A double-release traditional Chinese medicine nursing spray based on xanthium sibiricum and a preparation method thereof

Abstract

The present application relates to the technical field of external preparation of traditional Chinese medicine, and discloses a double-release traditional Chinese medicine nursing spray based on Xiang'ezi powder and a preparation method thereof; the spray comprises an active ingredient system formed by Xiang'ezi, Xinyi, Baizhi and four kinds of medicinal and edible herbs wrapped by β-cyclodextrin, and a double-release carrier system composed of chitosan microspheres and a carbomer gel matrix; the active ingredient is loaded in the microspheres and uniformly dispersed in the gel matrix to form a "microsphere-gel" composite sustained-release system, and is delivered to the nasal cavity through a matching atomizing nozzle with a particle size of 5-10 μm. The present application solves the problem of easy loss of active ingredients and maintenance of drug efficacy for only 2-3 hours of traditional Chinese medicine spray, and can realize rapid effect and 12-hour sustained release without hormones and chemical additives, and is suitable for the whole-scene nasal care needs of sensitive groups such as teenagers and pregnant women.

Description

Technical Field

[0001] This invention relates to the field of external preparations of traditional Chinese medicine, specifically to a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder and its preparation method. Background Technology

[0002] Allergic rhinitis and chronic rhinitis are common nasal diseases in clinical practice. Currently, commonly used nasal preparations are mainly divided into two categories: chemical nasal sprays and traditional Chinese medicine nasal preparations, but both have significant shortcomings.

[0003] Chemical nasal sprays often contain hormones, vasoconstrictors, and other ingredients. Long-term use can easily lead to side effects such as drug-induced rhinitis and nasal mucosal atrophy, and there is also the issue of drug resistance. Sensitive populations such as adolescents and pregnant women have poor tolerance to chemical drugs, making the medication safety risks particularly prominent. There is an urgent clinical need for gentler care solutions.

[0004] In the realm of traditional Chinese medicine nasal preparations, Xanthium sibiricum powder, a classic formula in TCM for treating sinusitis, is composed of four medicinal and edible herbs: Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Mentha haplocalyx. It possesses the effects of dispelling wind and cold, clearing the nasal passages, and has a long history of clinical application. However, most existing Xanthium sibiricum powder-based nasal preparations are ordinary solution-type sprays. The herbal active ingredients (volatile oils) are easily volatilized and lost, resulting in poor formulation stability, short nasal retention time, and efficacy typically lasting only 2-3 hours. Patients need to administer the medication frequently, leading to low compliance and difficulty in meeting the need for continuous nasal care.

[0005] Furthermore, existing products are polarized in their functional positioning: fast-acting products focus on immediate relief of acute symptoms, neglecting mucosal repair and long-term maintenance; milder products are slow-acting and difficult to address acute symptoms such as nasal congestion and runny nose. The clinical needs for rhinitis care have shifted from simple symptomatic treatment to a full-cycle management model combining "rapid relief during the acute phase" and "long-term maintenance during the remission phase." At the same time, existing products lack discreet and convenient designs for public settings such as offices and social gatherings, and the user experience needs improvement.

[0006] The problems existing in the above-mentioned prior art, such as easy loss of herbal active ingredients, short nasal retention time, insufficient duration of efficacy, and inability to meet the comprehensive nursing needs of both rapid and long-lasting effects, constitute technical issues that urgently need to be solved by those skilled in the art. To address these issues, a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder and its preparation method are proposed. Summary of the Invention

[0007] To address the shortcomings of existing technologies, this invention provides a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder and its preparation method, thereby solving the problems in the background technology.

[0008] To achieve the above objectives, the present invention provides the following technical solution: Firstly, a dual-release traditional Chinese medicine care spray based on Xanthium sibiricum powder includes: The active ingredient system is composed of traditional Chinese medicine extracts and β-cyclodextrin, wherein the traditional Chinese medicine extracts are derived from four medicinal and edible herbs: Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Mentha haplocalyx. The dual sustained-release carrier system is composed of chitosan microspheres and a carbomer gel matrix. The active ingredient system is loaded inside the chitosan microspheres and uniformly dispersed in the carbomer gel matrix to form a "microsphere-gel" composite sustained-release system.

