Medicinal and edible composition capable of reducing blood sugar as well as preparation method and application of medicinal and edible composition

Abstract

The invention relates to the technical field of compositions capable of reducing blood sugar, in particular to a medicinal and edible composition capable of reducing blood sugar as well as a preparation method and application of the medicinal and edible composition capable of reducing blood sugar. The preparation method comprises the following steps: weighing 1-30 parts of fructus lycii, 3-40 parts of radix puerariae, 2-40 parts of fructus gardeniae, 1-20 parts of radix panacis quinquefolii, 1-20 parts of folium mori, 3-12 parts of charantin, 0.1-5 parts of berberine, 0.1-5 parts of natto polysaccharide and 0.1-5 parts of mannan oligosaccharide; crushing medlar, kudzuvine root, cape jasmine, American ginseng and mulberry leaf, adding into a container, adding water, decocting and extracting, filtering and collecting first filtrate and filter residue, adding the filter residue into ethanol, filtering and collecting second filtrate; mixing the first filtrate and the second filtrate to obtain a mixed filtrate, adding charantin, natto polysaccharide and berberine into the mixed filtrate, and performing vacuum concentration and vacuum drying to obtain a dry extract; and uniformly mixing the dry extract with mannan oligosaccharide to obtain the composition. The hypoglycemic drug prepared from the medicinal and edible composition can effectively prevent diabetic complications and help hyperglycemia people to achieve the purpose of assisting in reducing blood sugar through diet.

Description

Technical Field

[0001] The present invention relates to the technical field of blood sugar-lowering compositions, and particularly to a homologous composition of medicine and food capable of lowering blood sugar, its preparation method and application. Background Art

[0002] Diabetes mellitus is a common systemic disease mainly characterized by sugar metabolism disorders, caused by absolute or relative insulin deficiency and increased glucagon, with the vast majority being primary. With the development of the global economy, the improvement of people's living standards, the change of lifestyle and the aging of the population, the prevalence of diabetes shows an upward trend worldwide, becoming another chronic non-communicable disease that seriously endangers public health after cardiovascular and cerebrovascular diseases and tumors.

[0003] Generally, to diagnose whether a person has diabetes, two blood sugars need to be measured: one is called fasting blood sugar, which refers to the blood sugar measured on an empty stomach before breakfast. When monitoring fasting blood sugar, it is required to have dinner the night before, and not to eat any more at night after dinner, otherwise it will affect the measurement of fasting blood sugar.

[0004] Another standard is the blood sugar two hours after a meal, which refers to the blood sugar monitored two hours after starting to eat. If the fasting blood sugar > 6.1, or the blood sugar two hours after a meal > 7.8, but it does not reach the diagnostic criteria for diabetes, this situation is called "pre-diabetes". Such tested individuals may become new diabetics every day. Therefore, the population with "pre-diabetes" is the key population for preventing diabetes, and blood sugar can be controlled through methods such as diet. Therefore, a homologous composition of medicine and food capable of lowering blood sugar is needed. Summary of the Invention

[0005] The purpose of the present invention is to provide a homologous composition of medicine and food capable of lowering blood sugar, its preparation method and application, effectively preventing the occurrence of diabetes complications, and helping hyperglycemic people achieve the purpose of assisting in lowering blood sugar through diet.

[0006] To achieve the above purpose, the present invention provides a homologous composition of medicine and food capable of lowering blood sugar, including the following parts by mass of each component: 1 - 30 parts of Chinese wolfberry, 3 - 40 parts of kudzu root, 2 - 40 parts of gardenia, 1 - 20 parts of American ginseng, 1 - 20 parts of mulberry leaf, 3 - 12 parts of momordica charantia extract, 0.1 - 5 parts of berberine, 0.1 - 5 parts of nattokinase polysaccharide, and 0.1 - 5 parts of mannan oligosaccharide.

