A Chinese medicine composition for treating allergic rhinitis and its application

Abstract

The invention provides a Chinese medicine composition for treating allergic rhinitis and application thereof, and relates to the technical field of Chinese medicine pharmaceutical manufacturing. The Chinese medicine composition consists of cicada slough, centipede, siler, silkworm, astragalus, atractylodes, magnolia, angelica dahurica, asarum, schrenckii, mint, burdock fruit, earthworm, xanthium sibiricum fruit, chicken gizzard lining and honey. The Chinese medicine composition can significantly improve the clinical symptoms of allergic rhinitis model mice, down-regulate the expression of IgE, IgG1 and OVA-sIgE in serum, inhibit Th2 cell activation, improve Th17 / Treg cell balance and relieve allergic reactions. Clinical trial results show that the Chinese medicine composition can significantly reduce the contents of IgE and IL-6 in the serum of patients with allergic rhinitis, correct immune disorders, reduce the occurrence of adverse reactions, and improve the total effective rate of clinical treatment, thereby providing a new scheme with good therapeutic effect, quick effect and high safety for the treatment of allergic rhinitis.

Description

Technical Field

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

[0002] Allergic rhinitis, also known as allergic rhinitis, is a non-infectious chronic inflammatory disease of the nasal mucosa caused by a response to inhaled allergens mediated by immunoglobulin E (Ig E). It is one of the common chronic diseases in otolaryngology, mainly manifested by nasal congestion, nasal itching, sneezing, runny nose, and may be accompanied by eye symptoms such as tearing and red eyes. In severe cases, it can cause patients to suffer from insomnia, memory loss or decline, asthma, etc. The disease has a long course and is difficult to cure, which seriously affects the patient's study, life, and physical and mental health. Statistics show that the global prevalence of allergic rhinitis is 10-40%, and the total incidence in my country is 11.1%. With the improvement of modern industrialization and changes in people's lifestyles and physical constitutions, the prevalence of allergic rhinitis has shown an increasing trend year by year. Studies have shown that 40% of children and 20-30% of adults are troubled by allergic rhinitis. At present, its pathogenesis has not been fully clarified. It is caused by the combined effects of multiple factors such as genetics, environmental endocrine disruptors, and allergens. Clinical treatment includes environmental endocrine disruptor regulation and drug therapy. Drug treatment mostly uses first-line drugs (nasal corticosteroids, antihistamines, leukotriene receptor antagonists), second-line drugs (oral corticosteroids, mast cell membrane stabilizers, decongestants and anticholinergics), specific immunotherapy, and surgical treatment. Although it has certain clinical efficacy, there are many adverse reactions. Long-term use can cause liver and kidney damage, drug resistance, and the long-term effect is not ideal. In addition, desensitization therapy and surgical treatment are expensive, and patients generally cannot accept them.

[0003] Traditional Chinese medicine has a long history in treating allergic diseases. Allergic rhinitis belongs to the category of "nasal congestion" in traditional Chinese medicine. Studies have shown that traditional Chinese medicine can regulate the patient's body holistically, improve allergic constitution, and enhance the body's resistance through syndrome differentiation and treatment, combining disease differentiation with syndrome differentiation. It has the characteristics of significant efficacy, few side effects, and high safety, and can avoid problems such as drug resistance and drug residues. However, at present, traditional Chinese medicine often combines acupuncture, acupoint application or massage in the treatment of allergic rhinitis. The treatment cycle is long, the recurrence rate is high, and it is difficult for patients to persist. Therefore, it is urgent to develop a traditional Chinese medicine preparation for the treatment of allergic rhinitis with good efficacy, quick effect, and high safety. Summary of the invention

[0004] 1. Technical issues to be resolved

[0005] In view of the deficiencies of the prior art, the present invention provides a Chinese medicine composition for treating allergic rhinitis and application thereof.

[0006] (II) Technical solution

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] The invention provides a traditional Chinese medicine composition for treating allergic rhinitis. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 3-20 parts of cicada slough, 1-15 parts of centipede, 15-35 parts of siler, 5-20 parts of bombyx batryticatus, 20-40 parts of astragalus, 10-30 parts of atractylodes macrocephala, 10-25 parts of magnolia, 3-20 parts of angelica dahurica, 3-20 parts of asarum, 5-25 parts of cape spatholobi, 5-25 parts of mint, 3-20 parts of burdock fruit, 3-15 parts of earthworm, 3-20 parts of xanthium sibiricum fruit, 5-25 parts of chicken's gizzard lining and 10-30 parts of honey.

[0009] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of cicada shells, 3-10 parts of centipedes, 20-28 parts of siler, 10-15 parts of bombyx batryticatus, 25-35 parts of astragalus, 15-25 parts of atractylodes, 12-18 parts of magnolia, 5-15 parts of angelica dahurica, 5-15 parts of asarum, 10-20 parts of cape urticaria, 10-20 parts of mint, 5-15 parts of burdock fruits, 5-10 parts of earthworms, 5-15 parts of Xanthium sibiricum fruits, 10-20 parts of chicken's gizzard lining, and 15-25 parts of honey.

