Solid tea beverage for assisting in reducing blood sugar and its preparation process

Abstract

The application discloses a kind of solid tea beverage and its preparation process for assisting hypoglycemic, belong to the technical field of health food;The solid tea beverage is prepared from the raw materials of mulberry leaf 5-10 parts, radix puerariae 4-10 parts, polygonatum 3-10 parts, astragalus 2-10 parts, poria 2-10 parts and dioscorea 1-10 parts;Its preparation process includes: after mixing raw materials, decoct twice with water, combine the liquid to vacuum concentration, the concentrated solution is spray dried, belt dried or freeze-dried to form solid material, then add accessories to make granules, or press into sheet or block, and then pack to obtain the product;The present application uses six kinds of medicine as raw materials, which are homologous traditional Chinese medicinal materials, and the prescription is scientific and reasonable. The components synergistically exert the effect of assisting hypoglycemic. The preparation process is stable and controllable. The product is in the form of solid tea beverage, which is convenient to carry and easy to brew and drink.

Description

Technical Field

[0001] This invention relates to the field of health beverage production technology, specifically to a solid tea beverage that helps lower blood sugar and its preparation process. Background Technology

[0003] Currently, commonly used hypoglycemic drugs in clinical practice mainly include biguanides (such as metformin), sulfonylureas (such as glimepiride), thiazolidinediones (such as rosiglitazone), and alpha-glucosidase inhibitors (such as acarbose). Although these drugs have clear efficacy, they are often accompanied by various side effects: biguanides can cause gastrointestinal discomfort and lactic acidosis; sulfonylureas can easily lead to weight gain and hypoglycemia; thiazolidinediones may cause edema and cardiovascular risks; and alpha-glucosidase inhibitors commonly cause gastrointestinal adverse reactions such as bloating and diarrhea. In addition, long-term use of chemical drugs may also lead to liver and kidney damage, limiting patient adherence to long-term use.

[0004] Traditional Chinese medicine (TCM) has a long history of preventing and treating diabetes and its complications. Diabetes is classified under the category of "Xiao Ke Bing" (wasting and thirsting disease), and its pathogenesis is considered to be rooted in Yin deficiency and manifested by dryness and heat. Prolonged disease progression can lead to syndromes such as Qi and Yin deficiency, or Yin and Yang deficiency. TCM treatment has the advantages of holistic regulation and multi-target effects; however, traditional decoctions have drawbacks such as cumbersome preparation, bitter taste, and inconvenience in carrying and taking, making them difficult to meet the daily conditioning needs of modern people with their fast-paced lifestyles.

[0005] Most existing blood sugar-lowering health drinks on the market are single-ingredient (such as mulberry leaf tea, bitter melon tea, and Eucommia ulmoides tea) or simple compound formulations, and generally have the following defects: First, the formula has weak synergy and fails to achieve the synergistic effects of clearing heat and moisturizing dryness, replenishing qi and nourishing yin, and strengthening the spleen and promoting body fluid through the reasonable combination of multiple components; Second, the target of action is singular, mostly targeting only α-glucosidase inhibition or a single pathway of insulin secretion, making it difficult to achieve overall regulation; Third, the taste and palatability are poor, with obvious herbal odor, resulting in low user compliance. Summary of the Invention

[0006] The main technical problem to be solved by this invention is to provide a solid tea beverage with extracts of medicinal and edible natural plants as the core, a scientifically synergistic formulation, excellent taste, convenient preparation, safety and non-addictive properties, and its preparation process, so that it can play a significant role in assisting in lowering blood sugar.

[0007] To solve the above-mentioned technical problems, the present invention provides the following technical solution: A solid tea beverage that helps lower blood sugar is prepared from the following ingredients in parts by weight: 5-10 parts mulberry leaves, 4-10 parts kudzu root, 3-10 parts Solomon's seal rhizome, 2-10 parts astragalus root, 2-10 parts poria cocos, and 1-10 parts yam.

[0008] Preferably, the solid tea beverage for assisting in lowering blood sugar is prepared from the following raw materials in parts by weight: 6-9 parts mulberry leaves, 5-8 parts kudzu root, 4-8 parts Solomon's seal rhizome, 3-8 parts astragalus root, 3-8 parts poria cocos, and 2-6 parts yam.

[0009] More preferably, the solid tea beverage that helps lower blood sugar is prepared from the following raw materials in parts by weight: 7 parts mulberry leaves, 7 parts kudzu root, 6 parts Solomon's seal rhizome, 5 parts astragalus root, 5 parts poria cocos, and 4 parts yam.

