Traditional Chinese medicine composition for treating allergic rhinitis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating allergic rhinitis and a preparation method thereof. The traditional Chinese medicine composition is prepared from seven medicinal materials including flos magnoliae, fructus xanthii, pericarpium citri reticulatae, herba pogostemonis, semen coicis, radix saposhnikoviae and radix angelicae dahuricae. On the basis of a classic formula of cocklebur fruit powder, the traditional Chinese medicine composition has the effects of ventilating the lung, opening orifices, invigorating the spleen, clearing damp, tonifying qi and strengthening superficies, and is suitable for spleen deficiency and excessive dampness type allergic rhinitis. Animal experiments show that the traditional Chinese medicine composition can significantly improve rhinitis symptoms, reduce serum IL4 and IgE levels and reduce nasal cavity inflammatory cell infiltration, has a curative effect superior to that of an original formula, is stable and is suitable for industrial production.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating allergic rhinitis and its preparation method. Background Technology

[0002] Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mediated by IgE. Clinical manifestations include paroxysmal sneezing, clear nasal discharge, nasal itching, and nasal congestion, often accompanied by ocular symptoms. Current Western medicine treatments primarily involve corticosteroids, antihistamines, and leukotriene receptor antagonists. While these can relieve symptoms, they suffer from problems such as high relapse rates, drug resistance, and numerous adverse reactions, and are unlikely to fundamentally regulate the body's immune status.

[0003] Traditional Chinese medicine (TCM) categorizes allergic rhinitis under the "nasal congestion" category, believing its pathogenesis is largely related to dysfunction of the lungs and spleen. External factors include wind-cold or damp-heat invading the nasal passages, while internal factors include deficiency of the internal organs and insufficient vital energy. Treatment emphasizes differentiation of syndromes and treatment addressing both the root cause and the symptoms. The classic formula "Xang Er Zi San" (Magnolia biondii, Xanthium sibiricum, Angelica dahurica, and Mentha haplocalyx) was first recorded in *Revised Yan Shi Ji Sheng Fang* and is a commonly used formula for clearing nasal passages. However, its composition is relatively simple, focusing primarily on dispelling wind and clearing the nasal passages, and its efficacy is limited for cases of spleen deficiency with dampness and insufficient vital energy.

[0004] Therefore, this invention modifies and optimizes the "Xanthium sibiricum powder" to form a traditional Chinese medicine composition that treats both the symptoms and the root cause, and regulates both the lungs and spleen, suitable for allergic rhinitis of the spleen deficiency and dampness type with lung obstruction. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis.

[0006] 1. Dialectical treatment Allergic rhinitis falls under the category of "nasal congestion" in Traditional Chinese Medicine (TCM), and its causes are divided into internal and external factors. External factors are mostly related to climate change, alternating hot and cold, and invasion of wind-cold or heat. Internal factors lie in the deficiency of the internal organs and insufficient vital energy, and are closely related to the lungs, spleen, and kidneys. Allergic rhinitis is located in the nose, but the affected organs are the lungs and spleen. Clinically, it is often characterized by deficiency of the root and excess of the branch, with external pathogenic factors invading, impaired lung and defensive qi circulation, abnormal spleen function, and internal accumulation of dampness and turbidity being the main pathogenic mechanisms. This invention is based on "Xanthium sibiricum Powder" (Magnolia biondii, Xanthium sibiricum, Angelica dahurica, and Mentha haplocalyx), combined with the "deficiency of the root and excess of the branch" pathogenesis of allergic rhinitis, and is formulated through modifications and additions. The formula focuses on dispelling wind and clearing the lungs, opening the nasal passages and relieving itching, supplemented by methods to strengthen the spleen and resolve dampness, and to relieve exterior wind. It embodies the treatment theory of addressing both the root cause and the symptoms and is suitable for allergic rhinitis of the spleen deficiency and dampness excess type with obstruction of the lung nasal passages. The main symptoms include: severe nasal congestion, copious clear or sticky white nasal discharge, decreased sense of smell, dizziness and heaviness in the head, fatigue and weakness, pale and swollen tongue with teeth marks, and white and greasy or slippery tongue coating.

