A traditional Chinese medicine composition for preventing and treating allergic rhinitis, a preparation method thereof and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis, its preparation method, and its application. The raw materials of the traditional Chinese medicine composition of this invention, by weight, consist of the following components: Astragalus membranaceus 20-60 parts, Angelica sinensis 10-30 parts, Saposhnikovia divaricata 10-30 parts, Atractylodes lancea 9-30 parts, Acorus tatarinowii 9-40 parts, Asarum heterotropoides 3-15 parts, Ligusticum chuanxiong 8-30 parts, and Angelica dahurica 6-20 parts. The traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis provided by this invention can strengthen the lungs and wei qi, clear nasal passages, and relieve pain and itching, exhibiting significant preventive and therapeutic effects on allergic rhinitis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for preventing and treating allergic rhinitis, a preparation method thereof, and an application thereof. Background Art

[0002] Allergic rhinitis, also known as allergic rhinitis, is a chronic non-specific inflammatory disease of the nasal mucosa mediated by immunoglobulin E (IgE) and type 2 helper T cells (Th2), characterized by nasal itching, nasal congestion, sneezing, runny nose, etc. The nasal and ocular symptoms experienced by patients can lead to a series of problems such as sleep disorders, irritability, depression, and decreased attention and memory. It not only seriously affects the physical and mental conditions of patients, but also increases the economic burden on individuals and society.

[0003] The treatment of allergic rhinitis includes environmental control, drug treatment, immunotherapy and other means. Among them, drug treatment can quickly and effectively control nasal symptoms and is currently the most important means of modern medicine for treating this disease. The first-line drugs recommended by the guidelines include: nasal glucocorticoids, second-generation oral and nasal antihistamines, leukotriene receptor antagonists, etc. Among them, nasal glucocorticoids are the first-choice first-line drugs, usually taking effect 12 - 24 hours after administration, and the best effect can be achieved after continuous use for 2 weeks. Its main adverse reactions are nasal burning sensation, dryness, stabbing pain, nosebleed, as well as pharyngitis and cough, etc.; the second-generation oral antihistamines, as the first-line basic drugs, may enhance the cognitive and psychomotor dysfunction caused by alcohol; for acute attack patients who need to quickly relieve symptoms, nasal antihistamines can be used as the first-line choice, with an onset time of 15 - 30 minutes, and the clinical efficacy is equivalent to or better than that of oral antihistamines. The most common adverse reaction of this type of drug is a bitter taste, with an incidence rate as high as 16.7%, and there are also other adverse reactions such as nasal burning sensation, nosebleed, headache, and drowsiness. Glucocorticoid drugs only "treat the symptoms" more, and long-term use will produce many serious adverse reactions such as Cushing's syndrome, osteoporosis, immunosuppression, and rebound phenomenon.

[0004] Allergic rhinitis belongs to the category of "biqiu" in traditional Chinese medicine. It is recorded in "Shi Ming": "Biqiu means nasal congestion. Qiu means long. The nasal discharge has not passed for a long time, and then it becomes blocked." Its etiology includes exogenous and endogenous pathogenic factors, which invade the nasal cavity and cause adverse qi movement and dysfunction of the nasal cavity. Clinically, oral traditional Chinese medicine, application, acupuncture, etc. are commonly used, but each has certain clinical limitations.

[0005] Chinese invention patent application CN202310323974.2 discloses a traditional Chinese medicine formula for treating rhinitis, its medicinal liquid, and its preparation method. It is derived from modified versions of Ma Huang Fu Zi Xi Xin Tang, Cang Er Zi San, Dang Gui Bu Xue Tang, and You Gui Wan, and consists of: 5-10 parts ephedra, 1-3 parts asarum, 5-10 parts magnolia flower, 5-10 parts cang Er Zi, 10-15 parts angelica dahurica, 10-15 parts saposhnikovia divaricata, and astragalus membranaceus. The formula consists of 15-30 parts Astragalus membranaceus, 15-30 parts Codonopsis pilosula, 15-30 parts Atractylodes macrocephala, 15-30 parts Poria cocos, 15-30 parts Rehmannia glutinosa, 15-30 parts Dioscorea opposita, 5-10 parts Cervi cornu colla, 15-30 parts Lycium barbarum, 10-15 parts Aconitum carmichaelii (processed), 5-10 parts Ophiopogon japonicus, 5-10 parts Schisandra chinensis, 10-15 parts Angelica sinensis (tail), 5-10 parts Panax notoginseng, 10-30 parts Pogostemon cablin, and 10-20 parts rice wine, etc. By warming and tonifying the lungs and kidneys, invigorating qi and blood circulation, dispelling cold and opening the nasal passages, it improves the root cause of lung and kidney deficiency and cold, regulates the symptoms of blood stasis and obstruction, and achieves a lasting effect in improving nasal congestion and runny nose. However, the formula involves a large variety of Chinese medicinal herbs, lacks a clear focus in its composition, and has an unclear therapeutic target.

