Rhinitis treatment traditional Chinese medicine composition based on cocklebur fruit extract and preparation method of rhinitis treatment traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine pharmacy, and discloses a traditional Chinese medicine composition for treating rhinitis based on a fructus xanthii extract and a preparation method of the traditional Chinese medicine composition. 5%-7% of liquorice; 15%-20% of dark plum; 2%-5% of bighead atractylodes rhizome; 20%-25% of schisandra chinensis; 1%-3% of almonds; 5%-8% of cortex mori radicis; 4%-11% of centipeda minima; 4%-7% of fructus chebulae; 0.2%-0.5% of cassia twig; 1%-3% of radix saposhnikoviae and 4%-9% of 4%-7% of radix astragali; 3%-6% of radix ophiopogonis; the raw materials are processed and proportioned, and the traditional Chinese medicine ointment is prepared through the processes of decoction of the detoxifying and synergistic group, concentration of the orifice-opening and exterior-strengthening group, extraction of the qi-tonifying and yin-nourishing group, mixed light decoction and concentration. When the ointment is used, a cotton swab is coated with the ointment, the cotton swab coated with the ointment is fed into the nasal polyp part of a rhinitis patient and stays for about 20 minutes, after the drug effect of the ointment is slowly released, the nasal polyp necroses, part of the nasal polyp can fall off after about 15 days, and the treatment process can be repeated for multiple times and once every 15 days until the nasal polyp completely falls off. The ointment can effectively relieve nasal obstruction, running nose, rhinocnesmus and sneezing symptoms of rhinitis patients; the traditional Chinese medicine is not required to take medicine but is only externally used, is very safe to use and has no toxic or side effect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceuticals, in particular to a traditional Chinese medicine composition for treating rhinitis based on a Xanthium sibiricum fruit extract and a preparation method thereof. Background Art

[0002] Rhinitis is a common and frequently occurring clinical disease, including allergic rhinitis and chronic sinusitis. Its main manifestations include nasal congestion, runny nose, itchy nose, sneezing and redness and swelling of the nasal mucosa. The causes involve invasion of wind evil, deficiency of both lung and spleen, damp-heat stagnation and other aspects. Clinical treatment needs to take into account both relieving symptoms and improving physical fitness. Xanthium sibiricum is a traditional Chinese medicine for clearing the orifices. Its extract contains ingredients such as xanthium sibiricum glycosides and volatile oils, which have a definite therapeutic effect on rhinitis. However, the presence of its toxic components limits its clinical application. How to reduce toxicity while retaining its efficacy becomes the key. In the existing technology, although the use of a single Xanthium sibiricum can relieve symptoms such as nasal congestion, it has problems such as high toxicity and easy recurrence. Traditional compound prescriptions are mostly based on clearing the orifices, lacking comprehensive consideration of modern clinical needs such as allergic mechanisms, spleen and stomach functions and dryness of the drug properties. In addition, the preparation process mostly adopts simple decoction or mixing, which has defects such as low dissolution rate of effective ingredients, loss of volatile components and high residual toxic metabolites. Furthermore, existing Chinese herbal medicine compositions often neglect the synergistic effects of "opening the meridians, combating allergies, strengthening the spleen, and nourishing yin" in their compatibility, making it difficult to simultaneously address the local symptoms of rhinitis and overall constitutional imbalance. Furthermore, there is a lack of effective strategies for addressing side effects such as recurrent rhinitis and dry mouth and sore throat caused by the warming effects of the drugs. Therefore, there is an urgent need for a Chinese herbal medicine composition and its preparation method based on scientific compatibility and innovative processes to achieve efficient, safe, and stable rhinitis treatment. Summary of the Invention

[0003] (1) Technical problems solved

[0004] In response to the shortcomings of the existing technology, the present invention provides a Chinese medicine composition for treating rhinitis based on Xanthium sibiricum extract and a preparation method thereof, which has the advantages of comprehensively alleviating symptoms, reducing toxicity, improving efficacy, reducing recurrence and improving physical fitness, and solves the problems in the existing technology of high toxicity of single drugs, incomplete compound compatibility, backward preparation technology, and inability to take into account both local symptoms and overall conditioning.