[0010] This invention also provides a preparation process for a solid tea beverage that helps lower blood sugar. The preparation process specifically includes the following steps: S1. Select and weigh the ingredients according to the formula, mix the ingredients and put them into 5 to 10 times the amount of water, and simmer at 60 to 100°C for 0.5 to 2.5 hours. S2. Add 5 to 10 times the amount of water to the dregs treated in step S1, and decoct at 80 to 100°C for 0.5 to 2.5 hours. S3. Transfer all the liquid material after the treatment in steps S1 and S2 into a vacuum concentrator and concentrate it under reduced pressure until the volume of the liquid is 0.5 to 2 times the total weight of the raw materials. S4. The concentrated liquid after step S3 is dried using a spray dryer, belt dryer or freeze dryer to produce a solid material; S5. Add auxiliary materials to the solid material obtained in step S4 as needed, mix evenly, add wetting agent to form granules, dry and package; or dry the granules and press them into sheet or block form for packaging.

[0011] The following is a further optimization of the above technical solution by the present invention: the excipients include one or more of fillers, binders, disintegrants, and flavoring agents.

[0012] Further optimization: The filler is one or more of dextrin, mannitol, sorbitol, inulin, and cyclodextrin.

[0013] Further optimization: The disintegrant is one or more of dry starch, sodium carboxymethyl starch, crospovidone, and sodium crospovidone carboxymethyl cellulose.

[0014] Further optimization: The flavoring agent is one or more of the following: steviol glycosides, sodium saccharin, aspartame, cyclamate, sucralose, citric acid, and malic acid.

[0015] Further optimization: The wetting agent is water or an aqueous solution of ethanol with a volume fraction of 40-90%.

[0016] Further optimization: In step S1 above, the raw materials are screened, washed, air-dried or low-temperature dried before frying, and then pulverized into coarse powder of 10-30 mesh.

[0017] Further optimization: In step S3 above, the vacuum degree in the vacuum concentrator is -0.06 to -0.08 MPa, the temperature is 50-85℃, and the relative density of the concentrated extract is 1.05 to 1.32 (measured at 60℃).

[0018] Further optimization: In step S4 above, the moisture content of the dried solid material is controlled at 3.0-6.0%, and it is pulverized through an 80-100 mesh sieve.

[0019] Further optimization: In step S5 above, after the granules are formed, they are dried at 50-115℃ until the moisture content is 3.0%-6.0% and the particle size is 10-30 mesh.

[0020] Beneficial effects The present invention adopts the above technical solution and has the following beneficial effects: 1. This invention uses scientifically compounded raw materials that are both food and medicine, with natural plant extracts as the core functional ingredients, and makes them into a solid tea beverage dosage form. It has the advantages of easy preparation, convenient carrying, and quick consumption. Users can prepare and drink it as needed without complicated decoction and processing, which greatly simplifies the consumption process, significantly improves the convenience of use and user compliance, and better meets the needs of modern people for convenient and daily health in their fast-paced lifestyle.

[0021] 2. This invention scientifically combines six medicinal and edible ingredients: mulberry leaves, kudzu root, Solomon's seal rhizome, astragalus root, poria cocos, and yam. The formula uses mulberry leaves and kudzu root as the principal ingredients to clear the lungs, moisten dryness, and quench thirst; Solomon's seal rhizome and astragalus root as the assistant ingredients to nourish yin, moisten dryness, and tonify qi and yang; and poria cocos and yam as the adjuvant ingredients to strengthen the spleen, eliminate dampness, and nourish yin and qi. The combined effects of these herbs are to nourish yin and qi, quench thirst, strengthen the spleen, and harmonize the stomach, thus synergistically lowering blood sugar from multiple targets. Compared to existing products with single ingredients or simple combinations, this invention has a scientifically rigorous formulation with clear distinctions between the principal, assistant, and adjuvant ingredients, resulting in significant synergistic effects.

[0022] 3. Through scientific formulation and reasonable compounding, the effects of each raw material are synergistic and complementary, with mild effects and high safety. The selected raw materials are all substances that are both food and medicine in accordance with the national "List of Substances that are both food and Chinese medicine", and have no dependence or toxic side effects. They are suitable for long-term daily conditioning for people with high blood sugar, meeting the market demand for mild auxiliary blood sugar lowering.

[0023] 4. This invention exerts its auxiliary hypoglycemic effect through multiple targets in a synergistic manner: it delays carbohydrate absorption by inhibiting α-glucosidase activity (mulberry leaf, poria cocos); it improves insulin levels by promoting insulin secretion (mulberry leaf polysaccharide, polygonatum polysaccharide); it enhances the utilization of glucose by peripheral tissues by improving insulin resistance (astragalus polysaccharide, puerarin); it delays pancreatic islet function decline by protecting pancreatic β cells (polysaccharide, yam polysaccharide); and it achieves overall regulation through regulating glucose and lipid metabolism, anti-inflammatory and antioxidant effects, and regulating intestinal flora.

