Traditional Chinese medicine prescription for treating nasosinusitis and application thereof

Abstract

According to the traditional Chinese medicine prescription, radix scrophulariae, wild buckwheat rhizome, platycodon grandiflorum and radix angelicae have the effects of detoxifying and expelling pus and are used as monarch drugs, radix angelicae sinensis, radix paeoniae rubra, cowherb seed and beautiful sweetgum fruit have the effects of activating blood and dredging orifices as auxiliary drugs, radix astragali, radix saposhnikoviae, pericarpium citri reticulatae and honey-fried licorice root have the effects of tonifying qi and regulating the spleen and stomach as guide drugs, periostracum cicada and stiff silkworm have the effects of dredging collaterals as assistant drugs, and through clinical observation of thousands of cases, the traditional Chinese medicine prescription has the advantages of quick curative effect, no toxic or side effect and the like. The effective rate can reach 100%, and the clinical cure rate is 70% or above.

Description

Technical Field

[0001] This invention relates to the field of medicine, and in particular to a traditional Chinese medicine formula for treating sinusitis and its application. Background Technology

[0002] Sinusitis is a common and frequently occurring disease, clinically classified into acute and chronic forms. Its etiology is complex, with external pathogens being the most common cause. It often involves alternating acute and chronic episodes, resulting in a persistent and difficult-to-cure condition. Currently, traditional Chinese medicine treatments have some efficacy, but the recurrence rate is high. Western medicine treatments using antibiotics, puncture, and surgery have significant side effects and are painful, and are also difficult to cure completely. Summary of the Invention

[0003] In view of this, in order to overcome the shortcomings of the prior art, the present invention is proposed.

[0004] The first aspect of this invention provides a traditional Chinese medicine formula for treating sinusitis, the formula comprising the following components: Scrophularia ningpoensis, Fagopyrum dibotrys, Platycodon grandiflorus, Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, Astragalus membranaceus, Liquidambar formosana, Saposhnikovia divaricata, Citrus reticulata peel, and Glycyrrhiza uralensis (processed).

[0005] In some implementations, the traditional Chinese medicine formula further includes the following components: cicada slough and silkworm pupa.

[0006] In this invention, the principal herbs are Scrophularia, Fagopyrum dibotrys, Platycodon grandiflorus, and Angelica dahurica, which detoxify and drain pus, and also guide the medicine upwards. The auxiliary herbs are Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, Liquidambar formosana, and herbs that invigorate blood and open the orifices. Saposhnikovia divaricata, Citrus reticulata peel, and Glycyrrhiza uralensis, which regulate the body's defensive qi and help with the deficiency of the middle qi, together achieve the effects of detoxifying, draining pus, invigorating blood and opening the orifices.

[0007] In some implementation schemes, cicada molting and silkworm larvae are used to promote blood circulation.

[0008] In some implementation plans, the need to use cicada molting or silkworm larvae is determined based on the patient's condition.

[0009] In some implementation schemes, when patients experience persistent and recurrent symptoms, or when CT or MRI scans show increased density, cicada slough and silkworm pupae are added to promote blood circulation and relieve pain.

[0010] In some implementation schemes, the components of the traditional Chinese medicine formula, by weight, include: Scrophularia ningpoensis 1-2, Fagopyrum dibotrys 2-4, Platycodon grandiflorus 1-1.5, Angelica dahurica 0.5-1, Angelica sinensis 1-2, Paeonia lactiflora 1-2, Vaccaria segetalis 1-3, Astragalus membranaceus 1-3, Liquidambar formosana 1, Saposhnikovia divaricata 1, Citrus reticulata 1, and Glycyrrhiza uralensis 0.6-1.

