A pharmaceutical composition for treating allergic rhinitis, and a preparation method and use thereof

Abstract

The application relates to the technical field of Chinese medicine preparation, in particular to a medicine composition for treating allergic rhinitis and a preparation method and application thereof, and the preparation method of the medicine composition for treating allergic rhinitis is as follows: step 1, preparing mixed Chinese herbal medicine A and mixed Chinese herbal medicine B; step 2, subjecting the mixed Chinese herbal medicine A to enzymatic treatment to obtain an enzymatic product; step 3, adding a synergistic agent and inoculating compound microorganisms into the enzymatic product, carrying out aerobic fermentation, adding the mixed Chinese herbal medicine B, and then carrying out anaerobic fermentation to obtain the medicine composition for treating allergic rhinitis. The medicine composition prepared in the application can not only effectively relieve the behavior symptoms such as scratching nose, sneezing and running nose of allergic rhinitis mice, inhibit allergic IgE immune response, but also efficiently relieve the symptoms of allergic rhinitis patients, and has good treatment effect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a pharmaceutical composition for treating allergic rhinitis, as well as the preparation process and clinical application of the composition. Background Technology

[0002] Allergic rhinitis, also known as hay fever, is classified as "nasal congestion" in traditional Chinese medicine. It is a chronic inflammation of the nasal mucosa caused by exposure to allergens in atopic individuals. Its core symptoms include nasal itching, paroxysmal sneezing, watery nasal discharge, and nasal congestion. It is often accompanied by a decreased sense of smell and can induce complications such as bronchial asthma in severe cases, seriously affecting the patient's quality of life.

[0003] In recent years, influenced by factors such as air pollution and increased allergens, the incidence of allergies has continued to rise, especially among children and adolescents, becoming a global public health issue. Current clinical treatment mainly relies on Western medicine, immunotherapy, and surgery. While antihistamines and corticosteroids are fast-acting, they have adverse reactions such as nasal dryness and bleeding, and only treat the symptoms, not the root cause, easily leading to relapse due to seasonal changes or exposure to allergens. Immunotherapy has a long treatment course, high cost, and may induce severe allergic reactions, limiting its applicability. Surgical treatment is invasive and only suitable for specific severe cases, making it difficult to promote as a routine treatment. Traditional Chinese medicine (TCM) treatment has the advantages of addressing both the symptoms and root cause, with fewer side effects. However, existing TCM preparations have significant shortcomings; some formulas are complex, costly, and have unclear synergistic mechanisms, making it difficult to meet the needs of comprehensive treatment. Therefore, developing a TCM composition with simplified components, clear efficacy, high safety, addressing both the symptoms and root cause, and retaining effective components using modern technology has significant clinical value and market potential. Summary of the Invention

[0004] To address the technical problems mentioned in the background art, this application provides a pharmaceutical composition for treating allergic rhinitis, its preparation method, and its application.

[0005] This application provides a method for preparing a pharmaceutical composition for treating allergic rhinitis, using the following technical solution:

[0006] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0007] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis, grind and sieve to obtain mixed Chinese herbal medicine A; mix Magnolia biondii and Mentha haplocalyx, dry at low temperature, mix with Xanthium sibiricum that has been stir-fried, grind and sieve to obtain mixed Chinese herbal medicine B;

[0008] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, enzymatically hydrolyze for 2-4 hours, and after enzyme inactivation treatment, cool to obtain the enzymatic hydrolysis product;

[0009] Step 3: Add a pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, adjust the water content of the system, and first perform aerobic fermentation for 24-36 hours. Then add mixed Chinese herbal medicine B and perform anaerobic fermentation for 24-48 hours. First dry at low temperature, then freeze dry until the water content is ≤5%. After pulverizing, sieve to obtain a drug composition for treating allergic rhinitis.