[0009] Preferably, the β-cyclodextrin inclusion treatment is performed by reacting a mixed volatile oil extract or alcohol extract of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Mentha haplocalyx with an aqueous solution of β-cyclodextrin to form an inclusion complex.

[0010] Preferably, the chitosan microspheres have a particle size range of 1-20 μm, and after being loaded with the traditional Chinese medicine inclusion complex, they are dispersed in a carbomer gel matrix with a mass percentage concentration of 0.5%-2.0%.

[0011] Secondly, a method for preparing a dual-release traditional Chinese medicine nursing spray according to the first aspect includes the following steps: S1: Extraction and inclusion of active ingredients: Take Xanthium sibiricum, Magnolia biondii, Angelica dahurica and Mentha haplocalyx and extract the mixed volatile oil by steam distillation or supercritical fluid extraction, or prepare the alcohol extract by ethanol reflux extraction; mix the obtained extract with β-cyclodextrin aqueous solution at a mass ratio of 1:5 to 1:10, stir and include at 40-60℃ for 1-3 hours, cool, filter and dry to obtain the Chinese medicine inclusion complex; S2: Preparation of drug-loaded chitosan microspheres: Chitosan was dissolved in an acidic solution, and the traditional Chinese medicine inclusion complex obtained in step S1 was added and stirred evenly to form an aqueous phase; under stirring conditions, the aqueous phase was dropped into an oil phase containing an emulsifier to form a W / O type emulsion, and then a crosslinking agent was added for curing. After separation, washing, and drying, chitosan microspheres loaded with traditional Chinese medicine inclusion complex were obtained. S3: Gel matrix preparation and homogenization: Carbomer powder is dispersed in purified water under stirring. After full swelling, a neutralizing agent is added to adjust the pH value to 6.0-7.0 to form a transparent gel matrix. The drug-loaded microspheres obtained in step S2 are slowly added and uniformly dispersed in the gel matrix under stirring. Humectant and preservative are added and stirred evenly to obtain the spray contents.

[0012] Preferably, the degree of deacetylation of the chitosan in step S2 is not less than 85%, and the crosslinking agent is glutaraldehyde or genipin, which is cured by chemical crosslinking.

[0013] Preferably, the crosslinking agent in step S2 is sodium tripolyphosphate, which is cured by ionic crosslinking.

[0014] Preferably, the moisturizer in step S3 is glycerin and / or propylene glycol, and the amount of the moisturizer added is 1%-5% based on the total mass of the gel matrix.

[0015] Preferably, the preservative in step S3 is one or more of parabens, benzoic acid and its salts, sorbic acid and its salts, and phenoxyethanol.

[0016] Thirdly, a nasal delivery device is provided for atomizing and delivering the dual-release traditional Chinese medicine care spray described in the first aspect. The device is equipped with an atomizing nozzle that can control the atomized particle size of the spray within the range of 5-10 μm, so that it acts on the nasal mucosa.

[0017] The application of the dual-release traditional Chinese medicine nursing spray described in the first aspect in the preparation of nasal care products for the prevention, relief or adjunctive treatment of allergic rhinitis and chronic rhinitis.

[0018] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention, by constructing a dual sustained-release carrier system of "microspheres-gel," is the first to apply a composite structure of chitosan microspheres and carbomer gel to a nasal preparation of Xanthium sibiricum powder, effectively addressing industry pain points such as the volatility, poor water solubility, and short nasal retention time of herbal active ingredients. The active ingredients loaded inside the microspheres, under the synergistic effect of the gel matrix, achieve a low burst release within 0.5 hours followed by a stable release over the next 12 hours. The duration of efficacy is extended from 2-3 hours in traditional formulations to 12 hours, reducing the frequency of administration and improving patient compliance.

[0019] 2. This invention employs β-cyclodextrin inclusion complexation technology to encapsulate the volatile oil-based active ingredients in Xanthium sibiricum powder. While retaining the traditional characteristics of the classic formula—"treating the symptoms in acute cases and addressing the root cause in chronic cases"—it significantly improves the stability and water solubility of the ingredients. The resulting spray, administered via the nasal cavity, can rapidly relieve acute symptoms such as nasal congestion within 3-5 minutes. Simultaneously, the dual sustained-release carrier provides long-lasting mucosal protection, addressing both the needs of acute relief and continuous conditioning during the relief period.

