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

Abstract

The application provides an anti-urticaria traditional Chinese medicine composition, a medicine preparation and a preparation method and application, and belongs to the field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is composed of the following raw materials: 12-18 parts of Fructus Mume, 8-12 parts of Glycyrrhiza, 12-18 parts of Imperata Cylindra, 8-12 parts of Smilax Glabra, 8-12 parts of Coix Lachryma-jobi, 8-12 parts of Radix Angelicae Dahuricae, 5-7 parts of Mentha, 5-7 parts of Astragalus, 8-12 parts of Pericarpium Citri Reticulatae, and 8-12 parts of Momordica Grosvenorii. The composition follows the compatibility principle of monarch, minister, assistant and messenger, has mild medicinal properties, can significantly improve the histopathological damage of skin tissues, reduce the infiltration of mast cells, reduce the serum IgE level, correct the Th1 / Th2 immune deviation by up-regulating the Th1-type cytokine IFN-gamma and down-regulating the Th2-type cytokines IL-4, IL-5 and IL-13, and reconstruct the local immune homeostasis of skin, and has significant advantages in relieving the symptoms of urticaria and reducing the recurrence.

Description

Technical Field

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

[0002] Urticaria (Urt) is a common allergic skin disease characterized by localized edematous wheals and intense itching on the skin or mucous membranes. It can have an acute or chronic course. Typical clinical manifestations include wheals of varying sizes and irregular shapes, often accompanied by significant itching. Some patients may also experience angioedema. In severe cases, it can affect the respiratory or digestive tract. It is prone to recurrence, and in some patients, it can last for months or even years, seriously affecting their quality of life, sleep, and mental health.

[0003] Epidemiological studies show that urticaria has a high incidence rate in the population, and chronic urticaria has a prolonged course and is prone to recurrence, indicating a significant need for long-term management. The pathogenesis of urticaria is complex, and it is currently believed to be closely related to immune dysfunction, abnormal activation of mast cells and basophils, and the release of histamine and various inflammatory mediators. It is also related to a variety of internal and external factors, including genetic factors, infectious factors, food or drug stimulation, physical factors, and psychological factors.

[0004] Currently, routine treatment for urticaria mainly includes oral second- or third-generation antihistamines, and, when necessary, the combined use of glucocorticoids, immunosuppressants, or biologics. Antihistamines can relieve itching and wheals to some extent, but their efficacy is limited for some patients, and relapse is common after discontinuation. While glucocorticoids have a rapid onset of action, they are not suitable for long-term use; long-term or repeated use may cause adverse reactions such as endocrine disorders and immunosuppression. Immunosuppressants and biologics have some efficacy in some refractory patients, but they are expensive, and their risks and long-term safety still require further evaluation, limiting their clinical application. Furthermore, patients with chronic urticaria often require long-term or even continuous medication. Existing treatment regimens often rely on the long-term use of single or multiple Western medicines, resulting in high treatment costs, poor patient compliance, and shortcomings in relapse control and overall symptom improvement. Especially for those requiring long-term maintenance therapy, how to ensure efficacy while reducing the risk of adverse reactions remains a pressing clinical challenge.

[0005] Traditional Chinese medicine has a long history of application in the prevention and treatment of urticaria. In ancient medical books of past dynasties, this disease was mostly classified into the category of "hidden rash" and it was considered that its occurrence was closely related to factors such as wind pathogen invasion, disharmony of qi and blood, and disorder of zang-fu functions. Clinical practice has shown that some traditional Chinese medicines or traditional Chinese medicine compound prescriptions have certain advantages in improving the symptoms of urticaria and reducing recurrence. However, there is still room for further optimization and improvement in the rationality of the formula, the stability of curative effect, the standardization degree, and the modern preparation technology of the existing traditional Chinese medicine preparations for treating urticaria. Therefore, there is an urgent need in the existing technology to provide a traditional Chinese medicine composition with high safety, mild medicinal properties, suitable for long-term oral administration, and capable of effectively treating urticaria, so as to make up for the deficiencies of the existing treatment means in long-term management, recurrence control, and adverse reactions. Summary of the Invention

[0006] This application provides a traditional Chinese medicine composition for treating urticaria, a pharmaceutical preparation, a preparation method and an application thereof, so as to provide a traditional Chinese medicine composition with high safety, mild medicinal properties, suitable for long-term oral administration, and capable of effectively treating urticaria.

[0007] In the first aspect, this application provides a traditional Chinese medicine composition for treating urticaria. Calculated by weight parts, the traditional Chinese medicine composition is composed of the following traditional Chinese medicine raw materials: smoked plum: 12 - 18 parts, liquorice root: 8 - 12 parts, imperata root: 12 - 18 parts, glabrous greenbrier rhizome: 8 - 12 parts, coix seed: 8 - 12 parts, dahurian angelica root: 8 - 12 parts, mint: 5 - 7 parts, astragalus root: 5 - 7 parts, dried tangerine peel: 8 - 12 parts, monk fruit: 8 - 12 parts.

[0008] Optionally, calculated by weight parts, the traditional Chinese medicine composition is composed of the following traditional Chinese medicine raw materials: smoked plum: 15 parts, liquorice root: 10 parts, imperata root: 15 parts, glabrous greenbrier rhizome: 10 parts, coix seed: 10 parts, dahurian angelica root: 10 parts, mint: 6 parts, astragalus root: 6 parts, dried tangerine peel: 10 parts, monk fruit: 10 parts.

[0009] In the second aspect, this application provides a pharmaceutical preparation prepared from the traditional Chinese medicine composition in the first aspect. The pharmaceutical preparation is a granule, pill, tablet or oral liquid.

[0010] In the third aspect, this application provides a preparation method of the pharmaceutical preparation in the second aspect. The method includes the following steps: [[ID=!9]]S1. Take the formula amount of smoked plum, liquorice root, imperata root, glabrous greenbrier rhizome, coix seed, dahurian angelica root, mint, astragalus root, dried tangerine peel and monk fruit, and soak them in water at normal temperature for 30 min; S2. First boil the soaked medicinal materials with strong fire, and then turn to slow fire for the first decoction, and the decoction time is 30 min; S3. Filter out the first decoction liquid, add water to the medicinal residues again, and decoct with slow fire for the second time, and the decoction time is 20 min; S4. Filter out the dregs, combine the two decoctions, and concentrate or directly dispense into oral doses.