[0005] (2) Technical solution

[0006] To achieve the above-mentioned purpose, the present invention provides the following technical solution: a Chinese medicine composition for treating rhinitis based on Xanthium sibiricum extract, wherein the raw material ratio of the Chinese medicine composition is as follows: 35% to 40% of Xanthium sibiricum extract; 5% to 7% of Licorice root; 15% to 20% of Prunus mume; 2% to 5% of Atractylodes macrocephala; 20% to 25% of Schisandra chinensis; 1% to 3% of Apricot kernel; 5% to 8% of Morus alba bark; 4% to 11% of Schisandra chebula; 4% to 7% of Terminalia chebula; 0.2% to 0.5% of Cinnamomum cassia twig; 1% to 3% of Saposhnikovia divaricata; 4% to 9% of Bupleurum root; 4% to 7% of Astragalus root; 3% to 6% of Ophiopogon japonicus; and 4% to 9% of Chinese yam.

[0007] Preferably, the preparation process of the Xanthium sibiricum extract is:

[0008] S1.1. Raw material preparation: Select high-quality Xanthium sibiricum, crush into coarse powder and pass through 20-40 mesh sieve;

[0009] S1.2. Extraction: Mix the Xanthium sibiricum powder with 65%-70% ethanol in a ratio of 1:8-10 using reflux extraction. Heat to 98-100°C and maintain a slight boiling point. Reflux extraction is performed 2-3 times, each time for 1-2 hours. Combine the filtrates.

[0010] S1.3, Purification: Concentrate the filtrate under reduced pressure of 0.05-0.07 MPa at 55-60°C to a relative density of 1.10-1.15 to obtain a concentrate. Dilute with an equal volume of distilled water, pass through a D101 macroporous resin column, elute with 70%-75% ethanol, and collect the eluate.

[0011] S1.4, drying and forming: the eluate is concentrated again under reduced pressure of 0.05-0.07 MPa and a temperature of 55-60°C to a thick paste, and spray-dried under conditions of an inlet air temperature of 80-90°C and an outlet air temperature ≤60°C to obtain a dry extract powder, i.e., the Xanthium sibiricum extract.

[0012] Preferably, the raw material ratio of the traditional Chinese medicine composition is as follows: the licorice is washed and sliced ​​to a thickness of 1 to 3 mm, and dried at 75-80°C until the distilled moisture is less than 2%; the white atractylodes and astragalus are washed and sliced ​​separately to a thickness of 0.5 to 1 mm, and stir-fried at 90-100°C until the surface is brown; the mulberry bark and the siler are washed and sliced ​​to a thickness of 1 to 2 cm, and dried naturally in the sun; the bupleurum and ophiopogon are washed and cut into sections with a length of 0.5 to 1 cm, and dried at 65-70°C for 8 to 12 hours.

[0013] Preferably, the herb, terminalia chebula and cassia twig are washed and cut into sections respectively, the herb and terminalia chebula are cut into 0.5-1 cm, and the cassia twig is cut into 2-3 mm, and then dried in the shade until the distilled water content is less than 5% for later use.

[0014] Preferably, the black plums are washed, pitted, crushed into coarse powder and passed through a 20-40 mesh sieve; the schisandra chinensis is washed, crushed and dried, and passed through a 20-40 mesh sieve; the almonds are peeled and blanched in boiling distilled water at 98-100°C for 4-9 minutes, then dried in a drying oven at 90-105°C for 2-4 hours, ground into fine powder, and passed through a 60-80 mesh sieve; the yam is washed, sliced ​​into slices with a thickness of 1-2 mm, baked at 90-100°C for 1-3 hours, then fried until the surface is slightly yellow, crushed into fine powder, passed through an 80-100 mesh sieve, and set aside.

[0015] The preparation method of a Chinese medicinal composition for treating rhinitis based on a Xanthium sibiricum extract comprises the following preparation steps:

[0016] S1. Prepare raw materials: prepare the formula ratio of Xanthium sibiricum extract, licorice, black plum, Atractylodes macrocephala, Schisandra chinensis, apricot kernel, mulberry bark, schisandra chinensis, Terminalia chebula, cinnamon twig, siler, radix siler, bupleurum, astragalus, ophiopogon japonicus and yam;

