Traditional Chinese medicine extract with blood sugar regulating effect

Abstract

The invention provides a traditional Chinese medicine extract with a blood sugar regulating effect, and relates to the technical field of traditional Chinese medicine extracts. The traditional Chinese medicine extract with the blood sugar regulating effect comprises an extract body, and the extract body comprises radix astragali, radix codonopsis, fructus lycii, semen coicis, rhizoma dioscoreae, radix puerariae, black mulberries, folium mori, red dates, fructus corni, poria cocos, herba taraxaci, semen armeniacae amarae, rhizoma polygonati, pumpkin seeds, radix glycyrrhizae, pericarpium citri reticulatae, herba dendrobii, radix polygonati officinalis, bitter gourd seeds, corn stigma and fructus momordicae. A tea bag is upgraded into health-care particles, an optimal sugar balance formula water extraction process is screened out, a combined weighting method is adopted, a G1-entropy weight method is used for comprehensive scoring, and an L9 (34) orthogonal design is combined, so that optimal water extraction process parameters are determined; scientific basis is provided for developing the sugar balance teabag into health food which is stable in process, controllable in quality and convenient to carry and take.

Description

Technical Field

[0001] The invention relates to the technical field of Chinese medicine extracts, in particular to a Chinese medicine extract with blood sugar regulating effect. Background Art

[0002] In the field of modern medicine, more and more individuals are beginning to adopt and use traditional Chinese medicine and natural medicine to lower blood sugar levels. The method of lowering blood sugar with traditional Chinese medicine has gradually become the preferred treatment for many diabetic patients. According to the theory of traditional Chinese medicine, diabetes is classified as a "thirstiness" disease, and it is recommended to use drugs that nourish the spleen and kidney, resolve phlegm, and clear the lungs and stomach. The Sugar Balance Recipe launched by Longxi Baohetang Pharmaceutical Co., Ltd. is a traditional Chinese medicine product in the form of tea bags. It can effectively regulate blood sugar levels by combining it with daily diet. Feedback from the market shows that this product is welcomed and loved by the majority of diabetic patients.

[0003] The Sugar Balance Recipe is composed of 22 kinds of Chinese medicinal materials that are both medicinal and edible, including Astragalus, Codonopsis, Chinese Yam, Jujube, Polygonatum, Taraxacum, Licorice, etc. Among these medicinal materials, Astragalus and Codonopsis are the main drugs, playing the main therapeutic role. Lycium barbarum, Coix seeds, Chinese Yam, Pueraria root, black mulberry, mulberry leaf, red dates, Cornus officinalis, Poria, Taraxacum, etc. are used as ministerial drugs in combination with Astragalus, further enhancing the effect of Astragalus in promoting fluid production and nourishing blood, and tonifying the spleen and kidney. In addition, bitter almonds, Polygonatum, pumpkin seeds, licorice, tangerine peel, Dendrobium, Polygonatum, bitter melon seeds, corn silk, Momordica grosvenori, etc. are used as adjuvants, and their addition helps to enhance the effect of the entire prescription in treating "diabetes".

[0004] These Chinese medicinal materials can not only assist in lowering blood sugar as medicine, but they can also be used as food supplements to help replenish the blood and essence needed by the human body. Studies have shown that the ingredients in the formula, such as astragalus polysaccharides, polygonatum polysaccharides, dandelion polysaccharides, wolfberry polysaccharides, and yam polysaccharides, have all been proven to have a positive effect in lowering blood sugar. However, although Sugar Balance Tea Bags have a certain effect in assisting in lowering blood sugar, it also has some limitations, such as inconvenience in use and restrictions on the target audience, which make it unable to meet the needs of a wider range of consumers. Summary of the invention

[0005] 1. Technical issues to be solved

[0006] In view of the deficiencies in the prior art, the present invention provides a Chinese herbal extract with the effect of regulating blood sugar, which solves the problems that sugar-balancing tea bag products are inconvenient to use, have a small target audience, and cannot meet the needs of more consumers.

[0007] (II) Technical solution

[0008] To achieve the above objectives, the present invention is implemented through the following technical scheme: a Chinese medicine extract with the effect of regulating blood sugar, including an extract body, the extract body including astragalus, codonopsis, wolfberry, coix seed, yam, kudzu root, black mulberry, mulberry leaf, red date, cornus officinalis, poria, dandelion, bitter almond, polygonatum, pumpkin seed, licorice, tangerine peel, dendrobium, polygonatum, bitter melon seed, corn silk, and monk fruit.

