External medicine for treating nasal diseases

Abstract

The invention belongs to the field of traditional Chinese medicines, and discloses an external medicine for treating nasal diseases, which comprises the following raw material medicines: cocklebur fruit, mint, radix angelicae, centipeda minima, asarum, magnolia flower, divaricate saposhnikovia root, agastache rugosus, houttuynia cordata and borneol. According to different dosage forms, the external medicine disclosed by the invention not only can be adhered to the nose bridge, but also can be applied in the nasal cavity during use, and is convenient to use. Especially, the nasal mucosa cannot be directly stimulated when the nasal mucosa is externally attached to the nose bridge, discomfort brought by treatment to a patient is reduced, the nasal mucosa patch is easy to accept by the patient, and treatment compliance and safety of the patient are high. The externally applied medicine disclosed by some examples has a good curative effect on various chronic rhinitis, 550 patients with various nasal diseases are treated in the clinical diagnosis and treatment process, the clinical cure rate of acute rhinitis reaches 92%, the clinical cure rate of chronic rhinitis, nasosinusitis, allergic rhinitis and postnasal drip syndrome reaches 89%, and the cure rate of infantile adenoid hypertrophy and nasal polyp reaches 93%.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to an external medicine for treating nasal diseases. Background Art

[0002] Chronic rhinitis is a common nasal disease, with clinical manifestations such as persistent or alternating nasal congestion, a large amount of thick nasal mucus, accompanied by nasal mucus flowing back to the nasopharynx, reduced sense of smell, headache, fatigue, stuffy nasal voice, etc. The symptoms worsen after fatigue or exposure to cold. Chronic rhinitis has a high incidence rate and generally a long course. Although it is not a fatal disease, if not cured for a long time, it will affect the blood supply to the human brain, damage the patient's intelligence, and seriously reduce the patient's quality of life.

[0003] Currently, the methods for treating chronic rhinitis include oral drug treatment and external nasal drops. Common drug treatments include local glucocorticoids, antibiotics, mucus expectorants, etc. However, long-term use of these drugs will have various degrees of systemic side effects, such as blurred vision, dry mouth, rapid heartbeat, slow reaction, nausea, constipation, weight gain, etc., and these drugs have almost no alleviating effect on the symptom of runny nose. External nasal drops can only relieve the symptoms but not cure the root cause, and are prone to recurrence after treatment. Moreover, the direct contact of external drops with the nasal cavity makes people feel uncomfortable and is likely to cause the liquid medicine to flow into the throat due to improper operation, which is not suitable for children with chronic rhinitis. Due to the problems of easy recurrence, multiple drug superimposed use, drug side effects, adverse reactions and drug resistance in the existing methods for treating chronic rhinitis, the compliance of patients is lost.

[0004] Traditional Chinese medicine treatments for chronic rhinitis, such as press-stud needle therapy, acupuncture, oral administration of traditional Chinese medicine, and massage, can regulate the functions of the human body in aspects such as qi and blood, immunity, etc., fundamentally improve the symptoms of rhinitis, and thus achieve a relatively satisfactory effect. However, the existing traditional Chinese medicine treatment methods have disadvantages such as relying on the experience and techniques of the doctor, being inconvenient to use and having a slow onset of effect, resulting in poor patient compliance.

[0005] Chinese Patent Application CN114010682A discloses a suppository for treating chronic rhinitis, which comprises the following raw materials in parts by weight: 8 - 12 g of moschus, 7 - 15 g of magnolia flower, 2 - 6 g of xanthium sibiricum, 6 - 9 g of mint, 9 - 13 g of borneol, 9 - 15 g of honeysuckle, 3 - 7 g of akebia quinata, 6 - 16 g of scutellaria baicalensis, 7 - 13 g of angelica dahurica and 1 - 4 g of senecio scandens. It can solve problems such as nasal congestion and headache caused by chronic rhinitis, make breathing smooth, clear-headed and refreshed. It is developed into a suppository-type medicine suppository and inserted into the nasal cavity, making the drug effect more persistent while further enhancing the drug effect, and can quickly and effectively solve the pain of rhinitis patients.

[0006] Chinese Patent Application CN104666421A discloses a drug for treating acute and chronic rhinitis, which is made from the following raw materials in parts by weight: 20 - 30 parts of Xanthium sibiricum, 10 - 14 parts of Angelica dahurica, 8 - 10 parts of Magnolia liliflora Desr., 8 - 10 parts of Borneol, 7 - 9 parts of Menthol, 5 - 7 parts of Sesame oil, 3 - 5 parts of Forsythia suspensa. It has the effects of expelling wind and removing dampness, aromatic orifice-opening, clearing heat and detumescence, removing stasis and alleviating pain, moistening mucosa, shrinking nasal polyps, etc., and is mainly used for treating chronic rhinitis, atrophic rhinitis, nasal polyps and other diseases.

