CN116370591A - A Chinese medicinal external preparation for treating rhinitis, and its preparation method and quality control method - Google Patents
A Chinese medicinal external preparation for treating rhinitis, and its preparation method and quality control method Download PDFInfo
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- CN116370591A CN116370591A CN202310448347.1A CN202310448347A CN116370591A CN 116370591 A CN116370591 A CN 116370591A CN 202310448347 A CN202310448347 A CN 202310448347A CN 116370591 A CN116370591 A CN 116370591A
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Abstract
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine external preparation for treating rhinitis and a preparation and quality control method thereof. The traditional Chinese medicine external preparation provided by the invention can obviously improve symptoms of patients with allergic rhinitis due to lung qi deficiency and cold, improves the quality of life, has higher safety, can be used as a potential traditional Chinese medicine compound preparation for treating allergic rhinitis, has low irritation, and can be used as an external medicine for long-term administration.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine external preparation for treating rhinitis and a preparation and quality control method thereof.
Background
Rhinitis (rhinitis) is a nasal mucosa inflammation caused by viruses, bacteria, allergens, various physicochemical factors and certain systemic diseases, and is clinically manifested by nasal obstruction, nasal discharge, olfaction decline, dizziness, headache and the like, and is mostly caused by lung qi deficiency and cold, loose skin striae and loose skin striae, and pathogenic wind-cold or abnormal qi is easy to enter due to deficiency. The disease is located in the nose, the internal causes are the deficiency of the lung, spleen and kidney, and the external causes are the invasion of six pathogenic factors such as wind, cold and fire. The symptoms of rhinitis are repeatedly caused by the long-term retention of pathogenic factors in collaterals and the disturbance of pathogenic factors, so that the therapeutic effect of treating the disease by dispersing pathogenic factors and inducing resuscitation is good.
For diagnosis and treatment of rhinitis, clinical common western medicine therapies comprise avoiding contact with allergen, medicine therapies, immunotherapy, operation therapies and the like, and common medicine therapies comprise glucocorticoids, antihistamine medicines, leukotriene receptor antagonists, decongestants, anticholinergic medicines and the like, and western medicine therapies can alleviate and improve nasal symptoms to a certain extent, but are easy to relapse and produce side effects, such as loratadine has a certain effect on treating allergic rhinitis, but cannot reduce eosinophil activity and cannot effectively improve nasal obstruction symptoms; the budesonide nasal spray, used in high doses for a long period of time, may have systemic effects of the glucocorticoid. Therefore, the traditional Chinese medicine has the advantages of simple, convenient, cheap and effective treatment of rhinitis, has the outstanding characteristics of durable medicine effect, less adverse reaction, small irritation, convenient taking and the like, and is more easily accepted by patients.
The Chinese medicinal external preparation is applied to treat various rhinitis, such as atrophic rhinitis by using myogenic Yuhong ointment, chronic atrophic rhinitis by using Beijing Wan hong ointment, chronic simple rhinitis by using Jiuhua ointment, and the like. The external preparation of the traditional Chinese medicine is developed, has reliable curative effect, simple operation, low treatment cost and no toxic or side effect, is easy to be accepted by patients, and has better clinical popularization prospect. The Chinese patent of the document No. CN103585540B discloses a type of wormwood incense oil which is an oily substance with aromatic smell and is prepared from the medicinal raw materials of rhizoma atractylodis, folium artemisiae argyi, wrinkled giant hyssop, herba eupatorii, clove, chinese pricklyash peel, cardamom, herba elsholtziae, grassleaf sweelflag rhizome, kaempferia galanga and the like, and the wormwood incense oil can be inhaled through a nasal cavity to further play the effects of regulating the local respiratory tract mucosa immunity function and preventing and treating the upper respiratory tract infection, and can relieve the acute inflammation symptoms caused by the acute upper respiratory tract infection, but the applicant finds that the wormwood incense oil has larger irritation to the nasal cavity when the dosage is excessive or the wormwood incense oil is used for a long time, so the wormwood incense oil cannot be used for treating chronic rhinitis and still needs to be further improved.