[0007] The preparation method of the above-mentioned homologous composition of medicine and food capable of lowering blood sugar includes the following steps

[0008] S1. Weigh 1-30 parts of wolfberry, 3-40 parts of kudzu root, 2-40 parts of gardenia, 1-20 parts of American ginseng, 1-20 parts of mulberry leaf, 3-12 parts of momordicin, 0.1-5 parts of berberine, 0.1-5 parts of nattokinase polysaccharide, and 0.1-5 parts of mannan oligosaccharide;

[0009] S2. Crush wolfberry, kudzu root, gardenia, American ginseng, and mulberry leaf and add them to a container. Add water for decoction extraction, filter to collect the first filtrate and the residue. Add the residue to ethanol for extraction, reflux in a water bath, and filter to collect the second filtrate;

[0010] S3. Mix the first filtrate and the second filtrate in S2 to obtain a mixed filtrate. Add momordicin, nattokinase polysaccharide, and berberine to the mixed filtrate, stir evenly, and under the condition of 45-55 °C, concentrate under reduced pressure to obtain an extract, and dry it in vacuo to obtain a dry extract;

[0011] S4. Mix the dry extract in S3 and mannan oligosaccharide evenly to obtain a composition.

[0012] Preferably, in S2, the crushing particle size is 25-100 mesh. When extracting with water, use strong fire first and then slow fire, and the decoction time is 45-60 min. When extracting with ethanol, reflux at 65% v / v ethanol aqueous solution and 60 °C for 1-3 h.

[0013] Preferably, in S3, the temperature for drying in vacuo is 35-50 °C.

[0014] The food-medicinal homologous composition prepared by the preparation method of the above food-medicinal homologous composition capable of reducing blood sugar.

[0015] The application of the above food-medicinal homologous composition capable of reducing blood sugar. The food-medicinal homologous composition is applied to the preparation of granules, capsules, oral preparations, injections, and tablets of hypoglycemic drugs, or to make medicinal meals for reducing blood sugar.

[0016] Therefore, the present invention adopts the above food-medicinal homologous composition capable of reducing blood sugar, its preparation method and application, and its beneficial effects are as follows:

[0017] 1. The food-medicinal homologous composition provided by the present invention has a good control effect on diabetes, can effectively reduce blood sugar, improve insulin resistance, improve blood sugar and blood lipid levels, etc.;

[0018] 2. The food-medicinal homologous composition provided by the present invention can effectively prevent the occurrence of diabetic complications and help hyperglycemic people achieve the purpose of auxiliary blood sugar reduction through diet.

[0019] The technical solutions of the present invention will be further described in detail below through the accompanying drawings and embodiments. Brief Description of the Drawings

[0020] Figure 1These are the HE staining diagrams of the liver and kidney tissue morphology of each group of rats. Specific Embodiments

[0021] The present invention will be further described below in conjunction with the accompanying drawings and embodiments. Unless otherwise defined, the technical terms or scientific terms used in the present invention should have the ordinary meaning understood by those of ordinary skill in the field to which the present invention belongs. The features mentioned above in the present invention or the features mentioned in the specific examples can be combined arbitrarily. These specific embodiments are only used to illustrate the present invention and not to limit the scope of the present invention.

[0022] Example 1

[0023] S1. Weigh 22 parts of wolfberry, 37 parts of kudzu root, 25 parts of gardenia, 15 parts of American ginseng, 18 parts of mulberry leaf, 3 parts of momordica charantia extract, 2 parts of berberine, 1.5 parts of natto polysaccharide, and 3 parts of mannan oligosaccharide.

[0024] S2. After crushing wolfberry, kudzu root, gardenia, American ginseng, and mulberry leaf, add them to a container, decoct with water for extraction, filter to collect the first filtrate and the residue. Add the residue to ethanol, reflux in a water bath, and filter to collect the second filtrate.

[0025] In S2, the crushing particle size is 80 mesh. When extracting with water, first use strong fire and then slow fire, and the decocting time is 50 min. When extracting with ethanol, reflux in 65% v / v ethanol aqueous solution at 60 °C for 2.5 h.

[0026] S3. Mix the first filtrate and the second filtrate in S2 to obtain a mixed filtrate. Add momordica charantia extract, natto polysaccharide, and berberine to the mixed filtrate, stir evenly, and under reduced pressure at 55 °C, concentrate to obtain an extract, and then vacuum dry to obtain a dry extract.

