A traditional Chinese medicine composition for treating nasal cavity diseases, a preparation method thereof and application thereof
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- 王允奎
- Filing Date
- 2026-06-29
- Publication Date
- 2026-08-07
AI Technical Summary
现有中药组合物停药后易复发的问题,也会导致患者丧失治愈的信心,最终放弃治疗
1、本发明的治疗鼻窍疾患的中药组合物,能用于制备治疗慢性鼻炎、过敏性鼻炎、慢性鼻窦炎;该中药组合物的内服药剂,能制成丸剂或汤剂,显效快,治愈率高,治愈后不易复发。
Abstract
Description
Technical Field
[0001] A traditional Chinese medicine composition for treating nasal cavity disorders, its preparation method, and its application belong to the field of traditional Chinese medicine preparations. Background Technology
[0002] Nasal disorders include acute rhinitis, chronic rhinitis, allergic rhinitis, acute sinusitis, and chronic sinusitis. Among them, acute rhinitis and acute sinusitis have a short course and a high cure rate, and can usually be cured in a short time. However, chronic rhinitis, allergic rhinitis, and chronic sinusitis have a longer course and are prone to recurrence, which greatly affect the quality of life of patients.
[0003] Acute rhinitis and chronic rhinitis generally refer to inflammation of the nasal mucosa and submucosal tissues; in traditional Chinese medicine, this is called nasal congestion. Acute rhinitis typically lasts 1-2 weeks and is caused by viral or bacterial infection, manifesting as nasal congestion, runny nose, and sneezing. Chronic rhinitis, on the other hand, is a condition characterized by recurrent and persistent symptoms that are difficult to cure. Symptoms usually last for more than 3 months, with the nasal mucosa remaining in an inflamed state for a prolonged period. Chronic rhinitis is further classified into simple chronic rhinitis and hypertrophic chronic rhinitis.
[0004] Allergic rhinitis refers to a non-infectious inflammatory disease of the nasal mucosa, primarily mediated by IgE-mediated histamine release and involving various immune cells and cytokines, after exposure to allergens in atopic individuals; in traditional Chinese medicine, it is called nasal congestion. Allergic rhinitis typically presents with seasonal or year-round recurrence.
[0005] Sinusitis is an inflammatory disease of the sinus mucosa. It is divided into acute and chronic sinusitis; in traditional Chinese medicine, it is called "nasal congestion." Chronic sinusitis is characterized by recurrent attacks and is difficult to cure, sometimes leading to loss of smell and mental fog. Because the nasal and sinus mucosa are continuous, nasal inflammation can trigger sinus inflammation, and vice versa. Clinically, some patients with chronic sinusitis experience simultaneous inflammation of both the nasal and sinus mucosa; this coexistence of rhinitis and sinusitis is also known as rhinosinusitis.
[0006] Existing traditional Chinese medicine compositions for treating nasal cavity disorders have the following problems: First, existing traditional Chinese medicine (TCM) formulas have low cure rates for chronic rhinitis, allergic rhinitis, and chronic sinusitis, and relapse is common after treatment, causing significant suffering for patients. These formulas are often effective during treatment but become ineffective upon discontinuation, with a relapse rate exceeding 90% within one year of stopping medication. Recurrent chronic rhinitis, allergic rhinitis, and chronic sinusitis can lead to breathing difficulties, poor sleep quality, lethargy, dizziness, memory loss, tinnitus, a feeling of ear blockage, facial pain, and headaches. Severe cases can even prevent patients from living and working normally. The high relapse rate after discontinuation of existing TCM formulas can also cause patients to lose confidence in a cure and ultimately abandon treatment.
[0007] Secondly, existing Chinese medicine compositions require long treatment courses and have slow effects when taken orally. They typically require at least one month to show results, but patients often lose motivation to continue taking them due to prolonged lack of effectiveness, frequently resulting in discontinuation.
[0008] Third, while some existing traditional Chinese medicine compositions have been formulated into topical medications, their effects are slow to appear and short-lived. Common symptoms of nasal disorders include runny nose, nasal congestion, chest tightness, and impaired breathing, further leading to decreased sleep quality. When patients use topical medications before bed, they often experience slow onset of action, typically requiring 40-60 minutes. By the time the effects are seen, although symptoms are relieved, the patient has lost all sleepiness. Furthermore, existing topical medications suffer from short-lasting effects, requiring repeated application, which is cumbersome and inconvenient. The efficacy of existing topical medications is also short-lived, usually not reaching 6 hours. Patients frequently experience recurring symptoms of nasal congestion, runny nose, and difficulty breathing during sleep, making it impossible to enter deep sleep due to discomfort, and sometimes even forcing them to wake up, preventing restful sleep.
[0009] There is an urgent need for a traditional Chinese medicine composition for treating nasal diseases that is fast-acting, has a high cure rate, and is not prone to recurrence after discontinuation of medication. Summary of the Invention
[0010] The technical problem this invention aims to solve is to overcome the shortcomings of existing technologies and provide a traditional Chinese medicine composition for treating nasal disorders, its preparation method, and its application. This traditional Chinese medicine composition can be used to prepare oral or topical medications for treating chronic rhinitis, allergic rhinitis, and chronic sinusitis. The oral medication has a rapid onset of action, a high cure rate, and a low recurrence rate after treatment. The topical medication has a rapid onset of action, can quickly relieve nasal discomfort symptoms, and has a long-lasting effect.
[0011] The technical solution adopted by this invention to solve its technical problem is: a traditional Chinese medicine composition for treating nasal diseases, comprising the following raw materials in parts by weight: 24-26 parts of *Ficus hirta*, 11-13 parts of *Hedyotis diffusa*, 11-13 parts of *Nardostachys chinensis*, 14-16 parts of *Coriander*, 9-11 parts of *Ligusticum striatum*, 14-16 parts of *Polygonum aviculare*, 8-10 parts of *Cicada slough*, 11-13 parts of *Vitex trifolia*, 9-11 parts of stir-fried *Hymenopus hyacinthus*, 9-11 parts of *Angelica dahurica*, 14-16 parts of *Ligusticum chuanxiong*, 11-13 parts of *Ampelopsis japonica*, 11-13 parts of *Siegesbeckia orientalis*, 14-16 parts of *Platycodon grandiflorus*, 14-16 parts of stir-fried *Atractylodes macrocephala*, 14-16 parts of raw *Atractylodes macrocephala*, and 9-11 parts of ginger-processed *Pinellia ternata*.
[0012] Preferably, the traditional Chinese medicine composition for treating nasal cavity disorders comprises the following raw materials in parts by weight: 25 parts of *Ficus hirta*, 12 parts of *Eriocaulon buergerianum*, 12 parts of *Nardostachys jatamansi*, 15 parts of *Coriander*, 10 parts of *Ligusticum striatum*, 15 parts of *Polygonum aviculare*, 9 parts of *Cicada slough*, 12 parts of *Vitex trifolia*, 10 parts of stir-fried white hyacinth bean, 10 parts of *Angelica dahurica*, 15 parts of *Ligusticum chuanxiong*, 12 parts of *Ampelopsis japonica*, 12 parts of *Siegesbeckia orientalis*, 15 parts of *Platycodon grandiflorus*, 15 parts of stir-fried *Atractylodes macrocephala*, 15 parts of raw *Atractylodes macrocephala*, and 10 parts of ginger-processed *Pinellia ternata*.
[0013] The mass ratio of stir-fried Atractylodes macrocephala to raw Atractylodes macrocephala is 1:0.9~1.1; the sum of the weights of stir-fried and raw Atractylodes macrocephala accounts for 12~14% of the total weight of the composition. Preferably, the mass ratio of stir-fried and raw Atractylodes macrocephala is 1:0.91~1.09; the sum of the weights of stir-fried and raw Atractylodes macrocephala accounts for 12.55~13.63% of the total weight of the composition. More preferably, the mass ratio of stir-fried and raw Atractylodes macrocephala is 1:1; the sum of the weights of stir-fried and raw Atractylodes macrocephala accounts for 13.39% of the total weight of the composition. The combined use of stir-fried and raw Atractylodes macrocephala at a mass ratio of 1:0.9~1.1 can synergistically enhance the effects, resulting in better anti-inflammatory, anti-allergic, antinasal and anti-swelling, nasal mucosa repair, anti-proliferation, and immune system regulation effects. Furthermore, it can achieve both rapid symptom control and long-term strengthening of the body's foundation. Raw Atractylodes macrocephala, unprocessed at high temperatures, contains various volatile oils with anti-inflammatory and anti-allergic properties, and the content is higher than that of processed Atractylodes macrocephala. Raw Atractylodes macrocephala has a high content of atractylone, which can quickly treat symptoms and control nasal congestion, rapidly stop sneezing, clear nasal discharge, relieve nasal itching caused by allergies, and alleviate inflammatory edema caused by rhinitis. This can shorten the onset time of the herbal composition of this invention, helping to shorten the onset time after administration, quickly relieve runny nose and nasal congestion, control symptoms, and increase patients' confidence in adhering to medication. Fried Atractylodes macrocephala involves frying raw Atractylodes macrocephala with wheat bran. During the frying process, a large number of ketones in raw Atractylodes macrocephala are converted into lactones, resulting in a higher content of atractylolone in fried Atractylodes macrocephala, which is more effective in correcting immune disorders, repairing damaged nasal mucosa, and reducing the probability of recurrence. The applicant's research found that a mass ratio of 1:0.9~1.1, preferably 1:1, has the best synergistic effect. The combined use of fried and raw Atractylodes macrocephala can both quickly control symptoms and provide long-term protection.
[0014] The weight of the five-finger peach accounts for 10-12% of the total weight of the composition. Preferably, the weight of the five-finger peach accounts for 10.46-11.48% of the total weight of the composition.
[0015] The combination of five-finger peach, stir-fried atractylodes macrocephala, and raw atractylodes macrocephala has the effect of regulating immune disorders and reducing recurrence after treatment. For this combination to achieve a high cure rate and reduce recurrence, the weight percentages of five-finger peach (10-12%) and the combined weight of stir-fried and raw atractylodes macrocephala (12.5-13.7%) are crucial. If the weight percentages of these three ingredients are too low, the combination will be ineffective in regulating the balance of activity among various Th cells and addressing immune disorders, resulting in a low cure rate and a high risk of recurrence. Conversely, if the weight percentages are too high, prolonged or multiple courses of oral administration may cause dryness and gastrointestinal discomfort, and the anti-inflammatory, swelling-reducing, and proliferative effects will be less pronounced.
