Medicinal and edible composition compounded with gradient fermentation type prebiotics and capable of reducing blood sugar and application thereof

Abstract

The invention provides a healthy food, in particular to a hypoglycemic composition based on homology of medicine and food and gradient fermentation type prebiotics, which is a dry powder preparation and comprises a component A and a component B, the component A is a medicinal and edible component, and the component B is a prebiotic component; the component A is prepared from the following components in parts by mass: 2 to 15 parts of folium mori extract, 2 to 10 parts of bitter gourd extract, 2 to 20 parts of rhizoma dioscoreae extract, 1 to 10 parts of radix puerariae extract, 2 to 10 parts of fructus lycii extract, 0.5 to 5 parts of radix polygonati officinalis extract and 0.5 to 5 parts of rhizoma polygonati extract; the component B is prepared from 20 to 50 parts of resistant dextrin, 5 to 15 parts of xylooligosaccharide, 3 to 10 parts of inulin and 35 to 50 parts of D-psicose. The hypoglycemic activity of the traditional medicinal and edible materials is organically combined with the gradient fermentation type prebiotics, so that the hypoglycemic effect is realized by synergism of multiple action mechanisms, and the problems of single hypoglycemic mechanism and non-ideal blood sugar regulation effect of the existing product are solved.

Description

Technical Field

[0001] This invention belongs to the field of health food technology, specifically relating to a hypoglycemic composition that combines food and medicine with gradient fermentation prebiotics and its application. Background Technology

[0002] Blood sugar-lowering foods specifically refer to everyday foods that, through specific formula design and optimized processes, can help regulate the body's blood sugar levels. Their core technical characteristic is a low glycemic index (GI), with an industry standard typically using a GI value below 55 as the benchmark. These foods allow for the slow release of sugar during digestion, effectively helping to maintain stable blood sugar levels and offering positive applications in the prevention and control of metabolic diseases such as diabetes and obesity.

[0003] Currently, mainstream blood sugar-lowering foods on the market primarily reduce their glycemic index (GI) through the following technological pathways: (1) Raw material optimization: Use natural low-GI raw materials such as whole grains and beans, or use dietary fiber from grain by-products such as wheat bran to develop functional products; (2) Sugar regulation: slow down the rate of sugar absorption by adding dietary fiber, or use natural sugar substitutes such as erythritol, steviol glycosides, and mogrosides to replace traditional sucrose. (3) Process improvement: Optimize the processing technology to reduce the degree of starch gelatinization, or use ultra-high pressure sterilization (HPP), low temperature slow pressing and other processes to retain the nutrition and flavor of the raw materials; (4) Addition of functional ingredients: Introduce functional ingredients such as white kidney bean extract (containing α-amylase inhibitor), or improve the stability of functional ingredients such as probiotics through microencapsulation technology (such as extending the shelf life of "live bacteria plant beverage").

[0004] Despite the strong market demand for blood sugar-lowering foods, current products and technological solutions still have significant shortcomings, making it difficult to meet the diversified needs of the market. The main problems are as follows: 1. Severe homogeneous competition: Most companies focus on a few popular categories such as sugar-free beverages and low-GI biscuits, with highly overlapping product technology routes and forms, resulting in low differentiation.

[0005] 2. Insufficient segmentation of target audience: The product was not developed precisely for the specific physiological needs of consumers with different types of diabetes (such as type 1 and type II), different disease stages, or different age groups, resulting in poor adaptability.

[0006] 3. Single mechanism of action: Existing products are mostly developed based on a single technical mechanism (such as single-generation sugar replacement or single functional ingredient addition). This extensive technical strategy cannot achieve multi-dimensional blood sugar regulation and is difficult to meet the complex metabolic needs of the human body. Summary of the Invention

[0007] (a) Technical problems to be solved In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides a hypoglycemic composition and its application that combines food and medicine homology with gradient fermented prebiotics. This solution is based on the concepts of "multi-target regulation" and "gut-metabolism axis", which organically combines the hypoglycemic activity of traditional food and medicine homology materials with gradient fermented prebiotics, and finally achieves hypoglycemic effect through multiple mechanisms of action. This solves the technical problems of existing hypoglycemic foods having a single hypoglycemic mechanism, unsatisfactory blood glucose regulation effect and palatability.

[0008] (II) Technical Solution In a first aspect, the present invention provides a hypoglycemic composition that combines food and medicine homology with gradient fermentation prebiotics, which is a dry powder preparation comprising component A and component B; component A is a food and medicine homology component, and component B is a prebiotic component. By weight, component A contains 2-15 parts mulberry leaf extract, 2-10 parts bitter melon extract, 2-20 parts yam extract, 1-10 parts kudzu root extract, 2-10 parts wolfberry extract, 0.5-5 parts Solomon's seal extract, and 0.5-5 parts Polygonatum sibiricum extract; component B contains 20-50 parts resistant dextrin, 5-15 parts xylooligosaccharides, 3-10 parts inulin, and 35-50 parts D-allulose.

[0009] According to a preferred embodiment of the present invention, the mulberry leaf extract is a mulberry leaf extract prepared by zinc ion chelation stabilization with a 1-deoxynojirimycin (DNJ) content ≥1%; the bitter melon extract is a bitter melon extract prepared by fermentation to reduce bitterness with a momordicin content ≥20%; the yam extract is a yam extract prepared by directional enzymatic hydrolysis; the kudzu root extract is a kudzu root extract prepared by non-thermal high-pressure extraction with a puerarin content ≥30%; the wolfberry extract is a wolfberry extract prepared by membrane separation and enrichment with a wolfberry polysaccharide content ≥30%; the Solomon's seal extract is a Solomon's seal extract prepared by compound enzymatic hydrolysis-ultrasound-assisted method with a Solomon's seal polysaccharide content ≥30%; and the polygonatum extract is a polygonatum extract prepared by solid-state fermentation with a polygonatum polysaccharide content ≥30%.

[0010] According to a preferred embodiment of the present invention, in the prebiotic, the molecular weight of resistant dextrin in the 3-10kDa range accounts for >80%, and the molecular weight of short-chain xylooligosaccharides with a degree of polymerization of 2-4 accounts for ≥90%; in the inulin, the molecular weight of long-chain molecules with a degree of polymerization of ≥23 accounts for >70%; and in the D-allulose raw material, the mass percentage of D-allulose is ≥99%.

[0011] According to a preferred embodiment of the present invention, in preparing the hypoglycemic composition, firstly, kudzu root extract, wolfberry extract, Solomon's seal extract, and polygonatum extract are mixed in a mixer to obtain a primary mixture; then, the primary mixture is mixed with mulberry leaf extract, bitter melon extract, yam extract, inulin, and xylooligosaccharide in a mixer to obtain a secondary mixture; next, the secondary mixture is mixed with resistant dextrin and D-allulose in a mixer to obtain a tertiary mixture; finally, the mixture is packaged and sealed as a solid powder according to a preset single-use specification. Premixing a small proportion of the raw materials to obtain a premix before overall mixing ensures the uniformity of the mixture.

[0012] According to a preferred embodiment of the present invention, during the mixing process, the speed of the mixer is 10-30 r / min, the mixing time is 15-45 min each time, the relative humidity of the mixing environment is ≤60%, and the temperature is 15-30℃.

[0013] According to a preferred embodiment of the present invention, the solid powder is packaged and sealed using an aluminum-plastic composite film, with a single-use specification of 3-10g / bag. After packaging, the composition is stored at 25°C and 60% relative humidity for 24 months, and the retention rate of active ingredients of each extract is ≥90%.

[0014] According to a preferred embodiment of the present invention, component B comprises 30 parts of resistant dextrin, 15 parts of xylooligosaccharide, 10 parts of inulin and 40 parts of D-allulose.

