Traditional Chinese medicine composition for treating nasal cavity inflammatory diseases, preparation and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and provides a traditional Chinese medicine composition for treating nasal cavity inflammatory diseases, a preparation and application thereof, and the traditional Chinese medicine composition is prepared from the following components in parts by weight: 5-20 parts of magnolia flower, 5-15 parts of curcuma zedoary, 5-10 parts of cocklebur fruit, 5-10 parts of honeysuckle, 5-10 parts of madder, 5-10 parts of wild chrysanthemum flower, 3-8 parts of clove and 2-5 parts of liquorice. The traditional Chinese medicine composition disclosed by the invention is simple in component, small in dosage and quick in effect, the medicinal components have a remarkable synergistic effect in treatment of nasal cavity inflammation, the content of fructus xanthii with liver and kidney toxicity is reduced, quality control is also facilitated while toxicity is reduced and efficacy is enhanced, and the traditional Chinese medicine composition has a remarkable anti-allergic effect and antibacterial and anti-inflammatory pharmacological effects and is worthy of popularization and application. The traditional Chinese medicine composition can be used for treating various diseases such as acute rhinitis, chronic rhinitis, nasosinusitis, allergic rhinitis, atrophic rhinitis and vasomotor rhinitis, and has a remarkable curative effect.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition, a preparation and application thereof for treating nasal inflammatory diseases. Background Art

[0002] Nasal inflammation is an inflammation of the nasal mucosa caused by viruses, bacteria, fungi, allergens, and allergens. It may originate from various physical and chemical factors or certain systemic diseases. It has the characteristics of long treatment time, great difficulty in treatment, and low cure rate. Common nasal inflammation diseases include: acute rhinitis, chronic rhinitis, sinusitis, allergic rhinitis, atrophic rhinitis, and vasomotor rhinitis. The main symptoms of rhinitis include nasal congestion, sneezing, runny nose, and nasal itching. The main pathological changes are nasal mucosal congestion, swelling, exudation, hyperplasia, atrophy, or necrosis.

[0003] Western medicine believes that rhinitis is caused by infection with viruses and bacteria. Common treatments include the use of antibiotics to kill bacteria and reduce inflammation, surgery, laser, etc. Although they can be effective quickly, they are very painful, only treat the symptoms but not the root cause, are prone to recurrence, and have high medical costs. Traditional Chinese medicine believes that the nose is the external orifice of the lungs, and the lungs open to the nose. When the lung qi is abundant, breathing is smooth. The source of rhinitis and sinusitis is in the "lungs", which are mostly caused by spleen and lung weakness, insufficient lung qi, and weak defense of the outside, which makes it easy to be affected by external evil. Spleen deficiency leads to dysfunction of transportation and transformation, phlegm and dampness stagnate, stagnate in the nasal orifices, and soak the sinus mucosa to form nasal sinusitis. Traditional Chinese medicine has a reliable effect on the treatment of rhinitis, with few toxic and side effects, and it is a fundamental treatment. Chinese medicine external preparations can avoid the potential toxicity of oral drugs. The drugs act directly on the nasal cavity, avoiding the trauma to the nasal cavity caused by laser, surgery and plasma. It only needs to apply the liquid medicine in the nasal cavity, without taking medicine or injections, and the drug effect is obvious.

[0004] Applying the holistic concept and the core idea of ​​syndrome differentiation and treatment in TCM theory to treat nasal inflammation can not only inhibit local allergic reactions and control the symptoms of rhinitis at all stages, but also effectively restore the body's immune balance and prevent recurrence. It has a significant clinical effect in treating rhinitis, treats the symptoms and the root cause, and has no side effects, which is quite accepted and selected by people. At present, there are quite a few patent applications involving Chinese medicine preparations for the treatment of rhinitis.

[0005] Chinese invention patent application CN114949166B discloses a Chinese medicine composition for treating allergic rhinitis, comprising the following raw materials in parts by weight: 10-40 parts of Codonopsis pilosula, 10-30 parts of Atractylodes macrocephala, 1-20 parts of Poria cocos, 10-30 parts of Cinnamomum cassia, 5-25 parts of White Peony Root, 1-11 parts of Ginger, 1-25 parts of Polygonatum sibiricum, 1-25 parts of Saposhnikovia divaricata, 1-10 parts of Angelica dahurica, 1-11 parts of Terminalia chebula and 1-8 parts of Licorice. Although the Chinese medicine composition has the effects of benefiting the lungs and strengthening the exterior, strengthening the spleen and opening the orifices, and has a prominent effect on the deficiency of lung and spleen qi, the raw material components of the composition are relatively large, and the synergistic effect between the components is not reflected. With the increase of the planting cost and production cost of the raw materials, the production cost of the Chinese medicine composition is bound to increase, which will increase the economic burden of patients to a certain extent.

