A traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, its preparation method and uses.

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, its preparation method, and its uses. The traditional Chinese medicine composition is made from Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (processed), Ligustrum lucidum, Magnolia biondii, Xanthium sibiricum (processed), Angelica dahurica, Ligusticum chuanxiong (processed), Platycodon grandiflorus, Cinnamomum cassia, Saposhnikovia divaricata, Glycyrrhiza uralensis (processed), and Asarum heterotropoides. This traditional Chinese medicine composition has the effects of clearing the lungs and dispelling pathogens, strengthening the spleen and replenishing qi, and draining pus and opening the nasal passages, showing significant therapeutic effects on chronic rhinitis-sinusitis. Furthermore, the preparation method of this traditional Chinese medicine composition has the advantages of simple preparation process, high efficiency, energy saving, and minimal destruction of effective components.

Description

Technical Field

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

[0002] Chronic rhinitis and sinusitis are common diseases in otolaryngology, referring 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 that occurs in atopic individuals after exposure to allergens. Allergic rhinitis is a common chronic nasal disease affecting 10% to 20% of the world's population, making it a global health problem. Chronic rhinitis-sinusitis and allergic rhinitis often present clinically with nasal congestion, runny nose, headache, sneezing, and decreased or absent sense of smell. They often coexist; 25% to 50% of adult patients with chronic rhinitis-sinusitis also have allergic rhinitis, and the proportion is even higher in children.

[0003] Western medicine's treatment strategy for chronic rhinitis and sinusitis primarily focuses on relieving mucosal inflammation, preventing infection, and clearing mucus from the sinuses. Treatment methods include oral and nasal antihistamines, oral and nasal mast cell membrane stabilizers, nasal decongestants, antibiotics, and surgery. While all these methods can control symptoms, the associated drug toxicity, side effects, and surgical complications cannot be ignored. For example, long-term medication may pose health risks due to drug toxicity and side effects, especially in children and the elderly. Surgical treatment is a destructive procedure with a risk of complications. In conclusion, the clinical treatment of chronic rhinitis and sinusitis remains very challenging.

[0004] Rhinitis and sinusitis fall under the category of "nasal congestion" in Traditional Chinese Medicine. Its etiology and pathogenesis have been widely considered by physicians throughout history to be caused by both internal and external factors. Internal factors are mostly due to dysfunction of the internal organs, primarily deficiency of the lungs, spleen, and kidneys; external factors are mostly caused by wind-cold or other pathogenic factors invading the lungs. Treatment primarily focuses on tonifying the body's resistance with oral medications, while external treatments often utilize pungent, aromatic, and nasal-opening herbs.

[0005] For the treatment of chronic rhinitis and sinusitis, Traditional Chinese Medicine (TCM) offers advantages such as good efficacy, low cost, ease of use, and minimal or no toxic side effects. It also has unique advantages in improving immunity and treating allergic diseases. The latest European Guidelines for the Diagnosis and Treatment of Rhinitis and Sinusitis (EPOS) state that there is sufficient evidence to suggest that TCM has significant therapeutic value for rhinitis and sinusitis, recommending its clinical use. my country's Guidelines for the Diagnosis and Treatment of Allergic Rhinitis also recommend 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 and sinusitis. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, its preparation method, and its uses.

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

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, characterized in that: the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 1-20 parts, Astragalus membranaceus (processed) 1-20 parts, Atractylodes macrocephala (processed) 1-20 parts, Ligustrum lucidum 1-20 parts, Magnolia biondii 1-15 parts, Xanthium sibiricum (processed) 1-15 parts, Angelica dahurica 1-15 parts, Ligusticum chuanxiong (processed) 1-15 parts, Platycodon grandiflorus 1-10 parts, Cinnamomum cassia 1-10 parts, Saposhnikovia divaricata 1-10 parts, Glycyrrhiza uralensis (processed) 1-8 parts, Asarum heterotropoides 1-10 parts.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 1-15 parts, Astragalus membranaceus (processed) 1-15 parts, Atractylodes macrocephala (processed) 1-15 parts, Ligustrum lucidum 1-15 parts, Magnolia biondii 1-10 parts, Xanthium sibiricum (processed) 1-10 parts, Angelica dahurica 1-10 parts, Ligusticum chuanxiong (processed) 1-10 parts, Platycodon grandiflorus 1-8 parts, Cinnamomum cassia 1-8 parts, Saposhnikovia divaricata 1-6 parts, Glycyrrhiza uralensis (processed) 1-6 parts, Asarum heterotropoides 1-5 parts.

[0011] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 5-8 parts, Astragalus membranaceus (processed) 5-8 parts, Atractylodes macrocephala (processed) 5-8 parts, Ligustrum lucidum 5-8 parts, Magnolia biondii 4-7 parts, Xanthium sibiricum (processed) 4-7 parts, Angelica dahurica 4-7 parts, Ligusticum chuanxiong (processed) 4-7 parts, Platycodon grandiflorus 3-6 parts, Cinnamomum cassia 3-6 parts, Saposhnikovia divaricata 3-6 parts, Glycyrrhiza uralensis (processed) 2-5 parts, Asarum heterotropoides 1-3 parts.

[0012] Alternatively, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 7.5 parts, Astragalus membranaceus (processed) 7.5 parts, Atractylodes macrocephala (processed) 7.5 parts, Ligustrum lucidum 7.5 parts, Magnolia biondii 6 parts, Xanthium sibiricum (processed) 6 parts, Angelica dahurica 6 parts, Ligusticum chuanxiong (processed) 6 parts, Platycodon grandiflorus 4.5 parts, Cinnamomum cassia 4.5 parts, Saposhnikovia divaricata 4.5 parts, Glycyrrhiza uralensis (processed) 3 parts, and Asarum heterotropoides 1.5 parts.