[0024] 5. This invention, in conjunction with flavoring agents, scientifically adjusts the flavor of the finished product, effectively masking the unpleasant odor of Chinese herbal extracts. It also solves the problems of bitter taste and poor solubility in traditional Chinese herbal products, thereby greatly improving the taste of tea beverages and enhancing consumer acceptance and consumption experience.

[0025] 6. The preparation process of this invention employs a two-stage decoction extraction, low-temperature vacuum concentration, and gentle drying, which effectively improves the extraction rate of active ingredients while avoiding the damage of heat-sensitive components (such as polysaccharides and flavonoids) caused by high temperatures, thus ensuring the stability of the product's efficacy. Spray drying can quickly dry the powder, keeping it fine and uniform; belt drying is suitable for large-scale continuous production; and freeze drying retains the active ingredients to the greatest extent. Detailed Implementation

[0026] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] Example 1 A solid tea beverage that helps lower blood sugar is prepared from the following ingredients in parts by weight: 7 parts mulberry leaves, 7 parts kudzu root, 6 parts Solomon's seal rhizome, 5 parts astragalus root, 5 parts poria cocos, and 4 parts yam.

[0028] Its preparation process includes the following steps: S1. Select and weigh the ingredients according to the formula. Choose high-quality mulberry leaves, kudzu root, Solomon's seal, astragalus, poria cocos, and yam. After screening, washing, air-drying or low-temperature drying, grind them into coarse powder of 1-20 mesh. Mix the raw materials and put them into 5-10 times the amount of purified water. Decoction at 60-100℃ for 0.5-2.5 hours. Filter while hot to obtain the medicinal liquid. Set aside the dregs. S2. Add 5 to 10 times the amount of purified water to the dregs treated in step S1, and decoct at 60 to 100°C for 0.5 to 2.5 hours. Filter while hot to obtain the decoction, discard the dregs, and combine the two decoctions. S3. Transfer all the combined liquid materials into a vacuum concentrator and concentrate them under reduced pressure at a vacuum of -0.06 to -0.08 MPa and a temperature of 60 to 85°C until the volume of the liquid is 0.2 to 2 times the total weight of the raw materials, to obtain a thick paste-like extract with a relative density controlled at 1.10 to 1.32 (measured at 60°C). S4. The concentrated liquid after step S3 is dried using a spray dryer with an inlet air temperature of 160-180℃ and an outlet air temperature of 80-90℃ to produce solid material with a moisture content of 4.0-5.0%, and then pulverized through an 80-mesh sieve. S5. Add dextrin (filler) and steviol glycosides (flavoring agent) to the solid material obtained in step S4. The mass ratio of solid material to excipients is 8:2. Mix thoroughly using a three-dimensional mixer, add an appropriate amount of purified water (wetting agent) to make a soft material, granulate through a 14-mesh sieve, dry at 60-115℃ until the moisture content is 4.0%, granulate, and package into 5g bags.

[0029] Example 2 A solid tea beverage that helps lower blood sugar is prepared from the following ingredients in parts by weight: 9 parts mulberry leaves, 6 parts kudzu root, 4 parts Solomon's seal rhizome, 8 parts astragalus root, 4 parts poria cocos, and 3 parts yam.

[0030] The preparation process is basically the same as that in Example 1, except that in step S5, the qualified granules are further compressed into block form by a tableting device and then packaged into 5g blocks.

[0031] Example 3 A solid tea beverage that helps lower blood sugar is prepared from the following ingredients in parts by weight: 6 parts mulberry leaves, 9 parts kudzu root, 8 parts Solomon's seal rhizome, 3 parts astragalus root, 6 parts poria cocos, and 5 parts yam.

[0032] The preparation process is basically the same as that in Example 1, except that in step S5, mannitol (filler) and citric acid (flavoring agent) are selected as excipients, the mass ratio of solid material to excipient is 7:3, and the wetting agent is an aqueous ethanol solution with a volume fraction of 60%.

[0033] Example 4 A solid tea beverage for assisting in lowering blood sugar is prepared from the following raw materials in parts by weight: 10 parts mulberry leaves, 4 parts kudzu root, 3 parts Solomon's seal rhizome, 10 parts astragalus root, 2 parts poria cocos, and 1 part yam. Its preparation process is basically the same as in Example 1.

[0034] Example 5 A solid tea beverage for assisting in lowering blood sugar is prepared from the following raw materials in parts by weight: 5 parts mulberry leaves, 10 parts kudzu root, 10 parts Solomon's seal rhizome, 2 parts astragalus root, 10 parts poria cocos, and 10 parts yam. Its preparation process is basically the same as in Example 1.

