Dietary nutrition intervention composition for improving diabetes mellitus as well as preparation method and application of dietary nutrition intervention composition

Abstract

The invention relates to the technical field of dietary nutrition products, and particularly discloses a dietary nutrition intervention composition for improving diabetes mellitus and a preparation method and application thereof, and the preparation method comprises the following steps: (S01) taking a proper amount of codonopsis pilosula polysaccharide and galactomannan, putting into a reaction kettle, adding water, and stirring for dissolving; (S02) continuing to add a proper amount of astragaloside, balsam pear polypeptide and mango extract into the dissolved matter in the step (S01), stirring and mixing, adding a proper amount of auxiliary carrier when the dissolved matter is in a transparent or slightly turbid state, and continuing to stir to obtain a compound liquid; (S03) performing vacuum concentration and homogeneous dispersion on the compound liquid in the step (S02) to obtain dispersion liquid; and (S04) carrying out vacuum freeze drying on the dispersion liquid obtained in the step (S03), and mixing the freeze-dried powder in a fluidized bed mixer to obtain a dietary nutrition intervention composition finished product. The invention has the characteristics of reducing blood sugar and improving intestinal flora structure and function.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of dietary nutrition products, in particular to a dietary nutrition intervention composition for improving diabetes, a preparation method and application. BACKGROUND

[0002] The gut microbiota of type 2 diabetes mellitus (T2DM) patients is significantly imbalanced compared with healthy people, and this dysbiosis is thought to play an important role in the development of diabetes. The main features include: 1. Decreased short-chain fatty acid (SCFA)-producing bacteria: such as Faecalibacterium prausnitzii, Roseburia spp., some species of Bacteroides, and Bifidobacterium, which are responsible for the fermentation of dietary fiber to produce SCFAs (such as butyrate and propionate). SCFAs (especially butyrate) are the main energy source for intestinal cells, can maintain intestinal barrier integrity, inhibit inflammatory response, promote glucagon-like peptide-1 (GLP-1) secretion (which helps to control blood glucose and appetite), and regulate insulin sensitivity. Their decrease directly weakens these protective effects. 2. Increased harmful bacteria: The abundance of opportunistic pathogens increases, such as members of the Enterobacteriaceae family (such as some strains of Escherichia coli, Enterobacter cloacae), Desulfovibrio, and some Clostridium. These bacteria may produce endotoxins (such as lipopolysaccharide LPS), pro-inflammatory metabolites, or competitively exclude beneficial bacteria, leading to increased intestinal permeability (leaky gut), systemic low-grade inflammation, and aggravated insulin resistance. 3. Decreased gut microbiota diversity: The species richness (α diversity) of the gut microbiota in diabetes patients (especially those not well controlled) is usually lower than that of healthy people. Gut microbiota diversity is an important indicator of ecosystem health and stability, and a decrease in diversity means impaired microbial function and reduced resilience. 4. Imbalance in the proportion of specific bacterial phyla: The ratio of Firmicutes to Bacteroidetes (F / B ratio) is not entirely consistent in studies of this ratio. Some studies suggest that it may be higher in diabetes patients (increased Firmicutes or decreased Bacteroidetes), or there is no significant difference. However, more emphasis is now placed on the increase or decrease of specific functional bacterial species (such as SCFA-producing Firmicutes) rather than fluctuations in the overall phylum level ratio.5. Alterations in metabolic function: Reduced ability to synthesize short-chain fatty acids (SCFAs). Gene function analysis shows that the abundance of gene pathways related to the biosynthesis of SCFAs (especially butyrate) is decreased in the gut microbiota of diabetic patients, consistent with the reduction in beneficial bacteria. The ability to produce harmful metabolites, such as secondary bile acids and hydrogen sulfide, may be enhanced, potentially interfering with host metabolism and promoting inflammation. Impaired SCFA synthesis is consistent with the reduction in beneficial bacteria, and the abundance of genes and metabolic pathways related to the biosynthesis of SCFAs (especially butyrate) is reduced in the gut microbiota of diabetic patients. Harmful metabolic activity may be enhanced, potentially producing more pro-inflammatory factors, endotoxin precursors, or harmful compounds that interfere with host metabolism (such as certain branched-chain amino acid precursors, trimethylamine oxide (TMAO) precursors, etc.). 6. Changes in gut microbiota related to impaired gut barrier function: As mentioned above, the reduction of Akkermansia muciniphila and the increase of pro-inflammatory bacteria together lead to a decline in gut mucosal barrier function and damage to gut tight junction proteins, making it easier for bacterial toxins in the gut (such as LPS) to enter the bloodstream (a condition known as "metabolic endotoxemia"), activate the innate immune system (such as the Toll-like receptor 4 pathway), trigger chronic low-grade inflammation, and further exacerbate insulin resistance and β-cell dysfunction.

[0003] In summary, the gut microbiota of diabetic patients is characterized by a decrease in protective bacteria (especially SCFA-producing bacteria), an increase in potentially harmful bacteria, reduced diversity, and impaired related metabolic functions. These changes participate in the pathophysiological process of diabetes by disrupting the intestinal barrier, inducing inflammation, and exacerbating insulin resistance. Therefore, regulating the gut microbiota is considered a potentially important direction for the prevention and treatment of diabetes (especially type 2 diabetes mellitus).

[0004] In existing technologies, some studies based on traditional Chinese medicine or functional food components have attempted to improve diabetes from the perspective of gut microbiota. For example, Astragalus extract can lower blood sugar through antioxidant and insulin-sensitizing effects; ginsenosides have certain metabolic regulatory functions; bitter melon polypeptides have been widely studied due to their insulin-like activity; and Codonopsis pilosula polysaccharides have been shown to promote the proliferation of beneficial bacteria and increase short-chain fatty acid levels. However, these active components are mostly used in single forms, lacking systematic compatibility design and in vitro / in vivo validation mechanisms. Single-component interventions are often affected by factors such as low absorption rates, poor stability of active components, and insufficient utilization by gut microbiota, making it difficult to achieve stable therapeutic effects. On the other hand, existing dietary nutritional preparations also have certain limitations at the process level. For example, polysaccharides are prone to degradation under high-temperature drying or acidic environments; polyphenols and protein peptides are prone to non-enzymatic browning reactions or oxidative polymerization during mixing; some active components have uneven release rates in the gastrointestinal environment, resulting in low bioavailability and affecting their synergistic effects; in addition, traditional powder compounding methods cannot guarantee molecular-level uniformity between components, leading to insufficient stability and functional consistency of the composite system, which restricts the industrialization and clinical promotion of the products.

[0005] Based on the above problems, researchers have begun to explore the concept of "multi-target, synergistic regulation" in compound dietary interventions. By integrating multiple active ingredients from both food and medicine at the molecular level, they aim to achieve systematic improvements in three dimensions: gut microbiota homeostasis, energy metabolism, and inflammatory response. This has become the direction for the future development of nutritional intervention technologies. Against this backdrop, developing a compound formula that combines gut microbiota regulation and glucose and lipid metabolism improvement, and establishing a scientific preparation process suitable for this formula, has become an urgent technical problem to be solved.

[0006] Patent document CN109674060A discloses a probiotic dietary supplement with the function of alleviating type 2 diabetes and its application. The probiotic dietary supplement with the function of alleviating type 2 diabetes includes freeze-dried bacterial powder, active polysaccharides, and dietary prebiotics. The freeze-dried bacterial powder consists of *Lactobacillus rhamnosus* freeze-dried bacterial powder and *Lactobacillus plantarum* X1 freeze-dried bacterial powder. After activation, the bacteria are sequentially cultured, centrifuged, and washed. Then, a freeze-drying protectant is added to resuspend the bacterial cells, obtaining a bacterial suspension. The bacterial suspension is pre-frozen and then freeze-dried to obtain the freeze-dried bacterial powder. The dietary supplement has a high content of active ingredients, with a live probiotic content of up to 10%. 11 CFU / g or higher can lower blood glucose levels in mice, significantly reduce glycosylated hemoglobin and endotoxin levels, and increase insulin and liver glycogen levels. However, this regimen uses exogenous probiotic supplementation to regulate the gut microbiota, and its effects depend on live bacteria colonization, making it susceptible to gastric acid and bile salts, resulting in poor stability. Summary of the Invention

[0007] In order to solve the above-mentioned technical problems existing in the prevention and treatment of diabetes by regulating gut microbiota, the present invention provides a dietary nutrition intervention composition, preparation method and application for improving diabetes, which has the characteristics of lowering blood sugar and improving the structure and function of gut microbiota.

[0008] The first technical solution of the present invention: a dietary nutrition intervention composition for improving diabetes, comprising the following components by weight,

[0009] Codonopsis polysaccharide 40-80 parts, astragaloside A 8-25 parts, and auxiliary carrier 10-40 parts.

[0010] Preferably, the product comprises the following components in parts by weight.

[0011] Codonopsis polysaccharide 45-75 parts, astragaloside A 10-22 parts, and auxiliary carrier 15-35 parts.

[0012] Preferably, the product comprises the following components in parts by weight.

[0013] Codonopsis polysaccharide 50-70 parts, astragaloside A 12-20 parts, and auxiliary carrier 18-32 parts.

[0014] Preferably, the product comprises the following components in parts by weight.

[0015] Codonopsis polysaccharide 50-70 parts, astragaloside A 15-18 parts, and auxiliary carrier 20-30 parts.

[0016] Preferably, the product comprises the following components in parts by weight.

[0017] Codonopsis polysaccharide 55-65 parts, astragaloside A 16-17 parts, and auxiliary carrier 22-28 parts.

[0018] Preferably, the product comprises the following components in parts by weight.

[0019] Codonopsis polysaccharide 60 parts, astragaloside A 16.5 parts, and auxiliary carrier 25 parts.

[0020] The second technical solution of the present invention: a method for preparing a dietary nutrition intervention composition to improve diabetes, comprising the following steps,

[0021] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel. Add water and stir to dissolve.

[0022] (S02) Add an appropriate amount of astragaloside A to the solution in step (S01) and stir until it becomes transparent or slightly turbid. Then add an appropriate amount of auxiliary carrier and continue stirring to obtain a composite solution.

[0023] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion.

[0024] (S04) The dispersion from step (S03) is sequentially spray-dried, low-temperature mixed and vacuum-dried to obtain the finished dietary nutrition intervention composition.

[0025] The third technical solution of the present invention: a dietary nutrition intervention composition for improving diabetes, comprising the following components by weight,

[0026] Codonopsis pilosula polysaccharide 40-80 parts, astragaloside A 8-25 parts, bitter melon polypeptide 1-10 parts, and auxiliary carrier 10-40 parts.

[0027] Preferably, the product comprises the following components in parts by weight.

[0028] Codonopsis pilosula polysaccharide 45-75 parts, astragaloside A 10-22 parts, bitter melon polypeptide 2-9 parts, and auxiliary carrier 15-35 parts.

[0029] Preferably, the product comprises the following components in parts by weight.

[0030] Codonopsis pilosula polysaccharide 50-70 parts, astragaloside A 12-20 parts, bitter melon polypeptide 3-8 parts, and auxiliary carrier 18-32 parts.

[0031] Preferably, the product comprises the following components in parts by weight.

[0032] Codonopsis pilosula polysaccharide 50-70 parts, astragaloside A 15-18 parts, bitter melon polypeptide 4-7 parts, and auxiliary carrier 20-30 parts.

[0033] Preferably, the product comprises the following components in parts by weight.

[0034] Codonopsis pilosula polysaccharide 55-65 parts, astragaloside A 16-17 parts, bitter melon polypeptide 5-6 parts, and auxiliary carrier 22-28 parts.

[0035] Preferably, the product comprises the following components in parts by weight.

[0036] Codonopsis pilosula polysaccharide 60 parts, astragaloside A 16.5 parts, bitter melon polypeptide 5.5 parts, and auxiliary carrier 25 parts.

[0037] The fourth technical solution of the present invention: a method for preparing a dietary nutrition intervention composition to improve diabetes, comprising the following steps,

[0038] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel. Add water and stir to dissolve.

[0039] (S02) Add an appropriate amount of astragaloside A and bitter melon polypeptide to the solution in step (S01) and stir until it becomes transparent or slightly turbid. Then add an appropriate amount of auxiliary carrier and continue stirring to obtain a composite solution.

[0040] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion.

[0041] (S04) The dispersion from step (S03) is sequentially spray-dried, low-temperature mixed and vacuum-dried to obtain the finished dietary nutrition intervention composition.

[0042] The fifth technical solution of the present invention: a dietary nutrition intervention composition for improving diabetes, comprising the following components by weight,

[0043] Codonopsis polysaccharide 40-80 parts, astragaloside A 8-25 parts, mango extract 5-20 parts, and auxiliary carrier 10-40 parts.

[0044] Preferably, the product comprises the following components in parts by weight.

[0045] Codonopsis polysaccharide 45-75 parts, astragaloside A 10-22 parts, mango extract 7-18 parts, and auxiliary carrier 15-35 parts.

[0046] Preferably, the product comprises the following components in parts by weight.

[0047] Codonopsis pilosula polysaccharide 50-70 parts, astragaloside A 12-20 parts, mango extract 8-16 parts, and auxiliary carrier 18-32 parts.

[0048] Preferably, the product comprises the following components in parts by weight.

[0049] Codonopsis polysaccharide 50-70 parts, astragaloside A 15-18 parts, mango extract 10-15 parts, and auxiliary carrier 20-30 parts.

[0050] Preferably, the product comprises the following components in parts by weight.

[0051] Codonopsis polysaccharide 55-65 parts, astragaloside A 16-17 parts, mango extract 11-14 parts, and auxiliary carrier 22-28 parts.

[0052] Preferably, the product comprises the following components in parts by weight.

[0053] Codonopsis polysaccharide 60 parts, astragaloside A 16.5 parts, mango extract 13 parts, and auxiliary carrier 25 parts.

[0054] The sixth technical solution of the present invention: a method for preparing a dietary nutrition intervention composition to improve diabetes, comprising the following steps,

[0055] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel. Add water and stir to dissolve.

[0056] (S02) Add an appropriate amount of astragaloside A and mango extract to the solution in step (S01) and stir until it becomes transparent or slightly turbid. Then add an appropriate amount of auxiliary carrier and continue stirring to obtain a composite solution.

[0057] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion.

[0058] (S04) The dispersion from step (S03) is sequentially spray-dried, low-temperature mixed and vacuum-dried to obtain the finished dietary nutrition intervention composition.

[0059] The seventh technical solution of the present invention: a dietary nutrition intervention composition for improving diabetes, comprising the following components by weight,

[0060] Codonopsis polysaccharide 40-80 parts, astragaloside A 8-25 parts, galactomannan 2-12 parts, and auxiliary carrier 10-40 parts.

[0061] Preferably, the product comprises the following components in parts by weight.

[0062] Codonopsis polysaccharide 45-75 parts, astragaloside A 10-22 parts, galactomannan 3-11 parts, and auxiliary carrier 15-35 parts.

[0063] Preferably, the product comprises the following components in parts by weight.

[0064] Codonopsis polysaccharide 50-70 parts, astragaloside A 12-20 parts, galactomannan 4-10 parts, and auxiliary carrier 18-32 parts.

[0065] Preferably, the product comprises the following components in parts by weight.

[0066] Codonopsis polysaccharide 50-70 parts, astragaloside A 15-18 parts, galactomannan 5-9 parts, and auxiliary carrier 20-30 parts.

[0067] Preferably, the product comprises the following components in parts by weight.

[0068] Codonopsis polysaccharide 55-65 parts, astragaloside A 16-17 parts, galactomannan 6-8 parts, and auxiliary carrier 22-28 parts.

[0069] Preferably, the product comprises the following components in parts by weight.

[0070] Codonopsis polysaccharide 60 parts, astragaloside A 16.5 parts, galactomannan 7 parts, and auxiliary carrier 25 parts.

[0071] The eighth technical solution of the present invention: a method for preparing a dietary nutrition intervention composition for improving diabetes, comprising the following steps,

[0072] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and galactomannan and put them into the reaction vessel, add water and stir to dissolve;

[0073] (S02) Add an appropriate amount of astragaloside A and an auxiliary carrier to the solution from step (S01) and continue stirring to obtain a composite solution;

[0074] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion.

[0075] (S04) The dispersion from step (S03) is sequentially spray-dried, low-temperature mixed and vacuum-dried to obtain the finished dietary nutrition intervention composition.

