Traditional Chinese medicine composition and traditional Chinese medicine solid beverage for regulating immune function and preparation method of traditional Chinese medicine composition and traditional Chinese medicine solid beverage

Abstract

The invention relates to the technical field of solid beverages, in particular to a traditional Chinese medicine composition for regulating an immune function, a traditional Chinese medicine solid beverage and a preparation method thereof. The solid beverage capable of regulating immunity comprises a traditional Chinese medicine composition, original sugarcane sugar, sugarcane leaf polysaccharide and a composite auxiliary material, the traditional Chinese medicine composition comprises radix fici simplicissimae, exocarpium citri rubrum, white hyacinth beans, fresh ginger, pinctada martensii meat, oyster meat, Chinese dates and star anise, and the prepared solid beverage adopts pure natural products as raw materials, and is green, safe and good in taste. The radix fici simplicissimae, the Chinese dates and other plants are widely applied to food and have the immunoregulation effect.

Description

Technical Field

[0001] This invention relates to the field of solid beverage technology, and in particular to a traditional Chinese medicine composition for regulating immune function, a traditional Chinese medicine solid beverage, and a method for preparing the same. Background Technology

[0002] Immunodeficiency is one of the core pathological bases for the development of many infectious and autoimmune diseases. Globally, the number of patients suffering from recurrent infections, malignant tumors, and autoimmune diseases due to immune dysfunction has exceeded 250 million, accounting for more than 12% of the global disease burden. Currently, clinical treatment mainly uses immunomodulators or biological agents, but long-term use can easily lead to complications such as opportunistic infections and metabolic disorders. Furthermore, with increasing environmental pollution and the expanding number of patients with chronic diseases, the incidence of immunodeficiency is increasing at a rate of 8%-12% annually, showing a significant upward trend, especially among adolescents, and has become a major health problem urgently needing to be addressed in modern society. Therefore, based on this background, how to use a variety of medicinal and edible herbs, through reasonable proportions and scientific preparation methods, to prepare a uniquely flavored solid beverage with immunomodulatory effects, capable of preventing disease before it occurs and preventing the progression of existing disease, is a pressing technical problem to be solved in this field. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition for regulating immune function, a traditional Chinese medicine solid beverage, and a method for preparing the same. By using a variety of medicinal and edible herbs in a reasonable ratio and through a scientific preparation method, a solid beverage with a unique flavor is prepared. This beverage has the effect of regulating immunity, and regular consumption can prevent disease before it occurs and prevent the progression of existing diseases.

[0004] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0005] One of the technical solutions of the present invention is a traditional Chinese medicine composition comprising the following components in parts by weight: 5-20 parts of five-finger peach, 1-5 parts of tangerine peel, 1-5 parts of white hyacinth bean, 1-5 parts of ginger, 1-10 parts of pearl oyster meat, 1-10 parts of oyster meat, 1-10 parts of jujube, and 1-10 parts of star anise.

[0006] The second technical solution of the present invention is a solid beverage comprising the above-mentioned traditional Chinese medicine composition, raw sugarcane sugar, sugarcane leaf polysaccharide and compound excipients.

[0007] The third technical solution of the present invention is a method for preparing the above-mentioned solid beverage, characterized by comprising the following steps:

[0008] The mixture of five-finger peach, tangerine peel, white hyacinth bean, ginger, Pinctada martensii meat, oyster meat, jujube and star anise was immersed in water for the first extraction to obtain the first extract and raw material residue.

[0009] The raw material residue is immersed in water for a second extraction to obtain a secondary extract.

[0010] The primary and secondary extracts are combined and then concentrated, dried, pulverized, and sieved sequentially to obtain the traditional Chinese medicine composition.

[0011] The traditional Chinese medicine composition is mixed with sugarcane natural sugar and sugarcane leaf polysaccharide. After the three are mixed, they are ground into powder again, sieved, and then mixed with compound excipients. The mixture is moistened with a humectant to form a soft mass. Then, it is granulated, dried, sized, packaged, and sterilized to obtain an immune-regulating solid beverage.

[0012] The fourth aspect of this invention provides the application of the above-mentioned traditional Chinese medicine composition or the above-mentioned solid beverage in the preparation of health foods for regulating immunity.

[0013] Compared with the prior art, the present invention has the following beneficial effects:

[0014] All ingredients in this formula, including ginger, jujube, tangerine peel, and five-finger peach, have undergone rigorous screening and meet national food safety standards, ensuring the absence of any harmful substances and protecting consumers' health and safety. This solid beverage formula is scientifically sound, with most of the selected ingredients being commonly used medicinal and edible herbs or new resource foods, and the sources of these ingredients are widely available. Five-finger peach, tangerine peel, white hyacinth bean, ginger, and other plants are widely used in traditional Chinese medicine and have immunomodulatory effects. The solid beverage prepared in this invention uses commonly used traditional Chinese medicines as raw materials, making it green, safe, and with a good taste. Furthermore, the synergistic effect of these ingredients not only provides immunomodulatory benefits but also effectively regulates sub-health conditions with long-term consumption. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the preparation method of an immune-modulating solid beverage according to the present invention.

[0016] Figure 2 This is the standard curve of total polysaccharides.

[0017] Figure 3 This is a standard curve for total protein.

[0018] Figure 4 This is a response surface plot of the overall score of the immune-regulating solid beverage for each factor.

[0019] Figure 5 The figure shows the effect of an immunomodulatory solid beverage on the body weight of mice.

[0020] Figure 6 The study observed the morphology of acutely toxic organs (heart, liver, spleen, lung, and kidney) in mice. A: Male in the blank control group; B: Female in the blank control group; C: Male in the drug-treated group; D: Female in the drug-treated group.

[0021] Figure 7 The histopathological results (100X) of acute toxicity mouse organs (heart, liver, spleen, lung, kidney) are shown, where AE: heart, liver, spleen, lung, and kidney of the blank group mice; ae: heart, liver, spleen, lung, and kidney of the drug-treated group mice.

[0022] Figure 8 The histopathological results (400X) of acute toxic mouse organs (heart, liver, spleen, lung, kidney) are shown. Among them, AE: heart, liver, spleen, lung, and kidney of mice in the blank group; ae: heart, liver, spleen, lung, and kidney of mice in the treatment group.

