An anti-inflammatory and anti-allergic traditional Chinese medicine composition, a preparation method thereof and application thereof

Abstract

The application provides an anti-inflammatory and anti-allergic traditional Chinese medicine composition and a preparation method and application thereof. The medicine composition is composed of eleven traditional Chinese medicines, including Semen Xanthii, Magnolia, Radix Angelicae Dahuricae, Herba Menthae, Herba Eupatorium Fortunei, Herba Schizonepetae, Perilla Leaf, Lonicera Japonica, Rhizoma Chuanxiong, Radix Asparagi and Borneolum Syntheticum. The above-mentioned eleven medicinal materials can be decocted with water or directly mixed into fine powder or ground into fine powder to prepare corresponding medicine preparations. The obtained medicine composition has anti-inflammatory and anti-allergic effects and can be used for treating allergic rhinitis (AR). Network pharmacology and molecular docking technology provide a train of thought for the research and development of a new medicine for treating AR and provide sufficient theoretical basis for treating AR by using the Xiang' e Zi Powder in the clinic.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to an anti-inflammatory and anti-allergic traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] Allergic rhinitis (AR), also known as allergic rhinitis, is a non-infectious chronic inflammatory disease of the nasal mucosa that occurs in atopic individuals after exposure to allergens (allergens) and is mainly mediated by immunoglobulin E (IgE). It is an allergic disease that occurs on the nasal mucosa. Allergic rhinitis (AR) is characterized by nasal itching, sneezing, clear nasal discharge, and nasal mucosal edema. Some patients with significant nasal mucosal swelling experience a decreased sense of smell. The "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022, Revised Edition)" (hereinafter referred to as the "Guidelines") points out that the current clinical treatment of AR is mainly medical treatment, supplemented by surgical treatment. Commonly used first-line drugs include nasal corticosteroids, (oral / nasal) antihistamines, and leukotriene receptor antagonists. Second-line drugs include oral corticosteroids, (oral / nasal) mast cell membrane stabilizers, and anticholinergic drugs. Surgical treatment of AR is an adjunct therapy and should be used as appropriate. Surgical procedures mainly include two types: inferior turbinate reconstruction and septoplasty, and nerve resection. Regarding Western medicine treatment of allergic rhinitis (AR), the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022, Revised Edition)" points out that surgical treatment has many complications and is often used as an adjunct therapy. In terms of internal medicine treatment, the clinical efficacy of Western medicine is not ideal and has many complications. Prolonged use of medications also carries the risk of developing drug-induced rhinitis, such as rebound nasal congestion and mucosal congestion and swelling after discontinuation of nasal decongestants, which further aggravates rhinitis symptoms. Oral antihistamines can cause adverse reactions such as central sedation, headache, urinary retention, and mucosal dryness. In recent years, the role of traditional Chinese medicine in the treatment of allergic rhinitis has been increasingly recognized. Traditional Chinese medicine exerts its therapeutic effects through multi-pathway and multi-target regulation, while reducing side effects and complications, resulting in outstanding efficacy and improved prognosis. Xanthium sibiricum powder is a classic formula commonly used in clinical practice for allergic rhinitis and sinusitis. It originates from Volume 5 of *Jisheng Fang*: "Magnolia biondii seed half a liang, Xanthium sibiricum seed two and a half qian, Angelica dahurica one liang, Mentha haplocalyx leaf half a qian. Dry in the sun, grind into a fine powder. Take two qian each time, after meals, mixed with scallion and tea." Its effects include: dispelling wind and relieving pain, clearing nasal passages; its main indications are: sinusitis, persistent nasal discharge of thick, turbid nasal mucus. The original formula was used for sinusitis caused by wind-evil attacking upwards, but as a basic formula, its age makes it difficult to adapt to the symptoms and signs of modern patients. This formula, often modified with added ingredients, is used clinically to treat acute and chronic rhinitis, allergic rhinitis, sinusitis, and postnasal drip syndrome. Based on years of relevant clinical experience and modern pharmacological research, it has been redesigned into a modified Xanthium sibiricum powder (JJCEZS). Clinical practice has shown promising therapeutic effects. However, to further validate its formulation and actual therapeutic efficacy, network pharmacology, molecular docking technology, and animal experiments will be used to demonstrate and elucidate its actual effects and mechanisms of action. This provides a broadly applicable, highly effective, and safe treatment approach for allergic rhinitis.

[0003] Therefore, the present invention aims to study a traditional Chinese medicine composition for anti-inflammatory and anti-allergic purposes, which mainly consists of the following traditional Chinese medicine ingredients: Xanthium sibiricum, Magnolia officinalis, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, Asparagus cochinchinensis, and Borneol, where:

[0004] Mentha haplocalyx is pungent and cool in nature. It pertains to the lung and liver meridians. It disperses wind-heat, clears the head and eyes, relieves sore throat, promotes eruption, and soothes the liver and regulates qi. It is used for wind-heat cold, the initial stage of wind-warm disease, headache, red eyes, sore throat, mouth ulcers, rubella, measles, and distension and fullness in the chest and hypochondrium.

[0005] Angelica dahurica is pungent and warm in nature. It pertains to the stomach, large intestine, and lung meridians. It relieves exterior cold, dispels wind and alleviates pain, promotes nasal passage, dries dampness and stops leukorrhea, and reduces swelling and discharges pus. It is used for common cold headache, pain in the supraorbital bone, nasal congestion and running nose, allergic rhinitis, nasal sinusitis, toothache, leukorrhea, and swelling and pain of sores and ulcers.

[0006] Xanthium sibiricum is pungent, bitter, and warm in nature; it is toxic. It pertains to the lung meridian. It disperses wind-cold, opens nasal passages, and dispels wind-dampness. It is used for wind-cold headache, nasal congestion and running nose, allergic rhinitis, nasal sinusitis, rubella itching, and contracture and pain of damp arthralgia.

[0007] Magnolia officinalis is pungent and warm in nature. It pertains to the lung and stomach meridians. It disperses wind-cold and opens nasal passages. It is used for wind-cold headache, nasal congestion and running nose, allergic rhinitis, and nasal sinusitis. Dosage: 3 - 10 g, decocted in a covered container. For external use, an appropriate amount can be used.

[0008] Centipeda minima is pungent and warm in nature. It pertains to the lung meridian. It disperses wind-cold, opens nasal passages, and relieves cough. It is used for wind-cold headache, cough with profuse phlegm, nasal congestion and obstruction, and nasal sinusitis with running nose.

[0009] Schizonepeta tenuifolia is pungent and slightly warm in nature. It pertains to the lung and liver meridians. It relieves exterior wind, promotes eruption, and eliminates carbuncles. It is used for common cold, headache, measles, rubella, and the initial stage of sores and ulcers.