[0011] Fourthly, this application provides the use of the traditional Chinese medicine composition described in the first aspect in the preparation of an anti-urticaria drug with immune homeostasis remodeling function.

[0012] Optionally, the urticaria is chronic urticaria.

[0013] Optionally, the immune homeostasis remodeling includes: reducing the expression levels of Th2 cytokines IL-4, IL-5, and IL-13, while increasing the expression level of Th1 cytokines IFN-γ.

[0014] The technical solutions provided in this application have the following advantages compared with the prior art: (1) Based on traditional Chinese medicine theory and long-term clinical experience, this application follows the principle of compatibility of principal, assistant, adjuvant, and guide herbs, and selects ten mild and non-toxic Chinese medicinal materials for scientific compatibility. Among them, Astragalus membranaceus is the principal herb, which is sweet and warm in nature and enters the spleen and lung meridians. It invigorates qi and strengthens the exterior, promotes tissue regeneration and eliminates toxins. It is used to address the underlying pathogenesis of urticaria patients who are weak due to long-term illness and have poor defensive qi. By invigorating the body and enhancing the skin's defense function, it can fundamentally improve the skin's susceptibility to external pathogens and recurrent inflammation. Smilax glabra, Imperata cylindrica, and Coix lacryma-jobi are the assistant herbs. The three herbs work together to address the damp-heat and heat-toxin from both ends, clearing away the internal damp-heat and reducing the erythema, exudation, and inflammatory reaction caused by damp-heat descending to the skin. They also assist the principal herb in eliminating damp-heat. To expel pathogenic factors, the formula uses Angelica dahurica, Mentha haplocalyx, Citrus reticulata peel, and Prunus mume as adjuvant herbs. Angelica dahurica and Mentha haplocalyx work together to dispel wind and relieve itching, clearing heat and alleviating skin itching and local discomfort. Citrus reticulata peel regulates qi and strengthens the spleen, reducing dampness production from within. Prunus mume, with its astringent and moisturizing properties, relieves dry skin. The combination of these adjuvant herbs ensures that the formula clears heat without harming the body's vital energy and expels pathogenic factors without causing excessive dryness. Licorice root and Luo Han Guo (monk fruit) are used as guiding herbs. Licorice root harmonizes the other herbs, slows down urgency and detoxifies, and balances the overall warming, cooling, tonifying, and purging properties of the formula. Luo Han Guo, sweet and cool, moistens dryness and improves taste. Together, these two herbs create a mild formula that is easy to take. Through the rigorous combination of the principal, assistant, adjuvant, and guiding herbs, the entire formula achieves a balance of tonifying and purging, using both warming and cooling herbs. It contains neither harsh nor excessively hot or cold herbs, thus ensuring a mild medicinal effect and high safety for long-term use.

[0015] (2) This application verified the immunomodulatory mechanism of the traditional Chinese medicine composition through modern pharmacological experiments. The experimental results showed that the composition not only relieved wheals and itching symptomatically, but also corrected the Th1 / Th2 immune shift existing in the pathological state of urticaria by upregulating Th1 cytokines (IFN-γ) and downregulating Th2 cytokines (IL-4, IL-5, IL-13), thereby rebuilding the local immune homeostasis of the skin. This effect of immune homeostasis remodeling enables the traditional Chinese medicine composition of this application to treat urticaria at the level of the immune microenvironment, reduce the tendency of recurrence, and is particularly suitable for patients with chronic urticaria who need long-term maintenance therapy.

[0016] (3) The preparation method provided in this application adopts the traditional process of conventional soaking, double decoction, concentration and packaging, without involving organic solvent extraction or complex chemical processes, which further ensures the safety and mild characteristics of the final product. At the same time, the composition can be made into a variety of oral dosage forms such as granules, pills, tablets or oral liquids, which are convenient to administer and have high patient compliance. Attached Figure Description

[0017] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application.

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 Figure 1 shows the effect of the traditional Chinese medicine composition provided in Example 1 of this application on pathological damage and mast cell infiltration of skin tissue in mice with urticaria; A: HE-stained sections of skin tissue from mice in each group; Control: normal control group, Urt: OVA-induced urticaria model group, Form: traditional Chinese medicine administration group alone, Urt+Form: urticaria model + traditional Chinese medicine composition intervention group; Scale bar 200μm; B: Left: semi-quantitative scoring statistics of skin pathological damage; Right: statistics of mast cell count in the skin; Statistical markers: *P<0.05, **P<0.01, ***P<0.001, n=5.

[0020] Figure 2 A: Diagram showing the inhibition of Th2-type inflammatory factor expression in mouse skin by the traditional Chinese medicine composition provided in Example 1 of this application; A: Laser confocal fluorescence imaging; IL-4 labeled green fluorescence (Alexa Fluor 488), IL-13 labeled red fluorescence (Alexa Fluor 555), DAPI labeled cell nuclei in blue; four groups are grouped as follows. Figure 1 A: Scale bar 20 μm; Merge is a three-color superimposed field of view; B: Quantitative bar graph of average fluorescence intensity of IL-4 and IL-13 proteins; C: ELISA detection of mouse serum IgE content; D: qPCR detection of relative expression levels of IL-4, IL-5, and IL-13 mRNA in skin tissue; Statistical markers: *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001, n=5.

