Traditional Chinese medicine composition for treating allergic rhinitis, orifice-warming and nose-refreshing oil and preparation method and application of orifice-warming and nose-refreshing oil

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating allergic rhinitis, orifice-warming and nose-refreshing oil as well as a preparation method and application of the orifice-warming and nose-refreshing oil. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 4-8 parts of amomum cardamomum, 4-8 parts of alpinia katsumadai, 6-10 parts of pericarpium citri reticulatae, 6-10 parts of fingered citron, 2-6 parts of galangal, 2-6 parts of mint, 4-8 parts of amomum tsao-ko, 4-8 parts of schisandra chinensis, 2-6 parts of immature bitter orange and 2-6 parts of fructus aurantii. By inhibiting excessive activation of immune cells and release of inflammatory mediators such as histamine and interleukin, stimulation of allergic mediators to nasal mucosa is reduced, so that inflammatory response is relieved, nasal mucosa barrier integrity is protected, invasion of external allergens to mucosa is reduced, allergic attack frequency is reduced, and symptoms such as nasal obstruction and clear nasal discharge are relieved. Comprehensive intervention on the allergic rhinitis is realized through ways of inhibiting inflammatory response, protecting mucous membrane barrier, relieving local discomfort and the like, and clinical symptoms of patients are effectively improved.

Description

TECHNICAL FIELD

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

[0002] Allergic rhinitis (AR), also known as allergic rhinitis, is a common non-infectious and chronic inflammatory disease. Its main pathogenesis is that specific immunoglobulin IgE is activated and triggers a series of immune responses after exposure to allergens. Clinically, AR is mainly characterized by persistent or recurrent sneezing, nasal congestion, nasal itching, and transparent watery nasal discharge. It not only seriously affects the daily life of patients, but also is closely related to other respiratory diseases such as asthma.

[0003] Globally, the prevalence of AR is generally increasing year by year. Although the disease itself does not directly endanger life, its long-term and recurrent attacks can significantly reduce the quality of life of patients, and lead to functional impairment such as fatigue and decreased energy in adult patients, thereby affecting work efficiency and social participation. SUMMARY

[0004] In view of this, the present application provides a traditional Chinese medicine composition for treating allergic rhinitis, a traditional Chinese medicine composition for treating allergic rhinitis, and a preparation method and application thereof, to treat allergic rhinitis.

[0005] To achieve the above-mentioned purpose, the following solutions are adopted in the present application:

[0006] A traditional Chinese medicine composition for treating allergic rhinitis, the traditional Chinese medicine composition is composed of the following raw materials by weight parts:

[0007] White cardamom 4-8 parts, cardamom 4-8 parts, dried tangerine peel 6-10 parts, bergamot 6-10 parts, high-quality ginger 2-6 parts, mint 2-6 parts, cardamom 4-8 parts, schisandra 4-8 parts, bitter orange 2-6 parts, and dried tangerine peel 2-6 parts.

[0008] Preferably, it includes pharmaceutically acceptable excipients or is prepared into a drug dosage form suitable for clinical use.

[0009] Preferably, the drug dosage form includes any one of powders, granules, tablets, granules or oral preparations, ointments, and nano-drug carriers.

[0010] Preferably, the preparation method of the ointment includes: weighing the above-mentioned raw materials by weight parts, crushing and sieving to obtain a crushed material, adding 8-12 times the amount of water to the crushed material, shaking and mixing, and then soaking at room temperature for 0.5-2 h to obtain a water extract; and concentrating and drying the water extract to obtain the ointment.

[0011] The above-mentioned traditional Chinese medicine composition is used to prepare a nasal oil for warming the orifices and waking the nose.

[0012] The preparation method of the above-mentioned warming and nasal-awakening oil includes the following steps:

[0013] S10. Weigh out 4-8 parts of white cardamom, 4-8 parts of black cardamom, 6-10 parts of dried tangerine peel, 6-10 parts of bergamot, 2-6 parts of galangal, 2-6 parts of peppermint, 4-8 parts of amomum fruit, 4-8 parts of schisandra fruit, 2-6 parts of immature bitter orange, and 2-6 parts of immature bitter orange peel. Crush the raw materials and sieve them to obtain a powder. Add 8-12 times the amount of water of the raw materials to the powder, shake and mix, and soak at room temperature for 0.5-2 hours to obtain an aqueous extract.