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

[0014] (1) Mix and pulverize Magnolia biondii, Ligusticum chuanxiong, Cinnamomum cassia and Asarum to obtain mixed ultrafine powder;

[0015] (2) Soak Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Ligustrum lucidum (processed), Xanthium sibiricum (stir-fried), Angelica dahurica, Platycodon grandiflorus, Saposhnikovia divaricata, and Glycyrrhiza uralensis (processed) in 5-10 times the amount of water for 10-20 minutes, then decoct. After the first decoction is 20-40 minutes, filter to obtain the first filtrate. Add 5-10 times the amount of water to the residue and decoct again for 20-40 minutes, then filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0016] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

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

[0018] As an optional method, in the above preparation method, in step (2), Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Ligustrum lucidum, Xanthium sibiricum (stir-fried), Angelica dahurica, Platycodon grandiflorus, Saposhnikovia divaricata, and Glycyrrhiza uralensis (processed) are soaked in 8 times the amount of water for 15 minutes and then decocted. After the first decoction is decocted for 30 minutes, the first filtrate is obtained. The residue is then decocted in 8 times the amount of water for another 30 minutes and filtered to obtain a second filtrate. The first and second filtrates are combined and concentrated to obtain a concentrated solution.

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

[0020] Alternatively, in the above-mentioned uses, the drug has the effects of clearing the lungs and dispelling pathogens, strengthening the spleen and replenishing qi, and draining pus and opening the orifices.

[0021] Alternatively, in the above-described uses, the rhinitis-sinusitis may be accompanied by allergic rhinitis.

[0022] Alternatively, in the above-described uses, the dosage form of the drug is granules, tablets, oral liquid, or capsules.

[0023] Alternatively, in the above-described uses, the dosage form of the drug is granules.

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

[0025] The traditional Chinese medicine composition of this invention has the effects of clearing the lungs and dispelling pathogens, strengthening the spleen and replenishing qi, and draining pus and opening the nasal passages. It has a significant therapeutic effect on chronic rhinitis and sinusitis. In addition, the traditional Chinese medicine composition of this invention adopts a dynamic decoction process and a one-step granulation technology. The preparation method of this invention has the advantages of simple preparation process, high efficiency, energy saving and minimal destruction of effective ingredients. Detailed Implementation

[0026] The efficacy and indications of each herb in the traditional Chinese medicine composition described in this invention are as follows:

[0027] "Codonopsis pilosula" refers to the dried root of *Codonopsis pilosula* (Franch.) Nannf., *Codonopsis pilosula* Nannf. var. *modesta* (Nannf.) L.Shen, or *Codonopsis tangshen* Oliv., all belonging to the Campanulaceae family. Its properties and channels are: neutral in nature and sweet in taste. It enters the spleen and lung channels. Its functions are: tonifying the middle energizer and replenishing qi, strengthening the spleen and benefiting the lungs. It belongs to the qi-tonifying category of tonifying herbs. It is used to treat spleen and lung deficiency, shortness of breath, palpitations, poor appetite, loose stools, wheezing cough, and internal heat with thirst. Modern pharmacological research shows that Codonopsis pilosula contains polysaccharides, various amino acids that constitute nutrients (lysine, methionine, leucine, lysine, phenylalanine, etc.), various inorganic elements (iron, copper, cobalt, potassium, sodium, calcium, magnesium, etc.), as well as sterols, glycosides, lactones, volatile oils, alkaloids, and other substances. It has effects on the immune system, digestive system, blood system, and the central nervous system as well as the effects of Codonopsis pilosula decoction. It can enhance the phagocytic function of the reticuloendothelial system and improve the body's disease resistance. Based on the pharmacological effects of Codonopsis pilosula on lung and spleen deficiency, shortness of breath, and weakness, modern pharmacological research on Codonopsis pilosula in the circulatory, digestive, and immune systems has been quite in-depth, reaching the cellular and molecular level, and in some cases even the gene level. This provides a strong theoretical basis for the clinical application, research and development, and application of this medicine as both food and medicine.

[0028] "Astragalus" refers to the root of two leguminous plants: *Astragalus membranaceus* Bge. var. *mongholicus* (Bge.) Hsiao and *A. membranaceus* (Fisch.) Bge. Its properties and channels are: slightly warm in nature and sweet in taste. It enters the spleen and lung channels. Its functions include: tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing edema, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and promoting tissue regeneration and wound healing. It belongs to the qi-tonifying category of tonifying deficiency herbs. It is used to treat shortness of breath, palpitations, fatigue, collapse, spontaneous sweating, night sweats, edema due to weakness, chronic nephritis, chronic diarrhea, rectal prolapse, uterine prolapse, carbuncles that are difficult to ulcerate, slow-healing sores, childhood bronchial asthma, chronic hepatitis B, chronic nephritis, and viral myocarditis. For tonifying qi, it is best used roasted; for stopping sweating, promoting diuresis, promoting pus drainage and wound regeneration, it is best used raw. Modern pharmacological studies have shown that Astragalus contains eight effective chemical components, including astragalus polysaccharides, astragalus saponins, and astragalus flavonoids. It possesses antiviral, anti-aging, hepatoprotective, hypoglycemic, bone marrow hematopoietic regulation, anti-osteoporosis, and anti-tumor effects, as well as influences on immune function, including enhancing cellular immunity, humoral immunity, non-specific immunity, and immunomodulatory functions.