[0076] The ninth technical solution of the present invention: a dietary nutrition intervention composition for improving diabetes, comprising the following components by weight,

[0077] Codonopsis pilosula polysaccharide 40-80 parts, astragaloside A 8-25 parts, bitter melon polypeptide 1-10 parts, mango extract 5-20 parts, galactomannan 2-12 parts, and auxiliary carrier 10-40 parts.In this invention, an appropriate amount of Codonopsis pilosula polysaccharide serves as a core prebiotic and immunomodulator, selectively promoting the proliferation of beneficial intestinal bacteria, maintaining intestinal barrier integrity, improving systemic inflammation and insulin resistance, and providing a sustained and fundamental intestinal microecological regulation effect. It is a pillar for achieving the core claims of the solution, providing major regulation of intestinal flora homeostasis, improving intestinal microecological homeostasis, promoting the production of short-chain fatty acids (SCFAs), increasing flora diversity, and lowering blood glucose and blood lipids. An appropriate amount of astragaloside A serves as a systemic potent regulator, primarily targeting host organs. Through anti-inflammatory, antioxidant, and immunomodulatory effects, it directly protects pancreatic β-cells and improves insulin sensitivity in peripheral tissues such as the liver and muscles. It has a clear effect in improving insulin resistance and cellular function, and works synergistically with prebiotics. The ingredients produce a synergistic effect, regulating insulin sensitivity, inhibiting the expression of inflammatory factors, and synergistically enhancing intestinal barrier repair with Codonopsis pilosula polysaccharides. A suitable amount of bitter melon polypeptides activates pathways such as AMPK, mimicking insulin action, promoting glucose utilization in peripheral tissues, providing a direct hypoglycemic effect, promoting glucose uptake and metabolism, enhancing insulin-like activity, and aiding in blood sugar control. A suitable amount of mango extract, as a natural α-glucosidase inhibitor, is rich in polyphenols such as mangiferin, which can inhibit α-glucosidase in the small intestine, thereby delaying carbohydrate digestion and absorption, easing postprandial blood sugar, and providing a clear and rapid postprandial blood sugar control effect. This complements the long-term regulatory effect of prebiotics. Rich in polyphenols, it has antioxidant and anti-inflammatory properties, improving... Glycolipid metabolism; an appropriate amount of galactomannan, as a dual-function dietary fiber, can form a gel in the stomach, increasing chyme viscosity, delaying gastric emptying and the diffusion of nutrients to the intestinal absorption surface. It is not digested by the human body; upon reaching the colon, it is fermented by gut microbiota as a prebiotic, producing short-chain fatty acids, which are beneficial to gut health and glucose metabolism. It provides a physical glucose barrier and additional prebiotic support, acting as a bridge between immediate blood sugar reduction and long-term gut microbiota regulation. As a fermentable dietary fiber, it promotes the proliferation of beneficial bacteria, increases the production of short-chain fatty acids in the intestine, and assists Codonopsis pilosula polysaccharide in restoring gut microbiota balance and barrier integrity. An appropriate amount of auxiliary carrier is used to improve the uniformity and stability of the composition and can regulate the dissolution rate. This invention constructs a multi-target, multi-mechanism three-dimensional intervention network. Mango extract and galactomannan synergistically control postprandial blood glucose, while Codonopsis pilosula polysaccharide and galactomannan, as prebiotics, synergistically regulate the intestinal microecology. Astragaloside A's anti-inflammatory properties improve systemic function, and bitter melon polypeptides promote the utilization of glucose by peripheral tissues. Codonopsis pilosula polysaccharide is the basic component, and astragaloside A enhances the effects of Codonopsis pilosula polysaccharide at the metabolic level by increasing insulin sensitivity and anti-inflammatory mechanisms. The combination of the two forms a dual regulatory system that improves the intestinal microenvironment and reduces systemic inflammation and hyperglycemia. Bitter melon polypeptides and mango extract provide synergistic effects in glucose metabolism and lipid metabolism, respectively. The former has insulin-like activity, while the latter can reduce oxidative stress and inflammatory response, thereby enhancing the overall metabolic improvement effect.

[0078] Preferably, the product comprises the following components in parts by weight.

[0079] Codonopsis pilosula polysaccharide 45-75 parts, astragaloside A 10-22 parts, bitter melon polypeptide 2-9 parts, mango extract 7-18 parts, galactomannan 3-11 parts, and auxiliary carrier 15-35 parts.

[0080] Preferably, the product comprises the following components in parts by weight.

[0081] Codonopsis pilosula polysaccharide 50-70 parts, astragaloside A 12-20 parts, bitter melon polypeptide 3-8 parts, mango extract 8-16 parts, galactomannan 4-10 parts, and auxiliary carrier 18-32 parts.

[0082] Preferably, the product comprises the following components in parts by weight.

[0083] Codonopsis pilosula polysaccharide 50-70 parts, astragaloside A 15-18 parts, bitter melon polypeptide 4-7 parts, mango extract 10-15 parts, galactomannan 5-9 parts, and auxiliary carrier 20-30 parts.

[0084] Preferably, the product comprises the following components in parts by weight.

[0085] Codonopsis pilosula polysaccharide 55-65 parts, astragaloside A 16-17 parts, bitter melon polypeptide 5-6 parts, mango extract 11-14 parts, galactomannan 6-8 parts, and auxiliary carrier 22-28 parts.

[0086] Preferably, the product comprises the following components in parts by weight.

[0087] Codonopsis pilosula polysaccharide 60 parts, astragaloside A 16.5 parts, bitter melon polypeptide 5.5 parts, mango extract 13 parts, galactomannan 7 parts, and auxiliary carrier 25 parts.

[0088] Preferably, the preparation of the Codonopsis pilosula polysaccharide includes the following steps:

[0089] (A01) Take dried Codonopsis root, crush it, add deionized water and perform hot reflux extraction to obtain the extract; take advantage of the high solubility of polysaccharides in hot water to leach the target product from the plant cells. Reflux can prevent solvent evaporation and maintain extraction efficiency. It can effectively transfer most of the Codonopsis polysaccharides to the aqueous phase and the extraction rate is high.

[0090] (A02) Filter the extract from step (A01) and concentrate the filtrate under reduced pressure to 1 / 5 to 1 / 4 of the original volume; filter to remove insoluble plant residues, and reduce the pressure to allow the solvent to boil and evaporate at a lower temperature, thus reducing the volume and preparing for the next step of alcohol precipitation. This avoids the damage of high temperature to the polysaccharide structure and yields a clear and concentrated polysaccharide aqueous solution, which significantly improves the efficiency of subsequent alcohol precipitation and reduces the amount of ethanol used.

[0091] (A03) Add an appropriate amount of ethanol to the concentrate in step (A02) and let it stand for alcohol precipitation; taking advantage of the principle that the solubility of polysaccharides decreases sharply in high-concentration ethanol, it is precipitated from the water, thereby achieving preliminary separation from water-soluble small molecule impurities, effectively precipitating polysaccharides with larger molecular weights, and achieving preliminary purification.

[0092] (A04) Centrifuge the precipitate obtained by standing in step (A03), wash it with anhydrous ethanol and then vacuum dry it to obtain crude polysaccharide; quickly separate the precipitated polysaccharide from the ethanol mother liquor, wash away the water and residual impurities attached to the surface of the precipitate, and promote dehydration. Remove ethanol and water at low temperature to obtain dry crude polysaccharide powder, which is convenient for storage and subsequent processing. Vacuum drying can prevent polysaccharide from deteriorating or clumping due to high temperature.

[0093] (A05) The crude polysaccharide from step (A04) is deproteinized by enzymatic method, then heated to inactivate the enzyme, and filtered through an ultrafiltration membrane to obtain a dialysate; the polysaccharide solution is separated according to molecular weight, which can remove small molecule impurities and some pigments, and realize the fractionation of polysaccharide components. Enzymatic method can effectively remove protein, and ultrafiltration can significantly improve the purity and uniformity of the product; the enzymatic deproteinization method is to add 1% of its mass of complex protease, and enzymatically hydrolyze it for 4 hours at 50℃ and pH 7.0, and then heat it to 90℃ to inactivate the enzyme for 10 minutes;

[0094] (A06) The dialysis solution from step (A05) is decolorized using macroporous adsorption resin, then concentrated under reduced pressure and freeze-dried to obtain Codonopsis pilosula polysaccharide. The plant pigments dissolved during the adsorption extraction process enhance the product's color. Further concentration after decolorization prepares the product for freeze-drying. Sublimation of water under extremely low temperature and vacuum maximizes the preservation of the polysaccharide's natural stereostructure and bioactivity, resulting in a loose, easily soluble, and high-quality polysaccharide product. The final product is white or off-white, with high activity. An AB-8 macroporous adsorption resin column can be used for decolorization. This process achieves high-purity extraction through multi-stage separation and selective precipitation, preserving the branched structure and bioactivity of Codonopsis pilosula polysaccharide. It significantly outperforms the traditional simple alcohol precipitation method in terms of yield and stability, ensuring good microbial community promotion and short-chain fatty acid production activity in in vitro fermentation systems.

[0095] Preferably, in step (A01), the material is pulverized to 60-80 mesh. More preferably, in step (A01), it is pulverized to 65-75 mesh. Even more preferably, in step (A01), it is pulverized to 70 mesh. Limiting the particle size increases the specific surface area of ​​the raw material, accelerates heat conduction and solute diffusion, thereby improving the dissolution rate and extraction rate of polysaccharides. If the particles are too coarse, the specific surface area is insufficient, resulting in low extraction efficiency and potentially high polysaccharide content in the residue. If the powder is too fine, although the extraction efficiency is high, it can lead to problems such as difficult filtration, excessively viscous extract, and increased dissolution of impurities, burdening subsequent purification.

[0096] Preferably, the number of reflux cycles in step (A01) is 2 to 5. More preferably, the number of reflux cycles in step (A01) is 3 to 4. Through multiple extractions, the effective components in the raw material are fully extracted using the concentration difference, reducing residues in the residue and maximizing the yield.

[0097] Preferably, in step (A01), 8 to 10 times the volume of the remaining material by weight of deionized water is added before each reflux. More preferably, 8.5 to 9.5 times the volume of the remaining material by weight of deionized water is added before each reflux. Even more preferably, 9 times the volume of the remaining material by weight of deionized water is added before each reflux. Providing sufficient solvent ensures that the polysaccharide can be fully dissolved and diffused into the solution. If the amount of water is too small, the solution will be too viscous, resulting in high mass transfer resistance, low extraction rate, and easy scorching. If the amount of water is too large, the extraction rate will not increase significantly, but it will significantly increase the energy consumption and time cost of subsequent concentration steps. The goal is to minimize the energy burden of subsequent processes while ensuring sufficient extraction.

[0098] Preferably, the reflux temperature in step (A01) is 90°C to 95°C. More preferably, the reflux temperature in step (A01) is 91°C to 94°C. Even more preferably, the reflux temperature in step (A01) is 92°C to 93°C. Increasing the temperature can reduce solvent viscosity, increase molecular motion rate, and disrupt plant cell walls, thereby significantly improving extraction rate and yield, achieving the fastest and most stable extraction kinetics.

[0099] Preferably, the reflux time in step (A01) is 1 to 2 hours each time. More preferably, the reflux time in step (A01) is 1.5 hours each time. This ensures that the mass transfer process reaches or approaches equilibrium, allowing for sufficient dissolution of the polysaccharide and providing a defined and efficient duration for each extraction.

[0100] Preferably, the filtration in step (A02) is performed through a filter cloth with a mesh size of 180-200. More preferably, it is performed through a filter cloth with a mesh size of 185-195. Even more preferably, it is performed through a filter cloth with a mesh size of 190. This thoroughly separates the liquid extract from the solid residue, providing a clear feed solution for subsequent purification, obtaining a clear extract, and preventing solid impurities from entering subsequent processes.

[0101] Preferably, the vacuum concentration in step (A02) is performed in a vacuum concentrator.

[0102] Preferably, the vacuum concentration temperature in step (A02) is 50°C to 60°C. More preferably, the vacuum concentration temperature in step (A02) is 52°C to 58°C. Even more preferably, the vacuum concentration temperature in step (A02) is 55°C. Under reduced pressure, the boiling point of water is lowered, thereby achieving gentle and rapid concentration, protecting the heat-sensitive polysaccharide structure from damage, rapidly reducing volume to prepare for alcohol precipitation, and maximizing the preservation of polysaccharide bioactivity.

[0103] Preferably, the ethanol added in step (A03) is 95% ethanol. 95% ethanol provides a high concentration of alcohol environment, ensuring that the polysaccharide can precipitate fully. Using a high concentration of ethanol can reduce the total volume added and achieve the target alcohol concentration more efficiently.

[0104] Preferably, in step (A03), the amount of ethanol added is 3 to 4 times the volume of the concentrated liquid. By adding a specific volume of ethanol, the final ethanol concentration of the mixed system reaches the critical concentration required for polysaccharide precipitation, ensuring complete polysaccharide precipitation while avoiding waste due to excessive ethanol.

[0105] Preferably, the static alcohol precipitation in step (A03) is completed in a refrigerator. Low temperature can significantly reduce the solubility of polysaccharides, promote precipitation formation, and improve precipitation rate and purity. Low temperature can also inhibit microbial growth.

[0106] Preferably, the alcohol precipitation temperature in step (A03) is 2°C to 4°C. More preferably, the alcohol precipitation temperature in step (A03) is 3°C.

[0107] Preferably, the settling time for alcohol precipitation in step (A03) is 10-12 hours. More preferably, the settling time for alcohol precipitation in step (A03) is 11 hours. Sufficient time is provided to allow the polysaccharide molecules to aggregate, form clusters, and settle completely. Too short a time results in incomplete precipitation and low yield, while too long a time is detrimental to production efficiency.

[0108] Preferably, the centrifugation speed in step (A04) is 4500 rpm to 5000 rpm. More preferably, the centrifugation speed in step (A04) is 4600 rpm to 4900 rpm. Even more preferably, the centrifugation speed in step (A04) is 4700 rpm to 4800 rpm. Providing sufficient relative centrifugal force ensures thorough and rapid separation of the denser polysaccharide precipitate from the ethanol supernatant, ensuring a dense polysaccharide precipitate, facilitating subsequent washing and transfer, and reducing losses.

[0109] Preferably, the centrifugation time in step (A04) is 10 min to 15 min. More preferably, the centrifugation time in step (A04) is 11 min to 14 min. Even more preferably, the centrifugation time in step (A04) is 12 min to 13 min.

[0110] Preferably, the washing process in step (A04) involves 2 to 4 washing cycles. More preferably, the washing process in step (A04) involves 3 washing cycles. Washing the precipitate with anhydrous ethanol removes water-soluble impurities adhering to the precipitate surface and dehydrates the precipitate, making it loose and easier to dry.

[0111] Preferably, the enzyme in step (A05) is a complex protease, which is composed of trypsin and papain in a 1:1 mass ratio.

[0112] Preferably, the deproteinization process in step (A05) is repeated 2 to 3 times.

[0113] Preferably, the molecular weight cutoff of the ultrafiltration membrane in step (A05) is 9 kDa to 10 kDa. More preferably, the molecular weight cutoff of the ultrafiltration membrane in step (A05) is 9.2 kDa to 9.8 kDa. Even more preferably, the molecular weight cutoff of the ultrafiltration membrane in step (A05) is 9.5 kDa. Ultrafiltration allows small molecule impurities and water to pass through the membrane pores while retaining and concentrating the target Codonopsis pilosula polysaccharide. Ultrafiltration not only desalinates and removes small molecule impurities but also fractionates the polysaccharide, obtaining a product with a more uniform molecular weight distribution, significantly improving product purity while maintaining the bioactivity of the polysaccharide. Tangential flow filtration is used, and dialysis is performed at a pressure of 0.1 MPa to 0.2 MPa until the conductivity of the retentate remains constant, indicating that small molecule impurities have been completely removed.

[0114] Preferably, the preparation of astragaloside A includes the following steps:

[0115] (B01) Take dried Astragalus root, crush it, and add an appropriate amount of ethanol for hot reflux extraction; take advantage of the good solubility of astragaloside A in ethanol to extract the target component from Astragalus root tissue. Ethanol, as a polar solvent, can extract saponins and reduce the dissolution of strong polar impurities such as polysaccharides and proteins. It is more selective than water extraction and yields crude extract containing astragaloside A and a large number of other alcohol-soluble impurities.

[0116] (B02) The extract from step (B01) is concentrated under reduced pressure until it is free of alcohol odor. After diluting with distilled water, it is eluted by fractionation on a macroporous adsorption resin column to remove impurities. The last eluted fraction is collected. The extract is concentrated under reduced pressure until it is free of alcohol odor to completely remove ethanol and avoid its influence on subsequent aqueous solution loading. The adsorption properties of the macroporous adsorption resin and the molecular sieving effect are used to separate the components according to their polarity. Astragaloside A can be adsorbed by the resin, while a large amount of water-soluble impurities flow out with the washing solution, thereby achieving impurity removal. Fractionation and elution are performed, and the last eluted fraction is collected to collect the fraction rich in astragaloside A. This can effectively remove polysaccharides and some pigments, so that astragaloside A is initially enriched, laying the foundation for subsequent purification.

[0117] (B03) After the elution fraction from step (B02) is concentrated under reduced pressure and purified by silica gel column chromatography, a portion of the astragaloside A peak region solution is collected; this can separate astragaloside A from other co-eluted saponins to obtain high-purity astragaloside A.

[0118] (B04) The collected solution from step (B03) is concentrated under reduced pressure and freeze-dried to obtain astragaloside A. Reduced pressure concentration removes a large amount of solvent, reduces volume, and allows water to sublimate at low temperature to obtain a dry solid product. This process perfectly maintains the chemical structural stability of astragaloside A, resulting in a loose, easily soluble powder. The obtained astragaloside A has a purity ≥95% as determined by HPLC, with a maximum UV absorption peak at 203 nm. Its structure is verified by LC-MS and H-NMR. The product is a pale yellow powder, easily soluble in methanol and DMSO, but with low solubility in water. This process effectively removes co-extracted astragalosides II and IV, achieving highly selective separation while preserving the structure of the parent glycoside. Gradient elution and a two-stage purification technique ensure that the obtained astragaloside A possesses excellent anti-inflammatory and insulin sensitivity-regulating effects, making it suitable for dietary applications.

[0119] Preferably, in step (B01), the particle size is pulverized to 50-60 mesh. More preferably, in step (B01), the particle size is pulverized to 52-58 mesh. Even more preferably, in step (B01), the particle size is pulverized to 55 mesh. Limiting the particle size increases the specific surface area and improves the extraction efficiency, ensuring efficiency without causing filtration difficulties or excessive dissolution of impurities due to excessive fineness.

