A traditional Chinese medicine composition for treating eczema, a traditional Chinese medicine preparation, a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating eczema, a traditional Chinese medicine preparation and a preparation method and application thereof. The traditional Chinese medicine composition for treating eczema is prepared from raw materials including the following components in parts by weight: rehmannia 50-75 parts, cortex moutan 50-75 parts, raw gypsum 100-150 parts, honeysuckle 50-75 parts, schizonepeta 30-50 parts, siler 30-50 parts, periostracum cypraea 30-50 parts, fried spongy moxa 30-50 parts, calcined oyster shell 120-150 parts, calcined concha murex 120-150 parts, cortex meliae 50-75 parts and liquorice 15-30 parts. The traditional Chinese medicine composition has the effects of clearing heat and cooling blood, dispelling wind and relieving itching. The eczema model of mice is constructed by 2,4-dinitrochlorobenzene induction, and the results show that the traditional Chinese medicine composition has a certain treatment effect on eczema. The granules not only maintain the characteristics of the original traditional Chinese medicine decoction, but also have the characteristics of convenient taking, easy storage and high dissolution rate of effective components, and can better play the treatment effects of the drugs.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition, preparation method and application for treating eczema. Background Technology

[0002] Eczema is an inflammatory and itchy skin disease characterized by polymorphic skin lesions and an exudative tendency. This disease is influenced by a variety of internal and external factors. Internal factors include immune dysfunction and systemic diseases (such as endocrine disorders, nutritional deficiencies, chronic infections, etc.) as well as hereditary or acquired skin barrier dysfunction. External factors mainly include allergens in the environment or food, microorganisms, changes in environmental temperature or humidity, and sun exposure. These factors can all trigger or aggravate eczema. After the onset of eczema, the affected skin presents with symmetrical rashes, intense itching, and polymorphic lesions, mainly manifested as papules, vesicles, erosions, and scaling. Eczema is caused by changes in various immune systems and environmental influences, leading to eczema and itchy skin lesions, triggering a local lymphocyte immune response in the skin, and causing CD4+... + The important subset of T helper cells (TH cells), TH1 / TH2, regulates immune response dysregulation. The expression of TH1 / TH2 cell-related molecules plays a crucial role in the pathological processes of many autoimmune diseases. Modern medicine's drug treatment for eczema primarily focuses on suppressing the inflammatory response, including topical corticosteroids, antihistamines, and immunosuppressants. Using hormones as the main treatment method, long-term use easily leads to various adverse reactions. Relapse is common after discontinuation of medication, and long-term use increases the risk of skin pigmentation, skin atrophy, and even serious side effects such as folliculitis. Traditional Chinese medicine (TCM) offers unique advantages in treating eczema, with its simplicity and affordability. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition, preparation, preparation method, and application for treating eczema. The composition consists of 12 herbs: Rehmannia glutinosa, Paeonia suffruticosa, Gypsum fibrosum, Lonicera japonica, Saposhnikovia divaricata, Schizonepeta tenuifolia, Dictamnus dasycarpus, Cicadae periostracum, Bombyx mori (stir-fried), Calcined Dragon Bone, Calcined Oyster Shell, and Glycyrrhiza uralensis. The combined effects of these herbs are to clear heat and cool the blood, and to dispel wind. A mouse eczema model was constructed using 2,4-dinitrochlorobenzene induction, and the results showed a certain therapeutic effect on eczema. The granules not only retain the characteristics of traditional Chinese medicine decoctions but also offer advantages such as convenient administration, easy storage, and high dissolution rate of active ingredients, thus better enhancing the therapeutic effects of each herb.

[0004] The present invention provides a traditional Chinese medicine composition for treating eczema, which is made from the following raw materials in parts by weight:

[0005] Rehmannia glutinosa 50-75 parts, Paeonia suffruticosa 50-75 parts, Gypsum fibrosum 100-150 parts, Lonicera japonica 50-75 parts, Schizonepeta tenuifolia 30-50 parts, Saposhnikovia divaricata 30-50 parts, Cicadae periostracum 30-50 parts, Bombyx mori 30-50 parts, Calcined dragon bone 120-150 parts, Calcined oyster shell 120-150 parts, Dictamnus dasycarpus 50-75 parts, Glycyrrhiza uralensis 15-30 parts.

[0006] Preferably, the traditional Chinese medicine composition is made from raw materials comprising the following parts by weight:

[0007] 75 parts Rehmannia glutinosa, 75 parts Paeonia suffruticosa, 150 parts Gypsum fibrosum, 75 parts Lonicera japonica, 50 parts Schizonepeta tenuifolia, 50 parts Saposhnikovia divaricata, 50 parts Cicadae periostracum, 50 parts stir-fried Bombyx mori, 150 parts calcined dragon bone, 150 parts calcined oyster shell, 75 parts Dictamnus dasycarpus, and 30 parts Glycyrrhiza uralensis.

[0008] The present invention further provides a traditional Chinese medicine preparation for treating eczema, which is made from the traditional Chinese medicine composition described in any one of the above claims and its pharmaceutically acceptable excipients.

[0009] Preferably, the traditional Chinese medicine preparation is in granule form.

[0010] The preparation method of the traditional Chinese medicine preparation includes the following steps:

[0011] S1. Mix the raw materials for preparing the traditional Chinese medicine composition, add water and decoct to obtain a decoction;

[0012] S2. Filter the decoction and concentrate the filtrate into a thick paste;

[0013] S3. Add sucrose and dextrin to the thick paste, mix well, form into granules, and dry to obtain the traditional Chinese medicine preparation.

[0014] More preferably, in the step of adding water and decocting, the amount of water added is 8 times the total amount of raw materials, and the decoction is performed twice, 1.5 hours each time, and the decoctions are combined; and / or,

[0015] The thick paste has a relative density of 1.30–1.35 at 50–60°C, and the mass ratio of the thick paste, the sucrose, and the dextrin is 1:2:1; and / or,

[0016] The drying temperature is 60-70°C, and the drying time can be up to 5 hours.

[0017] The present invention also provides the use of the traditional Chinese medicine composition, the traditional Chinese medicine preparation, or the traditional Chinese medicine preparation prepared by the preparation method described in any one of the above claims in the preparation of a drug for treating eczema.

