Traditional Chinese medicine composition for treating rhinitis and preparation method thereof

Abstract

The invention relates to the technical field of biological medicines, and discloses a traditional Chinese medicine composition for treating rhinitis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 1 to 8 parts of fructus xanthii, 3 to 8 parts of flos magnoliae, 5 to 20 parts of radix saposhnikoviae, 15 to 20 parts of herba menthae, 5 to 10 parts of radix scutellariae, 1 to 10 parts of periostracum cicadae, 1 to 5 parts of fructus arctii, 0.5 to 4 parts of trametes robiniophila mycoplasm, 0.01 to 0.1 part of zinc oxide nanoparticles, 12 to 20 parts of hydroxymethyl chitosan, 2 to 5 parts of poloxamer 407 and 1 to 3 parts of poloxamer 188. According to the traditional Chinese medicine composition for treating rhinitis and the preparation method, the trametes robiniophila mycoplasm and the zinc oxide nanoparticles cooperate with the fructus xanthii, the flos magnoliae, the radix saposhnikoviae, the herba menthae, the radix scutellariae, the periostracum cicada and the fructus arctii to jointly treat allergic rhinitis. The traditional Chinese medicine and western medicine combined method is adopted, inflammatory response is relieved, the immunologic function of a patient is enhanced, meanwhile, medicine use is reduced, and wide application prospects are achieved.

Description

Technical Field

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

[0002] Allergic rhinitis (AR) is an allergic disease involving multiple cells and cellular components. The main symptoms include paroxysmal sneezing, runny nose, nasal congestion, and nasal itching; some patients also experience itchy eyes, tearing, and itchy palate. The pathological mechanism of allergic rhinitis is complex, generally considered to be a type I hypersensitivity reaction mediated by IgE antibodies, but its clinical course often presents as a chronic, persistent condition. The process consists of two phases: an immediate reaction phase and a delayed reaction phase. Due to the unclear and complex pathogenesis, there are still no drugs or therapies with definitive efficacy and few side effects. Western medicine treatments for allergic rhinitis mainly include drug therapy, immunotherapy, and surgery, primarily targeting the reduction of inflammatory responses and eosinophilic lesion (EOS) infiltration. Glucocorticoids are the main representative drugs clinically. Western medicine treatment can provide temporary symptom relief, but it has drawbacks such as easy dependence, drug resistance, and significant adverse reactions. The combination of traditional Chinese and Western medicine in treating allergic rhinitis can not only clear the nasal passages and alleviate symptoms of stagnation and heat in the gallbladder meridian, but also provide significant improvement in symptoms with Western medicine and Chinese medicine with good anti-inflammatory, anti-allergic, and anti-edema effects. It is relatively safe, does not cause drug dependence, has almost no adverse reactions, and has a synergistic effect. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition and preparation method for treating rhinitis, which not only reduces inflammatory response and enhances the patient's immune function, but also reduces drug use, and has broad application prospects.

[0004] To achieve the above objectives, on the one hand, the present invention provides a traditional Chinese medicine composition for treating rhinitis, comprising the following components in parts by weight: 1-8 parts of Xanthium sibiricum, 3-8 parts of Magnolia biondii, 5-20 parts of Saposhnikovia divaricata, 15-20 parts of Mentha haplocalyx, 5-10 parts of Scutellaria baicalensis, 1-10 parts of Cicadae periostracum, 1-5 parts of Arctium lappa, 0.5-4 parts of Sophora japonica mycelium, 0.01-0.1 parts of zinc oxide nanoparticles, 12-20 parts of hydroxymethyl chitosan, 2-5 parts of poloxamer 407, and 1-3 parts of poloxamer 188.

[0005] Furthermore, the traditional Chinese medicine composition comprises the following components in parts by weight: 6-8 parts of Xanthium sibiricum, 3-5 parts of Magnolia biondii, 5-10 parts of Saposhnikovia divaricata, 15-18 parts of Mentha haplocalyx, 5-7 parts of Scutellaria baicalensis, 1-4 parts of Cicadae periostracum, 1-3 parts of Arctium lappa, 0.5-2 parts of Sophora japonica mycelium, 0.01-0.05 parts of zinc oxide nanoparticles, 12-15 parts of hydroxymethyl chitosan, 2-3 parts of poloxamer 407, and 1-2 parts of poloxamer 188.