[0023] Figure 9 Figure showing the effect of immunomodulatory solid beverage on mouse body weight (x±SD, n=12).

[0024] Figure 10 The effect of immunomodulatory solid beverages on immune organ indices (x±SD, n=12).

[0025] Note: Each data point is expressed as mean ± standard deviation. # indicates P < 0.05 compared to the control group; ## indicates P < 0.01 compared to the control group; ### indicates P < 0.001 compared to the control group; * indicates P < 0.05 compared to the model group; ** indicates P < 0.01 compared to the model group; *** indicates P < 0.001 compared to the model group, and so on.

[0026] Figure 11 The effect of immunomodulatory solid beverages on routine blood parameters (x±s, n=8).

[0027] Figure 12 The effect of immunomodulatory solid beverage on the proliferative capacity of splenic lymphocytes (x±SD, n=8).

[0028] Figure 13 The effect of immunomodulatory solid beverage on small intestinal morphology was investigated. AG: H&E-stained small intestinal tissue (100X) from the control group, model group, levamisole hydrochloride group, Zhenqi Fuzheng granule group, low-dose immunomodulatory solid beverage group, medium-dose immunomodulatory solid beverage group, and high-dose immunomodulatory solid beverage group; a–g: H&E-stained small intestinal tissue (400X) from the control group, model group, levamisole hydrochloride group, Zhenqi Fuzheng granule group, low-dose immunomodulatory solid beverage group, medium-dose immunomodulatory solid beverage group, and high-dose immunomodulatory solid beverage group.

[0029] Figure 14 Figure showing the effect of immunomodulatory solid beverage on small intestinal morphology (x±SD, n=9); where V: villus length; C: crypt depth.

[0030] Figure 15The effect of immunomodulatory solid beverage on the number of goblet cells in the small intestine (x±SD, n=8).

[0031] Figure 16 Figure 200X shows the effect of immunomodulatory solid beverage on the number of goblet cells in the small intestine. A1-A3: goblet cell staining in the control group; B1-B3: goblet cell staining in the model group; C1-C3: goblet cell staining in the levamisole hydrochloride group; D1-D3: goblet cell staining in the Zhenqi Fuzheng granules group; E1-E3: goblet cell staining in the low-dose immunomodulatory solid beverage group; F1-F3: goblet cell staining in the medium-dose immunomodulatory solid beverage group; G1-G3: goblet cell staining in the high-dose immunomodulatory solid beverage group. Detailed Implementation

[0032] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0033] All raw materials used in this invention can be obtained commercially or prepared using existing technologies.

[0034] This invention provides a traditional Chinese medicine composition comprising the following components in parts by weight: 5-20 parts of five-finger peach, 1-5 parts of tangerine peel, 1-5 parts of white hyacinth bean, 1-5 parts of ginger, 1-10 parts of pearl oyster meat, 1-10 parts of oyster meat, 1-10 parts of jujube, and 1-10 parts of star anise.

[0035] In this invention, the traditional Chinese medicine composition includes 5 to 20 parts of *Ficus hirta*, for example, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, or 20 parts, etc.

[0036] In this invention, the traditional Chinese medicine composition includes 1 to 5 parts of tangerine peel, for example, 1 part, 2 parts, 3 parts or 5 parts, etc.

[0037] In this invention, the traditional Chinese medicine composition includes 1 to 5 parts of white hyacinth bean, for example, 1 part, 2 parts, 4 parts or 5 parts, etc.

[0038] In this invention, the traditional Chinese medicine composition includes 1 to 5 parts of ginger, for example, 1 part, 3 parts, 4 parts or 5 parts, etc.

[0039] In this invention, the traditional Chinese medicine composition includes 1 to 10 parts of Pinctada martensii meat, for example, 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts or 10 parts, etc.

[0040] In this invention, the traditional Chinese medicine composition includes 1 to 10 parts of oyster meat, for example, 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts or 10 parts, etc.

[0041] In this invention, the traditional Chinese medicine composition includes 1 to 10 parts of jujube, for example, 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts or 10 parts, etc.

[0042] In this invention, the traditional Chinese medicine composition includes 1 to 10 parts of star anise, for example, 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts or 10 parts, etc.

[0043] The present invention also provides a solid beverage comprising the above-mentioned traditional Chinese medicine composition, raw sugarcane sugar, sugarcane leaf polysaccharide and compound excipients.

[0044] In this invention, the composite excipients include soluble starch and lactose; the mass ratio of the soluble starch to lactose is 2:1.

[0045] In this invention, the mass ratio of the traditional Chinese medicine composition, raw sugarcane sugar, and sugarcane leaf polysaccharide is 4:2:1.

[0046] In this invention, the total mass ratio of the mixture of the traditional Chinese medicine composition, raw sugarcane sugar, and sugarcane leaf polysaccharide to the mass ratio of the compound excipients is 1:1.

[0047] The present invention also provides a method for preparing the above-mentioned solid beverage, characterized by comprising the following steps:

[0048] The mixture of five-finger peach, tangerine peel, white hyacinth bean, ginger, Pinctada martensii meat, oyster meat, jujube and star anise was immersed in water for the first extraction to obtain the first extract and raw material residue.

[0049] The raw material residue is immersed in water for a second extraction to obtain a secondary extract.

[0050] The primary and secondary extracts are combined and then concentrated, dried, pulverized, and sieved sequentially to obtain the traditional Chinese medicine composition.

[0051] The traditional Chinese medicine composition is mixed with sugarcane natural sugar and sugarcane leaf polysaccharide. After the three are mixed, they are ground into powder again, sieved, and then mixed with compound excipients. The mixture is moistened with a humectant to form a soft mass. Then, it is granulated, dried, sized, packaged, and sterilized to obtain an immune-regulating solid beverage.

[0052] In this invention, five-finger peach, tangerine peel, white hyacinth bean, ginger, pearl oyster meat, oyster meat, jujube, and star anise are weighed out according to their weight proportions. The quality of the raw materials is strictly checked to ensure that there are no impurities before use.

[0053] This invention involves weighing and mixing five-finger peach, tangerine peel, white hyacinth bean, ginger, Pinctada martensii meat, oyster meat, jujube, and star anise. After mixing, water is added to submerge the raw materials. After cold soaking for 30 minutes, the mixture is placed in a reflux extraction device and refluxed for 171 minutes. After extraction, the mixture is cooled to room temperature and filtered through a fine mesh to obtain the raw material residue and the primary extract.

