A method of preparing a ginseng composition for regulating intestinal health

CN122998266APending Publication Date: 2026-10-30CHANGCHUN UNIV OF CHINESE MEDICINE
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Patent Information

Application Number
CN202611523209.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-09-29
Publication Date
2026-10-30

AI Technical Summary

Technical Problem

[0005]针对现有技术中人参皂苷稳定性差、生物利用度低,以及单一组分难以满足低免疫力人群肠道免疫协同调节需求的问题,本发明提供了一种调节肠道健康的人参组合物的制备方法

Benefits of technology

[0026]本发明所提供的调节肠道健康的人参组合物的制备方法,通过超声辅助处理使茯苓多糖分子链伸展,利用疏水相互作用与人参皂苷形成自组装复合物,有效解决了人参提取物中的皂苷水溶性差、在胃肠道环境中易降解失活的难题,显著提高了其生物利用度。同时,本发明创新性地引入莲子提取物中的原花青素,与山药提取物中的黏液质及壳聚糖形成致密的互穿网络结构,利用天然多酚的氢键与疏水作用增强了凝胶强度,避免了戊二醛等传统有毒交联剂的使用,仅使用食品级三聚磷酸钠进行离子交联,显著提升了产品在胃酸环境中的稳定性及肠道滞留时间,并赋予组合物优异的抗氧化活性。

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Abstract

This invention discloses a method for preparing a ginseng composition for regulating intestinal health, belonging to the technical field of ginseng composition. The method uses ginseng extract, Poria cocos polysaccharide, yam extract, lotus seed extract, chitosan, a freeze-drying protectant, and sodium tripolyphosphate as raw materials. Through ultrasound-assisted self-assembly technology, the ginseng extract and Poria cocos polysaccharide form a hydrophobic complex. Then, the mucilage in the yam extract and the proanthocyanidins in the lotus seed extract are used to construct a hydrogen-bonded hydrophobic synergistic network with chitosan. This network is then cross-linked with sodium tripolyphosphate ions to form a nanoparticle suspension. Finally, the suspension is mixed with the freeze-drying protectant, pre-frozen, and then freeze-dried under vacuum to obtain the ginseng composition. This invention solves the problems of poor stability and low bioavailability of ginseng extract, achieving synergistic effects of multiple food-medicine homologous components, and can regulate the intestinal flora and enhance the immune barrier in people with low immunity.
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Description

Technical Field

[0001] This invention belongs to the field of ginseng composition technology, and relates to a method for preparing a ginseng composition for regulating intestinal health. Background Technology

[0002] The integrity of the gut microbiota and intestinal barrier is closely related to the body's immunity. Ginseng, as a "superior tonic for qi," has core active ingredients, ginsenosides, which have been proven to have significant immunomodulatory effects. However, ginsenosides (especially proto-ginsenosides such as Rb1 and Rg1) have problems such as large molecular weight, poor water solubility, and easy degradation and inactivation under the acidic environment of the gastrointestinal tract and the action of digestive enzymes. This results in extremely low oral bioavailability, making it difficult to achieve effective concentrations at the target site, thus limiting their efficacy in functional foods.

[0003] In existing technologies, ginseng extract is often prepared by simple physical mixing with medicinal and edible raw materials such as Poria cocos and Dioscorea opposita. This method has the following main defects: (1) Poor stability and absorption: There is a lack of effective protection for ginsenosides, the release of each component in the gastrointestinal tract is asynchronous, ginsenosides are not effectively converted into easily absorbed active aglycones, and the bioavailability is low. (2) Lack of synergistic mechanism: The components are only a simple superposition of functions, lacking molecular-level interaction and synergistic effect design, and cannot achieve a virtuous cycle of "carrier promotes absorption and drug improves environment". (3) Safety risks: In order to improve stability, some existing technologies use chemical cross-linking agents such as glutaraldehyde or organic solvents for modification, which introduces additional safety risks.

[0004] Therefore, there is an urgent need to develop a ginseng composition that can significantly improve the bioavailability of ginsenosides and achieve synergistic regulation of immunity and gut microbiota. Summary of the Invention

[0005] To address the problems of poor stability and low bioavailability of ginsenosides in existing technologies, and the inability of single components to meet the needs of synergistic regulation of intestinal immunity in people with low immunity, this invention provides a method for preparing a ginseng composition for regulating intestinal health. This method combines ginsenosides with Poria cocos polysaccharides using ultrasound-assisted self-assembly technology, and utilizes an interpenetrating network constructed from mucilage in yam extract, proanthocyanidins in lotus seed extract, and chitosan for encapsulation. This significantly improves the gastrointestinal stability of the active ingredients, achieving the dual effects of immune regulation and intestinal flora improvement.

[0006] To achieve the above and other objectives, the technical solution adopted by the present invention is as follows:

[0007] This invention provides a ginseng composition for regulating intestinal health, the composition comprising the following parts by weight: 5-14 parts ginseng extract, 16-25 parts Poria cocos polysaccharide, 5-15 parts Dioscorea opposita extract, 3-10 parts lotus seed extract, 15-30 parts chitosan, 10-25 parts freeze-drying protectant, and 2.5-4.5 parts sodium tripolyphosphate.

[0008] Furthermore, the preparation method of the ginseng extract is as follows:

[0009] a. Take dried ginseng, crush it through a 40-80 mesh sieve, add 6-10 times the volume of 70% ethanol aqueous solution, heat and reflux to extract 2-3 times, each time for 1.5-2.5 hours, combine the extracts, filter, concentrate the filtrate under reduced pressure until there is no alcohol taste, and obtain crude extract;

[0010] b. Load the crude extract onto a D101 macroporous adsorption resin column and elute sequentially with deionized water, 30% ethanol aqueous solution, 60% ethanol aqueous solution, and 80% ethanol aqueous solution. Collect the elution fractions of 60% and 80% ethanol aqueous solutions, concentrate under reduced pressure, and freeze-dry to obtain the ginseng extract.

[0011] Furthermore, the total saponin content in the ginseng extract is ≥50%, wherein the total mass of ginsenosides Rg1, Rb1, and Re accounts for more than 30% of the mass of the ginseng extract (based on dried product).

[0012] Furthermore, the preparation method of the Poria cocos polysaccharide is as follows:

[0013] (1) Take Poria cocos powder, add 20-30 times the weight of deionized water, heat and extract at 90-95℃ for 2-3 hours, filter, collect the filtrate, concentrate the filtrate under reduced pressure to 1 / 5-1 / 3 of the original volume, add anhydrous ethanol to make the ethanol volume fraction in the solution reach 70%-80%, let stand overnight, and centrifuge to collect the precipitate.

