A Chinese medicine prescription for treating allergic rhinitis and its application

Abstract

The invention discloses a traditional Chinese medicine prescription for treating allergic rhinitis and application thereof. The traditional Chinese medicine prescription consists of 10-20 parts of black plum, 6-12 parts of cicada shell, 6-12 parts of siler, 6-12 parts of ganoderma lucidum, 15-20 parts of astragalus, 6-12 parts of scutellaria, 6-12 parts of schisandra, 3-9 parts of xanthium, 6-12 parts of magnolia and 3-9 parts of angelica dahurica. The traditional Chinese medicine prescription has a significant therapeutic effect on allergic rhinitis, and the therapeutic effect has been repeatedly tested in a long-term and large-scale clinical practice, and can greatly improve the quality of life of patients with allergic rhinitis.

Description

Technical Field

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

[0002] Rhinitis is a common clinical disease. It is an inflammation of the nasal mucosa caused by viruses, bacteria, allergens, various physical and chemical factors, and certain systemic diseases. Allergic rhinitis (AR) is a common type of rhinitis. It is a non-infectious chronic inflammatory disease of the nasal mucosa mediated mainly by IgE after the body is exposed to allergens. It was previously divided into seasonal and perennial. In recent years, it has been divided into intermittent and persistent according to the characteristics of symptom onset. The main clinical features are sudden and recurrent sneezing, clear nasal discharge, nasal congestion, and nasal itching. In severe cases, the sense of smell is reduced or disappears. Allergic rhinitis is mostly seen in children and young adults, and there is no significant difference in the incidence ratio between men and women. With the progress of industrialization, modern lifestyle, changes in dietary structure and drastic changes in the ecological environment, the prevalence of allergic rhinitis has been increasing year by year, becoming a global health problem, affecting 10%-25% of the population. Therefore, allergic rhinitis has always been a hot topic of concern and research in the international medical community. The industry unanimously believes that allergic rhinitis is a disease with a high recurrence rate and a low cure rate. Because of its many sensitizing factors, the pathogenesis is still not very clear. It is generally believed that genetics, environment, and diet are all important factors in inducing allergic rhinitis.

[0003] Although allergic rhinitis is not a life-threatening disease, it has the characteristics of a high recurrence rate and is prone to complications such as allergic sinusitis, bronchial asthma, secretory otitis media, cough variant asthma, etc., and can seriously affect the patient's quality of life, causing insomnia in severe cases, sleeplessness at night or obstructive sleep apnea syndrome, resulting in decreased work efficiency, memory loss, etc., seriously affecting the patient's daily life and work. At present, the treatment principles of allergic rhinitis include environmental control, drug therapy, immunotherapy and health education. The first-line treatment drugs for allergic rhinitis used clinically include glucocorticoids (mometasone furoate, betamethasone, etc.), second-generation antihistamines (cetirizine, loratadine, etc.), and leukotriene receptor antagonists (montelukast, zafirlukast, etc.). The above-mentioned existing drugs or therapies can relieve the symptoms of allergic rhinitis, but cannot cure the disease, and the drugs cause many adverse reactions after clinical use, including nasal mucosal bleeding, oral candidiasis, arrhythmia and drug tolerance, etc., which make the disease difficult to effectively control and cure. However, immunotherapy has a long cycle, high cost, poor patient compliance, large individual differences in treatment results, and currently there are relatively few types of allergens that can be treated with immunotherapy.

[0004] Studies have found that Chinese medicine has a significant effect on the treatment of allergic rhinitis, with few adverse reactions, and reduces the recurrence rate of allergic rhinitis. Its efficacy is mainly to dispel wind and relieve exterior symptoms, replenish qi and strengthen the spleen, and warm yang and dispel cold, mainly to the lung meridian and spleen meridian. Therefore, actively exploring effective Chinese medicinal materials for the prevention and treatment of allergic rhinitis will help the early intervention and treatment of allergic rhinitis, which has far-reaching research significance. At present, there is no research or report on the relevance of Chinese medicine composition composed of black plum, cicada shell, siler, ganoderma lucidum, astragalus, scutellaria, schisandra, xanthium, magnolia, and angelica dahurica on allergic rhinitis. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine prescription for treating allergic rhinitis and its application in the art to solve the problems existing in the above-mentioned prior art. The present invention proves for the first time that a Chinese medicine prescription composed of black plum, cicada slough, siler, ganoderma lucidum, astragalus, scutellaria, schisandra chinensis, xanthium sibiricum, magnolia bud, and angelica dahurica has a significant therapeutic effect on patients with allergic rhinitis and a mouse model of allergic rhinitis, and its therapeutic effect is significantly better than the traditional Chinese medicine prescription for treating allergic rhinitis composed of black plum, cicada slough, siler, ganoderma lucidum, astragalus, scutellaria, lily, xanthium sibiricum, magnolia bud, honeycomb, and raw licorice reported in the prior art. That is, the Chinese medicine prescription provided by the present invention has achieved unexpected technical effects compared with the prior art.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] A first aspect of the present invention provides a traditional Chinese medicine composition for treating allergic rhinitis.

[0008] Furthermore, the Chinese medicine composition consists of 10-20 parts of black plum, 6-12 parts of cicada shell, 6-12 parts of siler, 6-12 parts of siler, 6-12 parts of ganoderma, 15-20 parts of astragalus, 6-12 parts of scutellaria, 6-12 parts of schisandra, 3-9 parts of xanthium, 6-12 parts of magnolia and 3-9 parts of angelica.

[0009] Furthermore, the Chinese medicine composition consists of 15 parts of black plum, 9 parts of cicada shell, 10 parts of siler, 9 parts of ganoderma lucidum, 18 parts of astragalus, 9 parts of scutellaria, 9 parts of schisandra, 6 parts of xanthium, 9 parts of magnolia and 6 parts of angelica.

