried silkworm powder, Banaba extract, and drug Acarbose, which are known as raw materials to help reduce postprandial blood sugar , Acarbose, a drug, has the best antidiabetic effect, but fermented tea 50% alcohol extract has the highest level of food.

<Experimental Example 10> Evaluation of antidiabetic efficacy by systematic solvent fraction of 50% fermented tea extract

As a result of evaluating the antidiabetic efficacy using the systematic solvent fractions of the 50% fermented tea extract, the ethyl acetate fraction showed the highest alpha-glucosidase activity inhibiting ability at 94.5%, resulting in the highest antidiabetic effect (FIG. 9).

<Experimental Example 11> Antidiabetic efficacy evaluation of fractions separated into single substances using HPLC of ethyl acetate extract among systematic solvent fractions of 50% alcohol extract of fermented tea

Among the HPLC single fractions of the ethyl acetate fraction of 50% alcohol extract of fermented tea, fraction 15 had the highest alpha-glucosidase activity inhibitory ability, and fraction 16 and fraction 12 also exhibited excellent alpha-glucosidase enzyme activity inhibitory ability (FIG. 10). ).

<Experimental Example 12> Manufacture of (anti-diabetic) products for preventing or improving diabetes using 50% fermented tea extract

12-1. Manufacture of black tea (fermented tea) alcohol extract

Black tea (fermented tea) was prepared with 50% alcohol extract according to the manufacturing process shown in FIG.

12-2. Manufacturing process of liquid jelly for preventing or improving diabetes (anti-diabetes)

First, the materials were measured, mixed and heated to homogenize, and after boiling at 100° C. for 20 minutes, 20 g of each was packed in sticks and hardened to prepare a liquid jelly product (FIG. 12).

As shown in Table 2, liquid jelly products were prepared according to the amount of black tea 50% alcohol extract added, and are shown in Table 2. And the sensory evaluation results thereof are shown in Table 3.

Black tea 50% alcohol extract, liquid jelly product primary manufacturing ratio of ingredients by addition amount material Black tea 50% spirit extract 10% 20% 30% 40% 50% Black tea extract 3.5°brix 50 100 150 200 250 Oat dietary fiber extract (g) 3 3 3 3 3 Agar (g) 2 2 2 2 2 Gelatin (g) One One One One One Sodium alginate (g) 0.5 0.5 0.5 0.5 0.5 Enzyme Stevia (g) 0.25 0.25 0.25 0.25 0.25 water (g) 193.25 143.25 93.25 43.25 (-6.75) Total amount (g) 250 250 250 250 256.75

As a result, when 10% of black tea 50% alcohol extract was added, the sensory evaluation result was the best (Table 3).

Sensory evaluation after manufacturing liquid jelly for each amount of black tea 50% alcohol extract added division extract 10% Extract 20% extract 30% extract 40% extract 50% Product Preference 4.2±1.2 3.6±1.4 2.2±0.8 1.4±0.5 1.0±0.0 flavor 3.0±1.3 2.2±1.6 1.2±1.2 0.8±0.8 0.4±0.4 incense 4.8±0.4 4.2±0.4 2.8±0.8 2.0±1.1 1.6±1.2 color 4.2±1.0 4.2±0.4 3.0±0.0 1.6±0.8 1.4±0.8 antidiabetic efficacy 4.8±0.4 4.4±0.5 3.0±0.0 1.6±0.8 1.4±0.8 overall sign 4.2±1.2 3.6±1.4 2.4±0.8 1.2±0.4 1.0±0.0

* 7-point scale method, n=5, mean ± standard deviation

Next, as shown in Table 4, strawberry flavor or lemon flavor was added to the 50% alcohol extract of black tea, and a liquid jelly product was prepared. Tables 4 and 5 show the proportions of ingredients and their sensory evaluation results for the production of liquid jelly products for each amount of black tea 50% alcohol extract added, and strawberry flavor and lemon flavor added.