[0009] Preferably, the extract body is composed of 8g of astragalus, 5g of codonopsis, 5g of wolfberry, 6g of coix seed, 6g of yam, 6g of kudzu root, 6g of black mulberry, 5g of mulberry leaf, 5g of red dates, 5g of cornus officinalis, 5g of poria, 5g of dandelion, 4g of bitter almond, 4g of polygonatum, 3g of pumpkin seeds, 2g of licorice, 3g of tangerine peel, 3g of dendrobium, 3g of polygonatum, 5g of bitter melon seeds, 5g of corn silk, and 1g of momordica grosvenori.

[0010] Preferably, the extract is evaluated by a combined weighting method, with the G1-entropy weight comprehensive score of total polysaccharide content, puerarin, morroniside, loganin, chicoric acid, hesperidin content and extract yield as the evaluation index, and then combined with L 9 (3 4 ) orthogonal design was used to obtain the optimal water extraction process for making health-care granules, namely, the liquid-to-solid ratio was 12 times, the soaking time was 1.5h, the reflux extraction was 3h / time, and the extraction was performed 3 times.

[0011] (III) Beneficial effects

[0012] The present invention provides a Chinese medicine extract with a blood sugar regulating effect. It has the following beneficial effects. The present invention provides a Chinese medicine extract with a blood sugar regulating effect. In the present invention, after induction by streptozotocin (STZ), experimental mice showed a decrease in body weight and an increase in blood sugar levels. After drug intervention, the Sugar Balance Granules and the combined medication group with metformin showed a regulating effect on the changes in body weight and blood sugar levels of diabetic mice. In particular, the combined medication group had a significant effect on reducing the blood sugar level of diabetic mice. Analysis of blood lipid biochemical levels in the blood revealed the potential of Sugar Balance Granules in improving blood lipid metabolism disorders in type 2 diabetic mice. The triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) of diabetic mice were all abnormal. After intervention in each group of Sugar Balance Granules and the combined medication group, the concentrations of TG, TC, and LDL-C in type 2 diabetic mice were reduced, and the concentration of HDL-C was increased, and blood sugar balance was achieved by regulating the body's blood lipid metabolism. The results of enzyme-linked immunosorbent assay (ELISA) showed that the various dose groups and combined administration groups of Sugar Balance Granules could increase the serum insulin level of mice, reduce insulin resistance, and reduce the content of glycosylated hemoglobin, thus preventing the occurrence of diabetes-related complications. The detection of antioxidant enzyme content showed that the levels of total antioxidant capacity (T-AOC), glutathione peroxidase (GSH-Px), and superoxide dismutase (SOD) increased, and the level of malondialdehyde (MDA) decreased, indicating that Sugar Balance Granules could promote the decomposition of peroxides in mice, protect the body from oxidative damage, and thus regulate blood sugar levels. The results of hematoxylin-eosin (HE) staining of the pancreas, liver, and kidneys indicated that Sugar Balance Granules could improve liver and kidney damage in mice with type 2 diabetes. After drug intervention, Sugar Balance Granules and the combined administration group could reduce the damage to the pancreas, liver, and kidneys of mice. Finally, Sugar Balance Granules had a protective effect on the damage to the pancreas, liver, and kidney tissue cells in mice with type 2 diabetes. It can assist metformin in improving blood lipid metabolism disorders in type 2 diabetic mice, significantly improve the antioxidant capacity of the liver, pancreas and kidneys of type 2 diabetic mice, repair their oxidative damage, thereby increasing serum insulin content, alleviating insulin resistance, and having a blood sugar lowering effect. Therefore, Sugar Balance Granules can be selected as a health food to assist in lowering blood sugar, and provide a theoretical basis for its development and utilization. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 It is a schematic diagram of the axial side of the present invention;

[0014] Figure 2 This is a schematic diagram of the effect of the material-liquid ratio on the comprehensive score of the present invention;

[0015] Figure 3 This is a schematic diagram showing the effect of the soaking time on the comprehensive score of the present invention;

[0016] Figure 4 This is a schematic diagram showing the effect of the extraction time on the comprehensive score of the present invention;

[0017] Figure 5 This is a schematic diagram showing the effect of the number of extractions on the comprehensive score of the present invention;

[0018] Figure 6 Schematic diagram of the effect of TPH of the present invention on body weight (left) and blood sugar (right) of diabetic mice;