[0035] Example 6 A solid tea beverage for assisting in lowering blood sugar is prepared from the following raw materials in parts by weight: 8 parts mulberry leaves, 5 parts kudzu root, 5 parts Solomon's seal rhizome, 6 parts astragalus root, 6 parts poria cocos, and 6 parts yam. Its preparation process is basically the same as in Example 1.

[0036] Comparative Example 1 (Single Component Control) A solid tea beverage for assisting in lowering blood sugar is prepared from the following raw materials in parts by weight: 7 parts mulberry leaves. Its preparation process is basically the same as in Example 1.

[0037] Comparative Example 2 (Flavor-Deficient Control – Lacking Yam) A solid tea beverage for assisting in lowering blood sugar is prepared from the following ingredients in parts by weight: 7 parts mulberry leaves, 7 parts kudzu root, 6 parts Solomon's seal rhizome, 5 parts astragalus root, and 5 parts poria cocos (excluding yam). Its preparation process is basically the same as in Example 1.

[0038] Comparative Example 3 (Flavor-Deficient Control – Lacking Astragalus and Poria) A solid tea beverage for assisting in lowering blood sugar is prepared from the following ingredients in parts by weight: 7 parts mulberry leaves, 7 parts kudzu root, 6 parts Solomon's seal rhizome, and 4 parts yam (excluding astragalus and poria). Its preparation process is basically the same as in Example 1.

[0039] Efficacy verification test I. In vitro α-glucosidase inhibitory activity assay 1. Experimental materials: The solid tea beverages prepared in Example 1, Comparative Example 1, Comparative Example 2 and Comparative Example 3 were prepared into a solution with a concentration of 10 mg / mL using purified water. The solution was dissolved by sonication for 10 min, centrifuged (4000 r / min, 10 min), and the supernatant was collected for later use.

[0040] 2. Experimental Methods: 4-Nitrophenyl-α-D-glucopyranoside (PNPG) was used as a substrate to determine the inhibitory activity of each sample against α-glucosidase. 100 μL of 0.1 mol / L phosphate buffer (pH 6.8) was added, followed by 20 μL of sample solution and 20 μL of α-glucosidase solution (0.2 U / mL). After mixing, the mixture was incubated at 37°C for 10 min. Then, 20 μL of PNPG solution (2.5 mmol / L) was added, and the reaction was continued at 37°C for 20 min. The reaction was terminated by adding 100 μL of 0.2 mol / L sodium carbonate solution, and the absorbance was measured at 405 nm. Acarbose was used as a positive control. The inhibition rate was calculated as follows: Inhibition rate (%) = (1 - OD value of sample group / OD value of control group) × 100%.

[0041] 3. The experimental results are shown in Table 1.

[0042]

[0043] Table 1 The experimental results showed that the inhibitory activity of Example 1 on α-glucosidase was significantly higher than that of each comparative group (P<0.05), indicating that the formulation of the present invention has a synergistic effect, and the inhibition of α-glucosidase activity is significantly enhanced after the formulation is fully combined.

[0044] II. Animal Experiments 1. Laboratory animals: SPF-grade Kunming mice, male, weighing 20-25g, 80 mice in total. Housing environment: temperature 22±2℃, relative humidity 50±10%, 12h light / 12h dark cycle, free access to water and food.

[0045] 2. Model Establishment: A type 2 diabetic mouse model was established using a high-fat diet combined with streptozotocin (STZ). After one week of acclimatization, mice were randomly divided into a normal control group (n=10) and a model group (n=70). The model group was fed a high-fat diet for 4 weeks, then fasted for 12 hours and received an intraperitoneal injection of STZ 40 mg / kg (prepared with 0.1 mol / L citrate-sodium citrate buffer, pH 4.5 before use). The normal control group received an equal volume of citrate buffer. One week later, fasting blood glucose was measured by tail vein sampling; a blood glucose level ≥11.1 mmol / L was considered a successful model.

[0046] 3. Grouping and administration: Sixty mice that successfully established the model were randomly divided into a model control group, a positive control group (acarbose group), Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3, with 10 mice in each group.

[0047] Example 1 group was administered the product solution of Example 1 (500 mg / kg) by gavage; Comparative Example 1 group was administered the product solution of Comparative Example 1 (500 mg / kg) by gavage; Comparative Example 2 group was administered the product solution of Comparative Example 2 (500 mg / kg) by gavage; Comparative Example 3 group was administered the product solution of Comparative Example 3 (500 mg / kg) by gavage; the positive control group was administered acarbose solution (20 mg / kg) by gavage; and the model control group and normal control group were administered an equal volume of purified water by gavage. Administration was continued for 4 weeks, once daily.

[0048] 4. Detection indicators: (1) Fasting blood glucose (FPG): After administration, fast for 12 hours, blood is collected from the tail vein and fasting blood glucose is measured using a blood glucose meter.

