KR100564202B1 - Functional dietary supplement containing silkworm powder extract and its manufacturing method - Google Patents

Abstract

The present invention relates to a functional health supplement containing a silkworm powder extract and exhibiting a hypoglycemic effect and a method for manufacturing the same,

Silkworm powder extract 15-30% by weight; 10-20% by weight of the mixed extract of the upper leaves, Myeongil-yeop, ganoderma lucidum, tofu, Schizandra chinensis and Echochocho; 2 to 5 wt% of evening primrose oil; Beta carotene 1-3 wt%; 1-3 wt% vitamin C and 1-3 wt% vitamin E; Mixed vegetable oil of grapeseed oil, palm oil, lecithin and beeswax consists of the remainder,

      Synergistic effect of the silkworm powder extract with hypoglycemic action and various components that can give direct and indirect and supplementary effects to these effects, thus synergistic effect on the hypoglycemia, middle-aged obesity, lack of exercise, liver dysfunction, hypertension complications As a health supplement food for the prevention and treatment of diabetes mellitus due to high lipids, stress, genetic predisposition, etc. in the blood, it has a natural herbal extract. As it is inexpensive, it is easy to formulate in capsule form for improved convenience of taking and storing.

Silkworm extract, functional health supplement

Description

Functional dietary supplement containing silkworm powder extract and its manufacturing method {HEALTH ASSISTANT FUNCTIONAL FOODSTUFFS CONTAINING EXTRACT DERIVED FROM SILKWORM POWDER AND PREPARING METHOD THEREOF}

       1 is a graph showing the change in body weight over time of the experimental animal to which the composition of Formulation Example 1 of the present invention.

       Figure 2 is a graph showing the change in feed intake over time of the experimental animal to which the composition of Formulation Example 1 of the present invention.

       Figure 3 is a graph showing the change in drinking intake over time of the experimental animals to which the composition of Formulation Example 1 of the present invention.

       Figure 4 is a graph showing the blood sugar lowering effect of the experimental animal to which the composition of Formulation Example 1 of the present invention.

       Figure 5 is a graph showing the glucose tolerance test results of experimental animals administered with the composition of Formulation Example 1 of the present invention.

       6 (a) and 6 (b) are 400 magnification photographs of Langerhans island in streptozotocin-treated experimental animals, and FIG. 6 (a) shows a case of diabetic induction plus saline administration, and FIG. 6 (b). Shows the case of diabetes-induced + Formulation Example 1 composition high dose administration.

The present invention relates to a health supplement containing a silkworm powder extract and a method for producing the same, more specifically, silkworm powder extract as a main ingredient, the upper leaf, Myeongil leaf, Ganoderma lucidum, tofu, Schisandra chinensis and Echo herb mixture extract, Evening seed oil, The present invention relates to a dietary supplement containing beta carotene, vitamins C and E as an auxiliary ingredient and having a hypoglycemic effect, and a method of manufacturing the same.

       Diabetes mellitus is a systemic metabolic disease caused by genetic or environmental factors and is often defined and diagnosed as a chronic hyperglycemic state. Diabetes can be caused by a deficiency of insulin, a type of hormone in the pancreas of Langerhans Island, and endocrine gland hyperplasia of the pituitary gland, adrenal gland, and thyroid gland, and the central nervous system, especially the hypothalamus. It is believed that the factors such as the lesions of) are complexly involved, and genetic predisposition and dietary habits are closely related to the onset of the etiology.

       Its main symptoms include abnormalities in sugar, fat and protein metabolism, abnormal hyperglycemia and urine sugar are found, and characteristic tritiosis, that is, multiple meals, multiples, and urination. Severe fatigue and boredom along with various symptoms are the main symptoms of complications such as hypertension, myocardial infarction, angina pectoris, proteinuria, renal failure, visual impairment, and lower extremity. Diabetic vascular disorders, neurological disorders such as decreased, lost, perceptual disorders, limb pain, etc., and urinary tract infections, pyoderma, swelling, boils, periphery of hair follicles Infections such as eczema and candidiasis may occur, and in severe cases, diabetes mellitus can develop into acidosis (coma).

       According to the WHO, diabetes is classified as insulin dependent diabetes mellitus (type I), insulin independent diabetes mellitus (type II), and malnutrition diabetes mellitus (MRDM), especially type II diabetes, especially in the middle ages, especially in the 40s and 60s. The prevalence is high in people who are obese, inactive people, people with high blood pressure complications and liver function, and those with high blood triglycerides.

