Composition for treating diabetes as well as preparation method and application thereof

Abstract

The invention discloses a composition for treating diabetes mellitus and a preparation method and application thereof. The composition is prepared from, by weight, 3-7 parts of rice bran, 3-7 parts of bitter gourd, 1-5 parts of cinnamon, 3-7 parts of fermented soybean, 6-10 parts of fig, 1-5 parts of ginseng, 3-7 parts of fructus lycii, 1-5 parts of folium mori, 3-7 parts of radix puerariae, 1-5 parts of dendrobium officinale and 1-5 parts of wheat oligopeptide. 6-10 parts of fructo-oligosaccharide and 1-3 parts of dry yeast. The composition is unique and reasonable in compatibility, simple in preparation method and free of toxic and side effects, the medicine synergistic effect generated among the combined medicines is higher, the curative effect is better, the treatment effect is obvious, and the adverse reaction is low.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a composition for treating diabetes, and a preparation method and application thereof. Background Art

[0002] Diabetes is an endocrine metabolic disorder characterized by increased plasma glucose levels. It is one of the three major diseases in the world, along with cancer and cardiovascular disease. The pathogenesis of type II diabetes is related to pancreatic islet dysfunction. Oxidative stress is a key factor in the occurrence and development of type II diabetes, which can cause damage to pancreatic β-cell function and peripheral tissue insulin resistance, leading to the formation of diabetes and its various complications, seriously affecting the patient's quality of life. Therefore, it is of great significance to continue researching drugs for the treatment of type II diabetes.

[0003] Among the chronic complications of diabetes, diabetic peripheral neuropathy is the most common, and there are many pathogenic factors involved in its occurrence and development. At present, a variety of drugs with different mechanisms of action are used clinically to nourish nerves, but they still lack ideal therapeutic effects. Traditional Chinese medicine believes that the pathogenesis of diabetic peripheral neuropathy is based on qi deficiency, yin deficiency, and yang deficiency, and is marked by blood stasis and phlegm blocking the collaterals. Blood stasis runs through the entire course of diabetic peripheral neuropathy.

[0004] Traditional Chinese medicine has its unique advantages in the treatment and prevention of diabetes, and shows a good development prospect. Modern pharmacology shows that bitter Chinese medicine has multiple hypoglycemic mechanisms, and at the same time can prevent complications of diabetes and improve symptoms of diabetes. Its mechanism of action may be related to regulating the balance of cell glucose, protecting pancreatic β cells, restoring pancreatic β cell function, resisting oxidative stress, improving insulin resistance, improving the body's sugar metabolism, lipid metabolism, and resisting oxidative free radical damage. The use of hypoglycemic compound preparations with complementary mechanisms, reduced toxicity and increased efficacy has become a treatment trend for diabetes drugs.

[0005] Traditional Chinese medicine compound contains a variety of alkaloids, flavonoids, terpenes and polysaccharides, which are active ingredients for hypoglycemic effect. It enhances the sensitivity of Ins through multiple pathways and multiple links, such as regulating glucose and lipid metabolism, inflammatory pathways, oxidative stress levels, amino acid metabolism, repairing and regenerating pancreatic β cells, etc. The hypoglycemic mechanism is synergistic and complementary, and the combination of strong and strong can reduce toxicity and increase efficacy. Traditional Chinese medicine compound preparations have become the focus of domestic diabetes drug research and development.

[0006] Some compositions for treating diabetes are disclosed in the prior art, such as patent number: CN118649210A discloses "Chinese medicine composition, medicine and preparation method and application for preventing and treating type II diabetes osteoporosis", which is made of the following raw materials: 10-20 parts of epimedium, 10-15 parts of curculigo, 5-15 parts of trichosanthes, 25-35 parts of polygonatum, 10-15 parts of kudzu root, 5-12 parts of rhodiola and 10-20 parts of salvia. The compositions in the prior art each have their own advantages and disadvantages. It is of great significance to develop a new formula of composition for treating diabetes. Summary of the invention

[0007] In view of the deficiencies in the prior art, the purpose of the present invention is to develop a composition for treating diabetes and a preparation method thereof, wherein the composition has a unique and reasonable compatibility, no toxic side effects, obvious therapeutic effect, low adverse reactions, and a simple and reasonable preparation method.

[0008] The technical solution of the present invention is:

[0009] A composition for treating diabetes. The composition has a formula and a proportion by weight of: 3-7 parts of rice bran, 3-7 parts of bitter melon, 1-5 parts of cinnamon, 3-7 parts of light fermented black beans, 6-10 parts of figs, 1-5 parts of ginseng, 3-7 parts of wolfberries, 1-5 parts of mulberry leaves, 3-7 parts of kudzu roots, 1-5 parts of dendrobium officinale, 1-5 parts of wheat oligopeptides, 6-10 parts of oligofructose, and 1-3 parts of dry yeast.