[0016] The Nardostachys chinensis and Ampelopsis japonica are added at a weight ratio of 1:0.9~1.1. Preferably, the Nardostachys chinensis and Ampelopsis japonica are added at a weight ratio of 1:0.92~1.09.
[0017] Five-finger peach, nard, and white peony have a synergistic effect. Nardostachys chinensis can clear the nasal passages, reduce inflammation and swelling, and repair damaged nasal mucosa. Nardostachys chinensis can also stimulate spleen immune activity. When used in combination with five-finger peach, it can shorten the time to onset of action after oral administration, and can quickly relieve the patient's discomfort symptoms. White peony has a bidirectional regulatory effect on spleen-related immunity. It can enhance spleen immune activity when immunity is low, and can inhibit excessive activation and have anti-inflammatory and anti-allergic effects during inflammation and allergies. When white peony is used in combination with five-finger peach, white peony can assist five-finger peach in synergistically improving the ability to regulate the differentiation of Th cell subsets in the spleen, maintaining the Th1 / Th2 balance, regulating Treg and Th17, thereby controlling allergy symptoms and chronic inflammation, and regulating immune disorders. Ampelopsis japonica can clear heat and detoxify, reduce carbuncles and boils, promote wound healing and tissue regeneration, resist fibrosis, reduce mucosal thickening, and inhibit inflammatory mucosal hyperplasia. When used in combination with Nardostachys chinensis, it can reduce mucosal edema and congestion, decrease tissue damage, repair abnormal nasal mucosal hyperplasia, and reduce collagen deposition and fibrosis tendency. The combination of Nardostachys chinensis and Ampelopsis japonica can completely resolve edematous hyperplasia or thickening, and soften and shrink fibrotic hyperplasia, thereby improving or eliminating symptoms of nasal congestion and difficulty breathing. Using 24-26 parts of Ficus hirta, 11-13 parts of Nardostachys chinensis, and 11-13 parts of Ampelopsis japonica, with Nardostachys chinensis and Ampelopsis japonica added at a weight ratio of 1:0.9-1.1, yields the best synergistic effect, shortening the time to onset of action, increasing the cure rate, and relieving symptoms of mucosal edema, hyperplasia, and fibrosis.
[0018] This traditional Chinese medicine composition for treating nasal cavity disorders, when prepared into pills, also includes the following raw materials in parts by weight: 98-241 parts of excipient, with the excipient mass to the total weight of the composition being 0.5-1:1. Preferably, the excipient is 181.2-224.5 parts. The excipient is used to bind the raw materials in the composition to form pills.
[0019] The excipient is at least one of water, ginger juice, and honey. Preferably, the excipient is composed of water and honey in a mass ratio of 2-3:1. Alternatively, preferably, the excipient is composed of water, ginger juice, and honey in a mass ratio of 1-2:1-2:1. Ginger juice is pungent and warm, dispelling cold and dampness, and can dispel the cold evil that has been lurking in the lung meridian for a long time, clear the stagnant qi in the nasal passages, and improve nasal congestion, runny nose, and pale and edematous nasal mucosa. Ginger juice is pungent in both aroma and taste, and is good at dispersing and ascending, acting as a guiding medicine for the upper jiao, guiding the nasal passage-opening, wind-dispelling, anti-inflammatory, and anti-allergic drugs in the formula to the head, eyes, nasal cavity, and sinus areas; increasing the targeting intensity of the formula in the nasal cavity, sinus, and lung meridian, and enhancing the effects of opening the nasal passages, dispelling evil, and reducing swelling.
[0020] When prepared as an oral pill, the traditional Chinese medicine composition for treating nasal diseases is prepared using the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, sieve grass, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder and pass them through an 80-250 mesh sieve to obtain the medicinal powder. 2) Weigh the excipients according to the weight, heat the excipients, add the medicinal powder, stir and boil until it becomes a medicinal clump, remove the medicinal clump, cool it, knead it into a medicinal strip, divide the medicinal strip into segments, and then roll it into pills of 8.5~9.5 grams / pill through a pill-making board, and dry it to obtain the product.
[0021] The application of this traditional Chinese medicine composition for treating nasal diseases is specifically in the preparation of oral or topical medications for treating chronic rhinitis and allergic rhinitis.
[0022] The oral medication is an oral pill or decoction; the external medication is a medication administered through the respiratory tract or the nasal mucosa.
[0023] Preferably, the method for preparing the decoction is as follows: Take 220-230g of the composition, add water until it covers the medicinal materials, simmer over low heat, and filter to obtain the first filtrate; continue to use the composition, and repeat the process of adding water, simmering, and filtering twice more; combine the filtrates obtained from the three simmerings, and concentrate to obtain the decoction. Divide the decoction into three equal portions, and drink one portion three times a day.
[0024] Preferably, the respiratory administration agent is an inhalant, and more preferably, the inhalant is a sachet for external use.
[0025] The preparation method of the external sachet includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, siegesbeckia orientalis, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder, sift them, and obtain the medicinal powder. 2) Put the powder into a non-woven or cotton bag, 0.9~1.1g of powder per bag, and you will have a sachet for external use.
[0026] In the preparation of the external sachet, the specific operation of sieving in step 1) is as follows: first, filter through a 5-10 mesh sieve to remove coarse powder, then filter through a 40-60 mesh sieve to remove fine powder, thus obtaining medicinal powder. The prepared medicinal powder has a moderate fineness, so that it will not leak out of the external sachet due to being too fine and affecting the patient's breathing, nor will it cause the medicinal ingredients to evaporate too slowly due to being too coarse.
[0027] Instructions for use of the external sachets: Use 2 sachets per day, and replace them daily. Placement: The sachet should be placed between the mask and the face, and affixed to the mask. Place the two sachets on the Yingxiang acupoints on either side of the nose. The medicine is administered through the respiratory tract as the patient breathes, inhaling the volatile medicinal components from the sachet. This external sachet, administered via the respiratory tract, can relieve symptoms such as nasal congestion, runny nose, itchy throat, wheezing, dizziness, and chest tightness caused by rhinitis, allergic rhinitis, and sinusitis. It is fast-acting, showing noticeable relief within 30 minutes of wearing the sachet, with a gentle and long-lasting effect lasting ≥8 hours, making it suitable for daytime use.
[0028] Preferably, the medication administered through the nasal mucosa is a nasal drop; more preferably, the medication administered through the nasal mucosa is a nasal oil.
[0029] The preparation method of the nasal drops includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, sieve grass, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder, pass them through a 5-20 mesh sieve, and remove the coarse powder to obtain the medicinal powder. 2) Add base oil to the powder according to a ratio of 1:3~4, stir well, soak, filter, and obtain medicated oil; add white petrolatum and beeswax to the medicated oil according to a ratio of 1~1.5:0.1:0.01, heat to 65~75℃ and mix well to obtain nasal drops.
[0030] Nasal drops with high fluidity tend to flow easily down the nasal passages and be quickly absorbed by the mucous membrane after being dropped into the nasal cavity, resulting in a short-lasting effect. This invention, formulated with nasal drops in a ratio of 1-1.5:0.1:0.01 (nasal oil, white petrolatum, beeswax), increases the viscosity of the system and enhances its film-forming properties. The nasal drops spread more slowly on the nasal mucosa, while the petrolatum and beeswax form a hydrophobic oil film, prolonging the residence time of the active ingredients and allowing for a slow release. The effect lasts for 8 hours, making it suitable for bedtime drops. During the 8-hour sleep period, it provides long-lasting relief from discomfort caused by nasal obstruction.
[0031] The specific operation of filtration in step 2) is as follows: first, filter the medicine powder through a 300-400 mesh filter bag or filter paper to obtain crude medicine oil, and then filter the crude medicine oil through a 0.2-1 micron pore size filter element to remove impurities and obtain medicine oil.
[0032] Step 2) The base oil is at least one of olive oil, tea oil, perilla seed oil, and oat oil. Preferably, the acid value of the base oil is ≤0.5mgKOH / g, and a base oil with a low acid value is less irritating to the nasal mucosa.
[0033] Step 2) The soaking is performed at room temperature (20-28℃) in the dark for 7-10 days; or, Step 2) The soaking is performed at room temperature (20-28℃) in the dark for 18-24 hours, followed by water heating at 50-60℃ for 2-3 hours.
[0034] Preferably, in the preparation method of the nasal drops, the raw materials in step 1) are in the following weight proportions: 24 parts of *Ficus hirta*, 13 parts of *Hedyotis diffusa*, 11.9 parts of *Nardostachys chinensis*, 16 parts of *Coriander*, 9 parts of *Ligusticum striatum*, 16 parts of *Polygonum aviculare*, 8 parts of *Cicada slough*, 13 parts of *Vitex trifolia*, 9 parts of stir-fried white hyacinth bean, 11 parts of *Angelica dahurica*, 14 parts of *Ligusticum chuanxiong*, 13 parts of *Ampelopsis japonica*, 11 parts of *Siegesbeckia orientalis*, 16 parts of *Platycodon grandiflorus*, 14.6 parts of stir-fried *Atractylodes macrocephala*, 16 parts of raw *Atractylodes macrocephala*, and 9 parts of ginger-processed *Pinellia ternata*. With this weight proportion, the resulting nasal drops will have a faster onset of action and a higher efficacy rate.
[0035] The nasal drops are to be used as follows: Instill 2-3 drops into each nostril 2-3 times daily. These nasal drops are fast-acting and long-lasting, suitable for daytime or nighttime use, and can significantly relieve nasal congestion, runny nose, chest tightness, nighttime shortness of breath, wheezing, and insomnia caused by chronic rhinitis, allergic rhinitis, or chronic sinusitis.
