Traditional Chinese medicine composition for tonifying spleen and eliminating dampness and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for tonifying spleen and eliminating dampness and a preparation method thereof, the traditional Chinese medicine composition comprises the following active ingredients in parts by mass: 1-5 parts of serrate rabdosia herb, 8-15 parts of coix seed, 3-8 parts of poria cocos, 3-8 parts of red bean, 7-15 parts of black tea and 3-8 parts of dried orange peel. The traditional Chinese medicine composition takes rabdosia serra, coix seeds, poria cocos, phaseolus calcaratus, black tea and pericarpium citri reticulatae as raw materials of active ingredients, follows the medication principle of monarch, minister, assistant and guide of traditional Chinese medicines, is precise and appropriate in compatibility in the whole formula, is combined with cold and warm, is mainly used for promoting diuresis and excreting dampness, also has the effects of clearing heat, tonifying spleen, regulating qi, removing damp evil, strengthening spleen and stomach and regulating qi activity, and has good effects of tonifying spleen and eliminating dampness.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and more specifically, to a traditional Chinese medicine composition for strengthening the spleen and removing dampness and its preparation method. Background Technology

[0002] Modern lifestyles, often characterized by irregular eating habits and overwork, can easily lead to impaired spleen and stomach function, resulting in spleen and stomach weakness. Symptoms include decreased appetite, abdominal distension, lethargy, and loose stools. To address these issues, many people choose to take traditional Chinese medicine or existing herbal combinations. These methods primarily focus on strengthening the spleen and replenishing qi, often using herbs such as ginseng, atractylodes macrocephala, and poria cocos in their formulas. However, these existing herbal combinations still have several significant drawbacks in practical application. Existing herbal formulas largely follow ancient methods, with relatively fixed combinations, making it difficult to precisely adjust to the complex constitutions and syndromes of modern individuals, resulting in a relatively slow onset of action. Furthermore, traditional formulas often involve decoction, leading to low extraction rates of active ingredients and inconvenience in carrying and taking them, affecting patient adherence to long-term use. Some formulas, while emphasizing tonification, fail to properly address potential accompanying dampness, food stagnation, or other pathogenic factors, easily leading to "inability to tolerate tonification" or recurring symptoms. In addition, the mechanisms of action of most existing products are not clear enough, lack sufficient support from modern pharmacological and clinical data, and there are also challenges in quality stability control, resulting in their overall efficacy being unstable and not outstanding. Summary of the Invention

[0003] Based on the aforementioned technical problems in the existing technology, the present invention provides a traditional Chinese medicine composition that can strengthen the spleen and remove dampness. This traditional Chinese medicine composition mainly promotes diuresis and eliminates dampness, while also clearing heat, strengthening the spleen, and regulating qi. It can clear heat and remove dampness, strengthen the spleen and regulate qi. It is suitable for those who suffer from damp-heat in the liver and gallbladder due to oily diet and alcohol consumption, resulting in symptoms such as bitter taste in the mouth and discomfort in the hypochondriac region. It can also be used to prevent and relieve discomfort caused by damp-heat trapping the spleen. While strengthening the spleen and stomach function, it can effectively resolve dampness in the body and has a good effect of strengthening the spleen and removing dampness.

[0004] To achieve the above objectives, the technical solution of the present invention is as follows:

[0005] A traditional Chinese medicine composition for strengthening the spleen and removing dampness, wherein the active ingredients, by mass parts, include 1-5 parts of *Hedyotis diffusa*, 8-15 parts of *Coix lacryma-jobi*, 3-8 parts of *Poria cocos*, 3-8 parts of red adzuki bean, 7-15 parts of black tea, and 3-8 parts of dried tangerine peel.

[0006] In some embodiments, the active ingredients of the traditional Chinese medicine composition are composed of 1-5 parts of *Hedyotis diffusa*, 8-15 parts of *Coix lacryma-jobi*, 3-8 parts of *Poria cocos*, 3-8 parts of red adzuki bean, 7-15 parts of black tea, and 3-8 parts of dried tangerine peel, by mass.

[0007] In some embodiments, the raw materials of the active ingredients of the traditional Chinese medicine composition, by mass parts, include 3 parts of *Hedyotis diffusa*, 12 parts of *Coix lacryma-jobi*, 5 parts of *Poria cocos*, 5 parts of red adzuki bean, 10 parts of black tea, and 5 parts of dried tangerine peel.