[0006] Chinese invention patent application CN201910098439.5 discloses a traditional Chinese medicine composition for treating perennial allergic rhinitis. This composition is made from the following raw materials: Astragalus membranaceus 30 parts, Saposhnikovia divaricata 9 parts, processed Ephedra sinica 9 parts, Angelica dahurica 9 parts, Magnolia biondii 9 parts, Cicadae periostracum 9 parts, stir-fried Atractylodes macrocephala 15 parts, Poria cocos 15 parts, Prunus mume 9 parts, Paeonia lactiflora 15 parts, Asarum heterotropoides 6 parts, Zingiber officinale 6 parts, processed Glycyrrhiza uralensis 6 parts, and Schisandra chinensis 9 parts. This invention features the combined effect of tonifying the body's resistance and dispelling pathogenic factors. The entire formula is mild in nature, neither drying nor cold, combining dispersing and astringent properties, and integrating disease and syndrome differentiation, thus possessing the effects of tonifying qi and dispelling wind.

[0007] Chinese invention patent application 202110966782.4 discloses a pharmaceutical composition for treating allergic rhinitis and its preparation method. The composition consists of 10.3-15 parts Astragalus membranaceus, 6.85-10 parts Atractylodes macrocephala, 6.85-10 parts Saposhnikovia divaricata, 6.85-10 parts Magnolia biondii, 6.85-10 parts Angelica dahurica, 6.85-10 parts Alpinia officinarum, 6.85-10 parts Notopterygium incisum, 6.85-10 parts Paeonia suffruticosa, 6.85-10 parts Cicadae periostracum, 6.85-10 parts Prunus mume, and 4.1-6 parts Glycyrrhiza uralensis. It is used for persistent allergic rhinitis (allergic rhinitis) with deficiency of both lung and spleen, and invasion of external pathogens, characterized by symptoms such as sneezing, clear nasal discharge, nasal congestion, nasal itching, spontaneous sweating, aversion to wind, fatigue, and lethargy. The effect is significant.

[0008] The pathological characteristics of allergic rhinitis indicate that glandular secretion or vascular leakage is increased in the pathological state of the nasal mucosa. In particular, long-term exposure to allergens may induce insensitivity or resistance to lipid-soluble glucocorticoids. This has led modern medicine to use local administration as the first-line drug, avoiding many shortcomings of oral administration in the treatment of this disease. At present, the treatment of allergic rhinitis with traditional Chinese medicine still requires a combination of traditional Chinese medicine that can improve the key pathogenesis and an appropriate route of administration, and thus a stable preparation to achieve more significant and efficient therapeutic effects. Summary of the Invention

[0009] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis, its preparation method and application. The prescription is refined, the combination is rigorous, and the synergistic effect between the ingredients can significantly improve the prevention and treatment effect of allergic rhinitis.

[0010] To achieve the above-mentioned objectives, the technical solution of this invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis, which, by weight, is composed of the following raw materials: 20-60 parts of Astragalus membranaceus, 10-30 parts of Angelica sinensis, 10-30 parts of Saposhnikovia divaricata, 9-30 parts of Atractylodes lancea, 9-40 parts of Acorus tatarinowii, 3-15 parts of Asarum heterotropoides, 8-30 parts of Ligusticum chuanxiong, and 6-20 parts of Angelica dahurica.

[0011] In some specific embodiments of the present invention, the ingredients are composed of the following raw materials in parts by weight: 20-40 parts of Astragalus membranaceus, 10-20 parts of Angelica sinensis, 10-20 parts of Saposhnikovia divaricata, 10-20 parts of Atractylodes lancea, 10-20 parts of Acorus tatarinowii, 5-12 parts of Asarum heterotropoides, 10-20 parts of Ligusticum chuanxiong, and 9-15 parts of Angelica dahurica.

[0012] In some specific embodiments of the present invention, the mass ratio of Astragalus membranaceus to Angelica dahurica is 2.5-3.5:1, and the mass ratio of Saposhnikovia divaricata to Atractylodes lancea is 1-1.5:1.

[0013] In some specific embodiments of the present invention, the ingredients are composed of the following components by weight: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 10 parts Saposhnikovia divaricata, 10 parts Atractylodes lancea, 15 parts Acorus tatarinowii, 9 parts Asarum heterotropoides, 10 parts Ligusticum chuanxiong, and 10 parts Angelica dahurica.

[0014] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) Powder the following herbs: Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong, and Angelica dahurica. Soak and extract them in ethanol solution to obtain a decoction. (2) The decoction is concentrated into a thick paste.

[0015] In some specific embodiments of the present invention, in step (1), the pulverized material is passed through a 10-30 mesh sieve, and the soaking time is 0.5-2 hours.

