Traditional Chinese medicine composition for treating nasosinusitis, external ointment and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating nasosinusitis, an external ointment and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 45 to 55 parts of flos magnoliae liliflorae, 55 to 65 parts of radix angelicae, 25 to 35 parts of flos genkwa, 45 to 55 parts of fructus gleditsiae, 75 to 85 parts of leech, 115 to 125 parts of maggot, 95 to 105 parts of centipeda minima, 25 to 35 parts of fructus xanthii, 55 to 65 parts of muskmelon base, 25 to 35 parts of herba asari, 15 to 25 parts of borneol, 5 to 15 parts of menthol and 15 to 25 parts of sal ammoniac. The biond magnolia flower and the cocklebur fruit are used as monarch drugs, the radix angelicae, the centipeda minima and the asarum are used as ministerial drugs, the lilac daphne flower bud, the leech, the maggot, the muskmelon base, the fructus gleditsiae and the sal ammoniac are used as adjuvant drugs, and the borneol and the menthol are used as conductant drugs, so that a compound structure of dredging orifices, expelling pus and guiding channels is formed, and the traditional Chinese medicine composition is suitable for phlegm-heat congestion type nasosinusitis and is quick in effect and high in cure rate.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating sinusitis and application thereof. BACKGROUND

[0002] Sinusitis is a non-specific inflammation of the nasal mucosa, which is a common and frequently-occurring disease in rhinology. The inflammation of one or more sinuses is called sinusitis, and the involved sinuses include the maxillary sinus, ethmoid sinus, frontal sinus and sphenoid sinus. Sinusitis can be divided into acute and chronic types. Acute purulent sinusitis is usually secondary to acute rhinitis, and chronic purulent sinusitis develops from acute purulent sinusitis if the latter is not cured. In sinusitis, the most common type is the upper frontal sinusitis, followed by ethmoid sinusitis, frontal sinusitis and sphenoid sinusitis. Acute sinusitis is usually caused by upper respiratory tract infection, and bacterial and viral infections can occur simultaneously. Chronic sinusitis is more common than acute sinusitis, and multiple sinuses are often involved. Sinusitis is one of the common diseases in otolaryngology. Although its disability and mortality rates are very low, it has become one of the diseases that most affect the physical health and quality of life of Chinese citizens. The main recommended treatment regimens in the European and Chinese guidelines for the diagnosis and treatment of sinusitis are still the internal medicine treatment with glucocorticoids as the core and the surgical treatment with functional endoscopic sinus surgery to remove the lesions as the core.

[0003] The strategy for treating chronic rhinitis-sinusitis in Western medicine mainly aims to relieve mucosal inflammation, prevent infection and remove mucus in the sinuses. The treatment methods include oral and nasal antihistamines, oral and nasal mast cell membrane stabilizers, nasal decongestants, antibiotics, surgery and the like. Although the above methods can achieve the purpose of controlling symptoms, the problems such as drug toxicity, side effects and surgical complications cannot be ignored. For example, long-term medication may harm the health of patients, especially children and the elderly, and long-term use is easy to form drug rhinitis.

[0004] Sinusitis belongs to the category of "biennial" in traditional Chinese medicine, and the pathogenesis is mainly caused by internal and external factors. Internal factors are mainly dysfunction of viscera, mainly deficiency of lung, spleen and kidney; external factors are mainly invasion of wind-cold and foreign qi into the lung.

[0005] CN 112043744 A discloses an external medicine for treating rhinitis and sinusitis, which belongs to external medicine and is prepared from traditional Chinese medicinal materials such as gansui, toad skin, asarum, baizhi, xieshu, cuanwan, calcined oyster, honeysuckle and licorice root by means of crushing and blending to form an external ointment. The external ointment can treat rhinitis, sinusitis and complications caused by rhinitis and sinusitis, and has the advantages of simple use, short time effect, good effect, high cure rate and significant effect. However, it also has some disadvantages, such as the addition of toxic components, strong mucosal irritation, unreasonable compatibility and insufficient transdermal absorption.

[0006] CN 118615262 A discloses a traditional Chinese medicine composition, a patch, and its preparation method for treating sinusitis, belonging to the field of traditional Chinese medicine preparation technology. The composition is made from the following raw materials in parts by weight: Astragalus membranaceus 10-20 parts, Angelica dahurica 10-20 parts, Xanthium sibiricum 5-16 parts, Rheum palmatum 12-22 parts, Gleditsia sinensis thorns 10-20 parts, Borneol 8-18 parts, pig bile powder 10-16 parts, Magnolia biondii 10-20 parts, Senecio scandens 7-17 parts, Ficus pumila 6-16 parts, Lonicera japonica 10-20 parts, and Taraxacum mongolicum 10-20 parts. The raw materials are extracted with water, concentrated, dried, and then mixed with excipients, and then spread onto a dressing patch to obtain the final product.

[0007] CN 117244000 A discloses a traditional Chinese medicine composition for treating rhinitis, its preparation method, and its application, belonging to the field of medical pharmaceutical technology. This invention provides a traditional Chinese medicine composition for treating rhinitis, the raw materials of which include bee honeycomb, dried plum pulp, pomegranate peel, sophora flavescens, clove, white mustard seed, borax, alum, borneol, cinnamon twig, cuttlebone, dandelion, daphne genkwa, asarum, and cimicifuga. The traditional Chinese medicine composition provided by this invention can reduce toxic side effects and synergistically enhance the therapeutic effect on rhinitis, showing good efficacy for nasal turbinate hypertrophy, various types of sinusitis, allergic rhinitis, and nasal polyps. However, it also has shortcomings: daphne genkwa is highly toxic, borax and alum are excessively irritating to the mucous membranes, the compatibility is not ideal, and transdermal absorption is insufficient.

[0008] Therefore, there is an urgent need to develop a traditional Chinese medicine preparation and treatment method for sinusitis that is effective, fast-acting, safe, and highly targeted, so as to improve the quality of life of patients. Summary of the Invention

[0009] In view of the problems of existing Western medicines for treating sinusitis, such as easy dependence, drug resistance and adverse reactions, the tendency of long-term use of traditional Chinese medicine to cause drug-induced rhinitis, and the slow efficacy and side effects of traditional Chinese medicine decoctions and the lack of targeted Chinese medicine compositions for sinusitis, this invention provides a targeted Chinese medicine composition for treating sinusitis, a topical ointment, its preparation method and application.

[0010] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0011] A traditional Chinese medicine composition for treating sinusitis, comprising the following raw materials in parts by weight: 45-55 parts Magnolia biondii, 55-65 parts Angelica dahurica, 25-35 parts Daphne genkwa, 45-55 parts Gleditsia sinensis, 75-85 parts Hirudo medicinalis, 115-125 parts Eupolyphaga sinensis, 95-105 parts Centipeda minima, 25-35 parts Xanthium sibiricum, 55-65 parts Cucurbita melon stalk, 25-35 parts Asarum heterotropoides, 15-25 parts Borneol, 5-15 parts Menthol, and 15-25 parts Sal ammoniac.

