CN110882332A

CN110882332A - Traditional Chinese medicine composition for nose as well as preparation method and application thereof

Info

Publication number: CN110882332A
Application number: CN201911242789.0A
Authority: CN
Inventors: 曹龙祥; 申崇光; 杨志伟; 蔡虎
Original assignee: JICHUAN PHARMACEUTICAL GROUP Co Ltd
Current assignee: Jiangsu Pudilan Daily Chemical Co.,Ltd.
Priority date: 2019-12-06
Filing date: 2019-12-06
Publication date: 2020-03-17
Anticipated expiration: 2039-12-06
Also published as: CN110882332B

Abstract

The invention belongs to the field of traditional Chinese medicines, and relates to a nasal traditional Chinese medicine composition, and a preparation method and application thereof. The nasal traditional Chinese medicine composition comprises the Siberian cocklebur extract, the Pudilan extract, the borneol, the Baikal skullcap root extract and the catnip oil, has the effects of resisting inflammation, resisting allergy, inhibiting bacteria and the like, can be used for preparing a medicinal preparation for preventing and/or treating rhinitis (particularly allergic rhinitis), such as a traditional Chinese medicine nasal spray, and has the advantages of remarkable effect, convenience in use, stability in storage and the like.

Description

Traditional Chinese medicine composition for nose as well as preparation method and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for nasal administration, a preparation method thereof, and application thereof in preparing a medicine for preventing and/or treating rhinitis.

Background

Rhinitis (i.e. inflammatory diseases of nasal cavity) is caused by viruses, bacteria, allergens, various physicochemical factors and some systemic diseases, and occurs in inflammation of nasal mucosa, and the main pathological changes of the rhinitis include congestion, swelling, exudation, hyperplasia, atrophy, necrosis and the like of the nasal mucosa, and the pathogenesis of the rhinitis includes the following aspects: (1) viral infection or secondary bacterial infection on the basis of viral infection: more than 100 viruses are currently known to cause rhinitis, most commonly Rhinovirus (Rhinovirus), followed by Influenza (inflenza virus) and Parainfluenza (parainflenza virus), Adenovirus (Adenovirus), Coronavirus (Coronavirus), Coxsackievirus (Coxsackievirus), and Myxovirus (Myxovirus) and Paramyxovirus (parayxovirus), among others; (2) genetic factors: patients with family history of allergic diseases are susceptible to the allergic diseases, and most family members of the patients have asthma, urticaria or drug allergy history; (3) susceptibility of nasal mucosa: the development of susceptibility results from frequent stimulation by antigenic substances, but its severity depends on the number of mast cells and basophils in the nasal mucosa and the ability to release chemical mediators; (4) antigenic substance: the antigenic substance that stimulates the body to produce IgE antibodies is called allergen (or allergen), which, after re-entering the nasal mucosa, binds to the corresponding IgE causing an allergic reaction. Allergens causing rhinitis can be classified into two major categories, inhalant allergens including pollen, fungi, house dust mites, animal dander, indoor dust, and food allergens including milk, eggs, fish and shrimp, meat, fruits, vegetables, and the like, according to the way they enter the human body.

The rhinitis patients in China are numerous, and the rhinitis treatment is particularly prominent in southern areas, but the rhinitis treatment effect is mostly not ideal, and the rhinitis treatment is easy to relapse, so that the rhinitis patients are disturbed by the rhinitis treatment. Glucocorticoid drugs (such as fluticasone, triamcinolone acetonide and the like) have the effects of resisting inflammation, allergy, edema and the like, are widely applied in clinic, but are accompanied by relatively obvious adverse reactions, such as skin allergy, nasal dryness, epistaxis and the like (see Liweimei and the like, the research progress of Chinese and Western medicine treatment of allergic rhinitis [ J ], university of Guangxi traditional Chinese medicine and pharmacy, 2019, 22 (1): 71-75). The antihistamine drugs (such as cetirizine, loratadine and the like) which are the first-line drugs show adverse reactions in the peripheral and central nervous systems and digestive systems, such as lethargy, dizziness, bellyache, dry mouth and the like (see radix cynanchi hopeiensis and the like, and the adverse reactions and nursing analysis of oral antihistamine drugs for allergic rhinitis patients [ J ], Haixian pharmacy, 2013, 25 (2): 265 and 266), and the wide application of the antihistamine drugs is limited to a certain extent.

Traditional Chinese medicine in China accumulates a lot of precious experience in the aspect of treating rhinitis. The Luojian uses the combination of the ephedra, monkshood and asarum decoction to treat the allergic rhinitis so as to warm yang qi and dredge the whole body, so as to achieve the effects of dispelling cold, eliminating pathogenic factors and strengthening body resistance (see the observation of the curative effect of the combination of the Luojian, the ephedra, monkshood and asarum decoction on the treatment of the allergic rhinitis [ J ], the Shenzhen, the journal of the combination of traditional Chinese and western medicine, 2017, 27 (19): 43-45). The effective rate of the folacin is 96 percent by treating 100 cases of allergic rhinitis in acute attack stage by acupuncture (see folacin, clinical observation of allergic rhinitis in acute attack stage by acupuncture [ J ], latest medical information abstracts in the world, 2017, 17 (16): 155). Huangjia follows the pathology of deficiency of lung, spleen and kidney, applies Du-meridian assisted moxibustion to treat allergic rhinitis, can regulate yang channel qi and blood, strengthen body resistance and eliminate pathogenic factors (see Huangjia, et al, Du-meridian moxibustion has 50 cases of curative effect [ J ], Yunnan J.TCM, 2017, 38 (1): 69-70). However, most of the above therapies are focused on internal decoction, acupuncture, moxibustion, etc., and the method of applying a Chinese medicinal preparation via the nose is rare.

CN 1879676 a discloses a compound rhinitis spray, the main active ingredients of which comprise andrographis paniculata alcohol extract, centipeda minima water extract, ephedrine hydrochloride and diphenhydramine hydrochloride, but the spray belongs to a compound preparation combining Chinese and western medicines, and is not a simple traditional Chinese medicine preparation. CN 102670913 a discloses a Chinese herbal medicine fumigating spray for treating chronic rhinitis, which needs to be applied by fumigating medicine steam, and the actual operation is complicated. CN 106491929 a discloses a rhinitis spray, but the solvent of the spray contains alcohol, which can cause some irritation to nasal mucosa and even aggravate rhinitis symptoms.

