A composition for treating allergic rhinitis, its preparation method, and its application.

Abstract

This invention belongs to the field of traditional Chinese medicine technology, and provides a composition for treating allergic rhinitis, its preparation method, and its application. The composition, by weight, comprises the following raw materials: 1-5 parts of processed aconite root, 1-5 parts of cinnamon twig, 1-5 parts of atractylodes rhizome, 1-5 parts of angelica root, 1-5 parts of magnolia flower bud, 1-7 parts of acorus tatarinowii rhizome, 1-5 parts of poria cocos, 0.1-2 parts of prepared licorice root, and 1-13 parts of fresh ginger. The composition of this invention primarily functions to "warm the yang and release the exterior, clear the yang meridian," while also possessing the effects of "supporting yang and regulating the middle jiao, warming and invigorating the spleen," and "supporting yang and strengthening the body, replenishing essence and transforming qi." This combination of three methods can fundamentally resolve allergic rhinitis, demonstrating outstanding clinical efficacy.

Description

TECHNICAL FIELD

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

[0002] Allergic rhinitis (AR), also known as allergic rhinitis, is mainly manifested as nasal itching, sneezing, clear watery discharge, nasal congestion and the like, and is a common clinical disease with high incidence and difficult-to-cure recurrence. At present, the western medicine mainly adopts drug treatment for the disease, and the first-line drugs are nasal glucocorticoids, second-generation antihistamines and leukotriene receptor antagonists. Although these drugs exert certain effects through mechanisms such as anti-inflammatory, anti-allergic and airway remodeling regulation, long-term use is prone to drug resistance and side effects, and even improper use may lead to drug-induced rhinitis. Relatively speaking, the traditional Chinese medicine treatment can not only effectively improve the clinical symptoms of AR patients, but also enhance the patient's constitution as a whole, reduce the incidence and thus improve the quality of life. Through the treatment based on syndrome differentiation, individualized treatment plan can be achieved, which has certain advantages.

[0003] Chinese patent application CN108042692A discloses a rhinitis powder, and the effective components are as follows: 14-37 parts of Semen Xanthii, 21-39 parts of Radix et Rhizoma Anisidi, 0.2-6 parts of Borneolum Syntheticum, 16-47 parts of Ramulus Cinnamomi, 4-26 parts of Herba Menthae, 5-29 parts of Radix Glycyrrhizae, 11-28 parts of Pericarpium Citri Reticulatae Viride, 7-29 parts of Bupleurum, 11-38 parts of Eupatorium Fortunei, 15-43 parts of Rhizoma Pinelliae, and 11-26 parts of Rhizoma Typhonii. The rhinitis powder is a traditional Chinese medicine preparation with the effects of relieving superficies and clearing heat, improving nasal microcirculation and blocking pathological fluid accumulation in nasal orifice.

[0004] Chinese patent application CN119405739A discloses a rhinitis treatment formula, which is composed of the following raw materials by weight: Eupatorium Fortunei 10 g, Herba Schizonepetae 10 g, Magnolia Flower 10 g, Semen Xanthii 10 g, Radix Angelicae Dahuricae 15 g, Radix et Rhizoma Atractylodis 15 g, Rhizoma Acori Graminei 12 g, Seven Star Sword 12 g, Radix et Rhizoma Anisidi 6 g, Halite 9 g, Nitre 9 g, Musk 3 g, Borneolum Syntheticum 3 g, and 50-degree white wine 500 ml.

[0005] However, AR is a typical hypersensitivity disease, and its pathogenesis is not a single process, but there are intricate connections between the immune response mechanism and the neuroregulation mechanism, and between the genetic and environmental factors. These factors interweave and synergize to jointly promote the occurrence and development of AR. The prior art does not conduct in-depth research on the specific action mechanism of each traditional Chinese medicine component, lacks theoretical basis, and in the above formula, Radix et Rhizoma Anisidi and Rhizoma Pinelliae may cause gastrointestinal discomfort or allergic reaction; excessive Borneolum Syntheticum can cause nasal dryness; Halite contains ammonium chloride which needs to be strictly controlled in dosage, and Nitre contains alum which may stimulate the mucosa.

[0006] To reduce the side effects of medications, the use of related raw materials should be minimized. Furthermore, understanding the mechanisms of action of each drug component in allergic rhinitis and clarifying the compatibility between components is crucial for fully realizing the effectiveness of each raw material's active ingredients. Therefore, it is necessary to improve and optimize the raw materials of existing traditional Chinese medicines related to rhinitis, and at the same time, conduct in-depth research on their compatibility from the perspective of traditional Chinese medicine's syndrome differentiation and treatment principles. Summary of the Invention

[0007] To address the problems existing in the prior art, this invention provides a composition for treating allergic rhinitis, its preparation method, and its application. Based on the pathogenesis of allergic rhinitis (AR) and combined with clinical practice, this invention utilizes the compatibility of traditional Chinese medicine ingredients to fundamentally treat AR, achieving outstanding clinical results.

[0008] The technical solution of the present invention is as follows:

[0009] In a first aspect, the present invention provides a composition for treating allergic rhinitis, comprising the following raw materials by weight: 1-5 parts of processed aconite root, 1-5 parts of cinnamon twig, 1-5 parts of atractylodes rhizome, 1-5 parts of angelica root, 1-5 parts of magnolia flower, 1-7 parts of acorus tatarinowii rhizome, 1-5 parts of poria cocos, 0.1-2 parts of prepared licorice root, and 1-13 parts of fresh ginger.

[0010] Preferably, the composition comprises, by weight, the following raw materials: 2-4 parts of processed aconite root, 2-4 parts of cinnamon twig, 2-4 parts of atractylodes rhizome, 2-4 parts of angelica root, 2-4 parts of magnolia flower bud, 3-5 parts of acorus tatarinowii rhizome, 2-4 parts of poria cocos, 0.5-1.5 parts of prepared licorice root, and 4-8 parts of fresh ginger.

[0011] More preferably, the composition comprises, by weight, the following raw materials: 3 parts processed aconite root, 3 parts cinnamon twig, 3 parts Atractylodes lancea, 3 parts Angelica dahurica, 3 parts Magnolia biondii, 4 parts Acorus tatarinowii, 3 parts Poria cocos, 1 part processed licorice root, and 6 parts fresh ginger.

[0012] The aconite root in this formula is extremely pungent and hot, and can circulate through the twelve meridians. As the chief herb, it can enter the five internal organs, six bowels, four limbs, and nine orifices, supporting the yang energy of the whole body and dispelling deep-seated cold and dampness. The Compendium of Materia Medica states that it "can trigger the opening of the pores and pores of other herbs to expel wind and cold from the surface of the body."

[0013] The four herbs—cinnamon twig, atractylodes, angelica, and magnolia flower—are combined as assistant herbs to dispel cold, release the exterior, dry dampness, and open the nasal passages. Cinnamon twig opens the Taiyang meridian, relaxes the pores, regulates the Ying and Wei (nutritive and defensive qi), and unblocks the exterior and interior, acting as a "vanguard." Atractylodes and angelica enter the Yangming and Taiyin meridians, drying the spleen and eliminating dampness to stop nasal discharge, while also dispelling cold, releasing the exterior, and unblocking the channels between the exterior and interior, and between the upper and lower parts of the body. Magnolia flower specifically opens the nasal passages and dispels wind-cold, making it a specific herb for the main symptoms of nasal problems.

[0014] Combined with Acorus tatarinowii, Poria cocos, and ginger, this combination of three herbs dispels phlegm and dampness, strengthens the spleen, and warms and disperses phlegm-dampness. Acorus tatarinowii opens the orifices and resolves phlegm, effectively entering the lungs to transform cold phlegm and phlegm-dampness, while also resolving dampness and harmonizing the stomach. Poria cocos strengthens the spleen, eliminates dampness, separates clear from turbid, guides water from the chest downwards, and directs heart fire downwards to the kidneys, achieving a state of balance between water and fire in the body. Ginger assists the other herbs in relieving exterior symptoms and dispelling cold; it enters the lungs to warm and transform phlegm-dampness, and enters the spleen and stomach to warm and stop vomiting.

[0015] Prepared licorice root is used as an adjuvant, which can not only detoxify aconite poisoning, but also stabilize the spleen and harmonize the effects of other herbs.

[0016] This formula supports Yang Qi, clears the orifices and dispels cold, and warms and transforms phlegm and fluid retention. It is an effective formula for treating Yang deficiency and cold-induced rhinitis and lung and kidney Yang deficiency rhinitis.

[0017] Secondly, the present invention also provides a method for preparing a composition for treating allergic rhinitis, comprising the following steps:

[0018] (1) Prepared aconite root is decocted in water beforehand to obtain liquid 1;

[0019] (2) Add cinnamon twig, acorus tatarinowii, poria cocos, prepared licorice root and ginger to the medicinal liquid 1, continue to decoct, and after solid-liquid separation, obtain residue 1 and filtrate 1;

[0020] (3) The residue 1 was mixed with Angelica dahurica, Magnolia biondii and Atractylodes lancea, and decocted with water. After solid-liquid separation, filtrate 2 was obtained.

[0021] (4) Combine filtrate 1 and filtrate 2 to obtain the composition.

[0022] Furthermore, in step (1), the amount of water added is 4-10 times that of the prepared aconite root, and the decoction time is 30-60 minutes.

[0023] Furthermore, in step (2), the simmering time is 10-30 minutes.

[0024] Furthermore, in step (3), the simmering time is 10-30 minutes.

[0025] Thirdly, the present invention also provides a method for preparing another composition for treating allergic rhinitis, comprising the following steps:

[0026] (1) Prepared aconite root is decocted in water beforehand to obtain liquid 1;

[0027] (2) Add cinnamon twig, acorus tatarinowii, poria cocos, prepared licorice root and ginger to the medicinal liquid 1, continue to decoct, and separate the residue 1 and the filtrate 1.

[0028] (3) Angelica dahurica, Magnolia biondii and Atractylodes lancea were mixed and extracted by steam distillation to obtain volatile oil; the aqueous solution after distillation was separated into solid and liquid to obtain filter residue 2 and filtrate 2.

[0029] (4) Mix filter residue 1 and filter residue 2, add water and boil, and then separate to obtain filtrate 3;

[0030] (5) Combine filtrate 1, filtrate 2 and filtrate 3 and mix with volatile oil to obtain the composition.

[0031] Furthermore, in step (1), the amount of water added is 4-10 times that of the prepared aconite root, and the decoction time is 30-60 minutes.

[0032] Furthermore, in step (2), the simmering time is 10-30 minutes.

[0033] Furthermore, in step (3), the amount of water used in the steam distillation process is 4-10 times the total mass of Angelica dahurica, Magnolia biondii and Atractylodes lancea.

[0034] Furthermore, in step (4), the amount of water added is 3-8 times the total mass of filter residue 1 and filter residue 2, and the decoction time is 10-30 minutes.

[0035] Fourthly, the present invention also provides the use of any of the compositions described above or the compositions prepared by any of the preparation methods described above in the preparation of a medicament for treating allergic rhinitis.

[0036] Furthermore, the allergic rhinitis includes either the Yang deficiency and cold-induced rhinitis or the lung and kidney Yang deficiency rhinitis.

[0037] Fifthly, the present invention also provides a traditional Chinese medicine preparation for treating allergic rhinitis.

[0038] Furthermore, the traditional Chinese medicine preparation includes any of the compositions described above or the compositions prepared by any of the preparation methods described above, as well as any pharmaceutically acceptable excipients.

[0039] Furthermore, the dosage form of the traditional Chinese medicine preparation includes any one of tablets, granules, capsules, pills, mixtures, decoctions, and powders.

[0040] Compared with the prior art, the present invention has the following beneficial effects:

[0041] Through long-term clinical practice, it has been found that the pathogenesis of this disease mainly involves Yang deficiency with cold invasion, resulting in obstruction of the Taiyang meridian; spleen Yang deficiency with phlegm and fluid retention; and kidney Yang deficiency with insufficient essence and Qi. Treatment focuses on "warming Yang to release the exterior and clear the Taiyang meridian," while also incorporating the effects of "supporting Yang and regulating the middle Jiao, warming and invigorating the spleen" and "supporting Yang to build strength and replenish essence and transform Qi," combining these three methods. With supporting Yang as the guiding principle, the focus is on differentiating the location of the disease in the exterior and interior, the three Jiaos, and the Qi transformation functions of the lungs, spleen, and kidneys. The composition of this invention can work from the exterior to the interior, from top to bottom, clearing the lung orifices, improving the nasal cavity environment, enhancing the body's resistance to pathogens, improving the function of the middle Jiao, and ultimately helping to restore the body's original Yang and essence, fundamentally resolving AR, with outstanding clinical efficacy. Attached Figure Description

[0042] Figure 1 The results show the effect of the pharmaceutical composition of the present invention on nasal symptoms in AR rats;

[0043] Figure 2 The results show the effects of the pharmaceutical composition of the present invention on the pathological changes of the nasal mucosa in AR rats;

[0044] Figure 3 The results show the effect of the pharmaceutical composition of the present invention on the serum inflammatory factor levels in AR rats;

[0045] Figure 4 The results show the effects of the pharmaceutical composition of the present invention on the expression levels of RORγt, Foxp3, STAT3, p-STAT3, STAT5, and p-STAT5 proteins in the nasal mucosa of AR rats. Detailed Implementation

[0046] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0047] The Chinese herbal raw materials used in the comparative examples of this invention, namely, processed aconite root (batch number 20231101), cinnamon twig (batch number 20231001), atractylodes rhizome (batch number 20231102), angelica root (batch number 23110804), magnolia flower bud (batch number 20230601), acorus tatarinowii rhizome (batch number 23082302), poria cocos (batch number 20230301), prepared licorice root (batch number 20210308), fresh ginger, atractylodes macrocephala rhizome (batch number 23061702), saposhnikovia root (batch number 231101), cocklebur fruit (batch number 2303001), and agastache rugosa root (batch number 230803), were all provided by the pharmacy of Yulin Municipal Hospital of Traditional Chinese Medicine. The positive control drug, loratadine tablets, was produced by Henan Jiushili Pharmaceutical Co., Ltd. (batch number: National Drug Approval Number H20020174).

[0048] Example 1

[0049] A composition for treating allergic rhinitis, comprising the following ingredients: 3 parts prepared aconite root, 3 parts cinnamon twig, 3 parts atractylodes rhizome, 3 parts angelica root, 3 parts magnolia flower, 4 parts acorus tatarinowii rhizome, 3 parts poria cocos, 1 part prepared licorice root, and 6 parts fresh ginger.

[0050] The preparation method is as follows:

[0051] After crushing all raw materials, pass them through a 100-mesh sieve and set aside. Take prepared aconite root and decoct it for 1 hour with 4 times the amount of water. Then add cinnamon twig, acorus tatarinowii, poria cocos, prepared licorice root and ginger, and continue to decoct for 30 minutes. After filtration, obtain residue and filtrate 1. Mix the residue with angelica dahurica, magnolia flower and atractylodes lancea, add 3 times the amount of water and continue to decoct for 25 minutes. After filtration, obtain filtrate 2. Combine filtrate 1 and filtrate 2 to obtain the final product.

[0052] Example 2

[0053] A composition for treating allergic rhinitis, comprising the following ingredients: 2 parts processed aconite root, 4 parts cinnamon twig, 4 parts Atractylodes lancea rhizome, 4 parts Angelica dahurica root, 4 parts Magnolia biondii flower, 5 parts Acorus tatarinowii rhizome, 2 parts Poria cocos, 0.5 parts processed licorice root, and 4 parts fresh ginger. The preparation method is the same as in Example 1.

[0054] Example 3

[0055] A composition for treating allergic rhinitis, comprising the following ingredients: 4 parts processed aconite root, 2 parts cinnamon twig, 2 parts Atractylodes lancea rhizome, 2 parts Angelica dahurica root, 2 parts Magnolia biondii flower, 3 parts Acorus tatarinowii rhizome, 4 parts Poria cocos, 1.5 parts processed licorice root, and 8 parts fresh ginger. The preparation method is the same as in Example 1.

[0056] Example 4

[0057] A composition for treating allergic rhinitis, comprising the following ingredients: 1 part prepared aconite root, 5 parts cinnamon twig, 5 parts Atractylodes lancea rhizome, 1 part Angelica dahurica root, 1 part Magnolia biondii flower, 7 parts Acorus tatarinowii rhizome, 5 parts Poria cocos, 2 parts prepared licorice root, and 1 part fresh ginger. The preparation method is the same as in Example 1.

[0058] Example 5

[0059] A composition for treating allergic rhinitis, comprising the following ingredients: 5 parts processed aconite root, 1 part cinnamon twig, 1 part Atractylodes lancea rhizome, 4 parts Angelica dahurica root, 4 parts Magnolia biondii flower, 1 part Acorus tatarinowii rhizome, 1 part Poria cocos, 0.1 part processed licorice root, and 12.5 parts fresh ginger. The preparation method is the same as in Example 1.

[0060] Example 6

[0061] A composition for treating allergic rhinitis, comprising the following ingredients: 3 parts prepared aconite root, 3 parts cinnamon twig, 3 parts atractylodes rhizome, 3 parts angelica root, 3 parts magnolia flower, 4 parts acorus tatarinowii rhizome, 3 parts poria cocos, 1 part prepared licorice root, and 6 parts fresh ginger.

[0062] The preparation method is as follows:

[0063] After crushing all raw materials, pass them through a 100-mesh sieve and set aside. Take prepared aconite root and decoct it for 1 hour with 4 times the amount of water. Then add cinnamon twig, acorus tatarinowii, poria cocos, prepared licorice root, and ginger, and continue to decoct for 30 minutes. After filtration, obtain residue 1 and filtrate 1. Take angelica dahurica, magnolia biondii, and atractylodes lancea, add 5 times the amount of water, and extract by steam distillation. Collect the volatile oil. After solid-liquid separation, obtain residue 2 and filtrate 2. Mix residue 1 and residue 2, add 3 times the amount of water, and continue to decoct for 25 minutes. After filtration, obtain filtrate 3. Combine filtrate 1, filtrate 2, and filtrate 3 to obtain the final product.

[0064] Comparative Example 1

[0065] A composition for treating allergic rhinitis, comprising the following ingredients: 3 parts processed aconite root, 0.5 parts cinnamon twig, 0.5 parts Atractylodes lancea rhizome, 5.5 parts Angelica dahurica root, 5.5 parts Magnolia biondii flower, 4 parts Acorus tatarinowii rhizome, 3 parts Poria cocos, 1 part processed licorice root, and 6 parts fresh ginger. The preparation method is the same as in Example 1.

[0066] Comparative Example 2

[0067] A composition for treating allergic rhinitis, comprising the following ingredients: 9 parts processed aconite root, 1.5 parts cinnamon twig, 1.5 parts Atractylodes lancea rhizome, 1.5 parts Angelica dahurica root, 1.5 parts Magnolia biondii flower, 4 parts Acorus tatarinowii rhizome, 3 parts Poria cocos, 1 part processed licorice root, and 6 parts fresh ginger. The preparation method is the same as in Example 1.

[0068] Comparative Example 3

[0069] A composition for treating allergic rhinitis, differing from Example 1 only in that: Atractylodes lancea is replaced with an equal amount of Atractylodes macrocephala, and Acorus tatarinowii is replaced with an equal amount of Polygonum hydropiper; the specific ingredients are: 3 parts processed Aconitum carmichaelii, 3 parts Cinnamomum cassia, 3 parts Atractylodes macrocephala, 3 parts Angelica dahurica, 3 parts Magnolia biondii, 4 parts Polygonum hydropiper, 3 parts Poria cocos, 1 part processed Glycyrrhiza uralensis, and 6 parts fresh ginger.

[0070] The preparation method is as follows:

[0071] After crushing all raw materials, pass them through a 100-mesh sieve and set aside. Take prepared aconite root and decoct it for 1 hour with 4 times the amount of water. Then add cinnamon twig, atractylodes macrocephala, poria cocos, prepared licorice root and ginger, and continue to decoct for 30 minutes. After filtration, obtain residue and filtrate 1. Mix the residue with angelica dahurica, magnolia flower bud and atractylodes macrocephala, add 3 times the amount of water and continue to decoct for 25 minutes. After filtration, obtain filtrate 2. Combine filtrate 1 and filtrate 2 to obtain the final product.

[0072] Comparative Example 4

[0073] A composition for treating allergic rhinitis differs from Example 1 only in that: Atractylodes lancea, Angelica dahurica and Magnolia biondii are omitted, and Atractylodes macrocephala, Saposhnikovia divaricata and Xanthium sibiricum are added; the specific ingredients are: 3 parts processed Aconitum carmichaelii, 3 parts Cinnamomum cassia, 3 parts Atractylodes macrocephala, 3 parts Saposhnikovia divaricata, 3 parts Xanthium sibiricum, 4 parts Acorus tatarinowii, 3 parts Poria cocos, 1 part processed Glycyrrhiza uralensis and 6 parts fresh ginger.

[0074] The preparation method is as follows:

[0075] After crushing all raw materials, pass them through a 100-mesh sieve and set aside. Take prepared aconite root and decoct it for 1 hour with 4 times the amount of water. Then add cinnamon twig, acorus tatarinowii, poria cocos, prepared licorice root and ginger, and continue to decoct for 30 minutes. After filtration, obtain residue and filtrate 1. Mix the residue with atractylodes macrocephala, saposhnikovia divaricata and cocklebur, add 3 times the amount of water and continue to decoct for 25 minutes. After filtration, obtain filtrate 2. Combine filtrate 1 and filtrate 2 to obtain the final product.

[0076] Comparative Example 5

[0077] A composition for treating allergic rhinitis, differing from Example 1 only in that: Poria cocos is not added, and the amount of Acorus tatarinowii is increased accordingly; the raw materials are: 3 parts processed Aconitum carmichaelii, 3 parts Cinnamomum cassia, 3 parts Atractylodes lancea, 3 parts Angelica dahurica, 3 parts Magnolia biondii, 7 parts Acorus tatarinowii, 1 part processed Glycyrrhiza uralensis, and 6 parts fresh ginger.

[0078] The preparation method is as follows:

[0079] After crushing all raw materials, pass them through a 100-mesh sieve and set aside. Take prepared aconite root and decoct it for 1 hour with 4 times the amount of water. Then add cinnamon twig, acorus tatarinowii, prepared licorice root and ginger, and continue to decoct for 30 minutes. After filtration, obtain residue and filtrate 1. Mix the residue with angelica dahurica, magnolia flower and atractylodes lancea, add 3 times the amount of water and continue to decoct for 25 minutes. After filtration, obtain filtrate 2. Combine filtrate 1 and filtrate 2 to obtain the final product.

[0080] Comparative Example 6

[0081] A composition for treating allergic rhinitis differs from Example 1 only in that: Acorus tatarinowii is omitted, and the amount of Poria cocos is increased accordingly; the raw materials are: 3 parts processed Aconitum carmichaelii, 3 parts Cinnamomum cassia, 3 parts Atractylodes lancea, 3 parts Angelica dahurica, 3 parts Magnolia biondii, 7 parts Poria cocos, 1 part processed Glycyrrhiza uralensis, and 6 parts fresh ginger.

[0082] The preparation method is as follows:

[0083] After crushing each raw material, it is sieved through a 100-mesh sieve and set aside; take prepared aconite root and decoct it with 4 times the amount of water for 1 hour in advance; then add cassia twig, poria, roasted licorice root and ginger, and continue to decoct for 30 minutes. After filtration, filter residues and filtrate 1 are obtained. The filter residues are mixed with angelica dahurica, magnolia flower and atractylodes lancea, and decocted with 3 times the amount of water for 25 minutes. After filtration, filtrate 2 is obtained; combine filtrate 1 and filtrate 2 to obtain the product.

[0084] I. Pharmacodynamic experiment on allergic rhinitis model rats:

[0085] (1) Experimental animals:

[0086] SPF-grade SD rats, 4 - 5 weeks old, half male and half female, with a body weight of 140 - 180 g. They were purchased from Beijing SPF Biotechnology Co., Ltd., certificate number: SCXK (Beijing) 2019 - 0010. They were raised in the central laboratory of Yulin Traditional Chinese Medicine Hospital, temperature: 22 ± 3 °C, humidity: 45 ± 5%, with a 12-hour light / dark cycle. The rats had free access to water and food. All animal experiments in this study were conducted in accordance with the "Guide for the Care and Use of Laboratory Animals of the National Institutes of Health" and approved by the Ethics Committee of Yulin Traditional Chinese Medicine Hospital (Ethical number: YLZYYLL - 2022 - 006).

[0087] (2) Experimental drugs:

[0088] Preparation of the drug compositions prepared in Examples 1 - 6 and Comparative Examples 1 - 6: According to the daily adult dosage of 145 g of crude drug per person per day. Calculated based on the normal adult body weight of 60 kg, the clinical dosage is 145 g / 60 kg = 2.42 g of crude drug per kg. According to "Methodology of Traditional Chinese Medicine Pharmacological Research" edited by Chen Qi, the equivalent dose for rats was determined. The equivalent dose ratio for rats is 6.25, and the calculated daily clinical dosage for rats is 2.42 g of crude drug per kg × 6.25 = 15.13 g per kg as the equivalent dose (i.e., the medium dose). The low-dose group is 1 / 2 times the dose of the medium-dose group, which is 7.56 g per kg. The high-dose group is 2 times the dose of the medium-dose group, which is 30.26 g per kg;

[0089] Preparation of the positive control drug: According to the equivalent dose for rats, loratadine tablets were dissolved in sterile injection water to prepare a solution of 0.90 mg per kg. All the prepared drugs were stored in a 4 °C refrigerator for later use.

[0090] (3) Model establishment and grouped administration:

[0091] Rats were sensitized according to the "Guidelines for the Preparation of Animal Models of Allergic Rhinitis (Draft)". The sensitizing agent was 30 mg OVA dissolved in 100 mL of physiological saline, with 3 g of aluminum hydroxide [Al(OH)3] powder as an adjuvant. Except for the control group, other rats received basal sensitization via intraperitoneal injection of 1 mL every other day for a total of 7 days (days 1, 3, 5, 7, 9, 11, and 13). After basal sensitization, nasal challenge was performed: 0.05 mL of 2% OVA saline solution was instilled into each nostril once daily for a total of 7 days (days 15, 16, 17, 18, 19, 20, and 21). After successful model establishment, 1 g / L OVA was administered via nasal instillation every other day to maintain the model status.

[0092] Successful model establishment criteria: Timing was started 30 minutes after each OVA intranasal provocation in all modeled mice. The scoring criteria are shown in Table 1. Scores from the three evaluation methods were accumulated, and a total score ≥ 5 points was considered a successful model establishment.

[0093] Table 1 Scoring criteria for nasal symptoms in allergic rhinitis

[0094]

[0095] Rats that successfully developed the model were randomly divided into 16 groups: the model group, the positive control group, and the groups of Examples 1-6 and Comparative Examples 1-6. A blank control group was also included, with 10 rats in each group. During the treatment period (days 22-35), rats were administered oral gavage at a fixed time each day (1 hour before OVA nasal drops). The low-dose group of Example 1, the medium-dose group of Example 1, the high-dose group of Example 1, the high-dose group of Examples 2-6, and the high-dose group of Comparative Examples 1-6 were administered the drugs at the dosages described above. The blank control group and the model group were administered 10 mL / (kg·d) of sterile water by gavage; the loratadine group was administered 0.90 mg / kg of loratadine tablets in aqueous solution by gavage. The oral gavage volume for rats was 1 ml / 100 g, administered once daily for 14 days.

[0096] (4) Observation and detection indicators:

[0097] 4.1 After the last nasal instillation of OVA solution, the frequency or severity of sneezing, nose scratching, and runny nose symptoms in each group of rats within 30 minutes were observed and recorded. According to Table 1, these were scored as 0, 1, 2, and 3 points respectively, and the total score was recorded using the additive quantification method.

[0098] 4.2 After the last nasal instillation of OVA solution, the rats were anesthetized, and the abdominal wall was opened. 5 mL of blood was collected via the abdominal aorta. The blood was allowed to stand at room temperature for 2 hours, then centrifuged at 3000 rpm for 10 min. The supernatant was collected and stored at -80℃. Eight rats were randomly selected from each group, and the levels of inflammatory factors in the rat serum were detected by ELISA. The levels of OVA-sIgE, IL-17A, IL-6, IL-10, and IL-35 were measured in the retained serum.

[0099] 4.3 After blood collection, the rats were decapitated and euthanized. The fur on the head and face was quickly removed, and the mandible and teeth were separated to expose the skull. For subsequent tissue collection, a clean plastic wrap was laid on ice. The nasal bone was cut along the anterior midline to the midline of the forehead to expose the nasal septum. The nasal mucosa attached to the bilateral nasal septum and the lateral nasal cavity was quickly dissected. The rat nasal mucosa tissue was stored in cryovials. Two rats' nasal mucosa were taken from each group and directly fixed in 4% paraformaldehyde. Pathological changes in the nasal mucosa were observed using HE staining. The remaining 8 rats' nasal mucosa from each group were frozen in liquid nitrogen and stored at -80℃. Three rats from each group were randomly selected, and the expression levels of RORγt, Foxp3, STAT3, p-STAT3, STAT5, and p-STAT5 proteins in the rat nasal mucosa were detected by Western blotting.

[0100] All experimental results were statistically analyzed using SPSS 26.0 software and expressed as mean ± standard deviation. If homogeneity of variance was satisfied, one-way ANOVA was used; if variances were unequal, Dunnett's test was used, with P < 0.05 considered statistically significant.

[0101] (5) Experimental results:

[0102] 5.1 Effects of the pharmaceutical composition of the present invention on nasal symptoms and nasal mucosal pathological changes in AR rats

[0103] The total scores of nasal symptoms in each group of AR rats are shown in Table 2 and 2. Figure 1 Taking the pharmaceutical composition prepared in Example 1 as an example, the results of comparing the nasal pathological changes with the blank control group, model group, and positive control group are shown in the figure. Figure 2 .

[0104] Table 2. Symptom scores of rats after treatment (n=10)

[0105]

[0106] Note: Compared with the blank control group, # P < 0.05 ## P < 0.01; compared with the model group, $ P < 0.05 $$ P < 0.01; compared with the high-dose group in Example 1,& P < 0.05 && P < 0.01.

[0107] Depend on Figure 1 As shown in Table 2, within 30 minutes after the last OVA nasal provocation (day 35 of the experiment), rats in all groups exhibited varying degrees of nasal allergy symptoms. Compared with the control group, the behavioral scores of the model group rats were significantly higher (P < 0.01); compared with the model group, the behavioral scores of the low- and medium-dose groups of the drug composition in Example 1 of this invention were significantly lower (P < 0.05), and the behavioral scores of the high-dose group and the loratadine group were significantly lower (P < 0.01). This indicates that different concentrations of Fuyang Tongqiao Formula have varying degrees of alleviating effects on nasal itching, sneezing, and runny nose symptoms in AR rat models, and the effect increases with increasing drug concentration. The behavioral scores of other groups of rats at high doses of each drug composition also showed varying degrees of reduction, indicating varying degrees of relief from nasal allergy symptoms. However, overall, the total symptom scores of rats in each example group were lower than those in each comparative group; compared with the high-dose group of Example 1, the behavioral scores of rats in each comparative group were significantly higher (P < 0.01 or P < 0.05).

[0108] Depend on Figure 2 It can be seen that: in the blank control group, the nasal mucosa tissue structure of rats was intact, the epithelial cells were arranged regularly without obvious proliferation, the mucosal cilia were continuous, intact and neatly arranged, and there was no obvious necrotic cell shedding, eosinophil infiltration and goblet cell proliferation. In the model group and the low-dose group of Example 1, the nasal mucosa tissue structure of rats was significantly damaged, the epithelial cells were significantly proliferated and arranged disorderly, the mucosal cilia were shed, and some necrotic shed cells and inflammatory cell infiltration were visible. The submucosa showed dilation of surrounding glands and vascular congestion and edema. In the loratadine group and the high-dose group of Example 1, the structure of each layer of the nasal mucosa of rats was basically normal, the epithelial cell proliferation was not obvious, a small amount of cilia were shed, some blood vessels were dilated and congested, and there was no obvious goblet cell production and eosinophil infiltration. In the medium-dose group of Example 1, the mucosa layers were basically intact, some cilia were shed, and the mucosal congestion and edema were improved compared with the model group. No obvious necrotic shedding and inflammatory cell infiltration were observed.

[0109] 5.2 Effect of the pharmaceutical composition of the present invention on the serum inflammatory factor levels in AR rats

[0110] The results of serum inflammatory factor levels in AR rats in each group are shown in Table 3 and Figure 3 .

[0111] Table 3. Results of serum inflammatory factor levels in rats after treatment (n=8)

[0112]

[0113] Note: Compared with the blank control group, #P<0.05, ##P<0.01; compared with the model group, $P<0.05, $$P<0.01; compared with the high-dose group of Example 1, &P<0.05, &&P<0.01.

[0114] Depend on Figure 3 As shown in Table 3, compared with the blank control group, the serum OVA-sIgE content in the model group rats was significantly increased (P<0.05), the levels of pro-inflammatory factors IL-17A and IL-6 were significantly increased (P<0.05), while the levels of anti-inflammatory factors IL-10 and IL-35 were significantly decreased (P<0.05), indicating that the AR rat model sensitized by OVA was successfully established.

[0115] Compared with the model group, the high-dose group in Example 1, the high-dose group in Examples 2-6, and the positive control group of this invention all reduced serum OVA-sIgE, IL-17A, and IL-6, and increased the concentrations of IL-10 and IL-35. P <0.01), indicating that the composition of the present invention can effectively regulate the serum inflammatory factor levels in OVA-sensitized AR rats.

[0116] Compared with the high-dose group in Example 1, the reduction in OVA-sIgE, IL-17A, and IL-6 and the increase in IL-10 and IL-35 in the serum of rats in Comparative Examples 1-6 were significantly worse (P<0.05 or P<0.01).

[0117] 5.3 Effects of the pharmaceutical composition of the present invention on the expression of RORγt, Foxp3, STAT3, p-STAT3, STAT5, and p-STAT5 proteins in the nasal mucosa of AR rats

[0118] The pathogenesis of acute rhinitis (AR) is closely related to the imbalance of Th17 / Treg cells. Western blot analysis was performed on key proteins of the Foxp3 / STAT5 and RORγt / STAT3 pathways, which are closely related to this pathway. The expression results of RORγt, Foxp3, STAT3, p-STAT3, STAT5, and p-STAT5 proteins in the nasal mucosa of AR rats in each group are shown in Table 4. Figure 4 .

[0119] Table 4. RORγt, Foxp3, STAT3, p-STAT3, STAT5, and p-STAT5 proteins in the nasal mucosa of rats after treatment.

[0120] Relative expression level (n=3)

[0121]

[0122] Note: Compared with the blank control group,# P < 0.05 ## P < 0.01; compared with the model group, $ P < 0.05 $$ P < 0.01; compared with the high-dose group in Example 1, & P < 0.05 && P < 0.01.

[0123] Depend on Figure 4 As shown in Table 4, compared with the blank group, the expression of RORγt and p-STAT3 proteins in the nasal mucosa tissue of the model group rats was significantly increased; while the expression of Foxp3 and p-STAT5 proteins was significantly decreased (P<0.01), indicating that the AR rat model sensitized by OVA was successfully established, leading to the imbalance of Th17 / Treg cells.

[0124] Compared with the model group, the high-dose group in Example 1, the high-dose group in Examples 2-6, and the positive control group of this invention all showed varying degrees of upregulation and downregulation of RORγt and p-STAT3 protein expression; while upregulating Foxp3 and p-STAT5 protein expression. Furthermore, the p-STAT3 / STAT3 phosphorylated protein ratio was significantly decreased, and the p-STAT5 / STAT5 phosphorylated protein ratio was significantly increased.

[0125] Compared with the high-dose group in Example 1, the rat nasal mucosa of Comparative Groups 1-6 showed poor downregulation of RORγt and p-STAT3 protein expression and poor upregulation of Foxp3 and p-STAT5 protein expression, with significant differences (P < 0.05 or P < 0.01).

[0126] In summary, it can be inferred that the composition of the present invention regulates the expression of a series of inflammatory factors and proteins by inhibiting the RORγt / STAT3 signaling pathway and promoting the Foxp3 / STAT5 signaling pathway. Through this dual regulatory effect, it corrects the immune imbalance of Th17 / Treg cells, which is an important molecular mechanism for its treatment of AR.

[0127] II. Clinical Trials:

[0128] (1) General information of the subjects: Ninety patients with lung and kidney yang deficiency type allergic rhinitis who visited Yulin Traditional Chinese Medicine Hospital from May 2024 to May 2025 were selected and randomly divided into a treatment group and a control group using opaque sealed envelopes, with 45 cases in each group; the treatment group consisted of 23 males and 22 females, aged 18 to 56 years, with a mean age of (35.36±9.51) years and a disease duration of 0.5 to 20 years; the control group consisted of 21 males and 24 females, aged 19 to 63 years, with a mean age of (37.29±11.56) years and a disease duration of 1 to 20 years. There were no significant differences in general information between the groups ( P(>0.05), indicating comparability. This study was approved by the Ethics Committee of Yulin Municipal Hospital of Traditional Chinese Medicine, ethics review approval number: YLZYYLL-2024—KY-004.

[0129] (2) Diagnostic criteria: The criteria were formulated with reference to the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022, Revised Edition)," "Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Otorhinolaryngology," and "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine."

[0130] (3) Treatment methods: The treatment group was given the pharmaceutical composition prepared in Example 1 of this invention; the control group was given loratadine tablets (Yangtze River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd., National Drug Approval Number H20080134, specification: 10mg×12 tablets) orally, once a day, 10mg each time. The medicine was provided by the pharmacy of the East Branch of Yulin Traditional Chinese Medicine Hospital. Both groups were treated for 4 weeks. During the treatment period, all patients were instructed to: ① Go to bed early and get up early, keep warm, exercise moderately, and avoid raw and cold foods. ② Wash the nasal cavity with tap water every morning, once a day, for 1-2 minutes each time.

[0131] (4) Clinical efficacy criteria: Determined according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" and the "Principles and Recommendations for the Diagnosis and Treatment of Allergic Rhinitis (2004, Lanzhou)". The percentage reduction in TCM syndrome score (N) is calculated as: N = [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100%. Cure: Symptoms and signs basically disappear, N ≥ 90%; Significant improvement: Symptoms and signs significantly alleviated, N ≥ 66%; Effective: Symptoms and signs improved, N ≥ 26%; Ineffective: Symptoms and signs not alleviated, N ≤ 25%. Total effective rate = (Cure + Significant improvement + Effective) / Total number of cases × 100%.

[0132] (5) Clinical trial results:

[0133] The clinical efficacy is shown in Table 5. It can be seen that the total effective rate of the treatment group was 88.89%, which was better than that of the control group (71.11%), and the difference was significant (P<0.05).

[0134] Table 5 Comparison of clinical efficacy (n (%))

[0135]

[0136] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for treating allergic rhinitis, characterized by comprising, According to the weight parts, it is composed of the following raw materials: 1-5 parts of prepared aconite, 1-5 parts of cassia twig, 1-5 parts of Chinese artichoke, 1-5 parts of Baizhi, 1-5 parts of Xinyi, 1-7 parts of Acorus gramineus, 1-5 parts of Heushen, 0.1-2 parts of fried licorice, 1-13 parts of ginger.

2. The composition of claim 1, wherein, According to the weight parts, it is composed of the following raw materials: 2-4 parts of prepared aconite, 2-4 parts of cassia twig, 2-4 parts of Chinese artichoke, 2-4 parts of Baizhi, 2-4 parts of Xinyi, 3-5 parts of Acorus gramineus, 2-4 parts of Heushen, 0.5-1.5 parts of fried licorice, 4-8 parts of ginger.

3. The composition of claim 1, wherein, According to the weight parts, it is composed of the following raw materials: 3 parts of prepared aconite, 3 parts of cassia twig, 3 parts of Chinese artichoke, 3 parts of Baizhi, 3 parts of Xinyi, 4 parts of Acorus gramineus, 3 parts of Heushen, 1 part of fried licorice, 6 parts of ginger.

4. Process for the preparation of a composition according to any one of claims 1 to 3, characterized in that, It comprises the following steps: (1) Pre-cook prepared aconite with water to obtain medicinal liquid 1; (2) Add cassia twig, Acorus gramineus, Heushen, fried licorice and ginger to medicinal liquid 1, continue to cook, and separate to obtain filter residue 1 and filter liquid 1; (3) Mix filter residue 1, Baizhi, Xinyi and Chinese artichoke, and cook with water, and separate to obtain filter liquid 2; (4) Combine filter liquid 1 and filter liquid 2 to obtain the composition.

5. The preparation method according to claim 4, characterized in that, In step (1), the amount of water added is 4-10 times the amount of prepared aconite, and the cooking time is 30-60 min; and / or in step (2), the cooking time is 10-30 min; and / or in step (3), the cooking time is 10-30 min.

6. Process for the preparation of a composition according to any one of claims 1 to 3, characterized in that, It comprises the following steps: (1) Pre-cook prepared aconite with water to obtain medicinal liquid 1; (2) Add cassia twig, Acorus gramineus, Heushen, fried licorice and ginger to medicinal liquid 1, continue to cook, and separate to obtain filter residue 1 and filter liquid 1; (3) Mix Baizhi, Xinyi and Chinese artichoke, and extract with steam distillation to obtain volatile oil; separate the water solution after distillation to obtain filter residue 2 and filter liquid 2; (4) Mix filter residue 1 and filter residue 2, and cook with water, and separate to obtain filter liquid 3; (5) Combine filter liquid 1, filter liquid 2 and filter liquid 3, and mix with volatile oil to obtain the composition.

7. The production method according to claim 6, wherein In step (1), the amount of water added is 4-10 times the amount of prepared aconite, and the cooking time is 30-60 min; and / or in step (2), the cooking time is 10-30 min; and / or in step (3), the amount of water used in the steam distillation process is 4-10 times the total mass of Baizhi, Xinyi and Chinese artichoke; and / or in step (4), the amount of water added is 3-8 times the total mass of filter residue 1 and filter residue 2, and the cooking time is 10-30 min.

8. Use of the composition of any one of claims 1-3 or the composition prepared by the method of any one of claims 4-7 in the preparation of a medicament for treating allergic rhinitis.

9. Use according to claim 8, characterized in that, The allergic rhinitis is lung-kidney yang deficiency type rhinitis.

10. A traditional Chinese medicine preparation for treating allergic rhinitis, characterized in that, The composition of any one of claims 1-3 or the composition prepared by the method of any one of claims 4-7, and any pharmaceutically acceptable adjuvant; The dosage form of the traditional Chinese medicine preparation includes any one of tablets, granules, capsules, pills, mixtures, decoctions and powders.

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