Medicinal and edible composition for assisting in regulating blood sugar as well as preparation method, application and preparation of medicinal and edible composition

Abstract

The invention belongs to the technical field of medicinal and edible compositions, and particularly relates to a medicinal and edible composition for assisting in regulating blood sugar as well as a preparation method, application and a preparation of the medicinal and edible composition. The medicinal and edible composition consists of folium mori, black sesame, radix polygonati officinalis and Chinese yam. Animal experiments show that only four medicinal and edible substances including mulberry leaves, black sesames, polygonatum odoratum and Chinese yams are used as the medicinal and edible composition, so that the medicinal and edible composition has a very good hypoglycemic effect, and compared with the prior art, the composition disclosed by the invention is simple in component, reasonable in compatibility, low in cost, small in dosage and quick in short-term hypoglycemic effect. The medicinal and edible composition disclosed by the invention not only has a remarkable postprandial blood sugar reducing effect, but also has a remarkable improvement effect on common complications such as dry mouth and thirst of diabetes mellitus caused by deficiency of both qi and yin, and the medicinal and edible composition is natural and harmless in raw materials, high in safety, sweet and mild in integral taste and suitable for being taken for a long time.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicine and food homologous compositions, and particularly relates to a medicine and food homologous composition for assisting in regulating blood glucose, a preparation method and application thereof, and a preparation. Background Art

[0002] Diabetes is a chronic metabolic disorder characterized by hyperglycemia caused by various etiologies. The occurrence of diabetes is inevitably accompanied by blood glucose imbalance. When the pancreas secretes insulin into the blood, it causes the conduction of the insulin signal pathway, accelerating the body's uptake and utilization of glucose. After glucose is taken up by cells, it undergoes glycolysis or complete oxidation and reduction to supply the body's energy needs or is synthesized into glycogen for standby. Once any link in the above process is abnormal, it will lead to blood glucose imbalance and insulin resistance, thus causing diabetes. Diabetes, also known as consumptive thirst disorder in traditional Chinese medicine. From the perspective of traditional Chinese medicine, the most common syndrome type is qi and yin deficiency type, mainly manifested as dry mouth, thirst, and fatigue. At present, there are already many marketed chemical drugs for treating diabetes, such as insulin, metformin, sulfonylureas, and α-glucosidase inhibitors, etc. Chemical drugs for lowering blood glucose are targeted at the control of diabetes and can quickly inhibit and relieve symptoms, but they have many side effects; while traditional Chinese medicines for treating diabetes, such as total alkaloids from mulberry twigs tablets, require a treatment course of 24 weeks, with high costs, and may have side effects such as abdominal distension, diarrhea, and nausea and other gastrointestinal irritation symptoms; traditional Chinese medicine compounds generally have more pharmacologically active substances, lower pharmacological activity potencies, and weaker toxic effects, and exert the maximum drug efficacy through long-term accumulation, which makes traditional Chinese medicine have higher safety and play a role through multiple components, multiple targets, and multiple pathways. At the same time, many raw materials of traditional Chinese medicines have food therapy effects. As of 2025, 110 traditional Chinese medicines have been approved by the state as medicine and food homologous raw materials, that is, substances that are both food and traditional Chinese medicines according to tradition (medicine and food homologous) list, and can be developed into functional foods.

[0003] For example, the ancient classic prescription Sangma Pills, which comes from the Ming Dynasty medical book "Shoushi Baoyuan", was originally named Fusang Zhibao Pills, and was made by refining honey into pills with mulberry leaves and black sesame seeds. It is a medicine for prolonging life and is suitable for long-term use, making the human body "smooth all over, with renewed energy, no diseases; walking briskly and having clear eyes; prolonging life, replenishing marrow and adding essence; and also being able to eliminate phlegm and promote fluid production". It is suitable for long-term health care, and clinically can be used as a basic prescription for treating diabetes of the "qi and yin deficiency" type, but the dosage of the drug is not clearly defined in the book.

[0004] For another example, Chinese Invention Patent Publication No. CN108514093A discloses a multifunctional food composition for assisting in reducing blood sugar and its preparation method. The food composition includes the following components in parts by weight: 20 - 40 parts of Chinese yam, 10 - 30 parts of polygonatum odoratum, 2 - 20 parts of wolfberry fruit, 2 - 20 parts of poria cocos, 1 - 5 parts of balsam pear, 1 - 5 parts of polygonatum sibiricum, 1 - 5 parts of hawthorn, 1 - 5 parts of black sesame, 1 - 4 parts of mulberry leaf, 1 - 4 parts of dandelion, 1 - 2 parts of kudzu root, and 1 - 2 parts of platycodon grandiflorum. It has the functions of assisting in reducing blood sugar, increasing insulin sensitivity, protecting the liver, and improving the intestinal flora. However, the food composition of this invention not only has complex components and high costs, but also requires continuous administration for 35 days, with a long administration cycle and slow efficacy in reducing blood sugar.