[0006] Chinese invention patent application CN114425058B discloses a Chinese medicine composition for treating rhinitis. The Chinese medicine composition provided by the present invention comprises the following components by weight: 18-36 parts of white ox gall, 15-30 parts of wild chrysanthemum, 10-20 parts of cassia twig, 9-18 parts of goose grass, and 3-6 parts of asarum. The medicine and preparation prepared by the Chinese medicine composition have fast onset, small volume, convenient use, no side effects, and effectively relieve the symptoms of rhinitis patients, and are suitable for treating various rhinitis. Although the raw material ingredients of the invention are simple, according to its preparation method, the invention ignores the volatile oil components that have strong antagonistic effects on bacteria, fungi and viruses that cause rhinitis, that is, the invention does not give full play to the active ingredients of each medicine, resulting in a low drug utilization rate.

[0007] Chinese invention patent application CN102048860B discloses a soft capsule pharmaceutical preparation for nasal sinusitis and its preparation method, which is a soft capsule preparation made by using the ratio of 672g of Chinese medicine Xanthium sibiricum, 126g of Magnolia officinalis, 42g of Rubia cordifolia, 42g of Chrysanthemum indici, and 42g of Honeysuckle as raw materials, adding a certain proportion of vegetable oil, soybean lecithin and beeswax after extraction, and pressing. In addition, the currently marketed varieties for treating "nasal sinusitis" include Biyuan Tablets, Biyuan Pills and Biyuan Syrup (see "Chinese Medicine Formula Preparations (Volume 6) of the Ministry of Health of the People's Republic of China"), wherein the prescription of "Biyuan Tablets" in "Chinese Medicine Formula Preparations (Volume 6) of the Ministry of Health of the People's Republic of China" is "672g of Xanthium sibiricum, 126g of Magnolia officinalis, 42g of Honeysuckle, 42g of Rubia cordifolia, 42g of Chrysanthemum indici, made into 1000 tablets, 6 to 8 tablets are taken each time". It can be seen that the amount of Xanthium sibiricum contained in the Biyuan soft capsule or Biyuan tablet accounts for 72.7%, and the amount of 6 to 8 tablets taken at a time is relatively large. However, due to the hepatotoxicity of Xanthium sibiricum, the large amount of Xanthium sibiricum used leads to the prohibition of pregnant women and lactating women, and prohibition of people with hepatic and renal insufficiency. Therefore, the present invention optimizes the prescription on this basis, reduces the content of toxic Xanthium sibiricum while ensuring the efficacy, thereby expanding the scope of application of the prescription of the present invention.

[0008] Through searching and analyzing the Chinese medicines for rhinitis treatment that have been marketed, prescriptions containing Xanthium sibiricum or Magnolia officinalis account for more than 60%, which shows the importance of these two herbs for the treatment of rhinitis. Most prescriptions reuse Xanthium sibiricum, and clinical findings show that long-term oral administration is prone to liver and kidney toxicity. Based on the above analysis, the purpose of the present invention is to provide a Chinese medicine composition with simple medicinal flavor composition, clear medicinal flavor efficacy, significant efficacy and high safety. Through in vitro tests and in vivo efficacy tests, the formula of the composition is optimized, while reducing the content of Xanthium sibiricum to ensure efficacy and safety, it also improves the utilization rate of the herbs, reduces toxicity and increases efficacy, reduces costs, and significantly improves clinical value. Summary of the invention

[0009] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for treating nasal inflammation and infectious diseases. The traditional Chinese medicine composition is composed of synergistic Xanthium sibiricum, magnolia, zedoaria, madder, honeysuckle, wild chrysanthemum, clove and liquorice, and has the effects of clearing away heat and detoxifying, reducing swelling and relieving pain. It can dispel rheumatism, clear the nasal passages, stop nasal sinusitis and runny nose, clear liver heat, clear heat and relieve itching, and can effectively resist inflammation and bacteria. It is used to treat nasal inflammation to meet clinical needs.

[0010] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0011] The invention provides a traditional Chinese medicine composition for treating nasal inflammatory diseases. The traditional Chinese medicine composition is prepared from raw materials of magnolia, zedoaria, xanthium, madder, honeysuckle, wild chrysanthemum, clove and liquorice.

[0012] The magnolia includes but is not limited to magnolia, fried magnolia, stewed magnolia, and honeyed magnolia.

[0013] The zedoaria includes but is not limited to zedoaria, vinegar zedoaria, and turmeric.

[0014] The Xanthium sibiricum includes but is not limited to Xanthium sibiricum and stir-fried Xanthium sibiricum.

[0015] The madder includes but is not limited to madder and madder charcoal.

[0016] The honeysuckle includes but is not limited to honeysuckle, honeysuckle, and honeysuckle vine.

[0017] The wild chrysanthemum includes but is not limited to chrysanthemum and wild chrysanthemum.

[0018] The cloves include but are not limited to cloves and mother cloves.

[0019] The licorice includes but is not limited to licorice and roasted licorice.