[0019] Figure 7 Schematic diagram of the effect of TPH of the present invention on four blood lipids in diabetic mice;

[0020] Figure 8 Schematic diagram of blood glucose level (left) and AUC (right) at different time periods after oral glucose administration of the present invention;

[0021] Fig. 9 Schematic diagram of INS value (left) and HOMA-IR (right) of each group of mice in the present invention;

[0022] Fig.10 The contents of SOD (A), GSH-PX (B), MDA (C), and T-AOC (D) in the liver tissue of each group of mice of the present invention;

[0023] Fig.11 This is a schematic diagram of the effect of TPH of the present invention on the pancreatic pathological morphology of mice;

[0024] Fig.12 Schematic diagram of the effect of TPH of the present invention on the pathological morphology of mouse liver;

[0025] Fig.13 It is a schematic diagram of the effect of TPH of the present invention on the pathological morphology of mouse kidney. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] The embodiment of the present invention provides a Chinese medicine extract with a blood sugar regulating effect, comprising an extract body, the extract body comprising astragalus, codonopsis, wolfberry, coix seed, yam, kudzu root, black mulberry, mulberry leaf, red date, cornus officinalis, Poria, dandelion, bitter almond, polygonatum, pumpkin seed, licorice, tangerine peel, dendrobium, polygonatum, bitter melon seed, corn silk, and monk fruit, and the extract body is 8g of astragalus, 5g of codonopsis, 5g of wolfberry, 6g of coix seed, 6g of yam, 6g of kudzu root, 6g of black mulberry, 5g of mulberry leaf, 5g of red date, 5g of cornus officinalis, 5g of Poria, and dandelion. 5g, bitter almond 4g, polygonatum 4g, pumpkin seed 3g, liquorice 2g, tangerine peel 3g, dendrobium 3g, polygonatum 3g, bitter melon seed 5g, corn silk 5g, momordica grosvenori 1g, the extract body adopts the combined weighting method, with the total polysaccharide content, puerarin, morroniside, loganin, chicoric acid, hesperidin content and extract yield G1-entropy weight method comprehensive score as the evaluation index, and then combined with L9 (34) orthogonal design, the optimal water extraction process for making health-care granules is obtained, that is, the liquid-to-solid ratio is 12 times, the soaking time is 1.5h, the reflux extraction is 3h / time, and the extraction is 3 times.

[0028] Example 1: The following is a single factor investigation experiment of the sugar balance extraction process:

[0029] Investigation experiment 1: Investigation of material-liquid ratio

[0030] Weigh the medicinal materials according to the sugar balance prescription composition, add 6 times, 8 times, 10 times, 12 times, and 14 times the amount of water respectively, soak for 2 hours, heat to boiling and continue to reflux for 3 hours, collect the filtrate, concentrate to 50mL, and set aside. The filtrate is used for HPLC determination of the content of each index component, the yield of the extract, and the total polysaccharide content. The comprehensive score of each determination result is shown in Figure 1 ,From the comprehensive score, it can be seen that as the material-liquid ratio increases, the content of related indicators also increases, and the comprehensive score rises. Therefore, according to the results, the material-liquid ratios of 1:8, 1:10, and 1:12 are selected as the analysis levels of the orthogonal test;

[0031] Investigation experiment 2: Investigation of soaking time

[0032] Weigh the medicinal materials according to the sugar balance prescription, add 10 times water and soak for 0.5h, 1.0h, 1.5h, 2.0h, and 2.5h respectively, heat to boiling and continue to reflux for 3h, collect the filtrate, concentrate to 50mL, and set aside. The filtrate is used for HPLC determination of the content of each index component, the yield of the extract, and the total polysaccharide content. The comprehensive score of each determination result is shown in Figure 2 ,From the comprehensive score, it can be seen that with the extension of immersion time, the content of related indicators also increases, and the comprehensive score rises. The results show that the comprehensive score is the highest when the immersion time is 1.5h. Therefore, according to the results, immersion time of 1.5h, 2h, and 2.5h are selected as the analysis levels of the orthogonal test;

[0033] Observation experiment 3: Investigation of extraction time

[0034] Weigh the medicinal materials according to the sugar balance prescription, add 10 times water to soak for 1.5 hours, heat to boiling and reflux for 1 hour, 1.5 hours, 2 hours, 2.5 hours, and 3 hours respectively, collect the filtrate for HPLC determination of each index component content, extract yield determination and total polysaccharide content determination. The comprehensive score of each determination result is shown in Figure 3 ,The results showed that the comprehensive score was the highest when the extraction time was 2.5 h, therefore, extraction time of 2 h, 2.5 h, and 3 h were selected as the analysis levels of the orthogonal test according to the results;

