Preparation method and application of medicine for treating rhinitis

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation, and discloses a preparation method and application of a medicine for treating rhinitis, and the medicine for treating rhinitis comprises the following components by weight: 5-15 parts of magnolia flower; 3-10 parts of radix astragali; 2-8 parts of radix puerariae; 0.5 to 2 parts of calculus bovis; 0.1 to 0.5 part of musk; 1-4 parts of pangolin scales; 4 to 12 parts of honeysuckle flower; 0.5 to 2 parts of centipeda minima; 2-6 parts of radix angelicae dahuricae; 1-5 parts of radix saposhnikoviae; 0.2 to 1 part of slough; 0.5-2 parts of acorus calamus; 1-4 parts of smoked plum; 0.5 to 1.5 parts of herba asari; 0.1 to 0.5 part of borneol; and 1-3 parts of mint. By optimizing the fermentation process and formula design and combining air drying process control, the effects of increasing the content of effective components, uniformly distributing the effective components and enhancing the drug effect stability are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparation, and specifically to a preparation method and application of a drug for treating rhinitis. Background Art

[0002] With the wide popularization of functional traditional Chinese medicine preparations, how to improve the stability and long-lasting effect of active ingredients in drugs has become a common problem in practical applications. Especially in the treatment of immune regulation, anti-inflammatory or respiratory diseases, many drugs need to go through complex processing steps to maintain stable efficacy. Traditional preparations often have problems such as slow onset, uneven release of components, or difficulty in maintaining the efficacy, and the user experience is not ideal. Therefore, to develop a preparation method that can improve the extraction rate of active ingredients and still maintain their activity after processing, based on this, the present invention proposes to synergistically improve the generation, retention and release stability of efficacy components by optimizing the fermentation process, formula structure design and air-drying adsorption mechanism, thereby improving the overall treatment effect.

[0003] Currently, some technologies have tried to adjust the fermentation time or temperature to increase the content of certain single components. These processes do have certain advantages in extraction efficiency, such as being able to quickly separate the main components and reducing impurity interference; there are also technologies that use low-temperature drying to avoid the destruction of heat-sensitive components and improve the retention rate. In addition, some methods use slow-release coating means during the air-drying process, so that the drug efficacy release time is extended. These solutions have certain practicality in actual production, especially in terms of production cost and process simplification.

[0004] However, there are still some deficiencies in the existing technologies; firstly, the fermentation process mostly relies on empirical regulation, with large fluctuations in parameter control and poor stability of the generated products; secondly, there are obvious deviations between batches, and there are also problems in the extraction link. Many methods only focus on fast extraction and ignore the integrity of components, especially the insufficient retention ability for easily degradable substances; in addition, there are also common drawbacks in air-drying, such as uneven distribution of active ingredients and uneven adsorption effects, with dense components in some areas and almost ineffective in some areas; finally, some active components are severely lost during the drying process, and half of the drug efficacy is lost before it is used. Summary of the Invention

[0005] In view of the deficiencies of the existing technologies, the present invention provides a preparation method and application of a drug for treating rhinitis, which solves the problems of unstable fermentation, low extraction rate and serious loss of active ingredients during the air-drying process in the existing technologies.

[0006] To achieve the above purposes, the present invention is realized through the following technical solutions: According to the first aspect of the present invention, a drug for treating rhinitis is provided, and the drug for treating rhinitis includes the following components in parts by weight:

[0007] Magnolia flower: 5 - 15 parts. Magnolia flower is a commonly used traditional Chinese medicine, which has the effects of opening orifices to dispel cold and reducing swelling and alleviating pain. The volatile oil components in magnolia flower, especially magnolione, can play a role in local spasmolysis, reducing nasal congestion and swelling. By activating the local immune response in the nasal cavity, magnolia flower can reduce allergic reactions and relieve nasal congestion symptoms;

[0008] Astragalus membranaceus: 3 - 10 parts. The polysaccharides in Astragalus membranaceus can activate T cells and macrophages, enhance the immune response ability of the body, and at the same time have antioxidant effects, reducing oxidative damage to nasal tissues. By promoting antibody production and enhancing immune responses, Astragalus membranaceus helps slow down the occurrence of rhinitis;

[0009] Kudzu root: 2 - 8 parts. The isoflavone compounds in kudzu root, especially puerarin, have the effect of dilating blood vessels, enhancing blood fluidity, and relieving nasal congestion. It reduces nasal inflammation by regulating local blood flow and promoting lymphatic detoxification;

[0010] Calculus bovis: 0.5 - 2 parts. Calculus bovis contains rich flavonoid compounds, which have strong anti - inflammatory and antibacterial effects, can inhibit the growth of pathogenic microorganisms in the nasal cavity, reduce inflammatory reactions, and relieve nasal congestion and rhinorrhea symptoms;

[0011] Moschus: 0.1 - 0.5 parts. Muscone in Moschus can stimulate the nerve endings in the nasal cavity, enhance local blood circulation, and achieve the effects of anti - inflammation and relieving nasal congestion. At the same time, Moschus has antibacterial and antiviral effects, and can improve local immune defense ability;

[0012] Pangolin scales: 1 - 4 parts. Pangolin scales contain a variety of active ingredients, which can inhibit inflammatory reactions and relieve nasal swelling and congestion by improving local blood circulation and increasing the infiltration and action of white blood cells in the nasal cavity;

