A traditional Chinese medicine composition for strengthening the spleen and eliminating dampness, and a preparation method and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition of invigorating spleen and dampness and its preparation method and application, including the following weight parts of raw materials: 7-14 parts of ginseng, 10-20 parts of fried white bean, 10-20 parts of tuckahoe, 7-14 parts of orange peel, 15-30 parts of corn silk, 10-20 parts of gardenia, 12-24 parts of white lily root, 13-26 parts of kudzu root, 6-12 parts of white peony root, 6-12 parts of perilla leaf, 6-12 parts of shiitake mushroom, 1-4 parts of licorice root. It has the effect of invigorating spleen and dampness, ascending clear and descending turbid, promoting water and reducing swelling. It is used for body fatigue, limb soreness, edema, vomiting, diarrhea, polydipsia, loose stool and other symptoms caused by dampness. And it can be used as a health drink for chronic diseases related to dampness. The present application has a good application prospect with unique formula and no toxic side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine development technology, specifically relating to a traditional Chinese medicine composition for strengthening the spleen and resolving dampness, its preparation method and application. Background Technology

[0002] Dampness syndrome is one of the basic syndromes in Traditional Chinese Medicine (TCM). It is a core syndrome in cardiovascular and cerebrovascular diseases, diabetes, chronic kidney disease, obesity, and immune-related diseases. It can be caused by prolonged exposure to damp environments and the invasion of dampness or summer heat, which obstructs the middle jiao (middle burner) and damages yang qi. It can also be caused by spleen yang deficiency, which leads to spleen dysfunction and the inability of fluids to be properly distributed, resulting in the transformation of dampness into turbidity, thus preventing qi, blood, and body fluids from nourishing the whole body.

[0003] Dampness syndrome is characterized by its insidious onset, lingering and difficult-to-cure nature, and extremely wide range of pathogenic factors, affecting the skin, muscles, and tendons externally, and the internal organs, bone marrow, and blood internally. It often has a long course and involves multiple organs. Early prevention and treatment are of great significance for controlling major diseases and reducing recurrence and mortality rates. Given the harmfulness of dampness syndrome, the National Key Laboratory of Traditional Chinese Medicine Dampness Syndrome, jointly established by the Ministry of Education and Guangdong Province, was established in Guangzhou on March 21, 2021.

[0004] Currently, there are many drugs and health products on the market that dispel and resolve dampness, but their effects on the overall prevention and treatment of dampness syndrome are not satisfactory. Some, such as "Sanren Tang," can easily cause side effects with long-term use. Therefore, there is a need for a traditional Chinese medicine composition that can be taken long-term to solve the above-mentioned technical problems. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition, preparation method and application thereof, which can significantly improve the clinical symptoms of patients with dampness syndrome, improve the therapeutic effect, and slow down the progression of dampness syndrome-related cardiovascular and cerebrovascular diseases, diabetes, chronic kidney disease, obesity and immune-related diseases.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: In the first aspect, a traditional Chinese medicine composition is provided, comprising the following raw materials in parts by weight: 7-14 parts ginseng, 10-20 parts stir-fried white hyacinth bean, 10-20 parts poria cocos, 7-14 parts tangerine peel, 15-30 parts corn silk, 10-20 parts gardenia, 12-24 parts imperata cylindrica root, 13-26 parts kudzu root, 6-12 parts angelica dahurica, 6-12 parts perilla leaf, 6-12 parts elsholtzia ciliata, and 1-4 parts licorice.

[0007] In some embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: ginseng 8-12 parts, stir-fried white hyacinth bean 9-18 parts, poria cocos 12-24 parts, tangerine peel 8-16 parts, corn silk 12-24 parts, gardenia 10-20 parts, imperata cylindrica root 10-20 parts, kudzu root 15-30 parts, angelica dahurica 7-14 parts, perilla leaf 7-14 parts, sesame sedge 6-12 parts, and licorice 1-2 parts.