[0010] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 9 parts of cicada shells, 5 parts of centipedes, 24 parts of siler, 11 parts of bombyx batryticatus, 30 parts of astragalus, 20 parts of atractylodes, 15 parts of magnolia, 10 parts of angelica dahurica, 10 parts of asarum, 15 parts of cape urticaria, 15 parts of mint, 10 parts of burdock fruits, 7 parts of earthworms, 10 parts of Xanthium sibiricum, 15 parts of chicken's gizzard lining, and 20 parts of honey.

[0011] The present invention provides a method for preparing a Chinese medicine composition for treating allergic rhinitis. The medicine is prepared into any oral dosage form acceptable to the human body, including pills, powders, granules, oral liquids, decoctions and tablets, by conventional Chinese medicine pharmaceutical methods and with medically acceptable adjuvants.

[0012] Furthermore, a Chinese medicine composition decoction for treating allergic rhinitis is prepared according to the following steps:

[0013] (1) Weigh the raw materials according to the above weight proportions, remove the head and feet of the centipede, chop the raw materials into small pieces, mix them, and place them in a casserole, add 3-5 times the total weight of the medicine in water and soak them for 10-20 minutes, boil them over high heat, then simmer over low heat for 20-30 minutes, filter the decoction while it is hot, and collect the residue.

[0014] (2) Add 1-2 times the weight of water to the above-mentioned filter residue and soak it for 10-15 minutes, boil it for 20-30 minutes, filter the decoction while it is hot, and combine it with the decoction obtained in the above step (1) to obtain the product.

[0015] The present invention provides application of the traditional Chinese medicine composition in preparing medicine for preventing and / or treating allergic rhinitis.

[0016] The pharmacological effects of the various Chinese medicinal components in the Chinese medicinal composition of the present invention are as follows:

[0017] Cicada shell: sweet in taste, cold in nature, enters the lung and liver meridians; has the effects of dispersing wind-heat, relieving sore throat, clearing rashes, improving eyesight and removing cataracts, and relieving spasms; used for wind-heat colds, sore throats and hoarseness, measles that does not break out, itchy rubella, red eyes and cataracts, convulsions, and tetanus.

[0018] Centipede: pungent, warm in nature, enters the liver meridian; has the effects of calming wind and relieving spasms, unblocking meridians and relieving pain, attacking toxins and dispersing nodules; used for internal movement of liver wind, spasms and convulsions, infantile convulsions, stroke and oral cavity Hemiplegia, tetanus, rheumatism, migraine, sores, scrofula, snake and insect bites.

[0019] Saposhnikovia divaricata: spicy and sweet in taste, slightly warm in nature, enters the bladder, liver and spleen meridians; has the effects of dispelling wind and relieving exterior symptoms, eliminating dampness and relieving pain, and stopping spasms; used for colds and headaches, rheumatic pain, urticaria itching, and tetanus.

[0020] Bombyx batryticatus: salty and pungent in taste, neutral in nature, enters the liver, lung and stomach meridians; has the effects of calming wind and stopping spasms, dispelling wind and relieving pain, resolving phlegm and dispersing nodules; used for liver wind with phlegm, convulsions, acute convulsions in children, tetanus, stroke and oral cavity Wind-heat headache, red eyes and sore throat, itchy rashes, and mumps.

[0021] Astragalus: sweet in taste, slightly warm in nature, enters the lung and spleen meridians; has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting fluid and nourishing blood, relieving stagnation and relieving numbness, removing toxins and discharging pus, and healing sores and promoting tissue regeneration; used for qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, long-term diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, internal heat and thirst, blood deficiency and sallow complexion, hemiplegia, pain and numbness, carbuncles that are difficult to heal, and long-term sores that do not heal.

[0022] Atractylodes: bitter and sweet in taste, warm in nature, enters the spleen and stomach meridians; has the effects of strengthening the spleen and replenishing Qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus; used for spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm and fluid, dizziness and palpitations, edema, spontaneous sweating, and fetal movement disorder.

[0023] Magnolia: spicy in taste, warm in nature, enters the lung and stomach meridians; has the effect of dispersing wind and cold and clearing the nasal passages; used for wind-cold headache, nasal congestion and runny nose, allergic rhinitis, and sinusitis.

[0024] Angelica dahurica: spicy in taste, warm in nature, enters the stomach, large intestine, and lung meridians; has the effects of dispelling cold, expelling wind and relieving pain, clearing the nasal passages, drying dampness and stopping leukorrhea, reducing swelling and discharging pus; used for colds and headaches, brow pain, nasal congestion and runny nose, allergic rhinitis, sinusitis, toothache, leukorrhea, and sores and swelling.

