Traditional Chinese medicine composition for treating allergic rhinitis and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating allergic rhinitis and application thereof. The traditional Chinese medicine compound of the composition is composed of radix astragali, radix glehniae, rhizoma atractylodis macrocephalae, radix saposhnikoviae and the like, clinical experiments prove that the total effective rate of the composition in treating allergic rhinitis reaches 90%, and the composition has certain advantages in the aspects of symptom improvement speed, recurrence rate and patient satisfaction, is worthy of further popularization and application and has a wide application prospect. And more comprehensive evidence support is provided for clinic.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating allergic rhinitis and a use thereof. Background Art

[0002] Allergic rhinitis (AR) is an allergic disease with typical symptoms of nasal itching, nasal congestion, and frequent sneezing. As a common allergic disease, its incidence rate is increasing year by year worldwide, seriously affecting the quality of life of patients. It is reported that about 600 million people suffer from AR worldwide and the number is gradually increasing. The prevalence of AR in my country ranges from 4% to 38%. Although AR is not life-threatening, it will recur due to various external factors such as season, temperature, air, and the influence of allergens. Its typical symptoms are nasal itching, nasal congestion, clear nasal discharge, and sneezing. If the treatment is not timely or reasonable, it may lead to complications such as allergic conjunctivitis and asthma in patients. When the symptoms occur, it seriously affects the patient's life, work, and study. It is now a global health problem.

[0003] From the perspective of traditional Chinese medicine, most doctors believe that allergic rhinitis is mainly caused by dysfunction of internal organs, external wind and cold, and invasion of the nasal cavity by foreign qi. Among them, the main causes are deficiency of the lungs, spleen, and kidneys. The patient's physical condition can be adjusted and the patient's disease resistance can be strengthened by warming the lungs or kidney yang, strengthening the spleen and replenishing qi, and nourishing kidney yin.

[0004] At present, there are no particularly effective drugs on the domestic and foreign markets. Western medicine mainly uses anti-inflammatory, anti-allergic, analgesic and surgical treatments, which are generally difficult to cure. Chinese patent medicines include Tongqiao rhinitis capsules, Tongqiao rhinitis granules, rhinitis drops, rhinitis tablets, drops for rhinitis, Qianbai rhinitis tablets, etc. After using them, patients will have certain side effects more or less. Among the drug technologies disclosed in Chinese medicine patents, there are more Chinese medicines for the treatment of rhinitis, but fewer for the treatment of allergic rhinitis. Summary of the invention

[0005] Traditional Chinese medicine, with its unique theoretical system and treatment methods, has shown good application prospects in the treatment of allergic rhinitis. The present invention provides a Chinese medicine compound composed of Astragalus, Glehnia littoralis, Atractylodes macrocephala, Saposhnikovia divaricata, etc. (the name of the in-hospital preparation in this hospital is Yumin Tongbiyin) in the treatment of allergic rhinitis. The efficacy is definite in order to provide a scientific basis for clinical use. The product has been used in the hospital for nearly 10 years.

[0006] Specifically, the present invention is achieved through the following technical solutions:

[0007] The first object of the present invention is to provide a Chinese medicine composition for treating allergic rhinitis, wherein the Chinese medicine composition is made of the following Chinese medicines:

[0008] 10-30 weight parts of Astragalus, 10-30 weight parts of Adenophora, 10-30 weight parts of Atractylodes, 5-15 weight parts of Saposhnikovia, 5-15 weight parts of Arctium, 10-25 weight parts of Red Peony, 15-35 weight parts of Vinegar Bupleurum, 15-35 weight parts of Vinegar Schisandra, 5-15 weight parts of Prunus Mume, 5-15 weight parts of Magnolia, 5-15 weight parts of Xanthium, 5-15 weight parts of Ephedra, 5-15 weight parts of Aconite, 1-6 weight parts of Asarum, 30-50 weight parts of Amethyst, and 5-15 weight parts of Licorice tablets.

[0009] Furthermore, in order to improve the efficacy of the medicine, the magnolia is decocted, and the burdock and Xanthium are fried, thereby ensuring the effective ingredients of magnolia, burdock and Xanthium to the maximum extent.

[0010] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following Chinese medicines:

[0011] 20 weight parts of Astragalus, 20 weight parts of Adenophora, 20 weight parts of Atractylodes, 10 weight parts of Saposhnikovia, 10 weight parts of stir-fried Burdock Fruit, 15 weight parts of Red Peony Root, 25 weight parts of Vinegar Bupleurum, 25 weight parts of Vinegar Schisandra, 10 weight parts of Prunus Mume, 10 weight parts of Magnolia, 10 weight parts of stir-fried Xanthium sibiricum, 10 weight parts of Ephedra, 10 weight parts of Aconite, 3 weight parts of Asarum, 40 weight parts of Amethyst, and 10 weight parts of Licorice Tablets.