       Since diabetes is a hard to cure disease, it is most important to prevent the complications by administering a hypoglycemic agent at the beginning of the onset, and by lowering the glycemic hemoglobin by lowering the postprandial blood glucose level by drug administration, and lowering the average blood glucose level decreases the fasting blood sugar level. As a result, insulin resistance improves, and a normal life is possible.

       Blood glucose lowering drugs include insulin preparations, oral oral sulfonyl urea drugs, and biguanide drugs, but they have side effects such as allergies, myelosuppression, and hypoglycemia. Or patients with nephropathy, hypotension, myocardial infarction, hypoxia, the elderly need to be careful. In particular, these drugs have a rapid increase in blood glucose levels after ingestion of food, whereas the incidence of insulin in the blood due to the effect of the drug is relatively prone to delay. This problem is exacerbated by the administration of insulin by subcutaneous injection. As a result, postprandial hyperglycemia, high intake hyperinsulinemia and hypoglycemia may be accompanied. An ideal hypoglycemic agent is a fast-acting drug that effectively prevents rapid post-prandial blood sugar rise and does not lose its effect in a short time to cause hypoglycemia and needs to be a safe oral preparation without side effects.

       Therefore, prevention is particularly important, and once developed, there are no side effects due to the nature of the disease of diabetes, which requires lifelong treatment, and there is an urgent need to develop a functional dietary supplement with a hypoglycemic effect mainly composed of natural herbal ingredients with relatively low cost and good efficacy. It is requested.

         Conventionally, oriental medicine books including consent and compensatory silkworm pupa and silkworm cocoon have been recorded as effective in treating diabetes. I use it. Silkworms, on the other hand, are known to have alphaglucosidase inhibitory effects that promote food absorption. Silkworm Awakened from egg and transformed 4 molt into silkworm pupa and then completely transformed to become a moth, undergoing large physiological changes according to the stages of silkworm larva growth, and the difference in enzymes in larvae before and after molting has been reported. .

         Therefore, in powdering silkworms, methods such as freeze-drying under a nitrogen atmosphere to prevent inactivation of active active ingredients present in silkworms or oxidation by oxygen in the air, or methods of utilizing silkworms at specific time periods. Although there has been an example of attempting to suppress diabetes by using silkworm powder and / or the extract of the upper leaf by the back, etc., it is a fact that neither is satisfactory enough.

       Accordingly, the first object of the present invention is to provide a low-cost functional dietary supplement for lowering blood sugar, not as an expensive medicine, in view of the fact that prevention is particularly important and diabetes, which requires lifelong treatment once onset, is prevalent. It is to provide a stable.

       A second object of the present invention is to provide a functional health supplement for safe hypoglycemia with little side effects by using a natural herbal drug known to have little side effects as a main ingredient.

       The present inventors have made extensive efforts to achieve the above object, the main ingredient is silkworm powder extract which is a natural animal drug known to have an effective blood glucose lowering activity, and the main leaf, Myeongil leaf, Ganoderma lucidum, Tofu, Schisandra chinensis, Echo herb Mixed extracts, beta-carotene natural botanical herbal supplements, and dietary supplements containing vegetable oils and vitamins are excellent in sustaining and stable blood sugar lowering and blood pressure lowering effects due to the synergistic effect of each component with little side effects. As a result of the discovery and research, the present invention has been completed, and the functional dietary supplement according to the present invention can be produced at a relatively low cost.

Hereinafter, the present invention will be described.

Functional dietary supplement containing silkworm powder extract according to the present invention, 15 to 30% by weight silkworm powder extract as the main ingredient, 10 to 20% by weight of the upper leaf, Myeongil leaf, Ganoderma lucidum, tofu, Schisandra chinensis and Echochocho extract , Evening Primrose oil 2-5% by weight, beta-carotene 1-3%, vitamin C 1-3% by weight and vitamin E 1-3% by weight, grape seed oil, palm oil, lecithin, beeswax mixed vegetable oil is composed of the balance.

The silkworm powder extract as an animal herbal medicine as a main ingredient of the functional dietary supplement according to the present invention is lyophilized under a nitrogen atmosphere in order to prevent oxidation and inactivation, and then powdered and ultrasonically extracted in 60% aqueous ethanol solution (3 hours). By selectively extracting alkaloids and amino acids, including 1-deocynojirimycin, and then filtering, the filtrate was packed in an OH ^- type dowax anion exchange column chromatography column and eluted with water. It is obtained only by the alkaloid component, and then concentrated, and has the same ??-glycosidase inhibitory activity in addition to the animal drug 1-deoxynozirimycin, which is known to have an effect of lowering blood sugar, reducing lipid accumulation, and reducing active oxygen. Pagomin, 1,4-dideoxy-1,4-imino-D-arabinol, ecdysterone and the like.