[0007] 2. Prescription of medicine Magnolia flower is pungent and warm, and specifically enters the lung and stomach meridians. Its aroma ascends and directly reaches the nasal passages, making it an essential medicine for clearing nasal passages. Xanthium fruit is bitter, pungent, and warm, and enters the lung meridian. It is good at dispelling wind and dampness, clearing nasal passages, and relieving pain. The two complement each other and concentrate their medicinal power to clear nasal passages, targeting the main symptoms. Together, they serve as the principal medicines. Dried tangerine peel is bitter, pungent, and warm. It regulates qi, strengthens the spleen, dries dampness, and resolves phlegm. When qi flows smoothly, dampness is transformed, and when the spleen is healthy, phlegm and dampness will not be generated. Patchouli is pungent and slightly warm. It aromatically transforms dampness, harmonizes the stomach, stops vomiting, releases the exterior, and relieves summer heat. Its aromatic nature can help the principal medicine to open the nasal passages, and its dampness-transforming function directly removes the stagnant dampness and turbidity in the body. Coix seed is sweet, bland, and cool. It strengthens the spleen, drains dampness, clears heat, and drains pus. It can help dried tangerine peel and patchouli strengthen the spleen and promote diuresis. Its slightly cold nature can also restrain the excessive warmth of the principal medicine and the whole formula, making the medicinal properties mild. These three medicines constitute a highly efficient "strengthening the spleen and removing dampness" unit. Dried tangerine peel regulates qi, patchouli transforms dampness, and coix seed drains dampness. The three restore the spleen's transportation and transformation function from different angles, fundamentally reducing the generation of "dampness". At the same time, their aromatic and warming properties (especially patchouli and dried tangerine peel) can assist the principal medicine in opening the orifices, and together they serve as assistant medicines. Angelica dahurica is pungent and warm, dispelling wind and cold, clearing the orifices and relieving pain, drying dampness and draining pus. It assists the principal herb in enhancing its ability to clear the orifices and relieve pain, while its drying properties synergize with the assistant herbs, making it an adjuvant herb. Saposhnikovia divaricata is pungent, sweet, and slightly warm. On one hand, as an adjuvant herb, its ability to dispel wind and release the exterior helps the principal herb disperse external pathogens; on the other hand, as a guiding herb, its function of tonifying qi and consolidating the exterior enhances the body's ability to defend against external pathogens and prevents wind pathogens from invading again, reflecting the idea of ​​combining prevention and treatment.

[0008] 3. Adaptation Approach This formula is a significant modification based on the classic formula "Xanthium sibiricum Powder." Its core approach has evolved from simply "dispelling wind and opening the orifices" to a comprehensive treatment method integrating "aromatic opening of the orifices, strengthening the spleen and resolving dampness, and supporting the body's resistance and consolidating the exterior." This reflects the evolution of TCM's treatment of allergic rhinitis from addressing the symptoms to treating the root cause, and from the lung to the spleen in its diagnostic thinking. The specific modification approach is as follows: (1) Inheriting and strengthening the core of "clearing the nasal passages" (targeting symptoms): This invention retains the core power of clearing the nasal passages in the original formula "Xanthium sibiricum Powder" - Magnolia biondii, Xanthium sibiricum, and Angelica dahurica. When used together, the three have a strong effect of clearing the lungs and opening the nasal passages, dispelling wind and relieving pain, directly targeting the main symptoms such as nasal congestion, runny nose, and headache, and have a rapid effect.