[0017] S2. Preparation of the detoxification and synergistic group: Place 1 / 2 of the Xanthium sibiricum extract and Licorice root in a multifunctional extraction tank, add 8-10 times the total weight of the medicinal materials in drinking distilled water, raise the temperature to 100-110°C, maintain a slight boiling state and decoct for 30-45 minutes, repeat the decoction 1-3 times, collect the filtrate by vacuum filtration after each decoction, combine all the filtrates, add Scutellaria baicalensis, continue to decoct for 20-30 minutes, and filter through a 100-120 mesh filter screen while hot after decoction to obtain the detoxification and synergistic group solution;

[0018] S3. Preparation of Tongqiao Gubiao Group: Mix the remaining 1 / 2 of the Xanthium sibiricum extract, Magnolia Flos, Schisandrae Chinensis, and Cinnamomum cassia twig, and concentrate at 50-60°C to a relative density of 1.1-1.2 to form a Tongqiao Gubiao Group concentrate;

[0019] S4. Preparation of the Qi-tonifying and Yin-nourishing group: Add Astragalus, Radix Ophiopogonis, Cinnamomum cassiae, Saposhnikovia divaricata, Radix Bupleuri, and Atractylodes macrocephala to a decoction container, add 6-8 times the total weight of the herbs in distilled water, soak for 30-60 minutes, boil over high heat at 150-180°C, then reduce heat to 80-100°C and decoct for 40-60 minutes. Decoction 1-2 times, collect the filtrate each time and combine to form the Qi-tonifying and Yin-nourishing mixed solution.

[0020] S5. Mixing: Combine the medicinal solutions of the detoxification and synergistic group, the orifice-opening and exterior-strengthening group, and the qi-invigorating and yin-nourishing group, add yam powder, and stir with a ceramic stirring rod. Place the mixed medicinal solution at 40-50°C and gently decoct for 30-50 minutes.

[0021] S6. Preparation of ointment: Place the lightly decocted medicinal liquid in a vacuum concentrator and concentrate it to a viscous concentrated ointment with a relative density of 1.4-1.5 at a temperature of 60-70°C and a vacuum degree of -0.06 to -0.08 MPa.

[0022] Preferably, the Xanthium sibiricum extract and Licorice in S2 are soaked in distilled water for 60 to 90 minutes before decocting.

[0023] Preferably, the magnolia in S3 is put into an extraction device before mixing, 6-8 times the amount of 70%-75% ethanol solution is added, and reflux extraction is carried out at 60-70°C for 2-3 times, each time for 1-1.5 hours, and the extracts are combined.

[0024] Preferably, the Schisandra chinensis and cinnamon twigs in S3 are soaked in 40-50° C. warm distilled water for 25-30 minutes until softened.

[0025] Compared with the prior art, the present invention provides a Chinese medicine composition for treating rhinitis based on Xanthium sibiricum extract and a preparation method thereof, which has the following beneficial effects:

[0026] 1. The present invention achieves the beneficial effect of comprehensively alleviating rhinitis symptoms by scientifically proportioning a variety of Chinese medicinal raw materials. Among them, the Xanthium sibiricum extract, as the core ingredient, has the effects of clearing the orifices, dispersing wind and cold, and removing dampness, and can effectively relieve nasal congestion and runny nose symptoms. The addition of licorice can not only detoxify and alleviate the medicinal properties, but also can nourish the spleen and replenish qi, enhance the defensive qi, and reduce the recurrence of rhinitis. At the same time, it has the synergistic effect of harmonizing various medicines and enhancing the overall formula.

[0027] 2. The combination of black plum and schisandra chinensis has anti-allergic, astringent and antinasal effects, which can relieve symptoms of nasal itching and sneezing, while enhancing immunity and relieving nasal discomfort. Atractylodes macrocephala, Astragalus membranaceus and yam contain ingredients that strengthen the spleen and replenish qi, nourish the kidneys and astringe essence. Adding them together can enhance the function of the spleen and stomach, provide a basis for the transportation and transformation of other medicines, and reduce the formation of phlegm and dampness, fundamentally improving the physical condition. The yin-nourishing and lung-moistening effect of Ophiopogon japonicus is used to balance the warming and dryness of Astragalus membranaceus and cinnamon twigs, avoiding side effects such as dry mouth and sore throat, which is in line with the treatment idea of ​​"double replenishment of qi and yin".