       Upper leaf extract is a vegetable herb obtained from the extract of Morus alba Folium, which belongs to Moraceae, and its main ingredient is rich in gamma aminobutyl acid and rutin as well as 1-deoxynozirimycin with hypoglycemic action. It is known to contain fluorine, fagomine and 2-aryl benzofuran derivatives.

       Angelica MAKINO extract is a medicinal vegetable containing high amounts of vitamins A, B12 and C. Herbal medicine is effective in preventing hypertension, diabetes, arteriosclerosis, cancer, liver disease, and heart disease. Known.

       Ganoderma lucidum (G. tsugae) extract is a herb medicine, anti-cancer and cholesterol suppression in herbal medicine, and is rich in amino acids such as lysine, threonine, methionine, isoleucine, phenyl D-alanine, tryptophan, valine, leucine It is known to include polysaccharoids, lentenacin, and especially contains a large amount of germanium.

       Eucommia ulmoides extract contains a large amount of multi-structured saponins. According to the clinical test results of Nanjing Jiangsu New Medical School, this saponin component is known as hypertension, headache, dizziness and tinnitus insomnia. It is reported to have excellent symptoms.

       Schizandra nigra (Schizandra nigra) contains ingredients such as cizandruff luxuring citrate and citric acid and is widely used as a tonic to strengthen the heart, lower blood pressure and boost immunity.

       Houttuynia cordata Thunb extract contains high amounts of quercetin and tannin, and is known to be safe and excellent in inhibiting serum lipid formation and antioxidant activity.

       In the functional dietary supplement according to the present invention, the mixing ratio of these plant extracts is not limited, but the ratio of the upper leaf: Myeongil leaf: ganoderma: tofugi: Schisandra chinensis: Echo vinegar extract is about 1: 0.5 to 1.5: 0.5 to 1.5: 0.5 to 1.5 It is a weight ratio of: 0.5-1.5: 0.5-1.5, and generally contains each component by the same weight ratio.

       Vitamins and beta-carotene play a role in alleviating the symptoms of diabetes, and vitamins include C and E. Although the content of vitamin C and vitamin E is not limited, it is contained in the ratio of 1-3 weight% each in this invention.

       In addition, grape seed oil, palm oil, lecithin and beeswax are used as excipients, in particular grape seed oil contains linoleic acid, catechin and proanthocyanidins called pycnagenol. It has been reported to be effective in cerebral hemorrhage, leg swelling, varicose veins, decreased vision, diabetic retinopathy and cataracts, stress, arthritis, coronary arteriosclerosis, and hypercholesterolemia.

       The content of these excipients in the functional dietary supplement according to the present invention is also not limited, but in a preferred embodiment according to the present invention is known to have grape seed oil 30 ~ 45% by weight, palm oil 5 ~ 8% by weight, cholesterol and lipolytic ability 1 to 3% by weight of lecithin and 1-3% by weight of beeswax.

         The functional dietary supplement according to the present invention is believed to have a mechanism for preventing and treating diabetes due to the synergistic action of these components.

         In the method for preparing a functional health supplement according to the present invention, the silkworm is lyophilized in a nitrogen atmosphere and powdered, and after extracting a 60% ethanol aqueous solution, the silkworm powder extract obtained by concentrating the elution solution eluted with water using an anion exchange resin column. A homogeneous suspension was prepared by adding to the mixed extracts of the upper leaves, bright leaves, ganoderma lucidum, tortoise, schisandra chinensis and estuary herb, and mixing them homogeneously, and then mixing beta carotene, evening primrose oil, grape seed oil, palm oil, lecithin, beeswax, vitamins C and E The soft capsule then consists of filling in an amount, for example, 350 mg units.

       Although the dosage of the functional dietary supplement according to the present invention can be appropriately adjusted according to various variables such as the degree of diabetes, age, sex, and drug sensitivity of the administrator, the capsule is generally 350 mg. In this case, it is recommended to administer 2 ~ 4 capsules 2 times 4 times a day for 30 minutes before meals or during meals.