[0006] Further, the preparation method of the zinc oxide nanoparticles is as follows: under vigorous stirring, sodium hydroxide solution is slowly added dropwise to a mixed solution of zinc acetate and sodium citrate. The reaction temperature is 60-80℃, and the reaction is carried out continuously for 1-4 hours. After the reaction is completed, the mixture is naturally cooled to room temperature, centrifuged at 12000 rpm for 15 min to obtain a precipitate, washed 5 times with ultrapure water, washed once with anhydrous ethanol, and freeze-dried to obtain zinc oxide nanoparticles ZnO NPs modified with sodium citrate surface.

[0007] Furthermore, in the mixed solution of zinc acetate and sodium citrate, the zinc ion concentration is 0.04 mol / L, the sodium citrate concentration is 0.004 mol / L, and the sodium hydroxide solution concentration is 0.08 mol / L.

[0008] On the other hand, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: Step 1: Wash, dry, and crush Xanthium sibiricum, Saposhnikovia divaricata, Scutellaria baicalensis and Arctium lappa. Add distilled water and inoculate with Lactobacillus plantarum and Bacillus subtilis for fermentation. After fermentation, filter to obtain fermentation liquid. Step 2: Wash, dry, and crush the magnolia flower, peppermint, and cicada molting. Add water and decoct 1-2 times. Combine the decoctions, concentrate to obtain an extract, and cool to room temperature. Step 3: Dissolve the extract in the fermentation broth, then add the Sophora japonica mycelium, stir well, shake and culture, and filter to obtain the filtrate; Step 4: Take the filtrate and slowly add zinc oxide nanoparticles, magnesium hydroxide nanoparticles, hydroxymethyl chitosan, poloxamer 407 and poloxamer 188 in sequence. Mix well and react to obtain the traditional Chinese medicine composition.

[0009] Furthermore, in step 1, the total mass of Xanthium sibiricum, Saposhnikovia divaricata, Scutellaria baicalensis, and Arctium lappa to the solid-liquid ratio of distilled water is 1:10-20; the fermentation temperature is 35-37℃, and the fermentation time is 24-48 hours; the inoculum size of Lactobacillus plantarum and Bacillus subtilis is 1%, and the viable count is not less than 1×10⁻⁶. 8 CFU / mL.

[0010] Furthermore, in step 2, the ratio of ingredients to liquid during decocting is 1:10-15, the decocting time for each time does not exceed 60 minutes, and the soaking time after decocting is not less than 45 minutes.

[0011] Furthermore, in step 3, the shaking culture time is 2-6 hours.

[0012] Furthermore, in step 4, the reaction conditions are: temperature 2-4℃, time 24h.

[0013] On the other hand, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of drugs for relieving, improving and treating allergic rhinitis.

[0014] The advantages and positive effects of the traditional Chinese medicine composition for treating rhinitis and its preparation method described in this invention are as follows: 1. In this invention, Xanthium sibiricum and Magnolia biondii are pungent and warm, directly acting on the nasal passages to relieve nasal congestion and reduce secretions. Saposhnikovia divaricata dispels wind and releases the exterior, eliminates dampness and relieves itching, thus alleviating nasal itching and sneezing. Mentha haplocalyx is pungent and cool, dispersing wind-heat, clearing the head and eyes, providing a cooling sensation and quickly relieving nasal congestion and discomfort. Cicada slough disperses wind-heat, benefits the throat and voice; modern research has confirmed its clear anti-allergic and antihistamine effects, stabilizing mast cell membranes and reducing the core aspects of allergic reactions. Arctium lappa disperses wind-heat, clears the lungs and benefits the throat, and assists in clearing heat toxins. Scutellaria baicalensis is bitter and cold, clearing heat and drying dampness, purging fire and detoxifying. Rich in baicalin and other components, it has powerful anti-inflammatory, antioxidant, and anti-allergic effects, inhibiting various inflammatory factors. Sophora japonica mycelium is a fungal medicinal material with the effects of strengthening the body's resistance, promoting blood circulation and removing blood stasis. Modern research indicates that its polysaccharide components can regulate immunity, exerting an anti-allergic effect by balancing Th1 / Th2 cytokines (a key regulatory pathway for allergic reactions). Simultaneously, the addition of zinc oxide nanoparticles reduces nasal mucosal exudation; these nano-sized particles, with their large specific surface area, enhance contact and adsorption with the mucosa.