[0020] Furthermore, the weight proportions of the raw materials are: 5-20 parts of magnolia, 5-15 parts of zedoaria, 5-10 parts of xanthium sibiricum, 5-10 parts of honeysuckle, 5-10 parts of madder, 5-10 parts of wild chrysanthemum, 3-8 parts of cloves and 2-5 parts of liquorice.

[0021] Furthermore, the weight proportions of the raw materials are: 9-12 parts of magnolia, 6-9 parts of zedoaria, 5-8 parts of xanthium, 6-8 parts of madder, 6-8 parts of honeysuckle, 8-10 parts of wild chrysanthemum, 4-6 parts of cloves and 1-3 parts of liquorice.

[0022] The present invention also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition.

[0023] Furthermore, the pharmaceutical preparation also includes one or more pharmaceutically acceptable carriers and / or excipients.

[0024] Furthermore, the dosage form of the pharmaceutical preparation includes nasal preparations and oral preparations.

[0025] Furthermore, the nasal preparation includes nasal drops, nasal washes, sprays, nasal ointments, nasal creams, nasal gels, nasal powders, nasal powder sprays or nasal sticks.

[0026] Furthermore, the oral preparation includes pills, granules, tablets, capsules, powders, suspensions, emulsions, drops or liquid preparations.

[0027] The present invention also provides a method for preparing a Chinese medicine composition for treating nasal inflammatory diseases, which is characterized by comprising the following steps:

[0028] S1. Mix the raw materials in the formula: magnolia, zedoaria, xanthium, madder, honeysuckle, wild chrysanthemum, clove and liquorice, add water and distill to obtain volatile oil, extract A and medicinal residues;

[0029] S2, extracting the medicinal residue obtained in step S1 with water to obtain extract B;

[0030] S3, combining and concentrating the extracts A and B obtained in steps S1 and S2 to obtain a water-extracted concentrated solution C;

[0031] S4, adding ethanol precipitation to the water-extracted concentrated solution C obtained in step S3, letting it stand, and concentrating the supernatant to obtain a supernatant concentrated paste;

[0032] S5, adding the volatile oil obtained in step S1 to the supernatant concentrated paste of step S4, and mixing to obtain the Chinese medicine composition.

[0033] Furthermore, in step S1, the material-liquid ratio of the raw material to water is 1:5-10 (W / V), and the distillation time is 2-8 hours;

[0034] Furthermore, in step S2, the material-liquid ratio of the medicinal residue to water is 1:5-15 (W / V), the extraction time is 0.5-3h, and the number of extractions is 1-3 times.

[0035] Furthermore, the relative density of the concentrated solution C in step S3 is 1.05-1.35.

[0036] Furthermore, in step S4, ethanol is added so that the volume fraction of ethanol in the concentrated solution is 30-90%, and the relative density of the supernatant concentrated paste is 1.10-1.30.

[0037] Furthermore, the Chinese medicine composition of S5 is prepared into different dosage forms according to conventional processes.

[0038] The present invention also provides an application of the traditional Chinese medicine composition or the pharmaceutical preparation in preparing medicines for treating nasal inflammatory diseases.

[0039] Furthermore, the nasal inflammatory diseases include acute rhinitis, chronic rhinitis, sinusitis, allergic rhinitis, atrophic rhinitis, and vasomotor rhinitis.

[0040] The efficacy of the Chinese herbal medicine used in the present invention:

[0041] Magnolia has the effect of dispersing wind and cold and clearing the nasal passages. It is often used to treat wind-cold headaches, nasal congestion and runny nose, allergic rhinitis, and sinusitis. Modern research results show that magnolia volatile oil has a good anti-inflammatory effect and no obvious acute toxicity. Its anti-inflammatory mechanism may be related to multi-target inhibition of inflammatory mediators and inflammatory hyperplasia. Other studies have shown that magnolia and its volatile oil and other components have obvious anti-allergic effects and can be used to treat allergic rhinitis, asthma, allergic purpura and other diseases. The active ingredients of magnolia volatile oil, such as terpenes, phenols, alcohols, aldehydes, and ketone compounds, all have a broad spectrum of antibacterial effects. Magnolia aromatic substances are rich in alcohols, ketones, esters, ethers and other components, which have the effects of awakening the brain, calming and hypnotizing, and can directly act on the central nervous system through the olfactory pathway. Magnolia volatile oil also has other relatively wide-ranging pharmacological effects, such as anti-cancer, promoting transdermal absorption, analgesia, cough relief, and improving microcirculation.

[0042] Curcuma has the effects of promoting qi and removing blood, eliminating stagnation and relieving pain. Modern pharmacological studies have found that the effective ingredients of Curcuma oil and terpenoid compounds, curcumin and other active ingredients in Curcuma have anti-fibrosis, anti-inflammatory, anti-tumor, analgesic, anti-platelet aggregation, anti-thrombosis, and antioxidant effects. The main components of Curcuma volatile oil include Germacron, Curcumol, Curdiol, Curcumone and Curdione, which have antibacterial, antiviral, liver protection, blood cell elevation, anti-embolism, and increased gastrointestinal motility.