[0036] Preferably, the mass of *Polygonum cuspidatum* accounts for 6-8% of the total weight of the composition. The weight ratio of *Coriandrum sativum*, *Polygonum cuspidatum*, and *Siegesbeckia orientalis* is 1:1:0.6-1. More preferably, the mass of *Polygonum cuspidatum* accounts for 6.18-7.13% of the total weight of the composition. More preferably, the weight ratio of *Coriandrum sativum*, *Polygonum cuspidatum*, and *Siegesbeckia orientalis* is 1:1:0.69-0.93. When the three components are used together in this weight ratio, the effects of clearing nasal passages and promoting diuresis, astringing pus and draining nasal discharge, reducing inflammation and swelling, and detoxifying and dispersing nodules are optimal. The combined use of the three components can synergistically enhance anti-inflammatory and antibacterial effects, and cure chronic inflammation. *Centipeda minima* can quickly clear nasal passages, improve microcirculation, and rapidly provide superficial anti-inflammatory, antibacterial, and nasal discharge effects; *Polygonum cuspidatum* can clear dampness and turbidity, astringe purulent nasal discharge, reduce swelling, and improve purulent inflammation of the sinuses; *Siegesbeckia orientalis* can inhibit chronic and stubborn inflammation and prevent recurrent inflammation. Centipeda minima can antagonize histamine and reduce allergic exudation; Siegesbeckia orientalis can stabilize mast cells and block allergens; Polygonum aviculare can reduce mucosal edema and runny nose secondary to allergies. The combination of the three can not only synergistically reduce inflammation, but also relieve allergy-induced symptoms such as sneezing, runny nose, and itchy nose.
[0037] Preferably, the traditional Chinese medicine composition for treating nasal cavity disorders further includes the following raw materials in parts by weight: 14-16 parts of Patrinia scabiosifolia; more preferably, 15 parts of Patrinia scabiosifolia. In preparing the oral medication, the applicant discovered that the addition of Patrinia scabiosifolia has a good therapeutic effect on chronic sinusitis. Sinusitis is often characterized by thick yellow purulent nasal discharge, redness and swelling of the nasal mucosa, nasal congestion, and headache, mostly due to heat stagnation in the nasal cavity, dampness and phlegm stasis in the nasal cavity, and local blood stasis. Patrinia scabiosifolia can dry dampness and drain pus, clear nasal passages, and disperse stagnation. Combined with other raw materials in the traditional Chinese medicine composition of this invention, it can enhance the efficacy of the traditional Chinese medicine composition in resolving dampness and phlegm stasis in the nasal cavity and reducing yellow purulent and turbid nasal discharge. Patrinia scabiosifolia is slightly cold and clears heat, effectively clearing excess heat in the head, face, liver, gallbladder, lungs, and stomach. It can improve purulent nasal discharge, nasal swelling, dry and burning pain caused by sinusitis, and relieve facial swelling and dizziness caused by sinusitis.
[0038] The raw materials used in this invention have the following pharmacological properties: Five-finger peach root, source: dried root of *Ficus hirta*, a plant in the Moraceae family. Properties and channels: sweet, neutral. Enters the spleen, lung, and liver channels. Functions: strengthens the spleen and lungs, promotes qi circulation and eliminates dampness, relaxes muscles and tendons. Indications: edema due to spleen deficiency, poor appetite and weakness, pulmonary tuberculosis cough, night sweats, leukorrhea, postpartum agalactia, rheumatic pain, and traumatic injuries.
[0039] Magnolia biondii, also known as Magnolia denudata, is derived from the dried flower buds of Magnolia biondii, Magnolia grandiflora, or Magnolia wudangensis, all belonging to the Magnoliaceae family. Its properties and channels are pungent and warm. It enters the Lung and Stomach channels. Its functions include dispelling wind-cold, clearing nasal passages, and possessing anti-allergic, vasoconstrictive, and astringent effects on the nasal mucosa. It is used to treat wind-cold headache, nasal congestion and runny nose, rhinitis, and sinusitis.
[0040] Nardostachys jatamansi, source: dried root and rhizome of Nardostachys jatamansi, a plant in the Valerianaceae family. Properties and channels: pungent, sweet, warm. Enters the spleen and stomach channels. Functions: regulates qi and relieves pain, relieves stagnation and invigorates the spleen; externally used to dispel dampness and reduce swelling. Indications: abdominal distension, loss of appetite, vomiting; externally used to treat toothache, beriberi, and boils.
[0041] *Coriander*, also known as *Coriander*, is derived from the dried whole herb of *Coriander*, a plant in the Asteraceae family. Its properties and channels are pungent and warm, entering the Lung channel. Its functions include dispersing wind-cold, clearing nasal passages, and relieving cough. It is indicated for wind-cold headache, cough with excessive phlegm, nasal congestion, and runny nose.
[0042] Ligusticum striatum, source: dried rhizome and root of Ligusticum striatum or Ligusticum lilyense, belonging to the Apiaceae family. Properties and channels: pungent, warm. Enters the Bladder channel. Functions: dispels wind, disperses cold, eliminates dampness, and relieves pain. Indications: common cold due to wind-cold, vertex headache, and rheumatic arthralgia.
[0043] *Polygonum cuspidatum*, source: dried aerial parts of *Polygonum cuspidatum*, a plant in the Polygonaceae family. Properties and channels: sour, slightly cold. Channels entered: Lung, Bladder. Functions: clears heat and detoxifies, promotes diuresis and reduces swelling, relieves cough. Indications: sore throat, cough due to lung heat, whooping cough in children, edema with scanty urine, damp-heat diarrhea, eczema, boils, snake and insect bites.
[0044] Cicada molts, source: the exoskeleton shed by the nymph of the cicada (Cicadaidae) during molting. Properties and channels: sweet, cold. Enters the lung and liver channels. Functions: disperses wind-heat, soothes the throat, promotes rash eruption, improves vision and clears corneal opacity, relieves spasms. Has anti-allergic, anti-tumor, anti-inflammatory, and microcirculation-improving effects. Indications: common cold due to wind-heat, sore throat and hoarseness, incomplete measles eruption, itchy rashes, red and pterygium eyes, infantile convulsions, tetanus.
[0045] Vitex trifolia fruit, source: the dried, mature fruit of Vitex trifolia or Vitex negundo, a plant in the Verbenaceae family. Properties and channels: pungent, bitter, slightly cold. Channels entered: bladder, liver, stomach. Functions: disperses wind-heat, clears the head and eyes. Indications: headache due to wind-heat, swollen and painful gums, red and watery eyes, blurred vision, dizziness.
[0046] Stir-fried white hyacinth beans, source: stir-fried dried mature seeds of the legume plant *Hyacinth Bean*. Properties and channels: sweet, slightly warm. Enters the spleen and stomach channels. Functions: strengthens the spleen and eliminates dampness, harmonizes the middle jiao and relieves summer heat. Indications: weakness of the spleen and stomach, loss of appetite, loose stools, excessive leukorrhea, summer heat and dampness causing vomiting and diarrhea, chest tightness and abdominal distension. Preferably, the stir-fried white hyacinth beans are bran-fried white hyacinth beans. The preparation method is as follows: Using a 10:1 weight ratio of white hyacinth beans to wheat bran, first sprinkle wheat bran into a hot pan and heat over medium heat until smoking; then add the white hyacinth beans and stir-fry quickly until the surface is yellowish-brown and fragrant; remove, sift out the wheat bran, and let cool. The spleen-strengthening and dampness-eliminating effects of bran-fried white hyacinth beans are stronger than those of plain stir-fried white hyacinth beans.
[0047] Angelica dahurica, Source: The dried root of Angelica dahurica (Fisch.) Benth. var. formosana (Boiss.) Shan or Angelica dahurica (Fisch.) Benth. Ex Hoffm. Flavor and Meridian Tropism: Pungent, warm. It belongs to the stomach, large intestine, and lung meridians. Functions: Induce sweating to dispel cold, expel wind and relieve pain, promote nasal passage, dry dampness and arrest vaginal discharge, resolve swelling and drain pus. Indications: Common cold with headache, pain in the supraorbital ridge, nasal congestion and runny nose, allergic rhinitis, nasal sinusitis, toothache, vaginal discharge, swelling and pain of sores and ulcers.
[0048] Chuanxiong, Source: The dried rhizome of Ligusticum chuanxiong Hort. Flavor and Meridian Tropism: Pungent, warm. It belongs to the liver, gallbladder, and pericardium meridians. Functions: Promote blood circulation and activate qi, expel wind and relieve pain. Indications: Irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to mass in the abdomen, stabbing pain in the chest and hypochondrium, swelling and pain from falls and bruises, headache, rheumatic arthralgia.
[0049] Ampelopsis japonica, Source: The dried tuberous root of Ampelopsis japonica (Thunb.) Makino. Flavor and Meridian Tropism: Bitter, slightly cold. It belongs to the heart and stomach meridians. Functions: Clear heat and detoxify, disperse swelling and dissipate binds, astringe sore and promote granulation. Indications: Carbuncles and boils on the back, furuncles, scrofula, burns and scalds.
[0050] Siegesbeckia orientalis, Source: The dried aerial parts of Siegesbeckia orientalis L., Siegesbeckia pubescens Makino or Siegesbeckia glabrescens Makino. Flavor and Meridian Tropism: Pungent, bitter, cold. It belongs to the liver and kidney meridians. Functions: Dispel wind-dampness, benefit joints, detoxify. Indications: Rheumatic arthralgia, weakness of muscles and bones, soreness and weakness of the waist and knees, paralysis of the limbs, hemiplegia, rubella and eczema.
[0051] Platycodon grandiflorus, Source: The dried root of Platycodon grandiflorus (Jacq.) A. DC. Flavor and Meridian Tropism: Bitter, pungent, neutral. It belongs to the lung meridian. Functions: Promote the dispersing function of the lung, soothe the throat, resolve phlegm, drain pus. Indications: Cough with profuse sputum, chest distress, sore throat with hoarseness, expectoration of pus in lung abscess.
[0052] Fried Atractylodes macrocephala, Source: The fried product of the dried rhizome of Atractylodes macrocephala Koidz. of the Compositae family. Flavor and Meridian Tropism: Bitter, sweet, warm. It belongs to the spleen and stomach meridians. Functions: Tonify the spleen and benefit qi, dry dampness and promote diuresis, arrest sweating. The effect of fried Atractylodes macrocephala on strengthening the spleen and regulating the stomach is better. Indications: Hypofunction of the spleen with reduced food intake, abdominal distension and diarrhea, dizziness and palpitation due to phlegm retention, edema, spontaneous sweating, restlessness during pregnancy. Preferably, the fried Atractylodes macrocephala is bran-fried Atractylodes macrocephala. The processing method is as follows: Remove impurities from Atractylodes macrocephala, wash, moisten until thoroughly penetrated, cut into thick slices, dry to obtain Atractylodes macrocephala slices for later use. According to the mass ratio of Atractylodes macrocephala slices to honey-fried bran of 10:1, first sprinkle the honey-fried bran into a hot wok. When it starts to smoke, add the Atractylodes macrocephala slices and continuously stir-fry over low heat. Stir-fry until the surface of the Atractylodes macrocephala slices turns yellowish-brown and emits a burnt aroma, then take out, sieve off the honey-fried bran, and let it cool to obtain bran-fried Atractylodes macrocephala.
