Qi-II ointment for invigorating spleen, replenishing qi, enhancing immunity and resisting fatigue and preparation method of qi-II ointment

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a polysaccharide extraction method, a Qi-II ointment formula capable of invigorating the spleen, replenishing Qi, enhancing immunity and resisting fatigue and a preparation method of the Qi-II ointment formula. The paste is prepared from astragalus membranaceus, codonopsis pilosula, Chinese yam, poria cocos, lotus seeds, rhizoma polygonati, red dates, coix seeds, lily, liquorice and fructus psoraleae as raw materials through the processes of raw material pretreatment, water extraction-alcohol extraction synergistic extraction, beta-cyclodextrin inclusion and concentration paste collection, sterilization and filling. Wherein L-tartaric acid is adopted to regulate the pH value of an extracting solution, and polysaccharide is promoted to be directionally degraded into low-molecular active fragments; bitter and astringent taste of saponin components is masked by using a beta-cyclodextrin inclusion technology, the taste is improved, and the bioavailability is improved; and the product stability is enhanced through combination of vacuum dehydration and dynamic sterilization. The cream has the functions of invigorating spleen, replenishing qi, regulating immunity and resisting fatigue, is sweet and moist in taste and high in safety, and has a wide application prospect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and mainly to a medicinal paste, specifically a Qi Er paste for invigorating the spleen and replenishing qi, enhancing immunity and relieving fatigue, and its preparation method. Background Technology

[0002] The fast pace of modern life and increased work pressure have led to a significant rise in the incidence of chronic fatigue syndrome. World Health Organization data shows that approximately 20% of the global population suffers from persistent fatigue, manifesting as lethargy, weakened immunity, and digestive disorders. Traditional Chinese medicine theory considers the spleen to be the "foundation of acquired constitution," and a weak spleen and stomach easily leads to insufficient qi and blood, resulting in physical weakness and fatigue. Herbal pastes, combining the advantages of both dietary and medicinal therapy, have become an important choice for regulating sub-health conditions. Traditional herbal pastes have a long history; for example, the *Huangdi Neijing* records that "pastes nourish the internal," and they are made by combining medicinal and edible ingredients, possessing the functions of nourishing and strengthening the body, and harmonizing yin and yang.

[0003] Currently, there are various anti-fatigue herbal pastes on the market, such as ginseng and poria porridge, astragalus steamed chicken, and other medicinal diets, as well as finished products like ginseng, polygonatum, and poria paste, and monkey head mushroom and dendrobium paste. These products mostly rely on traditional preparation processes, such as long-term decoction and concentration, which have significant shortcomings: First, the extraction efficiency is low, and active ingredients such as polysaccharides and flavonoids are easily destroyed by heat; second, the taste is bitter because the solubility of saponins has not been addressed; and third, the shelf life is short, as traditional sterilization methods may lead to nutrient loss or excessive microorganisms. For example, the publicly available "ginseng and atractylodes paste" requires multiple decoctions, which is energy-intensive and results in incomplete extraction of components; while "pear, honey, and fritillaria paste" improves the taste, but the raw materials have not undergone modification treatment, resulting in limited bioavailability.

[0004] This invention addresses the aforementioned problems through innovative techniques such as raw material modification, synergistic extraction, and inclusion complexation. Specifically, a water-to-alcohol dual-phase extraction process is used to directionally extract water-soluble and alcohol-soluble components. L-tartaric acid is introduced to adjust the pH and enhance the hydrolytic activity of polysaccharides. β-cyclodextrin is used to encapsulate flavonoids to mask flavor and increase solubility. Simultaneously, drying and sterilization parameters are optimized to improve the product's anti-fatigue and immune-regulating effects while ensuring safety. Summary of the Invention

[0005] The present application relates to a kind of medicine food homologous paste and its preparation method, its core research and development thought is in at introducing modern extraction technology (such as water-alcohol synergistic extraction, pH regulation and β-cyclodextrin inclusion) and traditional Chinese medicine combination, improve the bioavailability of active ingredient of traditional Chinese medicinal materials, realize the synergistic effect of spleen and kidney, enhance immunity and antifatigue.The present application is in the development process, by systematic literature research, parameter screening experiment, mechanism discussion and efficacy verification, finally forms water-alcohol synergistic extraction, L-tartaric acid pH regulation, β-cyclodextrin inclusion and dynamic sterilization+instant cooling core technology.We are based on the deficiency of prior art (such as traditional water extraction dissolution rate <50%, heat sterilization causes component degradation >20%) iteration optimization: multiple experiments accidentally found under specific process, accidentally found not only improve extraction efficiency, also trigger active ingredient synergistic jump, such as immune index increases 40%, swimming time prolongs 30%, far beyond expectation, make great progress.

[0006] In view of the deficiency of the prior art, the present application provides a preparation method of polysaccharide, characterized in that it comprises a water extraction-alcohol extraction synergistic extraction step: astragalus, codonopsis, rhizoma polygonati, licorice, jujube, and psoralea are placed in an extraction tank, deionized water is added, L-tartaric acid is used to adjust the pH to 3.5-4.5, and dynamic reflux extraction is carried out at 90-95°C for 1.5-2.5h to promote the directional degradation of polysaccharide into low molecular active fragments; additionally, yam, poria cocos, lotus seed, and coix seed are added to an ethanol solution, and reflux extraction is carried out at 75-85°C for 1.0-1.5h; the extraction liquids are combined and concentrated to obtain a polysaccharide extract; further, a β-cyclodextrin inclusion step is included: the concentrated extract and a β-cyclodextrin solution are stirred at 55-65°C for 40-60min to further modify the polysaccharide complex and improve its bioavailability.

[0007] The present application also provides a preparation method of a medicine food homologous paste for invigorating the spleen and kidney, enhancing immunity, and resisting fatigue, and the specific preparation steps are as follows: S1, raw material pretreatment: 25-35 g of astragalus, 15-25 g of codonopsis, 20-30 g of yam, 10-20 g of poria cocos, 10-20 g of lotus seed, 8-12 g of rhizoma polygonati, 8-12 g of jujube, 10-15 g of coix seed, 8-12 g of lily, 4-8 g of licorice, and 3-6 g of psoralea are weighed, and impurities are removed after cleaning. The astragalus, codonopsis, rhizoma polygonati, licorice, and psoralea are cut into 1-2 mm slices with a slicing machine; the yam, poria cocos, lotus seed, and coix seed are crushed with a crusher and passed through a 60-100 mesh screen; the jujube is cored and pulped; then all the materials are placed in a hot air drying oven and dried at 55-65°C for 2-3h for standby. This step increases the specific surface area through slicing and gradient crushing, reduces the loss of heat-sensitive components, and lays a foundation for efficient extraction.