[0021] Figure 3 Figure 1 shows the upregulation of Th1-related factors and the reshaping of the Th1 / Th2 immune balance of the traditional Chinese medicine composition provided in Example 1 of this application; A: Laser confocal fluorescence imaging; IFN-γ labeled green fluorescence (Alexa Fluor 488); DAPI labeled cell nuclei in blue; four groups are grouped as shown in Figure 1, scale bar 20μm; Merge is the superimposed field of view; B: Quantitative bar graph of average fluorescence intensity of IFN-γ protein; C: qPCR detection of relative expression level of IFN-γ mRNA in skin tissue; Statistical markers: *P<0.05, **P<0.01, ***P<0.001, n=5; Figure 4 Venn diagram of the intersection targets of the traditional Chinese medicine composition provided in the embodiments of this application and the pathology of urticaria; Figure 5 This is a PPI interaction network topology diagram of the target of the traditional Chinese medicine composition for treating urticaria provided in the embodiments of this application; Figure 6 This is a KEGG pathway enrichment analysis diagram of the core target of the traditional Chinese medicine composition for treating urticaria provided in the embodiments of this application; Figure 7 This is a graph showing the enrichment analysis of the BP pathway at the core target of the traditional Chinese medicine composition for treating urticaria provided in the embodiments of this application. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0023] Unless otherwise specified, all raw materials, reagents, instruments and equipment used in this application can be purchased from the market or prepared by existing methods.

[0024] This application provides a traditional Chinese medicine composition for treating urticaria, which, by weight, is composed of the following traditional Chinese medicine raw materials: dried plum: 12-18 parts, licorice: 8-12 parts, Imperata cylindrica root: 12-18 parts, Smilax glabra: 8-12 parts, coix seed: 8-12 parts, Angelica dahurica: 8-12 parts, peppermint: 5-7 parts, Astragalus membranaceus: 5-7 parts, tangerine peel: 8-12 parts, and monk fruit: 8-12 parts.

[0025] In some embodiments, the traditional Chinese medicine composition is composed of the following traditional Chinese medicine raw materials in parts by weight: dried plum: 15 parts, licorice: 10 parts, Imperata cylindrica root: 15 parts, Smilax glabra: 10 parts, Coix seed: 10 parts, Angelica dahurica: 10 parts, peppermint: 6 parts, Astragalus membranaceus: 6 parts, tangerine peel: 10 parts, monk fruit: 10 parts.

[0026] Based on traditional Chinese medicine theory and long-term clinical experience, the above-mentioned Chinese herbal composition follows the principle of monarch, minister, assistant, and guide in drug formulation. To facilitate understanding of this application, the effects of the Chinese herbal raw materials are explained as follows: The principal herb is Astragalus membranaceus. Astragalus membranaceus is sweet and warm, and enters the spleen and lung meridians. It has the functions of tonifying qi and consolidating the exterior, and promoting tissue regeneration and detoxification. It is effective for chronic urticaria, which is caused by long-term illness and physical weakness, and the underlying pathogenesis of weak defense. It can improve the skin's susceptibility to external pathogens and the recurring rashes and itching by tonifying the body's vital energy and enhancing the skin's surface defense function. At the same time, its ability to promote tissue regeneration and detoxification helps to reduce skin lesions and promote the repair of damaged skin tissue, providing core support for the continuous conditioning effect of the whole formula.

[0027] The assistant herbs are: Smilax glabra, Imperata cylindrica root, and Coix seed. Smilax glabra is sweet, bland, and neutral, and is good at clearing damp-heat and toxic pathogens; Imperata cylindrica root is sweet and cold, and clears heat, cools the blood, and promotes urination; Coix seed strengthens the spleen, eliminates dampness, clears heat, and drains pus. The three herbs work together to address both damp-heat and heat toxicity. First, they clear the internal damp-heat; second, they reduce the erythema, edema, and inflammatory reactions caused by damp-heat stagnation in the skin, assisting the principal herb in expelling pathogens and ensuring that the pathogens have a way to leave.

[0028] The adjuvant herbs are: Angelica dahurica, Mentha haplocalyx, Citrus reticulata peel, and Prunus mume. Angelica dahurica is pungent and warm, dispelling wind, relieving itching, reducing swelling, and alleviating pain; Mentha haplocalyx is pungent and cool, dispelling wind and heat, and clearing the head and eyes. Together, they help relieve skin itching and local redness and swelling. Citrus reticulata peel regulates qi and strengthens the spleen, improving the spleen and stomach's digestive function and reducing dampness from the inside out; Prunus mume is sour and astringent, promoting fluid production and protecting the skin's surface, relieving symptoms such as dryness and tightness. The combination of these adjuvant herbs ensures that the heat is cleared without harming the body's vital energy, and the pathogens are dispelled without being overly drying, thus assisting the main formula in achieving its overall therapeutic effect. The guiding herbs are licorice root and monk fruit. Licorice root, being sweet and neutral, harmonizes the other herbs, alleviates urgency, and detoxifies, thus balancing the overall properties of the formula (warming, cooling, tonifying, purging) and enhancing medication safety. Monk fruit, being sweet and cooling, moistens dryness, soothes the throat, and improves taste, contributing to the palatability of oral preparations and patient compliance with long-term use. The combination of these two herbs results in a milder formula, making it convenient to take and beneficial for the long-term management of chronic urticaria.

[0029] Based on a general inventive concept, this application provides a pharmaceutical preparation made from the traditional Chinese medicine composition described above, wherein the pharmaceutical preparation is granules, pills, tablets or oral liquid.

[0030] It should be noted that this composition can be extracted, concentrated, spray-dried, granulated, made into pills, or made into dosage forms such as granules, pills, tablets, or oral liquids by adding pharmaceutically acceptable excipients, so as to facilitate long-term use or industrial production.

[0031] The pharmaceutical formulations described in this application are granules, pills, tablets, or oral liquids. Urticaria, especially chronic urticaria, requires long-term or even continuous medication, and oral dosage forms are the most convenient, resulting in high patient compliance. Granules, pills, and tablets are easy to carry and administer in measured doses, while oral liquids can be taken directly and are absorbed more quickly, meeting the medication habits of different populations. The diversity of dosage forms does not change the inherent compatibility of the composition and its core immunomodulatory function.