[0053] Raw Atractylodes macrocephala, Source: The dried rhizome of Atractylodes macrocephala Koidz. used raw. Flavor and Meridian Tropism: Bitter, sweet, warm. It belongs to the spleen and stomach meridians. Functions: Tonify the spleen and benefit qi, dry dampness and promote diuresis, arrest sweating. The effect of raw Atractylodes macrocephala on drying dampness and promoting diuresis is better. Indications: Hypofunction of the spleen with reduced food intake, abdominal distension and diarrhea, dizziness and palpitation due to phlegm retention, edema, spontaneous sweating, restlessness during pregnancy.
[0054] Ginger-processed Pinellia ternata, source: dried tuber of Pinellia ternata (Araceae family), processed with ginger. Properties and channels: pungent, warm. Channels entered: spleen, stomach, lung. Functions: warms the middle jiao and resolves phlegm, relieves nausea and vomiting. Indications: vomiting due to phlegm retention, epigastric fullness.
[0055] The processing method for ginger-processed Pinellia ternata is as follows: Prepare the medicinal materials according to a mass ratio of raw Pinellia ternata, raw ginger, and alum of 8:2:1. First, soak the raw Pinellia ternata in water until thoroughly cooked, then remove and set aside. Decoct the ginger in water; filter to obtain ginger broth, add alum to the ginger broth, and stir until completely dissolved to obtain ginger-alum solution. Pour the soaked Pinellia ternata into the ginger-alum solution and cook together until thoroughly cooked. Remove the Pinellia ternata and air dry to obtain ginger-processed Pinellia ternata.
[0056] The applicant's research found that, among different processing methods of Pinellia ternata, ginger-processed Pinellia ternata showed the best effect in the herbal composition of this invention. Unprocessed raw Pinellia ternata and processed Pinellia ternata with alum have strong drying properties when taken internally, but are also highly toxic. While processed Pinellia ternata using licorice and quicklime removes the toxicity of Pinellia ternata, the prolonged soaking in lime water during processing causes significant degradation of alkaloids and fat-soluble anti-allergic components, resulting in the weakest anti-inflammatory and anti-allergic effects. The ginger-processing method, however, causes less loss of anti-inflammatory and anti-allergic components in Pinellia ternata. Furthermore, ginger itself has anti-inflammatory, anti-allergic, antitussive, and antiemetic effects, which synergistically enhance the anti-inflammatory and anti-allergic effects of Pinellia ternata. Therefore, ginger-processed Pinellia ternata is slightly weaker in anti-inflammatory and anti-allergic effects than processed Pinellia ternata, but far stronger than processed Pinellia ternata, and its lower toxicity makes it more suitable for internal use, showing better efficacy in treating chronic rhinitis and allergic rhinitis.
[0057] Patrinia scabiosifolia, the dried whole herb of Patrinia scabiosifolia (either yellow or white), belonging to the Valerianaceae family. It is pungent, bitter, and slightly cold in nature. It enters the stomach, large intestine, and liver meridians. Functions: Clears heat and detoxifies, eliminates carbuncles and drains pus, removes blood stasis and relieves pain. Indications: Used for intestinal abscess, lung abscess with purulent sputum, boils and carbuncles, damp-heat diarrhea, jaundice with dark urine, red and swollen eyes, and postpartum abdominal pain due to blood stasis.
[0058] The applicant's research revealed that chronic rhinitis, allergic rhinitis, and chronic sinusitis are characterized by their long course, protracted nature, and difficulty in curing, causing immense suffering for patients. Although these diseases manifest in the nasal passages, their root cause lies in the dysfunction of the lungs, spleen, and liver, with the core pathogenesis being "spleen deficiency with dampness accumulation, impaired lung function, and wind-evil obstructing the nasal passages." Most physicians limit themselves to the concept that "the lungs open into the nose," focusing solely on clearing the lungs and nasal passages. While this may provide temporary relief, relapses are common. The applicant believes that the spleen is the source of phlegm production, and the lungs are the receptacle for phlegm. If the spleen's function in the middle jiao (middle burner) is impaired, dampness and turbidity are generated internally, rising upwards to the nasal passages and clashing with wind-evil, resulting in runny nose and nasal congestion. Furthermore, modern lifestyles often involve a diet high in fatty and sweet foods and a lack of exercise, leading to liver heat stagnation and spleen deficiency with dampness and turbidity, causing the condition to recur frequently and become chronic and difficult to cure.
[0059] Based on the above understanding, the applicant has proposed the composition of this invention, which has the effects of clearing the orifices and nourishing the vital energy, and its methods are to strengthen the spleen and resolve dampness, dispel wind and clear the orifices, and harmonize the liver and lungs. This formula heavily uses *Ficus hirta* as the chief ingredient to tonify the spleen and replenish qi, resolve dampness and clear the channels, taking advantage of its tonifying effect without causing dryness. It is used in conjunction with raw and stir-fried *Atractylodes macrocephala*, one to strengthen the spleen to transport dampness, and the other to moisten and descend, allowing dampness and turbidity to have an outlet and clear yang to rise. It is further supplemented with *Hedyotis diffusa*, *Angelica dahurica*, *Ligusticum striatum*, and *Vitex trifolia* to disperse wind-evil; *Cicada slough* to dispel wind and relieve allergies; *Symplocos edulis*, *Polygonum cuspidatum*, and *Siegesbeckia orientalis* to detoxify and disperse nodules; *Ligusticum chuanxiong*, *Ampelopsis japonica*, and *Nardostachys chinensis* to invigorate the spleen, regulate qi and blood, clear the orifices and drain pus; *Platycodon grandiflorus* to carry the medicine upwards; and stir-fried white hyacinth bean and ginger-processed *Pinellia ternata* to assist the spleen in resolving dampness. The entire formula combines tonification and purgation, addressing both the root cause and the symptoms.
[0060] This formula is based on the principle of "strengthening the spleen to generate metal, dispelling wind and clearing the nasal passages." The spleen belongs to earth, and the lungs belong to metal; spleen deficiency leads to lung weakness and nasal congestion. The formula uses five-finger peach, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, white hyacinth bean, and ginger-processed pinellia to strengthen the spleen and resolve dampness, thus strengthening the source of phlegm production; *Magnolia officinalis*, angelica dahurica, ligusticum striatum, vitex trifolia, and cicada slough to dispel wind and clear the nasal passages; *Coriander*, *Polygonum cuspidatum*, and *Siegesbeckia orientalis* to clear heat, promote diuresis, detoxify, and eliminate turbidity; *Ligusticum chuanxiong*, *Ampelopsis japonica*, and *Nardostachys chinensis* to invigorate the spleen, promote qi and blood circulation, resolve phlegm, and clear the meridians; and *Platycodon grandiflorus* guides the medicine upwards to the lungs. The combined effects of these herbs invigorate the spleen, resolve dampness, dispel wind, and clear the nasal passages, thus curing the nasal disease.
[0061] The applicant discovered in their research that while Astragalus membranaceus is commonly used in existing technologies, Ficus hirta is indispensable and irreplaceable in the herbal composition of this invention. Ficus hirta is neutral in nature and sweet in taste, and enters the spleen, lung, and liver meridians. Its effects are fourfold: First, it strengthens the spleen and replenishes qi, similar to Astragalus membranaceus, but milder in nature, without the drawbacks of excessive heat or dryness from long-term use, making it especially suitable for long-term treatment of chronic rhinitis; second, it resolves dampness and unblocks the meridians, removing dampness and turbidity deep within the nasal mucosa; third, it strengthens the body's resistance and eliminates pathogens, protecting the exterior and reducing the chance of external wind invasion by enhancing the qi of the spleen and lungs; fourth, it relaxes muscles and tendons, helping Ligusticum chuanxiong and Ampelopsis japonica to clear stagnation of qi and blood around the nasal passages. In this formula, Ficus hirta replenishes without causing stagnation and resolves without causing dryness, making it a core herb for "strengthening the earth to generate metal."
[0062] In this invention, the herbal composition uses both raw and stir-fried Atractylodes macrocephala. Atractylodes macrocephala is a key herb for strengthening the spleen, but its effects differ significantly depending on the processing method. Stir-fried Atractylodes macrocephala, after being stir-fried with wheat bran, has enhanced drying properties and its function leans towards strengthening the spleen and drying dampness, directly inhibiting the upward flow of spleen dampness and reducing recurrent immune disorders in the nasal passages. Raw Atractylodes macrocephala, on the other hand, is moistening and its function leans towards tonifying qi, generating fluids, and promoting bowel movements. Its moistening properties prevent the many pungent and drying herbs in the formula from damaging yin fluids, and it can also promote the downward flow of intestinal fluids, allowing dampness and turbidity to be expelled from the lower abdomen.
[0063] Nardostachys jatamansi is an indispensable ingredient in the composition of this invention. While the spleen-strengthening and dampness-resolving herbs in the composition are already sufficient, Nardostachys jatamansi is still added to utilize its unique spleen-invigorating properties, which helps shorten the time to onset of action after oral administration. Allergies are caused by immune system disorders. Nardostachys jatamansi and Ficus hirta regulate the disordered immune system, clear the nasal passages, reduce inflammation and swelling, and improve the efficacy for allergic rhinitis, chronic rhinitis, and chronic sinusitis, while also reducing the likelihood of recurrence.
[0064] Compared with the prior art, the beneficial effects of the traditional Chinese medicine composition for treating nasal diseases and its preparation method of the present invention are as follows: 1. The traditional Chinese medicine composition for treating nasal diseases of the present invention can be used to prepare medicines for treating chronic rhinitis, allergic rhinitis, and chronic sinusitis; the oral preparation of the traditional Chinese medicine composition can be made into pills or decoctions, with rapid effect, high cure rate, and low recurrence rate after cure.