Disclosure of Invention
In order to solve the technical problems, the invention aims to provide a traditional Chinese medicine external preparation for treating rhinitis and a preparation and quality control method thereof, wherein the traditional Chinese medicine external preparation has the effects of removing turbid pathogen by aromatics, avoiding dirt and detoxifying, purging lung and qi, nourishing spleen and eliminating dampness, inducing resuscitation and resolving depression, and is suitable for long-term treatment of chronic rhinitis.
In order to achieve the technical effects, the invention adopts the following technical scheme:
in a first aspect, the invention provides a traditional Chinese medicine external preparation for treating rhinitis, which comprises the following medicinal raw materials in parts by weight: 30-150 parts of rhizoma atractylodis, 30-150 parts of mugwort leaf, 15-75 parts of wrinkled gianthyssop herb, 15-75 parts of eupatorium, 15-75 parts of clove, 15-75 parts of pricklyash peel and 15-75 parts of cardamom; preferably, the traditional Chinese medicine external preparation comprises the following medicinal raw materials in parts by mass: 40-80 parts of rhizoma atractylodis, 40-80 parts of mugwort leaf, 40-55 parts of wrinkled gianthyssop herb, 30-55 parts of eupatorium, 30-55 parts of clove, 30-55 parts of pricklyash peel and 30-55 parts of cardamom;
further preferably, the external traditional Chinese medicine preparation comprises the following medicinal raw materials in parts by weight: 80 parts of rhizoma atractylodis, 80 parts of folium artemisiae argyi, 40 parts of wrinkled gianthyssop herb, 40 parts of eupatorium fortunei, 40 parts of clove, 40 parts of pepper and 40 parts of cardamom;
further, the external preparation of the traditional Chinese medicine also comprises pharmaceutically acceptable auxiliary materials.
Preferably, the pharmaceutically acceptable adjuvant comprises at least one of vegetable oil and beeswax.
Preferably, the external preparation of the traditional Chinese medicine and pharmaceutically acceptable auxiliary materials are prepared into any one of gel, cream, ointment and gel paste.
In a second aspect, the invention also provides a preparation method of the external traditional Chinese medicine preparation for treating rhinitis, which specifically comprises the following steps:
s1: weighing rhizoma atractylodis, folium artemisiae argyi, wrinkled gianthyssop herb, eupatorium fortunei, clove, chinese prickly ash and cardamom according to parts by weight, mixing and crushing into coarse powder to obtain a mixed raw material, and adding a proper amount of solvent into the mixed raw material to moisten the mixed raw material;
s2: extracting the above mixed materials with vegetable oil as extractant, filtering and mixing filtrates to obtain oil-immersed liquid, adding Cera flava into the oil-immersed liquid, heating to melt Cera flava, stirring until cooling, and obtaining the Chinese medicinal external preparation.
Preferably, the solvent is one or a mixture of purified water and ethanol; preferably, the adding amount of the beeswax is 0.1-0.5 times of the mass of the oil immersed liquid; preferably, the vegetable oil is any one or more of soybean oil, sesame oil, castor oil, tea oil or rapeseed oil.
Preferably, the extraction method comprises the following steps: adding vegetable oil with the mass 2-5 times of that of the mixed raw materials into the mixed raw materials for 3 times to leach the mixed raw materials for 10-30 hours each time, filtering and extruding dregs after each time of soaking to obtain filtrate, and merging the leaching filtrates to obtain oil-immersed liquid.
In a third aspect, the invention also provides a quality control method of the traditional Chinese medicine external preparation for treating rhinitis, wherein the contents of linalool, eugenol and beta-caryophyllene are respectively measured by a gas chromatography method.