[0043] Xanthium sibiricum has the effects of dispersing wind and cold, clearing the nasal passages, and removing rheumatism. It is often used to treat wind-cold headaches, nasal congestion and runny nose, allergic rhinitis, sinusitis, urticaria itching, and dampness and stiffness. Modern research results show that Xanthium sibiricum has multiple pharmacological effects such as anti-inflammatory, analgesic, immunosuppressive, anti-allergic, antioxidant, anti-pathogenic microorganisms, vasodilator, and hypoglycemic. Xanthium sibiricum mainly contains a variety of volatile oils and fatty acid components such as esters, alcohols, and acids, phenolic acids and their derivative compounds, lignans, sesquiterpene lactones, and water-soluble glycosides. Among them, volatile oils have the effects of regulating immune function and anti-inflammatory; phenolic acid components have anti-inflammatory and analgesic effects.

[0044] Rubia cordifolia has the effects of cooling blood, removing blood stasis, stopping bleeding and promoting menstruation. Rubia cordifolia contains a variety of active ingredients, and its main chemical components include anthraquinones, naphthoquinones, cyclohexyl peptides, terpenes and polysaccharides, as well as a variety of trace elements. Modern pharmacological studies have shown that Rubia cordifolia extract has significant antibacterial, anti-inflammatory, liver-protecting, antioxidant, anti-tumor, and hypertension-lowering effects.

[0045] Honeysuckle has the effects of clearing away heat, detoxifying, and evacuating wind-heat. Modern pharmacology has confirmed that honeysuckle has multiple pharmacological effects such as regulating immunity, broad-spectrum antibacterial, antiviral, anti-tumor, antipyretic and anti-inflammatory, and liver protection. Honeysuckle has the effect of promoting phagocytosis of white blood cells and inflammatory cells, restoring macrophage function, and regulating lymphocyte function. Honeysuckle extract can also play an anti-allergic role by reducing the level of specific IgE.

[0046] Wild chrysanthemum has the effects of clearing away heat and detoxifying, purging fire and calming the liver. Wild chrysanthemum contains volatile oils, flavonoids, glycoside compounds and other ingredients, which have the effects of lowering blood lipids, anti-oxidation, anti-inflammatory, anti-allergic and analgesic, and can be used to relieve pain symptoms such as headaches and toothaches.

[0047] Cloves have the effects of warming the middle and lowering adverse reactions, nourishing the kidney and supporting yang. The active ingredients in cloves are essential oils, flavonoids, terpenes, sterols and other chemical components. Modern pharmacological research has found that cloves have antioxidant, antibacterial and antiviral effects.

[0048] Licorice has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving urgency and relieving pain, and harmonizing various medicines. Its active ingredients include triterpenoid saponins, flavonoids, sugars, ascorbic acid, choline, etc., and have multiple pharmacological effects such as immunomodulation, anti-oxidation, anti-virus, anti-inflammatory and bactericidal.

[0049] Centipeda minima is the dried whole herb of Centipeda minima (CM), a plant of the Asteraceae family. It is pungent and warm in nature and enters the lung meridian. It has the effects of dispersing wind and cold, clearing the orifices and relieving cough.

[0050] The Chinese Pharmacopoeia records that it can "clear the nasal passages and relieve coughs" and is used for "wind-cold headache, cough with sputum, nasal congestion, runny nose and so on."

[0051] Compared with the prior art, the present invention can achieve the following beneficial effects:

[0052] (1) The present invention provides a Chinese medicine composition for treating nasal inflammatory diseases, which is prepared from the following components in parts by weight: 5-20 parts of magnolia, 5-15 parts of zedoaria, 5-10 parts of xanthium sibiricum, 5-10 parts of madder, 5-10 parts of honeysuckle, 5-10 parts of wild chrysanthemum, 3-8 parts of cloves and 2-5 parts of liquorice. It is prepared from Chinese medicinal materials with the effects of dispelling wind and cold, clearing nasal passages, clearing heat and detoxifying, tonifying the spleen and kidney, and promoting qi and blood circulation. It has the effects of dispelling wind and cold, promoting qi and opening the passages, clearing heat and relieving itching. The prescription conforms to the theory of traditional Chinese medicine for treating rhinitis and solves the acute stage symptoms. The composition is not only unique in conception and has no obvious toxic and side effects, but also safe and reliable in use, with significant therapeutic effects, achieving the effect of treating both the symptoms and the root causes.

[0053] (2) In the prescription of the present invention, the various medicinal flavors have significant synergistic effects in treating nasal inflammation. From the analysis of modern medicine, both the in vivo allergic rhinitis test and the in vitro antibacterial test have achieved good results. In addition, when cloves are replaced with Herba Lysimachiae, which also has anti-inflammatory volatile oil components, the effect and effective ingredient extraction rate of Herba Lysimachiae in the prescription are much lower than those of cloves, indicating that the cloves (various components) in the prescription of the present invention have an irreplaceable role in the prescription. The prescription of the present invention breaks through the conventional selection and achieves significant technical effects.