[0029] "Bai Zhu" refers to the rhizome of *Atractylodes macrocephala* Koidz., a plant in the Asteraceae family. Its properties and channels are: warm in nature, sweet and bitter in taste. It enters the spleen and stomach channels. Its functions include: strengthening the spleen, replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It belongs to the qi-tonifying category of tonifying herbs. It is used to treat weakness of the spleen and stomach qi, loss of appetite, fatigue, shortness of breath, abdominal distension, diarrhea, phlegm retention, edema, jaundice, dampness-related arthralgia, difficulty urinating, dizziness, spontaneous sweating, and threatened miscarriage. Modern pharmacological research shows that Bai Zhu is composed of volatile oils, acetic acid compounds, polysaccharides, glycosides, amino acids, and other compounds. Bai Zhu has high medicinal value, promoting cellular immune function, significantly increasing serum IgG, enhancing the body's disease resistance, regulating gastrointestinal function, diuresis, anti-tumor, anti-inflammatory, antibacterial, anticoagulant, and anti-aging effects, among more than 20 other pharmacological actions.

[0030] "Ligustrum lucidum" is the mature fruit of the Oleaceae plant *Ligustrum lucidum* Ait. Its properties and channels: cool in nature, sweet and bitter in taste. It enters the liver and kidney channels. Functions: nourishes the liver and kidneys, improves eyesight and darkens hair. It belongs to the category of yin-tonifying herbs under the category of tonifying deficiency herbs. It is used to treat tinnitus, deafness, dizziness, lower back and knee weakness, and premature graying of hair caused by liver and kidney yin deficiency. Modern pharmacological research shows that privet fruit and its pericarp contain oleanolic acid, ursolic acid, palmitic acid, stearic acid, and other acids.

[0031] Oleic acid, oleanolic acid, acetic acid, oleanolic acid, etc. Privet fruit contains various chemical components with multiple effects, including anti-cancer, anti-oxidative aging, immune regulation, and blood sugar and blood pressure reduction. In addition, it is also used to treat chronic atrophic gastritis.

[0032] "Magnolia biondii" refers to the flower buds of several magnolia species, including Magnolia denudata, Magnolia sprengeri, and Magnolia biondii. Its properties are warm and pungent, and it enters the Lung and Stomach meridians. Its functions include dispelling wind-cold and clearing nasal passages. It belongs to the category of pungent-warm exterior-releasing drugs under the subclass of exterior-releasing drugs. It is used to treat wind-cold headache, nasal congestion, sinusitis, and runny nose with thick discharge. Modern pharmacological research shows that Magnolia biondii has a clear anti-allergic effect and is mainly used to treat rhinitis, sinusitis, asthma, and other diseases. This herb also has a wide range of therapeutic effects, such as antihistamine, anti-inflammatory, local astringent, central nervous system depressant, antimicrobial, and antihypertensive effects.

[0033] "Xanthium sibiricum" is the fruit of the plant Xanthium sibiricum Patr., belonging to the Asteraceae family. Its properties are pungent, bitter, and warm. Its functions include dispelling wind and dampness, and it enters the Lung meridian. It is used to treat headaches due to wind-cold, sinusitis, and pain and contractures. Modern pharmacological research shows that Xanthium sibiricum contains volatile oils, sterols, fatty oils, and organic acids. Due to its significant analgesic and anti-allergic effects, it is effective in treating rhinitis and is a commonly used drug in otolaryngology. In addition, it has significant effects on the cardiovascular and respiratory systems, and also possesses anti-cancer and hypoglycemic properties.

[0034] "Bai Zhi" refers to 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., belonging to the Apiaceae family. Those produced in Changge and Yuxian, Henan Province, are commonly known as "Yu Bai Zhi," while those produced in Anguo, Hebei Province, are commonly known as "Qi Bai Zhi." Properties and Channels: Warm in nature, pungent in taste. Enters the Stomach, Large Intestine, and Lung channels. Functions: Dispels wind and dampness, clears the orifices and relieves pain, reduces swelling and drains pus. It belongs to the category of pungent-warm exterior-releasing drugs under the subclass of exterior-releasing drugs. Used to treat colds, headaches, supraorbital neuralgia, nasal congestion, sinusitis, toothache, leukorrhea, and sores and swellings. It has a good analgesic effect, especially for headaches, and also has detoxifying and anti-inflammatory effects. Recent findings suggest it has a dilating effect on coronary arteries, and its use in treating coronary heart disease may be considered. Modern pharmacological studies have shown that the coumarin and volatile oil components in Angelica dahurica extract have pharmacological effects such as antipyretic analgesia, anti-inflammatory, antibacterial, and inhibition of pathogenic microorganisms.

[0035] "Chuanxiong" is the rhizome of *Ligusticum chuam.iong Hort.*, a plant in the Apiaceae family. It is warm in nature and pungent in taste. It invigorates blood circulation, promotes qi flow, dispels wind, and relieves pain. It belongs to the category of blood-activating and pain-relieving drugs under the subcategory of blood-activating and stasis-removing drugs. It is used for chest pain, stabbing pain in the chest and ribs, swelling and pain from falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to masses, headache, and rheumatic pain. Modern pharmacological research shows that chuanxiong contains ligustrazine, which can regulate the PI3K / AKT / mTOR signaling pathway, inhibit nitric oxide, TNF-α, and interleukin 1β, and reduce inflammatory responses. This product has the effects of invigorating blood circulation, promoting qi flow, dispelling wind, and relieving pain, and can effectively treat qi and blood stagnation caused by chronic CRS.

[0036] "Platycodon grandiflorum" (Jacq.) A.DC., a plant in the Campanulaceae family, is the dried root of the plant. Its properties are bitter, pungent, and neutral. Its functions include clearing the lungs, relieving sore throat, resolving phlegm, and draining pus. It enters the Lung meridian. It is indicated for cough with excessive phlegm, chest tightness, sore throat, hoarseness, lung abscess with purulent sputum, and sores that have formed pus but have not yet ulcerated. Modern pharmacological research shows that Platycodon grandiflorum can inhibit the proliferation and invasion of tumor cells, promote their apoptosis, and enhance the body's immunity. It can be used to treat tumors such as liver cancer and stomach cancer. To a certain extent, Platycodon grandiflorum can protect cells damaged by oxidative stress and has a good antioxidant effect. It has a strong inhibitory effect on bacteria such as Salmonella, can inhibit the levels of inflammatory factors such as IL-8 and CRP, and reduce the degree of joint swelling in rats with rheumatoid arthritis, exhibiting antibacterial and anti-inflammatory effects. In addition, Platycodon grandiflorum can protect the liver and kidneys, regulate the body's immune mechanism, and has anti-diabetic, anti-obesity, and anti-fatigue effects.