[0012] As a preferred technical scheme of the present application, the Chinese medicinal composition for treating sinusitis is characterized by comprising the following raw materials in parts by weight: 48-52 parts of magnolia flower, 58-62 parts of radix angelicae pubescentis, 28-33 parts of radix strychni, 48-52 parts of ginseng, 78-83 parts of leech, 118-122 parts of pentatomidae, 98-103 parts of eriocaulon, 28-32 parts of xanthium sibiricum, 58-62 parts of melon stem, 28-32 parts of asarum, 18-23 parts of borneol, 8-13 parts of bomeol, and 18-22 parts of halite.

[0013] As a preferred technical scheme of the present application, the Chinese medicinal composition for treating sinusitis is characterized by comprising the following raw materials in parts by weight: 48-52 parts of magnolia flower, 58-62 parts of radix angelicae pubescentis, 28-33 parts of radix strychni, 48-52 parts of ginseng, 78-83 parts of leech, 118-122 parts of pentatomidae, 98-103 parts of eriocaulon, 28-32 parts of xanthium sibiricum, 58-62 parts of melon stem, 28-32 parts of asarum, 18-23 parts of borneol, 8-13 parts of bomeol, and 18-22 parts of halite.

[0014] The present application further provides use of the Chinese medicinal composition for treating sinusitis in the preparation of a medicine for preventing and / or treating sinusitis.

[0015] Preferably, the medicine further comprises pharmaceutically acceptable adjuvants, such as sesame oil, vaseline, transdermal penetration enhancers, etc.

[0016] An external ointment for treating sinusitis is prepared from the Chinese medicinal composition for treating sinusitis, comprising the following steps:

[0017] (1) The raw materials of the Chinese medicinal composition for treating sinusitis are weighed, dried, and then crushed into fine powder, and the powder is mixed to obtain the Chinese medicinal composition powder;

[0018] (2) The Chinese medicinal composition powder is mixed with appropriate amounts of sesame oil, vaseline, and transdermal penetration enhancers to obtain an ointment, which is then injected into a syringe, sealed with aluminum plastic film, and sterilized by irradiation to obtain the external ointment for treating sinusitis.

[0019] As a preferred technical scheme of the present application, the crushing is carried out at a low temperature of -25℃ to -15℃ to obtain fine powder with a particle size of 250-350 mesh, so as to protect the active ingredients of the raw materials from being damaged.

[0020] As a preferred technical scheme of the present application, the amount of sesame oil is 10%-15%, the amount of vaseline is 20%-30%, and the amount of transdermal penetration enhancer is 1.0%-3%, based on the mass of the Chinese medicinal composition powder.

[0021] As a preferred technical scheme of the present application, the content of the ointment in each syringe is 1.2 g, which is used externally, and one syringe is inserted into each nostril, and then removed after 40-60 minutes. The treatment is performed once every 5-7 days.

[0022] It should be noted that the medicine for treating sinusitis prepared from the traditional Chinese medicine composition for treating sinusitis according to the present application can be prepared into various dosage forms by adding pharmaceutically acceptable excipients, and is not limited to a plaster, but can also be a powder, an oil, etc.

[0023] The effects of each component of the traditional Chinese medicine composition for treating sinusitis according to the present application are as follows:

[0024] (1) Magnolia flower

[0025] Effect: Pungent, warm, enters the lung and stomach channels, dispels wind-cold, unblocks the nasal passages, and warms the lung to resolve fluid.

[0026] Action: It is the first choice of “nose unblocking medicine”, and is good at dispelling wind-cold and unblocking the nasal passages, and can quickly relieve the main symptoms of sinusitis such as nasal congestion, rhinorrhea, and reduced sense of smell. The volatile oil can promote the absorption of nasal mucosa secretions and reduce inflammation.

[0027] Compatibility basis: It is compatible with Bai Zhi to enhance the ability of pungent and dispersing and unblocking the nasal passages, and targets the core symptoms of sinusitis “nasal passage obstruction”.

[0028] (2) Bai Zhi

[0029] Effect: Pungent, warm, enters the lung, stomach, and large intestine channels, and resolves exterior cold, dispels wind and pain, unblocks the nasal passages, and dries dampness to stop leucorrhea.

[0030] Action: Pungent and warm, ascending to the head and face, it is good at unblocking the nasal passages, and can relieve symptoms such as nasal congestion, yellowish nasal discharge, and forehead pain caused by sinusitis (rhinitis and sinusitis in Western medicine).

[0031] Compatibility basis: It is used with Magnolia flower to strengthen the effect of unblocking the nasal passages, and targets the main symptoms of sinusitis “nasal congestion and headache”.

[0032] (3) Yunnan Baiyao

[0033] Effect: Bitter and pungent, warm; toxic (must be prepared for external use). Enters the lung, spleen, and kidney channels, and resolves fluid, expels phlegm, and stops cough.

[0034] Action: It can kill insects and heal sores when used externally, and can assist the monarch drug in dispelling wind and dampness, resolving phlegm and dispelling stasis, and relieve symptoms such as nasal discharge and nasal mucosa swelling caused by sinusitis. The volatile oil can stimulate the skin, but attention should be paid to avoid contact with the eyes and oral mucosa when used externally.

[0035] (4) Pig tooth saponin

[0036] Effect: Pungent and salty, warm; slightly toxic. Enters the lung and large intestine channels, and resolves phlegm, unblocks the nasal passages, and dispels stasis to relieve swelling.

[0037] Action: It can dispel stasis and relieve swelling when used externally, and enhance the effect of unblocking the nasal passages. The saponin component can promote the discharge of nasal secretions and relieve nasal mucosa congestion.

[0038] (5) Leech

[0039] Efficacy: Bitter, salty, flat; slightly toxic. Liver and bladder meridians. Expelling blood stasis, dredging channels and collaterals.

[0040] Action: External use can improve the nasal mucosa blood stasis, swelling, and auxiliary monarch drug against rhinosinusitis "dampness and blood stasis" pathogenesis. Its leechin component can inhibit inflammatory response and reduce pain.

[0041] (6) Five grain worms

[0042] Efficacy: Salty, cold. Spleen and stomach meridians. Spleen and stomach, heat clearing and removing.

[0043] Action: External use can clear heat and detoxify, remove accumulation and resolve nodes, and auxiliary monarch drug to remove the nasal cavity dampness and evil, relieve rhinosinusitis "flowing pus, nasal mucosa ulceration" symptoms. It is rich in protein and trace elements, which can promote mucosal repair.

[0044] (7) Goose not grass

[0045] Efficacy: Xinyun, warm. Lung meridian. Dispersing wind and cold, opening nasal passages, relieving cough.

[0046] Action: Xinyun, external use can open nasal passages, dispel wind and cold, and auxiliary monarch drug to relieve symptoms such as nasal congestion, rhinorrhea, sneezing and other symptoms caused by rhinosinusitis. It is often used to treat rhinitis by inserting the nose, and the effect is significant.

[0047] (8) Xanthium fruit

[0048] Efficacy: Xinyun, bitter, warm; toxic (must be used after frying). Lung meridian. Dispersing wind and cold, opening nasal passages, dispelling wind and dampness, relieving pain.