       Hereinafter, the present invention will be described in more detail with reference to Examples, Formulation Examples and Experimental Examples.

Example 1: Silkworm Powder Extract

      Each of the silkworm larvae at the end of the 4th to 5th periods was kept in a nitrogen atmosphere for 10 minutes for oxidation pretreatment, then placed in a deep freezer, frozen and freeze dried, and then ground to powder. To 500 g of this powder, 5 times of 60% aqueous ethanol solution was added and extracted 5 times for 2.5 hours using an ultrasonic generator at room temperature in order to prevent loss of activity due to thermal denaturation of the active ingredient. After the extract was filtered, the filtrate was loaded on an OH-type Wax anion exchange chromatography column, eluted with 8 times the volume of water, and concentrated to give 358 g of silkworm powder extract.

Formulation Examples: Preparation of Capsule Formulations

       Using the extract obtained in Example 1 to prepare a capsule (350 mg soft capsule) formulated in the following combination ratio (% by weight):

       Silkworm Powder Extract 22.0

       Lettuce Extract 3.5

       Menyle Leaf Extract 3.5

       Ganoderma lucidum extract 3.5

       Tofu extract 3.5

       Schizandra Extract 3.5

       Eochocho Extract 3.5

       Evening Primrose Oil 3.5

       Beta Carotene 3.0

       Ascorbic Acid (Vitamin C) 2.0

       Tocopherol (Vitamin E) 1.5

       Grape Seed Oil 36.0

       Palm oil 7.0

       Lecithin 2.0

       Beeswax 2.0

       -------------------------------------

                                      100.0

Experimental Example:

      Animal experiments were performed as follows to confirm the hypoglycemic effect of the functional health supplement according to the present invention prepared in the above formulation example.

1. Experimental Composition and Experimental Animal

A. Experimental Composition

   a. Test Subject: Composition Prepared in Formulation Example

   b. Storage and Handling of Experimental Compositions

       The test subject material composition was stored in a sealed container at room temperature.

B. Experimental Animal (Test System)

   a. System / species / source: SD (Sprague-Dawley) rat (Samtako Bio Korea Co., Ltd.)

   b. Number of animals purchased (by gender), age and weight range: 80 (male), 5 weeks of age, 210 ± 10g

      Number of animals (sex), age and weight range: 42 (males), 6 weeks of age, 240 ± 10 g

   c. Test system selection

      SD rats showing symptoms similar to human diabetes by streptozotocin administration were selected and tested.

   d. Animal breeding

      ① Environmental conditions: temperature 23 ± 2 ℃, relative humidity 60 ± 10%, ventilation frequency 10 ~ 15 times / hr

                   Lighting Cycle 12hr On / 12hr Off, Illumination 150 ~ 300Lux

      ② Breeding box:

         Four animals (quarantine and purifying period) / one animal (test period) were housed in a breeding box of 26W x 42L x 18H (cm) (polycarbonate, Myeongjin equipment).

      ③ feed and beverage

         Filtered purified water was fed freely using a rat feed (Samyang oil feed, 400-3 Usan-dong, Wonju-si, Gangwon-do) and a filter for experimental animals.

      ④ Quarantine and Purification

         Veterinary quarantine was conducted on the general health of all animals at the time of animal acquisition. Approximately one week of acclimation was allowed to select healthy animals suitable for conducting the test.

      ⑤ Military separation

         After 1 week of acclimatization, streptozotocin was administered at a dose of 45 mg / kg through the tail vein, and after 5 days, 12 hours of fasting and blood glucose measurement were performed to select only rats with a blood glucose level of 300 mg / dl or more. Groups were separated using randomization based on body weight. The group average weight and standard deviation were calculated for group separation to determine the uniformity.

      ⑥ Object Identification

         The breeding box was affixed with an identification card describing the test number, sex, group number, individual number, dose, and duration of the test, and the individual identification was indicated by pipichromic (picrinic acid) marking method.

2. Experimental method

A. Route of Administration

   The route of administration was oral in view of the planned route of administration.

B. Experimental group

Test group Dosage (mg / kg body wt.) Number of animals (object number) cock G1 Outbreak of diabetes 0 7 (M01-M07) G2 Non-diabetic + high dose group 2000 7 (M08-M014) G3 Diabetic Induction + Low Dose Group 500 7 (M15-M21) G4 Diabetic Induction + Medium Dose Group 1000 7 (M22-M28) G5 Diabetes-induced + high dose group 2000 7 (M29-M35) G6 Diabetes-induced saline solution group 0 7 (M36-M42)

C. Dosage and Dose

   Streptozotocin as a diabetes-causing substance was prepared at a dose of 45 mg / kg body weight and intravenously administered to the tail vein.