[0008] In some embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: ginseng 6-12 parts, stir-fried white hyacinth bean 12-17 parts, poria cocos 14-20 parts, tangerine peel 10-15 parts, corn silk 20-35 parts, gardenia 12-25 parts, imperata cylindrica root 11-25 parts, kudzu root 10-30 parts, angelica dahurica 5-12 parts, perilla leaf 5-12 parts, sesame sedge 7-10 parts, and licorice 2-3 parts.

[0009] Secondly, a method for preparing the aforementioned traditional Chinese medicine composition is provided, comprising the following steps: adding each raw material to water in proportion, performing water extraction, and concentrating to obtain the traditional Chinese medicine composition.

[0010] Thirdly, the application of the aforementioned traditional Chinese medicine composition in the preparation of medicines that strengthen the spleen and resolve dampness is provided.

[0011] Fourthly, a medicine for strengthening the spleen and resolving dampness is provided, the medicine comprising the aforementioned traditional Chinese medicine composition.

[0012] In some embodiments, the drug also comprises a pharmaceutically acceptable carrier.

[0013] In some embodiments, the dosage form of the drug is granules, tea bags, tablets, or capsules.

[0014] In the traditional Chinese medicine composition of this invention, ginseng, which greatly replenishes vital energy, strengthens the spleen and lungs, promotes the production of body fluids and nourishes blood, and calms the mind and improves intelligence, serves as the principal ingredient. It can invigorate the yang energy of the spleen, kidneys, heart, and lungs, preventing dampness from accumulating and phlegm from being generated. It can also warm the limbs, maintain body temperature, and resist external dampness invasion. The auxiliary ingredients are stir-fried white hyacinth bean, poria cocos, and tangerine peel, which strengthen the spleen, resolve dampness, harmonize the middle jiao, and relieve summer heat. Corn silk, imperata root, and gardenia, which promote diuresis, reduce swelling, and relieve strangury, also serve as auxiliary ingredients. Furthermore, corn silk and gardenia soothe the liver, promote bile secretion, and reduce jaundice, while imperata root and gardenia clear heat. This formula cools the blood, effectively clears heat from the lungs and stomach, and eliminates fire evil from the triple burner. Adding kudzu root helps relieve muscle tension and fever, unblocks meridians, and raises yang to stop diarrhea, acting as an adjuvant. Its function is to raise clear yang qi and assist the spleen in transporting dampness. Angelica dahurica, perilla leaf, and elsholtzia ciliata are pungent and warm, dispelling cold and relieving external pathogens, dispelling wind and relieving pain, reducing swelling, harmonizing the middle burner and descending turbidity. These also act as adjuvants, further promoting yang qi, promoting diuresis, regulating qi and unblocking meridians, clearing away stagnation, preventing dampness from accumulating and phlegm from forming, and warming the limbs to maintain body temperature and resist external dampness invasion. Licorice root harmonizes the other herbs and assists in tonifying the spleen and replenishing qi. The combined effects of these herbs are to strengthen the spleen, resolve dampness, raise clear qi and descend turbidity, and promote diuresis and reduce swelling. It is used for symptoms such as fatigue, limb pain, edema, vomiting, diarrhea, thirst, and loose stools caused by dampness syndrome. It can also be used as a health drink for chronic diseases related to dampness syndrome.

[0015] Compared with existing technologies, the beneficial effects of this invention are as follows: This invention adopts the treatment method of promoting the ascending of clear qi and descending of turbid qi, and using pungent and warm herbs to promote diuresis. Ginseng is used to greatly replenish vital energy, encouraging the ascending of yang qi in the spleen, lungs, heart, and kidneys; a formula for harmonizing the middle jiao and promoting diuresis is used to descend turbid yin, promoting food digestion, absorption, and metabolism; a formula for promoting diuresis with pungent and warm herbs is used to further enhance yang qi, warming the limbs to maintain body temperature and resist external dampness invasion, while also promoting diuresis. Strengthening the spleen and promoting diuresis prevents the generation of dampness. With a healthy spleen and stomach, the generation of qi and blood energy is abundant, leading to good health.