[0027] In S3, the temperature of vacuum drying is 45 °C.

[0028] S4. Mix the dry extract in S3 with mannan oligosaccharide evenly to obtain a composition.

[0029] Example 2

[0030] Take 15 g of the composition in Example 1, dissolve it in 100 mL of pure water, add 0.15 g of potassium sorbate, 0.5 g of glycyrrhizin, and 0.4 g of zinc gluconate, and stir evenly to obtain an oral preparation of the hypoglycemic drug.

[0031] Example 3

[0032] S1. Weigh 25 parts of wolfberry, 28 parts of kudzu root, 32 parts of gardenia, 15 parts of American ginseng, 18 parts of mulberry leaf, 3 parts of momordica charantia extract, 2 parts of berberine, 1.5 parts of natto polysaccharide, and 3 parts of mannan oligosaccharide.

[0033] S2. Crush wolfberry, kudzu root, gardenia, American ginseng and mulberry leaves, add them to a container, decoct with water for extraction, filter to collect the first filtrate and residue, add the residue to ethanol, reflux in a water bath, and filter to collect the second filtrate.

[0034] In S2, the crushing particle size is 90 mesh. When extracting with water, use strong fire first and then slow fire, and the decocting time is 50 min. When extracting with ethanol, reflux in 65% v / v ethanol aqueous solution at 60 °C for 2.5 h.

[0035] S3. Mix the first filtrate and the second filtrate in S2 to obtain a mixed filtrate. Add momordicin, nattokinase polysaccharide and berberine to the mixed filtrate, stir evenly, concentrate under reduced pressure at 55 °C to obtain an extract, and vacuum dry to obtain a dry extract.

[0036] In S3, the temperature of vacuum drying is 45 °C.

[0037] S4. Mix the dry extract in S3 with mannan oligosaccharide evenly to obtain a composition.

[0038] Example 4

[0039] S1. Weigh 26 parts of wolfberry, 32 parts of kudzu root, 25 parts of gardenia, 18 parts of American ginseng, 18 parts of mulberry leaves, 3 parts of momordicin, 2 parts of berberine, 1.5 parts of nattokinase polysaccharide and 3 parts of mannan oligosaccharide.

[0040] S2. Crush wolfberry, kudzu root, gardenia, American ginseng and mulberry leaves, add them to a container, decoct with water for extraction, filter to collect the first filtrate and residue, add the residue to ethanol, reflux in a water bath, and filter to collect the second filtrate.

[0041] In S2, the crushing particle size is 80 mesh. When extracting with water, use strong fire first and then slow fire, and the decocting time is 60 min. When extracting with ethanol, reflux in 65% v / v ethanol aqueous solution at 60 °C for 2.5 h.

[0042] S3. Mix the first filtrate and the second filtrate in S2 to obtain a mixed filtrate. Add momordicin, nattokinase polysaccharide and berberine to the mixed filtrate, stir evenly, concentrate under reduced pressure at 55 °C to obtain an extract, and vacuum dry to obtain a dry extract.

[0043] In S3, the temperature of vacuum drying is 50 °C.

[0044] S4. Mix the dry extract in S3 with mannan oligosaccharide evenly to obtain a composition.

[0045] Test Example 1

[0046] a. Establish a rat model

[0047] 180 male Sprague-Dawley rats (5 weeks old, 140 - 180 g) were selected. After one week of adaptive feeding, the modeling began. They were randomly divided into a blank control group of 30 rats and a high-sugar and high-fat group of 150 rats. The blank control group was fed with regular feed. After four weeks of feeding with a high-sugar and high-fat diet in the high-sugar and high-fat group, all rats in the blank control group and the high-sugar and high-fat group were fasted for 12 h without water restriction. Streptozotocin (STZ, from Sigma Company, USA) at a dose of 35 mg / kg was intraperitoneally injected into the rats in the high-sugar and high-fat group to induce a type II diabetes model, and an equal volume of 0.1 mol / L citrate buffer solution was intraperitoneally injected into the rats in the blank control group. One week later, the blood glucose of the rats in the high-sugar and high-fat group was measured from the posterior tail vein, and the fasting blood glucose values were continuously monitored for three days. The blood glucose values were all greater than 12 mmol / L, indicating successful model establishment.