Disclosure of Invention

Problems to be solved by the invention

The invention provides a nasal traditional Chinese medicine composition, a preparation method thereof and application thereof in preparing medicines for preventing and/or treating rhinitis, aiming at various problems of unsatisfactory curative effect, easy relapse, mixed traditional Chinese medicines and western medicines, inconvenient application mode, irritant auxiliary materials and the like of the existing nasal medicine preparation for preventing and treating rhinitis.

Means for solving the problems

In a first aspect, the invention provides a nasal traditional Chinese medicine composition, which comprises a Siberian cocklebur extract, a Pudilan extract, borneol, a Baikal skullcap root extract and catnip oil.

Preferably, the nasal traditional Chinese medicine composition consists of a Siberian cocklebur extract, a Pudilan extract, borneol, a Baikal skullcap root extract and catnip oil.

Preferably, in the nasal traditional Chinese medicine composition, the weight ratio of the Siberian cocklebur goose extract, the Pudilan blue extract, the borneol, the Baikal skullcap root extract and the catnip oil is 1: 0.02-0.5: 0.004-0.1: 0.002-0.05: 0.001-0.025.

More preferably, in the nasal traditional Chinese medicine composition, the weight ratio of the Siberian cocklebur goose extract, the Pudilan blue extract, the borneol, the Baikal skullcap root extract and the catnip oil is 1: 0.05-0.2: 0.01-0.04: 0.005-0.02: 0.0025-0.01.

Most preferably, in the nasal traditional Chinese medicine composition, the weight ratio of the Siberian cocklebur goose extract, the Pudilan blue extract, the borneol, the scutellaria baicalensis extract and the catnip oil is 1:0.1:0.02:0.01: 0.005.

In a second aspect, the invention provides a preparation method of the nasal traditional Chinese medicine composition, which comprises the steps of weighing and mixing the components.

In a third aspect, the invention provides an application of the nasal traditional Chinese medicine composition in preparing a pharmaceutical preparation for preventing and/or treating rhinitis.

Preferably, in the above use, the rhinitis includes acute rhinitis, chronic rhinitis, atrophic rhinitis, caseous rhinitis, rhinitis sicca, rhinitis medicamentosa and allergic rhinitis.

Preferably, in the above use, the pharmaceutical preparation is a traditional Chinese medicine nasal spray.

In a fourth aspect, the invention provides a traditional Chinese medicine nasal spray, which comprises the nasal traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

Preferably, in the traditional Chinese medicine nasal spray, the auxiliary materials comprise a humectant, parabens and cationic surfactant bacteriostats, a pH regulator, an osmotic pressure regulator, essence, a solubilizer, a cosolvent and a solvent.

In a fifth aspect, the invention provides a preparation method of the traditional Chinese medicine nasal spray, which comprises the following steps:

1) weighing a Siberian cocklebur extract, a Pudilan extract, borneol, a Scutellaria baicalensis extract, catnip oil, a humectant, parabens, a cationic surfactant bacteriostatic agent, a pH regulator, an osmotic pressure regulator, essence, a solubilizer, a cosolvent and a solvent;

2) adding cosolvent, essence, catnip oil, borneol and paraben bacteriostatic agent into a container, stirring until the cosolvent is dissolved, adding solubilizer, and stirring until the solubilizer is dissolved to obtain solution A;

3) adding a small amount of solvent and Scutellariae radix extract into another container, stirring, adding herba Pudiltiae and Siberian goose extract, stirring, adding a large amount of pH regulator, and filtering to obtain solution B;

4) adding a large amount of solvent into a container with a stirring device, sterilizing, starting stirring, adding the humectant and the osmotic pressure regulator, stirring until the humectant and the osmotic pressure regulator are dissolved, adding the cationic surfactant bacteriostatic agent, stirring until the cationic surfactant bacteriostatic agent is dissolved, adding the solution A, stirring uniformly, adding the solution B, stirring uniformly, adding the rest pH regulator and the solvent, stirring uniformly, and filtering to obtain the traditional Chinese medicine nasal spray.

ADVANTAGEOUS EFFECTS OF INVENTION

The traditional Chinese medicine composition for the nose contains extracts of traditional Chinese medicinal materials such as siberian cocklour herb, biond magnolia flower, centipeda minima, dandelion, bunge corydalis herb, isatis root, baical skullcap root, fineleaf schizonepeta herb and the like and natural borneol, has good anti-inflammatory, anti-allergic and antibacterial effects, and can be prepared into a pharmaceutical preparation for preventing and/or treating rhinitis (particularly allergic rhinitis). The traditional Chinese medicine nasal spray prepared based on the composition has the advantages of remarkable effect, convenience in use, stability in storage and the like.

Detailed Description

The invention provides a nasal traditional Chinese medicine composition. The composition comprises the following components: siberian goose extract, Pudilan blue extract, borneol, Baikal skullcap root extract and catnip oil.

As used herein, unless otherwise indicated, the term "nasal herbal composition" refers to a mixture consisting entirely of herbs, herbal pieces, herbal formula granules, herbal extracts, herbal volatile oils, or any form of processed product thereof, which is applied nasally to an individual.

In the composition, the extract of the Siberian cocklebur fruit, the biond magnolia flower and the centipeda minima is the extract of the fried Siberian cocklebur fruit, the biond magnolia flower and the centipeda minima, and the specific extraction method is as follows:

weighing the fried cocklebur fruit, the magnolia flower and the centipeda minima according to the weight ratio of 5:5: 3; adding 10 times of water for the first time, soaking for 30 minutes, decocting for 1 hour, and filtering; adding 8 times of water for the second time, decocting for 1 hr, and filtering; combining the filtrates, and concentrating under reduced pressure at a temperature of less than 80 ℃ until the relative density is 1.05-1.10; cooling to room temperature, adding ethanol until the ethanol content is 70%, and standing for 48 hours; and taking the supernatant, filtering and concentrating until no alcohol smell exists to obtain the xanthic goose extract.

The term "cocklebur fruit" as used herein, unless otherwise specified, refers to dried fruits of Xanthium sibiricum patr. ex widd. belonging to the annual herb of the family Compositae, which are produced mainly in Jiangxi, Shandong, Hubei, Jiangsu, etc. Collected in autumn and dried in the sun. The fried cocklebur fruit is obtained after the hard thorn is removed. Fructus Xanthii is warm in nature, pungent and bitter in flavor, enters lung meridian, and has effects of relieving stuffy nose, dispelling pathogenic wind and removing dampness, and relieving pain.