[0120] Preferably, the ethanol in step (B01) is 70% ethanol. 70% ethanol has good solubility for astragaloside A, while having low selectivity for highly polar impurities such as polysaccharides, thus reducing the burden on subsequent purification.

[0121] Preferably, in step (B01), the ratio of Astragalus root powder to ethanol is 1:8 to 10. More preferably, the ratio is 1:8.5 to 9.5. Even more preferably, the ratio is 1:9. Ensuring a sufficient solvent system and establishing an effective concentration gradient allows for the full dissolution of the active ingredients, guaranteeing a high extraction rate.

[0122] Preferably, the reflux extraction temperature in step (B01) is 70°C to 80°C. More preferably, the reflux extraction temperature in step (B01) is 72°C to 78°C. Even more preferably, the reflux extraction temperature in step (B01) is 75°C. This increases the molecular motion rate, reduces solvent viscosity, and disrupts cell structure, thereby significantly improving the extraction kinetics rate while ensuring efficiency and avoiding severe solvent evaporation and potential thermal damage.

[0123] Preferably, the hot reflux extraction time in step (B01) is 1 h to 2 h. More preferably, the hot reflux extraction time in step (B01) is 1.5 h.

[0124] Preferably, the hot reflux extraction in step (B01) is performed 2 to 4 times. More preferably, the hot reflux extraction in step (B01) is performed 3 times. By performing multiple extractions and utilizing the principle of concentration difference, the target components in the raw material are extracted to the maximum extent, achieving an extraction rate of >90%.

[0125] Preferably, in step (B02), the concentrate is diluted with distilled water until the ethanol volume fraction is <10%. This ensures the purification effect of the macroporous resin.

[0126] Preferably, the macroporous adsorption resin column in step (B02) is a D101 macroporous adsorption resin column. It exhibits good adsorption performance and selectivity for moderately polar components such as saponins and flavonoids.

[0127] Preferably, the fractional elution in step (B02) involves sequential elution with distilled water, 40% ethanol, and 80% ethanol, with the 80% ethanol eluent collected. By gradually increasing the polarity of the eluent, impurities of different polarities are sequentially eluted and separated from the target analyte. Water can elute highly polar impurities such as salts and sugars, 40% ethanol can elute some highly polar pigments and flavonoids, and 80% ethanol can effectively elute the target component, astragaloside A.

[0128] Preferably, the silica gel column chromatography purification involves using silica gel as the stationary phase, a mixed solution of chloroform, methanol, and water as the eluent, and high-performance liquid chromatography (HPLC) for online or offline monitoring. The main peak fraction corresponding to the chromatographic retention time of astragaloside A is collected to achieve extraction of a portion of the solution in the astragaloside A peak region.

[0129] Preferably, the silica gel is 100-200 mesh silica gel with granules. More preferably, the silica gel is 120-180 mesh silica gel with granules. Even more preferably, the silica gel is 140-160 mesh silica gel with granules. Even more preferably, the silica gel is 150 mesh silica gel with granules. This specific silica gel mesh size provides good separation performance and acceptable flow rates.

[0130] Preferably, the volume ratio of chloroform, methanol, and water in the eluent is 60–65:30–35:10. More preferably, the volume ratio of chloroform, methanol, and water in the eluent is 61–64:31–34:10. Even more preferably, the volume ratio of chloroform, methanol, and water in the eluent is 62–63:32–33:10. This method can effectively achieve baseline separation of astragaloside A from other structurally similar saponins, obtaining a high-purity product.

[0131] Preferably, the preparation of the bitter melon polypeptide includes the following steps:

[0132] (C01) Take fresh bitter melon pulp, remove the seeds and chop it. Add an appropriate amount of deionized water and then bathe it in water. Chopping destroys the bitter melon tissue structure, increases the contact area with water and enzymes, and inactivates the bitter melon endogenous enzymes through heat treatment and moderately denatures its own proteins, making it more susceptible to attack by exogenous proteases.

[0133] (C02) Add an appropriate amount of complex protease to the solution after water bath in step (C01), adjust the pH to 7.5-8.0 and then enzymatically hydrolyze; using the specificity of the protease, the protein in bitter melon is hydrolyzed into smaller polypeptide fragments.

[0134] (C03) After the enzymatic hydrolysis in step (C02) is completed, the enzyme is inactivated, and then the supernatant is collected after cooling and centrifugation. The protease is inactivated by high temperature, the hydrolysis reaction is terminated, the over-hydrolysis is prevented, and the product quality is ensured to be stable. The insoluble residue in the hydrolysate is separated by centrifugation to obtain the supernatant containing soluble peptides, which can effectively terminate the reaction and clarify the liquid.

[0135] (C04) The supernatant from step (C03) is filtered through an ultrafiltration membrane, and the dialysis solution is then decolorized using macroporous adsorption resin and freeze-dried to obtain bitter melon polypeptides. Ultrafiltration can remove large molecular weight protein residues, enzymes, and small molecular weight salts and amino acids, thereby enriching polypeptides within the target molecular weight range, significantly improving product purity and uniformity. Freeze-drying yields dry, loose polypeptide powder, maximizing the preservation of its biological activity. Bitter melon polypeptides are obtained from fresh bitter melon pulp using a combination of enzymatic hydrolysis, membrane separation, and freeze-drying purification. Measurements showed that its protein peptide content was ≥80%, with an average molecular weight ranging from 0.6kDa to 2kDa. Amino acid composition analysis showed that it was rich in leucine, lysine, and glutamic acid residues, exhibiting good insulin-like activity. This process innovatively employs dual-enzyme synergy and low-molecular-weight membrane separation control, resulting in peptides with stable structures and high bioavailability. Compared with traditional single-enzyme hydrolysis, the bitterness of the product is significantly reduced, and its solubility is enhanced, making it suitable for use in the nutritional fortification of products such as dietary powders and beverages.

[0136] Preferably, in step (C01), the ratio of chopped material to deionized water is 1:4-5. This provides a sufficient solvent system to ensure thorough dispersion of the bitter gourd tissue, facilitating heat and mass transfer and creating a favorable reaction environment for enzymatic hydrolysis. This ratio ensures fluidity without increasing the burden on subsequent concentration due to excessive dilution.

[0137] Preferably, the water bath temperature in step (C01) is 90°C to 95°C. More preferably, the water bath temperature in step (C01) is 92°C.

[0138] Preferably, the water bath time in step (C01) is 8 to 10 minutes. More preferably, the water bath time in step (C01) is 9 minutes. This completely inactivates all endogenous enzymes and microorganisms.

[0139] Preferably, enzymatic hydrolysis is performed in step (CO2) after adjusting the pH to 7.6–7.9. More preferably, enzymatic hydrolysis is performed in step (CO2) after adjusting the pH to 7.7–7.8. This provides an optimal alkaline working environment for alkaline proteases and trypsin, ensuring maximum enzyme activity.

[0140] Preferably, the enzymatic hydrolysis temperature in step (CO2) is 50°C to 55°C. More preferably, the enzymatic hydrolysis temperature in step (CO2) is 52°C to 53°C.

[0141] Preferably, the enzymatic hydrolysis time in step (CO2) is 3 to 4 hours. Temperature is the most efficient range for protease activity and also provides sufficient hydrolysis time, ensuring that the protein is deeply hydrolyzed into small polypeptide molecules. A good match between temperature and time can achieve efficient hydrolysis.

[0142] Preferably, the complex protease in step (CO2) is formed by combining an alkaline protease and a trypsin, wherein the mass ratio of the alkaline protease to the trypsin in the complex protease is 1.5–2:1. More preferably, the mass ratio of the alkaline protease to the trypsin in the complex protease is 1.6–1.9:1. Even more preferably, the mass ratio of the alkaline protease to the trypsin in the complex protease is 1.7–1.8:1. Alkaline protease has a wide range of cleavage sites and is mainly responsible for rapidly hydrolyzing large protein molecules into larger fragments, while trypsin has specific cleavage sites and can hydrolyze large fragments into smaller, sequence-specific peptides. The combination of the two achieves a synergistic effect of broad-spectrum hydrolysis and precise cleavage, resulting in higher yields and a richer variety of small molecule bioactive peptides.

[0143] Preferably, the amount of complex protease added in step (CO2) is 2% to 2.5% of the mass of the chopped material. More preferably, the amount of complex protease added in step (CO2) is 2.2% to 2.3% of the mass of the chopped material. This ensures a strong and rapid hydrolysis reaction.

[0144] Preferably, the enzyme inactivation temperature in step (CO3) is 90°C to 95°C. More preferably, the enzyme inactivation temperature in step (CO3) is 92°C to 93°C.

[0145] Preferably, the enzyme inactivation time in step (CO3) is 8 to 10 minutes. More preferably, the enzyme inactivation time in step (CO3) is 9 minutes. High temperature rapidly and permanently inactivates the protease, precisely terminating the hydrolysis reaction and preventing excessive hydrolysis that could lead to bitter peptides or further degradation of the target peptide. The limited temperature and time are sufficient to completely inactivate the enzyme, ensuring stable product quality.

[0146] Preferably, the centrifugation speed in step (CO3) is 7000 rpm to 8000 rpm. More preferably, the centrifugation speed in step (CO3) is 7200 rpm to 7800 rpm. More preferably, the centrifugation speed in step (CO3) is 7400 rpm to 7600 rpm. More preferably, the centrifugation speed in step (CO3) is 7500 rpm. Providing sufficient centrifugal force ensures thorough separation of the soluble polypeptide supernatant from insoluble plant fibers, residues, etc., effectively achieving solid-liquid separation.

[0147] Preferably, the centrifugation time in step (CO3) is 8 min to 10 min. More preferably, the centrifugation time in step (CO3) is 9 min.

[0148] Preferably, the molecular weight cutoff of the ultrafiltration membrane in step (CO4) is 2kDa to 3kDa. More preferably, the molecular weight cutoff of the ultrafiltration membrane in step (CO4) is 2.2kDa to 2.8kDa. Even more preferably, the molecular weight cutoff of the ultrafiltration membrane in step (CO4) is 2.5kDa. This method limits the retention of large molecular weight, incompletely hydrolyzed protein fragments and enzymes, while allowing the passage of small molecular weight target peptides and amino acids, achieving precise control over the molecular weight range of the product, enriching components with potential hypoglycemic activity, and simultaneously removing large molecular weight impurities and enzymes. The supernatant is filtered through a tangential flow ultrafiltration system, with the ultrafiltration membrane having a molecular weight cutoff of 2kDa to 3kDa, and the permeate is collected.

[0149] Preferably, the preparation of the mango extract includes the following steps:

[0150] (D01) Take ripe mangoes, wash, remove pits, dry and crush them in sequence, then add an appropriate amount of ethanol for ultrasonic-assisted extraction to obtain an extract; drying reduces moisture, stabilizes raw materials, and facilitates crushing and storage; crushing increases specific surface area and improves extraction efficiency; the cavitation effect and mechanical effect of ultrasound can be used to violently destroy plant cell walls, accelerate solvent penetration and dissolution of target substances; ethanol as a solvent can effectively extract polyphenols, flavonoids and other moderately polar active ingredients.

[0151] (D02) The extract from step (D01) is concentrated under reduced pressure to obtain a concentrate, which is then diluted with water and filtered through a membrane. The reduced pressure concentration removes ethanol and reduces the volume. The dilution with water adjusts the polarity of the solution, which may be intended to precipitate some lipid-soluble impurities and prepare for subsequent aqueous phase loading onto the column. The filtration membrane removes insoluble particles, macromolecular colloids, starch, proteins and other impurities, preventing them from contaminating and clogging the subsequent chromatography column. This effectively protects the polyamide column, extends its service life, and improves purification efficiency.

[0152] (D03) The filtrate from step (D02) is subjected to fractional elution on a polyamide adsorption column, and the last eluted fraction is collected. Polyamide adsorbs polyphenols through hydrogen bonding. Gradient elution is performed using ethanol-water solution of varying concentrations from low to high. Polyphenols of different polarities are eluted sequentially. The last eluted fraction is collected, which can effectively enrich mango polyphenols and remove water-soluble impurities such as sugars and organic acids.

[0153] (D04) The eluent collected in step (D03) was subjected to rotary evaporation to remove ethanol and then spray-dried to obtain mango extract. Rotary evaporation removed ethanol from the eluent, and spray drying instantly dried the liquid extract into powder. The obtained extract had a total polyphenol content ≥45%, and a mangiferin content ≥15% (based on gallic acid equivalent). It mainly contained antioxidant components such as mangiferin, quercetin, and gallic acid. The extract was light brownish-yellow in color and had good water solubility. This process utilized ultrasonic-enhanced diffusion to improve the extraction rate and achieved polar-selective adsorption separation through a polyamide column, avoiding thermal degradation loss and ensuring the integrity and stability of the effective components. Its polyphenolic components showed significant synergistic potential in regulating glucose and lipid metabolism and repairing intestinal flora inflammation.

[0154] Preferably, in step (D01), the material is dried to a moisture content of 8% to 10%. More preferably, in step (D01), the material is dried to a moisture content of 9%. This stabilizes the raw material, prevents mold growth, facilitates crushing and storage, effectively removes free water, and avoids increased energy consumption or changes in composition due to over-drying.

[0155] Preferably, the ethanol in step (D01) is a 70% ethanol solution. 70% ethanol has excellent solubility for polyphenols such as mangiferin, and also has good selectivity for the extraction of highly polar impurities such as polysaccharides.

[0156] Preferably, the ratio of the pulverized material to ethanol in step (D01) is 1:8 to 10. More preferably, the ratio is 1:9. This provides a sufficient solvent system to ensure complete dissolution of the active ingredients.

[0157] Preferably, the number of ultrasound-assisted extractions in step (D01) is 2 to 3 times.

[0158] Preferably, the ultrasonic power in step (D01) is 250W to 300W. More preferably, the ultrasonic power in step (D01) is 260W to 290W. Even more preferably, the ultrasonic power in step (D01) is 270W to 280W.

[0159] Preferably, the ultrasonic temperature in step (D01) is 40°C to 50°C. More preferably, the ultrasonic temperature in step (D01) is 45°C.

[0160] Preferably, the sonication time in step (D01) is 20-30 minutes. More preferably, the sonication time in step (D01) is 25 minutes. The limited power and time determine the total energy, directly affecting the degree of cell disruption and extraction rate. The limited temperature accelerates solute diffusion while remaining far below the boiling point of ethanol and the decomposition temperature of polyphenols, thus maximizing the protection of heat-sensitive active ingredients. The limited number of extractions achieves an economical and efficient extraction yield. The good correlation between the parameters constitutes a mild, efficient, and activity-protective extraction environment.

[0161] Preferably, in step (D02), water is added to dilute the ethanol to a volume fraction of <10%.

[0162] Preferably, the filter in step (DO2) is passed through a 0.4 μm to 0.5 μm membrane. More preferably, the filter in step (DO2) is passed through a 0.42 μm to 0.48 μm membrane. Even more preferably, the filter in step (DO2) is passed through a 0.45 μm membrane. This removes all insoluble particles, colloids, microorganisms, etc., protecting the polyamide column from contamination and clogging, and ensuring smooth and reproducible chromatography.

[0163] Preferably, the fractional elution in step (D03) involves sequential elution with distilled water, 40% ethanol, and 70% ethanol, with the 70% ethanol fraction collected. Distilled water elutes highly polar impurities such as salts, sugars, and organic acids; 40% ethanol elutes highly polar pigments or simple phenols; and 70% ethanol elutes the target component, mangiferin, and other major polyphenols. This effectively separates the target analyte from impurities and achieves precise collection of the mangiferin-rich fraction. During the 70% ethanol elution process, an online UV detector at 280 nm is used for monitoring. The eluent with a significant increase in absorbance reaching a plateau is collected, and the elution curve of the target analyte is captured in real time. This ensures that only the core fraction with the highest concentration of active ingredients is collected, maximizing product purity and activity, and guaranteeing absolute batch-to-batch consistency.

[0164] Preferably, the preparation of the galactomannan includes the following steps:

[0165] (E01) Take coffee bean endosperm or guar bean powder, add an appropriate amount of deionized water and stir to mix. After adjusting the pH to 8.5-9.0, continue stirring and extraction. The alkaline environment is used to swell and destroy the plant cell wall, so that the water-insoluble galactomannan can be better dissolved in the water. At the same time, some coexisting proteins are degraded, which can effectively leach out galactomannan.

[0166] (E02) Centrifuge the extract from step (E01) to obtain the supernatant, then adjust the pH to 4.0-4.5 and let it stand to allow polysaccharide precipitation; centrifugation separates the soluble polysaccharide extract from the insoluble residue. Adjusting the pH to acidic is an isoelectric point precipitation process. The protein in the extract has the lowest solubility at the isoelectric point and will precipitate. Acidic conditions may also cause some polysaccharides to aggregate and precipitate, which can remove most of the protein and achieve crude purification.

[0167] (E03) Separate the polysaccharide precipitate in step (E02), wash it with anhydrous ethanol and then vacuum dry it to obtain crude polysaccharide; separate the precipitate and collect the crude polysaccharide precipitated in the previous step, wash it with anhydrous ethanol to dehydrate and remove water-soluble small molecule impurities, and vacuum dry it to obtain the dried crude polysaccharide product.