[0016] Preferably, in step (1), the pulverized material is passed through a 20-mesh sieve, and the soaking time is 1 hour.

[0017] In some specific embodiments of the present invention, in step (1), the ethanol solution is a 60-80% aqueous ethanol solution.

[0018] Preferably, in step (1), the ethanol solution is a 75% aqueous ethanol solution.

[0019] In some specific embodiments of the present invention, in step (1), the extraction is a heating reflux extraction, the number of extractions is 1-3 times, and the extraction time for each extraction is 1-3 hours.

[0020] Preferably, in step (1), the extraction is performed twice, and each extraction takes 1 hour.

[0021] In some specific embodiments of the present invention, in step (1), the amount of ethanol solution added is 6-12 times the total mass of all medicinal materials.

[0022] Preferably, in step (1), the amount of ethanol solution added is 8 times the total mass of all medicinal materials.

[0023] In some specific embodiments of the present invention, the concentration operation in step (2) is to concentrate under reduced pressure at 40-50°C and a vacuum degree of 0.06-0.08 MPa to remove ethanol and obtain an alcohol-free extract.

[0024] Preferably, the concentration operation in step (2) is performed by vacuum concentration at 50°C and a vacuum degree of 0.07 MPa.

[0025] Preferably, in step (1), after concentration, the process may also include conventional steps in the art of drying, pulverizing, and sieving to prepare the traditional Chinese medicine composition into powder or granules.

[0026] Thirdly, the present invention provides a pharmaceutical preparation, the raw materials of which include the traditional Chinese medicine composition described above or the traditional Chinese medicine composition prepared by the preparation method described above, as well as pharmaceutically acceptable excipients.

[0027] The medicaments of the present invention can be in forms suitable for topical use, such as aerosols, creams, ointments, powders, or the like. Furthermore, the traditional Chinese medicine compositions can be in suitable forms for transdermal drug delivery devices. These formulations can be prepared using the traditional Chinese medicine compositions of the present invention through conventional processing methods. For example, a cream or ointment with a desired consistency can be prepared by mixing a hydrophilic material and water, and about 5 wt% to about 10 wt% of the compound.

[0028] In addition to the carrier components mentioned above, the above pharmaceutical formulations may include (if applicable) one or more additional carrier components, such as diluents, buffers, binders, surfactants, thickeners, lubricants, penetration enhancers, preservatives (including antioxidants), etc.

[0029] The drug of this invention may be prepared into an oral dosage form.

[0030] Fourthly, the present invention provides the above-mentioned traditional Chinese medicine composition, or the use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for preventing and treating allergic rhinitis.

[0031] Preferably, the allergic rhinitis is mild to moderate allergic rhinitis.

[0032] Preferably, the prevention and treatment of allergic rhinitis includes improving DAI score and spleen index, improving immunoglobulin E (IgE) level, improving the levels of inflammatory factors IFN-γ, IL-4, IL-10 and IL-17 in the inflammatory response, and has a significant ameliorative effect on pathological changes in the nasal mucosa.

[0033] In clinical practice of traditional Chinese medicine, attention should be paid to the key pathogenesis of diseases. The key pathogenesis of allergic rhinitis can be summarized as "evil invading the lung and wei, and nasal obstruction". Therefore, the key to its treatment is to "strengthen the lung and wei, expel evil qi, and clear the nasal passages to achieve the effects of relieving itching and pain". This invention is based on this.

[0034] Astragalus in the formula is sweet and warm, a holy medicine for replenishing qi, which can benefit qi, strengthen the exterior, promote detoxification, and drain pus, and is good at strengthening the qi of the lung and wei qi; Saposhnikovia is pungent and sweet, and has the effects of dispelling wind, relieving spasms, eliminating dampness, and relieving itching, and can expel pathogenic qi from the pores; Astragalus is tonifying and Saposhnikovia is dispersing, so when used together, the tonifying and dispersing effects are combined, which can both strengthen the lung and wei qi and expel pathogenic qi; Atractylodes has a strong flavor and can dry dampness and resolve phlegm, and its fragrance can dispel foulness and overcome the abnormal qi of the four seasons. Acorus tatarinowii and Asarum sieboldii promote qi circulation and open the nasal passages, while Angelica dahurica is aromatic and can open the nasal passages, relieve pain, reduce swelling and drain pus, effectively addressing the symptoms of nasal diseases. Angelica sinensis and Ligusticum chuanxiong nourish blood and moisten dryness, resolve blood stasis and promote qi circulation, thus assisting in strengthening the lungs and opening the nasal passages. The entire formula is carefully formulated to work together to strengthen the lungs and wei qi, open the nasal passages, and relieve pain and itching. It can achieve a significant effect of treating both the symptoms and the root cause of allergic rhinitis, which is characterized by nasal itching, nasal congestion, sneezing, runny nose, and even nasal pain and headache.