[0010] Preferred scheme 1: The formula and proportion of the composition in weight parts are: 5 parts of rice bran, 5 parts of bitter gourd, 3 parts of cinnamon, 5 parts of light fermented black beans, 8 parts of figs, 3 parts of ginseng, 5 parts of wolfberry, 3 parts of mulberry leaves, 5 parts of kudzu root, 3 parts of dendrobium officinale, 3 parts of wheat oligopeptides, 8 parts of oligofructose, and 1 part of dry yeast.

[0011] Preferred scheme 2: The formula and proportion of the composition in weight parts are: 6 parts of rice bran, 6 parts of bitter gourd, 4 parts of cinnamon, 5 parts of light fermented black beans, 7 parts of figs, 2 parts of ginseng, 6 parts of wolfberry, 4 parts of mulberry leaves, 7 parts of kudzu root, 4 parts of dendrobium officinale, 2 parts of wheat oligopeptide, 9 parts of oligofructose, and 2 parts of dry yeast.

[0012] Preferably, the formulas are all in the form of powders with a mesh size of 60-100.

[0013] The preferred preparation method is: crush rice bran, bitter melon, cinnamon, light black beans, figs, ginseng, wolfberry, mulberry leaves, kudzu root, and dendrobium candidum into fine powder according to the above proportions, and pass through a 60-mesh to 80-mesh sieve; then mix them evenly with wheat oligopeptides, oligofructose, and dry yeast, pass through an 80-mesh to 100-mesh sieve, and mix according to the above proportions to obtain the finished medicinal powder.

[0014] Furthermore, the finished drug powder is further made into one of tablets, granules, pills, capsules and oral liquids according to conventional techniques in the art.

[0015] The invention also provides application of the composition in preparing medicine for treating diabetes.

[0016] Preferably, the diabetes is type II diabetes.

[0017] The prescription of the present invention is explained as follows:

[0018] Rice bran: Rich in dietary fiber, vitamins and minerals, it helps improve digestive system function and lower cholesterol levels.

[0019] Oligofructose: It is a soluble dietary fiber that helps control blood sugar levels, prevent osteoporosis, and prevent diabetes-related complications.

[0020] Dry yeast: Dry yeast tablets are a nutritional supplement that contains rich nutrients, such as vitamin B group, amino acids, chromium, etc., and have an auxiliary therapeutic effect on indigestion. It can be used to treat indigestion, malnutrition, loss of appetite, vitamin B deficiency and other diseases.

[0021] Bitter melon: Traditionally used for cooling and detoxification, modern research suggests bitter melon extract may help lower blood sugar, with potential benefits for type 2 diabetes.

[0022] Cinnamon: Contains active ingredients such as cinnamaldehyde, which studies have shown may help improve insulin sensitivity, regulate blood sugar levels, and help improve blood lipids.

[0023] Light black beans: A fermented product, rich in B vitamins and enzymes, which aids digestion. It is also a traditional Chinese medicine that can be used to relieve exterior symptoms and relieve restlessness.

[0024] Figs: Rich in dietary fiber, minerals and antioxidants, they help improve intestinal health and promote cardiovascular health.

[0025] Ginseng: A traditional Chinese medicinal material, it is believed to be able to replenish vitality, strengthen physical fitness, improve immunity, and has a certain effect on anti-fatigue.

[0026] Wolfberry: Rich in antioxidants such as beta-carotene, vitamin C and selenium, it helps with eye health, enhances immune function and has anti-fatigue effects.

[0027] Mulberry leaf: Traditionally used to dispel wind-heat, cool blood and stop bleeding. Modern research has found that mulberry leaf extract helps regulate blood sugar, blood pressure and blood lipids.

[0028] Pueraria root: It has the effects of relieving fever, sobering up, raising yang and promoting body fluid. The isoflavone components of Pueraria root help regulate the endocrine system and have a certain protective effect on the cardiovascular system.

[0029] Wheat Oligopeptides: Easily absorbed small molecule protein fragments that help improve muscle recovery, increase physical strength, and are beneficial to cardiovascular health.

[0030] Dendrobium candidum: Dendrobium candidum contains polysaccharides, alkaloids, stilbenes, flavonoids, amino acids and trace elements and other active ingredients that are beneficial to human health. Modern pharmacological research shows that Dendrobium candidum has medicinal value such as lowering blood pressure, improving immunity, anti-tumor, anti-aging and lowering blood lipids.

[0031] Compared with the prior art, the advantages of the present invention are:

[0032] 1. The pharmacodynamic research data of the present invention prove that the composition of the present invention can reduce the fasting blood glucose value of diabetic rats to varying degrees, and has a certain improvement effect on insulin resistance and abnormal lipid metabolism.