[0014] S20. The water extract is heated, the volatiles of the water extract are collected, and the volatiles are condensed to obtain the warm nasal oil.

[0015] The application of the above-mentioned traditional Chinese medicine composition or the above-mentioned warming and nasal-awakening oil in the treatment of allergic rhinitis.

[0016] The aforementioned traditional Chinese medicine composition for treating allergic rhinitis, the Wenqiao Xingbi oil, and their preparation methods and applications, comprise ten medicinal herbs: white cardamom, black cardamom, dried tangerine peel, bergamot, galangal, peppermint, amomum fruit, schisandra fruit, immature bitter orange, and immature bitter orange peel. It is primarily used to treat symptoms such as nasal congestion with clear runny nose, frequent sneezing, abdominal distension, and decreased sense of smell. The natural active ingredients in the formula can intervene in the pathological process of allergic rhinitis through multi-target synergistic effects, reducing mucosal congestion and edema, thereby alleviating allergic reactions such as nasal itching and sneezing. By inhibiting excessive activation of immune cells and the release of inflammatory mediators such as histamine and interleukins, it reduces the stimulation of allergic mediators on the nasal mucosa, thereby reducing inflammatory reactions, protecting the integrity of the nasal mucosal barrier, reducing the invasion of external allergens into the mucosa, lowering the frequency of allergic attacks, and relieving symptoms such as nasal congestion and runny nose. Through multiple pathways, including inhibiting inflammatory reactions, protecting the mucosal barrier, and relieving local discomfort, it achieves comprehensive intervention for allergic rhinitis, effectively improving patients' clinical symptoms. The Wenqiao Xingbi Oil provided in this application is extracted from the above ten medicinal materials. Compared with the extract obtained from the Chinese medicine composition, the Wenqiao Xingbi Oil has better efficacy and is simple and convenient to use, which can improve patient compliance. Attached Figure Description

[0017] Figure 1 The scores for the animal behavior (scratching nose and sneezing) of each group in the experiment on the use of the Wenqiao Xingbi Oil in treating allergic rhinitis in this invention are shown.

[0018] Figure 2 The results of HE staining of the nasal mucosa of each group of animals in the experiment of using Wenqiao Xingbi Oil to treat allergic rhinitis in this invention are shown in the figure.

[0019] Figure 3 Figure 1 is a graph showing the results of HE staining of the trachea of animals in each group in the experiment of treating allergic rhinitis with the warm and clear nasal oil of the present application.

[0020] Figure 4 Figure 2 shows the changes in IgE, IL-4 and HIS in the serum of animals detected by enzyme-linked immunosorbent assay in the experiment of treating allergic rhinitis with the warm and clear nasal oil of the present application. DETAILED DESCRIPTION

[0021] To make the object, technical scheme of the present application clearer, the content of the present application is further described in detail by experiments, and the technical scheme and technical effect of the present application are further described. It should be noted that the following experimental researches are carried out on the basis of proving the safety of the drug, and the dosages in the experimental researches are within the safe dosage range; the inventors of other drugs also carried out pharmacodynamic experiments, and the experimental results showed the same or similar effects, but due to the limitation of the length, they are not listed here.

[0022] A traditional Chinese medicine composition for treating allergic rhinitis, which is composed of the following raw materials in parts by weight:

[0023] Amomum kravanh 4-8 parts, Amomum costatum 4-8 parts, Citrus reticulata 6-10 parts, Citrus medica 6-10 parts, Alpinia officinarum 2-6 parts, Mentha haplocalyx 2-6 parts, Amomum villosum 4-8 parts, Schisandra chinensis 4-8 parts, Citrus aurantium 2-6 parts, and Citrus aurantium 2-6 parts.

[0024] The traditional Chinese medicine composition provided in the present application is composed of Amomum kravanh, Amomum costatum, Citrus reticulata, Citrus medica, Alpinia officinarum, Mentha haplocalyx, Amomum villosum, Schisandra chinensis, Citrus aurantium, and Citrus aurantium, and is used for treating symptoms such as “nasal congestion and clear nasal discharge, sneezing, abdominal distension, and reduced olfaction”. The natural active ingredients contained in the formula can intervene in the pathological process of allergic rhinitis through multi-target synergistic action, reduce mucosal hyperemia and edema, and thus relieve allergic reactions such as nasal itching and sneezing. Through multiple pathways such as inhibiting inflammatory reactions, protecting the mucosal barrier, and relieving local discomfort, the traditional Chinese medicine composition realizes comprehensive intervention on allergic rhinitis and effectively improves the clinical symptoms of patients.