[0049] Action: Xinyun and toxic, external use can open nasal passages, dispel wind and cold, and relieve symptoms such as nasal congestion, headache and other symptoms caused by rhinosinusitis. But pay attention to its toxicity, must be used after processing (such as frying), avoid excessive.

[0050] (9) Sweet melon peduncle

[0051] Efficacy: Bitter, cold; toxic (need to control the amount). Spleen, stomach and liver meridians. Expelling sputum and food, dispelling dampness and reducing yellow.

[0052] Action: External use can dispel dampness and reduce yellow, relieve swelling and diuresis, and auxiliary monarch drug to relieve symptoms of rhinosinusitis "dampness and heat". Its cucurbitacins can inhibit inflammatory response and reduce nasal mucosal swelling.

[0053] (10) Asarum

[0054] Efficacy: Xinyun, warm, lung and kidney meridians, relieving exterior and dispelling cold, dispelling wind and relieving pain, opening orifices, warming lung and resolving fluid.

[0055] Function: Xinyi has small toxicity, and can be used externally to relieve nasal congestion, headache and other symptoms caused by rhinosinusitis. However, attention should be paid to its toxicity, and the dosage should not be too large (external use should be appropriate).

[0056] (11) Borneol

[0057] Function: Xinyi has small toxicity, and can be used externally to relieve nasal congestion, headache and other symptoms caused by rhinosinusitis. However, attention should be paid to its toxicity, and the dosage should not be too large (external use should be appropriate).

[0058] Function: Xinyi has small toxicity, and can be used externally to relieve nasal congestion, headache and other symptoms caused by rhinosinusitis. However, attention should be paid to its toxicity, and the dosage should not be too large (external use should be appropriate).

[0059] (12) Menthol

[0060] Function: Xinyi has small toxicity, and can be used externally to relieve nasal congestion, headache and other symptoms caused by rhinosinusitis. However, attention should be paid to its toxicity, and the dosage should not be too large (external use should be appropriate).

[0061] Function: Xinyi has small toxicity, and can be used externally to relieve nasal congestion, headache and other symptoms caused by rhinosinusitis. However, attention should be paid to its toxicity, and the dosage should not be too large (external use should be appropriate).

[0062] (13) Glauber's salt

[0063] Function: Xinyi has small toxicity, and can be used externally to relieve nasal congestion, headache and other symptoms caused by rhinosinusitis. However, attention should be paid to its toxicity, and the dosage should not be too large (external use should be appropriate).

[0064] Function: Xinyi has small toxicity, and can be used externally to relieve nasal congestion, headache and other symptoms caused by rhinosinusitis. However, attention should be paid to its toxicity, and the dosage should not be too large (external use should be appropriate).

[0065] Rhinosinusitis in traditional Chinese medicine is mostly "Biqin", and common causes include wind-cold, wind-heat, damp-heat, and blood stasis. The drugs used in the present application for treating rhinosinusitis are capable of clearing heat and resolving toxins, dispelling wind and unblocking the nasal passages, and removing dampness and draining pus.

[0066] The traditional Chinese medicine composition and its external ointment provided by the present application for treating rhinosinusitis are based on the compatibility principle of "jun, chen, zhu and shi", and the prescription is explained as follows:

[0067] The jun medicine is usually the main drug for the main symptoms. The main symptoms of rhinosinusitis are nasal congestion and purulent discharge, and the jun medicine should be selected from drugs with strong nasal passage unblocking effect. Xinyi flower and caryophylli fructus can be used as the jun medicine.

[0068] The chen medicine assists the jun medicine and enhances the curative effect. Bai zhi, goose grass, and halleria lucida also have the effect of unblocking the nasal passages and can be used as the chen medicine.

[0069] The zhu medicine is used to assist or restrict the toxicity or side effects of the jun and chen medicines. Yunnan flower, leech, pentatomidae, melon peduncle, pig tooth saponin, and glauber's salt are used as the zhu medicine. Leeches have the effect of activating blood and removing blood stasis, pentatomidae have the effect of clearing heat and resolving toxins, yunnan flower and melon peduncle have the effect of removing dampness and draining pus, pig tooth saponin has the effect of enhancing the unblocking effect of the nasal passages, and glauber's salt assists the jun medicine in relieving the symptoms of nasal mucosa ulceration and polyps.

[0070] Ice, menthol, open up, belong to the medicine. Guide the drug effect or harmonize the drugs. Lead the medicine to the nasal cavity, while harmonizing the drug properties.

[0071] According to the prescription principle of "monarch, minister and assistant" in traditional Chinese medicine, combined with the pathogenesis of sinusitis (due to wind-cold, damp-heat, blood stasis, phlegm and other pathological products blocking the nasal cavity, leading to clear yang not rising, turbid yin covering), the role of each drug in the prescription is analyzed as follows:

[0072] I. Monarch (core drug for main symptoms)

[0073] Magnolia flower function: pungent and warm, dispersing, unblocking the nasal cavity, dispelling wind-cold, is the monarch drug for treating rhinitis (sinusitis). Its volatile oil components can constrict nasal mucosal blood vessels, reduce secretions, and improve nasal congestion.

[0074] Dose basis: largest dosage (50g), reflecting its main direction.

[0075] Hemlock seed function: combined with magnolia, enhance the effect of unblocking the nasal cavity, and have the effect of eliminating dampness and relieving pain, commonly used for rhinitis purulent discharge, headache.

[0076] II. Minister (assist the monarch, strengthen the treatment of main symptoms)

[0077] Baizhi function: dispelling wind and cold, unblocking and relieving pain, good at treating forehead headache and nasal congestion, and synergistically enhancing the unblocking effect with magnolia and hemlock seed.

[0078] Goose herb function: pungent and warm, unblocking the nasal cavity, attacking nasal congestion and rhinorrhea, especially suitable for rhinitis with purulent discharge and congestion.

[0079] Xiaocin function: dispelling wind and cold, unblocking and relieving pain, and can also warm the lungs and resolve fluid, suitable for cold-damp type sinusitis.

[0080] III. Assistant (assist or restrict monarch and minister, treat both main and secondary symptoms)

[0081] Yuanhua and melon peduncle function: yuanhua can eliminate water and fluid, and melon peduncle can induce vomiting and phlegm, both of which can eliminate thick pus in the nasal cavity, but attention should be paid to toxicity and dosage should be controlled.

[0082] Leech function: promoting blood circulation and removing blood stasis, improving nasal mucosal microcirculation and resolving phlegm and blood stasis.

[0083] Five grain worms function: clearing heat and resolving toxins, removing stagnation and accumulation, and assisting in removing damp-heat evil.

[0084] Pig tooth soap function: externally used to disperse and resolve, enhance the effect of unblocking the nasal cavity. Its saponin components can promote the discharge of nasal secretions and reduce nasal mucosal congestion.

[0085] Oyster sand function: softening and resolving, eroding polyps, suitable for nasal polyps or sinus cavity pus

[0086] IV. Guiding herbs (or harmonizing other herbs)

[0087] The effects of borneol and menthol: borneol opens the orifices and refreshes the mind, while menthol (menthol) cools and penetrates the surface. The two guide the medicine upward to the nasal cavity, enhancing the effect of opening the orifices, and at the same time harmonize the properties of the whole prescription.