[0033] 2. The clinical use effect of the present invention proves that the patients treated with the composition of the present invention can effectively reduce the TCM syndrome score, cool sensation threshold, warm sensation threshold, pain threshold, dorsum VPT, and first toe VPT. The fasting blood sugar and 2h postprandial blood sugar test results are close to those of the metformin group. The effect is significant, the adverse reactions are small, the safety is high, and it is suitable for long-term use.

[0034] 3. The toxicity test of repeated administration of the composition of the present invention to rats by oral gavage for 6 months and the toxicity test of single administration to mice showed that the composition of the present invention is highly safe and has no toxic side effects.

[0035] 4. The preparation method of the composition of the present invention is simple and the clinical experimental effect is highly effective.

[0036] 5. Compared with the formula of the comparative example, the drug synergistic effect between the drugs in the composition of the present invention is stronger and the therapeutic effect is better.

[0037] The detailed structure of the present invention is further described below in conjunction with specific implementation methods. DETAILED DESCRIPTION

[0038] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. The following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0039] The parts by weight described in the embodiments of the present invention refer to mass, and the general unit is g or kg.

[0040] Example 1

[0041] A composition for treating diabetes, the formula and proportion by weight of which are: 5 parts of rice bran, 5 parts of bitter melon, 3 parts of cinnamon bark, 5 parts of light black beans, 8 parts of figs, 3 parts of ginseng, 5 parts of wolfberry, 3 parts of mulberry leaves, 5 parts of kudzu root, 3 parts of dendrobium officinale, 3 parts of wheat oligopeptide, 8 parts of oligofructose and 1 part of dry yeast.

[0042] Preparation method: Grind rice bran, bitter melon, cinnamon, light black beans, figs, ginseng, wolfberry, mulberry leaves, kudzu root, and dendrobium candidum into fine powder according to the above proportions, and pass through a 60-mesh to 80-mesh sieve; then mix evenly with wheat oligopeptides, oligofructose, and dry yeast, pass through an 80-mesh to 100-mesh sieve, and mix according to the above proportions to obtain the finished medicinal powder.

[0043] Comparative Example 1

[0044] A composition, the formula and proportion of the composition by weight are: 5 parts of bitter melon, 5 parts of light fermented black beans, 8 parts of figs, 3 parts of ginseng, 5 parts of wolfberries, 3 parts of mulberry leaves, and 8 parts of oligofructose.

[0045] The preparation method is the same as that in Example 1: crush bitter melon, light fermented black beans, figs, ginseng, wolfberry, and mulberry leaves into fine powder, and pass through a 60-80 mesh sieve; then mix evenly with oligofructose, pass through a 80-100 mesh sieve, and mix according to the above ratio to obtain the finished medicinal powder.

[0046] Comparative Example 2

[0047] A composition, the formula and proportion of the composition by weight are: 5 parts of rice bran, 5 parts of bitter melon, 3 parts of cinnamon, 5 parts of light fermented black beans, 8 parts of figs, 3 parts of ginseng, 5 parts of wolfberry, 3 parts of mulberry leaves, 3 parts of oligofructose, and 5 parts of kudzu root.

[0048] The preparation method is the same as that in Example 1: rice bran, bitter melon, cinnamon, light black beans, figs, ginseng, wolfberry, mulberry leaves, and kudzu root are crushed into fine powder and passed through a 60-80 mesh sieve; then, the powder is evenly mixed with oligofructose and passed through a 80-100 mesh sieve. The finished medicinal powder is obtained after mixing according to the above ratio.

[0049] Example 2 Toxicity test of single oral administration of the composition of Example 1 to rats

[0050] Purpose of the experiment: This study was carried out in accordance with the national GLP standard requirements to observe the acute toxic reactions and deaths of ICR mice after oral administration of the drug solution of Example 1, and to provide reference data for repeated dosing toxicity tests.

[0051] Test materials: 40 SPF-grade ICR mice that passed the quarantine were selected for the test, half of which were male and half were female, weighing 18.7-21.8g, and were raised in 310mm×205mm×180mm cages, with 5 mice in each cage. They were raised in accordance with the international (GB14925-2010) SPF-grade experimental animal environmental conditions, and the animals were quarantined and adapted to the environment for 3 days.

[0052] This experiment observed the acute toxicity test reaction of Example 1 by oral gavage in ICR mice. 40 ICR mice were selected, half male and half female, and randomly divided into 2 groups according to gender and weight, namely, a blank control group (pure water) and Example 1 group (405g / kg), with 20 mice in each group. Fasting but not water for more than 12 hours before the experiment, then oral gavage of pure water and Example 1 at 40mL / kg, twice on the day of administration, and close observation and recording of poisoning manifestations and characteristics, toxic reaction occurrence and recovery time, and death of each group of animals within 0 to 4 hours after each administration, and then observed twice a day, once in the morning and afternoon, for 14 consecutive days. Weigh the animals before administration (drug administration day) and on the 4th, 7th, 10th and 14th days after administration, and record the weight changes and death of the animals.