[0048] The high-sugar and high-fat group was randomly divided into a model group, a positive drug group, a low-dose composition group, a medium-dose composition group, and a high-dose composition group, with 30 rats in each group.

[0049] b. Administer drugs to rats in different groups

[0050] The composition in Example 1 was added to physiological saline to prepare a composition liquid medicine with a concentration of 1 g / mL and stored at 4°C. According to the research method of equivalent dosage for experimental animals, based on the "Table of Equivalent Dosage Ratio Converted from Human to Animal Body Surface Area", the dosage converted from human to mouse was 0.3 g / kg / d for the low dose, 0.6 g / kg / d for the medium dose, and 1.2 g / kg / d for the high dose.

[0051] The positive drug group was intragastrically administered metformin (from Sino-US Shanghai Squibb Pharmaceutical Co., Ltd.) at 0.4 g / kg·d, the low-dose composition group was intragastrically administered the composition liquid medicine at 0.3 g / kg / d, the medium-dose composition group was intragastrically administered the composition liquid medicine at 0.6 g / kg / d, the high-dose composition group was intragastrically administered the composition liquid medicine at 1.2 g / kg / d, and the blank control group and the model group were intragastrically administered an equal volume of physiological saline. Continuous intragastric administration was carried out for 8 weeks. The body weight of the rats was weighed weekly, the food intake was recorded, and the fasting blood glucose value was measured.

[0052] Rat liver and kidney tissues were taken, fixed in 4% paraformaldehyde solution, embedded, sectioned. The sections were dewaxed with xylene, hydrated with gradient alcohol (100% → 95% → 80% → 70%) to distilled water, immersed in hematoxylin solution for 5 min, differentiated with hydrochloric acid alcohol for 3 s, rinsed with water to return to blue for 15 min, immersed in eosin solution for 3 min, the staining was terminated by washing with water, dehydrated with gradient alcohol (low concentration → high concentration), cleared with xylene, and sealed with neutral gum. The morphological characteristics of HE staining of liver and kidney tissues were observed under a microscope.

[0053] c. Index detection

[0054] The rats in different groups in b were weighed every 7 days. After 14 days of drug administration, the tail veins of the rats in different groups were punctured to collect blood to measure fasting blood glucose (the manufacturers of the blood glucose meter and blood glucose test strips were both SanNuo). The results are shown in Table 1.

[0055] Table 1. Data table of body weight and blood glucose of rats in different groups

[0056]

[0057] After five weeks of drug administration, the data of insulin resistance index, triglyceride and high-density lipoprotein of the rats in each group were detected. The results are shown in Table 2.

[0058] Table 2. Data table of insulin resistance index, triglyceride and high-density lipoprotein of rats in different groups

[0059]

[0060] d. Detection of hepatic and renal morphological structures

[0061] Pathological changes of the liver in rats of each group

[0062] As Figure 1 shown, the HE staining results showed that the liver structure of the rats in the blank control group was intact, the hepatocytes were arranged regularly, and the morphology was normal. After modeling, the hepatocytes of the rats in the model group were arranged disorderly and densely, the cell nuclei were hypertrophied, the volume was enlarged, the boundaries were blurred, there were a large number of inflammatory cells mainly lymphocytes infiltrated, some cells were necrotic, and there were small lipid droplet vacuoles. The hepatocytes of the rats in the positive drug group and the treatment group tended to be normalized, the arrangement was relatively regular, and the inflammatory infiltration decreased.