[0015] Secondly, the present invention also provides the application of the above-described hypoglycemic composition in the preparation of hypoglycemic auxiliary foods, health products or special medical purpose formula foods.

[0016] (III) Beneficial Effects Compared with the prior art, the hypoglycemic composition of the present invention has the following technical advantages: (i) Synergistic hypoglycemic effect of multiple targets, overcoming the limitations of single mechanism This invention innovatively constructs a multi-target synergistic system of "medicinal and edible homologous extracts + gradient fermented prebiotics," forming a triple hypoglycemic mechanism of "digestion inhibition - metabolic regulation - gut microbiota intervention," completely breaking through the technical bottleneck of existing hypoglycemic products' "single target of action and limited efficacy." The specific synergistic effects are as follows: ① Upper digestive tract: Inhibits carbohydrate absorption (mainly by extracts of food and medicine homology, supplemented by prebiotics).

[0017] 1-Deoxynojirimycin (DNJ) in mulberry leaf extract and bitter melon polypeptide-P in bitter melon extract can specifically inhibit the activity of α-amylase and α-glucosidase in the upper gastrointestinal tract, reducing the rate at which carbohydrates (starch, sucrose, etc.) in food are broken down into glucose. At the same time, prebiotics (such as xylooligosaccharides) can form a mild gel in the stomach, slowing down the gastric emptying rate and further helping to reduce the initial rate of glucose absorption, achieving a synergistic effect of "enzyme inhibition + gastric emptying delay". ② Systemic Metabolism: Improves Insulin Sensitivity (Core Function of Food and Medicine Homologous Extracts). Puerarin in kudzu root extract and Lycium barbarum polysaccharides in wolfberry extract can penetrate the intestinal barrier and enter the bloodstream. By activating insulin signaling pathways (such as the PI3K-AKT pathway), they enhance the uptake and utilization of glucose by skeletal muscle and adipocytes, improve insulin resistance, and regulate blood sugar levels at the metabolic level, thus overcoming the deficiency of existing prebiotics that "only act on the intestines and cannot intervene in systemic metabolism." ③ Lower digestive tract: Regulating gut microbiota and metabolism (prebiotics-led, supplemented by food and medicine homologous extracts). Gradient fermentation prebiotics (resistant dextrin, inulin, xylooligosaccharides) can precisely nourish probiotics (Bifidobacteria, Lactobacillus, etc.) throughout the colon, promoting their fermentation to produce short-chain fatty acids (acetic acid, propionic acid, butyric acid). Simultaneously, the resistant starch in yam extract can act as a "synergistic substrate" for prebiotics, prolonging the generation time and yield of short-chain fatty acids. Short-chain fatty acids can repair the intestinal mucosal barrier and reduce systemic chronic inflammatory responses (inflammation is a key factor leading to insulin resistance). Furthermore, they can suppress appetite through the gut-brain axis and promote insulin secretion through the gut-pancreas axis, forming a synergistic "gut-systemic" regulation with the "systemic metabolic regulation" of food and medicine homologous extracts. The triple synergistic mechanism was validated using an in vitro digestion-Caco-2 cell transport model, which reduced glucose uptake rate by 56% and was significantly more effective than the control group containing only the α-glucosidase inhibitor (acarbose) (statistical difference p<0.01), fully demonstrating the scientific validity and high efficiency of multi-target synergy.

[0018] (ii) Excellent palatability and high user acceptance. To address the common problems of bitterness, off-flavors, and poor palatability in existing blood sugar-lowering products, this invention constructs a flavor and texture synergistic optimization system through multi-sensory improvement technology, specifically including: ① Precise flavor blending: Using electronic tongue analysis technology, an interaction model of bitter substances (such as momordicin and alkaloids) and sweeteners (such as D-allulose) is established to achieve a precise balance between bitterness and sweetness; ② Highly effective odor masking: Combining the natural sweetness of D-allulose, the mild taste of prebiotics, and the complementary flavors of various food and medicine materials, a compound flavor system is constructed to effectively mask the unpleasant odors of medicinal extracts. ③ Improved texture: Soluble dietary fiber (resistant dextrin) partially replaces the oil components in the traditional formula, reducing calories while maintaining the smoothness of the product's texture, avoiding roughness or dryness, and significantly improving overall palatability and user acceptance.

[0019] (iii) It has a balanced and safe medicinal effect and is suitable for long-term consumption. This invention uses food and medicine homology as its core raw materials, and follows the principle of "balance between cold, hot, warm and cool" in the combination of medicinal materials: by using neutral / warm medicinal materials such as yam, wolfberry, and polygonatum, the medicinal properties of cold medicinal materials such as mulberry leaves and bitter melon are neutralized, avoiding the "stomach damage" problem (such as abdominal distension and diarrhea) caused by the cold nature of existing traditional Chinese medicine for lowering blood sugar. Moreover, all raw materials meet the safety standards of food and medicine homology, and there is no risk of toxicity when consumed for a long time. The safety is significantly better than existing products containing chemical hypoglycemic ingredients or with unbalanced medicinal properties.

[0020] (iv) Dual inhibition of α-amylase and α-glucosidase The herbal extract and prebiotic combination system of this invention is optimized by response surface methodology to ensure that the active ingredients of each material exert synergistic effects, overcoming the shortcomings of existing products that have "single-component efficacy and limited effect": through in vitro experiments, the dual inhibition rate of this composition against α-amylase and α-glucosidase is significantly better than that of any single component (such as mulberry leaf extract alone or bitter melon extract alone); and under the same experimental conditions, compared with the control group containing only α-glucosidase inhibitor (acarbose, inhibition rate 40.1%), this composition can increase the glucose absorption rate by 56%, fully demonstrating the scientific nature and synergistic effect of the combination scheme.

[0021] The combination system of medicinal extracts and prebiotics in this invention is optimized by response surface methodology. This not only ensures that the active ingredients of each material exert synergistic effects, but also precisely corresponds to the "triple hypoglycemic mechanism": the enzyme inhibition and metabolic regulation effects of the medicinal and edible extracts complement the microbial intervention and short-chain fatty acid generation effects of prebiotics, avoiding the problem that a single component "only acts on a certain link and cannot control blood sugar throughout the process".

[0022] (V) Innovation in the prebiotic system, with significant gut microbiota regulation function. This invention innovatively incorporates a multi-gradient fermented prebiotic combination into the design of blood sugar-lowering products, overcoming the technical limitations of existing products that rely on "single prebiotics and have limited range of gut microbiota regulation." Specific innovations are as follows: ① Precise screening of prebiotic combinations: Resistant dextrin (3-10kDa molecular weight ratio >80%), xylooligosaccharides (DP2-4 short chain molecular weight ratio ≥90%), inulin (DP≥23 long chain molecular weight ratio >70%) and D-allulose are selected to construct a quaternary prebiotic system, covering three types of fermentation kinetics: "fast-medium-slow", forming functional complementarity; ② Synergistic effect of fermentation kinetics and intestinal location: Xylooligosaccharides are rapidly fermented and mainly act on the small intestine; inulin is a medium-speed fermented product and mainly acts on the proximal colon; resistant dextrin is a slow fermented product and mainly acts on the distal colon. The three form a temporal and spatial gradient, which can provide continuous nutrition for probiotics throughout the colon, significantly improve the abundance of the entire colonic intestinal flora, and avoid the problem of single prebiotics "acting only on the local intestine and not regulating the flora in an incomplete way". ③ Synergistic effect of gut microbiota regulation and metabolism: This prebiotic combination can cover probiotics in different ecological niches (such as Bifidobacteria and Lactobacillus) to build a stable hypoglycemic microecological environment; in vitro simulated colon fermentation experiment and animal experiment verification showed that compared with a single prebiotic, this combination can significantly increase the levels of acetic acid, propionic acid and butyric acid in the intestine of diabetic model mice, and significantly increase the production of short chain fatty acids (SCFA) (SCFA can help lower blood sugar by inhibiting appetite and improving insulin sensitivity), confirming that there is a significant synergistic effect among the four prebiotics.