[0054] (3) The prescription of the present invention reduces the dosage of Xanthium sibiricum, which has liver and kidney toxicity, on the basis of the existing Biyuan soft capsules / Biyuan tablets, and provides a Chinese medicine composition with a more reasonable medicinal flavor composition, clear medicinal flavor efficacy, significant therapeutic effect, and safety and non-toxicity, thereby expanding the scope of application of the prescription of the present invention, while ensuring the efficacy of the medicine, it also improves the utilization rate of the medicine, and significantly improves the clinical value.

[0055] (4) The Chinese medicine composition of the present invention can restore the body's positive energy to resist the invasion of external cold wind, and finally cure rhinitis from the perspective of curing the root cause. It has the effects of dispelling wind and cold, promoting qi and opening the orifices, clearing away heat and relieving itching, etc. It can dispel rheumatism, open the nasal orifices, stop nasal sinusitis and runny nose, clear liver heat, dry dampness and relieve itching. It has obvious anti-allergic effect and antibacterial and anti-inflammatory pharmacological effects, and can be used to treat various acute rhinitis, chronic rhinitis, sinusitis, allergic rhinitis, atrophic rhinitis, vasomotor rhinitis and other diseases, with significant therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0057] Figure 1 This is the pathological section of HE-stained nasal mucosa of guinea pig in Experiment 3. DETAILED DESCRIPTION

[0058] The present invention is described below by way of examples to make the technical solution of the present invention easier to understand and grasp, but the present invention is not limited thereto. The experimental methods described in the following examples are conventional methods unless otherwise specified; the medicinal materials and reagents described can be obtained from commercial channels unless otherwise specified; and the performance of products from different sources does not have a significant impact.

[0059] Basic Example

[0060] A traditional Chinese medicine composition for treating nasal inflammatory diseases comprises the following components in parts by weight: 5-20 parts of magnolia, 5-15 parts of zedoaria, 5-10 parts of xanthium, 5-10 parts of honeysuckle, 5-10 parts of madder, 5-10 parts of wild chrysanthemum, 3-8 parts of cloves and 2-5 parts of liquorice.

[0061] The raw materials and dosages of the Chinese medicine compositions of Examples 1 to 4 and Comparative Examples 1 to 8 are shown in Table 1.

[0062] Table 1 Prescription composition of examples and comparative examples

[0063]

[0064] Note: The “*” mark in Comparative Example 8 in Table 1 indicates that the cloves in the formula were replaced with an equal amount of Herba Lysimachiae.

[0065] The preparation methods of the Chinese medicine compositions of Examples 1-4 and Comparative Examples 1-7 are as follows:

[0066] S1. Weigh the whole prescription medicinal ingredients according to Table 1, add 8 times the amount of water and distill for 6 hours, collect the volatile oil and the extract after distillation and the medicinal residue;

[0067] S2, adding 10 times the amount of water to the medicinal residue after distillation in step S1 and distilling and extracting for 1 hour, extracting twice, and collecting the extract;

[0068] S3, combining the extracts in step S1 and S2, and concentrating under reduced pressure to a water extract concentrate with a relative density of 1.05;

[0069] S4, adding ethanol until the ethanol content of the water-extracted concentrated solution is 90%, letting it stand, taking the supernatant and concentrating it to obtain a supernatant concentrated paste with a relative density of 1.30;

[0070] S5. Add the volatile oil in S1 to the supernatant concentrated paste of S4 and mix well to obtain the Chinese medicine composition.

[0071] The granules of Example 5 are prepared as follows:

[0072] 40 parts of the traditional Chinese medicine composition obtained in S5 of Example 3 were added with 15 parts of dextrin, 10 parts of polyvinylpyrrolidone and 1 part of sucralose to prepare granules.

[0073] The nasal spray of Example 6 is prepared as follows:

[0074] 5 parts of water, 5 parts of Tween and 1 part of benzalkonium bromide were added to 40 parts of the traditional Chinese medicine composition obtained in S5 of Example 3 and mixed well to prepare a nasal spray.

[0075] The Chinese medicine composition of Comparative Example 8 is prepared as follows:

[0076] The difference between Comparative Example 8 and Example 2 is that the cloves in Example 2 are replaced with an equal amount of Herba Lysimachiae, and the rest of the prescriptions are the same, and the preparation method is the same as that of Example 2.

[0077] Test Example 1: Antibacterial activity of volatile oils

[0078] (1) Test sample

[0079] The volatile oil collected in step S1 of Example 1, Comparative Example 1 (the prescription does not contain Curcuma zedoaria, Licorice and Clove) and Comparative Example 4 (the prescription does not contain Clove).

[0080] (2) Test bacteria

[0081] Staphylococcus aureus, Pseudomonas aeruginosa, and corresponding culture media.

[0082] (3) Test groups and test samples

[0083] The groups and test samples of the volatile oil antibacterial test are shown in Table 2.