[0011] In this invention, the weight percentage of each component refers to the relative weight ratio between the components in the traditional Chinese medicine prescription. For example, Scrophularia ningpoensis 1~2, Fagopyrum dibotrys 2~4, Platycodon grandiflorus 1~1.5, Angelica dahurica 0.5~1, Angelica sinensis 1~2, Paeonia lactiflora 1~2, Vaccaria segetalis 1~3, Astragalus membranaceus 1~3, Liquidambar formosana 1, Saposhnikovia divaricata 1, Citrus reticulata 1, Glycyrrhiza uralensis 0.6~1 represents the weight ratio between Scrophularia ningpoensis, Fagopyrum dibotrys, Platycodon grandiflorus, Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, Astragalus membranaceus, Liquidambar formosana, Saposhnikovia divaricata, Citrus reticulata 1, and Glycyrrhiza uralensis 0.6~1 as (1~2):(2~4):(1~1.5):(0.5~1):(1~2):(1~2):(1~3):(1~3):(1):(1):(0.6~1).

[0012] In some implementation schemes, the traditional Chinese medicine formula, by weight, also includes: 0.5-2 parts of cicada molting and 0.5-1 parts of silkworm pupa.

[0013] In some implementation schemes, the components of the traditional Chinese medicine formula, by weight, include: Scrophularia ningpoensis 1, Fagopyrum dibotrys 2, Platycodon grandiflorus 1, Angelica dahurica 0.6, Angelica sinensis 1, Paeonia lactiflora 1, Vaccaria segetalis 1, Astragalus membranaceus 1.5, Liquidambar formosana 1, Saposhnikovia divaricata 1, Citrus reticulata 1, and Glycyrrhiza uralensis 0.6.

[0014] In some implementation schemes, the traditional Chinese medicine formula, by weight, also includes: 0.6 parts of cicada slough and 0.6 parts of silkworm pupa.

[0015] In some implementations, the types of the components include dried medicinal materials and fresh medicinal materials.

[0016] In some embodiments, the type of the component is selected from dried medicinal materials.

[0017] In some implementations, the types of the components include raw medicinal materials, processed medicinal materials, and prepared medicinal materials.

[0018] In some embodiments, the types of the components include the whole plant of the medicinal material, the effective parts of the whole plant of the medicinal material, the effective components of the medicinal material, and the medicinal salts of the effective components of the medicinal material.

[0019] In some embodiments, the type of the component is selected from the effective parts of the whole plant.

[0020] In some implementations, the active ingredient refers to the substance obtained by extracting the components of any form of the traditional Chinese medicine formula using a suitable pharmaceutical solvent such as water or an aqueous alcohol solution.

[0021] In some embodiments, the active ingredient is in the form of, but is not limited to, solid, semi-solid, solution, suspension, concentrate, paste, and powder. Water suitable for extracting the active ingredient from medicinal herbs according to this invention includes various types of water that can be used to prepare active extracts of traditional Chinese medicine, such as medicinal water, distilled water, or deionized water.

[0022] In some embodiments, the pharmaceutically acceptable salt includes acid addition salts and alkali addition salts.

[0023] In some embodiments, examples of acid addition salts are salts formed with inorganic acids, such as hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid, and perchloric acid, or salts formed with organic acids, such as acetic acid, oxalic acid, maleic acid, tartaric acid, citric acid, succinic acid, or malonic acid. Salts formed using methods conventional in the art are also included, such as ion exchange methods. Other pharmaceutically acceptable salts include: adipate, alginate, ascorbate, aspartate, benzenesulfonate, benzoate, bisulfate, borate, butyrate, camphorate, camphorsulfonate, citrate, cyclopentylpropionate, diglucuronate, dodecyl sulfate, ethanesulfonate, formate, fumarate, gluconate, glycerophosphate, hemisulfate, heptanate, hydroiodate, 2-hydroxyethanesulfonate, lactobionate, lactate, laurate, lauryl sulfate, malate, maleate, malonic acid, and methanesulfonate.

[0024] In some implementations, examples of alkali addition salts include, but are not limited to, aluminum salts, ammonium salts, calcium salts, copper salts, iron salts, ferrous salts, lithium salts, magnesium salts, manganese salts, manganese salts, potassium salts, sodium salts, and zinc salts.

[0025] In some implementations, when determining the weight fraction ratio of the components in the traditional Chinese medicine formula, components of the same type are used for comparison.