[0053] Test results: Effects on general activity, animal poisoning symptoms and death: Within 0 to 4 hours after the end of intragastric administration, there were no obvious abnormalities in the autonomous activity, mental state and diet of mice in the blank control group and Example 1 group, and no related toxic reactions or animal deaths were observed. After continuous observation for 14 days after administration, there were no obvious abnormalities in the autonomous activity, mental state and diet of mice in the blank control group and Example 1 group, and no related toxic reactions or animal deaths were observed.

[0054] Effect on body weight: The animals were weighed before administration (on the day of administration), 4 days, 7 days, 10 days and 14 days after administration. There was no significant difference in body weight between the Example 1 group and the blank control group, as shown in Table 1. This indicates that oral administration of Example 1 to ICR mice had no significant effect on the weight gain of the mice.

[0055] At the end of the experiment, gross anatomical observation of ICR mice showed no obvious abnormalities on the surface and cross-section of each organ.

[0056] Conclusion: Under the conditions of this experiment, mice were orally administered Example 1 with a dosing volume of 750 mL / kg, and the drug was administered twice on the day of administration, with a cumulative dose of 405 g / kg, which is equivalent to 150 times the clinically intended dose per kilogram of body weight for adults (the daily dose for adults is 0.5 g / kg). No related toxic reactions or deaths were observed in the animals.

[0057] Table 1 Effect of the composition of Example 1 on the body weight of ICR mice (n=20, X±s)

[0058]

[0059] Note: Compared with the blank control group, there is no statistical difference in the composition group of Example 1.

[0060] Example 3 Toxicity test of rats after oral administration of the composition of Example 1 for 6 months

[0061] Purpose of the experiment: This research project was carried out in accordance with the national GLP standard requirements, and the toxicity test of multiple administration of different doses of the drug solution of Example 1 was observed in SD rats by oral gavage, and the toxicity reaction of Example 1 after multiple administration to SD rats was evaluated, so as to provide reference materials for the clinical use of Example 1.

[0062] Test method: 120 qualified SD rats were selected, half male and half female, weighing 175.6-222.1 g, 475×350×200 mm 3 Cages were used for feeding, with 5 rats per cage. Animals were fed according to the international (GB14925-2010) SPF-grade experimental animal environmental conditions, and the animals were quarantined and acclimatized for 5 days. The animals were randomly divided into 4 groups according to gender and weight, namely, a blank control group, low-, medium- and high-dose groups (2.7, 5.4, and 10.8 g / kg) of Example 1, 30 animals in each group (half male and half female), and administered by gavage at a volume of 15 mL / kg for 6 consecutive months (26 weeks). 40 rats were dissected as planned at the middle of the medication period (the 13th weekend), the end of the medication period (the 26th weekend) and the end of the recovery period (the 30th weekend), half male and half female. The examination items include: general clinical observation; body weight and food intake determination; hematology, blood biochemistry, coagulation and organ coefficient determination; histopathological examination.

[0063] Experimental results: During the experiment, all animals were euthanized as planned, and no animals died during the experiment.

[0064] General clinical observation: During the observation period, when the dosage groups of Example 1 were compared with the blank control group during the same period, no abnormal reactions related to drug toxicity were found in the animal appearance, behavioral activities, cavity secretions and general conditions.

[0065] Body weight: Compared with the blank control group during the same period, the dose groups of Example 1 had no significant effect on the body weight of rats, as shown in Table 2.

[0066] Food intake: Compared with the blank control group during the same period, the dose groups of Example 1 had no significant effect on the average food intake of rats, as shown in Table 3.

[0067] Hematological examination: Compared with the blank control group in the same period, no toxicologically significant changes were observed in the hematological indices of each dosage group of Example 1. The results showed that Example 1 had no significant effect on the hematological indices of rats, as shown in Table 4.

[0068] Blood biochemical examination: Compared with the blank control group during the same period, no toxicologically significant changes were observed in the blood biochemical indices of each dosage group of Example 1. The results showed that Example 1 had no significant effect on the blood biochemical indices of rats, as shown in Table 5.

[0069] Coagulation test: Compared with the blank control group during the same period, no toxicologically significant changes were observed in the coagulation indices of each dosage group of Example 1. The results showed that Example 1 had no significant effect on the coagulation indices of rats, as shown in Table 6.

[0070] Organ coefficients: Compared with the blank control group during the same period, the organ coefficients of each dosage group of Example 1 had no obvious abnormalities. The results showed that Example 1 had no significant effect on the organ coefficients of rats, as shown in Table 7.

