A traditional Chinese medicine composition for regulating cold and heat, resolving toxicity and removing dampness and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for regulating cold and heat, resolving toxin and removing dampness and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine composition comprises, in terms of weight fractions, 6-9 parts of Huangbai, 6-9 parts of Sharen, 6-9 parts of Zhigancao, 10-15 parts of Baizhu, 15-25 parts of Yiyiren, 15-30 parts of Baihuasheshecao, 6-10 parts of Huangqi, 6-10 parts of Chaozaokongci, 15-30 parts of Shanzha and 1-5 parts of Rougui. The preparation method can be used to prepare a decoction, water pills or granules. Huangbai, Sharen, Zhigancao and Baizhu are used as the monarch, which can supplement the earth and suppress the fire, regulate yin and yang and cold and heat to treat the root cause; Yiyiren, Huangqi and Baihuasheshecao are used as the ministers, which can clear heat, remove dampness and resolve toxin to treat the symptoms; Shanzha and Chaozaokongci are used as the adjuvants, which can promote blood circulation, remove blood stasis, eliminate swelling and discharge pus; and Rougui is used as the guide, which can guide the fire to return to the origin. The whole prescription can treat the root and the branch, balance the cold and heat, and is used for treating the cold and heat mixed diseases, such as acne, rhinophyma, folliculitis and seborrheic dermatitis, and the clinical effective rate reaches 90.75%, and the adverse reaction rate is low.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a traditional Chinese medicine composition that harmonizes cold and heat, detoxifies, and removes dampness, and its preparation method. Background Technology

[0002] Acne, rosacea, folliculitis, and seborrheic dermatitis are common skin diseases in clinical practice. Their pathogenesis is often related to pathological factors such as abnormal sebum secretion, excessive keratinization of the hair follicle opening, microbial colonization, and immune-mediated inflammatory responses. Modern medicine mainly uses retinoids, antibiotics, anti-androgens, and physical therapy, but long-term use is often accompanied by skin irritation, drug resistance, and systemic side effects, and the recurrence rate is relatively high.

[0003] Traditional Chinese medicine believes that although this type of skin disease occurs on the face and in the hair follicle sebaceous gland units, its pathogenesis is mostly related to the dysfunction of the internal organs. Improper diet, excessive consumption of rich and fatty foods, leading to internal damp-heat; or a constitution with excessive heat, where heat evil attacks the lungs, causing heat accumulation in the lungs and stomach, which then rises to the face, and external invasion of toxins can all cause this disease. In addition, liver and kidney yin deficiency, excessive ministerial fire, or liver qi stagnation, spleen deficiency with dampness transforming into heat, and damp-heat and phlegm stagnation in the skin are also common pathogenesis mechanisms. Accordingly, conventional TCM treatment often adopts a syndrome differentiation approach: for those with wind-heat in the lung meridian, Loquat Lung-Clearing Decoction is used; for those with damp-heat accumulation, Artemisia capillaris Decoction or Coptis Decoction for Detoxification is used; for those with blood heat and stasis, Four-Substance Decoction for Cooling Blood is used; for those with phlegm-dampness stagnation, Two-Substance Decoction combined with Peach Blossom Four-Substance Decoction is used; and for those with liver and kidney yin deficiency, Six-Ingredient Rehmannia Pill or Two-Ingredient Pill are selected. The above treatments mainly focus on clearing heat, detoxifying, removing dampness, and promoting blood circulation, and are indeed effective for cases of excess heat or damp-heat syndrome.

[0004] However, with changes in modern lifestyles, factors such as prolonged sitting, excessive consumption of cold drinks, and staying up late have led to an increasing prevalence of spleen and stomach yang deficiency and internal generation of cold and dampness. These patients often present with symptoms of "upper heat and lower cold" or "mixed cold and heat." The pathogenesis is as follows: insufficient spleen yang in the middle jiao leads to impaired digestion and absorption, resulting in internal retention of dampness and upward floating of deficient fire; or kidney yang deficiency prevents the fire from being contained, causing it to rise upwards, further exacerbated by exposure to damp-heat toxins, which accumulate in the head and face. Clinically, this manifests as erythema, papules, pustules, and telangiectasia on the head and face, accompanied by symptoms of "upper heat" such as dry mouth, irritability, and insomnia; simultaneously, it presents with symptoms of "lower cold" such as a preference for warmth and pressure in the stomach, aversion to cold, cold limbs, lower back and knee pain, loose stools, clear urine, and dysmenorrhea in women. The tongue is often pale and swollen with teeth marks on the edges, a white, greasy, and moist coating, and the pulse is deep or wiry and slippery. For this type of syndrome involving mixed cold and heat, with upper body heat and lower body cold, simply using bitter and cold heat-clearing herbs may temporarily alleviate the upper body heat, but it further damages the yang qi of the middle and lower jiao, causing the deficient fire to rise even more. On the other hand, using only warming and tonifying herbs may exacerbate the damp-heat in the upper jiao, worsening the stagnation. Existing prescriptions tend to focus on purging and do not pay enough attention to the core pathogenesis of "harmonizing cold and heat and guiding fire back to its source." There is a lack of targeted preparations that can simultaneously warm the middle and lower jiao, clear the upper jiao, and address both the symptoms and the root cause.