[0020] 3. This invention uses four medicinal and edible herbs—Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Mentha haplocalyx—as the sole source of active ingredients. The entire formula is free of hormones and chemically synthesized drugs, and the ingredients are mild and non-irritating. It effectively avoids the side effects and drug resistance risks of long-term use of chemical nasal sprays and is suitable for the daily nasal care needs of sensitive groups such as teenagers and pregnant women.

[0021] 4. The preparation process of this invention is simple, can be mass-produced, adapts to the development trend of the TCM and health industry, and fills the market gap of natural Chinese medicine long-acting nasal care spray.

[0022] Other features and advantages of the invention will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practicing the invention. The objects and other advantages of the invention may be realized and obtained by means of the structures pointed out in the description, claims and drawings. Attached Figure Description

[0023] Figure 1 This is a flowchart of the preparation process of the present invention; Figure 2 This is a comparison chart of the in vitro cumulative drug release curves of the present invention; Figure 3 This is a comparison of drug release curves for microspheres obtained with different crosslinking agents according to the present invention; Figure 4 This is a comparative histopathological image of the nasal mucosa tissue of the present invention. Detailed Implementation

[0024] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0025] Please see Figures 1-4 The present invention discloses a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder and its preparation method, which solves the problems of easy loss of active ingredients, short duration of efficacy and slow effect of traditional Chinese medicine sprays, and achieves "rapid onset of action + 12-hour long-term sustained release", while retaining the advantages of traditional Chinese medicine being mild and non-irritating, and is suitable for the rhinitis care needs of all people and all scenarios.

[0026] It should be noted that, unless otherwise specified, all raw materials, reagents, and instruments used in the following examples can be purchased commercially. Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Mentha haplocalyx all meet the relevant quality standards of the Chinese Pharmacopoeia; β-cyclodextrin is pharmaceutical grade; chitosan is pharmaceutical grade with a degree of deacetylation of not less than 85%; carbomer is carbomer 934 or carbomer 940; the neutralizing agent is triethanolamine or sodium hydroxide solution; and the purified water used is water for injection or purified water that meets pharmacopoeia standards.

[0027] Example 1: This embodiment provides a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder, the preparation method of which includes the following steps: S1: Extraction and encapsulation of active ingredients Weigh 30g of Xanthium sibiricum, 20g of Magnolia biondii, 20g of Angelica dahurica, and 15g of Mentha haplocalyx. Grind them into powder and pass them through a 20-mesh sieve. Mix them evenly and place them in a volatile oil extractor. Extract the mixed volatile oil using steam distillation for 4 hours. Collect the obtained mixed volatile oil. Weigh 50g of β-cyclodextrin and add 400mL of purified water. Heat and stir to dissolve it, preparing a β-cyclodextrin aqueous solution. Mix the obtained mixed volatile oil and the β-cyclodextrin aqueous solution at a mass ratio of 1:8. Stir and incorporate at 50℃ for 2 hours. After cooling to room temperature, let it stand at 4℃ for 12 hours. Filter the mixture. Wash the precipitate with a small amount of purified water and dry it under vacuum at 40℃ to obtain the herbal inclusion complex.

[0028] In this step, steam distillation effectively extracts the volatile active ingredients from the four medicinal herbs, preserving their natural pharmacological activity. β-Cyclodextrin has a ring-shaped cavity structure that is hydrophilic on the outside and hydrophobic on the inside. Through inclusion complexation, it encapsulates volatile oil molecules within the cavity, significantly improving the stability and water solubility of the active ingredients, preventing the volatile oil from evaporating and dissipating during subsequent processes and storage, and improving the uniformity of its dispersion in the gel matrix, thus laying the foundation for stable drug release.

