A traditional Chinese medicine composition for atopic dermatitis and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for atopic dermatitis and its application. The composition is made from the following raw materials in parts by weight: 10-20 parts of dried plum, 5-15 parts of licorice root, 10-20 parts of Imperata cylindrica root, 5-15 parts of Smilax glabra rhizome, 5-15 parts of Coix seed, 5-15 parts of Angelica dahurica root, 3-9 parts of peppermint, 3-10 parts of Astragalus membranaceus root, 5-15 parts of dried tangerine peel, and 5-15 parts of Siraitia grosvenorii fruit. The composition can be prepared by soaking in water, decocting, and filtering to obtain a decoction, or further processed into granules, pills, tablets, capsules, or oral liquids for oral administration. Experimental results show that the composition of this invention can alleviate skin tissue damage in mice with DNFB-induced atopic dermatitis, reduce the area of ​​pathological skin tissue damage, and decrease the abnormal increase in mast cells. The raw materials of this invention are readily available, easy to prepare, and suitable for oral use, and can be used to prepare drugs for the treatment or adjuvant treatment of atopic dermatitis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition for atopic dermatitis and its application. Background Technology

[0002] Atopic dermatitis is a common, chronic, relapsing, inflammatory skin disease, clinically characterized by dry skin, erythema, papules, eczematous lesions, exudation, lichenification, and significant itching. The disease has a prolonged course and is prone to recurrence, requiring some patients to manage with long-term or even repeated medication, severely impacting their quality of life. The occurrence of atopic dermatitis is related to multiple factors, including genetic susceptibility, impaired skin barrier function, abnormal immune function, and environmental stimuli. Its pathogenesis is complex, and simply controlling inflammation or relieving itching in the short term is often insufficient to meet the needs of long-term treatment and recurrence management.

[0003] Currently, common treatments for atopic dermatitis include basic moisturizing care, topical corticosteroids, topical calcineurin inhibitors, oral antihistamines, and systemic corticosteroids, immunosuppressants, biologics, or small-molecule targeted drugs for moderate to severe cases. These treatments are effective in relieving itching, alleviating erythema, and controlling acute inflammation, but their long-term use has limitations. Corticosteroids have a rapid onset of action, but atopic dermatitis is characterized by its chronic and recurrent nature, often requiring prolonged medication. Long-term or improper use of topical corticosteroids may cause skin atrophy, telangiectasia, pigmentation changes, further damage to the skin barrier, and hormone dependence. Systemic corticosteroids or immunosuppressants can be used for short-term control of more severe cases, but long-term use may increase the risk of infection, liver and kidney burden, or other systemic adverse reactions. While biologics and small-molecule targeted drugs offer new treatment options for moderate to severe cases, their treatment costs are relatively high, placing a heavy burden on some patients requiring long-term medication. Oral antihistamines are primarily used to relieve itching, but their effect on improving skin lesions, inflammation, and skin barrier damage is limited. Basic moisturizing care helps repair the skin barrier, but it is usually difficult to control significant inflammatory responses on its own. Therefore, existing treatments still have certain limitations in terms of long-term safety, treatment costs, and the need for continued medication by patients.

[0004] Chinese patent CN115154547A discloses a traditional Chinese medicine composition for treating atopic dermatitis, consisting of Astragalus membranaceus, Codonopsis pilosula, Rehmannia glutinosa (processed), Atractylodes macrocephala, Poria cocos, Ophiopogon japonicus, Schisandra chinensis, Saposhnikovia divaricata, Scutellaria baicalensis, Citrus reticulata peel, and Glycyrrhiza uralensis (processed). This formula is based on the principles of tonifying qi and blood, strengthening the spleen, and dispelling wind, and is intended to improve symptoms such as itching and recurrent skin lesions in patients with atopic dermatitis. However, this formula is generally biased towards tonifying and regulating the body, with the medicinal components mainly consisting of tonifying herbs. For patients with significant erythema, exudation, itching, or recurrent inflammation, its specificity in clearing damp-heat and alleviating local inflammatory reactions remains insufficient.

[0005] Chinese patent CN103520572A discloses a traditional Chinese medicine composition for treating atopic dermatitis, comprising the following herbs: Coptis chinensis, Phellodendron chinense, Sophora flavescens, Sanguisorba officinalis, Punica granatum peel, Kochia scoparia, Astragalus membranaceus, Atractylodes macrocephala, Angelica sinensis, Polygonum multiflorum, Paeonia lactiflora, Ligusticum chuanxiong, Schizonepeta tenuifolia, Saposhnikovia divaricata, Uncaria rhynchophylla, Glycyrrhiza uralensis, Adenophora stricta, Coix lacryma-jobi, Poria cocos, Rehmannia glutinosa, Paeonia lactiflora, Lycium chinense root bark, Scutellaria baicalensis, Anemarrhena asphodeloides, Ophiopogon japonicus, Salvia miltiorrhiza, Spatholobus suberectus, Tribulus terrestris, etc. This formula treats atopic dermatitis by nourishing yin and clearing heat, nourishing blood and moisturizing the skin, and dispelling wind and relieving itching. However, this composition contains many herbs, resulting in a complex combination, making actual preparation and quality control relatively inconvenient. Furthermore, the presence of many bitter and cold herbs for clearing heat raises concerns about the cold nature of the herbs, their taste, and the patient's ability to continue taking them for long-term use in patients with chronic recurrent dermatitis.

[0006] Chinese patent CN113041296A discloses a traditional Chinese medicine composition for treating atopic dermatitis, comprising multiple components including traditional Chinese medicine A, traditional Chinese medicine B, and traditional Chinese medicine C, including both oral and topical preparations. This treatment method utilizes multiple pathways such as clearing heat and detoxifying, promoting blood circulation and removing dampness, astringing and healing sores, and tonifying qi and strengthening the body's resistance to improve the symptoms of atopic dermatitis. However, this method requires the combined use of multiple components, making the treatment process relatively cumbersome; for patients with a long course of disease requiring repeated medication, its ease of use remains somewhat limited.

[0007] Chinese patent CN113384636A discloses a topical Chinese medicine formula and method of use for treating atopic dermatitis in infants and young children. The formula consists of honeysuckle, mulberry bark, licorice root, purslane, lycium bark, peppermint, and Cibotium barometz, and is used as a soaking solution. This method primarily exerts its anti-inflammatory, antipruritic, moisturizing, and skin barrier-repairing effects through external washing. However, external washing or soaking solutions usually require certain conditions, such as water temperature, time, frequency, and proper care, limiting their application scenarios. For patients with extensive skin lesions, recurrent flare-ups, or those requiring long-term treatment, relying solely on topical soaking methods still has limitations.