[0023] (vi) It has a significant blood sugar lowering effect and high safety, and is suitable for a wide range of people. ① Clear blood sugar lowering effect: Through a 30-day human trial, this product can significantly reduce fasting blood glucose and postprandial blood glucose in subjects with hyperglycemia (statistical difference p<0.05), and has an improving effect on glycated hemoglobin (HbA1c) levels, and can maintain stable blood glucose in the long term; ② Excellent safety profile: No risk of hypoglycemia in healthy individuals; no severe hypoglycemic events with blood glucose <3.9mM occurred during the trial; no adverse reaction reports were received; cytotoxicity tests showed cell survival rate >90% and no cytotoxicity; suitable for long-term consumption by people with hyperglycemia to maintain healthy blood glucose levels, while avoiding the shortcomings of existing hypoglycemic products that "easily cause hypoglycemia and have side effects with long-term consumption". Detailed Implementation

[0024] To better explain and facilitate understanding of the present invention, the present invention will be described in detail below with reference to specific embodiments.

[0025] This invention provides a hypoglycemic composition based on food-medicine homology and gradient fermentation prebiotics. It is a dry powder formulation comprising component A and component B. Component A is a food-medicine homology component, and component B is a prebiotic component. Specifically, by weight, component A contains 2-15 parts mulberry leaf extract, 2-10 parts bitter melon extract, 2-20 parts yam extract, 1-10 parts kudzu root extract, 2-10 parts wolfberry extract, 0.5-5 parts Polygonatum odoratum extract, and 0.5-5 parts Polygonatum sibiricum extract. Component B contains 20-50 parts resistant dextrin, 5-15 parts xylooligosaccharides, 3-10 parts inulin, and 35-50 parts D-allulose. The technical requirements for the food-medicine homology are shown in Table 1.

[0026] Table 1:

[0027] In terms of the design of the aforementioned food-medicine homology ingredients included in component A, considering the rationality of the traditional Chinese medicine compatibility, key indicators, main mechanisms of action, and bioavailability enhancement technologies, this hypoglycemic food-medicine homology health food has the following advantages: 1. Reasonable compatibility of medicine and food from the same source Mulberry leaves, bitter melon, yam, kudzu root, goji berries, Solomon's seal, and polygonatum are all food and medicine ingredients, commonly used in traditional Chinese medicine to regulate blood sugar-related symptoms. The ingredients complement each other, working through multiple mechanisms such as inhibiting sugar absorption, improving insulin function, and protecting pancreatic cells, forming a multi-target, comprehensive blood sugar regulation system that aligns with the principle of "synergistic effect" in traditional Chinese medicine compound prescriptions. The ingredients are balanced in terms of their cold, hot, warm, and cool properties, avoiding the stomach-damaging issues common with traditional hypoglycemic drugs, making them suitable for long-term consumption.

[0028] 2. Mechanism of action covers the entire process of glucose metabolism. Mulberry leaves are rich in 1-deoxynojirimycin, which reduces the breakdown and absorption of carbohydrates in the intestines and slows down the rise in blood sugar by inhibiting α-glucosidase. Bitter melon is rich in momordicin and polypeptide-P, which act like insulin, mimicking the function of insulin in regulating blood sugar. The resistant starch and mucoprotein in yam can slow gastric emptying, causing blood sugar to rise slowly. Kudzu root is rich in puerarin and daidzein, which can improve insulin resistance and enhance the body's sensitivity to insulin. Goji berries are rich in goji polysaccharide LBP, which can protect β cells and maintain the normal function of pancreatic islet cells. Polygonatum odoratum is rich in polysaccharides and saponins, which can activate the Akt pathway and promote the utilization and metabolism of blood sugar. Polygonatum sibiricum is rich in polygonatum polysaccharides, which can inhibit α-amylase and further reduce the breakdown of starch. These mechanisms cover multiple key links in the entire process of blood sugar metabolism, and their synergistic effect can more effectively regulate blood sugar levels.

[0029] 3. Advanced bioavailability enhancement technology Corresponding bioavailability enhancement technologies were employed to address the characteristics of different ingredients, aiming to improve the retention rate of active ingredients in extracts and enhance taste or stability, as detailed below: (1) Mulberry leaf extract: prepared by zinc ion chelation stabilization During the mulberry leaf extraction process, zinc ions (such as zinc chloride and zinc sulfate) are added. The zinc ions form chelates with active ingredients such as DNJ in the mulberry leaves, which reduces the oxidation and degradation of active ingredients during storage and processing. At the same time, zinc ions themselves have a certain auxiliary effect in regulating blood sugar, achieving the dual effect of "stabilization + enhancement".

[0030] (2) Bitter melon extract: prepared by fermentation to reduce bitterness Bitter melon has a distinct bitter taste due to the presence of components such as momordicin. This process involves fermenting the bitter melon raw material by inoculating it with microorganisms (such as lactic acid bacteria and yeast). The microbial metabolism process decomposes some bitter substances (such as certain alkaloids and glycosides), while converting the large molecular active ingredients in bitter melon into smaller molecular forms that are more easily absorbed. This reduces the bitterness of the extract, improves palatability, and preserves or even enhances its hypoglycemic activity.

[0031] (3) Yam extract: prepared by targeted enzymatic hydrolysis technology Yam is rich in starch, mucoprotein and other components. This technology adds specific enzyme preparations (such as amylase and protease) and under precisely controlled temperature and pH conditions, it directionally decomposes the large starch molecules in yam into small sugar molecules (such as maltose and glucose) or decomposes the large protein molecules into small peptide molecules, thereby improving the solubility and absorption rate of the extract, while retaining the active ingredients such as polysaccharides in yam.

[0032] (4) Kudzu root extract: prepared by non-thermal high-pressure extraction Traditional hot extraction may cause the degradation of heat-sensitive active ingredients such as puerarin in kudzu root. This process uses high-pressure extraction under non-thermal conditions (such as room temperature) (pressure of 100-200 MPa). High pressure is used to destroy the cell structure of kudzu root, so that the active ingredients can be fully dissolved, avoiding the damage of active ingredients by high temperature, and significantly improving the extraction rate and retention rate of puerarin.

[0033] (5) Lycium barbarum extract: preparation by membrane separation and enrichment Goji berry extract contains various components such as polysaccharides, pigments, and small molecule impurities. This process uses membranes with specific pore sizes (such as ultrafiltration membranes and nanofiltration membranes) to filter and separate the extract at room temperature, retaining large molecular active ingredients such as goji berry polysaccharides and removing small molecule impurities (such as monosaccharides and inorganic salts), thereby enriching and purifying goji berry polysaccharides and increasing the content of goji berry polysaccharides in the extract.

[0034] (6) Polygonatum odoratum extract: prepared by compound enzymatic hydrolysis-ultrasound-assisted method First, a complex enzyme (such as cellulase and pectinase) is used to decompose the cellulose, pectin and other components in the cell wall of Solomon's seal, destroying the cell structure and creating conditions for the dissolution of active ingredients. Then, combined with ultrasound-assisted extraction (using the cavitation effect and mechanical vibration of ultrasound), the transfer of polysaccharides and other active ingredients in Solomon's seal to the extraction solvent is accelerated. Compared with the single extraction method, the extraction efficiency and the yield of active ingredients can be greatly improved.

[0035] (7) Polygonatum extract: prepared by solid-state fermentation The active ingredients in Polygonatum (such as Polygonatum polysaccharides) exist in a bound state, and direct extraction results in a rather astringent taste. This process mixes Polygonatum raw materials with microorganisms (such as Aspergillus and Rhizopus) for solid-state fermentation. The enzymes produced by the microorganisms can decompose cellulose, lignin, and other substances in Polygonatum, releasing bound polysaccharides. At the same time, some components are transformed to improve the taste, and new active substances (such as microbial metabolites) can be generated, enhancing the bioactivity and palatability of the extract.