[0005] Therefore, there is an urgent need in this field for a traditional Chinese medicine composition that can clear dampness and toxins in the upper burner, warm and tonify the spleen and kidneys, and subdue deficiency fire, while also balancing cold and heat and having few adverse reactions, in order to meet the clinical treatment needs of this type of skin disease with mixed cold and heat. Summary of the Invention

[0006] The present invention aims to provide a traditional Chinese medicine composition that harmonizes cold and heat, detoxifies, and removes dampness, and its preparation method, so as to solve the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] The first aspect of this invention provides a traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness. The raw materials of the traditional Chinese medicine composition include, by weight, the following: 6-9 parts of Phellodendron bark, 6-9 parts of Amomum villosum, 6-9 parts of prepared licorice root, 10-15 parts of Atractylodes macrocephala, 15-25 parts of Coix seed, 15-30 parts of Hedyotis diffusa, 6-10 parts of Scutellaria baicalensis, 6-10 parts of stir-fried Gleditsia sinensis thorns, 15-30 parts of Crataegus pinnatifida, and 1-5 parts of Cinnamomum cassia.

[0009] A second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, wherein the preparation of the decoction includes the following steps:

[0010] Take out all kinds of medicines according to the weight ratio, and soak the remaining medicinal materials except for cardamom in a clay pot for 30-60 minutes.

[0011] Bring to a boil over high heat, then simmer over low heat for 25 minutes to extract the first juice. Add the cardamom five minutes before turning off the heat.

[0012] Then simmer over low heat for 20 minutes to obtain the second juice;

[0013] The first juice and the second juice are combined to prepare a decoction.

[0014] Furthermore, the decoction is taken half an hour to an hour after meals, twice a day.

[0015] Furthermore, the preparation of the powder includes the following steps:

[0016] Ingredients: Take out each medicinal material according to the weight ratio;

[0017] Drying: Amomum villosum and cinnamon are air-dried naturally or dried at a low temperature of 30-40℃, while the other medicinal materials are dried with hot air at 50-60℃ until the moisture content is ≤7%.

[0018] Grinding: Grind Amomum villosum and cinnamon at low temperature, seal and store. Grind together Phellodendron chinense, prepared licorice root, Atractylodes macrocephala, Coix lacryma-jobi, Hedyotis diffusa, Scutellaria baicalensis, stir-fried Gleditsia sinensis thorns, and hawthorn, and pass through a 100-mesh sieve.

[0019] Mixing: Mix all the powders evenly to form a powder, and then divide into 3g portions for storage.

[0020] Furthermore, the preparation of capsules based on powder includes: filling 0.5g of the powder into gelatin capsules or hydroxypropyl methylcellulose capsules, and then sealing and storing them.

[0021] Furthermore, the preparation of water pellets based on powder formulation includes the following steps:

[0022] The powder is mixed with water and rolled into core pellets with a diameter of 0.8-1.0 mm;

[0023] After wetting the surface of the core pellet with water, add powder and roll it into a ball. Repeat this process multiple times until the target diameter of 2.5-3.5 mm is reached. For the last time, no water is added or only a small amount of water is added, so that the powder absorbs the excess moisture on the surface of the water pellet and forms a smooth and dense layer covering the surface.

[0024] After sieving out pills that are too large, too small, or deformed, dry them at 40-60℃ until the moisture content is ≤9%, and then store them in a sealed container.

[0025] Furthermore, the preparation of granules includes the following steps:

[0026] Volatile oil extraction: Coarsely crush Amomum villosum and cinnamon, soak them in 6-8 times the amount of water for 1 hour, and then extract the volatile oil by steam distillation. After extraction, separate the residue from the volatile oil for later use.