[0035] Experiment 4: Investigation of extraction times

[0036] Weigh the medicinal materials according to the sugar balance prescription, add 10 times water to soak for 1.5 hours, heat to boiling and continue to reflux, each reflux for 2.5 hours, extract 1, 2, 3, 4 times, collect the filtrate, concentrate to 50mL, and set aside. The filtrate is used for HPLC determination of the content of each index component, the yield of the extract, and the total polysaccharide content. The comprehensive score of each determination result is shown in Figure 4 When the extraction times were 3 times, the polysaccharide extraction rate was 98.35%, the extraction rates of morroniside, loganin, puerarin, chicoric acid and hesperidin were all greater than 98%, and the extract yield was 96.06%. Therefore, the extraction times were set to 3 times for subsequent experiments.

[0037] Orthogonal test

[0038] According to the results of single-factor experiments, three factors were selected, namely, solid-liquid ratio, soaking time and extraction time. Three levels were set for each factor. The experiment was carried out according to the L9(34) orthogonal table. The total polysaccharide content, HPLC content of five components, including puerarin, morroniside, loganin, chicoric acid and hesperidin, and the yield of extract were used as evaluation indicators. The combined weighting method was used for comprehensive scoring.

[0039] 1. Factor level table

[0040] Table 1 Orthogonal factor level table

[0041] Table 1Table of Orthogonal Factor Levels

[0042]

[0043] 2. Orthogonal experimental design and results

[0044] Table 2 Intuitive analysis table

[0045] Table 2Analyze tables visually

[0046]

[0047]

[0048]

[0049] Comprehensive evaluation variance analysis table

[0050] Table 3Comprehensive evaluation analysis of variance table

[0051]

[0052] From the intuitive analysis table, we can see that the degree of influence is A>B>C, that is, solid-liquid ratio>immersion time>extraction time. From the variance analysis results, we can see that the liquid-to-solid ratio has a significant effect on the extraction (p<0.05), and the immersion time and extraction time have no significant effect. It can be seen that the solid-to-liquid ratio has the greatest influence on the extraction of this recipe. The best optimized process finally screened out is A3B1C3, that is, the best extraction process is 12 times water, immersion for 1.5 hours, extraction for 3 hours, and extraction 3 times.

[0053] 3. Verification test

[0054] According to the compound ratio, three portions of medicinal materials were weighed, and the optimal water extraction process parameters were applied and extracted three times for verification. The results are shown in Table 4. The RSD values ​​of each calculation were all less than 3%, proving that the process was stable and feasible.

[0055] Table 4 Process validation test results

[0056]

[0057]

[0058] The optimal water extraction process of the Sugar Balance Formula was optimized through orthogonal experiments, namely, the liquid-to-solid ratio was 12 times, the soaking time was 1.5h, the reflux extraction was 3h / time, and the extraction was performed 3 times. The results of variance analysis showed that the liquid-to-solid ratio had a significant effect on the extraction (p<0.05), but the soaking time and extraction time had no significant effect. The reason may be that the experimental design scheme took into account the traditional Chinese medicine decoction conditions, and the factor level intervals were small. The three extractions narrowed the differences between the results of each group, but had no effect on the experimental results. The results of the optimal process verification confirmed that the process was stable and feasible, and was suitable for the extraction of various Chinese medicines in the Sugar Balance Formula, providing a scientific basis for the subsequent research and development and industrialization of the preparation.

[0059] Example 2: Study on the effect of Sugar Balance Granules in assisting blood sugar reduction

[0060] Experimental methods

[0061] 1 Grouping, modeling and drug administration

[0062] Modeling: 80 Balb / C male mice were adaptively fed for 1 week and randomly divided into a control group and a model group. The control group was fed with normal feed, and the rest were model groups. They were all fed with high-fat feed for 6 weeks. The T2MD model was established by a single intraperitoneal injection of STZ at a dose of 55 mg / kg per day through a preliminary experiment. The model was established for 3 consecutive days. The model was established successfully when the random fasting blood glucose was ≥11.1 mmol / L and the 2h postprandial blood glucose was ≥16.7 mmol / L. All mice in this experiment were successfully modeled.