Further, the quality control method specifically includes the following steps:
s11: testing the gas chromatography conditions and the system applicability;
the chromatographic column adopts an Agilent HP-5 quartz capillary chromatographic column (30 m×320 μm×0.25 μm); column temperature 40 ℃ (1 min, 10 ℃ C. 1 min) -1 The temperature is increased to 130 ℃ (kept for 5 min) and then 8 ℃ for 1min -1 The rate was increased to 180 ℃ (hold for 1 min); setting the temperature of the sample inlet to 200 ℃, and setting the carrier gas to be high-purity nitrogen with the volume flow of 1mL 1min at 1mL 1min -1 The method comprises the steps of carrying out a first treatment on the surface of the The flow is not split, and the sample injection amount is 1 mu L; the total separation time was 22.25min;
s12: preparation of control solution and test solution:
precisely weighing linalool, eugenol and beta-caryophyllene reference substance, adding n-hexane to dissolve, and preparing into reference substance solution; accurately weighing the external preparation of the traditional Chinese medicine, adding n-hexane to dissolve the external preparation of the traditional Chinese medicine, and preparing the external preparation of the traditional Chinese medicine into a sample solution;
s13: and (3) content measurement:
precisely sucking the reference substance solution and the sample solution respectively, and measuring in the gas chromatography condition in S11.
Compared with the prior art, the invention has the beneficial effects that:
firstly, the traditional Chinese medicine external preparation for treating rhinitis is developed by taking rhizoma atractylodis, mugwort leaf, wrinkled gianthyssop herb, eupatorium fortunei, clove, pricklyash peel and cardamom as raw materials, wherein the rhizoma atractylodis and the mugwort leaf are aromatic, resolve dampness and unblock, and are used for removing toxic substances and resolving stagnation; herba Agastaches herba Eupatorii Xiang Wu, and auxiliary drugs with fragrance are used as ministerial drugs for activating spleen, relieving Yu Hang stagnation, eliminating dampness and removing summer-heat; the clove and the pricklyash peel are mutually combined, and the effects of removing parasites and turbidity, removing dampness by means of spicy fragrance, enabling the medicine to pass through the triple energizer and guiding the menstruation to be used as an adjuvant, and the medicines are combined together to play roles of aromatic turbidity removal, dirt avoidance and detoxification, lung purging, qi regulation, spleen nourishing and dampness eliminating, and resuscitation and depression relieving. Meanwhile, the active ingredients of the raw materials take volatile oil as the main ingredient, researches show that the aromatic drugs are dry and violent, if the active ingredients are improper in use, the active ingredients consume qi to hurt yin, and the traditional inhalation preparation and the oral preparation are effective, but the problems of short acting time, difficult administration, inaccurate quantification and the like limit the clinical application of the active ingredients, especially the active ingredients are difficult to act on the nose for a long time, and meanwhile, the external preparations such as ointment and the like are prepared to be coated in the nasal cavity, and can also physically prevent external sensitizers from entering the respiratory tract to induce or exacerbate rhinitis symptoms.
The preparation method of the traditional Chinese medicine external preparation for treating rhinitis is mainly characterized in that vegetable oil is adopted to soak and extract the mixed raw materials, and then the mixed raw materials are added with a matrix and uniformly mixed, the preparation method is simple in process operation, short in production period, low in cost and suitable for industrial mass production, the preparation formulation is an external preparation, the safety is high, the use method is simple, and the preparation method is convenient to carry.
Finally, the invention establishes a quality control method of the traditional Chinese medicine external preparation for treating rhinitis, and the method can effectively, rapidly and accurately measure the contents of linalool, eugenol and beta-caryophyllene in the product according to gas chromatography, thereby ensuring the quality and the effectiveness of the product.
Drawings
FIG. 1 shows the results of a thin layer identification experiment of the provided pallor Ai Biyan ointment of the present invention using atractylin as a control in example 2 of the present invention;
FIG. 2 shows the results of the gas chromatography method according to example 2 of the present invention for quality control of the pale Ai Biyan ointment according to the present invention;
fig. 3 shows the results of the stimulation test of the pallium Ai Biyan ointment and the control ointment provided in example 3 of the present invention, in which the blank control group, the control ointment and the pallium Ai Biyan ointment provided in the present invention are sequentially shown from left to right.
Detailed Description
Embodiments of the technical scheme of the present invention will be described in detail below with reference to the accompanying drawings. The following examples are only for more clearly illustrating the technical aspects of the present invention, and thus are merely examples, and are not intended to limit the scope of the present invention. The test methods used in the following examples are conventional methods unless otherwise specified; the materials, reagents or apparatus used, unless specifically stated otherwise, are those commercially available and the specific conditions in the examples are as per conventional conditions or as recommended by the manufacturer.