[0007] Chinese Patent Application CN105616836A discloses a traditional Chinese medicine composition for treating acute and chronic rhinitis. The components and their parts by mass of the traditional Chinese medicine composition are as follows: 15 - 48 g of Taraxacum mongolicum, 15 - 25 g of Lonicera japonica, 8 - 16 g of Schizonepeta tenuifolia Briq., 5 - 15 g of Saposhnikovia divaricata (Turcz.) Schischk., 3 - 12 g of Bupleurum chinense DC., 4 - 12 g of Angelica dahurica, 10 - 16 g of Chrysanthemum morifolium Ramat., 4 - 12 g of Mentha haplocalyx Briq., 3 - 10 g of Xanthium sibiricum, 3 - 10 g of Magnolia liliflora Desr., 3 - 12 g of Ligusticum chuanxiong Hort., 3 - 9 g of Ligusticum sinense Oliv., 5 - 15 g of Scutellaria baicalensis Georgi, 8 - 15 g of Cyperus rotundus L., 1.5 - 9 g of Asarum sieboldii Miq.

[0008] Chinese Patent Application CN114984122A discloses a traditional Chinese medicine paste for treating acute and chronic rhinitis, which includes the following components in parts by weight: 5 - 10 parts of Centipeda minima, 2 - 8 parts of Xanthium sibiricum, 2 - 8 parts of Magnolia liliflora Desr., 1 - 3 parts of Muskmelon pedicel, 1 - 5 parts of Borneol, 1 - 3 parts of Ephedra sinica Stapf, 0.5 - 1.5 parts of Perilla frutescens (L.) Britt., 0.5 - 1.5 parts of Schizonepeta tenuifolia Briq., 0.5 - 1.5 parts of Chrysanthemum indicum L., 0.5 - 1.5 parts of Asarum sieboldii Miq., 1 - 3 parts of Indigo Naturalis, 2 - 8 parts of Angelica dahurica, 1 - 5 parts of Ligusticum chuanxiong Hort., 1 - 3 parts of Acorus tatarinowii Schott, 1 - 5 parts of Gleditsia sinensis Lam., 1 - 3 parts of Natrii Sulfas Exsiccatus, 0.5 - 1.5 parts of Mentha haplocalyx Briq., 0.5 - 1.5 parts of Ligusticum sinense Oliv., 0.5 - 1.5 parts of Scutellaria baicalensis Georgi, 0.5 - 1.5 parts of Viola philippica Cav., 0.5 - 1.5 parts of Pogostemon cablin (Blanco) Benth., 30 - 80 parts of Sesame seed oil.

[0009] Therefore, how to provide a product with wide applicability, simple operation, stable effect, small toxic and side effects, quick effect and capable of treating chronic rhinitis has become an urgent technical problem for those skilled in the art. Summary of the Invention

[0010] The purpose of the present invention is to overcome at least one deficiency of the prior art and provide an external medicine for treating nasal diseases.

[0011] The technical solution adopted by the present invention is: In the first aspect of the present invention, it provides: An external medicine for treating nasal diseases, and the mass parts ratio of the raw materials of the active ingredients is as follows: 10-30 parts of Xanthium sibiricum, 10-30 parts of Mentha haplocalyx, 10-30 parts of Angelica dahurica, 15-30 parts of Centipeda minima, 5-15 parts of Asarum sieboldii, 10-30 parts of Flos Magnoliae, 40-80 parts of Saposhnikovia divaricata, 60-120 parts of Pogostemon cablin, 10-30 parts of Houttuynia cordata, 5-15 parts of Borneol.

[0012] In some examples, the mass parts ratio of the raw materials of the active ingredients is as follows: 20 parts of Xanthium sibiricum, 20 parts of Mentha haplocalyx, 20 parts of Angelica dahurica, 20 parts of Centipeda minima, 8 parts of Asarum sieboldii, 20 parts of Flos Magnoliae, 60 parts of Saposhnikovia divaricata, 80 parts of Pogostemon cablin, 20 parts of Houttuynia cordata, 8 parts of Borneol.

[0013] In some examples, the preparation method includes: weighing the raw materials according to the ratio of the raw materials, extracting with water to obtain a traditional Chinese medicine liquid, and further preparing an external medicine.

[0014] In some examples, the preparation method includes the following steps: Weigh the raw materials according to the ratio of the raw materials and grind them into powder; Add the traditional Chinese medicine powder into water, heat to no less than 80 °C for extraction and concentrate to 0.4-0.7 times of the original water volume to obtain a traditional Chinese medicine liquid.

[0015] In some examples, the mass mixing ratio of the traditional Chinese medicine powder and water is 1:(4-8).

[0016] In some examples, the medicinal residues are removed after concentration to obtain a traditional Chinese medicine liquid.

[0017] In some examples, the nasal diseases are selected from acute rhinitis, chronic rhinitis, allergic rhinitis, sinusitis, pediatric adenoidal hypertrophy, nasal polyps.

[0018] In some examples, the external medicine is selected from ointments, nasal sprays, nasal drops.

[0019] In some examples, the external medicine is a patch, which is attached to the bridge of the nose during use.