[0010] Preferably, the weight parts of each raw material in step 1 are as follows: Astragalus membranaceus 18-30 parts, Atractylodes macrocephala 12-20 parts, Saposhnikovia divaricata 8-12 parts, Poria cocos 10-15 parts, Lonicera japonica 8-12 parts, Cicadae periostracum 5-8 parts, Glycyrrhiza uralensis 4-6 parts, Magnolia biondii 10-15 parts, Mentha haplocalyx 6-10 parts, Xanthium sibiricum 6-10 parts.

[0011] Preferably, the weight parts of each raw material in step 1 are as follows: Astragalus membranaceus 25 parts, Atractylodes macrocephala 16 parts, Saposhnikovia divaricata 10 parts, Poria cocos 12 parts, Lonicera japonica 10 parts, Cicadae periostracum 7 parts, Glycyrrhiza uralensis 5 parts, Magnolia biondii 12 parts, Mentha haplocalyx 8 parts, Xanthium sibiricum 8 parts.

[0012] Preferably, in step 1, the low-temperature drying temperature is 60-70℃ and the drying time is 10-12h; the frying treatment temperature is 120-140℃ and the frying time is 15-20min.

[0013] Preferably, the amount of compound enzyme added in step 2 is 2-3% of the mass of mixed Chinese herbal medicine A; the compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5-8:1-4.

[0014] Preferably, the mass ratio of the enzymatic hydrolysis product to the pharmacodynamic synergist in step 3 is 100-120:10-25.

[0015] Preferably, the synergistic agent in step 3 is composed of icariin and cyclocarya paliurus flavonoids in a mass ratio of 10-12:5-8.

[0016] Preferably, in step 3, the inoculation amount of the compound microorganism is 1-4% of the mass of the fermentation system, and the compound microorganism consists of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis and Rhodotorula glutinis with an effective viable count ratio of 10-12:3-6:2-4:1-3.

[0017] A pharmaceutical composition for treating allergic rhinitis is prepared by the method described above.

[0018] The use of a pharmaceutical composition for treating allergic rhinitis in the preparation of a medicament for treating and / or preventing allergic rhinitis.

[0019] In summary, this application has the following beneficial effects:

[0020] This application selects Astragalus membranaceus and Magnolia biondii as the principal herbs. The combination of the two directly targets the core pathogenesis and main symptoms of allergic rhinitis. Astragalus membranaceus has the core function of tonifying qi and consolidating the exterior. By tonifying the qi of the lungs and spleen, it strengthens the body's barrier against external pathogens and reduces the induction of allergic reactions from the root. Magnolia biondii, as a classic herb for clearing nasal passages, can quickly penetrate the nasal congestion barrier and relieve nasal obstruction. The two herbs, one tonifying and the other clearing, target the core causes and symptoms respectively, forming the core framework of the treatment. The assistant herbs are Atractylodes macrocephala, Saposhnikovia divaricata, Xanthium sibiricum, and Poria cocos, which precisely assist the principal herbs to amplify their therapeutic effects. Atractylodes macrocephala and Poria cocos focus on strengthening the spleen and eliminating dampness. Atractylodes macrocephala strengthens the spleen and promotes the production of qi and blood, while Poria cocos eliminates dampness and removes phlegm and dampness from the body. It strengthens the qi-tonifying and exterior-strengthening effects of Astragalus membranaceus from the perspective of the internal organs, preventing repeated deficiencies of vital energy. Saposhnikovia divaricata can remove wind-evil from the surface of the body. When combined with Magnolia biondii, it can enhance the effect of dispelling wind and opening the orifices, quickly relieving allergy symptoms such as nasal itching and sneezing. Xanthium sibiricum can help Magnolia biondii overcome stubborn nasal congestion and improve problems such as runny nose and decreased sense of smell. The two herbs strengthen the therapeutic effect of the principal herbs from the perspective of eliminating pathogens. The adjuvant herbs are peppermint, honeysuckle, and cicada slough. Peppermint neutralizes the pungent and warm properties of magnolia flower and cocklebur, preventing dryness and discomfort of the nasal mucosa from long-term use. Its cooling properties also clear the head and eyes, relieving dizziness and headache associated with rhinitis. Honeysuckle targets the heat symptoms of redness and congestion in the nasal mucosa, exerting a heat-clearing and anti-inflammatory effect, suitable for the local inflammatory manifestations during acute attacks of allergic rhinitis. Cicada slough is specifically designed to dispel wind and relieve itching, quickly alleviating unbearable nasal itching. Its light and upward-floating nature guides the entire formula's medicinal power to concentrate on the nasal passages, increasing the local drug concentration. The guiding herb is licorice, which plays a crucial role in harmonizing the entire formula and ensuring medication safety. It harmonizes the cold and hot properties of the principal, assistant, and adjuvant herbs, allowing different effects such as tonifying qi, opening nasal passages, and clearing heat to work synergistically without conflict. It also mitigates the potential irritation of cocklebur, reducing the burden on the gastrointestinal tract and significantly improving the safety and tolerability of the medication. This combination of icariin and Cyclocarya paliurus flavonoids, synergistically integrated with traditional Chinese medicine (TCM) compositions, addresses both the symptoms and the root cause. The TCM focuses on strengthening the body's resistance, clearing the nasal passages, dispelling wind, and reducing inflammation, addressing both organ dysfunction and local symptom relief. Icariin regulates immunity and inhibits inflammatory factors, while Cyclocarya paliurus flavonoids provide antioxidant benefits and improve nasal mucosal microcirculation. The synergistic effect of these three ingredients broadens the scope of their therapeutic action. This approach enhances the anti-inflammatory and anti-allergic effects of TCM while simultaneously providing rapid relief from nasal congestion and itching through immune regulation and local mucosal protection, reducing the recurrence of allergies. Furthermore, all ingredients are natural, and their synergistic effect reduces the dosage of any single ingredient, improving safety and tolerability, and achieving a synergistic therapeutic effect.