[0008] S2, water extraction-alcohol extraction synergistic extraction: the dried radix astragali, radix codonopsis, rhizoma polygonati, radix glycyrrhizae, red jujube paste, and fructus forsythiae obtained in step S1 were placed in an extraction tank, 0.5-1.0 L of deionized water was added, L-tartaric acid was used to adjust the pH to 3.5-4.5, and dynamic reflux extraction was performed at 90-95°C for 1.5-2.5 h, the operation was repeated twice, and the filtrates were combined. The yam, poria cocos, lotus seed, and coix seed powder obtained in step S1 were placed in another extraction tank, 0.3-0.4 L of 65-75% ethanol solution was added, and reflux extraction was performed at 75-85°C for 1.0-1.5 h. The two extraction solutions were combined and concentrated under reduced pressure to a relative density of 1.15 (60°C) using a rotary evaporator at 60°C and -0.1 MPa, and a concentrated paste was obtained. This step utilizes the acidic environment provided by L-tartaric acid to complex metal ions, while promoting the directional hydrolysis of polysaccharides and improving immune activity.

[0009] S3, β-cyclodextrin inclusion and concentrated paste collection: 8-15 g of β-cyclodextrin was dissolved in 40-60 mL of pure water at 60-70°C, and the concentrated paste obtained in step S2 was slowly added under constant stirring at 300 rpm using a magnetic stirrer at 55-65°C. The mixture was stirred for 40-60 min. Then, edible honey was preheated to 110-120°C for 20-30 min, cooled to 80-90°C, and 45-55 mL was taken and added to the above inclusion paste. The mixture was stirred at 65-75°C under vacuum at -0.08 MPa for 40-60 min, and a paste was obtained. This step achieves taste masking and solubilization by β-cyclodextrin inclusion of flavonoid saponins, and promotes Maillard reaction by vacuum dehydration to form a natural preservative layer.

[0010] S4, sterilization and filling: the paste obtained in step S3 was hot-filled into brown glass bottles that had been sterilized at 121°C for 15 min, and then treated in a water bath type rotary sterilization cabinet at 110-115°C for 12-18 min, followed by rapid cooling to 25°C using a cold water circulation system within 5 min. This step combines dynamic rotation with instantaneous cooling to completely kill heat-resistant spores, avoid degradation of heat-sensitive components, and ensure a shelf life of more than 12 months.

[0011] Preferably: in step S1, 29-31 g of radix astragali, 19-21 g of radix codonopsis, 24-26 g of yam, 14-16 g of poria cocos, 14-16 g of lotus seed, 9-11 g of rhizoma polygonati, 9-11 g of red jujube, 12-13 g of coix seed, 9-11 g of lily, 5-7 g of radix glycyrrhizae, and 4-5 g of fructus forsythiae were used.

[0012] Further preferably: in the step S1, the Astragalus 29 g, Codonopsis 19 g, Yam 24 g, Poria 14 g, Lotus seed 14 g, Yu 9 g, Red dates 9 g, Yiyiren 12 g, Lily 9 g, Licorice 5 g, Psoralea 4 g.

[0013] Preferably: in the step S1, the hot air drying temperature is 59~61℃, and the drying time is 2~3 h.

[0014] Further preferably: in the step S1, the hot air drying temperature is 59℃, and the drying time is 2 h.

[0015] Preferably: in the step S2, the amount of deionized water used in water extraction is 0.7~0.8 L, the pH is adjusted to 3.9~4.1, the extraction temperature is 92~93℃, and the extraction time is 1.9~2.1 h.

[0016] Further preferably: in the step S2, the amount of deionized water used in water extraction is 0.7 L, the pH is adjusted to 3.9, the extraction temperature is 92℃, and the extraction time is 1.9 h.

[0017] Preferably: in the step S2, the alcohol extraction is carried out with 70% ethanol, the amount of ethanol used is 0.3~0.4 L, the extraction temperature is 80℃, and the extraction time is 1.2~1.3 h.

[0018] Further preferably: in the step S2, the alcohol extraction is carried out with 70% ethanol, the amount of ethanol used is 0.3 L, the extraction temperature is 80℃, and the extraction time is 1.2 h.

[0019] Preferably: in the step S3, the amount of β-cyclodextrin used is 11~13 g, the amount of water used for dissolution is 48~52 mL, the stirring temperature is 59~61℃, and the stirring time is 48~52 min.

[0020] Further preferably: in the step S3, the amount of β-cyclodextrin used is 11 g, the amount of water used for dissolution is 48 mL, the stirring temperature is 59℃, and the stirring time is 48 min.

[0021] Preferably: in the step S3, the preheating temperature of refined honey is 114~116℃, the amount of refined honey added is 49~51 mL, the vacuum stirring temperature is 69~71℃, and the time is 48~52 min.

[0022] Further preferably: in the step S3, the preheating temperature of refined honey is 114℃, the amount of refined honey added is 49 mL, the vacuum stirring temperature is 69℃, and the time is 48 min.

[0023] Preferably: in the step S4, the sterilization temperature is 112~113℃, and the time is 14~16 min.

[0024] It is further preferred that the sterilization temperature in step S4 is 112 DEG C and the time is 14 min.

[0025] Preferably, the medicinal materials used in the application are purchased from Beijing Tong Ren Tang (Group) Co., Ltd. In step S1, the slicing machine is JQ-200A purchased from Beijing Precision Instrument Factory, the pulverizer is FW-100 purchased from Tianjin Test Instrument Co., Ltd., and the hot air drying oven is DHG-9240A purchased from Shanghai Yiheng Scientific Instrument Co., Ltd. In step S2, the rotary evaporator is RE-52AA purchased from Shanghai Alex Biochemical Instrument Factory. In step S4, the sterilization cabinet is YXQ-LS-50SII purchased from Shanghai Bo Xun Industry Co., Ltd.

[0026] The application has the following advantages: 1. The application uses psoralea corylifolia L. as the monarch drug together with astragalus and codonopsis pilosula to construct the core treatment method of "spleen and kidney tonification", which strengthens the effect of invigorating the spleen and tonifying qi and mildly enhances the bone marrow hematopoietic function.

[0027] 2. The application introduces L-tartaric acid for controllable acid hydrolysis to directionally degrade the macromolecular polysaccharide in the medicinal materials into low-molecular-weight polysaccharide and oligosaccharide, thereby significantly improving the immune regulation activity.

[0028] 3. The application uses β-cyclodextrin to molecularly include the bitter components such as saponins, thereby effectively masking the bad taste and improving the taste of the paste.

[0029] 4. The β-cyclodextrin inclusion technology in the application converts the fat-soluble active ingredients into water-soluble complexes, thereby enhancing the dissolution and absorption efficiency of the ingredients in the gastrointestinal tract. Through optimization of the sterilization process, the microorganisms are effectively controlled, and the active ingredients of the product are maximally reserved.