[0016] Animal experiments show that the traditional Chinese medicine composition of this invention has the effect of strengthening the spleen and resolving dampness in mice with spleen deficiency and dampness. Attached Figure Description

[0017] Figure 1 This is a flowchart of the preparation process of the present invention; Figure 2 Histopathological images of mouse intestines stained with HE at different doses using X200 staining. Detailed Implementation

[0018] To facilitate understanding of the present invention, a more comprehensive description will be given below. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the present invention.

[0019] As used in this article: "Prepared from" is synonymous with "comprising". The terms "comprising", "including", "having", "containing", or any other variations thereof as used herein are intended to cover non-exclusive inclusion. For example, a composition, step, method, article, or apparatus that includes the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article, or apparatus.

[0020] The conjunction "composed of..." excludes any unspecified elements, steps, or components. If used in a claim, this phrase makes the claim closed, excluding materials other than those described, except for associated conventional impurities. When the phrase "composed of..." appears in a clause of the body of a claim rather than immediately following it, it limits only the elements described in that clause; other elements are not excluded from the claim as a whole.

[0021] When a quantity, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pair of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range “1-5” is disclosed, the described range should be interpreted as including ranges “1-4”, “1-3”, “1-2”, “1-2 and 4-5”, “1-3 and 5”, etc. When numerical ranges are described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within that range.

[0022] In these embodiments, unless otherwise specified, the portions and percentages are all by weight.

[0023] "Parts by mass" refers to the basic unit of measurement that expresses the mass ratio of multiple components. One part can represent any unit mass, such as 1g or 2.689g. If we say that component A has "a" parts by mass and component B has "b" parts by mass, it means the ratio of the mass of component A to the mass of component B is a:b. Alternatively, it can mean that the mass of component A is aK and the mass of component B is bK (where K is any number representing a multiplier). It is important to understand that, unlike the number of parts by mass, the sum of the mass parts of all components is not limited to 100 parts.

[0024] "And / or" is used to indicate that one or both of the described situations may occur, for example, A and / or B includes (A and B) and (A or B).

[0025] A traditional Chinese medicine composition is provided, comprising the following raw materials in parts by weight: 7-14 parts ginseng, 10-20 parts stir-fried white hyacinth bean, 10-20 parts poria cocos, 7-14 parts tangerine peel, 15-30 parts corn silk, 10-20 parts gardenia, 12-24 parts imperata cylindrica root, 13-26 parts kudzu root, 6-12 parts angelica dahurica, 6-12 parts perilla leaf, 6-12 parts elsholtzia ciliata, and 1-4 parts licorice.

[0026] In different implementations, the weight of ginseng can be, but is not limited to, 7, 8, 9, 10, 11, 12, 13, or 14 parts; preferably 8-12 parts.

[0027] In different implementations, the weight of the stir-fried white hyacinth beans can be, but is not limited to, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 parts; preferably 13-17 parts.

[0028] In different embodiments, the weight parts of Poria cocos can be, but are not limited to, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 parts; preferably 15-20 parts.

[0029] In different embodiments, the weight of orange peel can be, but is not limited to, 7, 8, 9, 10, 10, 12, 13, or 14 parts; preferably 8-12 parts.

[0030] In different embodiments, the weight parts of corn silk can be, but are not limited to, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 parts; preferably 18-22 parts. In different embodiments, the weight parts of gardenia are, but not limited to, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 parts; preferably 12-15 parts.

[0031] In different embodiments, the weight parts of Imperata cylindrica root can be, but are not limited to, 12, 13, 14, 15, 16, 17, 18, 19, 22, 21, 22, 23, or 24 parts; preferably 14-20 parts.

[0032] In different implementations, the weight parts of kudzu root can be, but are not limited to, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, or 26 parts; preferably 15-20 parts.