   The composition of Formulation Example 1 as a test article was set to 2000mg / kg at a high dose, azeotropy 0.5 at 1000mg / kg medium dose, 500mg / kg was set as a low dose group.

   Dosing method and frequency of administration

     The composition of Formulation Example 1 was orally administered to the rat seven times a week once daily.

     The composition of Formulation Example 1 was a method of forced oral administration until the end of the test after separation of the group to the experimental animals G2, G3, G4, G5 group.

D. Observing General Symptoms

   General symptoms were observed once a day during the administration period of the composition of Formulation Example 1 and then written on the animal observation record sheet for each individual and confirmed whether or not death occurred twice a day.

E. Weighing

   Twice / 7 days after group separation and immediately before necropsy.

F. Feed and drinking water intake

   Feed and negative intake were measured once / 7 days after the start of test substance administration.

G. Blood Sugar Test (BST)

   Blood glucose levels were measured using Glucomen Sensor (A. MENARINI DAGNOSTICS) at 7, 14, 21, 27, and 35 days after administration and at the start of administration. Glucose readings at the test and insulin sensitivity test were used.

H. Intraperitoneal glucose tolerance test (IGTT)

   The rats were fasted for 12 hours on the 35th day before the necropsy after the administration of the composition of Formulation Example 1, and then the blood glucose was measured. Blood glucose was measured using a sensor (A. MENARINI DAGNOSTICS).

I. Autopsy

   At the end of the experiment, surviving animals were fasted for 18 hours before necropsy, and then anesthetized with ether and bleeded to death. The organ, kidney, and pancreas were weighed, fixed with formalin, cut into paraffin foam, and subjected to H & E staining.

J. Statistical Processing of Data

   a. Procedure 1: Levene's test was performed to compare the homogeneity of the variances for each experimental result, and if there was homogeneity of the variances, one-way ananlysis of variance (ANOVA) was observed. Dunnett's-teat was conducted to identify the test groups with significant differences.

   b. Procedure 2: If the Levene's test result is heterogeneous, perform the appropriate data transformation and rerun the Levene's test on the converted data again, if the variance is the same, proceed to procedure 1 and if the variance is not homogeneous, In this case, non-parametric ANOVA test was performed, and if the result was significant, the appropriate t-test method was selected for statistical analysis.

3. Experimental Results

A. Weight change (see Table 2 and FIG. 1)

   The change in body weight of the non-diabetic group tended to increase in body weight of the composition-administered group of Formulation Example 1 higher than that of the non-administrative group of Formulation Example 1 after 17 days of administration of the composition of Formulation Example 1. In the diabetes-induced group, there was no statistical significance due to the large deviation compared to the diabetes-induced + saline group (G6) .However, the diabetes-induced + saline group (G6) Body weight began to appear higher than 235.61 ± 24.57 g and continued to increase weight. On day 35, 253.89 ± 35.02g of diabetic + high dose group (G5) and 233.10 ± 33.72 of diabetic + saline group (G6). A weight difference of about 20 g was shown compared to g. In addition, the diabetic + low-dose group (G3) and diabetes-induced + medium-dose group (G4) showed a difference in the degree of weight increase than the diabetic + saline group (G6).

Weight Changes in SD Rats group Days after processing 0 7 14 21 28 35 G1 Average 254.22 * 313.81 *** 339.71 *** 349.05 *** 384.82 *** 398.66 *** S.D 6.24 19.39 25.20 23.49 29.22 35.90 G2 Average 252.91 * 318.62 *** 331.63 *** 370.81 *** 402.29 *** 421.19 *** S.D 8.93 8.72 11.29 16.33 21.04 24.27 G3 Average 229.31 223.07 226.26 227.40 253.08 244.94 S.D 15.64 24.00 32.69 25.98 23.33 36.79 G4 Average 228.55 216.08 214.48 225.97 238.43 232.67 S.D 13.92 14.89 25.81 25.13 31.68 34.08 G5 Average 226.05 225.34 229.26 249.38 263.86 253.89 S.D 19.62 25.05 37.74 33.77 28.99 35.02 G6 Average 231.53 227.29 230.30 230.34 238.13 233.10 S.D 10.07 13.52 25.57 22.66 34.93 33.72

B. Changes in feed intake (see Figure 2)

   Feed intake of non-diabetic + high dose group (G2) was about 4-6g less than that of non-diabetic + saline group (G1).