[0025] Asarum: spicy in taste, warm in nature, enters the heart, lung and kidney meridians; has the effects of dispelling cold, expelling wind and relieving pain, opening the orifices, warming the lungs and transforming fluid; used for colds, headaches, toothaches, nasal congestion and runny nose, allergic rhinitis, rhinitis, rheumatic pain, phlegm and cough.

[0026] Goose does not eat grass: spicy, warm in nature, enters the lung meridian; has the effects of dispersing wind and cold, clearing the nasal passages, and relieving cough; used for wind-cold headache, cough with sputum, nasal congestion, and runny nose due to nasal sinusitis.

[0027] Mint: spicy, cool in nature, enters the lung and liver meridians; has the effects of dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting rashes, and soothing the liver and promoting qi; used for wind-heat colds, initial onset of wind-fever, headaches, red eyes, throat paralysis, mouth sores, rubella, measles, and chest and flank distension.

[0028] Burdock seed: spicy and bitter in taste, cold in nature, enters the lung and stomach meridians; has the effects of dispersing wind-heat, clearing the lungs and relieving rashes, detoxifying and relieving sore throat; used for wind-heat colds, coughs with sputum, measles, rubella, sore throat, mumps, erysipelas, carbuncles and sores.

[0029] Earthworm: salty in taste, cold in nature, enters the liver, spleen, and bladder meridians; has the effects of clearing away heat and calming the nerves, unblocking meridians, relieving asthma, and promoting diuresis; used for high fever and coma, epilepsy and convulsions, joint pain, limb numbness, hemiplegia, lung heat and cough, edema and oliguria.

[0030] Xanthium sibiricum: It tastes pungent and bitter, is warm in nature, and enters the lung meridian; it has the effects of dispersing wind and cold, clearing the nasal passages, and removing rheumatism; it is used for wind-cold headaches, nasal congestion and runny nose, allergic rhinitis, sinusitis, urticaria itching, and dampness and cramps.

[0031] Chicken's gizzard lining: sweet in taste, neutral in nature, enters the spleen, stomach, small intestine, and bladder meridians; has the effects of strengthening the stomach and aiding food, astringing semen and stopping nocturnal emission, and relieving stranguria and dissolving stones; used for indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, nocturnal emission, stones and pain in stranguria, and gallbladder distension and pain in the ribs.

[0032] Honey: sweet in taste, neutral in nature, enters the lung, spleen, and large intestine meridians; has the effects of tonifying the middle, moistening dryness, relieving pain, and detoxifying; used for abdominal pain, dry cough due to lung dryness, constipation due to intestinal dryness, detoxification, and external treatment of sores that do not heal, and burns caused by water or fire.

[0033] (III) Beneficial effects

[0034] The invention provides a traditional Chinese medicine composition for treating allergic rhinitis and its application. The traditional Chinese medicine composition is composed of cicada slough, centipede, fangfeng, silkworm, astragalus, atractylodes, magnolia, angelica dahurica, asarum, cape scutellaria, mint, burdock fruit, earthworm, xanthium sibiricum, chicken gizzard lining and honey. The cicada slough, centipede and fangfeng are used as the main medicines for dispelling wind and relieving exterior symptoms, relieving spasms and relieving pain, and can quickly relieve symptoms such as nasal congestion, runny nose and sneezing; the silkworm, astragalus, atractylodes, magnolia, Angelica dahurica is the minister drug, which can strengthen the spleen and stomach functions, promote the biochemical transformation of qi and blood, and improve allergic constitution; asarum, goose not eating grass, mint, burdock fruit, earthworm, and Xanthium sibiricum are adjuvant drugs, which can assist the monarch and minister drugs, enhance the effects of dispelling wind and cold, relieving sore throat and rash, and clearing the nasal passages, and relieve symptoms such as nasal congestion, runny nose, sore throat, and cough caused by allergic rhinitis; chicken gizzard lining and honey are guiding drugs, which can harmonize the various drugs, guide the drugs directly to the diseased area, enhance the overall effect of the prescription, and promote the efficacy of the drugs.

[0035] The Chinese medicine composition of the present invention can significantly improve the clinical symptoms of allergic rhinitis model mice, down-regulate the expression of IgE, IgG1, and OVA-sIgE in serum, inhibit Th2 cell activation, and improve the balance of Th17 / Treg cells, thereby alleviating allergic reactions; clinical trial data show that the Chinese medicine composition of the present invention can significantly reduce the content of IgE and IL-6 in the serum of patients with allergic rhinitis, alleviate immune inflammatory reactions, correct immune disorders, reduce the occurrence of adverse reactions, and improve the total effective rate of clinical treatment, thereby providing a new solution with good therapeutic effect, rapid effect, and high safety for the treatment of allergic rhinitis. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] Example 1

[0038] A traditional Chinese medicine composition for treating allergic rhinitis, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 9 parts of cicada slough, 5 parts of centipede, 24 parts of siler, 11 parts of bombyx batryticatus, 30 parts of astragalus, 20 parts of atractylodes, 15 parts of magnolia, 10 parts of angelica dahurica, 10 parts of asarum, 15 parts of cape scutellaria, 15 parts of mint, 10 parts of burdock fruit, 7 parts of earthworm, 10 parts of xanthium sibiricum fruit, 15 parts of chicken's gizzard lining, and 20 parts of honey.