[0026] In some implementation schemes, when the weight fractions of Scrophularia, Fagopyrum dibotrys, Platycodon grandiflorus, Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, Astragalus membranaceus, Liquidambar formosana, Saposhnikovia divaricata, Citrus reticulata peel, Glycyrrhiza uralensis (processed), Cicadae periostracum, and Bombyx mori are compared, the weight of the dried medicinal materials is used for comparison.

[0027] In some implementation schemes, when the weight fractions of Scrophularia, Fagopyrum dibotrys, Platycodon grandiflorus, Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, Astragalus membranaceus, Liquidambar formosana, Saposhnikovia divaricata, Citrus reticulata peel, Glycyrrhiza uralensis (processed), Cicadae periostracum, and Bombyx mori are compared, the weight of the effective parts of the whole plant is used for comparison.

[0028] In some implementation schemes, when the weight fractions of Scrophularia, Fagopyrum dibotrys, Platycodon grandiflorus, Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, Astragalus membranaceus, Liquidambar formosana, Saposhnikovia divaricata, Citrus reticulata peel, Glycyrrhiza uralensis (processed), Cicadae periostracum, and Bombyx mori are compared, the weight of the dried medicinal materials of the effective parts of the whole plant is used for comparison.

[0029] In some implementations, when determining the weight fraction ratio of the components in the traditional Chinese medicine formula, different types of components are used for comparison.

[0030] In some implementation schemes, if it is necessary to replace some type (referred to as type I) components in a traditional Chinese medicine prescription with other type (referred to as type II) components, the weight of the component to be replaced (type I component) can be determined first based on the proportion of type I components given in the prescription. Then, the required weight of type II components can be calculated by converting the proportion of type I components to type II components. For example, if the original prescription requires 10 grams of dried herb A, and its fresh-to-dried ratio is 3:1, then 30 grams of fresh herb A are required.

[0031] In some implementations, the traditional Chinese medicine formula may be a pharmaceutical composition or a food composition.

[0032] In some embodiments, the traditional Chinese medicine formula is a pharmaceutical composition.

[0033] In some embodiments, the pharmaceutical composition further includes pharmaceutically acceptable excipients.

[0034] The term "pharmaceuticalally acceptable excipient" as used in this invention means any excipient conventionally used in the field of pharmaceutical preparations, as long as the excipient does not adversely affect the expected quality and efficacy of the traditional Chinese medicine formula of this invention.

[0035] Those skilled in the art can select and determine the appropriate excipients for the traditional Chinese medicine preparations of the present invention based on the disclosure in this specification. The selection of specific excipients will depend on the route of administration, dosage form, or disease type and condition for treating a particular patient.

[0036] In some embodiments, the excipients include, but are not limited to, fillers, disintegrants, lubricants, binders, flavoring agents, and / or preservatives.

[0037] In some embodiments, the filler includes, but is not limited to, starch, lactose, mannitol, microcrystalline cellulose, sucrose, and xylitol.

[0038] In some implementations, the disintegrant includes, but is not limited to, starch, microcrystalline cellulose, sodium carboxymethyl starch, and sodium low-substituted hydroxypropyl cellulose.

[0039] In some implementations, the lubricant includes, but is not limited to, talc, silica, sodium dodecyl sulfate, and magnesium stearate.

[0040] In some implementations, the adhesive includes, but is not limited to, starch paste, polyvinylpyrrolidone, and hydroxymethylcellulose.

[0041] In some implementations, flavoring agents include, but are not limited to, sweeteners and various flavorings.

[0042] In some implementations, sweeteners include, but are not limited to, sodium saccharin, aspartame, sucrose, cyclamate, and glycyrrhetinic acid.

[0043] In some implementations, the preservatives include, but are not limited to, parabens, benzoic acid, sodium benzoate, benzalkonium bromide, chlorhexidine acetate, eucalyptus oil, sorbic acid, or their salts.