[0010] In the above composition, the weight of the medicine is calculated based on the raw medicine, and the weight ratio is used as the proportion. It can be increased or decreased in proportion during production. For example, large-scale production can be in kilograms or tons, and small-scale production can also be in grams or milligrams. The weight can be increased or decreased, but the weight ratio of the raw medicines between the components remains unchanged. The above weight ratio is obtained through scientific screening. For special patients, such as severe or mild diseases, obese or thin patients, the amount ratio of the components can be adjusted accordingly, and the increase or decrease does not exceed 100%, and the efficacy remains unchanged.

[0011] A second aspect of the present invention provides a traditional Chinese medicine preparation for treating allergic rhinitis.

[0012] Furthermore, the effective ingredient of the traditional Chinese medicine preparation is the traditional Chinese medicine composition described in the first aspect of the present invention.

[0013] Furthermore, the traditional Chinese medicine preparation also contains a pharmaceutically acceptable buffer, a carrier and / or an excipient.

[0014] Furthermore, the buffer comprises phosphate, carbonate, acetate, citrate, glycolate, lactate, borate, tartrate, and cacodylate.

[0015] Furthermore, the buffer also includes Trizma, Bicine, Tricine, MOPS, MOPSO, MOBS, Tris, Hepes, HEPBS, MES, ACES, ADA, AMP, AMPD, AMPSO, BES, CABS, CHES, DIPSO, EPPS, ethanolamine, glycine, HEPPSO, imidazole, imidazole lactate, PIPES, SSC, SSPE, POPSO, TAPS, TABS, TAPSO, and TES.

[0016] Furthermore, the carrier includes an isotonic agent, an antioxidant, a suspending agent, a dispersing agent, an emulsifier, a chelating agent, a thickener, and a solubilizing agent.

[0017] Furthermore, the excipients include carbohydrates, polymers, lipids, and minerals.

[0018] Furthermore, the dosage forms of the Chinese medicine preparation include granules, tablets, pills, capsules, injections, oral liquids, tinctures, mixtures, powders, lotions, films, and pills.

[0019] Furthermore, the pharmaceutically acceptable buffer, carrier and / or excipient are described in detail in Remington's Pharmaceutical Sciences (19th ed., 1995). These substances are used to help the stability of the drug or to help improve the activity of the effective active ingredients in the drug as needed. The effective ingredients that can be used in such pharmaceutical compositions can be in the form of their original compounds themselves, or optionally in other pharmaceutically acceptable forms. The pharmaceutical compositions thus formulated can be administered in any appropriate manner known to those skilled in the art as needed.

[0020] Further, pharmaceutically acceptable buffer, carrier and / or excipient may additionally contain liquid, such as water, physiological saline, glycerol and ethanol. In addition, auxiliary substances such as wetting agents or emulsifiers or pH buffer substances may be present in the pharmaceutical composition. These carriers enable the pharmaceutical composition to be formulated into dosage forms such as granules, tablets, pills, capsules, injections, oral liquids, tinctures, mixtures, powders, lotions, films, dripping pills, etc., so that patients can take them.

[0021] Further, the method for preparing the above-mentioned pharmaceutical composition comprises the step of combining each component in the pharmaceutical composition with a carrier and optionally one or more auxiliary components. Generally, the pharmaceutical composition can be prepared by uniformly and closely combining Wumei, Cicadae Periostracum, Saposhnikovia divaricata, Ganoderma lucidum, Astragalus, Scutellaria baicalensis, Schisandra chinensis, Xanthium sibiricum, Magnolia officinalis, Angelica dahurica with a liquid carrier or a finely divided solid carrier or both, and then molding the product if necessary. Among them, the pharmaceutical composition suitable for oral administration can be in the form of granules, capsules, cachets, sachets, pills, tablets, lozenges (using flavoring bases, usually sucrose and gum arabic or tragacanth), powders, or solutions or suspensions in aqueous or non-aqueous liquids, or oil-in-water or water-in-oil liquid emulsions, or elixirs or syrups, or lozenges (using inert matrices such as gelatin and glycerin, or sucrose and gum arabic), each of which contains a predetermined amount of black plum, cicada shell, siler, ganoderma lucidum, astragalus, scutellaria, schisandra chinensis, xanthium sibiricum, magnolia, and angelica dahurica as active ingredients.

[0022] The third aspect of the present invention provides a method for preparing the traditional Chinese medicine preparation described in the second aspect of the present invention.

[0023] Furthermore, the method comprises the following steps: crushing the components in the Chinese medicine composition described in the first aspect of the present invention and mixing them according to weight to obtain the Chinese medicine preparation described in the second aspect of the present invention.

[0024] Furthermore, the Chinese medicinal raw materials contained in the above-mentioned Chinese medicine preparation can be directly prepared by feeding, or processed into pharmaceutical active substances by other methods, and then the active substances are used as raw materials, and pharmaceutically acceptable buffers, carriers and / or excipients are added when necessary, and the granule preparations of the present invention are prepared according to the conventional techniques of pharmaceutics. The active substances can be obtained by the following methods, for example: by crushing, pressing, calcining, grinding, sieving, percolation, extraction, water extraction, alcohol extraction, ester extraction, ketone extraction, chromatography and the like. These active substances can be substances in the form of extracts, which can be dry extracts or fluid extracts, and different concentrations are determined according to different needs of the preparations.

[0025] The fourth aspect of the present invention provides use of the Chinese medicine composition described in the first aspect of the present invention in the preparation of a medicament for treating allergic rhinitis.

[0026] The common pharmacological effects of the Chinese medicinal raw materials selected in the present invention in this field are as follows:

[0027] Wumei: It is the immature fruit of the plum tree, a deciduous tree of the Rosaceae family. It is sour, astringent, and neutral. It enters the liver, spleen, lung, and large intestine meridians. It has the functions of astringing the lungs and relieving cough, astringing the intestines and relieving diarrhea, promoting the production of body fluids and relieving thirst, and calming ascariasis and relieving pain. Modern research shows that its main components are citric acid, malic acid, succinic acid, carbohydrates, sitosterol, waxy substances, and oleanolic acid-like substances. It contains bitter acid, which has strong bactericidal properties and improves liver function, and bitter amygdalin, which has a thermal analgesic effect. The pulp also contains a high level of superoxide dismutase. It is commonly used clinically for chronic cough due to lung deficiency, chronic diarrhea and loose bowels, deficiency heat and thirst, ascariasis, vomiting, and abdominal pain; and biliary ascariasis.