[0039] Example 2

[0040] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 3 parts of cicada shells, 3 parts of centipedes, 15 parts of siler, 5 parts of bombyx batryticatus, 20 parts of astragalus, 10 parts of atractylodes, 10 parts of magnolia, 3 parts of angelica dahurica, 3 parts of asarum, 5 parts of cape urticaria, 5 parts of mint, 3 parts of burdock fruits, 3 parts of earthworms, 3 parts of Xanthium sibiricum fruits, 5 parts of chicken's gizzard lining, and 10 parts of honey.

[0041] Example 3

[0042] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of cicada shells, 11 parts of centipedes, 28 parts of siler, 16 parts of bombyx batryticatus, 32 parts of astragalus, 25 parts of atractylodes, 20 parts of magnolia, 15 parts of angelica dahurica, 15 parts of asarum, 20 parts of cape urticaria, 20 parts of mint, 15 parts of burdock seeds, 10 parts of earthworms, 15 parts of Xanthium sibiricum, 20 parts of chicken gizzard lining, and 27 parts of honey.

[0043] Example 4

[0044] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 18 parts of cicada shells, 13 parts of centipedes, 30 parts of siler, 17 parts of bombyx batryticatus, 35 parts of astragalus, 28 parts of atractylodes, 22 parts of magnolia, 18 parts of angelica dahurica, 18 parts of asarum, 22 parts of cape urticaria, 22 parts of mint, 18 parts of burdock fruits, 12 parts of earthworms, 18 parts of Xanthium sibiricum fruits, 22 parts of chicken's gizzard lining, and 28 parts of honey.

[0045] Example 5

[0046] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 9 parts of cicada shells, 5 parts of centipedes, 20 parts of siler, 10 parts of bombyx batryticatus, 28 parts of astragalus, 15 parts of atractylodes, 15 parts of magnolia, 7 parts of angelica dahurica, 7 parts of asarum, 12 parts of cape scutellaria, 12 parts of mint, 10 parts of burdock fruits, 5 parts of earthworms, 7 parts of Xanthium sibiricum fruits, 15 parts of chicken's gizzard lining, and 18 parts of honey.

[0047] Example 6

[0048] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 5 parts of cicada shells, 4 parts of centipedes, 16 parts of siler, 7 parts of bombyx batryticatus, 22 parts of astragalus, 11 parts of atractylodes, 11 parts of magnolia, 4 parts of angelica dahurica, 4 parts of asarum, 7 parts of cape scutellaria, 7 parts of mint, 4 parts of burdock fruits, 4 parts of earthworms, 4 parts of Xanthium sibiricum fruits, 7 parts of chicken's gizzard lining, and 12 parts of honey.

[0049] Example 7

[0050] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of cicada shells, 10 parts of centipedes, 25 parts of siler, 13 parts of bombyx batryticatus, 30 parts of astragalus, 22 parts of atractylodes, 18 parts of magnolia, 12 parts of angelica, 12 parts of asarum, 18 parts of cape urticaria, 18 parts of mint, 12 parts of burdock seeds, 8 parts of earthworms, 12 parts of Xanthium sibiricum, 18 parts of chicken's gizzard lining, and 25 parts of honey.

[0051] Example 8

[0052] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 7 parts of cicada shells, 5 parts of centipedes, 18 parts of siler, 8 parts of bombyx batryticatus, 25 parts of astragalus, 13 parts of atractylodes, 13 parts of magnolia, 5 parts of angelica dahurica, 5 parts of asarum, 9 parts of cape urticaria, 8 parts of mint, 5 parts of burdock fruits, 5 parts of earthworms, 5 parts of Xanthium sibiricum fruits, 9 parts of chicken's gizzard lining, and 15 parts of honey.

[0053] Example 9

[0054] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of cicada molts, 15 parts of centipedes, 35 parts of siler, 20 parts of bombyx batryticatus, 40 parts of astragalus, 30 parts of atractylodes, 25 parts of magnolia, 20 parts of angelica dahurica, 20 parts of asarum, 25 parts of cape urticaria, 25 parts of mint, 20 parts of burdock fruits, 15 parts of earthworms, 20 parts of Xanthium sibiricum fruits, 25 parts of chicken's gizzard lining, and 30 parts of honey.

[0055] Test Example 1

[0056] 1 Materials and methods

[0057] 1.1 Experimental animals

[0058] SPF BALB / c mice, female, 6-8 weeks old, weighing 18-22 g, were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd.