[0044] Any pharmaceutical composition covered in this invention may be delivered orally, for example, via any acceptable and suitable oral formulation.

[0045] In some embodiments, the pharmaceutical composition includes, but is not limited to, decoctions, pills, tablets, powders, capsules, granules, ointments, tinctures, syrups, or injections.

[0046] In some implementation schemes, decoctions are also called herbal decoctions, which are the liquid obtained after decocting and removing the dregs of traditional Chinese medicine.

[0047] In some implementation schemes, the method for preparing the decoction includes adding water to a level 3-5 cm above the level of the herbs, soaking for 30-60 minutes, and then quickly bringing the decoction to a boil over high heat. After boiling, the heat is reduced to low (keeping it at a gentle boil) and simmered for 20-30 minutes.

[0048] In some implementations, pills are also called medicinal pills, which are made by adding excipients to Chinese medicine powder.

[0049] In some implementations, the excipients include, but are not limited to, water, honey, medicinal juice, rice paste, and beeswax.

[0050] In some implementations, the pills include, but are not limited to, honey pills, water pills, concentrated pills, paste pills, and wax pills.

[0051] In some embodiments, tablets are tablet-shaped preparations made by pressing fine powder or extract of medicinal materials with suitable excipients or fine powder of medicinal materials, including extract tablets, semi-extract tablets, and whole powder tablets.

[0052] In some implementations, the excipients are the same as those described above as pharmaceutically acceptable excipients.

[0053] In some implementations, the powder refers to a powdered preparation made by crushing and mixing Chinese medicinal materials.

[0054] In this invention, the powder is an oral powder. Oral powders are generally dissolved or dispersed in water, diluent, or other liquids for administration, or can be taken directly with water.

[0055] In some implementations, capsules are dosage forms made by filling capsules with a suitable amount of herbal extracts, powders or excipients to form uniform powders or granules.

[0056] In some implementation schemes, the granules are dried granules made by concentrating the liquid medicine and adding sugar and dextrin, which can be dissolved into a liquid medicine by brewing with boiling water.

[0057] In some implementations, syrups (including oral solutions) are aqueous solutions made of drugs and sugars (oral solutions are clear and transparent).

[0058] In some implementations, the wine is often called medicinal wine, which is made by soaking medicine in wine.

[0059] In some implementation schemes, ointments refer to a thick, semi-fluid dosage form made by decocting medicinal materials with water, removing the residue, concentrating the liquid, and then adding sugar or honey. Ointments can be divided into two main categories: oral and topical.

[0060] In some implementation schemes, injections refer to sterile solutions, emulsions, suspensions made from extracts of traditional Chinese medicine, as well as sterile powders prepared into solutions or suspensions before use, which are a type of dosage form specifically for internal injection.

[0061] In some embodiments, the pharmaceutical composition may be formulated as a spray or inhaler for nasal administration.

[0062] In some embodiments, the food composition includes, but is not limited to, functional foods, nutritional supplements, health foods, and food additives.

[0063] In some embodiments, the food composition may be formulated as tea, juice, or beverage, or as granules, capsules, or powder as a health food. In some embodiments, the food composition of this disclosure may also be added to beverages (including alcoholic beverages), fruits and their processed products (e.g., canned fruit, bottled fruit, jams, tartare), fish, meat and their processed products (e.g., ham, sausages, corned beef), confectionery, noodles (e.g., udon noodles, buckwheat noodles, ramen, pasta, macaroni), juices, beverages, biscuits, Korean toffee, dairy products (e.g., butter, cheese), vegetable oils, margarine, vegetable proteins, pyrolyzed foods, frozen foods, condiments (e.g., soy sauce, savory sauces), etc.

[0064] In some embodiments, the food compositions of the present invention may include various flavorings, natural carbohydrates, etc., as additional ingredients. Carbohydrates are monosaccharides, such as glucose, fructose, etc.; disaccharides, such as maltose and sucrose; polysaccharides, such as dextrin and cyclodextrin; and sugar alcohols, such as xylitol, sorbitol, erythritol, etc. Sweeteners may be used, including natural sweeteners, such as martinidin taurine, stevia extract, etc., and synthetic sweeteners such as saccharin, aspartame, etc.