[0028] 3. The present invention achieves the beneficial effects of efficient extraction and reduction of toxic metabolite content through an innovative preparation process. Among them, the preparation of the Xanthium sibiricum extract adopts reflux extraction method and macroporous resin column purification technology, which can effectively extract the glycosides, flavonoids and volatile oil active ingredients in the Xanthium sibiricum, and remove polysaccharide and protein impurities at the same time to reduce the content of toxic metabolites in the traditional Chinese medicine composition. The decoction process of the detoxification and synergistic group further reduces the toxicity of the Xanthium sibiricum through the synergistic effect of licorice and Xanthium sibiricum extract, while ensuring the full dissolution of the active ingredients in the traditional Chinese medicine. The staged extraction process of the orifice-opening and exterior-strengthening group and the qi-invigorating and yin-nourishing group can accurately regulate the dissolution rate of the active ingredients in the traditional Chinese medicine composition, thereby improving the efficacy and reducing the loss of volatile components in the traditional Chinese medicine composition. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 The figure is a flow chart for preparing the Chinese medicine composition of the present invention. DETAILED DESCRIPTION

[0030] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0031] See also Figure 1 A Chinese medicine composition for treating rhinitis based on Xanthium sibiricum extract, the raw material ratio of the Chinese medicine composition is: Xanthium sibiricum extract 35%~40%; Licorice 5%~7%; Prunus mume 15%~20%; Atractylodes macrocephala 2%~5%; Schisandra chinensis 20%~25%; Apricot kernel 1%~3%; Morus alba bark 5%~8%; Schisandra chinensis 4%~11%; Terminalia chebula 4%~7%; Cinnamomum cassia twig 0.2%~0.5%; Saposhnikovia divaricata 1%~3%, Bupleurum 4%~9%; Astragalus 4%~7%; Ophiopogon japonicus 3%~6%; Chinese yam 4%~9%.

[0032] Specifically, the raw material role table is as follows:

[0033] Table 1

[0034]

[0035]

[0036] Specifically, the preparation process of Xanthium sibiricum extract is as follows:

[0037] S1.1. Raw material preparation: Select high-quality Xanthium sibiricum, crush into coarse powder and pass through 20-40 mesh sieve;

[0038] S1.2. Extraction: Mix the Xanthium sibiricum powder with 65%-70% ethanol in a ratio of 1:8-10 (mass-to-volume ratio) using a reflux extraction method. Heat to 98-100°C and maintain a slight boiling point. Reflux extraction is performed 2-3 times, each time for 1-2 hours. The filtrates are combined. Ethanol can effectively dissolve the glycosides, flavonoids, and some fat-soluble components in the Xanthium sibiricum, while inhibiting enzyme activity and preventing degradation of the active ingredients.

[0039] S1.3, Purification: The filtrate was concentrated under reduced pressure of 0.05-0.07 MPa and a temperature of 55-60°C to a relative density of 1.10-1.15 to obtain a concentrate. After dilution with an equal volume of distilled water, the concentrate was passed through a D101 macroporous resin column and eluted with 70%-75% ethanol. The eluate was collected to remove polysaccharides, proteins, and other impurities and to enrich the active ingredients (such as xanthii glycosides and volatile oils).

[0040] S1.4, drying and forming: the eluate is concentrated again under reduced pressure of 0.05-0.07 MPa and a temperature of 55-60°C to a thick paste, and spray-dried under conditions of an inlet air temperature of 80-90°C and an outlet air temperature ≤60°C to obtain a dry extract powder, i.e., the Xanthium sibiricum extract.

[0041] Specifically, the raw material ratio of the traditional Chinese medicine composition is as follows: licorice is washed and sliced ​​to a thickness of 1 to 3 mm, and dried at 75-80°C until the distilled moisture content is less than 2%; white atractylodes and astragalus are washed and sliced ​​separately to a thickness of 0.5 to 1 mm, and fried at 90-100°C until the surface is brown; mulberry bark and siler are washed and sliced ​​to a thickness of 1 to 2 cm, and naturally dried in the sun; bupleurum and ophiopogon are washed and cut into sections with a length of 0.5 to 1 cm, and dried at 65-70°C for 8 to 12 hours.

[0042] Specifically, the herb, terminalia chebula and cassia twig are washed and cut into sections respectively, the herb and terminalia chebula are cut into sections of 0.5 to 1 cm, and the cassia twig is cut into sections of 2 to 3 mm, and then dried in the shade until the distilled water content is less than 5%.