[0059] 1.2 Trial Drugs

[0060] Experimental group 1: 9 parts of cicada shells, 5 parts of centipedes, 24 parts of siler, 11 parts of bombyx batryticatus, 30 parts of astragalus, 20 parts of atractylodes, 15 parts of magnolia, 10 parts of angelica dahurica, 10 parts of asarum, 15 parts of cape spatholobi, 15 parts of mint, 10 parts of burdock fruits, 7 parts of earthworms, 10 parts of Xanthium sibiricum fruits, 15 parts of chicken's gizzard lining, and 20 parts of honey.

[0061] Experimental group 2: 11 parts of Bombyx Batryticatus, 30 parts of Astragalus, 20 parts of Atractylodes, 15 parts of Magnolia, 10 parts of Angelica dahurica, 10 parts of Asarum, 15 parts of Capsicum, 15 parts of Mentha, 10 parts of Burdock Fruit, 7 parts of Pheretima, 10 parts of Xanthium sibiricum, 15 parts of Chicken Gizzard Stone, and 20 parts of honey.

[0062] Experimental group 3: 9 parts of cicada shells, 5 parts of centipedes, 24 parts of siler, 10 parts of asarum, 15 parts of cape scutellaria, 15 parts of mint, 10 parts of burdock fruits, 7 parts of earthworms, 10 parts of Xanthium sibiricum fruits, 15 parts of chicken's gizzard lining, and 20 parts of honey.

[0063] Experimental group 4: 9 parts of cicada shells, 5 parts of centipedes, 24 parts of siler, 11 parts of bombyx batryticatus, 30 parts of astragalus, 20 parts of atractylodes, 15 parts of magnolia, 10 parts of angelica dahurica, 7 parts of earthworms, 10 parts of Xanthium sibiricum, 15 parts of chicken gizzard lining, and 20 parts of honey.

[0064] Experimental 5 groups: 9 parts of cicada shells, 5 parts of centipedes, 24 parts of siler, 11 parts of bombyx batryticatus, 30 parts of astragalus, 20 parts of atractylodes, 15 parts of magnolia, 10 parts of angelica dahurica, 10 parts of asarum, 15 parts of cape spatholobi, 15 parts of mint, and 10 parts of burdock fruit.

[0065] Weigh each raw material according to the above weight proportions, remove the head and feet of the centipede, chop each raw material into pieces, mix them, put them in a casserole, add water to soak for 10-20 minutes, boil over high heat, then simmer over low heat for 20-30 minutes, filter the decoction while it is hot; repeat twice, combine the decoctions, and concentrate to a crude drug content of 1 g / mL to obtain the Chinese medicine stock solution of test groups 1-5.

[0066] 1.3 Test methods

[0067] 1.3.1 Establishment of animal model, grouping and drug administration

[0068] After 1 week of adaptive feeding, 70 BALB / c mice were randomly divided into blank control group, model control group, loratadine group and test groups 1-5, with 10 mice in each group. Every other day, 30 μg OVA and 3 mg aluminum hydroxide (dissolved in PBS) were intraperitoneally injected into the remaining mice except the blank group, and the blank control group was injected with an equal amount of saline. After 7 injections, the basic sensitization was completed. Starting from the 14th day, 20 μL of 2% OVA solution was dripped into the nasal cavity of both sides of the mice every day for nasal provocation, and the blank control group was dripped with an equal amount of saline, and the provocation continued for 7 days.

[0069] After the mouse model was successfully established, the drugs were administered according to the human-mouse dosage conversion. The mice in the loratadine group were gavaged with 1.3 mg / kg of loratadine suspension, and the mice in test groups 1-5 were gavaged with 500 mg / kg of each test substance. The blank control group and the model control group were gavaged with an equal volume of normal saline, with a dose of 1 mL / 100 g, twice a day for 2 consecutive weeks.

[0070] 1.3.2 Behavioral evaluation

[0071] The nasal itching, sneezing and runny nose of each group of mice were observed within 30 minutes of the last nasal drop. According to the scoring standard of allergic rhinitis model animals, the total behavioral score was recorded by superposition quantitative integration method. The behavioral scoring standard is as follows: ① Nasal itching, mild scratching of the nose, scored as 1 point; repeated scratching of the face, scored as 2 points; scratching the nose continuously, scored as 3 points. ② Sneezing, 1-3 times, scored as 1 point; 4-10 times, scored as 2 points; ≥11 times, scored as 3 points. ③ Runny nose, flowing to the nostrils, scored as 1 point; flowing out of the anterior nostrils, scored as 2 points; running nose all over the face and hanging on the beard hair, scored as 3 points.

[0072] 1.3.3 Detection of IgE, IgG1, and OVA-sIgE levels in mouse serum

[0073] 24 hours after the last administration, each group of mice was anesthetized by intraperitoneal injection of 10% chloral hydrate 0.4 mL / 100 g, and 4 mL of blood was collected from the abdominal aorta. The blood was allowed to stand for 1-2 hours and centrifuged at 4°C and 1500 rpm for 15 minutes to separate the serum. The levels of Ig E, IgG1, and OVA-sIg E in the serum were detected according to the instructions of the ELISA kit.