[0029] S2: Preparation of drug-loaded chitosan microspheres Weigh 2g of chitosan and dissolve it in 100mL of 2% acetic acid solution. Stir until completely dissolved, then add 1g of the herbal inclusion complex obtained in step S1 and continue stirring until homogeneous. This is the aqueous phase. Measure 200mL of liquid paraffin and add 4g of Span 80 as an emulsifier. Stir until homogeneous. This is the oil phase. Under mechanical stirring at 800r / min, slowly add the aqueous phase dropwise to the oil phase and continue stirring for 30 minutes to form a stable W / O emulsion. Then add 4mL of glutaraldehyde solution (25% concentration) as a crosslinking agent and continue stirring to solidify for 2 hours. After the reaction is complete, centrifuge and wash the obtained microspheres twice each with petroleum ether, isopropanol, and purified water, and then vacuum dry at 40℃ to obtain chitosan microspheres loaded with the herbal inclusion complex.

[0030] In this step, chitosan, as a natural polymeric carrier material, possesses excellent biocompatibility, biodegradability, and mucosal adhesion. Under acidic conditions, the protonated amino groups on the chitosan molecular chains carry a positive charge, which can electrostatically adsorb onto the negatively charged mucosal surface, prolonging the residence time of the formulation in the nasal cavity. Microspheres are prepared using an emulsification-chemical crosslinking method, with glutaraldehyde as the crosslinking agent. A crosslinking network is formed through the reaction of the aldehyde groups with the Schiff bases of the amino groups on the chitosan molecules, physically encapsulating the traditional Chinese medicine inclusion complex within the microspheres. These microspheres act as the first layer of sustained-release barrier, allowing the active ingredient to be released gradually through the swelling of the polymer network and drug diffusion, avoiding burst release.

[0031] S3: Gel matrix preparation and homogenization Weigh 1.0 g of carbomer and slowly disperse it in 80 mL of purified water under stirring. Allow it to swell completely for 12 hours to form a uniform carbomer dispersion. Add triethanolamine dropwise under stirring to adjust the pH to 6.5, forming a transparent gel matrix. Weigh 2 g of the drug-loaded chitosan microspheres prepared in step S2 and slowly add them to the gel matrix under stirring at 300 rpm. Stir until fully dispersed. Then add 3 g of glycerin as a humectant. Separately, pre-dissolve 0.1 g of methylparaben in a small amount of ethanol and slowly add it to the gel matrix under stirring to achieve a mass percentage concentration of 0.1% in the formulation (this concentration is within the conventional dosage range of paraben preservatives recommended for external use in the Chinese Pharmacopoeia and has been verified to meet the requirements by antibacterial efficacy challenge experiments). Add purified water to a total mass of 100 g and stir until homogeneous to obtain the spray contents.

[0032] In this step, carbomer, as the gel matrix material, undergoes alkali neutralization followed by carboxyl ionization. Electrostatic repulsion between molecular chains allows the gel network to fully unfold, forming a clear and transparent three-dimensional network structure. The gel matrix acts as a second layer of sustained-release barrier; after the microspheres are dispersed within it, the active ingredient must first be released from within the microspheres into the gel matrix before diffusing to the mucosal surface, achieving a dual controlled-release effect. The resulting gel matrix increases the residence and adhesion time of the medication in the nasal cavity and synergistically prolongs the efficacy with the chitosan microspheres. Glycerin, as a humectant, maintains the water content of the gel system, reducing dryness and irritation to the nasal mucosa during use, while also enhancing the rheological stability of the system. Methylparaben, as a preservative, prevents microbial growth during repeated use, ensuring product safety.

[0033] S4: Filling and Assembly The contents of the spray obtained in step S3 are filled into a medical spray bottle, and a nasal atomizing nozzle is installed. The atomizing nozzle atomizes the gel-like contents to produce particles with a particle size range of 5-10 μm. The product is then sealed and packaged to obtain the finished product.

[0034] Example 2: This embodiment provides another dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder. The difference from Embodiment 1 is that genipin is used instead of glutaraldehyde as a crosslinking agent in step S2.

[0035] In step S2, the crosslinking agent is genipin, the amount of which is 10% of the chitosan mass, the crosslinking curing time is 6 hours, and other operations are the same as in Example 1.