[0028] Cicada slough: It is the skin and shell that falls off when the nymph of the Cicadidae insect black grasshopper emerges. It is sweet and cold. It enters the lung and liver meridians. It has the effects of dispersing wind-heat, promoting lung function, clearing rashes, improving eyesight and removing cataracts, extinguishing wind and stopping spasms. It is commonly used in clinical practice for exogenous wind-heat, hoarseness due to cough, poor measles, itching due to rubella, epilepsy in children, red eyes, cataracts, furunculosis, tetanus, etc. Modern research shows that cicada slough contains a large amount of potassium chitin. It also contains proteins, amino acids, organic acids, phenols, flavonoids, steroids, sugars, fats, volatile oils and ethanolamine, etc. It also contains calcium, aluminum, phosphorus, magnesium, iron, manganese, chromium, zinc and other trace elements. Modern pharmacology confirms that it has anticonvulsant, sedative and antipyretic effects.

[0029] Saposhnikovia divaricata: It is the root of Saposhnikovia divaricata of the Umbelliferae family. It is pungent and sweet in taste and warm in nature. It enters the bladder, lung, liver and spleen meridians. It has the effects of releasing wind, dispelling dampness, relieving pain and relieving spasm. It is mainly used in clinic to treat exogenous wind-cold, headache, dizziness, stiff neck, wind-cold-dampness arthralgia, joint pain, limb cramps, tetanus, etc. Modern research shows that its main components include volatile oils such as 2-methyl-3-butene-2-ol, valeraldehyde, α-pinene, hexanal, amyl alcohol, hexanol, octanal, nonanal, octanol, acetophenone, 7-octen-4-ol, naphthalene, β-bisabolene, thujacene, β-eudesmol, etc., coumarins such as psoralen, bergamotol, euphorbia acetophenone, corallin, etc., chromones, polyacetylenes, polysaccharides, β-sitosterol, carotene, etc. Pharmacology has confirmed that it has antipyretic, analgesic, sedative, antibacterial, anti-inflammatory and immune-enhancing effects.

[0030] Ganoderma lucidum: It is the dried fruiting body of Ganoderma lucidum or Ganoderma rubrum of the Polyporaceae family. It is sweet and neutral. It enters the heart, lung, liver and kidney meridians. It has the effects of replenishing qi and calming the mind, relieving cough and relieving asthma. It is clinically used for restlessness, insomnia and palpitations, lung deficiency cough and asthma, asthenia and shortness of breath, and loss of appetite. Modern research shows that its main active ingredients include polysaccharides, nucleosides, furans, sterols, alkaloids, triterpenes, oils and fats, various amino acids and proteins, enzymes, organic germanium and various trace elements. Pharmacology has confirmed that it has the effects of sedation, anti-epileptic, and brain tissue protection, as well as enhancing immune function, anti-tumor, liver protection, lowering blood sugar, inhibiting diabetic complications, anti-aging, lowering blood lipids, and anti-atherosclerosis.

[0031] Astragalus: It is the dried root of the leguminous plant Astragalus or Inner Mongolia Astragalus. It tastes sweet and is slightly warm. It enters the lung and spleen meridians. It has the effects of strengthening the body's defense system, promoting diuresis and reducing swelling, expelling toxins, and promoting tissue regeneration. It is clinically used for spontaneous sweating, night sweats, blood stasis, edema, carbuncle that does not ulcerate or ulcers that do not heal for a long time, etc. Modern research shows that its main components include astragaloside I, II, III, IV; carotene, β-sitosterol, palmitic acid, sucrose, oxyisoflavanone, ursin, choline, betaine, folic acid, calycosin, formononetin, triterpenoid cycloastragenol, etc. Pharmacology has confirmed that it has cardiotonic, antihypertensive, anti-fatigue, anti-aging and other effects.

[0032] Scutellaria baicalensis: It is the root of Scutellaria baicalensis, a plant of the Labiatae family. It tastes bitter and is cold in nature. It enters the heart, lung, gallbladder, and large intestine meridians. It has the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is clinically used to treat fever and thirst, lung heat cough, damp-heat diarrhea, jaundice, hot stranguria, vomiting and bleeding, metrorrhagia, red and swollen eyes, restless fetus, carbuncle, furuncle, etc. Modern research shows that its main components are flavonoids, among which baicalin and baicalin are the main active ingredients; it also contains wogonin, baicalin, and baicalin; it also contains volatile components and 14 kinds of amino acids, among which proline has the highest content. Pharmacology has confirmed that it has antibacterial, antipyretic, liver-protecting, choleretic, antispasmodic and anti-inflammatory effects.

[0033] Schisandra chinensis: It is the dried mature fruit of the Magnoliaceae plant Schisandra chinensis or Schisandra sphenanthera. It is sour and sweet, warm in nature, and enters the lung, heart, and kidney meridians. It has the effects of astringency, strengthening qi and promoting body fluid, and nourishing the kidney and calming the mind. It can be used clinically to treat chronic cough, weak asthma, nocturnal emission, enuresis, frequent urination, chronic diarrhea, spontaneous sweating, thirst due to loss of body fluid, palpitations and insomnia. Modern research shows that its main components include volatile oils, organic acids, tannins, vitamins, sugars, and resins. Among them, the main component of volatile oils is schisandrin. Pharmacology has confirmed that it has the effects of lowering blood pressure, promoting bile secretion, lowering serum transaminases, protecting liver cells, and stimulating the nervous system.

[0034] Xanthium sibiricum: It is the fruit of the plant Xanthium sibiricum with involucre of the Asteraceae family. It tastes sweet, is warm in nature, and is poisonous. It enters the lung and liver meridians. It has the effects of dispersing wind, relieving pain, removing dampness, and killing insects. It is mainly used in clinical treatment of wind-cold headache, sinusitis, toothache, wind-cold-damp arthralgia, limb cramps, scabies, itching, etc. Modern research shows that its main components are xanthium glycosides, xanthium alcohol, isoxanthium alcohol, xanthium esters, and fatty oils. The oil contains a large amount of linoleic acid, and also contains oleic acid, palmitic acid, and stearic acid. It also contains protein, alkaloids, vitamin C, and pigments. Pharmacology has confirmed that it has antibacterial, antitussive, hypoglycemic, antihypertensive, and respiratory stimulating effects.