The term "Magnolia" as used herein, unless otherwise specified, refers to the dried flower bud of Magnolia liliiflora lisflora desr. or Magnolia biondii pamp. which is a deciduous shrub plant of Magnolia, produced mainly in the south of the river, anhui, sichuan, etc. Picked up in early spring when bud is not opened, and dried in the sun. Flos Magnoliae is warm in nature and pungent in flavor, enters lung and stomach meridians, and has effects of relieving nasal obstruction and dispelling wind-cold.

The term "Centipeda minima" as used herein, unless otherwise specified, refers to the dried whole plant of the annual herb Centipeda minima (L.) A.Br.et Aschers. of the Compositae family, produced mainly in Liaoning, Hebei, Hubei, etc. Dried in the sun in summer and autumn. Flos Magnoliae is warm in nature and pungent in flavor, enters lung meridian, and has effects of dispelling pathogenic wind and cold, relieving nasal obstruction, relieving cough, and removing toxic substance.

In the composition, the Pudilan blue extract is the extract of dandelion, corydalis bungeana and isatis root, and the specific extraction method is as follows:

weighing dandelion, corydalis bungeana and isatis root according to the weight ratio of 4:1: 1.5; adding 10 times of water for the first time, soaking for 30 minutes, decocting for 1 hour, and filtering; adding 8 times of water for the second time, decocting for 1 hr, and filtering; mixing filtrates, concentrating to relative density of 1.15, adding ethanol until ethanol content is 65%, and standing for 48 hr; collecting supernatant, concentrating to relative density of 1.15, adding ethanol until ethanol content is 80%, and standing for 24 hr; taking the supernatant, and concentrating to a relative density of 1.26 to obtain Pudilan extract;

weighing the Pudilan extract, the purified water and the sodium citrate according to the weight ratio of 1:8.5:0.5, stirring for 5-10 minutes, heating and boiling for 30 minutes, cooling to room temperature, and refrigerating at 0-4 ℃ for 72 hours; taking out the liquid medicine, centrifuging, taking the supernatant, boiling, adding 0.2% of active carbon, and preserving the temperature for 30 minutes; cooling to 50-60 ℃, adding water to supplement the loss amount, filtering by a titanium rod with the diameter of 1 mu m, and concentrating the filtrate to be nearly dry to obtain the Pudilan extract.

As used herein, unless otherwise indicated, the term "dandelion" refers to the dried whole rooted grass of the perennial herb Taraxacum mongolicum hand-Mazz. of Compositae and its various congeners, all distributed across the country. Collected in autumn and dried in the sun. Dandelion is cold in nature, bitter and sweet in taste, enters liver and stomach meridians, and has the effects of clearing away heat and toxic materials, promoting diuresis and the like.

The term "Corydalis" as used herein, unless otherwise specified, refers to the dried whole plant of the biennial herb Corydalis bungeana turcz of the Papaveraceae family, which is produced in Liaoning, Hebei, Gansu, etc. Collected in summer and dried in the sun. The corydalis bungeana is cold in nature, bitter and pungent in taste, enters heart and spleen channels, and has the effects of clearing heat and removing toxicity and the like.

The term "Isatis root" as used herein means, unless otherwise specified, a dried root of the biennial herb of the family brassicaceae, Isatis tinctoria L. which is mainly produced in Hebei, Jiangsu, Anhui, etc. Digging, cleaning and drying before freezing on the land in autumn. Radix Isatidis has cold property and bitter taste, and has effects of clearing heat and detoxicating, cooling blood, relieving sore throat, etc.

Unless otherwise indicated, the term "borneol" as used herein refers to a crystal (or "plum slice") obtained by distilling and cooling a stem of a tree of Dryobalanops aromatica Gaertn.F. which is an evergreen arbor of Dryobalanops aromatica of the family Dryobalanops aromatica, or a sublimate (or "Blumea") of a leaf of Blumea balsamifera DC. which is a perennial herb of the family Compositae, wherein the borneol is mainly produced in southeast Asia, and the Taiwan in China has been introduced with a seed, and the Blumea is mainly produced in Guangdong, Guangxi, Yunnan, and the like. The finished product is stored in a shade and sealed. It is not used after being ground into powder. Borneol is slightly cold in nature, pungent and bitter in taste, and has the effects of inducing resuscitation, refreshing mind, clearing heat and relieving pain, and the like, and the borneol enters heart, spleen and lung channels.

In the composition, the specific extraction method of the scutellaria baicalensis extract is as follows:

taking the scutellaria baicalensis; adding 10 times of water for the first time, soaking for 30 minutes, decocting for 1 hour, and filtering; adding 8 times of water for the second time, decocting for 1 hour, and filtering; combining the filtrates, concentrating to relative density of 1.15, adjusting pH to 1.0-2.0 with hydrochloric acid, keeping the temperature at 80 ℃, standing for 12 hours, and filtering; adding water into the precipitate, stirring, adjusting pH to 7.0 with 40% sodium hydroxide solution, adding equal volume of ethanol, stirring for dissolving, and filtering; adjusting the pH value of the filtrate to 1.0-2.0 by using hydrochloric acid, preserving heat at 60 ℃, standing for 12 hours, and filtering; washing the precipitate with water and ethanol sequentially until pH reaches 7.0, volatilizing ethanol, and drying under reduced pressure to obtain Scutellariae radix extract.

The term "Scutellaria" as used herein, unless otherwise specified, refers to the dried root of Scutellaria baicalensis Scutellaria baicales Georgi, a perennial herb of the family labiatae, which is mainly produced in north Hebei, south Henan, Shanxi, Shaanxi, inner Mongolia, and the like. Digging in spring and autumn, removing residual stem and fibrous root, and sun drying. Unprocessed, stir-baked with wine or stir-baked to charcoal. The scutellaria is cold in nature and bitter in taste, enters lung, gallbladder, stomach and large intestine channels, and has the effects of clearing heat and drying dampness, purging fire and removing toxicity, stopping bleeding, preventing miscarriage and the like.

In the composition, the extraction method of the catmint oil is as follows:

taking schizonepeta; adding 5 times of water, soaking for 30 minutes, and distilling for 3 hours by adopting a steam distillation method; separating the distillate with oil-water separator to obtain oleum Schizonepetae.

The term "catnip" as used herein, unless otherwise specified, refers to the sequenced dry whole or ear of the one-year-old herbaceous plant Schizonepeta tenuifolia briq, of the family labiatae, and is produced in xinjiang, gansu, shanxi, henna, shanxi, etc. Harvesting in summer and autumn when the flower blooms to the top and the ear is green, removing impurities, and drying in the sun. Schizonepeta, herba Schizonepetae is slightly warm in nature and pungent in flavor, enters lung and liver meridians, and has effects of relieving exterior syndrome, dispelling pathogenic wind, promoting eruption, and eliminating sore.