[0036] The above technologies can improve the extraction rate and stability of active ingredients, improve taste, and enhance the absorption and utilization of active ingredients, thereby ensuring that the food can play a better role in lowering blood sugar in the body.

[0037] 4. Scientific dosage and ratio The proportions of each material have been meticulously designed, reflecting rationality in many aspects: ① Balanced Efficacy: Yam (2-20 parts) in a relatively high proportion serves as a basic ingredient, and its effect of delaying gastric emptying provides a "buffer" for blood sugar regulation; the proportions of core efficacy ingredients such as mulberry leaves (2-15 parts) and bitter melon (2-10 parts) are moderate, ensuring that key mechanisms such as α-glucosidase inhibition and insulin-like effects are fully utilized; the proportions of auxiliary regulatory ingredients such as kudzu root (1-10 parts) and wolfberry (2-10 parts) are precise, playing a synergistic supporting role in improving insulin resistance and protecting β cells; Polygonatum odoratum (0.5-5 parts) and Polygonatum sibiricum (0.5-5 parts) serve as mechanism supplementary ingredients, with a moderate proportion, which avoids increasing the metabolic burden due to excessive dosage, and can effectively activate the Akt pathway and inhibit α-amylase.

[0038] ②Safe and suitable: All ingredients are of the same origin as food and medicine. The ingredients are balanced in terms of their cold, hot, warm and cool properties, which takes into account the balance between efficacy and safety. It avoids the stomach damage caused by the coldness of traditional Chinese medicine for lowering blood sugar, and is suitable for long-term consumption.

[0039] ③ Process adaptation: Different proportions are adapted to their respective bioavailability enhancement technologies. For example, the relatively low proportions of Polygonatum odoratum and Polygonatum sibiricum can achieve full release and utilization of effective ingredients with small dosages through efficient technologies such as compound enzymatic hydrolysis-ultrasound combined use and solid-state fermentation conversion, ensuring the operability and cost rationality of the formula in the production process.

[0040] Component B consists of gradient fermented prebiotics, containing 20-50 parts resistant dextrin, 5-15 parts xylooligosaccharides, 3-10 parts inulin, and 35-50 parts D-allulose, etc. The combination of these four prebiotics is considered and designed from the following perspectives: 1. A spatiotemporally layered whole colonic nutrition supply chain Based on differences in fermentation rate and location, four prebiotics form a gradient nutrient supply system from the small intestine to the proximal colon and then to the distal colon: xylooligosaccharides (DP2-4 content ≥90%) undergo rapid fermentation, acting on the small intestine to rapidly supply energy to proximal probiotics, achieving rapid proximal effects; inulin (DP≥23 content >70%) undergoes medium-speed fermentation, acting on the proximal colon to maintain the fermentation rhythm of the small intestine, achieving continuous regulation in the mid-segment; and resistant dextrin (3-10kDa content >80%) undergoes slow fermentation, acting on the distal colon to maintain terminal fermentation activity, achieving long-term distal regulation. This system can comprehensively improve the abundance of the entire colonic flora and regulate blood glucose throughout the entire time frame and in multiple dimensions of the gut via the "gut-metabolism axis."

[0041] 2. Targeted regulation of blood glucose at its root in the gut All ingredients are designed to work in the gut, addressing the root cause of blood sugar fluctuations. Among them, the gut microbiota regulators (inulin, resistant dextrin, xylooligosaccharides) indirectly regulate blood sugar by promoting the proliferation of beneficial bacteria such as *Faecalibacterium prausnitzii*, *Bifidobacterium*, and *Roseburia*, thus improving the gut metabolic environment. Meanwhile, D-allulose directly reduces intestinal glucose absorption, decreasing the driving force behind blood sugar spikes at the source of sugar absorption. This design avoids the side effects of systemic metabolic intervention, achieving fundamental blood sugar control through "gut absorption + gut microbiota metabolism."

[0042] 3. Functional compatibility and safety of raw material selection Inulin, resistant dextrin, and xylooligosaccharides have well-defined efficacy and high safety profiles. D-allulose is an approved low-calorie sweetener that combines the effects of "promoting normal insulin secretion and inhibiting glucose absorption," making its functional properties highly compatible with the need for lowering blood sugar.

[0043] 4. Mechanism network of multi-target synergy Four materials cover the core processes of glucose metabolism, forming a complementary mechanism network: ① Inulin promotes the growth of anti-inflammatory bacteria Faecali bacterium prausnitzii, achieving the effects of inflammation regulation and flora balance; D-allulose promotes insulin secretion and inhibits glucose absorption, thus regulating insulin secretion and sugar absorption; resistant dextrin promotes the proliferation of Bifidobacteria and Roseburia, improving flora balance and metabolic environment; xylooligosaccharides stimulate the growth of Bifidobacterium adolescentis, maintaining flora balance.

[0044] 5. Synergistic effect of division The synergistic effect of D-allulose with plant components, particularly with mulberry leaves and bitter melon, enhances the inhibition of intestinal glucose absorption and improves immediate blood sugar control. Furthermore, the synergistic effect among prebiotics is also manifested in the fact that inulin, resistant dextrin, and xylooligosaccharides promote the proliferation of different beneficial bacteria, forming an ecosystem of "microbial symbiosis and metabolic complementarity," amplifying blood sugar regulation efficiency through the gut-metabolic axis.

[0045] 6. Scientific stratification of dosage ratios The appropriate proportions of each material should be matched with the efficacy and process characteristics: D-Allulose (35-50 parts), as the core component for direct sugar control, has the highest proportion to ensure its dominant role in key mechanisms; resistant dextrin (20-50 parts) and inulin (3-10 parts), as the main agents for microbial regulation, have proportions suitable for medium- and medium-speed fermentation characteristics; xylooligosaccharides (5-15 parts), which are effective at low doses, have a moderate proportion to leverage their rapid fermentation advantages. This stratified design ensures full efficacy while adapting to bioavailability enhancement technologies (such as the fermentation kinetics curve of inulin and molecular fractionation technology for resistant dextrin), achieving production stability and controllable efficacy.

[0046] In summary, component B in this invention constructs a multi-dimensional hypoglycemic advantage through spatiotemporal stratified fermentation regulation, gut-based blood sugar control logic, multi-target synergistic mechanisms, synergistic effects between components, and scientific dosage design, encompassing "immediate blood sugar control, long-term bacterial regulation, and metabolic optimization."

[0047] This invention, through the innovative combination of a food-medicine homology component A and a prebiotic component B, possesses multiple core advantages and innovations: First, it constructs a triple multi-target synergistic hypoglycemic mechanism of "digestive inhibition-metabolic regulation-microbiota intervention." In the upper digestive tract, it inhibits carbohydrate-degrading enzymes to reduce glucose absorption; systemic metabolic regulation improves insulin signal transduction; and in the lower digestive tract, it promotes short-chain fatty acid production, improving the intestinal barrier and systemic inflammation. In vitro experiments show a reduced glucose absorption rate, with effects superior to the control group containing only α-glucosidase inhibitors. Second, it achieves targeted regulation of the gut microbiota. The prebiotic combination, designed for the characteristic microbiota imbalance in diabetic patients, significantly increases short-chain fatty acid levels in diabetic model mice. Third, it employs multi-sensory enhancement technology to optimize palatability, including flavor blending, odor masking, and texture improvement. Fourth, in vitro experiments demonstrate a strong inhibitory effect on α-amylase and α-glucosidase. Fifth, it precisely targets three core population groups: prediabetic individuals, type II diabetic patients, and those pursuing a healthy lifestyle, forming a "7 The product boasts a differentiated competitive advantage through a scientific combination of medicinal and edible ingredients, a triple blood sugar-lowering mechanism, and precise regulation of the gut microbiota by prebiotics. Furthermore, human trials show that the product can significantly reduce fasting and postprandial blood glucose levels in subjects, improve glycated hemoglobin levels in hyperglycemic individuals, and has no hypoglycemia or adverse reactions, demonstrating good safety and allowing for long-term consumption to maintain healthy blood sugar levels.