[0054] In this invention, the mass ratio of the mixture to water is 1:12.2; the temperature of the first extraction is 100°C and the time is 171 min.

[0055] In this invention, the raw material residue obtained from the first extraction is added to water until it is submerged, and a second extraction is performed by heating. The extraction is also carried out by reflux. After the extraction is completed, the mixture is cooled and filtered to obtain the secondary extract.

[0056] In this invention, the mass ratio of the raw material residue to water is 1:12.2; the temperature of the second extraction is 100℃ and the time is 171 min.

[0057] This invention combines the extracts obtained from two extractions, concentrates them under reduced pressure to a thick paste, dries them in an oven, and then pulverizes the dried product using a pulverizer and sieves it to obtain a dry powder of the traditional Chinese medicine composition.

[0058] The drying temperature is 70℃ and the time is 96 hours; the sieving is done through a 120-mesh sieve.

[0059] This invention involves mixing the obtained traditional Chinese medicine composition dry powder with sugarcane natural sugar and sugarcane leaf polysaccharide. After mixing the three, the powder is ground again, sieved, and then mixed with compound excipients. The mixture is moistened with a humectant to form a soft mass, granulated through a No. 2 sieve, dried, cooled, and then granulated using a No. 1 and No. 5 sieve. The granules are then packaged and sterilized to obtain immune-regulating solid granules.

[0060] The wetting agent is ethanol; the volume fraction of the ethanol is 85%; the drying temperature is 65°C and the time is 60 min.

[0061] In some embodiments of the present invention, the high-temperature sterilization and packaging involves sending the product into a high-temperature sterilization device for high-temperature sterilization treatment to kill any existing bacteria and ensure the hygiene and safety of the product; after sterilization, the product is quickly cooled and then packaged; aseptic operation must be ensured during the packaging process to avoid secondary contamination; after packaging, a sealing check is performed to ensure that the product is properly sealed.

[0062] In some embodiments of the present invention, quality inspection and finished product warehousing are required: the packaged solid beverages are subject to quality inspection, including testing of appearance, taste, and hygiene indicators; the products can only be put into storage after ensuring that they meet relevant standards and requirements.

[0063] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition or the above-mentioned solid beverage in the preparation of health foods or medicines for regulating immunity.

[0064] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0065] Preparation Example 1

[0066] Weigh out 16 parts of five-finger peach, 3 parts of tangerine peel, 4 parts of white hyacinth bean, 3 parts of ginger, 7 parts of pearl oyster meat, 7 parts of oyster meat, 4 parts of jujube, and 1 part of star anise according to the weight ratio, and mix them to obtain a traditional Chinese medicine composition.

[0067] Example 1

[0068] Considering that polysaccharides and proteins may be key components for regulating immunity, their crude quantification and extraction process research based on this will help improve the efficacy of solid beverages.

[0069] 1. Experimental Methods

[0070] The herbal composition of Example 1 was extracted by reflux with pure water on a heating mantle. After extraction, it was filtered through a 200-mesh filter cloth and concentrated under reduced pressure to obtain an extract. Then, it was diluted with pure water to a crude drug weight of 1 g / mL for later use.

[0071] 1.1 Single-factor method

[0072] (1) Investigation of the liquid-to-material ratio

[0073] Weigh the Chinese herbal composition, soak for 60 minutes, extract once, and extract for 60 minutes. When 6, 9, 12, 15, and 18 times the prescription volume of water are added, the total polysaccharide content, total protein content, and dry extract rate are determined.

[0074] (2) Examination of extraction time

[0075] Weigh the prescribed amount of medicinal materials, soak for 60 minutes, extract once, and add 15 times the amount of water. Examine the extraction time at 30, 60, 90, 120, 150, and 180 minutes, and determine the total polysaccharide content, total protein content, and dry extract rate.

[0076] 1.1.1 Methods and results for the determination of total polysaccharides

[0077] (1) Preparation of reference solution

[0078] Accurately pipette 10 mg of D-anhydrous glucose reference standard into a 100 mL volumetric flask and shake well to obtain a 0.1 mg / mL glucose reference standard solution.

[0079] (2) Preparation of the test solution

[0080] Accurately pipette 1.0 mL of the aqueous extract into a 50 mL volumetric flask, dissolve in water and bring to volume (V1), shake well and filter. Take 10 mL of the filtrate and place it in a 50 mL centrifuge tube, add 40 mL of anhydrous ethanol, vortex to mix, precipitate for 30 min, centrifuge for 15 min (4000 r / min), discard the supernatant, wash with 25 mL of 80% ethanol aqueous solution, centrifuge for 10 min (4000 r / min), dissolve the precipitate in pure water, and bring to volume to 50 mL to obtain the test solution.

[0081] (3) Selection of detection wavelength

[0082] Accurately transfer 0.5 mL of L-anhydrous glucose standard solution and 0.5 mL of test solution into 5 mL stoppered graduated test tubes. Add water to each tube to a final volume of 1 mL, then add 0.4 mL of 5% phenol solution and 2.0 mL of concentrated sulfuric acid. Vortex for 10 seconds, let stand for 10 minutes, and then incubate in a boiling water bath for 15 minutes. Remove from the water and quickly cool to room temperature in ice water. Scan both the standard and the test solution using an ELISA reader at 400 nm–800 nm to select the wavelength of maximum absorption. Both the test solution and the standard solution exhibit a clear maximum absorption peak at 489 nm; therefore, 489 nm was selected as the detection wavelength for subsequent experiments.

[0083] (4) Examination of linear relationships

[0084] Accurately pipette 0.20, 0.30, 0.40, 0.50, 0.60, 0.70, and 0.8 mL of D-anhydrous glucose reference solution, respectively, and measure the absorbance at the maximum absorption wavelength according to the procedure in section “(3)”. Take 1 mL of distilled water as a blank and measure the absorbance at the maximum absorption wavelength in the same way. Plot a standard curve with glucose concentration (mg / mL) on the x-axis and absorbance value (A) on the y-axis.

[0085] (5) Plotting the standard curve

[0086] A standard curve was plotted with absorbance on the x-axis and the concentration of the reference solution on the y-axis. The regression equation was Y = 0.0398x - 0.0035, and the correlation coefficient R0 was [value missing]. 2 =0.998, see Figure 2 .