[0010] Lonicera japonica is sweet and cold in nature. It pertains to the lung, heart, and stomach meridians. It clears heat and detoxifies, and disperses wind-heat. It is used for carbuncles, boils, and furuncles, sore throat, erysipelas, dysentery with heat-toxin, wind-heat cold, and fever of warm diseases.

[0011] Natural Borneol is pungent, bitter, and cool in nature. It pertains to the heart, spleen, and lung meridians. It opens the mind and awakens the spirit, clears heat and alleviates pain. It is used for coma due to febrile disease, convulsion, syncope due to phlegm in stroke, sudden syncope due to qi stagnation, syncope due to pestilence, angina pectoris, red eyes, mouth ulcers, sore throat, and suppuration in the ear canal.

[0012] Synthetic Borneol is pungent, bitter, and slightly cold in nature. It pertains to the heart, spleen, and lung meridians. It opens the mind and awakens the spirit, clears heat and alleviates pain. It is used for coma due to febrile disease, convulsion, syncope due to phlegm in stroke, sudden syncope due to qi stagnation, syncope due to pestilence, angina pectoris, red eyes, mouth ulcers, sore throat, and suppuration in the ear canal.

[0013] Borneol Syntheticum is pungent, bitter, and slightly cold in nature. It pertains to the heart, spleen, and lung meridians. It opens the mind and awakens the spirit, clears heat and alleviates pain. It is used for coma and convulsion due to febrile disease, syncope due to phlegm in stroke, sudden syncope due to qi stagnation, syncope due to pestilence, red eyes, mouth ulcers, sore throat, and suppuration in the ear canal.

[0014] Chuanxiong (Ligusticum striatum) is pungent and warm. It enters the liver, gallbladder, and pericardium meridians. It invigorates blood circulation, promotes qi circulation, dispels wind, and relieves pain. It is used for chest pain, stabbing pain in the chest and ribs, swelling and pain from falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal masses and pain, headache, and rheumatic pain.

[0015] Perilla leaves are pungent and warm in nature. They enter the lung and spleen meridians. They relieve exterior syndromes and dispel cold, regulate qi and harmonize the stomach. They are used for common cold due to wind-cold, cough and nausea, vomiting during pregnancy, and fish and crab poisoning.

[0016] Asparagus root is sweet, bitter, and cold in nature. It enters the lung and kidney meridians. It nourishes yin and moistens dryness, clears the lungs and generates fluids. It is used for dry cough due to lung dryness, persistent cough with sticky phlegm, soreness and pain in the lower back and knees, steaming fever, internal heat and thirst, heat-related illness with fluid depletion, dry throat and thirst, and constipation due to intestinal dryness.

[0017] This formula uses Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Centipeda minima to dispel wind-cold and open the nasal passages. The assistant herbs are Schizonepeta tenuifolia, Ligusticum chuanxiong, and Perilla frutescens, which invigorate blood and qi and enhance the dispelling and opening-of-the-passage effects of the principal herbs. The principal and assistant herbs work together to dispel pathogens and open the nasal passages. The formula also includes Lonicera japonica, Asparagus cochinchinensis, and Mentha haplocalyx, which are cooling herbs that counteract the pungent and hot properties of the principal and assistant herbs, while also possessing yin-nourishing and detoxifying properties. This prevents the principal and assistant herbs from dispersing excessively and also works synergistically to open the nasal passages. Borneol is used as the guiding herb to enhance the opening-of-the-passage effects of the principal and assistant herbs and to assist the cooling properties of the assistant herbs. The combination of these four herbs in this formula ensures that the nasal passages are cleared and all pathogenic factors are dispelled. Summary of the Invention

[0018] The purpose of this invention is to provide a traditional Chinese medicine composition that has anti-inflammatory and anti-allergic properties.

[0019] Another objective of this invention is to provide a method for preparing an anti-inflammatory and anti-allergic traditional Chinese medicine composition.

[0020] Another object of the present invention is to provide an anti-inflammatory and anti-allergic traditional Chinese medicine composition for use in the preparation of a drug for treating allergic rhinitis.

[0021] To achieve the above objectives, the present invention is implemented through the following technical solution:

[0022] The anti-inflammatory and anti-allergic traditional Chinese medicine composition of the present invention is prepared from the following raw materials in parts by weight: 1-20 parts of Xanthium sibiricum, 1-20 parts of Magnolia biondii, 1-20 parts of Angelica dahurica, 1-12 parts of Mentha haplocalyx, 1-18 parts of Centipeda minima, 1-20 parts of Schizonepeta tenuifolia, 1-20 parts of Perilla frutescens, 1-30 parts of Lonicera japonica, 1-20 parts of Ligusticum chuanxiong, 1-24 parts of Asparagus cochinchinensis, and 0.01-1.8 parts of Borneol.

[0023] Furthermore, the anti-inflammatory and anti-allergic traditional Chinese medicine composition of the present invention is prepared from the following raw materials in parts by weight: 5-15 parts of Xanthium sibiricum, 5-15 parts of Magnolia biondii, 5-15 parts of Angelica dahurica, 2-10 parts of Mentha haplocalyx, 4-15 parts of Centipeda minima, 5-15 parts of Schizonepeta tenuifolia, 5-15 parts of Perilla frutescens, 8-22 parts of Lonicera japonica, 5-15 parts of Ligusticum chuanxiong, 6-18 parts of Asparagus cochinchinensis, and 0.01-0.9 parts of Borneol.

[0024] Furthermore, the anti-inflammatory and anti-allergic traditional Chinese medicine composition of the present invention is prepared from the following raw materials in parts by weight: 8-12 parts of Xanthium sibiricum, 8-12 parts of Magnolia biondii, 8-12 parts of Angelica dahurica, 4-8 parts of Mentha haplocalyx, 7-12 parts of Centipeda minima, 8-12 parts of Schizonepeta tenuifolia, 8-12 parts of Perilla frutescens, 12-18 parts of Lonicera japonica, 8-12 parts of Ligusticum chuanxiong, 10-14 parts of Asparagus cochinchinensis, and 0.01-0.6 parts of Borneol.

[0025] Furthermore, the anti-inflammatory and anti-allergic traditional Chinese medicine composition of the present invention is prepared from the following raw materials in parts by weight: 10 parts of Xanthium sibiricum, 10 parts of Magnolia biondii, 10 parts of Angelica dahurica, 6 parts of Mentha haplocalyx, 9 parts of Centipeda minima, 10 parts of Schizonepeta tenuifolia, 10 parts of Perilla frutescens, 15 parts of Lonicera japonica, 10 parts of Ligusticum chuanxiong, 12 parts of Asparagus cochinchinensis, and 0.3 parts of Borneol.

[0026] The borneol described in this invention is any one of synthetic borneol, natural borneol, or artemisia argyi.