[0027] Water extraction: Mix the dregs with the remaining eight medicinal materials, add 10 times the amount of water, soak for 1 hour, decoct for 1.5 hours, filter through 200 mesh to obtain the first filtrate, then add 8 times the amount of water, decoct for 1 hour, and filter through 200 mesh to obtain the second filtrate.

[0028] Concentration and drying: Mix the primary filtrate and the secondary filtrate, concentrate to a clear extract with a relative density of 1.10-1.15, and dry the clear extract into an extract powder for later use;

[0029] Preparation of volatile oil inclusion complex powder: β-cyclodextrin was ground into a paste with water, and then ground for 30-60 minutes. Volatile oil was added slowly at the same time to obtain the inclusion complex. After standing overnight at 4°C, it was vacuum dried at 40°C and pulverized through an 80-mesh sieve to obtain volatile oil inclusion complex powder.

[0030] Granulation: Mix the extract powder, dextrin, soluble starch and volatile oil inclusion complex powder and granulate, then package into 6g portions and seal for storage.

[0031] The principle and beneficial effects of this technical solution:

[0032] Formula Structure: Amomum villosum is pungent and warm, capable of nourishing the Qi of the five internal organs and returning to the kidneys; licorice root harmonizes the upper and lower parts of the body, "having the effect of tonifying the earth and suppressing fire"; Atractylodes macrocephala is warm and drying, and its sweet and bland properties strengthen the spleen and dispel dampness. The three herbs combined tonify the earth element and suppress deficient fire, transforming dampness; Phellodendron amurense is bitter and cold, drying dampness and strengthening Yin. The bitterness of Phellodendron amurense combined with the sweetness of licorice root transforms Yin; the pungent nature of Amomum villosum combined with the sweetness of licorice root transforms Yang, harmonizing Yin and Yang, cold and heat, serving as the principal herbs to warm the middle and lower parts of the body and treat the root cause. Coix seed is sweet, bland, and slightly cold, strengthening the spleen, draining dampness, clearing heat, and expelling pus; Scutellaria baicalensis is bitter and cold, entering the lung meridian, purging fire and eliminating damp heat; Hedyotis diffusa clears heat, promotes diuresis, and detoxifies, serving as the assistant herbs to clear the upper part of the body and treat the symptoms. Hawthorn is sour and sweet, slightly warm, promoting Qi circulation and dispersing blood stasis, transforming dampness and invigorating blood while lowering lipids; Gleditsia sinensis thorns are pungent and warm, dispersing and breaking up hard masses, warming and dispersing wind, reducing swelling and expelling pus, guiding the other herbs upwards. Cinnamon warms and draws fire downwards. The combined effects of these herbs in this formula address both the root cause and symptoms, harmonizing cold and heat, dispelling dampness, and detoxifying.

[0033] Advantages of this technical solution:

[0034] 1. Synchronously regulate the rise and fall of Yin and Yang, guide Qi back to the kidneys, and simultaneously address both "upper heat" and "lower cold" to avoid neglecting one aspect for the other.

[0035] 2. It targets multiple aspects of modern pathology, inhibits androgen receptors, lowers lipids and improves microcirculation, has antibacterial properties, and regulates immune inflammation.

[0036] 3. The lesions are most commonly found on the chin, providing a reference for clinical application.

[0037] 4. It detoxifies and removes dampness while also addressing phlegm and blood stasis, and can be used to treat late-stage skin lesions such as acne, rosacea, folliculitis, and seborrheic dermatitis.

[0038] 5. Protects the middle burner, balances cold and heat, and reduces stomach and spleen discomfort from long-term medication. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the embodiments. Here, the illustrative embodiments and descriptions of this invention are used to explain the invention, but are not intended to limit the invention.

[0040] It should be emphasized here that the step markers mentioned below are not a limitation on the order of the steps, but should be understood as meaning that the steps can be executed in the order mentioned in the embodiments, or in a different order than in the embodiments, or several steps can be executed simultaneously.

[0041] This formula is suitable for acne, rosacea, folliculitis, seborrheic dermatitis and other diseases, especially those with mixed cold and heat patterns and upper body heat and lower body cold.

[0042] Clinical observations: Upper body heat manifests as facial papules, pustules, and nodules, mostly dark red in color, recurring frequently, accompanied by dry mouth, irritability, and hot flashes in the head and face; lower body cold manifests as aversion to cold and cold limbs, especially in the lower back, knees, and lower extremities, loose stools, or dysmenorrhea, and a preference for warmth and pressure in the lower abdomen. The tongue and pulse are characterized by a pale, swollen tongue with teeth marks on the edges, a white, greasy or moist coating, and a deep or slippery pulse. Skin lesions are most prominent on the chin and cheeks.