[0005] Another Chinese Invention Patent Publication No. CN113730506A discloses a traditional Chinese medicine composition for reducing blood sugar and prolonging life and its preparation method. It is composed of the following raw materials in weight percentages: kudzu root, salvia miltiorrhiza, tartary buckwheat, Chinese yam, wolfberry fruit, astragalus membranaceus, ophiopogon japonicus, pumpkin seeds, mulberry leaf, American ginseng, polygonatum odoratum, and processed fleece-flower root. The kudzu root, salvia miltiorrhiza, and American ginseng are micronized powders after being broken and ground, with a particle size below 10 μm - 20 μm; the Chinese yam, wolfberry fruit, polygonatum odoratum, and processed fleece-flower root are powders obtained by subjecting the ground materials to blood sugar reduction treatment; the mulberry leaf refers to a powder obtained by mixing the concentrated extract of mulberry leaf with a coating agent and subjecting it to spray drying. In this invention, kudzu root and salvia miltiorrhiza are the monarch drugs, mulberry leaf and tartary buckwheat are the ministerial drugs. Pumpkin seeds contain cucurbitine, vitamin B1, and vitamins, and have good curative effects in regulating carbohydrate metabolism. Supplementary processed fleece-flower root, and astragalus membranaceus and ophiopogon japonicus are added to invigorate the middle qi, strengthen the spleen and stomach, promote yang and consolidate the root. Polygonatum odoratum, American ginseng, Chinese yam, and wolfberry fruit rich in amino acids are the adjuvant and guiding drugs. However, the raw materials of this traditional Chinese medicine composition are as many as 12 kinds, and it needs to be taken for 1 - 3 months. After long-term use, it is easy to damage the liver and produce side effects, and the preparation method is complex, including blood sugar reduction treatment, ultrafine grinding, and spray drying, which is difficult for industrial production.

[0006] Therefore, it is very important to provide a composition based on the principle of traditional Chinese medicine compatibility and using medicine and food homology substances as raw materials, which has simple components, high safety, low cost, quick efficacy for short-term use in assisting in regulating blood sugar, and obvious therapeutic effects on "qi and yin deficiency type" diabetes. Summary of the Invention

[0007] In view of the problems existing in the prior art, the present invention provides a medicine and food homology composition for assisting in regulating blood sugar, its preparation method, application, and preparation.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows: A medicine and food homology composition for assisting in regulating blood sugar, which is composed of mulberry leaf, black sesame, polygonatum odoratum, and Chinese yam.

[0009] Preferably, by weight parts, the medicine and food homology composition is composed of 10 parts - 14 parts of mulberry leaves, 2 parts - 4 parts of black sesame seeds, 3 parts - 6 parts of polygonatum odoratum, and 1 part - 3 parts of Chinese yam.

[0010] More preferably, by weight parts, the medicine and food homology composition is composed of 11 parts - 13 parts of mulberry leaves, 3 parts - 4 parts of black sesame seeds, 3 parts - 5 parts of polygonatum odoratum, and 1.5 parts - 3 parts of Chinese yam.

[0011] Further preferably, by weight parts, the medicine and food homology composition is composed of 12 parts of mulberry leaves, 4 parts of black sesame seeds, 3 parts of polygonatum odoratum, and 3 parts of Chinese yam.

[0012] The mechanism of the medicine and food homology composition of the present invention for assisting in regulating blood glucose: Mulberry leaves, [Nature and flavor] cold, sweet, bitter. [Meridian tropism] Return to the liver and lung meridians. [Functions and indications] Disperse wind-heat, moisten the lung and dryness, clear the liver and improve eyesight. Used for wind-heat cold, dry cough due to lung heat, dizziness and headache, red and dim eyes. The bioactive substances such as flavonoids, alkaloids, and polysaccharides contained in mulberry leaves can play a role in reducing blood glucose through pathways such as inhibiting α-glucosidase, reducing pancreatic islet oxidative damage, maintaining β-cell function, enhancing hepatic glycogen synthesis, and affecting the insulin signaling pathway.

[0013] Black sesame seeds, [Nature and flavor] sweet, flat. [Meridian tropism] Return to the liver, kidney, and large intestine meridians. [Functions and indications] Tonify the liver and kidney, benefit essence and blood, moisten the intestine and relieve constipation. Used for deficiency of essence and blood, dizziness and blurred vision, tinnitus and deafness, premature whitening of hair, hair loss after illness, and intestinal dryness and constipation.