[0008] In some embodiments, the active ingredients of the traditional Chinese medicine composition are composed of 3 parts by mass of *Cynanchum paniculatum*, 12 parts by mass of *Coix lacryma-jobi*, 5 parts by mass of *Poria cocos*, 5 parts by mass of red adzuki bean, 10 parts by mass of black tea, and 5 parts by mass of dried tangerine peel.

[0009] In some embodiments, the active ingredient of the traditional Chinese medicine composition is a powder of the raw material in the specified weight ratio or an extract of the raw material in water or an organic solvent.

[0010] In some embodiments, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0011] In some embodiments, the traditional Chinese medicine composition is a decoction, granules, pills, tablets, or capsules.

[0012] The present invention also provides a method for preparing the spleen-strengthening and dampness-removing traditional Chinese medicine composition according to any of the above embodiments, the method comprising the following steps:

[0013] Combine the herbs *Hedyotis diffusa*, *Coix lacryma-jobi*, *Poria cocos*, red adzuki bean, black tea, and dried tangerine peel, add water and decoct, filter, and obtain the filtrate to obtain the aforementioned traditional Chinese medicine composition.

[0014] In some embodiments, the preparation method includes the following steps:

[0015] Combine the herbs *Cynanchum paniculatum*, *Coix lacryma-jobi*, *Poria cocos*, red adzuki beans, black tea, and dried tangerine peel, and decoct twice with water. For the first decoction, add 10-15 times the amount of water, soak for 0.5-1 hour, and decoct for 0.5-1.5 hours. For the second decoction, add 8-10 times the amount of water and decoct for 0.5-1 hour. Combine the two decoctions to obtain the filtrate.

[0016] In some embodiments, the preparation method further includes the following steps:

[0017] The filtrate was concentrated to a relative density of 1.15-1.30 at 80°C to obtain a thick paste; then pharmaceutically acceptable excipients were added, mixed evenly, and the desired formulation was prepared.

[0018] The pharmacological effects of this invention are as follows:

[0019] Xi Huang Cao: bitter in taste and cold in nature; enters the liver, gallbladder and large intestine meridians; has the effects of clearing heat and detoxifying, promoting diuresis and relieving jaundice, dispersing blood stasis and reducing swelling; mainly treats damp-heat jaundice, cholecystitis, diarrhea, sores and swelling, and traumatic injuries.

[0020] Job's tears: sweet and bland in taste, cool in nature; enters the spleen, stomach and lung meridians; has the functions of promoting diuresis and removing dampness, strengthening the spleen and stopping diarrhea, relieving numbness, draining pus, detoxifying and dispersing nodules; mainly treats edema, beriberi, dysuria, spleen deficiency diarrhea, dampness-induced numbness and contracture, lung abscess, etc.

[0021] Poria cocos: sweet and bland in taste, neutral in nature; enters the heart, lung, spleen and kidney meridians; has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and calming the mind; mainly treats edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, etc.

[0022] Red beans: sweet and sour in taste, neutral in nature; enters the heart and small intestine meridians; has the effects of promoting diuresis and reducing swelling, detoxifying and draining pus; mainly treats edema, beriberi, jaundice, dark urine, rheumatic fever, etc.

[0023] Black tea: It has a slightly bitter and sweet taste and a slightly warm nature. It has the effects of strengthening the spleen and soothing the liver, calming the liver and improving eyesight, refreshing the mind and relieving fatigue, promoting body fluid production and clearing heat, reducing inflammation and killing bacteria, and promoting digestion.

[0024] Dried tangerine peel: bitter and pungent in taste, warm in nature; enters the lung and spleen meridians; has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm; mainly treats abdominal distension, poor appetite, vomiting and diarrhea, cough with excessive phlegm, etc.