[0014] (2) The precipitate was redissolved in deionized water and ultrafiltered first with an ultrafiltration membrane with a molecular weight cutoff of 20 kDa. The permeate was collected and then ultrafiltered with an ultrafiltration membrane with a molecular weight cutoff of 5 kDa. The retentate was collected and concentrated under reduced pressure and freeze-dried to obtain Poria cocos polysaccharide with a weight average molecular weight of 5-20 kDa.

[0015] Furthermore, the lotus seed extract is a lotus seed peel extract, which is prepared by: drying and pulverizing lotus seed peel, adding 10-15 times the weight of lotus seed peel in an ethanol aqueous solution with a volume fraction of 60%-70%, heating and refluxing to extract 2-3 times, each time for 1-2 hours, combining the extracts, filtering, concentrating the filtrate under reduced pressure, and freeze-drying to obtain the lotus seed extract.

[0016] Furthermore, the degree of deacetylation of the chitosan is not less than 90%, and the weight-average molecular weight is 20-100 kDa; the yam extract is a food-grade yam extract, wherein the polysaccharide content is 40%.

[0017] Furthermore, the freeze-drying protectant is a mixture of trehalose and mannitol in a mass ratio of 2:1.

[0018] This invention also provides a method for preparing the above-mentioned ginseng composition for regulating intestinal health, the specific steps of which are as follows:

[0019] S1: Dissolve Poria cocos polysaccharide in deionized water to prepare a Poria cocos polysaccharide aqueous solution with a mass fraction of 0.5%-1.0%. Sonicate the solution in a water bath at 30-40℃ with a power of 200-400 W for 10-20 minutes to induce conformational relaxation and stretching, exposing more hydrophobic binding sites and intermolecular interaction sites. Set aside for later use. Dissolve ginseng extract in 2-3 times its weight of anhydrous ethanol and sonicate for 5-10 minutes until the solution is clear to obtain a ginseng extract ethanol solution.

[0020] S2: Under constant temperature of 30-40℃ and ultrasonic assistance of 200-400 W, the ethanol solution of ginseng extract is slowly added dropwise to the aqueous solution of poria cocos polysaccharide obtained in S1 at a mass ratio of total saponins in ginseng extract to poria cocos polysaccharide of 1:3-6. The dropping rate is 0.5-1 mL / min. After the addition is completed, ultrasonic stirring is continued for 1-2 hours to obtain a complex solution. During this process, the amphiphilic molecules of ginseng saponins bind to the molecular chains of poria cocos polysaccharide through hydrophobic interactions and hydrogen bonds to form a complex. Then, the ethanol in the obtained complex solution is removed by vacuum distillation, and deionized water is added to make up the same volume as the aqueous solution of poria cocos polysaccharide in S1 to obtain the complex aqueous solution.

[0021] S3: Dissolve chitosan in a 1% (v / v) aqueous acetic acid solution to prepare a 0.8%-1.5% (w / v) chitosan-acetic acid aqueous solution. Adjust the pH to 4.5-5.0 with sodium acetate buffer solution. Prepare a 3%-6% (w / v) aqueous yam extract solution with deionized water. Prepare a 2%-4% (w / v) aqueous lotus seed extract solution with deionized water. Prepare a 0.5%-1.5% (w / v) sodium tripolyphosphate solution with deionized water. Adjust the pH to 4.5-5.0 with acetic acid solution.

[0022] S4: At 20-25℃, mix the aqueous solutions of yam extract and lotus seed extract at a volume ratio of 1:0.5-1 and stir for 10-20 minutes to obtain a mixed solution. The mucilage in the yam extract and the proanthocyanidins in the lotus seed extract form a pre-complex through hydrogen bonding and hydrophobic interaction. Then, mix the above mixed solution with the chitosan acetate aqueous solution at a volume ratio of 1:2-4 and stir for 20-30 minutes. The protein-polysaccharide complex in the yam mucilage undergoes intermolecular cross-linking with the chitosan molecular chain through hydrogen bonding. The catechol / pyrogallol structure of the lotus seed proanthocyanidins forms a hydrogen bond-hydrophobic synergistic network with the amino and hydroxyl groups of chitosan to obtain a composite solution.

[0023] S5: At 20-25℃, the aqueous solution of the complex obtained in S2 is mixed with the composite solution obtained in S4. Then, sodium tripolyphosphate aqueous solution is slowly added dropwise at a rate of 0.2-0.5 mL / min, controlling the mass ratio of chitosan to sodium tripolyphosphate to be 5-8:1. Stirring is continued for 0.5-1 hour. During this process, the positive charge of amino groups on the chitosan molecular chain and the negative charge of phosphate groups on sodium tripolyphosphate undergo ionic cross-linking, embedding the complex obtained in S2 inside the cross-linking network to form nanoparticles, thus obtaining a nanoparticle suspension.

[0024] S6: The nanoparticle suspension obtained in S5 is mixed evenly with the freeze-drying protectant, wherein the mass ratio of the solid content of the nanoparticle suspension to the freeze-drying protectant is 3.5-5:1. After pre-freezing at -45℃ to -40℃ for 4-6 hours, it is vacuum freeze-dried for 24-48 hours under vacuum conditions of ≤20Pa and cold trap temperature ≤-50℃ to obtain the ginseng composition for regulating intestinal health.

[0025] The beneficial effects achieved by this invention are as follows:

[0026] The present invention provides a method for preparing a ginseng composition for regulating intestinal health. Through ultrasound-assisted treatment, the molecular chains of Poria cocos polysaccharides are extended, and hydrophobic interactions are utilized to form a self-assembled complex with ginsenosides. This effectively solves the problems of poor water solubility and easy degradation and inactivation of ginsenosides in the gastrointestinal environment, significantly improving their bioavailability. Simultaneously, the present invention innovatively introduces proanthocyanidins from lotus seed extract, which, together with mucilage and chitosan from yam extract, form a dense interpenetrating network structure. The hydrogen bonding and hydrophobic interactions of natural polyphenols enhance gel strength, avoiding the use of traditional toxic cross-linking agents such as glutaraldehyde. Only food-grade sodium tripolyphosphate is used for ionic cross-linking, significantly improving the product's stability in the gastric acid environment and intestinal retention time, and endowing the composition with excellent antioxidant activity.

[0027] To address the coexisting issues of gut microbiota imbalance and immunodeficiency in individuals with low immunity, this invention employs a "drug-adjuvant integration" design. It organically combines prebiotic-functional Poria cocos polysaccharides, yam extract, and lotus seed extract rich in proanthocyanidins with immunomodulatory ginseng extract. The carrier material itself, acting as a prebiotic, regulates the gut microbiota, promoting the proliferation of beneficial bacteria. The enzymes produced during metabolism further promote the conversion of ginsenosides into active aglycones, achieving a deep synergistic effect of "microbiota regulation promoting drug absorption, and drug regulation improving the immune environment." This overcomes the shortcomings of traditional compositions, which often lack a single function and a mutually reinforcing mechanism. Attached Figure Description

[0028] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below.