[0168] (E04) Dissolve the crude polysaccharide from step (E03) in warm water and add mannosidase and galactosidase enzyme solutions to react. The monosaccharides are cleaved sequentially from the non-reducing ends of the polysaccharide chain by galactosidase and mannosidase, thereby reducing the molecular weight and viscosity of the polysaccharide. At the same time, the main chain of galactomannan is mannose and the side chain is galactose. By using these two enzymes in a controlled manner, the degree of substitution of galactose can be changed, thereby precisely regulating its water solubility and biological activity.

[0169] (E05) The material after the reaction in step (E04) is ultrafiltered through a dialysis bag, and the filtrate is then freeze-dried to obtain galactomannan. Dialysis bag filtration removes small molecule sugars and enzyme proteins produced after enzymatic hydrolysis, while retaining polysaccharides within the target molecular weight range. The final molar ratio of galactose to mannose is approximately 1:2, with a purity ≥90% and ash content <1%. This process innovatively introduces a dual-enzyme debranching process, effectively removing oligosaccharides and impurity proteins, resulting in a product with better swelling and viscosity characteristics in water. This enhances its fermentation utilization efficiency as a probiotic substrate and increases its potential for short-chain fatty acid formation.

[0170] Preferably, the volume of deionized water added in step (E01) is 8 to 10 times the volume of the solids. More preferably, the volume of deionized water added in step (E01) is 9 times the volume of the solids. This provides a sufficient solvent system to ensure complete dissolution of the polysaccharides.

[0171] Preferably, the pH is adjusted using a 0.5 mol / L NaOH solution in step (E01).

[0172] Preferably, the continued stirring temperature in step (E01) is 60°C to 70°C. More preferably, the continued stirring temperature in step (E01) is 62°C to 68°C. Even more preferably, the continued stirring temperature in step (E01) is 65°C.

[0173] Preferably, the stirring time in step (E01) is 1 to 2 hours. More preferably, the stirring time in step (E01) is 1.5 hours. This creates a mild and effective alkaline extraction environment. The alkali concentration of 0.5 mol / L is sufficient to swell the raw material without causing drastic degradation of the polysaccharide. The limited temperature accelerates the mass transfer process. With proper parameter matching, the natural structure of the polysaccharide can be well preserved while ensuring the extraction rate.

[0174] Preferably, the centrifugation speed in step (E02) is 5000 rpm to 6000 rpm. More preferably, the centrifugation speed in step (E02) is 5200 rpm to 5800 rpm. Even more preferably, the centrifugation speed in step (E02) is 5500 rpm.

[0175] Preferably, the centrifugation time in step (E02) is 8 to 10 minutes. More preferably, the centrifugation time in step (E02) is 9 minutes. This effectively separates soluble polysaccharides from insoluble residues, achieving efficient separation.

[0176] Preferably, the pH is adjusted using 3 mol / L HCl in step (E02).

[0177] Preferably, the settling time in step (E02) is 3 to 4 hours. More preferably, the settling time in step (E02) is 3.5 hours. Providing sufficient acid strength to quickly and accurately adjust the pH to the isoelectric point, the defined settling time allows ample time for the precipitation and aggregation of proteins and polysaccharides.

[0178] Preferably, the washing process in step (E03) is repeated 2 to 3 times to effectively remove impurities.

[0179] Preferably, in step (E04), the amount of mannosidase added is 1% to 3% of the mass of the crude polysaccharide, and the amount of galactosidase added is 0.5% to 2% of the mass of the crude polysaccharide. More preferably, in step (E04), the amount of mannosidase added is 2% of the mass of the crude polysaccharide, and the amount of galactosidase added is 1% to 1.5% of the mass of the crude polysaccharide.

[0180] Preferably, the reaction temperature in step (E04) is 40°C to 50°C. More preferably, the reaction temperature in step (E04) is 45°C.

[0181] Preferably, the reaction time in step (E04) is 2 to 3 hours. More preferably, the reaction time in step (E04) is 2.5 hours.

[0182] Preferably, the molecular weight cutoff of the dialysis bag in step (E05) is 6kDa to 8kDa. More preferably, the molecular weight cutoff of the dialysis bag in step (E05) is 6.5kDa to 7.5kDa. Even more preferably, the molecular weight cutoff of the dialysis bag in step (E05) is 7kDa. By removing the small molecule sugars and the enzyme protein itself generated by enzymatic hydrolysis, and retaining the target polysaccharide product with a defined molecular weight, oligosaccharides or small molecule polysaccharides are obtained, rather than large molecule polymers.

[0183] Preferably, the auxiliary carrier is at least one of resistant dextrin, fructooligosaccharides, or microcrystalline cellulose. Resistant dextrin and fructooligosaccharides, as prebiotic dietary fibers, do not raise blood sugar and can synergistically enhance the effects of other prebiotic ingredients in the formula; microcrystalline cellulose is calorie-free, does not raise blood sugar, and is also an ideal carrier.

[0184] The tenth technical solution of the present invention: a method for preparing a dietary nutrition intervention composition to improve diabetes, comprising the following steps,

[0185] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and galactomannan into the reaction vessel, add water and stir to dissolve; dissolve the two water-soluble components, Codonopsis pilosula polysaccharide and galactomannan, first, dissolve the large molecular polysaccharide, which helps to mix the subsequent materials and form a solution base with polysaccharide as the backbone.

[0186] (S02) Add appropriate amounts of astragaloside A, bitter melon polypeptide and mango extract to the solution in step (S01) and stir to mix. When the mixture is transparent or slightly turbid, add appropriate amounts of auxiliary carrier and continue stirring to obtain a composite solution. By first dissolving, then adsorbing and then homogenizing, the good solubility of resistant dextrin and fructooligosaccharides and the porous structure of microcrystalline cellulose are used to improve the physical stability and flowability of the composite system. At the same time, the bitter melon polypeptide and mango polyphenols are prevented from oxidative degradation during the subsequent drying process, thus achieving efficient fixation between the carrier and the formulation.

[0187] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion. Some water is removed at low temperature to increase the solid content and prepare for spray drying. The particles in the liquid are broken up by high-pressure homogenization or high-speed shearing to make them more evenly distributed, prevent sedimentation, and improve the fluidity of subsequent spray drying. After homogenization, the system is a light brown fluid with a viscosity of about 120 mPa·s to 180 mPa·s. This homogenization process ensures that a stable hydrogen bond network is formed between Codonopsis pilosula polysaccharide and galactomannan, so that the active components on the surface of the carrier are embedded at the molecular level, avoiding stratification or local concentration fluctuations in the formulation. After removing bubbles by vacuum degassing, a concentrated mixture with uniform structure and stable dispersion is obtained.

[0188] (S04) The dispersion from step (S03) is sequentially spray-dried, low-temperature mixed, and vacuum-dried to obtain the finished dietary nutrition intervention composition. The dried powder is immediately discharged through a 10°C cold air duct, collected, and then sealed and cooled in an inert gas environment to prevent oxidation. The resulting powder is sieved through a 120-200 mesh sieve, with an average particle size of approximately 65 μm and a loose packing density of 0.42 g / cm³. 3 The moisture content is controlled at 4%–6%. This process employs a coupled control of rapid drying and airflow cooling, which significantly reduces the oxidative degradation rate of bitter melon polypeptides and mango polyphenols, while maintaining the high specific surface area structure of Codonopsis pilosula polysaccharides and galactomannan. This results in excellent dispersibility of the powder upon resolution. During the drying process, the carrier forms a coating film, allowing the active components to be adsorbed and stably fixed by micropores, achieving controlled-release characteristics. 0.1% silica can be added at the end of mixing to prevent moisture absorption and clumping. The innovative low-temperature ripening and vacuum packaging processes form a stable molecular complex state between the medicinal and edible active substances and the carrier, maintaining ≥90% activity during storage. This ensures good resolubility and stability of the product during use. The final dietary nutrition intervention composition is a light yellow to brownish-yellow uniform powder with a mild odor.

[0189] The moisture content and purity of Codonopsis pilosula polysaccharide, astragaloside A, bitter melon polypeptide, mango extract, and galactomannan were checked beforehand. The products were dried in a vacuum drying oven at 35℃~40℃ for 5h~6h, controlling the residual moisture content to ≤5%. High-performance liquid chromatography (HPLC) was used to determine the astragaloside A content to be ≥95%, the total polyphenols in the mango extract to be ≥45%, the purity of Codonopsis pilosula polysaccharide to be ≥85%, the protein peptide content of bitter melon polypeptide to be ≥80%, and the purity of galactomannan to be ≥90%. The formulas were then placed in a desiccator and allowed to stand for 22h~24h to allow their moisture content to equilibrate with room temperature. The pretreated powders were then sieved through a 180-200 mesh sieve.

[0190] This step eliminates differences in moisture content in raw materials caused by different sources or batches, improves the stability and consistency of the compounding process, avoids particle agglomeration, and provides controllable physical conditions for subsequent uniform mixing.

[0191] Preferably, the reactor in step (S01) is a temperature-controlled reactor.

[0192] Preferably, the water used in step (S01) is deionized water. This ensures process control and avoids metal ions affecting component stability.

[0193] Preferably, the volume of water added in step (S01) is 6 to 8 times the volume of the solid mixture. More preferably, the volume of water added in step (S01) is 7 times the volume of the solid mixture. This provides sufficient solvent to dissolve the polysaccharide.

[0194] Preferably, the dissolution temperature in step (S01) is 40°C to 45°C. More preferably, the dissolution temperature in step (S01) is 41°C to 44°C. Even more preferably, the dissolution temperature in step (S01) is 42°C to 43°C.

[0195] Preferably, the dissolution time in step (S01) is 20 min to 30 min. More preferably, the dissolution time in step (S01) is 22 min to 28 min. Even more preferably, the dissolution time in step (S01) is 25 min. Gentle heating promotes the dissolution of polysaccharides, and the temperature is below the threshold that may cause denaturation of some components.

[0196] Preferably, the mixing time in step (S02) is 10 min to 15 min. More preferably, the mixing time in step (S02) is 11 min to 14 min. Even more preferably, the mixing time in step (S02) is 12 min to 13 min.

[0197] Preferably, in step (S02), the auxiliary carrier is dried and dehumidified before being added. Pre-removing moisture from the carrier prevents it from clumping in the subsequent aqueous phase, reduces the total moisture content of the final product, and improves its stability.

[0198] Preferably, the drying and dehumidification temperature of the auxiliary carrier is 70°C to 80°C. More preferably, the drying and dehumidification temperature of the auxiliary carrier is 72°C to 78°C. Even more preferably, the drying and dehumidification temperature of the auxiliary carrier is 75°C.

[0199] Preferably, in step (S02), the auxiliary carrier is added gradually at a stirring speed of 1500 rpm to 2000 rpm. More preferably, in step (S02), the auxiliary carrier is added gradually at a stirring speed of 1600 rpm to 1900 rpm. Even more preferably, in step (S02), the auxiliary carrier is added gradually at a stirring speed of 1700 rpm to 1800 rpm. This effectively prevents powder agglomeration, allowing it to disperse rapidly in the liquid phase and form a uniform slurry.

[0200] Preferably, the vacuum concentration in step (S03) is carried out in a plate vacuum evaporator.

[0201] Preferably, the vacuum concentration temperature in step (S03) is 40°C to 50°C. More preferably, the vacuum concentration temperature in step (S03) is 42°C to 48°C. Even more preferably, the vacuum concentration temperature in step (S03) is 45°C.

[0202] Preferably, the vacuum concentration vacuum degree in step (S03) is -0.1 MPa to -0.05 MPa. More preferably, the vacuum concentration vacuum degree in step (S03) is -0.095 MPa to -0.065 MPa. Even more preferably, the vacuum concentration vacuum degree in step (S03) is -0.085 MPa to -0.075 MPa. Low-temperature concentration protects heat-sensitive components, and the plate evaporator has high efficiency.

[0203] Preferably, step (S03) involves vacuum concentration to a volume of 1 / 4 to 1 / 3 of the initial volume. This significantly increases the solid content, preparing the product for spray drying.

[0204] Preferably, the homogeneous dispersion in step (S03) is a segmented pressure homogeneous dispersion.

[0205] Preferably, the pressure gradients for homogeneous dispersion in step (S03) are 20 MPa, 30 MPa and 40 MPa respectively.

[0206] Preferably, the homogenization and dispersion in step (S03) is carried out in a three-stage high-pressure homogenizer.

[0207] Preferably, the homogenization dispersion in step (S03) is performed 2 to 3 times. Segmented pressurization gradually refines the particles, avoiding material blockage or excessive energy consumption caused by a single high pressure, effectively reducing particle size, improving system stability, preventing component separation during spray drying, and improving the retortability of the final product.

[0208] Preferably, the homogenization time is 6 to 8 minutes each time. More preferably, the homogenization time is 7 minutes each time.

[0209] Preferably, step (S03) involves homogenizing the particles to a size of 5 μm to 15 μm. More preferably, step (S03) involves homogenizing the particles to a size of 7 μm to 13 μm. Clear and verifiable quality control standards for the intermediates are established.

[0210] Preferably, the vacuum freeze-drying in step (S04) is performed in a vacuum freeze dryer. Freeze-drying can maximize the protection of active ingredients.

[0211] Preferably, the vacuum freeze-drying in step (S04) involves pre-freezing at -40°C to -45°C, followed by initial drying at -10°C to 0°C and a vacuum of 5Pa to 10Pa, and then secondary drying at 25°C to 30°C and a vacuum of 3Pa to 5Pa. More preferably, the vacuum freeze-drying involves pre-freezing at -42°C, followed by initial drying at -5°C and a vacuum of 8Pa, and then secondary drying at 28°C and a vacuum of 4Pa. Pre-freezing ensures that the dispersion is completely and rapidly frozen into solid ice crystals, forming a uniform frozen matrix. Rapid deep freezing results in small ice crystals, which is beneficial for subsequent sublimation and obtaining a loosely structured product. Under high vacuum, the solid ice crystals are directly sublimated into water vapor and removed by micro-heat supply, removing approximately 95% of the moisture. Low temperature prevents the sample from melting. At higher vacuum and slightly higher temperature, residual moisture tightly bound to the material molecules is removed, ensuring the long-term stability of the final product.

[0212] Preferably, the pre-freezing time is 2-4 hours, the first drying time is 20-30 hours, and the second drying time is 5-10 hours. More preferably, the pre-freezing time is 3 hours, the first drying time is 25 hours, and the second drying time is 8 hours. The material temperature is basically the same as the freeze-drying temperature, and the vacuum degree is maintained at a stable value for more than 1 hour as the endpoint.

[0213] Preferably, the mixing speed in the fluidized bed mixer in step (S04) is 50 rpm to 60 rpm. More preferably, the mixing speed in the fluidized bed mixer in step (S04) is 52 rpm to 58 rpm. Even more preferably, the mixing speed in the fluidized bed mixer in step (S04) is 55 rpm.

[0214] Preferably, the mixing time in the fluidized bed mixer in step (S04) is 30 min to 40 min. More preferably, the mixing time in the fluidized bed mixer in step (S04) is 32 min to 38 min. Even more preferably, the mixing time in the fluidized bed mixer in step (S04) is 35 min.

[0215] Preferably, the mixing temperature in the fluidized bed mixer in step (S04) is 23°C to 27°C. More preferably, the mixing temperature in the fluidized bed mixer in step (S04) is 25°C.

[0216] Preferably, the relative humidity inside the fluidized bed mixer in step (S04) is ≤30%.

[0217] Preferably, in step (S05), the finished dietary intervention composition from step (S04) is sealed with nitrogen. This isolates the product from oxygen and moisture, ensuring the stability of the product, which is rich in easily oxidized and hygroscopic components such as polyphenols and polysaccharides, during its shelf life.

[0218] Preferably, the packaging in step (S05) is done using an aluminum-plastic composite bag or a vacuum can.

[0219] The eleventh technical solution of the present invention: The application of a dietary nutritional intervention composition for improving diabetes in daily dietary formula foods for diabetic patients. The dietary nutritional intervention composition is mixed with staple food ingredients at a mass ratio of 1:15-30 to prepare a food suitable for diabetic patients. The staple food ingredients include oat flour, brown rice flour, and whole wheat flour. More preferably, the dietary nutritional intervention composition is mixed with the staple food ingredients at a mass ratio of 1:20-25. All staple food ingredients are low glycemic index whole grains, which are highly synergistic with the blood sugar lowering target of the intervention composition. They are also rich in dietary fiber, which can further delay glucose absorption.

[0220] Preferably, the food includes compound nutritional powder, nutritional biscuits, or meal replacement porridge. Compound nutritional powder can be prepared and consumed, making it convenient to eat and suitable as a snack or meal replacement. Nutritional biscuits are easy to carry and store. Compound nutritional powder can be combined with konjac powder, chia seeds, etc., and mixed with hot water to make a porridge with high satiety and low GI.

[0221] Preferably, when the compound nutritional powder is made, it is directly packaged after dry mixing; specifically, the dietary nutrition intervention composition powder and the staple food raw material powder are physically mixed in a mixer at room temperature and the relative humidity inside the mixer is <40%.

[0222] When making meal replacement porridge, it is directly packaged after being mixed using a low-temperature wet method; specifically, a small amount of cold or warm water is added first for conditioning, and then stirred and mixed at a temperature of 40℃~45℃.

[0223] When making nutritional cookies, first add water to the compound nutritional powder and stir, then place it in a cookie mold, set the oven temperature to 150℃~165℃, control the cookie core temperature to ≤92℃, and bake for 12min~18min.