[0035] Magnolia: It is the flower bud of Magnolia, Magnolia, Wudang Magnolia or the same genus Magnolia of the deciduous shrub family. It tastes spicy and warm in nature. It enters the lung and stomach meridians. It has the effects of dispelling wind and opening the orifices. It is mainly used in clinical treatment of headache, sinusitis, nasal congestion, toothache, etc. Modern research shows that its main components are volatile oils, such as citral, eugenol, 1,8-cineole, terpinen-4-ol, bornyl acetate, 1,8-cineole, camphor, β-pinene, 1,8-cineole, etc. Alkaloids, pine resin alcohol dimethyl ether, tulip resin alcohol B dimethyl ether, cynanchum and magnolia. Pharmacology has confirmed that it has the effects of anti-stress, antibacterial and smooth muscle excitation.

[0036] Angelica dahurica: It is the dried root of the Umbelliferae plant Angelica dahurica or the Hang Angelica dahurica. It is pungent in taste and warm in nature. It enters the lung, spleen and stomach meridians. It has the effects of dispelling cold, dispelling wind and relieving pain, clearing the nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and discharging pus. It is mainly used in clinical treatment of headache, supraclavicular pain, toothache, sinusitis, cold and damp abdominal pain, intestinal wind and hemorrhoids, leukorrhea, carbuncle, ulcer, dry and itchy skin, and scabies. Modern research shows that its main components include volatile oils, coumarins, organic acids, polysaccharides, steroids, trace elements, etc. Pharmacology has confirmed that it has the effects of preventing hypertension, dilating coronary arteries, promoting fat decomposition, and inhibiting fat synthesis.

[0037] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0038] (1) The present invention provides for the first time a Chinese medicine prescription consisting of 10 raw materials, namely, black plum, cicada slough, fangfeng, ganoderma lucidum, astragalus, scutellaria, schisandra, xanthium, magnolia, and angelica dahurica. The results of clinical studies and animal model studies have shown that the Chinese medicine prescription has a significant therapeutic effect on allergic rhinitis. Comparative experiments have shown that the Chinese medicine prescription has a significantly better therapeutic effect than the traditional Chinese medicine prescription for treating allergic rhinitis, which consists of 11 raw materials, namely, black plum, cicada slough, fangfeng, ganoderma lucidum, astragalus, scutellaria, lily, xanthium, magnolia, honeycomb, and raw liquorice. That is, the Chinese medicine prescription provided by the present invention has achieved unexpected technical effects compared with the prior art.

[0039] (2) The Chinese medicine prescription for treating allergic rhinitis provided by the present invention is scientifically and rationally formulated, and the functions of various raw medicinal materials are different but complementary to each other. The preparation method is simple, the raw medicinal materials are widely available, the cost is low, there are no toxic side effects, the treatment cycle is short, the medication is convenient, the patient acceptance is high, the symptom relief rate is high, the efficacy of treating allergic rhinitis is significant, and it has been repeatedly tested in a long-term and extensive clinical practice. It can greatly improve the quality of life of patients with allergic rhinitis, and provides a new idea and strategy for the treatment of allergic rhinitis in the field, and has a good prospect for clinical application. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 The figure shows the comparison results of TNSS nasal itching symptoms in patients with allergic rhinitis before and after drug intervention. Compared with the group before treatment: *P < 0.05, ***P < 0.001, compared with the control group after treatment: △△ P < 0.01;

[0041] Figure 2 The figure shows the comparison results of TNSS sneezing symptoms in patients with allergic rhinitis before and after drug intervention. 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;

[0042] Figure 3 The figure shows the comparison results of TNSS watery nasal discharge symptoms in patients with allergic rhinitis before and after drug intervention. Compared with the group before treatment: *P<0.05, **P<0.01, ***P<0.001, compared with the control group after treatment: △△ P<0.01, △△△ P < 0.001;

[0043] Figure 4 The figure shows the comparison results of TNSS nasal congestion symptoms in patients with allergic rhinitis before and after drug intervention. Compared with the group before treatment: **P < 0.01, ***P < 0.001, compared with the control group after treatment: △△ P<0.01, △ P < 0.05;

[0044] Figure 5 This is a comparison chart of the TNSS itchy / red eyes symptoms of patients with allergic rhinitis before and after drug intervention. Compared with this group before treatment: *P < 0.05, ***P < 0.001, compared with the control group after treatment: △ P < 0.05; Figure 6The figure shows the comparison results of TNSS tearing symptoms in patients with allergic rhinitis before and after drug intervention. Compared with the group before treatment: **P<0.01, ***P<0.001, compared with the control group after treatment: △ P<0.05, △△ P < 0.01;

[0045] Figure 7 This is a dynamic comparison of the total score of TNSS nasal symptoms in patients with allergic rhinitis who were treated with drug 1 and drug 2 for 12 weeks;

[0046] Figure 8 This is a comparison of the PQLQ quality of life scores of patients with allergic rhinitis treated with drug 1 and drug 2 for 12 weeks;

[0047] Fig. 9 This is a graph comparing the effectiveness of drug 1 and drug 2 in patients with allergic rhinitis for 12 weeks;

[0048] Fig.10 The frequency diagram of sneezing and nose scratching in each group of allergic rhinitis mouse models, where A: sneezing, B: nose scratching, *P < 0.05, **P < 0.01, ***P < 0.001;

[0049] Fig.11 HE staining results of the histological changes of nasal mucosa in allergic rhinitis mouse models in each group (400X); Fig.12 The graphs show the expression levels of OVA-specific IgE antibodies and cytokines in the peripheral blood of allergic rhinitis mouse models in each group, where Figure A: OVA-specific IgE antibodies, Figure B: cytokines, *P<0.05, **P<0.01, ***P<0.001. DETAILED DESCRIPTION

[0050] The present invention is further described below in conjunction with specific embodiments, which are only used to explain the present invention and are not to be construed as limiting the present invention. It will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to these embodiments without departing from the principles and purposes of the present invention, and that the scope of the present invention is defined by the claims and their equivalents. The experimental methods for which specific conditions are not specified in the following examples are usually tested under conventional conditions or under conditions recommended by the manufacturer.