[0029] Figure 1 The figures show the results of the nanoparticle size and potential measurement in Examples 1-3 and Comparative Examples 1-3 of the present invention, where (a) is the average particle size, (b) is the polydispersity index, and (c) is the zeta potential.

[0030] Figure 2 The following are the results of the organ index measurement of mice in each group of the present invention, where (a) is the mouse body weight change graph, (b) is the spleen index, and (c) is the thymus index;

[0031] Figure 3 The images show the HE staining results of the thymus and spleen of mice in each group of this invention.

[0032] Figure 4 The images show the HE staining results of the mouse colon in each group of mice according to this invention.

[0033] Figure 5 The figure shows the results of serum cytokine levels in mice in each group of the present invention, where (a) is IL-1β, (b) is IL-22, (c) is IL-10, (d) is TNF-α, (e) is TGF-β, (f) is IFN-γ, and (g) is IL-17A.

[0034] Figure 6 The figure shows the results of serum intestinal permeability index measurement in mice of each group in this invention, where (a) is DAO, (b) is D-LAC, (c) is LPS, and (d) is Zonulin;

[0035] Figure 7 The diagram shows the OTU clustering analysis of the intestinal flora of mice in each group of the present invention, where (a) is a bar chart and (b) is a Venn diagram;

[0036] Figure 8The diagram shows the Alpha diversity index analysis of the gut microbiota of mice in each group of the present invention, where (a) is the Simpson index, (b) is the Shannon index, (c) is the Chao1 index, and (d) is the ACE index.

[0037] Figure 9 The diagrams show the Beta diversity analysis of the intestinal flora of mice in each group of the present invention, where (a) is the principal component analysis (PCA) diagram of the samples and (b) is the box plot of the PERMANOVA analysis.

[0038] Figure 10 This is a relative abundance map of species based on phylum-level determination in this invention;

[0039] Figure 11 This is a relative abundance map of species determined at the genus level according to the present invention. Detailed Implementation

[0040] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The preferred embodiments and materials described herein are for illustrative purposes only and do not limit the scope of this application.

[0042] Unless otherwise specified, all materials used in the following embodiments are new materials purchased from the market.

[0043] Example 1

[0044] This embodiment provides a ginseng composition for regulating intestinal health, which consists of the following raw materials in parts by weight: 5 parts ginseng extract, 16 parts Poria cocos polysaccharide, 5 parts yam extract, 3 parts lotus seed extract, 15 parts chitosan, 10 parts freeze-drying protectant, and 2.5 parts sodium tripolyphosphate.

[0045] The preparation method of the ginseng extract is as follows: a. Take dried ginseng, pulverize it through a 60-mesh sieve, add 8 times the amount of 70% ethanol, heat and reflux twice for 1.5 hours each time, combine the extracts, filter, and concentrate the filtrate until there is no alcohol taste to obtain crude extract; b. Load the crude extract onto D101 macroporous resin, and elute sequentially with water, 30%, 60%, and 80% ethanol gradient, collect the 60% and 80% fractions, concentrate and freeze dry to obtain the extract. The total saponin content is 52% (Rg1+Rb1+Re content is 33%).

[0046] The preparation method of the Poria cocos polysaccharide is as follows: (1) Take Poria cocos powder, add 25 times the weight of deionized water, heat and extract at 95°C for 2.5 hours, filter, collect the filtrate, concentrate the filtrate under reduced pressure to 1 / 4 of the original volume, add anhydrous ethanol to make the volume fraction of ethanol in the solution reach 75%, let stand overnight, and centrifuge to collect the precipitate; (2) Redissolve the precipitate in deionized water, first use an ultrafiltration membrane with a molecular weight cutoff of 20 kDa to perform ultrafiltration, collect the permeate, then use an ultrafiltration membrane with a molecular weight cutoff of 5 kDa to perform ultrafiltration, collect the retentate, concentrate the retentate under reduced pressure, freeze dry, and obtain Poria cocos polysaccharide with a weight average molecular weight of 12 kDa.

[0047] The lotus seed extract is a lotus seed peel extract, prepared by: drying and pulverizing the lotus seed peel through a 40-mesh sieve, adding 12 times the volume of 65% ethanol aqueous solution, heating and refluxing for extraction 3 times, 1.5 hours each time, combining the extracts, filtering, concentrating the filtrate under reduced pressure at 50°C to dryness, and freeze-drying for 48 hours to obtain the lotus seed extract, which has a proanthocyanidin content of 27.2 mg / g.

[0048] The degree of deacetylation of the chitosan is 92%, and the weight-average molecular weight is 50 kDa.

[0049] The yam extract is a commercially available food-grade yam extract, with a polysaccharide content of 40%.

[0050] The freeze-drying protectant is composed of trehalose and mannitol in a mass ratio of 2:1.

[0051] This embodiment also provides a method for preparing a ginseng composition for regulating intestinal health, comprising the following steps:

[0052] S1: Dissolve 16g of Poria cocos polysaccharide in 1600mL of deionized water to prepare a 1.0% (w / w) Poria cocos polysaccharide aqueous solution. Sonicate the solution in a 35℃ water bath at 300W power for 15 minutes and set aside. Dissolve 5g of ginseng extract in 12.5mL of anhydrous ethanol and sonicate the solution for 8 minutes until the solution is clear to obtain a ginseng extract ethanol solution.

[0053] S2: Under constant temperature of 35℃ and ultrasonic assistance of 300W, the ethanol solution of ginseng extract was slowly added dropwise to the aqueous solution of poria cocos polysaccharide obtained in S1 at a mass ratio of 1:6 of total saponins in ginseng extract to poria cocos polysaccharide. The dropwise addition rate was 0.8 mL / min. After the addition was completed, ultrasonic stirring was continued for 1.5 hours to obtain a complex solution. Then, the obtained complex solution was distilled under reduced pressure at 40℃ to remove ethanol, and deionized water was added to 1600 mL to obtain the aqueous solution of the complex.