[0014] Polygonatum odoratum, [Nature and flavor] sweet, slightly cold. [Meridian tropism] Return to the lung and stomach meridians. [Functions and indications] Nourish yin and moisten dryness, promote the production of body fluid and quench thirst. Used for yin injury of the lung and stomach, dry cough due to dryness-heat, dry throat and thirst, and internal heat and polydipsia. Modern research shows that polygonatum odoratum polysaccharide can improve insulin sensitivity, improve insulin resistance, and regulate glucose and lipid metabolism, etc.

[0015] Chinese yam, [Nature and flavor] sweet, flat. [Meridian tropism] Return to the spleen, lung, and kidney meridians. [Functions and indications] Tonify the spleen and stomach, promote the production of body fluid and benefit the lung, tonify the kidney and astringe essence. Used for poor appetite due to spleen deficiency, chronic diarrhea, cough due to lung deficiency, spermatorrhea due to kidney deficiency, leukorrhea, frequent urination, and deficiency-heat and polydipsia. Modern research also shows that Chinese yam polysaccharide has a significant blood glucose-lowering effect.

[0016] The combination of the above 4 kinds of substances homologous to medicine and food has not been reported in terms of assisting in reducing blood glucose and simultaneously improving symptoms of diabetes complications such as dry mouth and thirst.

[0017] In addition, in addition to referring to pharmacopoeias, ancient books, reported literature and other materials, the present invention also screened and enriched the active pharmaceutical ingredients and targets related to black sesame, mulberry leaves, yam and polygonatum in the formula through the traditional Chinese medicine system pharmacology database and analysis platform TCMSP to support the rationality and comprehensiveness of the formula of the present invention.

[0018] The present invention also provides a preparation for assisting in regulating blood sugar, comprising the above-mentioned medicine-food composition.

[0019] The present invention also provides a method for preparing the above-mentioned medicine-food composition, comprising the following steps: (1) First, crush and sieve mulberry leaves, black sesame seeds, polygonatum odoratum and yam, and mix them to obtain mixed powder; (2) adding water to the mixed medicine, soaking, boiling, filtering, and collecting the residue and filtrate; (3) Finally, boil the residue with water, filter, combine the filtrate and concentrate to obtain the product.

[0020] Preferably, the mesh size of the sieving in step (1) is 30-50 mesh.

[0021] Preferably, in step (2), the mass volume ratio of the mixed powder to water is 1 g:8 mL-12 mL, and the soaking time is 35-45 min.

[0022] Preferably, the mass volume ratio of the filter residue to water in step (3) is 1 g:4 mL-6 mL.

[0023] Preferably, the decoction temperatures in step (2) and step (3) are both 90° C.-100° C., and the decoction time is both 25 min-45 min.

[0024] Preferably, the density after concentration in step (3) is 0.4 g / mL-0.6 g / mL.

[0025] The present invention also provides the use of the medicine-food homologous composition prepared by the above preparation method in preparing products for regulating blood sugar levels.

[0026] Preferably, the product is a food or a medicine, and the product further comprises excipients acceptable to the food or medicine.

[0027] Preferably, the dosage form of the product is a liquid preparation, paste, pill, powder or granule.

[0028] Compared with the prior art, the present invention has the following beneficial effects: (1)Animal experiments of the present invention show that only four medicated and edible homologous substances, namely mulberry leaves, black sesame seeds, polygonatum odoratum, and Chinese yams, as a medicated and edible homologous composition can have a good blood sugar lowering effect. Compared with the prior art, the composition of the present invention has simple components, reasonable compatibility, low cost, small dosage, and rapid short-term blood sugar lowering effect.

[0029] (2)The medicated and edible homologous composition of the present invention has obvious therapeutic effect on "qi and yin deficiency type" diabetes. Its raw materials are natural and harmless, with high safety, suitable for long-term use, and the overall taste is sweet and flat. Description of the Drawings

[0030] Figure 1 Effect of the compositions prepared in Example 1, Comparative Example 1, and Comparative Example 2 on postprandial blood glucose levels.

[0031] Figure 2 Effect of the compositions prepared in Examples 2 - 3 and Comparative Examples 3 - 5 on postprandial blood glucose levels.

[0032] Figure 3 Effect on blood glucose levels of "qi and yin deficiency type" diabetes.

[0033] Figure 4 Effect on water intake of "qi and yin deficiency type" diabetes.

[0034] Figure 5 Effect on food intake of "qi and yin deficiency type" diabetes.

[0035] Figure 6 Venn diagram of the active ingredient targets of the medicated and edible homologous composition and diabetes targets.

[0036] Figure 7 GO functional analysis of the targets related to the treatment of diabetes by the medicated and edible homologous composition.

[0037] Figure 8 KEGG pathway analysis of the targets related to the treatment of diabetes by the medicated and edible homologous composition.

[0038] Figure 1 and Figure 2 In, compared with the control group, * indicates P <0.05, *** indicates P <0.001.