[0015] 2. This invention combines a temperature-sensitive gel with a bioadhesive material (hydroxymethyl chitosan), allowing the drug to remain in the nasal cavity for several hours or even longer. At the same time, the zinc oxide nanoparticles in the gel form a protective film on the surface of the nasal mucosa, which provides a certain physical barrier or adsorption effect on inhaled allergens (such as pollen and dust mites).

[0016] The technical solution of the present invention will be further described in detail below through embodiments. Detailed Implementation

[0017] The technical solution of the present invention will be further described below through embodiments.

[0018] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0019] Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this invention. Experimental methods in the following embodiments that do not specify specific conditions are generally determined according to national standards. Experimental instruments, equipment, and reagents in the following embodiments that do not specify their sources are all commercially available materials.

[0020] Unless otherwise defined or stated, all technical and scientific terms used in this invention have the same meaning as those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to the methods of this invention.

[0021] The Xanthium sibiricum, Magnolia biondii, Saposhnikovia divaricata, Mentha haplocalyx, Scutellaria baicalensis, Cicadae periostracum, and Arctium lappa in this invention are processed traditional Chinese medicine products purchased from the market. The mycelium of *Sophora japonica* is approved under the national drug approval number Z20000108. *Lactobacillus plantarum* is identified as *Lactobacillus plantarum* CICC20340, and *Bacillus subtilis* is identified as *Bacillus subtilis* CICC 20522.

[0022] Example 1 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 3 parts Xanthium sibiricum, 5 parts Magnolia biondii, 15 parts Saposhnikovia divaricata, 16 parts Mentha haplocalyx, 8 parts Scutellaria baicalensis, 6 parts Cicadae periostracum, 3 parts Arctium lappa, 2 parts Sophora japonica fungus, 0.05 parts zinc oxide nanoparticles, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188.

[0023] The zinc oxide nanoparticles were prepared as follows: Sodium hydroxide solution was slowly added dropwise to a mixed solution of zinc acetate and sodium citrate under vigorous stirring. The reaction temperature was 70℃, and the reaction was continued for 3 hours. After the reaction was completed, the mixture was naturally cooled to room temperature, centrifuged at 12000 rpm for 15 minutes to obtain a precipitate, washed five times with ultrapure water and once with anhydrous ethanol, and then freeze-dried to obtain zinc oxide nanoparticles (ZnO NPs) modified with sodium citrate. In the mixed solution of zinc acetate and sodium citrate, the zinc ion concentration was 0.04 mol / L, the sodium citrate concentration was 0.004 mol / L, and the sodium hydroxide solution concentration was 0.08 mol / L.

[0024] A method for preparing a traditional Chinese medicine composition for treating rhinitis includes the following steps: Step 1: Wash, dry, and crush Xanthium sibiricum, Saposhnikovia divaricata, Scutellaria baicalensis, and Arctium lappa. Add distilled water (solid-liquid ratio 1:20) and inoculate with 1% Lactobacillus plantarum CICC 20340 and 1% Bacillus subtilis CICC 20522 for fermentation (live count not less than 1×10⁻⁶). 8 (CFU / mL), fermentation temperature 35-37℃, fermentation time 24h, after fermentation, the fermentation broth was obtained by filtration; Step 2: Wash, dry, and crush the magnolia flower, peppermint, and cicada molting. Add water and decoct twice, 60 minutes each time. After decoction, soak for 45 minutes. The ratio of material to liquid during decoction is 1:15. Combine the decoctions, concentrate to obtain extract, and cool to room temperature. Step 3: Dissolve the extract in the fermentation broth, then add the Sophora japonica mycelium, stir well, shake and incubate for 4 hours, and filter to obtain the filtrate; Step 4: Take the filtrate and slowly add zinc oxide nanoparticles, magnesium hydroxide nanoparticles, hydroxymethyl chitosan, poloxamer 407 and poloxamer 188 in sequence. Mix well and react at 2-4℃ for 24 hours to obtain the traditional Chinese medicine composition.