In a preferred embodiment, the weight ratio of the Siberian goose extract, the Pudilan blue extract, the borneol, the radix scutellariae extract and the catnip oil in the composition is 1: 0.02-0.5: 0.004-0.1: 0.002-0.05: 0.001-0.025. For example, when the composition comprises 1g of the extract of the Siberian cocklebur goose, the composition also comprises 0.02-0.5 g of the extract of Pudilan, 0.004-0.1 g of borneol, 0.002-0.05 g of the extract of Scutellaria baicalensis, and 0.001-0.025 g of catnip oil. Likewise, the above weight ratios are also applicable to mg and kg grades.

In a more preferred embodiment, the weight ratio of the goose pungent extract, the dandelion extract, the borneol, the scutellaria baicalensis extract and the catmint oil in the composition is 1: 0.05-0.2: 0.01-0.04: 0.005-0.02: 0.0025-0.01. For example, when the composition comprises 1g of the extract of the Siberian cocklebur goose, the composition also comprises 0.05 to 0.2g of the extract of Pudilan, 0.01 to 0.04g of borneol, 0.005 to 0.02g of the extract of Scutellaria baicalensis, and 0.0025 to 0.01g of catnip oil. Likewise, the above weight ratios are also applicable to mg and kg grades.

In a more preferred embodiment, the weight ratio of the goose extract, dandelion extract, borneol, scutellaria extract and catmint oil in the composition of the invention is 1:0.1:0.02:0.01: 0.005. For example, when the composition comprises 1g of the extract of the Siberian cocklebur goose, 0.1g of the extract of Pudilan blue, 0.02g of borneol, 0.01g of the extract of Scutellaria baicalensis, and 0.005g of catnip oil are also included. Likewise, the above weight ratios are also applicable to mg and kg grades.

The invention also provides a preparation method of the nasal traditional Chinese medicine composition. The preparation method comprises the steps of weighing and mixing the components.

The invention also provides application of the nasal traditional Chinese medicine composition in preparing a medicinal preparation for preventing and/or treating rhinitis.

The term "prevention and/or treatment" as used herein, unless otherwise indicated, refers to three side-by-side regimens, i.e., prevention without disease, treatment after disease, and a combination of both.

In some preferred embodiments, rhinitis in the use of the invention includes, but is not limited to, acute rhinitis, chronic rhinitis, atrophic rhinitis, rhinitis caseosa, rhinitis sicca, rhinitis medicamentosa and allergic rhinitis (allergic rhinitis).

In some more preferred embodiments, the rhinitis for use according to the invention is rhinitis variabilis.

In some preferred embodiments, the pharmaceutical formulation in use of the invention is a traditional Chinese medicine nasal spray.

The term "spray" as used herein, unless otherwise indicated, refers to a formulation prepared by filling a pharmaceutical material (e.g., a composition of the present invention) with a pharmaceutically acceptable excipient (without propellant) in a specially prepared device, and releasing the contents in the form of mist or the like by means of a manual pump, high pressure gas, ultrasonic vibration or any other suitable method. The term "nasal spray" (or "nasal spray") refers to a spray that is sprayed directly onto the nasal cavity. The term "traditional Chinese medicine nasal spray" (or "traditional Chinese medicine nasal spray") refers to a nasal spray which takes a product prepared from traditional Chinese medicines, traditional Chinese medicine decoction pieces, traditional Chinese medicine formula granules, traditional Chinese medicine extracts, traditional Chinese medicine volatile oil or processed products of any forms thereof as raw material medicines.

The term "pharmaceutically acceptable excipient" as used herein, unless otherwise specified, refers to an auxiliary material used in the manufacture of a medicament which imparts the necessary physicochemical properties to the medicament, is compatible with the pharmaceutically active ingredient, and does not produce an adverse reaction in the individual to whom it is administered. Common pharmaceutically acceptable excipients include, but are not limited to, diluents (or fillers), binders, disintegrants, lubricants, wetting agents, humectants, thickeners, glidants, bacteriostats (or preservatives), antioxidants, pH modifiers (or acidity regulators), osmotic pressure regulators, flavoring agents, odor modifiers, fragrances (or fragrances), solvents, solubilizers, cosolvents, surfactants, and the like.

The invention also provides a traditional Chinese medicine nasal spray. The spray comprises the nasal traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

In some preferred embodiments, the nasal spray of the present invention comprises a humectant in addition to the composition of the present invention.

The term "humectant" as used herein, unless otherwise specified, refers to an excipient used to prevent the loss of moisture by evaporation. The humectant is selected from water absorbent (such as glycerol, sorbitol, and xylitol), bionic agent (such as ceramide and hyaluronic acid), and sealant (such as simethicone and shea butter).

In some preferred embodiments, the nasal spray of the present invention comprises a bacteriostatic agent in addition to the composition of the present invention.

The term "bacteriostatic agent" as used herein, unless otherwise indicated, refers to an adjuvant used to inhibit the growth of microorganisms. Common bacteriostatic agents include, but are not limited to, parabens (or parabens), benzoic acid and its salts, sorbic acid and its salts, cationic surfactants (e.g., benzalkonium chloride, benzalkonium bromide, cetylpyridinium chloride), chlorhexidine, and the like.

In some preferred embodiments, the nasal spray of the present invention comprises a pH adjuster in addition to the composition of the present invention.

The term "pH adjusting agent" as used herein, unless otherwise indicated, refers to an excipient used to adjust and maintain the pH to a suitable level. Common pH regulators include, but are not limited to, maleic acid and its salts, fumaric acid and its salts, malic acid and its salts, citric acid and its salts, tartaric acid and its salts, lactic acid and its salts, phosphoric acid and its salts, and the like.

In some preferred embodiments, the nasal spray of the present invention comprises an osmotic pressure regulator in addition to the composition of the present invention.

The term "osmotic pressure regulator" as used herein, unless otherwise indicated, refers to an excipient used to regulate and maintain osmotic pressure to a suitable level. Common osmolytes are classified into inorganic (e.g., sodium chloride) and organic (e.g., glucose) species.

In some preferred embodiments, the nasal spray of the present invention comprises a fragrance in addition to the composition of the present invention.

The term "flavour", as used herein, unless otherwise indicated, refers to an adjuvant used to improve the odour of pharmaceutical preparations. The essence is selected from natural essence (such as lemon oil and oleum Menthae Dementholatum) and artificial essence (such as apple essence and lemon essence).