[0033] In different embodiments, the weight parts of Angelica dahurica, Perilla frutescens leaves and Elsholtzia ciliata can be independently, but are not limited to, 6, 7, 8, 9, 10, 11, or 12 parts; preferably 7-9 parts.

[0034] In different embodiments, the weight of licorice can be, but is not limited to, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, or 4 parts; preferably 2-3 parts.

[0035] On the other hand, a method for preparing the aforementioned traditional Chinese medicine composition is provided, comprising the following steps: adding each raw material to water in proportion, performing water extraction, and concentrating to obtain the traditional Chinese medicine composition.

[0036] Secondly, the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for strengthening the spleen and resolving dampness is provided.

[0037] Thirdly, a medicine for strengthening the spleen and resolving dampness is provided, the medicine comprising the aforementioned traditional Chinese medicine composition.

[0038] In some embodiments, the drug also comprises a pharmaceutically acceptable carrier.

[0039] In some embodiments, the dosage form of the drug is granules, tea bags, tablets, or capsules.

[0040] There are no particular limitations on the dosage form of the drug described in this invention; it can be any dosage form suitable for oral administration in mammals. Preferably, the dosage form can be selected from: granules, tea bags, tablets, and capsules. From the perspective of ease of preparation, portability, and suitability for long-term use, solid dosage forms, especially granules, are preferred.

[0041] Example 1 This embodiment provides a granule preparation method as follows: S1: Weigh: 7 parts ginseng, 10 parts stir-fried white hyacinth bean, 10 parts poria cocos, 7 parts tangerine peel, 15 parts corn silk, 10 parts gardenia, 12 parts imperata root, 13 parts kudzu root, 6 parts angelica dahurica, 6 parts perilla leaf, 6 parts elsholtzia ciliata, and 1 part licorice. Place all raw materials in a Chinese medicine extraction tank, add 8 times the amount of water, and heat and decoct for 2 hours at a steam pressure of 0.2 MPa. Filter the aqueous solution and set aside. Add 6 times the amount of water a second time, heat and decoct for 1 hour at a steam pressure of 0.2 MPa, filter the aqueous solution, combine the two filtrates, turn on the vacuum concentration device, and draw the filtrate into a vacuum concentration tank. Concentrate under a vacuum of -0.05 MPa to -0.09 MPa to a thick paste with a relative density of 1.10-1.15 (measured at 50℃), and set aside. S2: Weigh 25 parts of soluble starch as excipient, add to the thick paste obtained in step 1, mix, granulate, and dry to obtain 30 parts of the granules described in this article. Pack the granules into aluminum-plastic bags, each bag containing 3 grams of raw medicinal material and 10.3 grams of raw medicinal material.

[0042] Example 2 This embodiment provides a tea bag preparation method as follows: S1: Weigh: 7 parts ginseng, 10 parts stir-fried white hyacinth bean, 10 parts poria cocos, 7 parts tangerine peel, 15 parts corn silk, 10 parts gardenia, 12 parts imperata root, 13 parts kudzu root, 6 parts angelica dahurica, 6 parts perilla leaf, 6 parts elsholtzia ciliata, and 1 part licorice. Grind all raw materials into coarse particles and pass them through 18-mesh and 50-mesh sieves. Continue to grind the coarse particles that cannot pass through the 18-mesh sieve. Take 27 parts of coarse particles that are between the 18-mesh and 50-mesh sieves for later use, and 76 parts of fine powder that pass through the 50-mesh sieve for later use. S2: Place 76 parts of the fine powder obtained in step S1 into a Chinese medicine extraction tank, add 12 times the amount of water, heat and decoct for 1 hour at a steam pressure of 0.2 MPa, let stand, extract the supernatant and filter, turn on the vacuum concentration device, and draw the filtrate into a vacuum concentration tank, concentrate it under a vacuum of -0.05 MPa to -0.09 MPa to a thick paste with a relative density of 1.10-1.15 (measured at 50℃), and set aside for later use; S3: Add 27 parts of coarse particles obtained in step S1 to the thick paste obtained in step S2, mix, and dry to obtain 30 parts of tea bags as described in this article. Pack the tea bags into filter bags and aluminum-plastic bags, each bag containing 3 grams and 10.3 grams of raw herbs.