   Diabetes-induced + Formulation Example 1 Diabetes-induced + high-dose group compared to 42.61 ± 3.85g / animal / day, which is the average of diabetes-induced + saline-administered group (G6), even when comparing the feed intake of the composition-administered group and the diabetic-induced saline-administered group (G6). Low feed intake was shown in 32.06 ± 3.51g / animal / day of (G5), 39.84 ± 5.12g / animal / day of diabetes-induced + medium dose group (G4), diabetes-induced + Formulation 1 composition-treated group.

C. Change in negative intake (see Figure 3)

   Changes in the negative intakes measured during the experiment were similarly measured with little difference between the intakes of diabetic noninduced + high dose group (G2) and the intakes of diabetic noninduced + saline group (G1).

   However, the negative intake at the second week of the diabetic + high dose group (G5) was 209.36 ± 10.29 ml / animal / day, showing a significant decrease compared to the 223.92 ± 9.96 ml / animal / day of the diabetic + saline administration group (G6). The weekly average of the diabetic + saline administration group (G6) was 204.75 ± 52.57ml / animal / day compared to the negative intake of the diabetic + formulation 1 administration group and the diabetic + saline administration group (G6) group. Induction + high dose group (G5) is 192.70 ± 40.22 ml / animal / day, diabetes-induced + medium dose group (G4) 205.44 ± 54.88 ml / animal / day, diabetes-induced + low dose group (G3) 194.27 ± 48.81 ml / animal As for the day, the diabetic + saline administration group showed a lower tendency in the negative intake except the diabetic induction + medium dose group (G4), and the weekly average intake was higher. Less intake was shown compared to (G6).

D. General symptoms and survival rates (see Table 3)

   In the diabetic group induced by streptozotocin during the experimental period, polyuria and hairy roughness were observed, but compared to the diabetic + saline-administered group (G6), the dosage of the composition of Example 1 composition was observed to be somewhat less. No abnormal symptoms were observed.

   Survival measurements showed no deaths in all experimental groups during the experimental period.

Survival of Streptozotocin-treated SD Rats group Weeks after processing Survival rate (%) 0 One 2 3 4 5 G1 The number of animals 7 7 7 7 7 7 100 Dead shooter 0 0 0 0 0 0 100 G2 The number of animals 7 7 7 7 7 7 100 Dead shooter 0 0 0 0 0 0 100 G3 The number of animals 7 7 7 7 7 7 100 Dead shooter 0 0 0 0 0 0 100 G4 The number of animals 7 7 7 7 7 7 100 Dead shooter 0 0 0 0 0 0 100 G5 The number of animals 7 7 7 7 7 7 100 Dead shooter 0 0 0 0 0 0 100 G6 The number of animals 7 7 7 7 7 7 100 Dead shooter 0 0 0 0 0 0 100

E. Blood Sugar Changes (see Figure 4)

   Blood was collected by tail vein blood collection once a week from 2 to 4 pm after the start of the experiment and blood glucose was measured using a Glucomen Sensor (A. Formulation Example 1 From 1 week after the administration of the composition, the blood glucose level of the diabetic + saline administration group (G6) began to increase from 394 ± 69.0mg / dl to 490 ± 27.5mg / dl and then increased to 546 ± 30.6mg / dl at 5 weeks. In the diabetic + high dose group (G5), the blood glucose level gradually increased from 440 ± 83.4mg / dl to 410 ± 83.4mg / dl at 1 week and 442 ± 83.4mg / dl at 2 weeks, then decreased to 403 ± at 4 weeks. At 38.7 mg / dl, there was a significant decrease compared to 584 ± 65.0 mg / dl in the diabetic + saline group (G6). At 5 weeks, gradual hypoglycemia was observed at 383 ± 140.2 mg / dl.

   At week 3, there was a significant decrease of 420 ± 58.5 mg / dl in the diabetes-induced + low dose group (G3) compared to the diabetes-induced + saline group (G6). Elevated blood glucose levels were observed at 523 ± 65.0mg / dl and 513 ± 87.9mg / dl, respectively, compared to 584 ± 65.0mg / dl in the diabetic + saline group (G6) at 4 weeks. All were lower and blood sugar levels were 456 ± 140.2mg / dl and 501 ± 64.2mg / dl, respectively, compared to the diabetes-induced + saline group (G6) of 546 ± 30.6mg / dl.