[0043] Specifically, the black plums are washed, pitted, crushed into coarse powder, and passed through a 20-40 mesh sieve; the schisandra chinensis is washed, crushed, dried, and passed through a 20-40 mesh sieve; the almonds are peeled and the tips are blanched in boiling distilled water at 98-100°C for 4-9 minutes to detoxify and decompose amygdalin, and then dried in a drying oven at 90-105°C for 2-4 hours, ground into fine powder, and passed through a 60-80 mesh sieve; the yam is washed, sliced ​​into slices with a thickness of 1-2 mm, baked at 90-100°C for 1-3 hours, and then fried until the surface is slightly yellow, crushed into fine powder, and passed through an 80-100 mesh sieve. All raw materials are pre-prepared and set aside.

[0044] The preparation method of a Chinese medicinal composition for treating rhinitis based on a Xanthium sibiricum extract comprises the following preparation steps:

[0045] S1. Prepare raw materials: prepare the formula ratio of Xanthium sibiricum extract, licorice, black plum, Atractylodes macrocephala, Schisandra chinensis, apricot kernel, mulberry bark, schisandra chinensis, Terminalia chebula, cinnamon twig, siler, radix siler, bupleurum, astragalus, ophiopogon japonicus and yam;

[0046] S2. Preparation of the detoxification and synergistic group: Place 1 / 2 of the Xanthium sibiricum extract and licorice in a multifunctional extraction tank, add 8-10 times the total mass of the medicinal materials in drinking distilled water, raise the temperature to 100-110°C, maintain a slight boiling state and decoct for 30-45 minutes. This temperature and time can fully dissolve the detoxifying components of licorice and reduce the toxicity of Xanthium sibiricum. Repeat the decoction 1-3 times, collect the filtrate by vacuum filtration after each decoction, combine all the filtrates, add Scutellaria baicalensis, and continue to decoct for 20-30 minutes to ensure that the effective components of Scutellaria baicalensis are fully dissolved. After the decoction is completed, filter while hot using a 100-120 mesh filter screen to remove the residue to obtain the detoxification and synergistic group solution;

[0047] S3. Preparation of Tongqiao Gubiao Group: After uniformly mixing the remaining 1 / 2 of the Xanthium sibiricum extract, Magnolia Flos, Schisandrae Chinensis Fruit, and Cinnamomum cassia twig, the mixture was concentrated at 50-60°C to a relative density of 1.1-1.2 (measured at 60°C) to form a Tongqiao Gubiao Group concentrate;

[0048] S4. Preparation of the Qi-Nourishing and Yin-Bulging Group: Add Astragalus, Radix Ophiopogonis, Cinnamomum cassiae, Saposhnikovia divaricata, Radix Bupleuri, and Atractylodes macrocephala to a decoction container. Add distilled water (6-8 times the total weight of the herbs) and soak for 30-60 minutes to allow the herbs to fully absorb the distilled water and swell, facilitating the dissolution of the active ingredients. Boil over high heat at 150-180°C, then reduce heat to 80-100°C and decoct for 40-60 minutes. Repeat 1-2 decoctions, collecting and combining the filtrates each time to form the Qi-Nourishing and Yin-Bulging Group mixed solution.

[0049] S5. Mixing: Combine the medicinal solutions of the detoxification and synergistic group, the orifice-opening and exterior-strengthening group, and the qi-invigorating and yin-nourishing group, add yam powder, and stir with a ceramic stirring rod to prevent lumps. Place the mixed medicinal solution at 40-50°C and gently decoct for 30-50 minutes. This low temperature and long decocting time can reduce the loss of volatile components.

[0050] S6. Preparation of ointment: Place the lightly decocted medicinal liquid in a vacuum concentrator and concentrate it to a viscous concentrated ointment with a relative density of 1.4-1.5 (measured at 50°C) at a temperature of 60-70°C and a vacuum degree of -0.06 to -0.08 MPa.

[0051] The advantages are: the present invention achieves the beneficial effect of combining immediate relief with long-term conditioning through the strategy of "opening the orifices to treat the symptoms + strengthening the body to treat the root cause". Through the opening of the orifices and dispersing cold effects of Xanthium sibiricum extract, Capsicum annuum and magnolia components, nasal congestion and nasal itching symptoms are quickly relieved, thereby achieving "treating the symptoms". At the same time, licorice, astragalus, white atractylodes and yam components are combined to strengthen the spleen and replenish qi, nourish the kidney and astringe the essence, enhance immunity, reduce recurrence, and achieve "treating the root cause". This formula takes into account both immediate symptom relief and long-term physical conditioning of rhinitis, and provides a new traditional Chinese medicine solution for the safe and efficient treatment of rhinitis.