[0020] The above features can be combined arbitrarily without conflict.

[0021] The second aspect of the present invention provides: The application of the external medicine described in the first aspect of the present invention in the preparation of a drug for treating nasal diseases, wherein the nasal diseases are selected from acute rhinitis, chronic rhinitis, allergic rhinitis, sinusitis, pediatric adenoidal hypertrophy, nasal polyps.

[0022] In some examples, the external medicine is selected from ointments, nasal sprays, nasal drops.

[0023] In some examples, the external medicine is a patch, which is attached to the bridge of the nose during use.

[0024] The beneficial effects of the present invention are as follows: For the external medicine of some examples of the present invention, according to different dosage forms, it can be applied to the bridge of the nose or administered in the nasal cavity during use, which is convenient to use. Especially when externally applied to the bridge of the nose, it will not directly stimulate the nasal mucosa, reduce the discomfort brought to the patient during treatment, is easy to be accepted by the patient, and the treatment compliance and safety of the patient are high.

[0025] The external medicine of some examples of the present invention has good curative effects on various chronic rhinitis. During the clinical diagnosis and treatment process, 550 person-times of patients with various nasal diseases were treated. Among them, the clinical cure rate of acute rhinitis reached 92%, and the clinical cure rate of chronic rhinitis, sinusitis, allergic rhinitis, and postnasal drip syndrome reached 89%. The cure rates of pediatric adenoid hypertrophy and nasal polyps reached 93%. Specific embodiments

[0026] An external medicine for treating nasal diseases, and the mass fraction ratio of the raw materials of its active ingredients is: 10 - 30 parts of Xanthium sibiricum, 10 - 30 parts of Mentha haplocalyx, 10 - 30 parts of Angelica dahurica, 15 - 30 parts of Centipeda minima, 5 - 15 parts of Asarum sieboldii, 10 - 30 parts of Magnolia liliflora, 40 - 80 parts of Saposhnikovia divaricata, 60 - 120 parts of Pogostemon cablin, 10 - 30 parts of Houttuynia cordata, and 5 - 15 parts of Borneol.

[0027] In some examples, the mass fraction ratio of the raw materials of its active ingredients is: 20 parts of Xanthium sibiricum, 20 parts of Mentha haplocalyx, 20 parts of Angelica dahurica, 20 parts of Centipeda minima, 8 parts of Asarum sieboldii, 20 parts of Magnolia liliflora, 60 parts of Saposhnikovia divaricata, 80 parts of Pogostemon cablin, 20 parts of Houttuynia cordata, and 8 parts of Borneol.

[0028] I. Core compatibility principle 1. Focus on promoting nasal passage and dispelling cold, and also take into account expelling wind and clearing heat The group of herbs with pungent-warm property for promoting nasal passage: Xanthium sibiricum, Angelica dahurica, Asarum sieboldii, Magnolia liliflora, Saposhnikovia divaricata, and Centipeda minima are all warm in nature and pungent in taste, and belong to the lung meridian. They work together to promote nasal passage and disperse wind-cold, targeting exterior cold syndromes such as nasal congestion, runny nose, and headache.

[0029] The group of herbs for clearing heat and expelling pathogenic factors: Mentha haplocalyx and Houttuynia cordata are cool in nature, and Borneol is cold in nature. They balance the warm and dry property of the whole formula and also clear internal heat, and are applicable to syndromes of cold-heat mixture or exterior cold with interior heat.

[0030] 2. Combine ascending and dispersing with descending and sinking to regulate qi movement Herbs with ascending and dispersing properties (Saposhnikovia divaricata, Pogostemon cablin, Mentha haplocalyx): Dispel wind and relieve exterior syndrome, lift the clear yang, and assist the medicinal power to ascend to the head and face.

[0031] Herbs with descending and sinking properties (Houttuynia cordata, Borneol): Clear heat and descend, guide pathogenic factors to excrete externally, and prevent the over-ascending of warm and dry herbs from causing heat in the head and eyes.

[0032] 3. Attach equal importance to resolving dampness and detoxifying Wetness-drying herbs: Pogostemon cablin is used in large doses and combined with Saposhnikovia divaricata to strengthen the function of drying dampness and regulating the middle-jiao, which is applicable to nasal sinusitis and heavy head caused by internal obstruction of damp turbidity.

[0033] Detoxifying herbs: Houttuynia cordata clears heat and detoxifies, and Borneol awakens the mind and opens the orifices, working together to prevent and treat the stasis of damp-heat toxins.

[0034] II. Innovative Compatibility 1. Dose Breakthrough: The unconventional ratio of Saposhnikovia divaricata to Pogostemon cablin The dosage of Saposhnikovia divaricata is 4 to 8 times that of traditional prescriptions, strengthening the power of expelling wind and eliminating dampness, especially applicable to stubborn nasal congestion caused by wind pathogen accompanied by dampness.