[0037] "Guizhi" refers to the tender branches of *Cinnamomum cassia* Presl., a plant in the Lauraceae family. Its properties and channels are: pungent and sweet in taste, warm in nature. It enters the bladder, heart, and lung channels. Its functions include: releasing exterior pathogens, warming the channels and unblocking the meridians, assisting yang and promoting qi circulation, and calming the upward flow of qi; it belongs to the category of pungent and warm exterior-releasing herbs. It is used to treat colds due to wind-cold, abdominal pain due to cold, amenorrhea due to blood stasis, joint pain, phlegm retention, edema, palpitations, and abdominal distension. Modern pharmacological research shows that components in guizhi, such as cinnamon twig alcohol and cinnamon oil, have antibacterial effects. Guizhi volatile oil inhibits the production of inflammatory mediators by inhibiting arachidonic acid metabolism, thereby exerting an anti-inflammatory effect. Guizhi extract can also exert an anti-allergic effect by inhibiting hyaluronidase.

[0038] "Fangfeng" refers to the root of *Saposhnikovia divaricata* (Turcz.) Schishk., a plant in the Apiaceae family. Its properties and channels are: warm in nature, sweet and pungent in taste. It enters the bladder, liver, and spleen channels. Its functions are: to release exterior pathogens, dispel wind, and eliminate dampness. It belongs to the category of pungent-warm exterior-releasing drugs. Taken internally, it treats colds, headaches, fever, anhidrosis, rheumatic pain, limb contractures, rheumatic itching, tetanus, etc. Modern pharmacological research shows that Fangfeng contains volatile oils, chromones, coumarins, organic acids, and other chemical components, with varying pharmacological activities among the different components. Fangfeng has antipyretic, analgesic, antiasthmatic, local astringent, anti-inflammatory, antimicrobial, antitumor, immune-enhancing, blood viscosity-reducing, and anticoagulant effects.

[0039] "Licorice" refers to the root and rhizome of *Glycyrrhiza uralensis* Fisch., *G. inflata* Bat., or *G. glabra* L., all belonging to the Leguminosae family. Licorice is neutral in nature, sweet in taste, and enters all twelve meridians. It has pharmacological effects such as detoxification, expectoration, analgesia, antispasmodic effects, and even anticancer properties. In Traditional Chinese Medicine, licorice tonifies the spleen and replenishes qi, nourishes the lungs and relieves cough, alleviates spasms and detoxifies, and harmonizes various medicines. Clinically, it is used in two ways: raw and honey-processed. Raw licorice is mainly used to treat sore throat, carbuncles, gastrointestinal ulcers, and to detoxify from drug poisoning and food poisoning. Honey-processed licorice is mainly used to treat weakened spleen and stomach function, loose stools, fatigue and fever, as well as cough and palpitations. Modern pharmacological research shows that the main chemical components of licorice include saponins, polysaccharides, and flavonoids. Glycyrrhizin has a good protective effect on hepatocytes, thereby inhibiting hepatocyte necrosis and degeneration. In addition, it also has multiple functions such as detoxification, anti-inflammatory and antibacterial, anti-hypersensitivity, antitussive and expectorant, antispasmodic and analgesic.

[0040] "Asarum" refers to the whole herb of *Asarum sieboldii* Miq., a plant in the Aristolochiaceae family. Its properties and channels are: warm in nature and pungent in taste. It enters the Heart, Lung, and Kidney channels. Its functions include: dispelling wind, dispersing cold, clearing the orifices and relieving pain, warming the lungs and resolving phlegm. It belongs to the category of pungent-warm exterior-releasing drugs under the subclass of exterior-releasing drugs. It is used to treat common cold due to wind-cold, headache, toothache, nasal congestion, sinusitis, rheumatic pain, and cough with phlegm. Modern pharmacological research shows that Asarum has cardiotonic, vasodilatory, peripheral resistance-reducing, sedative, analgesic, and other central inhibitory effects, as well as anti-inflammatory, anti-allergic, immunosuppressive, bronchial smooth muscle relaxant, and asthma-relieving effects.

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

[0042] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0043] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0044] Preparation Example:

[0045] Example 1:

[0046] A traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, the composition being made from the following raw materials in parts by weight: Codonopsis pilosula 7.5 parts, Astragalus membranaceus (processed) 7.5 parts, Atractylodes macrocephala (processed) 7.5 parts, Ligustrum lucidum 7.5 parts, Magnolia biondii 6 parts, Xanthium sibiricum (processed) 6 parts, Angelica dahurica 6 parts, Ligusticum chuanxiong (processed) 6 parts, Platycodon grandiflorus 4.5 parts, Cinnamomum cassia 4.5 parts, Saposhnikovia divaricata 4.5 parts, Glycyrrhiza uralensis (processed) 3 parts, Asarum heterotropoides 1.5 parts.

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

[0048] (1) Mix magnolia flower, chuanxiong rhizome, cinnamon twig and asarum root and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh.