[0084] Table 2 In vitro antibacterial test grouping and test samples

[0085]

[0086] (4) Test steps

[0087] The antibacterial activity of the test substances was detected by the microdilution method. The test substances were diluted 2, 4, 8, 16, 32, 64, 128, 256, 512 and 1024 times, respectively. After co-culture with the test bacteria, the plates were observed under fluorescent light. The last clear well in the co-culture well plate was observed by naked eyes and judged as the MIC (minimum inhibitory concentration).

[0088] (5) Test results

[0089] Table 3 Antibacterial test results

[0090]

[0091]

[0092] The results showed that the oil yield of test substance 2 was low at only 0.43%, the oil yield of test substance 3 increased to 0.61% after adding licorice and curcuma, and the oil yield of test substance 1 increased significantly to 3.64% after adding cloves.

[0093] As shown in Table 3, the volatile oils of test substance 1 and test substance 3 have strong inhibitory effects on rhinitis-related pathogens Staphylococcus aureus and Pseudomonas aeruginosa, and the inhibitory effect of clove volatile oil components on Staphylococcus aureus is stronger than that on Pseudomonas aeruginosa. The inhibitory effect of volatile oils with added clove components on rhinitis-related pathogens has been significantly improved, indicating that the addition of cloves significantly enhances the antibacterial effect of volatile oils, which provides a reference for developing them into preparations with volatile oil components.

[0094] Test Example 2: In vitro test evaluation

[0095] 1. Evaluation of in vitro anti-allergic and anti-inflammatory tests

[0096] (1) Test materials

[0097] Mouse macrophages (RAW264.7), dexamethasone, lipopolysaccharide (LPS), trypsin, FBS, DMEM medium, ELISA kit, cell culture flask, etc.

[0098] (2) Experimental groups, dosage, and experimental sequence

[0099] After the mouse macrophages were expanded to a certain number, cells with good growth status in the logarithmic growth phase were selected and digested with trypsin to form a cell suspension. The density was adjusted to 2×10 5 The cells were randomly divided into 15 groups, namely test group 1 to group 12, blank control group, positive control group and model control group, with 3 replicates in each group. The grouping and dosage are shown in Table 4.

[0100] Table 4 Grouping and dosage table of in vitro anti-inflammatory test

[0101]

[0102]

[0103] (3) Test steps

[0104] After the cells of each group were inoculated into 12-well plates, they were cultured at 37°C and 5% CO2 and reattached to the plate. Except for the blank control group, the other model groups were intervened with 0.5 mg / L LPS for 6 hours. After 6 hours of intervention, each test substance was added for 12 hours. The cell supernatant was collected and tested according to the operating instructions of the IL-9 (interleukin-6) and TNF-α (tumor necrosis factor) kits.

[0105] (4) Test results

[0106] Table 5 In vitro anti-inflammatory test results

[0107]

[0108]

[0109] Note: Compared with the model control group *P<0.05, **P<0.01; compared with the positive control group # P<0.05, ## P<0.01.

[0110] It can be seen from the data in Table 5 that Examples 1-4 and Comparative Examples 1-8 all have anti-allergic and anti-inflammatory effects, and the in vitro anti-inflammatory effects of Examples 1 to 4 are the best, with significant differences compared to the model control group. In addition, Comparative Examples 6-7 have all the medicinal flavors. Although the effects of test substances 10 and 11 are better than those of test substances 5-9 lacking 1-3 raw materials, they are still worse than the anti-inflammatory effects of test substances 1-4, which not only shows that the raw materials of the prescription of the present invention have a synergistic effect, and none of them is indispensable, but also shows that the content of the prescription has a significant effect on the effect of the present invention. In addition, it can be seen from the results of Comparative Example 8 and Example 2 that although only cloves are replaced with goose grass that also has anti-inflammatory volatile oil components, the effect of goose grass in the prescription is much lower than that of cloves, indicating that the cloves in the prescription of the present invention have an irreplaceable effect on the prescription and have achieved unexpected technical effects.

[0111] 2. In vitro antibacterial test evaluation

[0112] (1) Test materials

[0113] Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger, and corresponding culture media.

[0114] (2) Test groups and test samples

[0115] The grouping of the in vitro antibacterial test and the test articles are shown in Table 6.

[0116] Table 6 Grouping of the in vitro antibacterial test and test articles

[0117]

[0118]

[0119] (3) Test procedure

[0120] The microdilution method was used to detect the antibacterial activity of the test article. The test article was diluted into 2, 4, 8, 16, 32, 64, 128, 256, 512, and 1024 times respectively. After co-culturing with the test bacteria, it was observed under daylight. The last clear well in the co-culture well plate was judged as the MIC (minimum inhibitory concentration) by the naked eye; after using the microdilution method to detect the MIC, 50 μL of the clarified culture solution was taken from the co-culture after the culture ended and transferred to a sterile petri dish, and the MBC (minimum bactericidal concentration) of the test article was detected by the plate method.