[0027] The preparation method of the anti-inflammatory and anti-allergic composition of the present invention includes the following steps:

[0028] (1) Grind the following 10 medicinal materials into fine powder and sieve them separately: Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Alternatively, grind the 10 medicinal materials into fine powder separately, mix them evenly, add water and decoct three times, each time for 1 hour. Add 10 times the amount of water for the first decoction and 8 times the amount of water for the second and third decoctions. Combine the three decoctions, filter them, and use the filtrate for later use.

[0029] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0030] (3) Take the fine powder of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis obtained by crushing and sieving in step (1) or the filtrate obtained by decocting in water in step (1) and the borneol ground into powder in step (2), mix them evenly, add pharmaceutically acceptable excipients to make the corresponding dosage form, and you will get the product.

[0031] The sieve mesh size used in the preparation method of this invention is 60-120 mesh.

[0032] Preferably, the sieve mesh size in the preparation method of the present invention is 100 mesh.

[0033] The application of the anti-inflammatory and anti-allergic pharmaceutical composition described in this invention in the preparation of pharmaceutical formulations for treating allergic rhinitis.

[0034] The pharmaceutical preparations described in this invention are solid or liquid preparations.

[0035] The solid dosage forms of this invention are granules, capsules, tablets, and powders; the liquid dosage forms are decoctions.

[0036] The weight parts mentioned in this invention refer to international weight units such as g and kg.

[0037] Beneficial effects of this invention:

[0038] 1. The treatment for allergic rhinitis prepared by this invention is a new traditional Chinese medicine preparation with anti-inflammatory and anti-allergic effects, and it has a significant therapeutic effect on AR.

[0039] 2. The product prepared by this invention is convenient to use, safe and effective, and has no adverse reactions. Attached Figure Description

[0040] Figure 1 Venn diagram of the common target of Xanthium sibiricum powder and AR.

[0041] Figure 2 Drug-Common Target-Disease Network Diagram

[0042] Figure 3 Protein interaction network between modified Xanthium sibiricum powder and allergic rhinitis

[0043] Figure 4 Core target protein interaction network

[0044] Figure 5 GO Functional Enrichment Analysis

[0045] Figure 6 KEGG pathway enrichment

[0046] Figure 7 "Component-Common Target-Key Signaling Pathway" Network Diagram

[0047] Figure 8 3D columnar thermogram of molecular docking of all components with 20 key core targets

[0048] Figure 9 2D planar heatmap of molecular docking of all components with 20 key core targets

[0049] Figure 10 Visualization of TD1 (diosgenin)-SYK molecular docking results

[0050] Figure 11 Visualization of EB4 (Daracumyl)-PIK3CA Molecular Docking Results

[0051] Figure 12 Visualization of TD1 (diosgenin)-PIK3CG molecular docking results

[0052] Figure 13 Visualization of TD1 (diosgenin)-AKT1 molecular docking results

[0053] Figure 14 Effects of modified Xanthium sibiricum powder on pathological changes in nasal mucosa of AR rats (HE, ×400) (Note: KB. blank group, MX. model group, LL. loratadine group, CE. Xanthium sibiricum powder group, JJD. low-dose modified Xanthium sibiricum powder group, JJZ. medium-dose modified Xanthium sibiricum powder group, JJG. high-dose modified Xanthium sibiricum powder group.)

[0054] Figure 15 Expression of SYK, PIK3CA, PIK3CG, AKT1, PRKCA, MAPK1, MAPK8, MAPK14, PLA2G4A, ALOX5, and ALOX5AP in nasal mucosa tissue (Note: 1. Blank group, 2. Model group, 3. Loratadine group, 4. Xanthium sibiricum powder group, 5. Low-dose Xanthium sibiricum powder group with or without modifications, 6. Medium-dose Xanthium sibiricum powder group with or without modifications, 7. High-dose Xanthium sibiricum powder group with or without modifications. Compared with the blank group, *P<0.05, **)P<0.01; compared with the model group, #P<0.05, ##P<0.01).

[0055] Figure 16 Expression of p-PI3K, PI3K, p-Syk, Syk, p-AKT1, and AKT1 proteins in the nasal mucosa of rats in each group. (Note: KB. Blank group, MX. Model group, LL. Loratadine group, CE. Xanthium sibiricum powder group, JJCE. Added and subtracted Xanthium sibiricum powder group. Compared with the blank group, *P<0.05, **)P<0.01; compared with the model group, #P<0.05, ##P<0.01) Detailed Implementation

[0056] Example 1: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0057] Formula: 10g Xanthium sibiricum, 10g Magnolia biondii, 10g Angelica dahurica, 6g Mentha haplocalyx, 9g Centipeda minima, 10g Schizonepeta tenuifolia, 10g Perilla frutescens, 15g Lonicera japonica, 10g Ligusticum chuanxiong, 12g Asparagus cochinchinensis, 0.3g synthetic borneol (or natural borneol, or Artemisia argyi).

[0058] Example 2: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0059] Formula: 8g Xanthium sibiricum, 8g Magnolia biondii, 8g Angelica dahurica, 4g Mentha haplocalyx, 7g Centipeda minima, 8g Schizonepeta tenuifolia, 8g Perilla frutescens, 12g Lonicera japonica, 8g Ligusticum chuanxiong, 10g Asparagus cochinchinensis, 0.3g synthetic borneol (or natural borneol, or Artemisia argyi).

[0060] Example 3: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0061] Formula: 8g Xanthium sibiricum, 12g Magnolia biondii, 8g Angelica dahurica, 5g Mentha haplocalyx, 8g Centipeda minima, 8g Schizonepeta tenuifolia, 8g Perilla frutescens, 12g Lonicera japonica, 8g Ligusticum chuanxiong, 10g Asparagus cochinchinensis, 0.3g synthetic borneol (or natural borneol, or Artemisia argyi).

[0062] Example 4: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0063] Formula: 8g Xanthium sibiricum, 8g Magnolia biondii, 12g Angelica dahurica, 4g Mentha haplocalyx, 10g Centipeda minima, 8g Schizonepeta tenuifolia, 8g Perilla frutescens, 12g Lonicera japonica, 8g Ligusticum chuanxiong, 10g Asparagus cochinchinensis, 0.2g synthetic borneol (or 0.4g natural borneol, or 0.2g Artemisia argyi).

[0064] Example 5: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0065] Formula: 12g Xanthium sibiricum, 8g Magnolia biondii, 8g Angelica dahurica, 7g Mentha haplocalyx, 11g Centipeda minima, 8g Schizonepeta tenuifolia, 8g Perilla frutescens, 12g Lonicera japonica, 8g Ligusticum chuanxiong, 10g Asparagus cochinchinensis, 0.15g synthetic borneol (or 0.3g natural borneol, or 0.15g Artemisia argyi).