[0030] 5. The water extraction-alcohol extraction synergistic extraction may promote the directional degradation of polysaccharide into low-molecular-weight active fragments (such as astragalus polysaccharide chain breakage to improve dissolution) and extract saponins (such as psoralen saponins) by regulating the pH (3.5-4.5) through L-tartaric acid, and these components further activate the immune pathways (such as improving the spleen index) and energy metabolism (such as reducing serum lactate dehydrogenase), thereby achieving the effects of invigorating the spleen and tonifying qi and anti-fatigue. Similarly, the β-cyclodextrin inclusion is speculated to mask the bitter taste of saponins (form stable complexes) by molecular inclusion, thereby improving the taste and utilization rate, and the dynamic rotation sterilization + instantaneous cooling reduces the thermal damage (retention rate 92%), thereby enhancing the stability. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 The figure shows the comparison of the paste prepared by different monarch-subordinate combinations in examples 1-4 and comparative examples 1-2 of the application on the kidney function index and spleen deficiency improvement index of the spleen and kidney yang deficiency model rats.

[0032] Figure 2 This is a graph showing the relationship between L-tartaric acid and the molecular weight distribution of polysaccharide components in traditional Chinese medicine pastes and their macrophage immune activity in Examples 2 and Comparative Examples 3-4 of the present invention.

[0033] Figure 3 This is a graph showing the effect of β-cyclodextrin inclusion on the taste and saponin dissolution of the herbal paste in Example 2 and Comparative Examples 5-6 of the present invention.

[0034] Figure 4 and Figure 5 This is a photograph of the actual product of the herbal paste of this invention. Detailed Implementation

[0035] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0036] In this invention, the Astragalus membranaceus, Codonopsis pilosula, Dioscorea opposita, Poria cocos, Nelumbo nucifera, Polygonatum sibiricum, jujube, Coix lacryma-jobi, lily bulb, licorice, and Psoralea corylifolia used were all purchased from the market, and their quality all met the pharmacopoeia standards.

[0037] Example 1

[0038] S1. Raw Material Pretreatment: Weigh 25 g of Astragalus membranaceus, 15 g of Codonopsis pilosula, 20 g of Dioscorea opposita, 10 g of Poria cocos, 10 g of Nelumbo nucifera, 8 g of Polygonatum sibiricum, 8 g of Jujube, 10 g of Coix lacryma-jobi, 8 g of Lilium brownii, 4 g of Glycyrrhiza uralensis, and 3 g of Psoralea corylifolia. Clean and remove impurities. Slice Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, and Psoralea corylifolia into 1 mm thin slices using a slicer; pulverize Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi using a pulverizer and pass through a 60-mesh sieve; remove the pits from the Jujube and pulp it; then place all materials in a hot air drying oven and dry at 55℃ for 2 hours for later use. This step increases the specific surface area through thin slicing and gradient pulverization, reducing the loss of heat-sensitive components and laying the foundation for efficient extraction.

[0039] S2. Co-extraction with water and alcohol: The dried Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, jujube pulp, and Psoralea corylifolia obtained in step S1 were placed in an extraction tank, 0.5 L of deionized water was added, and the pH was adjusted to 3.5 with L-tartaric acid. The mixture was dynamically refluxed at 90℃ for 1.5 h, and this process was repeated twice. The filtrates were combined. Separately, the powdered Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi obtained in step S1 were placed in another extraction tank, 0.3 L of 65% ethanol solution was added, and the mixture was refluxed at 75℃ for 1.0 h. The two extracts were combined and concentrated under reduced pressure at 60℃ and -0.1 MPa using a rotary evaporator to a relative density of 1.15 (60℃) to obtain a concentrated extract. This step utilizes the acidic environment provided by L-tartaric acid to complex metal ions and simultaneously promotes the targeted hydrolysis of polysaccharides, thereby enhancing immune activity.

[0040] S3, β-Cyclodextrin Inclusion and Concentration: Weigh 8 g of β-cyclodextrin and dissolve it in 40 mL of purified water at 60°C. Stir continuously with a magnetic stirrer at 300 rpm at 55°C. Slowly add this solution to the concentrated paste obtained in step S2 and stir at a constant temperature for 40 min. Then, preheat edible honey to 110°C and maintain the temperature for 20 min. After cooling to 80°C, measure 45 mL of the honey and add it to the above inclusion paste. Stir under vacuum conditions of 65°C and -0.08 MPa for 40 min to obtain the paste. This step achieves flavor masking and solubilization through the inclusion of flavonoid saponins by β-cyclodextrin, while vacuum dehydration promotes the Maillard reaction, forming a natural preservative layer.

[0041] S4. Sterilization and Filling: While still hot, the paste obtained in step S3 is filled into brown glass bottles that have been autoclaved at 121°C for 15 minutes. The bottles are then treated in a water bath rotary sterilizer at 110°C for 12 minutes, followed by rapid cooling to 25°C within 5 minutes using a cold water circulation system. This step, through a combination of dynamic rotation and instantaneous cooling, thoroughly kills heat-resistant spores, prevents degradation of heat-sensitive components, and ensures a shelf life of over 12 months at room temperature.

[0042] Example 2

[0043] S1. Raw Material Pretreatment: Weigh out 29 g of Astragalus membranaceus, 19 g of Codonopsis pilosula, 24 g of Dioscorea opposita, 14 g of Poria cocos, 14 g of Nelumbo nucifera, 9 g of Polygonatum sibiricum, 9 g of Jujube, 12 g of Coix lacryma-jobi, 9 g of Lilium brownii, 5 g of Glycyrrhiza uralensis, and 4 g of Psoralea corylifolia. Clean and remove impurities. Slice Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, and Psoralea corylifolia into 1 mm thin slices using a slicer; pulverize Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi using a pulverizer and pass through a 76-mesh sieve; remove the pits from the Jujube and pulp it; then place all materials in a hot air drying oven and dry at 59℃ for 2 hours for later use. This step increases the specific surface area through thin slicing and gradient pulverization, reducing the loss of heat-sensitive components and laying the foundation for efficient extraction.

[0044] S2. Co-extraction with water and alcohol: The dried Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, jujube pulp, and Psoralea corylifolia obtained in step S1 were placed in an extraction tank, 0.7 L of deionized water was added, and the pH was adjusted to 3.9 with L-tartaric acid. The mixture was dynamically refluxed at 92℃ for 1.9 h, and this process was repeated twice. The filtrates were combined. Separately, the powdered Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi obtained in step S1 were placed in another extraction tank, 0.3 L of 70% ethanol solution was added, and the mixture was refluxed at 80℃ for 1.2 h. The two extracts were combined and concentrated under reduced pressure at 60℃ and -0.1 MPa using a rotary evaporator to a relative density of 1.15 (60℃) to obtain a concentrated extract. This step utilizes the acidic environment provided by L-tartaric acid to complex metal ions and simultaneously promotes the targeted hydrolysis of polysaccharides, thereby enhancing immune activity.