[0049] (2) Soak Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Ligustrum lucidum (processed), Xanthium sibiricum (stir-fried), Angelica dahurica, Platycodon grandiflorus, Saposhnikovia divaricata, and Glycyrrhiza uralensis (processed) in 8 times the amount of water for 15 minutes and then decoct them. After the first decoction is 30 minutes, filter to obtain the first filtrate. Add 8 times the amount of water to the residue and decoct for another 30 minutes. Filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0050] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0051] Example 2:

[0052] A traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, the composition being made from the following raw materials in parts by weight: Codonopsis pilosula 8 parts, Astragalus membranaceus (processed) 8 parts, Atractylodes macrocephala (processed) 8 parts, Ligustrum lucidum 8 parts, Magnolia biondii 5 parts, Xanthium sibiricum (processed) 5 parts, Angelica dahurica 6 parts, Ligusticum chuanxiong (processed) 6 parts, Platycodon grandiflorus 4.5 parts, Cinnamomum cassia 4.5 parts, Saposhnikovia divaricata 4.5 parts, Glycyrrhiza uralensis (processed) 3 parts, Asarum heterotropoides 1.5 parts.

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

[0054] (1) Mix magnolia flower, chuanxiong rhizome, cinnamon twig and asarum root and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh.

[0055] (2) Soak Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Ligustrum lucidum (processed), Xanthium sibiricum (stir-fried), Angelica dahurica, Platycodon grandiflorus, Saposhnikovia divaricata, and Glycyrrhiza uralensis (processed) in 8 times the amount of water for 15 minutes and then decoct them. After the first decoction is 30 minutes, filter to obtain the first filtrate. Add 8 times the amount of water to the residue and decoct for another 30 minutes. Filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0056] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0057] Example 3:

[0058] A traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, the composition being made from the following raw materials in parts by weight: Codonopsis pilosula 7 parts, Astragalus membranaceus (processed) 7 parts, Atractylodes macrocephala (processed) 7 parts, Ligustrum lucidum 7 parts, Magnolia biondii 6 parts, Xanthium sibiricum (processed) 6 parts, Angelica dahurica 6 parts, Ligusticum chuanxiong (processed) 6 parts, Platycodon grandiflorus 5 parts, Cinnamomum cassia 5 parts, Saposhnikovia divaricata 5 parts, Glycyrrhiza uralensis (processed) 3 parts, Asarum heterotropoides 2 parts.

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

[0060] (1) Mix magnolia flower, chuanxiong rhizome, cinnamon twig and asarum root and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh.

[0061] (2) Soak Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Ligustrum lucidum (processed), Xanthium sibiricum (stir-fried), Angelica dahurica, Platycodon grandiflorus, Saposhnikovia divaricata, and Glycyrrhiza uralensis (processed) in 8 times the amount of water for 15 minutes and then decoct them. After the first decoction is 30 minutes, filter to obtain the first filtrate. Add 8 times the amount of water to the residue and decoct for another 30 minutes. Filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0062] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0063] Comparative Example 1:

[0064] A traditional Chinese medicine composition, wherein the composition is made from the following raw materials in parts by weight: Codonopsis pilosula 7.5 parts, Astragalus membranaceus (processed) 7.5 parts, Atractylodes macrocephala (processed) 7.5 parts, Ligustrum lucidum 7.5 parts, Magnolia biondii 6 parts, Xanthium sibiricum (processed) 6 parts, Paeonia lactiflora 6 parts, Ligusticum chuanxiong (processed) 6 parts, Platycodon grandiflorus 4.5 parts, Cinnamomum cassia 4.5 parts, Saposhnikovia divaricata 4.5 parts, Glycyrrhiza uralensis (processed) 3 parts, Asarum heterotropoides 1.5 parts.

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

[0066] (1) Mix magnolia flower, chuanxiong rhizome, cinnamon twig and asarum root and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh.

[0067] (2) Soak Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Ligustrum lucidum (processed), Xanthium sibiricum (stir-fried), Paeonia lactiflora (white peony root), Platycodon grandiflorus (plum blossom), Saposhnikovia divaricata (saposhnikovia divaricata), and Glycyrrhiza uralensis (processed) in 8 times the amount of water for 15 minutes, then decoct them. After the first decoction is 30 minutes, filter to obtain the first filtrate. Add 8 times the amount of water to the residue and decoct for another 30 minutes, then filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0068] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0069] Comparative Example 2:

[0070] A traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 11.5 parts, Astragalus membranaceus (processed) 11 parts, Atractylodes macrocephala (processed) 7.5 parts, Magnolia biondii 6 parts, Xanthium sibiricum (processed) 6 parts, Angelica dahurica 6 parts, Ligusticum chuanxiong (processed) 6 parts, Platycodon grandiflorus 4.5 parts, Cinnamomum cassia 4.5 parts, Saposhnikovia divaricata 4.5 parts, Glycyrrhiza uralensis (processed) 3 parts, Asarum heterotropoides 1.5 parts.

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

[0072] (1) Mix magnolia flower, chuanxiong rhizome, cinnamon twig and asarum root and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh.

[0073] (2) Soak Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Xanthium sibiricum (stir-fried), Angelica dahurica, Platycodon grandiflorus, Saposhnikovia divaricata, and Glycyrrhiza uralensis (processed) in 8 times the amount of water for 15 minutes and then decoct them. After the first decoction is 30 minutes, filter to obtain the first filtrate. Add 8 times the amount of water to the residue and decoct for another 30 minutes. Filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0074] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0075] Comparative Example 3:

[0076] A traditional Chinese medicine composition, wherein the composition is made from the following raw materials in parts by weight: Codonopsis pilosula 7.5 parts, Astragalus membranaceus (processed) 7.5 parts, Atractylodes macrocephala (processed) 7.5 parts, Ligustrum lucidum 7.5 parts, Magnolia biondii 6 parts, Xanthium sibiricum (processed) 6 parts, Angelica dahurica 6 parts, Ligusticum chuanxiong (processed) 6 parts, Platycodon grandiflorus 4.5 parts, Cinnamomum cassia 4.5 parts, Saposhnikovia divaricata 4.5 parts, Glycyrrhiza uralensis (processed) 3 parts, Asarum heterotropoides 1.5 parts.