[0035] The dosage of Pogostemon cablin is 4 to 8 times that of traditional prescriptions, highlighting the effect of drying dampness and awakening the spleen. It targets the heavy head and poor appetite caused by excessive damp turbidity, reflecting the innovative idea of "treating the nose by first regulating the spleen".

[0036] 2. Combining Cold and Warm Herbs for Bidirectional Regulation The ratio of warm herbs (Xanthium sibiricum, Asarum sieboldii) to cold herbs (Houttuynia cordata, Borneol) is balanced (warm: cold ≈ 5:1). It can disperse exterior cold and clear interior heat, breaking through the limitation of traditional nasal orifice-opening prescriptions being overly warm and dry, and is applicable to the constitution of modern people with intermingled cold and heat.

[0037] 3. The Synergistic Effect of Borneol and Mentha haplocalyx Borneol (awakening the mind and opening the orifices) and Mentha haplocalyx (dispelling wind and dissipating heat) are combined to form a "cool-opening" combination, enhancing the permeability to nasal mucosa and quickly relieving nasal congestion, reflecting the modern concept of "targeted transmembrane penetration".

[0038] 4. Replacing Traditional Heat-clearing and Detoxifying Herbs with Houttuynia cordata Houttuynia cordata (instead of Scutellaria baicalensis, Coptis chinensis) is used to clear heat and detoxify. Its pungent and cold nature is more in line with the pathogenesis of nasal orifices. As a medicine and food homologous herb, it has higher safety, fewer side effects, and reduces the possible damage to the body.

[0039] The pharmacological effects of each raw material drug in the present invention are as follows: Xanthium sibiricum: It has the functions of dispersing wind and relieving pain, opening nasal orifices, and dispelling dampness and killing insects. It is mainly used for treating wind-cold headache, nasal sinusitis, toothache, wind-cold-damp arthralgia, limb spasm pain, scabies, and itching.

[0040] Mentha haplocalyx: Mentha haplocalyx has the effects of inducing sweating and relieving fever, soothing the liver and regulating qi, relieving sore throat and pain, and relieving itching. It is mainly used to relieve headache, toothache, nasal sinusitis, nausea, and symptoms such as skin itching, abdominal distension, diarrhea, dyspepsia, and constipation.

[0041] Angelica dahurica: It has the functions of dispersing wind and relieving exterior syndrome, dispelling dampness and relieving pain, and detumescence and discharging pus. It is mainly used for treating wind-cold cold, headache and nasal congestion, nasal sinusitis, toothache, facial swelling, and skin ulcers.

[0042] Centipeda minima: It has the effects of dispersing wind-cold, dredging nasal orifices, relieving cough and detoxifying, and also has antibacterial, insecticidal, anti-allergic, anti-tumor and other effects. It is mainly used for the treatment of acute and chronic rhinitis, allergic rhinitis, headache, whooping cough, chronic tracheitis, conjunctivitis, rheumatoid arthritis, malaria, damp sores and swelling toxins, traumatic swelling and pain, etc.

[0043] Asarum sieboldii: It has the effects of expelling wind, dispelling cold, relieving pain, dredging orifices, warming the lungs and resolving fluid-retention. It is mainly used for the treatment of arthralgia pain, low back pain, externally contracted wind-cold syndrome, asthma syndrome due to cold fluid-retention in the lungs, and nasal sinusitis.

[0044] Flos Magnoliae: It has the effects of dispersing wind-cold and dredging nasal orifices, and is mainly used for the treatment of symptoms such as cold, nasal congestion, running clear nasal discharge, headache, etc. caused by externally contracted wind-cold.

[0045] Saposhnikovia divaricata: It relieves exterior syndrome and dispels cold, dispels wind and dredges collaterals, raises yang qi, dries dampness and relieves pain, stops convulsions, dispels wind and relieves itching, nourishes blood, stops bleeding and dredges channels, and has antibacterial and anti-inflammatory effects. It is mainly used for symptoms such as cold with wind-cold, fever and aversion to cold, headache, body pain, as well as cold with wind-heat, fever and aversion to cold, red eyes, sore throat, rheumatic arthralgia, tetanus, locked jaws, opisthotonos, etc.

[0046] Agastache rugosa: It aromatizes dampness turbidity, harmonizes the stomach and stops vomiting, and induces sweating and relieves summer heat. It is used for dampness turbidity obstructing the middle-jiao, epigastric distension and vomiting, summer dampness exterior syndrome, initial stage of damp-warm syndrome, fever and lassitude, chest distress and discomfort, cold-dampness blocking summer heat, abdominal pain and vomiting and diarrhea, nasal sinusitis headache.

[0047] Houttuynia cordata: It has the effects of clearing heat and detoxifying, expelling pus, reducing swelling and treating sores, promoting diuresis and removing dampness, and strengthening the stomach and promoting digestion. It is used for treating lung abscess, sore and swelling toxins, hemorrhoids and bloody stools, accumulation of heat in the spleen and stomach, etc. caused by excess heat, heat toxin, damp pathogen, and damp-heat pathogen.