[0087] (6) Recovery test

[0088] Accurately pipette the test solution with known polysaccharide content, and accurately add an equal amount of reference solution to each solution. Prepare a total of 6 samples with the same amount of addition. Measure the absorbance at the maximum absorption wavelength according to the method in section “(3)”, and determine the recovery rate. The results show that the average recovery rate of this method is 102.38%, and the RSD is 1.10%, indicating that the recovery rate of this method is good. See Table 1 for specific data.

[0089] Table 1. Recovery rate test

[0090]

[0091] 1.1.2 Total Protein Determination Methods and Results

[0092] (1) Preparation of test solution

[0093] Accurately pipette 1.0 mL of the extract into a 5 mL centrifuge tube, centrifuge for 10 min (3500 r / min), and collect the supernatant.

[0094] (2) Preparation of Coomassie Brilliant Blue Solution

[0095] Dilute Coomassie Brilliant Blue stock solution 1:4 with double-distilled water to five times its original volume, and prepare fresh before use.

[0096] (3) Ultraviolet-Visible Light Analysis

[0097] Accurately pipette 0.05 mL of the test solution and 0.05 mL of the standard solution into 5 mL centrifuge tubes, add 3 mL of Coomassie solution, mix well, and let stand for 10 min. Use distilled water with the corresponding reagents as a blank control. Both the control and the test solution are scanned at 595 nm using a UV-Vis spectrophotometer.

[0098] (4) Examination of linear relationships

[0099] Accurately pipette 0.04, 0.08, 0.12, and 0.16 mL of protein solution standard with a concentration of 0.563 mg / mL, respectively, and perform the procedure under “(3)”. Measure the absorbance at the maximum absorption wavelength. Take 0.05 mL of distilled water as a blank and perform the same procedure, measuring the absorbance at the maximum absorption wavelength. Plot a standard curve with protein concentration (mg / mL) on the x-axis and absorbance value (A) on the y-axis.

[0100] (5) Plotting the standard curve

[0101] A standard curve was plotted with absorbance on the x-axis and the concentration of the reference solution on the y-axis. The regression equation was Y = 0.0366x - 0.012, and the correlation coefficient R0 was [value missing]. 2 =0.9983, see Figure 3 .

[0102] (6) Recovery test

[0103] Accurately pipette 1.0 mL of the prescription aqueous extract with known content, in a total of 6 portions, add appropriate amount of reference standard to each portion, prepare the test sample according to "(1)", operate according to "(3)", and measure the absorbance at the maximum absorption wavelength. The results show that the average recovery rate of this method is 105.54% and the RSD is 1.06%, indicating that the recovery rate of this method is good. Specific data are shown in Table 2.

[0104] Table 2. Recovery Rate Test

[0105]

[0106] 1.1.3 Method for determining the dry paste yield

[0107] Accurately pipette 5 mL of the extract into an evaporating dish dried to constant weight, evaporate to dryness in a 70℃ water bath, and then dry to constant weight (M1) in a 105℃ oven. After drying, place the dish in a desiccator and cool for 30 min, then weigh it (M2). The difference between the mass of M2 and M1 is the mass of the dried extract. Calculate the dry extract rate: Dry extract rate = Dry extract mass * 10 / Mass of medicinal slices × 100%. Each experiment is repeated three times.

[0108] 1.1.4 Results of the study on the feed-liquid ratio

[0109] The results are shown in Table 3. Further response surface experiments were conducted using feed-liquid ratios of 1:9, 1:12, and 1:15.

[0110] Table 3 Results of the single-factor experiment on the material-liquid ratio

[0111]

[0112]

[0113] 1.1.5 Results of the investigation on extraction time

[0114] The results are shown in Table 4. Further response surface experiments were conducted using extraction times of 120 min, 150 min, and 180 min.

[0115] Table 4 Results of the single-factor experiment extraction time

[0116]

[0117] 1.2 Response Surface Methodology

[0118] Two component contents (total polysaccharide and total protein) and dry extract yield were selected as critical quality attributes (CQA) for the formulation process, and extraction time (X1), number of extractions (X2), and solid-liquid ratio (X3) were selected as critical process parameters (CPP) for the extraction process.

[0119] 1.2.1 Determining the weight coefficients of each indicator using the AHP-CRITIC hybrid weighting method

[0120] (1) AHP method

[0121] The importance of the three indicators was assessed through pairwise comparisons, and the importance of each indicator was determined as follows: total polysaccharides > total protein > dry extract rate. Based on this, a priority matrix was established, as shown in Table 5. The priority matrix was then processed, and the weight coefficients of each indicator were calculated.

[0122] Table 5 Priority Matrix

[0123]

[0124] Based on the priority matrix results, the weight coefficients of total polysaccharide, total protein, and dry extract rate calculated using the AHP method are 0.6522, 0.2174, and 0.1304, respectively. The maximum eigenvalue (λ) is 3.000, the consistency index (CI) is 0, the random consistency index (RI) is 0.52, and the consistency ratio (CR) is 0.0 < 0.1, indicating that the priority matrix passes the consistency test and the weight coefficients of each evaluation index are effective.

[0125] (2) CRITIC method

[0126] The experimental results were standardized to eliminate dimensions. The formula was (index value - minimum index value) / (maximum index value - minimum index value) × 100%. After eliminating dimensions, the results were imported into SPSS 21 software for analysis, and the weight coefficients of each index were calculated.

[0127] The weighting coefficients of total polysaccharides, total protein, and total dry extract obtained by the CRITIC method were 0.4516, 0.3007, and 0.2477, respectively.

[0128] (3) AHP-CRITIC hybrid weighted method

[0129] To ensure the scientific validity and rationality of the experimental results, the AHP method and the CRITIC method were combined and weighted, and the comprehensive weight (ωcomprehensiveij) was calculated according to formula (1).

[0130] ωcomprehension-ij=ωAHPij×ωCRITICij / ∑ωAHPij×ωCRITICij (1)

[0131] The combined weighting coefficients of total polysaccharides, total protein, and total dry extract were calculated using the AHP-CRITIC mixed weighting method and were 0.7509, 0.1667, and 0.0824, respectively.