[0039] Figure 3 and Figure 4 In, compared with the blank control group, *** indicates P <0.001; compared with the group of Example 1, # indicates P <0.05,## Indicate P <0.01. Specific implementation mode

[0040] It is worth noting that the raw materials used in the present invention are all ordinary commercially available products.

[0041] Example 1 A medicated and edible homologous composition for assisting in regulating blood sugar, which is composed of 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum odoratum, and 300 g of Chinese yam.

[0042] The preparation method of this composition is as follows: (1) First, pulverize mulberry leaves, black sesame seeds, polygonatum odoratum, and Chinese yam and pass through a 40-mesh sieve, then mix to obtain a mixed powder; (2) Then add water to the mixed powder (the ratio of material to liquid is 1 g:10 mL), soak for 40 min, decoct at 100 °C for 30 min, filter, and collect the filter residue and filtrate; (3) Finally, add water to the filter residue (the ratio of material to liquid is 1 g:5 mL), decoct at 100 °C for 30 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.5 g / mL, thus obtaining the product.

[0043] Example 2 A medicated and edible homologous composition for assisting in regulating blood sugar, which is composed of 1200 g of mulberry leaves, 200 g of black sesame seeds, 300 g of polygonatum odoratum, and 300 g of Chinese yam.

[0044] The preparation method of this composition is as follows: (1) First, pulverize mulberry leaves, black sesame seeds, polygonatum odoratum, and Chinese yam and pass through a 30-mesh sieve, then mix to obtain a mixed powder; (2) Then add water to the mixed powder (the ratio of material to liquid is 1 g:8 mL), soak for 35 min, decoct at 90 °C for 45 min, filter, and collect the filter residue and filtrate; (3) Finally, add water to the filter residue (the ratio of material to liquid is 1 g:4 mL), decoct at 90 °C for 45 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.6 g / mL, thus obtaining the product.

[0045] Example 3 A medicated and edible homologous composition for assisting in regulating blood sugar, which is composed of 1200 g of mulberry leaves, 400 g of black sesame seeds, 600 g of polygonatum odoratum, and 150 g of Chinese yam.

[0046] The preparation method of this composition is as follows: (1) First, pulverize mulberry leaves, black sesame seeds, polygonatum odoratum, and Chinese yam and pass through a 50-mesh sieve, then mix to obtain a mixed powder; (2) Then add water to the mixed powder (the ratio of material to liquid is 1 g:12 mL), soak for 45 min, decoct at 100 °C for 35 min, filter, and collect the residue and filtrate; (3) Finally, add water to the residue (the ratio of material to liquid is 1 g:6 mL), decoct at 100 °C for 35 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.4 g / mL, thus obtaining the product.

[0047] Comparative Example 1 The difference from Example 1 is only that the components also contain wolfberry fruit, specifically as follows: A medicated and edible homologous composition for assisting in regulating blood sugar, which is composed of 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum odoratum, 300 g of Chinese yam, and 300 g of wolfberry fruit.

[0048] (1) First, crush mulberry leaves, black sesame seeds, polygonatum odoratum, Chinese yam, and wolfberry fruit through a 40-mesh sieve, and mix to obtain a mixed powder; (2) Then add water to the mixed powder (the ratio of material to liquid is 1 g:10 mL), soak for 40 min, decoct at 100 °C for 30 min, filter, and collect the residue and filtrate; (3) Finally, add water to the residue (the ratio of material to liquid is 1 g:5 mL), decoct at 100 °C for 30 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.5 g / mL, thus obtaining the product.

[0049] Comparative Example 2 The difference from Example 1 is only that the components also contain polygonatum sibiricum, specifically as follows: A medicated and edible homologous composition for assisting in regulating blood sugar, which is composed of 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum odoratum, 300 g of Chinese yam, and 300 g of polygonatum sibiricum.

[0050] The preparation method of this composition is as follows: (1) First, crush mulberry leaves, black sesame seeds, polygonatum odoratum, Chinese yam, and polygonatum sibiricum through a 40-mesh sieve, and mix to obtain a mixed powder; (2) Then add water to the mixed powder (the ratio of material to liquid is 1 g:10 mL), soak for 40 min, decoct at 100 °C for 30 min, filter, and collect the residue and filtrate; (3) Finally, add water to the residue (the ratio of material to liquid is 1 g:5 mL), decoct at 100 °C for 30 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.5 g / mL, thus obtaining the product.

[0051] Comparative Example 3 The difference from Example 1 is only that the component ratio is different, specifically as follows: A medicine-food homologous composition for assisting in regulating blood sugar, which is composed of 300 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum odoratum, and 300 g of Chinese yam.

[0052] The preparation method of this composition is the same as that of Example 1.