[0051] Example 1 Preparation of a Chinese medicine prescription for treating allergic rhinitis

[0052] Weigh 15 parts of black plum, 9 parts of cicada shell, 10 parts of siler, 9 parts of ganoderma lucidum, 18 parts of astragalus, 9 parts of scutellaria, 9 parts of schisandra, 6 parts of xanthium sibiricum, 9 parts of magnolia and 6 parts of angelica dahurica, and prepare the formula granules according to the conventional Chinese patent medicine preparation process.

[0053] Weigh 10 parts of black plum, 6 parts of cicada shell, 6 parts of siler, 6 parts of ganoderma lucidum, 15 parts of astragalus, 6 parts of scutellaria, 6 parts of schisandra, 3 parts of xanthium sibiricum, 6 parts of magnolia and 3 parts of angelica dahurica, and prepare the formula granules according to the conventional Chinese patent medicine preparation process.

[0054] Weigh 20 parts of black plum, 12 parts of cicada shell, 12 parts of siler, 12 parts of ganoderma, 20 parts of astragalus, 12 parts of scutellaria, 12 parts of schisandra, 9 parts of xanthium sibiricum, 12 parts of magnolia and 9 parts of angelica dahurica, and prepare the formula granules according to the conventional Chinese patent medicine preparation process.

[0055] Example 2 The therapeutic effect of the Chinese medicine prescription prepared by the present invention on patients with allergic rhinitis

[0056] 1. Experimental Materials

[0057] Drug 1 (experimental group): weigh 15 parts of black plum, 9 parts of cicada shell, 10 parts of siler, 9 parts of ganoderma lucidum, 18 parts of astragalus, 9 parts of scutellaria, 9 parts of schisandra, 6 parts of xanthium sibiricum, 9 parts of magnolia, and 6 parts of angelica dahurica, and prepare the formula granules according to the conventional Chinese patent medicine preparation process.

[0058] Drug 2 (positive control group): Weigh 20 parts of black plum, 10 parts of cicada shell, 10 parts of siler, 10 parts of ganoderma lucidum, 30 parts of astragalus, 10 parts of scutellaria, 20 parts of lily, 6 parts of xanthium sibiricum, 10 parts of magnolia, 10 parts of honeycomb, and 6 parts of raw licorice, and make a formula granule according to the conventional Chinese patent medicine preparation process (a Chinese medicine prescription for treating allergic rhinitis disclosed in the authorized patent "CN106334077B A Chinese medicine prescription for treating allergic rhinitis").

[0059] Control reagent (negative control group): purified water.

[0060] 2. Experimental methods

[0061] This study adopted a double-blind method in the first 2 weeks, and all subjects took Chinese medicine for treatment. The blinding was removed after 2 weeks of intervention, and the intervention continued for 12 weeks.

[0062] 141 patients with allergic rhinitis who met the exclusion criteria for allergic rhinitis were randomly divided into drug study group 1, drug study group 2 and a control group of their own study at a ratio of 1:1:1 according to the principle of randomization, double-blind, parallel control, with 47 cases in each group. The treatment methods of drug study group 1, drug study group 2 and control group are as follows:

[0063] Drug study group 1: Allergic rhinitis patients were treated with the above-mentioned drug 1, one dose per day, once in the morning and once in the evening, taken with boiled water.

[0064] Drug study group 2: Allergic rhinitis patients were treated with the above-mentioned drug 2, one dose per day, once in the morning and once in the evening, taken with boiled water.

[0065] Control group: patients with allergic rhinitis took the above control reagents once in the morning and once in the evening.

[0066] After 2 weeks of intervention, TNSS scores were performed, and statistical analysis was performed on symptoms such as nasal itching, sneezing, watery nasal discharge, nasal congestion, itchy / red eyes, and tearing, as well as the treatment efficacy of each group of subjects.

[0067] After 12 weeks of intervention, TNSS scores were performed, and the total TNSS nasal symptom scores, PQLQ quality of life scores, and treatment efficacy of each group of subjects were statistically analyzed.

[0068] 3. Experimental results

[0069] (1) Baseline data

[0070] In this example, there were 47 patients with allergic rhinitis in drug study group 1, 47 patients with allergic rhinitis in drug study group 2, and 44 patients with allergic rhinitis in the control group (47 patients were included in the initial stage and 44 patients were included after dropout). There was no significant difference in the baseline data of the allergic rhinitis patients in the three groups, such as gender, age, marital status, and educational level (P < 0.05).

[0071] (2) Symptom improvement of patients with allergic rhinitis after 2 weeks of drug intervention

[0072] ① Comparison of TNSS nasal itching symptoms before and after intervention

[0073] The comparison results of TNSS nasal itching symptoms before and after intervention are shown in Tables 1 and Figure 1 The results showed that the nasal itching symptoms of allergic rhinitis patients in drug study group 1, drug study group 2 and the control group were significantly improved after treatment compared with before treatment. The therapeutic effects of drug study group 1 and drug study group 2 on nasal itching symptoms were significantly better than those of the control group, and the therapeutic effect of drug study group 1 on nasal itching symptoms was significantly better than that of drug study group 2. It can be seen that the therapeutic effect of drug 1 prepared in Example 1 of the present invention is significantly better than that of drug 2.

[0074] Table 1 Comparison of TNSS nasal itching symptoms before and after intervention (0-3 points, the higher the score, the more severe the symptoms)

[0075]

[0076] ② Comparison of TNSS sneezing symptoms before and after intervention

[0077] The comparison results of TNSS sneezing symptoms before and after intervention are shown in Tables 2 and Figure 2The results showed that the sneezing symptoms of allergic rhinitis patients in drug study group 1, drug study group 2 and the control group were significantly improved after treatment compared with before treatment. The therapeutic effects on sneezing symptoms in drug study group 1 and drug study group 2 were significantly better than those in the control group, and the therapeutic effect on sneezing symptoms in drug study group 1 was significantly better than that in drug study group 2. It can be seen that the therapeutic effect of drug 1 prepared in Example 1 of the present invention is significantly better than that of drug 2.