[0025] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0026] The herbal composition of this invention uses *Hedyotis diffusa*, *Coix lacryma-jobi*, *Poria cocos*, red adzuki bean, black tea, and tangerine peel as raw materials for active ingredients. Following the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine, *Coix lacryma-jobi* is the principal ingredient, which strengthens the spleen, stops diarrhea, and nourishes the acquired constitution, promoting healthy spleen and stomach function and eliminating dampness. *Poria cocos* promotes diuresis and eliminates dampness without harming the body's vital energy. *Hedyotis diffusa* clears damp-heat from the liver and gallbladder. Together, *Poria cocos* and *Hedyotis diffusa* serve as assistant ingredients, effectively clearing heat, eliminating dampness, and strengthening the spleen. Red adzuki bean strengthens the spleen, eliminates dampness, detoxifies, and reduces swelling, assisting the principal ingredient in removing dampness and detoxifying. Tangerine peel is aromatic, invigorates the spleen, regulates qi, and dries dampness, allowing qi to flow smoothly and dampness to dissipate naturally, embodying the principle of "treating dampness by first regulating qi, and dampness will naturally disappear when qi is transformed." The warm nature of black tea counteracts the cold nature of *Hedyotis diffusa* and *Coix lacryma-jobi*, preventing damage to the middle jiao, and also guides the other herbs to the affected area. The formula is well-balanced, combining cold and warm properties. It primarily promotes diuresis and eliminates dampness, while also clearing heat, strengthening the spleen, and regulating qi. This allows dampness to be eliminated, the spleen and stomach to function properly, and the qi to flow smoothly, thus creating an effective formula for removing dampness. Attached Figure Description

[0027] Figure 1 HE staining images of stomach tissue sections from rats in each group (×64, scale bar 200μm); where A: normal control group; B: model group; C: low-dose group of Jianpi Qushi Fang (a traditional Chinese medicine formula for strengthening the spleen and removing dampness); D: medium-dose group of Jianpi Qushi Fang; E: high-dose group of Jianpi Qushi Fang; F: Shenling Baizhu granules group; G: Domperidone group;

[0028] Figure 2HE staining images of jejunal tissue sections from rats in each group (×64, scale bar 200μm); where A: normal control group; B: model group; C: low-dose group of Jianpi Qushi Fang (a traditional Chinese medicine formula for strengthening the spleen and removing dampness); D: medium-dose group of Jianpi Qushi Fang (a traditional Chinese medicine formula for strengthening the spleen and removing dampness); E: high-dose group of Jianpi Qushi Fang (a traditional Chinese medicine formula for strengthening the spleen and removing dampness); F: Shenling Baizhu Granules group; G: Domperidone group. Detailed Implementation

[0029] Numerous specific details are set forth in the following description to provide a full understanding of the invention. However, the invention can be practiced in many other ways different from those described herein, and similar modifications can be made by those skilled in the art without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0031] Example 1

[0032] The spleen-strengthening and dampness-removing formula consists of the following ingredients by weight:

[0033] 3 parts of *Cynanchum paniculatum*, 12 parts of *Coix lacryma-jobi*, 5 parts of *Poria cocos*, 5 parts of red adzuki bean, 10 parts of black tea, and 5 parts of Xinhui tangerine peel;

[0034] Weigh 100g of raw materials according to the mass ratio, add 1000mL of distilled water, and decoct for 50 minutes to obtain the decoction; then add 1000mL of distilled water to the dregs and repeat the decoction once; combine the two decoctions, concentrate them by rotary evaporation, and prepare low-dose (0.016g / mL), medium-dose (0.031g / mL), and high-dose (0.062g / mL) decoctions.

[0035] Comparative Example 1

[0036] Take domperidone tablets (Xi'an Janssen Pharmaceutical Co., Ltd., batch number: H10910003), grind them into powder, pass them through a 100-mesh sieve, add purified water and mix well to prepare a suspension containing domperidone at a concentration of 0.002 g / mL.

[0037] Comparative Example 2

[0038] Take Shenling Baizhu powder granules (Yunnan Tengyao Pharmaceutical Co., Ltd., batch number: Z53020280), add purified water and mix well to prepare a suspension containing 0.281g / mL of Shenling Baizhu powder granules.

[0039] Pharmacological experiments

[0040] To further evaluate the efficacy of the traditional Chinese medicine composition of this application, pharmacological experiments were conducted on the drugs of Example 1 and Comparative Examples 1-2, as follows:

[0041] I. Animal Experiments

[0042] 1. Materials

[0043] Experimental animals: 70 SPF-grade male SD rats, weighing (200±20) g.