[0054] S3: Dissolve 15g of chitosan in 1000mL of 1% (v / v) acetic acid aqueous solution to prepare a 1.5% (w / v) chitosan-acetic acid aqueous solution. Adjust the pH to 4.8 with 0.1mol / L sodium acetate buffer. Set aside. Dissolve 5g of yam extract in 167mL of deionized water to prepare a 3% (w / v) yam extract aqueous solution. Dissolve 3g of lotus seed extract in 150mL of deionized water to prepare a 2% (w / v) lotus seed extract aqueous solution. Dissolve 2.5g of sodium tripolyphosphate in 250mL of deionized water to prepare a 1.0% (w / v) sodium tripolyphosphate aqueous solution. Adjust the pH to 4.8 with 0.1mol / L acetic acid. Set aside.

[0055] S4: At 22℃, 167mL of yam extract aqueous solution and 150mL of lotus seed extract aqueous solution are mixed and stirred for 15 minutes to obtain a mixed solution. Then, the above mixed solution is mixed with 1000mL of chitosan acetate aqueous solution and stirred for 25 minutes to obtain a composite solution.

[0056] S5: At 22℃, the aqueous solution of the complex obtained in S2 is mixed with the composite solution obtained in S4, and sodium tripolyphosphate aqueous solution is slowly added dropwise at a rate of 0.3 mL / min, controlling the mass ratio of chitosan to sodium tripolyphosphate to be 6:1. Stirring is continued for 45 minutes to obtain a nanoparticle suspension.

[0057] S6: The nanoparticle suspension obtained in S5 is mixed evenly with the freeze-drying protectant, pre-frozen at -45°C for 5 hours, and then freeze-dried under vacuum at 15Pa and -55°C for 36 hours to obtain the ginseng composition for regulating intestinal health.

[0058] Example 2

[0059] This embodiment provides a ginseng composition for regulating intestinal health, which consists of the following raw materials in parts by weight: 10 parts ginseng extract, 22 parts poria cocos polysaccharide, 10 parts yam extract, 6.5 parts lotus seed extract, 22.5 parts chitosan, 17.5 parts freeze-drying protectant, and 3 parts sodium tripolyphosphate.

[0060] The preparation method of the ginseng extract is as follows: a. Take dried ginseng, crush it through a 60-mesh sieve, add 8 times the amount of 70% ethanol, heat and reflux twice for 2 hours each time, combine the extracts, filter, and concentrate the filtrate until there is no alcohol taste to obtain crude extract; b. Load the crude extract onto D101 macroporous resin, and elute sequentially with water, 30%, 60%, and 80% ethanol gradient, collect the 60% and 80% fractions, concentrate and freeze dry to obtain the extract. The total saponin content is 55% (Rg1+Rb1+Re content is 35%).

[0061] The preparation method of the Poria cocos polysaccharide is as follows: (1) Take Poria cocos powder, add 20 times the weight of deionized water, heat and extract at 90°C for 2 hours, filter, collect the filtrate, concentrate the filtrate under reduced pressure to 1 / 5 of the original volume, add anhydrous ethanol to make the volume fraction of ethanol in the solution reach 70%, let stand overnight, and centrifuge to collect the precipitate; (2) Redissolve the precipitate in deionized water, first use an ultrafiltration membrane with a molecular weight cutoff of 20 kDa to perform ultrafiltration, collect the permeate, then use an ultrafiltration membrane with a molecular weight cutoff of 5 kDa to perform ultrafiltration, collect the retentate, concentrate the retentate under reduced pressure, freeze dry, and obtain Poria cocos polysaccharide with a weight average molecular weight of 15 kDa.

[0062] The lotus seed extract is a lotus seed peel extract. The preparation method is as follows: take lotus seed peel, dry and crush it, add 10 times the volume of 60% ethanol aqueous solution, heat and reflux to extract twice, each time for 2 hours, combine the extracts, filter, concentrate the filtrate under reduced pressure and freeze dry to obtain the lotus seed extract, which has a proanthocyanidin content of 18.5 mg / g.

[0063] The degree of deacetylation of the chitosan is 95%, and the weight-average molecular weight is 60 kDa.

[0064] The yam extract is a commercially available food-grade yam extract, with a polysaccharide content of 40%.

[0065] The freeze-drying protectant is composed of trehalose and mannitol in a mass ratio of 2:1.

[0066] This embodiment also provides a method for preparing a ginseng composition for regulating intestinal health, comprising the following steps:

[0067] S1: Dissolve 22g of Poria cocos polysaccharide in 2200mL of deionized water to prepare a 1.0% Poria cocos polysaccharide aqueous solution. Sonicate the solution in a 40℃ water bath at 400W power for 10 minutes. Dissolve 10g of ginseng extract in 25mL of anhydrous ethanol and sonicate the solution for 10 minutes until the solution is clear to obtain a ginseng extract ethanol solution.

[0068] S2: Under constant temperature of 40℃ and ultrasonic assistance of 400W, the ethanol solution of ginseng extract was slowly added dropwise to the aqueous solution of poria cocos polysaccharide obtained in S1 at a mass ratio of 1:4 of total saponins in ginseng extract to poria cocos polysaccharide. The dropwise addition rate was 1.0 mL / min. After the addition was completed, ultrasonic stirring was continued for 2 hours to obtain a complex solution. Then, the obtained complex solution was distilled under reduced pressure at 45℃ to remove ethanol, and deionized water was added to 2200 mL to obtain the aqueous solution of the complex.

[0069] S3: Dissolve 22.5g of chitosan in 1500mL of 1% (v / v) acetic acid aqueous solution to prepare a 1.5% (w / v) chitosan-acetic acid aqueous solution. Adjust the pH to 5.0 with 0.1mol / L sodium acetate buffer. Set aside. Dissolve 10g of yam extract in 200mL of deionized water to prepare a 5% (w / v) yam extract aqueous solution. Dissolve 6.5g of lotus seed extract in 200mL of deionized water to prepare a 3.25% (w / v) lotus seed extract aqueous solution. Dissolve 3g of sodium tripolyphosphate in 300mL of deionized water to prepare a 1.0% (w / v) sodium tripolyphosphate aqueous solution. Adjust the pH to 5.0 with 0.1mol / L acetic acid. Set aside.

[0070] S4: At 25℃, mix 200mL of yam extract aqueous solution and 200mL of lotus seed extract aqueous solution and stir for 20 minutes to obtain a mixed solution. Then mix the above mixed solution with 1500mL of chitosan acetate aqueous solution and stir for 30 minutes to obtain a composite solution.

[0071] S5: At 25℃, the aqueous solution of the complex obtained in S2 is mixed with the composite solution obtained in S4, and sodium tripolyphosphate aqueous solution is slowly added dropwise at a rate of 0.5 mL / min, controlling the mass ratio of chitosan to sodium tripolyphosphate to be 7.5:1. Stirring is continued for 1 hour to obtain a nanoparticle suspension.