[0048] Borneol: It has the effects of dredging various orifices, dispersing stagnant fire, waking up the mind, removing nebula and improving eyesight, and reducing swelling and relieving pain. It is used for the treatment of sore throat, oral ulcers, carbuncles, sores and itching, eye diseases, etc.

[0049] In some examples, its preparation method includes: weighing the raw materials according to the proportion of the raw materials of traditional Chinese medicine, extracting with water to obtain the traditional Chinese medicine liquid, and further preparing to obtain the external medicine.

[0050] In some examples, its preparation method includes the following steps: Weigh the raw materials according to the proportion of the raw materials of traditional Chinese medicine and grind them into powder; Add the traditional Chinese medicine powder to water, heat it to no less than 80 °C for extraction and concentrate it to 0.4 - 0.7 times of the original water volume to obtain the traditional Chinese medicine liquid.

[0051] Grinding the raw materials of traditional Chinese medicine into powder can facilitate the water extraction of active ingredients and also be beneficial to the solubility of ingredients such as borneol.

[0052] Heating can make borneol dissolve better in water.

[0053] In some examples, the mass mixing ratio of the traditional Chinese medicine powder to water is 1:(4 - 8).

[0054] In some examples, after concentration, the medicinal residues are removed to obtain the traditional Chinese medicine liquid.

[0055] In some examples, the nasal diseases are selected from acute rhinitis, chronic rhinitis, allergic rhinitis, sinusitis, pediatric adenoid hypertrophy, and nasal polyps.

[0056] There is no special requirement for the dosage form of the external medicine, and it can be a commonly used nasal external medicine in the art. In some examples, the external medicine is selected from ointments, nasal sprays, and nasal drops.

[0057] In some examples, the external medicine is a patch, which is attached to the bridge of the nose during use. This can not only have a good therapeutic effect on nasal diseases but also avoid the discomfort caused by nasal administration, such as foreign body sensation, short action time, and affecting breathing, etc., which is more conducive to improving the compliance of patients and is more easily accepted by patients.

[0058] The above features can be combined arbitrarily without conflict.

[0059] The following combines examples and efficacy data to further illustrate the technical solution of the present invention.

[0060] Example 1 An external traditional Chinese medicine liquid for treating chronic rhinitis, and the mass ratio of its raw materials is: 15 parts of Xanthium sibiricum, 15 parts of Mentha haplocalyx, 15 parts of Angelica dahurica, 15 parts of Centipeda minima, 6 parts of Asarum sieboldii, 10 parts of Magnolia liliflora, 40 parts of Saposhnikovia divaricata, 60 parts of Pogostemon cablin, 15 parts of Houttuynia cordata, and 6 parts of Borneol.

[0061] Example 2 An external traditional Chinese medicine liquid for treating chronic rhinitis, and the mass ratio of its raw materials is: 30 parts of Xanthium sibiricum, 30 parts of Mentha haplocalyx, 30 parts of Angelica dahurica, 30 parts of Centipeda minima, 15 parts of Asarum sieboldii, 30 parts of Magnolia liliflora, 80 parts of Saposhnikovia divaricata, 120 parts of Pogostemon cablin, 30 parts of Houttuynia cordata, and 15 parts of Borneol.

[0062] Example 3 An external traditional Chinese medicine liquid for treating chronic rhinitis, and the mass ratio of its raw materials is: 10 parts of Xanthium sibiricum, 10 parts of Mentha haplocalyx, 10 parts of Angelica dahurica, 15 parts of Centipeda minima, 5 parts of Asarum sieboldii, 10 parts of Magnolia liliflora, 40 parts of Saposhnikovia divaricata, 60 parts of Pogostemon cablin, 10 parts of Houttuynia cordata, and 5 parts of Borneol.

[0063] The preparation method of the traditional Chinese medicine liquid includes the following steps: Weigh the Chinese medicinal materials such as Xanthium sibiricum, Mentha haplocalyx, Angelica dahurica, Centipeda minima, Asarum sieboldii, Magnolia liliflora, Saposhnikovia divaricata, Pogostemon cablin, Houttuynia cordata, and Borneol according to the above ratio; Weigh the raw materials in proportion and grind all the Chinese medicinal materials into fine powder; Dissolve 180 g of traditional Chinese medicine powder in 1000 ml of boiling water and stir to form a traditional Chinese medicine liquid. Continuously heat the traditional Chinese medicine liquid at a constant temperature of 80°C and finally concentrate it to form 800 ml of traditional Chinese medicine liquid. Remove the residue from the traditional Chinese medicine liquid, pour the liquid into a clean glass bottle, tighten the lid, and refrigerate it for later use.

[0064] When in use, take an appropriate amount of the traditional Chinese medicine liquid, pour it onto a cotton pad, and apply it to the bridge of the nose for about half an hour each time, twice a day.