[0065] The second aspect of this invention provides the application of the traditional Chinese medicine formula described in the first aspect of this invention in the preparation of a medicine for treating sinusitis.

[0066] In some implementations, the sinusitis includes acute sinusitis (nasal sinusitis) and chronic sinusitis (nasal sinusitis).

[0067] The third aspect of this invention provides the application of the traditional Chinese medicine formula described in the first aspect of this invention in the preparation of medicines for treating symptoms of gallbladder and visceral heat stagnation, spleen and lung qi deficiency, and spleen and kidney yang deficiency.

[0068] A fourth aspect of the present invention provides a method for treating sinusitis, the method comprising applying the traditional Chinese medicine formula described in the first aspect of the present invention.

[0069] The properties, flavors, meridian tropisms, and efficacy of the Chinese medicinal materials used in this invention are as follows: Scrophularia: Taste and nature: sweet, bitter, and salty; slightly cold. It enters the lung, stomach, and kidney meridians. It has the effects of clearing heat and cooling the blood, treating febrile diseases and rashes, nourishing yin and reducing fire, and detoxifying and dispersing nodules.

[0070] Buckwheat: Cool in nature, astringent, and slightly pungent. It enters the lung meridian. It has the effects of clearing heat and detoxifying, draining pus and removing blood stasis.

[0071] Platycodon grandiflorus: bitter and pungent in taste, neutral in nature, and enters the lung meridian. It has the effects of clearing the lungs and relieving sore throat, eliminating phlegm and draining pus.

[0072] Angelica dahurica: It has a pungent taste and warm properties, and enters the lung and stomach meridians. It has the effects of dispelling wind and relieving exterior syndromes, dispersing cold and relieving pain, drying dampness and stopping leukorrhea, and reducing swelling and draining pus.

[0073] Angelica sinensis: Angelica sinensis is sweet and pungent in taste, warm in nature, and enters the liver, heart, and large intestine meridians. It has the effects of nourishing blood and regulating menstruation, promoting blood circulation and relieving pain, and moistening the intestines and promoting bowel movements.

[0074] Red peony root: bitter in taste, slightly cold in nature, and enters the liver meridian. It has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis.

[0075] Wang Bu Liu Xing (Semen Vaccariae): Bitter and neutral in nature, it enters the lung and stomach meridians. It has the effects of promoting blood circulation, regulating menstruation, and promoting lactation.

[0076] Astragalus: Sweet in taste, slightly warm in nature, non-toxic, and enters the lung and spleen meridians. It has the effects of internally supporting ulcers and sores, promoting tissue regeneration and wound healing, externally strengthening the exterior to prevent night sweats, and replenishing the pores.

[0077] Lulutong (Lulutong): Bitter in taste, neutral in nature. It enters the liver and kidney meridians. It has the effects of dispelling wind and activating blood circulation, promoting diuresis, and regulating menstruation.

[0078] Fangfeng (Saposhnikovia divaricata): Pungent, sweet, and slightly warm. It enters the bladder, liver, and spleen meridians. It has the effects of relieving exterior syndromes and inducing sweating, dispelling wind and dampness.

[0079] Dried tangerine peel: It has a pungent and bitter taste, is warm in nature, and enters the spleen and lung meridians. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm, and regulating qi and harmonizing the stomach.

[0080] Prepared licorice root: A processed form of licorice root. Sweet and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and stomach, replenishing qi, and restoring pulse.

[0081] Cicada slough: It tastes sweet and salty, is cool in nature, and enters the lung and liver meridians. It has the effects of dispersing wind-heat, promoting rash eruption and relieving itching, improving eyesight and clearing away corneal opacity, and dispelling wind and relieving spasms.

[0082] Silkworm pupae: pungent, salty, and neutral in nature; enters the liver, lung, and stomach meridians. It has the effects of calming wind and relieving spasms, dispelling wind and relieving pain, and resolving phlegm and dissipating nodules.