[0032] Based on a general inventive concept, this application provides a method for preparing the pharmaceutical preparation described above, the method comprising the following steps: S1. Take the prescribed amounts of dried plum, licorice, Imperata cylindrica root, Smilax glabra, Coix seed, Angelica dahurica, peppermint, Astragalus membranaceus, dried tangerine peel, and monk fruit, and soak them in water at room temperature for 30 minutes. S2. After soaking, bring the herbs to a boil over high heat, then reduce to a simmer for 30 minutes. S3. Filter out the first decoction, add water to the dregs again, and simmer over low heat for 20 minutes. S4. Filter out the dregs, combine the two decoctions, and concentrate or directly dispense into oral doses.

[0033] It should be noted that soaking at room temperature for 30 minutes allows the medicinal materials to fully absorb water, swell, and soften, which is beneficial for the dissolution of active ingredients during subsequent decoction. Too short a time will result in insufficient soaking, while too long a time may lead to the degradation of some heat-sensitive components or the growth of microorganisms. Bringing to a boil over high heat first, then reducing to a simmer is a common practice in traditional Chinese medicine decoction. High heat quickly raises the temperature, causing the cell walls of the medicinal materials to rupture, while a simmer maintains a gentle boil to prevent the liquid from boiling over and to prevent high temperatures from damaging volatile or heat-labile components in herbs such as astragalus and peppermint. The first decoction should be 30 minutes, and the second decoction... The 20-minute decoction time is based on a balance of dissolution kinetics of various active substances (such as flavonoids, polysaccharides, organic acids, and volatile oils) in the ten medicinal herbs. A longer first decoction time is conducive to the full release of most components, while a slightly shorter second decoction time can further extract residual effective components without over-boiling to produce a bitter taste or destroy the sweet substances in monk fruit and licorice. Combining the two decoctions not only improves the extraction rate but also ensures the taste and safety of the decoction. Finally, the decoction is concentrated or directly packaged into oral doses, which makes it convenient for patients to take the medicine in a fixed volume, thus achieving standardization and repeatability of drug administration.

[0034] Based on a general inventive concept, this application provides the use of the above-described traditional Chinese medicine composition in the preparation of an anti-urticaria drug with immune homeostasis remodeling function.

[0035] The traditional Chinese medicine composition provided in this application does not merely relieve the symptoms of wheals and itching, but rather corrects the Th1 / Th2 immune imbalance present in the pathological state of urticaria by downregulating Th2 cytokines (IL-4, IL-5, IL-13) and upregulating Th1 cytokine IFN-γ, thereby rebuilding the local immune homeostasis of the skin. This immune homeostasis remodeling encompasses a bidirectional regulatory effect, promoting Th1 immune defense and inhibiting overactivated Th2 inflammatory responses. This bidirectional regulatory capacity is difficult to achieve with existing antihistamines or conventional traditional Chinese medicine compound formulas.

[0036] In some embodiments, the urticaria is chronic urticaria.

[0037] Chronic diseases are often accompanied by persistent immune disorders and recurrent flare-ups, making the need for long-term safe medication more urgent. The drug composition of this application is mild in nature and has no serious toxic side effects, making it particularly suitable for long-term maintenance therapy for chronic patients.

[0038] In some embodiments, the immune homeostasis remodeling includes: reducing the expression levels of Th2 cytokines IL-4, IL-5, and IL-13 while increasing the expression level of Th1 cytokine IFN-γ.

[0039] The present application is further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the application. Experimental methods in the following embodiments that do not specify specific conditions are generally determined according to industry standards. If there is no corresponding industry standard, then common international standards, conventional conditions, or conditions recommended by the manufacturer are followed.

[0040] Example 1: Preparation of a Traditional Chinese Medicine Composition for Treating Urticaria 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-mentioned medicinal materials according to the specified proportions. Use a clay pot, add water, and cover the medicinal materials with approximately 5 cm of water. 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 approximately 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 anti-urticaria traditional Chinese medicine composition. The decocted liquid can be refrigerated and should not be kept for more than 2 days. The traditional Chinese medicine composition of Example 1 can be abbreviated as Form.

[0041] Example 2: Establishment of a mouse model of urticaria and experimental grouping Experimental materials: BALB / c mice, OVA, aluminum hydroxide adjuvant, 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 feed and water. They were randomly divided into four groups according to body weight: a normal control group, a Urt model group, a traditional Chinese medicine (TCM) treatment group (Form group), and a model treatment group, with five mice in each group. One day before the experiment, the hair on the backs of the mice was shaved off in areas approximately 2.5 cm × 2.5 cm in size until fully exposed. To ensure effectiveness, depilatory cream was applied to the exposed skin to remove the hair completely. On day 1 after hair removal, the Urt model group and the model treatment group were sensitized by intraperitoneal injection of 200 μL of a mixture of 100 μg OVA and 4 mg aluminum hydroxide adjuvant. From day 21 to day 26, the Urt model group and the model treatment group were challenged by subcutaneous injection of 200 μL of the same mixture once daily. Mice in the normal control group and the group receiving only traditional Chinese medicine were subcutaneously injected with 200 μL of PBS at the hair-removed areas on their backs. On the 6th day after sensitization, each treatment group began receiving the corresponding drug via gavage. The normal control group and the model group were given distilled water under the same conditions. The treatment was administered once daily for 21 consecutive days. One hour after the last administration, the mice were enucleated to collect blood, and the serum was collected by centrifugation. The mice were then euthanized, and the skin from their backs was harvested.

[0042] After modeling, the mice in the Urt model group showed obvious raised wheal-like changes in the local skin and obvious pruritus-related behavioral changes, indicating that the OVA-induced urticaria model was successfully established.

[0043] Example 3: Effects of the traditional Chinese medicine composition of Example 1 on the histopathological changes of skin tissue in mice with urticaria. Experimental materials: Paraffin sections of mouse skin tissue; Hematoxylin and eosin (H&E) staining kit (Catalog No.: G1120, Beijing Solarbio Science & Technology Co., Ltd.); Toluidine blue staining kit (Catalog No.: C0105 Beyotime); Automated multispectral scanning microscopy system (VS200, Olympus).

[0044] 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 soaking 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. Place 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.