[0074] 1.3.4 Detection of cytokine levels in mouse nasal lavage fluid

[0075] 23 h after the last administration, the mice were anesthetized, a catheter was inserted into the nasopharynx through the tracheal incision, the nasal cavity was rinsed with 1 mL of normal saline to collect the nasal lavage fluid, and the supernatant was collected by centrifugation at 4°C and 5000×g for 15 min. The levels of IL-4, IL-6, IL-17A, and IL-10 in the nasal lavage fluid of mice were detected according to the instructions of the ELISA kit.

[0076] 1.4 Statistical methods

[0077] Graphpad Prism 8.0 statistical software was used for data processing and the mean values ​​of the measured data were calculated. ± standard deviation (s), one-way analysis of variance was used for comparison among multiple groups, and the differences were considered statistically significant when P < 0.05.

[0078] 2 Results

[0079] 2.1 Effects of various drugs on mouse behavior

[0080] Table 1 compares the total behavioral scores of mice in each group. Compared with the blank control group, the total behavioral scores of mice in the model control group were significantly increased (P<0.01), indicating that the allergic rhinitis mouse model was successfully established; compared with the model control group, the total behavioral scores of mice in test groups 1-5 were significantly decreased (P<0.01), indicating that the Chinese medicine composition of the present invention can significantly improve the clinical symptoms of allergic rhinitis model mice.

[0081] Table 1 Comparison of total behavioral scores of mice in each group

[0082]

[0083]

[0084] 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.

[0085] 2.2 Effects of each drug on the levels of serum IgE, IgG1, and OVA-sIgE in mice

[0086] As shown in Table 2, compared with the blank control group, the levels of Ig E, IgG1, and OVA-sIgE in the serum of mice in the model control group were significantly increased (P<0.01); compared with the model control group, the levels of Ig E, IgG1, and OVA-sIgE in the serum of mice in test groups 1-5 were reduced to varying degrees, among which the effect of test group 1 was the most significant, which was equivalent to the level of the positive drug loratadine group.

[0087] Table 2 Comparison of serum IgE, IgG1 and OVA-sIgE levels in each group of mice

[0088] Grouping Ig E (ng / mL) Ig G1 (ng / mL) OVA-sIg E (ng / mL) Blank control group 247.21±40.82 15.35±2.75 29.35±7.74 Model control group <![CDATA[537.24±28.77 ## ]]> <![CDATA[52.45±3.90 ## ]]> <![CDATA[170.20±11.84 ## ]]> Loratadine group <![CDATA[315.08±25.81 ** ]]> <![CDATA[22.05±3.50 ** ]]> <![CDATA[47.79±5.81 ** ]]> Test Group 1 <![CDATA[346.34±14.49 ** ]]> <![CDATA[26.62±1.93 ** ]]> <![CDATA[70.54±6.52 ** ]]> Test Group 2 493.82±12.31 46.13±2.68 155.51±11.55 Experiment 3 groups <![CDATA[432.56±12.12 ** ]]> <![CDATA[38.08±2.42 ** ]]> <![CDATA[115.32±9.03 ** ]]> Test 4 groups <![CDATA[399.15±15.06 ** ]]> <![CDATA[34.23±2.36 ** ]]> <![CDATA[101.75±4.79 ** ]]> Test 5 groups <![CDATA[380.82±11.81 ** ]]> <![CDATA[30.58±2.02 ** ]]> <![CDATA[87.12±5.09 ** ]]>

[0089] 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.

[0090] 2.3 Effects of various drugs on cytokine levels in mouse nasal lavage fluid

[0091] As shown in Table 3, compared with the blank control group, the levels of IL-4, IL-6, and IL-17A in the nasal lavage fluid of mice in the model control group were significantly increased (P<0.01), and the level of IL-10 was significantly decreased (P<0.01); compared with the model control group, the levels of IL-4, IL-6, and IL-17A in the nasal lavage fluid of mice in test groups 1-5 were significantly decreased (P<0.05, P<0.01), and the level of IL-10 was significantly increased (P<0.01), indicating that the Chinese medicine composition of the present invention can inhibit Th2 cell activation, improve Th17 / Treg cell balance, relieve allergic reactions, and improve the symptoms of allergic rhinitis.

[0092] Table 3 Comparison of cytokine levels in nasal lavage fluid of mice in each group