[0021] This application uses a combination of four bacteria—Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis—for fermentation. Through the functional complementarity and synergistic effect among the bacterial strains, a comprehensive upgrade is achieved in terms of component transformation, efficacy enhancement, process adaptation, and clinical efficacy. First, the four bacterial strains work synergistically to break down the release barriers of traditional Chinese medicine components, improving bioavailability. *Bacillus polymyxa* secretes cellulase and protease during the aerobic stage, working in conjunction with the previously synthesized enzymes to efficiently degrade the plant cell walls and insoluble polysaccharides of mixed herbal medicine A. *Lactobacillus plantarum* produces lactic acid during the anaerobic stage, regulating the system's pH and creating a suitable environment for component transformation, while also assisting in the decomposition of small molecule substrates. *Candida utilis* and *Rhodotorula glutinis*, through their fungal metabolic characteristics, transform astragalus polysaccharides and glycyrrhizic acid into more easily absorbed derivatives, significantly improving the dissolution rate and activity of core active ingredients, solving the problem of low bioavailability in traditional Chinese medicine. Second, the combined fermentation of the four bacterial strains not only preserves the basic anti-inflammatory, anti-allergic, and immunomodulatory effects of traditional Chinese medicine but also synergistically produces multiple metabolites. Short-chain fatty acids from *Lactobacillus plantarum* can regulate the nasal mucosal immune microenvironment, antimicrobial peptides from *Bacillus polymyxa* can inhibit the proliferation of harmful bacteria, and polysaccharides and flavonoids from yeast strains can enhance the body's anti-allergic response. These products complement the active ingredients of traditional Chinese medicine, quickly relieving symptoms such as runny nose and nasal itching, while also inhibiting allergic immune responses at their source, thus enriching the treatment dimensions. Furthermore, the precise adaptation to the "aerobic-anaerobic" process ensures product stability. In the aerobic stage, Bacillus polymyxa and yeast strains proliferate rapidly, with Lactobacillus plantarum dominating metabolism and synergistically transforming volatile components such as menthol and magnolia oil in the mixed herbal medicine B, preventing oxidative loss. The four strains work together to maintain system homeostasis, and the subsequent low-temperature freeze-drying process ensures product homogeneity and batch stability, supporting consistent clinical efficacy. The use of compound fermentation enriches the active ingredients and enhances their activity, making the drug superior to control formulations and positive control drugs in relieving symptoms and improving prognosis, providing a highly efficient and stable traditional Chinese medicine fermentation preparation solution for the treatment of allergic rhinitis. Detailed Implementation

[0022] The present application will be further described in detail below with reference to the embodiments.