[0088] In summary, this formula has a strong purgative effect: the herbs in the formula, such as Daphne genkwa, Cucurbita peduncle, and Salvia miltiorrhiza, are potent and suitable for severe sinusitis caused by phlegm and blood stasis. It emphasizes both clearing the nasal passages and draining pus: Magnolia biondii and Xanthium sibiricum clear the nasal passages, while Hirudo medicinalis and Gramineae spp. drain pus, reflecting the core concept of "detoxification therapy".

[0089] The beneficial effects of this invention are:

[0090] Magnolia flower and Xanthium fruit are the principal herbs: their combined effect in clearing the nasal passages is stronger, significantly improving symptoms such as nasal congestion, runny nose, and headache caused by rhinitis. Angelica dahurica, Centipeda minima, and Asarum are the assistant herbs: their combined effect enhances the nasal-clearing power of the principal herbs. Daphne genkwa, leech, five-grain insect, melon stalk, Gleditsia sinensis, and sal ammoniac are the adjuvant herbs: used to assist or restrain the toxicity or side effects of the principal and assistant herbs. This combination enhances the effects of softening and dispersing nodules, promoting diuresis and reducing swelling, and draining pus, removing thick purulent nasal discharge from the sinuses, promoting the discharge of nasal secretions, and enhancing nasal patency. Borneol and menthol are the guiding herbs, which direct the medicine upwards to the nasal passages, enhancing the nasal-clearing effect, while also harmonizing the overall properties of the formula. The above-mentioned herbal combination forms a compound structure of "nasal-clearing + pus-draining + meridian-guiding," suitable for sinusitis of the phlegm-heat obstruction type.

[0091] The present invention provides a traditional Chinese medicine composition with a simple processing procedure, few operation steps, and easy product preparation.

[0092] The traditional Chinese medicine composition provided by this invention is simple to use and can be operated by a single person at home or in a clinic. It effectively achieves safe, effective, simple operation, no toxic side effects, wide range of treatment, no surgery, no injections, no punctures, painless treatment, short treatment time, fast effect, low cost and high cure rate. Attached Figure Description

[0093] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0094] Figure 1 This is a nasal endoscopy image from clinical case 1.

[0095] Figure 2 This is a nasal endoscopy image from clinical case 2.

[0096] Figure 3This is a nasal endoscopy image from clinical case 3.

[0097] Figure 4 This is a comparison of sinus CT scans before and after treatment for a patient with sinusitis in Clinical Case 4. Detailed Implementation

[0098] The present invention will be further described below with reference to the accompanying drawings and specific embodiments. It should be understood that the following embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Those skilled in the art can make some non-essential improvements and adjustments based on the above description of the invention.

[0099] This invention provides a traditional Chinese medicine composition for treating sinusitis, comprising the following raw materials in parts by weight: 45-55 parts Magnolia biondii, 55-65 parts Angelica dahurica, 25-35 parts Daphne genkwa, 45-55 parts Gleditsia sinensis, 75-85 parts Hirudo medicinalis, 115-125 parts Eupolyphaga sinensis, 95-105 parts Centipeda minima, 25-35 parts Xanthium sibiricum, 55-65 parts Cucurbita melon stalk, 25-35 parts Asarum heterotropoides, 15-25 parts Borneol, 5-15 parts Menthol, and 15-25 parts Sal ammoniac.

[0100] Unless otherwise specified, the present invention does not impose any special restrictions on the source of the raw materials, and any commercially available products in the art can be used.

[0101] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention, by weight, comprises 45-55 parts of Magnolia biondii flower, preferably 48-52 parts, more preferably 50 parts, using whole dried flower buds. In the present invention, Magnolia biondii flower is pungent and warm in nature, dispersing nasal passages and wind-cold, and is the principal herb for treating sinusitis. Its volatile oil components can constrict nasal mucosal blood vessels, reduce secretions, and improve nasal congestion.

[0102] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention includes 55-65 parts of Angelica dahurica, preferably 58-62 parts, and more preferably 60 parts, by weight. In the present invention, Angelica dahurica dispels wind and cold, clears the nasal passages and relieves pain, and is good at treating frontal headache and nasal congestion. It works synergistically with Magnolia biondii and Xanthium sibiricum to enhance the effect of clearing the nasal passages.

[0103] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention, by weight, includes 25-35 parts of Daphne genkwa, preferably 28-33 parts, more preferably 30 parts, with Daphne genkwa being vinegar-processed to reduce toxicity. In the present invention, Daphne genkwa is used to drain water and promote vomiting, while the pedicel of the melon induces vomiting of phlegm. The combination of these two ingredients can remove thick purulent nasal discharge from the sinuses, but attention must be paid to toxicity, and dosage must be controlled.

[0104] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention, by weight, includes 45-55 parts of *Gnaphalium affine*, preferably 48-52 parts, and more preferably 50 parts. In the present invention, *Gnaphalium affine*, when applied externally, can disperse nodules and reduce swelling, enhancing nasal patency. Its saponin components can promote the discharge of nasal secretions and reduce nasal mucosal congestion.

[0105] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention includes 75-85 parts of leech, preferably 78-83 parts, and more preferably 80 parts, by weight. In the present invention, the leech promotes blood circulation, removes blood stasis, improves the microcirculation of the sinus mucosa, and resolves the mutual binding of phlegm and blood stasis.

[0106] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention includes 115-125 parts of *Polygonum multiflorum*, preferably 118-122 parts, and more preferably 120 parts, by weight. In the present invention, *Polygonum multiflorum* clears heat and detoxifies, eliminates stagnation and promotes the elimination of damp-heat toxins.

[0107] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention includes 95-105 parts of Centipeda minima, preferably 98-103 parts, and more preferably 100 parts, by weight. The Centipeda minima described in the present invention is pungent and warm, and can penetrate the nasal passages. It is specifically effective for nasal congestion and runny nose, and is especially suitable for nasal congestion with purulent nasal discharge.

[0108] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention, by weight, includes 25-35 parts of Xanthium sibiricum, preferably 28-32 parts, and more preferably 30 parts, wherein the Xanthium sibiricum is stir-fried to reduce toxicity. In the present invention, Xanthium sibiricum is combined with Magnolia biondii to enhance the ability to clear nasal passages, and also has the effects of dispelling dampness and relieving pain, and is commonly used for nasal discharge, purulent nasal discharge, and headache.

[0109] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention includes 55-65 parts by weight of melon stalk, preferably 58-62 parts, and more preferably 60 parts. The present invention uses Daphne genkwa to drain water and expel phlegm, and melon stalk to induce vomiting. The combination of the two can remove thick purulent nasal discharge from the sinuses, but attention should be paid to toxicity and the dosage should be controlled.

[0110] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention, by weight, comprises 25-35 parts of Asarum, preferably 28-32 parts, more preferably 30 parts, using the dried root and rhizome of Asarum, excluding the leaves, and preferably Liaoning Asarum. The Asarum described in this invention dispels wind and cold, clears the nasal passages and relieves pain, and also warms the lungs and resolves phlegm, making it suitable for cold-dampness type sinusitis.