[0083] The advantages and beneficial effects of this invention are as follows: This invention provides a traditional Chinese medicine formula for treating sinusitis and its application. The formula consists of Scrophularia ningpoensis, buckwheat, Platycodon grandiflorus, and Angelica dahurica as the principal herbs for detoxification and pus drainage; Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, and Liquidambar formosana as the auxiliary herbs for promoting blood circulation and clearing the nasal passages; Astragalus membranaceus, Saposhnikovia divaricata, Citrus reticulata, and Glycyrrhiza uralensis as the guiding herbs for invigorating qi, regulating the body, and harmonizing the middle jiao; and Cicadae periostracum and Bombyx mori as the adjuvant herbs for unblocking the meridians. Clinical observation of over a thousand cases has shown that the formula has a rapid therapeutic effect, a low recurrence rate, an effective rate of up to 100%, and a clinical cure rate of over 70%. Detailed Implementation

[0084] The present invention will be further described below with reference to embodiments. The following description is merely a preferred embodiment of the present invention and is not intended to limit the invention in any other way. Any person skilled in the art may make equivalent modifications to the disclosed technical content to create equivalent embodiments. Any simple modifications or equivalent changes made to the following embodiments based on the technical essence of the present invention without departing from the scope of the invention are all within the protection scope of the present invention.

[0085] Example 1: Using this formula to treat patients Based on extensive learning from previous experience and combined with modern medical understanding of the physiological, anatomical, and pathological changes of sinusitis, this approach, adhering to the principle of syndrome differentiation and treatment, utilized decoctions to treat acute and chronic sinusitis for over twenty years. Based on this experience, the formula was then modified into a powder. In 1997, research and development of the finished drug began. The project was initiated based on the "Guiding Principles for Research on New Traditional Chinese Medicines" as the diagnostic and judgment criteria. It comprehensively analyzed three syndrome types: gallbladder and visceral heat stagnation, spleen and lung qi deficiency, and spleen and kidney yang deficiency. It focused on characteristics such as nasal congestion, expectoration of thick, turbid nasal discharge, headache and dizziness, swollen and thickened mucosa, and CT scans showing blurred, cloudy, and dense sinus cavities, thickened mucosa, or fluid levels; or abnormal secretions found during catheter flushing. The approach emphasized both local pathological changes and overall holistic adjustment, treating both acute exacerbations and addressing chronic pathological changes.

[0086] The treatment plan combines detoxification, pus drainage, and meridian clearing with methods to regulate qi and blood, aiming to address the root cause while simultaneously tonifying the body. The goal is to restore the lesions and prevent recurrence.

[0087] The prescription consists of: Scrophularia ningpoensis 1g, Fagopyrum dibotrys 2g, Platycodon grandiflorus 1g, Angelica dahurica 0.6g, which are the principal herbs for detoxification and pus drainage; Angelica sinensis 1g, Paeonia lactiflora 1g, Vaccaria segetalis 1g, Liquidambar formosana 1g, which are the auxiliary herbs for promoting blood circulation and clearing the orifices; Astragalus membranaceus 1.5g, Saposhnikovia divaricata 1g, Citrus reticulata 1g, Glycyrrhiza uralensis 0.6g, which are the guiding herbs for invigorating qi, regulating the body, and harmonizing the middle jiao.

[0088] When patients experience persistent and recurrent symptoms, or when CT or MRI scans show increased density, 0.6g of cicada slough and 0.6g of silkworm pupa can be added to promote blood circulation.

[0089] The dosage of the medication should be adjusted according to the patient's weight. The overall dosage of the medication is 0.2g / kg. If the patient weighs 50kg, the overall dosage of the medication is 10g.