[0063] Grouping: The successfully modeled mice were randomly divided into metformin group (Met), sugar balance granules high (TPH-H), medium (TPH-M), low dose group (TPH-L), and sugar balance medium dose combined with metformin group (Met-TPH), with 10 mice in each group.

[0064] Administration: The oral drug dosage was calculated according to the body surface area of ​​humans and mice. The high, medium and low groups of Sugar Balance Granules were given Sugar Balance Granules 9.10 g / kg, 4.55 g / kg and 2.28 g / kg by oral administration, respectively. The metformin group was given metformin hydrochloride solution 0.2 g / kg. The control group and the model group were given normal saline by oral administration, once a day for 2 consecutive months.

[0065] 2. Sample Collection

[0066] The experimental sample collection is divided into mid-term collection and final collection, which are collected at 1 month and 2 months of drug administration respectively.

[0067] The mice were anesthetized with sodium pentobarbital, blood was collected from the eyeballs, left to stand at room temperature for 1 hour, centrifuged at 3500r / min for 5 minutes, and serum was collected and stored in a -80°C refrigerator for subsequent ELISA and biochemical index detection. Liver, pancreas, and kidney tissues were separated, rinsed with 4°C saline, and excess water was removed by filter paper. One part was stored in a -80°C refrigerator for subsequent Western blot and RT-qPCR detection, and the other part was fixed with 4% paraformaldehyde solution for subsequent HE staining.

[0068] 3. Observation of body weight, blood sugar and metabolic status

[0069] After one week of adaptive feeding, the mice were fed with a high-fat diet for 2 months, and then STZ injections were started for modeling. The body weight of each group of mice was recorded at the same time every week. In the second week after STZ injection, the body weight of the mice decreased significantly, the random fasting blood glucose was >11.1mmol / L, and the random postprandial blood glucose was >16.7mmol / L. The modeling was successful, and drug administration was started. At the same time, the drinking, eating and excretion of type 2 diabetic mice were observed.

[0070] 4 Oral glucose tolerance test (OGTT) and calculation of area under the curve

[0071] An oral glucose tolerance test was performed 4 weeks after administration. After fasting for 6 hours, the mice were gavaged with 0.1 mL / 10 g of a freshly prepared 20% glucose solution according to their body weight. The blood glucose levels at 0, 30, 60, and 120 minutes after glucose injection were measured with a blood glucose meter, and the area under the curve (AUC) was calculated to compare the glucose tolerance levels of each group.

[0072] 5. Detection of mouse serum biochemical indicators

[0073] 5.1 Blood lipid index detection

[0074] After 1 month and 2 months of intervention treatment, the whole blood of mice was collected and kept at room temperature for 1 hour, then centrifuged at 3000r / min at 4℃ for 5-10 minutes, and the upper light yellow serum was transferred for use. The total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL-C), and low-density lipoprotein (LDL-C) contents were determined using a biochemical analyzer.

[0075] 5.2 Serum insulin (INS) and glycosylated hemoglobin (HbAlc) content detection

[0076] One month after drug intervention, whole blood of mice was collected and allowed to stand at room temperature for 1 h, then centrifuged at 3000 r / min at 4°C for 5-10 min, the upper light yellow serum was transferred for use, and the glycosylated hemoglobin (HbAlc) content was determined using the mouse glycosylated hemoglobin enzyme-linked immunosorbent assay kit; after the end of drug administration, the glycosylated hemoglobin (HbAlc) content was determined again using the mouse glycosylated hemoglobin enzyme-linked immunosorbent assay kit, and the fasting serum insulin (INS) level was determined using the mouse insulin enzyme-linked immunosorbent assay kit, and the insulin resistance index (HOMA-IR) was calculated as fasting insulin (INS) × fasting blood glucose (FBG) / 22.5.

[0077] 6. Determination of mouse liver indexes

[0078] A certain weight of liver was weighed and added with normal saline in a ratio of 1:9 to prepare liver homogenate. The supernatant was collected by centrifugation (3000×g, 10 min) and the levels of T-AOC (total antioxidant capacity), GSH-PX (glutathione peroxidase), MDA (malondialdehyde), and SOD (superoxide dismutase) were determined using corresponding kits.

[0079] 7HE staining to detect the pathological morphology of liver, pancreas and kidney tissues

[0080] After the eyeball blood was drawn, the liver, kidney and pancreas tissues of the mice were taken out, and the samples were fixed with 10% formaldehyde, embedded in paraffin and sectioned in a conventional manner, stained with hematoxylin-eosin (HE), and examined for pathological damage under a light microscope.