[0025] Example 2 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 5 parts Xanthium sibiricum, 3 parts Magnolia biondii, 13 parts Saposhnikovia divaricata, 15 parts Mentha haplocalyx, 7 parts Scutellaria baicalensis, 3 parts Cicadae periostracum, 1 part Arctium lappa, 0.5 parts Sophora japonica mycelium, 0.06 parts zinc oxide nanoparticles, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188. The remaining preparation methods are the same as in Example 1.

[0026] Example 3 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 4 parts Xanthium sibiricum, 4 parts Magnolia biondii, 11 parts Saposhnikovia divaricata, 17 parts Mentha haplocalyx, 5 parts Scutellaria baicalensis, 7 parts Cicadae periostracum, 2 parts Arctium lappa, 1.5 parts Sophora japonica mycelium, 0.04 parts zinc oxide nanoparticles, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188. The remaining preparation methods are the same as in Example 1.

[0027] Example 4 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 2 parts Xanthium sibiricum, 7 parts Magnolia biondii, 12 parts Saposhnikovia divaricata, 18 parts Mentha haplocalyx, 6 parts Scutellaria baicalensis, 5 parts Cicadae periostracum, 3 parts Arctium lappa, 1 part Sophora japonica mycelium, 0.03 parts zinc oxide nanoparticles, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188. The remaining preparation methods are the same as in Example 1.

[0028] Example 5 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 1 part Xanthium sibiricum, 6 parts Magnolia biondii, 9 parts Saposhnikovia divaricata, 19 parts Mentha haplocalyx, 9 parts Scutellaria baicalensis, 4 parts Cicadae periostracum, 4 parts Arctium lappa, 2 parts Sophora japonica mycelium, 0.07 parts zinc oxide nanoparticles, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188. The remaining preparation method is the same as in Example 1.

[0029] Comparative Example 1 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 3 parts Xanthium sibiricum, 5 parts Magnolia biondii, 15 parts Saposhnikovia divaricata, 16 parts Mentha haplocalyx, 8 parts Scutellaria baicalensis, 6 parts Cicadae periostracum, 3 parts Arctium lappa, 0.05 parts zinc oxide nanoparticles, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188. The remaining preparation method is the same as in Example 1.

[0030] Comparative Example 2 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 3 parts Xanthium sibiricum, 5 parts Magnolia biondii, 15 parts Saposhnikovia divaricata, 16 parts Mentha haplocalyx, 8 parts Scutellaria baicalensis, 6 parts Cicadae periostracum, 3 parts Arctium lappa, 2 parts Sophora japonica mycelium, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188. The remaining preparation method is the same as in Example 1.

[0031] Comparative Example 3 A traditional Chinese medicine composition for treating rhinitis comprises the following components in parts by weight: 3 parts Xanthium sibiricum, 5 parts Magnolia biondii, 15 parts Saposhnikovia divaricata, 16 parts Mentha haplocalyx, 8 parts Scutellaria baicalensis, 6 parts Cicadae periostracum, 3 parts Arctium lappa, 13 parts hydroxymethyl chitosan, 3 parts poloxamer 407, and 2 parts poloxamer 188. The remaining preparation method is the same as in Example 1.

[0032] The specific proportions of each component in Examples 1-5 and Comparative Examples 1-3 are shown in Table 1: Table 1 shows the specific quantities of each component in Examples 1-5 and Comparative Examples 1-3.

[0033] Test Example 1 Experimental animals and grouping: Female SD rats, weighing 220-250g, 3-8 weeks old, were randomly divided into 10 groups: healthy group, Examples 1-5, Comparative Examples 1-3, and model group. All rats were housed in a room with suitable temperature and humidity (22±2℃, 55±10% relative humidity) under 12-hour dark-light cycles. All animals were given standard commercial pelleted feed and water freely. They were acclimatized to the environment for 7 days before the experiment.

[0034] Model construction: Rat sensitization was induced using ovalbumin (OVA) to construct an AR animal model. The process consisted of the following three stages: (1) Basic sensitization (d1~d14): A suspension containing 0.3 mg OVA + 30 mg Al(OH)3 per ml of physiological saline was prepared and injected intraperitoneally at 1 mL every other day for a total of 7 doses. The control group was injected intraperitoneally with 1 mL of physiological saline.