[0063] Pathological changes of the kidneys in rats of each group

[0064] As Figure 1 shown, the HE staining results showed that the glomerular basement membrane, mesangial matrix and capillary wall structure of the rats in the blank control group were all normal, and there were no hyperplasia, edema and inflammatory cell infiltration. After modeling, the kidneys of the rats in the model group showed diffuse damage as a whole, the glomerular basement membrane-like substances increased, the capillary walls thickened, the proximal tubular epithelial cells showed obvious edema, and obvious inflammatory cell infiltration was seen in some interstitium. In the positive drug group and the treatment group, there was mild hyperplasia in a small part of the glomerular mesangial matrix, the capillary walls were not significantly thickened, the interstitial fibrosis was not obvious, the overall morphology of the renal tubules was normal, there was no renal tubular atrophy or dilation, and there was no obvious inflammatory cell infiltration as a whole.

[0065] Test Example 2

[0066] I. Basic information

[0067] The research subjects were from Ningxia Hospital of Traditional Chinese Medicine and Traditional Chinese Medicine Research Institute. The starting time of the inclusion of cases for initial observation was October 2022, and the end time of observation was December 2024. Patients meeting the criteria for diabetes were selected, and an observational study was conducted after obtaining the informed consent of the patients. The random number table method was used for grouping, with 53 cases in the blank group, 68 cases in the traditional Chinese medicine group, and 59 cases in the control group.

[0068] II. Diagnostic Criteria

[0069] Refer to the diagnostic criteria for diabetes (ADA 1997 or WHO 1999)

[0070] 1. The typical symptoms of polyuria, polydipsia, polyphagia, and weight loss in diabetes plus random blood glucose ≥ 11.1 mmol / L (200 mg / dL), or 2. Fasting blood glucose ≥ 7.0 mmol / L (140 mg / dL), or 3. Two-hour blood glucose value in the oral 75-g glucose tolerance test (OGTT) ≥ 11.1 mmol / L. Each of the above diagnostic criteria should be verified again on another day.

[0071] Among them, random blood glucose refers to blood sampling at any time of the day, regardless of the time relationship with the previous meal;

[0072] Fasting blood glucose means fasting for more than 8 hours.

[0073] III. Inclusion Criteria:

[0074] Meeting the above diagnostic and syndrome differentiation criteria, regardless of gender; aged 18 - 70 years old; the patient or their family member is informed and signs the consent form.

[0075] IV. Exclusion Criteria:

[0076] Those who are allergic to the drugs in this study; those with combined organ function disorders such as the heart, liver, and kidneys; pregnant or lactating women; those with combined mental diseases.

[0077] V. Treatment Methods:

[0078] a. Blank Group

[0079] The patients in the blank group were treated with hypoglycemic drugs to control blood glucose at a normal level, and a targeted healthy diet and disease publicity and education plan were formulated, and exercise guidance was given. At the same time, antihypertensive and lipid-lowering treatments were taken to control blood pressure and blood lipid at a normal level.

[0080] b. Control Group

[0081] On the basis of the blank group, metformin was given orally, 1 g each time, three times a day (in the morning, middle, and evening), with a four-week course of treatment for a total of two courses.

[0082] c. Traditional Chinese Medicine Group

[0083] Based on the blank group, the oral liquid of the composition in Example 2 was given orally, 10 mL each time, once in the morning and once in the evening every day, and administered continuously for eight weeks.

[0084] VI. Observation Indicators

[0085] After treatment, fasting venous blood was examined. High-performance liquid chromatography was used to detect glycated hemoglobin (HbA1c), and glucose oxidase method was used to detect FBG; an automatic biochemical analyzer was used to detect blood lipid levels such as serum triglyceride (TG) and high-density lipoprotein cholesterol (HDL-C). The results are shown in Table 3. Each index of the traditional Chinese medicine group was significantly lower than that of the blank group.

[0086] Table 3. Index data table of each group after treatment

[0087]

[0088] VII. Efficacy Criteria and Treatment Effects

[0089] a. Efficacy Criteria

[0090] Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" to evaluate the treatment effect. Since diabetes still cannot be cured so far, to judge the drug efficacy, the changes in blood glucose and clinical symptoms after taking the medicine are used as the evaluation criteria, which are roughly divided into three levels.