[0044] Drugs and reagents: Low, medium, and high dose decoctions of Example 1, Domperidone suspension of Comparative Example 1, and Ginseng and Atractylodes Macrocephala Powder suspension of Comparative Example 2; Total protein quantification kit, D-xylose assay kit, and α-amylase kit (Nanjing Jiancheng Bioengineering Institute, catalog numbers: A045-3-2, A035-1-1, C016-1-1, respectively); Rat gastrin ELISA kit (Wuhan Hualianke Biotechnology Co., Ltd., catalog number: RA20639);

[0045] Instruments: Electric thermostatic incubator; Multifunctional microplate reader; High-speed centrifuge; Water bath; Electric thermostatic water bath; Portable electronic balance.

[0046] 2. Experimental Methods

[0047] (1) Animal grouping and model construction

[0048] Seventy SPF-grade male SD rats were randomly divided into a normal control group (n=10) and a model group (n=60). The normal control group rats were fed under standard conditions. The model group rats underwent a combined intervention using a multifactorial approach, involving external moisture stimulation, fatigue, and excessive water intake, as detailed below:

[0049] Sixty rats were placed in a 20cm pool with a water temperature of 25-27℃ for 15 minutes at regular intervals each day. After swimming, they were immediately given 4℃ ice water by gavage (20 mL / kg). The rats were then placed in cages with water at a height of 4 mm and allowed free access to food and water. This intervention was continued for 5 days.

[0050] The evaluation indicators for the model include the rat's activity status, changes in body weight, food intake, and fecal characteristics. Successful models are characterized by lethargy, curling up and reduced movement, slow or decreased body weight gain, reduced food intake, and loose stools.

[0051] Fifty rats were randomly selected from the successfully modeled rats and divided into four groups: Domperidone group, Ginseng and Atractylodes Macrocephala Granules group, Spleen-Strengthening and Dampness-Clearing Formula low-dose group (hereinafter referred to as low-dose group), medium-dose group, and high-dose group.

[0052] (2) Administration

[0053] The domperidone group was given 0.010 g / kg of domperidone suspension by gavage;

[0054] The group receiving Shenling Baizhu granules was given a suspension of 1.683 g / kg of Shenling Baizhu granules by gavage.

[0055] The low-dose group was given 0.094 g / kg of a spleen-strengthening and dampness-removing decoction by gavage;

[0056] The medium-dose group was given 0.187 g / kg of a spleen-strengthening and dampness-removing decoction by gavage;

[0057] The high-dose group was given 0.374 g / kg of a spleen-strengthening and dampness-removing decoction by gavage;

[0058] Administer gavage once daily for 7 consecutive days;

[0059] The normal control group and the model group rats were given the same volume of physiological saline.

[0060] (3) Indicator detection

[0061] Metabolic and behavioral indicators were observed and recorded daily during the modeling period and after drug administration, including changes in fecal characteristics, body weight, activity status, food intake, and water intake of rats in each group.

[0062] Normal rat feces are granular or short cylindrical, while abnormal feces include loose stools, hard pellets, and mucus.

[0063] The normal range of weight gain for rats is approximately 5-10g, while abnormal weight gain is characterized by weight loss or stagnation.

[0064] Normal rats are active; reduced activity, sluggishness, or obvious lethargy are considered abnormal. The food intake and water intake of rats in the spleen deficiency and dampness obstruction model were significantly reduced.

[0065] Determination of gastrointestinal propulsion rate and various indicators in rats: After fasting for 18 h after the last administration, each rat was given 1.5 mL of 10% activated charcoal suspension by gavage. The rats were sacrificed 15 min later. The total length of the gastrointestinal tract and the distance of charcoal propulsion were measured in each group of rats, and the gastrointestinal propulsion rate was calculated.

[0066] After the last administration, the rats were fasted for 18 hours. Blood was collected from the abdominal aorta under anesthesia, allowed to stand at room temperature for 2 hours, and then centrifuged at 3000 r / min for 10 min at 4℃ (centrifugation radius 350 mm). Serum was separated, and the serum amylase, total protein, and D-xylose content of each group of rats were detected by spectrophotometry. Gastrin was detected by enzyme-linked immunosorbent assay.

[0067] Histopathological observation of rat gastrointestinal tissue: Stomach and jejunal tissues of rats in each group were taken, fixed with 4% paraformaldehyde, embedded in paraffin and prepared into sections; hematoxylin-eosin (HE) staining method was used, and the staining was performed according to the reagent instructions. Histopathological changes were observed and images were acquired under an optical microscope.