   In general, blood glucose levels tended to be lower in the administration group of the Formulation Example 1 composition than in the diabetic + saline administration group (G6).

F. glucose tolerance test (IGTT: intraperitoneal glucose tolerance test (FIG. 5))

   In the glucose tolerance test, the glucose level in the diabetic non-induced group + high dose group (G2) gradually increased from 103 ± 5.3mg / dl to 192.3 ± 35.3mg / dl in the 30-minute period, and then decreased gradually after glucose intraperitoneal administration. The diabetic non-induced + saline administration group (G6) increased from 95.8 ± 5.3mg / dl to 235.5 ± 62.5mg / dl after 15 minutes and decreased in blood glucose at 120 minutes in both groups. Diabetic non-induced + saline group (G1) 131.6 ± 28.2mg / dl, diabetic non-induced + high dose group (G2) 127.5 ± 2.4mg / dl.

   In the diabetes-induced group, the diabetic-induced saline-administered group (G6) showed a gradual decrease after 45 minutes after the maximum glucose level reached 600 mg / dl.However, in the high dose group (G5), the composition was 578.5 at 45 minutes. There was a tendency to decrease after the maximum value was ± 30.4 mg / dl and the blood glucose of the diabetic + formulation 1 administration group at 120 minutes was lower than that of the diabetic + saline group (G6).

   Diabetic Non-Induced Diabetic + Formulation Example 1 In the group administered with the composition (G2), no significant increase in blood glucose was observed compared with the non-diabetic + saline-administered group (G6). Was observed.

G. Changes in organ weights taken after autopsy (see Table 4)

   The weights of the livers collected after autopsy were not significantly different (G3 group 10.5g, G4 group 9.4g, G6 group 11.6g) compared with G6 group 10.8g.

group Number of rats Weight (g) kidney Liver (g) Lt. (g) Rt. (G) G1 7 374.9 1.4 1.4 11.0 31.6 0.2 0.2 1.4 G2 7 402.4 1.5 1.4 11.5 23.6 0.1 0.1 1.0 G3 7 187.0 1.4 1.4 10.7 31.9 0.2 0.2 0.9 G4 7 213.3 1.5 1.5 9.4 26.8 0.2 0.2 3.4 G5 7 231.8 1.7 1.7 11.6 25.9 0.2 0.3 1.5 G6 7 206.8 1.5 1.5 10.8 22.9 0.1 0.2 1.0

H. Histopathological examination (Figures 1-4)

   Diabetes-induced + high-dose group in specific changes in the destruction of pancreatic β-cells by streptozotocin, nuclear changes such as chromatin aggregation, nuclear enrichment, and nucleus loss, secretory granule loss, bleeding and fear change Compared to the diabetic-induced saline-administered group (G6) exposed to continuous injury, (G5) tended to show less cellular damage such as nuclear enrichment, nucleophiles, fear degeneration, and eosinophilic deposition.

I. Summary of Results

   In summary,

   The composition-administered group of Formulation Example 1 of the present invention showed less feed intake than the non-administered group, and in terms of weight change, the diabetic-induced diabetes mellitus + formulation example 1 and the non-diabetic-induced diabetes mellitus + formulation-administered group were treated with diabetes-induced saline. Body weight gain tended to be higher than that of hyperdiabetic non-diabetic + saline group.

   In the change of blood glucose, the diabetic-induced composition 1 group showed lower blood glucose level than the diabetic-induced non-diabetic group,

   In the glucose tolerance test, the composition-treated group of Formulation Example 1 delayed the time to reach the maximum blood glucose compared with the non-administered group, and the blood glucose at 120 minutes was measured lower than that of the diabetic-saline group (G6),

   In histologic examination, β-cell damage in the pancreatic tissue Langerhans island of the diabetic-induced high-dose group (G5) was weaker than that of the β-cell in the diabetic-saline group (G6).