[0018] As an example, the eczema mentioned is chronic eczema.

[0019] In the above applications, the eczema manifests as at least one of the following: 1) skin lesions, including redness, swelling, thickening, keratinization, crusting, exudation, and dryness; 2) auricular swelling; 3) elevated thymus index and / or spleen index; 4) thickening of the epidermal spinous layer and interstitial edema; inflammatory cell and mast cell infiltration, angiogenesis, and / or congestion in the dermis; 5) increased thickness of the auricular tissue cortex; 6) increased expression of IL-6, TNF-α, and IL-1β; 7) elevated serum levels of LgE, IL-4, and IFN-γ; 8) elevated levels of IL-1β and IL-33 mRNA in tissues.

[0020] The present invention also provides the use of the traditional Chinese medicine composition, the traditional Chinese medicine preparation, or the traditional Chinese medicine preparation prepared by any of the above-described methods in the preparation of inflammatory factor inhibitors or anti-inflammatory drugs.

[0021] In the above applications, the inflammatory factors are inflammatory factors related to TH1 / TH2 cell balance, such as one or more of IL-6, TNF-α, IL-1β, IL-33, LgE, IL-4, and IFN-γ.

[0022] The inflammatory factor inhibitors are characterized by reducing the level of inflammatory factors and / or inhibiting the expression of inflammatory factors;

[0023] The inflammation is caused by an imbalance of TH1 / TH2 cells, such as inflammation associated with one or more of IL-6, TNF-α, IL-1β, IL-33, LgE, IL-4, and IFN-γ.

[0024] In this invention, the drug treatment is administered to humans or mammals (such as mice). In this invention, the dosage of the granules administered orally to KM mice was 3.75 g / kg, 7.5 g / kg, and 15 g / kg. Results showed that 7.5 g / kg and 15 g / kg were more effective.

[0025] The present invention has the following beneficial effects:

[0026] Eczema has a complex etiology. Severe eczema can cause widespread redness, crusting, and skin lesions with oozing fluid, significantly impacting patients' quality of life. While significant progress has been made in understanding the pathogenesis of eczema, a durable and well-tolerated treatment method remains lacking. Immunosuppressive drugs, such as steroids, are most commonly used to treat eczema, but they have serious side effects, including immunosuppression, opportunistic infections, and osteoporosis. Traditional Chinese medicine (TCM) has unique advantages in treating eczema. This invention's TCM granules consist of 12 herbs: Rehmannia glutinosa, Paeonia suffruticosa, Gypsum fibrosum, Lonicera japonica, Saposhnikovia divaricata, Schizonepeta tenuifolia, Dictamnus dasycarpus, Cicadae periostracum, Bombyx batryticatus, Calcined dragon bone, Calcined oyster shell, and Glycyrrhiza uralensis. Rehmannia glutinosa clears heat and cools the blood, while Paeonia suffruticosa cools the blood, invigorates blood circulation, and relieves irritability, embodying the principle of "treating wind by first treating blood, for when blood flows smoothly, wind will naturally subside." Gypsum fibrosum and Lonicera japonica clear heat and purge fire. These four herbs together form the principal ingredients. Schizonepeta, Saposhnikovia, Cicada slough, and Bombyx batryticatus dispel wind and eliminate pathogens, relieve rashes and itching, embodying the principle that "itching comes from wind, and to stop itching, one must first dispel wind," thus serving as assistant herbs. Calcined dragon bone and calcined oyster shell astringe and consolidate to stop itching, and also calm the mind; Dictamnus dasycarpus root bark clears heat, dries dampness, detoxifies, and relieves itching, serving as adjuvant herbs. Licorice detoxifies and harmonizes the middle jiao, harmonizing the effects of all the herbs, thus serving as an adjuvant and guiding herb. Together, these herbs work to clear heat, cool the blood, dispel wind, and relieve itching. Attached Figure Description

[0027] Figure 1 This is a process flow diagram of the granule formulation for treating eczema in Embodiment 1 of the present invention, wherein, This indicates a Class 300,000 cleanroom work area.

[0028] Figure 2 This is the skin lesion on the back of a mouse after administration in Example 2 of the present invention.

[0029] Figure 3 The image shows the H&E staining of the auricle tissue of mice with eczema in Example 2 of this invention (H&E staining, ×200). Note: A: blank group, B: model group, C: Xiaofeng Zhiyang granules group, D: high-dose group, E: medium-dose group, F: low-dose group.

[0030] Figure 4 This is an analysis of the cortical thickness of the auricle tissue in mice with eczema in Example 2 of the present invention. Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P < 0.01.

[0031] Figure 5 The image shows the H&E staining of the back tissue of mice with eczema in Example 2 of this invention (H&E staining, ×200). Note: A: Blank group; B: Model group; C: Xiaofeng Zhiyang granules group; D: High-dose group; E: Medium-dose group; F: Low-dose group.

[0032] Figure 6This is an analysis of the dermal thickness of the dorsal skin tissue of mice with eczema in Example 2 of the present invention. Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0033] Figure 7 The image shows the TB staining of the back tissue of mice with eczema in Example 2 of this invention (TB staining, ×200). Note: A: Blank group; B: Model group; C: Xiaofeng Zhiyang granules group; E: High-dose group; F: Medium-dose group; G: Low-dose group.

[0034] Figure 8 This is an analysis of the number of mast cells in the dorsal skin tissue of eczema mice in Example 2 of the present invention. Note: Compared with the control group, # P<0.05, ## P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0035] Figure 9 The effect of immunohistochemistry on the levels of IL-6, TNF-α, and IL-1β proteins in the back skin tissue of mice in Example 2 of this invention (×400). Note: A: Blank group; B: Model group; C: Xiaofeng Zhiyang granules group; D: High-dose group; E: Medium-dose group; F: Low-dose group.

[0036] Figure 10 The expression levels of inflammatory factors in mouse serum in Example 2 of this invention are shown below. Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, *P<0.05, **P<0.01. Detailed Implementation

[0037] The present invention will now be described in further detail with reference to specific embodiments. The given embodiments are merely illustrative of the invention and not intended to limit its scope. The embodiments provided below can serve as a guide for further improvements by those skilled in the art and do not constitute a limitation on the invention in any way.