[0132] 1.2.2 Box-Behnken experimental design

[0133] Weigh out the same batch of medicinal slices as the reference sample, using the same prescription amount. Based on the results of previous single-factor experiments, determine the water addition ratio and the upper and lower limits of extraction time. The number of extractions is designed as 1, 2, and 3 times according to actual production needs and experience. Use the experimental design software Design-Expert13 to arrange 17 groups of experiments with 3 factors and 3 levels, including 12 factorial points and 5 central points. Each group is operated in triplicate, and the average value of the results is taken. Calculate the comprehensive score using the weighting coefficients obtained by the AHP-CRITIC mixed weighting method. Comprehensive score = (total polysaccharide measured value / maximum total polysaccharide value) × 100 × 0.7509 + (total protein measured value / maximum total protein value) × 100 × 0.1667 + (dry extract rate measured value / maximum dry extract rate) × 100 × 0.0824. The factors and levels are shown in Table 6.

[0134] Table 6. Response Surface Factors and Levels

[0135]

[0136] Binomial fitting analysis using Design-Expert 13 software yielded the equation Y = 0.8897 + 0.2903A + 0.1297B + 0.0431C + 0.0135AB + 0.0528AC - 0.0149BC - 0.3107A 2 -0.0916B 2 -0.2406C 2 (R² = 0.9803, P < 0.05), indicating that the binomial fitting effect is good. Analysis using Design-Expert 13 software predicted the optimal parameters to be: 2.37 extractions, 171 min extraction time, and a solid-liquid ratio of 1:12.189. Based on practicality and convenience considerations, the optimal formula was adjusted to: 2 extractions, 171 min extraction time, and a solid-liquid ratio of 1:12.2. The Box-Behnken response surface design table and results for the immunomodulatory solid beverage are shown in Table 7, and the response surface plots of each factor on the overall score of the solid beverage are shown in [Table 7]. Figure 4 .

[0137] Table 7. Response Surface Design and Results of Box-Behnken Immunomodulatory Solid Beverage

[0138]

[0139] 1.2.3 Optimal Process Validation

[0140] Three batches of immunomodulatory solid beverage extracts were prepared according to the optimal prescription and subjected to verification tests to determine their comprehensive scores.

[0141] As shown in Table 8, the model has a P-value of 0.0001 (significant when P < 0.05), and the lack-of-fit term P = 0.238 > 0.05, indicating that the equation does not lack significant fit and has a good fit. This model can be used to predict and analyze the extraction process of immune-regulating solid beverages. R 2 =0.9803, indicating that the model has a high correlation with the measured values ​​and can accurately predict the actual situation. R 2 Adj =0.9549, indicating that the model can explain 95.49% of the changes in the response value.

[0142] Table 8. Analysis of Variance Table

[0143]

[0144]

[0145] 1.3 Process Validation

[0146] The optimal extraction process for immunomodulatory solid beverages obtained from previous response surface methodology was used for three extractions. The three batches of immunomodulatory solid beverages showed good total polysaccharide content, total protein content, and dry extract yield. The scores for each validation process indicator and the overall score are shown in Table 9. The average overall score was 0.9698, and the RSD was 0.42%.

[0147] Table 9. Verification Experiment Results

[0148]

[0149] In summary, the optimal extraction process for the traditional Chinese medicine composition selected through single-factor experiments and response surface methodology is 2 extractions, 171 min extraction time, and a material-to-liquid ratio of 1:12.2. The RSD result of the verification experiment is 0.42%.

[0150] Example 2

[0151] Investigation on the preparation process of immune-modulating solid beverage

[0152] Experimental objective: The original formula of this solid beverage has a high yield of paste. Making it into granules will help its subsequent development and research.

[0153] 1. Preparation of the extract

[0154] Take the prescribed amount of dried medicinal materials, add 12.2 times the amount of pure water, extract for 171 minutes, repeat twice, combine the extracts, filter twice through a 200-mesh filter, concentrate under reduced pressure to obtain an immunomodulatory solid beverage extract. Then spread the extract evenly on a tray, dry at 70℃, pulverize under a dry environment and pass through a 120-mesh sieve, and store in a sealed container.

[0155] 2. Selection of excipient types

[0156] Take the dry extract powder and select pharmaceutical dextrin, maltodextrin, water-soluble starch, lactose, and mannitol as excipients. Mix the dry extract powder and excipients evenly in a 1:1 ratio, prepare a soft mass with 85% ethanol, granulate by wet method, and dry at 65℃ for 30 min. Screen the soft mass based on its sieving condition, properties, and particle size to select the most suitable excipients and dosages. The results are shown in the table below. Of the five excipients to be selected in this experiment, only water-soluble starch and lactose can be successfully granulated. However, using either one as an excipient alone results in poor granule quality.

[0157] Table 10 Screening of Optimal Excipient Types for Immunomodulatory Solid Beverages

[0158]

[0159] 3. Screening of compound excipient ratios

[0160] A fixed ratio of dry powder to excipients of 1:1 was used to prepare a soft material with 85% ethanol. The material was dried at 65℃ for 30 min. The effects of soluble starch to lactose ratios of 1:2, 1:1.5, 1:1, 1.5:1, 2:1, and 2.5:1 on sieving, properties, and particle size were investigated. The effects of different ratios of compound excipients on particle size are shown in the table below. The particle size was smallest and the best condition was observed when the ratio of water-soluble starch to lactose was 2:1.

[0161] Table 11 Screening of the optimal compound ratio of excipients for immunomodulatory solid beverages

[0162]

[0163] 4. Selection of auxiliary material dosage

[0164] A soft material was prepared using 85% ethanol at a fixed ratio of soluble starch to lactose of 2:1 and dried at 65℃ for 30 min. The effects of the ratios of dry powder to excipients of 1:0.75, 1:1, 1:1.25, 1:1.5, and 1:1.75 on sieving, properties, and particle size were investigated. The results are shown in the table below. The optimal granulation state was achieved when the ratio of dry powder to excipients was 1:1.

[0165] Table 12 Screening of Optimal Excipient Dosage for Immunomodulatory Solid Beverages

[0166]

[0167] 5. Screening of wetting agent concentration

[0168] Take the dry powder and excipients, mix them evenly, and investigate the effects of a fixed dry powder to excipient ratio of 1:1 and a soluble starch to lactose ratio of 1:1. Dry at 65℃ for 30 min, and investigate the effects of ethanol volume fractions of 75%, 80%, 85%, and 90% on sieving, properties, and particle size to select the most suitable ethanol concentration. The results are shown in the table below. When the wetting agent concentration is 85%, the particles are easy to sieve, have a small particle size, and exhibit the best condition.