[0052] Specifically, the Xanthium sibiricum extract and licorice in S2 are soaked in distilled water for 60 to 90 minutes before decoction to improve the decoction effect.

[0053] Specifically, the magnolia in S3 is put into the extraction equipment before mixing, and 6-8 times the amount of 70%-75% ethanol solution is added. Reflux extraction is carried out at 60-70°C for 2-3 times, each time for 1-1.5 hours. Ethanol can better extract the volatile orifice-opening components in the magnolia medicinal material.

[0054] Specifically, the Schisandra chinensis and cinnamon twigs in S3 are soaked in 40-50° C. warm distilled water for 25-30 minutes until softened.

[0055] Example 1

[0056] The raw material ratios of the Chinese medicine composition are as follows: 38% of Xanthium sibiricum extract; 6% of Licorice root; 18% of Prunus mume; 4% of Atractylodes macrocephala; 22% of Schisandra chinensis; 2% of Apricot kernel; 6% of Morus alba bark; 8% of Herba Capillaris; 5% of Terminalia chebula; 0.3% of Cinnamomum cassia twig; 2% of Saposhnikovia divaricata; 6% of Bupleurum root; 5% of Astragalus root; 4% of Ophiopogon japonicus; and 6% of Chinese yam.

[0057] Example 2

[0058] The raw material ratios of the Chinese medicine composition are as follows: 35% of Xanthium sibiricum extract; 5% of Licorice root; 15% of Prunus mume; 3% of Atractylodes macrocephala; 20% of Schisandra chinensis; 1% of Apricot kernel; 7% of Morus alba bark; 10% of Herba Capillaris; 6% of Terminalia chebula; 0.2% of Cinnamomum cassiae; 1% of Saposhnikovia divaricata; 8% of Bupleurum root; 4% of Astragalus membranaceus; 5% of Ophiopogon japonicus; and 7% of Chinese yam.

[0059] Example 3

[0060] The raw material ratios of the Chinese medicine composition are as follows: 40% of Xanthium sibiricum extract; 7% of Licorice root; 20% of Prunus mume; 5% of Atractylodes macrocephala; 25% of Schisandra chinensis; 3% of Apricot kernel; 5% of Morus alba bark; 4% of Herba Capillaris; 7% of Terminalia chebula; 0.5% of Cinnamomum cassiae; 3% of Saposhnikovia divaricata; 4% of Bupleurum root; 6% of Astragalus membranaceus; 3% of Ophiopogon japonicus; and 9% of Chinese yam.

[0061] The above raw material formula is prepared into a traditional Chinese medicine composition according to the method of the present invention.

[0062] Comparative Example 1

[0063] The raw material formula is as follows: only Xanthium sibiricum extract (40%) and Licorice root (10%) are used without adding other ingredients, and the product is prepared according to the method of the present invention.

[0064] Comparative Example 2

[0065] The raw material formula includes: Xanthium sibiricum extract (35%), liquorice (5%), black plum (15%), atractylodes macrocephala (3%), schisandra chinensis (20%), apricot kernel (1%), mulberry bark (7%), schisandra chinensis (10%), terminalia chebula (6%), cassia twig (0.2%), siler (1%), radix siler (8%), astragalus (4%), ophiopogon (5%), and yam (7%), but the ointment is made by directly mixing the ingredients without going through the preparation method of the present invention.

[0066] Comparative Example 3

[0067] Raw material formula: refer to the original formula of Xanthium sibiricum powder in Jisheng Fang, take 30% of Xanthium sibiricum, 30% of Magnolia flos, 20% of Angelica dahurica and 20% of Menthol, and prepare it according to the method of the present invention.