[0068] (4) Data processing

[0069] SPSS 25.0 statistical software was used for statistical analysis of the data. Data are presented as mean ± standard deviation. The values ​​are indicated by the number of groups. One-way ANOVA was used for comparisons between the two groups. A p-value < 0.05 was considered statistically significant.

[0070] 3. Results

[0071] (1) Changes in fecal characteristics, body weight, activity, food intake and water intake of each rat

[0072] During the model establishment process, reduced activity was observed in rats on the second day after modeling, with some rats exhibiting loose stools, weakness in the limbs, and symptoms of curling up and reduced movement. On the third day, all rats showed loose stools, significantly reduced activity, and reduced food and water intake. By the fourth day, the above symptoms had further worsened, and a few rats were unable to complete a 15-minute swim.

[0073] After successful modeling, compared with the normal control group, the body weight, food intake and water intake of each experimental group were significantly reduced (P<0.05, P<0.01).

[0074] After the modeling was stopped, the rats in the model group continued to show symptoms such as loose or dry stools and weakness in the limbs, and their body weight and food and water intake did not recover significantly.

[0075] As shown in Table 1, compared with the model group, the body weight, food intake and water intake of rats in the Shenling Baizhu Granules group and the Domperidone group were significantly increased (P<0.05, P<0.01), and the fecal characteristics of the rats basically returned to normal. The body weight, food intake and water intake of rats in the low, medium and high dose groups of Jianpi Qushi Fang were also significantly increased (P<0.05, P<0.01), and the fecal characteristics of most rats basically returned to normal.

[0076] Table 1. Changes in body weight, food intake, and water consumption of rats in each group.

[0077]

[0078] Note: Compared with the normal control group, *P<0.05, **P<0.01; compared with the model group, +P<0.05, ++P<0.01.

[0079] (2) Changes in small intestinal propulsion rate, serum amylase and total protein in rats of each group

[0080] As shown in Table 2, compared with the normal control group, the small intestinal propulsion rate of the model group, the low-dose group and the high-dose group of the traditional Chinese medicine composition, and the Shenling Baizhu granule group were significantly reduced (P<0.05, P<0.01). The serum amylase content and total protein content of the rats in the model group were significantly reduced (P<0.01). Compared with the model group, the small intestinal propulsion rate of the rats in the Shenling Baizhu granule group and the domperidone suspension group were significantly increased (P<0.01), and the serum amylase and total protein content were significantly increased (P<0.05, P<0.01). The small intestinal propulsion rate of the rats in the low, medium and high dose groups of the traditional Chinese medicine composition was significantly increased (P<0.01), and the serum amylase and total protein content of the rats in the medium and high dose groups of the traditional Chinese medicine composition were significantly increased (P<0.05, P<0.01).

[0081] Table 2 Comparison of changes in small intestinal propulsion rate, serum amylase, and total protein in rats of different groups

[0082]

[0083] Note: Compared with the normal control group, *P<0.05, **P<0.01; compared with the model group, +P<0.05, ++P<0.01.

[0084] (3) Changes in serum gastrin levels and small intestinal D-xylose absorption rate in rats of each group

[0085] As shown in Table 3, compared with the normal control group, the serum gastrin and D-xylose levels in the model group were significantly decreased (P < 0.05, P < 0.01). Compared with the model group, the serum gastrin level and small intestinal D-xylose content in the Shenling Baizhu Granules group and the Domperidone group were significantly increased (P < 0.05, P < 0.01). The serum gastrin content in the medium and high dose groups of the Jianpi Qushi Decoction was significantly increased (P < 0.01), and the D-xylose content in the high dose group was significantly increased (P < 0.05).

[0086] Table 3 Comparison of serum gastrin levels and small intestinal D-xylose absorption rates in rats of different groups

[0087]

[0088] Note: Compared with the normal control group, *P<0.05, **P<0.01; compared with the model group, +P<0.05, ++P<0.01.

[0089] (4) Pathological changes in the stomach and jejunum tissues of rats in each group

[0090] like Figure 1As shown, the gastric mucosa of rats in the normal control group had an intact structure, with no pathological changes such as congestion, hematoma, inflammatory cell infiltration, or tissue edema. Scattered bleeding points and a small amount of lymphocyte infiltration were observed in the gastric mucosa of rats in the model group. The gastric mucosa of rats in the Shenling Baizhu Granules group and the Domperidone group had a relatively intact structure, with only a small amount of bleeding points and lymphocyte infiltration. The bleeding points in the gastric mucosa of rats in the low, medium, and high dose groups of Jianpi Qushi Fang were significantly reduced, and the degree of inflammatory cell infiltration was improved.