[0081] Experimental Results

[0082] Effects of 1 Sugar Balance Granules on Body Weight, Fasting Blood Glucose and Metabolism of Type 2 Diabetic Mice

[0083] Weight: From Table 5 and Figure 5 It can be seen that after the model was successfully established, the body weight of the mice was reduced compared with that of the normal group mice, but the body weight of the mice gavaged with metformin, sugar balance granules and the combined drug administration group showed a steady-state fluctuation. The body weight of the diabetic mice in the untreated model group showed a downward trend. At the end of the entire experiment, the body weight of the mice in the model group was significantly lower than that of the mice in the normal group and other drug administration groups.

[0084] Fasting blood sugar: from Table 6 and Figure 5 It can be seen that compared with the model group, the Met-TPH group can reduce the blood sugar of type 2 diabetic mice by about 3mmol / L, the TPH-H group can reduce the blood sugar of type 2 diabetic mice by about 2mmol / L, and the positive drug Met can reduce the blood sugar of type 2 diabetic mice by about 2.3mmol / L. The above results show that Sugar Balance Granules have a blood sugar-lowering effect, but combined with metformin can play a better blood sugar-lowering effect.

[0085] Metabolic status of mice: Observations showed that compared with the blank group, the amount of water drunk, food eaten and excreted by type 2 diabetic model mice increased significantly. The litter of type 2 diabetic mice became moist and hardened, had a noticeable odor, and was changed more frequently. With drug intervention, the mice in each treatment group showed significant improvement.

[0086] Table 5 Body weight of mice in each group

[0087]

[0088]

[0089] Table 6 FBG values ​​of mice in each group after successful modeling

[0090]

[0091] Effects of 2 Sugar Balance Granules on Four Items of Blood Lipids in Type Ⅱ Diabetic Mice

[0092] The relationship between blood lipid levels and diabetes is very close, and diabetes can be improved by improving blood lipid levels, as shown in Table 7 and Figure 6 As shown in the figure, compared with the blank group, the TG, TC, and LDL-C levels in the model group were significantly increased (p<0.05), and the HDL-C level was significantly decreased (p<0.05). Among the drug-treated groups, the Met-TPH group had the most obvious improvement effect, followed by the Met and TPH-H groups, which could improve the symptoms to varying degrees, indicating that Sugar Balance Granules can improve dyslipidemia in type 2 diabetes.

[0093] Table 7 Changes of four blood lipids in each group of mice

[0094]

[0095]

[0096] Note: Compared with the blank group, ## indicates p<0.01, # indicates p<0.05; compared with the model group, ** indicates p<0.01, * indicates p<0.05.

[0097] Effects of 3-sugar balance granules on oral glucose tolerance in type Ⅱ diabetic mice

[0098] OGTT is an important method for diagnosing diabetes and is used to assess the body's ability to absorb a specific amount of glucose, as shown in Table 8 and Figure 7 As shown in the figure, after intragastric administration of glucose solution 4 weeks after administration, the blood glucose levels of each group reached a peak within 30 minutes and then began to decline. At each time point, the blood glucose of the mice in the Mod group was significantly higher than that in the Con group (p<0.01), indicating that the glucose tolerance of diabetic mice was abnormal; compared with the Mod group, the blood glucose concentrations of the Met-TPH, Met, TPH-H, TPH-M, and TPH-L groups were significantly reduced (p<0.05), indicating that Sugar Balance Granules can improve the abnormal glucose tolerance of type 2 diabetic mice.

[0099] Table 8 Blood glucose levels and AUC of mice in each group at different time periods after oral glucose administration

[0100]

[0101]

[0102] Note: Compared with the blank group, ## indicates p<0.01, # indicates p<0.05; compared with the model group, ** indicates p<0.01, * indicates p<0.05.