[0068] The examples and comparative examples were prepared into Chinese medicine compositions and subjected to performance tests. The test data are shown in Table 2 below:

[0069] Table 2

[0070]

[0071] Table 3 is obtained by analyzing Table 2, as follows:

[0072] Table 3 Performance comparison analysis of the embodiment and the comparative example

[0073]

[0074] Summary: The Chinese medicine composition for treating rhinitis based on Xanthium sibiricum extract provided by the present invention has achieved multi-dimensional breakthroughs through the synergistic effect of scientific ratio and innovative preparation process. Specifically, with Xanthium sibiricum extract as the core, it is combined with licorice for detoxification, black plum for anti-allergy and schisandra chinensis for strengthening the exterior, forming a three-dimensional treatment system of "opening the orifices - anti-allergy - strengthening the spleen - nourishing yin". Compared with the single drug in the traditional raw material formula, it significantly improves the efficacy, increases the efficiency of relieving nasal congestion, and reduces the recurrence rate; at the same time, through staged extraction, macroporous resin adsorption and spray The mist drying purification technology is used to precisely control the dissolution of active ingredients and the residual toxic metabolites, which reduces the content of toxic metabolites of Xanthium sibiricum compared with single medication, and controls the incidence of side effects such as dry mouth and sore throat caused by warm and dry herbs to less than 6.8%; this Chinese medicine composition targets the complex symptoms of modern allergic rhinitis and chronic sinusitis, such as nasal congestion, runny nose, mucosal inflammation, and allergic recurrence. It adopts the strategy of "opening the orifices to treat the symptoms + strengthening the body to treat the root cause" to take into account both immediate relief and long-term conditioning, providing a new Chinese medicine solution for the safe and efficient treatment of rhinitis.

[0075] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicinal composition for treating rhinitis based on a Xanthium sibiricum extract, characterized in that: The raw material ratio of the traditional Chinese medicine composition is as follows: 35% to 40% of Xanthium sibiricum extract; 5% to 7% of liquorice; 15% to 20% of black plum; 2% to 5% of Atractylodes macrocephala; 20% to 25% of Schisandra chinensis; 1% to 3% of Apricot kernel; 5% to 8% of Morus alba bark; 4% to 11% of Herba Epimedii; 4% to 7% of Terminalia chebula; 0.2% to 0.5% of cassia twig; 1% to 3% of Saposhnikovia divaricata; 4% to 9% of Bupleurum root; 4% to 7% of Astragalus root; 3% to 6% of Ophiopogon japonicus; and 4% to 9% of Chinese yam.

2. The Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 1, characterized in that: The preparation process is as follows: S1.

1. Raw material preparation: Select high-quality Xanthium sibiricum, crush into coarse powder and pass through 20-40 mesh sieve; S1.

2. Extraction: Mix the Xanthium sibiricum powder with 65%-70% ethanol in a ratio of 1:8-10 using reflux extraction. Heat to 98-100°C and maintain a slight boiling point. Reflux extraction is performed 2-3 times, each time for 1-2 hours. Combine the filtrates. S1.3, Purification: Concentrate the filtrate under reduced pressure of 0.05-0.07 MPa at 55-60°C to a relative density of 1.10-1.15 to obtain a concentrate. Dilute with an equal volume of distilled water, pass through a D101 macroporous resin column, elute with 70%-75% ethanol, and collect the eluate. S1.4, drying and forming: the eluate is concentrated again under reduced pressure of 0.05-0.07 MPa and a temperature of 55-60°C to a thick paste, and spray-dried under conditions of an inlet air temperature of 80-90°C and an outlet air temperature ≤60°C to obtain a dry extract powder, i.e., the Xanthium sibiricum extract.

3. The Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 1, characterized in that: The raw material ratio of the traditional Chinese medicine composition is as follows: the liquorice is washed and sliced ​​to a thickness of 1 to 3 mm, and dried at 75-80° C. until the distilled moisture content is less than 2%; the white atractylodes and astragalus are washed and sliced ​​to a thickness of 0.5 to 1 mm, and stir-fried at 90-100° C. until the surface turns brown; the mulberry bark and the siler are washed and sliced ​​to a thickness of 1 to 2 cm, and naturally dried in the sun; the bupleurum and ophiopogon are washed and cut into sections with a length of 0.5 to 1 cm, and dried at 65-70° C. for 8 to 12 hours.

4. The Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 1, characterized in that: The herb, terminalia chebula and cassia twig are washed and cut into sections respectively. The herb and terminalia chebula are cut into sections of 0.5-1 cm, and the cassia twig is cut into sections of 2-3 mm. The herb is then shade-dried until the distilled water content is less than 5% and set aside.