[0091] like Figure 2 As shown, in the normal control group, the small intestinal mucosa of rats was intact, the villi were neatly arranged, and no pathological changes such as erosion or swelling were observed. In the model group, the small intestinal mucosa of rats showed obvious swelling at the villus tips, degeneration and necrosis of glandular cells, accompanied by significant hemorrhage and lymphocyte infiltration. The morphology and structure of the small intestine of rats in the Shenling Baizhu Granules group and the Domperidone group were basically restored to normal, and no obvious erosion or villus swelling was observed. In the high-dose group of Jianpi Qushi Fang, the villus structure was basically restored to normal, the swelling phenomenon basically disappeared, and the morphology of glandular cells tended to be at a normal level.

[0092] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0093] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition for strengthening the spleen and removing dampness, characterized in that, The active ingredients, by mass, include 1-5 parts of *Hedyotis diffusa*, 8-15 parts of *Coix lacryma-jobi*, 3-8 parts of *Poria cocos*, 3-8 parts of red adzuki bean, 7-15 parts of black tea, and 3-8 parts of dried tangerine peel.

2. The spleen-strengthening and dampness-removing traditional Chinese medicine composition according to claim 1, characterized in that, The active ingredients are composed of 1-5 parts by weight of *Cynanchum paniculatum*, 8-15 parts of *Coix lacryma-jobi*, 3-8 parts of *Poria cocos*, 3-8 parts of red adzuki bean, 7-15 parts of black tea, and 3-8 parts of dried tangerine peel.

3. The spleen-strengthening and dampness-removing traditional Chinese medicine composition according to claim 1, characterized in that, The active ingredients, by mass, include 3 parts of *Cynanchum paniculatum*, 12 parts of *Coix lacryma-jobi*, 5 parts of *Poria cocos*, 5 parts of red adzuki bean, 10 parts of black tea, and 5 parts of dried tangerine peel.

4. The traditional Chinese medicine composition for strengthening the spleen and removing dampness according to claim 1, characterized in that, The active ingredients are composed of 3 parts by weight of *Cynanchum paniculatum*, 12 parts of *Coix lacryma-jobi*, 5 parts of *Poria cocos*, 5 parts of red adzuki bean, 10 parts of black tea, and 5 parts of dried tangerine peel.

5. The spleen-strengthening and dampness-removing traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The active ingredient of the traditional Chinese medicine composition is the powder of the raw materials in the specified weight ratio or an extract of the raw materials in water or organic solvent.

6. The spleen-strengthening and dampness-removing traditional Chinese medicine composition according to claim 5, characterized in that, The traditional Chinese medicine composition also includes pharmaceutically acceptable excipients.

7. The spleen-strengthening and dampness-removing traditional Chinese medicine composition according to claim 6, characterized in that, The traditional Chinese medicine composition is in the form of decoction, granules, pills, tablets, or capsules.

8. The method for preparing the spleen-strengthening and dampness-removing traditional Chinese medicine composition according to any one of claims 1-7, characterized in that, Includes the following steps: Combine the herbs *Hedyotis diffusa*, *Coix lacryma-jobi*, *Poria cocos*, red adzuki bean, black tea, and dried tangerine peel, add water and decoct, filter, and obtain the filtrate to obtain the aforementioned traditional Chinese medicine composition.

9. The method for preparing the spleen-strengthening and dampness-removing traditional Chinese medicine composition according to claim 8, characterized in that, Includes the following steps: Combine the herbs *Cynanchum paniculatum*, *Coix lacryma-jobi*, *Poria cocos*, red adzuki beans, black tea, and dried tangerine peel, and decoct twice with water. For the first decoction, add 10-15 times the amount of water, soak for 0.5-1 hour, and decoct for 1-2 hours. For the second decoction, add 8-10 times the amount of water and decoct for 1-1.5 hours. Combine the two decoctions to obtain the filtrate.

10. The method for preparing the spleen-strengthening and dampness-removing traditional Chinese medicine composition according to claim 9, characterized in that, It also includes the following steps: The filtrate was concentrated to a relative density of 1.15-1.30 at 80°C to obtain a thick paste; then pharmaceutically acceptable excipients were added, mixed evenly, and the desired formulation was prepared.

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