[0045] Toluidine blue staining: Dewax paraffin sections in xylene for 5-10 min, then in anhydrous ethanol for 5 min, 90% ethanol for 2 min, 80% ethanol for 2 min, 70% ethanol for 2 min, and distilled water for 2 min. Use a Liquid Blocker Super PAP Pen immunohistochemistry pen to circle the tissue. Add 50 μL of toluidine blue staining solution to each section to completely cover the tissue and stain for 5-10 min. Remove the staining solution and rinse with tap water for about 5 min to remove excess staining solution. Differentiate with differentiation solution for about 2-5 seconds, then rinse with tap water for 5 min. Immerse the sections sequentially in 70% ethanol for 10 seconds, 80% ethanol for 10 seconds, 90% ethanol for 10 seconds, and anhydrous ethanol for 10 seconds. Clear through xylene for 5 min, replace with fresh xylene, clear again for 5 min, and then mount with neutral resin on a glass slide.

[0046] Experimental results: such as Figure 1As shown in Figure A, HE staining results revealed that the normal control group had intact skin tissue structure, uniform epidermal thickness, clear dermal structure, and less inflammatory cell infiltration. Compared with the normal control group, the Urt model group showed significant edema in the superficial dermis, local vasodilation with congestion, and perivascular inflammatory cell infiltration. The overall structure of the epidermis and dermis remained largely intact, indicating a significant urticarial inflammatory response. The skin tissue structure of the single-drug group was similar to that of the normal control group, with no obvious abnormal pathological changes observed. Compared with the Urt model group, the pathological damage to the skin tissue in the model-drug group was reduced, and inflammatory cell infiltration was improved, indicating that the herbal composition in Example 1 can alleviate skin tissue damage caused by urticaria. Toluidine blue staining results showed that the normal control group had fewer mast cells in its skin tissue, which were more dispersed. The Urt model group had a significantly increased number of mast cells, which showed an aggregated distribution. The number of mast cells in the skin tissue of the single-drug group was similar to that of the normal control group. The number of mast cells in the Urt model treatment group was reduced and the degree of aggregation was decreased compared with that in the model group, indicating that the traditional Chinese medicine composition of this application has an ameliorative effect on the abnormal increase of mast cells in the urticaria model. Figure 1 The quantitative analysis of B's ​​histopathological damage score and mast cell count was consistent with the above results.

[0047] This experiment included a single Chinese medicine administration group (Form group), in which normal mice were continuously given the same dose of the Chinese medicine composition. No abnormal changes were observed in the skin histopathology or mast cell infiltration of the mice, confirming that the Chinese medicine composition has no skin toxicity within the dosage range and has good safety. This provides a safety test basis for the long-term oral treatment of chronic urticaria with this compound.

[0048] Example 4: Inhibitory effect of the traditional Chinese medicine composition of Example 1 on Th2 type immune response in the skin tissue of mice with urticaria. Experimental materials: IgE detection ELISA kit, TRIzol (RNA extraction reagent); SYBR GreenMaster Mix (SYBR Green premix, ThermoFisherScientific, Waltham, MA, USA); fully automated multispectral scanning microscopy system (VS200, Olympus); IL-4 and IL-13 specific primary antibodies, corresponding fluorescent secondary antibodies, and DAPI nuclear dye.

[0049] Experimental methods: ELISA (Serum IgE Detection): Collect mouse serum in sterile tubes. Allow the blood to clot naturally at room temperature for 120 min. Centrifuge at 2–8°C for 20 min (3000 rpm). Carefully collect the supernatant for detection. Remove the required strips from the foil pouch after equilibration at room temperature for 20 min. Seal the remaining strips in a resealable bag and return to 4°C. Set up standard and sample wells. Add 50 μL of different concentrations of standard to each standard well. Add 10 μL of the sample to be tested to each sample well, followed by 40 μL of sample diluent. Do not add any to the blank wells. Except for the blank wells, add 100 μL of horseradish peroxidase (HRP)-labeled detection antibody to each standard and sample well. Seal the reaction wells with sealing film and incubate at 37°C for 60 min. Discard the liquid, pat dry on absorbent paper, fill each well with washing buffer, let stand for 1 min, 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 IgE concentration of each sample according to the curve equation.

[0050] RNA extraction and RT-PCR steps: RNA extraction: Weigh 20 mg of skin tissue, wash with cold PBS, mince, and place in a 1.5 mL centrifuge tube. Add 1 mL of TRIzol reagent and homogenize at 12000 rpm for 10 min. Collect the supernatant, add 200 μL of chloroform, incubate for 5 min, and then centrifuge at 12000 rpm for 10 min. Mix the supernatant with 600 μL of isopropanol, incubate at -20℃ for 15 min, and centrifuge again. Discard the supernatant, wash the RNA precipitate with 1 mL of 70% ethanol, dry, and resuspend in 20 μL of DEPC water. Quantify the RNA concentration and purity using Nanodrop.

[0051] Reverse transcription: 2 μg RNA was mixed with 5×gDNAEraser buffer and gDNAEraser, and incubated at 42°C for 2 min to remove genomic DNA. Then the remaining components of the reverse transcription system were added, and the mixture was incubated at 37°C for 15 min, followed by incubation at 85°C for 5 seconds to terminate the reaction, synthesizing cDNA. The cDNA was stored at -20°C for later use.

[0052] Real-time quantitative PCR: A 20 μL reaction mixture was prepared, consisting of 2 μL cDNA, 5 μL SYBR Green Master Mix, 0.5 μL each of forward and reverse primers for IL-4 / IL-5 / IL-13, and 2 μL RNase-free water. Amplification was performed using an Applied Biosystems TMViiA TM7 instrument. The program was: 50℃ for 2 min, 95℃ for 2 min; 40 amplification cycles (95℃ for 15 s, 60℃ for 1 min); melting curve phase: 95℃ for 15 s, 60℃ for 1 min. The relative mRNA expression levels of IL-4, IL-5, and IL-13 in each group were detected.