Example 1
The embodiment provides a traditional Chinese medicine external preparation for treating rhinitis and a preparation method thereof, wherein the traditional Chinese medicine external preparation is prepared from the following medicinal raw materials in parts by mass and pharmaceutically acceptable auxiliary materials:
90g of rhizoma atractylodis, 90g of mugwort leaf, 45g of wrinkled gianthyssop herb, 45g of eupatorium fortunei, 45g of clove, 45g of pepper, 45g of cardamom, 405g of soybean oil and beeswax.
The external traditional Chinese medicine preparation for treating rhinitis is prepared into gel paste and named as a pallor Ai Biyan ointment, and the preparation method of the pallor Ai Biyan ointment is as follows:
s1: weighing rhizoma atractylodis, mugwort leaf, wrinkled gianthyssop herb, eupatorium fortunei, clove, chinese prickly ash and cardamom according to the weight parts, mixing and crushing into coarse powder to obtain a mixed raw material, and adding a proper amount of water into the mixed raw material to moisten the mixed raw material;
s2: adding soybean oil into the mixed raw materials for 3 times, leaching for 18 hours each time, filtering and extruding dregs after each time of leaching to obtain filtrate, combining the filtrate obtained by leaching for multiple times to obtain oil-immersed liquid, adding beeswax into the oil-immersed liquid, heating until the beeswax is melted, and stirring until the beeswax is cooled to obtain the pall Ai Biyan ointment.
Example 2
The embodiment further provides an identification method and a quality control method of the pallor Ai Biyan ointment for treating rhinitis based on the embodiment 1, specifically:
2.1, the identification method adopts atractylin as a reference substance to carry out thin-layer identification, and comprises the following steps:
(1) Preparation of control solution
Adding methanol into atractylin reference substance to obtain solution containing atractylin 0.2 mg/1 mL.
(2) Preparation of test solutions
Taking 5g of the traditional Chinese medicine ointment, adding 20mL of methanol, carrying out ultrasonic treatment for 1h, filtering, evaporating filtrate to dryness, and re-dissolving residues with 1mL of methanol to obtain a sample solution.
(3) Assay
When identification is carried out, the sample solution and the reference substance solution are respectively absorbed by 2-5 mu 1 and respectively spotted on the same silica gel G thin layer plate, petroleum ether (60-90 ℃) and ethyl acetate (10:0.5) are taken as developing agents, and the developing agents are developed, taken out and dried, sprayed with 5% vanillin sulfuric acid solution, and heated until spots develop clearly. Spots of the same color appear in the sample chromatogram at positions corresponding to those of the control chromatogram.
The experimental results of the above identification method are shown in FIG. 1, from left to right, 1 represents an atractylone control; 2 to 5 represent the test results of one test solution, respectively, and 6 represents the test results of a negative control.
2.2 gas chromatography quality control method comprising:
s11: chromatographic conditions and system suitability test:
the column temperature was 40℃for 1min and 10℃for min, using an Agilent HP-5 quartz capillary chromatography column (30 mX320. Mu.m X0.25 μm) -1 The temperature is increased to 130 ℃ (kept for 5 min) and 8 ℃ for min -1 The rate was increased to 180 ℃ (hold for 1 min); the temperature of the sample inlet is 200 ℃, the carrier gas is high-purity nitrogen, and the volume flow is 1.5 mL.min -1 The method comprises the steps of carrying out a first treatment on the surface of the The flow is not split, and the sample injection amount is 1 mu L; the total separation time was 22.25min.
S12: preparing a reference substance solution and a test substance solution, wherein:
preparation of a control solution:
precisely weighing linalool, eugenol and beta-caryophyllene reference substances, precisely weighing, adding n-hexane to dissolve, and obtaining solutions with the concentrations of linalool, eugenol and beta-caryophyllene of 0.3mg, 0.5mg and 0.2mg of linalool and eugenol and beta-caryophyllene contained in each 1mL of solution as reference substance solutions.