[0012] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following Chinese medicines:

[0013] 10 parts by weight of Astragalus, 10 parts by weight of Adenophora, 10 parts by weight of Atractylodes, 5 parts by weight of Saposhnikovia, 5 parts by weight of stir-fried Burdock Fruit, 10 parts by weight of Red Peony Root, 15 parts by weight of Vinegar Bupleurum, 15 parts by weight of Vinegar Schisandra, 5 parts by weight of Prunus Mume, 5 parts by weight of Magnolia, 5 parts by weight of stir-fried Xanthium sibiricum, 5 parts by weight of Ephedra, 5 parts by weight of Aconite, 1 part by weight of Asarum, 30 parts by weight of Amethyst, and 5 parts by weight of Licorice Tablets.

[0014] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following Chinese medicines:

[0015] 30 parts by weight of Astragalus, 30 parts by weight of Adenophora, 30 parts by weight of Atractylodes, 15 parts by weight of Saposhnikovia, 15 parts by weight of stir-fried Burdock Fruit, 25 parts by weight of Red Peony Root, 35 parts by weight of Vinegar Bupleurum, 35 parts by weight of Vinegar Schisandra, 15 parts by weight of Prunus Mume, 15 parts by weight of Magnolia, 15 parts by weight of stir-fried Xanthium sibiricum, 15 parts by weight of Ephedra, 15 parts by weight of Aconite, 6 parts by weight of Asarum, 50 parts by weight of Amethyst, and 15 parts by weight of Licorice Tablets.

[0016] From the perspective of traditional Chinese medicine, the allergic rhinitis described in the present invention is any one of the types of wind-cold type, wind-heat type, spleen deficiency type, kidney deficiency type, and phlegm-dampness type, and the Chinese medicine composition is used in the preparation of treatment for wind-cold type allergic rhinitis.

[0017] From the origin of the disease, the allergic rhinitis described in the present invention includes any one of seasonal allergic rhinitis, perennial allergic rhinitis, occupational allergic rhinitis, and mixed allergic rhinitis. The effect of treating seasonal allergic rhinitis is significant.

[0018] The Chinese medicine oral preparation is any one of decoction, granule, pill, tablet, mixture, capsule and powder. The decoction of the present invention has better preparation effect, so the preparation of the decoction is developed and found that the aconite root and calcined purple quartz need to be decocted first, and the magnolia flower adopts the decoction treatment method, which has the best therapeutic effect.

[0019] Furthermore, the decoction method comprises the following steps:

[0020] The preparation process is as follows:

[0021] 1) First, decoct the root of aconite and calcined purple quartz with a slow fire, boil for 10 minutes, and set aside the liquid for later use;

[0022] 2) Put the magnolia into a cloth bag or other container for decoction, and set aside the liquid medicine;

[0023] 3) decoct the remaining Chinese medicinal materials twice, each time for 20 minutes, combine the two filtrates, and then mix and filter with the filtrates of steps 1) and 2) to obtain a decoction.

[0024] The above treatment course is preferably taken for 2-3 courses. Each prepared Chinese medicine decoction is taken in 2 doses, twice a day, for a course of seven days, and preferably taken for 2-3 courses.

[0025] Compared with the prior art, the present invention has achieved unexpected technical effects:

[0026] 1) The Chinese medicine composition described in the present invention has a proper ratio. The name of the Chinese medicine composition in the prescription is Yumin Tongbi Drink. This compound is mainly composed of drugs such as Astragalus, Glehnia littoralis, Atractylodes macrocephala, etc. that can invigorate qi and strengthen the exterior, strengthen the spleen and benefit the lungs, supplemented by herbs such as Saposhnikovia divaricata, Magnolia officinalis, and stir-fried Xanthium sibiricum that can dispel wind and open the orifices, while herbs such as Schisandra chinensis and Prunus mume that can astringe lung qi, asarum and ephedra that can dispel pungent and warm exterior symptoms, and calcined purple quartz that can warm the kidney and absorb qi. The whole prescription has the functions of invigorating qi and strengthening the exterior, dispelling wind and opening the orifices, and warming the kidney and absorbing qi, and treats allergic rhinitis according to the pathogenesis characteristics.

[0027] 2) Pharmacological experiments confirmed that the pharmaceutical composition of the present invention can significantly reduce the weight of nasal mucosa caused by allergic reactions, so that the symptoms of nasal congestion and runny nose are significantly improved, achieving the same therapeutic effect as current Western medicines. The therapeutic effect of the preferred embodiment 1 is even better than that of the positive group (Western medicine treatment method).