[0091] 1. Marked effect: After treatment, the symptoms basically disappear, fasting blood glucose drops to <130 mg / dL, 2-hour postprandial blood glucose <150 mg / dL, 24-hour urine sugar quantification <10 g, or blood glucose and 24-hour urine sugar quantification decrease by more than 30% compared with before treatment.

[0092] 2. Effective: After treatment, the symptoms are significantly improved, fasting blood glucose drops to <150 mg / dL, 2-hour postprandial blood glucose <180 mg / dL, 24-hour urine sugar quantification is between 10 - 25 g, or blood glucose and 24-hour urine sugar quantification decrease by 10 - 29% compared with before treatment.

[0093] 3. Ineffective: After treatment for more than three months, the decrease in blood glucose and urine sugar does not reach the effective standard.

[0094] b. Treatment Results

[0095] As shown in Table 4, it is the treatment effect table of blood glucose and urine sugar before and after treatment.

[0096] Table 4. Data table of treatment effects of the control group and the traditional Chinese medicine group

[0097]

[0098] It can be seen that the treatment effect of the traditional Chinese medicine group is similar to that of the control group, indicating that the composition provided by the present invention has the effect of lowering blood glucose.

[0099] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that they can still modify or equivalently replace the technical solutions of the present invention, and these modifications or equivalent replacements cannot make the modified technical solutions deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. A medicine-food homologous composition capable of reducing blood sugar, characterized in that: Each component is included by mass parts: 1 - 30 parts of wolfberry, 3 - 40 parts of kudzu root, 2 - 40 parts of gardenia, 1 - 20 parts of American ginseng, 1 - 20 parts of mulberry leaf, 3 - 12 parts of momordica charantia extract, 0.1 - 5 parts of berberine, 0.1 - 5 parts of nattokinase polysaccharide, and 0.1 - 5 parts of mannan oligosaccharide.

2. The preparation method of the medicine-food homologous composition capable of reducing blood sugar according to claim 1, characterized in that: It includes the following steps. S1. Weigh 1 - 30 parts of wolfberry, 3 - 40 parts of kudzu root, 2 - 40 parts of gardenia, 1 - 20 parts of American ginseng, 1 - 20 parts of mulberry leaf, 3 - 12 parts of momordica charantia extract, 0.1 - 5 parts of berberine, 0.1 - 5 parts of nattokinase polysaccharide, and 0.1 - 5 parts of mannan oligosaccharide. S2. After crushing wolfberry, kudzu root, gardenia, American ginseng, and mulberry leaf, add them into a container, decoct with water for extraction, filter to collect the first filtrate and the residue, add the residue into ethanol for extraction, reflux in a water bath, and filter to collect the second filtrate. S3. Mix the first filtrate and the second filtrate in S2 to obtain a mixed filtrate, add momordica charantia extract, nattokinase polysaccharide, and berberine into the mixed filtrate, stir evenly, under the condition of 45 - 55 °C, concentrate under reduced pressure to obtain an extract, and dry it in vacuum to obtain a dry extract. S4. Mix the dry extract in S3 with mannan oligosaccharide evenly to obtain a composition.

3. The preparation method of the medicine-food homologous composition capable of reducing blood sugar according to claim 2, characterized in that: In S2, the crushing particle size is 25 - 100 mesh. When extracting with water, it is first with strong fire and then with slow fire, and the decocting time is 45 - 60 min. When extracting with ethanol, reflux at 65% v / v ethanol aqueous solution and 60 °C for 1 - 3 h.

4. The preparation method of the medicine and food homologous composition capable of reducing blood sugar according to claim 2, characterized in that: In S3, the temperature for vacuum drying is 35 - 50 °C.

5. A medicated and edible homologous composition prepared by the preparation method of the medicated and edible homologous composition capable of reducing blood sugar according to any one of claims 2 - 4.

6. Use of the medicated and food homologous composition capable of reducing blood glucose according to claim 5, characterized in that: The medicated and edible homologous composition is applied to the preparation of granules, capsules, oral preparations, injections, and tablets of hypoglycemic drugs, or to make medicated diets for reducing blood sugar.

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