[0071] Gross anatomy: No obvious changes were observed in the color, size, texture, etc. of the surface and cross-section of the organs of the blank control group and the low-, medium-, and high-dose groups of Example 1 by naked eye observation at the middle, final, and recovery stages of drug administration.

[0072] Pathological examination: No significant differences were found in the animals in the high-dose group of Example 1 dissected at the middle, end and recovery stages compared with the blank control group during the same period, and no pathological changes of toxicological significance were found.

[0073] Conclusion: Under the experimental conditions, no obvious drug-related toxicity was observed in SD rats after oral administration of the composition of Example 1 for 6 months.

[0074] Table 2 Effect of the composition of Example 1 on animal body weight (g, )

[0075]

[0076]

[0077] Table 3 Effect of the composition of Example 1 on the average food intake of animals (g / animal / day, )

[0078]

[0079]

[0080] Table 4 Effect of the composition of Example 1 on animal hematology

[0081]

[0082]

[0083] Note: Compared with the blank control group,* P<0.05, ** P<0.01.

[0084] Table 5 Effect of the composition of Example 1 on animal blood biochemical indicators

[0085]

[0086]

[0087] Note: Compared with the blank control group, * P<0.05, ** P<0.01.

[0088] Table 6 Effect of the composition of Example 1 on animal coagulation

[0089]

[0090] Table 7 Statistical table of the effect of the composition of Example 1 on the animal organ coefficient ( mg / g)

[0091]

[0092]

[0093] Note: Compared with the blank control group, * P<0.05.

[0094] Example 4 Animal Pharmacodynamics Experimental Data

[0095] Experiment 1: Effects of the composition of Example 1 and the comparative example on obese type II diabetic rat model

[0096] 1. Test purpose:

[0097] This experiment replicated the obese type II diabetic rat model to investigate the therapeutic effect of the composition of Example 1 on obese type II diabetes, providing a pharmacological basis for the clinical application of the composition of Example 1.

[0098] 2. Test materials:

[0099] Test substance (test product): the composition of Example 1 (Guyitang (Hunan) Health Technology Co., Ltd.), the composition of Comparative Example 1 (Guyitang (Hunan) Health Technology Co., Ltd.), the composition of Comparative Example 2 (Guyitang (Hunan) Health Technology Co., Ltd.), clinical route: oral, 10g once, 3 times a day, clinical course of treatment: 3 months, positive control group, name: metformin, specification: 0.5g × 10 tablets × 2 plates, production unit: Sino-US Shanghai Bristol-Myers Squibb Pharmaceutical Co., Ltd.

[0100] Experimental animals: 60 SPF-grade SD male rats, weight range: 180-220 g; (Hunan Slake Jingda Experimental Animal Co., Ltd.)

[0101] 3. Test methods:

[0102] 3.1 Model preparation and drug administration

[0103] 60 SD rats that passed the quarantine were selected, and 10 were randomly divided into a blank control group, and normal feed and free drinking water were given; the remaining rats were fed with high sugar and high fat for 4 weeks, and after 4 weeks of feeding, they were fasted for 12 hours, and streptozotocin (STZ) 35mg / kg was injected intraperitoneally to induce an obese type II diabetes model. After 5 days of STZ injection, the tail vein blood was taken to measure fasting blood sugar after fasting and water was not allowed for 12 hours. If the fasting blood sugar value of the rat is greater than 11mmol / L, it is determined that the model is successful. The rats with successful models were randomly divided into: model control group, comparative example 1, comparative example 2, embodiment 1, positive control group, 10 in each group. The drug group was gavaged with the corresponding dose of drugs at 25mL / kg, and the model control group and the blank control group were gavaged with equal volumes of pure water for 4 consecutive weeks.

[0104] 3.2 Dose setting

[0105] The proposed clinical dosage of the composition of Example 1 and Comparative Examples 1 and 2 is 30 g / day, which is converted into a rat clinical equivalent dosage based on body surface area = adult dosage × 0.018 × 5 = 2.7 g / kg. The dosage of the metformin group is set to 0.25 g / kg according to the literature.

[0106] 3.3 Drug preparation method:

[0107] Positive control group (metformin group): Take 3 tablets of metformin hydrochloride (1.5g), grind and add pure water to prepare 60mL (0.025g / mL)

[0108] Comparative Example 1, Comparative Example 2, Example 1: Weigh 6 g of the composition and add pure water to make up to 60 mL (0.1 g drug powder / mL)

[0109] The preparation volume was adjusted according to the weekly changes in rat body weight.

[0110] 3.4 Detection indicators

[0111] General observation: During the experiment, closely observe and record the appearance, behavior, secretions, excretions, diet, etc. of each group of animals. If an animal is found dead or dying, the animal should be dissected and observed in time. Weigh the animal every week.