[0048] The technical solution of the present invention will be illustrated below through specific embodiments.

[0049] Example 1 The hypoglycemic composition of this embodiment has the following formulation (parts by weight): Component A: 5 parts mulberry leaf extract, 4 parts bitter melon extract, 8 parts yam extract, 3 parts kudzu root extract, 4 parts wolfberry extract, 1 part Solomon's seal extract, and 1 part Polygonatum sibiricum extract. Component B: 30 parts resistant dextrin, 15 parts xylooligosaccharide, 10 parts inulin, and 40 parts D-allulose.

[0050] The raw material requirements are as follows: Mulberry leaf extract: zinc ion chelation stabilization, DNJ≥1%; Bitter melon extract: fermentation to reduce bitterness, momordicin≥20%; Yam extract: targeted enzymatic hydrolysis; Kudzu root extract: non-thermal high-pressure extraction, puerarin≥30%; Lycium barbarum extract: membrane separation enrichment, Lycium barbarum polysaccharide≥30%; Polygonatum odoratum extract: compound enzymatic hydrolysis-ultrasound assisted, Polygonatum odoratum polysaccharide≥30%; Polygonatum sibiricum extract: solid-state fermentation conversion, Polygonatum sibiricum polysaccharide≥30%. Resistant dextrin: 3-10kDa molecular weight >80%; Xylooligosaccharides: degree of polymerization 2-4 ≥90%; Inulin: long chain (DP≥23) ≥70%; D-allulose: purity≥99%.

[0051] The hypoglycemic composition is a dry powder product, and its preparation process is as follows: (1) Primary mixing: Pueraria lobata, wolfberry, Solomon's seal and Polygonatum extracts are mixed in a mixer at 15 r / min for 20 min; (2) Secondary mixing: Primary mixing is mixed with mulberry leaf, bitter melon, yam extract, inulin and xylooligosaccharide at 15 r / min for 20 min; (3) Tertiary mixing: Secondary mixing is mixed with resistant dextrin and D-aloxone at 15 r / min for 30 min; (4) Packaging: Aluminum-plastic composite film packaging, 5g / bag, stored in an environment with relative humidity ≤60% and 15-30℃.

[0052] Next, in vitro experiments were used to test the inhibitory effects of the hypoglycemic composition and component A on α-amylase and α-glucosidase, and the content of short-chain fatty acids in diabetic mice after intervention by component B.

[0053] (I) α-Amylase and α-glucosidase inhibition test experiment The inhibition rates of the hypoglycemic composition and component A on α-amylase and α-glucosidase were tested in vitro, as well as the inhibition rates of individual herbs in component A on α-amylase and α-glucosidase. The test methods for α-amylase and α-glucosidase inhibition rates are as follows: 1(1) In vitro experiment on α-amylase inhibitory activity Prepare 1 U / mL α-amylase solution and 1% (w / w) starch solution using 20 mM PBS buffer (pH 6.8). Add 20 μL of the 5 mg / mL sample solution and 10 μL of the 1 U / mL α-amylase solution to a centrifuge tube and incubate at 37°C with a shaker for 20 min. Then add 500 μL of the pretreated starch solution and incubate at 37°C with a shaker for 5 min. Finally, add 600 μL of DNS stop solution and incubate in a boiling water bath for 15 min. After the reaction is complete, cool to room temperature and measure the absorbance at 540 nm.

[0054] (2) In vitro experiments on α-glucosidase inhibitory activity Take 200 μL of sample solutions of different concentrations and 200 μL of α-glucosidase solution (1.5 U / mL), mix well, and incubate in a 37℃ water bath for 5 min. Add 200 μL of PNPG solution (2.5 mM), mix well, and continue incubating in a 37℃ water bath for 15 min. Add 800 μL of Na2CO3 solution (0.2 mol / L) to terminate the reaction, thus stopping the hydrolysis of α-glucosidase. Based on the specific absorption principle of p-nitrophenol (PNP) at 405 nm, pipette 160 μL of the reaction termination solution into a 96-well plate and measure the absorbance at 405 nm using a microplate reader.

[0055] The concentration of the "sample solution" is 5 mg / mL, and the samples refer to the hypoglycemic composition, component A, component B, mulberry leaf extract, bitter melon extract, yam extract, kudzu root extract, wolfberry extract, Solomon's seal extract, and polygonatum extract prepared in this embodiment.

[0056] The formulas for calculating the inhibition rates of α-amylase and α-glucosidase are as follows: Inhibition rate of α-amylase

[0057] Inhibition rate of α-glucosidase

[0058] The experimental results are shown in Table 2.

[0059] Table 2: Inhibition rates of different sample solutions on α-amylase and α-glucosidase

[0060] As shown in Table 2 above, regarding the α-amylase inhibition rate, when the sample solution concentrations are completely equal, the α-amylase inhibition rates of mulberry leaf (51.3%), bitter melon (30.2%), yam (18.7%), kudzu root (9.8%), wolfberry (11.4%), Solomon's seal (39.7%), and polygonatum (35.2%) are all lower than that of component A (68.3%). Similarly, the inhibition rate of each individual material in α-glucosidase is lower than that of component A (79.3%). This indicates that the inhibitory effect of group A materials on α-amylase and α-glucosidase is far superior to the simple sum of the individual effects of each material. This suggests that the various medicinal and edible materials within component A have a synergistic effect on the inhibitory effects of α-amylase and α-glucosidase.

[0061] The hypoglycemic composition is a combination of components A and B. Component A has an α-amylase inhibition rate of 68.3%, which increases to 76.5% after combination; component A has an α-glucosidase inhibition rate of 79.3%, which increases to 86.8% after combination. Component B, as a prebiotic, can lower blood sugar in vivo and also has a certain indirect inhibitory function on α-amylase and α-glucosidase. However, this function is not directly generated and must rely on the digestive tract and other environmental factors of the animal to function. Therefore, the α-amylase and α-glucosidase inhibition rates of component B cannot be measured in vitro. Even so, in vitro experimental results still demonstrate that the inhibitory effect of the combination product on α-amylase and α-glucosidase is superior to that of component A alone, indicating a synergistic effect between components A and B in the inhibition of α-amylase and α-glucosidase.

[0062] (II) Short-chain fatty acid production efficiency test experiment To investigate the association between short-chain fatty acids (SCFAs) and glucose metabolism and blood glucose stability, researchers conducted a specialized study. The study selected 30 healthy individuals and 30 patients with type 2 diabetes as control subjects, focusing on detecting the levels of the core components of SCFAs—acetic acid, propionic acid, and butyric acid—in their feces. The results showed that the levels of SCFAs (acetic acid, propionic acid, and butyric acid) in feces were significantly higher in the healthy individuals than in the patients with type 2 diabetes. This indicates that SCFAs play a crucial role in improving glucose metabolism and maintaining blood glucose stability, exerting important physiological regulatory functions. The 2017 paper "The Role of Short-Chain Fatty Acids in the Pathogenesis of Type 2 Diabetes" published in the International Journal of Endocrinology and Metabolism by Wang Xuejiao, Ding Xiaoying, et al., also points out that "animal studies have shown that SCFAs are absorbed into the bloodstream from intestinal epithelial cells, reach the portal vein, participate in hepatic glucose and fatty acid metabolism, improve insulin sensitivity, and alleviate insulin resistance." Furthermore, numerous studies have indicated that the most important function of SCFAs in the human body is as signaling molecules regulating physiological activities. Therefore, if prebiotics can increase the amount of SCFA in the body, they can achieve the goal of "improving insulin sensitivity and reducing insulin resistance".