[0093] Grouping IL-4 (ng / mL) IL-6 (pg / mL) IL-17A (pg / mL) IL-10 (pg / mL) Blank control group 35.21±2.27 23.78±1.69 49.92±2.36 56.85±1.93 Model control group <![CDATA[68.40±5.66 ## ]]> <![CDATA[77.35±2.78 ## ]]> <![CDATA[92.68±2.84 ## ]]> <![CDATA[12.14±2.26 ## ]]> Loratadine group <![CDATA[41.14±1.75 ** ]]> <![CDATA[34.58±3.58 ** ]]> <![CDATA[58.11±2.34 ** ]]> <![CDATA[48.06±1.67 ** ]]> Test Group 1 <![CDATA[45.21±1.38 ** ]]> <![CDATA[39.42±1.96 ** ]]> <![CDATA[62.80±1.62 ** ]]> <![CDATA[41.87±1.68 ** ]]> Test Group 2 <![CDATA[58.48±1.48 ** ]]> <![CDATA[62.60±2.27 ** ]]> <![CDATA[84.07±1.78 ** ]]> <![CDATA[19.43±4.46 ** ]]> Experiment 3 groups <![CDATA[54.49±2.41 ** ]]> <![CDATA[54.21±1.39 ** ]]> <![CDATA[77.00±1.45 ** ]]> <![CDATA[25.71±1.21 ** ]]> Test 4 groups <![CDATA[52.34±1.02 ** ]]> <![CDATA[48.25±1.83 ** ]]> <![CDATA[70.01±1.78 ** ]]> <![CDATA[30.26±1.86 ** ]]> Test 5 groups <![CDATA[49.50±1.16 ** ]]> <![CDATA[42.91±2.58 ** ]]> <![CDATA[66.39±3.06 ** ]]> <![CDATA[35.44±1.16 ** ]]>

[0094] 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.

[0095] 3 Conclusion

[0096] The above experimental data show that the Chinese medicine composition of the present invention can significantly improve the clinical symptoms of allergic rhinitis model mice, down-regulate the expression of Ig E, IgG1, and OVA-sIg E in mouse serum, inhibit Th2 cell activation, and improve the balance of Th17 / Treg cells, thereby alleviating allergic reactions. Among them, the test group 1 has a significant effect on the treatment of allergic rhinitis, and its effect is equivalent to that of the positive control drug loratadine, while the test groups 2 to 5 lack certain Chinese medicine ingredients, and their efficacy is correspondingly weakened. This fully demonstrates that the Chinese medicine composition of the present invention effectively alleviates the symptoms of allergic rhinitis through the principle of compatibility of monarch, minister, assistant and envoy on the basis of considering the pathological mechanism of allergic rhinitis.

[0097] Test Example 2

[0098] 1 Materials and methods

[0099] 1.1 General Information

[0100] The clinical data of 84 patients with allergic rhinitis admitted to our hospital from November 2022 to May 2024 were selected and randomly divided into a control group and an observation group according to the random number method, with 42 cases in each group. There were 13 males and 29 females in the control group, aged 18-50 years, with an average age of (35.04±12.98) years, and an average course of (3.78±1.45) years; there were 15 males and 27 females in the observation group, aged 19-52 years, with an average age of (34.77±13.65) years, and an average course of (3.83±1.56) years. There was no significant difference in gender, age, and course of disease between the two groups (P>0.05), and they were comparable.

[0101] 1.2 Diagnostic criteria

[0102] 1.2.1 TCM diagnostic criteria

[0103] The diagnostic criteria were formulated with reference to "rhinitis" in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases". Symptoms include nasal itching, nasal congestion, continuous sneezing, increased clear nasal discharge, aversion to wind and cold; inspection showed that the nasal mucosa was light red, the tongue was light red, and the tongue coating was thin white.

[0104] 1.2.2 Western medicine diagnostic criteria

[0105] In accordance with the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022, revised edition)": (1) The main clinical symptoms are watery nasal discharge, sneezing, nasal itching, and persistent nasal congestion. More than two of the above symptoms occur and last for more than 1 hour per day, accompanied by eye symptoms such as itchy eyes and conjunctival congestion; (2) Allergic rhinitis is confirmed based on clinical manifestations, medical history, and positive skin prick test or serum specific immunoglobulin E (IgE) test results.

[0106] 1.3 Inclusion criteria

[0107] Meet the above-mentioned Chinese and Western medicine diagnostic standards; be able to communicate normally and cooperate with treatment; and voluntarily sign the informed consent form.

[0108] 1.4 Exclusion criteria

[0109] Patients with other allergic diseases or immune system diseases; severe organic lesions; combined acute and chronic infections; pregnant and lactating patients; patients taking disease-related medications two weeks before enrollment; patients with severe cognitive impairment, mental illness, such as bipolar disorder, schizophrenia, etc.

[0110] 1.5 Treatment

[0111] The control group was given loratadine, 10 mg / tablet, 1 tablet each time, once a day, for 4 weeks.

[0112] The observation group was treated with a decoction of the Chinese medicine composition of the present invention in addition to the control group. Prescription: 9 parts of cicada slough, 5 parts of centipede, 24 parts of siler, 11 parts of bombyx batryticatus, 30 parts of astragalus, 20 parts of atractylodes, 15 parts of magnolia, 10 parts of angelica, 10 parts of asarum, 15 parts of cape scutellaria, 15 parts of mint, 10 parts of burdock, 7 parts of earthworm, 10 parts of xanthium sibiricum, 15 parts of chicken gizzard lining, 20 parts of honey. 1 dose / day, decocted in water, taken in the morning and evening, and continued for 4 weeks.