Preparation of test solution:
taking 0.1g of the pallor Ai Biyan ointment prepared in the embodiment 1, precisely weighing, precisely adding 1mL of n-hexane, weighing, performing ultrasound for 10min, standing at 4 ℃ for 30min, supplementing light weight with n-hexane, centrifuging, taking supernatant, and filtering with a 0.22 mu m microporous filter membrane to obtain a sample solution.
S13: and (3) content measurement:
respectively precisely sucking 1 μl of the reference substance solution and 1 μl of the sample solution, and analyzing and determining by using S11 chromatographic condition to obtain linalool, eugenol, and beta-caryophyllene content in the fructus Xanthii Ai Biyan ointment, wherein each g of the fructus Xanthii Ai Biyan ointment contains linalool not less than 0.15mg, eugenol not less than 1mg, and beta-caryophyllene not less than 0.1mg, which can be qualified.
Referring to fig. 2, fig. 2 is a gas chromatography detection result of a pale Ai Biyan ointment according to embodiment 1 of the present invention, wherein 1: linalool, 2: eugenol, 3: beta-caryophyllene.
Example 3
The embodiment provides an animal experiment of the pale Ai Biyan ointment, and the experimental method and the results are as follows:
in this example, the following pharmaceutical materials and pharmaceutically acceptable excipients were used to prepare a control ointment, which was prepared according to the preparation method provided in example 1.
90g of rhizoma atractylodis, 90g of mugwort leaf, 45g of wrinkled gianthyssop herb, 45g of eupatorium fortunei, 45g of clove, 45g of pricklyash peel, 45g of cardamom, 45g of elsholtzia, 45g of grassleaf sweelflag rhizome, 45g of rhizoma kaempferiae, 540g of soybean oil and beeswax.
After the preparation is completed, mice are used as acute irritation test objects respectively for the pallium Ai Biyan ointment prepared in the example 1 and the control ointment prepared in the example 3, and the experimental results are shown in the attached chart 3, and the experimental results show that the irritation of the control ointment is obviously larger, and the mouth and nose of the mice have obvious red swelling, so that the pallium Ai Biyan ointment provided by the invention is less in safety and irritation and is suitable for long-term administration.
Example 4
This example is a clinical efficacy verification example of the pallor Ai Biyan ointment prepared in example 1, and is prepared as follows:
4.1 general data
Clinical data of patients suffering from allergic rhinitis with lung qi deficiency and cold symptoms diagnosed and treated in 2018, 10 months and 2021, 12 months of a first affiliated hospital of Yunnan traditional Chinese medicine university are collected and retrospectively analyzed. Of the 48 patients in the group, 20 men and 28 women; the age is 18-65 years.
4.2 group entry criteria
The diagnosis basis, the syndrome classification and the treatment effect assessment of the allergic rhinitis and the allergic rhinitis diagnosis and treatment guidelines (2015, tianjin) in the Chinese medical industry standard of the people's republic of China and the diagnosis treatment effect standard of the Chinese medical otorhinolaryngology disease are referred to, and the following conditions are met: (1) at least more than 2 main symptoms exist, and the total integral of the total nasal symptoms and signs is more than or equal to 6 minutes; (2) age 18-65 years, and is not limited for men and women; (3) the astemizole and the immunomodulating drug were not received within 4 weeks, and the other antihistamines were stopped for more than 2 weeks.
4.3 exclusion criteria
Comprising any one of the following:
(1) other types of rhinitis with symptoms such as itching nose, sneezing, nasal obstruction, clear nasal discharge, etc. caused by non-allergic rhinitis;
(2) patients with nasal cavity organic lesions such as upper and lower respiratory tract infection, sinusitis, nasal polyp, hypertrophic rhinitis and serious nasal septum deflection, or with persistent asthma and asthma acute exacerbators;
(3) allergic rhinitis treatment such as antihistamines, sodium tryptophanate, etc. (including systemic or nasal topical administration) with adrenoglucocorticoid for nearly 1 month, or within 2 weeks;
(4) those who are using macrolide antibiotics and/or systems using imidazole-type antifungal agents;
(5) for those who have a history of allergy to the components of the pallium Ai Biyan paste;
(6) patients with concomitant medication (e.g., tricyclic antidepressants) for long-term use that may have an impact on the evaluation of the test drug;
(7) has severe primary heart, liver, lung, kidney, blood or serious diseases affecting its survival, such as tumor or AIDS;
(8) women in gestation and intended gestation and lactation;
(9) a person suspected or confirmed history of alcohol, drug abuse;
is being engaged in other clinical trials or is considered unsuitable by researchers to be enrolled.