[0023] Icariin used in the embodiments and comparative examples of this application was purchased from Wuhan Jiangxin Biotechnology Co., Ltd.; Cyclocarya paliurus flavonoids were purchased from Baoji Fangcheng Biotechnology Development Co., Ltd.; Lactobacillus plantarum (product number: B94797), Bacillus polymyxa (product number: B81089), Candida utilis (product number: B81627), and Rhodotorula glutinis (product number: B94951) were all purchased from Ningbo Mingzhou Biotechnology Co., Ltd.; cellulase (enzyme activity: 50,000 u / g) and β-mannanase (enzyme activity: 100,000 u / g) were both purchased from Jinhua Qianxun Biotechnology Co., Ltd.

[0024] Examples 1-3 provide a pharmaceutical composition for treating allergic rhinitis and a method for preparing the same.

[0025] Example 1

[0026] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, and Glycyrrhiza uralensis 4 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 10:5.

[0027] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0028] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry them at low temperature, then mix them with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 60℃ and the drying time is 10h, and the stir-frying temperature is 120℃ and the stir-frying time is 15min.

[0029] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0030] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 100:10. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃, add mixed Chinese herbal medicine B, adjust the pH value to 4.8, and perform anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 10:3:2:1.

[0031] Example 2

[0032] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 25 parts, Magnolia biondii 12 parts, Atractylodes macrocephala 16 parts, Saposhnikovia divaricata 10 parts, Xanthium sibiricum 8 parts, Poria cocos 12 parts, Mentha haplocalyx 8 parts, Lonicera japonica 10 parts, Cicadae periostracum 7 parts, and Glycyrrhiza uralensis 5 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 11:7.

[0033] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0034] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to the weight proportions, pulverize and pass through a 90-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry at low temperature, then mix with Xanthium sibiricum that has been stir-fried according to the weight proportions, pulverize and pass through a 90-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 65℃ and the drying time is 11h, and the stir-frying temperature is 130℃ and the stir-frying time is 18min.

[0035] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 45%, and enzymatically hydrolyze for 3 hours at a temperature of 48℃ and a pH of 5.2. Then, inactivate the enzyme at 95℃ for 20 minutes and cool to 36℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2.5% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 7:3.

[0036] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 110:15. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 3% of the fermentation system mass. Adjust the system moisture content to 55%. At a temperature of 30℃ and an aeration rate of 0.8 vvm, perform aerobic fermentation for 30 hours. Maintain the temperature at 30℃, add mixed Chinese herbal medicine B, adjust the pH to 5.0, and perform anaerobic fermentation for 36 hours. First, dry at a low temperature of 55℃ for 45 minutes, then freeze-dry until the moisture content is 4%. After pulverizing, pass through a 110-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 11:5:3:2.

[0037] Example 3

[0038] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 30 parts, Magnolia biondii 15 parts, Atractylodes macrocephala 20 parts, Saposhnikovia divaricata 12 parts, Xanthium sibiricum 10 parts, Poria cocos 15 parts, Mentha haplocalyx 10 parts, Lonicera japonica 12 parts, Cicadae periostracum 8 parts, and Glycyrrhiza uralensis 6 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 12:8.

[0039] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0040] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize and pass through a 100-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry at low temperature, then mix with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize and pass through a 100-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 70℃ and the drying time is 12h, and the stir-frying temperature is 140℃ and the stir-frying time is 20min.