[0043] Example 3 Application of Traditional Chinese Medicine Combinations To verify whether the traditional Chinese medicine composition of the present invention has a therapeutic effect on dampness syndrome.

[0044] I. Experimental Principle This experiment, based on the classic TCM theories of "spleen governing transformation and transportation," "dampness trapping the spleen," and "spleen deficiency with dampness accumulation," constructed an animal model and evaluated the effects of drug intervention. According to TCM etiology, the spleen governs the transformation and transportation of water and dampness. Factors such as improper diet (e.g., high-fat diet), overexertion (e.g., swimming with heavy loads), and external dampness (high humidity environment) can all damage spleen function, leading to impaired spleen function, internal retention of water and dampness, and thus a series of symptoms of spleen deficiency with dampness accumulation, such as reduced appetite, decreased body weight, loose stools, fatigue, and weakness.

[0045] The experimental principle lies in simulating the pathogenesis and pathological process of the TCM syndrome of "spleen deficiency and dampness" through a combination of factors (i.e., dietary indiscretion, overwork, and environmental dampness). Long-term high-fat diets and irregular eating habits damage the spleen and stomach qi, while excessive exertion (swimming) depletes qi and blood. Combined with external dampness from a high-humidity environment, the internal and external dampness further hinders the spleen's digestive function, leading to impaired water metabolism and the inability to separate clear and turbid fluids. This results in animal models exhibiting biological characteristics consistent with clinical spleen deficiency and dampness, such as slow weight gain, reduced food intake, loose stools (increased fecal water content), poor mental state, and reduced activity. After successful modeling, different doses of the test drug were administered, with a non-treatment control group as a reference, to observe the improvement in symptoms and objective indicators related to spleen deficiency and dampness, thereby verifying the drug's spleen-strengthening and dampness-resolving effects.

[0046] II. Sample The sample is a traditional Chinese medicine composition for strengthening the spleen and resolving dampness prepared in Example 1. It is in granule form, with a sample specification of 3 grams. The human dosage is 3 grams three times a day. The high, medium and low doses are set at 1400 mg / kg, 2800 mg / kg and 7000 mg / kg, respectively, which are equivalent to 1, 2 and 5 times the human equivalent dose.

[0047] During the detection, due to the need for gavage, the sample was prepared into gradient concentration solutions with pure water, and the solvent pure water was used as the test substance for the blank control group and the model control group. The gavage volume of each group was kept consistent.

[0048] III. Experimental Animals 50 SPF-grade C57BL / 6J mice, with 25 males and 25 females, batch number 20250045, provided by the Guangdong Provincial Center for Medical Laboratory Animals. The production license number for experimental animals: SCXK(Yue)2022 - 0002, and the quality certificate number for experimental animals: No.SCXK(Yue)2022 - 00022025559503.

[0049] IV. Experimental Conditions The license number for the use of experimental animals: SYXK(Yue)2024 - 0201. After being quarantined and passing the inspection, the animals were housed in IVC cages in a barrier environment, with 5 animals in each cage. The facility temperature was 20 - 26 °C, and the humidity was 30 - 70%. During the quarantine adaptation period, irradiated mouse maintenance feed was given to the animals. During the model establishment period, the model group (model control group and three dose groups) was given high-fat feed, the blank control group was given irradiated mouse maintenance feed, and the drinking water was all high-pressure sterilized water. The supplier of irradiated mouse maintenance feed is Xietong Biology, and the production license number: Su Feed License(2024)01008. The supplier of high-fat feed is the Guangdong Provincial Center for Medical Laboratory Animals, and the production license number: Yue Feed License(2024)05073.

[0050] V. Experimental Methods After the animal quarantine adaptation period, the animals were randomly divided into 5 groups: blank control group, model control group, high-dose drug group, medium-dose group, and low-dose group, with 10 animals in each group, 5 males and 5 females.