[0036] Genipin is a naturally derived cross-linking agent that reacts with the amino groups on chitosan molecules through its olefin oxide structure to form stable microsphere structures. Compared to glutaraldehyde, genipin exhibits better cell compatibility and is suitable for formulation applications with strict requirements regarding chemical cross-linking agent residues.

[0037] Example 3: This embodiment provides another dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder. The difference from Embodiment 1 is that sodium tripolyphosphate is used instead of glutaraldehyde in step S2, and curing is carried out by ion crosslinking.

[0038] In step S2, the crosslinking agent is an aqueous solution of sodium tripolyphosphate (1% by mass), and the amount is 10 mL. It is added dropwise to the W / O type emulsion under stirring. Through electrostatic action, the protonated amino groups on the chitosan molecular chain undergo an ionic crosslinking reaction with the tripolyphosphate anions. The curing time is 30 minutes. Other operations are the same as in Example 1.

[0039] Ionic crosslinking does not introduce chemical crosslinking agents, thus avoiding the toxicity problems that organic crosslinking agents may cause. The process is gentler, and the microspheres can maintain better structural integrity in the gel matrix.

[0040] Example 4: This embodiment provides another dual-release traditional Chinese medicine care spray based on Xanthium sibiricum powder, which differs from Embodiment 1 in that the extraction method of the active ingredient in step S1 is different.

[0041] In step S1, 30g of Xanthium sibiricum, 20g of Magnolia biondii, 20g of Angelica dahurica, and 15g of Mentha haplocalyx were pulverized and added to 8 times their volume of 70% ethanol solution. The mixture was heated under reflux and extracted twice, 1.5 hours each time. The filtrates were combined, the ethanol was recovered under reduced pressure, and the extract was concentrated to a relative density of 1.05-1.10, which is the ethanol extract. The obtained ethanol extract was mixed with β-cyclodextrin aqueous solution at a mass ratio of 1:8 for inclusion complexation. After low-temperature drying, the herbal inclusion complex was obtained. Other operations were the same as in Example 1.

[0042] Ethanol reflux extraction can simultaneously extract multiple active ingredients such as volatile oils and flavonoids from medicinal materials, with a wider extraction range, and is suitable for preparing formulations containing multiple polar components.

[0043] Example 5: This embodiment provides another dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder. The difference from Embodiment 1 is that the extraction of active ingredients in step S1 is carried out by supercritical fluid extraction.

[0044] In step S1, 30g of Xanthium sibiricum, 20g of Magnolia biondii, 20g of Angelica dahurica, and 15g of Mentha haplocalyx were pulverized and placed in a supercritical extraction vessel. Carbon dioxide was used as the extraction fluid, the extraction pressure was 25MPa, the extraction temperature was 45℃, and the extraction time was 2 hours. The resulting mixed volatile oil was collected. Subsequent inclusion operations were the same as in Example 1.

[0045] Supercritical fluid extraction has the advantages of low extraction temperature, no organic solvent residue, and minimal damage to heat-sensitive active ingredients, which can preserve the natural chemical composition and pharmacological properties of volatile active components in Xanthium sibiricum powder to the greatest extent.

[0046] Example 6: This embodiment provides an application example of a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder for the preparation of nasal care products to prevent or relieve nasal congestion symptoms of chronic rhinitis, and evaluates its efficacy through animal experiments.

[0047] Animal grouping: Forty SD rats were randomly divided into four groups of 10 each: Group A was the normal control group, receiving no treatment; Group B was the model group, where a chronic rhinitis model was established using the ovalbumin sensitization method, with no drug treatment; Group C was the ordinary Xanthium sibiricum powder solution group, where, after model establishment, the rats were given an unencapsulated, unloaded microsphere-laden ordinary Xanthium sibiricum powder solution spray; Group D was the group described in Example 1 of this invention, where, after model establishment, the rats were given the dual-release sustained-release traditional Chinese medicine nursing spray prepared in Example 1. Both Groups C and D received intranasal administration twice daily, morning and evening, with each nostril sprayed once (approximately 100 μL) for 14 consecutive days.

[0048] Nasal symptoms in rats of each group were observed and recorded during the administration period. The results showed that the nasal ventilation of rats in group D was significantly improved within 3-5 minutes after administration, with an onset speed comparable to that of group C; the efficacy of a single administration lasted for more than 12 hours, while that in group C lasted only 2-3 hours, requiring frequent administration.