[0035] The beneficial effects of this invention are as follows: (1) The present invention uses Astragalus membranaceus, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Angelica dahurica, Asarum heterotropoides, Angelica sinensis and Ligusticum chuanxiong in a specific ratio to achieve synergistic effect. The formula is refined and effective, and has a significant effect on the prevention and treatment of allergic rhinitis.

[0036] (2) The traditional Chinese medicine composition of the present invention is based on the key pathogenesis of allergic rhinitis and is combined to exert a synergistic effect. It can significantly improve the inflammatory response and the pathological state of the nasal mucosa, and has the effects of strengthening the lungs and relieving nasal congestion, clearing the nasal passages, and relieving pain and itching. It includes improving the DAI score and spleen index, improving the level of immunoglobulin E (IgE), effectively controlling the levels of inflammatory factors IFN-γ, IL-4, IL-10 and IL-17 in the inflammatory response, and having a significant effect on the pathological changes of the nasal mucosa. Attached Figure Description

[0037] Figure 1 These are microscopic images of H&E-stained nasal mucosa from different groups of rats.

[0038] Figure 2 Microscopic images of toluidine blue stained nasal mucosa from different groups of rats. Detailed Implementation

[0039] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of protection claimed in this application.

[0040] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention were obtained through conventional commercial means. Unless otherwise specified, all contents mentioned below are mass contents. Unless otherwise specified, it is understood that the process was carried out at room temperature.

[0041] Example 1 This embodiment provides a traditional Chinese medicine composition, which, by weight, is composed of the following traditional Chinese medicines: Astragalus membranaceus 30 parts, Angelica sinensis 15 parts, Saposhnikovia divaricata 10 parts, Atractylodes lancea 10 parts, Acorus tatarinowii 15 parts, Asarum heterotropoides 9 parts, Ligusticum chuanxiong 10 parts, and Angelica dahurica 10 parts.

[0042] The preparation method of Example 1 is as follows: (1) Pulverize the eight herbs, namely Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, pass them through a 20-mesh sieve, and soak them in 8 times the volume of 75% ethanol aqueous solution for 1 hour. (2) After soaking, the decoction was extracted by heating and reflux, and decocted twice, each time for 1 hour. The two decoctions were combined and filtered to obtain the decoction. (3) The decoction is concentrated under reduced pressure at 50°C and 0.07 MPa, while removing ethanol, to obtain a thick paste.

[0043] Example 2 This embodiment provides a traditional Chinese medicine composition, which, by weight, is composed of the following traditional Chinese medicines: Astragalus membranaceus 20 parts, Angelica sinensis 10 parts, Saposhnikovia divaricata 10 parts, Atractylodes lancea 9 parts, Acorus tatarinowii 9 parts, Asarum heterotropoides 3 parts, Ligusticum chuanxiong 8 parts, Angelica dahurica 6 parts; The preparation method of Example 2 is as follows: (1) Pulverize the eight herbs, namely Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, pass them through a 20-mesh sieve, and soak them in 8 times the volume of 75% ethanol aqueous solution for 1 hour. (2) After soaking, the decoction was extracted by heating and reflux, and decocted 3 times, each time for 1 hour. The 3 decoctions were combined and filtered to obtain the decoction. (3) The decoction is concentrated under reduced pressure at 40°C and 0.08 MPa to remove ethanol, resulting in a thick paste.

[0044] Example 3 This embodiment provides a traditional Chinese medicine composition, which, by weight, is composed of the following traditional Chinese medicines: Astragalus membranaceus 60 parts, Angelica sinensis 30 parts, Saposhnikovia divaricata 30 parts, Atractylodes lancea 30 parts, Acorus tatarinowii 40 parts, Asarum heterotropoides 15 parts, Ligusticum chuanxiong 30 parts, Angelica dahurica 20 parts; The preparation method of Example 3 is as follows: (1) Pulverize the eight herbs, namely Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, pass them through a 20-mesh sieve, and soak them in 8 times the volume of 65% ethanol aqueous solution for 1 hour. (2) After soaking, the decoction was obtained by heating and reflux extraction for 3 hours and then filtered. (3) The decoction is concentrated under reduced pressure at 50°C and 0.07 MPa to remove ethanol, resulting in a thick paste.

[0045] Comparative Example 1 The difference between this comparative example and Example 1 is that it does not contain Astragalus membranaceus or Angelica sinensis, but instead includes 45 parts of Xanthium sibiricum. The specific formula by weight is: 10 parts of Saposhnikovia divaricata, 10 parts of Atractylodes lancea, 15 parts of Acorus tatarinowii, 9 parts of Asarum heterotropoides, 10 parts of Ligusticum chuanxiong, 10 parts of Angelica dahurica, and 10 parts of Xanthium sibiricum.