[0025] In a specific embodiment, the traditional Chinese medicine composition includes a pharmaceutically acceptable excipient or is prepared into a pharmaceutical dosage form suitable for clinical use.

[0026] Further, the pharmaceutical dosage form includes any one of a powder, a granule, a tablet, a granule or an oral preparation, a plaster, and a nano drug carrier.

[0027] In a specific embodiment, the preparation method of the paste comprises: weighing the raw materials according to the weight parts, crushing and sieving to obtain a crushed material, adding 8-12 times the amount of water to the crushed material, shaking and mixing, then soaking at room temperature for 0.5-2 hours to obtain a water extract; and concentrating and drying the water extract to obtain an extract.

[0028] The Wengqiaoxingbi oil is prepared from the traditional Chinese medicine composition.

[0029] The Wengqiaoxingbi oil provided in the application is extracted from ten medicinal materials, i.e., Amomum villosum, Amomum kravanh, Citrus reticulata, Citrus medica, Alpinia officinarum, Mentha haplocalyx, Annona squamosa, Schisandra chinensis, Citrus aurantium and Citrus aurantium, and is used for treating symptoms such as nasal congestion, sneezing, abdominal distension, and reduced olfactory function. The active ingredients in the prescription can inhibit the overactivation of immune cells and the release of inflammatory mediators such as histamine and interleukin, reduce the stimulation of allergic mediators on the nasal mucosa, alleviate inflammatory reactions, protect the mucosal barrier, and relieve local discomfort, thereby achieving comprehensive intervention on allergic rhinitis and effectively improving the clinical symptoms of patients. Compared with the extract obtained from the traditional Chinese medicine composition, the Wengqiaoxingbi oil contains more effective components for treating allergic rhinitis, has better efficacy, and is simple and convenient to use, which can improve the compliance of patients.

[0030] The preparation method of the Wengqiaoxingbi oil comprises the following steps:

[0031] S10. Weighing Amomum villosum 4-8 parts, Amomum kravanh 4-8 parts, Citrus reticulata 6-10 parts, Citrus medica 6-10 parts, Alpinia officinarum 2-6 parts, Mentha haplocalyx 2-6 parts, Annona squamosa 4-8 parts, Schisandra chinensis 4-8 parts, Citrus aurantium 2-6 parts, and Citrus aurantium 2-6 parts, crushing and sieving the raw materials to obtain a crushed material, adding 8-12 times the amount of water to the crushed material, shaking and mixing, then soaking at room temperature for 0.5-2 hours to obtain a water extract;

[0032] S20. Heating the water extract, collecting the volatiles of the water extract, and condensing the volatiles to obtain the Wengqiaoxingbi oil.

[0033] Specifically as follows:

[0034] Take each of the following medicinal materials: white cardamom, cardamom, dried tangerine or orange peel, bergamot, galangal, mint, cardamom, schisandra chinensis, immature bitter orange fruit, immature bitter orange, crush, sieve, add 8-12 times the amount of water to a flask, shake and mix, soak at room temperature for 0.5-2 hours, connect the warm nostril oil detector, add water to the upper end of the detector until the scale is full and overflow into the flask, then connect the reflux condenser, heat the contents of the flask to boiling, and maintain a gentle boil for about 4-10 hours. Stop heating. Let the oil and water separate, read the scale, open the lower piston of the detector, and slowly release the water layer. Collect the volatile oil, which is a light yellow liquid with a fragrance. Weigh it accurately, put it in a brown bottle, seal it, store it in the dark, and refrigerate it for future use.

[0035] The above-mentioned traditional Chinese medicine composition or the above-mentioned warm nostril oil is used in the treatment of allergic rhinitis.

[0036] 1. Drug materials

[0037] Ovalbumin, aluminum hydroxide, normal saline, OVA solution, loratadine (all from the market);

[0038] Warm nostril oil (prepared by Ningxia Medical University Laboratory).