[0053] Immunofluorescence (IL-4 and IL-13 protein localization and quantification) Skin paraffin sections were baked in a 67°C oven for 120 min to enhance tissue adhesion. They were then dewaxed by sequentially immersing in xylene I and xylene II for 10 min each; hydrated in a gradient of anhydrous ethanol, 95% ethanol, and 80% ethanol for 5 min each; and rinsed with distilled water / PBS. The sections were then immersed in sodium citrate antigen retrieval buffer, boiled in an autoclave for 2 min, and allowed to cool naturally to room temperature; washed three times with PBS for 5 min each time. Permeabilization was performed with PBS containing 0.1% Triton X-100 for 10 min, followed by PBS washing; and then blocked with blocking buffer at room temperature for 60 min.

[0054] Remove the blocking solution. Dilute the IL-4 and IL-13 primary antibodies 1:200 with antibody dilution buffer and incubate overnight at 4°C in a humidified chamber. Wash three times with PBS to remove free primary antibodies. Match the host species and add the corresponding fluorescent secondary antibodies: IL-4 paired with Alexa Fluor 488 (green fluorescence) and IL-13 paired with Alexa Fluor 555 (red fluorescence), incubate at room temperature in the dark for 60 min. Wash three times with PBS for 5 min each time, in the dark. Add DAPI to stain the nuclei and incubate at room temperature in the dark for 10 min. Rinse 2-3 times with PBS in the dark. Wipe away excess liquid, mount with anti-fluorescence quenching mounting medium, and image using a laser confocal microscope. Simultaneously collect fluorescence intensity values ​​for statistical analysis. Store the mounted sections at 4°C in the dark.

[0055] Experimental Results: To evaluate the regulatory effect of the traditional Chinese medicine composition of Example 1 on the Th2 inflammatory pathway in the pathological process of urticaria, this example simultaneously detected the serum allergy marker IgE, the protein levels of Th2 characteristic cytokines IL-4 and IL-13 in skin tissue, and the mRNA expression levels of IL-4, IL-5, and IL-13 in model mice.

[0056] like Figure 2As shown by laser confocal imaging, the intensity of IL-4 green fluorescence and IL-13 red fluorescence in the skin of mice in the OVA-induced urticaria model group (Urt) was significantly higher than that in the normal control group (Control). Figure 2 B. Quantitative fluorescence statistics confirmed that the average fluorescence intensity of IL-4 and IL-13 in the model group increased significantly; Figure 2 Serum ELISA results showed that the IgE content in the model group was significantly increased, indicating that a severe Th2-type allergic immune response occurred in the local skin of the model mice.

[0057] After intervention with the traditional Chinese medicine composition of Example 1 (Urt+Form group), compared with the Urt model group, the expression of skin IL-4 and IL-13 fluorescent proteins was significantly reduced. Figure 2 A, 2B); Serum IgE concentration decreased significantly ( Figure 2 C); Figure 2 DqPCR results showed a significant downregulation of the relative expression levels of IL-4, IL-5, and IL-13 mRNA in the skin. No significant abnormal increase was observed in the Form group treated alone.

[0058] The above multi-dimensional data confirms that the traditional Chinese medicine composition in Example 1 can effectively inhibit the Th2-type inflammatory cascade response in the process of urticaria, downregulate the release of IgE and allergic inflammatory factors such as IL-4, IL-5, and IL-13, and reduce skin allergic inflammation at the immune molecular level. This is the core pharmacological mechanism by which it rapidly relieves the redness, swelling, and itching symptoms of urticaria, demonstrating that the traditional Chinese medicine composition has excellent activity and application value in the treatment of allergic skin diseases.

[0059] Example 5: The traditional Chinese medicine composition of Example 1 exerts a therapeutic effect on urticaria by regulating the Th1 / Th2 immune imbalance, enhancing the level of Th1-type immunity, and inhibiting excessive inflammation. Experimental materials: TRIzol (RNA extraction reagent); SYBR Green Master Mix (SYBR Green premix, ThermoFisherScientific, Waltham, MA, USA); fully automated laser confocal scanning microscopy system; IFN-γ primary antibody, corresponding fluorescent secondary antibody, DAPI cell nuclear staining solution.

[0060] Experimental methods: RNA extraction and RT-PCR steps: RNA extraction: Weigh 20 mg of skin tissue, wash with cold PBS, mince, and place in a 1.5 mL centrifuge tube. Add 1 mL of TRIzol reagent and homogenize at 12000 rpm for 10 min. Collect the supernatant, add 200 μL of chloroform, incubate for 5 min, and then centrifuge at 12000 rpm for 10 min. Mix the supernatant with 600 μL of isopropanol, incubate at -20℃ for 15 min, and centrifuge again. Discard the supernatant, wash the RNA precipitate with 1 mL of 70% ethanol, dry, and resuspend in 20 μL of DEPC water. Quantify the RNA concentration using Nanodrop.

[0061] Reverse transcription: 2 μg RNA was mixed with 5×gDNA Eraser buffer and gDNA Eraser, and incubated at 42°C for 2 min to remove genomic DNA. The remaining reverse transcription components were then added, and the mixture was incubated at 37°C for 15 min, followed by incubation at 85°C for 5 sec to complete cDNA synthesis. The cDNA was stored at -20°C for later use.

[0062] Real-time quantitative PCR: The reaction mixture consisted of 2 μL cDNA, 5 μL SYBR Green Master Mix, 0.5 μL each of IFN-γ specific forward and reverse primers, and 2 μL RNase-free water. Amplification was performed using an Applied Biosystems TMViiA™7 system under the following conditions: 50℃ for 2 min, 95℃ for 2 min; 40 amplification cycles (95℃ for 15 s, 60℃ for 1 min); melting curves were collected at the final stage at 95℃ for 15 s and 60℃ for 1 min to detect the relative expression level of IFN-γ mRNA.