[0090] Clinical observation and follow-up of severely ill patients were conducted. A double-blind, controlled study was performed on the cases. During the peak of the epidemic (influenza season), 120 cases were randomly collected from schools. 60 cases were in the treatment group, and the other 60 cases were in the control group, receiving Huodan Pills, Qianbai Rhinitis Tablets, and Sinusitis Oral Solution. After excluding factors such as administration method, course of treatment, and difficulty in follow-up, the treatment group (n=30) and control group (n=30) were used for efficacy observation. The efficacy evaluation criteria were determined according to GB / T16751.3-1997. All physicochemical indicators, local examinations, case writing, drug collection, and processing were carried out according to traditional methods (referencing the standard: *Guidelines for Pharmaceutical Research of Traditional Chinese Medicine*). Processing, dosage form, and specification testing procedures were completed. Before treatment, the cardiopulmonary, digestive, and urinary systems of all patients in the treatment group were tested, and no adverse reactions were observed in those taking the formula. The experimental results of the treatment are shown in Table 1.

[0091] Table 1 Treatment Efficacy

[0092] Over a thousand patients have been treated with decoctions or pills, with satisfactory clinical results, characterized by rapid efficacy and a low recurrence rate. During clinical observation, some patients used antibiotics, while others took oral sinusitis solutions, all of whom returned for treatment after more than two weeks. Symptoms improved significantly after three days of treatment, with purulent secretions expectorated from the nasal passages or posterior nasal cavity. A small number of patients with longer disease duration or those using antibiotics required puncture drainage before taking traditional Chinese medicine. Many new patients were referred by cured patients, resulting in a 100% effectiveness rate. Countless patients have been cured, and the treatment enjoys a high reputation in the region.

[0093] Example 2: Acute and slow toxicity experiments were conducted on this formula. Acute and chronic toxicity experiments were conducted on this formula at the Department of Pharmacology, Hebei Polytechnic Medical College. The experimental methods are as follows: I. Acute toxicity test (maximum tolerated dose test) 1. Animals: Sixty normal healthy Kunming mice, weighing 18-22 grams, were randomly divided into three groups of 20 mice each, with half males and half females.

[0094] 2. Experimental conditions: room temperature 20±2°C, humidity 90%, sufficient light, and good feeding and hygiene conditions.

[0095] 3. Route and method of administration: Oral (oral gavage). Administration is divided into three dosage groups. The drug is dissolved in distilled water, administered at a volume of 0.2 ml per 10g body weight. Fasting for 12 hours is required before administration. The three dosage groups are as follows: (1) Maximum tolerated dose: The dosage is 60g / kg, divided into three doses, with an interval of 2 hours. (The human dosage is 0.2g / kg, based on a body weight of 50kg).

[0096] (2) Medium dose group: The dosage was 30g / kg, given in two doses with a 2-hour interval between doses.

[0097] (3) Low-dose group: The dosage was 15g / kg, given all at once.

[0098] 4. Experimental Results: During the 10-day observation period, the mice in all groups exhibited normal activity and diet. Their fur remained glossy, without any loss or abnormalities. The average weight gain was 2 grams, and no mice died within 10 days.

[0099] II. Chronic toxicity test 1. Animals: 40 Westear rats, weighing 230-260 grams, were randomly divided into 4 groups of 10 rats each, with half males and half females.

[0100] 2. Experimental conditions were the same as above: Administration was performed via gavage at three doses: 16 g / kg (80 times the human dose), 8 g / kg (40 times the human dose), and 4 g / kg (20 times the human dose). A control group was also included, administering the same volume of distilled water via gavage. Administration was performed once daily for 40 consecutive days.

[0101] 3. Experimental Results: During the experiment, the animals' general behavior, including diet, water intake, and activity, was the same as the control group, and no abnormalities were found. They were weighed every 10 days, and the weight of each group showed an increasing trend, similar to that of the control group.

[0102] At the end of the experiment, the participants fasted for 12 hours, and blood was drawn to measure blood routine and liver function. Organs (liver, heart, kidney, and lung) were also examined for pathological changes. The experimental results are shown in Table 2.

[0103] Table 2 Results of Chronic Toxicity Tests

[0104] There were no statistically significant differences between the experimental indicators and the control group. No abnormalities were observed in any tissues or organs by gross examination, and no abnormal changes were found in morphology or structure by pathological histological examination.