[0028] 3) The Chinese medicine compound of the present invention may exert therapeutic effects through multiple pathways such as regulating the body's immune function, reducing inflammatory reactions, and improving local microcirculation in the nasal cavity. In addition, the multi-component and multi-target action characteristics of traditional Chinese medicine may give it unique advantages in the treatment of complex diseases. The Chinese medicines in this compound are all commonly used Chinese medicines, with high safety, good patient feedback, and high compliance. Clinical experiments have confirmed that the total effective rate of the composition of the present invention in the treatment of allergic rhinitis reaches 90%, and it shows certain advantages in terms of symptom improvement speed, recurrence rate and patient satisfaction. Therefore, this Chinese medicine compound can be used as an effective choice for the treatment of allergic rhinitis, and it is worthy of further promotion and application. Future studies can further explore its mechanism of action and long-term efficacy to provide more comprehensive evidence support for clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 :Each group had a significant effect on the changes in capillary permeability.

[0030] Figure 2 : The examples show the score of nasal scratching, runny nose and sneezing in rats with allergic rhinitis induced by ovalbumin.

[0031] Figure 3 : Comparison of INF-γ (interferon-γ) content in each embodiment.

[0032] Figure 4 : Comparison of IL-4 content in each embodiment.

[0033] Figure 5 : Comparison of IgE (immunoglobulin E) content in each embodiment. DETAILED DESCRIPTION

[0034] The following are only a few examples given. During the development, the inventors have repeatedly experimented and obtained the same or similar results. The method is effective and feasible and has good clinical application value. The Chinese medicine component formula for treating allergic rhinitis of the present invention shows certain advantages in terms of symptom improvement speed, recurrence rate and patient satisfaction. The present invention has repeatedly studied the efficacy of Yumintongbiyin obtained in each embodiment in treating allergic rhinitis model rats, and achieved satisfactory therapeutic effects. The relevant research data are as follows:

[0035] Example 1: A Chinese medicine composition for treating allergic rhinitis and its use

[0036] Astragalus 20g, Northern Adenophora 20g, Atractylodes 20g, Saposhnikovia 10g, stir-fried Burdock Fruit 10g, Red Peony 15g, Northern Bupleurum 25g with vinegar, Schisandra 25g with vinegar, Prunus mume 10g, Magnolia 10g, stir-fried Xanthium 10g, Ephedra 10g, Aconite 10g, Asarum 3g, calcined purple quartz 40g, and 10g liquorice tablets.

[0037] The preparation process is as follows:

[0038] 1) First, decoct the root of aconite and calcined purple quartz with a slow fire, boil for 10 minutes, and set aside the liquid for later use;

[0039] 2) Put the magnolia into a cloth bag or other container for decoction, and set aside the liquid medicine;

[0040] 3) decoct the remaining Chinese medicinal materials twice, each time for 20 minutes, combine the two filtrates, and then mix and filter with the filtrates of steps 1) and 2) to obtain a decoction.

[0041] Example 2: A Chinese medicine composition for treating allergic rhinitis and its use

[0042] 10g of Astragalus, 10g of Northern Adenophora, 10g of Atractylodes, 5g of Saposhnikovia, 5g of stir-fried Burdock Fruit, 10g of Red Peony Root, 15g of Vinegar Northern Bupleurum, 15g of Vinegar Schisandra, 5g of Prunus Mume, 5g of Magnolia, 5g of stir-fried Xanthium sibiricum, 5g of Ephedra, 5g of Aconite, 1g of Asarum, 30g of calcined purple quartz, and 5g of liquorice tablets.

[0043] The preparation process is the same as that of Example 1.

[0044] Example 3: A Chinese medicine composition for treating allergic rhinitis and its use

[0045] Astragalus 30g, Northern Adenophora 30g, Atractylodes 30g, Saposhnikovia 15g, stir-fried Burdock Fruit 15g, Red Peony 25g, Northern Bupleurum 35g with vinegar, Schisandra 35g with vinegar, Prunus mume 15g, Magnolia 15g, stir-fried Xanthium 15g, Ephedra 15g, Aconite 15g, Asarum 6g, calcined purple quartz 50g, and 15g liquorice tablets.

[0046] The preparation process is the same as that of Example 1.

[0047] Example 4: A Chinese medicine composition for treating allergic rhinitis and its use

[0048] Astragalus 20g, Northern Adenophora 20g, Atractylodes 20g, Saposhnikovia 10g, stir-fried Burdock Fruit 10g, Red Peony 15g, Northern Bupleurum 25g with vinegar, Schisandra 25g with vinegar, Prunus mume 10g, Magnolia 10g, stir-fried Xanthium 10g, Ephedra 10g, Aconite 10g, Asarum 3g, calcined purple quartz 40g, and 10g liquorice tablets.

[0049] After being prepared into a decoction, it is rotary evaporated to dryness and then pharmaceutical excipients are added, and granules are prepared by conventional processes.