[0049] (2) Oral glucose tolerance test (OGTT): After the administration of the drug, the mice in each group were fasted for 12 hours and were given 2 g / kg glucose solution by gavage. The blood glucose values ​​were measured at 0, 30, 60 and 120 min and the area under the blood glucose curve (AUC) was calculated.

[0050] (3) Glycated hemoglobin (HbA1c): Measured using a fully automated biochemical analyzer.

[0051] (4) Insulin resistance index (HOMA-IR): Fasting insulin level was measured using an ELISA kit. HOMA-IR = fasting blood glucose (mmol / L) × fasting insulin (mU / L) / 22.5.

[0052] 5. The experimental results are shown in Table 2-4.

[0053]

[0054] Table 2

[0055] Table 3

[0056] Table 4 The experimental results showed that Example 1 significantly reduced FPG, HbA1c, area under the curve of OGTT and HOMA-IR in diabetic mice (P < 0.05), and the effect was better than that of each comparative group (P < 0.05), indicating that the formulation of the present invention has a synergistic effect and can effectively improve blood glucose levels and insulin resistance.

[0057] III. Acute Toxicity Test 1. Experimental animals: SPF-grade Kunming mice, half male and half female, weighing 18-22g, totaling 20 mice.

[0058] 2. Experimental Methods: The solid tea beverage prepared in Example 1 was diluted with purified water to obtain a solution at its maximum concentration (0.5 g / mL). Mice were fasted for 12 hours but allowed free access to water, and then administered the drug by gavage at the maximum dosage volume (40 mL / kg) twice within 24 hours, for a total dose of 40 g / kg (equivalent to 200 times the clinical human dose). Mice were observed for 14 consecutive days after administration, and their general condition, behavior, food and water intake, weight changes, and mortality were recorded. Mice were sacrificed on day 14 for gross necropsy.

[0059] 3. Experimental Results: Within 14 days after administration, no obvious abnormal reactions were observed in any of the mice, and no deaths occurred. The mice exhibited normal weight gain, normal food and water intake, and normal behavior. Gross anatomical examination revealed no obvious organ abnormalities. The results indicate that the product of this invention, at a maximum dosage of 40 g / kg, did not show any significant toxic reactions and demonstrated good safety.

[0060] IV. Human Food Testing 1. Subject Selection: One hundred patients with prediabetes (fasting blood glucose 6.1-7.0 mmol / L, or 2-hour postprandial blood glucose 7.8-11.1 mmol / L) were selected according to the inclusion criteria and randomly divided into four groups: Example 1, Example 2, Comparative Example 1, Comparative Example 2, and Comparative Example 3, with 20 patients in each group. There were no statistically significant differences among the five groups in terms of age, gender, and fasting blood glucose level (P > 0.05).

[0061] 2. Experimental Methods: Each group consumed the corresponding solid tea beverage once daily (5g each time, dissolved in 200mL of warm water) for 8 consecutive weeks. During the experiment, subjects maintained their original diet and exercise habits and did not use other hypoglycemic products or medications. Fasting plasma glucose (FPG), 2-hour postprandial glucose (2h PG), and glycated hemoglobin (HbA1c) were measured before the start of the experiment, at week 4, and at week 8.

[0062] 3. The experimental results are shown in Table 5.

[0063]

[0064] Table 5 The experimental results showed that after 8 weeks of continuous consumption of this product, the fasting blood glucose, 2-hour postprandial blood glucose, and glycated hemoglobin levels in both Example 1 and Example 2 groups were significantly lower than before the intervention (P < 0.05), and the improvement in blood glucose was more significant compared with the control groups (P < 0.05). During the trial, no significant adverse reactions occurred in any of the subjects, indicating that the product of this invention has good safety and auxiliary hypoglycemic effects.

[0065] V. Stability Test The solid tea beverage prepared in Example 1 was packaged in aluminum foil composite film bags and stored at room temperature (25℃±2℃, relative humidity 60%±10%) for 24 months. Samples were taken and tested at 0, 3, 6, 12, 18, and 24 months. The test indicators included: sensory indicators (color, odor, texture), moisture, total flavonoid content, puerarin content, polysaccharide content, and microbiological indicators (total bacterial count, coliform bacteria, molds, and yeasts). (Note: The last three items in the table are not provided.) according to The results are shown in Table 6.

[0066]

[0067] Table 6 Stability test results show that the product of this invention, after being stored at room temperature for 24 months, meets all the requirements, with no significant changes in sensory indicators, the content of active ingredients remains above 90% of the initial value, and the microbiological indicators meet national standards, indicating good product stability.