In some preferred embodiments, the nasal spray of the present invention comprises a solvent in addition to the composition of the present invention.

The term "solvent" as used herein, unless otherwise indicated, refers to an excipient used to dissolve a solute to form a solution. The solvents are classified into polar solvents (such as water and dimethyl sulfoxide), semi-polar solvents (such as ethanol and polyethylene glycol) and non-polar solvents (such as fatty oil and liquid paraffin) according to the dielectric constant.

In some preferred embodiments, the nasal spray of the present invention comprises a solubilizing agent in addition to the composition of the present invention.

The term "solubilizer" as used herein, unless otherwise specified, refers to an excipient used to increase the solubility of a poorly soluble drug in a solvent. The solubilizing agent is typically a surfactant. Common solubilizing agents include, but are not limited to, polysorbates (or tweens), polyoxyethylene fatty acid esters (or spans), and hydrogenated vegetable oils (e.g., hydrogenated castor oil).

In some preferred embodiments, the nasal spray of the present invention comprises a cosolvent in addition to the composition of the present invention.

The term "co-solvent" as used herein, unless otherwise indicated, refers to an excipient used to form a complex or double salt with a poorly soluble drug to increase the solubility of the poorly soluble drug in a solvent. The co-solvent is typically a small molecule compound, not a surfactant. The specific type of co-solvent depends on the actual use of the solute and solvent.

In some more preferred embodiments, the nasal spray of the present invention further comprises at least one of a moisturizing agent, a bacteriostatic agent, a pH adjusting agent, an osmotic pressure adjusting agent, a fragrance, a solvent, a solubilizing agent, and a solubilizing agent, in addition to the composition of the present invention.

In some more preferred embodiments, the nasal spray of the present invention comprises, in addition to the composition of the present invention, a moisturizer, a bacteriostatic agent, a pH adjuster, an osmotic pressure adjuster, a fragrance, a solvent, a solubilizer, and a cosolvent.

In some more preferred embodiments, the nasal spray of the present invention consists of the composition of the present invention, a humectant, a bacteriostatic agent, a pH adjuster, an osmotic pressure adjuster, a fragrance, a solvent, a solubilizer, and a cosolvent.

The nasal spray comprises, by weight, 1% of a Siberian goose extract, 0.02-0.5% of a Pudilan extract, 0.004-0.1% of borneol, 0.002-0.05% of a Baikal skullcap root extract, 0.001-0.025% of catnip oil, 1-25% of a humectant, 0.014-0.35% of a bacteriostatic agent, 0.034-0.85% of a pH regulator, 0.18-4.5% of an osmotic pressure regulator, 0.008-0.2% of essence, 0.06-1.5% of a solubilizer, 0.1-2.5% of a cosolvent and the balance of a solvent.

In some preferred embodiments, the nasal spray comprises, by weight, 1% of a Siberian goose extract, 0.05-0.2% of a Pudilan extract, 0.01-0.04% of borneol, 0.005-0.02% of a Scutellaria baicalensis extract, 0.0025-0.01% of catnip oil, 2.5-10% of a humectant, 0.035-0.14% of a bacteriostatic agent, 0.085-0.34% of a pH regulator, 0.45-1.8% of an osmotic pressure regulator, 0.02-0.08% of an essence, 0.15-0.6% of a solubilizer, 0.25-1.0% of a cosolvent and the balance of a solvent.

In some more preferred embodiments, the nasal spray of the present invention consists of 1% of a Siberian goose extract, 0.1% of a Pudilan extract, 0.02% of borneol, 0.01% of a Scutellaria baicalensis extract, 0.005% of catnip oil, 5% of a humectant, 0.07% of a bacteriostatic agent, 0.17% of a pH regulator, 0.9% of an osmotic pressure regulator, 0.04% of a perfume, 0.3% of a solubilizer, 0.5% of a cosolvent, and the balance of a solvent, in weight percentage.

In the nasal spray, the humectant is a water absorbent, preferably glycerin (or glycerol).

In the nasal spray, the bacteriostatic agent is a paraben and/or cationic surfactant bacteriostatic agent, preferably methylparaben (or methylparaben and methylparaben) and/or cetylpyridinium chloride.

In the nasal spray, the pH regulator is citric acid and its salt, preferably sodium citrate (or trisodium citrate, sodium citrate, trisodium citrate).

In the nasal spray, the osmotic pressure regulator is an inorganic osmotic pressure regulator, and preferably sodium chloride (or called salt).

In the nasal spray, the essence is an artificial essence, preferably lemon essence.

In the nasal spray, the solvent is a polar solvent, preferably water, more preferably purified water.

In the nasal spray, the solubilizer is a polysorbate solubilizer, preferably polysorbate-60 (tween-60).

In the nasal spray, the cosolvent is propylene glycol.

The invention also provides a preparation method of the traditional Chinese medicine nasal spray. The preparation method comprises the following steps:

In some preferred embodiments, the preparation method of the present invention further comprises the steps of detecting the finished product (e.g. pH detection), subpackaging, packaging, and the like.

In some preferred embodiments, the small amount of solvent in step 3) is 10% solvent.

In some preferred embodiments, the bulk of the pH adjusting agent in step 3) is 70% pH adjusting agent.

In some preferred embodiments, the bulk solvent in step 4) is 70% solvent.

The technical solution of the present invention will be further described with reference to specific examples. It should be understood that the following examples are only for illustrating and explaining the present invention and are not intended to limit the scope of the present invention. Unless otherwise indicated, the instruments, materials, reagents and the like used in the following examples are all available by conventional commercial means.

Example 1: preparing the extract of the xanthate goose.

Weighing 100g of fried cocklebur fruit, 100g of biond magnolia flower and 60g of centipeda minima; adding 10 times of water for the first time, soaking for 30 minutes, decocting for 1 hour, and filtering; adding 8 times of water for the second time, decocting for 1 hr, and filtering; combining the filtrates, and concentrating under reduced pressure (not more than 80 ℃) until the relative density is 1.05-1.10 (65 ℃); cooling to room temperature, adding ethanol until the ethanol content is 70%, and standing for 48 hours; collecting supernatant, filtering, and concentrating until no alcohol smell is generated (ethanol is removed as much as possible) to obtain the extract of Siberian goose.

Example 2: preparation of Pudilan extract.