[0045] S3, β-Cyclodextrin Inclusion and Concentration: Weigh 11 g of β-cyclodextrin and dissolve it in 48 mL of purified water at 64°C. Stir continuously with a magnetic stirrer at 300 rpm at 59°C. Slowly add this solution to the concentrated paste obtained in step S2 and stir at a constant temperature for 48 min. Then, preheat edible honey to 114°C and maintain the temperature for 24 min. After cooling to 84°C, measure 49 mL of the honey and add it to the above inclusion paste. Stir under vacuum conditions of 69°C and -0.08 MPa for 48 min to obtain the paste. This step achieves flavor masking and solubilization through the inclusion of flavonoid saponins by β-cyclodextrin, while vacuum dehydration promotes the Maillard reaction, forming a natural preservative layer.

[0046] S4. Sterilization and Filling: While still hot, the paste obtained in step S3 is filled into brown glass bottles that have been autoclaved at 121°C for 15 minutes. The bottles are then treated in a water bath rotary sterilizer at 112°C for 14 minutes, followed by rapid cooling to 25°C within 5 minutes using a cold water circulation system. This step, through a combination of dynamic rotation and instantaneous cooling, thoroughly kills heat-resistant spores, prevents degradation of heat-sensitive components, and ensures a shelf life of over 12 months at room temperature.

[0047] Example 3

[0048] S1. Raw Material Pretreatment: Weigh out 31 g of Astragalus membranaceus, 21 g of Codonopsis pilosula, 26 g of Dioscorea opposita, 16 g of Poria cocos, 16 g of Nelumbo nucifera, 11 g of Polygonatum sibiricum, 11 g of Jujube, 13 g of Coix lacryma-jobi, 11 g of Lilium brownii, 7 g of Glycyrrhiza uralensis, and 5 g of Psoralea corylifolia. Clean and remove impurities. Slice Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, and Psoralea corylifolia into 2 mm thin slices using a slicer; pulverize Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi using a pulverizer and pass through an 84-mesh sieve; remove the pits from Jujube and pulp it; then place all materials in a hot air drying oven and dry at 61℃ for 3 hours for later use. This step increases the specific surface area through thin slicing and gradient pulverization, reducing the loss of heat-sensitive components and laying the foundation for efficient extraction.

[0049] S2. Co-extraction with water and alcohol: The dried Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, jujube pulp, and Psoralea corylifolia obtained in step S1 were placed in an extraction tank, 0.8 L of deionized water was added, and the pH was adjusted to 4.1 with L-tartaric acid. The mixture was dynamically refluxed at 93℃ for 2.1 h, and this process was repeated twice. The filtrates were combined. Separately, the powdered Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi obtained in step S1 were placed in another extraction tank, 0.4 L of 70% ethanol solution was added, and the mixture was refluxed at 80℃ for 1.3 h. The two extracts were combined and concentrated under reduced pressure at 60℃ and -0.1 MPa using a rotary evaporator to a relative density of 1.15 (60℃) to obtain a concentrated extract. This step utilizes the acidic environment provided by L-tartaric acid to complex metal ions and simultaneously promotes the targeted hydrolysis of polysaccharides, thereby enhancing immune activity.

[0050] S3, β-Cyclodextrin Inclusion and Concentration: Weigh 13 g of β-cyclodextrin and dissolve it in 52 mL of purified water at 66°C. Stir continuously with a magnetic stirrer at 300 rpm at 61°C. Slowly add this solution to the concentrated paste obtained in step S2 and stir at a constant temperature for 52 min. Then, preheat edible honey to 116°C and maintain the temperature for 26 min. After cooling to 86°C, measure 51 mL of the honey and add it to the above inclusion paste. Stir under vacuum conditions of 71°C and -0.08 MPa for 52 min to obtain the paste. This step achieves flavor masking and solubilization through the inclusion of flavonoid saponins by β-cyclodextrin, while vacuum dehydration promotes the Maillard reaction, forming a natural preservative layer.

[0051] S4. Sterilization and Filling: While still hot, the paste obtained in step S3 is filled into brown glass bottles that have been autoclaved at 121°C for 15 minutes. The bottles are then treated in a water bath rotary sterilizer at 113°C for 16 minutes, followed by rapid cooling to 25°C within 5 minutes using a cold water circulation system. This step, through a combination of dynamic rotation and instantaneous cooling, thoroughly kills heat-resistant spores, prevents degradation of heat-sensitive components, and ensures a shelf life of over 12 months at room temperature.

[0052] Example 4

[0053] S1. Raw Material Pretreatment: Weigh out 35 g of Astragalus membranaceus, 25 g of Codonopsis pilosula, 30 g of Dioscorea opposita, 20 g of Poria cocos, 20 g of Nelumbo nucifera, 12 g of Polygonatum sibiricum, 12 g of Jujube, 15 g of Coix lacryma-jobi, 12 g of Lilium brownii, 8 g of Glycyrrhiza uralensis, and 6 g of Psoralea corylifolia. Clean and remove impurities. Slice Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, and Psoralea corylifolia into 2 mm thin slices using a slicer; pulverize Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi using a pulverizer and pass through a 100-mesh sieve; remove the pits from Jujube and pulp it; then place all materials in a hot air drying oven and dry at 65℃ for 3 hours for later use. This step increases the specific surface area through thin slicing and gradient pulverization, reducing the loss of heat-sensitive components and laying the foundation for efficient extraction.

[0054] S2. Co-extraction of water and alcohol: The dried Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, jujube pulp, and Psoralea corylifolia obtained in step S1 were placed in an extraction tank, 1.0 L of deionized water was added, and the pH was adjusted to 4.5 with L-tartaric acid. The mixture was dynamically refluxed at 95℃ for 2.5 h, and this process was repeated twice. The filtrates were combined. Separately, the powdered Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi obtained in step S1 were placed in another extraction tank, and 0.4 L of 75% ethanol solution was added. The mixture was refluxed at 85℃ for 1.5 h. The two extracts were combined and concentrated under reduced pressure at 60℃ and -0.1 MPa using a rotary evaporator to a relative density of 1.15 (60℃) to obtain a concentrated extract. This step utilizes the acidic environment provided by L-tartaric acid to complex metal ions and simultaneously promotes the targeted hydrolysis of polysaccharides, thereby enhancing immune activity.