[0078] Table 2 Comparison of TNSS sneezing symptoms before and after intervention (0-3 points, the higher the score, the more severe the symptoms)

[0079]

[0080] ③ Comparison of TNSS watery nasal discharge symptoms before and after intervention

[0081] The comparison results of TNSS watery nasal discharge symptoms before and after intervention are shown in Table 3 and Figure 3 The results showed that the watery nasal discharge symptoms of allergic rhinitis patients in drug study group 1, drug study group 2 and the control group were significantly improved after treatment compared with before treatment. The therapeutic effects on watery nasal discharge symptoms of drug study group 1 and drug study group 2 were significantly better than those of the control group, and the therapeutic effect on watery nasal discharge symptoms of drug study group 1 was significantly better than that of drug study group 2. It can be seen that the therapeutic effect of drug 1 prepared in Example 1 of the present invention is significantly better than that of drug 2.

[0082] Table 3 Comparison of TNSS watery nasal discharge symptoms before and after intervention (0-3 points, the higher the score, the more severe the symptoms)

[0083]

[0084] ④Comparison of TNSS nasal congestion symptoms before and after intervention

[0085] The comparison results of TNSS nasal congestion symptoms before and after intervention are shown in Tables 4 and Figure 4 The results showed that the nasal congestion symptoms of allergic rhinitis patients in drug study group 1 and drug study group 2 were significantly improved after treatment compared with before treatment, and the therapeutic effect of drug study group 1 on nasal congestion symptoms was significantly better than that of drug study group 2. It can be seen that the therapeutic effect of drug 1 prepared in Example 1 of the present invention is significantly better than that of drug 2.

[0086] Table 4 Comparison of TNSS nasal congestion symptoms before and after intervention (0-3 points, the higher the score, the more severe the symptoms)

[0087]

[0088] ⑤ Comparison of TNSS itchy / red eyes symptoms before and after intervention

[0089] The comparison results of TNSS eye itching / redness symptoms before and after intervention are shown in Table 5 and Figure 5The results showed that the itchy / red eyes symptoms of allergic rhinitis patients in drug study group 1, drug study group 2 and the control group were significantly improved after treatment compared with before treatment. The therapeutic effects of drug study group 1 and drug study group 2 on itchy / red eyes symptoms were significantly better than those of the control group, and the therapeutic effect of drug study group 1 on itchy / red eyes symptoms was significantly better than that of drug study group 2. It can be seen that the therapeutic effect of drug 1 prepared in Example 1 of the present invention is significantly better than that of drug 2.

[0090] Table 5 Comparison of TNSS itchy / red eyes symptoms before and after intervention (0-3 points, the higher the score, the more severe the symptoms)

[0091]

[0092] ⑥ Comparison of TNSS tearing symptoms before and after intervention

[0093] The comparison results of TNSS tearing symptoms before and after intervention are shown in Tables 6 and Figure 6 The results showed that the tearing symptoms of patients with allergic rhinitis in drug study group 1, drug study group 2 and the control group were significantly improved after treatment compared with before treatment. The therapeutic effects on tearing symptoms of drug study group 1 and drug study group 2 were significantly better than those of the control group, and the therapeutic effect on tearing symptoms of drug study group 1 was significantly better than that of drug study group 2. It can be seen that the therapeutic effect of drug 1 prepared in Example 1 of the present invention is significantly better than that of drug 2.

[0094] Table 6 Comparison of TNSS tearing symptoms before and after intervention (0-3 points, the higher the score, the more severe the symptoms)

[0095]

[0096]

[0097] (3) Overall efficacy evaluation after 12 weeks of drug intervention

[0098] ①Dynamic comparison of TNSS nasal symptom total score

[0099] The dynamic comparison results of the total TNSS nasal symptom scores of patients with allergic rhinitis treated with drug 1 or drug 2 for 12 weeks are shown in Tables 7, 8 and Figure 7 (Among them, 53 and 55 patients were selected for single-arm trials after the RCT trial was unblinded. As the treatment time prolonged, some patients dropped out. Therefore, the number of patients in 4-12 weeks was reduced.) The results showed that the total TNSS nasal symptom scores of patients with allergic rhinitis in drug study group 1 and drug study group 2 were significantly improved, and with the increase in the number of intervention weeks, there was a gradual improvement trend. In addition, the effect of drug study group 1 on improving the total TNSS nasal symptom score of patients with allergic rhinitis was significantly better than that of drug study group 2.

[0100] Table 7 Dynamic comparison of TNSS nasal symptom total scores in patients with allergic rhinitis after 12 weeks of drug 1 intervention (0-18 points, the higher the score, the more severe the symptoms)

[0101]

[0102] Table 8 Dynamic comparison of TNSS nasal symptom total scores in patients with allergic rhinitis after 12 weeks of drug 2 intervention (0-18 points, the higher the score, the more severe the symptoms)

[0103]

[0104] ②Comparison of PQLQ quality of life scores

[0105] The results of the comparison of PQLQ quality of life scores of patients with allergic rhinitis who received drug 1 or drug 2 for 12 weeks are shown in Tables 9, 10 and Figure 8 The results showed that the PQLQ quality of life scores of patients with allergic rhinitis in both drug study group 1 and drug study group 2 were significantly improved, and showed a gradual improvement trend with the increase in the number of intervention weeks. In addition, the effect of drug study group 1 on improving the PQLQ quality of life scores of patients with allergic rhinitis was significantly better than that of drug study group 2.