[0049] After 14 days of continuous drug administration, rats in each group were sacrificed, and nasal septum and inferior turbinate mucosa tissues were collected. These tissues were fixed, embedded, sectioned, stained with hematoxylin and eosin (HE), and then subjected to histopathological observation. Results are as follows: Figure 4 As shown in the diagram, Group A showed intact and continuous mucosal epithelium with neatly and densely arranged cilia and no inflammatory cell infiltration in the lamina propria; Group B showed eroded and sloughed mucosal epithelium with a large number of missing cilia, extensive inflammatory cell infiltration in the lamina propria, and vasodilation and congestion; Group C showed some improvement compared to Group B, with a basically continuous epithelial layer but still sparse cilia and a moderate amount of inflammatory cell infiltration in the lamina propria; Group D showed complete recovery of the mucosal epithelium, with neatly arranged cilia approaching the level of Group A, and significant regression of inflammatory cells in the lamina propria. The spray group of this invention is significantly superior to the ordinary solution group in mucosal tissue repair, possessing the dual effects of rapid relief of acute symptoms and long-term mucosal repair and maintenance.

[0050] Drug release performance verification experiment: In vitro drug release experiments were conducted on the spray contents obtained in Examples 1-3. Using the main volatile components of Xanthium sibiricum powder as the detection index, the Franz diffusion cell method was employed. The receiving medium was pH 6.8 phosphate buffer, the temperature was 37℃, and the stirring speed was 200 r / min. Samples were taken at 0.5, 1, 2, 4, 6, 8, 10, and 12 hours to detect the cumulative release rate. The experimental results are attached. Figure 2 and attached Figure 3 As shown.

[0051] like Figure 2 As shown, the spray obtained in Example 1 had a cumulative release rate of 12% after 0.5 hours, exhibiting a clear low burst release characteristic; subsequent 12 hours saw a continuous and stable release, with a cumulative release rate reaching 85%, and the release curve conformed to first-order kinetics. In contrast, the ordinary Xanthium sibiricum powder spray achieved a cumulative release rate of 65% within 0.5 hours and was essentially completely released within 2 hours, failing to achieve long-term sustained release.

[0052] like Figure 3 As shown, Example 1 (glutaraldehyde crosslinking) had a cumulative release rate of 12% after 0.5 hours and 85% after 12 hours; Example 2 (genipin crosslinking) had a cumulative release rate of 11% after 0.5 hours and 82% after 12 hours; and Example 3 (sodium tripolyphosphate crosslinking) had a cumulative release rate of 14% after 0.5 hours and 87% after 12 hours. All three groups of microspheres exhibited a low burst release at 0.5 hours followed by stable release over the next 12 hours. The genipin crosslinking group released slightly slower than the glutaraldehyde group, while the sodium tripolyphosphate crosslinking group had the fastest release rate. However, all three groups achieved a long-lasting sustained-release effect, indicating that the present invention has good process adaptability to different crosslinking methods.

[0053] This experiment confirms that the present invention has indeed achieved a technological breakthrough in long-term stable drug release over 12 hours through the "microsphere-gel" composite sustained-release system.

[0054] In summary, this invention enhances the stability of active ingredients through β-cyclodextrin inclusion technology, uses chitosan microspheres as the first sustained-release carrier and carbomer gel as the second sustained-release carrier, forming a dual controlled-release system of "microsphere-gel," and further utilizes a dedicated nasal atomizing nozzle for precise delivery. This successfully upgrades Xanthium sibiricum powder-type nasal preparations from traditional solution form to a dosage form of "rapid onset + long-lasting sustained release." The sprays obtained in each embodiment have mild components, are free of hormones and chemically synthesized drugs, and are suitable for sensitive populations such as adolescents and pregnant women. They cover the full-cycle care needs of nasal mucosal maintenance during the acute phase and the remission phase, demonstrating good industrialization prospects and clinical application value.