[0041] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 50%, and enzymatically hydrolyze for 4 hours at a temperature of 50℃ and a pH of 5.5. Then, inactivate the enzyme at 100℃ for 25 minutes and cool to 37℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 3% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 8:4.

[0042] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 120:25. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 4% of the fermentation system mass. Adjust the system water content to 60%. At a temperature of 32℃ and an aeration rate of 1.0 vvm, perform aerobic fermentation for 36 hours. Maintain the temperature at 32℃, add mixed Chinese herbal medicine B, adjust the pH to 5.2, and perform anaerobic fermentation for 48 hours. First, dry at a low temperature of 60℃ for 60 minutes, then freeze-dry until the water content is 3%. After pulverizing, pass through a 120-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 12:6:4:3.

[0043] Comparative Example 1

[0044] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, and Glycyrrhiza uralensis 4 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 10:5.

[0045] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0046] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry them at low temperature, then mix them with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 60℃ and the drying time is 10h, and the stir-frying temperature is 120℃ and the stir-frying time is 15min.

[0047] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0048] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 100:10. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃, add mixed Chinese herbal medicine B, adjust the pH value to 4.8, and perform anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 10:2:1.

[0049] Comparative Example 2

[0050] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, and Glycyrrhiza uralensis 4 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 10:5.

[0051] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0052] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry them at low temperature, then mix them with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 60℃ and the drying time is 10h, and the stir-frying temperature is 120℃ and the stir-frying time is 15min.

[0053] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0054] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 100:10. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃, add mixed Chinese herbal medicine B, adjust the pH to 4.8, and perform anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, and Rhodotorula glutinis with an effective live bacteria ratio of 10:3:1.

[0055] Comparative Example 3

[0056] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, and Glycyrrhiza uralensis 4 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 10:5.

[0057] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0058] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry them at low temperature, then mix them with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 60℃ and the drying time is 10h, and the stir-frying temperature is 120℃ and the stir-frying time is 15min.

[0059] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0060] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to be 100:10. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to be 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃, add mixed Chinese herbal medicine B, adjust the pH value to 4.8, and perform anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, and Candida utilis with an effective live bacteria ratio of 10:3:2:1.

[0061] Comparative Example 4

[0062] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, and Glycyrrhiza uralensis 4 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 10:5.

[0063] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0064] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to the weight proportions, pulverize and pass through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; mix Magnolia biondii and Mentha haplocalyx, pulverize and pass through an 80-mesh sieve to obtain mixed Chinese herbal medicine B;

[0065] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0066] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 100:10. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃, add mixed Chinese herbal medicine B, adjust the pH value to 4.8, and perform anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 10:3:2:1.

[0067] Comparative Example 5

[0068] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, Glycyrrhiza uralensis 4 parts; the synergistic agent is Cyclocarya paliurus flavonoids.

[0069] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0070] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry them at low temperature, then mix them with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 60℃ and the drying time is 10h, and the stir-frying temperature is 120℃ and the stir-frying time is 15min.

[0071] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0072] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 100:10. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃, add mixed Chinese herbal medicine B, adjust the pH value to 4.8, and perform anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 10:3:2:1.

[0073] Comparative Example 6

[0074] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, Glycyrrhiza uralensis 4 parts; the synergistic agent is icariin.

[0075] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0076] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry them at low temperature, then mix them with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 60℃ and the drying time is 10h, and the stir-frying temperature is 120℃ and the stir-frying time is 15min.

[0077] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0078] Step 3: Control the mass ratio of enzymatic hydrolysis product to pharmacodynamic synergist to 100:10. Add pharmacodynamic synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃, add mixed Chinese herbal medicine B, adjust the pH value to 4.8, and perform anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 10:3:2:1.