[0112] Detection indicators: After the last administration, the rats were fasted but not watered for about 12 hours. Blood was collected using a blood glucose meter to measure fasting blood glucose levels. Blood was collected from the abdominal aorta to measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (TC), and triglyceride (TG) levels in rats.

[0113] Insulin level detection: The insulin level in rat serum was detected.

[0114] 3.5 Result calculation and statistics

[0115] SPSS 21.0 software was used for data statistics. Indicates that the comparison between multiple groups was first compared for normality and homogeneity of variance. When the variance was homogeneous and normal, the one-way analysis of variance was used. When it was not normal, the Nonparametric T test was used. When it was normal but the variance was not homogeneous, the Tamhane's T2 test was used. If it was not normal, the Kruskal-Wallis test was used, and the Mann-Whitney test was used for pairwise comparison analysis. P<0.05 indicated statistical significance, and P<0.01 indicated that the difference tested was very significant.

[0116] 4 Test results

[0117] 4.1 Effects on fasting blood glucose and insulin levels in rats

[0118] As shown in Table 8, compared with the blank control group, the fasting blood glucose values ​​of the animals in each group after modeling were significantly increased (P<0.01), and the fasting blood glucose value and insulin level of the model control group were significantly increased after administration (P<0.01); compared with the model control group, the fasting blood glucose values ​​of Comparative Example 1, Comparative Example 2, Example 1, and the positive control drug were significantly decreased after administration (P<0.05 or P<0.01), and the insulin levels of Comparative Example 2, Example 1, and the positive control drug were significantly decreased (P<0.05), and the insulin level of Comparative Example 1 was decreased, but the difference was not statistically significant (P>0.05); the fasting blood glucose value and insulin level of Example 1 were significantly decreased compared with Comparative Example 1 and Comparative Example 2 (P<0.05), and the fasting blood glucose value of Example 1 and the positive control drug decreased by a similar amount, and the insulin level decreased, but the differences were not statistically significant (P>0.05), and the fasting blood glucose value and insulin level of Comparative Example 2 and Comparative Example 1 were decreased, but the difference was not statistically significant (P>0.05), and the results are shown in Table 8. The test results indicate that the composition of Example 1 can significantly reduce the fasting blood glucose level of diabetic rats and has a certain improvement effect on insulin resistance.

[0119] Table 8 Effect of the composition of Example 1 on fasting blood glucose and insulin levels in rats ( n=10)

[0120]

[0121] Note: Compared with the blank control group, "**" indicates P < 0.01, compared with the model control group, "Δ" indicates P < 0.05, "ΔΔ" indicates P < 0.01, compared with comparative example 1, "#" indicates P < 0.05, compared with comparative example 2, "▲" indicates P < 0.05

[0122] 4.2 Effects on blood biochemical parameters of rats

[0123] As shown in Table 9, compared with the blank control group, the ALT, AST, TG, and TC levels of the model control group rats were significantly increased (P<0.01); compared with the model control group, the ALT, AST, TG, and TC levels of the comparative example 1, comparative example 2, embodiment 1, and the positive control group rats were significantly reduced (P<0.05 or P<0.01); compared with comparative example 1 and comparative example 2, the ALT, AST, TG, and TC levels of embodiment 1 were significantly reduced (P<0.05 or P<0.01), and compared with the positive control group, the ALT, AST, TG, and TC levels of embodiment 1 were reduced, but the difference was not statistically significant (P>0.05), and compared with comparative example 2, TG and TC were significantly reduced (P<0.05), and compared with comparative example 1, the ALT, AST, and levels of comparative example 2 were reduced, but the difference was not statistically significant (P>0.05). The results are shown in Table 9, and the test results indicate that the composition of embodiment 1 can effectively improve the abnormal lipid metabolism of diabetic rats.

[0124] Table 9 Effects of the composition of Example 1 on blood biochemical indices of rats ( n=10)

[0125]

[0126] Note: Compared with the blank control group, "**" indicates P < 0.01, compared with the model control group, "Δ" indicates P < 0.05, "ΔΔ" indicates P < 0.01, compared with comparative example 1, "#" indicates P < 0.05, "##" indicates P < 0.01, compared with comparative example 2, "▲" indicates P < 0.05

[0127] 5 Conclusion: Under the conditions of this experiment, the compositions of Comparative Example 1, Comparative Example 2 and Example 1 can reduce the fasting blood glucose values ​​of diabetic rats to varying degrees, and have a certain improvement effect on insulin resistance and abnormal lipid metabolism. Example 1 has better efficacy than Comparative Example 1 and Comparative Example 2; and Example 1 has a significant synergistic effect compared with Comparative Example 1 and Comparative Example 2.

[0128] The composition of Example 1 has a good therapeutic effect on obese type II diabetic rats.