[0050] Example 5: A Chinese medicine composition for treating allergic rhinitis and its use

[0051] Astragalus 20g, Northern Adenophora 20g, Atractylodes 20g, Saposhnikovia 10g, stir-fried Burdock Fruit 10g, Red Peony 15g, Northern Bupleurum 25g with vinegar, Schisandra 25g with vinegar, Prunus mume 10g, Magnolia 10g, stir-fried Xanthium 10g, Ephedra 10g, Aconite 10g, Asarum 3g, calcined purple quartz 40g, and 10g liquorice tablets.

[0052] After being prepared into a decoction, it is rotary evaporated to dryness and then pharmaceutical excipients are added, and then it is prepared into capsules by conventional processes.

[0053] Example 6: A Chinese medicine composition for treating allergic rhinitis and its use

[0054] Astragalus 20g, Northern Adenophora 20g, Atractylodes 20g, Saposhnikovia 10g, stir-fried Burdock Fruit 10g, Red Peony 15g, Northern Bupleurum 25g with vinegar, Schisandra 25g with vinegar, Prunus mume 10g, Magnolia 10g, stir-fried Xanthium 10g, Ephedra 10g, Aconite 10g, Asarum 3g, calcined purple quartz 40g, and 10g liquorice tablets.

[0055] After being prepared into a decoction, it is rotary evaporated to dryness and then pharmaceutical excipients are added, and an oral liquid is prepared by conventional processes.

[0056] Example 7: A Chinese medicine composition for treating allergic rhinitis and its use

[0057] Astragalus 20g, Northern Adenophora 20g, Atractylodes 20g, Saposhnikovia 10g, stir-fried Burdock Fruit 10g, Red Peony 15g, Northern Bupleurum 25g with vinegar, Schisandra 25g with vinegar, Prunus mume 10g, Magnolia 10g, stir-fried Xanthium 10g, Ephedra 10g, Aconite 10g, Asarum 3g, calcined purple quartz 40g, and 10g liquorice tablets.

[0058] After being prepared into a decoction, it is rotary evaporated and then pharmaceutical excipients are added, and it is prepared into pills by conventional processes.

[0059] Comparative Example 1: A Chinese medicine composition for treating allergic rhinitis and its use

[0060] 20g of Astragalus, 20g of Northern Adenophora, 20g of Atractylodes, 10g of stir-fried Burdock Fruit, 15g of Red Peony Root, 25g of Vinegar Northern Bupleurum, 25g of Vinegar Schisandra, 10g of Magnolia, 10g of stir-fried Xanthium sibiricum, 10g of Aconite, 40g of calcined purple quartz, and 10g of liquorice tablets.

[0061] The preparation process is the same as that of Example 1.

[0062] Comparative Example 2: A Chinese medicine composition for treating allergic rhinitis and its use

[0063] Astragalus 20g, Adenophora 20g, Atractylodes 20g, Schizonepeta 10g, stir-fried Burdock Fruit 10g, White Peony 15g, Cistanche 25g, Actinolite 25g, Prunus Mume 10g, Magnolia 10g, stir-fried Xanthium 10g, Ephedra 10g, Aconite 10g, Polygonum multiflorum 3g, calcined purple quartz 40g, and licorice tablets 10g.

[0064] The preparation process is the same as that of Example 1.

[0065] Comparative Example 3: A Chinese medicine composition for treating allergic rhinitis and its use

[0066] 20g of Atractylodes macrocephala, 10g of Saposhnikovia divaricata, 10g of stir-fried Burdock fruit, 15g of Red Peony Root, 25g of Bupleurum chinense with vinegar, 25g of Schisandra chinensis with vinegar, 10g of Prunus mume, 10g of Magnolia officinalis, 10g of stir-fried Xanthium sibiricum, 10g of Ephedra sinica, 10g of Aconite root, 3g of Asarum, 40g of calcined purple quartz, and 10g of liquorice tablets.

[0067] The preparation process is the same as that of Example 1.

[0068] Comparative Example 4: A Chinese medicine composition for treating allergic rhinitis and its use

[0069] 10g of Saposhnikovia divaricata, 10g of stir-fried burdock fruit, 15g of red peony root, 25g of vinegar-cooked Bupleurum chinense, 25g of vinegar-cooked Schisandra chinensis, 10g of Prunus mume, 10g of Magnolia officinalis, 10g of stir-fried Xanthium sibiricum, 10g of Ephedra sinica, 10g of Aconite root, 3g of Asarum, 40g of calcined purple quartz, and 10g of liquorice tablets.

[0070] The preparation process is the same as that of Example 1.

[0071] Comparative Example 5: A Chinese medicine composition for treating allergic rhinitis and its use

[0072] Astragalus 8g, Northern Adenophora 44g, Atractylodes 8g, Saposhnikovia 20g, stir-fried Burdock Fruit 5g, Red Peony 5g, Vinegar Northern Bupleurum 25g, Vinegar Schisandra 5g, Prunus Mume 10g, Magnolia 10g, stir-fried Xanthium 10g, Ephedra 11g, Aconite 5g, Asarum 2g, Calcined Amethyst 60g, Licorice Tablets 20g.