[0038] Unless otherwise specified, the methods used in the following embodiments are conventional methods, performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Unless otherwise specified, the materials and reagents used in the following embodiments are commercially available.

[0039] The raw materials used in the following examples, including Rehmannia glutinosa, Paeonia suffruticosa, Gypsum fibrosum, Lonicera japonica, Schizonepeta tenuifolia, Saposhnikovia divaricata, Cicadae periostracum, stir-fried Bombyx mori, calcined dragon bone, calcined oyster shell, Dictamnus dasycarpus, and Glycyrrhiza uralensis, are all medicinal materials listed in the Chinese Pharmacopoeia or the Chinese Medicine Processing Standards. After identification, all indicators meet the requirements.

[0040] Example 1: Preparation of a granular formulation for treating eczema

[0041] I. Formula

[0042] Rehmannia glutinosa 75g, Paeonia suffruticosa 75g, Gypsum fibrosum 150g, Lonicera japonica 75g

[0043] 50g of Schizonepeta tenuifolia, 50g of Saposhnikovia divaricata, 50g of Cicadae Periostracum, and 50g of stir-fried Bombyx mori.

[0044] Calcined dragon bone 150g, calcined oyster shell 150g, Dictamnus dasycarpus root bark 75g, licorice root 30g

[0045] II. Preparation Process

[0046] according to Figure 1 The process flow diagram shown illustrates the preparation of granular formulations. The specific steps are as follows:

[0047] Add 8 times the amount of water to the above formula and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to a thick paste with a relative density of 1.30-1.35 (50-60℃). Add appropriate amounts of sucrose and dextrin, mix well, granulate, dry, and make 1000-1500g.

[0048] III. Selection of Dosage Form

[0049] This prescription is based on clinical experience and has the effects of clearing heat and cooling blood, dispelling wind and relieving itching. It is for oral administration. The prescription consists of twelve Chinese herbs, and the dosage is relatively large. Preliminary experiments show a high yield of ointment. If it were made into capsules or tablets, the dosage would be too large, difficult to swallow, and unacceptable to patients. Compared with capsules and tablets, granules have the advantages of large drug loading, better taste, and faster absorption. Choosing granules not only preserves the characteristics of the original Chinese herbal decoction but also offers the advantages of convenient administration, easy storage, and high dissolution rate of active ingredients, thus better exerting the therapeutic effects of each drug. Therefore, granules are chosen as the dosage form for this prescription.

[0050] IV. Extraction Process Route Design and Parameter Determination

[0051] (I) Process route design

[0052] Based on the polarity of the effective chemical components contained in each herb in this formula, and in conjunction with clinical applications, a preparation process was designed. The preliminary process was determined to be extraction by decocting all the medicinal materials in water.

[0053] (II) Study on water decoction extraction process and parameter determination

[0054] 1. Orthogonal experimental design and selection of index components

[0055] Single-factor preliminary experiments showed that the main factors affecting the extraction efficiency of decoction were the number of extractions, extraction time, and amount of water added. Three factors were selected, and three levels were chosen for each factor in an orthogonal experiment using an L9(3)2 model. 4 Experiments were conducted using orthogonal arrays.

[0056] In this formula, Rehmannia glutinosa, Paeonia suffruticosa, Gypsum fibrosum, and Lonicera japonica are the four principal herbs. Rehmannia glutinosa contains relatively low levels of catalpol and rehmannia glycoside D. Lonicera japonica contains relatively high levels of chlorogenic acid, but this had negative interference in the specificity test. Therefore, Paeonia suffruticosa was chosen as the evaluation index. In preliminary experiments, paeonol in Paeonia suffruticosa was found to be unstable and volatile. After decoction extraction, its content in the finished product was low, so it was not used at this time. Based on the quality standards for Paeonia suffruticosa granules, paeoniflorin from Paeonia suffruticosa was ultimately selected as the index component to optimize the process conditions. The factor level table is shown in Table 1.

[0057] Table 1. Factor Levels in Water Decoction Extraction

[0058]

[0059] 2. Test methods and index determination methods

[0060] Weigh out twelve medicinal materials, including Rehmannia glutinosa, according to the prescription. Extract them by decoction according to orthogonal experimental design. Concentrate the extract, dry at low temperature, pulverize, accurately weigh a certain amount of dry powder, and determine the content of paeoniflorin. Convert the paeoniflorin content to the amount extracted per gram of Paeonia suffruticosa as the basis for calculating the extraction efficiency.

[0061] Determination method: High performance liquid chromatography

[0062] Instruments and Chromatographic Conditions: Agilent 1260 High Performance Liquid Chromatograph, ZORBAX SB-C 18 (250mm × 4.6mm, 5μm); Column temperature: 30℃; Mobile phase: acetonitrile-0.1% phosphoric acid solution, 0-20min (16:84-14:86); Flow rate: 1.0mL / min; Injection volume: 10μl each of the reference solution and the test solution. The theoretical plate number, calculated based on the paeoniflorin peak, should be no less than 2000.

[0063] Preparation of the reference solution: Take an appropriate amount of paeoniflorin reference standard, accurately weigh it, and add methanol to prepare a solution containing 0.03 mg per ml.

[0064] Preparation of the test solution: Take an appropriate amount of this product, grind it into a fine powder, accurately weigh about 1.5 g, place it in a stoppered conical flask, accurately add 50 ml of dilute ethanol (Pharmacopoeia: take 529 mL of ethanol, dilute with water to 1000 mL), weigh, sonicate (power 150 W, frequency 40 kHz) for 30 minutes, cool, weigh again, replenish the lost weight with dilute ethanol, shake well, let stand, filter, and accurately measure 20 ml of the filtrate to obtain the test solution. The paeoniflorin content in the solution is determined by HPLC.

[0065] The results are shown in Tables 2 and 3.

[0066] Table 2. Orthogonal Experiment Arrangement and Results

[0067]

[0068] Table 3. Analysis of variance of paeoniflorin content

[0069]

[0070] Note: F 0.05 (2,2)=19.0F 0.10 (2,2)=9.0

[0071] 3. Determination of process parameters

[0072] Analysis of variance for paeoniflorin (Table 3) showed that factors A, B, and C had no significant impact. Intuitive analysis (Table 2) indicated that level three of factors A, B, and C yielded the highest extraction efficiency, with the optimal process being A3B3C3. However, the differences between levels two and three for each factor were not significant. Therefore, considering practical production and energy-saving costs, the final extraction process was determined to be A2B2C2, which involves two decoctions with 8 times the volume of water, each lasting 1.5 hours. This extraction process was adopted in subsequent experiments.