[0111] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention includes 15-25 parts of borneol, preferably 18-22 parts, and more preferably 20 parts, by weight. In the present invention, borneol has the functions of opening the orifices and refreshing the mind, clearing heat and relieving pain, and promoting transdermal absorption, which can enhance the effect of the drug reaching the affected area directly and relieve nasal congestion.

[0112] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention, by weight, includes 5-15 parts of menthol, preferably 8-13 parts, and more preferably 10 parts. In this invention, the menthol is pungent and cool, penetrating the exterior, clearing the head and eyes, and guiding the medicine upwards to the nasal passages. It relieves nasal congestion and, as a harmonizing agent, balances the warming and drying properties of the entire formula, allowing the medicinal power to concentrate in the nasal passages. Borneol opens the orifices and refreshes the mind, while menthol (thin menthol) is cool and penetrating the exterior; both guide the medicine upwards to the nasal passages, enhancing the nasal opening effect, while simultaneously harmonizing the overall medicinal properties of the formula.

[0113] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention includes 15-25 parts of ammoniacal saliva, preferably 18-22 parts, and more preferably 20 parts, by weight. The ammoniacal saliva in the present invention softens and disperses nodules, corrodes polyps, and is suitable for nasal polyps or sinus effusion.

[0114] In some embodiments, the traditional Chinese medicine composition for treating sinusitis provided by the present invention, by weight, includes 50 parts of Magnolia biondii, 60 parts of Angelica dahurica, 30 parts of Daphne genkwa, 50 parts of Gleditsia sinensis, 80 parts of Hirudo medicinalis, 120 parts of Eupolyphaga sinensis, 100 parts of Centipeda minima, 30 parts of Xanthium sibiricum, 60 parts of Cucurbita melon stalk, 30 parts of Asarum heterotropoides, 20 parts of Borneol, 10 parts of Menthol, and 20 parts of Sal ammoniac.

[0115] The formula of this invention has a strong purgative effect: the ingredients such as Daphne genkwa, melon stalk, and sal ammoniac are potent and suitable for sinusitis with severe phlegm and blood stasis. It emphasizes both clearing the nasal passages and draining pus: Magnolia biondii and Xanthium sibiricum clear the nasal passages, while leeches and worm pus drain pus, embodying the core concept of "detoxification therapy." This invention uses Magnolia biondii and Xanthium sibiricum as the principal herbs, Angelica dahurica, Centipeda minima, and Asarum heterotropoides as the assistant herbs, Daphne genkwa, leeches, worm pus, melon stalk, Gleditsia sinensis, and sal ammoniac as adjuvant herbs, and borneol and menthol as guiding herbs, forming a compound structure of "clearing the nasal passages + draining pus + guiding the medicine to the meridians," suitable for sinusitis of the phlegm-heat obstruction type.

[0116] The present invention also provides a topical ointment made using the above-mentioned traditional Chinese medicine composition for treating sinusitis, comprising the following steps:

[0117] (1) Weigh the above-mentioned raw materials of the Chinese medicine composition for treating rhinitis, dry them, pulverize them to obtain fine powder, and mix them evenly to obtain the Chinese medicine composition powder.

[0118] (2) Add appropriate amounts of sesame oil, petrolatum, and transdermal penetration enhancer to the powder of the Chinese herbal composition, mix evenly into a paste, inject into a syringe, seal with aluminum-plastic film and sterilize by irradiation to obtain a topical ointment for the treatment of sinusitis.

[0119] As a preferred technical solution of the present invention: the pulverization is carried out by low-temperature cell wall breaking ultrafine processing at -25°C to -15°C to produce fine powder of 250-350 mesh.

[0120] As a preferred technical solution of the present invention: based on the mass of the traditional Chinese medicine composition powder, add 10%-15% sesame oil, 20%-30% petrolatum, and 1.0%-3% transdermal penetration enhancer.

[0121] This invention provides a method for using the traditional Chinese medicine composition described in the above technical solution, comprising the following steps (taking "Dulitong Nasal Congestion Relief Ointment" as an example):

[0122] Using the special applicator containing "Dulitong Nasal Congestion Relief Ointment," push the ointment 1 cm into the back of the nostril and into the middle nasal meatus, ensuring the ointment adheres closely to the nasal mucosa and reaches the middle nasal meatus (the openings of the maxillary sinus, frontal sinus, and anterior ethmoid sinus open into the middle nasal meatus), facilitating detoxification of the nasal mucosa and sinus openings. Leave the "Dulitong Nasal Congestion Relief Ointment" in the nasal cavity for 40-60 minutes before blowing it out. Immediately after blowing out the ointment, the nostrils will feel exceptionally clear and comfortable. Nasal congestion may occur as detoxification begins, but it will clear up in approximately 10-24 hours. It is recommended to use the nasal congestion relief ointment approximately every 5-7 days, with 6-8 boxes (two tubes per box) constituting one course of treatment. Those with severe sinusitis may require two courses of treatment.

[0123] Example 1

[0124] The traditional Chinese medicine composition used in this embodiment for treating sinusitis consists of the following raw materials in parts by weight: 50 parts Magnolia biondii, 60 parts Angelica dahurica, 30 parts Daphne genkwa, 50 parts Gleditsia sinensis, 80 parts Hirudo medicinalis, 120 parts Eupolyphaga sinensis, 100 parts Centipeda minima, 30 parts Xanthium sibiricum, 60 parts Cucurbita melon stalk, 30 parts Asarum heterotropoides, 20 parts Borneol, 10 parts Menthol, and 20 parts Sal ammoniac.

[0125] The preparation of a topical ointment using the above-mentioned traditional Chinese medicine composition for treating sinusitis includes the following steps:

[0126] (1) Weigh the above-mentioned raw materials of the Chinese medicine composition for treating rhinitis, dry them, and then process them into fine powder of 250-350 mesh at a low temperature of -20℃. After mixing them evenly, the powder of the Chinese medicine composition is obtained.

[0127] (2) Based on the mass of the Chinese medicine composition powder, add 12% sesame oil, 25% petrolatum and 2% transdermal penetration enhancer to the Chinese medicine composition powder, mix evenly into a paste, inject into a syringe, seal with aluminum-plastic film and sterilize by irradiation to obtain a topical ointment for the treatment of sinusitis.

[0128] The method of using this invention is as follows: Use the applicator to push the ointment 1 cm into the back of the nostril and into the middle nasal meatus, ensuring that the nasal decongestant ointment adheres closely to the nasal mucosa and reaches the middle nasal meatus (the openings of the maxillary sinus, frontal sinus, and anterior ethmoid sinus open into the middle nasal meatus), facilitating detoxification of the nasal mucosa and sinus openings. Leave the "Dulitong Nasal Decongestant Ointment" in the nasal cavity for 40-60 minutes before blowing it out.

[0129] Example 2

[0130] The traditional Chinese medicine composition for treating sinusitis in this embodiment consists of the following raw materials in parts by weight: 48 parts Magnolia biondii, 58 parts Angelica dahurica, 28 parts Daphne genkwa, 48 parts Gleditsia sinensis, 78 parts Hirudo medicinalis, 118 parts Eupolyphaga sinensis, 95 parts Centipeda minima, 28 parts Xanthium sibiricum, 58 parts Cucurbita melon stalk, 28 parts Asarum heterotropoides, 18 parts Borneol, 8 parts Menthol, and 18 parts Sal ammoniac.