[0055] S3, β-Cyclodextrin Inclusion and Concentration: Weigh 15 g of β-cyclodextrin and dissolve it in 60 mL of purified water at 70°C. Stir continuously with a magnetic stirrer at 300 rpm at 65°C. Slowly add this solution to the concentrated paste obtained in step S2 and stir at a constant temperature for 60 min. Then, preheat edible honey to 120°C and maintain the temperature for 30 min. After cooling to 90°C, measure 55 mL of the honey and add it to the above inclusion paste. Stir under vacuum conditions of 75°C and -0.08 MPa for 60 min to obtain the paste. This step achieves flavor masking and solubilization through the inclusion of flavonoid saponins by β-cyclodextrin, while vacuum dehydration promotes the Maillard reaction, forming a natural preservative layer.

[0056] S4. Sterilization and Filling: While still hot, the paste obtained in step S3 is filled into brown glass bottles that have been autoclaved at 121°C for 15 minutes. The bottles are then treated in a water bath rotary sterilizer at 115°C for 18 minutes, followed by rapid cooling to 25°C within 5 minutes using a cold water circulation system. This step, through a combination of dynamic rotation and instantaneous cooling, thoroughly kills heat-resistant spores, prevents degradation of heat-sensitive components, and ensures a shelf life of over 12 months at room temperature.

[0057] Comparative Example 1: Except for step S1, which does not include psoralen, all other steps are the same as in Example 2.

[0058] Comparative Example 2: Except for replacing the psoralea corylifolia in step S1 with an equal amount of wolfberry, all other steps are the same as in Example 2.

[0059] Comparative Example 3: Except for step S2, in which L-tartaric acid was not added during water extraction, all other steps were the same as in Example 2.

[0060] Comparative Example 4: Except for replacing L-tartaric acid with an equal amount of citric acid in step S2, all other steps are the same as in Example 2.

[0061] Comparative Example 5: Except for step S3, which does not use β-cyclodextrin, all other steps are the same as in Example 2.

[0062] Comparative Example 6: Except for step S3, in which hydroxypropyl methylcellulose (HPMC) was used instead of β-cyclodextrin, all other steps were the same as in Example 2.

[0063] Comparative Example 7: Except for step S4, which uses static autoclaving, i.e., autoclaving at 121°C for 20 min followed by natural cooling to room temperature, all other steps are the same as in Example 2.

[0064] Comparative Example 8: Except for step S4, which uses pasteurization, i.e., pasteurization at 85°C for 35 min followed by natural cooling to room temperature, all other steps are the same as in Example 2.

[0065] I. Verifying the necessity of the principal and assistant formula of Psoralea corylifolia One hundred and sixty SPF-grade SD rats (half male and half female, initial weight 180±20 g) were used for the experiment after 3 days of acclimatization. A spleen-kidney yang deficiency animal model was established by intraperitoneal injection of hydrocortisone (25 mg / kg body weight daily) for 14 consecutive days, combined with 4°C low-temperature stimulation (4 h daily). Successful model establishment was defined as follows: rats exhibited symptoms such as lethargy, brittle hair, slow weight gain, and aversion to cold and curling up; serum creatinine (Cr) and blood urea nitrogen (BUN) levels were significantly elevated (P<0.05), and D-xylose absorption rate was significantly decreased (P<0.05).

[0066] After successful model establishment, the animals were randomly divided into 8 groups of 20 each: A. Blank control group (normal feeding, no model establishment, administered an equal volume of physiological saline via gavage); B. Model group (model establishment, administered an equal volume of physiological saline via gavage); C. Example 1 group (model establishment, administered Example 1 herbal paste via gavage at a dose of 1.0 g / kg body weight); D. Example 2 group (model establishment, administered Example 2 herbal paste via gavage at a dose of 1.0 g / kg body weight); E. Example 3 group (model establishment, administered Example 3 herbal paste via gavage at a dose of 1.0 g / kg body weight); F. Example 4 group (model establishment, administered Example 4 herbal paste via gavage at a dose of 1.0 g / kg body weight); G. Comparative Example 1 group (model establishment, administered Comparative Example 1 herbal paste via gavage at a dose of 1.0 g / kg body weight); H. Comparative Example 2 group (model establishment, administered Comparative Example 2 herbal paste via gavage at a dose of 1.0 g / kg body weight). The animals were administered the medication once daily for 28 consecutive days. During the treatment period, the animals had free access to food and water, and the ambient temperature was controlled at 22±2℃ and the humidity at 55±5%.

[0067] Detection indicators and methods: After fasting for 12 hours on day 29 (with unlimited water), the following indicators were detected: (1) Serum indicators: Blood was collected from the abdominal aorta, centrifuged (3000 rpm, 10 min) to separate serum, and Cr, BUN levels and D-xylose absorption rate were detected using a fully automated biochemical analyzer (model AU5800, Beckman Coulter); (2) Anti-fatigue ability: One hour after the last administration, a forced swimming test was conducted. Rats were placed in a swimming tank with a water depth of 30 cm and a water temperature of 25±1℃. The time it took for the rats to be unable to float to the surface for 8 seconds after entering the water (exhaustion time) was recorded. The experimental data were statistically analyzed using SPSS 26.0 software. One-way ANOVA was used for comparison between groups. P < 0.05 was considered statistically significant.

[0068] Table 1. Effects of the combination of Psoralea corylifolia (the main ingredient in the formula) on spleen and kidney function and anti-fatigue indicators.

[0069]

[0070] Table 1 shows the effects of the combination of Psoralea corylifolia and its principal ingredients on spleen and kidney function and anti-fatigue indicators. Figure 1 This is a comparison chart showing the effects of different principal-assistant combinations of herbal pastes prepared in Examples 1-4 and Comparative Examples 1-2 of this invention on renal function indicators and spleen deficiency improvement indicators in rats with a spleen-kidney yang deficiency model. (Table 1 and...) Figure 1It was found that the levels of Cr and BUN in the model group rats were significantly increased, while the D-xylose absorption rate and exhaustion time were significantly decreased, indicating that the spleen and kidney yang deficiency model was successfully established. Compared with the model group, all treatment groups significantly improved the above indicators (P < 0.05), but the indicators of the groups in Examples 1-4 recovered to near the level of the blank control group, and were significantly better than those in Comparative Example 1 (without Psoralea corylifolia) and Comparative Example 2 (Psoralea corylifolia replaced with Lycium barbarum) (P < 0.05). This demonstrates that the combination of Psoralea corylifolia with Astragalus membranaceus and Codonopsis pilosula can synergistically activate the dual function of spleen and kidney tonification, which is the key to achieving the effects of invigorating the spleen and replenishing qi and anti-fatigue, and none of them can be omitted.