4.4 treatment regimen
(1) The usage amount is as follows: after cleaning the nasal cavity, dipping a proper amount of ointment with a cotton swab, and sending the ointment into the nasal cavity at a position of 1-2 cm, and uniformly smearing the cotton swab for 3-4 times a day; (2) treatment course: 14 days.
4.5 evaluation index
A patient profile was established before the start of all patient treatments and rhinitis symptom scores (total nasal symptoms score, TNSS), TCM symptom scores, and quality of life questionnaires (QRLQ) related to rhinoconjunctivitis were recorded for all patients before and 2 weeks after the treatment.
4.6 results
Table 5 the pale Ai Biyan ointment is used for treating allergic rhinitis patients with lung qi deficiency and cold syndrome before and after treatment (S, n=48, minutes)
Compared with the pre-treatment (P < 0.05).
The results of the rhinitis symptom score (TSS) evaluation before and after treatment show that the rhinitis symptom score after 2 weeks of treatment of 48 patients is significantly lower than that before treatment, and the difference has statistical significance (P < 0.05), as shown in Table 5.
The evaluation results of the traditional Chinese medicine syndrome scores before and after treatment show that the traditional Chinese medicine syndrome scores of 48 patients after 2 weeks of treatment are obviously lower than those before treatment, and the difference has statistical significance (P is less than 0.05), as shown in Table 5.
The quality of life index (QRLQ) evaluation results of allergic rhinitis patients show that the quality of life index (QRLQ) of allergic rhinitis patients is significantly lower after 2 weeks of treatment than before treatment, and the difference has statistical significance (P < 0.05), as shown in table 5.
4.7 conclusion
The pallor Ai Biyan ointment provided by the invention can obviously improve symptoms of patients with allergic rhinitis due to lung qi deficiency and cold, improves the quality of life, has higher safety, can be used as a potential traditional Chinese medicine compound preparation for treating allergic rhinitis, has small irritation, is convenient to use, and has a larger clinical application value.
The above embodiments are only for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications and equivalents may be made thereto without departing from the spirit and scope of the technical solution of the present invention, which is intended to be covered by the scope of the claims of the present invention. The technology, shape, and construction parts of the present invention, which are not described in detail, are known in the art.
Claims (10)
1. The traditional Chinese medicine external preparation for treating rhinitis is characterized by comprising the following medicinal raw materials in parts by weight: 30-150 parts of rhizoma atractylodis, 30-150 parts of mugwort leaf, 15-75 parts of wrinkled gianthyssop herb, 15-75 parts of eupatorium, 15-75 parts of clove, 15-75 parts of pricklyash peel and 15-75 parts of cardamom.
2. The external preparation for treating rhinitis according to claim 1, wherein: the external preparation of the traditional Chinese medicine also comprises pharmaceutically acceptable auxiliary materials.
3. The external preparation for treating rhinitis according to claim 2, wherein: the pharmaceutically acceptable auxiliary materials comprise at least one of vegetable oil and beeswax.
4. A Chinese medicinal external preparation for treating rhinitis according to claim 3, wherein: the external preparation of the traditional Chinese medicine and pharmaceutically acceptable auxiliary materials are prepared into any one of gel, cream, ointment and gel paste.