[0131] The preparation of a topical ointment using the above-mentioned traditional Chinese medicine composition for treating sinusitis includes the following steps:

[0132] (1) Weigh the above-mentioned raw materials of the Chinese medicine composition for treating rhinitis, dry them, and then process them into fine powder of 250-350 mesh at a low temperature of -25℃. After mixing them evenly, the powder of the Chinese medicine composition is obtained.

[0133] (2) Based on the mass of the Chinese medicine composition powder, add appropriate amounts of 10% sesame oil, 30% petrolatum and 1.0% transdermal penetration enhancer to the Chinese medicine composition powder, mix evenly into a paste, inject into a syringe, seal with aluminum-plastic film and sterilize by irradiation to obtain a topical ointment for the treatment of sinusitis.

[0134] The method of using the topical ointment for treating sinusitis in this embodiment is the same as in Embodiment 1.

[0135] Example 3

[0136] The traditional Chinese medicine composition for treating sinusitis in this embodiment consists of the following raw materials in parts by weight: 52 parts Magnolia biondii, 62 parts Angelica dahurica, 33 parts Daphne genkwa, 52 parts Gleditsia sinensis, 83 parts Hirudo medicinalis, 122 parts Eupolyphaga sinensis, 103 parts Centipeda minima, 32 parts Xanthium sibiricum, 62 parts Cucurbita melon stalk, 32 parts Asarum heterotropoides, 23 parts Borneol, 13 parts Menthol, and 22 parts Sal ammoniac.

[0137] The preparation of a topical ointment using the above-mentioned traditional Chinese medicine composition for treating sinusitis includes the following steps:

[0138] (1) Weigh the above-mentioned raw materials of the Chinese medicine composition for treating rhinitis, dry them, and then process them into fine powder of 250-350 mesh at a low temperature of -15℃. After mixing them evenly, the powder of the Chinese medicine composition is obtained.

[0139] (2) Based on the mass of the Chinese medicine composition powder, add 15% sesame oil, 20% petrolatum and 3% transdermal penetration enhancer to the Chinese medicine composition powder, mix evenly into a paste, inject into a syringe, seal with aluminum-plastic film and sterilize by irradiation to obtain a topical ointment for the treatment of sinusitis.

[0140] The method of using the topical ointment for treating sinusitis in this embodiment is the same as in Embodiment 1.

[0141] Example 4

[0142] The traditional Chinese medicine composition for treating sinusitis in this embodiment consists of the following raw materials in parts by weight: 49 parts Magnolia biondii, 59 parts Angelica dahurica, 29 parts Daphne genkwa, 49 parts Gleditsia sinensis, 80 parts Hirudo medicinalis, 119 parts Eupolyphaga sinensis, 100 parts Centipeda minima, 29 parts Xanthium sibiricum, 59 parts Cucurbita melon stalk, 29 parts Asarum heterotropoides, 20 parts Borneol, 9 parts Menthol, and 19 parts Sal ammoniac.

[0143] The preparation method and usage method of the topical ointment for treating sinusitis in this embodiment are the same as in Embodiment 1.

[0144] Example 5

[0145] The traditional Chinese medicine composition for treating sinusitis in this embodiment consists of the following raw materials in parts by weight: 51 parts Magnolia biondii, 60 parts Angelica dahurica, 31 parts Daphne genkwa, 50 parts Gleditsia sinensis, 82 parts Hirudo medicinalis, 120 parts Eupolyphaga sinensis, 102 parts Centipeda minima, 31 parts Xanthium sibiricum, 60 parts Cucurbita melon stalk, 30 parts Asarum heterotropoides, 21 parts Borneol, 12 parts Menthol, and 21 parts Sal ammoniac.

[0146] The preparation method and usage method of the topical ointment for treating sinusitis in this embodiment are the same as in Embodiment 1.

[0147] Example 6

[0148] The traditional Chinese medicine composition for treating sinusitis in this embodiment consists of the following raw materials in parts by weight: 52 parts Magnolia biondii, 61 parts Angelica dahurica, 32 parts Daphne genkwa, 51 parts Gleditsia sinensis, 83 parts Hirudo medicinalis, 122 parts Eupolyphaga sinensis, 103 parts Centipeda minima, 32 parts Xanthium sibiricum, 62 parts Cucurbita melon stalk, 32 parts Asarum heterotropoides, 23 parts Borneol, 13 parts Menthol, and 22 parts Sal ammoniac.

[0149] The preparation method and usage method of the topical ointment for treating sinusitis in this embodiment are the same as in Embodiment 1.

[0150] Example 7

[0151] A traditional Chinese medicine composition for treating sinusitis, comprising the following raw materials in parts by weight: 45 parts Magnolia biondii, 55 parts Angelica dahurica, 25 parts Daphne genkwa, 45 parts Gleditsia sinensis, 75 parts Hirudo medicinalis, 115 parts Eupolyphaga sinensis, 95 parts Centipeda minima, 25 parts Xanthium sibiricum, 55 parts Cucurbita melon stalk, 25 parts Asarum heterotropoides, 15 parts Borneol, 5 parts Menthol, and 15 parts Sal ammoniac.

[0152] The preparation method and usage method of the topical ointment for treating sinusitis in this embodiment are the same as in Embodiment 1.

[0153] Example 8

[0154] A traditional Chinese medicine composition for treating sinusitis, comprising the following raw materials in parts by weight: 55 parts Magnolia biondii, 65 parts Angelica dahurica, 35 parts Daphne genkwa, 55 parts Gleditsia sinensis, 85 parts Hirudo medicinalis, 125 parts Eupolyphaga sinensis, 105 parts Centipeda minima, 35 parts Xanthium sibiricum, 65 parts Cucurbita melon stalk, 35 parts Asarum heterotropoides, 25 parts Borneol, 15 parts Menthol, and 25 parts Sal ammoniac.

[0155] The preparation method and usage method of the topical ointment for treating sinusitis in this embodiment are the same as in Embodiment 1.

[0156] Comparative Example 1

[0157] A traditional Chinese medicine composition for treating sinusitis, with the same components and preparation method as in Example 1, except that Magnolia biondii is not added.

[0158] Treatment outcome: There is still a lot of discharge, and the nasal congestion is improving slowly.

[0159] Comparative Example 2

[0160] A traditional Chinese medicine composition for treating sinusitis, with the same components and preparation method as in Example 1, except that the cantaloupe stalk is not added.

[0161] Therapeutic effects: The combination of Daphne genkwa and melon stalk can remove thick, purulent nasal discharge from the sinuses; the combination of melon stalk and sal ammoniac can disperse nodules, reduce swelling, eliminate accumulations, and break up blood stasis, thus dissipating "nasal hemorrhoids". Without the addition of melon stalk, the ability to drain purulent nasal discharge from the sinuses and treat "nasal hemorrhoids" extending from the sinuses is greatly weakened.