[0073] The preparation process is the same as that of Example 1.

[0074] Verification Experiment Example 1: Inhibitory Effect of Histamine on Increased Capillary Permeability in Rat Nasal Mucosa

[0075] An animal model was established by histamine-induced increased capillary permeability in rat nasal mucosa, and the inhibition rate of each prescription on histamine was investigated and compared, providing a theoretical basis for the efficacy of drugs for the treatment of rhinitis and sinusitis. Histamine is an inflammatory mediator, and its release can cause increased local capillary permeability and inflammatory cell infiltration, resulting in increased nasal mucosal weight.

[0076] Materials and reagents

[0077] SPF grade SD male rats, 200 ± 10 g, Beijing BGI Protein Research and Development Center Co., Ltd., experimental animal production license number: SYXK (Beijing) 2023-0075. The treatment of animals during the experiment complies with animal ethics standards.

[0078] 1.2 Feed and drinking water

[0079] SPF rat feed and purified water.

[0080] 1.3 Reagents

[0081] The decoctions prepared in Examples 1-3 and Comparative Examples 1-5 were calculated based on the amount of crude drugs in each example, and 22.32 g / kg (human body weight was calculated based on 70 kg) was administered by gavage; positive group (ephedrine diphenhydramine tablets, national medicine standard H22024870; Jilin Province Broad Pharmaceutical Co., Ltd.; drug standard code 86903352000318).

[0082] 1.4 Experimental methods

[0083] 1.4.1 Grouping

[0084] There were 11 groups in total, with 6 SD rats in each group, including groups 1 to 3 of Examples, groups 1 to 5 of Comparative Examples, the model group and the positive group, and 6 rats as normal group controls.

[0085] 1.4.2 Administration

[0086] The corresponding decoction was administered by gavage once a day at 8 pm in each example. The normal group and the model group were administered with the same dose of saline by gavage. In the positive group, the tablets were ground into a suspension and administered by gavage. The drug was administered for 3 consecutive days for index detection.

[0087] 1.4.3 Determination of inhibition rate

[0088] Thirty minutes after the third administration, the animals in each group were opened in the chest, the right atrium was cut open, the aorta was punctured through the left ventricle, and saline was perfused until the outflow from the right atrium became clear. The nasal cavity was opened through the midsagittal plane, and the entire nasal mucosa in the respiratory area was removed and cut into 2 mm × 2 mm small pieces, which were weighed using an electronic balance.

[0089] Statistical methods

[0090] All quantitative data were expressed as % and the significance of mean differences was analyzed by analysis of variance using GraphPad Prism 9.0 statistical software.

[0091] 1.6. Experimental results

[0092] Figure 1 :By comparison, it can be seen that there is a significant difference between the normal group and the model group 2 (P<0.01). Comparative Examples 1-5 are significantly different from Examples 1-3 (P<0.01), indicating that different drug combinations or different dosages have a significant effect on the change of capillary permeability. Examples 1-3 are not significantly different from the positive group, but the nasal mucosal weight of Example 1 is lower than that of the positive control group, which also shows that the antihistamine effect of Example 1 is more obvious.

[0093] Verification Example 2: Effect of ovalbumin sensitization (allergic rhinitis model)

[0094] Ovalbumin can induce allergic symptoms such as nasal scratching, runny nose, sneezing, etc. in rats, increase mucosal eosinophils (EOS), and increase IgE content. Ovalbumin rats are a common model of allergic rhinitis. The present invention uses ovalbumin to construct a rat model.

[0095] Rats were given an intraperitoneal injection of 1 mL of ovalbumin sensitizer solution, once every other day for a total of 7 times. This was the basic sensitization. After the basic sensitization, 5% ovalbumin stimulating solution was dripped into the nose every other day, 10 μL on each side. The behavioral changes of the rats (scratching the nose, runny nose, sneezing, etc.) within 30 minutes after stimulation were observed, and the behavioral scores of the experimental rats were recorded. The total score was recorded according to the standard superposition method. A total score of 5 or more for each rat was considered a successful model, and a score of less than 5 was considered a failed model (see Table 1 for scoring criteria).

[0096] Table 1 Symptom grading criteria for allergic rhinitis in rats

[0097]

[0098] Materials and reagents

[0099] SPF grade SD male rats, 200 ± 10 g, Beijing BGI Protein Research and Development Center Co., Ltd., experimental animal production license number: SYXK (Beijing) 2023-0075. The treatment of animals during the experiment complies with animal ethics standards.