[0073] (III) Molding Process Research

[0074] 1. Selection and dosage determination of auxiliary materials

[0075] The commonly used excipients for water-soluble granules are sucrose and dextrin. This product was initially planned to be granulated by adding the excipients to a thick paste, stirring and mixing thoroughly. Based on preliminary experiments and considering economic factors, dextrin and sucrose were used in the experiments. Following the results of the preliminary experiments, the extract was concentrated to 1.30-1.35 (50-60℃), and different proportions of sucrose and dextrin were added, stirred and mixed thoroughly, and then granulated. The amount of excipients used was determined based on the ease of granulation and the yield of granules.

[0076] Granule yield (%) = Qualified granules / Total amount (thick paste + excipients)

[0077] The qualified particles are the sum of particles that can pass through sieve No. 1 and particles that cannot pass through sieve No. 5.

[0078] Table 4. Amount of excipients (by mass)

[0079]

[0080] Results: By adding different proportions of sucrose and dextrin, the difficulty of granulation and the yield of granules were compared. The results showed that when the ratio of sucrose to dextrin was 2:1, the granulation difficulty met the requirements. A ratio of 2.5:1 also met the requirements. Considering reducing the amount of excipients used, the proposed excipient ratio of thick paste:sucrose:dextrin was 1:2:1. Therefore, this ratio was used in subsequent experiments.

[0081] 2. Determination of Particle Drying Temperature

[0082] A comparative experiment was conducted on the granules at different drying temperatures through preliminary experiments. The drying time, finished product color, and solubility were observed and recorded. The results are shown in Table 5.

[0083] Table 5 Results of the investigation on drying methods

[0084]

[0085] The results showed that, considering factors such as drying time, finished product color, and solubility, a drying temperature of 60-70℃ was optimal for the granules. Therefore, this temperature was used in subsequent experiments.

[0086] 3. Determination of hygroscopicity and flowability of particles

[0087] 3.1 Determination of Particle Hygroscopicity

[0088] Weigh out three equal portions of raw materials according to the formula ratio, and label them No. 1, No. 2, and No. 3 respectively. Add 8 times the amount of water to each portion, decoct and extract twice, 1.5 hours each time. Combine the extracts, filter, and concentrate to a thick paste of 1.30-1.35 (50-60℃). Add 2 parts of sucrose and 1 part of dextrin to the thick paste, stir and mix well, granulate, and dry for later use.

[0089] Sodium chloride was added to a glass desiccator containing a saturated sodium chloride solution at the bottom at regular intervals until a supersaturated sodium chloride solution was formed, bringing the relative humidity inside the desiccator to 75%. 1.5g of each of the above-mentioned particles was accurately weighed and spread evenly in a flat weighing bottle that had been dried to constant weight. The bottle was then placed in the desiccator containing the supersaturated sodium chloride solution (with the bottle caps open). After 24 hours, the bottles were weighed, and the percentage of moisture absorption was calculated. The results are shown in Table 6.

[0090]

[0091] Table 6. Determination of Particle Hygroscopicity

[0092]

[0093] The results showed that the granules prepared with the excipient ratio of thick paste: sucrose: dextrin of 1:2:1 had a moisture absorption percentage of 9.5%, which met the requirements.

[0094] 3.2 Determination of particle flowability

[0095] Using the fixed funnel method, two funnels were connected in series and fixed at a height of 1 cm on a horizontally placed graph paper. The mixtures were poured into the uppermost funnel along the funnel wall until the tip of the powder cone formed on the graph paper touched the funnel opening. The diameter of the bottom of the cone (2R) was measured from the graph paper, and the angle of repose tan=H / R was calculated. The operation was repeated three times in parallel, and the average value was calculated. The results are shown in Table 7. It can be seen that the angle of repose of the three batches of samples is less than 40°, indicating that the particles have good flowability.

[0096] Table 7. Determination of Angle of Repose

[0097]

[0098] The results showed that the granules prepared by using the excipients in a ratio of 1:2:1 of thick paste: sucrose: dextrin had good flowability and met the requirements of the next packaging process in industrialization.

[0099] In summary, by examining the effects of different proportions of excipients on granulation difficulty and yield, the optimal ratio of thick paste:dextrin:sucrose was determined to be 1:2:1. Through investigation of different drying temperatures, granules dried at 60-70℃ showed suitable drying time, appearance, color, and solubility. Finally, the hygroscopicity and flowability of the granules were measured, and both met the requirements, facilitating industrial production.

[0100] Example 2: Therapeutic effect on mice with eczema

[0101] This embodiment aims to explore the effect of the traditional Chinese medicine granules prepared in Example 1 on a 2,4-dinitrochlorobenzene (DNCB)-induced mouse eczema model. By observing the skin lesions, ear swelling, organ index, pathological changes in the skin tissue of the auricle and back, the levels of inflammatory factors in serum and skin tissue, and the expression level of mRNA in mice, this embodiment provides a theoretical basis for the treatment of eczema with Liangxue Shufeng granules.

[0102] 1. Experimental Materials

[0103] 1.1 Laboratory Animals

[0104] Forty-eight male SPF-grade KM mice, weighing (30±3) g, were purchased from Spf (Beijing) Biotechnology Co., Ltd., with the license number: SCXK (Beijing) 2019-0010. The animal experiment was approved by the Ethics Committee of Shanxi University of Traditional Chinese Medicine (No. AWE202305315).