[0009] (2) Through key modifications, the approach shifts from "dispelling wind and clearing heat" to "strengthening the spleen and resolving dampness" (targeting the root cause of the disease): mint In the original formula, peppermint is cool in nature and its function is to dispel wind and heat, clear the head and eyes. It is suitable for the initial stage of wind-heat or the stage of wind-cold turning into heat. Patients with allergic rhinitis are mostly of the constitution of deficiency-cold or cold-dampness, or have repeated attacks and lingering illness. Overuse of cooling medicine may damage yang qi. Therefore, peppermint was removed to reduce its cooling nature and make the overall medicine of the formula more mild. Add dried tangerine peel, patchouli, and coix seed.This is the most distinctive adjustment in this formula. All three herbs enter the spleen and stomach meridians, forming a combination of "strengthening the spleen and regulating qi, and aromatically resolving dampness". Traditional Chinese medicine believes that "the spleen is the source of phlegm, and the lungs are the receptacle of phlegm". The clear nasal discharge of allergic rhinitis is actually the outward overflow of "dampness". When the spleen is weak and unable to transport and transform, internal dampness will be generated and invade the lungs and nose. Strengthening the spleen and removing dampness to eliminate the source of nasal discharge is the fundamental solution. Add windproof Fangfeng (Saposhnikovia divaricata) is considered a "moistening agent among wind-dispelling herbs," working synergistically with the principal herb to dispel wind and release the exterior (treating the symptoms) while also tonifying qi, strengthening the exterior, and resisting external pathogens (treating the root cause), embodying the preventative philosophy of "preventing disease before it occurs." The formula's approach of strengthening the spleen and eliminating dampness shares similarities with regulating immunity, improving allergic constitution, and reducing mucosal secretions.

[0010] 4. Analysis of the compatibility characteristics of the whole formula Treating both the symptoms and the root cause, with addressing the root cause being the priority. Magnolia flower, cocklebur fruit, and angelica root are used to treat the symptoms and clear the orifices; tangerine peel, agastache, and coix seed are used to strengthen the spleen and remove dampness to treat the root cause; and saposhnikovia root is used to strengthen the body's resistance and prevent recurrence. The structure is clear and the layers are distinct.

[0011] The lungs and spleen should be regulated in a coordinated manner, with an emphasis on strengthening the spleen. Although the whole formula treats the lungs, the focus of the medicine is on the spleen. Strengthening the spleen and eliminating dampness to prevent the source of phlegm production is the key strategy for controlling the recurrence of allergic rhinitis.

[0012] There is supplementation within circulation, and a combination of distribution and collection. The formula contains the "dispersing" properties of Magnolia biondii, Xanthium sibiricum, Angelica dahurica, and Saposhnikovia divaricata, as well as the "protecting" properties of Citrus reticulata and Coix lacryma-jobi, and the "consolidating" properties of Saposhnikovia divaricata. This avoids excessive depletion of vital energy by the pungent and dispersing herbs, making it suitable for patients with a long course of illness and a weak constitution.

[0013] It has mild medicinal properties and a wide range of applications. The cooling properties of peppermint are removed, and the slightly cooling properties of coix seed are added to counteract the warming effect, making the overall medicinal properties of the formula more balanced, without being too hot or too cold, which is more suitable for the complex pathogenesis of allergic rhinitis, such as deficiency-cold, cold-dampness, or mixed cold-heat.

[0014] Aromatic fragrance dispels turbidity, permeating the entire process. Magnolia flower, cocklebur fruit, patchouli, tangerine peel, and angelica root all possess aromatic properties. Aromatic herbs can invigorate the spleen, resolve dampness, promote the flow of qi, and open the orifices, making them very suitable for the pathogenesis of nasal obstruction due to dampness and turbidity.

[0015] Based on this, the present invention provides a traditional Chinese medicine composition for treating allergic rhinitis, which is made from the following medicinal materials in parts by weight: 10-60 parts Magnolia biondii, 10-60 parts Xanthium sibiricum, 10-60 parts Citrus reticulata peel, 10-60 parts Pogostemon cablin, 30-120 parts Coix lacryma-jobi, 10-60 parts Saposhnikovia divaricata, and 20-100 parts Angelica dahurica.

[0016] Preferably, the medicinal materials are in the following weight proportions: 20-40 parts Magnolia biondii, 20-40 parts Xanthium sibiricum, 20-40 parts Citrus reticulata peel, 20-40 parts Pogostemon cablin, 60-100 parts Coix lacryma-jobi, 20-40 parts Saposhnikovia divaricata, and 40-80 parts Angelica dahurica.

[0017] More preferably, the medicinal materials are in the following weight proportions: 35 parts Magnolia biondii, 25 parts Xanthium sibiricum, 20 parts Citrus reticulata peel, 30 parts Pogostemon cablin, 75 parts Coix lacryma-jobi, 30 parts Saposhnikovia divaricata, and 65 parts Angelica dahurica.