[0065] First, it has a rapid effect. The traditional Chinese medicine composition for treating nasal diseases of this invention has a significant effect after oral administration for 1.5 to 2.9 days, and patients' symptoms such as runny nose, tearing, nasal congestion and sneezing are significantly relieved. Clinical observation shows that after patients take the medicine orally for a total of 14 to 21 days, that is, after 2 to 3 courses of treatment, the symptoms improve or disappear completely. After taking the medicine orally for a total of 7 to 8 courses of treatment, the condition can be maintained for many years and is not prone to recurrence.
[0066] Secondly, it has a high cure rate. The traditional Chinese medicine composition for treating nasal diseases of this invention has a cure rate of 60.0%~85.0% and an effective rate of 90.0%~98.4%. The cure rate is high and it is generally effective after patients take it orally.
[0067] Third, recurrence is rare after treatment. The applicant conducted follow-up visits every year during the willow pollen season. The oral medication made from the traditional Chinese medicine composition of this invention for treating nasal diseases generally showed no recurrence for 3 years after treatment, with the longest duration being 5 years. Among the cured cases, there were almost no recurrences one year after stopping medication, with the cure rate remaining at 60.0%~85.0%; a few recurrences occurred occasionally after 3 years of stopping medication, but the cure rate still remained at 58.3%~85.0%; and the cure rate remained at 51.6%~81.7% after 5 years of stopping medication, with most cured cases remaining relapse-free for 5 years.
[0068] 2. The traditional Chinese medicine composition for treating nasal cavity disorders of the present invention can be formulated into a topical medicine and can be used to prepare medicines for respiratory tract administration or nasal mucosal administration. First, the topical application provides rapid onset of action and can quickly relieve nasal discomfort. The topical sachet of the present invention generally takes effect within 30 minutes after being worn. The nasal drops generally take effect within 10 minutes after being instilled into the nasal cavity, with an average onset time of 5.2 to 7.5 minutes. The topical medicine of the present invention is convenient to use, provides rapid onset of action, and relieves nasal discomfort symptoms. Second, the topical medicine of the present invention has a long-lasting effect; the effect of the topical sachet lasts for ≥8 hours; the average effect of the nasal drops lasts for 8.0 to 8.4 hours, and the effect can cover 8 hours of sleep, providing long-term relief from discomfort symptoms caused by nasal cavity disorders.
[0069] 3. The application of the traditional Chinese medicine composition for treating nasal diseases in this invention can be both taken internally and applied externally. It can be used to prepare oral or external medications for treating chronic rhinitis, allergic rhinitis, and chronic sinusitis. The oral medication can cure the condition, and recurrence is rare after treatment. The external medication provides rapid and long-lasting relief from symptoms and is suitable for various dosage forms, such as inhaled sachets, nasal drops, and skin patches. The external medication allows for localized administration, quickly relieving the discomfort caused by chronic rhinitis, allergic rhinitis, and chronic sinusitis, and improving the patient's quality of life, including work and sleep. Detailed Implementation
[0070] The following examples and comparative examples further illustrate the traditional Chinese medicine composition for treating nasal diseases according to the present invention.
[0071] Examples 1-4 are specific embodiments of the oral pills of the traditional Chinese medicine composition for treating nasal cavity diseases according to the present invention; among them, Example 1 is the optimal embodiment of the oral pills of the traditional Chinese medicine composition for treating nasal cavity diseases according to the present invention. Example 5 is a specific embodiment of the external sachet of the traditional Chinese medicine composition for treating nasal cavity diseases according to the present invention; Example 6 is a specific embodiment of the external nasal drops of the present invention. In the examples: the stir-fried white hyacinth bean used is stir-fried white hyacinth bean with wheat bran; the stir-fried Atractylodes macrocephala used is stir-fried Atractylodes macrocephala with wheat bran. The honey used is commercially available multifloral honey. The ginger juice used is obtained by pressing fresh ginger with a juicer and filtering to remove residue. The beeswax used is white beeswax. The tea oil used is a commercially available product.
[0072] Example 1 The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is composed of the following raw materials: 25 parts of *Ficus hirta*, 12 parts of *Hedyotis diffusa*, 12 parts of *Nardostachys chinensis*, 15 parts of *Coriander*, 10 parts of *Ligusticum striatum*, 15 parts of *Polygonum aviculare*, 9 parts of *Cicada slough*, 12 parts of *Vitex trifolia*, 10 parts of stir-fried white hyacinth bean, 10 parts of *Angelica dahurica*, 15 parts of *Ligusticum chuanxiong*, 12 parts of *Ampelopsis japonica*, 12 parts of *Siegesbeckia orientalis*, 15 parts of *Platycodon grandiflorus*, 15 parts of stir-fried *Atractylodes macrocephala*, 15 parts of raw *Atractylodes macrocephala*, 10 parts of ginger-processed *Pinellia ternata*, and 224 parts of excipients (composed of water, ginger juice, and honey in a weight ratio of 1:2:1). Excluding excipients, the raw materials of the composition are as follows: the weight ratio of stir-fried Atractylodes macrocephala to raw Atractylodes macrocephala is 1:1, and the sum of the weights of stir-fried and raw Atractylodes macrocephala accounts for 13.39 wt% of the total weight of the composition; the weight of Ficus hirta accounts for 11.16 wt% of the total weight of the composition; Nardostachys chinensis and Ampelopsis japonica are added in a weight ratio of 1:1; the mass of Polygonum aviculare accounts for 6.70% of the total weight of the composition; and the weight ratio of Coriander, Polygonum aviculare, and Siegesbeckia orientalis is 1:1:0.8. The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is prepared into oral pills, and its preparation method includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, siegesbeckia orientalis, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder and pass them through a 200-mesh sieve to obtain the medicinal powder. 2) Weigh the excipients according to the weight, heat the excipients, add the medicinal powder, stir and boil until it becomes a medicinal clump, remove the medicinal clump, cool it, knead it into a medicinal strip, divide the medicinal strip into segments, and then roll it into pills of 9 grams each through a pill-making board, and dry it to obtain the product.
[0073] Example 2 The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is composed of the following raw materials: 26 parts of *Ficus hirta*, 11 parts of *Hedyotis diffusa*, 13 parts of *Nardostachys chinensis*, 14 parts of *Coriander*, 11 parts of *Ligusticum striatum*, 14 parts of *Polygonum aviculare*, 10 parts of *Cicada slough*, 11 parts of *Vitex trifolia*, 11 parts of stir-fried white hyacinth bean, 9 parts of *Angelica dahurica*, 16 parts of *Ligusticum chuanxiong*, 11.9 parts of *Ampelopsis japonica*, 13 parts of *Siegesbeckia orientalis*, 14 parts of *Platycodon grandiflorus*, 16 parts of stir-fried *Atractylodes macrocephala*, 14.6 parts of raw *Atractylodes macrocephala*, 11 parts of ginger-processed *Pinellia ternata*, and 181.2 parts of excipients (composed of water and honey in a weight ratio of 2:1). Excluding excipients, the raw materials of the composition are as follows: the weight ratio of stir-fried Atractylodes macrocephala to raw Atractylodes macrocephala is 1:0.91; the sum of the weights of stir-fried and raw Atractylodes macrocephala accounts for 13.51 wt% of the total weight of the composition; the weight of Ficus hirta accounts for 11.48 wt% of the total weight of the composition; Nardostachys chinensis and Ampelopsis japonica are added at a weight ratio of 1:0.92; the mass of Polygonum aviculare accounts for 6.18% of the total weight of the composition; the weight ratio of Coriander, Polygonum aviculare, and Siegesbeckia orientalis is 1:1:0.93. The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is prepared into oral pills, and its preparation method includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, siegesbeckia orientalis, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder and pass them through an 80-mesh sieve to obtain the medicinal powder. 2) Weigh the excipients according to the weight, heat the excipients, add the medicinal powder, stir and boil until it becomes a medicinal clump, remove the medicinal clump, cool it, knead it into a medicinal strip, divide the medicinal strip into segments, and then roll it into pills of 9.5 grams each through a pill-making board, and dry it to obtain the product.
[0074] Example 3 The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is composed of the following raw materials: 24 parts of *Ficus hirta*, 13 parts of *Hedyotis diffusa*, 11.9 parts of *Nardostachys chinensis*, 16 parts of *Coriander*, 9 parts of *Ligusticum striatum*, 16 parts of *Polygonum aviculare*, 8 parts of *Cicada slough*, 13 parts of *Vitex trifolia*, 9 parts of stir-fried white hyacinth bean, 11 parts of *Angelica dahurica*, 14 parts of *Ligusticum chuanxiong*, 13 parts of *Ampelopsis japonica*, 11 parts of *Siegesbeckia orientalis*, 16 parts of *Platycodon grandiflorus*, 14.6 parts of stir-fried *Atractylodes macrocephala*, 16 parts of raw *Atractylodes macrocephala*, 9 parts of ginger-processed *Pinellia ternata*, and 224.5 parts of excipients (composed of water:honey = 3:1). Excluding excipients, the raw materials of the composition are as follows: the weight ratio of stir-fried Atractylodes macrocephala to raw Atractylodes macrocephala is 1:1.09; the sum of the weights of stir-fried and raw Atractylodes macrocephala accounts for 13.63 wt% of the total weight of the composition; the weight of Ficus hirta accounts for 10.69 wt% of the total weight of the composition; Nardostachys chinensis and Ampelopsis japonica are added at a weight ratio of 1:1.09; the mass of Polygonum aviculare accounts for 6.18% of the total weight of the composition; and the weight ratio of Coriander, Polygonum aviculare, and Siegesbeckia orientalis is 1:1:0.69. The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is prepared into oral pills, and its preparation method includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, siegesbeckia orientalis, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder and pass them through a 250-mesh sieve to obtain the medicinal powder. 2) Weigh the excipients according to the weight, heat the excipients, add the medicinal powder, stir and boil until it becomes a medicinal clump, remove the medicinal clump, cool it, knead it into a medicinal strip, divide the medicinal strip into segments, and then roll it into pills of 8.5 grams each through a pill-making board, and dry them to obtain the product.