[0105] 1.2 Drugs and reagents

[0106] The traditional Chinese medicine granule prepared in Example 1 was named Liangxue Shufeng Granule (hospital preparation of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, filing number: Jin Medicine Preparation Word Z20230290000); Xiaofeng Zhiyang Granule (Shaanxi Huaxi Pharmaceutical Co., Ltd., batch number: Z20044319) (ingredients: Saposhnikovia divaricata, Cryptotympana pustulata, Lycium chinense Miller, Atractylodes lancea (fried), Linum usitatissimum, Angelica sinensis, Rehmannia glutinosa, Akebia quinata, Schizonepeta tenuifolia, Gypsum fibrosum, Glycyrrhiza uralensis Fisch); DNCB (Beijing百灵威科技有限公司, batch number LD50W04); Olive oil (Shanghai Macklin Biochemical Co., Ltd., batch number: C15376194); Hematoxylin-eosin (H&E) staining solution set (Wuhan Sevier Technology Co., Ltd., batch number: G1003); Mast cell staining solution (Wuhan Sevier Technology Co., Ltd., batch number: 20230216); Primary antibodies: IL-6, TNF-α, IL-1β (Beijing Biosynthesis Biotechnology Co., Ltd., batch numbers: BC03302588, BC02013429, BB10113890); Secondary antibody (Beijing Biosynthesis Biotechnology Co., Ltd., batch number: BA12163708); DAB (Jiangsu KeyGen Biotech Co., Ltd., batch number: 20230825); Endogenous peroxidase blocker (Wuhan Elabscience Biotechnology Co., Ltd., batch number: GY02JOXZ606); Normal goat serum (Wuhan Sevier Technology Co., Ltd., batch number: MPC2302068); Immunohistochemistry pen (Guangzhou Xiangbo Biotechnology Co., Ltd., batch number: 23185642) Neutral gum (Sinopharm Chemical Reagent Co., Ltd., batch number: 10004160); Enzyme-linked immunosorbent assay kits for immunoglobulin E (LgE), interleukin 4 (IL-4) and interferon-γ (IFN-γ) (Guangdong Andy Gene Biotechnology Co., Ltd., batch number: 202307); Xylene (Tianjin Beichen Fangzheng Reagent Factory, batch number: 20230702); Absolute ethanol (Tianjin Tianli Chemical Reagent Co., Ltd., batch number: 20230702); Citric acid (Tianjin Fengchuan Chemical Reagent Co., Ltd., batch number: 20230211); Sodium citrate (Tianjin Katong Chemical Reagent Co., Ltd., batch number: 20220610); Disodium hydrogen phosphate (Tianjin Beichen Fangzheng Reagent Factory, batch number: 20230528); Sodium dihydrogen phosphate (Tianjin Beichen Fangzheng Reagent Factory, batch number: 20230528).

[0107] 1.3 Experimental instruments

[0108] AC8 plate washer (Thermo Fisher Scientific Shanghai Instruments Co., Ltd.), Donatello dehydrator, Giotto stainer (Taip Biosciences China Co., Ltd.), JB-P5 embedding machine (Wuhan Junjie Electronics Co., Ltd.), RM2016 pathology slide machine (Shanghai Leica Instruments Co., Ltd.), Axioscope 5 microscope (Carl Zeiss Shanghai Management Co., Ltd.), HC3018R high-speed refrigerated centrifuge (Anhui Zhongke Zhongjia Scientific Instruments Co., Ltd.), Multiskan FC microplate reader (Thermo Fisher Scientific Shanghai Instruments Co., Ltd.), GFL-230 oven (Tianjin Laiborui Instrument Equipment Co., Ltd.), electronic balance (Ohaus Instruments Changzhou Co., Ltd.).

[0109] 2. Experimental Methods and Content

[0110] 2.1 Animal grouping, model establishment, and drug administration

[0111] Forty-eight mice were acclimatized for one week and then randomly divided into six groups of eight each: a control group, a model group, a Xiaofeng Zhizhi Granules group (5 g / kg), a high-dose group (15 g / kg), a medium-dose group (7.5 g / kg), and a low-dose group (3.75 g / kg). The Xiaofeng Zhizhi Granules group served as the positive control group. The clinical dose of the positive control drug was used as the dosage.

[0112] 2.5g and 0.35g of DNCB were accurately weighed and dissolved in a mixture of olive oil and acetone (1:4) to prepare 5% DNCB solution and 0.7% DNCB solution, respectively, as the sensitization solution and the challenge solution for experimental modeling. During the sensitization process, approximately 2cm × 2cm of hair was removed from the backs of 48 mice. From day 1 to day 5 of the experiment, mice in the control group were sensitized by applying 100μL of distilled water to the hair-removed area on their backs and 25μL to their right ears. The remaining mice were sensitized by applying 100μL of 5% DNCB solution to the hair-removed area on their backs and 25μL to their right ears. During the stimulation process, a small dose of 0.7% DNCB solution was repeatedly applied to the ears and back of mice at the above dosage to establish an eczema model {Sun Xiaojing, Zhang Yisheng, Xu Aiqin, et al. Regulation of H1R, PAR-2 / TRPV1 itch signaling pathways in mice with chronic dermatitis and eczema by T-cell-mediated immune balance through Fuxian lotion [J / OL]. Chinese Journal of Modern Applied Pharmacy: 1-9 [2023-11-03]}, once every 3 days, for 4 consecutive times. The skin in the sensitized area on the back of the mice showed redness, swelling, crusting, dryness, and obvious scratching. The right ear of the mice showed local redness, swelling, crusting, or a small amount of dandruff, indicating that the eczema mouse model was successfully established {Zhang Qian, Shi Yanmei, Li Xiumin, et al. Analysis of specific dermatitis animal models based on the clinical characteristics of traditional Chinese and Western medicine [J]. Chinese Journal of Traditional Chinese Medicine, 2021, 46: 762-766.}. Mice in each group were administered the drug by gavage daily starting on the day of stimulation. If DNCB stimulation was required on the day of administration, the interval between administration and stimulation was 2 hours. The drugs used in the high-dose group (15g / kg), medium-dose group (7.5g / kg), low-dose group (3.75g / kg), and Xiaofeng Zhizhi granules group were dissolved in distilled water, while the blank group and model group were given distilled water. The administration lasted for 14 days.

[0113] 2.2 Determination of the degree of skin lesions on the back

[0114] In the experiment, the severity of skin lesions on the back of mice in each group was scored on days 3, 7, 10 and 14 before stimulation. Scoring was based on redness and swelling, keratinization and crusting, exudation and dryness. The severity of the skin in the sensitized area on the back was divided into four levels: none, mild, moderate and severe, and scored as 0, 1, 2 and 3 points respectively, for a total of 12 points [Zheng Xinru, Zhang Xiaoqing, Yang Yang et al. Establishment of a 2,4-dinitrochlorobenzene-induced atopic dermatitis model in BALB / c mice [J]. Experimental Animal Science, 2022, 39(06):57-62.].