Weighing 500g of dandelion, 125g of corydalis bungeana and 188g of isatis root; adding 10 times of water for the first time, soaking for 30 minutes, decocting for 1 hour, and filtering; adding 8 times of water for the second time, decocting for 1 hour, and filtering; mixing filtrates, concentrating to relative density of 1.15, adding ethanol until ethanol content is 65%, and standing for 48 hr; collecting supernatant, concentrating to relative density of 1.15, adding ethanol until ethanol content is 80%, and standing for 24 hr; taking the supernatant, and concentrating to a relative density of 1.26 to obtain Pudilan extract;

taking 100g of Pudilan extract, 850g of purified water and 50g of sodium citrate, uniformly stirring for 5-10 minutes, heating and boiling for 30 minutes, cooling to room temperature, and placing in a refrigeration house at 0-4 ℃ for refrigeration for 72 hours; taking out the liquid medicine, centrifuging, taking the supernatant, boiling, adding 0.2% of activated carbon, preserving the heat for 30 minutes, cooling to 50-60 ℃, adding water to supplement the loss amount, filtering by using a 1 mu m titanium rod, and concentrating the filtrate to be nearly dry to obtain the Pudilan extract.

Example 3: preparing Scutellariae radix extract.

500g of scutellaria baicalensis is taken; adding 10 times of water for the first time, soaking for 30 minutes, decocting for 1 hour, and filtering; adding 8 times of water for the second time, decocting for 1 hour, and filtering; combining the filtrates, concentrating to relative density of 1.15, adjusting pH to 1.0-2.0 with hydrochloric acid, keeping the temperature at 80 ℃, standing for 12 hours, and filtering; adding appropriate amount of water into the precipitate, stirring, adjusting pH to 7.0 with 40% sodium hydroxide solution, adding equal volume of ethanol, stirring for dissolving, and filtering; adjusting the pH value of the filtrate to 1.0-2.0 by using hydrochloric acid, preserving heat at 60 ℃, standing for 12 hours, and filtering; washing the precipitate with appropriate amount of water and ethanol of different concentrations to pH 7.0, volatilizing ethanol, and drying under reduced pressure to obtain Scutellariae radix extract. The extract contains baicalin (C) in dry matter₂₁H₁₈O₁₁) The content should not be less than 85.0%.

Example 4: and (4) preparing the catmint oil.

Taking 500g of schizonepeta; adding 5 times of water, soaking for 30 minutes, and distilling for 3 hours by adopting a steam distillation method; separating the distillate with oil-water separator to obtain oleum Schizonepetae.

Examples 5 to 10: the invention relates to a preparation method of a nasal traditional Chinese medicine composition.

The components are weighed according to the parts by weight in the table 1, each part is about 10g, and the nasal traditional Chinese medicine composition is obtained after mixing.

TABLE 1 composition of nasal herbal composition.

Examples 11 to 15: the invention relates to a preparation method of a traditional Chinese medicine nasal spray.

TABLE 2 composition of the Chinese medicinal nasal spray.

The preparation method comprises the following steps:

1) weighing a Siberian goose extract, a Pudilan extract, borneol, a Baikal skullcap root extract, fineleaf schizonepeta herb oil, glycerin, cetylpyridinium chloride, methylparaben, sodium citrate, sodium chloride, lemon essence, polysorbate-60, propylene glycol and purified water according to the prescription amount in the table 2;

2) adding propylene glycol, lemon essence, catnip oil, borneol and methyl hydroxybenzoate into a clean stainless steel pot (or barrel), stirring to dissolve, adding polysorbate-60, stirring to dissolve to obtain solution A;

3) adding purified water (first ingredient) and Scutellariae radix extract into another clean stainless steel pot (or barrel), stirring, adding herba Pudiliae blue extract and herba Xanthii goose extract, stirring, slowly adding sodium citrate (seventh ingredient) to adjust pH, and filtering to obtain solution B;

4) adding purified water (seven ingredients) (reserving a proper amount of purified water to wash a stainless steel pot or barrel), sterilizing, stirring, adding glycerol and sodium chloride, stirring to dissolve, adding cetylpyridinium chloride, stirring to dissolve, adding the solution A, stirring uniformly, adding the solution B, stirring uniformly, adding the rest sodium citrate to adjust pH, supplementing the rest purified water, stirring uniformly, detecting the qualified pH, filtering, subpackaging and packaging to obtain the traditional Chinese medicine nasal spray.

Experimental example 1: the invention relates to a pharmacodynamics test of a traditional Chinese medicine nasal spray.

1. Experimental materials:

1.1 Experimental animals:

BALB/c mice, SPF grade, 6-8 weeks old, 20-30 g, provided by Beijing Wintonlihua laboratory animal technology, Inc.; SD rats, SPF grade, 8-10 weeks old, 200-300 g, provided by Beijing Witonglihua laboratory animal technology, Inc.

1.2 experimental strains:

staphylococcus aureus (ATCC 6538, passage 5) and Escherichia coli (ATCC 8099, passages 5-7) were provided by the China center for type culture Collection.

1.3 drugs and reagents:

the test drugs are: the spray of the invention is prepared according to the prescription and the method in the embodiment 13, and the specification is as follows: 15 mL/bottle; positive control drug: aspirin tablet, huarun shuanghe pharmaceutical industry gmbh (production), national standard character H11021494, specification: 0.3 g/tablet; levocabastine hydrochloride nasal spray, Janssen pharmaceutical n.v. (belgium) (production)/shanghai qiangsheng pharmaceutical limited (split charging), national drug standard J20100004, specification: 10mL is 5 mg/bottle; triamcinolone acetonide nasal spray, Nanjing Xingying pharmaceutical industry group Limited (production), national drug standard H20020360, specification: 6mL:1.1 mg/bottle.

2. Experimental methods and results:

2.1 anti-inflammatory assay:

the method comprises the following steps: 50 BALB/c mice are randomly divided into 5 groups, 10 mice in each group are respectively marked as a blank control (normal saline) group, a high-dose (2.0g/kg), medium-dose (1.0g/kg) and low-dose (0.5g/kg) group of the spray, and a positive control (aspirin, 0.5g/kg) group. Each drug group mouse is administrated by nasal drip 1 time a day, a blank control group mouse is administrated by intragastric administration with physiological saline with the same volume every day for 3 days continuously, after 1 hour of the last administration, the mouse is respectively administrated by 0.5% Evans blue physiological saline solution (10mL/kg) to the tail vein, then 0.6% acetic acid physiological saline solution (0.20 mL/mouse) is administrated to the abdominal cavity, the mouse is killed after 20min, the abdominal skin muscle is cut, the abdominal cavity is washed by physiological saline (6mL) for several times, the washing solution is sucked out, the physiological saline is added to 10mL, the centrifugation is carried out for 15min, the supernatant is taken, the absorbance is measured at 590nm by a spectrophotometer, and the result is shown in Table 3.