[0075] Example 4 The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is composed of the following raw materials: 25 parts of *Ficus hirta*, 12 parts of *Hedyotis diffusa*, 12 parts of *Nardostachys chinensis*, 15 parts of *Coriander*, 10 parts of *Ligusticum striatum*, 15 parts of *Polygonum aviculare*, 9 parts of *Cicada slough*, 12 parts of *Vitex trifolia*, 10 parts of stir-fried white hyacinth bean, 10 parts of *Angelica dahurica*, 15 parts of *Ligusticum chuanxiong*, 12 parts of *Ampelopsis japonica*, 12 parts of *Siegesbeckia orientalis*, 15 parts of *Platycodon grandiflorus*, 15 parts of stir-fried *Atractylodes macrocephala*, 15 parts of raw *Atractylodes macrocephala*, 10 parts of ginger-processed *Pinellia ternata*, 15 parts of *Patrinia scabiosaefolia*, and 224 parts of excipients (composed of water, ginger juice, and honey in a weight ratio of 1:2:1). Excluding excipients, the raw materials of the composition are as follows: the weight ratio of stir-fried Atractylodes macrocephala to raw Atractylodes macrocephala is 1:1, and the sum of the weights of stir-fried and raw Atractylodes macrocephala accounts for 12.55 wt% of the total weight of the composition; the weight of Ficus hirta accounts for 10.46 wt% of the total weight of the composition; Nardostachys chinensis and Ampelopsis japonica are added in a weight ratio of 1:1; the mass of Polygonum aviculare accounts for 6.28% of the total weight of the composition; and the weight ratio of Coriander, Polygonum aviculare, and Siegesbeckia orientalis is 1:1:0.8. The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is prepared into oral pills, and its preparation method includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, siegesbeckia orientalis, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, ginger-processed pinellia, and patrinia scabiosaefolia. Grind them into powder and pass them through a 200-mesh sieve to obtain the medicinal powder. 2) Same as Example 1.
[0076] Example 5 The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment is composed of the following raw materials: 25 parts of five-finger peach, 12 parts of wood-brush flower, 12 parts of nardostachys chinensis, 15 parts of coriander, 10 parts of ligusticum striatum, 15 parts of angelica sinensis, 9 parts of cicada slough, 12 parts of vitex trifolia, 10 parts of stir-fried white hyacinth bean, 10 parts of angelica dahurica, 15 parts of chuanxiong rhizome, 12 parts of white peony root, 12 parts of siegesbeckia orientalis, 15 parts of platycodon grandiflorus, 15 parts of stir-fried atractylodes macrocephala, 15 parts of raw atractylodes macrocephala, and 10 parts of ginger-processed pinellia ternata. The method for preparing a sachet from the traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, siegesbeckia orientalis, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder. First, filter the powder through a 10-mesh sieve to remove the coarse powder, and then filter it through a 40-mesh sieve to remove the fine powder to obtain the medicinal powder. 2) Put the powder into a non-woven bag, 1g of powder per bag, and you will have a sachet for external use.
[0077] Example 6 The traditional Chinese medicine composition for treating nasal cavity disorders in this embodiment includes the following raw materials: 24 parts of *Ficus hirta*, 13 parts of *Hedyotis diffusa*, 11.9 parts of *Nardostachys chinensis*, 16 parts of *Coriander*, 9 parts of *Ligusticum striatum*, 16 parts of *Polygonum aviculare*, 8 parts of *Cicada slough*, 13 parts of *Vitex trifolia*, 9 parts of stir-fried white hyacinth bean, 11 parts of *Angelica dahurica*, 14 parts of *Ligusticum chuanxiong*, 13 parts of *Ampelopsis japonica*, 11 parts of *Siegesbeckia orientalis*, 16 parts of *Platycodon grandiflorus*, 14.6 parts of stir-fried *Atractylodes macrocephala*, 16 parts of raw *Atractylodes macrocephala*, 9 parts of ginger-processed *Pinellia ternata*, and 675 parts of base oil; the base oil is tea oil with an acid value ≤0.5mgKOH / g; it also includes white petrolatum and beeswax, the dosage of which is described in the preparation method. The method for preparing the traditional Chinese medicine composition for treating nasal cavity disorders into nasal drops according to this embodiment includes the following steps: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, sieve grass, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder and pass them through a 20-mesh sieve to obtain the medicinal powder. 2) Add base oil to the powder and stir well; place it in a room temperature environment of 20~28℃ and soak for 7 days in the dark. First filter the powder through a 300-mesh filter bag to obtain crude medicated oil. Then, filter the crude medicated oil through a filter element with a pore size of 0.45 microns to remove impurities and obtain medicated oil. Add white petrolatum and beeswax to the medicated oil in a weight ratio of 1:0.1:0.01, heat to 75℃ and mix well. Let it cool naturally to obtain nasal drops.
[0078] Comparative Example 1 This comparative example is a pill. The raw material composition and preparation method of the traditional Chinese medicine composition in this comparative example are the same as those in Example 1. The difference is that the weight parts of five-finger peach, stir-fried white atractylodes, and raw white atractylodes are reduced to: five-finger peach 5 parts, stir-fried white atractylodes 5 parts, and raw white atractylodes 5 parts.
[0079] Comparative Example 2 This comparative example is a pill. The raw material composition and preparation method of the traditional Chinese medicine composition in this comparative example are the same as those in Example 1, except that: no nardostachys chinensis was added, and the amount of Ampelopsis japonica was changed to 24 parts.
[0080] Comparative Example 3 This comparative example is a pill. The raw material composition and preparation method of the traditional Chinese medicine composition in this comparative example are the same as those in Example 1, except that: no white peony root was added, and the amount of nardostachys chinensis was changed to 24 parts.
[0081] The clinical practice summary of this invention is as follows: The clinical practice guidelines for rhinitis are formulated based on the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine Otorhinolaryngology" (Standard No. ZY / T001.6—1994), the "Terminology of Clinical Diagnosis and Treatment in Traditional Chinese Medicine" (GB / T16751.1-2023 for Diseases, GB / T16751.2-2021 for Syndromes, GB / T16751.3-2023 for Treatment Principles), and the textbook "Traditional Chinese Medicine Otorhinolaryngology" published by China Traditional Chinese Medicine Press. The proposed criteria for judging symptoms and efficacy are as follows: I. Symptoms 1. Chronic simple rhinitis: intermittent or alternating nasal congestion, which worsens with cold and at night; mucous nasal discharge, occasional nasal itching, heavy nasal voice, and slight loss of smell; frequent dizziness; nasal examination: congestion and swelling of the nasal mucosa, with no tissue hyperplasia or thickening.
[0082] 2. Chronic hypertrophic rhinitis: Persistent unilateral or bilateral nasal congestion, thick nasal discharge that is difficult to expel, occasional headache and tinnitus. Decreased sense of smell, frequent headaches, ear fullness and blockage, dry throat and foreign body sensation; nasal examination: congestion and swelling of the nasal mucosa, and hypertrophy and enlargement of the turbinates.
[0083] 3. Allergic rhinitis: Caused by allergens, it usually occurs immediately after contact with the allergen; symptoms include frequent and continuous sneezing, itchy nose, persistent clear nasal discharge, severe bilateral nasal congestion, itchy and watery eyes, itchy throat, cough, dizziness, and fatigue. Nasal examination: pale nasal mucosa, bilateral inferior turbinate edema, and clear or mucous nasal discharge visible in the common nasal passage and nasal floor.
[0084] 5. Chronic sinusitis: Unilateral or bilateral nasal congestion, purulent nasal discharge, occasionally with a fishy odor, frontal or facial swelling and pain, headache, decreased or lost sense of smell, or accompanied by low-grade fever, dizziness, recurrent dry throat and cough with sputum, fatigue, often accompanied by ear fullness and tinnitus, dry throat and excessive sputum. Nasal cavity examination: The nasal mucosa is congested and swollen, especially in the middle turbinate, middle meatus and olfactory cleft. In anterior group sinusitis, purulent accumulation in the middle meatus can be seen; in posterior group sinusitis, purulent accumulation in the olfactory cleft can be seen, or purulent discharge can flow from above into the posterior nasal cavity. Cases of rhinosinusitis are recorded as chronic sinusitis cases.
[0085] II. Criteria for Judging Therapeutic Effect Based on the improvement of the above symptoms, the treatment effect is divided into cured, improved, and not cured: Cured: Nasal congestion and runny nose symptoms disappeared, nasal cavity examination was normal, all symptoms disappeared, and symptoms did not recur 5 days after stopping medication; Improvement: Nasal congestion and runny nose symptoms have lessened, and other symptoms have significantly improved, but not all symptoms have disappeared; Not cured: Symptoms have not improved significantly; Total number of cases = number of cured cases + number of improved cases + number of uncured cases; Cure rate = (Number of cured cases ÷ Total number of cases) × 100%; Improvement rate = (Number of improved cases ÷ Total number of cases) × 100%; Overall effectiveness rate = cure rate + improvement rate.
[0086] III. Usage of Oral and Topical Medications 1. Dosage of oral pills: Take 1 pill three times a day; this constitutes one dose. One course of treatment is 7 days (7 doses). Continue taking the pills between courses of treatment. Oral treatment courses for cases: Statistics were compiled after 7 courses of treatment for chronic simple rhinitis; after 7 courses of treatment for chronic hypertrophic rhinitis; after 7 courses of treatment for allergic rhinitis; after 8 courses of treatment for chronic sinusitis; the number of cured, improved, and not cured cases was counted, and the statistical results of efficacy were entered into the table below; Record the time to noticeable effect after taking the medication. The time to noticeable effect refers to the time from the first day of taking the medication to the appearance of symptom improvement. The time to noticeable effect is measured in days. After recording, take the average value and enter the average time to noticeable effect in the table below. Follow-up visits were conducted on cured cases. If a relapse occurred after medication was discontinued, it was recorded as a relapse case. The number of cured cases after medication was discontinued = number of cured cases - number of relapse cases; the cure rate after medication was discontinued = (number of cured cases - number of relapse cases) ÷ total number of cases × 100%. The cure rate after 1 year of medication discontinuation, the cure rate after 3 years of medication discontinuation, and the cure rate after 5 years of medication discontinuation were recorded and entered into the table below.