[0072] S6: The nanoparticle suspension obtained in S5 is mixed evenly with the freeze-drying protectant, pre-frozen at -40°C for 6 hours, and then freeze-dried under vacuum at 10 Pa and -50°C for 48 hours to obtain the ginseng composition for regulating intestinal health.

[0073] Example 3

[0074] This embodiment provides a ginseng composition for regulating intestinal health, which consists of the following raw materials in parts by weight: 14 parts ginseng extract, 25 parts poria cocos polysaccharide, 15 parts yam extract, 10 parts lotus seed extract, 30 parts chitosan, 25 parts freeze-drying protectant, and 4.5 parts sodium tripolyphosphate.

[0075] The preparation method of the ginseng extract is as follows: a. Take dried ginseng, crush it through a 60-mesh sieve, add 10 times the amount of 70% ethanol, heat and reflux to extract 3 times, 2.5 hours each time, combine the extracts, filter, and concentrate the filtrate until there is no alcohol taste to obtain crude extract; b. Load the crude extract onto D101 macroporous resin, and elute sequentially with water, 30%, 60%, and 80% ethanol gradient, collect the 60% and 80% fractions, concentrate and freeze dry to obtain the extract. The total saponin content is 58% (Rg1+Rb1+Re content is 38%).

[0076] The preparation method of the Poria cocos polysaccharide is as follows: (1) Take Poria cocos powder, add 30 times the weight of deionized water, heat and extract at 95°C for 3 hours, filter, collect the filtrate, concentrate the filtrate under reduced pressure to 1 / 3 of the original volume, add anhydrous ethanol to make the volume fraction of ethanol in the solution reach 80%, let stand overnight, and centrifuge to collect the precipitate; (2) Redissolve the precipitate in deionized water, first use an ultrafiltration membrane with a molecular weight cutoff of 20 kDa to perform ultrafiltration, collect the permeate, then use an ultrafiltration membrane with a molecular weight cutoff of 5 kDa to perform ultrafiltration, collect the retentate, concentrate the retentate under reduced pressure, freeze dry, and obtain Poria cocos polysaccharide with a weight average molecular weight of 20 kDa.

[0077] The lotus seed extract is a lotus seed peel extract. The preparation method is as follows: take lotus seed peel, dry and crush it, add 15 times the volume of 70% ethanol aqueous solution, heat and reflux to extract 3 times, 1 hour each time, combine the extracts, filter, concentrate the filtrate under reduced pressure and freeze dry to obtain the lotus seed extract, which has a proanthocyanidin content of 22.8 mg / g.

[0078] The chitosan has a degree of deacetylation of 90% and a weight-average molecular weight of 80 kDa.

[0079] The yam extract is a commercially available food-grade yam extract, with a polysaccharide content of 40%.

[0080] The freeze-drying protectant is composed of trehalose and mannitol in a mass ratio of 2:1.

[0081] This embodiment also provides a method for preparing a ginseng composition for regulating intestinal health, comprising the following steps:

[0082] S1: Dissolve 25g of Poria cocos polysaccharide in 2500mL of deionized water to prepare a 1.0% Poria cocos polysaccharide aqueous solution. Sonicate the solution in a 30℃ water bath at 200W power for 20 minutes. Dissolve 14g of ginseng extract in 35mL of anhydrous ethanol and sonicate the solution for 5 minutes until the solution is clear to obtain a ginseng extract ethanol solution.

[0083] S2: Under constant temperature of 30℃ and ultrasonic assistance of 200W, the ethanol solution of ginseng extract was slowly added dropwise to the aqueous solution of poria cocos polysaccharide obtained in S1 at a mass ratio of 1:3 of total saponins in ginseng extract to poria cocos polysaccharide. The dropwise addition rate was 0.5 mL / min. After the addition was completed, ultrasonic stirring was continued for 1 hour to obtain a complex solution. Then, the obtained complex solution was distilled under reduced pressure at 35℃ to remove ethanol, and deionized water was added to 2500 mL to obtain the aqueous solution of the complex.

[0084] S3: Dissolve 30g of chitosan in 2000mL of 1% (v / v) acetic acid aqueous solution to prepare a 1.5% (w / v) chitosan-acetic acid aqueous solution. Adjust the pH to 4.5 with 0.1mol / L sodium acetate buffer. Set aside. Dissolve 15g of yam extract in 250mL of deionized water to prepare a 6% (w / v) yam extract aqueous solution. Dissolve 10g of lotus seed extract in 250mL of deionized water to prepare a 4% (w / v) lotus seed extract aqueous solution. Dissolve 4.5g of sodium tripolyphosphate in 300mL of deionized water to prepare a 1.5% (w / v) sodium tripolyphosphate aqueous solution. Adjust the pH to 4.5 with 0.1mol / L acetic acid. Set aside.

[0085] S4: At 20℃, mix 250mL of yam extract aqueous solution and 250mL of lotus seed extract aqueous solution and stir for 10 minutes to obtain a mixed solution. Then mix the above mixed solution with 2000mL of chitosan acetate aqueous solution and stir for 20 minutes to obtain a composite solution.

[0086] S5: At 20℃, the aqueous solution of the composite obtained in S2 is mixed with the composite solution obtained in S4, and sodium tripolyphosphate aqueous solution is slowly added dropwise at a rate of 0.2 mL / min, controlling the mass ratio of chitosan to sodium tripolyphosphate to be 6.7:1. Stirring is continued for 0.5 hours to obtain a nanoparticle suspension.

[0087] S6: The nanoparticle suspension obtained in S5 is mixed evenly with the freeze-drying protectant, pre-frozen at -45°C for 4 hours, and then freeze-dried under vacuum at a vacuum degree of 20Pa and a cold trap temperature of -50°C for 24 hours to obtain the ginseng composition for regulating intestinal health.

[0088] Comparative Example 1

[0089] The difference between this comparative example and Example 2 is that: in step S2, ultrasonic-assisted dropwise addition is not used, but the ginseng extract ethanol solution is directly and rapidly added to the Poria cocos polysaccharide aqueous solution obtained in S1 at the same temperature without ultrasonic treatment, and the remaining steps are the same as in Example 2.

[0090] Comparative Example 2

[0091] The difference between this comparative example and Example 2 is that the process of "premixing the aqueous solution of yam extract and the aqueous solution of lotus seed extract" in step S4 is omitted. Instead, the yam extract and lotus seed extract are directly added to the chitosan-chitosan acetate aqueous solution and stirred. The remaining steps are the same as in Example 2.

[0092] Comparative Example 3

[0093] The difference between this comparative example and Example 2 is that sodium tripolyphosphate aqueous solution is not added in step S5; instead, the aqueous solution of complex S2 is mixed and stirred with the complex solution of complex S4. The remaining steps are the same as in Example 2.