[0043] This formula was clinically used on 512 patients with complex symptoms of alternating cold and heat, and upper body heat and lower body cold, including facial acne, rosacea, folliculitis, and seborrheic dermatitis. Of these, 335 patients returned for follow-up visits, with 304 reporting symptom relief and 31 reporting no effect. Statistically, the effective rate of the modified formula for harmonizing cold and heat, dispelling dampness and detoxifying was 90.75%. Seven patients reported diarrhea and loose stools after taking the medicine; they were advised to reduce the dosage after meals to alleviate these symptoms. Ten patients experienced mild nausea and taste discomfort; they were advised to take the medicine half an hour after meals to alleviate these symptoms. The adverse reaction rate was 5.07%.

[0044] This traditional Chinese medicine composition, which harmonizes cold and heat, dispels dampness, and detoxifies, consists of ten herbs: Phellodendron bark, Amomum villosum, prepared licorice root, Atractylodes macrocephala, Coix seed, Hedyotis diffusa, Crataegus pinnatifida, Scutellaria baicalensis, stir-fried Gleditsia sinensis thorns, and Cinnamon. Amomum villosum, prepared licorice root, Atractylodes macrocephala, Crataegus pinnatifida, and stir-fried Gleditsia sinensis are sour and warm in nature, while Cinnamon is hot. Phellodendron bark, Hedyotis diffusa, and Scutellaria baicalensis are cold in nature, while Coix seed is slightly cold. The overall formula balances cold and heat. Amomum villosum, stir-fried Gleditsia sinensis thorns, and Cinnamon are pungent; prepared licorice root, Atractylodes macrocephala, Coix seed, Hedyotis diffusa, and Crataegus pinnatifida are sweet; and Phellodendron bark and Scutellaria baicalensis are bitter. The majority of the herbs are pungent and sweet, and they enter the spleen, stomach, lung, and kidney meridians, exhibiting a mild medicinal property.

[0045] Example 1

[0046] A traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and dispelling dampness includes: 8g of Phellodendron bark, 6g of Amomum villosum, 8g of prepared licorice root, 10g of Atractylodes macrocephala, 25g of Coix seed, 15g of Hedyotis diffusa, 9g of Scutellaria baicalensis, 9g of stir-fried Gleditsia sinensis thorns, 20g of Crataegus pinnatifida, and 3g of Cinnamomum cassia.

[0047] Example 2

[0048] A method for preparing a decoction from a traditional Chinese medicine composition that harmonizes cold and heat, detoxifies, and dispels dampness includes the following steps:

[0049] Take the medicines according to the weight ratio in Example 1 above, and soak the remaining medicinal materials (except for Amomum villosum) in a clay pot for 30-60 minutes.

[0050] Bring to a boil over high heat, then simmer over low heat for 25 minutes to extract the first juice. Add the cardamom five minutes before turning off the heat.

[0051] Then simmer over low heat for 20 minutes to obtain the second juice;

[0052] The first juice and the second juice are combined to prepare a decoction.

[0053] The prepared decoction should be taken half an hour to an hour after meals, twice a day.

[0054] Example 3

[0055] A method for preparing a powder from a traditional Chinese medicine composition that harmonizes cold and heat, detoxifies, and dispels dampness includes the following steps:

[0056] Ingredients: Take each medicinal material according to the weight ratio in Example 1;

[0057] Drying: The drying process uses a hot air circulating oven. The cardamom and cinnamon are air-dried naturally or dried at a low temperature of 30-40℃, while the other medicinal materials are dried with hot air at 50-60℃ until the moisture content is ≤7%.

[0058] Grinding: Amomum villosum and cinnamon are ground at low temperature and stored in an airtight container. The remaining medicinal materials, including Phellodendron chinense, prepared licorice root, Atractylodes macrocephala, Coix lacryma-jobi, Hedyotis diffusa, Scutellaria baicalensis, stir-fried Gleditsia sinensis thorns, and hawthorn, are mixed and ground using a universal grinder and then passed through a 100-mesh sieve.

[0059] Mixing: Using a two-dimensional mixer, all powders are mixed for 45 minutes to form a uniform powder. After the moisture, fineness and content are tested and found to meet the standards, the powder is packaged into 3g portions for storage.

[0060] Dosage: 3g each time, 3 times a day, taken with warm water after meals.