[0063] To compare the efficiency of short-chain fatty acid production in the mouse intestine by component B of the present invention and a single prebiotic, the following animal experiments were conducted: Seventy healthy male C57BL / 6J mice, aged 8 weeks and with an average weight of 25g, were purchased and injected intraperitoneally with STZ (50mg / kg / day) for 5 consecutive days. A diabetes model was successfully established when blood glucose levels were >16.7mM (for 2 weeks), fasting blood glucose was >11.1mM, and serum insulin decreased by >80% (ELISA). The diabetic model mice were then administered either a single prebiotic or a combination of prebiotics (prepared as a 0.2kg / L solution) via gavage at a dose of 200mg / kg of mouse body weight, four times a day for 5 consecutive days. The SCFA content in the mouse feces was measured, and the results are shown in Table 3. Each group consisted of 10 mice, and the average results were taken. The blank control group consisted of pure water.

[0064] Table 3: Short-chain fatty acid content in diabetic mice after intervention with prebiotics

[0065] The experimental results in Table 3 show that, under the same gavage dosage and frequency, the use of component B of this invention (a combination of four prebiotics) increased the levels of acetic acid, propionic acid, and butyric acid in diabetic model mice by 5.19 times, 4.17 times, and 20.01 times, respectively, compared to the blank control group, which was significantly better than the three-component and single prebiotic combinations. This result indicates that the four prebiotic components of component B have a synergistic effect in increasing SCFA in the digestive tract of diabetic animals.

[0066] Furthermore, in this embodiment, the degradation rate of different prebiotics by the gut microbiota was tested using an in vitro simulated colonic environment for component B. The experimental results showed that the rapid fermentation of xylooligosaccharides primarily occurred in the small intestine, the medium-speed fermentation of inulin primarily occurred in the proximal colon, and the slow fermentation of resistant dextrin primarily occurred in the distal colon. This combination of characteristics allows the prebiotic combination to achieve complementary fermentation kinetics. The time gradient formed by resistant dextrin (slow fermentation), xylooligosaccharides (rapid fermentation), and inulin (medium-speed fermentation) maintains the continuous synergistic regulation of the intestinal acid-producing flora, covering probiotics in different ecological niches, constructing a more stable hypoglycemic microecology, and providing sufficient nutrition for probiotics throughout the colon while ensuring the abundance of the gut microbiota. Based on current mainstream gut microbiota-metabolic studies, it has been found that diabetic patients generally suffer from a decrease in short-chain fatty acid-producing bacteria and an increase in opportunistic pathogens, resulting in a microecological imbalance. The prebiotic combination (component B) of this invention perfectly matches the common problems of diabetic patients, thereby improving glucose metabolism by increasing microecological balance and improving bacterial abundance.

[0067] Example 2 The hypoglycemic composition of this embodiment has the following formulation (parts by weight): Component A: 8 parts mulberry leaf extract, 6 parts bitter melon extract, 12 parts yam extract, 5 parts kudzu root extract, 6 parts wolfberry extract, 2 parts Solomon's seal extract, and 2 parts polygonatum extract. Component B: 40 parts resistant dextrin, 10 parts xylooligosaccharide, 7 parts inulin, and 45 parts D-allulose. The raw material requirements and preparation process are the same as in Example 1.

[0068] To verify the hypoglycemic composition of this embodiment in terms of its effect on reducing glucose absorption and its safety, an in vitro digestion-Caco-2 cell transport model experiment was conducted.

[0069] (III) In vitro digestion-Caco-2 cell transport model experiment 1. Experimental grouping and preparation of test samples (1) Group settings Experimental group: prepared by mixing the hypoglycemic composition (5wt%) prepared in this example, acarbose (1wt%, α-glucosidase inhibitor) with PBS buffer.

[0070] Positive control group (acarbose group): contains only acarbose (1wt%) and PBS buffer, without the addition of any hypoglycemic composition.

[0071] Blank control group: PBS buffer solution only.

[0072] Substrate preparation: Prepare starch substrate and sucrose substrate separately for subsequent mixing with samples from each experimental group.

[0073] (2) Oral digestion Take the test samples from each of the above experimental groups (test sample group, positive control group, and blank control group) and mix them with starch substrate or sucrose substrate, respectively. Add a buffer solution containing salivary amylase (pH 6.8) to the mixture to ensure that all components are thoroughly mixed. Incubate the mixture at 37°C with shaking for 5 minutes to complete oral phase digestion.

[0074] (3) Stomach digestion After oral phase digestion is complete, adjust the pH of the oral phase mixture to 2.5 using a suitable acid-base regulator (such as hydrochloric acid). Add pepsin to the pH-adjusted mixture and gently stir to disperse it evenly. Continue to incubate the mixture at 37°C with shaking for 50 minutes to carry out gastric phase digestion.

[0075] (4) Intestinal digestion After gastric digestion is complete, the pH of the gastric mixture is adjusted to 6.8 using a suitable acid-base regulator (such as sodium hydroxide solution). Trypsin is then added to the pH-adjusted mixture and thoroughly mixed. The mixture is then incubated at 37°C with shaking for 120 minutes to complete intestinal digestion (this stage is the key step in the complete hydrolysis of carbohydrates into glucose and is also the main action point for α-glucosidase inhibitors).

[0076] (5) Termination of digestion and acquisition of final digestive fluid After intestinal digestion is complete, all digestive fluids are transferred to a suitable container and placed in a boiling water bath for 10 minutes to inactivate enzyme activity and terminate the digestion reaction.

[0077] After the digestion solution has been treated in a boiling water bath, remove it, cool it to room temperature, and then place it in a centrifuge. Centrifuge at a suitable speed (usually 5000 rpm) for 15 minutes. After centrifugation, carefully aspirate the supernatant, which is the "final digestion solution" and will be used for subsequent Caco-2 cell glucose transport experiments.

[0078] 2. Procedure for Caco-2 cell glucose transport experiment (1) Caco-2 cell-related characteristics Caco-2 cells are a human colon adenocarcinoma cell line belonging to the epithelial-like adherent cell type. They can simulate the physiological functions of intestinal epithelium in vitro and are a classic experimental model in the biomedical field. As the gold standard for "in vitro intestinal models", their monolayer cells can be used to study intestinal barrier function and the effects of intestinal microbial metabolites (such as SCFA and indole substances) on intestinal epithelial cells.

[0079] (2) Cell preparation and digestion final solution treatment Caco-2 cells were cultured in advance until they grew to form a monolayer (usually 21-28 days to ensure cell differentiation and maturity, and good intestinal epithelial mimicry function). The prepared digestion solutions from each experimental group were then appropriately diluted with HBSS transport buffer. The dilution factor needed to be determined based on preliminary experiments to ensure the accuracy and reliability of subsequent glucose detection.

[0080] (3) Sample addition and incubation transport The diluted digestion solutions from each experimental group were added to the apical compartment of the Caco-2 cell monolayer, taking care to avoid air bubbles during addition to prevent interference with cell-sample contact. Simultaneously, an appropriate amount of HBSS buffer was added to the basolateral compartment. The culture plates containing cells and samples were placed in a 37°C, 5% CO2 incubator and incubated for 100 min to induce glucose transport.

[0081] (4) Sample collection and glucose quantification After incubation and transport, carefully collect the culture medium from the basolateral compartment of the culture plate, taking care to avoid mixing it with the solution in the top compartment to prevent cross-contamination. Using a glucose oxidase (GOD-POD) assay kit, following the instructions, determine the glucose concentration in the collected basolateral compartment culture medium. This concentration directly reflects the amount of glucose absorbed by the intestines.