[0094] Comparative Example 4

[0095] The difference between this comparative example and Example 2 is that: ginseng extract, poria cocos polysaccharide, yam extract, lotus seed peel extract, and chitosan were directly dissolved in water according to the specified ratio and stirred evenly. They were not subjected to the ultrasonic-assisted self-assembly, pre-composite, and ionic cross-linking treatments in S1-S5. After adding the freeze-drying protectant, they were directly freeze-dried. The other conditions were the same as in Example 2.

[0096] To verify the performance of the compositions of the present invention, the products obtained in the above examples and comparative examples were subjected to the following tests:

[0097] 1. Nanoparticle size and potential determination: The composition samples prepared in Examples 1-3 and Comparative Examples 1-3 were reconstituted with deionized water to a mass concentration of 0.5 mg / mL. The average particle size, polydispersity index (PDI), and zeta potential of the nanoparticles were determined using a dynamic light scattering nanoparticle size analyzer. The results are as follows: Figure 1 As shown.

[0098] 2. Encapsulation efficiency determination: Weigh 50 mg of each composition sample prepared in each example and comparative example, add 5 mL of deionized water to reconstitute, centrifuge at 12000 rpm for 30 minutes at 4℃, collect the supernatant, and determine the content of free ginsenosides Rg1, Rb1, and Re in the supernatant using high performance liquid chromatography (HPLC). Take another equal amount of sample, add 5 mL of 70% (v / v) ethanol aqueous solution, and sonicate for 15 minutes to break the emulsion. Determine the total ginsenoside content (i.e., total saponin amount) using the same method, and calculate the encapsulation efficiency. Encapsulation efficiency (%) = (Total saponin amount - Free saponin amount) / Total saponin amount × 100%.

[0099] 3. Intestinal Adhesion Test: SPF-grade SD rats were fasted overnight and then sacrificed. Small intestinal segments were quickly removed, rinsed thoroughly with pre-cooled PBS buffer (pH 7.4), and cut into 2 cm × 2 cm intestinal mucosa pieces for later use. The compositions prepared in each example and comparative example were diluted with simulated intestinal fluid to form a 1 mg / mL suspension. 2 mL of this suspension was evenly spread onto the intestinal mucosa surface and incubated at 37°C for 2 hours. After incubation, the samples were gently rinsed three times with 10 mL of PBS buffer each time to remove any unadhesive samples. The intestinal mucosa was then minced, and 5 mL of 70% (v / v) ethanol aqueous solution was added and sonicated for 15 minutes to extract the adhered ginsenosides. The content of these ginsenosides was determined by HPLC. The adhesion rate was calculated using the following formula: Adhesion rate (%) = (Amount of adhered saponins / Total amount of added saponins) × 100%.

[0100] Table 1. Results of encapsulation rate determination and intestinal adhesion determination for each embodiment and comparative example.

[0101]

[0102] Depend on Figure 1 As shown in Table 1, the compositions prepared in Examples 1-3 had an average particle size in the range of 150-200 nm, a PDI of less than 0.21, and a high Zeta potential, indicating the formation of a uniform and stable nanoparticle system with an encapsulation efficiency exceeding 85%. In contrast, Comparative Example 1, lacking an ultrasound-assisted self-assembly step, exhibited uneven particle size distribution and a significantly reduced encapsulation efficiency, indicating that ultrasound treatment promoted the hydrophobic binding of ginsenosides and poria cocos polysaccharides. Comparative Example 2 lacked a pre-composite step with yam and lotus seeds, resulting in incomplete cross-linking network formation and inferior particle size and encapsulation efficiency compared to the Examples. Comparative Example 3 lacked ionic cross-linking, resulting in a loose system and low encapsulation efficiency, confirming that ionic cross-linking is key to constructing the nanoskeleton. Comparative Example 4 failed to form a nanoparticle structure and had the lowest encapsulation efficiency. Furthermore, the intestinal mucosal adhesion rates of the Example groups were all higher than those of the Comparative Example groups. This is attributed to the hydrogen-bonded hydrophobic synergistic network formed by chitosan, yam mucilage, and lotus seed proanthocyanidins, which endowed the material with excellent intestinal retention capacity.

[0103] 4. Simulated Gastrointestinal Fluid Release Experiment: Simulated gastric fluid (SGF, pH 1.2, containing 0.32% pepsin) and simulated intestinal fluid (SIF, pH 6.8, containing 1% trypsin) were prepared. 100 mg of each composition sample prepared in each example and comparative example was accurately weighed and placed in 100 mL of SGF. The mixture was shaken for 2 hours at 37 ± 0.5 °C and 100 rpm in a constant temperature shaker. The release medium was then replaced with 100 mL of SIF, and shaking continued for 4 hours under the same conditions. 1 mL samples were taken at 0.5, 1, 2, 3, 4, and 6 hours, and an equal amount of fresh medium was added simultaneously. The contents of ginsenosides Rg1, Rb1, and Re in the release medium were determined by HPLC, and the cumulative release rate at each time point was calculated. Each sample was measured in triplicate, and the results are expressed as mean ± standard deviation. The results are shown in Table 2.

[0104] Table 2. Cumulative release rate (%) of the compositions of each example and comparative example in simulated gastrointestinal fluid.

[0105]

[0106] As shown in Table 2, the cumulative release rates of Examples 1-3 in simulated gastric fluid (0-2h) were all ≤16.8%, demonstrating good gastric acid tolerance and effectively avoiding the sudden release and degradation of ginsenosides in the stomach. After being transferred to simulated intestinal fluid, the release rate increased significantly, exhibiting pH-responsive release characteristics, with a cumulative release rate of 58.2%-67.5% over 6h, achieving the effect of targeted release into the intestine. Comparative Examples 1-4, due to the lack of a complete multi-level cross-linking network or insufficient cross-linking, showed large release rates or abnormal release curves in gastric fluid. Among them, Comparative Example 4 (simple physical mixing) had a release rate of 45.2% in 0.5h, with almost no controlled release effect.

[0107] 5. Immunomodulation and Intestinal Barrier Function Experiment: Forty SPF-grade male BALB / c mice were randomly divided into four groups of ten mice each: a normal control group (K), a model group (M), a positive control group (Y), and a ginseng composition group (RS, corresponding to Example 2 of this invention). Except for the K group mice which were injected intraperitoneally with an equal volume of physiological saline, the other groups were injected intraperitoneally with cyclophosphamide (CTX) 80 mg / (kg·d) for three consecutive days. Starting on the fourth day, the K and M groups were administered phosphate-buffered saline (PBS) by gavage; the Y group was administered levamisole hydrochloride (40 mg / kg) by gavage; and the RS group was administered ginseng composition (100 mg / kg) by gavage. All groups were administered the same volume of the ginseng composition once daily.