[0115] 2.3 Measurement of ear swelling

[0116] After the experiment, the auricles on both sides were cut off along the base of the mouse's ear. A 6mm diameter metal punch was used to make holes in the same location on both ears. The weight of the left and right ears of the mouse was measured using an electronic balance. The difference in weight was calculated as the degree of ear swelling and used as an indicator of the intensity of the inflammatory response.

[0117] 2.4 Determination of organ indices

[0118] The body weight of mice in each group was measured, and the thymus and spleen of the mice were separated. The weight of the thymus and spleen was measured using an electronic balance, and the thymus index and spleen index were calculated. Organ index (mg / g) = (organ weight ÷ mouse body weight) × 10 [Yao Baihui. Study on the effect of Danggui Yinzi on the immune mechanism of a blood deficiency and wind dryness type atopic dermatitis model in young mice [D]. Southwest Medical University, 2023. DOI:10.27215 / d.cnki.glzyu.2023.000056.].

[0119] 2.5 Observe the pathological morphology of skin tissue

[0120] After the experiment, two skin tissue samples, approximately 1 cm × 0.5 cm in size, were taken from diagonally opposite areas of the sensitized skin on the mouse's ear and back. These samples were fixed in 4% paraformaldehyde, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (H&E) and toluidine blue (TB), respectively. The sections were then mounted with neutral resin, and the pathological changes in the mouse's back and ear tissues were observed under a microscope. Six fields of view were randomly selected from each group under 200x magnification, and ImageJ software was used to measure cortical thickness and count mast cells.

[0121] 2.6 Determination of inflammatory factors in mouse dorsal tissue

[0122] Paraffin sections from the back of mice were sequentially immersed in xylene solution, anhydrous ethanol solution, 95% ethanol solution, 85% ethanol solution, and tap water for dewaxing and hydration. Antigen retrieval was performed using microwave. 10-15 μL of endogenous peroxidase blocking agent (3% H2O2) was added to remove interference from endogenous peroxidase in the tissue. Normal goat serum blocking solution was added and incubated at room temperature for 30 min. The prepared primary antibody dilutions IL-6 (1:100), TNF-α (1:100), and IL-1β (1:100) were added to cover the tissue. The tissue was placed in a humidified chamber and refrigerated at 4°C overnight. The prepared secondary antibody dilution (1:300) was added and the tissue was incubated in a humidified chamber at room temperature for 3 h. Add the prepared DAB staining solution and place the slides in a humidified chamber in the dark for staining. The staining time should not be too long, not exceeding 15 minutes. Prolonged staining can easily lead to false positives. Once the specific areas turn brownish-red and the background is relatively clean, place the slides in ultrapure water to stop staining. Pour hematoxylin into the staining jar, shake off the water from the slides, and place them in the staining jar. Stain for 1 minute and observe the staining. Place the slides in tap water to regain blue color, then in 1% hydrochloric acid alcohol for 5 seconds to separate the colors. Immediately place them in tap water to observe whether the cytoplasm and nuclei are clear. Finally, place the slides sequentially in specimen bottles containing 70% ethanol, 80% ethanol, 90% ethanol, 95% ethanol, anhydrous ethanol, and xylene for dehydration and clearing, and mount with neutral resin. The sections were observed under a microscope, and six images were collected for each group under a 400x microscope. The average optical density of the protein-positive expression area was measured using the ImageJ image analysis system [Zhao Wenjun, Zhang Yuwei, Li Weijie, et al. Therapeutic effect of Bacillus DU-106 lysate on 2,4-dinitrofluorobenzene-induced atopic dermatitis mice [J]. Bulletin of Microbiology, 2023, 50(07):2970-2982.].

[0123] 2.7 Analysis of expression levels of inflammatory factors in serum

[0124] Blood was collected from mouse eyeballs at 3000 r·min -1 Centrifuge at 4℃ for 15 min, separate the upper serum layer, and determine the levels of IgE, IL-4, and IFN-γ in mouse serum according to the ELISA kit instructions.

[0125] 2.8 Expression of IL-1β and IL-33 mRNA in mouse dorsal tissue

[0126] A skin tissue specimen was taken from the back of a mouse for RNA extraction and reverse transcription. The primer sequences are as follows: IL-1β: upstream primer 5'-ATGATGATGATAACCTGCTGGTG-3', downstream primer 5'-TTGTCGTTGCTTGGTTCTCC-3';

[0127] IL-33: Upstream primer: 5'-GAATCCAGGGCTACACAAATC-3', downstream primer: 5'-AACATCACACAAGACCAGACTC-3', calculate the expression levels of each gene.

[0128] 2.9 Statistical Methods

[0129] Data with The data were processed using one-way ANOVA in Graphpad Prism 9 software, and P < 0.05 indicated that the difference was statistically significant.

[0130] 3. Experimental Results and Analysis

[0131] 3.1 Skin lesion score

[0132] Observation of mice from day 1 to day 14 after drug administration showed that the skin on the back of mice in the blank group was normal, while the skin lesions on the back of mice in the model group were more severe, including redness, swelling, thickening, keratinization, crusting, shedding, exudation, and dryness. The skin lesions on the back of mice in the high, medium, and low dose groups of Liangxue Shufeng Granules were significantly reduced, with obvious signs of crusting and shedding, and normal hair growth. Furthermore, the redness, swelling, crusting, exudation, and dryness were significantly reduced. The high-dose group showed the most significant effect. (See results below.) Figure 2 Compared with the blank group, the back score of the model group was significantly increased (P<0.01). Compared with the model group, the scores of the high, medium and low dose groups of Liangxue Shufeng Granules were all decreased (P<0.01). The results are shown in Table 8.

[0133] Table 8. Scoring of skin lesions on the back of mice with eczema.

[0134]

[0135] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P < 0.01.

[0136] 3.2 Ear swelling degree

[0137] Compared with the control group, the ear swelling of mice in the model group was significantly increased (P<0.01). Compared with the model group, the ear swelling of mice in the high-dose and medium-dose groups of Liangxue Shufeng Granules was significantly decreased (P<0.01), indicating that Liangxue Shufeng Granules can significantly reduce the degree of ear swelling in mice and has an inhibitory effect on DNCB-induced ear swelling in mice with eczema. The results are shown in Table 9.