[0061] Example 4

[0062] A method for preparing a capsule from a traditional Chinese medicine composition that harmonizes cold and heat, detoxifies, and dispels dampness includes the following steps:

[0063] The powder prepared in Example 3 was filled into No. 0 gelatin capsules, with each capsule containing 0.5g of powder.

[0064] Advantages: Low cost, but it is hygroscopic and suitable for short-term use.

[0065] Alternatively, the powder prepared in Example 3 can be filled into hydroxypropyl methylcellulose (HPMC) capsules, with each capsule containing 0.5g of powder.

[0066] Advantages: Low moisture content (≤8%), good moisture resistance, suitable for Chinese medicine powders, recommended for use.

[0067] After filling, the capsules are polished to remove surface powder, and then bottled and sealed.

[0068] Dosage: Take 6 pills (about 3g) each time, 3 times a day, with warm water after meals.

[0069] Example 5

[0070] A method for preparing a traditional Chinese medicine composition that harmonizes cold and heat, detoxifies, and dispels dampness into water pills includes the following steps:

[0071] Using a sugar-coating pan, the powder prepared in Example 3 was mixed with water and rolled into core pellets with a diameter of 0.8-1.0 mm. The core pellets were then passed through a 1 mm sieve to remove those with excessively large particle sizes. Those with excessively large particle sizes were crushed and remade.

[0072] After wetting the surface of the core pellet with water, add powder and roll it into a ball. Repeat this process multiple times until the target diameter of 2.5-3.5 mm is reached. For the last time, no water is added or only a small amount of water is added, so that the powder absorbs the excess moisture on the surface of the water pellet and forms a smooth and dense layer covering the surface.

[0073] After passing the finished product through a 3mm sieve to remove oversized, undersized, and deformed pills, it is dried at 40-60℃ until the moisture content is ≤9%, then bottled and sealed for storage.

[0074] Dosage: 6g each time, 3 times a day, taken with warm water after meals.

[0075] Example 6

[0076] Volatile oil extraction: Take the medicinal materials according to the weight ratio in Example 1, coarsely crush the cardamom and cinnamon, put them in the volatile oil extraction tank, add 6-8 times the amount of water to soak for 1 hour, extract the volatile oil by steam distillation, collect for at least 4 hours until the oil volume no longer increases, after extraction, separate the residue and volatile oil and weigh for later use.

[0077] Water extraction: Mix the dregs with the remaining eight medicinal materials, add 10 times the amount of water, soak for 1 hour, decoct for 1.5 hours, filter through 200 mesh to obtain the first filtrate, then add 8 times the amount of water, decoct for 1 hour, and filter through 200 mesh to obtain the second filtrate.

[0078] Concentration and drying: Mix the primary filtrate and the secondary filtrate, concentrate to a clear extract with a relative density of 1.10-1.15, and dry the clear extract into an extract powder for later use;

[0079] Preparation of volatile oil inclusion complex powder: β-cyclodextrin was ground into a paste with water, and then ground for 30-60 minutes. Volatile oil was added slowly at the same time to obtain the inclusion complex. After standing overnight at 4°C, it was washed with a small amount of ethanol, dried under vacuum at 40°C, and pulverized through an 80-mesh sieve to obtain volatile oil inclusion complex powder.

[0080] Granulation: The extract powder, dextrin, soluble starch and volatile oil inclusion complex powder are placed in a three-dimensional mixer and mixed for 20 minutes to achieve a soft material that "can be formed into a ball when squeezed but can be dispersed when touched". Then the material is discharged and passed through a 14-mesh sieve to obtain granules.

[0081] The granules are passed through a 10-mesh sieve to remove fine powder and a 65-mesh sieve to remove large particles. They are then packaged into 6g portions and sealed for storage.

[0082] Usage: Take 1 packet (6g) each time, 3 times a day, dissolved in hot water after meals.

[0083] The manufacturing process of the above embodiments must comply with the standard manufacturing process required by the "Good Manufacturing Practice for Preparations of Medical Institutions" and the General Rules of the Chinese Pharmacopoeia.

[0084] It should be clarified that the present invention is not limited to the specific configurations and processes described above. For the sake of brevity, detailed descriptions of known methods are omitted here. In the above embodiments, several specific steps are described and shown as examples. However, the method process of the present invention is not limited to the specific steps described and shown. Those skilled in the art can make various changes, modifications, and additions, or change the order of steps, after understanding the spirit of the present invention.