[0046] Xanthium sibiricum has the effects of dispelling wind-cold, opening nasal passages, and expelling wind-dampness (Chinese Pharmacopoeia 2020 Edition, Volume I). Shennong Ben Cao Jing records: "It is mainly used for headache due to wind-cold, rheumatic arthralgia, pain in the limbs with muscle spasms, and necrotic muscles with evil qi." Compendium of Materia Medica records: "Xanthium sibiricum is mainly used for the treatment of chronic malaria... massive abdominal edema, difficult urination... toothache... nasal sinusitis..." etc. In modern clinical practice, it is often used for the treatment of nasal diseases such as rhinitis or sinusitis. The purpose of this comparative example is to reduce the effect of benefiting the lung and defense, and enhance the function of opening nasal passages.

[0047] The preparation method is as follows: (1) After proportioning the above medicinal flavors and pulverizing them, pass through a 20-mesh sieve, add 8 times the volume of 75% ethanol aqueous solution, and soak for 1 hour; (2) After soaking, use the heating reflux extraction method, decoct twice, each decoction time is 1 hour, combine the two decoction liquids, and filter to obtain decoction 1; (3) Decoction 1 is concentrated under reduced pressure at 50°C with a vacuum degree of 0.07 MPa to remove ethanol simultaneously, and a thick paste is obtained, thus obtaining the product.

[0048] Comparative Example 2 The difference between this comparative example and Example 1 is only that the composition is different. Specifically, Angelica sinensis is replaced by Paeonia lactiflora, and Angelica dahurica is replaced by Magnolia liliflora.

[0049] Comparative Example 3 The difference between this comparative example and Example 1 is only that the composition is different. Specifically, Saposhnikovia divaricata is replaced by a 1:1 mass ratio of Notopterygium incisum and Ligusticum sinense, Atractylodes lancea is replaced by Pogostemon cablin, and Asarum sieboldii is replaced by Xanthium sibiricum.

[0050] Comparative Example 4 The difference between this comparative example and Example 1 is the proportion. It is specifically composed of the following raw materials: Astragalus membranaceus 24 parts, Angelica sinensis 15 parts, Saposhnikovia divaricata 7 parts, Atractylodes lancea 13 parts, Acorus tatarinowii 15 parts, Asarum sieboldii 9 parts, Ligusticum chuanxiong 10 parts, and Angelica dahurica 16 parts.

[0051] I. Pharmacodynamic experiments 1. Materials and methods 1.1 Experimental animals SPF-grade male Wistar rats, weighing about 200±10 g, were purchased from Beijing Spearf Bio-Technology Co., Ltd., license number: SCXK (Beijing) 2019-0010. Feeding conditions: temperature 20-26°C, humidity 40%-60%, lighting: 12 h / 12 h, change bedding regularly every 2 days, clean drinking water and feed are provided for rats to freely intake. After one week of adaptive feeding, they enter the research procedure.

[0052] 1.2 Experimental drugs Blank control group and model group: purified water; Experimental group: The traditional Chinese medicine compositions prepared in Example 1, Comparative Examples 1-4 were prepared into a solution with a concentration of 0.5g crude drug / Kg using purified water before use.

[0053] Positive control drug: Fluticasone propionate aerosol (Fluticasone Propionate, 120 sprays, GlaxoSmithKline).

[0054] 1.3 Experimental Reagents The main reagents used in this experiment are shown in Table 1.

[0055] Table 1

[0056] 1.4 Experimental Apparatus The main experimental instruments used in this study are shown in Table 2.

[0057] Table 2

[0058] 2. Experimental Methods 2.1 Establishment of animal models This experiment induced a rat model of allergic rhinitis using ovalbumin (OVA) combined with aluminum hydroxide (Al(OH)3) adjuvant for 21 days, divided into two phases. From day 1 to day 14, rats were intraperitoneally injected every other day with a 1 mL saline suspension containing 0.3 mg OVA and 30 mg Al(OH)3 to establish a systemic immune response. Subsequently, from day 15 to day 21, rats were given 50 μL of 5% OVA solution via nasal drops daily in each nostril to induce nasal allergic symptoms.

[0059] 2.2 Animal grouping After the model was successfully established, the rats were randomly divided into 8 groups of 10 each: control group, model group, positive drug control group, traditional Chinese medicine group (Example 1 group), and comparative group (comparative group 1-comparative group 4).

[0060] 2.3 Dosing Design A 7-day treatment intervention was initiated from day 22 to day 28 of the modeling process.

[0061] During this period, the control group and the model group were given nasal sprays with purified water using cotton swabs once a day; the positive control group was given fluticasone propionate aerosol nasal spray once a day, with a dose of 50 μg each time; the traditional Chinese medicine group and each comparative group were given the corresponding traditional Chinese medicine liquid (prepared fresh for use) nasal spray once a day, with a dose of 0.1 g of raw drug each time.