[0071] II. Verification of the effects of L-tartaric acid on polysaccharide components and immune activity 1. Determination of polysaccharide molecular weight distribution using gel permeation chromatography: ① Sample pretreatment: Take 1.0 g each of the pastes from Examples 2 and Comparative Examples 3-4, accurate to 0.001 g, add 4 times the volume of anhydrous ethanol, let stand overnight at 4℃ for alcohol precipitation, centrifuge (4000 rpm, 10 min), collect the precipitate, redissolve in deionized water (concentration 1.0 mg / mL), filter through a 0.45 μm microporous membrane, and inject the sample; ② Detection conditions: Use a Waters 1515 gel permeation chromatography system (equipped with a TSK-GEL G4000PWxl column), column temperature 30℃, mobile phase deionized water, flow rate 1.0 mL / min, monitor the elution peak with a differential refractive index detector, and measure the absolute molecular weight using a multi-angle laser light scattering instrument; ③ Standard curve: Plot a standard curve in advance using 2-5000 kDa dextran standards (lgMw = -0.2579t + 8.9888, R²=0.9986), ensuring a good linear relationship. The calculation method for the proportion of low molecular weight polysaccharides is: Low molecular weight polysaccharide proportion (%) = (Total peak area of ​​polysaccharides with a molecular weight ≤10 kDa in the sample / Total peak area of ​​polysaccharides in all molecular weight ranges of the sample) × 100%.

[0072] 2. Immunological activity was assessed using a RAW264.7 macrophage phagocytosis assay: ① Sample preparation: The pastes prepared in Examples 2, 3, and 4 were diluted to the same concentration (2.5 g / L based on crude drug weight) with D-Hanks balanced salt solution, the pH was adjusted to 7.2 with 1 M NaOH solution, and the samples were sterilized by filtration through a 0.22 μm microporous membrane. A positive control group was set up: LPS (lipopolysaccharide) was dissolved in D-Hanks balanced salt solution to prepare a solution with a concentration of 200 ng / mL, which was then sterilized by filtration through a 0.22 μm microporous membrane. A blank control group was set up: an equal volume of D-Hanks balanced salt solution was sterilized by filtration through a 0.22 μm microporous membrane. ② Cell experiments: RAW264.7 macrophages were phagocytosed at a concentration of 1×10⁻⁶ cells / mL. 4100 μL of sample solution was seeded per well in a 96-well plate and cultured at 37 °C in a 5% CO2 incubator for 24 h. The experimental group was pretreated with an equal volume (100 μL) of sample solution (final concentration 1.25 g / L) for 12 h. The positive control group was pretreated with an equal volume (100 μL) of LPS solution (final concentration 100 ng / mL) for 12 h. The blank control group was pretreated with an equal volume (100 μL) of D-Hanks balanced salt solution for 12 h. Then, fluorescently labeled E. coli (FITC-E. coli) was added at a multiplicity of infection ratio of 50:1, and incubated at 37°C for 1.5 h; ③ Detection steps: After terminating the reaction, the cells were washed three times with PBS to remove unphagocytosed free bacteria, and the cells were fixed with 4% paraformaldehyde solution for 15 min. The cell nuclei were then stained with DAPI staining solution for 5 min. Images were acquired and fluorescence intensity was analyzed using a high-content imaging system (OperettaCLS). Three replicates were set for each sample, and the experiment was repeated three times.

[0073] Table 2. Effects of L-tartaric acid on polysaccharide components and their immunomodulatory activity

[0074]

[0075] Table 2 shows the effects of L-tartaric acid on polysaccharide components and their immune activity. Figure 2 This is a graph showing the effect of L-tartaric acid on the molecular weight distribution of polysaccharide components in traditional Chinese medicine pastes and their macrophage immune activity in Examples 2 and Comparative Examples 3-4 of the present invention. (Table 2 and...) Figure 2 It can be seen that the proportion of low molecular weight polysaccharides in Example 2 was significantly higher than that in Comparative Examples 3 and 4, and the corresponding macrophage phagocytic index was also significantly higher. This indicates that the acidic environment provided by L-tartaric acid can specifically chelate metal ions, promoting the directional hydrolysis of polysaccharides into low molecular weight fragments (≤10 kDa), and low molecular weight polysaccharides have stronger immune-activating activity. Comparative Example 3 used a traditional water extraction method without acid catalysis, resulting in insufficient hydrolysis of polysaccharides; although citric acid was used as a substitute in Comparative Example 4 to promote partial hydrolysis, the effect was weaker than that of L-tartaric acid, demonstrating the specific advantage of L-tartaric acid.

[0076] III. Verification of the effects of β-cyclodextrin on taste and saponin dissolution 1. Sensory Evaluation: ① Evaluation Personnel Selection: 30 sensory evaluation personnel with no oral diseases and normal taste were recruited and trained to master the scoring criteria; ② Blind Evaluation Process: The pastes of Example 2 and Comparative Examples 5-6 were randomly provided to the evaluation personnel after being numbered. The evaluation environment was a sensory evaluation room with a temperature of 22±2℃ and no odor. The evaluation personnel rinsed their mouths with water before evaluation, and the evaluation interval between each sample was 10 minutes; ③ Detailed Scoring Criteria: 1 point (very bitter and unpalatable), 2 points (somewhat bitter and barely palatable), 3 points (slightly bitter and acceptable), 4 points (slightly sweet and basically no bitterness), 5 points (sweet and smooth with no odor and excellent taste).

[0077] 2. The determination of saponin dissolution rate was performed using high performance liquid chromatography (HPLC): ① Sample preparation: Weigh 1.0 g of the paste samples prepared in Example 2 and Comparative Examples 5-6, accurate to 0.001 g, and place them in a 50 mL centrifuge tube. Add 20 mL of 70% ethanol solution (ethanol:water = 7:3, volume ratio), shake for 2 min to fully disperse the sample, sonicate (power 200 W, frequency 40 kHz) for 30 min, then centrifuge at 4000 rpm for 10 min. Filter the supernatant through a 0.45 μm microporous membrane to obtain the test solution; ② Reference solution: Accurately weigh 10 mg of ginsenoside Rg1 reference standard (purity ≥98%), dissolve it in methanol and dilute to 10 mL to prepare a 1 mg / mL standard stock solution, then dilute to prepare a series of standard solutions of 0.02, 0.05, 0.1, 0.2, and 0.5 mg / mL; ③ Chromatographic conditions: Use a 250 mm × 4.6 chromatographic tube. A 5 μm C18 column was used at a column temperature of 30℃; the mobile phase was acetonitrile-water gradient elution (0-10 min: acetonitrile 10-20%; 10-20 min: acetonitrile 20-30%; 20-30 min: acetonitrile 30-40%), with a flow rate of 1.0 mL / min; the detection wavelength was 203 nm, and the injection volume was 10 μL; ④ Recovery experiment: A certain amount of ginsenoside Rg1 reference standard was added to a sample with known content, and the recovery rate was calculated to ensure the reliability of the method (recovery rate 95.2-102.3%, RSD < 2.0%).

[0078] Table 3. Effects of β-cyclodextrin inclusion complexation on the taste and saponin dissolution of the herbal paste.

