Traditional Chinese medicine composition for treating chronic rhinitis-nasosinusitis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chronic rhinitis-nasosinusitis as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from codonopsis pilosula, radix astragali preparata, fried rhizoma atractylodis macrocephalae, glossy privet fruit, magnolia flower, fried cocklebur fruit, radix angelicae, wine-processed ligusticum wallichii, platycodon grandiflorum, cassia twig, divaricate saposhnikovia root, honey-fried licorice root and asarum. The traditional Chinese medicine composition disclosed by the invention has the effects of diffusing the lung, dispelling evil, invigorating the spleen, replenishing qi, expelling pus and dredging orifices, and has a remarkable treatment effect on chronic rhinitis-nasosinusitis. In addition, the preparation method of the traditional Chinese medicine composition has the advantages of simple and convenient preparation process, high efficiency, energy conservation and less damage to effective components.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, and a preparation method and use thereof. Background Art

[0002] Chronic rhinitis and sinusitis are common diseases in rhinology, which refer to chronic inflammation of the nasal mucosa, sinus mucosa and underlying tissues. Allergic rhinitis is a non-infectious chronic inflammatory disease of the nasal mucosa caused by atopic individuals exposed to allergens (allergens). Allergic rhinitis is a common chronic nasal disease in clinical practice, affecting 10% to 20% of the world's population and has become a global health problem. Chronic rhinitis-sinusitis and allergic rhinitis are often manifested clinically as nasal congestion, runny nose, headache, sneezing, decreased or absent sense of smell, and chronic rhinitis-sinusitis and allergic rhinitis often coexist. Among adult patients with chronic rhinitis-sinusitis, 25% to 50% have allergic rhinitis, and the proportion of children is even higher.

[0003] The strategies of Western medicine for treating chronic rhinitis and sinusitis are mainly to relieve mucosal inflammation, prevent infection and clear mucus in the sinuses. Treatment methods include oral and nasal antihistamines, oral and nasal mast cell membrane stabilizers, nasal decongestants, antibiotics, surgery, etc. Although the above methods can achieve the purpose of controlling symptoms, the problems such as drug toxicity, side effects and surgical complications cannot be ignored. For example, long-term medication may cause drug toxicity and side effects that endanger the health of patients, especially children and elderly patients. Surgical treatment is a destructive operation with the risk of complications. In short, the current clinical treatment of chronic rhinitis and sinusitis is still very difficult.

[0004] Rhinitis and sinusitis belong to the category of "nasal sinusitis" in traditional Chinese medicine. The etiology and pathogenesis of rhinitis and sinusitis are mostly believed to be caused by internal and external factors. The internal cause is mostly due to dysfunction of internal organs, mainly the deficiency of lung, spleen and kidney; the external cause is mostly due to the invasion of wind, cold and foreign qi into the lung. The treatment of internal medicine is mainly to strengthen the body, and the external treatment is mostly with drugs that are pungent, dispersing, aromatic and clearing the orifices.

[0005] For the treatment of chronic rhinitis and sinusitis, traditional Chinese medicine has good efficacy, low price, simple operation, easy to promote and use, and no or mild side effects. It has its unique advantages in improving self-immunity and treating allergic diseases. The latest "European Guidelines for the Diagnosis and Treatment of Rhinitis and Sinusitis" (EPOS) points out that there is sufficient evidence that Chinese herbal medicine has important therapeutic value for rhinitis and sinusitis, and it is recommended for clinical use. my country's "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis" also recommends it.

[0006] In view of this, there is an urgent clinical need to develop a safe, effective, simple to prepare, and low-cost traditional Chinese medicine preparation for the treatment of chronic rhinitis-sinusitis. Summary of the invention

[0007] The purpose of the present invention is to overcome the deficiencies in the prior art and provide a Chinese medicine composition for treating chronic rhinitis-sinusitis and a preparation method and use thereof.

[0008] Specifically, the present invention is realized through the following technical solutions:

[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic rhinitis and sinusitis, characterized in that the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 1-20 parts of Codonopsis pilosula, 1-20 parts of roasted Astragalus membranaceus, 1-20 parts of stir-fried Atractylodes macrocephala, 1-20 parts of Ligustrum lucidum, 1-15 parts of Magnolia officinalis, 1-15 parts of stir-fried Xanthium sibiricum, 1-15 parts of Angelica dahurica, 1-15 parts of wine-soaked Chuanxiong, 1-10 parts of Platycodon grandiflorum, 1-10 parts of cinnamon twig, 1-10 parts of Saposhnikovia divaricata, 1-8 parts of roasted Licorice root, and 1-10 parts of Asarum.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 1-15 parts of Codonopsis pilosula, 1-15 parts of roasted Astragalus membranaceus, 1-15 parts of stir-fried Atractylodes macrocephala, 1-15 parts of Ligustrum lucidum, 1-10 parts of Magnolia officinalis, 1-10 parts of stir-fried Xanthium sibiricum, 1-10 parts of Angelica dahurica, 1-10 parts of wine-soaked Chuanxiong, 1-8 parts of Platycodon grandiflorum, 1-8 parts of cinnamon twig, 1-6 parts of Saposhnikovia divaricata, 1-6 parts of roasted Licorice root, and 1-5 parts of Asarum.

[0011] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 5-8 parts of Codonopsis pilosula, 5-8 parts of roasted Astragalus membranaceus, 5-8 parts of stir-fried Atractylodes macrocephala, 5-8 parts of Ligustrum lucidum, 4-7 parts of Magnolia officinalis, 4-7 parts of stir-fried Xanthium sibiricum, 4-7 parts of Angelica dahurica, 4-7 parts of wine-soaked Chuanxiong, 3-6 parts of Platycodon grandiflorum, 3-6 parts of cinnamon twig, 3-6 parts of Saposhnikovia divaricata, 2-5 parts of roasted Licorice root, and 1-3 parts of Asarum.

[0012] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 7.5 parts of Codonopsis pilosula, 7.5 parts of roasted Astragalus membranaceus, 7.5 parts of stir-fried Atractylodes macrocephala, 7.5 parts of Ligustrum lucidum, 6 parts of Magnolia officinalis, 6 parts of stir-fried Xanthium sibiricum, 6 parts of Angelica dahurica, 6 parts of wine-soaked Chuanxiong, 4.5 parts of Platycodon grandiflorum, 4.5 parts of cinnamon twig, 4.5 parts of Saposhnikovia divaricata, 3 parts of roasted Licorice root, and 1.5 parts of Asarum.