[0062] 2.4 Indicator Testing Rats were scored on behavioral indicators on days 26 and 28. After administration, spleen tissue, abdominal aorta blood samples, and nasal tissue samples were collected for relevant indicator testing.

[0063] The handling of animals during the experiment complied with the animal ethics requirements stipulated in the "Regulations on the Management of Experimental Animals" issued by the State Science and Technology Commission.

[0064] 2.4.1 Behavioral scoring Behavioral indicators of rats in each group were scored on days 26 and 28, using a quantitative cumulative scoring method. Scoring criteria: 1. Nose scratching: No nose scratching behavior, 0 points; lightly touching the nose several times, 1 point; repeatedly scratching the nose and face, 2 points; constantly rubbing the nose and face, 3 points; 2. Sneezing: No sneezing, 0 points; 1-3 sneezes, 1 point; 4-10 sneezes, 2 points; 11 or more sneezes, 3 points. 3. Runny nose: No runny nose, 0 points; runny nose to the nostrils, 1 point; runny nose beyond the nostrils, 2 points; runny nose to the face, 3 points.

[0065] 2.4.2 Spleen Index Measurement Before sampling, the rats were weighed, and after sampling, the wet weight of the spleen was measured, and the spleen index was calculated.

[0066] Spleen index = Spleen wet weight / Body weight × 100%.

[0067] 2.4.3 Detection of Immunoglobulin E (IgE) Levels After blood was collected from the abdominal aorta, the sample was centrifuged at 2000g for 10 minutes at 4°C, and the supernatant was collected and stored at -80°C for later use. The level of immunoglobulin E (IgE) in the serum was detected by ELISA.

[0068] 2.4.4 Detection of Inflammatory Response Levels Blood was drawn from the abdominal aorta, centrifuged at 2000g for 10 min at 4℃, and the supernatant was collected and stored at -80℃ for later use. The levels of INF-γ, IL-4, IL-10, and IL-17 were detected using ELISA.

[0069] 2.4.5 Histopathological examination of nasal mucosa After nasal tissue was harvested, it was decalcified, fixed with 4% paraformaldehyde, embedded in paraffin, cut (2-3 μm), and stained with H&E and toluidine blue, and observed under a microscope.

[0070] 2.5 Statistical Analysis All experimental data were processed using SPSS 27.0 statistical software and expressed as mean ± standard deviation. One-way ANOVA was used when the data conformed to normal distribution and homogeneity of variance. The LSD method was used for multiple comparisons between groups. For data that did not meet the homogeneity of variance requirement, Welch's method was used to correct the F-values. The Dunnett T3 method was used for further multiple comparisons. P < 0.05 was considered statistically significant.

[0071] 3. Results 3.1 Effects of Traditional Chinese Medicine Formulas on Symptoms in Rats with Allergic Rhinitis After systemic sensitization and local nasal provocation, the DAI score of the model group rats was significantly increased compared with the control group (P < 0.01), indicating that this method can successfully replicate the rat model of allergic rhinitis. After nasal administration of the positive control drug (fluticasone propionate), the symptoms of rhinitis rats were significantly improved, and the DAI score was significantly reduced compared with the model group (P < 0.01). After nasal application of traditional Chinese medicine (Example 1), the symptoms of rhinitis rats were significantly corrected, and the DAI score was significantly reduced compared with the model group (P < 0.01). After nasal application of traditional Chinese medicine in each comparative proportion group, the DAI score was reduced, but there was no statistically significant difference compared with the model group (P > 0.05). The results are shown in Table 3.

[0072] 3.2 Effects of Traditional Chinese Medicine Formula on Spleen Index in Rats with Allergic Rhinitis After systemic sensitization and local nasal stimulation, the spleen index of the model group rats was significantly increased compared with the control group (P < 0.01), indicating that the immune system of the rhinitis rats was severely damaged. Nasal spray of the positive control drug (fluticasone propionate) significantly improved the spleen index of the rhinitis rats, with a significant reduction in spleen weight compared with the model group (P < 0.01). Nasal spray of traditional Chinese medicine (Example 1) significantly corrected the immune damage in the rhinitis rats, with a significant decrease in spleen index compared with the model group (P < 0.01). Nasal spray of the comparative control group showed some reduction in spleen size, but the difference was not statistically significant compared with the model group (P > 0.05). The spleen index of the Example 1 group was significantly reduced compared with each comparative control group (P < 0.01). The results are shown in Table 3.