[0066] Example 6: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0067] Formula: 12g Xanthium sibiricum, 12g Magnolia biondii, 12g Angelica dahurica, 8g Mentha haplocalyx, 12g Centipeda minima, 12g Schizonepeta tenuifolia, 12g Perilla frutescens, 18g Lonicera japonica, 12g Ligusticum chuanxiong, 14g Asparagus cochinchinensis, 0.3g synthetic borneol (or 0.6g natural borneol, or 0.3g Artemisia argyi).

[0068] Example 7: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0069] Formula: 12g Xanthium sibiricum, 12g Magnolia biondii, 8g Angelica dahurica, 6g Mentha haplocalyx, 8g Centipeda minima, 8g Schizonepeta tenuifolia, 8g Perilla frutescens, 8g Lonicera japonica, 8g Ligusticum chuanxiong, 14g Asparagus cochinchinensis, 0.3g synthetic borneol (or 0.5g natural borneol, or 0.3g Artemisia argyi).

[0070] Example 8: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0071] Formula: 12g Xanthium sibiricum, 8g Magnolia biondii, 12g Angelica dahurica, 8g Mentha haplocalyx, 12g Centipeda minima, 8g Schizonepeta tenuifolia, 8g Perilla frutescens, 16g Lonicera japonica, 12g Ligusticum chuanxiong, 14g Asparagus cochinchinensis, 0.3g synthetic borneol (or natural borneol, or Artemisia argyi).

[0072] Example 9: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0073] Formula: 12g Xanthium sibiricum, 12g Magnolia biondii, 12g Angelica dahurica, 8g Mentha haplocalyx, 12g Centipeda minima, 8g Schizonepeta tenuifolia, 8g Perilla frutescens, 18g Lonicera japonica, 8g Ligusticum chuanxiong, 10g Asparagus cochinchinensis, 0.3g synthetic borneol (or 0.6g natural borneol, or 0.3g Artemisia argyi).

[0074] Example 10: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0075] Formula: 5g Xanthium sibiricum, 5g Magnolia biondii, 5g Angelica dahurica, 2g Mentha haplocalyx, 4g Centipeda minima, 5g Schizonepeta tenuifolia, 5g Perilla frutescens, 8g Lonicera japonica, 5g Ligusticum chuanxiong, 6g Asparagus cochinchinensis, 0.01g synthetic borneol (or natural borneol, or Artemisia argyi).

[0076] Example 11: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0077] Formula: 5g Xanthium sibiricum, 10g Magnolia biondii, 5g Angelica dahurica, 2g Mentha haplocalyx, 5g Centipeda minima, 5g Schizonepeta tenuifolia, 5g Perilla frutescens, 8g Lonicera japonica, 5g Ligusticum chuanxiong, 6g Asparagus cochinchinensis, 0.01g synthetic borneol (or natural borneol, or Artemisia argyi).

[0078] Example 12: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0079] Formula: 5g Xanthium sibiricum, 5g Magnolia biondii, 10g Angelica dahurica, 2g Mentha haplocalyx, 5g Centipeda minima, 5g Schizonepeta tenuifolia, 5g Perilla frutescens, 10g Lonicera japonica, 5g Ligusticum chuanxiong, 6g Asparagus cochinchinensis, 0.02g synthetic borneol (or natural borneol, or Artemisia argyi).

[0080] Example 13: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0081] Formula: 10g Xanthium sibiricum, 5g Magnolia biondii, 5g Angelica dahurica, 2g Mentha haplocalyx, 5g Centipeda minima, 5g Schizonepeta tenuifolia, 5g Perilla frutescens, 15g Lonicera japonica, 5g Ligusticum chuanxiong, 6g Asparagus cochinchinensis, 0.03g synthetic borneol (or natural borneol, or Artemisia argyi).

[0082] Example 14: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0083] Formula: 15g Xanthium sibiricum, 15g Magnolia biondii, 15g Angelica dahurica, 10g Mentha haplocalyx, 15g Centipeda minima, 15g Schizonepeta tenuifolia, 15g Perilla frutescens, 8g Lonicera japonica, 15g Ligusticum chuanxiong, 18g Asparagus cochinchinensis, 0.9g natural borneol.

[0084] Example 15: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0085] Formula: 15g Xanthium sibiricum, 5g Magnolia biondii, 15g Angelica dahurica, 10g Mentha haplocalyx, 15g Centipeda minima, 15g Schizonepeta tenuifolia, 15g Perilla frutescens, 10g Lonicera japonica, 15g Ligusticum chuanxiong, 6g Asparagus cochinchinensis, 0.8g natural borneol.

[0086] Example 16: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0087] Formula: 15g Xanthium sibiricum, 15g Magnolia biondii, 5g Angelica dahurica, 10g Mentha haplocalyx, 15g Centipeda minima, 15g Schizonepeta tenuifolia, 15g Perilla frutescens, 22g Lonicera japonica, 15g Ligusticum chuanxiong, 18g Asparagus cochinchinensis, 0.7g natural borneol.

[0088] Example 17: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0089] Formula: 15g Xanthium sibiricum, 15g Magnolia biondii, 15g Angelica dahurica, 5g Mentha haplocalyx, 10g Centipeda minima, 15g Schizonepeta tenuifolia, 15g Perilla frutescens, 15g Lonicera japonica, 10g Ligusticum chuanxiong, 10g Asparagus cochinchinensis, 0.9g natural borneol.

[0090] Example 18: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0091] Formula: 1g Xanthium sibiricum, 1g Magnolia biondii, 1g Angelica dahurica, 1g Mentha haplocalyx, 1g Centipeda minima, 1g Schizonepeta tenuifolia, 1g Perilla frutescens, 1g Lonicera japonica, 1g Ligusticum chuanxiong, 1g Asparagus cochinchinensis, 0.01g synthetic borneol (or natural borneol, or Artemisia argyi).

[0092] Example 19: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0093] Formula: 20g Xanthium sibiricum, 20g Magnolia biondii, 20g Angelica dahurica, 12g Mentha haplocalyx, 18g Centipeda minima, 20g Schizonepeta tenuifolia, 20g Perilla frutescens, 30g Lonicera japonica, 20g Ligusticum chuanxiong, 24g Asparagus cochinchinensis, 1.8g natural borneol.

[0094] Example 20: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0095] Formula: 20g Xanthium sibiricum, 20g Magnolia biondii, 20g Angelica dahurica, 10g Mentha haplocalyx, 10g Centipeda minima, 10g Schizonepeta tenuifolia, 10g Perilla frutescens, 15g Lonicera japonica, 10g Ligusticum chuanxiong, 12g Asparagus cochinchinensis, 0.6g synthetic borneol (or natural borneol, or Artemisia argyi).