[0013] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition described in the first aspect, the preparation method comprising the following steps:

[0014] (1) Mix and ultrafinely grind magnolia flower, chuanxiong rhizome, cassia twig and asarum to prepare mixed ultrafine powder;

[0015] (2) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root in 5-10 times the amount of water for 10-20 minutes and then decocting, filtering to obtain a primary filtrate after the first decoction for 20-40 minutes, adding 5-10 times the amount of water to the residue and decocting again for 20-40 minutes, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution;

[0016] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

[0017] As an optional manner, in the above preparation method, in step (1), the fineness of the ultrafine powder is 100 mesh.

[0018] As an optional manner, in the above preparation method, in step (2), add 8 times the amount of water to soak Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Fructus Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root for 15 minutes and then decoct. After the first decoction for 30 minutes, filter out a primary filtrate. Add 8 times the amount of water to the filter residue and decoct for another 30 minutes, filter out a secondary filtrate, combine the primary filtrate and the secondary filtrate, and concentrate to obtain a concentrated solution.

[0019] In a third aspect, the present invention provides use of the Chinese medicine composition described in the first aspect or the Chinese medicine composition prepared by the preparation method described in the second aspect in preparing a medicament for treating chronic rhinitis and sinusitis.

[0020] As an optional mode, in the above-mentioned use, the medicine has the effects of dispersing lung pathogens, strengthening spleen and replenishing qi, and discharging pus and opening the orifices.

[0021] As an option, in the above use, the rhinitis-sinusitis may be accompanied by allergic rhinitis.

[0022] As an optional mode, in the above-mentioned use, the dosage form of the drug is granules, tablets, oral liquid or capsules.

[0023] As an alternative, in the above use, the dosage form of the drug is granules.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] The Chinese medicine composition of the present invention has the effects of dispersing lung pathogens, strengthening spleen and replenishing qi, and draining pus and opening the orifices, and has a significant therapeutic effect on chronic rhinitis and sinusitis. In addition, the Chinese medicine composition of the present invention adopts a dynamic decoction process and a one-step granulation technology, and the preparation method of the present invention has the advantages of simple preparation process, high efficiency, energy saving, less destruction of effective ingredients, etc. DETAILED DESCRIPTION

[0026] The efficacy and main treatment of each medicinal ingredient in the Chinese medicine composition of the present invention are as follows:

[0027] "Dangshen" is the dried root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) LTShen or Codonopsis tangshen Oliv. of the Campanulaceae family. Nature and flavor: neutral, sweet. Enters the spleen meridian and lung meridian. Efficacy: tonifies the middle and replenishes qi, strengthens the spleen and lungs. It is a qi-tonifying drug under the category of tonic drugs. It is used to treat spleen and lung weakness, shortness of breath and palpitations, poor appetite and loose stools, asthma and cough, internal heat and thirst. Modern pharmacological research: Codonopsis contains polysaccharides, various amino acids (lysine, methionine, leucine, thiazine, phenylalanine, etc.) that constitute nutrients, various inorganic elements (iron, copper, cobalt, potassium, sodium, calcium, magnesium and other trace elements) and sterols, glycosides, lactones, volatile oils, alkaloids and other substances. It has effects on the immune system, digestive system, blood system, and the effects of Codonopsis pilosula decoction on the central nervous system. It can enhance the phagocytic function of the reticuloendothelial system and improve the body's disease resistance. Based on the study of the pharmacological effects of Codonopsis pilosula on lung and spleen weakness, shortness of breath and weakness, it was found that modern pharmacological research on Codonopsis pilosula in the circulation, digestion and immune systems is relatively in-depth, reaching the cellular and molecular levels, and some even reaching the genetic level, providing a strong theoretical basis for the clinical application, research and development, and application of medicine and food homology of the drug.

[0028] "Huangqi" is the root of Astragalus membranaceus Bge.var.mongholicus(Bge.)Hsiao and A.membranaceus(Fisch.)Bge., both of the leguminous plants. Nature and flavor: slightly warm, sweet. It enters the spleen and lung meridians. Efficacy: replenishing 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, expelling toxins and draining pus, and healing sores and promoting tissue regeneration. It is a qi-replenishing medicine under the category of tonic medicine. It is used to treat shortness of breath, palpitations, fatigue, collapse, spontaneous sweating, night sweats, edema due to physical weakness, chronic nephritis, chronic diarrhea, rectal prolapse, uterine prolapse, carbuncle that is difficult to ulcerate, sores that do not heal for a long time, pediatric bronchial asthma, chronic hepatitis B, chronic nephritis and viral myocarditis. It is suitable to be roasted for replenishing qi, and it is suitable to be used raw for stopping sweating, promoting diuresis, expelling toxins and draining pus and promoting tissue regeneration. Modern pharmacological research: Astragalus contains 8 effective chemical components, including astragalus polysaccharides, astragalus saponins, and astragalus flavonoid compounds. It has antiviral, anti-aging, liver protection, blood sugar lowering, bone marrow hematopoiesis regulation, osteoporosis, anti-tumor and other effects, as well as effects on immune function, including enhancing cellular immunity, humoral immunity, nonspecific immune function, and immune regulation.

[0029] "Atractylodes" is the rhizome of Atractylodes macrocephala Koidz., a plant of the Asteraceae family. Nature and flavor: warm, sweet and bitter. It enters the spleen and stomach meridians. Efficacy: invigorating the spleen, replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is a qi-tonifying medicine under the category of tonic medicine. It is used to treat weak spleen and stomach qi, loss of appetite, fatigue and lack of energy, bloating, diarrhea, phlegm and fluid, edema, jaundice, dampness and arthralgia, urination difficulties, dizziness, spontaneous sweating, and restless fetus. Modern pharmacological research: Atractylodes is composed of volatile oils, acetic acid compounds, polysaccharides, glycosides, amino acids and other compounds. Atractylodes has a high medicinal value, and has more than 20 pharmacological effects such as promoting cellular immune function, significantly increasing serum IgG, improving the body's disease resistance, regulating gastrointestinal function, diuresis, anti-tumor, anti-inflammatory, antibacterial, anti-coagulation, and anti-aging.