[0035] (2) Activation phase (d15~d21): 1 mL of 10% OVA suspension was dripped into each nostril of each group of rats once a day for a total of 7 times.

[0036] After allergen stimulation on day 21, nasal symptoms such as nose scratching, sneezing, and nasal secretions were observed in rats within 30 minutes. Based on behavioral criteria scoring (Table 2), a total score >5 was considered a successful model.

[0037] Table 2 Behavioral Standard Scoring

[0038] (3) Drug treatment (d22~d50): The traditional Chinese medicine composition prepared at 10mL / kg was sprayed into the nose in groups 1-5 of Examples and groups 1-3 of Comparative Examples. The model group and healthy group rats were given an equal amount of physiological saline for 28 consecutive days.

[0039] 1. Behavioral symptom observation: After the experiment, the mice were observed and scored for symptoms such as sneezing, runny nose, and nose scratching. The behavioral symptom scoring criteria for mice are shown in Table 2. The results are shown in Table 3.

[0040] Table 3 Scoring Results

[0041] As shown in Table 3, the traditional Chinese medicine compositions prepared in Examples 1-3 can significantly improve the symptoms of nose scratching, sneezing and runny nose in rats with rhinitis, indicating that the traditional Chinese medicine compositions prepared in Examples 1-3 have a good therapeutic effect on rhinitis.

[0042] 2. Serum levels of tumor necrosis factor-α (TNF-α), interleukin-4 (IL-4), and transforming growth factor-β1 (TGF-β1) were detected by ELISA. Blood samples were collected from the tail vein of rats, and plasma was separated by centrifugation. The levels of IL-4, HIS, IgE, and TNF-α in the plasma were detected by ELISA. The procedure was strictly performed according to the kit instructions (as shown in Table 4).

[0043] Table 4 Serum levels of TNF-α, IL-4, and TGF-β1

[0044] Table 4 shows that, compared with the model control group, the serum levels of TNF-α and IL-4 in rats in Examples 1-5 were significantly reduced, and the TGF-β1 level tended to normalize. This indicates that the traditional Chinese medicine compositions prepared in Examples 1-5 significantly reduced the inflammatory response, making the rats healthier and playing a role in treating rhinitis. Compared with Example 1, the serum levels of TNF-α, IL-4, and TGF-β1 in rats in Comparative Examples 1-3 were not significantly reduced, indicating that the compositions worked synergistically. The absence of Sophora japonica extract or zinc oxide nanoparticles would disrupt this synergistic mechanism.

[0045] Therefore, this invention employs the aforementioned traditional Chinese medicine composition and preparation method for treating rhinitis. *Sophora japonica* mycelium, a fermentation product of the medicinal fungus *Sophora japonica*, can regulate the Th1 / Th2 balance, helping to correct immune imbalance in allergic rhinitis. Zinc oxide nanoparticles are essential cofactors for immune-related enzymes and signaling proteins, helping to maintain immune balance. Both, in conjunction with other traditional Chinese medicine components (*Xanthium sibiricum*, *Magnolia biondii*, *Saposhnikovia divaricata*, *Mentha haplocalyx*, *Scutellaria baicalensis*, *Cicada slough*, and *Arctium lappa*), work together to treat allergic rhinitis. This invention utilizes a combination of traditional Chinese and Western medicine, not only reducing inflammatory responses and enhancing patients' immune function but also reducing drug usage, thus possessing broad application prospects.

[0046] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the technical solutions of the present invention, and these modifications or equivalent substitutions cannot cause the modified technical solutions to deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. A traditional Chinese medicine composition for treating rhinitis, characterized in that, It includes the following components by weight: Xanthium sibiricum 1-8 parts, Magnolia biondii 3-8 parts, Saposhnikovia divaricata 5-20 parts, Mentha haplocalyx 15-20 parts, Scutellaria baicalensis 5-10 parts, Cicadae periostracum 1-10 parts, Arctium lappa 1-5 parts, Sophora japonica mycelium 0.5-4 parts, zinc oxide nanoparticles 0.01-0.1 parts, hydroxymethyl chitosan 12-20 parts, poloxamer 407 2-5 parts, and poloxamer 188 1-3 parts.