[0100] 2.2 Experimental methods

[0101] 2.2.1 Grouping

[0102] Examples 1 to 3, comparative examples 1 to 5, model group and positive group, and 6 rats were taken as normal control group, a total of 11 groups, each with 6 SD rats. Positive group (loratadine syrup; national medicine standard H20244373; Zhejiang Kairun Pharmaceutical Co., Ltd.; drug standard code 86983864000020, loratadine 1 mg / kg).

[0103] 2.2.2 Administration

[0104] The rats with successful modeling were selected and given the corresponding decoction in each example by gavage once a day at 8 pm. The normal group and the model group were given the same dose of saline by gavage. Six SD rats in each group were given the drug for 5 consecutive days for index detection.

[0105] 3. Sample collection and testing

[0106] After the experiment, the rats were anesthetized with 0.1 mL·100 g-1 of 3% sodium pentobarbital, fixed on the animal operating table in a supine position, the abdominal wall was cut open, the abdominal aorta was exposed, blood was collected from the abdominal aorta, placed in a sample collection tube, and allowed to stand at room temperature for 2 h, centrifuged at 2000 rpm / min for 10 min, the supernatant was taken, and placed in 1.5 mL EP tubes, respectively, and frozen in a -80 ° C refrigerator for testing. The levels of interferon-γ (INF-γ), interleukin-4 (IL-4) and immunoglobulin E (IgE) in rat serum were detected by ELISA.

[0107] 4. Statistical methods

[0108] All quantitative data were expressed as % and the significance of mean differences was tested by analysis of variance using GraphPad Prism 6 statistical software.

[0109] 5. Experimental Results

[0110] 5.1 Behavioral Observation

[0111] After the model was stimulated, the animals showed obvious symptoms such as scratching the nose, runny nose, and sneezing. The symptoms of the medication group were significantly alleviated. After scoring using Table 1, there was a significant difference between the medication group and the saline group. The scores of each group are shown in Figure 2 .

[0112] Figure 2: By comparison, it can be seen that there is a significant difference between the normal group and the model group (P<0.01). Each embodiment can significantly reduce the symptoms of nasal scratching, runny nose and sneezing in rats with allergic rhinitis caused by ovalbumin. Compared with Examples 1-3, Comparative Examples 1-5 have significant differences (P<0.01), indicating that different drug combinations or different dosages have a significant effect on the obvious changes in symptoms such as nasal scratching, runny nose and sneezing. Finally, it is presented in the apparent integral. There is a significant difference between Examples 1-3 and Comparative Examples 1-5. The relief of the above symptoms in each group of Comparative Examples 1-5 is not obvious. The anti-allergic rhinitis effect of Example 1 is stronger than that of the loratadine positive group, which shows the superiority of the composition of the present invention.

[0113] 5.2 Changes in cytokines

[0114] Figure 3 : INF-γ (interferon-γ) is an important cytokine, mainly secreted by T cells and natural killer (NK) cells. It plays a key role in the immune system. Figure 3 It shows that each administration group can increase the INF-γ concentration in serum, and there is a significant difference between the normal group and the model group (P<0.01). Each embodiment can significantly increase the content of INF-γ, activate macrophages, improve their phagocytic and bactericidal abilities, and enhance cell-mediated immune responses. Examples 1-3 are significantly different from Comparative Examples 1-5. Each group of Comparative Examples 1-5 is significantly different from the model group, but the effect of increasing INF-γ is lower than that of Example 1-3 and the positive group.

[0115] Figure 4 : IL-4 is closely related to allergic diseases (such as asthma, allergic rhinitis, etc.). It is an important cytokine, mainly secreted by T helper cells (especially Th2 cells). It can promote the production of IgE antibodies, thereby triggering allergic reactions. Figure 4 The results showed that each administration group reduced the content of IL-4 in serum, and there was a significant difference between the normal group and the model group (P<0.01). Each embodiment can significantly reduce the content of IL-4 and reduce the possibility of allergic reactions.

[0116] Figure 5:IgE (immunoglobulin E) is a specific type of antibody, mainly related to allergic reactions and parasitic infections. It shows that each administration group reduces the content of IgE in serum. IgE is an important biomarker for allergic diseases (such as allergic rhinitis, asthma, urticaria, etc.). Its increased level usually indicates that the body has an allergic reaction to certain allergens (such as pollen, dust mites, food, etc.). As can be seen from the results, there is a significant difference between the normal group and the model group (P<0.01). Each embodiment and the positive group can significantly reduce the content of IgE and reduce the possibility of allergic reactions. Compared with comparative examples 1-5, embodiments 1-3 have significant differences (P<0.01), indicating that the compositions or dosages not of the present invention cannot achieve the technical effects described in the present invention.