[0105] Conclusion: No toxicity was found in the acute and chronic toxicity tests of Biyuan Powder.

[0106] The above description of the embodiments is only for understanding the method and core ideas of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from the principles of the invention, and these improvements and modifications will also fall within the protection scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine formula for treating sinusitis, characterized in that, The traditional Chinese medicine formula includes the following components: Scrophularia, Fagopyrum dibotrys, Platycodon grandiflorus, Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Vaccaria segetalis, Astragalus membranaceus, Liquidambar formosana, Saposhnikovia divaricata, Citrus reticulata peel, and Glycyrrhiza uralensis (processed). Preferably, the traditional Chinese medicine formula further includes the following components: cicada slough and silkworm pupa.

2. The traditional Chinese medicine formula according to claim 1, characterized in that, The components of the traditional Chinese medicine formula, by weight, include: Scrophularia ningpoensis 1-2, Fagopyrum dibotrys 2-4, Platycodon grandiflorus 1-1.5, Angelica dahurica 0.5-1, Angelica sinensis 1-2, Paeonia lactiflora 1-2, Vaccaria segetalis 1-3, Astragalus membranaceus 1-3, Liquidambar formosana 1, Saposhnikovia divaricata 1, Citrus reticulata 1, Glycyrrhiza uralensis 0.6-1; Preferably, the traditional Chinese medicine formula further includes, by weight, 0.5-2 parts of cicada molting and 0.5-1 parts of silkworm pupa.

3. The traditional Chinese medicine formula according to claim 2, characterized in that, The components of the traditional Chinese medicine formula, by weight, include: Scrophularia ningpoensis 1, Fagopyrum dibotrys 2, Platycodon grandiflorus 1, Angelica dahurica 0.6, Angelica sinensis 1, Paeonia lactiflora 1, Vaccaria segetalis 1, Astragalus membranaceus 1.5, Liquidambar formosana 1, Saposhnikovia divaricata 1, Citrus reticulata 1, and Glycyrrhiza uralensis 0.

6. Preferably, the traditional Chinese medicine formula further includes, by weight, 0.6 parts of cicada slough and 0.6 parts of silkworm pupa.

4. The traditional Chinese medicine formula according to any one of claims 1-3, characterized in that, The types of the components include dried medicinal materials and fresh medicinal materials; Preferably, the types of the components include raw medicinal materials, processed medicinal materials, and prepared medicinal materials; Preferably, the types of the components include the whole plant of the medicinal material, the effective parts of the whole plant of the medicinal material, the effective components of the medicinal material, and the medicinal salts of the effective components of the medicinal material; Preferably, the pharmaceutically usable salt includes acid addition salts and alkali addition salts.

5. The traditional Chinese medicine formula according to any one of claims 1-3, characterized in that, The traditional Chinese medicine formula may be a drug composition or a food composition; Preferably, the traditional Chinese medicine formula is a pharmaceutical composition.

6. The traditional Chinese medicine formula according to claim 5, characterized in that, The pharmaceutical composition also includes pharmaceutically acceptable excipients; Preferably, the excipients include fillers, disintegrants, lubricants, binders, flavoring agents, and / or preservatives.

7. The traditional Chinese medicine formula according to claim 5, characterized in that, The pharmaceutical composition includes decoctions, pills, tablets, powders, capsules, granules, ointments, tinctures, syrups, injections, sprays, or inhalers.

8. The traditional Chinese medicine formula according to claim 5, characterized in that, The food composition includes functional foods.

9. The use of the traditional Chinese medicine formula according to any one of claims 1-8 in the preparation of a medicine for treating sinusitis; Preferably, the sinusitis includes acute sinusitis and chronic sinusitis.

10. The use of the traditional Chinese medicine formula according to any one of claims 1-8 in the preparation of a medicine for treating symptoms of gallbladder and visceral heat stagnation, spleen and lung qi deficiency, and spleen and kidney yang deficiency.

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