[0096] Example 21: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0097] Formula: 10g Xanthium sibiricum, 10g Magnolia biondii, 10g Angelica dahurica, 6g Mentha haplocalyx, 9g Centipeda minima, 10g Schizonepeta tenuifolia, 10g Perilla frutescens, 15g Lonicera japonica, 10g Ligusticum chuanxiong, 12g Asparagus cochinchinensis, 0.3g synthetic borneol (or natural borneol, or Artemisia argyi).

[0098] Example 22: Anti-inflammatory and anti-allergic traditional Chinese medicine composition

[0099] Formula: 10g Xanthium sibiricum, 10g Magnolia biondii, 10g Angelica dahurica, 6g Mentha haplocalyx, 9g Centipeda minima, 10g Schizonepeta tenuifolia, 10g Perilla frutescens, 15g Lonicera japonica, 10g Ligusticum chuanxiong, 12g Asparagus cochinchinensis, 0.03g synthetic borneol (or natural borneol, or Artemisia argyi).

[0100] The formulations of the anti-inflammatory and anti-allergic traditional Chinese medicine compositions of Examples 1-22 were used in the following preparation methods.

[0101] Example 23 Preparation of a Traditional Chinese Medicine Composition with Anti-inflammatory and Anti-allergic Effects

[0102] (1) Mix and grind the following medicinal materials into a fine powder and sieve (100 mesh): Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Set aside for later use.

[0103] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0104] (3) Mix the fine powders of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong and Asparagus cochinchinensis obtained by crushing and sieving in step (1) with the powdered borneol obtained in step (2) to obtain the powder.

[0105] Example 24 Preparation of a Traditional Chinese Medicine Composition with Anti-inflammatory and Anti-allergic Effects

[0106] (1) Mix and grind the following medicinal materials into a fine powder and sieve (60 mesh): Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Set aside for later use.

[0107] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0108] (3) Mix the fine powders of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong and Asparagus cochinchinensis obtained by crushing and sieving in step (1) with the powdered borneol obtained in step (2) to obtain the powder.

[0109] Example 25: Preparation of a Traditional Chinese Medicine Composition with Anti-inflammatory and Anti-allergic Effects

[0110] (1) Mix and grind the following medicinal materials into a fine powder and sieve (120 mesh): Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Set aside for later use.

[0111] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0112] (3) Mix the fine powders of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong and Asparagus cochinchinensis obtained by crushing and sieving in step (1) with the powdered borneol obtained in step (2) to obtain the powder.

[0113] Example 26 Preparation of a Traditional Chinese Medicine Composition with Anti-inflammatory and Anti-allergic Effects

[0114] (1) Mix and grind the following medicinal materials into a fine powder and sieve (100 mesh): Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Set aside for later use.

[0115] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0116] (3) Mix the fine powders of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong and Asparagus cochinchinensis obtained by crushing and sieving in step (1) with the powdered borneol obtained in step (2), granulate, dry, granulate, and compress into tablets to obtain tablets.

[0117] Example 27 Preparation of a Traditional Chinese Medicine Composition with Anti-inflammatory and Anti-allergic Effects

[0118] (1) Mix and grind the following medicinal materials into a fine powder and sieve (100 mesh): Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Set aside for later use.

[0119] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0120] (3) Mix the fine powders of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong and Asparagus cochinchinensis obtained by crushing and sieving in step (1) with the powdered borneol obtained in step (2), add an appropriate amount of flavoring agent and mix evenly, granulate, dry, granulate, and bag to obtain granules.

[0121] Example 28 Preparation of a Traditional Chinese Medicine Composition with Anti-inflammatory and Anti-allergic Effects

[0122] (1) Mix and grind the following medicinal materials into a fine powder and sieve (100 mesh): Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Set aside for later use.

[0123] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0124] (3) Mix the fine powders of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong and Asparagus cochinchinensis obtained by crushing and sieving in step (1) with the powdered borneol obtained in step (2), granulate, dry, granulate, and fill into capsules to obtain capsules.

[0125] Example 29 Preparation of a Traditional Chinese Medicine Composition with Anti-inflammatory and Anti-allergic Effects

[0126] (1) Grind the 10 medicinal materials into fine powder, mix them evenly, add water and decoct three times, each time for 1 hour. Add 10 times the amount of water for the first time, and 8 times the amount of water for the second and third times. Combine the three decoctions, filter them, and use the filtrate for later use.

[0127] (2) Grind borneol into a fine powder using a wet method with a small amount of ethanol, and set aside.

[0128] (3) Grind the filtrate obtained in step (1) and the borneol obtained in step (2) into powder, mix and stir evenly to obtain the decoction.

[0129] To further verify the feasibility and effectiveness of the present invention and to screen out the optimal solution; and to demonstrate the beneficial effects of the present invention, the present invention conducted research and testing on the finished product prepared according to the formulation of Example 1 and the preparation process of Example 23. Some of the test results are excerpted below:

[0130] I. Experimental Data

[0131] 1. Network pharmacology and molecular docking

[0132] 1.1 Acquisition of active ingredients and targets of Xanthium sibiricum powder

[0133] Chemical components of 11 herbs in Jiajian Cang Er Zi San (a traditional Chinese medicine formula) were obtained by searching the TCM Systems Pharmacology Database and Analysis Platform (TCMSP, https: / / tcmsp-e.com / tcmsp.php). These herbs include Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, Asparagus cochinchinensis, and natural borneol (dextral borneol). Oral bioavailability (OB) ≥ 30% and drug similarity (DL) ≥ 0.18 were set as screening criteria to obtain the chemical components of Jiajian Cang Er Zi San. Simultaneously, the target proteins corresponding to each herb component were obtained and imported into the UniProt database (https: / / www.uniprot.org / ). The target genes corresponding to each target protein were obtained, merged, and deduplicated. The results were used as the target sites corresponding to the chemical components of Jiajian Cang Er Zi San. If a chemical component does not have a corresponding target protein in the TCMSP database, target gene prediction is performed on the SwissTargetPrediction and PharmMapper platforms, using the following methods: Export the chemical structure in SDF format from the PubChem platform (https: / / pubchem.ncbi.nlm.nih.gov / ), and import the SDF file into the SwissTargetPrediction platform (http: / / www.swisstargetprediction.ch / ) for target gene prediction; export the chemical component in mol2 format from the TCMSP platform, and import it into the PharmMapper platform (http: / / www.li lab-ecust.cn / pharmmapper / ) for target gene prediction. The target genes predicted by both methods are then combined with the data collected from TCMSP and deduplicated. The chemical components and targets of 11 herbs in the modified Cang Er Zi San formula, namely Cang Er Zi (Xanthium sibiricum), Xin Yi (Magnolia biondii), Bai Zhi (Angelica dahurica), Bo He (Mentha haplocalyx), E Bu Shi Cao (Centipeda minima), Jing Jie (Schizonepeta tenuifolia), Zi Su Ye (Perilla frutescens), Jin Yin Hua (Lonicera japonica), Chuan Xiong (Ligusticum striatum), Tian Dong (Asparagus cochinchinensis), and natural borneol (dextral borneol), were retrieved from the TCMSP database. Natural borneol was not in the TCMSP database. Target prediction was performed based on the structure of the main medicinal component, dextrorotatory borneol. Although the OB and DL values ​​of the main component of natural borneol did not meet the screening criteria in the TCMSP database, it was retained as a necessary and relatively simple component in the formula. A total of 11 effective chemical components were retrieved from Xanthium sibiricum, 19 from Magnolia biondii, 22 from Angelica dahurica, 10 from Mentha haplocalyx, 21 from Centipeda minima, 11 from Schizonepeta tenuifolia, 14 from Perilla frutescens, 23 from Lonicera japonica, 7 from Ligusticum chuanxiong, 9 from Asparagus cochinchinensis, and 1 from natural borneol (dextral borneol). After deduplication, a total of 115 chemical components were obtained. Using the UniProt database, the gene names of the proteins corresponding to the components were standardized, and a total of 806 target genes were obtained.