[0065] Efficacy experiment: The control summary of some clinical experimental results of the present invention is as follows: 1. Clinical application report of acute rhinitis: Conduct an effect test on Example 1 1.1 Inclusion criteria: The diagnosis is made with reference to the relevant criteria in the "Common Cold and Nasal Obstruction" chapter in "Traditional Chinese Medicine Otorhinolaryngology (National Planning Textbook for Higher Chinese Medicine Institutions, 11th Edition)".

[0066] 1.2 Efficacy evaluation: ① Safety observation: Include detection of general vital signs (blood pressure, heart rate, respiration) and adverse reactions such as rebound nasal congestion, dizziness, headache, heart palpitations, and nasal mucosa dryness.

[0067] ② Efficacy observation: Formulate a quantitative standard for traditional Chinese medicine syndromes according to the relevant standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". It includes symptoms such as nasal itching, runny nose, nasal congestion, sneezing, and coughing. Each symptom is divided into four grades: normal, mild, moderate, and severe, and is recorded as 0, 1, 2, and 3 points respectively, with a maximum total score of 15 points. The evaluation is based on the improvement degree of the total score before and after treatment. Marked effect: The clinical symptoms are significantly improved, and the total score is reduced by ≧ 70%; Effective: The patient's clinical symptoms are relieved, and the total score is reduced by ≧ 30%; Ineffective: The patient's clinical symptoms have no obvious change, and the total score is reduced by less than 30%. The total clinical effective rate = marked effective rate + effective rate.

[0068] 1.3 Select 100 patients with acute rhinitis in the Civilian General Clinic of Maoming City, aged 2 - 60 years. Divide the patients into 2 groups. Among them, there are 50 cases in the experimental group, with a male - to - female ratio of 1:1 and an age distribution of 2 - 60 years; 50 cases in the control group, with a male - to - female ratio of 1:1 and an age distribution of 2 - 60 years. There is no significant statistical difference in the general clinical data of the two groups. On the basis of basic treatment, in the control group, oxymetazoline nasal spray is used, 1 spray on one side each time, once in the morning and once before bedtime; in the experimental group, the external traditional Chinese medicine liquid is used, poured onto a cotton pad and applied to the bridge of the nose for about half an hour each time, once in the morning and once before bedtime. The treatment time for both groups of patients is 5 days. The results are shown in Table 1 and Table 2.

[0069] Table 1 Comparison of the total effective rates of the two treatment groups [n (%)] Group Number of cases Marked effect Effective Ineffective Total effective rate (%) Control group 50 15(30%) 25(50%) 10(20%) 80 Experimental group 50 24(48%) 22(44%) 4(8%) 92① Note: ① There was no statistically significant difference between the experimental group and the control group P > 0.05.

[0070] Table 2 Comparison of side effects between the two groups [n (%)] Group Number of cases Rebound nasal congestion Dizziness and headache Accelerated heartbeat Dry nasal mucosa Incidence of side effects (%) Control group 50 6(12%) 4(8%) 3(6%) 2(4%) 30% Experimental group 50 0(0%) 1(2%) 0(0%) 1(2%) 4% Note: ① There was a statistically significant difference between the experimental group and the control group P <0.01.

[0071] The above treatment results show that the external traditional Chinese medicine liquid described in the present invention has a good effect of relieving symptoms and treating acute rhinitis, and there is no difference in its clinical effect compared with the western medicine control ( P > 0.05). The incidence of side effects such as rebound nasal congestion, dizziness, headache, nasal mucosa dryness, and heart palpitations is relatively high in the control group of patients using the nasal decongestant oxymetazoline hydrochloride nasal drops. The incidence of side effects of the external traditional Chinese medicine liquid of the present invention is low, and its safety is superior to that of the control drug.

[0072] 2. Clinical application reports on chronic rhinitis, sinusitis, allergic rhinitis, and postnasal drip syndrome: The effect of Example 2 was tested 2.1 Inclusion criteria: Diagnosis was made with reference to the relevant criteria in the chapters of "nasal obstruction", "nasal sinusitis", and "allergic rhinitis" in "Traditional Chinese Medicine Otorhinolaryngology (National Higher Education Traditional Chinese Medicine Planning Textbook, 11th Edition)".

[0073] 2.2 Efficacy evaluation: ① Safety observation: Detection of general vital signs (blood pressure, heart rate, respiration) and adverse reactions such as rebound nasal congestion, dizziness, headache, heart palpitations, and nasal mucosa dryness was included.

[0074] ② Efficacy observation: According to the relevant criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", a quantitative standard for traditional Chinese medicine syndromes was formulated. Symptoms such as nasal itching, runny nose, nasal congestion, sneezing, and coughing were included. Each symptom was divided into four grades: normal, mild, moderate, and severe, and 0, 1, 2, and 3 points were recorded respectively, with a maximum total score of 15 points. Evaluation was carried out according to the improvement degree of the total score before and after treatment. Marked effect: Obvious improvement in clinical symptoms, and the total score decreased by ≧ 70%; Effective: The clinical symptoms of the patient were relieved, and the total score decreased by ≧ 30%; Ineffective: There was no obvious change in the clinical symptoms of the patient, and the total score decreased by less than 30%. The total clinical effective rate = marked effective rate + effective rate.