[0117] Verification Experiment Example 3: Clinical Experiment on Allergic Rhinitis

[0118] 2.1. Research subjects

[0119] A total of 100 patients diagnosed with allergic rhinitis in our outpatient clinic from January 2021 to January 2023 were selected and randomly divided into an observation group and a control group, 50 cases in each group. There were 26 males and 24 females in the observation group; the age ranged from 19 to 49 years old, with an average age of (37.43±6.73) years old; 39 married cases and 11 unmarried cases. There were 28 males and 22 females in the control group; the age ranged from 21 to 50 years old, with an average age of (37.28±7.08) years old; 41 married cases and 9 unmarried cases. There was no significant difference in the clinical data between the two groups (P>0.05), and they were comparable.

[0120] 2.2. Inclusion criteria

[0121] ① Clearly diagnosed as AR, the Western medicine diagnostic standards refer to the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015)", and the traditional Chinese medicine diagnostic standards refer to the "Traditional Chinese Medicine Otorhinolaryngology"; ② Complete clinical data and can cooperate with the research work; ③ No relevant treatment has been received within 2 weeks before enrollment.

[0122] Exclusion criteria: ①combined with other nasal diseases; ②allergic to study drugs; ③combined with other malignant tumors; ④pregnancy and lactation.

[0123] 2.3. Treatment options:

[0124] Treatment group: The decoction prepared in Example 1, specifically as follows: a Chinese medicine compound (Yumin Tongbi Yin) was given for treatment, specifically composed of: 20g of Astragalus, 20g of Adenophora, 20g of Atractylodes macrocephala, 10g of Saposhnikovia divaricata, and 10g of fried Burdock seeds.

[0125] 10g red peony root 15g vinegar northern bupleurum 25g vinegar schisandra 25g, black plum 10g magnolia ( 10g fried Xanthium sibiricum 10g

[0126] Ephedra 10g, Aconite root 10g, Asarum 3g, Calcined Amethyst 40g, Licorice tablets 10g.

[0127] Take one dose daily, decocted in water 200 ml, divided into two doses, once in the morning and once in the evening, for continuous treatment for 2 weeks.

[0128] Control group: given conventional western medicine treatment, antihistamine loratadine 10 mg qd and budesonide nasal spray, 1 spray in each nostril, 2 times a day, the course of treatment is the same as the treatment group.

[0129] 2.4 Observation indicators:

[0130] Clinical symptom score. The most classic clinical symptoms were used as the basis for scoring, including sneezing, nasal congestion, nasal itching and runny nose. The visual analog scale (VAS) was used for evaluation and was divided into asymptomatic (0 points), mild (1-3 points), moderate (4-7 points) and severe (8-10 points). The lower the score, the milder the clinical symptoms. SPSS13.0 software was used for analysis. The quantitative data were expressed as (x±s) and tested by t, and the counting data were expressed as (%) and tested by χ2. 2 Test, P < 0.05 was considered statistically significant.

[0131] Evaluation criteria for efficacy: Complete disappearance of symptoms is markedly effective. Significant improvement of symptoms is effective. Ineffective if the criteria for efficacy are not met.

[0132] Results

[0133] After 2 weeks of treatment, the results of the comparison of the therapeutic effects between the treatment group and the control group are as follows:

[0134] The comparison of clinical efficacy between the two groups is shown in Tables 2 and 3.

[0135] Table 2 Comparison of clinical efficacy between the two groups

[0136]

[0137] Table 3 Comparison of clinical symptom scores between the two groups before and after treatment (scores, x±s)

[0138]

[0139] The treatment group showed advantages in terms of symptom improvement speed, relapse rate and symptom relief rate. Patients in the treatment group generally reported that their symptoms were relieved faster and there were fewer relapses after stopping the medication.

[0140] Yumin Tongbiyin is a compound prescription that mainly uses herbs such as Astragalus, Adenophora, and Atractylodes macrocephala to invigorate qi and strengthen the exterior, strengthen the spleen and benefit the lungs, supplemented by herbs such as Saposhnikovia divaricata, Magnolia officinalis, and fried Xanthium sibiricum to dispel wind and open the orifices. At the same time, it adds herbs such as Schisandra chinensis and Prunus mume to astringe lung qi, asarum and ephedra to dispel the exterior, and calcined purple quartz to warm the kidney and absorb qi. The whole prescription works together to invigorate qi and strengthen the exterior, dispel wind and open the orifices, and warm the kidney and absorb qi, and treats allergic rhinitis according to the pathogenesis characteristics. Yumin Tongbiyin Chinese medicine compound may exert its therapeutic effect through multiple pathways such as regulating the body's immune function, reducing inflammatory response, and improving local microcirculation in the nasal cavity. In addition, the multi-component and multi-target action characteristics of Chinese medicine may give it a unique advantage in treating complex diseases. The Chinese medicines in this compound are all commonly used Chinese medicines, with high safety, good patient feedback, and high compliance.