[0169] Table 13 Screening of Optimal Humectant Concentrations for Immunomodulatory Solid Beverages

[0170]

[0171] 6. Selection of drying temperature

[0172] With a fixed ratio of extract powder to excipients of 1:1, a soluble starch to lactose ratio of 2:1, and a soft material prepared with 70% ethanol, the effects of drying temperatures of 55℃, 60℃, 65℃, and 70℃ on particle properties and particle size were investigated. The results are shown in the table below. When the oven drying temperature was set to 65℃, the resulting particles had the smallest particle size and the best condition.

[0173] Table 14 Screening of Optimal Drying Temperatures for Immunomodulatory Solid Beverages

[0174]

[0175]

[0176] The optimal molding process for immunomodulatory solid beverages, as determined by single-factor experimental studies, is as follows: the ratio of dried medicinal powder to excipients is 1:1, the ratio of water-soluble starch to lactose in the mixed excipients is 2:1, the concentration of ethanol as a humectant is 85%, and the drying temperature in the oven is 65℃.

[0177] Example 3

[0178] Safety Study of Immunomodulatory Solid Beverages

[0179] Experimental objective: To conduct an acute toxicity test on the solid beverage prepared in Example 2 to demonstrate that the present invention has sufficient safety.

[0180] 1. Select SPF-grade KM mice, with an equal number of males and females, weighing 20 ± 2 g, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd. (License number: SCXK(Xiang)2021-0002). Take 40 KM mice weighing 18 - 22 g, with an equal number of males and females, and randomly divide them into a blank group and a drug administration group, with 20 mice in each group. Fast the mice for 12 h before drug administration, allowing them to drink water. Each mouse in the drug administration group is administered with the maximum concentration (about 1.04 g / mL) of the immunomodulatory solid beverage carboxymethylcellulose sodium suspension by gavage, administered 2 times, once every 6 h, and the administration volume is 40 mL / kg. The blank group is gavaged with an equal volume of distilled water. Observe the weight, appearance, behavior, respiration, limb movement, food intake, excretion, death, etc. of the mice within 14 days after drug administration. Weigh the mice once a week. On the 15th day, sacrifice the mice by cervical dislocation, dissect and take the heart, liver, spleen, lungs, and kidneys, and visually observe whether there are any abnormalities in each organ. Randomly select the heart, liver, spleen, lungs, and kidney tissues of 5 mice from each group, fix them with 4% paraformaldehyde, and evaluate the pathological lesions of each tissue by hematoxylin-eosin (H&E) staining.

[0181] 2. H&E staining

[0182] Fix the rat heart tissue and dehydrate it with an automatic dehydrator; fix the tissue, dehydrate it with an automatic dehydrator, embed it, and section it as per the following table:

[0183] Table 15 H&E staining operation steps

[0184]

[0185]

[0186] 3. Body weight changes

[0187] Within 14 days after drug administration, there were no obvious abnormalities in the appearance, behavior, respiration, limb movement, food intake, excretion, etc. of the mice; there was no death; there was no significant difference in the body weight of the mice between the drug administration group and the blank group ( Figure 5 ).

[0188] 4. Observation of organ status <​​​​​​​​​​​​

[0192] In summary, there were no significant differences in the body weights and organ indices of the mice in the dosing group compared with those in the blank group (P>0.05), and no pathological changes were found in the organs after gross examination and H&E pathological section staining. The acute oral MTD of the mice was >80 g / kg·bw, which was more than 125 times the recommended human dose. According to the acute toxicity classification standard, the acute toxicity grade of the immune-regulating solid beverage was non-toxic.

[0193] Example 4

[0194] Functional evaluation of the immune-regulating solid beverage

[0195] Experimental purpose: To conduct an animal immunomodulation test using the solid beverage prepared in Example 2 to prove that the present invention has the efficacy of immunomodulation.

[0196] Experimental animals: SPF-grade male BALB / c mice, weighing 20±2 g, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd. (License number: SCXK(Xiang)2021-0002).

[0197] Preparation of drugs: Accurately weigh 500.0 mg of cyclophosphamide and dissolve it in 100.0 mL of normal saline to obtain the modeling agent for the mouse immunosuppression model; accurately weigh 80.0 mg of levamisole hydrochloride and dissolve it in 30.0 mL of 0.5% CMC-Na to obtain the dosing sample for the levamisole hydrochloride group; accurately weigh 7.80 g of Zhenqi Fuzheng Granules and suspend it in 30.0 mL of 0.5% CMC-Na to obtain the dosing sample for the Zhenqi Fuzheng Granules group; separately and accurately weigh 3.90 g, 7.80 g, and 15.60 g of the immune-regulating solid beverage, crush them, and suspend them in 30.0 mL of 0.5% CMC-Na to obtain the dosing samples for the low, medium, and high dose groups of the immune-regulating solid beverage.

[0198] Animal Experiment Design: Eighty-four SPF-grade male BALB / c mice were acclimatized for one week and then randomly divided into seven groups of 12 mice each: a blank control group, a model group, a levamisole hydrochloride group, a Zhenqi Fuzheng granule group, and low-, medium-, and high-dose immunomodulatory solid beverage groups. On the eighth day of the experiment, except for the blank control group, the other six groups were intraperitoneally injected with cyclophosphamide at a dose of 80 mg / kg body weight for three consecutive days. The blank control group was intraperitoneally injected with an equal volume of physiological saline. On the eleventh day of the experiment, each treatment group was administered levamisole hydrochloride at a dose of 40 mg / kg body weight, Zhenqi Fuzheng granules at a dose of 3.9 g / kg body weight, the low-dose immunomodulatory solid beverage group at a dose of 1.95 g / kg body weight, the medium-dose immunomodulatory solid beverage group at a dose of 3.9 g / kg body weight, and the high-dose immunomodulatory solid beverage group at a dose of 7.8 g / kg body weight for 10 consecutive days. During this period, the blank control group and the model group were given an equal volume of distilled water. Throughout the experiment, the mice's condition was recorded daily, and their body weight was measured every 7 days.