[0068] Quality control methods To effectively control product quality, this invention also establishes a corresponding quality control method, including: 1. Thin-layer chromatography identification: (1) Identification of mulberry leaves: Take 2g of the powder, add 20mL of methanol, sonicate for 30min, filter, evaporate the filtrate to dryness, add 10mL of water to dissolve the residue, extract twice with 10mL of ethyl acetate each time, combine the ethyl acetate solutions, evaporate to dryness, add 1mL of methanol to dissolve the residue, and use as the test solution. Take another 2g of mulberry leaf reference material and prepare a reference material solution in the same way.

[0069] Perform the thin-layer chromatography test (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0502). Apply 5 μL of each of the two solutions to the same silica gel G thin-layer plate. Develop the plate using toluene-ethyl acetate-formic acid (5:3:1) as the developing solvent. Remove the plate, air-dry it, spray with 1% aluminum trichloride ethanol solution, and heat at 105℃ until the spots are clearly visible. Examine the plate under ultraviolet light (365 nm). The chromatogram of the test sample should show fluorescent spots of the same color at the corresponding positions as the chromatogram of the reference medicinal material.

[0070] (2) Identification of kudzu root: Take 2g of the powder, add 20mL of methanol, sonicate for 30min, filter, evaporate the filtrate to dryness, dissolve the residue in 1mL of methanol to prepare the test solution. Separately, take puerarin reference standard, add methanol to prepare a solution containing 1mg per 1mL to prepare the reference solution.

[0071] Perform thin-layer chromatography (TLC). Apply 5 μL of each of the two solutions to the same silica gel G TLC plate. Develop the plate using chloroform-methanol-water (7:2.5:0.25) as the developing solvent. Remove the plate, air dry, and examine under ultraviolet light (365 nm). The test sample chromatogram should show fluorescent spots of the same color at the corresponding positions as the reference sample chromatogram.

[0072] 2. Content determination: (1) Determination of total flavonoid content: Ultraviolet-visible spectrophotometry was used. Rutin was used as a reference standard, and the absorbance was measured at a wavelength of 510 nm using the sodium nitrite-aluminum nitrate colorimetric method. The total flavonoid content was calculated. Each bag (5g) of this product contains no less than 30mg of total flavonoids.

[0073] (2) Determination of puerarin content: High performance liquid chromatography (HPLC) was used. Chromatographic conditions: Octadecylsilane-bonded silica gel was used as the packing material; methanol-water (25:75) was used as the mobile phase; and the detection wavelength was 250 nm. The theoretical plate number calculated based on the puerarin peak should not be less than 3000. Each sachet (5g) of this product contains not less than 5mg of puerarin.

[0074] (3) Polysaccharide content determination: The phenol-sulfuric acid method was used. Anhydrous glucose was used as a reference standard, and the absorbance was measured at a wavelength of 490 nm to calculate the polysaccharide content. Each sachet (5g) of this product contains no less than 50mg of polysaccharide.

[0075] 3. Microbial limit test: The test shall be conducted in accordance with the provisions of General Chapters 1105 and 1106 of Part IV of the 2025 edition of the Chinese Pharmacopoeia. The test shall meet the following requirements: total aerobic bacteria ≤1000 CFU / g, molds and yeasts ≤100 CFU / g, and Escherichia coli shall not be detected.

[0076] Raw material analysis and formulation principles The plant materials used in this invention are all medicinal and edible substances, and therefore have high safety. The efficacy and mechanism of action of each ingredient in this invention are analyzed below: 1. Mulberry leaves Properties: Cold in nature, sweet and bitter in taste.

[0077] Meridian Tropism: It enters the Lung and Liver meridians.

[0078] Efficacy: Disperses wind-heat, clears the lungs and moistens dryness, calms liver yang, clears the liver and improves eyesight.

[0079] Modern pharmacological studies have shown that alkaloids (such as 1-deoxynojirimycin DNJ), polysaccharides, and flavonoids in mulberry leaves are the main hypoglycemic active substances. DNJ is a potent α-glucosidase inhibitor that competitively inhibits the activity of α-glucosidase in the brush border of the small intestine, delaying the digestion and absorption of carbohydrates, thereby lowering postprandial blood glucose.

[0080] Mulberry leaf polysaccharides can promote insulin secretion, improve insulin resistance, and upregulate the expression of glucose transporter GLUT4.

[0081] Mulberry leaf flavonoids have antioxidant and anti-inflammatory effects, which can reduce oxidative stress damage caused by diabetes.

[0082] 2. Kudzu root Properties: Cool in nature, sweet and pungent in taste.

[0083] Meridian Tropism: It enters the spleen, stomach, and lung meridians.

[0084] Efficacy: Relieves muscle tension and reduces fever, promotes body fluid production and quenches thirst, promotes rash eruption, raises yang and stops diarrhea, and unblocks meridians and collaterals.

[0085] Modern pharmacological studies have shown that isoflavones such as puerarin and soy isoflavones in kudzu root have significant effects in lowering blood sugar, improving insulin resistance, and protecting pancreatic β-cell function.