2. The traditional Chinese medicine composition for treating rhinitis according to claim 1, characterized in that, It includes the following components by weight: 6-8 parts of Xanthium sibiricum, 3-5 parts of Magnolia biondii, 5-10 parts of Saposhnikovia divaricata, 15-18 parts of Mentha haplocalyx, 5-7 parts of Scutellaria baicalensis, 1-4 parts of Cicadae periostracum, 1-3 parts of Arctium lappa, 0.5-2 parts of Sophora japonica mycelium, 0.01-0.05 parts of zinc oxide nanoparticles, 12-15 parts of hydroxymethyl chitosan, 2-3 parts of poloxamer 407, and 1-2 parts of poloxamer 188.

3. The traditional Chinese medicine composition for treating rhinitis according to claim 2, characterized in that, The zinc oxide nanoparticles are prepared as follows: Sodium hydroxide solution is slowly added dropwise to a mixed solution of zinc acetate and sodium citrate under vigorous stirring. The reaction temperature is 60-80℃, and the reaction is carried out continuously for 1-4 hours. After the reaction is completed, the mixture is naturally cooled to room temperature, centrifuged at 12000 rpm for 15 minutes to obtain a precipitate, washed 5 times with ultrapure water and 1 time with anhydrous ethanol, and freeze-dried to obtain zinc oxide nanoparticles (ZnO NPs) modified with sodium citrate surface.

4. The traditional Chinese medicine composition for treating rhinitis according to claim 3, characterized in that, In a mixed solution of zinc acetate and sodium citrate, the zinc ion concentration is 0.04 mol / L, the sodium citrate concentration is 0.004 mol / L, and the sodium hydroxide solution concentration is 0.08 mol / L.

5. A method for preparing a traditional Chinese medicine composition for treating rhinitis according to any one of claims 1-4, characterized in that, Includes the following steps: Step 1: Wash, dry, and crush Xanthium sibiricum, Saposhnikovia divaricata, Scutellaria baicalensis and Arctium lappa. Add distilled water and inoculate with Lactobacillus plantarum and Bacillus subtilis for fermentation. After fermentation, filter to obtain fermentation liquid. Step 2: Wash, dry, and crush the magnolia flower, peppermint, and cicada molting. Add water and decoct 1-2 times. Combine the decoctions, concentrate to obtain an extract, and cool to room temperature. Step 3: Dissolve the extract in the fermentation broth, then add the Sophora japonica mycelium, stir well, shake and culture, and filter to obtain the filtrate; Step 4: Take the filtrate and slowly add zinc oxide nanoparticles, magnesium hydroxide nanoparticles, hydroxymethyl chitosan, poloxamer 407 and poloxamer 188 in sequence. Mix well and react to obtain the traditional Chinese medicine composition.

6. The method for preparing a traditional Chinese medicine composition for treating rhinitis according to claim 5, characterized in that: In step 1, the total mass of Xanthium sibiricum, Saposhnikovia divaricata, Scutellaria baicalensis, and Arctium lappa to distilled water has a solid-liquid ratio of 1:10-20; the fermentation temperature is 35-37℃, and the fermentation time is 24-48 hours; the inoculum size of Lactobacillus plantarum and Bacillus subtilis is 1%, and the viable count is not less than 1×10⁻⁶. 8 CFU / mL.

7. The method for preparing a traditional Chinese medicine composition for treating rhinitis according to claim 5, characterized in that: In step 2, the ratio of ingredients to liquid is 1:10-15 during decocting, and the decocting time for each time should not exceed 60 minutes. The soaking time after decocting should not be less than 45 minutes.

8. The method for preparing a traditional Chinese medicine composition for treating rhinitis according to claim 5, characterized in that: In step 3, the shaking culture time is 2-6 hours.

9. A method for preparing a traditional Chinese medicine composition for treating rhinitis according to claim 5, characterized in that, In step 4, the reaction conditions are: temperature 2-4℃, time 24h.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 5-9 in the preparation of a drug for relieving, improving and treating allergic rhinitis.

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