[0113] 1.6 Observation indicators

[0114] 1.6.1 Clinical efficacy

[0115] Before and after treatment, four nasal symptoms and two eye symptoms were scored according to the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition)", including sneezing, runny nose, itchy nose, nasal congestion, itchy eyes / foreign body sensation / red eyes, and tearing. 0 points indicated no symptoms, 1 point indicated mild symptoms that were easy to tolerate, 2 points indicated obvious symptoms that were annoying but tolerable, and 3 points indicated severe symptoms that were unbearable. The total score ranged from 0 to 18 points, and the efficacy was evaluated according to the reduction in the total score. Significantly effective: the reduction rate of TCM syndrome points ≥ 66%; effective: 30% ≤ the reduction rate of TCM syndrome points ≤ 66%; ineffective: the reduction rate of TCM syndrome points ≤ 30%.

[0116] TCM syndrome score reduction rate = (score after treatment - score before treatment) / score before treatment × 100%

[0117] 1.6.2 Serum indicators

[0118] Before and after treatment, 3 mL of fasting venous blood was collected from the patients in the morning, centrifuged at 4°C and 3500 rpm for 15 min, and the supernatant was obtained. ELISA kits were used to detect serum IL-6 and Ig E levels.

[0119] 1.6.3 Incidence of adverse reactions

[0120] Adverse reactions were observed in both groups of patients during the treatment, including dry mouth, headache, drowsiness, etc.

[0121] 1.7 Statistical methods

[0122] SPSS 20.0 statistical software was used for data analysis. Count data were expressed as percentages (%) and inter-group comparisons were performed using the χ 2 Test; average ± standard deviation (s) represents measurement data. The inter-group comparison was performed with the non-independent sample t-test, and the intra-group comparison was performed with the paired sample t-test. The difference was considered statistically significant at P < 0.05.

[0123] 2 Results

[0124] 2.1 Clinical efficacy

[0125] As shown in Table 1, among the patients in the control group, 10 cases were markedly effective, 18 cases were effective, 14 cases were ineffective, and the total effective rate was 66.67%; among the patients in the observation group, 15 cases were markedly effective, 21 cases were effective, 6 cases were ineffective, and the total effective rate was 85.71%, which was significantly higher than that of the control group (P<0.05).

[0126] Table 1 Comparison of clinical efficacy between the two groups of patients

[0127]

[0128] 2.2 Serum indicators

[0129] As shown in Table 2, there was no significant difference in the levels of serum Ig E and IL-6 between the two groups of patients before treatment (P>0.05). After treatment, the levels of serum Ig E and IL-6 in the control group and the observation group were significantly reduced (P<0.05, P<0.01), and the levels of serum Ig E and IL-6 in the observation group were significantly lower than those in the control group (P<0.05), indicating that the Chinese medicine preparation of the present invention can inhibit the expression of Ig E and IL-6 and correct immune disorders.

[0130] Table 2 Comparison of serum indicators between the two groups of patients

[0131]

[0132]

[0133] Note: Compared with the group before treatment, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01.

[0134] 2.3 Adverse Reactions

[0135] As shown in Table 3, 3 cases of dry mouth, 5 cases of headache, and 4 cases of drowsiness occurred in the control group, and the incidence of adverse reactions was 28.57%; 1 case of dry mouth and 2 cases of drowsiness occurred in the observation group, and the incidence of adverse reactions was 7.14%, which was significantly lower than that of the control group (P<0.05).

[0136] Table 3 Comparison of the incidence of adverse reactions between the two groups

[0137]

[0138] 3 Conclusion

[0139] The above clinical trial data show that the Chinese medicine composition of the present invention can significantly reduce the levels of IgE and IL-6 in the serum of patients with allergic rhinitis, alleviate immune inflammatory reactions, correct immune disorders, reduce the occurrence of adverse reactions, and improve the overall effective rate of clinical treatment.

[0140] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for treating allergic rhinitis, characterized in that: The invention is composed of the following raw materials in parts by weight: 9 parts of cicada slough, 5 parts of centipede, 24 parts of siler, 11 parts of bombyx batryticatus, 30 parts of astragalus, 20 parts of atractylodes, 15 parts of magnolia, 10 parts of angelica dahurica, 10 parts of asarum, 15 parts of cape scutellaria, 15 parts of mint, 10 parts of burdock fruit, 7 parts of earthworm, 10 parts of xanthium sibiricum fruit, 15 parts of chicken's gizzard lining and 20 parts of honey.

2. A Chinese medicine composition for treating allergic rhinitis according to claim 1, characterized in that: According to conventional Chinese medicine pharmaceutical methods, the drug is combined with medically acceptable auxiliary materials to prepare any oral dosage form acceptable to the human body, including pills, powders, granules, oral liquids, decoctions, and tablets.

3. Use of the Chinese medicine composition as claimed in claim 1 in the preparation of a medicament for preventing and / or treating allergic rhinitis.

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