[0030] "Ligustrum lucidum fruit" is the mature fruit of Ligustrum lucidum Ait., a plant of the Oleaceae family. Nature and flavor: cool in nature, sweet and bitter in taste. It enters the liver and kidney meridians. Efficacy: nourishes the liver and kidneys, improves eyesight and darkens hair. It is a yin-tonifying drug under the category of tonic drugs. It is used to treat tinnitus, deafness, dizziness, soreness of waist and knees, premature graying of hair and beard caused by liver and kidney yin deficiency. Modern pharmacological research: Ligustrum lucidum fruit and its peel contain oleanolic acid, ursolic acid, palmitic acid, stearic acid,

[0031] Oleic acid, oleic acid, acetic acid, oleanolic acid, etc. Ligustrum lucidum contains a variety of chemical components, which have anti-cancer, anti-oxidation and aging, immune regulation, hypoglycemic and blood pressure lowering effects. In addition, it is also used to treat chronic atrophic gastritis, etc.

[0032] "Xinyi" is the flower bud of Magnolia biondii Pamp., Magnolia denudata Desr. or Magnolia sprengeri Pamp. of the Magnoliaceae family. Nature and flavor: warm in nature, pungent in taste. Enters the lung meridian and stomach meridian. Efficacy: dispel wind and cold, clear the nasal passages. It is a pungent and warm antipyretic drug under the category of antipyretic drugs. It is used to treat wind-cold headache, nasal congestion, nasal sinusitis, and turbid nasal discharge. Modern pharmacological research: Xinyi has a clear anti-allergic effect and is mainly used to treat rhinitis, sinusitis, asthma and other diseases. The drug also has a wide range of therapeutic effects, such as antihistamine, anti-inflammatory, local astringent, central inhibition, anti-pathogenic microorganisms, and blood pressure reduction.

[0033] "Xanthium sibiricum" is the fruit with involucre of Xanthium sibiricum Patr., a plant of the Asteraceae family. It has a pungent, bitter and warm nature. It has the effect of dispelling wind and dampness. It enters the lung meridian. It has the effect of sweating, dispersing wind and removing dampness. It is mainly used for treating headache caused by wind-cold, sinusitis, arthralgia and cramps. Modern pharmacological research shows that Xanthium sibiricum contains volatile oil, sterol, fatty oil, organic acid and other ingredients. It has a good effect in treating rhinitis and other aspects because of its outstanding effects of eliminating pain and relieving allergies. It is one of the commonly used drugs in the department of nasal medicine. In addition, it also has obvious effects on the cardiovascular system and respiratory system, and has anti-cancer and blood sugar-lowering effects.

[0034] "Angelica dahurica" ​​is the root of Angelica dahurica (Fisch.ex Hoffm) Benth.et Hook.f. var.formosana (Boiss.) Shan et Yuan or Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f. of the Apiaceae family. Those grown in Changge and Yuxian, Henan are commonly known as "Yu Baizhi", and those grown in Anguo, Hebei are commonly known as "Qi Baizhi". Nature and flavor: warm in nature, pungent in taste. It enters the stomach meridian, large intestine meridian, and lung meridian. Efficacy: dispersing wind and removing dampness, opening the orifices and relieving pain, reducing swelling and draining pus. It is a pungent and warm antipyretic drug under the category of antipyretic drugs. It is used to treat colds, headaches, brow pain, nasal congestion, sinusitis, toothache, leucorrhea, sores, swelling and pain. It has a good analgesic effect, especially for headaches, and has detoxification and anti-inflammatory effects. Recently, it has been found to have a dilating effect on the coronary arteries of the heart, and can be considered for the treatment of coronary heart disease. Modern pharmacological research: The coumarins and volatile oil components of Angelica dahurica extract have pharmacological effects such as antipyretic, analgesic, anti-inflammatory, antibacterial, and inhibition of pathogenic microorganisms.

[0035] "Chuanxiong" is the rhizome of the plant Chuanxiong Ligusticum chuam.iong Hort. of the Umbelliferae family. It is warm in nature and pungent in taste. It can promote blood circulation and qi, dispel wind and relieve pain. It is a blood-activating and analgesic drug under the category of blood-activating and stasis-removing drugs. It is used for chest pain, chest and flank pain, swelling and pain due to falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to addiction, headache, and rheumatic pain. Modern pharmacological research: Chuanxiongzine contained in Chuanxiong can regulate the PI3K / AKT / mTOR signaling pathway, inhibit nitric oxide, TNF-α and interleukin-1β, and reduce inflammatory response. This product has the effects of promoting blood circulation and qi, dispelling wind and relieving pain, and can effectively treat qi and blood stasis caused by long-term treatment of CRS.

[0036] "Platinum" is the dried root of Platycodon grandiflorum (Jacq.) A.DC., a plant of the Campanulaceae family. Nature and flavor: bitter, pungent, flat. Efficacy: clearing the lungs, relieving sore throat, removing phlegm, and draining pus. It belongs to the lung meridian. Indications: cough with sputum, chest tightness, sore throat, hoarseness, lung abscess with pus, and pus formation without ulceration. Modern pharmacological research: Platycodon can inhibit the proliferation and invasion of tumor cells, promote their apoptosis, and improve the body's immunity. It can be used to treat tumors such as liver cancer and gastric cancer. Platycodon can protect cells induced by oxidative stress to a certain extent and has a good antioxidant effect. Platycodon has a strong inhibitory effect on Salmonella and other bacteria, can inhibit the levels of inflammatory factors such as IL-8 and CRP, reduce the swelling of the joints of rats with rheumatoid arthritis, and has antibacterial and anti-inflammatory effects. In addition, Platycodon can also protect the liver and kidneys, regulate the body's immune mechanism, and has anti-diabetic, anti-obesity, and anti-fatigue effects.

[0037] "Cinnamon twig" is the young branch of Cinnamomum cassia Presl., a plant of Lauraceae. Nature and flavor: spicy, sweet, warm. It enters the bladder meridian, heart meridian, and lung meridian. Efficacy: It can relieve muscle pain, warm meridians and dredge blood vessels, assist yang and transform qi, and balance and descend qi. It is a spicy and warm antipyretic. It is used to treat colds, cold pain in the abdomen, amenorrhea due to blood cold, joint pain, phlegm, edema, palpitations, and running pig. Modern pharmacological research: the ingredients contained in cinnamon twig, such as cinnamyl alcohol and cinnamon oil, have antibacterial effects. Cinnamon twig volatile oil inhibits the production of inflammatory mediators by inhibiting the metabolism of arachidonic acid, thereby exerting an anti-inflammatory effect. Cinnamon twig extract can also exert an anti-allergic effect by inhibiting hyaluronidase.