[0199] Animal sampling: After the last administration of the drug, the mice were fasted for 12 hours but allowed free access to water. Blood was collected from the inner canthus of the eye, and the mice were then euthanized by cervical dislocation. The spleen was aseptically removed, and the thymus, small intestine, and cecum were also collected. The contents of the cecum were placed in cryovials and temporarily stored in dry ice. After sampling, all tissues and organs were transferred to a -80°C freezer.

[0200] Statistical analysis: GraphPad Prism 9 software was used for one-way ANOVA analysis and graphing, and Turkey's test and LSD method were used for multiple comparisons between groups. Data are expressed as mean ± standard deviation, and P < 0.05 was used as the criterion for whether a difference was statistically significant.

[0201] Experimental results

[0202] 1. Effects of Immunomodulatory Solid Beverages on Mouse Body Weight: Changes in mouse body weight are an important indicator for assessing their survival status. For example... Figure 9 As shown in Table 16, on day 7 after the establishment of the immunosuppression model (day 14 of the experiment), except for the control group, the body weight of mice in all other groups decreased significantly compared with that before modeling. This phenomenon suggests that cyclophosphamide successfully induced an immunosuppressive state in mice. After 14 consecutive days of drug intervention (day 21 of the experiment), the body weight of mice in each treatment group showed varying degrees of recovery. At this time, the average body weight of the model group was the lowest, while the high- and medium-dose groups of the immunomodulatory solid beverage and the Zhenqi Fuzheng granules group showed the most significant recovery effects. The improvement in the levamisole hydrochloride group and the low-dose group of the immunomodulatory solid beverage was at a moderate level. The above results suggest that the immunomodulatory solid beverage, especially the medium- and high-dose groups, can effectively improve the survival status of immunosuppressed mice.

[0203] Table 16 Effects of immunomodulatory solid beverages on mouse body weight (x±SD, n=12)

[0204]

[0205]

[0206] 2. Determination of organ index: The spleen and thymus of mice were taken, the surface moisture was absorbed with filter paper and weighed, and then the organ index was calculated.

[0207] Organ Index = Organ weight (g) / Mouse body weight (g) * 100%

[0208] The thymus and spleen play important roles in the body's immune system, and thymus and spleen indices reflect the body's immune capacity to some extent. Figure 10 As shown, the spleen index in the model group was significantly higher than that in the control group, while the thymus index in the model group was significantly lower than that in the control group. This indicates that cyclophosphamide can significantly inhibit the immune function of mice and induce compensatory hyperplasia of the spleen, signifying the successful establishment of a mouse immunosuppression model. Compared with the model group, the low- and medium-dose groups of the immunomodulatory solid beverage significantly reduced the spleen index of mice (P<0.01; P<0.05), while all three dose groups of the immunomodulatory solid beverage significantly increased the thymus index of immunosuppressed mice (P<0.05; P<0.01). The results indicate that the immunomodulatory solid beverage can restore immune organ damage in immunosuppressed model mice by inhibiting cyclophosphamide-induced compensatory hyperplasia of the spleen and thymus atrophy.

[0209] Table 17 Effects of immunomodulatory solid beverages on immune organ indices in mice (x±SD, n=12)

[0210]

[0211] 3. Blood routine examination: Blood was collected from the inner canthus of the mouse eye and placed in an anticoagulant tube containing EDTA. The sample was then analyzed on a blood routine analyzer to determine the total number of white blood cells, the number of lymphocytes, and the percentage of lymphocytes in each mouse.

[0212] From Table 18 and Figure 11It was found that, compared with the control group, the total number of lymphocytes, the total number of white blood cells, and the percentage of lymphocytes in the model group were significantly decreased, indicating that the immunosuppressant cyclophosphamide damaged the immune system of mice. Medium and high doses of the immunomodulatory solid beverage significantly increased the total number of lymphocytes in the whole blood of immunosuppressed mice (P<0.05), and all doses of the immunomodulatory solid beverage significantly increased the total number of white blood cells and the percentage of lymphocytes in the whole blood of immunosuppressed mice (P<0.05, P<0.01, P<0.001), indicating that the immunomodulatory solid beverage can improve the immune function of immunosuppressed model mice.

[0213] Table 18 Effects of immunomodulatory solid beverages on routine blood parameters (x±SD, n=8)

[0214]

[0215] 4. Examination of Lymphocyte Proliferative Capacity: Spleens were aseptically harvested from mice. Using the core of a disposable syringe, the spleen was gently ground and passed through a 200-mesh sieve to generate a single-cell suspension. The suspension was then washed three times with Hank's solution. Cells were treated with erythrocyte lysis buffer and centrifuged (1000 rpm, 5 min) to remove erythrocytes. Cells were washed and resuspended in RPMI 1640 complete medium (containing 10% fetal bovine serum). Cell counts were performed using trypan blue staining, and the cell suspension was diluted to 5 × 10⁶ cells / mL. 6 Cells / mL. Then, diluted cell suspensions were added to LPS or ConA and seeded into 96-well plates, 100 μL per well, with blank wells included. The 96-well cell culture plates were incubated at 37°C in a 5% CO2 incubator for 48 h. Two h before the end of the culture period, 10% MTS solution was added to each well, and the absorbance at 450 nm was measured using a high-throughput microplate reader. The lymphocyte proliferation capacity after stimulation was calculated using the following formula.

[0216] Stimulation index (%) = OD value of test well / OD value of blank well * 100%

[0217] The spleen is an organ where mature T cells and B cells reside, and it is a major site of the innate immune response to blood-derived antibodies. For example... Figure 12 As shown in Table 19, compared with the control group, the proliferation capacity of T lymphocytes and B lymphocytes in the model group was significantly decreased, indicating that cyclophosphamide inhibited specific and non-specific immunity in mice. The medium and high doses of the immunomodulatory solid beverage significantly increased the proliferation capacity of T lymphocytes (P<0.01, P<0.001), while the high dose group significantly increased the proliferation capacity of B lymphocytes (P<0.01). These results indicate that cyclophosphamide damages the immune system of mice, and the immunomodulatory solid beverage can significantly restore this damage by promoting the proliferation capacity of splenic lymphocytes in mice.