[0018] The aforementioned Chinese herbal raw materials can be processed using conventional techniques into any dosage form suitable for clinical use, including: ointments, decoctions, tablets, granules, capsules, pills, mixtures, syrups, etc. For example, the raw materials can be decocted in water to make a decoction for oral administration, following traditional methods. To improve efficacy, reduce side effects, and facilitate administration, a better approach is to extract and refine the medicinal materials, and then process them into dosage forms suitable for patients according to pharmaceutical methods and processes.

[0019] The preferred dosage forms of this invention are ointments, syrups, oral liquids, and granules. These dosage forms have good patient compliance, rapid digestion and absorption, and few side effects. The excipients used in preparing these dosage forms can be one or more combinations of common pharmaceutical excipients such as sucrose, starch, dextrin, sorbitol, steviol glycosides, mannitol, lactose, honey, carboxymethyl cellulose, water, flavoring agents, and preservatives. The specific excipient(s) selected depend on the desired dosage form.

[0020] The present invention provides a preferred preparation method as follows: (1) Weigh out the five medicinal materials: Magnolia biondii, Citrus reticulata peel, Pogostemon cablin, Angelica dahurica, and Saposhnikovia divaricata, and extract the volatile oil using steam distillation. (2) The volatile oil extracted in step (1) was encapsulated using β-cyclodextrin; (3) Add ethanol to the residue after extracting the volatile oil in step (1) and heat and reflux to extract, filter, and concentrate the filtrate until there is no alcohol taste; (4) Weigh out Xanthium sibiricum and Coix lacryma-jobi, add water and decoct to extract, filter and collect the filtrate; (5) The filtrate obtained in steps (3) and (4) is concentrated under vacuum to obtain an extract; (6) Add pharmaceutically acceptable excipients and the volatile oil encapsulation obtained in step (2) to the extract to prepare a pharmaceutical preparation suitable for clinical use.

[0021] Preferably, the steam distillation time is 3-6 hours.

[0022] Preferably, the embedding method in step (2) is the saturated aqueous solution method, and the mass ratio of β-cyclodextrin to volatile oil is 5-15:1.

[0023] Preferably, the concentration of ethanol in step (3) is 40-70%.

[0024] Preferably, the water decoction extraction in step (4) is performed 1-3 times, and the decoction time is 1-2 hours each time.

[0025] All ethanol concentrations mentioned in this invention are volume concentrations. For example, 60% ethanol means that 100 ml of ethanol aqueous solution contains 60 ml of ethanol.

[0026] An ovalbumin-based guinea pig model of allergic rhinitis was constructed. The traditional Chinese medicine of this invention improves the symptoms of allergic rhinitis, reduces serum IL-4 and IgE levels, decreases the content of eosinophils and lymphocytes in nasal lavage fluid, and reduces pathological damage to nasal turbinate tissue. Moreover, the effect is better than that of "Xanthium sibiricum powder", indicating that this invention has a high clinical efficacy for allergic rhinitis. Attached Figure Description

[0027] Figure 1 : Observe the pathological changes of nasal turbinate tissue in each group of guinea pigs by HE staining. Detailed Implementation

[0028] The present invention will be further described in detail below with reference to specific embodiments.

[0029] Example 1 Prescription: Magnolia flower buds 350g, stir-fried Xanthium sibiricum 250g, dried tangerine peel 200g, patchouli 300g, stir-fried coix seed 750g, saposhnikovia divaricata 300g, angelica dahurica 650g.

[0030] Preparation method: (1) Weigh the above five medicinal materials: Magnolia biondii, Citrus reticulata peel, Pogostemon cablin, Angelica dahurica and Saposhnikovia divaricata, and extract the volatile oil by steam distillation for 5 hours. The yield of volatile oil is 0.47%. (2) Take an appropriate amount of β-cyclodextrin and use the saturated aqueous solution method to encapsulate the volatile oil extracted in step (1). The mass ratio of β-cyclodextrin to volatile oil is 9:1, and the volatile oil encapsulation is obtained (volatile oil content is 0.0943 mL / g, and the encapsulation rate is 85.08%). (3) Add ethanol to the residue after extracting the volatile oil in step (1) to make the alcohol content reach 60%, then heat and reflux for 2.5 hours, filter, and concentrate the filtrate until there is no alcohol taste; (4) Weigh out the fried cocklebur seeds and the bran-fried coix seeds, add water and decoct twice, 1.5 hours each time, filter and collect the filtrate; (5) The filtrate obtained in steps (3) and (4) is concentrated under vacuum to obtain an extract with a relative density of 1.25 (60°C); (6) Add dextrin, sucrose, volatile oil inclusion complex and steviol glycoside to the extract to make granules, and the granules are obtained.