TABLE 3 Effect of drugs on the permeability of the capillaries in the mouse peritoneal cavity

Group of	Dosage (g/kg)	Absorbance of the solution
			Physiological saline group	/	0.566±0.022
Nasal spray high dose compositions	2.0	0.219±0.021
			Nasal spray medium dose group	1.0	0.253±0.023
Nasal spray low dose group	0.5	0.291±0.019
			Aspirin group	0.5	0.202±0.025

As a result: as shown in Table 3, compared with the blank control group, the high, medium and low dose groups of the nasal spray can remarkably reduce the increase of the permeability of capillary vessels in abdominal cavities of mice caused by acetic acid (P is less than 0.01), and the nasal spray has better anti-inflammatory effect.

2.2 antiallergic experiment:

the method comprises the following steps: 60 SD rats were treated once every other day on days 1-15 with 20. mu.g Ovalbumin (OVA) and 1mg Al (OH)₃And 1X 10⁹Carrying out basal sensitization on the intraperitoneal injection of Bordetella pertussis to each rat, and carrying out local excitation on the 16 th to 20 th days by using 20 mu g of OVA (OVA) nasal drops; after local excitation, the rats are divided into 6 groups at random, each group is divided into 10 groups, and the groups are respectively marked as blank control (normal saline) groups, spray high dose (1.0g/kg), medium dose (0.5g/kg) and low dose (0.25g/kg), positive control levocabastine (0.2g/kg) group and triamcinolone acetonide (0.15g/kg) group, nasal symptoms of the rats are observed for 5 days continuously, and the rats are scored by an overlay method (see Chinese medicine institute traditional Chinese medicine experiment pharmacology professional committee, allergic rhinitis animal model preparation specification (draft) [ J)]Chinese herbal medicine, 2018, 49 (1): 50-57); after 5 days, each drug group is administrated by nasal drip once a day for 14 days continuously, and a blank control group is subjected to nasal drip by physiological saline with the same volume; on day 2 after the last administration, 20 μ g OVA was further applied to the nose, and the nasal symptoms of the rats were observed for 5 consecutive days, scored by the superposition method, and the total IgE level in the serum of the rats was measured (after sacrifice, 5mL of fresh blood was collected by heart bleeding, left to stand at room temperature for 2 hours, centrifuged at 4 ℃ and 3000rpm for 5min, and the supernatant was taken for measurement). Nasal symptom results are shown in table 4 and total IgE level results in serum are shown in table 5.

TABLE 4 Effect of drugs on OVA sensitization (nasal symptoms)

Group of	Dosage (g/kg)	Pre-dose scoring	Post-dose scoring
				Physiological saline group	/	8.5±3.3	8.8±3.1
Nasal spray high dose compositions	1.0	8.4±2.8	4.2±4.4
				Nasal spray medium dose group	0.5	8.3±2.3	5.9±3.3
Nasal spray low dose group	0.25	8.1±2.9	7.1±3.8
				Levocabastine group	0.2	8.3±2.5	4.1±3.5
Triamcinolone acetonide group	0.15	8.8±3.1	3.2±3.9

TABLE 5 Effect of drugs on OVA sensitization (IgE levels)

Group of	Dosage (g/kg)	IgE levels (ng/mL)
			Physiological saline group	/	33.50±1.25
Nasal spray high dose compositions	1.0	16.24±2.15
			Nasal spray medium dose group	0.5	19.68±1.83
Nasal spray low dose group	0.25	22.42±1.28
			Levocabastine group	0.2	20.21±2.25
Triamcinolone acetonide group	0.15	15.98±1.59

As a result: as shown in table 4, the nasal spray provided significant relief of nasal symptoms due to OVA in the high, medium and low dose groups compared to the blank control group (P <0.01), wherein the high dose group was comparable to the positive control levocabastine group; as shown in table 5, the IgE levels of the nasal spray were reduced (P <0.01) in the high, medium and low dose groups compared to the blank control group, wherein the high dose group showed similar results to the positive control triamcinolone acetonide group, and the medium dose group showed similar differences to the positive control levocabastine group. The results show that the spray has better anti-allergic effect.

2.3 bacteriostatic experiment:

2.3.1 bacteriostatic experiments on Staphylococcus aureus:

1) the test bacteria were washed with PBS for 24 hours and the slant culture was made into a bacterial suspension (the number of recovered bacteria was 1X 10)⁴～9×10⁴cfu/mL)。

2) The spray of the present invention was used as a test sample, and the sterilized sample containing no antibacterial material was used as a control sample, each of which was 4 tubes.

3) And (3) taking the bacterial suspension, respectively dropwise adding 100 mu L of the bacterial suspension into each sample solution to be tested and each control sample solution, uniformly mixing, timing, when the samples act for 2min, 5min, 10 min and 20min, respectively putting each sample solution (0.5mL) into a test tube containing 5mL of PBS (phosphate buffer solution), fully and uniformly mixing, diluting properly, then taking 2-3 dilutions, respectively sucking 0.5mL, placing into two plates, pouring by using a 40-45 ℃ nutrient agar medium (bacteria) or a Sageria agar medium (yeast) 15mL, rotating the plates to fully and uniformly, turning over the plates after agar is solidified, culturing for 48h at 35 +/-2 ℃ and counting viable bacteria colonies.

4) The test was repeated 3 times and the bactericidal rate was calculated as follows:

x ═ a-B)/ax100%; in the formula:

x: bacteriostatic rate (%); a: average colony number of the control sample liquid; b: average colony number of test sample liquid.

5) Results and analysis:

TABLE 6 antibacterial test results for Staphylococcus aureus

Note: negative control was grown aseptically.

As can be seen from Table 6, the results of 3 times of experiments show that the average bacteriostasis rate of staphylococcus aureus of more than 99.99 percent can be achieved after the sample acts for 2min, and the sample shows stronger bacteriostasis.

2.3.2 bacteriostatic experiments on E.coli:

the experimental procedure was as described in 2.3.1, with E.coli being substituted accordingly.

TABLE 7 results of Escherichia coli bacteriostatic experiments

Note: negative control was grown aseptically.

As can be seen from Table 7, the results of 3 times of experiments show that the average bacteriostasis rate of the Escherichia coli can reach more than 99.99% after the sample acts for 2min, and the Escherichia coli shows stronger bacteriostasis.