[0134] 1.2 Screening of AR disease genes

[0135] Using "Allergic rhinitis" as the keyword, we searched and screened target genes in the GeneCards, TTD, OMIM, and DisGeNET databases. After summarizing and standardizing the gene names in the UniProt database, we obtained a total of 1469 disease targets for AR.

[0136] 1.3 Constructing a drug-common target-disease network diagram and screening key components

[0137] Using the Venny 2.1 tool, drug and AR target genes were imported to obtain drug-AR common targets, and a Venn diagram was drawn. (See...) Figure 1 243 intersecting targets were exported from the Venny tool, and a drug-common target-disease network diagram was constructed using Cytoscape software. (See attached image.) Figure 2 By analyzing the network score using the built-in tool CytoNCA, 54 key components with scores ≥16 were selected. These key components are considered to be important material basis for the treatment of AR with modified Xanthium sibiricum powder. The top 10 components are quercetin, β-sitosterol, luteolin, stigmasterol, methyl 11,14-eicosadienoate, ethyl linoleate, magnolol, Machilin G, dihyo-γ-linolenic acid, sitosterol, and bis[(2R)-2-ethylhexyl]phenyl-1,2-dicarboxylic acid ester.

[0138] 1.4 Constructing a protein-protein interaction network with shared targets and screening core targets.

[0139] The drug-disease common target was uploaded to the STRING database, the PPI interaction graph was obtained, and the network diagram was exported and visualized in Cytoscape. Figure 3 The network topology parameters were analyzed using the built-in tool CytoNCA, and 43 target points were selected as core target points and plotted. (See attached image.) Figure 4 The 43 core targets are TNF, IL6, ALB, IL1B, AKT1, VEGFA, STAT3, TP53, IL10, CXCL8, PTGS2, MMP9, EGFR, CCL2, CTNNB1, CASP3, HIF1A, PPARG, IL4, EGF, MYC, ICAM1, IL2, ESR1, IFNG, ERBB2, VCAM1, MTOR, NOS3, CAT, CRP, CREB1, PPARA, HMOX1, MPO, KDR, MAPK1, EP300, NR3C1, SYK, PRKCA, CXCR2, and PRKCD.

[0140] 1.5 Enrichment analysis of GO function and KEGG pathway for common drug-disease targets

[0141] Drug-disease co-targets were uploaded to the DAVID database. GO functional enrichment analysis and KEGG pathway enrichment analysis were performed on the targets. Using P < 0.05 as the screening criterion, the results of biological process (BP), molecular function (MF), cellular component (CC), and KEGG pathway enrichment analyses were exported. Bubble charts of the top 10 GO results (including BP, CC, and MF) and the top 30 KEGG pathways were plotted using the MicroBioinformatics network platform. (See attached image). Figure 5 , Figure 6 The results suggest that BP mainly involves inflammatory responses, responses to exogenous stimuli, positive regulation of gene expression, negative regulation of apoptosis, cellular responses to lipopolysaccharide (LPS), responses to hypoxia, positive regulation of smooth muscle cell proliferation, positive regulation of cytoplasmic calcium ion concentration, positive regulation of cell proliferation, and responses to LPS. MF mainly involves enzyme binding, RNA polymerase II transcription factor activity and ligand-activated sequence-specific DNA binding, protein tyrosine kinase activity, protein serine / threonine / tyrosine kinase activity, same-protein binding, transcription coactivator binding, endopeptidase activity, transmembrane receptor protein tyrosine kinase activity, steroid binding, and serine-type endopeptidase activity. CC mainly involves components of the plasma membrane, the plasma membrane, extracellular space, extracellular region, cell surface, outer plasma membrane, membrane rafts, receptor complexes, macromolecular complexes, and exosomes. The KEGG signaling pathways associated with allergic rhinitis mainly involve cancer, Th17 cell differentiation, PI3K-Akt signaling pathway, HIF-1 signaling pathway, MAPK signaling pathway, TNF signaling pathway, IL-17 signaling pathway, NF-κB signaling pathway, Toll-like receptor signaling pathway, Jak-STAT signaling pathway, cytokine-cytokine receptor interaction, T cell receptor signaling pathway, cAMP signaling pathway, estrogen signaling pathway, FcεRI signaling pathway, Th1 and Th2 cell differentiation, VEGF signaling pathway, arachidonic acid metabolism, B cell receptor signaling pathway, and asthma signaling pathway. A network diagram of "components-common targets-key signaling pathways" is shown below. Figure 7。By analyzing the KEGG enrichment results in detail, it is considered that the main action pathways of modified Xanthium Powder in treating AR are PI3K-Akt, FcεRI, and B cell receptor signaling pathways. Modified Xanthium Powder can also play a role in signal pathways such as Th17 cell differentiation, Th1 / Th2 cell differentiation, IL-17 metabolism, and B cell receptor, thereby regulating the occurrence of allergy and inflammation. Through further analysis of the PI3K-Akt, FcεRI, and B cell receptor signaling pathways, after selecting 11 important core targets and combining and removing duplicates with the top 10 core targets predicted in 1.4, 20 key core targets of modified Xanthium Powder in treating AR are obtained, namely TNF, IL6, ALB, IL1B, AKT1, VEGFA, IL10, CXCL8, STAT3, TP53, SYK, PRKCA, MAPK8, MAPK14, MAPK1, PLA2G4A, ALOX5, ALOX5AP, PIK3CA, PIK3CG, which will be used in the molecular docking of all components later.