[0073] 3.3 Effects of Traditional Chinese Medicine Formula on Immunoglobulin E (IgE) Levels in Rats with Allergic Rhinitis After systemic sensitization and local nasal provocation, the IgE level in the model group was significantly higher than that in the control group (P < 0.01), further demonstrating that this method can successfully replicate the rat model of allergic rhinitis. Nasal spray of the positive control drug (fluticasone propionate) significantly improved IgE levels, showing a significant decrease compared to the model group (P < 0.01). Nasal spray of the traditional Chinese medicine (Example 1) significantly corrected the local immune response in the rhinitis rats, showing a significant decrease in IgE levels compared to the model group (P < 0.01). Nasal spray of the comparative control group also reduced IgE levels, showing a significant difference compared to the model group (P < 0.05). Compared to each comparative control group, the IgE level in Example 1 group was significantly lower (P < 0.01). The results are shown in Table 3.

[0074] Table 3

[0075] Note: Compared with the control group: #P<0.05, ##P<0.01; Compared with the model group: P < 0.05 P < 0.01; Compared with the traditional Chinese medicine group: △ P < 0.05 △△ P < 0.01.

[0076] 3.4 Effects of Traditional Chinese Medicine Formulas on Inflammatory Factors in Rats with Allergic Rhinitis After systemic sensitization and local nasal stimulation, compared with the control group, the levels of INF-γ and IL-17 in the model group rats were significantly increased (P < 0.01), while the levels of IL-4 and IL-10 were significantly decreased (P < 0.01), indicating a significant enhancement of the inflammatory response in the allergic rhinitis rat model. After nasal administration of the positive control drug (fluticasone propionate) and the nasal application of traditional Chinese medicine (Example 1), the expression of inflammatory factors was significantly improved compared with the model group (P < 0.01). After administration of the nasal spray to each comparative group, the expression of INF-γ, IL-17, IL-10, and IL-4 was significantly improved compared with the model group (P < 0.05). Compared with the comparative group, the traditional Chinese medicine (Example 1) group showed significant improvement in all inflammatory indicators, with statistically significant differences (P < 0.01). The results are shown in Table 4.

[0077] Table 4

[0078] Note: Compared with the control group: #P<0.05, ##P<0.01; Compared with the model group: P < 0.05 P < 0.01; Compared with the traditional Chinese medicine group: △ P < 0.05△△ P < 0.01.

[0079] 3.5 Effects of Traditional Chinese Medicine Formulas on Histopathology of Rats with Allergic Rhinitis Pathological studies on the nasal mucosa showed that, under light microscopy, the nasal mucosa of normal rats was structurally intact, with epithelial cells arranged neatly and tightly. In the model group, a large number of epithelial cells showed significant degeneration, necrosis, and loss, with sparsely arranged cells and significant diffuse infiltration of inflammatory cells. After nasal spraying with a positive control agent, a small amount of inflammatory cell infiltration was observed. In the nasal spray group and the control group, the inflammatory cell infiltration was significantly reduced. Results are as follows... Figure 1 As shown.

[0080] After toluidine blue staining, the number of mast cells in the model group increased significantly. After drug administration, the number of mast cells in the positive control group and the traditional Chinese medicine group decreased significantly. The number of mast cells in the nasal mucosa of the control group was reduced compared with the model group, but not significantly. Results are as follows: Figure 2 As shown.

[0081] In summary, the traditional Chinese medicine formula for treating rhinitis, obtained through pulverization, alcohol extraction, and vacuum concentration, significantly improved the disease state of rats with allergic rhinitis, and had important intervention effects such as reducing inflammatory response, immune response, and pathological changes.

[0082] Clinical Cases 1. Ms. Du, female, 38 years old, presented on January 26, 2026, complaining of allergic rhinitis for 15 years, with recurrent episodes. Nasal endoscopy revealed: rough anterior nasal septum mucosa bilaterally, congestion and swelling of the bilateral middle and inferior turbinates, clean left middle meatus, and yellow purulent discharge in the right middle meatus flowing back into the common nasal meatus. The nasopharyngeal mucosa was congested and swollen, with sticky secretions adhering to it. The bilateral nasal recesses were symmetrical, and the pharyngeal orifices of the bilateral Eustachian tubes were generally normal. The clinical diagnosis was allergic rhinitis. She was treated with the herbal composition of Example 1 of this invention for 2 weeks. The results showed: the symptom score improved from 7 points before treatment to 1 point after treatment. Nasal endoscopy revealed: slight congestion of the bilateral middle and inferior turbinates, clean bilateral middle meatuses, slight congestion of the nasopharyngeal mucosa, symmetrical bilateral nasal recesses, and generally normal pharyngeal orifices of the bilateral Eustachian tubes, indicating a significant improvement in the pathological state of the nasal mucosa; all indicators, including the VAS score, showed significant improvement.