[0129] Example 5 Clinical analysis data of the composition of Example 1

[0130] General information: 144 patients who met the criteria for the diagnosis of diabetes were selected for observation and randomly divided into Example 1 and a control group. Among them, in Example 1, there were 40 male patients and 32 female patients, aged 44 to 76 years old, with an average age of (58.25±7.36) years old. In terms of the course of diabetes, the course of disease was 6 to 15 years, with an average of (9.32±2.16) years. In terms of the course of peripheral neuropathy, the course of disease was 2 to 8 years, with an average of (5.47±1.82) years. In the control group, there were 38 male patients and 34 female patients, aged 45 to 74 years old, with an average age of (57.68±7.73) years old. In terms of the course of diabetes, the course of disease was 6 to 14 years, with an average of (9.63±2.31) years. In terms of the course of peripheral neuropathy, the course of disease was 2 to 8 years, with an average of (5.32±1.76) years. There was no significant difference in general data between the two groups (P>0.05), indicating that the two groups were comparable.

[0131] Inclusion criteria: (1) All patients met the WHO diagnostic criteria for type 2 diabetes; (2) All patients met the diagnostic criteria for diabetic peripheral neuropathy; (3) All patients had symptoms such as pain in the extremities and paresthesias; (4) All patients had a positive vibration threshold test.

[0132] Exclusion criteria: lactating and pregnant women, people with a history of drug allergies, people with speech and communication disorders, people with mental illness, people with complications of diabetes, people with chronic digestive system diseases, people with severe dysfunction of the heart, liver, kidney, etc., people with limb movement dysfunction, people with hematopoietic system diseases, and people with mental illness.

[0133] Treatment method: The control group took metformin orally (National Medicine Standard No. H20050699, specification: 0.5g), 0.5g / time, 3 times / d; the Example 1 group took the product of Example 1 of the present invention orally (provided by Gu Yitang (Hunan) Health Technology Co., Ltd., 10g / bag), 1 bag each time, 3 times a day, and both groups of patients were treated continuously for 3 months.

[0134] Observation indicators (1) TCM syndrome score. It includes pain, numbness, burning sensation, and abnormal sensation, each with 0 to 3 points, and a total score of 0 to 12 points, ranging from none to severe. (2) Cool and warm sensation threshold. (3) Blood sugar and blood lipid levels. (4) Vibration perception threshold (VPT), ​​including VPT of the dorsum of the foot and the first toe. (5) Observation of the incidence of adverse reactions. (6) Clinical efficacy: Cured: After treatment, the patient has no lower limb discomfort symptoms, the TCM syndrome score and VPT are reduced by 70% to 100%, and life and work return to normal; markedly effective: After treatment, the patient has basically no or significantly milder symptoms, and the TCM syndrome score and VPT are reduced by 50% to 69%; effective: After treatment, the patient has milder symptoms, and the TCM syndrome score and VPT are reduced by 30% to 49%; ineffective: After treatment, the patient's symptoms do not change significantly, and the TCM syndrome score and VPT examination are reduced by 0 to 29% or do not decrease or even increase. Total effective rate = (cured + markedly effective + effective) ÷ total number of cases × 100%

[0135] Statistical methods: SPSS16.0 statistical software was used for data collection and analysis. The t-test was used to compare the quantitative data, and the x2 test was used to compare the counting data; P < 0.05 indicated statistical significance.

[0136] Table 10 Comparison of TCM syndrome scores between the two groups of patients with diabetic peripheral neuropathy before and after treatment

[0137]

[0138]

[0139] Note: Compared with the group before treatment, "*" indicates P < 0.05, "**" indicates P < 0.01; compared with the control group after treatment, "#" indicates P < 0.05

[0140] Table 11 Comparison of cool sensation threshold, warm sensation threshold and pain sensation threshold between the two groups of patients with diabetic peripheral neuropathy before and after treatment

[0141]

[0142]

[0143] Note: Compared with the group before treatment, "*" indicates P < 0.05, "**" indicates P < 0.01; compared with the control group after treatment, "#" indicates P < 0.05

[0144] Table 12 Comparison of blood glucose levels before and after treatment in two groups of patients with diabetic peripheral neuropathy ( mmol / L)

[0145]

[0146] Note: Compared with the group before treatment, "*" indicates P < 0.05

[0147] Table 13 Comparison of VPT before and after treatment between the two groups of patients with diabetic peripheral neuropathy ( V)

[0148]

[0149] Note: Compared with the group before treatment, "*" indicates P < 0.05, "**" indicates P < 0.01; compared with the control group after treatment, "#" indicates P < 0.05, "##" indicates P < 0.01

[0150] Table 14 Comparison of clinical efficacy between two groups of patients with diabetic peripheral neuropathy [cases (%)]

[0151]

[0152] Note: Compared with the control group, "*" indicates P < 0.05

[0153] Table 15 Comparison of the incidence of adverse reactions between the two groups of patients with diabetic peripheral neuropathy [cases (%)]

[0154]

[0155] Note: Compared with the control group after treatment, *P<0.05.