[0141] This study showed that the total effective rate of the Yumintongbiyin Chinese medicine compound in the treatment of allergic rhinitis reached 90%, and it showed certain advantages in symptom improvement speed, recurrence rate and patient satisfaction. Therefore, this Chinese medicine compound can be used as an effective choice for the treatment of allergic rhinitis and is worthy of further promotion and application. Future studies can further explore its mechanism of action and long-term efficacy to provide more comprehensive evidence support for clinical practice.

Claims

1. A Chinese medicine composition for treating allergic rhinitis, characterized in that: The Chinese medicine composition is made from the following Chinese medicines: 10-30 weight parts of Astragalus, 10-30 weight parts of Adenophora, 10-30 weight parts of Atractylodes, 5-15 weight parts of Saposhnikovia, 5-15 weight parts of Arctium, 10-25 weight parts of Red Peony, 15-35 weight parts of Vinegar Bupleurum, 15-35 weight parts of Vinegar Schisandra, 5-15 weight parts of Prunus Mume, 5-15 weight parts of Magnolia, 5-15 weight parts of Xanthium, 5-15 weight parts of Ephedra, 5-15 weight parts of Aconite, 1-6 weight parts of Asarum, 30-50 weight parts of Amethyst, and 5-15 weight parts of Licorice tablets.

2. The Chinese medicine composition according to claim 1, characterized in that The magnolia is wrapped and fried; the burdock fruit and Xanthium sibiricum fruit are stir-fried.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is made from the following Chinese medicines: 20 weight parts of Astragalus, 20 weight parts of Adenophora, 20 weight parts of Atractylodes, 10 weight parts of Saposhnikovia, 10 weight parts of stir-fried Burdock Fruit, 15 weight parts of Red Peony Root, 25 weight parts of Vinegar Bupleurum, 25 weight parts of Vinegar Schisandra, 10 weight parts of Prunus Mume, 10 weight parts of Magnolia, 10 weight parts of stir-fried Xanthium sibiricum, 10 weight parts of Ephedra, 10 weight parts of Aconite, 3 weight parts of Asarum, 40 weight parts of Amethyst, and 10 weight parts of Licorice Tablets.

4. The Chinese medicine composition as claimed in claim 2, characterized in that The Chinese medicine composition is made from the following Chinese medicines: 10 parts by weight of Astragalus, 10 parts by weight of Adenophora, 10 parts by weight of Atractylodes, 5 parts by weight of Saposhnikovia, 5 parts by weight of stir-fried Burdock Fruit, 10 parts by weight of Red Peony Root, 15 parts by weight of Vinegar Bupleurum, 15 parts by weight of Vinegar Schisandra, 5 parts by weight of Prunus Mume, 5 parts by weight of Magnolia, 5 parts by weight of stir-fried Xanthium sibiricum, 5 parts by weight of Ephedra, 5 parts by weight of Aconite, 1 part by weight of Asarum, 30 parts by weight of Amethyst, and 5 parts by weight of Licorice Tablets.

5. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is made from the following Chinese medicines: 30 parts by weight of Astragalus, 30 parts by weight of Adenophora, 30 parts by weight of Atractylodes, 15 parts by weight of Saposhnikovia, 15 parts by weight of stir-fried Burdock Fruit, 25 parts by weight of Red Peony Root, 35 parts by weight of Vinegar Bupleurum, 35 parts by weight of Vinegar Schisandra, 15 parts by weight of Prunus Mume, 15 parts by weight of Magnolia, 15 parts by weight of stir-fried Xanthium sibiricum, 15 parts by weight of Ephedra, 15 parts by weight of Aconite, 6 parts by weight of Asarum, 50 parts by weight of Amethyst, and 15 parts by weight of Licorice Tablets.

6. The allergic rhinitis according to any one of claims 2 to 5 is any one of wind-cold type, wind-heat type, spleen deficiency type, kidney deficiency type, and phlegm-dampness type.

7. The allergic rhinitis according to any one of claims 2 to 5 is any one of seasonal allergic rhinitis, perennial allergic rhinitis, occupational allergic rhinitis, and mixed allergic rhinitis.

8. A Chinese medicine preparation prepared from the Chinese medicine composition according to any one of items 2-5, characterized in that: The Chinese medicine oral preparation is any one of decoction, granules, pills, tablets, mixtures, capsules and powders.

9. A method for preparing the decoction as claimed in claim 7, characterized in that: The method comprises the following steps: 1) First, decoct the root of aconite and calcined purple quartz with a slow fire, boil for 10 minutes, and set aside the liquid for later use; 2) Put the magnolia into a cloth bag or other container for decoction, and set aside the liquid medicine; 3) The remaining Chinese medicinal materials are decocted twice, each time for 20 minutes, the two filtrates are combined, and then mixed with the filtrates of steps 1) and 2) and filtered to obtain a decoction.

10. Use of the Chinese medicine composition according to any one of claims 1 or 2-5 in preparing a medicine for treating wind-cold type allergic rhinitis.

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