[0079] Comparative Example 7

[0080] A pharmaceutical composition for treating allergic rhinitis includes a traditional Chinese medicine composition and a synergistic agent; wherein the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 18 parts, Magnolia biondii 10 parts, Atractylodes macrocephala 12 parts, Saposhnikovia divaricata 8 parts, Xanthium sibiricum 6 parts, Poria cocos 10 parts, Mentha haplocalyx 6 parts, Lonicera japonica 8 parts, Cicadae periostracum 5 parts, and Glycyrrhiza uralensis 4 parts; the synergistic agent is composed of icariin and Cyclocarya paliurus flavonoids in a mass ratio of 10:5.

[0081] A method for preparing a pharmaceutical composition for treating allergic rhinitis includes the following preparation steps:

[0082] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine A; Mix Magnolia biondii and Mentha haplocalyx and dry them at low temperature, then mix them with Xanthium sibiricum that has been stir-fried according to their weight proportions, pulverize them and pass them through an 80-mesh sieve to obtain mixed Chinese herbal medicine B. The low temperature drying temperature is 60℃ and the drying time is 10h, and the stir-frying temperature is 120℃ and the stir-frying time is 15min.

[0083] Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, adjust the water content of the system to 40%, and enzymatically hydrolyze for 2 hours at a temperature of 45℃ and a pH of 5.0. Then, inactivate the enzyme at 90℃ for 15 minutes and cool to 35℃ to obtain the enzymatic hydrolysis product. The amount of compound enzyme added is 2% of the mass of mixed Chinese herbal medicine A. The compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5:1.

[0084] Step 3: Control the mass ratio of enzymatic hydrolysis product to fermentation auxiliary components to be 100:10. Add a pharmacodynamic synergist and mixed Chinese herbal medicine B to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, controlling the inoculation amount of compound microorganisms to be 1% of the mass of the fermentation system. Adjust the water content of the system to 50%. At a temperature of 28℃ and an aeration rate of 0.5 vvm, perform aerobic fermentation for 24 hours. Maintain the temperature at 28℃ and adjust the pH to 4.8 for anaerobic fermentation for 24 hours. First, dry at a low temperature of 50℃ for 30 minutes, then freeze-dry until the water content is 5%. After pulverizing, pass through a 100-mesh sieve to obtain a drug composition for treating allergic rhinitis. The compound microorganisms consist of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis, and Rhodotorula glutinis with an effective live bacteria ratio of 10:3:2:1.

[0085] Performance testing

[0086] The performance of the pharmaceutical compositions for treating allergic rhinitis prepared in Examples 1-3 and Comparative Examples 1-7 of this application was tested, as follows:

[0087] Animal selection and preparation: 240 five-week-old female SPF mice, weighing 18-22g, were selected and acclimatized for 7 days. During this period, the mice had free access to food and water. The ambient temperature was controlled at 22±2℃, the humidity at 50-60%, and the photoperiod was 12h / 12h to eliminate the interference of stress and potential diseases on the experiment.

[0088] Preparation of antigen-adjuvant suspension: 25 μg ovalbumin (OVA) and 1 mg aluminum hydroxide adjuvant were fully suspended in 200 μL PBS solution, vortexed until uniformly suspended, stored at 4°C in the dark, and prepared fresh before use.

[0089] Modeling: A "peritoneal sensitization + nasal challenge" modeling procedure was adopted, with the specific time points as follows: Sensitization phase: On days 0, 7, and 14, mice were intraperitoneally injected with the above-mentioned OVA-aluminum hydroxide suspension, 200 μL per mouse per injection, to induce a specific immune response. Challenge phase: Starting from day 21, 1% OVA solution (5 μL per nostril) was instilled into the nasal cavity of mice daily for 7 consecutive days to directly stimulate the nasal mucosa and induce allergic inflammation.

[0090] After modeling, the success of the model was determined by a comprehensive assessment of the indicators in Table 1: Behavioral score: Referring to the standards in Table 1, a behavioral score ≥6 points in mice indicated significant nasal allergy symptoms. Serum IgE level: The total serum IgE content was detected using ELISA. If the IgE level in the model group was more than twice that of the normal control group, it indicated activation of the allergic immune response.