[0121] (4) Test results

[0122] Table 7 Results of the antibacterial experiment

[0123]

[0124] It can be seen from the results in Table 7 that they are consistent with the results of the in vitro anti-inflammatory test in Table 6. Examples 1-4 and Comparative Examples 1-8 all have antibacterial and bactericidal effects, and the in vitro antibacterial effect of Examples 1-4 is the best. Even when diluted to 512 times, they still have certain antibacterial and bactericidal effects, which are significantly better than Test Articles 5-8, indicating that each medicinal flavor in the prescription of the present invention has a significant synergistic effect in antibacterial or bactericidal, and its conclusion is consistent with the results in Table 5.

[0125] Test Example Three, In vivo test evaluation

[0126] 1. Anti-inflammatory test on mice

[0127] (1) Animals: Kunming mice, a total of 90, half male and half female, 3-4 weeks old, 16.6-24.5 g, purchased from Guangdong Vital River Laboratory Animal Technology Co., Ltd., and the experimental animal production license number is: SCXK(Yue)2022-0063, quarantined for 4 days.

[0128] (2) Grouping: The Kunming mice were randomly divided into 9 groups, with 10 in each group, half male and half female, namely the model control group (normal saline), the positive control group (Compound Dexamethasone Acetate Cream), and Test Article 1-7 groups. The grouping and dosage are shown in Table 11.

[0129] Table 8 Grouping and Dosage Table of Anti-inflammatory Test in Vivo

[0130]

[0131] (3) Modeling method and detection method: Xylene-induced ear swelling model in mice. Xylene was evenly applied to both the inner and outer surfaces of the right auricle of each animal for 30 minutes to induce inflammation, and the left ear was not treated. 30 minutes after inflammation induction, 0.1 mL of the test substance sample was applied to each animal in each group. 4 hours after administration, both auricles were cut off, the test sample on the right auricle was washed off with physiological saline, wiped clean, the two auricles were overlapped, and two round ear pieces were punched out with a puncher and weighed separately to calculate the swelling value (the weight difference between the right ear piece and the left ear).

[0132] (4) Test results

[0133] Table 9 Results of Anti-inflammatory Test in Vivo

[0134]

[0135]

[0136] Note: Compared with the model control group, *P<0.05, **P<0.01; compared with the positive control group, # P<0.05, ## P<0.01.

[0137] It can be seen from the results of the anti-inflammatory test in vivo in Table 9 that Test Substances 1-7 all have anti-inflammatory effects in vivo to a certain extent. The anti-inflammatory effects in vivo of Examples 1-2 are comparable to those of the positive control group, and their swelling inhibition rates are both around 50%, and there are significant differences in the swelling degree compared with the model control group. In addition, since one to three medicinal flavors in the prescription are missing in Comparative Examples 1, 3, and 5 respectively, their swelling inhibition effects are lower than those of other full-prescription groups. In Comparative Example 8, Herba Centipedae was used to replace the cloves in Test Substance 2, which also has anti-inflammatory volatile oil components. Its swelling inhibition effect is significantly lower than that of Example 2 containing cloves, indicating that cloves and other components have a significant synergistic antibacterial effect.

[0138] 2. Allergic rhinitis experiment

[0139] 2.1 Guinea pig allergic rhinitis experiment

[0140] (1) Animals: SPF-grade guinea pigs, a total of 90, half male and half female, 6-8 weeks old, 250-300 g, purchased from Guangdong Vital River Laboratory Animal Technology Co., Ltd., and the experimental animal production license number is: SCXK(Yue)2022-0063, quarantined for 4 days.

[0141] (2) Grouping: A total of 90 SPF guinea pigs were randomly divided into 9 groups, with 10 in each group, namely, a blank group, a model control group (0.9% sodium chloride injection), a positive drug control group, and test substance groups 1-6. The grouping and dosage are shown in Table 10.

[0142] Table 10 Grouping and dosage of allergic rhinitis

[0143]

[0144] (3) Modeling and drug administration:

[0145] Sensitization: On the 1st, 3rd, 5th, 7th, 9th, 11th, and 13th days, the sensitization solution (10 mg / ml OVA-Al(OH)3 adjuvant solution) was injected intraperitoneally, 0.2 ml / mouse, once every other day, for a total of 7 times. Challenge: Starting from the 15th day, 10% OVA solution was administered bilaterally by nasal drops, 50 μl on each side, once a day, for 7 consecutive days. The normal group was challenged with bilateral nasal drops of normal saline. After the challenge, the guinea pigs were observed for 15 minutes, and the guinea pigs were scored for allergic rhinitis symptoms based on the three dimensions of the number of sneezes, the number of nose scratching, and the number of nasal discharge. The scoring criteria are shown in Table 11. The total score of the guinea pig symptom score ≥ 5 points means that the model is successfully established.

[0146] Administration: Oral administration by gavage, once a day for 7 consecutive days.