[0031] Dosage and administration: Oral administration, one packet three times a day (equivalent to 30g of raw medicinal material). This product is brownish-yellow to brownish-brown granules with an aromatic odor and a sweet, slightly bitter taste. Shelf life is twenty-four months. Store at room temperature.

[0032] Example 2 Prescription: Magnolia flower buds 350g, stir-fried Xanthium sibiricum 250g, dried tangerine peel 200g, patchouli 300g, stir-fried coix seed 750g, saposhnikovia divaricata 300g, angelica dahurica 650g.

[0033] Preparation method: (1) Weigh the above five medicinal materials: Magnolia biondii, Citrus reticulata peel, Pogostemon cablin, Angelica dahurica and Saposhnikovia divaricata, and extract the volatile oil by steam distillation for 5 hours. The yield of volatile oil is 0.42%. (2) Take an appropriate amount of β-cyclodextrin and use the saturated aqueous solution method to encapsulate the volatile oil extracted in step (1). The mass ratio of β-cyclodextrin to volatile oil is 6:1, and the volatile oil encapsulation material is obtained (volatile oil content is 0.0987 mL / g, and the encapsulation rate is 75.76%). (3) Mix the dregs after extracting the volatile oil in step (1) with the prescribed amount of stir-fried Xanthium sibiricum and stir-fried Coix lacryma-jobi, add water and decoct twice, 2 hours each time, filter and collect the filtrate; (4) The filtrate obtained in step (3) is concentrated under vacuum to obtain an extract with a relative density of 1.25 (60°C); (5) Add dextrin, sucrose, volatile oil inclusion complex and steviol glycoside to the extract to make granules, and then obtain granules.

[0034] Example 3 Prescription: Magnolia flower buds 350g, stir-fried Xanthium sibiricum 250g, dried tangerine peel 200g, patchouli 300g, stir-fried coix seed 750g, saposhnikovia divaricata 300g, angelica dahurica 650g.

[0035] Preparation method: (1) Weigh the above five medicinal materials: Magnolia biondii, Citrus reticulata peel, Pogostemon cablin, Angelica dahurica and Saposhnikovia divaricata, and extract the volatile oil by steam distillation for 6 hours. The yield of volatile oil is 0.49%. (2) Take an appropriate amount of β-cyclodextrin and use the saturated aqueous solution method to encapsulate the volatile oil extracted in step (1). The mass ratio of β-cyclodextrin to volatile oil is 12:1, and the volatile oil encapsulation material is obtained (volatile oil content is 0.0882 mL / g, and the encapsulation rate is 86.11%). (3) Add ethanol to the residue after extracting the volatile oil in step (1) to make the alcohol content reach 40%, then heat and reflux for 3 hours, filter, and concentrate the filtrate until there is no alcohol taste. (4) Weigh out the fried cocklebur seeds and the bran-fried coix seeds, add water and decoct 3 times, 1 hour each time, filter and collect the filtrate; (5) The filtrate obtained in steps (3) and (4) is concentrated under vacuum to obtain an extract with a relative density of 1.25 (60°C); (6) Add dextrin, sucrose, volatile oil inclusion complex and steviol glycoside to the extract to make granules, and the granules are obtained.

[0036] Example 4 Prescription: Magnolia flower buds 350g, stir-fried Xanthium sibiricum 250g, dried tangerine peel 200g, patchouli 300g, stir-fried coix seed 750g, saposhnikovia divaricata 300g, angelica dahurica 650g.