[0224] The twelfth technical solution of the present invention: the application of a dietary nutrition intervention composition for improving diabetes in functional meal replacement products for people with diabetes or prediabetes. Appropriate amounts of skim milk powder, isomaltooligosaccharide, and plant protein powder are added to the dietary nutrition intervention composition, and then directly mixed evenly using a dry mixing process to form a finished meal replacement powder; or the dietary nutrition intervention composition is dissolved in deionized water, and then appropriate amounts of skim milk powder, isomaltooligosaccharide, and plant protein powder are added, followed by high-shear homogenization, sterilization, and filling to directly produce a finished liquid meal replacement. This product offers a convenient and nutritionally complete meal replacement solution. Through precise control of macronutrients and the addition of functional ingredients, it achieves stable blood sugar levels and increased satiety. Skim milk powder provides high-quality protein, calcium, and a creamy flavor; protein helps slow gastric emptying and stabilize post-meal blood sugar. Isomaltooligosaccharides, as a prebiotic, promote the growth of beneficial gut bacteria. Plant protein powder supplements protein, increases satiety, and together with milk powder, forms the protein base. High-shear homogenization ensures complete dissolution and dispersion of all powder components, forming a stable, smooth-tasting emulsion, avoiding sedimentation and stratification. It is directly formulated into a liquid meal replacement, and the homogenized liquid is directly sterilized and bottled for convenient consumption and improved taste. Sterilization can be performed using ultra-high temperature (UHT) sterilization. Homogenization conditions include two homogenizations at 50℃~60℃ and 40MPa~50MPa pressure. When consuming the finished meal replacement powder, simply mix an appropriate amount with warm water.

[0225] Preferably, the ratio of the dietary nutrient intervention composition to deionized water is 1.0 g / 100 mL to 2.5 g / 100 mL. More preferably, the ratio is 1.5 g / 100 mL to 2.0 g / 100 mL.

[0226] As a preferred option, 5-10 parts by weight of skim milk powder, 2-5 parts by weight of isomaltooligosaccharide and 10-20 parts by weight of plant protein powder are added.

[0227] As a preferred option, 6-9 parts by weight of skim milk powder, 3-4 parts by weight of isomaltooligosaccharide and 12-18 parts by weight of plant protein powder are added.

[0228] As a preferred option, 7-8 parts skim milk powder, 3-4 parts isomaltooligosaccharide and 14-16 parts plant protein powder are added by weight.

[0229] As a preferred option, by weight, add 8 parts skim milk powder, 3.5 parts isomaltooligosaccharide and 15 parts plant protein powder.

[0230] The present invention has the following beneficial effects:

[0231] (1) An appropriate amount of Codonopsis pilosula polysaccharide, as a core prebiotic and immunomodulator, can selectively promote the proliferation of beneficial intestinal bacteria, maintain the integrity of the intestinal barrier, improve systemic inflammation and insulin resistance, and provide a lasting and fundamental intestinal microecological regulation effect. It is the pillar for achieving the core proposition of the program, providing the main intestinal flora homeostasis regulation, improving intestinal microecological homeostasis, promoting the production of short-chain fatty acids (SCFAs), increasing flora diversity, and reducing blood glucose and blood lipids. An appropriate amount of astragaloside A, as a systemic potent regulator, mainly targets host organs and directly protects pancreatic β cells through anti-inflammatory, antioxidant, and immunomodulatory effects. It improves insulin sensitivity in peripheral tissues such as the liver and muscles, and has a clear effect on improving insulin resistance and cell function. It can produce a synergistic effect with prebiotic components, regulate insulin sensitivity, inhibit the expression of inflammatory factors, and enhance intestinal barrier repair in conjunction with Codonopsis pilosula polysaccharide. An appropriate amount of bitter melon polypeptide activates pathways such as AMPK, mimics the action of insulin, promotes the utilization of glucose in peripheral tissues, provides a direct hypoglycemic effect, promotes glucose uptake and metabolism, enhances insulin-like activity, and helps control blood sugar. An appropriate amount of auxiliary carrier is used to improve the uniformity and stability of the composition and can regulate the dissolution rate.

[0232] (2) Appropriate amounts of mango extract, as a natural α-glucosidase inhibitor, are rich in polyphenols such as mangiferin, which can inhibit α-glucosidase in the small intestine, thereby delaying the digestion and absorption of carbohydrates, easing postprandial blood sugar, providing a clear and rapid postprandial blood sugar control effect, complementing the long-term regulation of prebiotics, and are rich in polyphenols, which have antioxidant and anti-inflammatory properties, and improve glucose and lipid metabolism.

[0233] (3) An appropriate amount of galactomannan, as a dual-function dietary fiber, can form a gel in the stomach, increase the viscosity of chyme, delay gastric emptying and the diffusion of nutrients to the intestinal absorption surface. It is not digested by the human body. After reaching the colon, it is fermented by the flora as a prebiotic to produce short-chain fatty acids, which are beneficial to intestinal health and sugar metabolism. It can provide a physical blood sugar barrier and additional prebiotic support. It is a bridge connecting immediate blood sugar reduction and long-term bacterial regulation. As a fermentable dietary fiber, it promotes the proliferation of beneficial bacteria, increases the production of short-chain fatty acids in the intestine, and assists Codonopsis pilosula polysaccharide in restoring the balance of intestinal flora and the integrity of the barrier.

[0234] (4) A multi-target, multi-mechanism three-dimensional intervention network was constructed. Mango extract and galactomannan can synergistically control postprandial blood glucose. Codonopsis polysaccharide and galactomannan, as prebiotics, can synergistically regulate intestinal microecology. Astragaloside A has anti-inflammatory properties that can improve systemic function. Bitter melon polypeptide can promote the utilization of glucose by peripheral tissues. Codonopsis polysaccharide is the basic component. Astragaloside A enhances the effect of Codonopsis polysaccharide at the metabolic level by enhancing insulin sensitivity and anti-inflammatory mechanism. The two are combined to form a dual regulatory system, which can improve the intestinal microenvironment and reduce systemic inflammation and hyperglycemia. Bitter melon polypeptide and mango extract provide synergistic effects in glucose metabolism and lipid metabolism, respectively. The former has insulin-like activity, and the latter can reduce oxidative stress and inflammatory response, thereby enhancing the overall metabolic improvement effect.

[0235] (5) The preparation process incorporates a comprehensive process of low-temperature dissolution, carrier adsorption, vacuum concentration, vacuum freeze drying and nitrogen protection packaging, which improves the dispersibility and activity stability of the powder, effectively avoids the thermal degradation and oxidative deactivation of active components, and realizes the industrial stable preparation of dietary nutrition grade products.

[0236] (6) At the application level, the composition can be flexibly used for functional dietary combinations for diabetic patients, including mixing with cereal powder in a certain proportion to make a compound nutritional staple food, or mixing with oligosaccharides and protein powder to make a meal replacement product. Through scientific ratio control and carrier coating technology, the active components in the composition can be released slowly in the gastrointestinal tract, continuously regulate the balance of intestinal flora, stabilize blood sugar levels and improve abnormal glucose and lipid metabolism. Attached Figure Description

[0237] Figure 1 This is a schematic diagram of the formulation of the dietary nutrition intervention composition for improving diabetes of the present invention;

[0238] Figure 2 This is a schematic flowchart of the preparation method of the dietary nutrition intervention composition for improving diabetes according to the present invention. Detailed Implementation

[0239] The present invention will be further described below with reference to the accompanying drawings and embodiments, but this should not be construed as limiting the present invention.

[0240] Example 1: A dietary nutritional intervention composition for improving diabetes, comprising the following components by weight:

[0241] Codonopsis polysaccharide 40 parts, astragaloside A 8 parts, and auxiliary carrier 10 parts.

[0242] A method for preparing a dietary nutrition intervention composition to improve diabetes includes the following steps:

[0243] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel, add water and stir to dissolve; the reaction vessel in step (S01) is a temperature-controlled reaction vessel; the water in step (S01) is deionized water; the volume of water added in step (S01) is 6 times the volume of the solid mixture; the dissolution temperature in step (S01) is 40℃; the dissolution time in step (S01) is 30min;

[0244] (S02) Add an appropriate amount of astragaloside A to the solution from step (S01) and stir until it becomes transparent or slightly turbid. Then add an appropriate amount of auxiliary carrier and continue stirring to obtain a composite solution. The mixing time in step (S02) is 10 min. Before adding the auxiliary carrier in step (S02), the auxiliary carrier is dried and dehumidified. The drying and dehumidification temperature of the auxiliary carrier is 70℃. The auxiliary carrier in step (S02) is added gradually at a stirring speed of 1500 rpm.

[0245] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion; the vacuum concentration temperature in step (S03) is 40℃; the vacuum degree in step (S03) is -0.1MPa; the vacuum concentration in step (S03) is carried out to 1 / 4 of the initial volume; the homogenization in step (S03) is a segmented pressure homogenization; the pressure gradient in step (S03) is 20MPa, 30MPa and 40MPa respectively; the homogenization in step (S03) is carried out in a three-stage high-pressure homogenizer; the homogenization in step (S03) is carried out twice; the homogenization time for each time is 6min; the homogenization in step (S03) is carried out to a particle size of 5μm to 15μm.

[0246] (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition; the auxiliary carrier is a mixture of resistant dextrin and microcrystalline cellulose in a mass ratio of 1:1; the vacuum freeze-drying in step (S04) is carried out in a vacuum freeze dryer; the vacuum freeze-drying in step (S04) involves pre-freezing at -40℃, first drying at -10℃ and 5Pa vacuum, and then second drying at 25℃ and 3Pa vacuum; the pre-freezing time is 2h, the first drying time is 20h, and the second drying time is 5h; the mixing speed in the fluidized bed mixer in step (S04) is 50rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 23℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%;

[0247] (S05) The finished product of the dietary nutrition intervention composition in step (S04) is sealed with nitrogen; the sealing in step (S05) is done using an aluminum-plastic composite bag.

[0248] Example 2: This example is basically the same as Example 1, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 80 parts of Codonopsis pilosula polysaccharide, 25 parts of astragaloside A, and 40 parts of auxiliary carrier.

[0249] In step (S01), the volume of water added is 8 times the volume of the solid mixture; the dissolution temperature in step (S01) is 45℃; the dissolution time in step (S01) is 20 min; the mixing time in step (S02) is 15 min; the drying and dehumidification temperature for the auxiliary carrier is 80℃; the auxiliary carrier in step (S02) is added gradually at a stirring speed of 2000 rpm; the vacuum concentration temperature in step (S03) is 50℃; the vacuum degree in step (S03) is -0.05 MPa; the vacuum concentration in step (S03) is completed to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 8 min; the homogenization in step (S03) is completed. The particles are dispersed to a particle size of 7μm to 13μm; the auxiliary carrier is a mixture of fructooligosaccharides and microcrystalline cellulose in a mass ratio of 1:1; the vacuum freeze-drying in step (S04) involves pre-freezing at -45℃, then drying at 0℃ and 10Pa vacuum, and then drying at 30℃ and 5Pa vacuum; the pre-freezing time is 4h, the first drying time is 30h, and the second drying time is 10h; the mixing speed in the fluidized bed mixer in step (S04) is 60rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 27℃; the packaging in step (S05) uses a vacuum can.

[0250] Example 3: This example is basically the same as Example 1, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 60 parts of Codonopsis pilosula polysaccharide, 16.5 parts of astragaloside A, and 25 parts of auxiliary carrier.

[0251] In step (S01), the volume of water added is 7 times the volume of the solid mixture; the dissolution temperature in step (S01) is 43℃; the dissolution time in step (S01) is 25 min; the mixing time in step (S02) is 12 min; the drying and dehumidification temperature of the auxiliary carrier is 75℃; the auxiliary carrier is added at 1800 rpm in step (S02); the vacuum concentration temperature in step (S03) is 45℃; the vacuum degree of vacuum concentration in step (S03) is -0.085 MPa; the vacuum concentration in step (S03) is reduced to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 7 min; the homogenization dispersion in step (S03) is reduced to a particle size of 5 μm to 15 μm. The auxiliary carrier is a mixture of resistant dextrin, fructooligosaccharides, and microcrystalline cellulose in a mass ratio of 1:1:1; the vacuum freeze-drying process involves pre-freezing at -42℃, followed by initial drying at -5℃ and 8Pa vacuum, and then secondary drying at 28℃ and 4Pa vacuum; the pre-freezing time is 3 hours, the initial drying time is 25 hours, and the secondary drying time is 8 hours; the mixing speed in the fluidized bed mixer in step (S04) is 55 rpm; the mixing time in the fluidized bed mixer in step (S04) is 35 minutes; the mixing temperature in the fluidized bed mixer in step (S04) is 25℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%; and the packaging in step (S05) uses an aluminum-plastic composite bag.

[0252] Example 4: A dietary nutritional intervention composition for improving diabetes, comprising the following components by weight:

[0253] 40 parts of Codonopsis pilosula polysaccharide, 8 parts of astragaloside A, 1 part of bitter melon polypeptide, and 10 parts of auxiliary carrier.

[0254] A method for preparing a dietary nutrition intervention composition to improve diabetes includes the following steps:

[0255] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel, add water and stir to dissolve; the reaction vessel in step (S01) is a temperature-controlled reaction vessel; the water in step (S01) is deionized water; the volume of water added in step (S01) is 6 times the volume of the solid mixture; the dissolution temperature in step (S01) is 40℃; the dissolution time in step (S01) is 30min;

[0256] (S02) Add appropriate amounts of astragaloside A and bitter melon polypeptide to the solution from step (S01) and stir until it becomes transparent or slightly turbid. Then add appropriate amounts of auxiliary carrier and continue stirring to obtain a composite solution. The mixing time in step (S02) is 10 min. Before adding the auxiliary carrier in step (S02), the auxiliary carrier is dried and dehumidified. The drying and dehumidification temperature of the auxiliary carrier is 70℃. The auxiliary carrier is added gradually at a stirring speed of 1500 rpm in step (S02).

[0257] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion; the vacuum concentration temperature in step (S03) is 40℃; the vacuum degree in step (S03) is -0.1MPa; the vacuum concentration in step (S03) is carried out to 1 / 4 of the initial volume; the homogenization in step (S03) is a segmented pressure homogenization; the pressure gradient in step (S03) is 20MPa, 30MPa and 40MPa respectively; the homogenization in step (S03) is carried out in a three-stage high-pressure homogenizer; the homogenization in step (S03) is carried out twice; the homogenization time for each time is 6min; the homogenization in step (S03) is carried out to a particle size of 5μm to 15μm.

[0258] (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition; the auxiliary carrier is a mixture of resistant dextrin and microcrystalline cellulose in a mass ratio of 1:1; the vacuum freeze-drying in step (S04) is carried out in a vacuum freeze dryer; the vacuum freeze-drying in step (S04) involves pre-freezing at -40℃, first drying at -10℃ and 5Pa vacuum, and then second drying at 25℃ and 3Pa vacuum; the pre-freezing time is 2h, the first drying time is 20h, and the second drying time is 5h; the mixing speed in the fluidized bed mixer in step (S04) is 50rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 23℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%;

[0259] (S05) The finished product of the dietary nutrition intervention composition in step (S04) is sealed with nitrogen; the sealing in step (S05) is done using an aluminum-plastic composite bag.

[0260] Example 5: This example is basically the same as Example 4, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 80 parts of Codonopsis pilosula polysaccharide, 25 parts of astragaloside A, 10 parts of bitter melon polypeptide, and 40 parts of auxiliary carrier.

[0261] In step (S01), the volume of water added is 8 times the volume of the solid mixture; the dissolution temperature in step (S01) is 45℃; the dissolution time in step (S01) is 20 min; the mixing time in step (S02) is 15 min; the drying and dehumidification temperature for the auxiliary carrier is 80℃; the auxiliary carrier in step (S02) is added gradually at a stirring speed of 2000 rpm; the vacuum concentration temperature in step (S03) is 50℃; the vacuum degree in step (S03) is -0.05 MPa; the vacuum concentration in step (S03) is completed to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 8 min; the homogenization in step (S03) is completed. The particles are dispersed to a particle size of 7μm to 13μm; the auxiliary carrier is a mixture of fructooligosaccharides and microcrystalline cellulose in a mass ratio of 1:1; the vacuum freeze-drying in step (S04) involves pre-freezing at -45℃, then drying at 0℃ and 10Pa vacuum, and then drying at 30℃ and 5Pa vacuum; the pre-freezing time is 4h, the first drying time is 30h, and the second drying time is 10h; the mixing speed in the fluidized bed mixer in step (S04) is 60rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 27℃; the packaging in step (S05) uses a vacuum can.

[0262] Example 6: This example is basically the same as Example 4, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 60 parts of Codonopsis pilosula polysaccharide, 16.5 parts of astragaloside A, 5.5 parts of bitter melon polypeptide, and 25 parts of auxiliary carrier.

[0263] In step (S01), the volume of water added is 7 times the volume of the solid mixture; the dissolution temperature in step (S01) is 43℃; the dissolution time in step (S01) is 25 min; the mixing time in step (S02) is 12 min; the drying and dehumidification temperature of the auxiliary carrier is 75℃; the auxiliary carrier is added at 1800 rpm in step (S02); the vacuum concentration temperature in step (S03) is 45℃; the vacuum degree of vacuum concentration in step (S03) is -0.085 MPa; the vacuum concentration in step (S03) is reduced to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 7 min; the homogenization dispersion in step (S03) is reduced to a particle size of 5 μm to 15 μm. The auxiliary carrier is a mixture of resistant dextrin, fructooligosaccharides, and microcrystalline cellulose in a mass ratio of 1:1:1; the vacuum freeze-drying process involves pre-freezing at -42℃, followed by initial drying at -5℃ and 8Pa vacuum, and then secondary drying at 28℃ and 4Pa vacuum; the pre-freezing time is 3 hours, the initial drying time is 25 hours, and the secondary drying time is 8 hours; the mixing speed in the fluidized bed mixer in step (S04) is 55 rpm; the mixing time in the fluidized bed mixer in step (S04) is 35 minutes; the mixing temperature in the fluidized bed mixer in step (S04) is 25℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%; and the packaging in step (S05) uses an aluminum-plastic composite bag.