[0008] In summary, it is particularly important to provide a traditional Chinese medicine composition that is readily available, cost-controllable, convenient for oral administration, and suitable for long-term management. Summary of the Invention

[0009] The purpose of this invention is to provide a traditional Chinese medicine composition for atopic dermatitis and its application, addressing the problems of insufficient safety, high treatment cost, inconvenient usage, and poor patient adherence in existing atopic dermatitis treatments. This traditional Chinese medicine composition uses stable raw materials, has a simple preparation method, and is suitable for oral use. It can be used to improve symptoms such as dry skin, itching, erythema, skin lesions, and recurrent inflammation caused by atopic dermatitis, providing a suitable long-term treatment or adjunctive therapy for patients in the chronic, remission, and recurrent phases of atopic dermatitis.

[0010] To achieve the above objectives, the present invention provides the following technical solution: A traditional Chinese medicine composition for atopic dermatitis is made from the following raw materials in parts by weight: 10-20 parts of dried plum, 5-15 parts of licorice root, 10-20 parts of Imperata cylindrica root, 5-15 parts of Smilax glabra rhizome, 5-15 parts of coix seed, 5-15 parts of Angelica dahurica root, 3-9 parts of peppermint, 3-10 parts of Astragalus membranaceus root, 5-15 parts of dried tangerine peel, and 5-15 parts of monk fruit.

[0011] Furthermore, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 12-18 parts of dried plum, 8-12 parts of licorice, 12-18 parts of Imperata cylindrica root, 8-12 parts of Smilax glabra, 8-12 parts of Coix seed, 8-12 parts of Angelica dahurica, 4-7 parts of peppermint, 4-7 parts of Astragalus membranaceus, 8-12 parts of dried tangerine peel, and 8-12 parts of monk fruit.

[0012] Furthermore, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts dried plum, 10 parts licorice, 15 parts Imperata cylindrica root, 10 parts Smilax glabra, 10 parts Coix seed, 10 parts Angelica dahurica, 6 parts peppermint, 6 parts Astragalus membranaceus, 10 parts dried tangerine peel, and 10 parts Luo Han Guo.

[0013] Furthermore, the traditional Chinese medicine composition is a decoction extract, concentrated liquid, extract, dry extract powder, granules, pills, tablets, capsules, or oral liquid.

[0014] A method for preparing a traditional Chinese medicine composition, characterized by comprising the following steps: weighing out parts by weight of dried plum, licorice, Imperata cylindrica root, Smilax glabra, Coix seed, Angelica dahurica, peppermint, Astragalus membranaceus, tangerine peel and Siraitia grosvenorii, soaking in water and then decocting, filtering to remove the dregs, and obtaining the traditional Chinese medicine composition.

[0015] Furthermore, the amount of water added is sufficient to cover the surface of the raw materials. After soaking at room temperature for 20 to 60 minutes, the herbs are decocted. The decoction includes two decoctions: the first decoction lasts for 20 to 40 minutes, and the second decoction lasts for 10 to 30 minutes. The decoctions are combined and then filtered to obtain the traditional Chinese medicine composition.

[0016] The present invention also protects a pharmaceutical preparation for atopic dermatitis, the pharmaceutical preparation comprising the traditional Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

[0017] Furthermore, the pharmaceutical preparation is an oral preparation, which is selected from granules, pills, tablets, capsules or oral liquids.

[0018] The use of the above-mentioned traditional Chinese medicine composition or the above-mentioned pharmaceutical preparation in the preparation of a medicine for treating and / or relieving atopic dermatitis.

[0019] Furthermore, the drug is used to improve dry skin, itching, erythema, eczematous lesions, thickened skin tissue, inflammatory cell infiltration and / or abnormal increase of mast cells caused by atopic dermatitis; and / or, the drug is used to regulate the expression of atopic dermatitis-related inflammatory factors or immune-related factors, said inflammatory factors or immune-related factors including one or more of IL-2, IFN-γ, IL-10, IL-4, IL-5, IL-13 and TNF-α.

[0020] This invention relates to a traditional Chinese medicine composition using a combination of dried plum, licorice root, Imperata cylindrica root, Smilax glabra rhizome, Coix seed, Angelica dahurica root, peppermint, Astragalus membranaceus root, tangerine peel, and monk fruit. From the perspective of traditional Chinese medicine compatibility, Astragalus membranaceus root tonifies qi and strengthens the exterior, improving the condition of patients with atopic dermatitis who experience prolonged and recurrent illness and insufficient skin surface defense; Imperata cylindrica root, Smilax glabra rhizome, and Coix seed clear heat and promote diuresis, helping to reduce erythema, exudation, and inflammatory reactions caused by internal damp-heat; Angelica dahurica root and peppermint dispel wind and relieve itching, alleviating skin itching and local discomfort; Tangerine peel regulates qi and strengthens the spleen, aiding in spleen and stomach function and reducing internal dampness; Dried plum, being sour and astringent, promotes fluid production, improving discomfort such as dry and tight skin; licorice root harmonizes the other herbs; and monk fruit, being sweet and mild, improves the palatability of oral preparations and is beneficial for long-term use by patients.

[0021] From the perspective of modern pharmacology, the occurrence of atopic dermatitis is related to skin barrier damage, inflammatory cell infiltration, abnormal increase of mast cells, and imbalance of immune factor expression. The herbal composition of this invention, after oral administration, can alleviate skin tissue damage in DNFB-induced atopic dermatitis-like mice, manifested as reduced epidermal thickening, decreased inflammatory cell infiltration, and a reduced number of mast cells. Further testing showed that this composition can increase serum IL-2 levels in model mice, upregulate the mRNA expression levels of IL2, IFN-γ, and IL10 in skin tissue, and reduce the abnormal expression of inflammatory factors such as IL4, IL13, TNF-α, and IL5. These results suggest that the herbal composition of this invention does not simply exert its effect through short-term antipruritic or anti-inflammatory action, but rather can regulate the expression of atopic dermatitis-related immune factors while alleviating local skin inflammation, thereby helping to improve the local inflammatory state and immune imbalance of the skin.

[0022] Compared with the prior art, the present invention has at least the following beneficial effects: The traditional Chinese medicine composition of this invention consists of dried plum, licorice, Imperata cylindrica root, Smilax glabra, Coix seed, Angelica dahurica, peppermint, Astragalus membranaceus, tangerine peel, and monk fruit. The raw materials used are commonly used Chinese medicinal materials with relatively stable sources. The preparation process is simple and can be prepared into decoctions, granules, pills, tablets, capsules, or oral liquids using conventional processes such as decoction, concentration, drying, and granulation, which is convenient for industrial preparation and clinical use.