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

[0078] (1) Soak Codonopsis pilosula, Astragalus membranaceus (processed), Atractylodes macrocephala (stir-fried), Ligustrum lucidum, Xanthium sibiricum (stir-fried), Angelica dahurica, Platycodon grandiflorus, Saposhnikovia divaricata, Glycyrrhiza uralensis (processed), Magnolia biondii, Ligusticum chuanxiong (processed with wine), Cinnamomum cassia, and Asarum heterotropoides in 8 times the amount of water for 15 minutes and then decoct. After the first decoction is 30 minutes, filter to obtain the first filtrate. Add 8 times the amount of water to the residue and decoct for another 30 minutes. Filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0079] (2) The concentrate obtained in step (1) is concentrated to obtain the extract of the traditional Chinese medicine composition. Example of effectiveness:

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

[0081] 1. Experimental Methods

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

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

[0084] Mice were fed normally after surgery, and their general condition was observed, including nasal secretions, nasal congestion, sneezing, and scratching of the nose. Eight weeks after modeling, HE staining revealed chronic inflammation in the nasal mucosa, with cilia loss, necrosis and shedding of some mucosal epithelial cells, and hyperplasia of submucosal glands. Numerous inflammatory cell infiltrations were also observed, indicating the successful establishment of the chronic rhinitis-sinusitis mouse model.

[0085] The sham-operated mice underwent the same procedures as above, except that they did not use Merocel high-expansion hemostatic material and pneumococcal inoculation to treat the nasal cavity.

[0086] Take the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-3 respectively, add distilled water to prepare a 200 mg / mL oral administration solution for later use.

[0087] 1.2 Animal grouping and drug treatment

[0088] Mice that successfully developed the model were randomly divided into 7 groups: a model control group, Example 1-3 groups, and Comparative Example 1-3 groups, with 8 mice in each group. Additionally, 8 mice were used in a sham-operated group. The Example 1-3 and Comparative Example 1-3 groups were administered the test drugs at 50 mg / kg via gavage 8 weeks after model establishment. The blank control group and the model control group were administered the same volume of distilled water via gavage. Administered once daily for 14 consecutive days.

[0089] 1.3 Sample Collection

[0090] Mice were fasted for 12 hours after the last administration. After anesthetizing the mice, blood was collected from the retroocular venous plexus. The supernatant was collected by centrifugation at 35,000 rpm at 4°C. The mouse serum was stored for later use.

[0091] Mice were euthanized, and nasal mucosa tissue was collected, rinsed with physiological saline containing 0.2% diethyl pyrocarbonate (DEPC), and divided into two equal parts. One part was placed in a cryovial and stored in liquid nitrogen for later use, and the other part was fixed in 4% paraformaldehyde.

[0092] 1.4 Histopathological staining and quantitative analysis

[0093] HE staining revealed histopathological changes and polymorphonuclear neutrophil (PMN) infiltration in the sinus mucosa; PAS staining showed goblet cells in the mucosal epithelium; and Masson-Trichrome staining showed submucosal collagen fibers. Five sections with similar anatomical structures from each specimen were selected for observation and analysis (including maxillary sinus, ethmoid sinus, etc.). Quantitative histopathological analysis was performed using a high-resolution medical image analysis system. PMN infiltration in the lamina propria of the sinus mucosa was expressed as the number of PMNs per square millimeter of lamina propria (cells / mm). 2 The number of goblet cells in the mucosal epithelium is expressed as the number of goblet cells per millimeter of epithelial basement membrane length (cells / mm); the collagen fiber deposition in the lamina propria of the mucosa is expressed as the collagen staining area per micrometer of epithelial basement membrane length (μm). 2 / μm).

[0094] 1.5 Detection of serum inflammatory factor levels in mice using ELISA

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

[0096] 1.4 Data Representation and Statistical Analysis Methods

[0097] Data analysis was performed using SPSS 23.0 statistical software. Quantitative data were expressed as mean ± standard deviation (mean ± SD). One-way ANOVA was used for comparisons between groups. The LSD test was used for homogeneous variances, and the Euskal-Walli SH test was used for nonparametric tests for heterogeneous variances. A p-value < 0.05 was considered statistically significant.

[0098] 2. Experimental Results

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

[0100] In the sham-operated group, the nasal mucosal epithelial cells and cilia structure of the mice were intact and neatly arranged, with a small number of scattered goblet cells occasionally observed in the submucosa. In the model group, the nasal mucosa of the mice showed signs of chronic inflammation, with disordered arrangement of mucosal epithelial cells, loss of cilia, necrosis and shedding of some cells, proliferation of glands and fibrous tissue in the submucosa, and infiltration of a large number of lymphocytes and plasma cells.

[0101] The nasal mucosal epithelial cells and ciliary structures of mice in each of the example groups were basically intact and arranged relatively neatly, with fewer submucosal lymphocytes. The nasal mucosal structure of mice in Example 1 group was similar to that of the sham-operated group.

[0102] In each control group, varying degrees of nasal mucosal necrosis and shedding were observed, with moderate to minimal infiltration of inflammatory cells such as lymphocytes and glandular hyperplasia in the submucosa.

[0103] The PMN number, goblet cell number, 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 herbal composition of the present invention on PMN number, goblet cell number and collagen fiber deposition in the lamina propria of mouse sinus mucosa

[0105]

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

[0107] As shown in Table 1, after 14 days of administration of the test drug, the number of PMNs, goblet cells, and collagen fiber deposition in the lamina propria of the sinus mucosa of mice in Examples 1-3 and Comparative Examples 1-3 decreased to varying degrees. Among them, the number of PMNs, goblet cells, and collagen fiber deposition in the lamina propria of the sinus mucosa of mice in Examples 1-3 were significantly lower than those in the model group (P<0.05, P<0.01). In particular, the herbal composition in Example 1 showed the best effect, indicating that the herbal composition of the present invention has a good therapeutic effect on infectious rhinitis-sinusitis.