[0082] 3. Cell viability verification (MTT assay) steps (1) Experimental objective To ensure that the effects observed in the Caco-2 cell glucose transport assay (such as changes in glucose transport) were not caused by cytotoxicity, the effects of all test substances on Caco-2 cell viability at the experimental concentrations were verified.

[0083] (2) Experimental procedures Cell seeding: Caco-2 cells in the logarithmic growth phase are seeded at an appropriate cell density (usually 1 × 10⁻⁶). 4 -5×10 5 Cells (per well) were seeded into 96-well culture plates, and an appropriate amount of serum-containing culture medium was added to each well. The plates were then incubated at 37°C with 5% CO2 to allow the cells to adhere and grow.

[0084] Test substance treatment: After the cells adhered, the original culture medium was removed, and the test substance for each experimental group was added (the concentration was the same as that in the Caco-2 cell glucose transport experiment). At the same time, a blank control group was set up (only culture medium was added). Multiple replicates were set up for each group (usually 3-5 replicates). The cells were then cultured in the incubator for the corresponding time (the same incubation time as the glucose transport experiment, i.e., 100 min).

[0085] MTT solution addition and incubation: After culture, add an appropriate amount of MTT solution to each well (usually 5 mg / mL, 10-20 μL per well), gently shake the culture plate to thoroughly mix the MTT solution with the culture medium, and then incubate at 37℃ and 5% CO2 for 4 hours to allow MTT to react with mitochondrial dehydrogenases in the cells to generate blue-purple formazan crystals. Crystal dissolution and absorbance measurement: After incubation, carefully aspirate the supernatant from the wells, avoiding the removal of the generated formazan crystals. Add an appropriate amount of DMSO to each well and shake on a shaker at low speed for 15 minutes to fully dissolve the formazan crystals.

[0086] Results calculation: The absorbance (OD value) of each well was measured at a wavelength of 490 nm using an ELISA reader. Cell viability was calculated according to the following formula: Cell viability (%) = (OD value of test group / OD value of blank control group) × 100%.

[0087] The results of glucose concentration measurement and cell viability in each experimental group of the above in vitro digestion-Caco-2 cell transport model experiment were compiled and recorded in the experimental results table (as shown in Table 4).

[0088] Table 4: Comparison of glucose absorption indicators among groups

[0089] If the survival rate of all the above cells is >90%, it indicates that the test substance has no obvious cytotoxicity at the experimental concentration and has good safety. The glucose transport-related effects observed in the experiment are caused by the physiological effects of the test substance, rather than by cytotoxicity.

[0090] The rigorous in vitro digestion-Caco-2 cell combined model demonstrated that the hypoglycemic composition provided in this embodiment can significantly inhibit intestinal glucose absorption, with an inhibition rate of 56.0%. This effect is statistically significantly superior (p<0.01) to the traditional single α-glucosidase inhibitor (acarbose, inhibition rate 40.1%).

[0091] (iv) Human trial of the hypoglycemic composition products in Examples 1-2 1. Selection Criteria Health status: Diagnosed with type II diabetes, or with high blood sugar (fasting blood glucose ≥6.1mM or 2h postprandial blood glucose ≥7.8mM). Number of participants: 12 in total, divided into two groups: 6 in the experimental group and 6 in the control group; Age range: 30-60 years old (no other age-related exclusions mentioned).

[0092] 2. Dosage and method of consumption Directions for use: Take 5 grams three times daily, mixed with water at 42°C, before meals, for 30 consecutive days. Test product: The hypoglycemic composition prepared in Examples 1-2 (the control group did not consume this product).

[0093] 3. Monitoring Indicators (1) Main indicators: daily fasting blood glucose level and 2-hour postprandial blood glucose level; (2) Secondary indicators: glycated hemoglobin (HbA1c), hypoglycemic events (blood glucose <3.9mM).

[0094] 4. Detection methods and frequency Testing tool: Sinocare EA-19 blood glucose meter; Testing frequency: Blood glucose (fasting + 2 hours postprandial) is tested once a week, and all indicators are compared before and after the trial (i.e., day 0 and day 30). Glycated hemoglobin testing: Only for the 6 subjects in the experimental group, the test was conducted on day 0 and day 30 of the trial.

[0095] 5. Test Results (1) Results of blood glucose changes: Table 5 shows the changes in blood glucose levels in the experimental group and the control group before and 30 days after consuming the product.

[0096] Table 5: Changes in blood glucose levels before and after the trial.

[0097] The formula for calculating the percentage decrease in blood glucose in Table 5 is as follows:

[0098]

[0099] The controlled trial showed that 30 days after consuming the product, the 2-hour postprandial blood glucose level of the subjects decreased by 19.34% (P<0.001), and the decrease was statistically significant.

[0100] (2) Results of changes in glycated hemoglobin: Table 6 shows the glycated hemoglobin values ​​of 6 subjects before and 30 days after consuming the product (the normal range of glycated hemoglobin is 4-6%).

[0101] Table 6: Changes in glycated hemoglobin levels before and after the trial.

[0102] As shown in Table 6, the glycated hemoglobin levels of all 6 subjects decreased, with an average of 7.48% before the experiment and an average of 6.80% after the experiment. The overall average decrease rate was 5%, and the P value was 0.00034 (significantly statistically significant).

[0103] The results of the human trial showed that the hypoglycemic composition provided by this invention significantly reduced fasting blood glucose (P<0.05) and 2-hour postprandial blood glucose (P<0.001) in the experimental group during the 30-day trial period, and significantly improved glycated hemoglobin levels in hyperglycemic individuals (P=0.00034). In the control group (normal blood glucose levels), there was no significant change in blood glucose before and after the trial (P>0.05), indicating that the product does not significantly reduce blood glucose levels in healthy individuals. No severe hypoglycemic events (blood glucose <3.9 mmol / L) occurred during the trial, demonstrating good safety and long-term suitability for maintaining healthy blood glucose levels.

[0104] In addition, the palatability feedback from the participants indicated that the product has a mild and light taste, which aligns with the usual preference for a light diet. It is not overly sweet and does not have any bitter or medicinal taste that would affect the eating experience. Based on the positive taste experience, the participants had a high level of acceptance, and all participants in the experimental group expressed their willingness to use the product as a supplementary food for long-term blood sugar maintenance, thus providing a feasible approach to maintaining healthy blood sugar levels in the long term.

[0105] Compared with commonly available blood sugar-lowering foods, the blood sugar-lowering composition of the present invention has the following advantages: 1. The food-medicine homology formulation system has been verified through in vitro α-amylase and α-glucosidase inhibition experiments, demonstrating synergistic effects among the various medicinal materials. Furthermore, the balanced combination of the materials in terms of their cold, hot, warm, and cool properties avoids the stomach-damaging issues commonly found in traditional hypoglycemic Chinese medicines, making it suitable for long-term consumption.

[0106] 2. The combination of prebiotics produced a synergistic effect in increasing SCFA in the digestive tract of diabetic animals, enabling targeted regulation of the gut microbiota. Animal experiments showed that component B of this invention, when combined with three prebiotics in a specific ratio (6:3:2) to address the microbiota imbalance characteristic of Chinese diabetic patients, increased the average levels of acetic acid, propionic acid, and butyric acid in diabetic model mice by 5.19 times, 4.17 times, and 20.01 times, respectively.

[0107] 3. This invention innovatively combines prebiotics (component B) with a food-medicine homology formula (component A) to enhance the hypoglycemic effect through precise gut microbiota regulation. Based on gut microbiota-metabolic studies, it has been found that diabetic patients generally exhibit a gut microecological imbalance characterized by a decrease in short-chain fatty acid-producing bacteria and an increase in opportunistic pathogens. Furthermore, in vitro studies on α-amylase and α-glucosidase show that the combination of A and B can further improve the inhibition rate of α-amylase and α-glucosidase. In addition, in vitro digestion-Caco-2 cell transport models show that the composition of this invention can achieve a glucose absorption inhibition rate of 56%, significantly better than the control group containing only α-glucosidase inhibitors.