[0039] 2. Related technical solutions

[0040] 2.1 Collect experimental animals

[0041] 56 SPF female Balb / c mice were selected from the Ningxia Medical University Experimental Animal Center. They were kept in a well-ventilated, dry, room temperature 22-25℃, humidity 50%-70% animal room with free access to water and quantitative feeding of mouse feed.

[0042] 2.2 Grouping of experimental animals

[0043] The 56 SPF female Balb / c mice were randomly divided into seven groups: blank control group, allergic rhinitis model group, positive drug group (3mg / kg), warm nostril oil gavage medium concentration group (60mg / kg), warm nostril oil gavage high concentration group (120mg / kg), warm nostril oil nasal drops low concentration group (30mg / kg), and warm nostril oil + extract group (60mg / kg+1.32g / kg), 8 mice in each group.

[0044] 2.3 Model establishment

[0045] 6-8 week old SPF female Balb / c mice, except for the blank control group, the rest were established allergic rhinitis model by whole body sensitization and local challenge with ovalbumin (OVA).

[0046] Abdominal sensitization operation method: 100 μg of egg white protein was used as antigen, 2 mg of aluminum hydroxide [Al(OH)3] was used as adjuvant, dissolved in 200 μl of normal saline, 0.1 ml / 10 g was injected intraperitoneally for each mouse, and the blank group mice were injected intraperitoneally with the same amount of normal saline. The head, neck, trunk and tail of the mouse were grasped and fixed with the left hand to fully expose the abdominal skin, and the needle was inserted slowly to prevent injury to internal organs. After injection, the needle was slowly withdrawn. Every three days, a total of 6 times (1st, 4th, 7th, 10th, 13th, 16th day), for basic sensitization.

[0047] Local challenge operation method: one week after basic sensitization, nasal challenge was started on the 23rd day of the experiment, and the nasal intensification challenge phase was entered. Except for the normal group of mice, 20 μL of OVA solution (25 mg / mL) was dropped into the bilateral nasal cavity of the mice, and the same dose of normal saline was dropped into the normal group of mice. Each side of the nostril was dropped once a day for 10 days. The head, neck, trunk and tail of the mouse were grasped and fixed with the left hand, 10 μl of solution was taken with a pipette, and the droplet was slowly introduced into the mouse's nasal cavity to avoid causing coughing. Once a day for 10 days, for local challenge.

[0048] 2.4 Administration method

[0049] During the nasal instillation challenge phase, administration was carried out at the same time, i.e. on the 23rd day of the experiment, administration was carried out 30 min before nasal instillation, once a day for 10 days.

[0050] The blank control group and the model group were given normal saline 0.1 mL / 10 g (body weight) daily; the positive drug group was given loratadine 3 mg / kg by gavage daily; the medium dose and high dose groups of Wenqiaoxingbi oil were given Wenqiaoxingbi oil 60 mg / kg and 120 mg / kg by gavage daily respectively; the low concentration group of Wenqiaoxingbi oil was given 30 mg / kg of Wenqiaoxingbi oil for nasal instillation, and the Wenqiaoxingbi oil + extract group was given Wenqiaoxingbi oil 60 mg / kg + extract 1.32 g / kg.

[0051] 2.5 Behavioral scoring

[0052] After the last nasal instillation 30 min, the nasal symptoms of each group of mice within 10 min were observed and recorded, i.e. the number of scratching and sneezing, and the specific evaluation criteria are shown in Table 1, and the scoring results are shown in Table 2. Figure 1

[0053] Table 1 AR mouse behavioral scoring table Item 1 minute 2 minutes 3 minutes Scratch nose Scratch nose Scratch a few times Scratch face more than once Sneeze 1-3 times 4-10 times More than 11 times

[0054] 2.6 H&E staining

[0055] ​The pathological changes in the nasal mucosa and trachea of ​​mice in each group were analyzed by H&E staining, and the results are as follows: Figure 2 and Figure 3 As shown.

[0056] 2.7 Detection of inflammatory factors

[0057] Changes in serum IL-4, HIS, and IgE were observed using enzyme-linked immunosorbent assay (ELISA).

[0058] 3. Experimental Results

[0059] Depend on Figure 1 The results showed that, compared with the normal group, the number of sneezing and nose scratching in the model group mice was significantly increased. Compared with the model group, the number of sneezing was significantly reduced after drug intervention, and the number of nose scratching also showed a decreasing trend. However, the number of sneezing and nose scratching in the Wenqiao Xingbi Oil nasal drops group was increased, suggesting that the Wenqiao Xingbi Oil nasal drops may have a certain stimulating effect on the mice.