[0051] Model establishment for spleen deficiency and dampness excess syndrome: From 17:00 to 9:00 the next day, the mice for model establishment (model control group and high, medium, and low-dose drug groups) were placed in a modeling box with a humidity of (90 ± 5)% (for 16 hours). On odd days, they were fed with high-fat feed ad libitum, and on even days, they were fasted. At the same time, on the fasting days, the mice were forced to swim for 20 minutes. The model establishment continued for 14 consecutive days. During the model establishment period, the mice in the blank control group were fed under normal conditions, with unlimited supply of feed and drinking water.

[0052] Observation and detection indicators during model establishment: During the model establishment period, observe the clinical manifestations, growth status, defecation and urination status, food intake of the animals, and measure the body weight every week. At the end of the model establishment, all animals were scored according to the physical sign scoring table, and feces were collected by group. Weigh the wet weight of the fresh feces and the dry weight after drying at 50 °C for 24 hours, and calculate the fecal water content.

[0053] Administration after model establishment: The blank control group and the model control group were given the same volume of solvent, and the drug group was given gradient doses of the drug. Gavage administration was carried out at the same time every day for 7 consecutive days.

[0054] Efficacy observation indicators: During the administration period, the animals' clinical manifestations, growth status, defecation and urination status, and feed intake were observed. At the end of administration, the following indicators were measured for all animals: physical signs score; feces were collected by group, and the wet weight of fresh feces and the dry weight after drying at 50℃ for 24 hours were measured to calculate the fecal moisture content; urine was collected in metabolic cages for 24 hours to measure urine volume and urine biochemical indicators; blood was collected from animals after anesthesia, and serum was collected after centrifugation for 15 minutes after standing, and the following indicators were measured: lactate, Na ions, K ions, Cl ions, Ca, lactate dehydrogenase, urea nitrogen, and albumin; body weight before dissection, weight of spleen, heart, liver, and kidneys, and organ index was calculated; pathological sections of liver, kidney, spleen, stomach, and intestine tissues were stained with HE and observed under a microscope. Data processing: The SPSSAU project (2026).SPSSAU. (Version 26.0) [Online Application Software]. ANOVA was performed on the data. Quantitative data were expressed as (mean ± standard deviation), and P < 0.05 was considered statistically significant.

[0055] VI. Results 1. During the modeling period, all animals exhibited slightly poor mental state, somewhat disheveled and dull fur, decreased activity, reduced feed intake, slow or even weight gain, and soft, white stools. The physical examination scores and total scores of the model control group were significantly higher than those of the blank control group. Feed intake in the model group was lower than that of the blank control group. The condition of the animals in the medium-to-high dose groups improved slightly after drug administration. Compared with the same-sex model control group, the total scores of the male medium-to-high dose group and the female low-to-medium-high dose group were all lower.

[0056] 2. At the end of the modeling process, the fecal water content of the modeling animals was significantly higher than that of the blank control group. After the drug administration was completed, except for the model control group, the fecal water content of male and female animals at high, medium and low doses was significantly reduced. See Table 1 for fecal water content.

[0057] 3. No significant abnormalities were found in the organ weight and organ index of the spleen, heart, liver and kidneys in the animal dissection. The differences were within the normal range of the laboratory in history and were considered to be of no biological significance. See Table 2 for organ weight and organ index.

[0058] 4. Compared with the blank control group, the 24-hour urine output of the model control group animals was significantly reduced. Compared with the model control group animals, the 24-hour urine output of both male and female animals at high, medium, and low doses was increased. See Table 3 for details on 24-hour urine output.

[0059] 5. At the end of the administration, except for the model control group, the protein content in the urine of male and female animals at high, medium and low doses was significantly reduced, as shown in Table 4.

[0060] 6. Compared with the blank control group, the serum lactate content of the model control group animals was significantly increased; compared with the same sex model control group animals, the serum lactate content of both high, medium and low dose male and female animals was significantly decreased; compared with the same sex model control group animals, the serum lactate dehydrogenase content of high and medium dose male and female animals was significantly decreased, and the serum urea content of high and medium dose male animals was significantly decreased. See Table 5 for serum test results.