[0103] Effects of 4-sugar balance granules on serum insulin (INS) and insulin resistance index (HOMA-IR) in type Ⅱ diabetic mice

[0104] Insulin is a substance secreted by the body that can lower blood sugar. In the early stages of diabetes, abnormally high blood sugar levels cause increased insulin secretion. As the disease progresses, pancreatic islet cells become damaged, and the insulin content in serum decreases, eventually leading to insulin resistance, which can cause peripheral tissue damage or other lesions. At the end of the experiment, the serum insulin content of each group of mice was tested, and the insulin resistance index of each group of diabetic mice was calculated, as shown in Table 9 and Figure 8 As shown, compared with the Con group, the INS content in the Mod group was significantly reduced (p<0.01), and the islet resistance index was also significantly increased (p<0.05), indicating that the insulin sensitivity of diabetic mice was decreased; compared with Mod, the INS content of diabetic mice in each group treated with drug was significantly higher than that in the Mod group (p<0.01), among which the Met-TPH group had the most obvious effect, followed by the metformin and TPH-H groups, indicating that the administration of Sugar Balance Granules combined with metformin can reduce the insulin resistance of type 2 diabetic mice.

[0105] Table 9 INS values ​​and HOMA-IR of mice in each group

[0106]

[0107]

[0108] Note: Compared with the blank group, ## indicates p<0.01, # indicates p<0.05; compared with the model group, ** indicates p<0.01, * indicates p<0.05.

[0109] Effects of 5-sugar balance granules on glycosylated hemoglobin (HbAlc) in type Ⅱ diabetic mice

[0110] Glycated hemoglobin can be used as a disease monitoring indicator for diabetic patients, which can reflect the changes in blood sugar levels of patients in the past 1-2 months. Fig. 9 The results showed that after one month of administration, there was no significant difference in the HbAlc content of diabetic mice in each group. After two months of administration, the HbAlc content of Mod group mice was significantly increased compared with that of Con group (p<0.01). Compared with Mod group, the HbAlc content of Met-TPH, Met and TPH groups was significantly decreased (p<0.01), indicating that Sugar Balance Granules can regulate blood sugar in type 2 diabetic mice.

[0111] Table 10 Glycated hemoglobin (HbAlc) content of mice in each group at two periods

[0112]

[0113] Note: Compared with the blank group, ## indicates p<0.01, # indicates p<0.05; compared with the model group, ** indicates p<0.01, * indicates p<0.05.

[0114] Effects of 6-sugar balance granules on antioxidant enzyme activities in the liver of type Ⅱ diabetic mice

[0115] As shown in Table 11 and Fig.10 As shown, compared with the Con group, the MDA content in the liver tissue of the Mod group was significantly increased (p<0.01), and the SOD, GSH-Px and T-AOC contents were significantly decreased (p<0.01); compared with the Mod group, the MDA content in the liver tissue of the Met-TPH, Met and TPH groups was significantly decreased (p<0.01), and the SOD, GSH-Px and T-AOC contents were significantly increased (p<0.01), indicating that Sugar Balance Granules can clear lipid peroxides in mice, promote the decomposition of peroxides in mice, and protect the body from oxidative damage.

[0116] Table 11 Contents of SOD, GSH-PX, MDA and T-AOC in liver tissues of mice in each group

[0117]

[0118] Note: Compared with the blank group, ## indicates p<0.01, # indicates p<0.05; compared with the model group, ** indicates p<0.01, * indicates p<0.05.

[0119] 7HE staining to detect the pathological morphology of pancreas, liver and kidney tissues

[0120] Mouse pancreatic tissue morphology Fig.11 Compared with the Con group, the number of islet cells in the Mod group was reduced, the cells were arranged more loosely, and the islet structure was significantly destroyed, with obvious vacuoles in some cytoplasms. The number and structure of islets in the Met group were significantly improved. The size and cell compactness of the islets in each dose group of TPH were higher than those in the Mod group in a dose-dependent manner. The islet morphology of the combined group and TPH-H group was improved to a greater extent, which was comparable to that of the Con group, indicating that Sugar Balance Granules had a good protective effect on the islets of diabetic mice.

[0121] The cell morphology of the liver of mice in the Con group was plump, healthy, and had obvious boundaries. The liver of mice in the Mod group had obvious pathological phenomena, with loosely arranged hepatocytes, cysticness or necrosis in some cells, and obvious intercellular spaces and fibrosis (indicated by the red arrows in the figure). The Met group showed a greater degree of improvement, with tighter cell arrangement, smaller spaces, and fewer vacuoles. The liver lesions of mice in each dose group of TPH were improved to varying degrees compared with the Mod group, and were dose-dependent; among them, the liver fibrosis of mice in the Met-TPH combination group was greatly improved, with tight and orderly arranged hepatocytes, smaller spaces, and fewer vacuoles. This shows that Sugar Balance Granules can reduce the degree of liver damage in type 2 diabetic mice. The results are shown in the table. Fig.12 .