[0091] Group design: The successfully modeled allergic rhinitis mice were randomly divided into 12 groups of 20 mice each. The specific groups are as follows: positive control group (loratadine intervention group), blank control group, Example 1-3 groups, and Comparative Examples 1-7 groups. For Example 1-3 groups and Comparative Examples 1-7 groups, the corresponding drug compositions were prepared into 5% homogeneous aqueous solutions. The homogeneity of the system was ensured by vortexing and sterile filtration to avoid interference from differences in drug distribution on the experimental results.

[0092] Administration method and dosage: The positive control group was given loratadine solution by gavage at a dose of 3 mg / kg. The dosage was calculated precisely based on the individual body weight of the mice to ensure the consistency of the dosage within the group.

[0093] Examples 1-3 and Comparative Examples 1-7: Each mouse was administered 0.6 mL of the corresponding group's 5% drug composition aqueous solution by gavage each time.

[0094] Blank control group: Each mouse was given an equal volume of physiological saline (0.6 mL) by gavage each time to exclude experimental interference from the gavage procedure and the solvent itself.

[0095] All treatment groups received the drug via gavage three times daily for 10 consecutive days. After the treatment period, behavioral scores and serum IgE levels were measured. The behavioral scoring criteria are shown in Table 1.

[0096] The test results are shown in Table 2.

[0097] Table 1 Behavioral Scoring Criteria

[0098] Table 2 Comparison of behavioral and blood IgE levels in mice with allergic rhinitis from different treatment groups

[0099]

[0100] As shown in Tables 1-2, the allergic rhinitis drug composition prepared in this application can significantly improve allergic symptoms in mice. The behavioral scores of the example group were significantly lower than those of the blank control group, the comparative group, and the positive control group; their serum IgE levels were also significantly lower than those of the blank control group, the comparative group, and the positive control group. This indicates that the drug composition can effectively alleviate behavioral symptoms such as nose scratching, sneezing, and runny nose in mice with allergic rhinitis, and inhibit allergy-related IgE immune responses, demonstrating significant advantages in the treatment of allergic rhinitis.

[0101] Clinical application research

[0102] A total of 330 patients aged 8-16 years with allergic rhinitis, half male and half female, were selected, in accordance with the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022, Revised Edition)". Patients presented with runny nose, nasal itching, sneezing, and dizziness as their main symptoms, with a disease duration of ≥3 months. Patients with concurrent sinusitis, nasal polyps, asthma, or other respiratory diseases were excluded, as were those with severe liver or kidney dysfunction, immunodeficiency, or who had used other anti-allergy medications within the past month. All participants voluntarily participated in the study and signed informed consent forms.

[0103] The experiment was divided into 11 groups, with 30 patients in each group. The specific protocols were as follows: Positive control group: oral loratadine tablets (10mg / tablet), one tablet daily, taken on an empty stomach before bedtime. Examples 1-3 and Comparative Examples 1-7: taking the drug compositions corresponding to Examples 1-3 and Comparative Examples 1-7 of this application (8 grams per dose based on raw drug), three times daily, taken with warm water 30 minutes before meals. Symptom comprehensive scoring and grading were used, as follows: Marked effect: symptom scores such as runny nose, nasal itching, sneezing, and dizziness decreased by ≥70% compared to before treatment, symptoms basically disappeared, and did not affect daily learning; Effective: symptom scores decreased by 30%-70% compared to before treatment, symptoms were somewhat relieved, and the impact on daily learning was reduced; Ineffective: symptom scores decreased by <30% compared to before treatment, or symptoms worsened, and the impact on daily learning was not improved; symptom scoring used a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe), and the scores for the four categories of symptoms were summed.

[0104] The experimental period and records were conducted as a 20-day clinical study. Symptom scores were recorded on day 0 (baseline), day 10, and day 20 of treatment. The efficacy was determined based on the results on day 20. The number of cases with significant effect, effective, and ineffective in each group and the total effective rate (significant effect + effective) were statistically analyzed.