[0023] The herbal composition of this invention is suitable for oral administration, and the treatment process is relatively simple, requiring no external washing, soaking, or combination of multiple preparations, thus reducing the operational burden on patients during long-term medication. The addition of licorice and monk fruit to the composition improves the bitter taste of traditional Chinese medicine decoctions, increasing oral acceptability and facilitating long-term use by patients in the chronic phase, remission phase, and recurrent phases.

[0024] The herbal composition of this invention does not contain glucocorticoids, immunosuppressants or biological agents, and can be used as one of the options for long-term treatment or adjuvant treatment of atopic dermatitis. It helps to reduce patients' dependence on hormone drugs or high-cost targeted drugs, and is especially suitable for people who need long-term treatment and repeated management.

[0025] The herbal composition of this invention can improve atopic dermatitis-like skin lesions. Animal experimental results showed that after DNFB induction, mouse skin tissue exhibited pathological changes such as epidermal thickening, increased inflammatory cell infiltration, and increased mast cell number; after administration of the herbal composition of this invention, the area of ​​pathological lesions in the skin tissue decreased, and the abnormal increase in mast cells decreased, indicating that the composition can alleviate atopic dermatitis-related skin lesions and inflammatory responses.

[0026] The herbal composition of this invention can regulate the expression of inflammatory and immune-related factors associated with atopic dermatitis. Experimental results show that this composition can increase serum IL-2 levels in model mice, upregulate the mRNA expression levels of IL2, IFN-γ, and IL10 in skin tissue, and downregulate the abnormal expression of inflammatory factors such as IL4, IL13, TNF-α, and IL5. These results indicate that the herbal composition of this invention, while improving skin lesions, can also regulate the imbalance of local skin inflammatory response and immune factor expression, thereby improving its overall efficacy for long-term treatment or adjuvant therapy of atopic dermatitis. Attached Figure Description

[0027] Figure 1 Images of hematoxylin-eosin staining and toluidine blue staining of mouse skin tissues in each group are shown in the specific implementation method. Figure 2 This is a quantitative analysis diagram showing the area of ​​pathological lesions in the skin tissue of mice in each group and the number of mast cells per field of view in a specific implementation method. Figure 2 Figure A shows a quantitative analysis of the area of ​​pathological damage in the skin tissue of mice in each group. Figure 2 B is a quantitative analysis diagram of the number of mast cells per field of view in the skin tissue of mice in each group; Figure 3 This is a Venn diagram showing the relationship between the target points of the traditional Chinese medicine composition and the target points of atopic dermatitis in a specific implementation method. Figure 4 This is a protein interaction network diagram of the common target of the traditional Chinese medicine composition and atopic dermatitis in a specific implementation method. Figure 5 This is a diagram showing the enrichment analysis of the biological processes of the traditional Chinese medicine composition and the common target of atopic dermatitis in a specific implementation method. Figure 6 The graph shows the detection results of IL-2 content in the serum of mice in each group in the specific implementation method; Figure 7 This is a graph showing the relative mRNA expression levels of IL2, IFN-γ, and IL10 in the skin tissue of mice in each group, as described in the specific implementation method. Figure 7 Figure A shows the results of the detection of the relative expression level of IL2 mRNA. Figure 7 Figure B shows the results of the detection of the relative expression level of IFN-γ mRNA. Figure 7 C represents the results of detecting the relative expression level of IL10 mRNA; Figure 8 The images shown are immunofluorescence staining images of IFN-γ and TNF-α protein expression in the skin tissues of mice in each group, as described in the specific implementation method. Figure 8 A is an immunofluorescence staining image of IFN-γ protein expression. Figure 8 B is an immunofluorescence staining image of TNF-α protein expression; Figure 9 This is a quantitative analysis diagram of the average fluorescence intensity of IFN-γ and TNF-α in the skin tissue of each group of mice in a specific implementation method. Figure 9 A is a quantitative analysis diagram of the average fluorescence intensity of IFN-γ. Figure 9 B is a quantitative analysis diagram of the average fluorescence intensity of TNF-α; Figure 10 The image shows immunofluorescence staining of IL4 protein expression in the skin tissue of mice in each group during the specific implementation method. Figure 11 The image shows immunofluorescence staining of IL13 protein expression in the skin tissue of mice in each group during the specific implementation method. Figure 12 This is a quantitative analysis diagram of the average fluorescence intensity of IL13 and TNF-α in the skin tissue of mice in each group according to a specific implementation method. Figure 12 A is a quantitative analysis graph of the average fluorescence intensity of IL13. Figure 12B is a quantitative analysis diagram of the average fluorescence intensity of TNF-α; Figure 13 This is a graph showing the results of detecting the relative mRNA expression levels of IL5 in the skin tissues of mice in each group during a specific implementation method. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] In the following experimental results and figures, Control represents the normal control group, i.e., mice that were not induced with DNFB and were treated with an equal volume of distilled water; DNFB or AD represents the model group, i.e., mice that underwent DNFB induction to establish an atopic dermatitis-like skin inflammation model and were treated with an equal volume of distilled water; Form represents the treatment control group, i.e., mice that were not induced with DNFB but were treated with the herbal composition of this invention; DNFB+Form or AD+Form represents the model treatment group, i.e., mice that underwent DNFB induction to establish an atopic dermatitis-like skin inflammation model and were then treated with the herbal composition of this invention. Unless otherwise specified, the number of experimental animals in each group was 5. An asterisk in the figures indicates that the difference between the corresponding groups was statistically significant. Example

[0030] Take 12 parts of dried plum, 8 parts of licorice root, 12 parts of Imperata cylindrica root, 8 parts of Smilax glabra rhizome, 8 parts of Coix seed, 8 parts of Angelica dahurica root, 5 parts of peppermint, 4 parts of Astragalus membranaceus root, 8 parts of dried tangerine peel, and 8 parts of monk fruit. Combine the above-mentioned medicinal materials according to the specified proportions. Use a clay pot, add water to cover the medicinal materials by about 5 cm, and soak at room temperature for about 30 minutes. First, bring to a boil over high heat, then reduce to a simmer for a second decoction. The first decoction should be 30 minutes, and the second decoction about 20 minutes. Filter the residue and combine the decoctions. Concentrate the decoction as usual or directly dispense into oral doses, each approximately 500 mL. This yields the aforementioned traditional Chinese medicine composition for treating dermatitis. The decocted liquid can be refrigerated and should not be kept for more than 2 days. Example

[0031] Take 15 parts of dried plum, 10 parts of licorice root, 15 parts of Imperata cylindrica root, 10 parts of Smilax glabra rhizome, 10 parts of Coix seed, 10 parts of Angelica dahurica root, 6 parts of peppermint, 6 parts of Astragalus membranaceus root, 10 parts of dried tangerine peel, and 10 parts of monk fruit. Combine the above herbs according to the specified proportions. Use a clay pot, add water to cover the herbs by about 5 cm, and soak at room temperature for about 30 minutes. First, bring to a boil over high heat, then reduce to a simmer for a second decoction. The first decoction should be 30 minutes, and the second decoction about 20 minutes. Filter the residue and combine the decoctions. Concentrate the decoction as usual or directly dispense into oral doses, approximately 500 mL per dose. This yields the aforementioned traditional Chinese medicine composition for treating dermatitis. The decocted liquid can be refrigerated but should not be kept for more than 2 days.