[0075] 2.3 Select 500 patients with chronic rhinitis, sinusitis, allergic rhinitis, and postnasal drip syndrome from Meizhou Yicheng Hospital of Integrated Traditional Chinese and Western Medicine for Geriatrics and Rehabilitation, aged 2 - 60 years. Divide the patients into two groups. The control group has 100 cases, with a male - to - female ratio of 1:1 and an age distribution of 2 - 60 years. The experimental group has 100 cases, with a male - to - female ratio of 1:1 and an age distribution of 2 - 60 years. There are no statistically significant differences in the general clinical data between the two groups. On the basis of basic treatment, the control group uses oxymetazoline nasal spray, 1 spray on one side each time, once in the morning and once before bedtime. The experimental group uses an external traditional Chinese medicine liquid, which is poured onto a cotton pad and pasted on the bridge of the nose for about half an hour each time, once in the morning and once before bedtime. 7 days is one course of treatment, and the two groups of patients are treated for three courses, a total of 21 days. The results are shown in Table 3 and Table 4.

[0076] Table 3 Comparison of the total effective rates of the two groups of treatments [n (%)] Group Number of cases Marked effect Effective Ineffective Total effective rate (%) Control group 100 47(30%) 38(38%) 15(15%) 85% Experimental group 400 276(69%) 80(22%) 44(11%) 89%① Note: ① There are statistically significant differences when comparing the experimental group with the control group P <0.01.

[0077] Table 4 Comparison of side effects of the two groups [n (%)] Group Number of cases Rebound nasal congestion Dizziness and headache Accelerated heartbeat Dry nasal mucosa Incidence of side effects (%) Control group 100 11(11%) 9(9%) 10(10%) 8(8%) 38% Experimental group 400 8(2%) 4(1%) 2(0.5%) 6(1.5%) 5% Note: ① There are statistically significant differences when comparing the experimental group with the control group P <0.01.

[0078] The above treatment results show that the external traditional Chinese medicine liquid described in the present invention has a good effect of relieving symptoms and treating chronic rhinitis, sinusitis, allergic rhinitis, and postnasal drip syndrome, and the clinical efficacy is superior to that of the control group ( P <0.01). The incidence of side effects such as rebound nasal congestion, dizziness, headache, nasal mucosa dryness, and heart palpitations is relatively high in the control group of patients using the nasal decongestant oxymetazoline hydrochloride nasal drops. Especially as the use time prolongs, the incidence shows an upward trend. However, the number of side effects of using the external traditional Chinese medicine liquid of the present invention is significantly less, and the incidence of adverse reactions is low, and the safety is superior to the control drug.

[0079] 3. Clinical application report of adenoid hypertrophy and nasal polyps: Conduct an efficacy test on Example 3 3.1 Inclusion criteria: Refer to the relevant criteria in the chapters of "Nasal Polyps" and "Snoring and Sleep Disorders" in "Traditional Chinese Medicine Otorhinolaryngology (Textbook for National Higher Chinese Medicine and Pharmacy Colleges, 11th Edition)" for diagnosis.

[0080] 3.2 Efficacy evaluation: ① Safety observation: Include general vital signs (blood pressure, heart rate, respiration) and detection of adverse reactions such as drowsiness, dizziness, headache, gastrointestinal discomfort, and nasal mucosa dryness.

[0081] ② Therapeutic efficacy observation: The quantitative criteria for traditional Chinese medicine syndromes were formulated according to the relevant standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine". Symptoms such as snoring at night, mouth breathing, nasal congestion, and cough were included. Each symptom was divided into four grades: normal, mild, moderate, and severe, and 0, 1, 2, and 3 points were recorded respectively, with a maximum total score of 12 points. Evaluation was based on the improvement degree of the total score before and after treatment. Marked effect: Obvious improvement in clinical symptoms, and the total score decreased by ≧ 70%; Effective: The clinical symptoms of the patient were relieved, and the total score decreased by ≧ 30%; Ineffective: No obvious change in the clinical symptoms of the patient, and the total score decreased by less than 30%. The total clinical effective rate = marked effective rate + effective rate.

[0082] 3.3 Two hundred patients with adenoid hypertrophy and nasal polyps aged 2 - 12 years were selected from Meizhou Yicheng Hospital of Integrated Traditional Chinese and Western Medicine for Geriatrics and Rehabilitation. The patients were divided into two groups. There were 100 patients in the control group, with a male - to - female ratio of 1:1 and an age distribution of 2 - 12 years. Among them, there were 100 patients in the experimental group, with a male - to - female ratio of 1:1 and an age distribution of 2 - 12 years. There were no statistically significant differences in the general clinical data between the two groups. On the basis of basic treatment, the control group used mometasone furoate nasal spray, 1 spray on one side each time, and at the same time used cetirizine tablets, with an oral dose of 2.5 - 5 mg given according to age and body weight, once a day. The experimental group used the external traditional Chinese medicine liquid, which was poured onto a cotton pad and applied to the bridge of the nose for about half an hour each time, once in the morning and once before going to bed. 7 days was one course of treatment, and the two groups of patients were treated for four courses, a total of 28 days. The results are shown in Table 5 and Table 6.