[0038] "Saposhnikovia" is the root of Saposhnikovia divaricata (Turcz.) Schischk., a plant of the Umbelliferae family. Nature and flavor: warm, sweet and pungent. It enters the bladder meridian, liver meridian, and spleen meridian. Efficacy: release, dispel wind, and remove dampness. It belongs to the category of pungent and warm diaphoretic drugs under the category of diaphoretic drugs. It is taken orally to treat colds, headaches, fever, anhidrosis, rheumatic pain, limb cramps, rheumatic itching of the skin, tetanus, etc. Modern pharmacological research: Saposhnikovia contains a variety of chemical components such as volatile oils, chromones, coumarins, organic acids, etc., and the pharmacological activities of different components are also different. Saposhnikovia has the effects of antipyretic, analgesic, antiasthmatic, local astringent, anti-inflammatory, anti-pathogenic microorganisms, anti-tumor, enhancing the body's immune activity, reducing blood viscosity, and anti-coagulation.

[0039] Licorice is the root and rhizome of the dicotyledonous plants Leguminosae Glycyrrhiza uralensis Fisch., G. inflata Bat., or G. glabra L. Licorice is flat in nature, sweet in taste, and belongs to the twelve meridians. It has pharmacological effects such as detoxification, expectoration, analgesia, spasm relief, and even anti-cancer. In traditional Chinese medicine, licorice nourishes the spleen and replenishes qi, nourishes coughs and moistens the lungs, relieves urgency and detoxifies, and harmonizes hundreds of medicines. Clinical application is divided into "raw use" and "honey roasting". Raw use is mainly used to treat sore throat, painful carbuncle, gastrointestinal ulcers, and detoxification, food poisoning, etc.; honey roasting is mainly used to treat spleen and stomach dysfunction, loose stools, fatigue and fever, cough, palpitations, etc. Modern pharmacological research: The main chemical components contained in licorice include sapogenins, polysaccharides, flavonoids, etc. Glycyrrhizin has a good protective effect on liver cells, thereby inhibiting liver cell necrosis and degeneration. In addition, it also has many functions such as detoxification, anti-inflammatory and antibacterial, anti-hypersensitivity, antitussive and expectorant, antispasmodic and analgesic.

[0040] "Asarum" is the whole herb of Asarum sieboldii Miq., a plant of the Aristolochiaceae family. Nature and flavor: warm in nature, pungent in taste. It enters the heart meridian, lung meridian, and kidney meridian. Efficacy: dispel wind, dispel cold, open the orifices and relieve pain, warm the lungs and eliminate phlegm. It is a pungent and warm antipyretic drug under the category of antipyretic drugs. It is used to treat colds caused by wind and cold, headaches, toothaches, nasal congestion, rheumatic pain, phlegm and cough. Modern pharmacological research shows that Asarum has the effects of strengthening the heart, dilating blood vessels, reducing peripheral resistance, sedation, analgesia and other central inhibition, anti-inflammatory, anti-allergic and immunosuppression, relaxing bronchial smooth muscles, and relieving asthma.

[0041] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0042] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0043] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0044] Preparation Example:

[0045] Embodiment 1:

[0046] A traditional Chinese medicine composition for treating chronic rhinitis and sinusitis, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7.5 parts of Codonopsis pilosula, 7.5 parts of roasted Astragalus membranaceus, 7.5 parts of stir-fried Atractylodes macrocephala, 7.5 parts of Ligustrum lucidum fruit, 6 parts of Magnolia officinalis, 6 parts of stir-fried Xanthium sibiricum fruit, 6 parts of Angelica dahurica, 6 parts of wine-soaked Chuanxiong, 4.5 parts of Platycodon grandiflorum, 4.5 parts of cinnamon twig, 4.5 parts of Saposhnikovia divaricata, 3 parts of roasted Licorice root, and 1.5 parts of Asarum.

[0047] The preparation method of the Chinese medicine composition comprises the following steps:

[0048] (1) Mixing magnolia, chuanxiong, cassia twig and asarum and grinding them into a mixed superfine powder, wherein the fineness of the superfine powder is 100 mesh;

[0049] (2) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root in 8 times the amount of water for 15 minutes and then decocting, filtering to obtain a primary filtrate after the first decoction for 30 minutes, adding 8 times the amount of water to the residue and decocting for another 30 minutes, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution;

[0050] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

[0051] Embodiment 2:

[0052] A traditional Chinese medicine composition for treating chronic rhinitis and sinusitis, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8 parts of Codonopsis pilosula, 8 parts of roasted Astragalus membranaceus, 8 parts of stir-fried Atractylodes macrocephala, 8 parts of Ligustrum lucidum fruit, 5 parts of Magnolia officinalis, 5 parts of stir-fried Xanthium sibiricum fruit, 6 parts of Angelica dahurica, 6 parts of wine-soaked Chuanxiong, 4.5 parts of Platycodon grandiflorum, 4.5 parts of cinnamon twig, 4.5 parts of Saposhnikovia divaricata, 3 parts of roasted Licorice root, and 1.5 parts of Asarum.

[0053] The preparation method of the Chinese medicine composition comprises the following steps:

[0054] (1) Mixing magnolia, chuanxiong, cassia twig and asarum and grinding them into a mixed superfine powder, wherein the fineness of the superfine powder is 100 mesh;

[0055] (2) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root in 8 times the amount of water for 15 minutes and then decocting, filtering to obtain a primary filtrate after the first decoction for 30 minutes, adding 8 times the amount of water to the residue and decocting for another 30 minutes, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution;

[0056] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

[0057] Embodiment 3:

[0058] A traditional Chinese medicine composition for treating chronic rhinitis and sinusitis, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7 parts of Codonopsis pilosula, 7 parts of roasted Astragalus membranaceus, 7 parts of stir-fried Atractylodes macrocephala, 7 parts of Ligustrum lucidum fruit, 6 parts of Magnolia officinalis, 6 parts of stir-fried Xanthium sibiricum fruit, 6 parts of Angelica dahurica, 6 parts of wine-soaked Chuanxiong, 5 parts of Platycodon grandiflorum, 5 parts of cinnamon twig, 5 parts of Saposhnikovia divaricata, 3 parts of roasted Licorice root, and 2 parts of Asarum.