[0053] Comparative Example 4 The difference from Example 1 is only in the component ratios, which are specifically as follows: A medicine-food homologous composition for assisting in regulating blood sugar, which is composed of 1200 g of mulberry leaves, 2000 g of black sesame seeds, 300 g of polygonatum odoratum, and 300 g of Chinese yam.

[0054] The preparation method of this composition is the same as that of Example 1.

[0055] Comparative Example 5 The difference from Example 1 is only in the component ratios, which are specifically as follows: A medicine-food homologous composition for assisting in regulating blood sugar, which is composed of 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum odoratum, and 2000 g of Chinese yam.

[0056] The preparation method of this composition is the same as that of Example 1.

[0057] Test Example 1 Postprandial blood sugar reduction assessment experiments were respectively conducted on the medicine-food homologous compositions for assisting in regulating blood sugar prepared in Example 1, Comparative Example 1, and Comparative Example 2. The specific experimental methods are as follows: 1. Experimental materials 1.1 Research objects: The medicine-food homologous compositions prepared in Example 1, Comparative Example 1, and Comparative Example 2.

[0058] 1.2 Experimental animals: 24 SPF-grade male ICR mice, 3 weeks old, with a body weight of 15 g - 20 g, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., and the experimental animal production license number: SCXK (Jing) 2021 - 0006.

[0059] 2. Experimental methods The ICR mice had free access to water. After fasting for 12 h, they were randomly divided into a control group, an Example 1 group, a Comparative Example 1 group, and a Comparative Example 2 group, a total of 4 groups, with 6 mice in each group. The gavage doses for the Example 1 group, the Comparative Example 1 group, and the Comparative Example 2 group were 2.86 g / kg; the control group was gavaged with an equal volume of distilled water. Half an hour later, each group was gavaged with 3 g / kg of sucrose. The blood glucose values were measured using a blood glucose meter at 30 min, 60 min, and 120 min after the last gavage, and the AUC value was calculated using GraphPad Prism 8 software to evaluate the effect of the composition on the total blood sugar.

[0060] Note: The area under the curve (AUC) of the blood glucose curve is an indicator used to evaluate blood glucose control. It reflects the overall change in blood glucose by calculating the area under the blood glucose curve over a certain period of time. The larger the AUC value, the greater the blood glucose fluctuation and the worse the control; the smaller the AUC value, the smaller the blood glucose fluctuation and the better the control. Therefore, as an important indicator for evaluating blood glucose control, the AUC value is of great significance for the management and treatment of diabetic patients.

[0061] 3. Statistical methods Statistical differences between groups were compared using one-way analysis of variance. P A p-value < 0.05 indicates statistical significance.

[0062] 4. Data analysis The experimental results are shown in Table 1 and Figure 1 as follows. Compared with the control group, the blood glucose values at 30 min, 60 min, and the AUC value of the mice in Example 1 were significantly decreased ( P p < 0.05 or P p < 0.001), indicating that the hypoglycemic effect of Example 1 was significant.

[0063] Compared with the control group, although the blood glucose value of Comparative Example 1 at 30 min was significantly lower than that of the control group, it did not reach the blood glucose peak, and it still showed a slow upward trend from 30 min to 60 min. In particular, the blood glucose value at 60 min was even slightly higher than that of the control group. Considering that its AUC value was not significantly decreased, it indicated that this comparative example could delay blood glucose absorption but had no significant effect on reducing the total blood glucose. In addition, from the perspective of the total blood glucose, the AUC value of Comparative Example 1 was significantly higher than that of Example 1, indicating that its overall hypoglycemic effect was weaker than that of Example 1; while there were no significant differences in the blood glucose peak and AUC value of Comparative Example 2, and the AUC value was significantly higher than that of Example 1.

[0064] The above experimental results show that only the specific medicated diet composition of the present invention has a significant hypoglycemic effect on both postprandial blood glucose value and total blood glucose. It has simple components, low cost, small dosage, and fast hypoglycemic effect.

[0065] Table 1 Effects of the compositions prepared in Example 1, Comparative Example 1, and Comparative Example 2 on postprandial blood glucose value and total blood glucose

[0066] Note: Compared with the blood glucose value at the same time point in the control group, * indicates P p < 0.05, *** indicates P< 0.001; when the letters a and b are the same, it indicates that there is no significant difference between the AUC values of the two, and when the letters are different, it indicates that there is a significant difference between the AUC values of the two.

[0067] Test Example 2 Postprandial blood glucose reduction assessment experiments were respectively conducted on the medicated and edible homologous compositions for assisting in regulating blood glucose prepared in Examples 2 - 3 and Comparative Examples 3 - 5. The specific experimental methods are as follows: 1. Experimental materials 1.1 Research objects: Medicated and edible homologous compositions prepared in Examples 2 - 3 and Comparative Examples 3 - 5.