5. The method for preparing the external preparation of traditional Chinese medicine for treating rhinitis according to claim 1, which is characterized by comprising the following steps:
s1: weighing medicinal raw materials including rhizoma atractylodis, folium artemisiae argyi, wrinkled gianthyssop herb, eupatorium fortunei, clove, chinese prickly ash and cardamom according to parts by weight, mixing and crushing into coarse powder to obtain mixed raw materials, and adding a proper amount of solvent into the mixed raw materials to moisten the mixed raw materials;
preferably, the medicine raw materials comprise the following medicines in parts by weight: 30-150 parts of rhizoma atractylodis, 30-150 parts of mugwort leaf, 15-75 parts of wrinkled gianthyssop herb, 15-75 parts of eupatorium, 15-75 parts of clove, 15-75 parts of pricklyash peel and 15-75 parts of cardamom;
further preferably, the medicine raw materials comprise the following medicines in parts by weight: 80-100 parts of rhizoma atractylodis, 80-100 parts of folium artemisiae argyi, 40-50 parts of wrinkled gianthyssop herb, 40-50 parts of eupatorium, 40-50 parts of clove, 40-50 parts of pepper and 40-50 parts of cardamom;
s2: extracting the above mixed materials with vegetable oil as extractant, filtering and mixing filtrates to obtain oil-immersed liquid, adding Cera flava into the oil-immersed liquid, heating to melt Cera flava, stirring until cooling, and obtaining the Chinese medicinal external preparation.
6. The method for preparing the external preparation of traditional Chinese medicine for treating rhinitis according to claim 5, which is characterized in that: the solvent is one or a mixture of purified water and ethanol; preferably, the adding amount of the beeswax is 0.1-0.5 times of the mass of the oil immersed liquid; preferably, the vegetable oil is any one or more of soybean oil, sesame oil, castor oil, tea oil or rapeseed oil.
7. The method for preparing the external preparation of traditional Chinese medicine for treating rhinitis according to claim 5, wherein the extraction method is as follows: adding vegetable oil with the mass 2-5 times of that of the mixed raw materials into the mixed raw materials for 3 times to leach the mixed raw materials for 10-30 hours each time, filtering and extruding dregs after each time of soaking to obtain filtrate, and merging the leaching filtrates to obtain oil-immersed liquid.
8. The quality control method of a traditional Chinese medicine external preparation for treating rhinitis according to claim 1, which is characterized in that: the contents of linalool, eugenol, and beta-caryophyllene were determined by gas chromatography, respectively.
9. The quality control method of a traditional Chinese medicine external preparation for treating rhinitis according to claim 8, wherein the quality control is performed by adopting gas chromatography, and the method specifically comprises the following steps:
s11: chromatographic conditions and system applicability test;
the chromatographic column adopts an Agilent HP-5 quartz capillary chromatographic column (30 m×320 μm×0.25 μm); column temperature 40 ℃ (1 min, 10 ℃ C. 1 min) -1 The temperature is increased to 130 ℃ (kept for 5 min) and then 8 ℃ for 1min -1 The rate was increased to 180 ℃ (hold for 1 min); setting the temperature of the sample inlet to 200 ℃, and setting the carrier gas to be high-purity nitrogen with the volume flow of 1mL 1min at 1mL 1min -1 The method comprises the steps of carrying out a first treatment on the surface of the The flow is not split, and the sample injection amount is 1-2 mu L; the total separation time is not less than 20min;
s12: preparation of control solution and test solution:
precisely weighing linalool, eugenol and beta-caryophyllene reference substance, adding n-hexane to dissolve, and preparing into reference substance solution; accurately weighing the external preparation of the traditional Chinese medicine, adding n-hexane to dissolve the external preparation of the traditional Chinese medicine, and preparing the external preparation of the traditional Chinese medicine into a sample solution;
s13: and (3) content measurement:
and respectively precisely sucking the reference substance solution and the sample solution, and measuring under the gas chromatography condition in S11.
10. The quality control method of a traditional Chinese medicine external preparation for treating rhinitis according to claim 9, which is characterized in that: the quality control standard of the external traditional Chinese medicine preparation for treating rhinitis by adopting gas chromatography is as follows: each g of the finished Chinese medicinal external preparation contains linalool not less than 0.15mg, eugenol not less than 1mg and beta-caryophyllene not less than 0.1mg, and can be qualified.
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