[0079] Table 3 shows the effect of β-cyclodextrin inclusion complexation on the taste and saponin dissolution of the herbal paste. Figure 3 This is a graph showing the effect of β-cyclodextrin inclusion on the taste and saponin dissolution of the herbal paste in Example 2 and Comparative Examples 5-6 of the present invention. (Table 3 and...) Figure 3It can be seen that the bitterness score and overall acceptability score of Example 2 were significantly higher than those of Comparative Examples 5 and 6, and the saponin dissolution rate was also significantly higher. The hydrophobic cavity of β-cyclodextrin can form inclusion complexes with saponin components, which not only masks the bitterness of saponins but also increases the water solubility of fat-soluble saponins, thereby improving dissolution rate. Although HPMC can improve some taste, its inclusion effect is weak and cannot achieve the synergistic effect of β-cyclodextrin, demonstrating the necessity of β-cyclodextrin in improving taste and enhancing bioavailability.

[0080] IV. Verify the effects of different sterilization processes on the retention rate of active ingredients and microbiological indicators. 1. The retention rate of heat-sensitive components was determined by high-performance liquid chromatography (HPLC): ① Detected components: Astragaloside A (a characteristic component of Astragalus membranaceus) and Polygonatum sibiricum polysaccharide (a characteristic component of Polygonatum sibiricum) were selected as heat-sensitive index components; ② Sample preparation: 1.0 g of the samples from Example 2 and Comparative Examples 7-8 before and after sterilization were weighed, accurate to 0.001 g. Astragaloside A determination: 20 mL of methanol was added, ultrasonicated (200 W, 40 kHz) for 30 min, centrifuged (4000 rpm, 10 min), and the supernatant was filtered through a 0.45 μm filter membrane; Polygonatum sibiricum polysaccharide determination: 20 mL of distilled water was added, ultrasonicated for 30 min, centrifuged, and the supernatant was filtered through a 0.45 μm filter membrane; ③ Chromatographic conditions (Astragaloside A): ODS column (250 mm × 4.0 mm, 5 μm), column temperature 40℃, mobile phase acetonitrile-water (36:64, v / v), flow rate 0.6 mL / min, detection wavelength 203 nm. nm, injection volume 20 μL; ④ Precision experiment: inject the same reference solution 6 times consecutively, and the peak area RSD < 2.0% to ensure the stability of the method.

[0081] 2. Detection of Microbial Indicators: ① Dilution Procedure: Aseptically weigh 10 g of the paste samples from Example 2 and Comparative Examples 7-8, add 90 mL of sterile physiological saline, homogenize in a homogenizer for 2 min to prepare a 1:10 test solution. Further dilute 1 mL of the 1:10 test solution with 9 mL of sterile physiological saline to prepare a 1:100 test solution; ② Culture Conditions: Inject 1 mL of the 1:100 dilution into sterile plates. Set up 3 parallel plates for each dilution. Add nutrient agar medium (for detecting total colony count) and Bengal red agar medium (for detecting mold and yeast count) cooled to 45±1℃, respectively. Gently shake to fully mix the bacterial solution with the medium. After the medium solidifies, invert the plates for incubation. The culture conditions for total colony count are 36±1℃ for 48±2 h, and the culture conditions for mold and yeast count are 28±1℃ for 72±2 h; ③ Result determination: After the culture is completed, plates with colony counts between 30 and 300 are selected for counting, and the average value is calculated; if the colony counts of all plates are less than 30, they are calculated as 30; if they are all greater than 300, they are calculated according to the colony count of the lowest dilution plate; at the same time, a blank control (sterile physiological saline) is set up to ensure that the experiment is free from contamination by other microorganisms; ④ Microbiological control standards: According to the National Food Safety Standard for Health Food GB 16740-2014, the total colony count is ≤1000 CFU / g, the number of molds and yeasts is ≤100 CFU / g, and coliform bacteria, Salmonella, and Staphylococcus aureus must not be detected.

[0082] Table 4. Effects of different sterilization processes on the retention rate of active ingredients and microbiological indicators.

[0083]

[0084] Table 4 shows the effects of different sterilization processes on the retention rate of active ingredients and microbial indicators. The results in Table 4 show that: Comparative Example 7 (static high-pressure sterilization) achieved the strongest sterilization effect, but its 121℃ high-temperature and high-pressure environment led to severe thermal degradation of heat-sensitive components; the retention rate of astragaloside A was only 72.4±4.2%, and the retention rate of Polygonatum polysaccharide was only 68.5±3.9%. Comparative Example 8 (85℃ pasteurization) reduced the rapid degradation of heat-sensitive components to some extent and had a relatively good retention effect, but the 35-minute low-temperature long-time treatment mode could not completely kill heat-resistant spores and other microorganisms, resulting in a total bacterial count as high as 1860±120 CFU / g, exceeding the GB standard. The limits set by ISO 16740-2014 pose safety hazards. However, the "dynamic rotary sterilization + instantaneous cooling" process used in Example 2 achieves synergistic optimization of microbial control and active ingredient retention. On the one hand, the dynamic rotation module constructs a uniform temperature field (temperature difference ≤ ±0.5℃) throughout the sterilization chamber through forced convection and material tumbling, eliminating the problem of local overheating caused by heat transfer gradients in static sterilization mode. This avoids the glycosidic bond breakage and polysaccharide chain depolymerization caused by local overheating of components such as astragaloside A and Polygonatum polysaccharides. The instantaneous cooling unit rapidly reduces the material from the sterilization temperature to room temperature, which is much shorter than the heat preservation time of 85℃ pasteurization in the comparative example. This significantly reduces the cumulative damage caused by heat. Therefore, the retention rates of astragaloside A and Polygonatum polysaccharides can reach 92.6±2.0 and 92.7±2.8, respectively, which are better than those of comparative example 8. On the other hand, the uniform heating effect brought about by dynamic rotation ensures that the sterilization process is thorough and without dead angles, so that the total number of colonies, mold, and yeast counts all meet the GB16740-2014 standard, and the sterilization effect is stable and reliable. In summary, the dynamic rotation sterilization combined with instantaneous cooling process adopted in this invention can completely kill microorganisms and ensure product safety while minimizing the degradation of heat-sensitive active ingredients. It effectively solves the technical pain points of "incomplete sterilization" or "serious loss of ingredients" in traditional sterilization processes, and provides key technical support for extending product shelf life and maintaining the stability of the efficacy of herbal pastes.

[0085] During the research and development of this invention, through literature review and parameter iteration experiments, it was unexpectedly discovered that only this specific process combination can trigger a synergistic leap in active ingredients; further exploration of the potential of this process in regulating gut microbiota and other aspects can expand its multifunctional applications.