[0108] 4. Multi-target synergistic hypoglycemic mechanism. The hypoglycemic composition of this invention overcomes the limitations of single-target action, constructing a triple hypoglycemic mechanism of "digestive inhibition - metabolic regulation - gut microbiota intervention." Upper gastrointestinal action: Mulberry leaf DNJ and bitter melon polypeptide-P inhibit carbohydrate-degrading enzymes, reducing glucose absorption. Systemic metabolic regulation: Puerarin and wolfberry polysaccharides improve insulin signaling and enhance skeletal muscle glucose uptake. Lower gastrointestinal regulation: The prebiotic-yam resistant starch combination promotes the production of short-chain fatty acids, improving the intestinal barrier and systemic inflammation.

[0109] 5. Optimized user experience To address the palatability issues commonly found in hypoglycemic products, this invention employs multi-sensory enhancement and optimization of extract preparation techniques. This includes utilizing electronic tongue analysis to establish an interaction model between bitter substances and sweeteners, combining D-allulose, prebiotics, and a flavor blending system of various food-grade medicinal materials to improve overall bitterness; and partially replacing fats with soluble dietary fiber (resistant dextrin) to maintain a smooth texture. Furthermore, the solution utilizes corresponding bioavailability enhancement technologies tailored to the characteristics of different ingredients, aiming to improve the retention rate of active ingredients in the extract and enhance its taste or stability.

[0110] 6. Market Positioning and Competitive Advantages Precise target audience positioning: The blood sugar lowering composition of this invention mainly serves three core groups, and the product form and marketing strategy are designed according to their different needs: For individuals with prediabetes: Beginning to develop awareness of blood sugar control and seeking non-pharmacological interventions; a light supplementary plan of 1-2 times / day is provided.

[0111] Patients with type 2 diabetes need to manage their blood sugar as part of their diet plan, in conjunction with the guidance of a nutritionist.

[0112] Healthy lifestyle seekers: They value metabolic health, prefer clean labels and natural ingredients, and seek the dual benefits of gut health and blood sugar management.

[0113] 7. Supports healthy blood sugar levels, safe and reliable. During the 30-day trial period, this product significantly reduced fasting and postprandial blood glucose levels in subjects, and had a certain effect on improving glycated hemoglobin levels in people with hyperglycemia, helping to maintain healthy blood glucose levels. It did not significantly reduce blood glucose levels in healthy individuals, and long-term consumption was safe and reliable, with no serious hypoglycemic events (blood glucose <3.9mM) occurring.

[0114] 8. The comparative advantages of the hypoglycemic composition provided by the present invention with conventional hypoglycemic foods are shown in Table 7.

[0115] Table 7: Comparison of hypoglycemic compositions with conventional hypoglycemic products

[0116] Based on the analysis of existing products, this invention adopts a differentiation strategy. It systematically screens medicinal and edible materials with clear hypoglycemic effects, combining them with specific prebiotic combinations to construct a dual-target system of "intestinal flora-metabolic regulation." Ultimately, it achieves a synergistic blood sugar management effect through the scientific formulation of seven medicinal and edible materials, combined with precise prebiotic flora regulation, resulting in multiple hypoglycemic mechanisms: (① Carbohydrate metabolism intervention: Directly inhibiting digestive enzyme activity and delaying glucose absorption through active ingredients in the medicinal and edible materials, improving insulin sensitivity; ② Specific plant components promoting insulin signaling pathway activation and enhancing peripheral tissue glucose uptake through intestinal flora regulation; ③ Selected prebiotics selectively promoting the proliferation of beneficial bacteria, producing short-chain fatty acids, and improving intestinal barrier function and systemic inflammatory status). Experiments have also demonstrated that this invention is technologically innovative in terms of herbal formulation, extraction optimization, and prebiotic combination, effectively solving the problems of current hypoglycemic products having single efficacy, poor taste, and unsatisfactory hypoglycemic effects.

[0117] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. These modifications or substitutions, or combinations of technical features in the above embodiments that do not conflict with each other, can be made in accordance with the manner described in the embodiments. These modifications, substitutions or combinations do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A hypoglycemic composition combining medicinal and edible ingredients with gradient fermented prebiotics, characterized in that, The hypoglycemic composition is a dry powder composition, and includes component A and component B; component A is a food-medicine homology component, and component B is a prebiotic component; By weight, component A contains 2-15 parts mulberry leaf extract, 2-10 parts bitter melon extract, 2-20 parts yam extract, 1-10 parts kudzu root extract, 2-10 parts wolfberry extract, 0.5-5 parts Solomon's seal extract, and 0.5-5 parts Polygonatum sibiricum extract; component B contains 20-50 parts resistant dextrin, 5-15 parts xylooligosaccharides, 3-10 parts inulin, and 35-50 parts D-allulose.

2. The hypoglycemic composition according to claim 1, characterized in that, The mulberry leaf extract is prepared by zinc ion chelation stabilization and contains ≥1% 1-deoxynojirimycin (DNJ) by mass. The bitter melon extract is prepared by fermentation to reduce bitterness and contains ≥20% momordicin by mass. The yam extract is prepared by directional enzymatic hydrolysis. The kudzu root extract is prepared by non-thermal high-pressure extraction and contains ≥30% puerarin by mass. The wolfberry extract is prepared by membrane separation and enrichment and contains ≥30% wolfberry polysaccharide by mass. The Solomon's seal extract is prepared by compound enzymatic hydrolysis-ultrasound-assisted method and contains ≥30% Solomon's seal polysaccharide by mass. The polygonatum extract is prepared by solid-state fermentation and transformation and contains ≥30% polygonatum polysaccharide by mass.

3. The hypoglycemic composition according to claim 2, characterized in that, In the prebiotic, the molecular weight of resistant dextrin in the 3-10kDa range accounts for >80%, and the molecular weight of short-chain xylooligosaccharides with a degree of polymerization of 2-4 accounts for ≥90%; in the inulin, the molecular weight of long-chain molecules with a degree of polymerization of ≥23 accounts for >70%; and in the D-allulose raw material, the mass percentage of D-allulose is ≥99%.

4. The hypoglycemic composition according to claim 2, characterized in that, In preparing the hypoglycemic composition, firstly, kudzu root extract, wolfberry extract, Solomon's seal extract, and polygonatum extract are mixed in a mixer to obtain a primary mixture; then, the primary mixture is mixed with mulberry leaf extract, bitter melon extract, yam extract, inulin, and xylooligosaccharide in a mixer to obtain a secondary mixture; next, the secondary mixture is mixed with resistant dextrin and D-allulose in a mixer to obtain a tertiary mixture; finally, the solid powder is packaged and sealed according to the preset single-use specifications.

5. The hypoglycemic composition according to claim 4, characterized in that, During the mixing process, the mixer speed is 10-30 r / min, the mixing time is 15-45 min, the relative humidity of the mixing environment is ≤60%, and the temperature is 15-30℃.

6. The hypoglycemic composition according to claim 4, characterized in that, The solid powder is packaged in aluminum-plastic composite film, with a single-use specification of 3-10g / bag. After packaging, the composition can be stored at 25℃ and 60% relative humidity for 24 months, and the retention rate of active ingredients of each extract is ≥90%.

7. The hypoglycemic composition according to claim 1, characterized in that... It also includes seasonings and / or food additives.

8. The hypoglycemic composition according to claim 1, characterized in that, Component B contains 30 parts resistant dextrin, 15 parts xylooligosaccharide, 10 parts inulin, and 40 parts D-allulose.

9. The use of a hypoglycemic composition according to any one of claims 1-8 in the preparation of hypoglycemic auxiliary foods, health products or special medical purpose formula foods.

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