[0083] Table 5 Comparison of the total effective rates of the two groups in treatment [n (%)] Group Number of cases Marked effect Effective Ineffective Total effective rate (%) Control group 100 44(44%) 34(34%) 22(22%) 78% Experimental group 100 75(75%) 18(18%) 7(7%) 93%① Note: ① There was no statistically significant difference between the experimental group and the control group P <0.01.

[0084] Table 6 Comparison of side effects of the two groups [n (%)] Group Number of cases Drowsiness Dizziness and headache Gastrointestinal discomfort Dry nasal mucosa Incidence of side effects (%) Control group 100 13(13%) 6(6%) 5(5%) 8(8%) 32% Experimental group 100 1(1%) 2(2%) 1(1%) 2(2%) 6% Note: ① There was a statistically significant difference between the experimental group and the control group P <0.01.

[0085] The above - mentioned treatment results show that the external traditional Chinese medicine liquid described in the present invention has a good effect on relieving symptoms and treating adenoid hypertrophy and nasal polyps, and the clinical efficacy is superior to that of the control group ( P <0.01). The incidence of side effects such as drowsiness, dizziness, headache, gastrointestinal discomfort, and nasal mucosa dryness in the control group using mometasone furoate nasal spray combined with cetirizine tablets was relatively high, while the number of side effects of using the external traditional Chinese medicine liquid of the present invention was significantly less, the incidence of adverse reactions was low, and there was no obvious increase in the incidence of adverse reactions with the prolongation of the medication time. The safety is superior to that of the control drug.

[0086] The above is a further detailed description of the present invention, and it should not be regarded as a limitation to the specific implementation of the present invention. For those of ordinary skill in the technical field to which the present invention pertains, any simple deduction or substitution without departing from the concept of the present invention falls within the protection scope of the present invention.

Claims

1. An external medicine for treating nasal diseases, characterized in that, The parts by mass of the raw materials of its active ingredients are as follows: 10-30 parts of Xanthium sibiricum, 10-30 parts of Mentha haplocalyx Briq., 10-30 parts of Angelica dahurica, 15-30 parts of Centipeda minima (L.) A. Br. et Aschers., 5-15 parts of Asarum sieboldii Miq., 10-30 parts of Magnolia liliflora Desr., 40-80 parts of Saposhnikovia divaricata (Turcz.) Schischk., 60-120 parts of Pogostemon cablin (Blanco) Benth., 10-30 parts of Houttuynia cordata Thunb., 5-15 parts of Borneol.

2. The external medicine according to claim 1, characterized in that, The parts by mass of the raw materials of its active ingredients are as follows: 20 parts of Xanthium sibiricum, 20 parts of Mentha haplocalyx Briq., 20 parts of Angelica dahurica, 20 parts of Centipeda minima (L.) A. Br. et Aschers., 8 parts of Asarum sieboldii Miq., 20 parts of Magnolia liliflora Desr., 60 parts of Saposhnikovia divaricata (Turcz.) Schischk., 80 parts of Pogostemon cablin (Blanco) Benth., 20 parts of Houttuynia cordata Thunb., 8 parts of Borneol.

3. The topical drug according to claim 1, wherein Its preparation method includes: weighing the raw materials according to the ratio of the raw materials, extracting with water to obtain a traditional Chinese medicine liquid, and further preparing an external medicine.

4. The topical medicine according to claim 3, wherein, Its preparation method includes the following steps: Weigh the raw materials according to the ratio of the raw materials and grind them into powder; Add the traditional Chinese medicine powder into water, heat to no less than 80 °C for extraction, and concentrate to 0.4-0.7 times of the original water volume to obtain a traditional Chinese medicine liquid.

5. The external medicine according to claim 4, characterized in that, The mass mixing ratio of the traditional Chinese medicine powder to water is 1:(4-8).

6. The external medicine according to claim 4, characterized in that, After concentration, remove the medicinal residues to obtain a traditional Chinese medicine liquid.

7. The external medicine according to claim 1, characterized in that The nasal diseases are selected from acute rhinitis, chronic rhinitis, allergic rhinitis, sinusitis, pediatric adenoidal hypertrophy, and nasal polyps.

8. The external medicine according to claim 1, characterized in that, The external medicine is selected from ointments, nasal sprays, and nasal drops.

9. The external medicine according to claim 8, characterized in that, The external medicine is a patch, which is attached to the nasal bridge during use.

10. Use of the external medicine according to any one of claims 1-9 in the preparation of a drug for treating nasal diseases, wherein the nasal diseases are selected from acute rhinitis, chronic rhinitis, allergic rhinitis, sinusitis, pediatric adenoidal hypertrophy, and nasal polyps.