[0085] In this invention, features described and / or illustrated for one embodiment may be used in the same or similar manner in one or more other embodiments, and / or combined with or in place of features of other embodiments.

[0086] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, various modifications and variations of the embodiments of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness, characterized in that: The raw materials of the traditional Chinese medicine composition, by weight, include: 6-9 parts of Phellodendron bark, 6-9 parts of Amomum villosum, 6-9 parts of prepared licorice root, 10-15 parts of Atractylodes macrocephala, 15-25 parts of Coix seed, 15-30 parts of Hedyotis diffusa, 6-10 parts of Scutellaria baicalensis, 6-10 parts of stir-fried Gleditsia sinensis thorns, 15-30 parts of Crataegus pinnatifida, and 1-5 parts of Cinnamomum cassia.

2. A method for preparing the traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness as described in claim 1, characterized in that, The preparation of the decoction includes the following steps: Take out all kinds of medicines according to the weight ratio, and soak the remaining medicinal materials except for cardamom in a clay pot for 30-60 minutes. Bring to a boil over high heat, then simmer over low heat for 25 minutes to extract the first juice. Add the cardamom five minutes before turning off the heat. Then simmer over low heat for 20 minutes to obtain the second juice; The first juice and the second juice are combined to prepare a decoction.

3. The method for preparing a traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness according to claim 2, characterized in that, The decoction is taken half an hour to an hour after meals, twice a day.

4. A method for preparing a traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness as described in claim 1, characterized in that, The preparation of the powder includes the following steps: Ingredients: Take out each medicinal material according to the weight ratio; Drying: Amomum villosum and cinnamon are air-dried naturally or dried at a low temperature of 30-40℃, while the other medicinal materials are dried with hot air at 50-60℃ until the moisture content is ≤7%. Grinding: Grind Amomum villosum and cinnamon at low temperature, seal and store. Grind together Phellodendron chinense, prepared licorice root, Atractylodes macrocephala, Coix lacryma-jobi, Hedyotis diffusa, Scutellaria baicalensis, stir-fried Gleditsia sinensis thorns, and hawthorn, and pass through a 100-mesh sieve. Mixing: Mix all the powders evenly to form a powder, and then divide into 3g portions for storage.

5. The method for preparing a traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness according to claim 4, characterized in that, Preparing capsules based on powder formulations includes: filling 0.5g of the powder formulation into gelatin capsules or hydroxypropyl methylcellulose capsules, and then sealing and storing them.

6. A method for preparing the traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness as described in claim 4, characterized in that, The preparation of water pellets based on powder includes the following steps: The powder is mixed with water and rolled into core pellets with a diameter of 0.8-1.0 mm; After wetting the surface of the core pellet with water, add powder and roll it into a ball. Repeat this process multiple times until the target diameter of 2.5-3.5 mm is reached. For the last time, no water is added or only a small amount of water is added, so that the powder absorbs the excess moisture on the surface of the water pellet and forms a smooth and dense layer covering the surface. After sieving out pills that are too large, too small, or deformed, dry them at 40-60℃ until the moisture content is ≤9%, and then store them in a sealed container.

7. The method for preparing a traditional Chinese medicine composition for harmonizing cold and heat, detoxifying, and removing dampness according to claim 1, characterized in that, The preparation of granules includes the following steps: Volatile oil extraction: Coarsely crush Amomum villosum and cinnamon, soak them in 6-8 times the amount of water for 1 hour, and then extract the volatile oil by steam distillation. After extraction, separate the residue from the volatile oil for later use. Water extraction: Mix the dregs with the remaining eight medicinal materials, add 10 times the amount of water, soak for 1 hour, decoct for 1.5 hours, filter through 200 mesh to obtain the first filtrate, then add 8 times the amount of water, decoct for 1 hour, and filter through 200 mesh to obtain the second filtrate. Concentration and drying: Mix the primary filtrate and the secondary filtrate, concentrate to a clear extract with a relative density of 1.10-1.15, and dry the clear extract into an extract powder for later use; Preparation of volatile oil inclusion complex powder: β-cyclodextrin was ground into a paste with water, and then ground for 30-60 minutes. Volatile oil was added slowly at the same time to obtain the inclusion complex. After standing overnight at 4°C, it was vacuum dried at 40°C and pulverized through an 80-mesh sieve to obtain volatile oil inclusion complex powder. Granulation: Mix the extract powder, dextrin, soluble starch and volatile oil inclusion complex powder and granulate, then package into 6g portions and seal for storage.