[0264] Example 7: A dietary nutrition intervention composition for improving diabetes, comprising the following components by weight: 40 parts of Codonopsis pilosula polysaccharide, 8 parts of astragaloside A, 5 parts of mango extract, and 10 parts of auxiliary carrier.

[0265] A method for preparing a dietary nutrition intervention composition to improve diabetes includes the following steps:

[0266] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel, add water and stir to dissolve; the reaction vessel in step (S01) is a temperature-controlled reaction vessel; the water in step (S01) is deionized water; the volume of water added in step (S01) is 6 times the volume of the solid mixture; the dissolution temperature in step (S01) is 40℃; the dissolution time in step (S01) is 30min;

[0267] (S02) Add appropriate amounts of astragaloside A and mango extract to the solution from step (S01) and stir until it becomes transparent or slightly turbid. Then add appropriate amounts of auxiliary carrier and continue stirring to obtain a composite solution. The mixing time in step (S02) is 10 min. Before adding the auxiliary carrier in step (S02), the auxiliary carrier is dried and dehumidified. The drying and dehumidification temperature of the auxiliary carrier is 70℃. The auxiliary carrier in step (S02) is added gradually at a stirring speed of 1500 rpm.

[0268] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion; the vacuum concentration temperature in step (S03) is 40℃; the vacuum degree in step (S03) is -0.1MPa; the vacuum concentration in step (S03) is carried out to 1 / 4 of the initial volume; the homogenization in step (S03) is a segmented pressure homogenization; the pressure gradient in step (S03) is 20MPa, 30MPa and 40MPa respectively; the homogenization in step (S03) is carried out in a three-stage high-pressure homogenizer; the homogenization in step (S03) is carried out twice; the homogenization time for each time is 6min; the homogenization in step (S03) is carried out to a particle size of 5μm to 15μm.

[0269] (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition; the auxiliary carrier is resistant dextrin; the vacuum freeze-drying in step (S04) is carried out in a vacuum freeze dryer; the vacuum freeze-drying in step (S04) is pre-freezing at -40℃, then drying at -10℃ and 5Pa vacuum, and then drying at 25℃ and 3Pa vacuum; the pre-freezing time is 2h, the first drying time is 20h, and the second drying time is 5h; the mixing speed in the fluidized bed mixer in step (S04) is 50rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 23℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%;

[0270] (S05) The finished product of the dietary nutrition intervention composition in step (S04) is sealed with nitrogen; the sealing in step (S05) is done using an aluminum-plastic composite bag.

[0271] Example 8: This example is basically the same as Example 7, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 80 parts of Codonopsis pilosula polysaccharide, 25 parts of astragaloside A, 20 parts of mango extract, and 40 parts of auxiliary carrier.

[0272] In step (S01), the volume of water added is 8 times the volume of the solid mixture; the dissolution temperature in step (S01) is 45℃; the dissolution time in step (S01) is 20 min; the mixing time in step (S02) is 15 min; the drying and dehumidification temperature of the auxiliary carrier is 80℃; the auxiliary carrier in step (S02) is added gradually at a stirring speed of 2000 rpm; the vacuum concentration temperature in step (S03) is 50℃; the vacuum degree of vacuum concentration in step (S03) is -0.05 MPa; the vacuum concentration in step (S03) is carried out to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is carried out 3 times; the homogenization dispersion time for each time is 8 min; Step (S03) involves homogenizing and dispersing the particles to a size of 7μm–13μm; the auxiliary carrier is fructooligosaccharide; in step (S04), the vacuum freeze-drying process involves pre-freezing at -45℃, followed by initial drying at 0℃ and 10Pa vacuum, and then secondary drying at 30℃ and 5Pa vacuum; the pre-freezing time is 4 hours, the initial drying time is 30 hours, and the secondary drying time is 10 hours; in step (S04), the mixing speed in the fluidized bed mixer is 60 rpm; the mixing time in the fluidized bed mixer in step (S04) is 40 minutes; the mixing temperature in the fluidized bed mixer in step (S04) is 27℃; and in step (S05), the packaging is done using a vacuum can.

[0273] Example 9: This example is basically the same as Example 7, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 60 parts of Codonopsis pilosula polysaccharide, 16.5 parts of astragaloside A, 13 parts of mango extract, and 25 parts of auxiliary carrier.

[0274] In step (S01), the volume of water added is 7 times the volume of the solid mixture; the dissolution temperature in step (S01) is 43℃; the dissolution time in step (S01) is 25 min; the mixing time in step (S02) is 12 min; the drying and dehumidification temperature for the auxiliary carrier is 75℃; the auxiliary carrier is added at 1800 rpm in step (S02); the vacuum concentration temperature in step (S03) is 45℃; the vacuum degree in step (S03) is -0.085 MPa; the vacuum concentration in step (S03) is completed to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 7 min; the homogenization dispersion in step (S03) is completed to... The particle size is 5μm~15μm; the auxiliary carrier is microcrystalline cellulose; the vacuum freeze-drying process involves pre-freezing at -42℃, first drying at -5℃ and 8Pa vacuum, and second drying at 28℃ and 4Pa vacuum; the pre-freezing time is 3h, the first drying time is 25h, and the second drying time is 8h; the mixing speed in the fluidized bed mixer in step (S04) is 55rpm; the mixing time in the fluidized bed mixer in step (S04) is 35min; the mixing temperature in the fluidized bed mixer in step (S04) is 25℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%; the packaging in step (S05) uses an aluminum-plastic composite bag.

[0275] Example 10: A dietary nutrition intervention composition for improving diabetes, comprising the following components by weight: 40 parts of Codonopsis pilosula polysaccharide, 8 parts of astragaloside A, 2 parts of galactomannan, and 10 parts of auxiliary carrier.

[0276] A method for preparing a dietary nutrition intervention composition to improve diabetes includes the following steps:

[0277] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and galactomannan and put them into the reaction vessel, add water and stir to dissolve; the reaction vessel in step (S01) is a temperature-controlled reaction vessel; the water in step (S01) is deionized water; the volume of water added in step (S01) is 6 times the volume of the solid mixture; the dissolution temperature in step (S01) is 40℃; the dissolution time in step (S01) is 30min;

[0278] (S02) Add an appropriate amount of astragaloside A and auxiliary carrier to the solution in step (S01) and continue stirring to obtain a composite solution; the mixing time in step (S02) is 10 min; the auxiliary carrier is dried and dehumidified before being added in step (S02); the drying and dehumidification temperature of the auxiliary carrier is 70℃; the auxiliary carrier is added gradually at a stirring speed of 1500 rpm in step (S02);

[0279] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion; the vacuum concentration temperature in step (S03) is 40℃; the vacuum degree in step (S03) is -0.1MPa; the vacuum concentration in step (S03) is carried out to 1 / 4 of the initial volume; the homogenization in step (S03) is a segmented pressure homogenization; the pressure gradient in step (S03) is 20MPa, 30MPa and 40MPa respectively; the homogenization in step (S03) is carried out in a three-stage high-pressure homogenizer; the homogenization in step (S03) is carried out twice; the homogenization time for each time is 6min; the homogenization in step (S03) is carried out to a particle size of 5μm to 15μm.

[0280] (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition; the auxiliary carrier is resistant dextrin; the vacuum freeze-drying in step (S04) is carried out in a vacuum freeze dryer; the vacuum freeze-drying in step (S04) is pre-freezing at -40℃, then drying at -10℃ and 5Pa vacuum, and then drying at 25℃ and 3Pa vacuum; the pre-freezing time is 2h, the first drying time is 20h, and the second drying time is 5h; the mixing speed in the fluidized bed mixer in step (S04) is 50rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 23℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%;

[0281] (S05) The finished product of the dietary nutrition intervention composition in step (S04) is sealed with nitrogen; the sealing in step (S05) is done using an aluminum-plastic composite bag.

[0282] Example 11: This example is basically the same as Example 10, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 80 parts of Codonopsis pilosula polysaccharide, 25 parts of astragaloside A, 12 parts of galactomannan, and 40 parts of auxiliary carrier.

[0283] In step (S01), the volume of water added is 8 times the volume of the solid mixture; the dissolution temperature in step (S01) is 45℃; the dissolution time in step (S01) is 20 min; the mixing time in step (S02) is 15 min; the drying and dehumidification temperature of the auxiliary carrier is 80℃; the auxiliary carrier in step (S02) is added gradually at a stirring speed of 2000 rpm; the vacuum concentration temperature in step (S03) is 50℃; the vacuum degree of vacuum concentration in step (S03) is -0.05 MPa; the vacuum concentration in step (S03) is carried out to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is carried out 3 times; the homogenization dispersion time for each time is 8 min; Step (S03) involves homogenizing and dispersing the particles to a size of 7μm–13μm; the auxiliary carrier is fructooligosaccharide; in step (S04), the vacuum freeze-drying process involves pre-freezing at -45℃, followed by initial drying at 0℃ and 10Pa vacuum, and then secondary drying at 30℃ and 5Pa vacuum; the pre-freezing time is 4 hours, the initial drying time is 30 hours, and the secondary drying time is 10 hours; in step (S04), the mixing speed in the fluidized bed mixer is 60 rpm; the mixing time in the fluidized bed mixer in step (S04) is 40 minutes; the mixing temperature in the fluidized bed mixer in step (S04) is 27℃; and in step (S05), the packaging is done using a vacuum can.

[0284] Example 12: This example is basically the same as Example 10, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 60 parts of Codonopsis pilosula polysaccharide, 16.5 parts of astragaloside A, 7 parts of galactomannan, and 25 parts of auxiliary carrier.

[0285] In step (S01), the volume of water added is 7 times the volume of the solid mixture; the dissolution temperature in step (S01) is 43℃; the dissolution time in step (S01) is 25 min; the mixing time in step (S02) is 12 min; the drying and dehumidification temperature for the auxiliary carrier is 75℃; the auxiliary carrier is added at 1800 rpm in step (S02); the vacuum concentration temperature in step (S03) is 45℃; the vacuum degree in step (S03) is -0.085 MPa; the vacuum concentration in step (S03) is completed to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 7 min; the homogenization dispersion in step (S03) is completed to... The particle size is 5μm~15μm; the auxiliary carrier is microcrystalline cellulose; the vacuum freeze-drying process involves pre-freezing at -42℃, first drying at -5℃ and 8Pa vacuum, and second drying at 28℃ and 4Pa vacuum; the pre-freezing time is 3h, the first drying time is 25h, and the second drying time is 8h; the mixing speed in the fluidized bed mixer in step (S04) is 55rpm; the mixing time in the fluidized bed mixer in step (S04) is 35min; the mixing temperature in the fluidized bed mixer in step (S04) is 25℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%; the packaging in step (S05) uses an aluminum-plastic composite bag.

[0286] Example 13: As Figure 1 The dietary intervention composition for improving diabetes shown comprises the following components by weight:

[0287] 40 parts of Codonopsis pilosula polysaccharide, 8 parts of astragaloside A, 1 part of bitter melon polypeptide, 5 parts of mango extract, 2 parts of galactomannan, and 10 parts of auxiliary carrier.

[0288] like Figure 2 The method for preparing the dietary nutritional intervention composition for improving diabetes, as shown, includes the following steps:

[0289] (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and galactomannan and put them into the reaction vessel, add water and stir to dissolve; the reaction vessel in step (S01) is a temperature-controlled reaction vessel; the water in step (S01) is deionized water; the volume of water added in step (S01) is 6 times the volume of the solid mixture; the dissolution temperature in step (S01) is 40℃; the dissolution time in step (S01) is 30min;

[0290] (S02) Add appropriate amounts of astragaloside A, bitter melon polypeptide and mango extract to the solution in step (S01) and stir until it becomes transparent or slightly turbid. Then add appropriate amounts of auxiliary carrier and continue stirring to obtain a composite solution. The mixing time in step (S02) is 10 min. Before adding the auxiliary carrier in step (S02), the auxiliary carrier is dried and dehumidified. The drying and dehumidification temperature of the auxiliary carrier is 70℃. The auxiliary carrier is added gradually at a stirring speed of 1500 rpm in step (S02).

[0291] (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion; the vacuum concentration in step (S03) is carried out in a plate vacuum evaporator; the vacuum concentration temperature in step (S03) is 40℃; the vacuum degree in step (S03) is -0.1MPa; the vacuum concentration in step (S03) is carried out to 1 / 4 of the initial volume; the homogenization in step (S03) is a segmented pressure homogenization; the pressure gradient in step (S03) is 20MPa, 30MPa and 40MPa respectively; the homogenization in step (S03) is carried out in a three-stage high-pressure homogenizer; the homogenization in step (S03) is carried out twice; the homogenization time for each time is 6min; the homogenization in step (S03) is carried out to a particle size of 5μm to 15μm;

[0292] (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition; the auxiliary carrier is a mixture of resistant dextrin and microcrystalline cellulose in a mass ratio of 1:1; the vacuum freeze-drying in step (S04) is carried out in a vacuum freeze dryer; the vacuum freeze-drying in step (S04) involves pre-freezing at -40℃, first drying at -10℃ and 5Pa vacuum, and then second drying at 25℃ and 3Pa vacuum; the pre-freezing time is 2h, the first drying time is 20h, and the second drying time is 5h; the mixing speed in the fluidized bed mixer in step (S04) is 50rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 23℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%;

[0293] (S05) The finished product of the dietary nutrition intervention composition in step (S04) is sealed with nitrogen; the sealing in step (S05) is done using an aluminum-plastic composite bag.

[0294] Example 14: This example is basically the same as Example 13, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 80 parts of Codonopsis pilosula polysaccharide, 25 parts of astragaloside A, 10 parts of bitter melon polypeptide, 20 parts of mango extract, 12 parts of galactomannan, and 40 parts of auxiliary carrier.

[0295] In step (S01), the volume of water added is 8 times the volume of the solid mixture; the dissolution temperature in step (S01) is 45℃; the dissolution time in step (S01) is 20 min; the mixing time in step (S02) is 15 min; the drying and dehumidification temperature for the auxiliary carrier is 80℃; the auxiliary carrier in step (S02) is added gradually at a stirring speed of 2000 rpm; the vacuum concentration temperature in step (S03) is 50℃; the vacuum degree in step (S03) is -0.05 MPa; the vacuum concentration in step (S03) is completed to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 8 min; the homogenization in step (S03) is completed. The particles are dispersed to a particle size of 7μm to 13μm; the auxiliary carrier is a mixture of fructooligosaccharides and microcrystalline cellulose in a mass ratio of 1:1; the vacuum freeze-drying in step (S04) involves pre-freezing at -45℃, then drying at 0℃ and 10Pa vacuum, and then drying at 30℃ and 5Pa vacuum; the pre-freezing time is 4h, the first drying time is 30h, and the second drying time is 10h; the mixing speed in the fluidized bed mixer in step (S04) is 60rpm; the mixing time in the fluidized bed mixer in step (S04) is 40min; the mixing temperature in the fluidized bed mixer in step (S04) is 27℃; the packaging in step (S05) uses a vacuum can.

[0296] Example 15: This example is basically the same as Example 13, except that the dietary nutrition intervention composition for improving diabetes includes the following components by weight: 60 parts of Codonopsis pilosula polysaccharide, 16.5 parts of astragaloside A, 5.5 parts of bitter melon polypeptide, 13 parts of mango extract, 7 parts of galactomannan, and 25 parts of auxiliary carrier.

[0297] In step (S01), the volume of water added is 7 times the volume of the solid mixture; the dissolution temperature in step (S01) is 43℃; the dissolution time in step (S01) is 25 min; the mixing time in step (S02) is 12 min; the drying and dehumidification temperature of the auxiliary carrier is 75℃; the auxiliary carrier is added at 1800 rpm in step (S02); the vacuum concentration temperature in step (S03) is 45℃; the vacuum degree of vacuum concentration in step (S03) is -0.085 MPa; the vacuum concentration in step (S03) is reduced to 1 / 3 of the initial volume; the homogenization dispersion in step (S03) is performed 3 times; the homogenization dispersion time for each time is 7 min; the homogenization dispersion in step (S03) is reduced to a particle size of 5 μm to 15 μm. The auxiliary carrier is a mixture of resistant dextrin, fructooligosaccharides, and microcrystalline cellulose in a mass ratio of 1:1:1; the vacuum freeze-drying process involves pre-freezing at -42℃, followed by initial drying at -5℃ and 8Pa vacuum, and then secondary drying at 28℃ and 4Pa vacuum; the pre-freezing time is 3 hours, the initial drying time is 25 hours, and the secondary drying time is 8 hours; the mixing speed in the fluidized bed mixer in step (S04) is 55 rpm; the mixing time in the fluidized bed mixer in step (S04) is 35 minutes; the mixing temperature in the fluidized bed mixer in step (S04) is 25℃; the relative humidity in the fluidized bed mixer in step (S04) is ≤30%; and the packaging in step (S05) uses an aluminum-plastic composite bag.