[0108] Furthermore, the results from Comparative Examples 1-3 also show that the types of raw materials used in the traditional Chinese medicine composition and the preparation method of the traditional Chinese medicine composition have a significant impact on the efficacy of the traditional Chinese medicine composition of the present invention in treating infectious rhinitis-sinusitis.

[0109] 2.2 Serum levels of inflammatory factors TNF-α and IFN-γ in each group of mice

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

[0111] Table 2: Effects of the herbal composition of the present invention on the serum levels of inflammatory factors TNF-α and IFN-γ in mice

[0112] Group TNF-α (pg / mL) IFN-γ (pg / mL) Sham surgery 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 Groups 40.13±3.81 49.68±4.97

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

[0114] As shown in Table 2, compared with the sham-operated group, the serum levels of TNF-α and IFN-γ in the model group mice were significantly increased.

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

[0116] Furthermore, the results from Comparative Examples 1-3 also show that the types of raw materials used in the traditional Chinese medicine composition and the preparation method of the traditional Chinese medicine composition have a significant impact on the efficacy of the traditional Chinese medicine composition of the present invention in treating infectious rhinitis-sinusitis.

[0117] Example 2: Therapeutic effect of the herbal composition of the present invention on experimental animals with allergic rhinitis. 1. Experimental methods

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

[0119] SD rats weighing 180–200 g (purchased from Liaoning Changsheng Biotechnology) were initially immunized by intraperitoneal injection of a mixture of 0.3 mg ovalbumin, 30 mg Al(OH)3, and 1 mL of physiological saline. On day 15, a booster immunization was administered via intranasal drops of 200 μg (50 μL) of 4% ovalbumin. The blank control group rats received only intraperitoneal injections and intranasal administration of the same volume of physiological saline.

[0120] Take the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-3 respectively, add distilled water to prepare a 200 mg / mL oral administration solution for later use.

[0121] 1.2 Animal grouping and drug treatment

[0122] Sixty-four male rats were randomly divided into eight groups: a blank control group, a model control group, and groups 1-3 (Examples 1-3 and Comparative Examples 1-3), with eight rats in each group. Groups 1-3 (Examples 1-3 and Comparative Examples 1-3) were administered the test drugs by gavage at a dose of 1 mL / 100 g body weight 15 days after sensitization. The blank control group and the model control group were given an equal volume of distilled water. Administered once daily for 10 consecutive days.

[0123] 1.3 Immunological Factor Measurement

[0124] One hour after the last administration, 5 mL of femoral vein blood was collected from each group of rats and injected into a heparin-anticoagulated sterile bottle. The sample was centrifuged at 2500 rpm for 10 min, and the supernatant was collected and frozen at -20℃. The samples were then analyzed according to the manufacturer's instructions for histamine (HIS), immunoglobulin E (IgE), and interleukin-4 (IL-4). 1.4 Data Presentation and Statistical Analysis Methods

[0125] Data analysis was performed using SPSS 23.0 statistical software. Quantitative data were expressed as mean ± standard deviation (mean ± SD). One-way ANOVA was used for comparisons between groups. The LSD test was used for homogeneous variances, and the Euskal-Walli SH test was used for nonparametric tests for heterogeneous variances. A p-value < 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 each group of rats are shown in Table 3.

[0128] Table 3: Effects of the herbal 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] As shown in Table 3, after 10 days of administration of the test drug, the levels of HIS, IgE, and IL-4 in rats in Examples 1-3 and Comparative Examples 1-3 decreased to varying degrees. In particular, the levels of various tested immune factors in Examples 1-3 were significantly lower than those in the model group (P<0.01), indicating that the herbal composition of this invention has a good therapeutic effect on allergic rhinitis.

[0132] Furthermore, the results from comparative examples 1-3 also show that the types of raw materials used in the traditional Chinese medicine composition and the preparation method of the traditional Chinese medicine composition have a significant impact on the efficacy of the traditional Chinese medicine composition of the present invention in treating allergic rhinitis.

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

[0134] Patients with chronic rhinitis-sinusitis who visited the Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine were diagnosed. Eighty patients who met the diagnostic criteria and inclusion / exclusion criteria of the "Guidelines for the Diagnosis and Treatment of Chronic Rhinitis-Sinusitis (2018 Edition)" were randomly divided into four groups of 20 patients each.

[0135] Patients were given the herbal compositions prepared in Example 1 and Comparative Examples 1-3 (with the same amount of raw herbs in each experimental group), one sachet each time, twice daily. One course of treatment lasted 10 days. There were no statistically significant differences in gender, age, or disease duration among the groups, making them comparable.

[0136] The diagnostic criteria for this disease are formulated based on the "New Century Textbook of Traditional Chinese Medicine Otorhinolaryngology" and the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" compiled by the State Administration of Traditional Chinese Medicine as follows:

[0137] (1) Main symptoms: Nasal congestion (long-term persistent nasal congestion, or intermittent or alternating nasal congestion), excessive nasal discharge; Accompanying symptoms: may be accompanied by dizziness, tinnitus, ear fullness, memory loss, insomnia, etc.

[0138] (2) The course of the disease is long, and the symptoms become more pronounced after overexertion or exposure to wind and cold. It is prone to complications such as ear fullness and ear blockage.

[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 grading and scoring criteria:

[0141] (1) Scoring of signs of chronic rhinitis: The turbinates are smooth and moist, and the nasal septum and middle turbinate are visible, 0 points. The turbinates are slightly swollen, smooth and moist, and the middle turbinate and nasal septum are also visible. The nasal mucosa is chronically congested and has a dry appearance, 1 point.