[0147] (4) Testing indicators:

[0148] ① Behavioral observation: 30 minutes after the last administration, the number of nose scratching, sneezing and runny nose was recorded and scored according to the scoring criteria in Table 11;

[0149] Table 11 Scoring criteria

[0150]

[0151] ② After guinea pigs were anesthetized, blood was collected, serum was separated, and the levels of IgE and IL-6 were determined.

[0152] ③ Pathological section detection of nasal mucosa: After administration of the blank group, test substance 1 and test substance 3, the skin on the surface of the maxillary bone, the mandible and the brain were removed, and the animal's head was cut off from the cervical vertebrae. The whole head was fixed in 10% formalin solution, paraffin sectioned, HE stained and pathological histological observation was performed.

[0153] (5) Test results

[0154] ①Behavioral observation results

[0155] Table 12 Comparison of behavioral scores of guinea pigs before and after treatment with the test substance

[0156]

[0157] Note: Compared with the model control group, *P<0.05, **P<0.01.

[0158] ② Serum inflammatory factor test results

[0159] Table 13 Serum inflammatory factor detection results

[0160]

[0161] Note: Compared with the model control group, *P<0.05, **P<0.01.

[0162] According to the results of Tables 12-13, Example 1, Example 3 and Example 5 can significantly improve the symptoms of allergic rhinitis in behavioral scores and serum inflammatory factor detection, and the therapeutic effect is better than or equivalent to the positive drug, and is significantly better than Comparative Examples 1, 5 and 8, indicating that the prescription of the present invention has a significant effect in treating rhinitis.

[0163] ③Results of pathological sections of nasal mucosa

[0164] After 7 days of continuous oral administration, Figure 1 It can be seen that the HE staining results show that the overall structure of the nasal mucosa is basically normal, the tissue mucosal layer is covered with a repair layer of ciliated columnar epithelium, the tissue mucosal epithelium has clear layers and is arranged relatively regularly, there is no obvious degeneration such as shedding, edema, necrosis, etc. in the mucosal epithelium, and there is no obvious inflammatory cell infiltration in the tissue, indicating that the prescription of the present invention is non-toxic and non-irritating.

[0165] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating nasal inflammatory diseases, characterized in that: The weight proportions of the raw materials of the Chinese medicine composition are: 5-20 parts of magnolia, 5-15 parts of zedoaria, 5-10 parts of xanthium sibiricum, 5-10 parts of madder, 5-10 parts of honeysuckle, 5-10 parts of wild chrysanthemum, 3-8 parts of cloves and 2-5 parts of liquorice.

2. The method for preparing the Chinese medicine composition according to claim 1, characterized in that: The following steps are involved: S1. Mix the raw materials in the formula: magnolia, zedoaria, xanthium, honeysuckle, madder, wild chrysanthemum, clove and liquorice, add water and distill to obtain volatile oil, extract A and medicinal residues; S2, extracting the medicinal residue obtained in step S1 with water to obtain extract B; S3, combining and concentrating the extracts A and B obtained in steps S1 and S2 to obtain a water-extracted concentrated solution C; S4, adding ethanol to the water-extracted concentrated solution C obtained in step S3 for precipitation, letting it stand, and concentrating the supernatant to obtain a supernatant concentrated paste; S5, adding the volatile oil obtained in step S1 to the supernatant concentrated paste of step S4, and mixing to obtain the Chinese medicine composition extract.

3. The preparation method according to claim 2, characterized in that: In step S1, the material-liquid ratio of the raw material to water is 1:5-10 (W / V), and the distillation time is 2-8 hours.

4. The preparation method according to claim 2, characterized in that: In step S2, the material-liquid ratio of the medicinal residue to water is 1:5-15 (W / V), the extraction time is 0.5-3h, and the number of extractions is 1-3 times.

5. The preparation method according to claim 2, characterized in that: In step S4, ethanol is added so that the volume fraction of ethanol in the concentrated solution is 30-90%, and the relative density of the supernatant concentrated paste is 1.10-1.

30.

6. A pharmaceutical preparation, characterized in that The invention relates to a Chinese medicine composition prepared according to the preparation method according to claim 1 or any one of claims 2 to 5.

7. The pharmaceutical preparation according to claim 6, characterized in that The pharmaceutical preparation further comprises one or more pharmaceutically acceptable carriers and / or excipients.

8. The pharmaceutical preparation according to any one of claims 6 to 7, characterized in that The preparations include pills, granules, tablets, capsules, powders, suspensions, emulsions, drops or liquid preparations.

9. Use of the Chinese medicine composition according to claim 1, the Chinese medicine composition prepared by the preparation method according to any one of claims 2 to 5, or the pharmaceutical preparation according to any one of claims 6 to 8 in preparing drugs for treating nasal inflammatory diseases.

10. The use according to claim 9, characterized in that: The nasal inflammatory diseases include acute rhinitis, chronic rhinitis, sinusitis, allergic rhinitis, atrophic rhinitis, and vasomotor rhinitis.

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