[0298] Example 16: The preparation of Codonopsis pilosula polysaccharides includes the following steps:

[0299] (A01) Take dried Codonopsis pilosula root, pulverize it, add deionized water and perform hot reflux extraction to obtain the extract; in step (A01), pulverize to 60-80 mesh; the number of hot refluxes in step (A01) is 2; before each hot reflux in step (A01), add 8 times the volume of the remaining material in deionized water; the temperature of hot reflux in step (A01) is 90℃; the time of each hot reflux in step (A01) is 2h;

[0300] (A02) Filter the extract from step (A01) and concentrate the filtrate under reduced pressure to 1 / 5 of the original volume; the filtration in step (A02) is through a 180-mesh filter cloth; the reduced pressure concentration in step (A02) is completed in a reduced pressure concentrator; the reduced pressure concentration temperature in step (A02) is 50°C.

[0301] (A03) Add an appropriate amount of ethanol to the concentrate in step (A02) and allow it to stand for alcohol precipitation; the ethanol added in step (A03) is 95% ethanol; the amount of ethanol added in step (A03) is 3 times the volume of the concentrate; the alcohol precipitation in step (A03) is completed in a refrigerator; the alcohol precipitation temperature in step (A03) is 2℃; the alcohol precipitation time in step (A03) is 10h;

[0302] (A04) Centrifuge the precipitate from step (A03) and wash it with anhydrous ethanol. Then, vacuum dry it to obtain crude polysaccharide. The centrifugation speed in step (A04) is 4500 rpm. The centrifugation time in step (A04) is 15 min. The number of washing cycles in step (A04) is 2.

[0303] (A05) The crude polysaccharide in step (A04) is deproteinized by enzymatic method, and then filtered through an ultrafiltration membrane to obtain dialysate; the enzyme in the enzymatic method in step (A05) is a complex protease, which is composed of trypsin and papain in a 1:1 mass ratio; the deproteinization in step (A05) is performed twice; the molecular weight cutoff of the ultrafiltration membrane in step (A05) is 9 kDa;

[0304] (A06) The dialysis solution from step (A05) was decolorized by macroporous adsorption resin, then concentrated under reduced pressure and freeze-dried to obtain Codonopsis pilosula polysaccharide.

[0305] Example 17: This example is basically the same as Example 16, except that in step (A01), the material is pulverized to 65-75 mesh; the number of reflux cycles in step (A01) is 5; 10 times the volume of deionized water is added before each reflux in step (A01); the temperature of the reflux in step (A01) is 95°C; and the time of each reflux in step (A01) is 1 hour.

[0306] (A02) Filter the extract from step (A01) and concentrate the filtrate under reduced pressure to 1 / 4 of the original volume; the filtration in step (A02) is through a 200-mesh filter cloth; the reduced pressure concentration temperature in step (A02) is 60°C.

[0307] In step (A03), the amount of ethanol added is 4 times the volume of the concentrated liquid; the alcohol precipitation temperature in step (A03) is 4℃; and the alcohol precipitation time in step (A03) is 12h.

[0308] The centrifugation speed in step (A04) is 5000 rpm; the centrifugation time in step (A04) is 10 min; the number of washes in step (A04) is 4;

[0309] The deproteinization process in step (A05) is repeated 3 times; the molecular weight cutoff of the ultrafiltration membrane in step (A05) is 10 kDa.

[0310] Example 18: This example is basically the same as Example 16, except that the number of refluxes in step (A01) is 3; before each reflux in step (A01), 9 times the volume of the remaining material is added as deionized water; the temperature of the reflux in step (A01) is 92°C; and the time of each reflux in step (A01) is 1.5 hours.

[0311] Filtered through a 190-mesh filter cloth; the vacuum concentration temperature in step (A02) is 55°C;

[0312] The alcohol precipitation temperature in step (A03) is 3°C; the alcohol precipitation time in step (A03) is 11 hours.

[0313] The centrifugation speed in step (A04) is 4800 rpm; the centrifugation time in step (A04) is 12 min; the number of washes in step (A04) is 3;

[0314] Step (A05) The molecular weight cutoff of the ultrafiltration membrane is 9.5 kDa.

[0315] Example 19: The preparation of astragaloside A includes the following steps:

[0316] (B01) Take dried Astragalus root, pulverize it, and add an appropriate amount of ethanol for hot reflux extraction; in step (B01), pulverize to 50-60 mesh; the ethanol in step (B01) is 70% ethanol; the material-to-liquid ratio of Astragalus root powder to ethanol in step (B01) is 1:8; the hot reflux extraction temperature in step (B01) is 70℃; the hot reflux extraction time in step (B01) is 2h; the hot reflux extraction is performed twice in step (B01).

[0317] (B02) The extract from step (B01) is concentrated under reduced pressure to obtain a concentrated solution without alcohol odor, and then diluted with distilled water. After fractional elution with a macroporous adsorption resin column, impurities are removed, and the last eluted fraction is collected. In step (B02), the concentrated solution is diluted with distilled water until the ethanol volume fraction is <10%. The macroporous adsorption resin column in step (B02) is a D101 macroporous adsorption resin column. The fractional elution in step (B02) is to elute with distilled water, 40% ethanol and 80% ethanol in sequence, and the 80% ethanol eluent is collected.

[0318] (B03) The eluted fraction from step (B02) is concentrated under reduced pressure and purified by silica gel column chromatography. The astragaloside A peak region is then collected. The silica gel column chromatography purification process involves using silica gel as the stationary phase and a mixture of chloroform, methanol, and water as the eluent. High-performance liquid chromatography (HPLC) is used for online or offline monitoring. The main peak fraction corresponding to the chromatographic retention time of astragaloside A is collected to extract the astragaloside A peak region. The silica gel is 100-mesh granular silica gel. The volume ratio of chloroform, methanol, and water in the eluent is 60:30:10.

[0319] (B04) After concentrating the collected solution from step (B03) under reduced pressure and freeze-drying it, astragaloside A is obtained.

[0320] Example 20: This example is basically the same as Example 19, except that in step (B01), the powder is pulverized to 52-58 mesh; the ratio of Astragalus root powder to ethanol in step (B01) is 1:10; the hot reflux extraction temperature in step (B01) is 80℃; the hot reflux extraction time in step (B01) is 2 hours; the number of hot reflux extractions in step (B01) is 4; the silica gel is 200-mesh granular silica gel; and the volume ratio of chloroform, methanol, and water in the eluent is 65:35:10.

[0321] Example 21: This example is basically the same as Example 19, except that the ratio of Astragalus root powder to ethanol in step (B01) is 1:9; the hot reflux extraction temperature in step (B01) is 75℃; the hot reflux extraction time in step (B01) is 1.5h; the number of hot reflux extractions in step (B01) is 3; the silica gel is 150-mesh granular silica gel; and the volume ratio of chloroform, methanol and water in the eluent is 62:32:10.

[0322] Example 22: The preparation of bitter melon polypeptide includes the following steps:

[0323] (C01) Take fresh bitter melon pulp, remove the seeds and chop it, add an appropriate amount of deionized water and then bathe it in a water bath; the ratio of chopped material to deionized water in step (C01) is 1:4; the water bath temperature in step (C01) is 90℃; the water bath time in step (C01) is 10min.

[0324] (CO2) Add an appropriate amount of complex protease to the solution after water bath in step (CO1), adjust the pH to 7.5, and then perform enzymatic hydrolysis; the enzymatic hydrolysis temperature in step (CO2) is 50℃; the enzymatic hydrolysis time in step (CO2) is 4h; the complex protease in step (CO2) is formed by the combination of alkaline protease and trypsin, and the mass ratio of alkaline protease to trypsin in the complex protease is 1.5:1; the amount of complex protease added in step (CO2) is 2% of the mass of the chopped material;

[0325] (CO3) After the enzymatic hydrolysis in step (CO2) is completed, the enzyme is inactivated, then cooled and centrifuged to collect the supernatant; the enzyme inactivation temperature in step (CO3) is 90℃; the enzyme inactivation time in step (CO3) is 10 min; the centrifugation speed in step (CO3) is 7000 rpm; the centrifugation time in step (CO3) is 10 min.

[0326] (C04) After filtering the supernatant from step (C03) through an ultrafiltration membrane, the dialysis solution is taken, decolorized by macroporous adsorption resin, and freeze-dried to obtain bitter melon polypeptide; the molecular weight cutoff of the ultrafiltration membrane in step (C04) is 2 kDa.

[0327] Example 23: This example is basically the same as Example 22, except that the ratio of shredded material to deionized water in step (C01) is 1:5; the water bath temperature in step (C01) is 95°C; and the water bath time in step (C01) is 8 minutes.

[0328] (CO2) Add an appropriate amount of complex protease to the solution after water bath in step (CO1), adjust the pH to 8.0, and then perform enzymatic hydrolysis; the enzymatic hydrolysis temperature in step (CO2) is 55℃; the enzymatic hydrolysis time in step (CO2) is 3h; the mass ratio of alkaline protease to trypsin in the complex protease is 2:1; the amount of complex protease added in step (CO2) is 2.5% of the mass of the chopped material;

[0329] The enzyme inactivation temperature in step (CO3) is 95℃; the enzyme inactivation time in step (CO3) is 8 min; the centrifugation speed in step (CO3) is 8000 rpm; the centrifugation time in step (CO3) is 8 min.

[0330] In step (C04), the molecular weight cutoff of the ultrafiltration membrane is 3 kDa.

[0331] Example 24: This example is basically the same as Example 22, except that the water bath temperature in step (CO1) is 92℃; the water bath time in step (CO1) is 9 min; the pH is adjusted to 7.8 before enzymatic hydrolysis in step (CO2); the enzymatic hydrolysis temperature in step (CO2) is 53℃; the enzymatic hydrolysis time in step (CO2) is 3.5 h; the mass ratio of alkaline protease to trypsin in the complex protease is 1.7:1; the amount of complex protease added in step (CO2) is 2.2% of the mass of the chopped material; the enzyme inactivation temperature in step (CO3) is 92℃; the enzyme inactivation time in step (CO3) is 9 min; the centrifugation speed in step (CO3) is 7500 rpm; the centrifugation time in step (CO3) is 9 min; and the molecular weight cutoff of the ultrafiltration membrane in step (CO4) is 2.5 kDa.

[0332] Example 25: The preparation of mango extract includes the following steps:

[0333] (D01) Take ripe mangoes, wash, pit, dry, and crush them in sequence, then add an appropriate amount of ethanol for ultrasonic-assisted extraction to obtain an extract; in step (D01), dry to a moisture content of 8%; the ethanol in step (D01) is a 70% ethanol solution; the ratio of crushed material to ethanol in step (D01) is 1:8; the number of ultrasonic-assisted extractions in step (D01) is 2; the ultrasonic power in step (D01) is 250W; the ultrasonic temperature in step (D01) is 40℃; the ultrasonic time in step (D01) is 30min.

[0334] (D02) The extract from step (D01) is concentrated under reduced pressure to obtain a concentrate, then diluted with water and filtered through a membrane; in step (D02), water is added to dilute to an ethanol volume fraction of <10%; in step (D02), the extract is filtered through a 0.4 μm membrane.

[0335] (D03) The filtrate from step (D02) is subjected to fractional elution on a polyamide adsorption column, and the last elution fraction is collected; the fractional elution in step (D03) is performed by sequentially passing the filtrate through distilled water, 40% ethanol and 70% ethanol, and the 70% ethanol elution fraction is collected.

[0336] (D04) The eluted fraction collected in step (D03) was subjected to rotary evaporation to remove alcohol and spray drying to obtain mango extract.

[0337] Example 26: This example is basically the same as Example 25, except that in step (D01), the material is dried to a moisture content of 10%; in step (D01), the ratio of the pulverized material to ethanol is 1:10; in step (D01), the ultrasonic-assisted extraction is performed 3 times; in step (D01), the ultrasonic power is 300W; in step (D01), the ultrasonic temperature is 50℃; in step (D01), the ultrasonic time is 20min; and in step (D02), the material is filtered through a 0.5μm filter membrane.

[0338] Example 27: This example is basically the same as Example 25, except that in step (D01), the moisture content is dried to 9%; in step (D01), the ratio of pulverized material to ethanol is 1:9; in step (D01), the ultrasonic power is 280W; in step (D01), the ultrasonic temperature is 45℃; in step (D01), the ultrasonic time is 25min; and in step (D02), the sample is filtered through a 0.45μm filter membrane.

[0339] Example 28: The preparation of galactomannan includes the following steps:

[0340] (E01) Take coffee bean endosperm or guar bean powder, add an appropriate amount of deionized water and stir to mix. After adjusting the pH to 8.5, continue stirring and extraction. The volume of deionized water added in step (E01) is 8 times the volume of the solid. In step (E01), 0.5 mol / L NaOH solution is used to adjust the pH. The stirring temperature in step (E01) is 60℃. The stirring time in step (E01) is 2 hours.

[0341] (E02) Centrifuge the extract from step (E01) to obtain the supernatant, then adjust the pH to 4.0 and let it stand to allow polysaccharide precipitation; the centrifugation speed in step (E02) is 5000 rpm; the centrifugation time in step (E02) is 10 min; the pH is adjusted using 3 mol / L HCl in step (E02); the standing time in step (E02) is 3 h;

[0342] (E03) The polysaccharide precipitate from step (E02) is separated, washed with anhydrous ethanol, and then vacuum dried to obtain crude polysaccharide; the washing is performed twice in step (E03);

[0343] (E04) Dissolve the crude polysaccharide from step (E03) in warm water, and add mannosidase and galactosidase enzyme solutions to react; the amount of mannosidase added in step (E04) is 1% of the mass of crude polysaccharide, and the amount of galactosidase added is 0.5% of the mass of crude polysaccharide; the reaction temperature in step (E04) is 40℃; the reaction time in step (E04) is 3h.

[0344] (E05) The substance after the reaction in step (E04) is ultrafiltered through a dialysis bag, and the filtrate is freeze-dried to obtain galactomannan; the molecular weight cutoff of the dialysis bag in step (E05) is 6 kDa.

[0345] Example 29: This example is basically the same as Example 28, except that (E01) coffee bean endosperm or guar bean powder is taken, an appropriate amount of deionized water is added and stirred, the pH is adjusted to 9.0, and stirring extraction is continued; the volume of deionized water added in step (E01) is 10 times the volume of the solid matter; the stirring temperature in step (E01) is 70°C; and the stirring time in step (E01) is 1 hour.

[0346] (E02) Centrifuge the extract from step (E01) to obtain the supernatant, then adjust the pH to 4.5 and let it stand to allow polysaccharide precipitation; the centrifugation speed in step (E02) is 6000 rpm; the centrifugation time in step (E02) is 8 min; the standing time in step (E02) is 4 h.

[0347] (E03) The polysaccharide precipitate from step (E02) is separated, washed with anhydrous ethanol, and then vacuum dried to obtain crude polysaccharide; the washing is performed 3 times in step (E03);

[0348] In step (E04), the amount of mannosidase added is 3% of the mass of crude polysaccharide, and the amount of galactosidase added is 2% of the mass of crude polysaccharide; the reaction temperature in step (E04) is 50℃; and the reaction time in step (E04) is 2h.

[0349] In step (E05), the molecular weight cutoff of the dialysis bag is 8 kDa.

[0350] Example 30: This example is basically the same as Example 28, except that the volume of deionized water added in step (E01) is 9 times the volume of the solid; the stirring temperature in step (E01) is 65°C; and the stirring time in step (E01) is 1.5 hours.

[0351] The centrifugation speed in step (E02) is 5500 rpm; the centrifugation time in step (E02) is 9 min; the settling time in step (E02) is 3.5 h.

[0352] In step (E04), the amount of mannosidase added is 2% of the mass of crude polysaccharide, and the amount of galactosidase added is 1.5% of the mass of crude polysaccharide; the reaction temperature in step (E04) is 45℃; the reaction time in step (E04) is 2.5h; and the molecular weight cutoff of the dialysis bag in step (E05) is 7kDa.

[0353] Example 31: Application of the dietary nutrition intervention composition for improving diabetes in daily dietary formula food for diabetic patients. The dietary nutrition intervention composition is mixed with staple food ingredients at a mass ratio of 1:15 to make food that can be consumed by diabetic patients. The staple food ingredient is oat flour. The food is a compound nutritional powder. When the compound nutritional powder is made, it is directly packaged after dry mixing.

[0354] Example 32: This example is basically the same as Example 31, except that the dietary nutrition intervention composition is mixed with staple food ingredients at a mass ratio of 1:30 to make food that can be consumed by diabetic patients; the staple food ingredient is brown rice flour; the food is nutritional biscuits; when making nutritional biscuits, water is first added to the compound nutritional powder and stirred, placed in a biscuit mold, the baking oven temperature is set to 150℃, the core temperature is controlled to ≤92℃, and baked for 18 minutes.

[0355] Example 33: This example is basically the same as Example 32, except that the dietary nutrition intervention composition is mixed with staple food ingredients at a mass ratio of 1:20 to make food that can be consumed by diabetic patients; the baking oven temperature is set to 165℃ and baked for 12 minutes.

[0356] Example 34: This example is basically the same as Example 32, except that the dietary nutrition intervention composition is mixed with staple food ingredients at a mass ratio of 1:25 to make food that can be consumed by diabetic patients; the baking oven temperature is set to 160℃ and baked for 15 minutes.