[0106] Table 9 PQLQ quality of life scores of patients with allergic rhinitis treated with drug 1 for 12 weeks (the higher the score, the worse the quality of life)

[0107]

[0108] Table 10 PQLQ quality of life scores of patients with allergic rhinitis treated with drug 2 for 12 weeks (the higher the score, the worse the quality of life)

[0109]

[0110] ③ Comparison of the effectiveness of drug 1 and drug 2 in patients with allergic rhinitis after 12 weeks of intervention

[0111] The results of the comparison of the efficacy of drug 1 or drug 2 in patients with allergic rhinitis for 12 weeks are shown in Tables 11, 12 and Fig. 9 The results showed that the total effective rate of drug 1 after 4 weeks of intervention was 98.00%, the total effective rate after 8 weeks of intervention was 100.00%, and the total effective rate after 12 weeks of intervention was 100.00%; the total effective rate of drug 2 after 4 weeks of intervention was 92.31%, the total effective rate after 8 weeks of intervention was 95.92%, and the total effective rate after 12 weeks of intervention was 97.87%. It can be seen that the total effective rate of drug 1 was better than that of drug 2 at each intervention time point.

[0112] Table 11 Comparison of the effectiveness of drug 1 in patients with allergic rhinitis after 12 weeks of intervention

[0113]

[0114] Table 12 Comparison of the effectiveness of 2 drugs in patients with allergic rhinitis after 12 weeks of intervention

[0115]

[0116]

[0117] (4) Records of other reactions that occurred during medication

[0118] The results of other reactions that occurred during the medication process of the subjects of the present invention are recorded in Table 13, and the numbers recorded in the table are examples.

[0119] Table 13 Medication reaction record

[0120] Gastrointestinal disorders Infection (cold) Dry nose Dry throat Nosebleeds Serious adverse events Week 1 0 0 1 0 0 0 Week 2 0 0 0 0 0 0 Week 3 0 0 0 0 0 0 Week 4 0 0 0 1 0 0 Week 5 0 0 1 0 0 0 Week 6 0 0 0 0 0 0 Week 7 1 0 0 0 0 0 Week 8 0 0 0 0 0 0 Week 9 0 1 0 0 0 0 Week 10 0 0 0 0 1 0 Week 11 0 0 0 0 0 0 Week 12 1 0 0 0 0 0

[0121] Example 3 The therapeutic effect of the Chinese medicine prescription prepared by the present invention on the mouse model of allergic rhinitis 1. Experimental materials

[0122] Drug 1 (drug 1 treatment group): Weigh 15 parts of black plum, 9 parts of cicada shell, 10 parts of siler, 9 parts of ganoderma lucidum, 18 parts of astragalus, 9 parts of scutellaria, 9 parts of schisandra, 6 parts of xanthium sibiricum, 9 parts of magnolia, and 6 parts of angelica dahurica, and prepare the formula granules according to the conventional Chinese patent medicine preparation process.

[0123] Drug 2 (drug 2 treatment group): Weigh 20 parts of black plum, 10 parts of cicada shell, 10 parts of siler, 10 parts of siler, 10 parts of ganoderma, 30 parts of astragalus, 10 parts of scutellaria, 20 parts of lily, 6 parts of xanthium sibiricum, 10 parts of magnolia, 10 parts of honeycomb, and 6 parts of raw licorice, and prepare the formula granules according to the conventional Chinese medicine preparation process.

[0124] Experimental animals: 6-8 week old SPF BALB / c mice.

[0125] 2. Construction of mouse model of allergic rhinitis

[0126] Basic sensitization stage: ovalbumin was prepared into 0.5 mg / mL ovalbumin solution with normal saline, and the same volume of aluminum hydroxide gel (40 mg / mL) was added and mixed, and 0.2 mL was injected intraperitoneally into each mouse, that is, 100 μg OVA and 4 mg aluminum adjuvant were injected intraperitoneally into each mouse, and sensitization was performed once every week for a total of 3 times. The blank group mice were injected intraperitoneally with the same volume of normal saline each time.

[0127] Enhanced sensitization phase: From day 15 to day 21, 1% OVA saline solution was dripped into the nose bilaterally, 10 μL / nostril / time, once a day. Provocation phase: From day 22 to day 28, 2% OVA saline solution was dripped into the nose bilaterally, 10 μL / nostril / time, once a day. The blank control group was dripped with the same volume of saline. From day 29 to day 38, 2% OVA saline solution was dripped into the nose bilaterally, 10 μL / nostril / time, and the drug was administered orally at the same time according to the dosing schedule.

[0128] 3. Dosage regimen

[0129] According to the human dosage, calculated based on the body surface area of ​​mice, the dosage was administered orally once a day, 0.2 mL each time.

[0130] 4. Symptoms and scores

[0131] After 10 days of drug intervention, the rats were challenged 1 hour after the last oral gavage, and nasal symptoms were observed within 10 minutes. The number of sneezing and scratching of the nose was recorded for statistical analysis.

[0132] 5. HE staining to observe the morphology of the nasal mucosa of mice in each group

[0133] HE staining and histopathological observation of the nasal mucosa tissues of mice in each group were performed. The samples were collected, fixed with 4% paraformaldehyde, dehydrated, embedded and sectioned, and then HE staining was performed. The morphological changes of the nasal mucosa tissues were observed under a microscope.

[0134] 6. ELISA method to detect the expression of factors in each group of mice

[0135] The levels of OVA-specific IgE antibodies, IL-4, IFN-γ, IL-17, and TGF-β cytokines in the peripheral blood of mice in each group were determined by ELISA.

[0136] 7. Experimental results

[0137] (1) Symptoms and scores

[0138] The frequency of sneezing and nose scratching in mice after 10 days of drug intervention Fig.10 According to the behavioral evaluation criteria, the number of sneezes and nose scratching in the allergic rhinitis model group of mice within 10 minutes after the last stimulation was significantly different from that in the normal group. The experiment proved that the allergic rhinitis model was successfully established. Compared with the allergic rhinitis model group, the sneezing and nose scratching frequencies of the drug 1 treatment group and the drug 2 treatment group were significantly reduced, and the therapeutic effect of drug 1 was significantly better than that of drug 2.

[0139] (2) HE staining to observe the morphology of the nasal mucosa of mice in each group

[0140] The results of HE staining of the histological changes of the mouse nasal mucosa are shown in Fig.11The results showed that drug treatment reduced the pathological damage of nasal mucosal tissue in allergic rhinitis. The allergic rhinitis model group had typical characteristics of allergic rhinitis. In the mucosa, the follicles were enlarged and infiltrated with a large number of inflammatory cells; compared with the control group, the nasal edema and inflammatory cells in the drug 1 treatment group and the drug 2 treatment group were significantly reduced.