4. Evaluation of the results

    Formulation Example 1 The composition of Formulation Example 1 compared to the Diabetic + Saline administration group (G6), in which the feed intake was lower than the diabetes-induced group depending on the concentration of the composition administered in the composition of Formulation Example 1, but the weight loss was suppressed due to the decrease in body weight and the increase in the age. Increasing or decreasing weight in the administration group was evaluated that the formulation 1 composition is effective in inhibiting weight loss by the decomposition of body fat and body protein in diabetes mellitus, diabetes mellitus + saline administration group (G6) It was confirmed that the blood glucose level of the formulation example 1 composition treatment group is lower than the blood glucose level of). In particular, significant suppression of elevated blood glucose levels was observed at the 4th and 3rd week of the diabetic + high dose group (G5) and the diabetic + low dose group (G3), and the diabetic + saline group in the diabetic + high dose group (G5). The blood glucose level of (G6) increased with age, but gradually increased after the induction of diabetes mellitus by STZ administration, but also showed a decrease in blood glucose levels, and also in the diabetic + medium dose group (G3) and low dose group (G4). Overall, the blood glucose level was lower than that of diabetes-induced saline solution (G6). Formulation Example 1 No difference in blood glucose was observed between the composition-administered group (G2) and the diabetic non-induced group (G1), and the time taken to reach the highest blood glucose concentration by glucose administered intraperitoneally in the GTT test was diabetes-induced + high-dose group (G5). ) Has a tendency to be delayed than the diabetic + saline group (G6), and in the diabetic + high dose group (G2), it did not show a decrease in blood sugar level compared to normal, and suppressed the time to reach the highest blood sugar level and lowered the peak blood glucose level. Formulation Example 1 composition from the fact that it maintains a blood glucose state similar to that of inhibiting blood sugar rise, while the silkworms and the extracts of the upper leaf extract contained therein are digested and absorbed by the disaccharides into monosaccharides during the digestion and absorption of carbohydrates. By inhibiting α-glucosidase involved in the process, it suppresses the rapid blood sugar rise after eating It was judged to have a do not cause a lean secretion efficacy to prevent the hypoglycemia shock.

   In addition, histological examination showed a tendency of less cellular damage such as nuclear enrichment, nucleophilic loss, fear degeneration, and eosinophilic deposition.

       As described above, the functional dietary supplement according to the present invention is a silkworm powder extract exhibiting a hypoglycemic action as a main ingredient, and a mixed extract of upper leaf, Myeongil leaf, ganoderma lucidum, tofu, Schisandra chinensis and Echo herb as a main ingredient, beta carotene, and evening primrose oil It is enhanced with various ingredients that can give direct or indirect and supplementary effects on blood sugar drop such as vitamins C and E and grapeseed oil, which can produce synergistic effects on blood sugar drop. It is a health supplement that has excellent effects on the prevention and treatment of insulin-dependent and non-dependent diabetes mellitus, which is caused by high blood pressure complications, high lipids in the blood, stress, genetic predisposition, and natural herbal extracts. The side effects are relatively much safer and relative to organic chemical formulations. As it is inexpensive, it can be easily formulated in capsule form for convenience in taking and storing.

Claims (5)

      15 to 30% by weight of a silkworm powder extract obtained by freezing-drying silkworms under a nitrogen atmosphere to powder, extracting 60% aqueous ethanol solution, and then concentrating the eluted solution eluted with water using an anion exchange resin column; 10 to 20% by weight of the mixed extract of the upper leaves, Myeongil Leaf, Ganoderma lucidum, Tofu, Schisandra chinensis and Echochocho in a ratio of 1: 0.5 to 1.5: 0.5 to 1.5: 0.5 to 1.5: 0.5 to 1.5: 0.5 to 1.5 ; 2 to 5 wt% of evening primrose oil; Beta carotene 1-3 wt%; 1-3 wt% vitamin C and 1-3 wt% vitamin E; Functional health supplement containing silkworm powder extract, consisting of 30% to 45% by weight of grapeseed oil, 5 to 8% by weight of palm oil, 1 to 3% by weight of lecithin, and 1 to 3% by weight of beeswax. food. delete delete delete       In the dietary supplement foods prepared by filling a soft capsule into a suspension, Silkworms were lyophilized under nitrogen atmosphere to powder, extracted with 60% ethanol aqueous solution, and 15-30% by weight of silkworm powder extract obtained by concentrating the eluate eluted with water using an anion exchange resin column. , Add 10 ~ 20% by weight of the mixed extracts of Schizandra chinensis and Echoseong       Beta Carotene 1-3%, Evening Primrose Oil 2-5%, Grape Seed Oil 30-45%, Palm Oil 5-8%, Lecithin 1-3%, Beeswax 1-3%, Vitamins C and E, respectively A method of producing a functional health supplement containing silkworm powder extract, characterized in that by mixing 1 to 3% by weight to prepare a homogeneous suspension, and then filling into a soft capsule by a conventional method.

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