According to the amount of black tea 50% alcohol extract added and the proportion of ingredients for the manufacture of flavored liquid jelly products material Black tea 50% spirit extract 5% 10% 20% 30% Black tea extract 3.5°brix (g) 50 100 150 200 Oat dietary fiber extract (g) 3 3 3 3 agar (g) 2 2 2 2 Strawberry flavor or lemon flavor (g) 2 2 2 2 Gelatin (g) One One One One Sodium Alginate (g) 0.5 0.5 0.5 0.5 Enzyme Stevia (g) 0.25 0.25 0.25 0.25 water (g) 191.25 141.25 91.25 41.25 Total amount (g) 250 250 250 250

As a result, when strawberry flavor or lemon flavor was added, the sensory evaluation was better compared to the liquid jelly in Table 2 without strawberry flavor or lemon flavor. And strawberry flavor had better sensory evaluation results than lemon flavor, and when flavor was added, the sensory evaluation result was better when 50% alcohol extract of black tea was added, 5% of black tea 50% alcohol extract was added than 10%, when flavor was added. Even better (Table 5).

Sensory evaluation of liquid jelly products by the amount of black tea 50% alcohol extract added and by adding strawberry and lemon flavor division extract 5% extract 10% Extract 20% extract 30% strawberry flavor lemon flavor strawberry flavor lemon flavor strawberry flavor lemon flavor strawberry flavor lemon flavor Product Preference 5.3±1.1 4.89±1.2 5.1±1.3 5.1±0.6 4.1±1.7 4.1±1.7 2.8±1.8 3.0±2.0 color 5.1±1.1 4.4±1.3 4.6±1.3 4.7±1.1 4.8±1.8 4.3±1.7 2.9±1.9 1.8±2.1 strawberry flavor 5.4±0.9 4.2±0.9 4.7±1.6 3.7±1.4 4.1±1.5 3.2±1.6 2.7±1.9 2.3±1.7 flavor 5.0±1.2 4.67±1.2 4.2±1.1 4.3±1.1 3.2±0.9 3.0±1.0 2.0±1.1 2.6±1.7 antidiabetic efficacy 4.9±0.6 4.6±1.0 4.4±1.1 4.7±1.2 4.1±1.1 3.8±1.3 2.8±1.8 2.9±2.1 overall sign 5.3±0.9 4.7±1.1 5.1±1.3 4.6±1.3 3.7±1.6 3.4±1.7 2.4±1.6 2.6±1.9

* 7-point scale method, n=9, mean ± standard deviation

In addition, as shown in Table 6, the content of the 50% alcohol extract of black tea (fermented tea) was further subdivided and adjusted to 3 to 10% to prepare a liquid jelly product and sensory evaluation was performed.

Black tea (fermented tea) 50% by amount of alcohol extract and proportion of ingredients for manufacturing liquid jelly products with strawberry flavor material Black tea 50% spirit extract 3% 5% 7% 10% Black tea extract 3.5° brix (g) 30 50 70 100 Oat dietary fiber extract (g) 5 5 5 5 agar (g) 2 2 2 2 strawberry flavor 2 2 2 2 Gelatin (g) One One One One Sodium Alginate (g) 0.75 0.75 0.75 0.75 Enzyme Stevia (g) 0.25 0.25 0.25 0.25 water (g) 209 189 169 139 Total amount (g) 250 250 250 250

As a result, as shown in Table 7, when 5% of black tea (fermented tea) 50% alcohol extract was added and strawberry flavor was added, the sensory evaluation result was the best compared to other contents.

Sensory evaluation of black tea (fermented tea) 50% alcohol extract and strawberry flavored liquid jelly division extract 3% extract 5% Extract 7% extract 10% Product Preference 4.3±1.5 4.6±1.0 4.7±1.7 4.0±2.1 color 4.4±1.7 5.1±1.3 4.3±1.9 3.9±2.0 incense 4.8±1.3 4.8±1.3 4.3±1.6 3.4±1.6 flavor 5.2±1.4 4.9±1.3 3.7±1.1 3.7±1.9 antidiabetic efficacy 4.2±1.4 5.0±1.2 4.2±1.5 4.0±2.5 overall sign 4.6±0.5 5.1±1.1 4.3±1.1 3.9±1.9

* 7-point scale method, n=9, mean ± standard deviation

12-3. Manufacture of anti-diabetic liquid jelly products using 50% black tea alcohol extract, strawberry flavor and red ginseng extract

Next, a liquid jelly product was prepared as shown in Table 8 by adding a red ginseng extract to the composition of Table 6 above.