[0142] (2) The nasal mucosa is dark red, swollen, smooth and moist; the inferior turbinate mucosa is smooth and elastic, and it will be indented when gently pressed and will recover immediately after being removed; the turbinate can be rapidly reduced under the effect 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, appearing pale red or purplish-red. The anterior end and free edge of the inferior turbinate are swollen, with an uneven surface that may resemble a mulberry or nodules. The inferior turbinate or both the middle and inferior turbinates are enlarged, leading to nasal obstruction. Purulent or mucous secretions may be seen in the inferior meatus. Gentle pressure on the turbinates does not cause significant indentation, and the turbinates feel hard to the touch. The mucosa does not contract significantly under the influence of ephedrine, scoring 3 points.

[0144] Efficacy evaluation criteria:

[0145] Based on the new century textbook "Traditional Chinese Medicine Otorhinolaryngology" and the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine" compiled by the State Administration of Traditional Chinese Medicine, the efficacy of treatment for chronic rhinitis is evaluated according to changes in local symptoms and signs scores.

[0146] (1) Cured: After treatment, symptoms and signs returned to normal, there was no nasal congestion or runny nose, and a specialist examination showed that the nasal mucosa was pale red, without congestion or swelling, and there was no abnormal secretion in the nasal passages.

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

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

[0149] Therapeutic efficacy index (n) = [(Sum of pre-treatment symptom and sign scores - Sum of post-treatment symptom and sign scores) / Sum of pre-treatment symptom and sign scores] × 100%

[0150] Significant efficacy: Therapeutic efficacy index ≥ 66%;

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

[0152] Ineffective: Therapeutic index <26%.

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

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

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

[0156] Group Number of examples Significant effect (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 Groups 20 5 11 4 80

[0157] The above clinical efficacy observation results indicate that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on chronic rhinitis-sinusitis. Furthermore, the results of comparative examples 1-3 also show that the types of raw materials used in the traditional Chinese medicine composition and the preparation method of the composition have a significant impact on the efficacy of the traditional Chinese medicine composition of the present invention in treating chronic rhinitis-sinusitis.

[0158] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating chronic rhinitis-sinusitis, characterized in that: The traditional Chinese medicine composition is made of raw medicinal materials in the following weight proportions: 7.5 parts of radix codonopsis, 7.5 parts of prepared radix astragali, 7.5 parts of fried atractylodes, 7.5 parts of ligustrum lucidum aiton, 6 parts of lonicera, 6 parts of fried semen crotonis, 6 parts of radix angelicae pubescentis, 6 parts of chuanxiong rhizome, 4.5 parts of platycodon grandiflorum, 4.5 parts of cassia twig, 4.5 parts of siler, 3 parts of prepared licorice, and 1.5 parts of asarum, the rhinitis-sinusitis is infectious rhinitis-sinusitis, and the preparation method of the traditional Chinese medicine composition comprises the following steps: ​ (1) mixing lonicera, chuanxiong rhizome, cassia twig and asarum and performing ultrafine grinding to prepare mixed ultrafine powder; (2) soaking radix codonopsis, prepared radix astragali, fried atractylodes, ligustrum lucidum aiton, fried semen crotonis, radix angelicae pubescentis, platycodon grandiflorum, siler and prepared licorice in 8 times the amount of water for 15 minutes, performing decocting for the first time, filtering first filtrate after 30 minutes, adding 8 times the amount of water to the filter residue and performing decocting for 30 minutes again, filtering second filtrate, combining the first filtrate and the second filtrate, and preparing concentrated liquid through concentration; (3) spraying the mixed ultrafine powder prepared in step (1) into the concentrated liquid prepared in step (2) as a base material, performing one-step granulation, mixing uniformly, and preparing the traditional Chinese medicine composition granules.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The rhinitis-sinusitis is infectious rhinitis-sinusitis accompanied by allergic rhinitis.

3. The preparation method of the traditional Chinese medicine composition according to claim 1 or claim 2, characterized in that: The preparation method comprises the following steps: (1) mixing lonicera, chuanxiong rhizome, cassia twig and asarum and performing ultrafine grinding to prepare mixed ultrafine powder; (2) soaking radix codonopsis, prepared radix astragali, fried atractylodes, ligustrum lucidum aiton, fried semen crotonis, radix angelicae pubescentis, platycodon grandiflorum, siler and prepared licorice in 8 times the amount of water for 15 minutes, performing decocting for the first time, filtering first filtrate after 30 minutes, adding 8 times the amount of water to the filter residue and performing decocting for 30 minutes again, filtering second filtrate, combining the first filtrate and the second filtrate, and preparing concentrated liquid through concentration; (3) spraying the mixed ultrafine powder prepared in step (1) into the concentrated liquid prepared in step (2) as a base material, performing one-step granulation, mixing uniformly, and preparing the traditional Chinese medicine composition granules.

4. The method of claim 3, wherein: In step (1), the fineness of the ultrafine powder is 100 meshes.

5. The use of the traditional Chinese medicine composition of claim 1 or claim 2 or the traditional Chinese medicine composition prepared by the preparation method of claim 3 or claim 4 in the preparation of a drug for treating chronic rhinitis-sinusitis, characterized in that: The rhinitis-sinusitis is infectious rhinitis-sinusitis.

6. Use according to claim 5, characterized in that: The medicine has the effects of expelling pathogenic factors from the lung, invigorating the spleen and tonifying qi, and discharging pus and dredging the orifices.

7. Use according to claim 5, characterized in that: The rhinitis-sinusitis is infectious rhinitis-sinusitis accompanied by allergic rhinitis.

8. Use according to claim 5, characterized in that: The dosage form of the medicine is granules, tablets or capsules.

9. Use according to claim 8, characterized in that: The dosage form of the medicine is granules.

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