[0138] Table 9. Effects of Liangxue Shufeng Granules on Ear Swelling in Mice with Eczema

[0139]

[0140] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P < 0.01.

[0141] 3.3 Organ Index

[0142] Compared with the control group, the thymus index and spleen index of the model group were significantly increased (P < 0.01). Compared with the model group, the high-dose Liangxue Shufeng granules group significantly reduced the thymus index of eczema mice (P < 0.01), and both the high-dose and medium-dose groups significantly reduced the spleen index of eczema mice (P < 0.01), indicating that Liangxue Shufeng granules have a certain inhibitory effect on the DNCB-induced mouse eczema model. The results are shown in Table 10.

[0143] Table 10 Effects of Liangxue Shufeng Granules on Thymus and Spleen Indices in Eczema Mice

[0144]

[0145] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P < 0.01.

[0146] 3.4 Results of Dermatopathological Examination

[0147] The results of H&E staining of mouse auricles are shown in the figure. Figure 3 The control group showed intact tissue structure and normal appearance. Compared with the control group, after repeated stimulation with DNCB, the model group mice showed thickening of the epidermal spinous layer, interstitial edema, and infiltration of inflammatory cells and mast cells, angiogenesis, and congestion in the dermis, with a significant increase in the thickness of the auricular cortex. Intervention with high, medium, and low doses of Liangxue Shufeng granules all reduced inflammatory cell infiltration and vascular congestion, with the high-dose group showing the most significant effect. Compared with the control group, the thickness of the auricular skin tissue in the model group was significantly increased (P < 0.01). Compared with the model group, high, medium, and low doses of Liangxue Shufeng granules significantly reduced the thickness of the epidermis and dermis of the auricular tissue (P < 0.01), alleviating the DNCB-induced skin lesions in the mouse auricular tissue. Results are shown below. Figure 4 .

[0148] The results of H&E staining of mouse dorsal skin are shown in the figure. Figure 5In the control group, the epidermal cells of the back skin of mice were arranged in an orderly manner, and the tissue structure appeared normal. Compared with the control group, after repeated DNCB stimulation, the back skin of the model group mice showed keratinization, epidermal crust formation, mild hyperplasia, and neutrophils in lymphocytes, with significant lymphocyte infiltration in the dermis. Compared with the model group, the high, medium, and low dose groups of Liangxue Shufeng granules significantly reduced inflammatory cell infiltration in the back skin tissue, with the high dose group showing the most significant reduction. Compared with the control group, the dermal thickness of the back skin tissue in the model group was significantly increased (P < 0.01). Compared with the model group, the high, medium, and low dose groups of Liangxue Shufeng granules significantly reduced the thickness of the epidermis and dermis in the back skin tissue (P < 0.01). This indicates that Liangxue Shufeng granules can significantly improve the pathological changes of DNCB-induced eczema. (See results below.) Figure 6 .

[0149] Results of TB staining of mouse dorsal skin are shown in the figure. Figure 7 The control group showed intact tissue structure and distinct layers, with no mast cell infiltration. Compared with the control group, after repeated stimulation with DNCB, the model group mice showed a large number of mast cell infiltrations in the back tissue. Intervention with high, medium, and low doses of Liangxue Shufeng granules reduced mast cell infiltration. Compared with the control group, the number of mast cells in the back tissue of the model group was significantly increased (P<0.01). Compared with the model group, high, medium, and low doses of Liangxue Shufeng granules significantly reduced the number of mast cells in the skin (P<0.01), thereby alleviating DNCB-induced skin lesions in mice. Results are shown below. Figure 8 .

[0150] 3.5 Expression of inflammatory factors in mouse dorsal skin tissue

[0151] Immunohistochemical staining results of mouse back are shown in the figure. Figure 9 The positive substances for IL-6, TNF-α, and IL-1β were brownish-yellow or yellow, mostly granular, with a few irregular shapes. Compared with the blank group, the expression of IL-6, TNF-α, and IL-1β in the model group was significantly increased (P<0.01); compared with the model group, the expression of IL-6, TNF-α, and IL-1β in the high, medium, and low dose groups of Liangxue Shufeng Granules was significantly decreased (P<0.01). The results are shown in Table 11.

[0152] Table 11 Analysis of OD values ​​of IL-6, TNF-α, and IL-1β proteins in mouse dorsal skin tissue.

[0153]

[0154]

[0155] Note: Compared with the blank group, # P<0.05, ##P<0.01; compared with the model group, * P<0.05, ** P < 0.01.

[0156] 3.6 Serum inflammatory factor levels

[0157] Compared with the control group, the serum levels of LgE, IL-4, and IFN-γ in the model group mice were significantly increased. Compared with the model group, intervention with high, medium, and low doses of Liangxue Shufeng granules significantly reduced the serum levels of LgE, IL-4, and IFN-γ in eczema mice (P < 0.01), indicating that Liangxue Shufeng granules have a significant anti-inflammatory effect. Results are shown below. Figure 10 .

[0158] 3.7 Expression of IL-1β and IL-33 mRNA in mouse dorsal skin tissue

[0159] Compared with the control group, the levels of IL-1β and IL-33 mRNA in the back tissue of the model group were significantly increased (P<0.01). Compared with the model group, the levels of IL-1β mRNA in the back tissue of mice in the high-dose Liangxue Shufeng Granules group were significantly decreased (P<0.01), and the levels of IL-33 mRNA were significantly decreased (P<0.05). The results are shown in Table 12.

[0160] Table 12 Expression of IL-1β mRNA and IL-33 mRNA in mouse dorsal tissue

[0161]

[0162] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P < 0.01.

[0163] In this embodiment, Liangxue Shufeng Granules were used as the target drug to investigate their therapeutic effect on mice with eczema. Repeated stimulation of the mouse auricle and back skin with DNCB resulted in obvious erythema, papules, itching, and crusting. The ear weight of the mice was significantly higher than that of the control group, and the auricle score, spleen index, and thymus index were also increased. Compared with the model group, the herbal composition of this invention significantly improved ear swelling and inflammatory infiltration of the skin in the right ear of mice, and reduced the thymus index and spleen index.