[0083] 2. Mr. Peng, male, 22 years old, presented on December 25, 2025, with a chief complaint of allergic rhinitis for one year, characterized by persistent attacks. Nasal endoscopy revealed: rough and eroded anterior nasal septum mucosa bilaterally, slight congestion of the bilateral middle and inferior turbinates, a clean left middle meatus, and a small amount of watery secretions in the right middle and common nasal meatus. The nasopharyngeal mucosa was slightly congested, the bilateral recesses were symmetrical, and the pharyngeal orifices of the bilateral Eustachian tubes were generally normal. The clinical diagnosis was allergic rhinitis. After two weeks of topical application of the herbal composition of Example 2 of this invention, the results showed: the symptom score decreased from 9 points to 1 point; nasal endoscopy revealed: slight congestion and swelling of the bilateral middle and inferior turbinates, watery secretions in the bilateral middle meatus and olfactory cleft, slight congestion of the nasopharyngeal mucosa, symmetrical bilateral recesses, and the pharyngeal orifices of the bilateral Eustachian tubes were generally normal; all indicators, including the VAS score, showed significant improvement.

[0084] 3. Mr. Wang, male, 28 years old, presented on December 27, 2025, with a chief complaint of allergic rhinitis for 3 years, with intermittent attacks, approximately 7 times per year. Nasal endoscopy revealed: pale and edematous mucosa of both middle turbinates; watery secretions were visible in both middle and common nasal meatuses; the nasopharyngeal mucosa was congested and swollen; the bilateral recesses were symmetrical; and the pharyngeal orifices of both Eustachian tubes were generally normal. He was clinically diagnosed with allergic rhinitis. After 2 weeks of topical application of the herbal composition of Example 3 of this invention, the results showed: the symptom score decreased from 12 to 4; nasal endoscopy revealed: leftward deviation of the nasal septum; slight congestion and swelling of both middle and inferior turbinates; clean bilateral middle nasal meatuses; slight congestion of the nasopharyngeal mucosa; symmetrical bilateral recesses; and the pharyngeal orifices of both Eustachian tubes were generally normal; all indicators, including the VAS score, showed significant improvement. The results indicate that the composition of Example 3 of this invention has a good therapeutic effect on allergic rhinitis.

[0085] This article uses specific examples to illustrate the inventive concept in detail. The description of the above embodiments is only for the purpose of helping to understand the core idea of ​​the present invention. It should be noted that any obvious modifications, equivalent substitutions or other improvements made by those skilled in the art without departing from the inventive concept should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating allergic rhinitis, characterized in that, By weight, it consists of the following ingredients: Astragalus membranaceus 20-60 parts, Angelica sinensis 10-30 parts, Saposhnikovia divaricata 10-30 parts, Atractylodes lancea 9-30 parts, Acorus tatarinowii 9-40 parts, Asarum heterotropoides 3-15 parts, Ligusticum chuanxiong 8-30 parts, and Angelica dahurica 6-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it consists of the following ingredients: Astragalus membranaceus 20-40 parts, Angelica sinensis 10-20 parts, Saposhnikovia divaricata 10-20 parts, Atractylodes lancea 10-20 parts, Acorus tatarinowii 10-20 parts, Asarum heterotropoides 5-12 parts, Ligusticum chuanxiong 10-20 parts, and Angelica dahurica 9-15 parts.

3. The traditional Chinese medicine external application composition according to claim 1, characterized in that, The mass ratio of Astragalus membranaceus to Angelica dahurica is 2.5-3.5:1, and the mass ratio of Saposhnikovia divaricata to Atractylodes lancea is 1-1.5:

1.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it consists of the following ingredients: Astragalus membranaceus 30 parts, Angelica sinensis 15 parts, Saposhnikovia divaricata 10 parts, Atractylodes lancea 10 parts, Acorus tatarinowii 15 parts, Asarum heterotropoides 9 parts, Ligusticum chuanxiong 10 parts and Angelica dahurica 10 parts.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Powder the following herbs: Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, soak and extract them in ethanol solution to obtain decoction; (2) The decoction is concentrated into a thick paste.

6. The preparation method according to claim 5, characterized in that, In step (1), the powder is passed through a 10-30 mesh sieve, and the soaking time is 0.5-2 hours.

7. The preparation method according to claim 5, characterized in that, In step (1), the ethanol solution is a 60-80% aqueous ethanol solution; And / or, in step (1), the extraction is a heating reflux extraction, the number of extractions is 1-3 times, and the extraction time for each extraction is 1-3 hours; And / or, in step (1), the amount of ethanol solution added is 6-12 times the total mass of all medicinal materials.

8. The preparation method according to claim 5, characterized in that, The concentration operation in step (2) is to concentrate under reduced pressure at 40-50℃ and a vacuum degree of 0.06-0.08MPa to remove ethanol and obtain an alcohol-free extract.

9. A pharmaceutical preparation, characterized in that, The raw materials of the pharmaceutical preparation include 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 5-8, as well as pharmaceutically acceptable excipients.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-4, or the traditional Chinese medicine composition according to any one of claims 5-8, in the preparation of a medicament for the prevention and treatment of allergic rhinitis.

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