[0032] Example 3 Take 18 parts of dried plum, 12 parts of licorice root, 18 parts of Imperata cylindrica root, 12 parts of Smilax glabra rhizome, 12 parts of Coix seed, 12 parts of Angelica dahurica root, 8 parts of peppermint, 8 parts of Astragalus membranaceus root, 12 parts of dried tangerine peel, and 12 parts of monk fruit. Combine the above herbs according to the specified proportions. Use a clay pot, add water to cover the herbs by about 5 cm, and soak at room temperature for about 30 minutes. First, bring to a boil over high heat, then reduce to a simmer for a second decoction. The first decoction should be 30 minutes, and the second decoction about 20 minutes. Filter the residue and combine the decoctions. Concentrate the decoction as usual or directly dispense into oral doses, approximately 500 mL per dose. This yields the aforementioned traditional Chinese medicine composition for treating dermatitis. The decocted liquid can be refrigerated but should not be kept for more than 2 days.

[0033] Experimental Example 1: Establishment of a mouse model of atopic dermatitis and experimental grouping Experimental materials: BALB / c mice, DNFB, traditional Chinese medicine, gavage device, olive oil Experimental Methods: Twenty BALB / c mice, weighing 18–20 g, were acclimatized for one week with free access to food and water. They were randomly divided into four groups (n=5 per group): a normal control group, an AD model group, a drug-treated control group, and a model-treated group. One day prior to the experiment, the hair on the backs of the mice was shaved off in sections approximately 2.5 cm × 2.5 cm until fully exposed. To ensure effectiveness, depilatory cream was applied to the exposed skin to remove the hair. DNFB reagent was prepared using a 3:1 volume ratio of acetone to olive oil. On days 1, 2, and 3 after hair removal, 200 μL of 0.5% DNFB solution was applied to the backs of the AD model group and the model-treated group to sensitize the skin. This was done once daily for a total of three applications. On days 8, 10, 12, and 14, 0.25% DNFB solution was repeatedly applied to the backs of the mice to stimulate stimulation, once daily. 200 μL of acetone-olive oil (3:1 volume ratio) was applied to the shaved areas on the backs of mice in both the normal control and treatment control groups. After sensitization on day 8, each treatment group was administered the traditional Chinese medicine oral solution prepared in Example 2 of this invention via gavage for animal experimental treatment. The normal control and model groups were given distilled water under the same conditions, twice daily for 7 consecutive days. One hour after the last administration, blood was collected from the eyes of the mice, and serum was obtained by centrifugation. The mice were then euthanized, and the skin from their backs was harvested.

[0034] After modeling, the AD model group mice showed obvious skin inflammation, indicating that the specific dermatitis model was successfully established.

[0035] Experimental Example 2: Effects of the Traditional Chinese Medicine Composition from Example 1 on Histopathological Changes in Skin Histopathology of Mice with Atopic Dermatitis Experimental materials: Paraffin sections of mouse skin tissue; Hematoxylin and eosin (H&E) staining kit (catalog number: G1120, Beijing Solarbio Science & Technology Co., Ltd.); Toluidine blue staining kit (catalog number: C0105, Beyotime); Automated multispectral scanning microscopy system (VS200, Olympus).

[0036] Experimental methods: H&E staining: Place the prepared paraffin sections in an oven at 60℃-70℃ for 1 hour to ensure the tissue adheres firmly to the slide. Remove the paraffin by immersion in xylene, then hydrate using a gradient of alcohols, and finally rinse with tap water to restore hydration. Immerse the hydrated sections in hematoxylin staining solution for 5-10 minutes. Hematoxylin is a basic dye that will turn the cell nuclei blue-purple. After a brief rinse with running water, differentiate using 0.5% hydrochloric acid-alcohol solution to remove excess hematoxylin dye and control the staining depth of the cell nuclei under a microscope. Immerse the sections in a weakly alkaline solution to restore the cell nuclei to a stable blue-purple color, then rinse thoroughly with running water. Immerse the sections in 0.5% eosin-alcohol solution for 5 minutes. Eosin is an acidic dye that will turn the cytoplasm, muscle fibers, and extracellular matrix pink. After staining, the sections need to be dehydrated using a gradient of alcohols and then cleared with xylene. Remove the slide, add a drop of neutral resin, cover with a coverslip to seal, and then observe under a microscope.

[0037] Toluidine blue staining solution is used for paraffin sections. Dewaxing is performed in xylene for 5-10 minutes, followed by anhydrous ethanol for 5 minutes, 90% ethanol for 2 minutes, 80% ethanol for 2 minutes, 70% ethanol for 2 minutes, and distilled water for 2 minutes. The tissue is circled using a Liquid Blocker SuperPAPPen immunohistochemical pen. 50 μL of toluidine blue staining solution is added to each section to completely cover the tissue and stain for 5-10 minutes. The staining solution is removed, and the sections are rinsed in tap water for about 5 minutes to remove excess stain. Differentiation is performed using differentiation solution for about 2-5 seconds, followed by rinsing with tap water for 5 minutes. The sections are then sequentially immersed in 70% ethanol for 10 seconds, 80% ethanol for 10 seconds, 90% ethanol for 10 seconds, and anhydrous ethanol for 10 seconds. Clearing is performed in xylene for 5 minutes, then replaced with fresh xylene, and clearing is repeated for another 5 minutes. Neutral resin is then added to the slide and the slide is mounted.