[0059] The preparation method of the Chinese medicine composition comprises the following steps:

[0060] (1) Mixing magnolia, chuanxiong, cassia twig and asarum and grinding them into a mixed superfine powder, wherein the fineness of the superfine powder is 100 mesh;

[0061] (2) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root in 8 times the amount of water for 15 minutes and then decocting, filtering to obtain a primary filtrate after the first decoction for 30 minutes, adding 8 times the amount of water to the residue and decocting for another 30 minutes, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution;

[0062] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

[0063] Comparative Example 1:

[0064] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7.5 parts of Codonopsis pilosula, 7.5 parts of roasted Astragalus membranaceus, 7.5 parts of stir-fried Atractylodes macrocephala, 7.5 parts of Ligustrum lucidum fruit, 6 parts of Magnolia officinalis, 6 parts of stir-fried Xanthium sibiricum fruit, 6 parts of White Peony Root, 6 parts of Ligusticum chuanxiong, 4.5 parts of Platycodon grandiflorum, 4.5 parts of Cinnamon Twig, 4.5 parts of Saposhnikovia divaricata, 3 parts of roasted Licorice root, and 1.5 parts of Asarum.

[0065] The preparation method of the Chinese medicine composition comprises the following steps:

[0066] (1) Mixing magnolia, chuanxiong, cassia twig and asarum and grinding them into a mixed superfine powder, wherein the fineness of the superfine powder is 100 mesh;

[0067] (2) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Fructus Xanthii, Paeonia lactiflora, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root in 8 times the amount of water for 15 minutes and then decocting, filtering to obtain a primary filtrate after the first decoction for 30 minutes, adding 8 times the amount of water to the residue and decocting for another 30 minutes, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution;

[0068] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

[0069] Comparative Example 2:

[0070] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 11.5 parts of Codonopsis pilosula, 11 parts of roasted Astragalus membranaceus, 7.5 parts of stir-fried Atractylodes macrocephala, 6 parts of Magnolia officinalis, 6 parts of stir-fried Xanthium sibiricum, 6 parts of Angelica dahurica, 6 parts of wine-soaked Chuanxiong, 4.5 parts of Platycodon grandiflorum, 4.5 parts of cinnamon twig, 4.5 parts of Saposhnikovia divaricata, 3 parts of roasted Licorice root, and 1.5 parts of Asarum.

[0071] The preparation method of the Chinese medicine composition comprises the following steps:

[0072] (1) Mixing magnolia, chuanxiong, cassia twig and asarum and grinding them into a mixed superfine powder, wherein the fineness of the superfine powder is 100 mesh;

[0073] (2) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, stir-fried Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root in 8 times the amount of water for 15 minutes and then decocting them; filtering to obtain a primary filtrate after the first decoction for 30 minutes; adding 8 times the amount of water to the residue and decocting it for another 30 minutes; filtering to obtain a secondary filtrate; combining the primary filtrate and the secondary filtrate, and concentrating them to obtain a concentrated solution;

[0074] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

[0075] Comparative Example 3:

[0076] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7.5 parts of Codonopsis pilosula, 7.5 parts of roasted Astragalus membranaceus, 7.5 parts of stir-fried Atractylodes macrocephala, 7.5 parts of Ligustrum lucidum fruit, 6 parts of Magnolia officinalis, 6 parts of stir-fried Xanthium sibiricum fruit, 6 parts of Angelica dahurica, 6 parts of wine-soaked Chuanxiong, 4.5 parts of Platycodon grandiflorum, 4.5 parts of cinnamon twig, 4.5 parts of Saposhnikovia divaricata, 3 parts of roasted Licorice root, and 1.5 parts of Asarum.

[0077] The preparation method of the Chinese medicine composition comprises the following steps:

[0078] (1) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, roasted Licorice root, Magnolia officinalis, wine-brewed Chuanxiong, Cinnamon twig, and Asarum in 8 times the amount of water for 15 minutes and then decocting, filtering to obtain a primary filtrate after the first decoction for 30 minutes, adding 8 times the amount of water to the residue and decocting for another 30 minutes, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution;

[0079] (2) Concentrating the concentrated solution obtained in step (1) to obtain the extract of the Chinese medicine composition.

[0080] Effect Example 1: The therapeutic effect of the Chinese medicine composition of the present invention on experimental animals with bacterial chronic rhinitis-sinusitis model

[0081] 1. Experimental Methods

[0082] 1.1 Preparation of bacterial chronic rhinitis-sinusitis mouse model and drug preparation

[0083] C57BL / 6J male mice weighing 18-22 g (purchased from Liaoning Changsheng Biotechnology) were anesthetized, and a 5 mm incision was made in the middle of the nasal dorsum under a dissecting microscope. The skin flap was lifted, and the nasal dorsum bone was cut open with a dental electric drill. The mucosa was cut to enter the nasal cavity on that side, and the Merocel high expansion hemostatic material (purchased from Medtronie-Xomed, USA) plus Streptococcus pneumoniae (ATCC49619, purchased from Shanghai Beino Biotechnology Co., Ltd.) was implanted (1.0×10 12 The nasal cavity on that side was treated with 50 μL of a solution containing 500 μL of Streptococcus pneumoniae (CFU / L) infiltrated with an expanded sponge, and then the skin incision was sutured. The contralateral nasal cavity was treated in the same way.

[0084] After the operation, the mice were raised normally and their general conditions were observed, including nasal secretions, nasal congestion, sneezing, scratching the nose, etc. Eight weeks after modeling, HE staining showed chronic inflammation in the nasal mucosa of the mice, with loss of cilia, necrosis and loss of some mucosal epithelial cells, hyperplasia of glands in the submucosal layer, and infiltration of a large number of inflammatory cells, indicating that the chronic rhinitis-sinusitis mouse model was successfully established.

[0085] The sham-operated mice underwent the same procedures as above, except that the nasal cavity was not treated with Merocel high-expansion hemostatic material plus Streptococcus pneumoniae.

[0086] The Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-3 were respectively taken, and distilled water was added to prepare 200 mg / mL intragastric administration solution for use.