[0108] Test method:

[0109] (1) Organ index determination: After the mice were sacrificed, the spleen and thymus were removed, washed with physiological saline, and weighed. The spleen index and thymus index of the mice were calculated according to the following formula: Thymus (spleen) index = thymus (spleen) weight (mg) / body weight (g), and the results are as follows. Figure 2 As shown.

[0110] The weight changes in mice during drug administration are as follows: Figure 2 As shown in Figure a, on day 3 after model establishment, except for the control group, the body weight of mice in all other groups decreased significantly, indicating successful model establishment. After entering the drug administration phase, the body weight of each group gradually recovered, and on day 17, the body weight of mice in each drug-treated group significantly increased (p < 0.05). Figure 2 As shown in b and 2c, compared with group K, the spleen (p < 0.001) and thymus (p < 0.001) indices of mice in group M were significantly decreased. Compared with group M, the spleen and thymus indices of mice in groups Y and RS were significantly increased (p < 0.001). These results indicate that the ginseng composition can improve immune organ indices to a certain extent and has a protective and ameliorative effect on cyclophosphamide-induced immune function damage.

[0111] (2) Histopathological observation: Thymus, spleen, and colon specimens were fixed in 4% paraformaldehyde solution for 48 h. After fixation, the tissues were dehydrated with graded alcohols, cleared with xylene, embedded in paraffin, and then serially sectioned (5 μm / section) using a microtome. The sections were baked at 60°C overnight for later use. After dewaxing and hydration, the sections were stained with hematoxylin and eosin (HE), and finally mounted with neutral resin. The sections were observed and photographed under a microscope. The results are as follows: Figure 3 and Figure 4 As shown.

[0112] HE staining of thymus and spleen tissues from each group of mice is as follows: Figure 3As shown, the thymus structure of mice in group K was intact, with a clear boundary between the cortex and medulla and dense cell arrangement. The thymus structure of group M was significantly damaged, with loose tissue arrangement, a significantly reduced cell number, and obvious inflammatory infiltration. The number of thymic cells in group RS increased, and the tissue structure became more regular. Similar results were observed in the spleen tissue; the white pulp area of ​​the spleen in group M was significantly reduced, and the boundary between the red and white pulp was blurred; the spleen structure in group RS was relatively intact, with increased immune cells and clear boundaries. These results indicate that the composition of this invention has a significant protective effect on the structure of the thymus and spleen.

[0113] Colon HE staining results as follows Figure 4 As shown, the colonic mucosa of mice in group K was intact, with abundant goblet cells and regular crypt morphology, and no obvious inflammatory cell infiltration, tissue degeneration, or sloughing was observed. In group M, the colonic tissue showed obvious inflammatory cell infiltration, altered crypt shape, and significant tissue structural damage. Compared to group M, mice in group RS showed reduced inflammatory cell infiltration in the intestinal mucosa, better restoration of crypt morphology, and significantly improved tissue structural damage, indicating that the composition of this invention has a protective effect against CTX-induced colonic pathological damage.

[0114] (3) Serum biochemical index determination: After administration, blood was collected from the eyeballs into EP tubes, stored at 4°C for 1 hour, centrifuged, and the supernatant was collected. The levels of cytokines (IL-17A, TNF-α, IL-10, IL-22, IL-1β, TGF-β and IFN-γ) and intestinal barrier function-related indicators (LPS, D-LAC, DAO and Zonulin) in the serum were detected by enzyme-linked immunosorbent assay (ELISA).

[0115] The results are as follows Figure 5 As shown, compared with group K, the serum levels of IL-1β (p < 0.001), IL-22 (p < 0.001), IL-10 (p < 0.001), and IFN-γ (p < 0.001) in group M mice were significantly decreased, while TGF-β was slightly decreased; the levels of IL-17 and TNF-α were significantly increased (p < 0.01). After drug intervention, the RS groups were able to improve the activity of immune factors in immunocompromised mice to some extent, consistent with the trend in group Y. Compared with the M group mice, the RS group mice showed significantly increased levels of IL-1β (p<0.001), IL-22 (p<0.001), IL-10 (p<0.05), and IFN-γ (p<0.001) in serum, slightly increased levels of TGF-β, and significantly decreased levels of IL-17 (p<0.001) and TNF-α (p<0.001). This indicates that the composition of the present invention can effectively alleviate CTX-induced immune dysfunction and improve immunodeficiency.

[0116] Serum DAO, D-LAC, LPS, and zonalin levels are important biochemical indicators reflecting intestinal barrier integrity. Figure 6 As shown, compared with group K, the levels of DAO, LPS, and Zonulin in mice in group M were significantly increased (p < 0.05); compared with group M, the levels of DAO, D-LAC, LPS, and Zonulin in mice in group RS were significantly decreased (p < 0.01). The results indicate that the composition of this invention can effectively reduce intestinal permeability and repair damaged intestinal mucosal barrier function.

[0117] (4) 16S rRNA sequencing analysis of gut microbiota: Fecal samples were collected from mice in each group. DNA was extracted from the fecal samples according to the instructions of the PowerSoil® DNA Isolation Kit (MOBIO Laboratories). High-throughput sequencing analysis was performed on the purified samples using the Illumina Hiseq 2500 platform (PE250). Tags were clustered using Usearch software to obtain OTUs, and taxonomic annotations were performed on the OTUs based on the Silva and UNITE taxonomic databases. A species abundance table was generated using QIIME software, and functional and species diversity analyses were performed based on the annotation results of the differential gene alignment databases.

[0118] OTU cluster analysis ( Figure 7 The results showed that group K had 5569 OTUs, group M had 6141 OTUs, group Y had 5193 OTUs, and group RS had 5122 OTUs. Gut microbiota diversity analysis mainly includes Alpha diversity analysis and Beta diversity analysis. Alpha diversity analysis ( Figure 8 The results showed that the Chao1, ACE, Shannon, and Simpson indices in group M were significantly higher than those in group K (p<0.05), indicating that immunodeficiency led to dysbiosis and abnormally high bacterial richness. After drug intervention, the Chao1, ACE, and Simpson indices in group RS significantly decreased (p<0.05), and the Shannon curve tended to balance, indicating that the sequencing data was sufficient and that the composition of this invention could restore bacterial diversity to normal levels. Beta diversity analysis results are as follows... Figure 9 As shown, p ≤ 0.05 indicates high reliability of the experiment. PERMANOVA analysis results show that R... 2 =0.235, p=0.004, indicating a statistically significant difference between the groups.