[0141] (3) ELISA method to detect the expression of factors in each group of mice

[0142] The expression levels of OVA-specific IgE antibodies and cytokines in the peripheral blood of mice in each group are shown in Fig.12 The results showed that compared with the control group, the OVA-specific IgE antibody in the allergic rhinitis animal model group was significantly increased, and the drug treatment group was able to significantly reduce the antibody level, among which the effect of drug 1 was better than that of drug 2; in the mice of the allergic rhinitis model group, compared with the control group, the levels of IFN-γ and TGF-β were significantly reduced, the drug group was able to significantly increase the level of these cytokines, and the effect of drug 1 was significantly better than that of drug 2; in the mice of the allergic rhinitis model group, compared with the control group, the levels of IL-4 and IL-17 were significantly increased, and the drug was able to significantly reduce their expression levels, among which the effect of drug 1 was significantly better than that of drug 2. IFN-γ, TGF-β, IL-4, and IL-17 are related to the immune balance of Th1, Treg, Th2, and Th17 cells, respectively, which preliminarily indicates that the expression of Th1 / Th2 and Treg / Th17 cytokines is unbalanced in the allergic rhinitis model group, and the drug can correct the immune balance, and the effect of drug 1 is better than that of drug 2.

[0143] Example 4 The therapeutic effect of the Chinese medicine prescription prepared by the present invention on patients with allergic rhinitis

[0144] 1. Experimental Materials

[0145] Drug 3: Weigh 10 parts of black plum, 6 parts of cicada shell, 6 parts of siler, 6 parts of ganoderma lucidum, 15 parts of astragalus, 6 parts of scutellaria, 6 parts of schisandra, 3 parts of xanthium, 6 parts of magnolia, and 3 parts of angelica dahurica, and prepare the formula granules according to the conventional Chinese patent medicine preparation process.

[0146] Drug 4: Weigh 20 parts of black plum, 12 parts of cicada shell, 12 parts of siler, 12 parts of ganoderma, 20 parts of astragalus, 12 parts of scutellaria, 12 parts of schisandra, 9 parts of xanthium, 12 parts of magnolia, and 9 parts of angelica, and prepare the formula granules according to the conventional Chinese patent medicine preparation process.

[0147] 2. Experimental methods

[0148] The experiment was performed as described in Example 2.

[0149] 3. Experimental results

[0150] The comparison results of TNSS nasal itching symptoms before and after intervention are shown in Table 14, and the results show that the improvement effects of drug 3 and drug 4 on nasal itching symptoms in patients with allergic rhinitis are better than those of the control group and drug 2. It shows that the Chinese medicine prescription composed of 10-20 parts of black plum, 6-12 parts of cicada shell, 6-12 parts of siler, 6-12 parts of ganoderma lucidum, 15-20 parts of astragalus, 6-12 parts of scutellaria, 6-12 parts of schisandra, 3-9 parts of xanthium, 6-12 parts of magnolia, and 3-9 parts of angelica can effectively treat allergic rhinitis, and its therapeutic effect is significantly better than the traditional Chinese medicine prescription for treating allergic rhinitis reported in the prior art, that is, the Chinese medicine prescription provided by the present invention has achieved unexpected technical effects relative to the prior art.

[0151] Table 14 Comparison of TNSS nasal itching symptoms before and after intervention (0-3 points, the higher the score, the more severe the symptoms)

[0152]

[0153] The description of the above embodiments is only used to understand the method and core idea of ​​the present invention. It should be pointed out that, for those skilled in the art, several improvements and modifications can be made to the present invention without departing from the principle of the present invention, and these improvements and modifications will also fall within the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine composition for treating allergic rhinitis, characterized in that: The traditional Chinese medicine composition is prepared from 10-20 parts of black plum, 6-12 parts of cicada shell, 6-12 parts of siler, 6-12 parts of siler, 6-12 parts of ganoderma lucidum, 15-20 parts of astragalus, 6-12 parts of scutellaria, 6-12 parts of schisandra, 3-9 parts of xanthium, 6-12 parts of magnolia and 3-9 parts of angelica.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from 15 parts of black plum, 9 parts of cicada shell, 10 parts of siler, 9 parts of ganoderma lucidum, 18 parts of astragalus, 9 parts of scutellaria, 9 parts of schisandra chinensis, 6 parts of xanthium sibiricum, 9 parts of magnolia and 6 parts of angelica dahurica.

3. A Chinese medicine preparation for treating allergic rhinitis, characterized in that: The effective ingredient of the traditional Chinese medicine preparation is the traditional Chinese medicine composition according to claim 1 or 2.

4. The Chinese medicine preparation according to claim 3, characterized in that: The traditional Chinese medicine preparation further comprises a pharmaceutically acceptable buffer, a carrier and / or an excipient.

5. The Chinese medicine preparation according to claim 4, characterized in that: The buffer is phosphate, carbonate, acetate, citrate, glycolate, lactate, borate, tartrate and / or cacodylate.

6. The Chinese medicine preparation according to claim 4, characterized in that: The carrier is an isotonic agent, an antioxidant, a suspending agent, a dispersing agent, an emulsifier, a chelating agent, a thickening agent and / or a solubilizing agent.

7. The Chinese medicine preparation according to claim 4, characterized in that: The excipients are carbohydrates, polymers, lipids and / or minerals.

8. The Chinese medicine preparation according to claim 4, characterized in that: The dosage form of the Chinese medicine preparation is granules, tablets, pills, capsules, oral liquids, tinctures, suppositories, mixtures, powders, lotions, films or pills.

9. A method for preparing the Chinese medicine preparation according to any one of claims 3 to 8, characterized in that: The method comprises the following steps: crushing the components in the Chinese medicine composition according to claim 1 or 2 and mixing them according to weight to obtain the Chinese medicine preparation according to any one of claims 3 to 8.

10. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating allergic rhinitis.

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