[0162] Comparative Example 3

[0163] A traditional Chinese medicine composition for treating sinusitis, with the same components and preparation method as in Example 1, except that Daphne genkwa is not added.

[0164] Therapeutic effect: The formula's function of draining water and eliminating nasal mucosal edema is weakened. The herb Daphne genkwa assists the principal herb in dispelling wind and dampness, resolving phlegm and dissipating nodules, thus alleviating the symptoms of sinusitis such as "purulent nasal discharge and nasal mucosal swelling".

[0165] Comparative Example 4

[0166] A traditional Chinese medicine composition for treating sinusitis, with the same components and preparation method as in Example 1, except that no sal ammoniac is added.

[0167] Therapeutic effect: The auxiliary medication can alleviate the symptoms of sinusitis such as "nasal mucosal ulceration and polyps".

[0168] Application Example 1

[0169] The efficacy of the traditional Chinese medicine composition prepared in Example 1 will be verified below. In the following efficacy verification, the external ointment prepared using the traditional Chinese medicine composition of the present invention will be referred to as "Dulitong Nasal Congestion Relief Ointment".

[0170] "Dulitong Nasal Congestion Relief Ointment" has been used to treat nasal discomfort such as nasal congestion, purulent nasal discharge, headache, and dizziness in 227 cases, achieving satisfactory results. Details are as follows:

[0171] Clinical case observation at Du Xicheng Clinic, Xinmi City, Henan Province, from April 2023 to June 2025:

[0172] 1. This group included 317 patients with sinusitis. Among them...

[0173] All cases ranged in age from 5 to 68 years. Among them, 57 cases were between 5 and 12 years old, and 260 cases were between 12 and 68 years old. There were 227 males and 90 females.

[0174] 2. Case Selection Target

[0175] Sinusitis causing discomfort for more than 2 years, including: frontal sinusitis, maxillary sinusitis, ethmoid sinusitis, sphenoid sinusitis, with thick, sticky, yellow, purulent nasal discharge that is difficult to clear. Also experiencing headaches, dizziness, hearing loss, vision impairment, and memory loss.

[0176] 3. "Dulitong Nasal Congestion Relief Ointment" can be used for all types of sinusitis.

[0177] 4. Usage and Observation

[0178] Apply the "Dulitong Nasal Congestion Relief Ointment" using the special applicator, inserting the ointment 1 cm into the back of the nostril and into the middle nasal meatus. Ensure the ointment adheres closely to the nasal mucosa and reaches the middle nasal meatus (the openings of the maxillary sinus, frontal sinus, and anterior ethmoid sinus open into the middle nasal meatus), facilitating detoxification of the nasal mucosa and sinus openings. Leave the "Dulitong Nasal Congestion Relief Ointment" in the nasal cavity for 40-60 minutes before blowing it out. Immediately after blowing out the ointment, the nostrils will feel exceptionally clear and comfortable. Nasal congestion may occur as detoxification begins, but it will clear up in approximately 10-24 hours. It is recommended to use the ointment approximately every 5-7 days, with 6-8 boxes constituting one course of treatment (one box contains two tubes of "Dulitong Nasal Congestion Relief Ointment"). Those with severe sinusitis may require two courses of treatment.

[0179] 5. Performance Standards

[0180] Recovery: The patient feels that the nasal ventilation is good, without thick and sticky nasal discharge or yellow nasal discharge, and headache and dizziness disappear.

[0181] Improvement: The patient feels that the nasal ventilation has improved, and there is not much thick, sticky or yellow nasal discharge, and headache and dizziness basically disappear.

[0182] Ineffective: The patient feels that the nasal ventilation has improved, the yellow nasal discharge is less, and headache and dizziness are intermittent.

[0183] The observation period is up to 2 years at most and 6 months at least (recovery is considered if there is no recurrence for more than 6 months).

[0184] Among 317 cases of sinusitis: 302 cases were cured, accounting for 95.2%; 312 cases showed marked improvement, accounting for 98.4%; 315 cases were effective, accounting for 99.3%; 2 cases were ineffective, accounting for 0.6%.

[0185] Through the analysis of this group of cases: "Dulitong Nasal Clear Health Care Paste" has a significant effect on treating various sinusitis.

[0186] Application Example 2

[0187] Perform toxicological tests (annex) on the traditional Chinese medicine composition prepared in Example 1 of the present invention.

[0188] Sample Name: Dulitong Nasal Clear Health Care Paste

[0189] Test Items: Acute Eye Irritation Test

[0190] 1. Materials

[0191] 1.1 Experimental animals: New Zealand rabbits, ordinary grade, 3 females, body weight 2.0 kg - 2.5 kg.

[0192] 1.2 Experimental animal environment: Ordinary environment, use license number: SYXK(Yu)2023 - 0008, environmental temperature: 20°C - 25°C, environmental relative humidity: 40% - 70%.

[0193] 1.3 Animal source: Provided by Shaanxi Junxing Biotechnology Co., Ltd., certificate number: 61003200002769.

[0194] 1.4 Feed: Rabbit maintenance feed, provided by Henan Huanyu Hekang Biotechnology Co., Ltd., certificate number: 4109782500033448.

[0195] 2. Test Methods and Procedures

[0196] 2.1 Test basis: "Cosmetics Safety and Technology Specifications" (2015 Edition), Chapter 6 (5) "Acute Eye Irritation / Corrosion Test".

[0197] 2.2 Sample treatment method: No treatment.

[0198] 2.3 Experimental Procedure: Gently pull back the lower eyelid of one rabbit's eye and instill 0.1 mL of the test substance into the conjunctival sac. Passively close the eye for 1 second to prevent loss of the test substance. The other eye is left untreated as a control. After instilling the test substance, close the eye for 1 second. At 30 seconds, flush the eye with a sufficient volume of water at a relatively fast flow rate, but without causing eye damage, for 30 seconds. Examine the animal's eyes at 1 hour, 24 hours, 48 ​​hours, 72 hours, and on days 4 and 7 after instillation. If no irritation reaction occurs after 72 hours, the experiment can be terminated early. If an irritation reaction occurs and does not recover within 7 days, the observation period should be extended, generally not exceeding 21 days. Observe the conjunctiva, iris, cornea, and other damage. Score the degree of irritation and evaluate the intensity of eye irritation according to the scoring criteria.

[0199] 3. Results:

[0200] The test results and scores are shown in the table below.

[0201] Results of acute eye irritation test on rabbits using Dulitong Nasal Congestion Relief Ointment

[0202]

[0203] 4. Conclusion:

[0204] Dulitong Nasal Congestion Relief Oil showed acute eye irritation in rabbits: 1 hour after instillation, the conjunctiva of all 3 rabbits was significantly edematous, and all 3 rabbits recovered completely after 24 hours. The mean maximum score of the stimulation response of the cornea, iris, and conjunctiva of the 3 rabbits at the observation points of 24h, 48h, and 72h after administration of the test substance was 0, indicating no irritation.

[0205] Application Example 3

[0206] The traditional Chinese medicine composition ("Dulitong Nasal Congestion Relief Ointment") prepared in Example 1 of this invention was tested for harmful components such as lead, arsenic, and mercury (see Appendix). The test results are shown in Table 2.