[0055] The above description is merely a preferred embodiment of the present invention and does not limit the scope of protection of the present invention. Any equivalent structural transformations made based on the inventive concept of the present invention and the content of this specification, or direct or indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. A dual-release traditional Chinese medicine care spray based on Xanthium sibiricum powder, characterized in that, include: The active ingredient system is composed of traditional Chinese medicine extracts and β-cyclodextrin, wherein the traditional Chinese medicine extracts are derived from four medicinal and edible herbs: Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Mentha haplocalyx. The dual sustained-release carrier system is composed of chitosan microspheres and a carbomer gel matrix. The active ingredient system is loaded inside the chitosan microspheres and uniformly dispersed in the carbomer gel matrix to form a "microsphere-gel" composite sustained-release system.

2. The dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder according to claim 1, characterized in that, The β-cyclodextrin inclusion treatment is performed by reacting a mixed volatile oil extract or alcohol extract of Xanthium sibiricum, Magnolia biondii, Angelica dahurica, and Mentha haplocalyx with an aqueous solution of β-cyclodextrin to form an inclusion complex.

3. The dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder according to claim 1, characterized in that, The chitosan microspheres have a particle size range of 1-20 μm. After being loaded with traditional Chinese medicine inclusion complex, they are dispersed in a carbomer gel matrix with a mass percentage concentration of 0.5%-2.0%.

4. A method for preparing a dual-release traditional Chinese medicine nursing spray according to any one of claims 1-3, characterized in that, Includes the following steps: S1: Extraction and inclusion of active ingredients: Take Xanthium sibiricum, Magnolia biondii, Angelica dahurica and Mentha haplocalyx and extract the mixed volatile oil by steam distillation or supercritical fluid extraction, or prepare the alcohol extract by ethanol reflux extraction; mix the obtained extract with β-cyclodextrin aqueous solution at a mass ratio of 1:5 to 1:10, stir and include at 40-60℃ for 1-3 hours, cool, filter and dry to obtain the Chinese medicine inclusion complex; S2: Preparation of drug-loaded chitosan microspheres: Chitosan was dissolved in an acidic solution, and the traditional Chinese medicine inclusion complex obtained in step S1 was added and stirred evenly to form an aqueous phase; under stirring conditions, the aqueous phase was dropped into an oil phase containing an emulsifier to form a W / O type emulsion, and then a crosslinking agent was added for curing. After separation, washing, and drying, chitosan microspheres loaded with traditional Chinese medicine inclusion complex were obtained. S3: Gel matrix preparation and homogenization: Carbomer powder is dispersed in purified water under stirring. After full swelling, a neutralizing agent is added to adjust the pH value to 6.0-7.0 to form a transparent gel matrix. The drug-loaded microspheres obtained in step S2 are slowly added and uniformly dispersed in the gel matrix under stirring. Humectant and preservative are added and stirred evenly to obtain the spray contents.

5. The preparation method of a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder according to claim 4, characterized in that, In step S2, the degree of deacetylation of the chitosan is not less than 85%, and the crosslinking agent is glutaraldehyde or genipin, which is cured by chemical crosslinking.

6. The preparation method of a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder according to claim 4, characterized in that, The crosslinking agent mentioned in step S2 is sodium tripolyphosphate, which is cured by ionic crosslinking.

7. The preparation method of a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder according to claim 4, characterized in that, The moisturizer in step S3 is glycerin and / or propylene glycol, and the amount of the moisturizer added is 1%-5% based on the total mass of the gel matrix.

8. The preparation method of a dual-release traditional Chinese medicine nursing spray based on Xanthium sibiricum powder according to claim 4, characterized in that, The preservative mentioned in step S3 is one or more of parabens, benzoic acid and its salts, sorbic acid and its salts, and phenoxyethanol.

9. A nasal delivery device, characterized in that, The device is used to atomize and deliver the dual sustained-release traditional Chinese medicine nursing spray according to any one of claims 1-3, the device being equipped with an atomizing nozzle that can control the atomized particle size of the spray within the range of 5-10 μm, so that it acts on the nasal mucosa.

10. The use of the dual-release traditional Chinese medicine nursing spray according to any one of claims 1-3 in the preparation of nasal care products for the prevention, relief or adjunctive treatment of allergic rhinitis and chronic rhinitis.

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