[0063] Immunofluorescence: Skin paraffin sections were baked in a 67°C oven for 120 min to improve tissue adhesion stability. They were then thoroughly dewaxed by immersion in xylene I and xylene II for 10 min each; hydrated in a gradient of anhydrous ethanol, 95% ethanol, and 80% ethanol for 5 min each; and rinsed with distilled water and PBS until completely hydrated. The sections were then immersed in sodium citrate antigen retrieval buffer, boiled in an autoclave for 2 min, and allowed to cool naturally to room temperature; washed three times with PBS for 5 min each time. Permeabilization was performed with PBS containing 0.1% Triton X-100 for 10 min, followed by three thorough PBS washes; the liquid was aspirated, and the sections were blocked with blocking buffer at room temperature for 60 min.

[0064] Remove the blocking solution. Dilute the primary antibody (IFN-γ) with antibody dilution buffer and incubate overnight in a humidified chamber at 4°C. Wash three times with PBS to remove unbound primary antibody. Add the fluorescent secondary antibody (IFN-γ paired with Alexa Fluor 488 (green fluorescence)) to match the host species and incubate at room temperature in the dark for 60 min. Wash three times with PBS for 5 min each time, in the dark. Add DAPI nuclear dye and incubate at room temperature in the dark for 10 min. Rinse 2-3 times with PBS in the dark. Wipe away excess liquid from the slides, add anti-fluorescence quenching mounting medium, and mount the slides. Image and photograph using a laser confocal microscope. Store the mounted slides at 4°C in the dark.

[0065] Experimental results: Immunofluorescence imaging results ( Figure 3 A) Quantitative fluorescence statistics ( Figure 3 B) and transcriptional level qPCR detection ( Figure 3 C) Jointly revealing the regulatory effects of traditional Chinese medicine composition on the immune imbalance in the OVA-induced urticaria model: IFN-γ (Th1 marker factor, green fluorescence): Compared with the normal control group, the IFN-γ fluorescence intensity and mRNA expression level in the Urt urticaria model group were significantly decreased, indicating that Th1 immune function was significantly suppressed under the pathology of urticaria; the IFN-γ level in the Form-only treatment group was slightly higher than that in the control group; the IFN-γ protein fluorescence intensity and mRNA expression level in the Urt+Form treatment intervention group were significantly increased compared with the Urt model group, significantly reversing the downregulation of Th1 factors caused by the model.

[0066] Overall trend: The urticaria model showed a significant immune imbalance with suppressed Th1 response and overactive Th2 response; after intervention with this traditional Chinese medicine composition, IFN-γ expression was significantly restored, effectively raising the Th1 immune level and correcting the Th1 / Th2 imbalance.

[0067] The above results indicate that the traditional Chinese medicine composition can effectively regulate the disordered Th1 / Th2 immune balance in urticaria: by upregulating IFN-γ to restore the suppressed Th1 immune response, counteracting the overactivated Th2 allergic reaction, and correcting immune imbalance, it can alleviate the skin allergy and inflammatory damage caused by urticaria. This provides sufficient experimental data to support the use of this composition in treating urticaria and regulating the immune internal environment of allergic reactions.

[0068] Example 6: Systemic intervention mechanism of the traditional Chinese medicine composition of this application on urticaria 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.

[0069] Database Source: The active ingredients and their targets in traditional Chinese medicine are compiled from public databases and literature. The genes related to urticaria 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: By searching public databases and literature, the main active ingredients of the aforementioned 10 traditional Chinese medicines were obtained, and 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 "urticaria" as the keyword, relevant genes were searched in disease-related databases, and a set of disease-related targets was obtained by screening and organizing them, removing duplicate values. Intersection analysis of the traditional Chinese medicine composition targets and urticaria-related genes was performed using R language to screen common targets. Based on the above two gene sets, Venn diagrams were drawn using the ggVennDiagram tool to visually demonstrate the overlap between the traditional Chinese medicine composition targets and urticaria-related genes.

[0070] Experimental results: To elucidate the scientific compatibility logic of the formulation in this application, this study employed network pharmacology methods for systematic analysis. For example... Figure 4 As shown, there are 202 direct intersection target PPI network protein interactions between the active ingredients of the ten medicinal materials in this application and the pathological targets of urticaria. Figure 5 Analysis shows that these intersecting targets have extremely high connectivity in the network, forming a robust synergistic cluster centered on IL-4, IFN-γ, and TNF-α. This high degree of topological connectivity confirms that the various medicinal materials in this formula are not simply a superposition of functions, but rather work together on specific molecular regulatory modules, forming a system that synergistically intervenes in the pathological network of urticaria. Figure 6 KEGG pathway multi-target intervention, pathway enrichment analysis showed that core targets were significantly enriched in T cell differentiation, cytokine-receptor interactions, and inflammatory signaling pathways. Figure 7 It is known that the biological processes of the core target are mainly enriched in related pathways such as leukocyte migration, inflammatory signal cascade regulation, immune response, and protein phosphorylation modification. This indicates that this compound can regulate immune cell infiltration, inhibit excessive local inflammatory response in the skin, correct abnormal immune signal transduction, bidirectionally regulate the secretion of Th1 / Th2 cytokines, and reshape disordered immune homeostasis. It can synergistically block the allergic pathological process of urticaria from multiple biological links, providing a theoretical support at the biological functional level for the mechanism of action of this traditional Chinese medicine composition in treating chronic urticaria and reducing the recurrence rate.

[0071] Based on the aforementioned network intervention logic, this embodiment first evaluated the inhibitory effect of the traditional Chinese medicine composition on Th2-type inflammation. Experimental results showed that in an OVA-induced urticaria model, the expression levels of Th2-type pro-inflammatory factors mRNAs such as IL-4 and IL-13 in the skin of mice in the model group were significantly higher than those in the normal group. After intervention with the traditional Chinese medicine composition, the expression levels of these factors were significantly downregulated compared to the model group, confirming that this formula can precisely block the pathological process of allergic inflammation.

[0072] Further research revealed that the expression of Th1 cytokines (IFN-γ and IL-2) in the skin of urticaria model mice was suppressed, exhibiting an immune imbalance of "Th2 hyperactivity-Th1 inhibition." After intervention with the traditional Chinese medicine composition, the mRNA expression levels of IFN-γ and IL-2 significantly rebounded compared to the model group. This result confirms the "bidirectional regulatory" ability predicted by network pharmacology at the molecular level: that is, this formula actively repairs the damaged Th1 immune surveillance function while downregulating pro-inflammatory Th2 factors.