[0038] Figure 1 Images show hematoxylin-eosin and toluidine blue staining of mouse skin tissues from each group. The horizontal axis represents the Control group, AD group, Form group, and AD+Form group, respectively; the vertical axis is labeled HE and TB, where HE represents hematoxylin-eosin staining and TB represents toluidine blue staining. HE staining was used to observe skin tissue structure, epidermal thickness, and inflammatory cell infiltration, while TB staining was used to observe the distribution of mast cells in the skin tissue. Figure 1 It was observed that the skin tissue structure in the Control group was relatively intact; the skin tissue in the AD group showed epidermal thickening, disordered tissue structure, and increased inflammatory cell infiltration, with an increased number of mast cells under TB staining; the skin tissue damage in the AD+Form group was less severe than that in the AD group, with a decrease in the number and aggregation of mast cells. These results indicate that the traditional Chinese medicine composition can improve the pathological damage of skin tissue in atopic dermatitis-like mice.

[0039] Figure 2 This image shows a quantitative analysis of the area of ​​pathological lesions in the skin tissue of mice in each group and the number of mast cells per field of view. Among them, Figure 2 The horizontal axis of A is Control, DNFB, Form and DNFB+Form, respectively, and the vertical axis is Histopathological lesion area, which represents the area of ​​pathological damage to the skin tissue. Figure 2 The x-axis of B represents Control, DNFB, Form, and DNFB+Form, respectively, while the y-axis represents Mast cells per field, indicating the number of mast cells in each field of view. Figure 2 As can be seen from A, the area of ​​pathological skin lesions was higher in the DNFB group than in the Control group, and lower in the DNFB+Form group than in the DNFB group; Figure 2 As shown in Figure B, the number of mast cells per field of view increased in the DNFB group compared to the Control group, while it decreased in the DNFB+Form group compared to the DNFB group. These results further indicate that the traditional Chinese medicine composition can reduce the degree of skin tissue damage in an atopic dermatitis-like model and decrease the abnormal increase in mast cells.

[0040] Network target analysis of traditional Chinese medicine composition for treating atopic dermatitis in Experiment Example 3 Experimental materials: The traditional Chinese medicine composition described in this embodiment includes the following medicinal materials: dried plum, licorice, Imperata cylindrica root, Smilax glabra, Coix seed, Angelica dahurica, peppermint, Astragalus membranaceus, tangerine peel, and monk fruit.

[0041] Database Source: The active ingredients and their targets in traditional Chinese medicine are compiled from public databases and literature. Genes related to atopic dermatitis (AD) were obtained from disease gene databases (such as GeneCards, DisGeNET, etc.). Software tools used included R (for data processing and plotting) and ggVennDiagram plotting tool. Experimental methods: The main active ingredients of the aforementioned 10 traditional Chinese medicines were obtained through public database and literature searches. Their corresponding targets were further screened and uniformly converted into standard gene symbols to construct a target set for the traditional Chinese medicine composition. Using "atopic dermatitis" as the keyword, relevant genes were searched in disease-related databases, and a set of disease-related targets was obtained by screening and organizing the data, removing duplicates. Intersection analysis of the traditional Chinese medicine composition targets and atopic dermatitis-related genes was performed using R language to screen for common targets. Based on the above two gene sets, a Venn diagram was constructed using the ggVennDiagram tool to visually demonstrate the overlap between the traditional Chinese medicine composition targets and atopic dermatitis-related genes.

[0042] The aforementioned genes are all key molecules in the inflammatory response and immune regulation processes, playing an important role in the occurrence and development of atopic dermatitis. This result suggests that the traditional Chinese medicine composition may exert its therapeutic effect on atopic dermatitis by regulating inflammatory signaling pathways through multiple targets. This study identified six overlapping targets (IL6, TNF, STAT3, MAPK1, RELA, and TLR4) through Venn diagram screening. These targets are all key molecules in the inflammatory response and immune regulation, playing a central role in the occurrence and development of atopic dermatitis, suggesting that the traditional Chinese medicine composition may exert its therapeutic effect by regulating inflammatory signaling pathways.

[0043] Experimental results: Figure 3 This is a Venn diagram showing the correlation between targets associated with the traditional Chinese medicine (TCM) composition and targets associated with atopic dermatitis. In the diagram, "Form" represents targets associated with the TCM composition, and "AD" represents targets associated with atopic dermatitis. "Form" contains 745 unique targets, "AD" contains 843 unique targets, and both groups share 174 common targets. This diagram illustrates the overlap between targets associated with the TCM composition and targets associated with atopic dermatitis, suggesting that the composition may participate in the regulation of atopic dermatitis-related pathological processes through these common targets.

[0044] Figure 4 This is a protein interaction network diagram showing the common targets of a traditional Chinese medicine composition and atopic dermatitis. Each node in the diagram represents a target, the text above the node is the target name, and the lines connecting the nodes indicate the interaction relationships between the targets. Figure 4 As can be seen, targets such as IL6, TNF, STAT3, RELA, TLR4, MAPK1, AKT1, TP53, EGFR, IL2, CXCL8, CXCR4, and NFKB1 are located in the network and interact with other targets. This figure indicates that the common targets of the traditional Chinese medicine composition and atopic dermatitis involve networks related to inflammatory responses and immune regulation.

[0045] Figure 5This is a graph showing the bioprocess enrichment analysis of common targets of traditional Chinese medicine compositions and atopic dermatitis. The graph is titled "Biological Process," with the horizontal axis representing the EnrichmentScore (-log10(pvalue)), indicating the significance of enrichment. The vertical axis lists the enriched bioprocesses, including response to molecule of bacterial origin, response to lipopolysaccharide, leukocyte migration, positive regulation of response to external stimulus, regulation of inflammatory response, cell chemotaxis, positive regulation of smooth muscle cell proliferation, muscle cell proliferation, regulation of smooth muscle cell proliferation, and smooth muscle cell proliferation. The "Count" on the right indicates the number of targets enriched in the corresponding bioprocess, and the "pvalue" indicates the significance of enrichment. Figure 5 It is evident that the common targets are mainly enriched in biological processes such as inflammatory response regulation, leukocyte migration, chemotaxis, bacterial-derived molecular responses, and lipopolysaccharide responses. These results suggest that the traditional Chinese medicine composition may participate in the treatment of atopic dermatitis by regulating inflammatory responses and immune cell recruitment-related processes.

[0046] As shown in the figure above, the traditional Chinese medicine composition has a highly correlated biological basis with atopic dermatitis (AD). Network pharmacology analysis reveals 174 overlapping targets between the active ingredient group of the traditional Chinese medicine composition and the pathological targets of AD. This indicates that the formula does not act through a single component, but rather through a multi-component, multi-target systemic regulatory network, providing a molecular-level predictive basis for the significant clinical efficacy of the formula in treating AD. Component analysis and target mapping revealed that monk fruit flavonoids (such as kaempferol derivatives) and monk fruit polysaccharides (SGP) have a very high degree of matching with immune regulatory pathways. The active ingredients in monk fruit can synergistically act on the immune regulatory network with the principal herbs such as astragalus in the formula.