According to the amount of black tea 50% alcohol extract added and the proportion of ingredients for manufacturing liquid jelly products with strawberry flavor and red ginseng extract material By adding 50% alcohol extract of black tea 3% 5% 7% 10% Black tea extract 3.5°brix (g) 30 50 70 100 Oat dietary fiber extract (g) 5 5 5 5 agar (g) 5 5 5 5 strawberry flavor 2 2 2 2 Red Ginseng Extract (3°brix) 2 2 2 2 Gelatin (g) One One One One Sodium Alginate (g) 0.75 0.75 0.75 0.75 Enzyme Stevia (g) 0.25 0.25 0.25 0.25 water (g) 204 184 164 134 Total amount (g) 250 250 250 250

* 7-point scale, n=15, mean±standard deviation

Thereafter, sensory evaluation was performed as shown in Table 9. As a result, as shown in Table 9, even when red ginseng extract was added, when 5% of black tea (fermented tea) 50% alcohol extract was added, the sensory evaluation result was the best.

Sensory evaluation of liquid jelly products with added amount of black tea 50% alcohol extract and strawberry flavor and red ginseng extract division extract 3% extract 5% Extract 7% extract 10% Product Preference 5.2±1.3 5.4±1.0 4.3±14 3.9±1.4 color 5.4±0.9 5.4±0.9 4.4±1.2 4.1±1.5 incense 4.6±0.8 5.3±0.9 4.3±1.3 3.7±1.2 flavor 5.0±0.9 5.3±0.8 4.0±1.4 3.2±1.6 antidiabetic efficacy 4.7±1.3 5.3±0.8 4.9±1.3 4.6±1.8 overall sign 5.1±1.3 5.5±0.9 4.4±1.4 4.1±1.5

12-4. Prototype manufacturing in the anti-diabetic liquid jelly product industry

Liquid jelly was prepared in the same way as 12-2 and 12-3, and the mixing ratio of ingredients for manufacturing anti-diabetic liquid jelly product is shown in Table 10.

After mixing in the ratio of Table 10, it was prepared by boiling, stick packaging in liquid form, and cooling.

Mixing ratio of ingredients for making liquid jelly with 50% black tea and 5% alcohol extract material Add 50% black tea and 5% alcohol extract laboratory test manufacturing industrial prototyping weight Ratio (wt%) weight Ratio (wt%) Black tea extract 3.5°brix (g) 50 20 4,000 20 Oat dietary fiber extract (g) 5 2 400 2 agar (g) 5 2 400 2 strawberry flavor 2 0.8 160 0.8 Red Ginseng Extract (3 °brix) 2 0.8 160 0.8 Gelatin (g) One 0.4 80 0.4 Sodium Alginate (g) 0.75 0.3 60 0.3 Enzyme Stevia (g) 0.25 0.1 20 0.1 Water (g) * Considering the evaporation rate of water (+10%) 184 73.6 14,720 73.6 Total amount (g) 250 100 20,000 100

Table 11 shows the characteristics of the anti-diabetic liquid jelly product prepared using the composition of Table 10.

Liquid jelly with 50% black tea and 5% alcohol extract division Soluble solids (°brix) pH chromaticity L value a value b value Product Preference 1.2 5.3 36.4±1.4 9.9±0.6 9.4±0.5

Claims (6)

A pharmaceutical composition for preventing or treating diabetes, comprising an extract of fermented tea leaves of tea tree ( Camellia sinensis ) or a fraction thereof. The method of claim 1, wherein the extract of the fermented tea leaves is water, C ₁ to A _{pharmaceutical composition that is extracted with C 4} alcohol or a mixed solvent thereof. The pharmaceutical composition according to claim 2, wherein the extract is a 50% alcohol extract. The pharmaceutical composition of claim 1, wherein the fraction is a hexane fraction, an ethyl acetate fraction, a butanol fraction, or a water fraction. The method of claim 1, wherein the fermented tea leaves wither; rubbing step; fermentation step; and a drying step, the pharmaceutical composition. A food composition for preventing or improving diabetes, comprising an extract of fermented tea leaves of tea tree ( Camellia sinensis ) or a fraction thereof.

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