[0122] HE staining results showed that the renal tissue structure of mice in the Con group was clear and complete, without inflammatory cell infiltration, and the boundary between the renal medulla and renal cortex was obvious. Compared with the Con group, the glomeruli of mice in the Mod group were enlarged, with cell proliferation and irregular cell morphology, narrow renal capsule cavity, partial edema of cells, blurred boundary between renal medulla and renal cortex, and inflammatory cell infiltration. Compared with the model group, the above pathological damage of the renal tissue of mice in each drug-treated group was alleviated to varying degrees, and the high-dose group and the Met-TPH combined group had significant effects. Results are shown in Fig.13 .

[0123] The purpose of this study was to explore the auxiliary hypoglycemic effect of Sugar Balance Granules on type 2 diabetic mice. The mice induced by STZ had reduced body weight and increased blood sugar. After drug intervention, Sugar Balance Granules and the combined drug group had a regulatory effect on the changes in body weight and blood sugar levels of diabetic mice, and the combined drug group could significantly reduce the blood sugar of diabetic mice. The results of blood lipid biochemical levels showed that Sugar Balance Granules could improve the lipid metabolism disorders in type 2 diabetic mice. The TG, TC, LDL-C, and HDL-C of diabetic mice were abnormal. After intervention with Sugar Balance Granules and the combined drug group, it was found that it could reduce the concentrations of TG, TC, and LDL-C in type 2 diabetic mice, and increase the concentration of HDL-C. And it plays a role in balancing blood sugar; ELISA results showed that each dose group of Sugar Balance Granules and the combined administration group could increase the serum insulin content of mice, reduce their islet resistance, reduce the glycated hemoglobin content, and prevent the occurrence of other complications; the results of antioxidant enzyme content detection showed that T-AOC, GSH-Px, and SOD levels increased, and MDA levels decreased, indicating that Sugar Balance Granules can promote the decomposition of peroxides in mice and protect the body from oxidative damage, thereby regulating blood sugar; HE staining results of pancreas, liver, and kidney suggested that Sugar Balance Granules can improve liver and kidney damage in type 2 diabetic mice. After drug intervention, Sugar Balance Granules and the combined administration group were able to reduce the damage to the pancreas, liver, and kidneys of mice.

[0124] In summary, Sugar Balance Granules have a protective effect on pancreatic, liver and kidney tissue cell damage in type 2 diabetic mice. It can assist metformin in improving blood lipid metabolism disorders in type 2 diabetic mice. It can also significantly improve the antioxidant capacity of the liver, pancreas and kidneys of type 2 diabetic mice and repair their oxidative damage, thereby increasing serum insulin levels and alleviating insulin resistance. It has a hypoglycemic effect and can be used as an option for auxiliary blood sugar-lowering health food, providing a theoretical basis for its development and utilization.

[0125] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese herbal medicine extract having a blood sugar regulating effect, comprising an extract body, characterized in that: The extract comprises astragalus, codonopsis, wolfberry, coix seed, yam, kudzu root, black mulberry, mulberry leaf, red date, cornus officinalis, tuckahoe, dandelion, bitter almond, polygonatum, pumpkin seed, licorice, tangerine peel, dendrobium, polygonatum, bitter melon seed, corn silk, and monk fruit.

2. The Chinese herbal extract having a blood sugar regulating effect according to claim 1, characterized in that: The extract body is matched by weight with 8g of astragalus, 5g of codonopsis, 5g of wolfberry, 6g of coix seed, 6g of yam, 6g of kudzu root, 6g of black mulberry, 5g of mulberry leaf, 5g of red date, 5g of cornus officinalis, 5g of poria, 5g of dandelion, 4g of bitter almond, 4g of polygonatum, 3g of pumpkin seed, 2g of licorice, 3g of tangerine peel, 3g of dendrobium, 3g of polygonatum, 5g of bitter melon seed, 5g of corn silk, and 1g of momordica grosvenori.

3. The Chinese herbal extract having a blood sugar regulating effect according to claim 1, characterized in that: The extract ontology adopts a combined weighting method, taking the G1-entropy weight method comprehensive score of total polysaccharide content, puerarin, morroniside, loganin, chicoric acid, hesperidin content and extract yield as evaluation indicators, and then combining L9(3 4 ) orthogonal design was used to obtain the optimal water extraction process for making health-care granules, namely, the liquid-to-solid ratio was 12 times, the soaking time was 1.5h, the reflux extraction was 3h / time, and the extraction was performed 3 times.

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