[0047] Experimental Example 4: The promoting effect of the traditional Chinese medicine composition of the present invention on the Th1 type immune response in the skin tissue of mice with atopic dermatitis Experimental materials: IL-2 ELISA kit (catalog number MM-0701M1, enzyme immunoassay), TRIzol (RNA extraction reagent); SYBR Green Master Mix (SYBR Green premix, ThermoFisherScientific, Waltham, MA, USA); fully automated multispectral scanning microscope system (VS200, Olympus).

[0048] Experimental methods: ELISA: Collect mouse serum in sterile tubes. Allow the blood to clot naturally at room temperature for 120 minutes or overnight at 2-8°C. Centrifuge at 2-8°C for 20 minutes (3000 rpm) and carefully collect the supernatant for detection. Remove the required strips from the foil pouch after equilibration at room temperature for 20 minutes. Return the remaining strips to 4°C in a resealable bag. Set up standard and sample wells. Add 50 μL of different concentrations of standard reagent to each standard well. Add 10 μL of the test sample to each sample well, followed by 40 μL of sample diluent. Do not add any reagent to the blank wells. Add 100 μL of horseradish peroxidase (HRP)-labeled detection antibody to each well (except the blank wells). Seal the reaction wells with sealing film and incubate at 37°C for 60 minutes. Discard the liquid, pat dry on absorbent paper, fill each well with washing buffer, let stand for 1 minute, discard the washing buffer, and pat dry on absorbent paper. Repeat this washing process 5 times. Add 50 μL of substrate A and substrate B to each well and incubate at 37°C in the dark for 15 min. Add 50 μL of stop solution to each well and measure the OD value of each well at 450 nm within 15 min. In an Excel worksheet, plot the linear regression curve of the standard with the standard concentration on the x-axis and the corresponding OD value on the y-axis, and calculate the concentration value of each sample according to the curve equation.

[0049] RNA extraction and RT-PCR steps RNA extraction: Weigh 20 mg of tissue, wash with cold PBS, chop, and place in a 1.5 mL centrifuge tube. Add... Add 1 mL of TRIzol reagent and grind the mixture at 12000 rpm for 10 minutes using a grinder. Collect the supernatant and add... Add 200 μL of chloroform and incubate for 5 minutes, then centrifuge at 12000 rpm for 10 minutes. Mix the supernatant with 600 μL of isopropanol, incubate at -20°C for 15 minutes, and centrifuge again. Discard the supernatant, wash the RNA with 1 mL of 70% ethanol, dry, and resuspend in 20 μL of DEPC water. Quantify the RNA using Nanodrop.

[0050] Reverse transcription: Mix 2 μg RNA with 5×gDNA Eraser buffer and gDNA Eraser, and incubate at 42°C for 2 minutes to remove genomic DNA. Then add the remaining components, incubate the mixture at 37°C for 15 minutes, followed by incubation at 85°C for 5 seconds to synthesize cDNA. Store the cDNA at -20°C. Real-time quantitative PCR: Prepare the reaction mixture including 2 μL cDNA, 5 μL LSYBR Green Master Mix, 0.5 μL each of forward and reverse primers, and 2 μL RNase-free water. Perform PCR using an AppliedBiosystems TMViiA™7 system under the following conditions: incubation at 50°C for 2 minutes, incubation at 95°C for 2 minutes, followed by 40 cycles, each cycle consisting of 95°C for 15 seconds and 60°C for 1 minute, and finally 95°C for 15 seconds and 60°C for 1 minute.

[0051] For immunofluorescence, paraffin sections are baked in a 67°C incubator for 60-120 minutes to enhance tissue adhesion. They are then soaked in xylene I and xylene II for 10 minutes each to completely remove paraffin. Next, they are soaked in a gradient of alcohols (e.g., anhydrous ethanol, 95% ethanol, 80% ethanol) for 5 minutes each, and finally rinsed with distilled water or PBS to ensure complete tissue hydration. The sections are then immersed in sodium citrate buffer. The retrieval solution containing the sections is placed in an autoclave or pressure cooker and heated to boiling, held for 2 minutes, and then immediately stopped. The retrieval solution is allowed to cool to room temperature. The sections are washed three times with PBS for 5 minutes each time. A PBS solution containing 0.1% Triton X-100 is added, and the sections are incubated at room temperature for 10 minutes. The sections are then washed three times with PBS. The liquid is aspirated, and blocking buffer is added, with incubation at room temperature for 60 minutes. The primary antibody (IFN-γ) is diluted 1:200 with antibody dilution buffer. The blocking buffer is removed, and the diluted primary antibody is added. Typically, incubation overnight in a humidified chamber at 4°C is chosen. Wash three times with PBS to thoroughly remove unbound primary antibody. Dilute the fluorescently labeled secondary antibody with antibody dilution buffer, ensuring it matches the host species of the primary antibody. Add Alexa Fluor 555 fluorescent secondary antibody and incubate at room temperature in the dark for 60 minutes. Wash three times with PBS in the dark, 5 minutes each time. Add nuclear dye (DAPI) and incubate at room temperature in the dark for 5–10 minutes. Wash 2–3 times with PBS or ultrapure water in the dark. Aspirate excess liquid from the slide, add a small amount of anti-fluorescence quenching mounting medium to the slide, and gently invert a coverslip containing cells onto the mounting medium. Observe and photograph using a laser confocal microscope. The mounted slide should be stored at 4°C in the dark.

[0052] Experimental results: Figure 6The graph shows the results of IL-2 levels in the serum of mice in each group. The horizontal axis represents Control, DNFB, Form, and DNFB+Form, respectively, and the vertical axis represents IL-2 (pg / ml), indicating the serum IL-2 content. Figure 6 It was observed that the serum IL-2 level in the DNFB group was lower than that in the Control group, while the serum IL-2 level in the DNFB+Form group was higher than that in the DNFB group. This result indicates that the traditional Chinese medicine composition can increase serum IL-2 levels in atopic dermatitis-like model mice.

[0053] Figure 7 The figure shows the results of detecting the relative mRNA expression levels of IL2, IFN-γ, and IL10 in the skin tissue of mice in each group. Figure 7 The vertical axis of A represents the relative mRNA level of IL2, indicating the relative mRNA expression level of IL2. Figure 7 The vertical axis of B represents the relative mRNA level of IFN-γ, indicating the relative mRNA expression level of IFN-γ. Figure 7 The vertical axis of C represents the relative mRNA level of IL10, indicating the relative mRNA expression level of IL10. Figure 7 A, Figure 7 B and Figure 7 The x-coordinates of C are Control, DNFB, Form, and DNFB+Form, respectively. Figure 7 It was observed that the mRNA expression levels of IL2, IFN-γ, and IL10 in the DNFB group were lower than those in the Control group, while those in the DNFB+Form group were higher than those in the DNFB group. These results indicate that the traditional Chinese medicine composition can improve the abnormal expression of IL2, IFN-γ, and IL10 in the skin tissue of atopic dermatitis-like mouse models.