[0087] 1.2 Animal grouping and drug treatment

[0088] The mice with successful modeling were randomly divided into 7 groups, namely the model control group, the embodiment 1-3 group and the comparative example 1-3 group, with 8 mice in each group. In addition, 8 mice were taken from the sham operation group. Among them, the embodiment 1-3 group and the comparative example 1-3 group were gavaged with 50 mg / kg of each test drug 8 weeks after modeling. The blank control group and the model control group were gavaged with an equal amount of distilled water. Once a day for 14 consecutive days.

[0089] 1.3 Sample collection

[0090] After the last administration, the mice were fasted for 12 h. After being anesthetized, blood was collected from the retroorbital venous plexus and centrifuged at 4°C, 35,000 rpm to collect the supernatant. The mouse serum was stored for later use.

[0091] The mice were killed, and the nasal mucosal tissues were taken and washed with physiological saline containing 0.2% diethyl pyrocarbonate (DEPC), and divided into two equal parts, one of which was placed in a cryovial and stored in liquid nitrogen for later use, and the other was fixed in 4% paraformaldehyde.

[0092] 1.4 Histopathological staining and quantitative analysis

[0093] The sections were stained with HE to show pathological changes in the sinus mucosa and polymorphonuclear neutrophil (PMN) infiltration; PAS staining showed goblet cells in the mucosal epithelium; Masson-Trichrome staining showed submucosal collagen fibers. Five sections with similar anatomical structures were selected for observation and analysis for each specimen (including anatomical structures such as the maxillary sinus and ethmoid sinus). A high-definition medical graphic analysis system was used for quantitative histopathological analysis. PMN infiltration in the lamina propria of the sinus mucosa was expressed as the number of PMNs per square millimeter of the lamina propria (number / mm 2 ); the number of goblet cells in the mucosal epithelium was expressed as the number of goblet cells per millimeter of epithelial basement membrane length (number / mm); the deposition of collagen fibers in the mucosal lamina propria was expressed as the collagen staining area per micrometer of epithelial basement membrane length (μm 2 / μm).

[0094] 1.5ELISA method to detect the level of inflammatory factors in mouse serum

[0095] The serum of mice in each group was collected, and the levels of TNF-α and IFN-γ in the serum were detected according to the instructions of the ELISA kit.

[0096] 1.4 Data representation and statistical analysis methods

[0097] SPSS23.0 statistical software was used for data analysis. The measurement data were expressed as mean ± standard deviation (mean ± SD). One-way ANOVA was used for comparison among the groups. LSD test was used for equal variance test, and Euskal-Walli SH method was used for non-parametric test for unequal variance. P < 0.05 was considered statistically significant.

[0098] 2. Experimental results

[0099] 2.1 Pathological morphology of nasal mucosa of mice in each group

[0100] The nasal mucosal epithelial cells and cilia of mice in the sham operation group were intact and neatly arranged, with a small number of scattered goblet cells occasionally seen in the submucosal layer. The nasal mucosa of mice in the model group showed chronic inflammation, with disordered arrangement of mucosal epithelial cells, cilia shedding, some cells necrotizing and shedding, hyperplasia of glands and fibrous tissue in the submucosal layer, and infiltration of a large number of lymphocytes and plasma cells.

[0101] The epithelial cells and ciliary structures of the nasal mucosa of mice in each example group were basically intact and arranged in a relatively neat manner, with few submucosal lymphocytes. The nasal mucosa structure of mice in Example 1 group was similar to that of the sham operation group.

[0102] In each comparative group, different degrees of nasal mucosal necrosis and shedding were observed, and moderate to small amounts of inflammatory cell infiltration such as lymphocytes and glandular hyperplasia were present in the submucosal layer.

[0103] The number of PMNs, goblet cells and collagen fiber deposition in the lamina propria of the sinus mucosa of mice in each group are shown in Table 1.

[0104] Table 1: Effects of the Chinese medicine composition of the present invention on the number of PMNs, goblet cells and collagen fiber deposition in the lamina propria of the mouse sinus mucosa

[0105]

[0106] Note: Compared with the model group, *P<0.05; **P<0.01.

[0107] It can be seen from the experimental results in Table 1 that 14 days after the administration of the test drug, the number of PMNs, the number of goblet cells and the deposition of collagen fibers in the lamina propria of the nasal sinus mucosa of mice in the Example 1-3 group and the Comparative Example 1-3 group were reduced to varying degrees. Among them, the number of PMNs, the number of goblet cells and the deposition of collagen fibers in the lamina propria of the nasal sinus mucosa of mice in the Example 1-3 group were significantly lower than those in the model group (P<0.05, P<0.01), especially the Chinese medicine composition of the Example 1 group had the best effect, indicating that the Chinese medicine composition of the present invention has a good therapeutic effect on infectious rhinitis-sinusitis.

[0108] Furthermore, it can be seen from the results of Comparative Examples 1-3 that the types of raw materials used in the Chinese medicine composition and the preparation method of the Chinese medicine composition have a great influence on the effect of the Chinese medicine composition of the present invention in treating infectious rhinitis-sinusitis.

[0109] 2.2 Levels of inflammatory factors TNF-α and IFN-γ in the serum of mice in each group

[0110] The levels of inflammatory factors TNF-α and IFN-γ in the serum of mice in each group are shown in Table 2.

[0111] Table 2: Effect of the Chinese medicine composition of the present invention on the levels of inflammatory factors TNF-α and IFN-γ in mouse serum

[0112] Group TNF-α(pg / mL) IFN-γ (pg / mL) Sham operation group 12.67±1.94 21.63±1.96 Model Group 51.38±4.05 60.37±5.24 Example 1 Group <![CDATA[18.21±2.03 ** ]]> <![CDATA[25.09±2.38 ** ]]> Example 2 Group <![CDATA[23.56±2.27 ** ]]> <![CDATA[29.41±2.47 ** ]]> Example 3 Group <![CDATA[19.14±2.15 ** ]]> <![CDATA[30.15±2.42 ** ]]> Comparative Example 1 37.99±3.62 48.96±4.89 Comparative Example 2 42.87±3.96 53.42±5.03 Comparative Example 3 40.13±3.81 49.68±4.97

[0113] Note: Compared with the model group, **P<0.01.

[0114] From the experimental results in Table 2, it can be seen that compared with the sham operation group, the levels of TNF-α and IFN-γ in the serum of the mice in the model group were significantly increased.