[0037] Preparation method: (1) Weigh the above 7 medicinal materials, add water and decoct 3 times, 1.5 hours each time, filter and collect the filtrate; (2) The filtrate obtained in step (1) is concentrated under vacuum to obtain an extract with a relative density of 1.25 (60℃); (3) Add dextrin, sucrose and steviol glycosides to the extract to make granules, and then obtain granules.

[0038] Experimental Example 1: Determination of the content of active ingredients in traditional Chinese medicine A small amount of extract from Examples 1-4 was taken, weighed, and dried under reduced pressure to constant weight. The weight of the dried extract was then measured, and the total yield of the prescription medicinal materials was calculated based on the weight of the dried extract. The content of hesperidin in the dried extract was then determined by HPLC, and the total lignan content in the dried extract was determined by UV spectrophotometry. The results are shown in Table 1 below.

[0039] Method for determining hesperidin content: Octadecylsilane-bonded silica gel is used as the filler; acetonitrile-water (22:78) is used as the mobile phase; the detection wavelength is 283 nm, and the theoretical plate number calculated based on the hesperidin peak should not be less than 2000.

[0040] Determination of total lignan content: Ultraviolet spectrophotometry was used, with magnolin as the reference standard. The absorbance was plotted on the ordinate, and the mass concentration of the reference standard on the abscissa. A linear regression equation was established: y = 6.013x - 0.0265 (R²). 2 =0.999 3), and the total lignan content was determined based on this.

[0041] Table 1: Extract yield and active ingredient content

[0042] Experiment Example 2: Efficacy Evaluation Experiment 1. Preparation of test drugs Weigh the prescription medicinal materials from Example 1, add water and decoct twice, each time adding water at a rate of 6 times the weight of the medicinal materials, and each decoction time being 2 hours. Combine the filtrates and concentrate them into an extract with a relative density of 1.22 (60°C), stir well, and use it as the test drug.

[0043] Weigh out 150g of Magnolia biondii, 75g of stir-fried Xanthium sibiricum, 300g of Angelica dahurica, and 15g of Mentha haplocalyx. Add water and decoct twice, each time adding water equal to 6 times the weight of the herbs. Each decoction lasts for 2 hours. After decoction, filter the mixture, combine the filtrates, and concentrate them into a thick paste with a relative density of 1.22, which will serve as the control drug.

[0044] 2. Test Methods After the acclimatization observation, Hartley guinea pigs (280g±20g) were first randomly selected as a blank control group (half male and half female) according to their body weight. The remaining animals were sensitized by intraperitoneal injection of 0.5mL of 10mg / mL albumin solution once every other day for a total of 3 times. On the 20th day after the last sensitization, nasal challenge was started, with 30μL of 500mg / mL albumin solution in each nostril once a day for a total of 11 times. After the last challenge, animals that successfully developed the model were selected and randomly divided into a model control group, low-, medium-, and high-dose test substance groups, and a positive control group according to their rhinitis scores, with 10 animals in each group (half male and half female). The low, medium, and high dose groups of the test substance were 3.6 g / kg, 7.2 g / kg, and 14.4 g / kg, respectively. The positive control group was given the control drug (14.4 g / kg) by gavage, while the blank control group and model control group were given an equal volume of pure water. The drug was administered by gavage at a volume of 10 mL / kg, twice daily for 14 consecutive days. During the administration period, nasal stimulation was performed every other day, and rhinitis scores were assessed on day 35 (the day of the first administration) and day 49 (the day of the last administration). Approximately one hour after the last stimulation, the animals underwent final treatment, and serum, nasal irrigation fluid, and nasal turbinates were collected for relevant index analysis.

[0045] Rhinitis scoring method: The scoring time starts from the time of drug administration and is observed continuously for 30 minutes. The scoring details are shown in Table 2.

[0046] Table 2: Scoring Indicators for Allergic Rhinitis

[0047] Serum biochemical index detection method: One hour ± 10 minutes after the last intranasal administration of the maintenance model, guinea pigs were anesthetized, and blood samples were collected from the guinea pigs using the abdominal aorta blood collection method. The blood volume should be more than 4 mL. After blood collection, the blood was placed at room temperature and centrifuged at 2000g for 15 min to separate the serum. After serum separation, it was stored at -65℃ or below, and the levels of histamine and IL-4 in the serum were detected using an ELISA kit.