[0087] 2. How to use the external sachet: Use 2 sachets per day and change them daily. Wear for 8 hours daily. One course of treatment is 7 days, and wear continuously between courses. Placement of the external sachet: Place the external sachet between the mask and the face, attach the external sachet to the mask, and place the two external sachets on the Yingxiang acupoints on both sides of the nose. Treatment course for external use: After two courses of treatment for chronic simple rhinitis, chronic hypertrophic rhinitis, allergic rhinitis and chronic sinusitis, the number of cured, improved and not cured cases were counted and the results of efficacy statistics were recorded in the table below.
[0088] 3. How to use nasal drops: Put 3 drops into each nasal cavity twice a day. Treatment course for external use: After three courses of treatment for chronic simple rhinitis, chronic hypertrophic rhinitis, allergic rhinitis, and chronic sinusitis, the number of cured, improved, and uncured cases was counted, and the results of the efficacy statistics were recorded in the table below.
[0089] The time it takes for the above-mentioned external sachets and nasal drops to show effect and the duration of their effects were statistically analyzed, and the average time to show effect and the average duration of their effects were recorded. The average time to noticeable effect refers to the time taken from the moment the patient first applies the topical sachet or nasal drops into the nasal cavity, until the symptoms improve. The average time is calculated and recorded in the table below. The average duration of drug effect is recorded as follows: when the patient uses the external application for the first time, the time is recorded from the moment the external sachet is put on or the nasal drops are put into the nasal cavity, until the drug effect takes effect, until the effect subsides, and until the symptoms of nasal congestion and runny nose reappear. After statistics are collected, the average value is calculated and entered into the table below.
[0090] IV. Case Statistics The cases selected in Examples 1-6 ranged in age from 8 to 58 years. In each example, for each disease, the selected cases were 50% male and 50% female. To avoid interference with drug efficacy and reduce variables, during the period when the cases in Examples 1-6 were taking the medication of that example and the change in cure rate after discontinuation of the medication was statistically analyzed, no other topical or oral medications other than the medication of that example were used. Cure rate, improvement rate, effectiveness rate, and average time to significant effect are all rounded to one decimal place; the statistics for each example are shown in the table below.
[0091] Table 1. Case statistics of oral pills containing the traditional Chinese medicine composition in Example 1. .
[0092] Table 1 shows that the cure rate of the pills in Example 1 was 66.77%~85.0%, and the total effective rate was 91.6%~98.3%. The average time for patients to see noticeable effects after oral administration was 1.6~2.8 days, and they could feel a significant improvement in the discomfort symptoms of nasal congestion, runny nose, and nasal itching. Among the cured cases, there were almost no relapses one year after stopping the medication, and the cure rate remained at 65.0%~85.0%. Three years after stopping the medication, there were only a few relapses, with a cure rate of 63.3%~85.0%. Five years after stopping the medication, the cure rate remained at 60.0%~81.7%, proving that relapse is not common after treatment.
[0093] Table 2. Case statistics of oral pills containing traditional Chinese medicine composition in Example 2. .
[0094] Table 2 shows that the cure rate of the pills in Example 2 was 60.0%–83.3%, and the effective rate was 90.0%–96.7%. The average time for patients to show significant effects after oral administration was 2.0–2.9 days. A 5-year follow-up study showed that among the cured cases of each disease, relapse after discontinuation of medication was rare, indicating a low recurrence rate after treatment.
[0095] Table 3. Case statistics of oral pills containing traditional Chinese medicine composition in Example 3. .
[0096] Table 3 shows that the cure rate of the pills in Example 3 was 61.7%–81.7%, and the effective rate was 91.6%–98.4%. The average time for patients to show significant effects after oral administration was 1.5–2.7 days. A 5-year follow-up study showed that among the cured cases of each disease, relapse after discontinuation of medication was rare, indicating a low recurrence rate after treatment.
[0097] Table 4. Case statistics of the traditional Chinese medicine composition pills in Example 4. .
[0098] Table 4 shows that the cure rate of the pills in Example 4 was 78.3%–83.3%, and the total effective rate was 95.0%–96.7%. Example 4 had the same formula and excipients as Example 1, except for the addition of Patrinia scabiosaefolia. The comparison shows that the herbal composition pills in Example 4 significantly improved the cure rate for chronic sinusitis, increased the effective rate for chronic sinusitis, and improved the cure rate for chronic hypertrophic rhinitis. Follow-up visits showed that after one year of discontinuation of medication, the cure rate remained at 76.7%–83.3%; after three years of discontinuation, the cure rate remained at 71.7%–83.3%; and after five years of discontinuation, the cure rate remained at 66.7%–78.3%. This indicates that the vast majority of cured patients remained relapse-free for a long period.
[0099] Table 5. Case statistics of external application sachets using the traditional Chinese medicine composition in Example 5. .
[0100] Table 5 shows that the improvement rate of Example 5 was 87.5%~95.0%, and the total effective rate was 87.5%~95.0%. The external sachet in Example 5 had a high total effective rate and rapid onset of action. After wearing it, the average time to show effect for each symptom was 16.7~25.8 minutes; patients experienced noticeable effects within 30 minutes of wearing it, relieving discomfort symptoms such as nasal congestion, runny nose, nasal itching, and facial and eye swelling caused by the symptoms, thus improving the patients' quality of life. Furthermore, the efficacy of the external sachet was long-lasting; Example 5 was worn for 8 hours, remaining effective throughout the wearing period, making it suitable for patients to wear during the daytime work and daily life.
[0101] Table 6. Case statistics of the traditional Chinese medicine composition nasal drops in Example 6. .
[0102] Table 6 shows that the cure rate of the nasal drops in Example 6 was 3.8%–26.3%, the improvement rate was 73.7%–93.8%, and the effective rate was 96.3%–100%. The nasal drops in Example 6 have a rapid onset of action, with an average effective time of 5.2–7.5 minutes after application. They quickly relieve patient discomfort and are suitable for daytime use during work and daily life, as well as bedtime use, providing rapid relief without affecting sleep. Clinical observations show that the nasal drops are effective for symptoms of chronic simple rhinitis, chronic hypertrophic rhinitis, allergic rhinitis, and chronic sinusitis, with an average duration of effect of 8.0–8.4 hours. This relatively long duration of effect covers the duration of nighttime sleep, relieving discomfort such as difficulty breathing, stuffiness, and inability to achieve deep sleep caused by nasal problems, thus improving sleep quality. Clinical observations show that nasal drops have a good curative effect on mild cases of chronic simple rhinitis and mild cases of chronic hypertrophic rhinitis.
[0103] Table 7. Case statistics of oral pills containing traditional Chinese medicine composition in Comparative Example 1. .
[0104] Table 7 shows that in Comparative Example 1, the dosages of *Ficus hirtaecarpa*, stir-fried *Atractylodes macrocephala*, and raw *Atractylodes macrocephala* in the pills were too low. Although the symptom improvement rate was high, the cure rate was significantly reduced, and the time to show efficacy was prolonged. A follow-up visit one year after discontinuation of medication revealed a high number of relapses among the cured cases. Comparative Example 1 demonstrates that *Ficus hirtaecarpa*, stir-fried *Atractylodes macrocephala*, and raw *Atractylodes macrocephala* must be used according to the weight percentages in the herbal composition of this invention to achieve a high cure rate for various nasal cavity diseases and to reduce the likelihood of relapse after treatment.
[0105] Table 8. Case statistics of oral pills containing traditional Chinese medicine composition in Comparative Example 2. .
[0106] Table 8 shows that: in Comparative Example 2, no Nardostachys jatamansi was added to the pills, but the dosage of Ampelopsis japonica was increased, resulting in a significantly longer onset time and a significant decrease in the cure rate of chronic hypertrophic rhinitis, chronic sinusitis, and allergic rhinitis.
[0107] Table 9. Case statistics of oral pills containing traditional Chinese medicine composition in Comparative Example 3. .
[0108] Table 9 shows that: in Comparative Example 3, the pills did not contain Ampelopsis japonica, but the dosage of Nardostachys chinensis was increased, while the weight proportions of other ingredients remained unchanged. The cure rates for chronic hypertrophic rhinitis, chronic sinusitis, and allergic rhinitis decreased significantly. Follow-up visits one year after discontinuation of medication revealed a high number of relapses among the cured cases. Comparative Examples 2 and 3 demonstrate that the combined use of Nardostachys chinensis and Ampelopsis japonica has a synergistic effect, showing good efficacy in treating nasal diseases caused by inflammation-induced mucosal edema, hypertrophy, collagen deposition, and fibrosis. It can improve the cure rate of chronic hypertrophic rhinitis and chronic sinusitis, and also shorten the time to significant effect and reduce the probability of recurrence.
[0109] V. Typical Cases Case 1 (Constitution: Spleen deficiency and dampness accumulation; Symptom: Allergic rhinitis) Ms. Wang, female, 34 years old, teacher. First visit in early March 2019. Chief complaint: Nasal congestion, runny nose with clear discharge, and excessive sneezing for 5 years, worsening with smog or in air-conditioned rooms. Accompanied by fatigue, abdominal distension after meals, loose stools, pale and swollen tongue with teeth marks, and a white and greasy tongue coating. Diagnosis: Allergic rhinitis, due to spleen deficiency and dampness. After taking 7 doses (7 days) of the pills described in Example 1, follow-up visit: sneezing decreased, nasal discharge became thinner, and stools became formed. After continuing to take 21 more doses, follow-up visit: symptoms disappeared. Follow-up visit on May 2, 2020: no recurrence during the willow pollen season. Follow-up visit on May 13, 2022: no further recurrence.
[0110] Case 2 (Constitution: Qi deficiency type in children; Symptoms: Allergic rhinitis) Mr. Zhou, male, 8 years old. First visit in early February 2022. Chief complaint: Recurrent nasal congestion, rubbing of the nose, sneezing, and mouth breathing at night for 2 years. Accompanied by poor appetite, weight loss, sallow complexion, and pale tongue. Diagnosis: Allergic rhinitis, Qi deficiency. He took the pills from Example 1, reducing the dosage from one pill to half a pill each time. After 7 doses (i.e., 7 days), the nasal congestion was relieved, and his appetite increased. After taking 35 doses in total, the symptoms disappeared, and he gained weight. Follow-up visit on May 5, 2023: Allergic rhinitis did not recur. Follow-up visit on May 1, 2026: Occasionally, he experienced nasal congestion due to colds, but the allergic rhinitis did not recur.