[0115] After 14 days of administration of the test drug, the levels of TNF-α and IFN-γ in the serum of mice in the Example 1-3 group and the Comparative Example 1-3 group were reduced to varying degrees. Among them, the levels of TNF-α and IFN-γ in the serum of mice in the Example 1-3 group were significantly lower than those in the model group (P<0.01), and the Chinese medicine composition in the Example 1 group had the best effect, indicating that the Chinese medicine composition of the present invention has a good therapeutic effect on infectious rhinitis and sinusitis.

[0116] Furthermore, it can be seen from the results of Comparative Examples 1-3 that the types of raw materials used in the Chinese medicine composition and the preparation method of the Chinese medicine composition have a great influence on the effect of the Chinese medicine composition of the present invention in treating infectious rhinitis-sinusitis.

[0117] Effect Example 2: The therapeutic effect of the Chinese medicine composition of the present invention on allergic rhinitis model experimental animals 1. Experimental method

[0118] 1.1 Preparation of allergic rhinitis rat model and drug preparation

[0119] SD rats weighing 180-200 g (purchased from Liaoning Changsheng Biotechnology) were injected intraperitoneally with a mixture of 0.3 mg ovalbumin, 330 mg Al(OH)3 and 1 mL saline for the first immunization, and 200 μg (50 μL) of 4% ovalbumin was administered intranasally for booster immunization on day 15. Rats in the blank control group were only injected intraperitoneally with the same amount of saline administered intranasally.

[0120] The Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-3 were respectively taken, and distilled water was added to prepare 200 mg / mL intragastric administration solution for use.

[0121] 1.2 Animal grouping and drug treatment

[0122] 64 male rats were randomly divided into 8 groups, namely, blank control group, model control group, Example 1-3 group and Comparative Example 1-3 group, 8 rats in each group. Among them, Example 1-3 group and Comparative Example 1-3 group were given each test drug by gavage at 1 mL / 100 g body weight 15 days after sensitization. The blank control group and the model control group were given an equal amount of distilled water, once a day, for 10 consecutive days.

[0123] 1.3 Immune factor determination

[0124] One hour after the last administration, 5 mL of femoral venous blood was collected from each group of rats and injected into a sterile heparin anticoagulated bottle. The blood was centrifuged at 2500 rpm for 10 min, and the supernatant was frozen at -20°C. The specimens were taken out and tested for histamine (HIS), immunoglobulin E (IgE), and interleukin-4 (IL-4) according to the instructions. 1.4 Data representation and statistical analysis methods

[0125] SPSS23.0 statistical software was used for data analysis. The measurement data were expressed as mean ± standard deviation (mean ± SD). One-way ANOVA was used for comparison among the groups. LSD test was used for equal variance test, and Euskal-Walli SH method was used for non-parametric test for unequal variance. P < 0.05 was considered statistically significant.

[0126] 2. Experimental results

[0127] At the end of the experiment, the changes in the levels of immune factors HIS, IgE and IL-4 in rats in each group are shown in Table 3.

[0128] Table 3: Effects of the Chinese medicine composition of the present invention on the levels of various immune factors in rats

[0129]

[0130] Note: Compared with the model group, *P<0.05; **P<0.01.

[0131] It can be seen from the experimental results in Table 3 that after 10 days of administration of the tested drug, the levels of HIS, IgE and IL-4 in rats in Example 1-3 and Comparative Example 1-3 groups were reduced to varying degrees. Among them, the levels of various tested immune factors in Example 1-3 groups were significantly lower than those in the model group (P<0.01), indicating that the Chinese medicine composition of the present invention has a good therapeutic effect on allergic rhinitis.

[0132] Furthermore, it can be seen from the results of Comparative Examples 1-3 that the types of raw materials used in the Chinese medicine composition and the preparation method of the Chinese medicine composition have a great influence on the effect of the Chinese medicine composition of the present invention in treating allergic rhinitis.

[0133] Effect Example 3: Clinical efficacy observation results of the Chinese medicine composition of the present invention

[0134] Patients with chronic rhinitis and sinusitis who visited the Affiliated Hospital of Heilongjiang University of Chinese Medicine were diagnosed. A total of 80 patients who met the diagnostic criteria and inclusion and exclusion criteria of the "Guidelines for the Diagnosis and Treatment of Chronic Rhinitis and Sinusitis (2018 Edition)" were randomly divided into 4 groups, with 20 patients in each group.

[0135] The Chinese medicine composition prepared in Example 1 and Comparative Examples 1-3 was given to the patient respectively (the amount of crude drugs in each experimental group was the same), one bag each time, twice a day. One course of treatment was 10 days, and one course of treatment was given. There was no significant difference in the gender, age, and course of disease of the patients in each group after statistical processing, and they were comparable.

[0136] The diagnostic criteria for this disease are formulated as follows with reference to the New Century Textbook of TCM Otolaryngology and the Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes compiled by the State Administration of Traditional Chinese Medicine:

[0137] (1) Main symptoms: nasal congestion (long-term persistent nasal congestion, or intermittent or alternating nasal congestion), and excessive nasal discharge; associated symptoms: dizziness, tinnitus, stuffy ears, memory loss, insomnia, etc.;

[0138] (2) The disease lasts for a long time, and the symptoms are obvious after excessive fatigue or exposure to wind and cold. It is easy to be complicated by ear swelling and ear closure;

[0139] (3) Specialist examination: The nasal mucosa is red and congested, or may be dark red, and the inferior turbinate is obviously swollen.

[0140] Symptom classification and scoring criteria:

[0141] (1) Scoring of signs of chronic rhinitis: 0 points if the nasal concha is smooth and moist, and the nasal septum and middle turbinate are visible. 1 point if the nasal concha is slightly enlarged, smooth and moist, and the middle turbinate and nasal septum are still visible, and the nasal mucosa is chronically congested and dry in appearance.

[0142] (2) The nasal mucosa is dark red, swollen, smooth, and moist; the mucosa of the inferior turbinate is smooth and elastic, and will dent when pressed lightly, but will recover immediately after removal; the nasal concha can shrink rapidly under the action of 1% ephedrine to shrink the mucosa; purulent or mucous secretions can be seen in the common nasal meatus or inferior nasal meatus, 2 points.