[0156] As shown in Tables 10-15, the TCM syndrome scores, cool and warm sensation thresholds, blood glucose, and VPT of the two groups of patients before and after treatment were compared. Before treatment, there were no significant differences in the scores of pain, numbness, burning sensation, and abnormal sensation, as well as the total score of TCM syndrome, cool sensation threshold, warm sensation threshold, pain threshold, fasting blood glucose, 2h postprandial blood glucose, VPT of the dorsum of the foot, and VPT of the first toe between the two groups (P>0.05). After treatment, the scores of pain, numbness, burning sensation, and abnormal sensation, as well as the total score of TCM syndrome, cool sensation threshold, warm sensation threshold, fasting blood glucose, and postprandial blood glucose were significantly different between the two groups. 2h blood glucose, dorsum VPT, first toe VPT, and pain threshold were all lower than those before treatment (P<0.05); comparison of the efficacy of the two groups after treatment, fasting blood glucose and 2h postprandial blood glucose of the control group were close to those of the Example 1 group, with no significant difference (P>0.05), and other values ​​of the Example 1 group were lower than those of the control group (P<0.05); comparison of clinical efficacy: the Example 1 group had better efficacy than the control group (P<0.05); comparison of adverse reaction observation: the incidence of adverse reactions in the Example 1 group after treatment was lower than that in the control group, and the difference was statistically significant (P<0.05).

[0157] Example 6

[0158] A composition for treating diabetes, the formula and proportion by weight of which are: 6 parts of rice bran, 6 parts of bitter melon, 4 parts of cinnamon bark, 5 parts of light black beans, 7 parts of fig, 2 parts of ginseng, 6 parts of wolfberry, 4 parts of mulberry leaf, 7 parts of kudzu root, 4 parts of dendrobium officinale, 2 parts of wheat oligopeptide, 9 parts of oligofructose and 2 parts of dry yeast.

[0159] The preparation method is the same as that of Example 1, and the effect verification of the example is the same as that of Example 1, which has a hypoglycemic effect and will not be repeated here.

Claims

1. A composition for treating diabetes, characterized in that: The formula and proportion of the composition are as follows: 3-7 parts of rice bran, 3-7 parts of bitter melon, 1-5 parts of cinnamon, 3-7 parts of light black beans, 6-10 parts of figs, 1-5 parts of ginseng, 3-7 parts of wolfberries, 1-5 parts of mulberry leaves, 3-7 parts of kudzu roots, 1-5 parts of dendrobium officinale, 1-5 parts of wheat oligopeptides, 6-10 parts of oligofructose, and 1-3 parts of dry yeast.

2. The composition for treating diabetes according to claim 1, characterized in that: The formula and proportion of the composition are as follows: 5 parts of rice bran, 5 parts of bitter melon, 3 parts of cinnamon, 5 parts of light black beans, 8 parts of figs, 3 parts of ginseng, 5 parts of wolfberry, 3 parts of mulberry leaves, 5 parts of kudzu root, 3 parts of dendrobium officinale, 3 parts of wheat oligopeptide, 8 parts of oligofructose and 1 part of dry yeast.

3. The composition for treating diabetes according to claim 1, characterized in that: The formula and proportion of the composition are as follows: 6 parts of rice bran, 6 parts of bitter melon, 4 parts of cinnamon, 5 parts of light black beans, 7 parts of figs, 2 parts of ginseng, 6 parts of wolfberries, 4 parts of mulberry leaves, 7 parts of kudzu roots, 4 parts of dendrobium officinale, 2 parts of wheat oligopeptides, 9 parts of oligofructose, and 2 parts of dry yeast.

4. The composition for treating diabetes according to claim 1, characterized in that: The formulas are all in the form of powders with a mesh size of 60-100.

5. The method for preparing the composition for treating diabetes according to any one of claims 1 to 4, characterized in that: The preparation method comprises the steps of crushing rice bran, bitter melon, cinnamon bark, light black beans, fig, ginseng, wolfberry, mulberry leaf, kudzu root and dendrobium officinale into fine powder according to the above proportions, and passing through a 60-80 mesh sieve; then uniformly mixing with wheat oligopeptide, oligofructose and dry yeast, passing through a 80-100 mesh sieve, and mixing according to the above proportions to obtain a finished medicinal powder.

6. The method for preparing the composition for treating diabetes according to any one of claims 1 to 4, characterized in that: The finished drug powder is further made into one of tablets, granules, pills, capsules and oral liquids according to conventional techniques in the art.

7. Use of the composition according to any one of claims 1 to 4 in the preparation of a medicament for treating diabetes.

8. The use according to claim 7, characterized in that: The diabetes is type II diabetes.

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