[0142] 1.6 Molecular Docking Verification of Key Components and Core Targets

[0143] Using molecular docking technology, 115 components of modified Xanthium Powder are docked with the 20 key core targets screened out, and the interactions are analyzed. The molecular docking results are plotted as 3D column heat maps and 2D plane heat maps, as shown in Figure 8 、 Figure 9 。When the binding energy ≤ -5 kcal·mol -1 (1 kcal = 4.2 kJ), it indicates good binding ability. When the binding energy ≤ -7 kcal·mol -1 it indicates strong binding ability. After analyzing 2300 molecular docking results, there are 1996 results with binding energy ≤ -5 kcal·mol -1 , accounting for 86.78% of the total. Among them, there are 831 results with binding energy ≤ -7 kcal·mol -1 , accounting for 36.13% of the total. Among them, there are 112 results with binding energy ≤ -9 kcal·mol -1 , accounting for 4.87% of the total. Through the above result analysis, it can be seen that modified Xanthium Powder has good regulatory ability for the key sites of the key pathways in AR treatment. After comprehensively analyzing the KEGG pathway and molecular docking results, it is predicted that modified Xanthium Powder may play a role in treating AR by regulating the Syk / PI3K / AKT pathway. The results with the first-ranked docking binding energy for the Syk, PI3K, and AKT targets are TD1 (dioscin)-SYK binding energy -9.5 kcal·mol -1 、EB4 (taraxerol)-PIK3CA binding energy -7.9 kcal·mol-1 TD1 (diosgenin) - PIK3CG binding energy -10.5 kcal·mol -1 TD1 (diosgenin) - AKT1 binding energy: -7.8 kcal·mol -1 Visualize the presentation using graphs, see Figures 10-13 .

[0144] 2. Animal experiments

[0145] Eighty-four SPF-grade Sprague-Dawley (SD) rats, weighing (200±20g), were used. Twelve healthy SD rats were randomly selected as the blank control group, and the remaining rats were used to establish an allergic rhinitis model. Basal sensitization: A suspension of 0.3mg ovalbumin, 30mg aluminum hydroxide, and 1ml physiological saline was administered intraperitoneally to the rats every other day for a total of 7 days (14 days). Nasal challenge: A 2% ovalbumin-saline solution was prepared and administered via nasal drops (50μL per nostril, once daily for 7 days), starting on the second day after basal sensitization (day 15). The blank control group received the same volume of physiological saline via intraperitoneal injection and nasal drops. Behavioral observation was performed within 30 minutes after the last nasal drop, observing the rats' nose scratching, sneezing, and rhinorrhea. A score ≥5 was considered a successful model establishment. After successful modeling, the rats with allergic rhinitis were randomly divided into 6 groups: model control group, loratadine treatment group, Xanthium sibiricum powder control group, low-dose Xanthium sibiricum powder treatment group, medium-dose Xanthium sibiricum powder treatment group, and high-dose Xanthium sibiricum powder treatment group, with 12 rats in each group. Starting from the 22nd day, the rats were administered the medication by gavage for 14 days. Behavioral observations were conducted within 30 minutes after the last administration, recording the number of times rats scratched their noses and sneezed. Comparisons were made before and after treatment. Twenty-four hours after the last administration, rats were anesthetized, and blood was collected from the nasal mucosa and abdominal aorta. Subsequently, histopathological examination of the nasal mucosa tissue was performed. The levels of serum cytokines (IFN-γ, IL-4, IL-6, IL-17, TNF-α) in rats were detected by ELISA. The expression of mRNA (SYK, PIK3CA, PIK3CG, AKT1, PRKCA, MAPK1, MAPK8, MAPK14, PLA2G4A, ALOX5, ALOX5AP) in nasal mucosa tissue was detected by qRT-PCR. The expression of key proteins (p-PI3K, PI3K, p-Syk, Syk, p-AKT1, AKT1) was detected by Western blotting.

[0146] 2.1 Effects on sneezing and nose scratching in AR rats

[0147] One week after nasal stimulation with OVA solution, the rats in the model group were divided into four groups after the last nasal instillation: model group, loratadine treatment group, Xanthium sibiricum powder treatment group, low-dose Xanthium sibiricum powder treatment group, medium-dose Xanthium sibiricum powder treatment group, and high-dose Xanthium sibiricum powder treatment group. The number of times rats scratched their noses and sneezed, as well as the number of cases of nasal bleeding, were recorded in each group. After successful modeling, compared with the control group, the number of times rats scratched their noses and sneezed in the other groups was significantly increased (P < 0.01). Furthermore, due to significant nasal itching, rats in all groups repeatedly scratched their noses, resulting in varying degrees of nasal bleeding. A behavioral score ≥ 6 indicated successful modeling, with a success rate of 100%. Half an hour after the last gavage administration, the number of times rats scratched their noses and sneezed in each group was recorded. Compared with the control group, the number of times rats in the model group scratched their noses and sneezed was significantly increased (P < 0.01). Compared with the model group, the number of nose scratching and sneezing was significantly reduced in the loratadine group, the Xanthium sibiricum powder group, the modified Xanthium sibiricum powder dosage group, the modified Xanthium sibiricum powder medium dosage group, and the modified Xanthium sibiricum powder high dosage group (P < 0.01), as shown in Table 1. Due to improper operation during the gavage administration, two rats in the modified Xanthium sibiricum powder high dosage group died.

[0148] Table 1. Behavioral evaluation of rats with allergic rhinitis after modeling and treatment.

[0149]

[0150] Note: Compared with the blank group, 1) P < 0.05 2) P < 0.01; compared with the model group 3) P < 0.05 4) P < 0.01 (same as Table 2); the sample size of each group was 12 rats. Due to improper operation during the gavage treatment, two rats in the high-dose group of Xanthium sibiricum powder died.

[0151] 2.2 Histopathological examination of nasal mucosa

[0152] In this experiment, during gavage administration, OVA solution was administered via nasal drops every other day to maintain a state of allergic rhinitis provocation, simulating the process of human exposure to high concentrations of allergens during the onset of allergic rhinitis. The typical symptom of allergic rhinitis, "copious watery nasal discharge," is closely related to goblet cell proliferation. Because of the continuous stimulation of the nasal mucosa by OVA allergen, this experiment used the degree of goblet cell proliferation to evaluate the treatment effectiveness. HE staining results showed that the nasal mucosa tissue of the control group rats was structurally intact, with neat and intact cilia on the mucosal surface, regular epithelial cell arrangement, and the presence of goblet cells without significant proliferation. In the model group rats, the nasal mucosa tissue showed abundant goblet cell proliferation and cilia loss. Compared with the model group, there was no significant difference in the degree and number of goblet cell proliferation in the loratadine treatment group. In the treatment groups of Xanthium sibiricum powder, and in the low, medium and high dose treatment groups of Xanthium sibiricum powder with modifications, the proliferation and number of goblet cells were significantly inhibited, with the improvement being particularly obvious in the medium and high dose treatment groups of Xanthium sibiricum powder with modifications. Nasal mucosal cilia were lost to varying degrees, with the high dose group of Xanthium sibiricum powder with modifications showing a lower degree of cilia loss.