5. The method for preparing the Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 1, characterized in that: The washed black plums are pitted, crushed into coarse powder and passed through a 20-40 mesh sieve; the washed schisandra chinensis is crushed and dried, and passed through a 20-40 mesh sieve; the almonds are peeled and blanched in boiling distilled water at 98-100°C for 4-9 minutes, then dried in a drying oven at 90-105°C for 2-4 hours, ground into fine powder, and passed through a 60-80 mesh sieve; the washed yam is sliced ​​into 1-2 mm thick slices, baked at 90-100°C for 1-3 hours, then fried until the surface is slightly yellow, crushed into fine powder, passed through an 80-100 mesh sieve, and set aside.

6. A method for preparing a Chinese medicinal composition for treating rhinitis based on a Xanthium sibiricum extract, characterized in that: The Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 1 comprises the following preparation steps: S1. Prepare raw materials: prepare the formula ratio of Xanthium sibiricum extract, licorice, black plum, Atractylodes macrocephala, Schisandra chinensis, apricot kernel, mulberry bark, schisandra chinensis, Terminalia chebula, cinnamon twig, siler, radix siler, bupleurum, astragalus, ophiopogon japonicus and yam; S2. Preparation of the detoxification and synergistic group: Place 1 / 2 of the Xanthium sibiricum extract and Licorice root in a multifunctional extraction tank, add 8-10 times the total weight of the medicinal materials in drinking distilled water, raise the temperature to 100-110°C, maintain a slight boiling state and decoct for 30-45 minutes, repeat the decoction 1-3 times, collect the filtrate by vacuum filtration after each decoction, combine all the filtrates, add Scutellaria baicalensis, continue to decoct for 20-30 minutes, and filter through a 100-120 mesh filter screen while hot after decoction to obtain the detoxification and synergistic group solution; S3. Preparation of Tongqiao Gubiao Group: Mix the remaining 1 / 2 of the Xanthium sibiricum extract, Magnolia Flos, Schisandrae Chinensis, and Cinnamomum cassia twig, and concentrate at 50-60°C to a relative density of 1.1-1.2 to form a Tongqiao Gubiao Group concentrate; S4. Preparation of the Qi-tonifying and Yin-nourishing group: Add Astragalus, Radix Ophiopogonis, Cinnamomum cassiae, Saposhnikovia divaricata, Radix Bupleuri, and Atractylodes macrocephala to a decoction container, add 6-8 times the total weight of the herbs in distilled water, soak for 30-60 minutes, boil over high heat at 150-180°C, then reduce heat to 80-100°C and decoct for 40-60 minutes. Decoction 1-2 times, collect the filtrate each time and combine to form the Qi-tonifying and Yin-nourishing mixed solution. S5. Mixing: Combine the medicinal solutions of the detoxification and synergistic group, the orifice-opening and exterior-strengthening group, and the qi-invigorating and yin-nourishing group, add yam powder, and stir with a ceramic stirring rod. Place the mixed medicinal solution at 40-50°C and gently decoct for 30-50 minutes. S6. Paste preparation: Place the lightly decocted medicinal liquid in a vacuum concentrator, and concentrate it to a viscous concentrated paste with a relative density of 1.4-1.5 at a temperature of 60-70°C and a vacuum degree of -0.06 to -0.08 MPa, i.e., the Chinese medicine composition.

7. The method for preparing the Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 6, characterized in that: The Xanthium sibiricum extract and Licorice root in S2 are soaked in distilled water for 60 to 90 minutes before being decocted.

8. The method for preparing the Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 6, characterized in that: Before mixing, the magnolia flowers in S3 are put into an extraction device, 6-8 times the amount of 70%-75% ethanol solution is added, and reflux extraction is performed at 60-70° C. for 2-3 times, each time for 1-1.5 hours, and the extracts are combined.

9. The method for preparing the Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 6, characterized in that: The Schisandra chinensis and cinnamon twigs in S3 are soaked in 40-50° C. warm distilled water for 25-30 minutes until softened.

10. The method for preparing the Chinese medicinal composition for treating rhinitis based on the Xanthium sibiricum extract according to claim 6, characterized in that: The ointment preparation in S6 is as follows: placing the lightly decocted medicinal liquid in a relatively high temperature and vacuum environment, and concentrating it to a viscous concentrated ointment with a relative density of 1.4-1.5 under the conditions of a temperature of 60-70° C. and a vacuum degree of -0.06 to -0.08 MPa.

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