[0068] 1.2 Experimental animals: 30 SPF - level male ICR mice, 3 - week - old, with a body weight of 15 g - 20 g, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., and the experimental animal production license number: SCXK (Jing) 2021 - 0006.

[0069] 2. Experimental methods The ICR mice had free access to water. After fasting for 12 h, they were randomly divided into a control group, Example 2 groups - Example 3 groups, and Comparative Example 3 groups - Comparative Example 5 groups, a total of 6 groups, with 5 mice in each group. The gavage doses for Example 2 groups - Example 3 groups and Comparative Example 3 groups - Comparative Example 5 groups were 2.86 g / kg; the gavage dose for the control group was an equal volume of distilled water. Half an hour later, each group was gavaged with 3 g / kg of sucrose. Blood glucose values were measured using a blood glucose meter at 30 min, 60 min, and 120 min after the last gavage, and the AUC value was calculated using GraphPad Prism 8.0 software to evaluate the effect of the composition on the total blood glucose.

[0070] 3. Statistical methods Statistical differences between groups were compared using one - way ANOVA. P < 0.05 indicates that the difference is statistically significant.

[0071] 4. Data analysis The experimental results are shown in Table 2 and Figure 2 As shown, compared with the control group, the blood glucose values and AUC of the mice in Examples 2 and 3 were significantly decreased ( P < 0.05), indicating that both examples had significant blood glucose - lowering effects. Compared with the control group, although the AUC values of the blood glucose curves of the mice in Comparative Examples 3 and 4 were significantly decreased, there was no significant difference in the blood glucose peak values. There was no significant difference in the blood glucose peak values and AUC values of the mice in Comparative Example 5, indicating that only the medicated and edible homologous composition under the specific ratio of the present invention had a significant blood glucose - lowering effect both in terms of blood glucose peak value and total blood glucose.

[0072] Table 2 Effects of the composition of the present invention on blood glucose value and total blood glucose

[0073] Note: When comparing with the blood glucose values at the same time points in the control group, * indicates P <0.05; when comparing with the AUC value of the control group, # indicates P <0.05.

[0074] Test Example 3 The therapeutic effect of the medicated diet composition with homologous origin of medicine and food prepared in Test Example 1 on diabetes is as follows. The specific experimental method is as follows: 1. Experimental materials 1.1 Research objects: The medicated diet composition with homologous origin of medicine and food prepared in Example 1 and the concentrated mulberry leaf extract.

[0075] The preparation method of the concentrated mulberry leaf extract is as follows: Weigh 81 g of mulberry leaves, add 3000 mL of purified water and soak for 40 min, then decoct for 30 min, filter, add 3000 mL of water to the filter residue and decoct again for 30 min, combine the two decoction solutions and concentrate to prepare a concentrated mulberry leaf extract with a concentration of 0.27 g / mL for standby.

[0076] 1.2 Experimental animals: 32 Wistar rats, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., and the experimental animal production license number: SCXK (Beijing) 2021-0006.

[0077] 2. Animal model establishment The Wistar rats were first fed adaptively for 1 week, then fed with high-fat diet for 2 weeks, fasted overnight without water deprivation for 1120 min, and then intraperitoneally injected with streptozotocin (STZ) at a dose of 35 mg / kg (in an ice bath at 4°C, STZ was freshly prepared with a pH = 4.5 citrate-citrate buffer solution with a concentration of 0.1 mol / L). One week after injecting STZ, the rats were bled from the tail vein to measure fasting blood glucose (fasting for 16 h) and glucose tolerance. Rats with fasting blood glucose > 11.1 mmol / L and the area under the glucose curve (AUC) > 30 were selected as the "qi and yin deficiency type" diabetes model.

[0078] 3. Animal grouping and administration Wistar rats were randomly divided into a blank control group, a model group, an Example 1 group, and a mulberry leaf group, with a total of 4 groups, 8 rats in each group. Except for the blank control group, rats in the other groups were used to establish a model of type 2 diabetes with qi and yin deficiency. After modeling, rats in the Example 1 group and the mulberry leaf group were given the corresponding concentrated solution, with a gavage dose of 10 mL / kg each time, twice a day, for 6 weeks; the blank control group and the model group were given the same volume of distilled water. Once a week, after 4 hours of fasting, blood was collected from the tail vein of the rats, and the blood glucose value (mmol·L -1 ) was measured using a blood glucose meter, and the average AUC value was calculated using GraphPad Prism 8 software.

[0079] 4. Statistical methods Statistical differences between groups were compared using one-way ANOVA, P and <0.05 indicated that the difference was statistically significant.