[0073] Network pharmacology enrichment results suggest that the core targets of this compound are concentrated in signaling pathways related to T cell differentiation and Th1 / Th2 immune balance regulation. This is consistent with the mechanism of action confirmed by in vivo animal experiments, which involves "downregulating Th2-type inflammatory factors such as IL-4, IL-5, and IL-13 and upregulating IFN-γ to reshape immune homeostasis." This explains the scientific mechanism of this compound's multi-component, multi-target treatment of chronic urticaria from a bioinformatics perspective, and further corroborates the technical efficacy of the invention in pharmaceutical applications.

[0074] In summary, this application has the following advantages: (1) Deep immune homeostasis bidirectional regulation to improve the root cause of recurrence: Unlike antihistamines that only passively suppress itchy wheals, this compound achieves bidirectional balance reshaping of Th1 / Th2: significantly downregulates the overactive Th2 inflammatory factors IL-4, IL-5, and IL-13, and simultaneously restores the Th1 marker factor IFN-γ that is suppressed by urticaria, thus rebuilding the skin's immune surveillance ability; relying on the synergistic effect of multiple medicinal materials to regulate the T cell differentiation pathway, it alleviates the clinical shortcomings of traditional therapies such as easy recurrence and impaired immune surveillance from the level of immune microenvironment.

[0075] (2) Quickly relieves typical symptoms of urticaria: It can effectively improve various clinical manifestations caused by urticaria, such as wheals, severe itching, local redness and swelling, skin lesions, and dry skin, and has a clear immediate symptomatic effect.

[0076] (3) Suitable for chronic and recurrent urticaria: The whole formula has mild properties, no strong irritating medicinal materials, low toxicity and side effects, and supports long-term continuous oral administration, which meets the treatment needs of patients with chronic persistent urticaria who need long-term stability and reduced recurrence frequency.

[0077] (4) High safety of medication and suitable for long-term use: The combination of medicinal materials is mild and the risk of toxic side effects is small. Unlike some Western medicines, which have problems such as tolerance, drowsiness and organ burden when used for a long time, this medicine can be used for long-term maintenance treatment.

[0078] (5) Convenient administration, flexible formulation, and improved compliance: Supports multiple oral dosage forms such as granules, pills, tablets, and oral liquids; can be taken in a fixed amount for convenient carrying, or can be absorbed quickly as an oral liquid, adapting to the medication habits of different groups of people, and the oral operation is simple.

[0079] (6) The medicinal materials are readily available, the supply is stable, and it is easy to promote industrialization: all raw materials are common Chinese medicinal materials used in clinical practice, the market has sufficient and stable sources of medicinal materials, and there are no rare or precious medicinal materials; there are no expensive or rare medicinal materials, the raw material procurement cost is controllable and cost-effective; the preparation only adopts conventional soaking, double decoction, concentration and packaging process, the process is mature and traditional, no need for complex and high-end equipment, it is easy to establish a standardized production line, and it is suitable for large-scale industrial production.

[0080] Various embodiments of this application may exist in the form of a range; it should be understood that the description in the form of a range is merely for convenience and brevity and should not be construed as a hard limitation on the scope of this application; therefore, it should be considered that the range description has specifically disclosed all possible sub-ranges and single numerical values ​​within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Furthermore, whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the referred range.

[0081] The above description is merely a specific embodiment of this application, enabling those skilled in the art to understand or implement this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A traditional Chinese medicine composition for treating urticaria, characterized in that, The traditional Chinese medicine composition is composed of the following traditional Chinese medicine raw materials in parts by weight: smoked plum: 12 - 18 parts, liquorice root: 8 - 12 parts, lanceolate leaf of imperata: 12 - 18 parts, glabrous greenbrier rhizome: 8 - 12 parts, coix seed: 8 - 12 parts, dahurian angelica root: 8 - 12 parts, mint: 5 - 7 parts, astragalus root: 5 - 7 parts, dried tangerine peel: 8 - 12 parts, monk fruit: 8 - 12 parts.

2. The traditional Chinese medicine composition for treating urticaria according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following traditional Chinese medicine raw materials in parts by weight: smoked plum: 15 parts, liquorice root: 10 parts, lanceolate leaf of imperata: 15 parts, glabrous greenbrier rhizome: 10 parts, coix seed: 10 parts, dahurian angelica root: 10 parts, mint: 6 parts, astragalus root: 6 parts, dried tangerine peel: 10 parts, monk fruit: 10 parts.

3. A pharmaceutical preparation prepared from the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The pharmaceutical preparation is a granule, pill, tablet or oral liquid.

4. A method for preparing the pharmaceutical formulation as described in claim 3, characterized in that, The method comprises the following steps: S1. Take the formula amount of smoked plum, liquorice root, lanceolate leaf of imperata, glabrous greenbrier rhizome, coix seed, dahurian angelica root, mint, astragalus root, dried tangerine peel and monk fruit, and soak them in water at room temperature for 30 min; S2. First boil the soaked medicinal materials with strong fire, and then turn to slow fire for the first decoction, and the decoction time is 30 min; S3. Filter out the first decoction liquid, add water to the medicinal residues again, and decoct with slow fire for the second time, and the decoction time is 20 min; S4. Filter out the medicinal residues, combine the two decoction liquids, and concentrate or directly subpackage them into oral doses.

5. Use of the traditional Chinese medicine composition according to claim 1 or 2 in preparing an anti - urticaria drug with the function of immune homeostasis remodeling.

6. The application according to claim 5, characterized in that, The urticaria is chronic urticaria.

7. The application according to claim 5, characterized in that, The immune homeostasis remodeling includes: reducing the expression levels of Th2 - type cytokines IL - 4, IL - 5, IL - 13, and simultaneously increasing the expression level of Th1 - type cytokine IFN - γ.

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