[0060] Depend on Figure 2 The results showed that the nasal mucosa tissue structure of the normal group mice was intact, with no abnormal edema or hyperplasia and few inflammatory cell infiltrations. Compared with the normal group, the nasal mucosa tissue of the model group mice was disordered, with interstitial edema, goblet cell hyperplasia of mucosal epithelium, enlarged glands, and high expression of inflammatory cells in the nasal mucosa. After intervention with loratadine and Wenqiao Xingbi Oil, compared with the model group, it can be seen that the nasal mucosa damage of the mice in the drug intervention group was improved to varying degrees and the inflammatory cell infiltration was reduced.

[0061] Depend on Figure 3 The results showed that the tracheal tissue of the normal group mice was smooth and intact, with no abnormal lesions and few inflammatory cell infiltrations. Compared with the normal group, the tracheal tissue of the model group mice was diseased, with necrotic mucosal epithelial cells sloughed off, cilia lying down and falling off, rupture of the tracheal smooth muscle layer, congestion of the tracheal wall, and a large number of inflammatory cell infiltrations. After intervention with loratadine and Wenqiao Xingbi Oil, compared with the model group mice, it can be seen that the degree of lesion damage in the tracheal tissue of the mice in each drug intervention group was improved, and the expression of inflammatory cells in the trachea was significantly reduced.

[0062] Depend on Figure 4 It can be seen that the model group had significantly higher levels of inflammatory factors compared to the normal group. After intervention with loratadine and Wenqiao Xingbi Oil, the levels of inflammatory factors decreased.

[0063] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in the present invention, and such modifications or substitutions should all be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating allergic rhinitis, characterized in that, The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Amomum kravanh 4-8 parts, Amomum costatum 4-8 parts, dried tangerine or orange peel 6-10 parts, bergamot 6-10 parts, Alpinia officinarum 2-6 parts, Mentha haplocalyx 2-6 parts, Amomum maximum 4-8 parts, Schisandra chinensis 4-8 parts, immature bitter orange fruit 2-6 parts, immature bitter orange 2-6 parts.

2. The Chinese medicine composition for treating allergic rhinitis according to claim 1, characterized in that, The traditional Chinese medicine composition includes a pharmaceutically acceptable pharmaceutical adjuvant or is prepared into a pharmaceutical dosage form suitable for clinical use.

3. The Chinese medicine composition for treating allergic rhinitis according to claim 1, characterized in that, The pharmaceutical dosage form includes any one of a powder, granules, tablets, granules or oral preparations, a plaster, and a nano-drug carrier.

4. The Chinese medicine composition for treating allergic rhinitis according to claim 3, characterized in that, The preparation method of the plaster includes: weighing the raw materials in the above-mentioned parts by weight, crushing and sieving to obtain a crushed product, adding 8-12 times the amount of water to the crushed product, shaking and mixing, then soaking at room temperature for 0.5-2 hours to obtain a water extract; and concentrating and drying the water extract to obtain the plaster.

5. A warm-nasal oil prepared from the traditional Chinese medicine composition of claim 1.

6. The process for the preparation of the warm-cool and refreshing nasal oil as claimed in claim 5, wherein, The method includes the following steps: S10. Weighing Amomum kravanh 4-8 parts, Amomum costatum 4-8 parts, dried tangerine or orange peel 6-10 parts, bergamot 6-10 parts, Alpinia officinarum 2-6 parts, Mentha haplocalyx 2-6 parts, Amomum maximum 4-8 parts, Schisandra chinensis 4-8 parts, immature bitter orange fruit 2-6 parts, immature bitter orange 2-6 parts, crushing and sieving the raw materials to obtain a crushed product, adding 8-12 times the amount of water to the crushed product, shaking and mixing, then soaking at room temperature for 0.5-2 hours to obtain a water extract; S20. Heating the water extract, collecting the volatiles of the water extract, and condensing the volatiles to obtain the warm-nasal oil.

7. Use of the traditional Chinese medicine composition of claim 1 or the warm-nasal oil of claim 5 in the treatment of allergic rhinitis.

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