[0086] Puerarin can activate the AMPK signaling pathway, promoting glucose uptake and utilization and inhibiting hepatic gluconeogenesis. Puerarin can also activate the PI3K / Akt signaling pathway, promoting the translocation and expression of GLUT4 and increasing glucose uptake by skeletal muscle and adipose tissue.

[0087] Kudzu root can also improve microcirculation, inhibit platelet aggregation, and reduce diabetic vascular complications.

[0088] 3. Polygonatum odoratum Properties: Slightly cold in nature, sweet in taste.

[0089] Meridian Tropism: It belongs to the Lung and Stomach meridians.

[0090] Efficacy: Nourishes Yin and moistens dryness, promotes body fluid production and quenches thirst.

[0091] Modern pharmacological studies have shown that Polygonatum odoratum polysaccharides have significant effects in lowering blood sugar, improving glucose tolerance, and regulating lipid metabolism, and have a good preventive and ameliorative effect on diabetes and its complications.

[0092] Polygonatum polysaccharides can promote the repair of pancreatic β cells, increase insulin secretion, and improve the utilization of glucose by peripheral tissues.

[0093] The aqueous extract of Polygonatum odoratum can inhibit the activity of α-amylase and α-glucosidase, thus delaying the absorption of carbohydrates.

[0094] 4. Astragalus Properties: Slightly warm in nature, sweet in taste.

[0095] Meridian Tropism: Spleen and Lung Meridians.

[0096] Efficacy: Tonifies Qi and raises Yang, strengthens the exterior and stops sweating, promotes diuresis and reduces swelling, generates body fluids and nourishes blood.

[0097] Modern pharmacological studies have shown that astragalus polysaccharides are its main active ingredients, which can exert hypoglycemic effects through multiple mechanisms such as improving insulin resistance, promoting insulin secretion, and regulating immune function.

[0098] Astragalus polysaccharides can activate the PI3K / Akt signaling pathway, promote the translocation and expression of glucose transporter GLUT4, and increase glucose uptake by skeletal muscle and adipose tissue.

[0099] Astragalus can also improve insulin resistance by inhibiting the expression of inflammatory factors (such as TNF-α and IL-6). Astragalus can also delay the onset and progression of diabetic nephropathy and protect kidney function.

[0100] 5. Poria cocos Properties: Neutral in nature, sweet and bland in taste.

[0101] Meridian Tropism: It enters the Heart, Lung, Spleen, and Kidney meridians.

[0102] Efficacy: Promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind.

[0103] Modern pharmacological studies have shown that Poria cocos polysaccharides have immunomodulatory, anti-inflammatory, and antioxidant effects. Its spleen-strengthening effect helps improve the "spleen deficiency" state, thereby assisting in the regulation of glucose metabolism.

[0104] The triterpenoids in Poria cocos can inhibit α-glucosidase activity and synergistically reduce postprandial blood glucose.

[0105] Poria cocos can also regulate gut microbiota, increase the abundance of beneficial bacteria, and improve diabetes-related gut microbiota disorders.

[0106] 6. Yam Properties: Neutral in nature, sweet in taste.

[0107] Meridian Tropism: It enters the spleen, lung, and kidney meridians.

[0108] Efficacy: Tonifies the spleen and stomach, promotes the production of body fluids and benefits the lungs, and tonifies the kidneys and astringes essence.

[0109] Modern pharmacological studies have shown that yam polysaccharides have significant hypoglycemic, lipid-regulating, and antioxidant effects, and can protect pancreatic β cells.

[0110] Yam polysaccharides can increase insulin sensitivity and promote glucose utilization by peripheral tissues. The mucoprotein in yam can slow gastric emptying and reduce carbohydrate absorption, thereby lowering postprandial blood glucose levels.

[0111] Overall mechanism of action of the formulation: The formula uses mulberry leaves and kudzu root as the main ingredients, directly addressing the core pathogenesis of diabetes mellitus: "dryness and heat as the symptoms, and yin deficiency as the root cause." It clears the lungs, moistens dryness, generates fluids, and quenches thirst, thus inhibiting the rise in blood sugar from the source.

[0112] With Polygonatum odoratum and Astragalus membranaceus as assistant herbs, the formula enhances the effects of nourishing yin and moisturizing dryness, replenishing qi and raising yang. It nourishes both qi and yin, working together to help the principal herb enhance its hypoglycemic effect.

[0113] With Poria cocos and Dioscorea opposita as adjuvants, this formula invigorates the spleen and replenishes qi, eliminates dampness and harmonizes the stomach. On the one hand, it promotes the transformation and utilization of nutrients by strengthening the spleen and aiding digestion; on the other hand, it prevents the cold nature of the principal ingredient from harming the stomach, while also harmonizing the properties of the entire formula. The synergistic effects of these herbs, targeting multiple aspects such as replenishing qi, nourishing yin, generating fluids, and strengthening the spleen, collectively achieve the health benefits of assisting in lowering blood sugar.