[0054] Figure 8 Immunofluorescence staining images of IFN-γ and TNF-α protein expression in the skin tissues of mice in each group. Figure 8 A shows the immunofluorescence staining pattern of IFN-γ protein expression. The horizontal axis represents the Control group, DNFB group, Form group, and DNFB+Form group, while the vertical axis represents the Merge group, IFN-γ group, and DAPI group. IFN-γ is shown in red fluorescence, and DAPI is shown in blue to represent the cell nucleus. Figure 8 B shows the immunofluorescence staining pattern of TNF-α protein expression. The horizontal axis represents the control group, DNFB group, Form group, and DNFB+Form group, while the vertical axis represents Merge, TNF-α, and DAPI. TNF-α is shown as green fluorescence, and DAPI is shown as blue to represent the cell nucleus. Figure 8The distribution and expression of IFN-γ and TNF-α proteins in the skin tissue of mice in each group were shown.

[0055] Figure 9 This is a quantitative analysis of the average fluorescence intensity of IFN-γ and TNF-α in the skin tissues of mice in each group. Figure 9 The x-axis of A represents Control, DNFB, Form, and DNFB+Form, respectively, and the y-axis represents the Mean Fluorescence Intensity of IFN-γ, indicating the average fluorescence intensity of IFN-γ. Figure 9 The x-axis of B represents Control, DNFB, Form, and DNFB+Form, respectively, while the y-axis represents the Mean Fluorescence Intensity of TNF-α, indicating the average fluorescence intensity of TNF-α. Figure 9 As can be seen, the average fluorescence intensity of IFN-γ in the DNFB group was lower than that in the Control group, while that in the DNFB+Form group was higher than that in the DNFB group; under the detection conditions shown in the figure, TNF-α was lower in the DNFB group than in the Control group, while that in the DNFB+Form group was higher than that in the DNFB group. Figure 8 and Figure 9 This indicates that the traditional Chinese medicine composition can regulate the expression of IFN-γ and TNF-α proteins in the skin tissue of atopic dermatitis-like model mice.

[0056] Combination Figures 6 to 9 The results showed that DNFB induction decreased serum IL-2 levels in mice, and decreased mRNA expression levels of IL-2, IFN-γ, and IL-10 in skin tissue, along with weakened IFN-γ protein expression. After administration of the traditional Chinese medicine composition, these indicators rebounded compared to the DNFB group. These results indicate that the traditional Chinese medicine composition can regulate the expression of immune-related factors such as IL-2, IFN-γ, and IL-10 in atopic dermatitis-like model mice.

[0057] Experimental Example 5: The herbal composition of the present invention inhibits the Th2-type inflammatory response and pro-inflammatory factor levels in the skin tissue of mice with atopic dermatitis. Experimental materials: TRIzol (RNA extraction reagent); SYBR Green Master Mix (SYBR Green premix, ThermoFisherScientific, Waltham, MA, USA); Experimental methods: RNA extraction and RT-PCR steps RNA extraction: Weigh 20 mg of tissue, wash with cold PBS, chop, and place in a 1.5 mL centrifuge tube. Add... Add 1 mL of TRIzol reagent and grind the mixture at 12000 rpm for 10 minutes using a grinder. Collect the supernatant and add... Add 200 μL of chloroform and incubate for 5 minutes, then centrifuge at 12000 rpm for 10 minutes. Mix the supernatant with 600 μL of isopropanol, incubate at -20°C for 15 minutes, and centrifuge again. Discard the supernatant, wash the RNA with 1 mL of 70% ethanol, dry, and resuspend in 20 μL of DEPC water. Quantify the RNA using Nanodrop.

[0058] For reverse transcription, 2 μg of RNA was mixed with 5×gDNA Eraser buffer and gDNA Eraser, and incubated at 42°C for 2 minutes to remove genomic DNA. The remaining components were then added, and the mixture was incubated at 37°C for 15 minutes, followed by incubation at 85°C for 5 seconds to synthesize cDNA. The cDNA was stored at -20°C. For real-time quantitative PCR, the reaction mixture consisted of 2 μL cDNA, 5 μL LSYBR Green Master Mix, 0.5 μL each of forward and reverse primers, and 2 μL RNase-free water. PCR was performed using an AppliedBiosystems TMViiA™7 system under the following conditions: 50°C for 2 minutes, 95°C for 2 minutes, followed by 40 cycles, each consisting of 95°C for 15 seconds and 60°C for 1 minute, and finally 95°C for 15 seconds and 60°C for 1 minute.

[0059] For immunofluorescence, paraffin sections are baked in a 67°C incubator for 60-120 minutes to enhance tissue adhesion. They are then soaked in xylene I and xylene II for 10 minutes each to completely remove paraffin. Next, they are soaked in a gradient of alcohols (e.g., anhydrous ethanol, 95% ethanol, 80% ethanol) for 5 minutes each, and finally rinsed with distilled water or PBS to ensure complete tissue hydration. The sections are then immersed in sodium citrate buffer. The retrieval solution containing the sections is placed in an autoclave or pressure cooker and heated to boiling, held for 2 minutes, and then immediately stopped. The retrieval solution is allowed to cool to room temperature. The sections are washed three times with PBS for 5 minutes each time. A PBS solution containing 0.1% Triton X-100 is added, and the sections are incubated at room temperature for 10 minutes. The sections are then washed three times with PBS. The liquid is aspirated, and blocking buffer is added, with incubation at room temperature for 60 minutes. The primary antibody (IL4, IL13, TNF-α) is diluted 1:200 using antibody dilution buffer. The blocking buffer is removed, and the diluted primary antibody is added. Typically, incubation overnight in a humidified chamber at 4°C is chosen. Wash three times with PBS to thoroughly remove unbound primary antibody. Dilute the fluorescently labeled secondary antibody with antibody diluent, ensuring it matches the host species of the primary antibody. Add Alexa Fluor 488 and 555 fluorescent secondary antibodies and incubate at room temperature in the dark for 60 minutes. Wash three times with PBS in the dark, 5 minutes each time. Add nuclear dye (DAPI) and incubate at room temperature in the dark for 5–10 minutes. Wash 2–3 times with PBS or ultrapure water in the dark. Aspirate excess liquid from the slide, add a small amount of anti-fluorescence quenching mounting medium to the slide, and gently invert a coverslip containing cells onto the mounting medium. Observe and photograph using a laser confocal microscope. The mounted slide should be stored at 4°C in the dark.