[0207] 1. Test items: lead, arsenic, mercury, cadmium, total bacterial count, total mold and yeast count, Pseudomonas aeruginosa, Staphylococcus aureus, and thermotolerant coliforms.

[0208] 2. Testing basis: "Cosmetic Safety Technical Specifications" (2015 edition).

[0209] 3. Test results: The tested items of this product meet the requirements of the Henan Provincial Health Industry Development Research Association Group Standard T / HNIK03-2020 "Technical Specifications for Production of Ointment-Based Health Care Products".

[0210] Table 2. Results of detection of harmful components such as lead, arsenic, and mercury in the traditional Chinese medicine composition prepared in Example 1.

[0211]

[0212] (The following is blank)

[0213] Application Example 4

[0214] Specific clinical trial examples include:

[0215] Clinical Case 1

[0216] Ms. Guo, a 4-year-old girl, had sinusitis for over a year, frequently experiencing nasal congestion, copious yellow purulent nasal discharge that was difficult to clear, and dizziness. Upon arrival, she coughed severely, approximately 30-40 times per minute, continuously, and experienced postnasal drip. Multiple treatments had been ineffective. She came for treatment today and received six sessions of this invention, resulting in a complete cure. Figure 1 No recurrence was observed during a two-year follow-up period.

[0217] Clinical Case 2

[0218] Mr. Sun, male, 6 years old, had sinusitis for over three years, frequently experiencing thick, yellow nasal discharge that was difficult to clear, and postnasal drip. Introduced by a long-term rhinitis patient, he sought treatment at the clinic and was cured after 7 treatments using this invention. Figure 2 No recurrence was observed during a two-year follow-up period.

[0219] Clinical Case 3

[0220] Mr. Wang, male, 22 years old. He had suffered from sinusitis for over ten years. He had sought treatment at multiple clinics with little effect. Referral from a long-time rhinitis patient, he came to the clinic. Upon arrival, he had bluish lower eyelids, severe nasal congestion, headaches, dizziness, and yellow purulent nasal discharge. He had been out of work for about four years, spoke very softly, walked weakly, and his overall mental state was poor. After three treatments with this invention, all the above symptoms disappeared. He was cured after six treatments. Figure 3 No recurrence was observed during a two-year follow-up period.

[0221] Clinical Case 4

[0222] A sinusitis patient suffered from frequent, severe headaches, regardless of the time of day. For over a month, he had been taking painkillers multiple times a day, severely impacting his work and sleep. He had also been diagnosed with sinusitis elsewhere, but with little success. The patient was in great pain and, on the recommendation of a long-term sinusitis patient, came to my clinic for treatment. Nasal endoscopy revealed a large amount of yellow purulent discharge in both nasal meatuses (normally, the sinuses are bony spaces in the face, normally containing oxygen to supply the brain. Prolonged and repeated colds and inflammation can lead to purulent discharge within the sinus cavities, reducing their size and oxygen levels, causing brain hypoxia, resulting in headaches, dizziness, memory loss, hearing loss, and vision loss; severely affecting study and work). A sinus CT scan showed... Figure 4The patient had sinusitis (the hospital recommended surgery, but the patient refused). This invention was used to treat the patient, who was then inserted into the nostrils to drain pus. A large amount of yellow purulent nasal discharge was expelled. After using the nasal ointment to drain the pus, the headache lessened with each treatment. After the fourth treatment, the patient basically no longer needed painkillers, and the pain no longer affected their work or sleep. The patient's mental state also improved significantly. The patient was instructed to continue treatment. After seven treatments, the patient was cured, and a two-year follow-up showed no recurrence.

[0223] The foregoing has shown and described the basic principles and main features of the present invention, as well as its advantages. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating sinusitis, characterized in that, It is composed of the following ingredients in parts by weight: Magnolia biondii 45-55 parts, Angelica dahurica 55-65 parts, Daphne genkwa 25-35 parts, Gleditsia sinensis 45-55 parts, Hirudo medicinalis 75-85 parts, Gnaphalium affine 115-125 parts, Centipeda minima 95-105 parts, Xanthium sibiricum 25-35 parts, Melon stalk 55-65 parts, Asarum heterotropoides 25-35 parts, Borneol 15-25 parts, Mentha haplocalyx 5-15 parts, and Sal ammoniac 15-25 parts.

2. The traditional Chinese medicine composition for treating sinusitis according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: Magnolia biondii 48-52 parts, Angelica dahurica 58-62 parts, Daphne genkwa 28-33 parts, Gleditsia sinensis 48-52 parts, Hirudo medicinalis 78-83 parts, Gnaphalium affine 118-122 parts, Centipeda minima 98-103 parts, Xanthium sibiricum 28-32 parts, Melon stalk 58-62 parts, Asarum heterotropoides 28-32 parts, Borneol 18-23 parts, Mentha haplocalyx 8-13 parts, and Sal ammoniac 18-22 parts.

3. The traditional Chinese medicine composition for treating sinusitis according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: 50 parts Magnolia biondii, 60 parts Angelica dahurica, 30 parts Daphne genkwa, 50 parts Gleditsia sinensis, 80 parts Hirudo medicinalis, 120 parts Insecta spp., 100 parts Centipeda minima, 30 parts Xanthium sibiricum, 60 parts Melon stalk, 30 parts Asarum heterotropoides, 20 parts Borneol, 10 parts Menthol, and 20 parts Sal ammoniac.

4. The use of the traditional Chinese medicine composition for treating sinusitis according to any one of claims 1-3 in the preparation of a medicament for the prevention and / or treatment of sinusitis.

5. The application according to claim 4, characterized in that, The drug also includes pharmaceutically acceptable excipients.

6. A topical ointment for treating sinusitis, characterized in that, It is made using the traditional Chinese medicine composition for treating sinusitis as described in any one of claims 1-3.

7. The method for preparing the topical ointment for treating sinusitis according to claim 6, characterized in that... Includes the following steps: (1) Weigh the above-mentioned parts by weight of the raw materials of the Chinese medicine composition for treating sinusitis, dry them, pulverize them to obtain fine powder, mix them evenly to obtain the Chinese medicine composition powder. (2) Add appropriate amounts of sesame oil, petrolatum and transdermal penetration enhancer to the powder of traditional Chinese medicine composition, mix evenly into a paste, inject into a syringe, seal with aluminum-plastic film and sterilize by irradiation to obtain a topical ointment for the treatment of sinusitis.

8. The method for preparing the topical ointment for treating sinusitis according to claim 7, characterized in that: The pulverization process involves low-temperature cell wall breaking and ultra-micro processing at -25~-15℃ to produce fine powder of 250-350 mesh.

9. The method for preparing the topical ointment for treating sinusitis according to claim 7, characterized in that: Based on the mass of the Chinese herbal medicine powder composition, the dosage of sesame oil is 10%-15%, the dosage of petroleum jelly is 20%-30%, and the dosage of transdermal penetration enhancer is 1.0%-3%.

10. The method for preparing the topical ointment for treating sinusitis according to claim 7, characterized in that: Each applicator contains 1.2 grams of ointment for external use. Insert one applicator into each nostril and leave for 40-60 minutes before blowing it out. Use once every 5-7 days.

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