[0105] Table 3 Comparison of clinical trial results among different treatment groups

[0106] As shown in Table 3, the pharmaceutical composition for treating allergic rhinitis prepared in this application has significant therapeutic effects. The total effective rate of groups 1-3 reached 90-96.7%, with group 2 reaching as high as 96.7%, all of which were superior to the comparative group and overall superior to the positive control group. This indicates that the pharmaceutical composition can more effectively relieve patients' symptoms, has a high rate of significant efficacy, and its therapeutic effect is superior to the control formulation and positive drug, demonstrating outstanding advantages in clinical application.

[0107] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A method for preparing a pharmaceutical composition for treating allergic rhinitis, characterized by, The preparation steps include the following: Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Saposhnikovia divaricata, Poria cocos, Lonicera japonica, Cicadae periostracum, and Glycyrrhiza uralensis, grind and sieve to obtain mixed Chinese herbal medicine A; mix Magnolia biondii and Mentha haplocalyx, dry at low temperature, mix with Xanthium sibiricum that has been stir-fried, grind and sieve to obtain mixed Chinese herbal medicine B; Step 2: Add compound enzyme and purified water to mixed Chinese herbal medicine A, enzymatically hydrolyze for 2-4 hours, and after enzyme inactivation treatment, cool to obtain the enzymatic hydrolysis product; Step 3: Add a pharmacological synergist to the enzymatic hydrolysis product to obtain a fermentation system. Inoculate the fermentation system with compound microorganisms, adjust the water content of the system, and first perform aerobic fermentation for 24-36 hours. Then add mixed Chinese herbal medicine B and perform anaerobic fermentation for 24-48 hours. First dry at low temperature, then freeze dry until the water content is ≤5%. After pulverizing, sieve to obtain a pharmaceutical composition for treating allergic rhinitis. In step 2, the amount of the compound enzyme added is 2-3% of the mass of the mixed Chinese herbal medicine A; the compound enzyme is composed of cellulase and β-mannanase in a mass ratio of 5-8:1-4. In step 3, the synergistic agent is composed of icariin and cyclocarya flavonoids in a mass ratio of 10-12:5-8. In step 3, the mass ratio of the enzymatic hydrolysis product to the pharmacodynamic synergist is 100-120:10-25. In step 3, the inoculation amount of the compound microorganism is 1-4% of the mass of the fermentation system. The compound microorganism consists of Lactobacillus plantarum, Bacillus polymyxa, Candida utilis and Rhodotorula glutinis with an effective viable count ratio of 10-12:3-6:2-4:1-3. The weight parts of each raw material in step 1 are as follows: Astragalus membranaceus 18-30 parts, Atractylodes macrocephala 12-20 parts, Saposhnikovia divaricata 8-12 parts, Poria cocos 10-15 parts, Lonicera japonica 8-12 parts, Cicadae periostracum 5-8 parts, Glycyrrhiza uralensis 4-6 parts, Magnolia biondii 10-15 parts, Mentha haplocalyx 6-10 parts, Xanthium sibiricum 6-10 parts.

2. The method of claim 1, wherein the pharmaceutical composition for treating allergic rhinitis is prepared by mixing the active ingredient and the pharmaceutically acceptable carrier. The weight parts of each raw material in step 1 are as follows: Astragalus membranaceus 25 parts, Atractylodes macrocephala 16 parts, Saposhnikovia divaricata 10 parts, Poria cocos 12 parts, Lonicera japonica 10 parts, Cicadae periostracum 7 parts, Glycyrrhiza uralensis 5 parts, Magnolia biondii 12 parts, Mentha haplocalyx 8 parts, Xanthium sibiricum 8 parts.

3. A pharmaceutical composition for treating allergic rhinitis prepared by the method of preparing the pharmaceutical composition for treating allergic rhinitis according to any one of claims 1-2.

4. Use of the pharmaceutical composition for treating allergic rhinitis according to claim 3 in the preparation of a medicament for treating and / or preventing allergic rhinitis.

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