[0048] Assessment of inflammatory cells in nasal lavage fluid: 1 h ± 20 min after the last nasal instillation of the maintenance model, the animal's nose was removed, and 1 mL of 0.9% sodium chloride injection solution was gently instilled into the nostril using a syringe from the posterior nasal aperture to collect nasal lavage fluid (NALF). The collected NALF was centrifuged at 2000 r / min for 10 min to separate the cells from the fluid. Cells were stained with Wright-Giemsa stain (see Wright-Giemsa stain instructions), and observed under a microscope. The total number of each type of inflammatory cell (eosinophils, lymphocytes) was calculated in 5 fields of view.

[0049] Methods for pathological examination of nasal turbinates: Animals were necropsy 1 hour ± 20 minutes after the last nasal drop maintenance model administration. The entire nasal turbinates from the orbital anterior edge to the snout were cut off. The skin tissue on the outer side of the nasal turbinates and the mandible were removed. The turbinates were fixed, decalcified, and pathological samples were taken, slides were prepared, and HE staining was performed. Four transverse sections of the nasal turbinates were included for histopathological observation.

[0050] 3. Test Results The results of the rhinitis symptom scoring showed that, compared with the blank control group, the rhinitis symptom scores of the model control group, the positive control group, and the low, medium, and high dose groups of the test substance were significantly increased before administration; compared with the model control group, the rhinitis symptom scores of the positive control group and the low, medium, and high dose groups of the test substance were significantly decreased after administration, indicating that the rhinitis symptoms were improved after administration, and the test substance dose groups were better than the positive control group (Table 3).

[0051] Table 3: Rhinitis Scoring Table for OVA-Induced Allergic Rhinitis Model

[0052] Note: Compared with the blank control group, # P <0.05; ## P <0.01; compared with the model control group, * P <0.05;** P <0.01; compared with the positive control group, ※ P <0.05; ※※ P <0.01.

[0053] Serum marker detection results showed that, compared with the model control group, the low, medium and high dose groups of the test substance after administration significantly reduced serum IL-4 and IgE levels (p<0.05 or 0.01), and each dose group was better than the positive control group (Table 4).

[0054] Table 4: Serum Indicator Statistics Table

[0055] Note: Compared with the blank control group, # P <0.05; ## P <0.01; compared with the model control group, * P <0.05;** P <0.01; compared with the positive control group, ※ P <0.05; ※※ P <0.01.

[0056] Nasal inflammatory cell counts showed that, compared with the model control group, all low, medium and high doses of the test substance reduced the number of eosinophils and lymphocytes in the nasal lavage fluid (p<0.05 or 0.01), and all dose groups were superior to the positive control group (Table 5).

[0057] Table 5: Inflammatory cell count

[0058] Note: Compared with the blank control group, # P <0.05; ## P <0.01; compared with the model control group, * P <0.05;** P <0.01; compared with the positive control group, ※ P <0.05; ※※ P <0.01.

[0059] Histopathological examination of the nasal turbinate showed that, compared with the model control group, all three dose groups of the test substance reduced inflammatory cell infiltration, epithelial hyperplasia / metaplasia, etc. after administration. Figure 1 ).

[0060] This indicates that the test substance is significantly effective in treating OVA-induced allergic rhinitis in guinea pigs.

[0061] Example 5 Prescription: Magnolia flower bud 500g, stir-fried Xanthium fruit 250g, dried tangerine peel 150g, patchouli 150g, stir-fried coix seed 500g, Saposhnikovia root 100g, Angelica dahurica root 250g Preparation: Take five medicinal materials: Magnolia biondii, Citrus reticulata peel, Pogostemon cablin, Angelica dahurica, and Saposhnikovia divaricata. First, extract the volatile oil using steam distillation. Then, add ethanol to the residue after extracting the volatile oil to make the alcohol content reach 60%. Heat and reflux for 2.5 hours, filter, and concentrate the filtrate until there is no alcohol taste. Take stir-fried Xanthium sibiricum and stir-fried Coix lacryma-jobi, add water and decoct twice, 1.5 hours each time, filter, and collect the filtrate. Concentrate the filtrate obtained from the alcohol extraction and water extraction under vacuum and dry. Powder the dried extract, spray in the volatile oil, and add appropriate amounts of starch, microcrystalline cellulose, and sodium carboxymethyl cellulose. Compress into tablets.