[0164] Inflammation is present throughout the entire course of eczema, at every stage. When the body is stimulated by antigens, T lymphocytes proliferate and differentiate, producing a large number of inflammatory factors that induce inflammatory skin lesions such as redness, swelling, and exudation. TH1 / TH2 cell imbalance is a crucial mechanism in the pathogenesis of eczema. This imbalance leads to the release of histamine and inflammatory mediators from mast cells and basophils, inducing excessive proliferation of keratinocytes and ultimately resulting in dermal thickening. TH1 cells secrete IFN-γ and TNF-α, while TH2 cells secrete IL-33, IL-6, and IL-4. The expression of inflammatory factors is positively correlated with the severity of eczema. Overexpression of IL-4 can also induce B lymphocytes to produce specific IgE antibodies, thereby increasing skin vascular permeability and causing eczematous skin pathological changes such as redness, swelling, and itching. IL-1β is a key pro-inflammatory cytokine involved in various autoimmune inflammatory responses and multiple cellular activities; its excessive production is related to the pathophysiological changes of eczema. IL-33 can induce immune cell differentiation, produce pro-inflammatory factors, and promote TH2 immune responses, making it an important factor in initiating and maintaining allergic inflammation. Studies have found that eczema manifests as a TH1 / TH2 shift, and its pathogenesis may be closely related to inflammatory responses, immune imbalances, and epidermal barrier dysfunction, leading to dry, cracked, and itchy skin. After treatment, the TH1 / TH2 ratio gradually reaches a balanced state; therefore, a balanced TH1 / TH2 ratio helps alleviate eczema symptoms. By investigating the effects of the herbal composition of this invention on eczema, an eczema model was established by sensitizing the skin on the back and ears of mice with DNCB solution. This induced TH1 / TH2 imbalance, the release of histamine and inflammatory mediators from mast cells and basophils, and the excessive proliferation of keratinocytes, ultimately leading to dermal thickening. The appearance of redness, swelling, crusting, papules, vesicles, exudate, and dryness at the application site was used as indicators of successful model establishment. At the same time, different concentrations of granules were administered. It was found that the granules of this invention could significantly improve acanthosis, vasodilation, erosion, and inflammatory infiltration, and reduce the number of mast cells. It also reduced the levels of IgE, IFN-γ, and IL-4 in mouse serum and decreased the expression of IL-6, TNF-α, and IL-1β, as well as the expression of IL-1β and IL-33 mRNA in the skin lesions on the back of mice.

[0165] In summary, the herbal composition and granules of this invention have a certain therapeutic effect on eczema. Their mechanism of action can be achieved by regulating the TH1 / TH2 balance of T helper cells, reducing inflammatory factors and mast cell numbers, and increasing the expression of skin barrier-related proteins, thereby improving skin lesions in eczema model mice. However, the specific mechanism of action requires further research to provide a basis for developing treatments for infection-related diseases.

[0166] The present invention has been described in detail above. Those skilled in the art will recognize that the invention can be practiced in a wide range of ways with equivalent parameters, concentrations, and conditions without departing from its spirit and scope. While specific embodiments have been provided, it should be understood that further modifications can be made to the invention. In summary, according to the principles of the invention, this application is intended to include any changes, uses, or improvements to the invention, including modifications made using conventional techniques known in the art that depart from the scope disclosed herein.

Claims

1. A traditional Chinese medicine composition for treating eczema, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Rehmannia glutinosa 50-75 parts, Paeonia suffruticosa 50-75 parts, Gypsum fibrosum 100-150 parts, Lonicera japonica 50-75 parts, Schizonepeta tenuifolia 30-50 parts, Saposhnikovia divaricata 30-50 parts, Cicadae periostracum 30-50 parts, Bombyx mori 30-50 parts, Calcined dragon bone 120-150 parts, Calcined oyster shell 120-150 parts, Dictamnus dasycarpus 50-75 parts, Glycyrrhiza uralensis 15-30 parts.

2. The traditional Chinese medicine composition for treating eczema according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 75 parts Rehmannia glutinosa, 75 parts Paeonia suffruticosa, 150 parts Gypsum fibrosum, 75 parts Lonicera japonica, 50 parts Schizonepeta tenuifolia, 50 parts Saposhnikovia divaricata, 50 parts Cicadae periostracum, 50 parts stir-fried Bombyx mori, 150 parts calcined dragon bone, 150 parts calcined oyster shell, 75 parts Dictamnus dasycarpus, and 30 parts Glycyrrhiza uralensis.

3. A traditional Chinese medicine preparation for treating eczema, characterized in that, It is made from the traditional Chinese medicine composition according to any one of claims 1-2 and its pharmaceutically acceptable excipients.

4. The traditional Chinese medicine preparation according to claim 3, characterized in that: The traditional Chinese medicine preparation is in granule form.

5. The method for preparing the traditional Chinese medicine preparation according to claim 4, characterized in that, Includes the following steps: S1. Mix the raw materials for preparing the traditional Chinese medicine composition, add water and decoct to obtain a decoction; S2. Filter the decoction and concentrate the filtrate into a thick paste; S3. Add sucrose and dextrin to the thick paste, mix well, form into granules, and dry to obtain the traditional Chinese medicine preparation.

6. The preparation method according to claim 5, characterized in that: In the step of adding water and decocting, the amount of water added is 8 times the total amount of raw materials, and the decoction is performed twice, 1.5 hours each time, and the decoctions are combined; and / or, The thick paste has a relative density of 1.30-1.35 at 50-60°C, and the mass ratio of the thick paste, sucrose, and dextrin is 1:2:1; and / or, The drying temperature is 60~70℃.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-2, the traditional Chinese medicine preparation according to any one of claims 3-4, or the traditional Chinese medicine preparation prepared by the preparation method according to any one of claims 5-6 in the preparation of a drug for treating eczema.

8. The application according to claim 7, characterized in that: The eczema described is chronic eczema.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-2, the traditional Chinese medicine preparation according to any one of claims 3-4, or the traditional Chinese medicine preparation prepared by the preparation method according to any one of claims 5-6 in the preparation of inflammatory factor inhibitors or anti-inflammatory drugs.

10. The application according to claim 9, characterized in that: The inflammatory factors mentioned are those related to the TH1 / TH2 cell balance. The inflammation described is caused by an imbalance of TH1 / TH2 cells.

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