[0218] Table 19 Effects of immunomodulatory solid beverages on the proliferation capacity of splenic lymphocytes (x±SD, n=8)

[0219]

[0220]

[0221] 5. Observation of H&E staining of small intestine: After mouse small intestine was fixed in 10% formalin solution for more than 24 hours, paraffin sections were prepared. The tissue structure was observed using the hematoxylin-eosin (H&E) staining method. Subsequently, the tissue was observed and photographed at 100x and 400x magnification. The villus length and crypt depth of the small intestine were also measured.

[0222] The intestinal mucosa is the body's first line of defense against pathogens. The basic functional unit of the intestinal mucosa is the villous-crypt axis, and its structural integrity and normal function are fundamental to maintaining tissue and systemic homeostasis. The ratio of villus length to crypt depth (V / C) is also considered an important indicator for assessing intestinal morphology. To investigate the effects of immunomodulatory solid beverages on intestinal morphology, this study collected small intestinal tissue for pathological analysis. Figure 13 H&E staining results showed that the small intestinal villi in the control group were intact and neatly arranged, with no inflammation or epithelial cell damage; while the small intestinal villi in the model group were significantly shortened and showed significant structural disorder. Quantitative analysis results of small intestinal villi length (V) and crypt depth (C) are as follows: Figure 14 As shown in Table 20, compared with the control group, the model group showed significantly shorter villus length, significantly shallower crypts (P<0.001), and a significantly lower V / C ratio (P<0.01). This indicates that the modeling process caused severe damage to the small intestinal structure. Notably, compared with the model group, all doses of the immunomodulatory solid beverage significantly increased small intestinal villus length, decreased crypt depth, and significantly increased the V / C ratio (P<0.05), suggesting that the immunomodulatory solid beverage can effectively repair small intestinal structural damage.

[0223] Table 20 Effects of immunomodulatory solid beverages on small intestinal morphology (x±SD, n=9)

[0224]

[0225] 6. AB-PAS staining to observe the number of goblet cells in the small intestine: After fixing the small intestine tissue in 10% formalin solution for more than 24 hours, paraffin sections were prepared. The number of goblet cells was detected by Alcian blue / periodic acid-Schiff staining (AB-PAS). The slides were imaged using a slide scanning imaging system. For each slide, the entire tissue was first observed at low magnification, and then three 200x microscopic images were acquired. The number of goblet cells in the images was counted using ImagePro software. The average of the different results of the three 200x microscopic images of each slide was taken as the count value of the sample.

[0226] Goblet cells are a specific cell type in the intestinal epithelium that secretes mucus. They effectively prevent pathogens from adhering to the intestinal epithelium by secreting gel-forming mucins. After AB-PAS staining, goblet cells appear deep blue, as shown in the image. Figure 16 Goblet cell count results are shown in Table 21 and... Figure 15 As shown, the number of goblet cells in the model group was significantly lower than that in the control group (P<0.05), indicating that cyclophosphamide may disrupt the intestinal mucosal barrier by interfering with the secretory function of goblet cells. After intervention with an immunomodulatory solid beverage, cyclophosphamide-induced intestinal damage was partially alleviated. Specifically, the number of goblet cells in the high-dose immunomodulatory solid beverage group was significantly increased (P<0.05), suggesting that the immunomodulatory solid beverage can alleviate cyclophosphamide-induced intestinal damage.

[0227] Table 21 Effect of immunomodulatory solid beverage on the number of goblet cells in the small intestine (x±SD, n=8)

[0228]

[0229] Immunomodulatory solid beverages can improve the survival status of immunosuppressed mice, increase immune organ indices, significantly increase the length of small intestinal villi and the depth of crypts; improve blood routine indicators; upregulate the expression of tight junction proteins Occludin, ZO-1 and Claudin-1; repair the epithelial mucus barrier function; promote the restoration of CD4+ / CD8+ T cell subset balance; enhance the proliferation capacity of T / B lymphocytes; and strengthen the mucus barrier by increasing the number of goblet cells.

[0230] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The ingredients include the following components in parts by weight: 5-20 parts of five-finger peach, 1-5 parts of tangerine peel, 1-5 parts of white hyacinth bean, 1-5 parts of ginger, 1-10 parts of Pinctada martensii meat, 1-10 parts of oyster meat, 1-10 parts of jujube, and 1-10 parts of star anise.

2. A solid beverage, characterized in that, It includes the traditional Chinese medicine composition as described in claim 1, sugarcane natural sugar, sugarcane leaf polysaccharide, and compound excipients.

3. The solid beverage according to claim 2, characterized in that, The compound excipients include soluble starch and lactose; the mass ratio of soluble starch to lactose is 2:

1.

4. The solid beverage according to claim 2, characterized in that, The mass ratio of the traditional Chinese medicine composition, raw sugarcane sugar, and sugarcane leaf polysaccharide is 4:2:

1.

5. The solid beverage according to claim 2, characterized in that, The total mass ratio of the traditional Chinese medicine composition, raw sugarcane sugar, and sugarcane leaf polysaccharide to the mass ratio of the compound excipients is 1:

1.

6. The method for preparing the solid beverage according to any one of claims 2 to 5, characterized in that, Includes the following steps: According to the mass fractions, the mixture of five-finger peach, tangerine peel, white hyacinth bean, ginger, pearl oyster meat, oyster meat, jujube and star anise was immersed in water for the first extraction to obtain the first extract and raw material residue. The raw material residue is immersed in water for a second extraction to obtain a secondary extract. The primary and secondary extracts are combined and then concentrated, dried, pulverized, and sieved sequentially to obtain the traditional Chinese medicine composition. The traditional Chinese medicine composition is mixed with sugarcane natural sugar and sugarcane leaf polysaccharide. After the three are mixed, they are ground into powder again, sieved, and then mixed with compound excipients. The mixture is moistened with a humectant to form a soft mass. Then, it is granulated, dried, sized, packaged, and sterilized to obtain an immune-regulating solid beverage.

7. The preparation method according to claim 6, characterized in that, The mass ratio of the mixture to water is 1:12.2; the temperature of the first extraction is 100°C and the time is 171 min.

8. The preparation method according to claim 6, characterized in that, The mass ratio of the raw material residue to water is 1:12.2; the temperature of the second extraction is 100℃ and the time is 171 min.

9. The preparation method according to claim 6, characterized in that, The wetting agent is ethanol; the volume fraction of the ethanol is 85%.

10. The use of the traditional Chinese medicine composition according to claim 1 or the solid beverage according to any one of claims 2 to 5 in the preparation of health foods for regulating immunity.

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