[0086] The above-described embodiments are merely illustrative of specific implementations of the present invention, and while the descriptions are detailed, they should not be construed as limiting the scope of protection of the present invention. It should be noted that for those skilled in the art, any changes, modifications, substitutions, combinations, or simplifications made without departing from the spirit and principle of the present invention should be considered equivalent substitutions and are included within the scope of protection of the present invention.

Claims

1. A method for preparing a polysaccharide, characterized in that, The extraction process includes a water-ethanol synergistic extraction step: Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, Ziziphus jujuba, and Psoralea corylifolia are placed in an extraction tank, deionized water is added, and the pH is adjusted to 3.5-4.5 with L-tartaric acid. The mixture is then dynamically refluxed at 90-95℃ for 1.5-2.5 hours to promote the directed degradation of polysaccharides into low-molecular-weight active fragments. Separately, Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi are added to an ethanol solution and refluxed at 75-85℃ for 1.0-1.5 hours. The extracts are combined and concentrated to obtain the polysaccharide extract. The process also includes a β-cyclodextrin inclusion step: the concentrated extract is stirred with a β-cyclodextrin solution at 55-65℃ for 40-60 minutes to further modify the polysaccharide complex and improve its bioavailability.

2. A method for preparing a Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste, characterized in that: Includes the following steps: Raw material pretreatment: Astragalus membranaceus, Codonopsis pilosula, Dioscorea opposita, Poria cocos, Nelumbo nucifera, Polygonatum sibiricum, jujube, Coix lacryma-jobi, lily bulb, licorice, and Psoralea corylifolia are cleaned, sliced, crushed, and dried. Water-ethanol co-extraction: Part of the raw material is extracted by reflux in an acidic aqueous solution, and the other part is extracted in an ethanol solution. The extracts are combined and concentrated. β-Cyclodextrin inclusion and concentration: The concentrated paste is mixed with β-cyclodextrin solution for inclusion, and then refined honey is added and vacuum stirred to concentrate the paste. Sterilization and filling: After the paste is filled, it is subjected to rotary dynamic sterilization and instantaneous cooling.

3. The preparation method of the Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste according to claim 2, characterized in that: The specific preparation method of the herbal paste is as follows: S1. Raw material pretreatment: Weigh 25-35 g of Astragalus membranaceus, 15-25 g of Codonopsis pilosula, 20-30 g of Dioscorea opposita, 10-20 g of Poria cocos, 10-20 g of Nelumbo nucifera, 8-12 g of Polygonatum sibiricum, 8-12 g of Jujube, 10-15 g of Coix lacryma-jobi, 8-12 g of Lilium brownii, 4-8 g of Glycyrrhiza uralensis, and 3-6 g of Psoralea corylifolia. Slice Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, and Psoralea corylifolia into 1-2 mm thin slices using a slicer; pulverize Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi using a pulverizer and pass them through a 60-100 mesh sieve; remove the pits from the Jujube and pulp it; then place all materials in a hot air drying oven and dry at 55-65℃ for 2-3 hours for later use. S2. Co-extraction of water and alcohol: The dried Astragalus membranaceus, Codonopsis pilosula, Polygonatum sibiricum, Glycyrrhiza uralensis, jujube pulp, and Psoralea corylifolia obtained in step S1 are placed in an extraction tank, 0.5-1.0 L of deionized water is added, and the pH is adjusted to 3.5-4.5 with L-tartaric acid. The mixture is dynamically refluxed at 90-95℃ for 1.5-2.5 h, and the operation is repeated twice. The filtrates are combined. Separately, the powders of Dioscorea opposita, Poria cocos, Nelumbo nucifera, and Coix lacryma-jobi obtained in step S1 are placed in another extraction tank, 0.3-0.4 L of 65-75% ethanol solution is added, and the mixture is refluxed at 75-85℃ for 1.0-1.5 h. The two extracts are combined, and the mixture is concentrated under reduced pressure at 60℃ and -0.1 MPa using a rotary evaporator to a relative density of 1.15 to obtain a concentrated extract. S3, β-Cyclodextrin Inclusion and Concentration: Weigh 8-15 g of β-cyclodextrin and dissolve it in 40-60 mL of purified water at 60-70℃. Stir continuously with a magnetic stirrer at 300 rpm at 55-65℃. Slowly add the solution to the concentrated paste obtained in step S2 and stir at a constant temperature for 40-60 min. Then, preheat edible honey to 110-120℃ and maintain the temperature for 20-30 min. After cooling to 80-90℃, measure 45-55 mL of the honey and add it to the above inclusion paste. Stir at 65-75℃ and -0.08 MPa vacuum for 40-60 min to obtain the paste. S4. Sterilization and filling: While the paste obtained in step S3 is still hot, it is filled into brown glass bottles that have been autoclaved at 121°C for 15 minutes. The bottles are then treated in a water bath rotary sterilizer at 110-115°C for 12-18 minutes, and then rapidly cooled to 25°C within 5 minutes using a cold water circulation system.

4. The preparation method of the Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste according to claim 2, characterized in that: In step S1, weigh out 29-31 g of Astragalus membranaceus, 19-21 g of Codonopsis pilosula, 24-26 g of Dioscorea opposita, 14-16 g of Poria cocos, 14-16 g of Nelumbo nucifera, 9-11 g of Polygonatum sibiricum, 9-11 g of jujube, 12-13 g of Coix lacryma-jobi, 9-11 g of lily bulb, 5-7 g of Glycyrrhiza uralensis, and 4-5 g of Psoralea corylifolia.

5. The method for preparing a Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste according to claim 3, characterized in that: In step S1, the hot air drying temperature is 59~61℃ and the drying time is 2~3 h; in step S2, the amount of deionized water used during water extraction is 0.7~0.8 L, the pH is adjusted to 3.9~4.1, the extraction temperature is 92~93℃, and the extraction time is 1.9~2.1 h.

6. The method for preparing a Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste according to claim 5, characterized in that: In step S2, the ethanol mass fraction is 70%, the amount used is 0.3~0.4 L, the extraction temperature is 80℃, and the extraction time is 1.2~1.3 h.

7. The method for preparing a Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste according to claim 2, characterized in that: In step S3, the amount of β-cyclodextrin used is 11~13 g, the amount of water used for dissolution is 48~52 mL, the stirring temperature is 59~61℃, and the stirring time is 48~52 min.

8. The method for preparing a Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste according to claim 7, characterized in that: In step S3, the honey is preheated at 114~116℃, added in an amount of 49~51 mL, and the vacuum stirring temperature is 69~71℃ for 48~52 min.

9. The method for preparing a Qi-tonifying, Qi-boosting, immunity-enhancing, and fatigue-relieving Qi-tonifying paste according to claim 2, characterized in that: In step S4, the sterilization temperature is 112~113℃ and the time is 14~16 min.

10. The Qi-Qi plaster prepared by the preparation method according to any one of claims 2-9, which invigorates the spleen and replenishes Qi, enhances immunity and fights fatigue.

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