[0143] (3) The nasal mucosa is red, light red or purple, the front end of the inferior turbinate and its free edge are swollen, the surface is uneven, and may be mulberry-like or nodular. The inferior turbinate or the middle and inferior turbinate are all swollen, resulting in nasal obstruction; purulent or mucous secretions can be seen in the inferior nasal meatus; the nasal concha is not obviously sunken when gently pressed, and it feels hard to the touch. The mucosal contraction is not obvious under the action of ephedrine, 3 points.

[0144] Efficacy evaluation criteria:

[0145] According to the new century textbook of TCM Otolaryngology "TCM Otolaryngology" and the "TCM Disease Diagnosis and Efficacy Standards" compiled by the State Administration of Traditional Chinese Medicine, the efficacy of treating chronic rhinitis is evaluated according to the changes in local symptoms and signs:

[0146] (1) Recovery: After treatment, symptoms and signs return to normal, with no nasal congestion or runny nose. Specialist examinations show that the nasal mucosa is light red, without congestion or swelling, and no abnormal secretions in the nasal passages.

[0147] (2) Effective: After treatment, symptoms and signs improved, nasal congestion was relieved, nasal discharge decreased, specialist examination showed that nasal mucosal congestion and swelling were relieved, and a small amount of secretions was visible in the nasal passages;

[0148] (3) Ineffectiveness: Symptoms and signs do not improve or even worsen after treatment; nasal congestion and runny nose do not improve, or the condition even worsens.

[0149] Efficacy index (n) = [(the sum of the symptom and sign scores before treatment - the sum of the symptom and sign scores after treatment) / the sum of the symptom and sign scores before treatment] × 100%

[0150] Markedly effective: efficacy index ≥66%;

[0151] Effective: efficacy index ≥26% and <66%;

[0152] Ineffective: efficacy index <26%.

[0153] The sum of marked effect and effective effect is the total effective rate.

[0154] The clinical efficacy observation results of the Chinese medicine composition of the present invention are shown in Table 4 below.

[0155] Table 4: Clinical efficacy observation results of the Chinese medicine composition of the present invention

[0156] Group Number of cases Significantly effective (example) Valid (Example) Invalid (Example) Effectiveness (%) Example 1 Group 20 14 6 0 100 Comparative Example 1 20 5 12 3 85 Comparative Example 2 20 4 10 6 70 Comparative Example 3 20 5 11 4 80

[0157] The above clinical efficacy observation results show that the Chinese medicine composition of the present invention has a good therapeutic effect on chronic rhinitis-sinusitis. In addition, from the results of comparative examples 1-3, it can be seen that the type of raw materials used in the Chinese medicine composition and the preparation method of the Chinese medicine composition have a great influence on the effect of the Chinese medicine composition of the present invention in treating chronic rhinitis-sinusitis.

[0158] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for treating chronic rhinitis-sinusitis, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-20 parts of Codonopsis pilosula, 1-20 parts of roasted Astragalus membranaceus, 1-20 parts of stir-fried Atractylodes macrocephala, 1-20 parts of Ligustrum lucidum fruit, 1-15 parts of Magnolia officinalis, 1-15 parts of stir-fried Xanthium sibiricum fruit, 1-15 parts of Angelica dahurica, 1-15 parts of wine-brewed Chuanxiong, 1-10 parts of Platycodon grandiflorum, 1-10 parts of cinnamon twig, 1-10 parts of Saposhnikovia divaricata, 1-8 parts of roasted Licorice root, and 1-10 parts of Asarum.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-15 parts of Codonopsis pilosula, 1-15 parts of roasted Astragalus membranaceus, 1-15 parts of stir-fried Atractylodes macrocephala, 1-15 parts of Ligustrum lucidum fruit, 1-10 parts of Magnolia officinalis, 1-10 parts of stir-fried Xanthium sibiricum fruit, 1-10 parts of Angelica dahurica, 1-10 parts of wine-brewed Chuanxiong, 1-8 parts of Platycodon grandiflorum, 1-8 parts of cinnamon twig, 1-6 parts of Saposhnikovia divaricata, 1-6 parts of roasted Licorice root, and 1-5 parts of Asarum.

3. The Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-8 parts of Codonopsis pilosula, 5-8 parts of roasted Astragalus membranaceus, 5-8 parts of stir-fried Atractylodes macrocephala, 5-8 parts of Ligustrum lucidum fruit, 4-7 parts of Magnolia officinalis, 4-7 parts of stir-fried Xanthium sibiricum fruit, 4-7 parts of Angelica dahurica, 4-7 parts of wine-brewed Chuanxiong, 3-6 parts of Platycodon grandiflorum, 3-6 parts of cinnamon twig, 3-6 parts of Saposhnikovia divaricata, 2-5 parts of roasted Licorice root, and 1-3 parts of Asarum.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: (1) Mix and ultrafinely grind magnolia flower, chuanxiong rhizome, cassia twig and asarum to prepare mixed ultrafine powder; (2) soaking Codonopsis pilosula, roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Fructus Ligustri Lucidi, stir-fried Xanthium sibiricum, Angelica dahurica, Platycodon grandiflorum, Saposhnikovia divaricata, and roasted Licorice root in 5-10 times the amount of water for 10-20 minutes and then decocting, filtering to obtain a primary filtrate after the first decoction for 20-40 minutes, adding 5-10 times the amount of water to the residue and decocting again for 20-40 minutes, filtering to obtain a secondary filtrate, combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution; (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

5. The preparation method according to claim 4, characterized in that: In step (1), the fineness of the ultrafine powder is 100 mesh.

6. The preparation method according to claim 4 or claim 5, characterized in that: In step (2), dangshen, roasted astragalus, stir-fried atractylodes, glossy privet, stir-fried xanthium sibiricum, angelica dahurica, platycodon grandiflorum, saposhnikovia divaricata, and roasted liquorice are soaked in 8 times the amount of water for 15 minutes and then decocted. After the first decoction for 30 minutes, a primary filtrate is obtained by filtering. The filter residue is added with 8 times the amount of water and decocted for another 30 minutes, and a secondary filtrate is obtained by filtering. The primary filtrate and the secondary filtrate are combined and concentrated to obtain a concentrated solution.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 6 in the preparation of a medicament for treating chronic rhinitis and sinusitis.

8. The use according to claim 7, characterized in that: The medicine has the effects of dispersing lung pathogens, strengthening spleen and replenishing qi, and discharging pus and opening the orifices.

9. The use according to claim 7 or claim 8, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid or capsules.

10. The use according to claim 9, characterized in that: The dosage form of the drug is granules.

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