[0062] Example 6 Prescription: Magnolia flower buds 200g, stir-fried Xanthium fruit 350g, dried tangerine peel 350g, patchouli 200g, stir-fried coix seed 900g, Saposhnikovia root 200g, Angelica dahurica root 450g Preparation: Take five medicinal materials: Magnolia biondii, Citrus reticulata peel, Pogostemon cablin, Angelica dahurica, and Saposhnikovia divaricata. First, extract the volatile oil using steam distillation. Then, add ethanol to the residue after extracting the volatile oil to make the alcohol content reach 60%. Heat and reflux for 2.5 hours, filter, and concentrate the filtrate until there is no alcohol taste. Take stir-fried Xanthium sibiricum and stir-fried Coix lacryma-jobi, add water and decoct twice, 1.5 hours each time, filter, and collect the filtrate. Concentrate the filtrate obtained from the alcohol extraction and water extraction under vacuum and dry. Powder the dried extract, spray in the volatile oil, add an appropriate amount of starch and micronized silica gel, fill with capsules, and make capsules.

Claims

1. A traditional Chinese medicine composition for treating allergic rhinitis, characterized in that, It is made from the following medicinal materials in parts by weight: Magnolia biondii 10-60 parts, Xanthium sibiricum 10-60 parts, Citrus reticulata peel 10-60 parts, Pogostemon cablin 10-60 parts, Coix lacryma-jobi 30-120 parts, Saposhnikovia divaricata 10-60 parts, and Angelica dahurica 20-100 parts.

2. The traditional Chinese medicine composition for treating allergic rhinitis as described in claim 1, characterized in that, The weight proportions of the medicinal materials are as follows: 20-40 parts Magnolia biondii, 20-40 parts Xanthium sibiricum, 20-40 parts Citrus reticulata peel, 20-40 parts Pogostemon cablin, 60-100 parts Coix lacryma-jobi, 20-40 parts Saposhnikovia divaricata, and 40-80 parts Angelica dahurica.

3. The traditional Chinese medicine composition for treating allergic rhinitis as described in claim 1, characterized in that, The weight proportions of the medicinal materials are as follows: 35 parts Magnolia biondii, 25 parts Xanthium sibiricum, 20 parts Citrus reticulata peel, 30 parts Pogostemon cablin, 75 parts Coix lacryma-jobi, 30 parts Saposhnikovia divaricata, and 65 parts Angelica dahurica.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating allergic rhinitis.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Weigh out the five medicinal materials: Magnolia biondii, Citrus reticulata peel, Pogostemon cablin, Angelica dahurica, and Saposhnikovia divaricata, and extract the volatile oil using steam distillation. (2) The volatile oil extracted in step (1) was encapsulated using β-cyclodextrin; (3) Add ethanol to the residue after extracting the volatile oil in step (1) and heat and reflux to extract, filter, and concentrate the filtrate until there is no alcohol taste; (4) Weigh out Xanthium sibiricum and Coix lacryma-jobi, add water and decoct to extract, filter and collect the filtrate; (5) The filtrate obtained in steps (3) and (4) is concentrated under vacuum to obtain an extract; (6) Add pharmaceutically acceptable excipients and the volatile oil encapsulation obtained in step (2) to the extract to prepare a pharmaceutical preparation suitable for clinical use.

6. The preparation method according to claim 5, characterized in that: The steam distillation time is 3-6 hours.

7. The preparation method according to claim 5, characterized in that: The embedding method described in step (2) is the saturated aqueous solution method, and the mass ratio of β-cyclodextrin to volatile oil is 5-15:

1.

8. The preparation method according to claim 5, characterized in that: The concentration of ethanol mentioned in step (3) is 40-70%.

9. The preparation method according to claim 5, characterized in that: The water decoction extraction in step (4) is performed 1-3 times, and each decoction takes 1-2 hours.

10. The preparation method according to claim 5, characterized in that: The pharmaceutical preparations include granules, tablets, syrups, ointments, and capsules.

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