[0114] From the perspective of modern medicine, this formula exerts its hypoglycemic effect through multiple pathways, including inhibiting α-glucosidase activity, promoting insulin secretion, improving insulin resistance, protecting pancreatic β cells, regulating glucose and lipid metabolism, anti-inflammatory and antioxidant effects, and regulating intestinal flora. It reflects the advantages of traditional Chinese medicine in overall regulation and multi-target intervention, and is suitable for long-term use as an auxiliary conditioning method for patients with prediabetes and type 2 diabetes.

[0115] For those skilled in the art, any changes, modifications, substitutions, and variations made to the embodiments without departing from the principles and spirit of the present invention, based on the teachings of the present invention, still fall within the protection scope of the present invention.

Claims

1. A solid tea beverage for assisting in lowering blood sugar, characterized in that: It is prepared from the following raw materials in parts by weight: 5-10 parts mulberry leaves, 4-10 parts kudzu root, 3-10 parts Solomon's seal, 2-10 parts astragalus, 2-10 parts poria cocos, and 1-10 parts yam.

2. The solid tea beverage for assisting in lowering blood sugar according to claim 1, characterized in that: It is prepared from the following raw materials in parts by weight: 6-9 parts mulberry leaves, 5-8 parts kudzu root, 4-8 parts Solomon's seal rhizome, 3-8 parts astragalus root, 3-8 parts poria cocos, and 2-6 parts yam.

3. A solid tea beverage for assisting in lowering blood sugar according to claim 1, characterized in that: It is prepared from the following raw materials in parts by weight: 7 parts mulberry leaves, 7 parts kudzu root, 6 parts Solomon's seal, 5 parts astragalus, 5 parts poria cocos, and 4 parts yam.

4. A preparation process for a solid tea beverage that assists in lowering blood sugar, based on the solid tea beverage for assisting in lowering blood sugar as described in any one of claims 1 to 3, characterized in that: Includes the following steps: S1. Select and weigh the ingredients according to the formula, mix the ingredients and put them into 5 to 10 times the amount of water, and simmer at 60 to 100°C for 0.5 to 2.5 hours. S2. Add 5 to 10 times the amount of water to the dregs treated in step S1, and decoct at 80 to 100°C for 0.5 to 2.5 hours. S3. Transfer all the liquid material after the treatment in steps S1 and S2 into a vacuum concentrator and concentrate it under reduced pressure until the volume of the liquid is 0.5 to 2 times the total weight of the raw materials. S4. The concentrated liquid after step S3 is dried using a spray dryer, belt dryer or freeze dryer to produce a solid material; S5. Add auxiliary materials to the solid material obtained in step S4 as needed, mix evenly, add wetting agent to form granules, dry and package; or dry the granules and press them into sheet or block form for packaging.

5. The preparation process of a solid tea beverage for assisting in lowering blood sugar according to claim 4, characterized in that: The excipients include one or more of fillers, binders, disintegrants, and flavoring agents.

6. The preparation process of a solid tea beverage for assisting in lowering blood sugar according to claim 5, characterized in that: The filler is one or more of dextrin, mannitol, sorbitol, inulin, and cyclodextrin; the disintegrant is one or more of dry starch, sodium carboxymethyl starch, crospovidone, and crospovidone carboxymethyl cellulose; and the flavoring agent is one or more of steviol glycosides, sodium saccharin, aspartame, cyclamate, sucralose, citric acid, and malic acid.

7. The preparation process of a solid tea beverage for assisting in lowering blood sugar according to claim 4, characterized in that: The wetting agent is water or an aqueous solution of ethanol with a volume fraction of 40-90%.

8. The preparation process of a solid tea beverage for assisting in lowering blood sugar according to claim 4, characterized in that: In step S1, the raw materials are screened, washed, air-dried or low-temperature dried before frying, and then pulverized into coarse powder of 10-30 mesh.

9. The preparation process of a solid tea beverage for assisting in lowering blood sugar according to claim 4, characterized in that: In step S3, the vacuum degree in the vacuum concentrator is -0.06 to -0.08 MPa, the temperature is 50 to 85°C, and the relative density of the concentrated extract is 1.05 to 1.32, which is measured at 60°C.

10. The preparation process of a solid tea beverage for assisting in lowering blood sugar according to claim 4, characterized in that: In step S4, the moisture content of the dried solid material is controlled at 3.0% to 6.0%, and it is crushed through an 80 to 100 mesh sieve. In step S5, after being made into granules, it is dried at 50 to 115°C until the moisture content is 3.0% to 6.0% and the particle size is 10 to 30 mesh.

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