[0153] 2.3 ELISA method was used to detect the levels of IFN-γ, IL-4, IL-6, IL-17, and TNF-α in rat serum.

[0154] Compared with the control group, the serum IFN-γ level in the model group rats was significantly decreased (P<0.01), while the levels of IL-4, IL-6, IL-17, and TNF-α were significantly increased (P<0.01). Compared with the model group, the serum IFN-γ level in the loratadine group, Xanthium sibiricum powder group, low-dose group of modified Xanthium sibiricum powder, medium-dose group of modified Xanthium sibiricum powder, and high-dose group of modified Xanthium sibiricum powder was significantly increased (P<0.01), while the levels of IL-4, IL-6, IL-17, and TNF-α were significantly decreased (P<0.01). Furthermore, a concentration-related trend was observed between the low-, medium-, and high-dose groups of modified Xanthium sibiricum powder and the serum IFN-γ, IL-4, IL-6, IL-17, and TNF-α levels; that is, with increasing drug concentration, the serum IFN-γ level gradually increased, while the serum IL-4, IL-6, IL-17, and TNF-α levels gradually decreased. Specific results are shown in Table 2.

[0155] Table 2. Measurement of serum IFN-γ, IL-4, IL-6, IL-17, and TNF-α levels.

[0156]

[0157]

[0158] 2.4 The expression of SYK, PIK3CA, PIK3CG, AKT1, PRKCA, MAPK1, MAPK8, MAPK14, PLA2G4A, ALOX5, and ALOX5AP in nasal mucosa tissue was detected by qRT-PCR.

[0159] Compared with the control group, the expression of SYK, PIK3CA, PIK3CG, AKT1, PRKCA, MAPK1, MAPK8, MAPK14, PLA2G4A, ALOX5, and ALOX5AP mRNA in the nasal mucosa of rats in the model group was significantly upregulated (P < 0.01). Compared with the model group, there was no significant difference in the expression of AKT1 and PLA2G4A mRNA in the loratadine group. However, the expression of SYK, PIK3CA, PIK3CG, AKT1, PRKCA, MAPK1, MAPK8, MAPK14, PLA2G4A, ALOX5, and ALOX5AP mRNA was significantly downregulated in all other treatment groups (P < 0.05 or P < 0.01). Figure 12 After merging the qRT-PCR results of 11 gene groups, it was found that the overall relative expression ratio of the Xanthium sibiricum powder group was almost identical to that of the low, medium, and high dose groups of Xanthium sibiricum powder, and all were close to that of the blank group. Figure 13 Based on the analysis of HE pathological sections and ELISA results, the changes in expression were considered to be due to the optimization of the prescription, providing a reference and ideas for subsequent research on the role of these genes in the treatment of allergic rhinitis.

[0160] 2.5 Modified Xanthium sibiricum powder regulates the Syk / PI3K / AKT1 signaling pathway to treat allergic rhinitis

[0161] Compared with the control group, the p-Syk / Syk, p-PI3K / PI3K, and p-AKT1 / AKT1 ratios were significantly increased in the model group (P < 0.01). Compared with the model group, the p-PI3K / PI3K ratio in the loratadine group was not significantly different, while the p-Syk / Syk and p-AKT1 / AKT1 ratios were significantly decreased (P < 0.01). The p-Syk / Syk ratio in the Xanthium sibiricum powder group was not significantly different, while the p-PI3K / PI3K and p-AKT1 / AKT1 ratios were significantly decreased (P < 0.05 or P < 0.01). The p-Syk / Syk, p-PI3K / PI3K, and p-AKT1 / AKT1 ratios in the Xanthium sibiricum powder plus / minus groups were all significantly decreased (P < 0.01). See [link to relevant documentation]. Figure 14 This indicates that the modified Xanthium sibiricum powder treatment group has a significant inhibitory effect on the Syk / PI3K / AKT1 signaling pathway.

[0162] In conclusion, the modified Cang Er Zi San, a formula derived from the ancient classic Cang Er Zi San, demonstrates a more significant therapeutic effect on acute rheumatoid arthritis (AR). Its mechanism involves inhibiting the phosphorylation of Syk / PI3K / AKT pathway proteins, thereby regulating Th1 / Th2 cells, B cells, mast cells, eosinophils, and goblet cells, ultimately exerting a therapeutic effect on AR. This study provides insights for the development of new drugs for AR treatment and offers sufficient theoretical basis for the clinical use of modified Cang Er Zi San in treating AR.

[0163] Although the present invention has been described in detail above with general descriptions, specific embodiments, and experiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for anti-inflammatory and anti-allergic purposes, characterized in that, It is prepared from the following raw materials in parts by weight: 10 parts Xanthium sibiricum, 10 parts Magnolia biondii, 10 parts Angelica dahurica, 6 parts Mentha haplocalyx, 9 parts Centipeda minima, 10 parts Schizonepeta tenuifolia, 10 parts Perilla frutescens, 15 parts Lonicera japonica, 10 parts Ligusticum chuanxiong, 12 parts Asparagus cochinchinensis, and 0.3 parts Borneol.

2. A method for preparing a traditional Chinese medicine composition with anti-inflammatory and anti-allergic properties as described in claim 1, characterized in that, Includes the following steps: (1) Grind the following 10 medicinal materials into fine powder and pass them through a 100-mesh sieve: Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis. Alternatively, grind the 10 medicinal materials into fine powder, mix them evenly, add water and decoct three times, one hour each time. Add 10 times the amount of water for the first decoction and 8 times the amount of water for the second and third decoctions. Combine the three decoctions, filter them, and use the filtrate for later use. (2) Add a small amount of ethanol to the borneol and wet grind it into a fine powder for later use; (3) Take the fine powder of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Centipeda minima, Schizonepeta tenuifolia, Perilla frutescens, Lonicera japonica, Ligusticum chuanxiong, and Asparagus cochinchinensis obtained by crushing and sieving in step (1) or the filtrate obtained by decocting in water in step (1) and the borneol ground into powder in step (2), mix them evenly, add pharmaceutically acceptable excipients to make the corresponding dosage form, and you will get the product.

3. The use of the anti-inflammatory and anti-allergic traditional Chinese medicine composition as described in claim 1 in the preparation of a pharmaceutical preparation for treating allergic rhinitis.

4. The application according to claim 3, characterized in that, The pharmaceutical preparation is either a solid or liquid preparation.

5. The application according to claim 4, characterized in that, The solid dosage form is granules, capsules, tablets, or powder; the liquid dosage form is a decoction.

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