[0080] 5. Data analysis 5.1 Effect on blood glucose value: As Figure 3 shown, at the 6th week, compared with the blank control group, the blood glucose value of rats in the model group was significantly higher than that of the blank control group ( P <0.001), indicating that the "qi and yin deficiency type" diabetes model was successfully established; compared with the Example 1 group, the blood glucose values of the model group and the mulberry leaf group were significantly higher than that of the Example 1 group ( P <0.05), indicating that the medicated diet composition of Example 1 had significant hypoglycemic activity and was stronger than mulberry leaf. In addition, the blood glucose value of the mulberry leaf group was higher than that of the model group, and there was no significant difference between the two, indicating that mulberry leaf had no significant hypoglycemic activity. The above results showed that for "qi and yin deficiency type" diabetes, long-term use of mulberry leaf alone had no hypoglycemic effect, while the medicated diet composition of the present invention had a significant effect of reducing blood glucose in diabetic patients.

[0081] 5.2 Effect on water intake: As Figure 4 shown, at the 6th week, compared with the blank control group, the water intake of rats in the model group was significantly higher than that of the blank control group ( P <0.001), indicating that the "qi and yin deficiency type" diabetes model would show the phenomenon of dry mouth and excessive drinking; compared with the Example 1 group, the water intakes of the model group and the mulberry leaf group were significantly higher than that of the Example 1 group ( P <0.01), indicating that the medicated diet composition of Example 1 had a significant effect of improving dry mouth and could basically make the water intake reach the normal state. In addition, the water intake of the mulberry leaf group was higher than that of the model group, and there was no significant difference between the two, indicating that mulberry leaf had no activity of improving dry mouth and excessive drinking in diabetic patients. The above results showed that for "qi and yin deficiency type" diabetes, long-term use of mulberry leaf alone had no effect on improving dry mouth and excessive drinking in diabetes, while the medicated diet composition of the present invention had a significant effect of improving dry mouth and excessive drinking in diabetic patients.

[0082] 5.3 Effect on food intake: As Figure 5 shown, at the 4th week, the food intake of the rats in Example 1 group was slightly lower than that in the model group and the mulberry leaf group, having the potential efficacy of improving the symptom of "polyphagia".

[0083] Test Example 4 Apply bioinformatics methods to screen and enrich analyze the active ingredients and targets in the medicated diet and homologous composition of the present invention, and further verify the rationality of the formula of the composition of the present invention. The steps are as follows: 1. Search for the medicated diet and homologous components black sesame, mulberry leaf, Chinese yam and polygonatum odoratum of the present invention through the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP https: / / old.tcmsp-e.com / tcmspsearch.php), and set the oral bioavailability (OB) ≥ 30% and drug likeness (DL) ≥ 0.18, combined with Lipinski's five principles (Mw ≤ 500, miLogP ≤ 5, nOHNH ≤ 5, nOH ≤ 10) as the screening conditions to search for the drug active ingredients and targets related to the medicated diet and homologous composition.

[0084] Through screening by the TCMSP database, 5 active ingredients of black sesame, 18 active ingredients of mulberry leaf, 9 active ingredients of Chinese yam, and 8 active ingredients of polygonatum odoratum were obtained. The ingredient information is shown in Table 3 - Table 6 respectively. Through collection by the Pubchem database and TCMSP database, and processing by the SwissTargetPrediction database and Uniprot database, a total of 572 potential targets were identified for 40 active ingredients.

[0085] Table 3 Active Ingredients of Black Sesame

[0086] Table 4 Active Ingredients of Mulberry Leaf

[0087] Table 5 Active Ingredients of Chinese Yam

[0088] Table 6 Active Ingredients of Polygonatum Odoratum

[0089] 2. Use the Pubchem database (https: / / pubchem.ncbi.nlm.nih.gov) to find the Canonical SMILES of the components homologous to medicine and food, predict the targets of the components homologous to medicine and food through SwissTargetPrediction (http: / / www.swisstargetprediction.ch), and screen the action targets with a possibility greater than 0; use the TCMSP database (https: / / old.tcmsp-e.com / tcmsp.php) to find the protein targets corresponding to the active ingredients of the components homologous to medicine and food, convert the key chemical component information screened from the TCMSP database into target proteins through the Uniprot database (https: / / www.uniprot.org), eliminate the non-human target proteins, and comprehensively integrate the targets of the two databases to finally determine the targets corresponding to the components homologous to medicine and food.

[0090] 3. Use "Diabetes mellitus" as the keyword to retrieve the potential targets of the disease in the DisGeNET ( https: / / www.disgenet.org ), and GeneCards ( https: / / www.genecards.org ). Integrate the targets of the two databases and remove the duplicate targets to obtain the potential targets of diabetes.

[0091] There are 1,455 related targets in the DisGeNET database and 1,829 related targets in the Gene Cards database. After merging the targets of the two disease databases and deleting the duplicate values, 2,476 targets related to diabetes are obtained.