[0357] Example 35: This example is basically the same as Example 31, except that the dietary nutrition intervention composition is mixed with staple food ingredients at a mass ratio of 1:25 to make a food that can be consumed by diabetic patients; the staple food ingredient is whole wheat flour; the food is a meal replacement porridge; when making the meal replacement porridge, it is directly packaged after being mixed by a low-temperature wet method.

[0358] Example 36: Application of a dietary nutrition intervention composition for improving diabetes in functional meal replacement products for people with diabetes or prediabetes. After adding appropriate amounts of skim milk powder, isomaltooligosaccharide and plant protein powder to the dietary nutrition intervention composition, the mixture is directly mixed evenly through a dry mixing process to form a finished meal replacement powder.

[0359] The finished meal replacement powder contains, by weight, 5 parts skim milk powder, 2 parts isomaltooligosaccharide and 10 parts plant protein powder, including 1 part of dietary nutrition intervention composition.

[0360] Example 37: This example is basically the same as Example 36, except that, by weight, 10 parts of skim milk powder, 5 parts of isomaltooligosaccharide and 20 parts of plant protein powder are added, including 3 parts of dietary nutrition intervention composition.

[0361] Example 38: This example is basically the same as Example 36, except that, by weight, 6 parts skim milk powder, 3 parts isomaltooligosaccharide and 12 parts plant protein powder are added, of which 1.2 parts are dietary nutrition intervention composition.

[0362] Example 39: Application of a dietary nutrition intervention composition for improving diabetes in functional meal replacement products for people with diabetes or prediabetes. The dietary nutrition intervention composition is dissolved in deionized water, and then an appropriate amount of skim milk powder, isomaltooligosaccharide and plant protein powder are added. After high-shear homogenization, sterilization and filling are carried out to directly produce a liquid meal replacement product. The ratio of dietary nutrition intervention composition to deionized water is 1.0g / 100mL.

[0363] The liquid meal replacement product, by weight, contains 9 parts skim milk powder, 4 parts isomaltooligosaccharide, and 18 parts plant protein powder, of which 2.8 parts are dietary nutrition intervention composition.

[0364] Example 40: This example is basically the same as Example 39, except that the ratio of the dietary nutrition intervention composition to deionized water is 2.5g / 100mL.

[0365] The liquid meal replacement product, by weight, contains 7 parts skim milk powder, 3 parts isomaltooligosaccharide, and 14 parts plant protein powder, including 1.5 parts of dietary nutrition intervention composition.

[0366] Example 41: This example is basically the same as Example 39, except that the ratio of the dietary nutrition intervention composition to deionized water is 1.5g / 100mL.

[0367] The liquid meal replacement product, by weight, contains 8 parts skim milk powder, 3.5 parts isomaltooligosaccharide, and 15 parts plant protein powder, including 2 parts of dietary nutrition intervention composition.

[0368] Simultaneously, a control group (low-fat group) and a model group (high-fat group) were established. The control group was fed a standardized low-fat diet D12450J with a fat energy content of approximately 10%, while the model group was fed a standardized high-fat diet D12492 with a fat energy content of approximately 60%. The effects of this composition on regulating blood sugar, improving insulin sensitivity, regulating blood lipid metabolism, and repairing intestinal microecological homeostasis were verified through animal models and in vitro microecological fermentation. The comprehensive efficacy of the formula was verified from multiple levels of metabolism, inflammation, and microecology.

[0369] Animal experiments were conducted using male C57BL / 6J mice, weighing 20-22 g, randomly divided into a control group, a model group, and four representative examples (Example 3, Example 6, Example 9, and Example 12), with 10 mice in each group. The experiment lasted for 8 weeks. During the experiment, mice had free access to water and were kept at a constant temperature of 20-22°C and a constant humidity of 60%, with a 12-hour light cycle. The control group was fed a standardized low-fat diet (D12450J) to provide a normal metabolic baseline; the model group was fed a standardized high-fat diet (D12492) to induce insulin resistance and glucose metabolism disorders, thus establishing a diabetes model. The example groups were all based on the high-fat diet (D12492), and were supplemented with different formulations of dietary nutrient intervention solutions administered by gavage for 8 weeks.

[0370] During the administration process, the dosages for Examples 3, 6, 9, and 12 are as follows:

[0371] Example 3: Each mouse was given 200 μL of the mixed drug by gavage daily, with the effective components of Codonopsis pilosula polysaccharide and astragaloside A at concentrations of 600 mg / kg / d and 120 mg / kg / d, respectively.

[0372] Example 6: Each mouse was administered 200 μL of the mixed drug via gavage daily, with the effective component concentrations of Codonopsis pilosula polysaccharide, astragaloside A, and bitter melon polypeptide being 600 mg / kg / d, 120 mg / kg / d, and 11.2 mg / kg / d, respectively.

[0373] Example 9: Each mouse was administered 200 μL of the mixed drug via gavage daily, wherein the effective ingredient concentrations of Codonopsis pilosula polysaccharide, astragaloside A, and mango extract were 600 mg / kg / d, 120 mg / kg / d, and 50 mg / kg / d, respectively.

[0374] Example 12: Each mouse was given 200 μL of the mixed drug by gavage daily, wherein the effective ingredient concentrations of Codonopsis pilosula polysaccharide, astragaloside A and galactomannan were 600 mg / kg / d, 120 mg / kg / d and 20 mg / kg / d, respectively.

[0375] All gavage solutions were prepared using deionized water as the solvent and stored at 4°C protected from light. Fresh solutions were prepared daily to ensure activity and stability.

[0376] The experimental tests included multiple dimensions: First, fasting blood glucose (FBG) levels were measured using tail vein blood collection and glucose oxidase method; lipid metabolism indicators, including triglycerides (TG), low-density lipoprotein (LDL-C) and high-density lipoprotein (HDL-C), were detected using a fully automated biochemical analyzer; and inflammatory status was assessed by changes in serum interleukin-1β (IL-1β) concentration using ELISA method.

[0377] At the end of week 8 of the experiment, mice were sacrificed and cecal contents were collected for intestinal microbiota structure analysis. 16S rRNA high-throughput sequencing was used to calculate the α-diversity (Shannon index) and compare the changes in the ratio of Firmicutes to Bacteroidetes. All experimental data are expressed as mean ± standard deviation. Statistical analysis was performed using one-way ANOVA for significance comparison (p < 0.05 was considered statistically significant). The experimental results are shown in Table 1, where units are: fasting blood glucose (mmol / L), TG / TC / LDL-C / HDL-C (mmol / L), IL-1β (pg / mL), and intestinal α-diversity (dimensionless).

[0378]

[0379] Note: * in each row indicates a significant difference compared to the control group (p<0.05); # indicates a significant difference compared to the model group (p<0.05).

[0380] Blood glucose lowering effect: Examples 3 and 6 significantly reduced fasting blood glucose compared to the model group, while Examples 9 and 12 had no significant blood glucose lowering effect. The blood glucose lowering effect of Example 6 was significant, indicating that the multiple group ratios of bitter melon polypeptide, Codonopsis pilosula polysaccharide, and astragaloside A have a stronger synergistic effect in improving blood glucose lowering effect, and the effect is better than that of mango extract and / or galactomannan in improving blood glucose lowering effect.

[0381] Improving lipid metabolism: Compared with the model group, Examples 6, 9, and 12 all significantly reduced TG levels, and Example 6 showed a better lipid-lowering effect than Examples 9 and 12, indicating that the multiple group allocation ratio has a stronger synergistic effect in improving blood lipid levels. Furthermore, bitter melon polypeptides had a more significant lipid-lowering effect than mango extract and mannan. In addition, compared with the model group, Examples 6 and 12 also significantly increased HDL-C levels, confirming the synergistic effect of bitter melon polypeptides and galactomannan in improving lipid metabolism when combined with Codonopsis pilosula polysaccharide and astragaloside A.

[0382] Inflammatory factor release: IL-1β was significantly lower in Examples 3, 6, 9 and 12 than in the model group, with Example 12 showing the lowest level, indicating that bitter melon polypeptide, mango powder or galactomannan had a synergistic effect with Codonopsis pilosula polysaccharide and astragaloside A in the process of inhibiting the release of inflammatory factors.

[0383] Microecology and metabolic substrates: Compared with the model group, Ace and Chao index (α diversity) were highest in Example 3, showed a decreasing trend in Example 6, and were significantly reduced in Example 12, suggesting that bitter melon peptides or mango extract have an improving effect on intestinal microecology, and that the multiple allocation ratios of Codonopsis pilosula polysaccharide and astragaloside A have a synergistic effect in regulating intestinal microecology.

[0384] Key differences:

[0385] Bitter melon polypeptides: If bitter melon polypeptides are lacking, the improvement effect on fasting blood glucose and triglycerides is significantly limited. As a substrate, it is crucial for improving the body's glucose and lipid metabolism.

[0386] Codonopsis polysaccharides and astragaloside A: The combination of Codonopsis polysaccharides and astragaloside A has advantages in α-diversity, and the multi-component allocation ratio of Codonopsis polysaccharides and astragaloside A is crucial for regulating the intestinal microecology.

[0387] The four embodiments exhibit different regulatory effects in improving glucose and lipid metabolism and overall health. Among them, Embodiment 3 showed the best performance in three-dimensional indicators of blood sugar reduction, lipid control, and anti-inflammation; Embodiment 6 showed regulatory effects in three-dimensional indicators of lipid control, anti-inflammation, and regulation of gut microbiota; Embodiment 9 showed regulatory effects in two-dimensional indicators of lipid control and anti-inflammation. The bitter melon polypeptide, codonopsis polysaccharide, and astragaloside A in the formula showed excellent performance in achieving coordinated improvement in blood sugar reduction, lipid control, metabolism, inflammation, and gut microbiota.

[0388] The dietary intervention composition of this invention can significantly reduce fasting blood glucose, improve blood lipid profile, reduce inflammatory factor levels, and promote the restoration of gut microbiota diversity; bitter melon polypeptides play a key role in improving diabetes-related metabolism and gut microbiota. Therefore, this composition has good effects on metabolic homeostasis regulation and intestinal repair, providing a scientific basis for nutritional intervention in diabetes.

Claims

1. A dietary intervention composition for improving diabetes, characterized by: It includes the following components in parts by weight. Codonopsis polysaccharide 40-80 parts, astragaloside A 8-25 parts, bitter melon polypeptide 1-10 parts, auxiliary carrier 10-40 parts; The method for preparing the dietary nutrition intervention composition for improving diabetes, Includes the following steps, (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel. Add water and stir to dissolve. (S02) Add an appropriate amount of astragaloside A and bitter melon polypeptide to the solution in step (S01) and stir to mix. When the solution is transparent or slightly turbid, add an appropriate amount of auxiliary carrier and continue stirring to obtain a composite solution. The auxiliary carrier is at least one of resistant dextrin, fructooligosaccharide and microcrystalline cellulose. (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion. (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition.

2. A dietary intervention composition for improving diabetes, characterized by: It includes the following components in parts by weight. Codonopsis polysaccharide 40-80 parts, astragaloside A 8-25 parts, mango extract 5-20 parts, auxiliary carrier 10-40 parts; The method for preparing the dietary nutrition intervention composition for improving diabetes, Includes the following steps, (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and put it into the reaction vessel. Add water and stir to dissolve. (S02) Add an appropriate amount of astragaloside A and mango extract to the solution from step (S01) and stir until it becomes transparent or slightly turbid. Then add an appropriate amount of auxiliary carrier and continue stirring to obtain a composite solution. The auxiliary carrier is at least one of resistant dextrin, fructooligosaccharide and microcrystalline cellulose. (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion. (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition.

3. A dietary intervention composition for improving diabetes, characterized by: It includes the following components in parts by weight. Codonopsis polysaccharide 40-80 parts, astragaloside A 8-25 parts, galactomannan 2-12 parts, auxiliary carrier 10-40 parts; The method for preparing the dietary nutrition intervention composition for improving diabetes, Includes the following steps, (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and galactomannan and put them into the reaction vessel, add water and stir to dissolve; (S02) Add an appropriate amount of astragaloside A and an auxiliary carrier to the solution from step (S01) and continue stirring to obtain a composite solution; the auxiliary carrier is at least one of resistant dextrin, fructooligosaccharide and microcrystalline cellulose; (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion. (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition.

4. A dietary intervention composition for improving diabetes, characterized by: It includes the following components in parts by weight. Codonopsis polysaccharide 40-80 parts, astragaloside A 8-25 parts, bitter melon polypeptide 1-10 parts, mango extract 5-20 parts, galactomannan 2-12 parts, auxiliary carrier 10-40 parts; A method for preparing a dietary nutrition intervention composition to improve diabetes, characterized by comprising the following steps: (S01) Take an appropriate amount of Codonopsis pilosula polysaccharide and galactomannan and put them into the reaction vessel, add water and stir to dissolve; (S02) Add appropriate amounts of astragaloside A, bitter melon polypeptide and mango extract to the solution in step (S01) and stir to mix. When the mixture is transparent or slightly turbid, add appropriate amounts of auxiliary carrier and continue stirring to obtain a composite solution. The auxiliary carrier is at least one of resistant dextrin, fructooligosaccharide and microcrystalline cellulose. (S03) The composite liquid in step (S02) is vacuum concentrated and homogenized to obtain a dispersion. (S04) The dispersion from step (S03) is subjected to vacuum freeze-drying, and then the freeze-dried powder is mixed in a fluidized bed mixer to obtain the finished dietary nutrition intervention composition.

5. The dietary intervention composition for improving diabetes according to claim 1, 2, 3 or 4, characterized in that: The preparation of the Codonopsis pilosula polysaccharide includes the following steps: (A01) Take dried Codonopsis pilosula root, crush it, add deionized water and perform hot reflux extraction to obtain the extract; (A02) Filter the extract from step (A01) and concentrate the filtrate under reduced pressure to 1 / 5 to 1 / 4 of the original volume. (A03) Add an appropriate amount of ethanol to the concentrate in step (A02) and let it stand for alcohol precipitation; (A04) Centrifuge the precipitate obtained by standing in step (A03), wash it with anhydrous ethanol and then vacuum dry it to obtain crude polysaccharide. (A05) The crude polysaccharide in step (A04) is deproteinized by enzymatic method, and then filtered through an ultrafiltration membrane to obtain dialysate; (A06) The dialysis solution from step (A05) was decolorized by macroporous adsorption resin, then concentrated under reduced pressure and freeze-dried to obtain Codonopsis pilosula polysaccharide.

6. The dietary intervention composition for improving diabetes according to claim 1, 2, 3 or 4, characterized in that: The preparation of the astragaloside A includes the following steps: (B01) Take dried Astragalus root, pulverize it, and add an appropriate amount of ethanol for hot reflux extraction; (B02) The extract from step (B01) is concentrated under reduced pressure to obtain a concentrated solution without alcohol odor, and then diluted with distilled water. After fractionation and elution to remove impurities by macroporous adsorption resin column, the last eluted fraction is collected. (B03) The elution fraction from step (B02) was successively concentrated under reduced pressure and purified by silica gel column chromatography, and a portion of the solution from the astragaloside A peak region was collected. (B04) After concentrating the collected solution from step (B03) under reduced pressure and freeze-drying it, astragaloside A is obtained.

7. The dietary intervention composition for improving diabetes according to claim 1 or 4, characterized in that: The preparation of the bitter melon polypeptide includes the following steps: (C01) Take fresh bitter melon pulp, remove the seeds, chop it, add an appropriate amount of deionized water, and then bathe it in water. (C02) Add an appropriate amount of complex protease to the solution after water bath in step (C01), adjust the pH to 7.5-8.0, and then enzymatically hydrolyze; (C03) After the enzymatic hydrolysis in step (C02) is completed, the enzyme is inactivated, then cooled and centrifuged to collect the supernatant; (C04) After filtering the supernatant from step (C03) through an ultrafiltration membrane, the dialysis solution is taken, decolorized by macroporous adsorption resin, and freeze-dried to obtain bitter melon polypeptide.

8. The dietary intervention composition for improving diabetes according to claim 2 or 4, characterized in that: The preparation of the mango extract includes the following steps: (D01) Take a ripe mango, wash it, remove the pit, dry it and crush it in sequence, then add an appropriate amount of ethanol for ultrasonic-assisted extraction to obtain the extract; (D02) The extract from step (D01) is concentrated under reduced pressure to obtain a concentrated solution, which is then diluted with water and filtered through a membrane. (D03) The filtrate from step (D02) is subjected to fractionation and elution on a polyamide adsorption column, and the last eluted fraction is collected. (D04) The eluted fraction collected in step (D03) was subjected to rotary evaporation to remove alcohol and spray drying to obtain mango extract.

9. The application of the dietary nutritional intervention composition for improving diabetes according to any one of claims 1 to 4 in the daily dietary formula food for diabetic patients, wherein the dietary nutritional intervention composition is mixed with staple food ingredients at a mass ratio of 1:15 to 30 to prepare a food that can be consumed by diabetic patients; wherein the staple food ingredients include oat flour, brown rice flour and whole wheat flour.

10. The application of the dietary nutrition intervention composition for improving diabetes according to any one of claims 1 to 4 in functional meal replacement products for people with diabetes or prediabetes, wherein an appropriate amount of skim milk powder, isomaltooligosaccharide and plant protein powder are added to the dietary nutrition intervention composition, and then the mixture is directly mixed evenly by a dry mixing process to form a finished meal replacement powder; or the dietary nutrition intervention composition is dissolved in deionized water, and then an appropriate amount of skim milk powder, isomaltooligosaccharide and plant protein powder are added, and then the mixture is sterilized and filled after high shear homogenization to directly produce a finished liquid meal replacement.

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