[0119] Furthermore, the composition of the gut microbiota was analyzed, and differences in the species structure of the gut microbiota among the samples were compared at the phylum level, such as... Figure 10As shown, there were small differences in species diversity among the four groups, but significant differences in abundance. On average, over 90% of the bacteria in each group consisted of Firmicutes, Bacteroidetes, and Proteobacteria. Compared to group K, group M showed a decrease in the relative abundance of Firmicutes and Bacteroidetes, and an increase in the relative abundance of Proteobacteria. Compared to group M, groups Y and RS showed a decrease in the relative abundance of Proteobacteria, and an increase in the relative abundance of Firmicutes. Species differences in the gut microbiota of mice in each group were analyzed at the genus level, such as... Figure 11 As shown, the main gut microbiota in each group of mice included *Ligilactobacillus*, *Lactobacillus*, *Romboutsia*, *Bacteroides*, and the *Lachnospiraceae* NK4A136 group. Compared with group K, group M showed decreased abundance of *Prevotellaceae* UCG 001, unclassified *Lachnospiraceae*, and *Limosilactobacillus*, while increasing abundance of *Streptococcus* and *Lactobacillus*. Compared with group M, group Y mainly altered the abundance of *Prevotellaceae* UCG 001, while group RS mainly restored the abundance of *Limosilactobacillus*.

[0120] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

[0121] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention. The actual application is not limited to this. In conclusion, if those skilled in the art are inspired by this description and design similar methods and embodiments without departing from the spirit of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A method for preparing a ginseng composition for regulating intestinal health, characterized in that, Specifically, the following steps are included: S1: Dissolve Poria cocos polysaccharide in deionized water to prepare a Poria cocos polysaccharide aqueous solution, and then sonicate it for later use. Dissolve ginseng extract in anhydrous ethanol and sonicate it to obtain a ginseng extract ethanol solution. S2: Under ultrasonic conditions, the ethanol solution of ginseng extract was added dropwise to the aqueous solution of poria cocos polysaccharide at a mass ratio of 1:3-6 of total saponins in ginseng extract to poria cocos polysaccharide. After the addition was completed, ultrasonic treatment was continued to obtain a complex solution. Subsequently, the complex solution was distilled under reduced pressure and deionized water was added to obtain the complex aqueous solution. S3: Dissolve chitosan in an acetic acid aqueous solution to prepare a chitosan-acetic acid aqueous solution, adjust the pH to 4.5-5.0 and set aside. Prepare a yam extract aqueous solution with deionized water. Prepare a lotus seed extract aqueous solution with deionized water. Prepare a sodium tripolyphosphate aqueous solution with deionized water, adjust the pH to 4.5-5.0 and set aside. S4: Mix the aqueous solution of yam extract and the aqueous solution of lotus seed extract to obtain a mixed solution, and then mix the mixed solution with the aqueous solution of chitosan acetate to obtain a composite solution; S5: After mixing the complex aqueous solution with the complex solution, add sodium tripolyphosphate aqueous solution dropwise and continue stirring to obtain a nanoparticle suspension; S6: Mix the nanoparticle suspension with the lyophilization protectant evenly, pre-freeze and then vacuum dry to obtain the composition.

2. The method for preparing a ginseng composition for regulating intestinal health according to claim 1, characterized in that, In the preparation method, the amount of each raw material by weight is as follows: 5-14 parts of ginseng extract, 16-25 parts of poria cocos polysaccharide, 5-15 parts of yam extract, 3-10 parts of lotus seed extract, 15-30 parts of chitosan, 10-25 parts of freeze-drying protectant, and 2.5-4.5 parts of sodium tripolyphosphate.

3. The method for preparing a ginseng composition for regulating intestinal health according to claim 1, characterized in that, The preparation method of the ginseng extract includes the following steps: a. Take dried ginseng, crush it, sieve it, add ethanol aqueous solution, heat and reflux to extract 2-3 times, combine the extracts, filter, concentrate under reduced pressure to obtain crude extract; b. Load the crude extract onto a D101 macroporous adsorption resin column and elute sequentially with deionized water, 30% ethanol aqueous solution, 60% ethanol aqueous solution, and 80% ethanol aqueous solution. Collect the elution fractions of 60% and 80% ethanol aqueous solutions, concentrate under reduced pressure, and freeze-dry to obtain the ginseng extract.

4. The method for preparing a ginseng composition for regulating intestinal health according to claim 3, characterized in that, The ginseng extract contains ≥50% total saponins, of which the total mass of ginsenosides Rg1, Rb1, and Re accounts for more than 30% of the mass of the ginseng extract.

5. The method for preparing a ginseng composition for regulating intestinal health according to claim 1, characterized in that, The preparation method of the Poria cocos polysaccharide is as follows: (1) Take Poria cocos powder, add deionized water and heat to extract, filter, collect the filtrate, concentrate the filtrate under reduced pressure, add anhydrous ethanol to make the volume fraction of ethanol in the solution reach 70%-80%, let stand overnight, and centrifuge to collect the precipitate; (2) Redissolve the precipitate in deionized water, first use a 20 kDa ultrafiltration membrane for ultrafiltration, collect the permeate, then use a 5 kDa ultrafiltration membrane for ultrafiltration, collect the retentate, concentrate the retentate under reduced pressure and freeze dry to obtain the Poria cocos polysaccharide.

6. The method for preparing a ginseng composition for regulating intestinal health according to claim 5, characterized in that, The weight-average molecular weight of the Poria cocos polysaccharide is 5-20 kDa.

7. The method for preparing a ginseng composition for regulating intestinal health according to claim 1, characterized in that, The lotus seed extract is a lotus seed peel extract, and its preparation method is as follows: take lotus seed peel, dry and crush it, add 10-15 times the weight of lotus seed peel and an ethanol aqueous solution with a volume fraction of 60%-70%, heat and reflux to extract 2-3 times, combine the extracts, filter, concentrate the filtrate under reduced pressure and freeze dry to obtain the lotus seed peel extract.

8. The method for preparing a ginseng composition for regulating intestinal health according to claim 1, characterized in that, The degree of deacetylation of the chitosan is not less than 90%, and the weight-average molecular weight is 20-100 kDa; the yam extract is a food-grade yam extract, wherein the polysaccharide content is 40%; the freeze-drying protectant is a mixture of trehalose and mannitol in a mass ratio of 2:

1.

9. The method for preparing a ginseng composition for regulating intestinal health according to claim 1, characterized in that, The volume ratio of the yam extract aqueous solution to the lotus seed extract aqueous solution in step S4 is 1:0.5-1; the volume ratio of the mixed solution to the chitosan acetate aqueous solution in step S4 is 1:2-4.