[0060] Experimental results: Figure 10 Immunofluorescence staining images of IL4 protein expression in mouse skin tissues from each group are shown. The horizontal axis represents the Control group, DNFB group, Form group, and DNFB+Form group, respectively; the vertical axis represents Merge, IL4, and DAPI, respectively. IL4 is shown as green fluorescence, and DAPI is shown as blue representing the cell nucleus. Figure 10 It was observed that the IL4 fluorescence signal in the skin tissue of the DNFB group was enhanced compared to the Control group, while the IL4 fluorescence signal in the DNFB+Form group was weakened compared to the DNFB group. This result indicates that the traditional Chinese medicine composition can reduce the abnormal expression of IL4 protein in the skin tissue of atopic dermatitis-like mouse models.

[0061] Figure 11Immunofluorescence staining images of IL13 protein expression in mouse skin tissues from each group are shown. The horizontal axis represents the Control group, DNFB group, Form group, and DNFB+Form group, respectively; the vertical axis represents Merge, IL13, and DAPI, respectively. IL13 is shown as red fluorescence, and DAPI is shown as blue fluorescence indicating the cell nucleus. Figure 11 It was observed that the IL13 fluorescence signal in the skin tissue of the DNFB group was enhanced compared to the Control group, while the IL13 fluorescence signal in the DNFB+Form group was weakened compared to the DNFB group. This result indicates that the traditional Chinese medicine composition can reduce the abnormal expression of IL13 protein in the skin tissue of atopic dermatitis-like mouse models.

[0062] Figure 12 This is a quantitative analysis of the average fluorescence intensity of IL13 and TNF-α in the skin tissue of mice in each group. Figure 12 The x-axis of A represents Control, DNFB, Form, and DNFB+Form, respectively, and the y-axis represents the Mean Fluorescence Intensity of IL13, indicating the average fluorescence intensity of IL13. Figure 12 The x-axis of B represents Control, DNFB, Form, and DNFB+Form, respectively, while the y-axis represents the Mean Fluorescence Intensity of TNF-α, indicating the average fluorescence intensity of TNF-α. Figure 12 It was observed that the average fluorescence intensity of IL13 and TNF-α in the DNFB group was higher than that in the Control group, while that in the DNFB+Form group was lower than that in the DNFB group. These results indicate that the traditional Chinese medicine composition can reduce the expression levels of IL13 and TNF-α proteins in the skin tissue of atopic dermatitis-like mouse models.

[0063] Figure 13 This figure shows the relative mRNA expression levels of IL5 in the skin tissues of mice in each group. The horizontal axis represents Control, DNFB, Form, and DNFB+Form, respectively, and the vertical axis represents the relative mRNA level of IL5, indicating the relative mRNA expression level of IL5. Figure 13 It was observed that the relative expression level of IL5 mRNA in the DNFB group was higher than that in the Control group, and lower in the DNFB+Form group than in the DNFB group. This result indicates that the traditional Chinese medicine composition can reduce the abnormal expression of IL5 in the skin tissue of atopic dermatitis-like mouse models. Figures 10 to 13 It is known that the traditional Chinese medicine composition can downregulate the expression of inflammatory factors such as IL4, IL13, TNF-α and IL5, thereby reducing local inflammatory reactions in the skin.

[0064] Combination Figures 10 to 13It was found that the expression of inflammatory factors such as IL4, IL13, TNF-α, and IL5 in mouse skin tissue increased after DNFB induction; after administration of the traditional Chinese medicine composition, the expression of the above-mentioned inflammatory factors decreased compared with the DNFB group. This result indicates that the traditional Chinese medicine composition can downregulate the abnormal expression of Th2-type inflammatory factors and pro-inflammatory factors in an atopic dermatitis-like model, thereby alleviating local skin inflammation.

Claims

1. A traditional Chinese medicine composition for atopic dermatitis, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-20 parts of dried plum, 5-15 parts of licorice, 10-20 parts of Imperata cylindrica root, 5-15 parts of Smilax glabra, 5-15 parts of Coix lacryma-jobi, 5-15 parts of Angelica dahurica, 3-9 parts of peppermint, 3-10 parts of Astragalus membranaceus, 5-15 parts of dried tangerine peel, and 5-15 parts of Siraitia grosvenorii.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 12-18 parts of dried plum, 8-12 parts of licorice, 12-18 parts of Imperata cylindrica root, 8-12 parts of Smilax glabra, 8-12 parts of coix seed, 8-12 parts of Angelica dahurica, 4-7 parts of peppermint, 4-7 parts of Astragalus membranaceus, 8-12 parts of dried tangerine peel, and 8-12 parts of monk fruit.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts dried plum, 10 parts licorice, 15 parts Imperata cylindrica root, 10 parts Smilax glabra, 10 parts Coix lacryma-jobi, 10 parts Angelica dahurica, 6 parts peppermint, 6 parts Astragalus membranaceus, 10 parts dried tangerine peel, and 10 parts Luo Han Guo.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition is a decoction extract, concentrated liquid, extract, dry extract powder, granules, pills, tablets, capsules or oral liquid.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The process includes the following steps: Weigh out the following ingredients by weight: dried plum, licorice root, Imperata root, Smilax glabra, Coix seed, Angelica dahurica, peppermint, Astragalus membranaceus, tangerine peel, and monk fruit. Soak them in water, then decoct them. Filter to remove the dregs to obtain the Chinese herbal composition.

6. The preparation method according to claim 5, characterized in that, The amount of water added should be enough to cover the surface of the raw materials. After soaking at room temperature for 20 to 60 minutes, the raw materials are decocted. The decoction includes two decoctions: the first decoction is 20 to 40 minutes and the second decoction is 10 to 30 minutes. The decoctions are combined and filtered to obtain the Chinese herbal composition.

7. A pharmaceutical preparation for atopic dermatitis, characterized in that, The pharmaceutical preparation comprises the traditional Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

8. The pharmaceutical preparation according to claim 7, characterized in that, The pharmaceutical preparation is an oral preparation, which is selected from granules, pills, tablets, capsules or oral liquids.

9. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the pharmaceutical preparation according to any one of claims 7 to 8 in the preparation of a medicament for treating and / or relieving atopic dermatitis.

10. The application according to claim 9, characterized in that, The drug is used to improve dry skin, itching, erythema, eczema-like lesions, thickened skin tissue, inflammatory cell infiltration and / or abnormal increase of mast cells caused by atopic dermatitis.

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