[0092] 4. Use Venny 2.1.0 ( https: / / bioinfogp.cnb.csic.es / tools / venny ) to intersect the screened chemical component targets with the disease targets to obtain 257 potential action targets of the components homologous to medicine and food in treating diabetes, as shown in Figure 6 .

[0093] 5. Use the Cytoscape 3.10.1 software to construct the active ingredient - target network of the components homologous to medicine and food and visualize the network. This network contains 587 nodes and 1,660 edges.

[0094] Construct the active ingredient - common target - diabetes network of the components homologous to medicine and food. It is found that there are 296 common nodes, 37 active ingredients of the components homologous to medicine and food in treating diabetes, 257 targets that act synergistically on diabetes, and 1,132 action relationships, that is, edges, between the nodes.

[0095] 6. By inputting the medicine-food homology composition and the common targets of diabetes into the String database (https: / / string-db.org), a PPI network diagram is obtained with a cut-off value of correlation r > 0.400, and the interaction network diagram of the medicine-food homology composition and diabetes is exported.

[0096] 7. Import the intersection genes into the DAVID database ( https: / / david.ncifcrf.gov ), and perform GO and KEGG enrichment analyses on the intersection targets.

[0097] For GO analysis, the top 10 genes in terms of the number of genes are selected for visualization processing, and a bar chart is constructed using the microbioinformatics platform. The results are shown in Figure 7 . From the GO functional enrichment analysis results of the key genes of traditional Chinese medicine compound - diabetes in the DAVID database, 798 pathways in Biological process, 97 pathways in Cellular component, and 172 pathways in Molecular function are obtained. According to the number of enriched genes, the top 10 entries are plotted as a bar chart. The GO functional enrichment analysis results show that the mechanism acts on diabetes mainly through pathways such as cell signal transduction, plasma membrane, and protein binding.

[0098] For KEGG analysis, the top 20 significant signaling pathways ranked by P value are selected for visualization processing, and a bubble chart is constructed using the microbioinformatics platform. The results are shown in Figure 8 . The KEGG pathway enrichment analysis results show that the key genes are mainly enriched in pathways such as Pathways in cancer, HF-1 signaling pathway, and PI3K-Akt signaling pathway.

[0099] From the perspective of big data bioinformatics analysis, it fully demonstrates the rationality, comprehensiveness of the formula of the present invention, and its potential for assisting in reducing blood sugar.

[0100] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than limiting the protection scope of the present invention. Any simple modification or equivalent replacement of the technical solution of the present invention by those of ordinary skill in the art does not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A medicine-food composition for assisting in regulating blood sugar, characterized in that: The medicine-food composition consists of mulberry leaves, black sesame, polygonatum odoratum and yam.

2. The medicine-food composition according to claim 1, characterized in that: The edible-medicinal composition consists of 10-14 parts of mulberry leaves, 2-4 parts of black sesame seeds, 3-6 parts of polygonatum odoratum and 1-3 parts of yam in parts by weight.

3. The medicine-food composition according to claim 2, characterized in that: In terms of weight, the edible-medicinal composition consists of 11-13 parts of mulberry leaves, 3-4 parts of black sesame seeds, 3-5 parts of polygonatum odoratum and 1.5-3 parts of yam.

4. A preparation for assisting in regulating blood sugar, characterized in that: The invention comprises the medicine-food composition as described in any one of claims 1 to 3.

5. A method for preparing the medicine-food composition according to any one of claims 1 to 3, characterized in that: The steps include: (1) First, crush and sieve mulberry leaves, black sesame seeds, polygonatum odoratum and yam, and mix them to obtain mixed powder; (2) adding water to the mixed powder, soaking, boiling, filtering, and collecting the residue and filtrate; (3) Finally, boil the residue with water, filter, combine the filtrate and concentrate to obtain the product.

6. The preparation method according to claim 5, characterized in that: The mesh size of the sieving in step (1) is 30-50 mesh; the mass volume ratio of the mixed powder to water in step (2) is 1 g: 8 mL-12 mL, and the soaking time is 35 min-45 min; the mass volume ratio of the filter residue to water in step (3) is 1 g: 4 mL-6 mL.

7. The preparation method according to claim 5, characterized in that: The decoction temperatures in step (2) and step (3) are both 90° C.-100° C., and the decoction time is both 25 min-45 min.

8. The preparation method according to claim 5, characterized in that: The density after the concentration in step (3) is 0.4 g / mL-0.6 g / mL.

9. Use of the medicine-food composition prepared by the preparation method according to any one of claims 5 to 8 in preparing a product for regulating blood sugar levels.

10. The use according to claim 9, characterized in that: The product is a food or a medicine, and further comprises excipients acceptable to the food or medicine. The dosage form of the product is a liquid preparation, an ointment, a pill, a powder or a granule.

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