[0061] 7. Pathological histological examination results showed that the colonic mucosa of the model control group and the low-to-medium dose groups had local infiltration of inflammatory cells, intestinal mucosal shedding, and increased mucus; pathological images are shown below. Figure 2 As shown.

[0062] In summary, compared with normal animals, the model animals exhibited symptoms such as reduced food intake, loose stools (increased fecal water content), decreased 24-hour urine output, poor mental state, reduced activity, significantly shorter swimming time under load, elevated blood lactate levels after exercise, and pathological reactions of intestinal inflammation and damage. These symptoms are consistent with the biological characteristics of spleen deficiency and dampness accumulation syndrome, thus establishing the spleen deficiency and dampness accumulation model. Compared with the model control animals, the treated animals showed improved clinical signs, increased food intake, decreased fecal water content, increased 24-hour urine output, significantly reduced urinary biochemical protein, and significantly reduced serum lactate, lactate dehydrogenase, and urea levels after exercise. Intestinal inflammation and damage were also alleviated, indicating a certain degree of improvement.

[0063] VII. Results Evaluation Under the conditions of this experiment, the test sample had the effect of strengthening the spleen and resolving dampness in mice with spleen deficiency and dampness accumulation.

[0064] Table 1. Fecal moisture content (%) Note: Fecal moisture content (%) = (Fecal wet weight - Fecal dry weight) / Fecal wet weight * 100% Table 2. Organ weight and organ index (mean ± standard deviation) Note: "*" indicates a significant difference between the model control group and the blank control group; "#" indicates a significant difference between each dose group and the model control group.

[0065] Table 3 Results of 24-hour urine output Table 5. Results of urine biochemistry tests Table 5. Serum test results (mean ± standard deviation) Note: "*" indicates a significant difference between the model control group and the blank control group; "#" indicates a significant difference between each dose group and the model control group.

[0066] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The raw materials include the following parts by weight: ginseng 7-14 parts, stir-fried white hyacinth bean 10-20 parts, poria cocos 10-20 parts, tangerine peel 7-14 parts, corn silk 15-30 parts, gardenia 10-20 parts, imperata root 12-24 parts, kudzu root 13-26 parts, angelica dahurica 6-12 parts, perilla leaf 6-12 parts, sesame 6-12 parts, and licorice 1-4 parts.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The raw materials include the following parts by weight: ginseng 8-12 parts, stir-fried white hyacinth bean 9-18 parts, poria cocos 12-24 parts, tangerine peel 8-16 parts, corn silk 12-24 parts, gardenia 10-20 parts, imperata cylindrica root 10-20 parts, kudzu root 15-30 parts, angelica dahurica 7-14 parts, perilla leaf 7-14 parts, sesame sedge 6-12 parts, and licorice 1-2 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials include the following parts by weight: ginseng 6-12 parts, stir-fried white hyacinth bean 12-17 parts, poria cocos 14-20 parts, tangerine peel 10-15 parts, corn silk 20-35 parts, gardenia 12-25 parts, imperata cylindrica root 11-25 parts, kudzu root 10-30 parts, angelica dahurica 5-12 parts, perilla leaf 5-12 parts, sesame sedge 7-10 parts, and licorice 2-3 parts.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: By adding the raw materials to water in the specified proportions and then extracting and concentrating them, a traditional Chinese medicine composition can be obtained.

5. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for strengthening the spleen and resolving dampness.

6. A spleen-strengthening and dampness-resolving medicine, characterized in that, The drug comprises the traditional Chinese medicine composition as described in any one of claims 1-3.

7. The drug as described in claim 6, characterized in that, The drug also contains a pharmaceutically acceptable carrier.

8. The drug as described in claim 6, characterized in that, The dosage forms of the drug are granules, tablets, capsules, and tea bags.

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