2.3.3 stability experiments:

the spray is stored for 90 days at 37 ℃, and the antibacterial performance test is carried out to investigate the stability of the spray. The experimental procedure was as described in 2.3.1.

TABLE 8 antibacterial test results for Staphylococcus aureus

Note: negative control was grown aseptically.

As can be seen from Table 8, the results of 3 times of experiments show that the average bacteriostasis rate of staphylococcus aureus of more than 99.99 percent can be still achieved after the sample acts for 2min, and the spray has stronger bacteriostasis, thereby showing that the spray has more ideal stability.

In conclusion, the traditional Chinese medicine nasal spray has good effects of resisting inflammation, resisting allergy, inhibiting bacteria and the like, and provides experimental basis for clinical experiments and use of the traditional Chinese medicine nasal spray.

Experimental example 2: toxicology tests of the traditional Chinese medicine nasal spray of the invention.

1. Experimental materials:

1.1 Experimental animals:

BALB/c mice, SPF grade, 6-8 weeks old, 20-30 g, provided by Beijing Wintorlawa laboratory animal technology, Inc.

1.2 medicine:

the test drugs are: the spray of the invention is prepared according to the prescription and the method in the embodiment 13, and the specification is as follows: 15 mL/bottle.

2. Experimental methods and results:

2.1 determination of the median Lethal Dose (LD)₅₀)：

30 BALB/c mice were randomly divided into 3 groups (10 mice per group) and recorded as 15 g/kg. d of the spray of the present invention^-1、20g/kg·d^-1And 25 g/kg. d^-1In the group, fasting (without water), a single gavage administration is carried out after 12h, each time is 0.5mL/10g, the general conditions (weight, diet, behavior, excrement and the like) and the toxic and dead conditions of the mice are observed, and the mice are continuously observed for 14 d.

2.2 maximum dose experiment:

BALB/c mice 20, the administration volume 0.4ml/10g, according to 80g/kg d^-1The administration dose of (2) was administered by gavage three times, and the general condition and death condition of the mice were observed for 14 days, and the results are shown in Table 9.

TABLE 9 weight change in rats in the experiment of maximum drug administration

Sample (I)	Before administration	After 7 days of administration	After 14 days of administration
				The invention relates to a spray	21.5±2.5	22.6±1.8	23.1±2.1

3. As a result:

LD₅₀the general condition of each group of mice in the test period is good, no death is found, and LD can not be calculated₅₀(ii) a The weight of the mice is increased in the maximum dose test, and the general condition is good. The results show that the traditional Chinese medicine nasal spray provided by the invention has low acute toxicity to mice and high safety.

Experimental example 3: the invention relates to an acute eye irritation experiment of a traditional Chinese medicine nasal spray.

1. Experimental materials:

1.1 Experimental animals:

new Zealand rabbits, 3, female and male are not limited. A breeding environment: 21.5-22.8 ℃, 53.6-59.4% RH, 12 hours of light/dark circulation, 8-10 times of ventilation per hour, and free drinking water.

1.2 medicine:

2. Experimental methods and results:

1) preliminary examination of experimental animals: within 24h before the start of the test, both eyes of the test animals were examined for 2% sodium fluorescein, and animals with eye irritation symptoms, corneal defects, and conjunctival lesions were excluded.

2) Slightly pulling the lower eyelid at one side of the rabbit, dripping 0.1mL of the spraying agent into the conjunctival sac, and dripping equal volume of normal saline into the eyelid at the other side to serve as a normal control.

3) After administration, the upper and lower eyelids were passively closed for 4s, and both eyes were rinsed with physiological saline 30s later.

4) The eyes of the animals were examined at 1h, 24h, 48h, 72h, 7d, 14d and 21d after the administration, and the damage and recovery of the conjunctiva, iris and cornea of the eyes of the rabbits were visually observed. If no irritation response occurred at 72h, or the eye irritation response was completely restored at 7d or 14d, the test was terminated prematurely. If necessary, the cornea and iris changes were examined with 2% sodium fluorescein solution or slit lamp, magnifying glass.

5) Evaluation methods and results:

TABLE 10 Rabbit eye injury scoring sheet

The acute corneal, iris and conjunctival irritation responses of the rabbits were scored according to table 10, and the "mean score" for each animal in terms of corneal damage, iris damage, conjunctival congestion and conjunctival edema at three different observation times (24h, 48h and 72h) was calculated, respectively (i.e., the sum of the 24h, 48h and 72h scores for each animal divided by the number of observations 3).

TABLE 11 Rabbit eye irritation test results

As can be seen from Table 11, 3 rabbits showed slight hyperemia and edema only 1 hour after administration, and recovered to normal state after 24 hours, indicating that the spray of the present invention has no irritation and certain safety in administration.

Claims

1. A nasal Chinese medicinal composition comprises extract of Siberian cocklebur, extract of Pudilan, Borneolum Syntheticum, extract of Scutellariae radix and oleum Schizonepetae.

2. The nasal traditional Chinese medicine composition according to claim 1, characterized in that:

the nasal traditional Chinese medicine composition consists of a Siberian cocklebur extract, a Pudilan extract, borneol, a Baikal skullcap root extract and catnip oil.

3. A nasal traditional Chinese medicine composition according to claim 1 or 2, characterized in that:

the weight ratio of the Siberian cocklebur extract, the Pudilan extract, the borneol, the Baikal skullcap root extract and the catnip oil is 1: 0.02-0.5: 0.004-0.1: 0.002-0.05: 0.001-0.025.

4. A method of preparing a nasal traditional Chinese medicine composition according to any one of claims 1 to 3, comprising the step of weighing and mixing the components.

5. Use of a nasal traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a pharmaceutical preparation for preventing and/or treating rhinitis.

6. Use according to claim 5, characterized in that:

the rhinitis includes acute rhinitis, chronic rhinitis, atrophic rhinitis, caseous rhinitis, rhinitis sicca, rhinitis medicamentosa and allergic rhinitis.

7. Use according to claim 5 or 6, characterized in that:

the medicinal preparation is a traditional Chinese medicine nasal spray.

8. A traditional Chinese medicine nasal spray, which comprises the nasal traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable auxiliary materials.

9. The traditional Chinese medicine nasal spray according to claim 8, characterized in that:

the auxiliary materials comprise a humectant, parabens and cationic surfactant bacteriostats, a pH regulator, an osmotic pressure regulator, essence, a solubilizer, a cosolvent and a solvent.

10. The preparation method of the traditional Chinese medicine nasal spray according to claim 9, which comprises the following steps: