Medicinal patch needle for preventing and treating allergic rhinitis as well as preparation method and application of medicinal patch needle

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a medicine patch needle for preventing and treating allergic rhinitis and a preparation method and application thereof. The medicine patch needle mainly comprises a traditional Chinese medicine composition and a medicine patch thumbtack needle, and the traditional Chinese medicine composition is prepared from, by weight, 30-60 parts of radix astragali, 15-30 parts of radix angelicae sinensis, 10-25 parts of radix saposhnikoviae, 10-30 parts of rhizoma atractylodis, 10-30 parts of rhizoma acori graminei, 5-15 parts of herba asari, 10-30 parts of rhizoma chuanxiong, 10-20 parts of radix angelicae and 1-5 parts of borneol. The medicine needle patch can be used for preventing and treating allergic rhinitis, mild and lasting acupuncture stimulation is achieved on the skin part of the acupoint, the medicine can rapidly enter the acupoint along with the needle hole, in other words, the acupoint achieves the effects of harmonizing qi and blood, relieving stuffy nose and removing pathogenic qi under the dual action of the acupuncture stimulation and the medicine, and the medicine needle patch has the remarkable preventing and treating effect on the allergic rhinitis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a medicated patch for the prevention and treatment of allergic rhinitis, its preparation method, and its application. Background Technology

[0002] Allergic rhinitis, also known as hay fever, is a chronic, nonspecific inflammatory disease of the nasal mucosa characterized by nasal itching, congestion, sneezing, and runny nose. It is mediated by immunoglobulin E (IgE) and type 2 helper T cells (Th2). The nasal and ocular symptoms can lead to a range of problems, including sleep disturbances, irritability, depression, and decreased attention and memory, severely impacting not only the patient's physical and mental well-being but also increasing the economic burden on individuals and society.

[0003] The pathological characteristics of allergic rhinitis indicate that glandular secretion or vascular leakage increases in the pathological state of the nasal mucosa. In particular, long-term exposure to allergens may induce insensitivity or resistance to lipid-soluble glucocorticoids. This has led modern medicine to use local administration as the first-line drug, avoiding many of the shortcomings of oral administration in the treatment of this disease.

[0004] In a sense, acupoints are like "windows" to the internal organs on the body surface, reflecting symptoms in pathological states. Guided by traditional Chinese medicine theory, TCM scholars have attempted to apply drugs to acupoints, i.e., local drug administration via acupoint injection. This therapy not only enriches the treatment methods of TCM but also provides a new route of drug delivery for modern medicine.

[0005] A search revealed that Chinese invention patent CN117018126A discloses a traditional Chinese medicine formula for treating allergic rhinitis, sinusitis, nasal polyps, adenoid hypertrophy, and turbinate hypertrophy. The formula is characterized by the following ingredients in parts by weight: 2-6g artificial musk, 10-20g magnolia flower, 20-35g cocklebur fruit, 10-15g chuanxiong rhizome, 10-18g lindera root, 10-18g chrysanthemum flower, 20-25g mugwort leaf, 10-25g scutellaria root, 10-25g acorus tatarinowii rhizome, 10-25g angelica dahurica root, and hibiscus flower. 20-35g of Cistanche deserticola leaves, 10-25g of Platycodon grandiflorus, 10-15g of Bambusa textilis, 10-15g of Dioscorea nipponica, 10-15g of Inula japonica, 20-35g of Artemisia capillaris, 10-25g of Pogostemon cablin, 10-25g of Eupatorium fortunei, 25-40g of Codonopsis pilosula, 10-15g of Boswellia carterii, 10-15g of Commiphora myrrha, 10-25g of Bletilla striata, 10-15g of Dracaena cochinchinensis, 25-40g of Pseudostellaria heterophylla, 25-40g of Panax ginseng, 55-65g of Astragalus membranaceus, 5-12g of Gleditsia sinensis, 5-12g of Asarum heterotropoides, 25- 40g, Red Peony Root 20-35g, Safflower 8-12g, Angelica Root 25-40g, Cinnamon Twig 20-35g, Saposhnikovia Root 20-35g, Dendrobium Root 20-35g, Dalbergia odorifera 10-15g, Amaranthus 25-40g, Iron-clad Gold 20-35g, Underground Pearl 15-25g, Piglet 10-25g, Antrodia Camphorata 8-12g, Dictamnus Root Bark 8-12g, Pseudobulbus Cremastrae 8-12g, Red Lady Root 10-25g, Golden Sparrow Root 12-18g, King of Songs 10-15g, American Cockroach 25- 40g, Kava 5-12g, Tongguanteng 20-35g, Kuanjinteng 20-35g, Baiyaozi 10-25g, Dafengzi 10-25g, Dujiaogan 18-25g, Shedui 5-8g, Chansu 2-5g, Longgu 20-35g, Muli 20-35g, Zishaohua 20-35g, Hailong 5-12g, Shuizhi 5-12g, Quanxie 4-8g, Wugong 4-8, Chaozaoren 20-35g, Sangpiaoxiao 8-12g, Bingpian 10-15g, Menthol 8-12g. This invention can effectively treat nasal polyps, allergic rhinitis, sinusitis, adenoid hypertrophy, and other diseases, and has multiple effects such as anti-allergy, anti-inflammatory, vasodilator, swelling reduction and hemostasis, immune system regulation, analgesia, and nerve soothing.

[0006] Chinese utility model patent ZL202222964788.0 discloses a medicated patch press needle, which describes a blank medicated patch containing vitamin B12 or as needed according to specific conditions.

[0007] To improve clinical efficacy and highlight the clinical advantages of acupuncture and acupoint drug administration, thereby producing stable and lasting acupuncture stimulation and drug pharmacological effects, and maximizing the stimulation of meridian qi and blood and regulating organ function, it is necessary to scientifically and organically combine the two. This is also a new method of local treatment for allergic rhinitis proposed in this invention, so as to achieve more significant and efficient clinical prevention and treatment effects. Summary of the Invention

[0008] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a medicated patch for the prevention and treatment of allergic rhinitis, its preparation method and application. By combining the press-fit needle body and the medicated patch, a new attempt is made to locally prevent and treat allergic rhinitis, thereby exerting the effects of regulating qi and blood, clearing nasal passages and dispelling pathogenic factors, and has a significant preventive and therapeutic effect on allergic rhinitis.

[0009] To achieve the above-mentioned objectives, the technical solution of this invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis, which, by weight, consists of the following raw materials: 30-60 parts of Astragalus membranaceus, 15-30 parts of Angelica sinensis, 10-25 parts of Saposhnikovia divaricata, 10-30 parts of Atractylodes lancea, 10-30 parts of Acorus tatarinowii, 5-15 parts of Asarum heterotropoides, 10-30 parts of Ligusticum chuanxiong, 10-20 parts of Angelica dahurica, and 1-5 parts of Borneol.

[0010] In some specific embodiments of the present invention, a traditional Chinese medicine composition for preventing and treating allergic rhinitis is composed of the following raw materials in parts by weight: In some specific embodiments of the present invention, a traditional Chinese medicine composition for preventing and treating allergic rhinitis is composed of the following raw materials in parts by weight: 30 parts of Astragalus membranaceus, 20 parts of Angelica sinensis, 15 parts of Saposhnikovia divaricata, 15 parts of Atractylodes lancea, 20 parts of Acorus tatarinowii, 6 parts of Asarum heterotropoides, 20 parts of Ligusticum chuanxiong, 15 parts of Angelica dahurica, and 2 parts of Borneol.

[0011] In some specific embodiments of the present invention, a traditional Chinese medicine composition for preventing and treating allergic rhinitis is composed of the following raw materials by weight: 60 parts of Astragalus membranaceus, 30 parts of Angelica sinensis, 25 parts of Saposhnikovia divaricata, 30 parts of Atractylodes lancea, 30 parts of Acorus tatarinowii, 15 parts of Asarum heterotropoides, 30 parts of Ligusticum chuanxiong, 20 parts of Angelica dahurica, and 5 parts of Borneol. In some specific embodiments of the present invention, a traditional Chinese medicine composition for preventing and treating allergic rhinitis is composed of the following raw materials in parts by weight: 30 parts of Astragalus membranaceus, 15 parts of Angelica sinensis, 10 parts of Saposhnikovia divaricata, 10 parts of Atractylodes lancea, 10 parts of Acorus tatarinowii, 5 parts of Asarum heterotropoides, 10 parts of Ligusticum chuanxiong, 10 parts of Angelica dahurica, and 1 part of Borneol.

[0012] Secondly, the present invention provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: (1) Mix Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, pulverize them to obtain drug powder; (2) Mix the drug powder with borneol and grind it into a fine powder.

[0013] In some specific embodiments of the present invention, after pulverization in step (1), the material is passed through a 50-70 mesh sieve, preferably a 60 mesh sieve.

[0014] In some specific embodiments of the present invention, after grinding into fine powder in step (2), the powder is passed through a 70-90 mesh sieve, preferably an 80 mesh sieve.

[0015] Thirdly, the present invention provides a medicated patch for preventing and treating allergic rhinitis, comprising the aforementioned traditional Chinese medicine composition and a medicated patch press needle, wherein the medicated patch press needle comprises a needle body, a medicated layer, and an adhesive layer.

[0016] The medicated patch needle can be any commercially available product, a product that implements the function of the medicated patch needle of this invention, or the medicated patch needle defined in this invention.

[0017] In some specific embodiments of the present invention, the adhesive layer is located on the outer periphery of the drug-containing layer, and the needle body passes through the adhesive layer and the drug-containing layer sequentially from bottom to top; the drug-containing layer includes an absorbent pad.

[0018] In some specific embodiments of the present invention, the absorbent pad is a non-woven fabric with a polymer release film attached or a pure cotton webbing with a polymer release film attached.

[0019] Preferably, the adhesive layer is a silicone gel tape coated with adhesive, a spunlace nonwoven fabric, or an elastic spandex fabric.

[0020] Preferably, the needle body is a press needle-like needle body.

[0021] Preferably, the drug-containing layer further includes a protective film, which is used to prevent adhesion and allow the drug to pass through smoothly.

[0022] The protective film can be made of medical-grade polyethylene (PE), polypropylene (PP) or polyester (PET) film, or medical-grade polyurethane (PU) material can also be used.

[0023] In some specific embodiments of the present invention, the medicated patch is divided into a children's type and an adult type, and the diameter of the medicated layer in the children's type is 2-10mm.

[0024] In some specific embodiments of the present invention, the diameter of the adult-sized drug-containing layer is 10-20 mm.

[0025] Preferably, the size of the drug-containing layer is adapted to both children's and adult types, with diameters ranging from 2-7 mm (children's type) and 6-16 mm (adult type), respectively.

[0026] In some specific embodiments of the present invention, the length of the pediatric needle body is 0.8-1.5 mm, and the length of the adult needle body is 1.5-2.5 mm.

[0027] Preferably, the diameter of the needle body is 0.2-0.25 mm.

[0028] Preferably, the size of the needle body is adapted to both children's and adult types, with the following specifications (needle body diameter × needle body length): 0.2-0.25mm × 0.8-1.5mm (children's type) and 0.2-0.25mm × 1.5-2.5mm (adult children's type).

[0029] Fourthly, the present invention provides a method for preparing the aforementioned medicated needle patch, comprising the following steps: uniformly applying a traditional Chinese medicine composition onto an absorbent pad, and covering the surface with a protective film; then fixing the drug-containing layer containing the traditional Chinese medicine composition onto an adhesive layer; and passing the needle through the adhesive layer and the drug-dispensing layer sequentially from bottom to top to form the medicated needle patch.

[0030] Furthermore, after the medicated needle patch is assembled, it undergoes EO sterilization treatment, is sealed and packaged as a sterile medicated needle patch, and can only be used once. The use process should be carried out in accordance with standard operating procedures, and reuse is prohibited.

[0031] Fifthly, the present invention provides the application of the traditional Chinese medicine composition described herein, or the traditional Chinese medicine composition prepared by the preparation method described herein, or the medicated needle patch described herein, or the medicated needle patch prepared by the preparation method described herein, in the preparation of products for the prevention and treatment of allergic rhinitis.

[0032] Preferably, the allergic rhinitis is mild to moderate allergic rhinitis.

[0033] Preferably, the prevention and treatment of allergic rhinitis includes improving DAI score and spleen index, improving immunoglobulin E (IgE) level, improving the levels of inflammatory factors IFN-γ, IL-4, IL-10 and IL-17 in the inflammatory response, and has a significant ameliorative effect on pathological changes in the nasal mucosa.

[0034] In clinical practice of traditional Chinese medicine, attention should be paid to the key pathogenesis of diseases. The key pathogenesis of allergic rhinitis can be summarized as "evil invading the lung and wei, and nasal obstruction". Therefore, the key to its treatment is to "strengthen the lung and wei, expel evil qi, and clear the nasal passages to achieve the effects of relieving itching and pain". This invention is based on this.

[0035] The pathogenesis of allergic rhinitis in traditional Chinese medicine can be summarized as "weak lung defense, stagnation of pathogenic factors, and obstruction of nasal passages". Therefore, the key to its treatment is to "strengthen the lung defense, harmonize qi and blood, dispel pathogenic factors, and clear nasal passages to achieve the effects of relieving itching and pain". The Chinese medicine composition contained in the medicated layer of this medicated patch is designed based on this principle.

[0036] Astragalus membranaceus, sweet and warm in nature, is a holy medicine for tonifying qi. It can benefit qi, strengthen the exterior, promote detoxification, and drain pus, and is good at strengthening the qi of the lung and wei qi. Saposhnikovia divaricata, pungent and sweet, has the effects of dispelling wind, relieving spasms, eliminating dampness, and relieving itching. It can expel pathogens through the pores. Astragalus membranaceus is tonifying while Saposhnikovia divaricata is dispersing. When used together, they combine tonification and dispersion, which can strengthen the lung and wei qi and expel pathogens. Atractylodes lancea has a strong flavor and can dry dampness and resolve phlegm. It is fragrant and can dispel foulness to overcome the abnormal qi of the four seasons. Acorus tatarinowii and Asarum heterotropoides promote qi and open the pores. Angelica dahurica is fragrant and can open the pores, relieve pain, reduce swelling and drain pus, which is exactly the symptoms of nasal diseases. Angelica sinensis and Ligusticum chuanxiong nourish blood and moisten dryness, resolve blood stasis and promote qi circulation to help strengthen the lungs and open the pores. Borneol is pungent and cool. It is fragrant and can disperse. It first enters the lungs, then spreads to the heart and spleen and penetrates the bones. It opens the pores, disperses stagnant fire, reduces swelling and relieves pain to alleviate the stagnant fire of long-term nasal diseases, and can also reduce the warming nature of the formula. The formula is meticulously formulated to harmonize Qi and blood, clear nasal passages, and dispel pathogenic factors.

[0037] The combination of the drug-containing layer and the press-needle-like body aligns with the concept of "needles assisting medicine, and medicine supporting needles." The immediate effect of acupuncture at acupoints can quickly relieve symptoms, while the medicine can penetrate rapidly through the needle puncture channels, thus enhancing the efficacy of the medicine and prolonging the clinical effect. The combination of medicine and acupuncture stimulates the orderly flow of Qi and blood in the meridians, thereby achieving a significant effect of treating both the symptoms and the root cause of allergic rhinitis, which is characterized by nasal itching, nasal congestion, sneezing, runny nose, and even nasal pain and headache.

[0038] The beneficial effects of this invention are as follows: (1) The medicated needle patch of the present invention is mainly composed of three parts: a medicated layer, a press needle-like needle body and an adhesive layer. It is designed for children and adults, is convenient to use and has outstanding therapeutic effect.

[0039] (2) The medicated patch of the present invention contains a traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis. The composition is made by combining specific medicinal materials such as Astragalus membranaceus, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Angelica dahurica, Angelica sinensis, Ligusticum chuanxiong and borneol in a specific ratio to achieve synergistic effect. The formula is precise and effective. Compared with other combinations of medicinal ingredients with similar effects, the prevention and treatment effect of allergic rhinitis is more significant.

[0040] (3) The medicated acupuncture patch of the present invention is based on the key pathogenesis of allergic rhinitis. It combines the effects of drugs and acupuncture to exert a synergistic effect, which can significantly improve the inflammatory response and the pathological state of the nasal mucosa. It has the effects of harmonizing qi and blood, clearing the nasal passages, and dispelling pathogenic factors. It includes improving DAI score and spleen index, improving immunoglobulin E (IgE) level, effectively controlling the levels of inflammatory factors IFN-γ, IL-4, IL-10 and IL-17 in the inflammatory response, and having a significant effect on the pathological changes of the nasal mucosa. Attached Figure Description

[0041] Figure 1 This is a schematic diagram of the structure of the medicated patch press needle, where 1-needle body, 2-medicated layer, and 3-adhesive layer.

[0042] Figure 2 These are microscopic images of H&E-stained nasal mucosa from different groups of rats.

[0043] Figure 3 Microscopic images of toluidine blue stained nasal mucosa from different groups of rats. Detailed Implementation

[0044] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of protection claimed in this application.

[0045] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention were obtained through conventional commercial means. Unless otherwise specified, all contents mentioned below are mass contents. Unless otherwise specified, it is understood that the process was carried out at room temperature.

[0046] Example 1 This invention provides a traditional Chinese medicine composition, which, by weight, consists of the following ingredients: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Saposhnikovia divaricata, 15 parts Atractylodes lancea, 20 parts Acorus tatarinowii, 6 parts Asarum heterotropoides, 20 parts Ligusticum chuanxiong, 15 parts Angelica dahurica, and 2 parts Borneol.

[0047] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: (1) Mix eight herbs, including Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, and then pulverize them and pass them through a 60-mesh sieve to obtain the drug powder; (2) Mix the drug powder with borneol, grind them into a fine powder, and pass them through an 80-mesh sieve to obtain the final product.

[0048] The present invention also provides a medicated acupuncture patch, which consists of a traditional Chinese medicine composition and a medicated patch press needle. A schematic diagram of the structure of the medicated patch press needle is shown below. Figure 1 .

[0049] The preparation of the medicated acupuncture patch is as follows: The obtained powder was evenly spread on an absorbent pad to form a 4mm diameter drug-containing layer. A protective film was applied to the surface to prevent adhesion and allow the drug to pass through smoothly. The outer periphery of the drug-containing patch was an elastic adhesive layer, and a 0.2mm × 1.0mm press-fit needle was inserted through the center, finally forming an 8mm diameter drug-filled patch. This press-fit needle was then stored in a plastic needle box, sealed, and sterilized.

[0050] The absorbent pad is a non-woven fabric with a polymer release film attached; the adhesive layer is a silicone gel tape coated with adhesive; the needle is a snap-on needle; and the protective film is a medical-grade polyethylene (PE) film.

[0051] Example 2 This invention provides a traditional Chinese medicine composition, which, by weight, comprises the following components: Astragalus membranaceus 60 parts, Angelica sinensis 30 parts, Saposhnikovia divaricata 25 parts, Atractylodes lancea 30 parts, Acorus tatarinowii 30 parts, Asarum heterotropoides 15 parts, Ligusticum chuanxiong 30 parts, Angelica dahurica 20 parts, and Borneol 5 parts.

[0052] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: (1) Mix eight herbs, including Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, and then pulverize them and pass them through a 60-mesh sieve to obtain the drug powder; (2) Mix the drug powder with borneol, grind them into a fine powder, and pass them through an 80-mesh sieve to obtain the final product.

[0053] The present invention also provides a medicated acupuncture patch, which is prepared as follows: The powder obtained in Example 2 was evenly spread on an absorbent pad to form a 15mm diameter drug-containing layer. A protective film (medical-grade polyethylene (PE) film) was applied to the surface to prevent adhesion and allow for smooth drug penetration. The outer periphery of the medicated patch had an elastic adhesive layer, and a 0.25mm × 2.5mm press-fit needle was inserted through the center, ultimately forming a 20mm diameter medicated patch. This press-fit needle was then stored in a plastic needle box, sealed, and sterilized.

[0054] Example 3 This invention provides a traditional Chinese medicine composition, which, by weight, comprises the following ingredients: Astragalus membranaceus 30 parts, Angelica sinensis 15 parts, Saposhnikovia divaricata 10 parts, Atractylodes lancea 10 parts, Acorus tatarinowii 10 parts, Asarum heterotropoides 5 parts, Ligusticum chuanxiong 10 parts, Angelica dahurica 10 parts, and Borneol 1 part.

[0055] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: (1) Mix eight herbs, including Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, and then pulverize them and pass them through a 60-mesh sieve to obtain the drug powder; (2) Mix the powder with borneol, grind them into a fine powder, and pass them through an 80-mesh sieve to obtain the final product.

[0056] This invention provides a medicated acupuncture patch, prepared as follows: The obtained medicinal powder was evenly applied to an absorbent pad to form a medicated layer with a diameter of 10 mm. A protective film (medical-grade polyethylene (PE) film) was covered on the surface to prevent adhesion and allow the drug to pass through smoothly. The periphery of the medicated patch was an elastic adhesive layer, and a press needle-like needle body with a size of 0.22 mm × 1.5 mm passed through the middle. Finally, a medicated needle patch with a diameter of 15 mm was made. Then, this press needle was stored in a plastic needle box, sealed, and disinfected.

[0057] Comparative Example 1 In this comparative example, the formula of the traditional Chinese medicine composition was as follows by weight: 15 parts of Saposhnikovia divaricata, 15 parts of Atractylodes lancea, 20 parts of Acorus tatarinowii, 6 parts of Asarum sieboldii, 20 parts of Ligusticum chuanxiong, 15 parts of Angelica dahurica, and 10 parts of Xanthium sibiricum. The difference from Example 1 was that it did not contain Astragalus membranaceus, Angelica sinensis, and Borneol, but added Xanthium sibiricum.

[0058] Xanthium sibiricum has the effects of dispelling wind-cold, opening nasal passages, and removing rheumatism (Pharmacopoeia of the People's Republic of China 2020 Edition, Volume I). It is recorded in Shennong Ben Cao Jing: "It is mainly used for headache due to wind-cold, rheumatic arthralgia, pain in the limbs with contracture, and necrotic muscle with evil flesh." It is recorded in Compendium of Materia Medica: "Xanthium sibiricum is mainly used for treating chronic malaria... massive abdominal edema, dysuria... toothache... nasal sinusitis..." etc. In modern clinical practice, it is often used for the treatment of nasal diseases such as rhinitis or sinusitis. The purpose of this comparative example was to reduce the effect of benefiting the lung and defense, and enhance the function of opening nasal passages.

[0059] The preparation method was as follows: (1) After proportioning the above medicinal herbs, they were pulverized, passed through a 20-mesh sieve, and soaked in 8 times the amount of 75% ethanol aqueous solution for 1 hour; (2) After soaking, the reflux extraction method was used, and decocted twice, each decoction time was 1 hour. The two decoction liquids were combined and filtered to obtain decoction 1; (3) Decoction 1 was concentrated under reduced pressure while removing ethanol to obtain a thick paste, thus obtaining the product.

[0060] The preparation method was different from that of the medicated needle patch and was similar to the administration form of the positive drug. That is, before use, it was prepared into a liquid medicine with a concentration of 0.5 g of crude drug / Kg with purified water for nasal spraying. This was close to the commonly used nasal dropping method in clinical practice, and the effects of different administration methods and compositions on allergic rhinitis were observed by comparison.

[0061] Comparative Example 2 The difference between this comparative example and Example 1 was only that the formula was different. Specifically, Angelica sinensis was replaced by Paeonia lactiflora, and Angelica dahurica was replaced by a 1:1 mass ratio of Magnolia liliflora and Xanthium sibiricum, and the rest was the same as Example 1.

[0062] Comparative Example 3 The difference between this comparative example and Example 1 was only that the formula was different. Specifically, Saposhnikovia divaricata was replaced by a 1:1 mass ratio of Notopterygium incisum and Ligusticum sinense, Atractylodes lancea was replaced by Pogostemon cablin, and Asarum sieboldii was replaced by Xanthium sibiricum, and the rest was the same as Example 1.

[0063] Comparative Example 4 The difference between this comparative example and Example 1 is only the proportion, which is specifically composed of the following raw materials: 20 parts of Astragalus membranaceus, 10 parts of Angelica sinensis, 30 parts of Saposhnikovia divaricata, 15 parts of Acorus tatarinowii, 2 parts of Asarum sieboldii, 35 parts of Ligusticum chuanxiong, 24 parts of Angelica dahurica and 2 parts of Borneol. The rest is the same as that of Example 1.

[0064] I. Pharmacodynamic experiments 1. Materials and methods 1.1 Experimental animals SPF-grade male Wistar rats, weighing 200±10 g, were purchased from Beijing Spearf Bio-Technology Co., Ltd., with the license number: SCXK (Beijing) 2019-0010. Breeding conditions: temperature 20-26°C, humidity 40%-60%, illumination: 12 h / 12 h. The bedding was regularly changed every two days, and clean drinking water and feed were freely available for the rats. After one week of adaptive feeding, they entered the research program.

[0065] 1.2 Experimental drugs Blank control group and model group: purified water.

[0066] Experimental group: the medicinal needle patches prepared in Example 1 and Comparative Examples 2-4; the traditional Chinese medicine composition prepared in Comparative Example 1, which was formulated into a medicinal solution with a concentration of 0.5 g of crude drug / Kg with purified water before use.

[0067] Positive control drug: Fluticasone Propionate Aerosol (Flixonase, specification 120 sprays, GlaxoSmithKline). 1.3 Experimental reagents The main reagents used in this experiment are shown in Table 1.

[0068] Table 1

[0069] 1.4 Experimental instruments The main experimental instruments used in this research are shown in Table 2.

[0070] Table 2

[0071] 2. Experimental methods 2.1 Establishment of animal models This experiment induced a rat model of allergic rhinitis using ovalbumin (OVA) combined with aluminum hydroxide (Al(OH)3) adjuvant for 21 days, divided into two phases. From day 1 to day 14, rats were intraperitoneally injected every other day with a 1 mL saline suspension containing 0.3 mg OVA and 30 mg Al(OH)3 to establish a systemic immune response. Subsequently, from day 15 to day 21, rats were given 50 μL of 5% OVA solution via nasal drops daily in each nostril to induce nasal allergic symptoms.

[0072] 2.2 Animal grouping After the model was successfully established, the rats were randomly divided into 8 groups of 10 each: control group, model group, positive drug control group, medicated acupuncture patch group (Example 1 group), and comparative examples 1-4.

[0073] 2.3 Intervention Design A 7-day treatment intervention was initiated from day 22 to day 28 of the modeling process.

[0074] During this period, the control group and the model group were treated by wiping the nose with a cotton swab dipped in purified water once a day; the positive control group was given fluticasone propionate aerosol nasal spray once a day at a dose of 50 μg each time; the comparative group 1 was given traditional Chinese medicine liquid (prepared fresh for use) nasal spray once a day at a dose of 0.1 g of raw drug each time; the medicated acupuncture patch group (Example 1 group) and the comparative groups 2-4 were treated by applying the corresponding medicated acupuncture patches to the Lung Shu acupoints (on both sides of the intercostal spaces below the third thoracic vertebra of the rat) once a day for 1 hour each time.

[0075] 2.4 Indicator Testing Rats were scored on behavioral indicators on days 26 and 28. After administration, spleen tissue, abdominal aorta blood samples, and nasal tissue samples were collected for relevant indicator testing.

[0076] The handling of animals during the experiment complied with the animal ethics requirements stipulated in the "Regulations on the Management of Experimental Animals" issued by the State Science and Technology Commission.

[0077] 2.4.1 Behavioral scoring Behavioral indicators of rats in each group were scored on days 26 and 28, using a quantitative cumulative scoring method. Scoring criteria: 1. Nose scratching: No nose scratching behavior, 0 points; lightly touching the nose several times, 1 point; repeatedly scratching the nose and face, 2 points; constantly rubbing the nose and face, 3 points; 2. Sneezing: No sneezing, 0 points; 1-3 sneezes, 1 point; 4-10 sneezes, 2 points; 11 or more sneezes, 3 points. 3. Runny nose: No runny nose, 0 points; runny nose to the nostrils, 1 point; runny nose beyond the nostrils, 2 points; runny nose to the face, 3 points.

[0078] 2.4.2 Spleen Index Measurement Before sampling, the rats were weighed, and after sampling, the wet weight of the spleen was measured, and the spleen index was calculated.

[0079] Spleen index = Spleen wet weight / Body weight × 100%.

[0080] 2.4.3 Detection of Immunoglobulin E (IgE) Levels After blood was collected from the abdominal aorta, the sample was centrifuged at 2000g for 10 minutes at 4°C, and the supernatant was collected and stored at -80°C for later use. The level of immunoglobulin E (IgE) in the serum was detected by ELISA.

[0081] 2.4.4 Detection of Inflammatory Response Levels Blood was drawn from the abdominal aorta, centrifuged at 2000g for 10 min at 4℃, and the supernatant was collected and stored at -80℃ for later use. The levels of INF-γ, IL-4, IL-10, and IL-17 were detected using ELISA.

[0082] 2.4.5 Histopathological examination of nasal mucosa After nasal tissue was harvested, it was decalcified, fixed with 4% paraformaldehyde, embedded in paraffin, cut (2-3 μm), and stained with H&E and toluidine blue, and observed under a microscope.

[0083] 2.5 Statistical Analysis All experimental data were processed using SPSS 27.0 statistical software and expressed as mean ± standard deviation. One-way ANOVA was used when the data conformed to normal distribution and homogeneity of variance. The LSD method was used for multiple comparisons between groups. For data that did not meet the homogeneity of variance requirement, Welch's method was used to correct the F-values. The Dunnett T3 method was used for further multiple comparisons. P < 0.05 was considered statistically significant.

[0084] 3. Results 3.1 Changes in symptoms of allergic rhinitis in rats After systemic sensitization and local nasal provocation, the DAI score of the model group rats was significantly increased compared with the control group (P < 0.01), indicating that this method can successfully replicate the rat model of allergic rhinitis. After nasal administration of the positive control drug (fluticasone propionate), the symptoms of rhinitis rats were significantly improved, and the DAI score was significantly reduced compared with the model group (P < 0.01). After intervention with the acupuncture patch of Example 1 at the Feishu acupoint, the symptoms of rhinitis rats were significantly corrected, and the DAI score was significantly reduced compared with the model group (P < 0.01). After nasal administration of the control group drug, the DAI score was reduced, but there was no statistically significant difference compared with the model group (P > 0.05). The results are shown in Table 3.

[0085] 3.2 Changes in spleen index in rats with allergic rhinitis After systemic sensitization and local nasal stimulation, the spleen index of rats in the model group was significantly higher than that in the control group (P < 0.01), indicating that the immune system of rhinitis rats was severely damaged. Nasal spray of the positive control drug (fluticasone propionate) significantly improved the spleen index of rhinitis rats, with a significant reduction in spleen weight compared to the model group (P < 0.01). Acupuncture and moxibustion at the Feishu acupoint significantly corrected the immune damage in rhinitis rats, with a significant decrease in spleen index compared to the model group (P < 0.01). Nasal spray of the control group showed some reduction in spleen size, but the difference was not statistically significant compared to the model group (P > 0.05). The results are shown in Table 3.

[0086] 3.3 Effects of immunoglobulin E (IgE) levels in rats with allergic rhinitis After systemic sensitization and local nasal provocation, the IgE level in the model group was significantly higher than that in the control group (P < 0.01), further demonstrating that this method can successfully replicate the rat model of allergic rhinitis. Nasal spray administration of the positive control drug (fluticasone propionate) significantly improved IgE levels, showing a significant decrease compared to the model group (P < 0.01). Intervention at the Feishu acupoint with a medicated patch significantly corrected the local immune response in the rhinitis rats, resulting in a significant decrease in IgE levels compared to the model group (P < 0.01). Nasal spray administration to the control group also reduced IgE levels, showing a significant difference compared to the model group (P < 0.05). The results are shown in Table 3.

[0087] Table 3

[0088] Note: Compared with the control group: #P<0.05, ##P<0.01; Compared with the model group: P < 0.05 P < 0.01; Compared with Example 1 group: △ P < 0.05 △△ P < 0.01.

[0089] 3.4 Changes in inflammatory factors in rats with allergic rhinitis After systemic sensitization and local nasal stimulation, compared with the control group, the levels of INF-γ and IL-17 in the model group rats were significantly increased (P<0.01), while the levels of IL-4 and IL-10 were significantly decreased (P<0.01), indicating that the inflammatory response of the allergic rhinitis rat model was significantly enhanced. After administration of the positive control drug (fluticasone propionate) nasal spray and the nasal spray of traditional Chinese medicine (Example 1), the expression of inflammatory factors was significantly improved compared with the model group (P < 0.01). After intervention with the medicated acupuncture patch at the Feishu acupoint of rats, the inflammatory response of rhinitis rats was significantly corrected. Compared with the model group, all indicators of the inflammatory response were significantly improved, and the differences were statistically significant (P < 0.01). After administration of the nasal spray to the control group, the expression of INF-γ, IL-17 and IL-4 was significantly improved compared with the model group (P < 0.05), while the improvement of IL-10 level was not obvious. Compared with each control group, the expression of inflammatory factors in the medicated acupuncture patch group was significantly different (P < 0.05). The results are shown in Table 4.

[0090] Table 4

[0091] Note: Compared with the control group: #P<0.05, ##P<0.01; Compared with the model group: P < 0.05 P < 0.01; Compared with the medicated acupuncture patch group: △ P < 0.05 △△ P < 0.01.

[0092] 3.5 Effects on the histopathology of rats with allergic rhinitis Pathological studies on the nasal mucosa showed that, under a light microscope, the nasal mucosa of normal rats was structurally intact, with epithelial cells arranged neatly and tightly. In the model group, a large number of epithelial cells showed significant degeneration, necrosis, and loss, with sparsely arranged cells and significant diffuse infiltration of inflammatory cells. After nasal spraying with a positive nasal medication, a small amount of inflammatory cell infiltration was observed. In rats treated with a medicated acupuncture patch at the Feishu acupoint, compared to nasal spraying, the inflammatory cell infiltration was significantly reduced. Results are as follows... Figure 2 As shown.

[0093] After toluidine blue staining, the number of mast cells in the model group increased significantly. After drug administration, the number of mast cells in the positive control group and the drug injection patch group decreased significantly. The number of mast cells in the nasal mucosa of the control group was reduced compared with the model group, but not significantly. Results are as follows: Figure 3 As shown.

[0094] In summary, the traditional Chinese medicine composition for the prevention and treatment of allergic rhinitis of the present invention, after being pulverized and ground into powder, is evenly applied to an absorbent pad to form a drug-containing layer. This layer, together with the press-fit needle and the adhesive layer, forms a medicated patch, which can significantly improve the clinical symptoms, immunoglobulin E (IgE) and inflammatory response in rats with allergic rhinitis. It also has a significant intervention effect on the pathological changes of the nasal mucosa.

[0095] This article uses specific examples to illustrate the inventive concept in detail. The description of the above embodiments is only for the purpose of helping to understand the core idea of ​​the present invention. It should be noted that any obvious modifications, equivalent substitutions or other improvements made by those skilled in the art without departing from the inventive concept should be included within the protection scope of the present invention.

[0096] Clinical Cases 1. Mr. Liu, male, 60 years old, presented on December 23, 2025, with a chief complaint of allergic rhinitis for over 10 years, with frequent relapses throughout the year. Nasal endoscopy revealed: high leftward deviation of the nasal septum; slight congestion and edema of the bilateral middle and inferior turbinates; clean bilateral middle nasal meatuses; significant swelling and congestion of the nasopharyngeal mucosa; symmetrical bilateral recesses; and generally normal bilateral Eustachian tube orifices. He was clinically diagnosed with allergic rhinitis. He used the herbal composition acupuncture patch of Example 3 of this invention for 2 weeks. The results showed: the symptom score decreased from 8 to 2. Nasal endoscopy revealed: erosion of the anterior nasal septum of the left inferior turbinate; slight congestion and swelling of the bilateral middle and inferior turbinates; clean bilateral middle nasal meatuses; slight congestion of the nasopharyngeal mucosa; symmetrical bilateral recesses; and generally normal bilateral Eustachian tube orifices. All indicators, including the VAS score, showed significant improvement.

[0097] 2. Ms. Sun, female, 27 years old, visited the clinic on December 25, 2025, complaining of allergic rhinitis for more than half a year, with frequent attacks. Nasal endoscopy showed: rough mucosa at the anterior end of the bilateral nasal septum, swelling and congestion of the bilateral middle and inferior turbinates, watery secretions in the bilateral middle and common nasal meatuses, slight congestion and swelling of the nasopharyngeal mucosa, symmetrical bilateral recesses, and roughly normal pharyngeal orifices of the bilateral Eustachian tubes. The clinical diagnosis was allergic rhinitis. After applying the herbal composition patch of Example 2 of this invention for 2 weeks, the results showed that the symptom score decreased from 3 to 1. Nasal endoscopy showed that the nasal septum was deviated; the anterior mucosa of the bilateral nasal septum was rough, the bilateral middle and inferior turbinates were slightly congested and edematous, the bilateral uncinate processes were edematous, the bilateral middle nasal meatuses were generally normal, and a small amount of watery secretions were seen in the common nasal meatus; the nasopharyngeal mucosa was slightly congested and swollen, with sticky secretions attached, the bilateral recesses were symmetrical, and the bilateral pharyngeal orifices of the eustachian tubes were generally normal; all indicators, including the VAS score, showed significant improvement.

[0098] 3. Mr. Ma, male, 29 years old, visited the clinic on January 7, 2026, complaining of allergic rhinitis for more than 10 years, with frequent attacks and recent worsening. Nasal endoscopy showed: slight swelling and hemorrhage of the bilateral middle and inferior turbinates, yellow purulent secretions in the bilateral middle meatuses, slight congestion and swelling of the nasopharyngeal mucosa, symmetrical bilateral recesses, and roughly normal bilateral Eustachian tube orifices. The clinical diagnosis was allergic rhinitis. He used the herbal composition acupuncture patch of Example 3 of this invention for 2 weeks. The results showed that the symptom score decreased from 5 points to 1 point. Nasal endoscopy showed: slight congestion of the bilateral middle and inferior turbinates, a small amount of watery secretions in the right olfactory cleft of the middle meatus, slight congestion of the nasopharyngeal mucosa, symmetrical bilateral recesses, and roughly normal bilateral Eustachian tube orifices. All indicators, including the VAS score, showed significant improvement. The results showed that the composition of Example 3 of this invention has a good therapeutic effect on allergic rhinitis.

[0099] This article uses specific examples to illustrate the inventive concept in detail. The description of the above embodiments is only for the purpose of helping to understand the core idea of ​​the present invention. It should be noted that any obvious modifications, equivalent substitutions or other improvements made by those skilled in the art without departing from the inventive concept should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating allergic rhinitis, characterized in that, By weight, it consists of the following ingredients: Astragalus membranaceus 30-60 parts, Angelica sinensis 15-30 parts, Saposhnikovia divaricata 10-25 parts, Atractylodes lancea 10-30 parts, Acorus tatarinowii 10-30 parts, Asarum heterotropoides 5-15 parts, Ligusticum chuanxiong 10-30 parts, Angelica dahurica 10-20 parts, and Borneol 1-5 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it consists of the following ingredients: 30 parts Astragalus membranaceus, 20 parts Angelica sinensis, 15 parts Saposhnikovia divaricata, 15 parts Atractylodes lancea, 20 parts Acorus tatarinowii, 6 parts Asarum heterotropoides, 20 parts Ligusticum chuanxiong, 15 parts Angelica dahurica, and 2 parts Borneol. Alternatively, 60 parts Astragalus membranaceus, 30 parts Angelica sinensis, 25 parts Saposhnikovia divaricata, 30 parts Atractylodes lancea, 30 parts Acorus tatarinowii, 15 parts Asarum heterotropoides, 30 parts Ligusticum chuanxiong, 20 parts Angelica dahurica, and 5 parts Borneol; Alternatively, use 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 10 parts Saposhnikovia divaricata, 10 parts Atractylodes lancea, 10 parts Acorus tatarinowii, 5 parts Asarum heterotropoides, 10 parts Ligusticum chuanxiong, 10 parts Angelica dahurica, and 1 part Borneol.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) Mix Astragalus membranaceus, Angelica sinensis, Saposhnikovia divaricata, Atractylodes lancea, Acorus tatarinowii, Asarum heterotropoides, Ligusticum chuanxiong and Angelica dahurica, pulverize them to obtain drug powder; (2) Mix the drug powder with borneol and grind it into a fine powder.

4. The preparation method according to claim 3, characterized in that, After crushing in step (1), the powder is passed through a 50-70 mesh sieve; And / or, after being ground into fine powder in step (2), pass it through a 70-90 mesh sieve.

5. A medicated patch for preventing and treating allergic rhinitis, characterized in that, The invention includes the traditional Chinese medicine composition and the medicated patch needle as described in claim 1 or 2, wherein the medicated patch needle comprises a needle body, a medicated layer, and an adhesive layer.

6. The medicated patch according to claim 5, characterized in that, The adhesive layer is located on the outer periphery of the drug-containing layer, and the needle passes through the adhesive layer and the drug-containing layer sequentially from bottom to top; the drug-containing layer includes an absorbent pad.

7. The medicated patch according to claim 6, characterized in that, The absorbent pad is a nonwoven fabric with a polymer release membrane or a pure cotton tape with a polymer release membrane; the adhesive layer is a silicone gel tape coated with adhesive, a spunlace nonwoven fabric, or an elastic spandex fabric; the needle is a snap-on needle; the drug-containing layer also includes a protective film to prevent adhesion and allow the drug to pass through smoothly.

8. The medicated patch according to claim 5, characterized in that, The medicated needle patch is divided into children's type and adult type. The diameter of the medicated layer in the children's type is 2-10mm, and the diameter of the medicated layer in the adult type is 10-20mm. The length of the needle in the children's type is 0.8-1.5mm, and the length of the needle in the adult type is 1.5-2.5mm.

9. A method for preparing a medicated acupuncture patch according to any one of claims 6-8, characterized in that, The process includes the following steps: evenly applying the traditional Chinese medicine composition onto an absorbent pad, and then covering the surface with a protective film; then fixing the drug-containing layer containing the traditional Chinese medicine composition onto the adhesive layer; and then passing the needle through the adhesive layer and the drug-dispensing layer from bottom to top to make a medicated needle patch.

10. The use of the traditional Chinese medicine composition according to claim 1 or 2, or the traditional Chinese medicine composition prepared by the preparation method according to claim 3 or 4, or the medicated needle patch according to any one of claims 5-8, or the medicated needle patch prepared by the preparation method according to claim 9, in the preparation of products for the prevention and treatment of allergic rhinitis.

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