[0111] Case 3 (Constitution: Qi deficiency and wind-related type; Symptoms: Allergic rhinitis) Ms. Guo, female, 41 years old, office worker. First visit in early July 2019. Chief complaint: Nasal congestion, runny nose with clear discharge, and itchy throat upon exposure to cold or dust, with a 5-year history of the condition. Accompanied by fatigue, excessive sweating, shortness of breath, and reluctance to speak; pale tongue with teeth marks on the edges, and a thin white coating. Diagnosis: Allergic rhinitis, lung and spleen qi deficiency, lingering wind-evil. Prescribed 10 doses of the pills in Example 1. Follow-up visit: Sneezing decreased, nasal discharge became clearer. After taking 28 doses consecutively, nasal congestion and runny nose completely disappeared. Follow-up visit on May 5, 2023: Only brief discomfort during colds, no recurrence of rhinitis.
[0112] Case 4 (Constitution: Dampness and turbidity obstructing the middle jiao; Symptoms: Chronic simple rhinitis) Mr. Lin, male, 38 years old, driver. First visit in early May 2020. Chief complaint: nasal congestion with sticky discharge, decreased sense of smell, frequent sneezing upon waking, with a 3-year history of the condition. Accompanying symptoms included dizziness, chest tightness, postprandial drowsiness, and sticky stools. Tongue was pale and swollen with a white, greasy coating. Diagnosis: Chronic simple rhinitis, spleen deficiency with dampness obstruction. He took 14 doses of the pills described in Example 1 (i.e., 14 days). Second visit: nasal discharge decreased, and nasal congestion lessened. After taking another 21 doses, symptoms disappeared, and sense of smell returned. Follow-up visit on May 5, 2023: rhinitis had not recurred.
[0113] Case 5 (Constitution: Spleen deficiency and turbidity type; Symptoms: Chronic hypertrophic rhinitis) Mr. Yin, male, 45 years old, self-employed. First visit in early December 2018. Chief complaint: alternating bilateral nasal congestion, copious thick white nasal discharge, 6-year history. Accompanying symptoms included abdominal distension after meals, heaviness in the limbs, loose stools, enlarged tongue with teeth marks and a white, greasy coating. Diagnosis: chronic hypertrophic rhinitis, spleen deficiency with dampness, turbidity obstructing the nasal passages. He was prescribed 35 doses of the pills in Example 1. After taking the medicine, the nasal congestion was basically relieved, and the nasal discharge became a small amount of clear, thick discharge. He took another 21 doses for consolidation, and all symptoms disappeared. A follow-up visit on May 2, 2024, revealed occasional nasal congestion during colds, which resolved spontaneously within seven days, with no recurrence of chronic rhinitis.
[0114] Case 6 (Constitution: Damp-Heat Rhinitis; Symptom: Chronic Sinusitis) Ms. Ma, female, 26 years old, student. First visit in early August 2022. Chief complaint: nasal congestion, thick yellow nasal discharge, headache, and decreased sense of smell, recurring for 2 years. Accompanying symptoms: sticky mouth, poor appetite, and incomplete bowel movements; red tongue with a yellow, greasy coating. Diagnosis: chronic sinusitis with damp-heat accumulation. Prescribed 14 doses of the pills in Example 1. Follow-up visit: nasal discharge turned white, headache lessened. After another 14 doses, nasal congestion cleared, and sense of smell returned. Follow-up for 2 years: occasional colds with runny nose, but no sinusitis developed.
[0115] Case 7 (Constitution: Lung Qi Deficiency and Cold Type; Symptoms: Allergic Rhinitis) Ms. Zhao, female, 55 years old, retired. First visit in early September 2018. Chief complaint: Nasal congestion, runny nose with clear discharge, and chills in the back upon exposure to cold wind, with an 8-year history of the condition. Accompanied by shortness of breath, lethargy, spontaneous sweating, pale tongue with a thin white coating. Diagnosis: Allergic rhinitis, lung qi deficiency and cold. The dosage of *Ficus hirtaecarpa* was increased to 35g. After taking 10 doses, the chills and runny nose decreased. She took a total of 45 doses of the pills in Example 2 (i.e., 45 days of treatment), and the symptoms were completely controlled. Follow-up visit on May 1, 2019, no recurrence during the willow pollen season. Follow-up visit on May 12, 2021, no recurrence. Follow-up visit on May 5, 2022, no recurrence.
[0116] Case 8 (Constitution: Cold-dampness nasal congestion type; Symptom: Chronic simple rhinitis) Mr. Shi, male, 52 years old, farmer. First visit in early January 2021. Chief complaint: Persistent nasal congestion, excessive clear nasal discharge, worsening in the morning and evening, with an 8-year history. Accompanied by aversion to wind and cold, coldness in the back, loose stools, pale tongue with a white, slippery coating. Diagnosis: Chronic simple rhinitis, cold-dampness invading the upper body, spleen yang deficiency. He took 21 doses of the pills in Example 3. After taking the pills, his nasal congestion was significantly relieved, and his clear nasal discharge was halved. He continued taking the pills for 28 more doses, and all symptoms disappeared; he no longer sneezed in the morning. Follow-up visit on May 4, 2024, showed no recurrence.
[0117] Case 9 (Constitution: Dampness and turbidity transforming into heat type; Symptom: Chronic sinusitis) Mr. Li, male, 42 years old, chef. First visit in early January 2020. Chief complaint: nasal congestion, yellow and turbid nasal discharge, headache, and loss of smell for 2 years. Accompanied by bitter taste in the mouth, sticky and foul-smelling stools, red tongue with a yellow and greasy coating. Diagnosis: chronic sinusitis, damp-heat type. After taking 14 doses (14 days) of the pills in Example 4, the yellow nasal discharge cleared and the headache was relieved. After continuing to take 28 doses, all symptoms disappeared. Follow-up visit on May 1, 2026: Occasionally experiencing colds and nasal congestion, which healed within a week, but there was no recurrence of sinusitis.
[0118] The above 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 changes or modifications to the above-disclosed technical content to create equivalent embodiments. However, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the protection scope of the present invention.
Claims
1. A traditional Chinese medicine composition for treating nasal cavity disorders, characterized in that, The ingredients include the following parts by weight: 24-26 parts of *Ficus hirta*, 11-13 parts of *Hedyotis diffusa*, 11-13 parts of *Nardostachys chinensis*, 14-16 parts of *Coriander*, 9-11 parts of *Ligusticum striatum*, 14-16 parts of *Polygonum aviculare*, 8-10 parts of *Cicada slough*, 11-13 parts of *Vitex trifolia*, 9-11 parts of stir-fried white hyacinth bean, 9-11 parts of *Angelica dahurica*, 14-16 parts of *Ligusticum chuanxiong*, 11-13 parts of *Ampelopsis japonica*, 11-13 parts of *Siegesbeckia orientalis*, 14-16 parts of *Platycodon grandiflorus*, 14-16 parts of stir-fried *Atractylodes macrocephala*, 14-16 parts of raw *Atractylodes macrocephala*, and 9-11 parts of ginger-processed *Pinellia ternata*.
2. The traditional Chinese medicine composition for treating nasal cavity disorders according to claim 1, characterized in that, The ingredients include the following parts by weight: 25 parts of five-finger peach, 12 parts of wood-brush flower, 12 parts of nardostachys chinensis, 15 parts of coriander, 10 parts of ligusticum striatum, 15 parts of angelica sinensis, 9 parts of cicada molting, 12 parts of vitex trifolia, 10 parts of stir-fried white hyacinth bean, 10 parts of angelica dahurica, 15 parts of chuanxiong rhizome, 12 parts of white peony root, 12 parts of siegesbeckia orientalis, 15 parts of platycodon grandiflorus, 15 parts of stir-fried atractylodes macrocephala, 15 parts of raw atractylodes macrocephala, and 10 parts of ginger-processed pinellia ternata.
3. The traditional Chinese medicine composition for treating nasal cavity disorders according to claim 1 or 2, characterized in that: The mass ratio of stir-fried Atractylodes macrocephala to raw Atractylodes macrocephala is 1:0.9~1.1; the sum of the weights of stir-fried Atractylodes macrocephala and raw Atractylodes macrocephala accounts for 12~14% of the total weight of the composition.
4. The traditional Chinese medicine composition for treating nasal cavity disorders according to claim 1 or 2, characterized in that: The weight of the five-finger peach accounts for 10-12% of the total weight of the composition.
5. The traditional Chinese medicine composition for treating nasal cavity disorders according to claim 1 or 2, characterized in that: The Nardostachys chinensis and Ampelopsis japonica are added at a weight ratio of 1:0.9~1.
1.
6. The traditional Chinese medicine composition for treating nasal cavity disorders according to claim 1 or 2, characterized in that, It also includes the following raw materials in parts by weight: 98 to 241 parts of excipients, with the ratio of the mass of the excipients to the total weight of the composition being 0.5 to 1:
1.
7. The traditional Chinese medicine composition for treating nasal cavity disorders according to claim 6, characterized in that: The excipient is at least one of water, ginger juice, and honey.
8. A method for preparing a traditional Chinese medicine composition for treating nasal cavity disorders according to any one of claims 1 to 7, characterized in that, The following steps are used: 1) Mix the following ingredients by weight: five-finger peach, wood-brush flower, nardostachys, coriander, ligusticum, angelica sinensis, cicada slough, vitex trifolia, stir-fried white hyacinth bean, angelica dahurica, chuanxiong rhizome, white peony root, sieve grass, platycodon grandiflorus, stir-fried atractylodes macrocephala, raw atractylodes macrocephala, and ginger-processed pinellia ternata. Grind them into powder and pass them through an 80-250 mesh sieve to obtain the medicinal powder. 2) Weigh the excipients according to the weight, heat the excipients, add the medicinal powder, stir and boil until it becomes a medicinal clump, remove the medicinal clump, cool it, knead it into a medicinal strip, divide the medicinal strip into segments, and then roll it into pills of 8.5~9.5 grams / pill through a pill-making board, and dry it to obtain the product.
9. The application of the traditional Chinese medicine composition for treating nasal diseases according to any one of claims 1 to 5, characterized in that: Applications in the preparation of oral or topical medications for the treatment of chronic rhinitis, allergic rhinitis, and chronic sinusitis.
10. The application of the traditional Chinese medicine composition for treating nasal diseases according to claim 9, characterized in that: The oral medication is an oral pill or decoction; the external medication is a medication administered through the respiratory tract or the nasal mucosa.