[0013] Honeysuckle flower: 4 - 12 parts. The flavonoid and glycoside components in honeysuckle flower have strong antibacterial and anti - inflammatory effects, can inhibit the reproduction of bacteria and viruses in the nasal cavity, and reduce local inflammatory reactions. It helps eliminate nasal inflammation and relieve nasal congestion symptoms;

[0014] Centipeda minima: 0.5 - 2 parts. The active ingredients in Centipeda minima can reduce the occurrence of allergic reactions by regulating immune responses. It can inhibit the stimulation of nasal mucosa by allergic substances and relieve nasal congestion and rhinorrhea symptoms caused by allergies;

[0015] Angelica dahurica: 2 - 6 parts. Angelica dahurica contains volatile oil and organic acid components, which can relieve nasal congestion by dilating nasal blood vessels and improving nasal ventilation. Its analgesic effect also helps relieve headache, facial pain and other symptoms caused by rhinitis;

[0016] Fangfeng: 1 - 5 parts. Fangfeng can regulate local immune responses and enhance the defense of the nasal cavity. It has an anti-inflammatory effect, can reduce nasal swelling and pain, and relieve nasal congestion symptoms;

[0017] Huatui: 0.2 - 1 part. Huatui has an antiviral effect, can inhibit the invasion of the nasal cavity by viruses, reduce inflammatory responses, and thus help relieve nasal discomfort symptoms;

[0018] Calamus: 0.5 - 2 parts. The active ingredients in calamus can regulate the body's dampness, improve nasal humidity, and promote the discharge of secretions, thus relieving nasal congestion and nasal discomfort;

[0019] Black Plum: 1 - 4 parts. Black Plum has a strong anti-inflammatory effect, can reduce nasal congestion and swelling, and through its astringent effect, relieve local blood vessel dilation and relieve nasal congestion;

[0020] Asarum: 0.5 - 1.5 parts. The active ingredients in asarum can stimulate the nerve endings in the nasal cavity, promote local blood circulation, and reduce nasal congestion symptoms. In addition, asarum has a strong antibacterial effect, which helps relieve the infection symptoms caused by rhinitis;

[0021] Borneol: 0.1 - 0.5 part. Through its volatile components, borneol can stimulate the nasal mucosa to achieve a cool and comfortable effect, relieve nasal congestion and discomfort;

[0022] Mentha: 1 - 3 parts. The menthol component in mentha can achieve a cool and analgesic effect by locally stimulating nerve endings, relieving symptoms such as nasal congestion and headache.

[0023] According to the second aspect of the present invention, there is provided a preparation method of a drug for treating rhinitis, which is used to prepare the above-mentioned drug for treating rhinitis, and includes the following steps:

[0024] S1. Medicinal material treatment: Remove the impurities of each medicinal material and wash them clean, and then carry out drying treatment;

[0025] S2. Medicinal material pulverization: Pulverize the dried medicinal materials to make the powder uniform;

[0026] S3. Soaking and extraction: Add the pulverized medicinal materials into a solvent for soaking and extraction to ensure the extraction of active ingredients;

[0027] S4. Liquid medicine filtration and fermentation: Filter the soaked liquid medicine, and add probiotics for fermentation to promote the biological transformation of components;

[0028] S5. Clarification treatment: Carry out centrifugation and thin-layer filtration treatment on the fermented liquid medicine to obtain the liquid medicine;

[0029] S6, Drip-feeding and air-drying: Drip-feed the medicinal liquid into the natural sponge body and air-dry it to ensure complete absorption of the medicinal liquid;

[0030] S7, Encapsulation and packaging: Encapsulate the sponge body adsorbed with the medicinal liquid and perform appropriate packaging treatment to ensure the stability of the drug.

[0031] Preferably, the medicinal material treatment includes:

[0032] Remove the surface impurities and sediment from the raw materials in sequence and then rinse them with clean water 2 - 4 times. Sediment and impurities will affect the permeability of the extraction solvent and the release of the active ingredients of the medicinal materials, reducing the quality and efficacy of the drug. Cleaning the medicinal materials can remove harmful substances such as impurities, bacteria, and pesticide residues on the surface and inside of the medicinal materials, ensuring that the medicinal materials do not contain unnecessary chemical substances, which helps to improve the safety and efficacy of the drug. Multiple cleanings can minimize the pollution source and ensure the quality of the medicinal materials;

[0033] Place the cleaned medicinal materials in a drying oven and perform air-drying treatment at a temperature of 50°C - 60°C for 12 - 18 hours. By controlling the drying temperature and time, the moisture in the medicinal materials can be effectively removed, preventing mildew, rot, and other biodegradation processes. Controlling the temperature between 50°C - 60°C can not only ensure the effective evaporation of the moisture in the medicinal materials but also avoid the destruction of certain heat-sensitive components in the medicinal materials by high temperature, ensuring the preservation of their active ingredients;

[0034] After drying, control the moisture content of each medicinal material between 8 - 10%. Maintaining the moisture of the medicinal materials between 8 - 10% can ensure that the medicinal materials are not overly dried or moist, avoiding affecting the subsequent extraction effect.

[0035] Preferably, the medicinal material pulverization includes:

[0036] Use an air-flow type ultrafine pulverization device to pulverize the dried medicinal materials. The ultrafine pulverization technology breaks the medicinal materials into micron-level particles through the action of air flow, greatly increasing the surface area of the medicinal materials, which has a significant effect on improving the extraction rate of the active ingredients of the medicinal materials. After pulverization, the active ingredients of the medicinal materials can be more easily extracted by solvents or other media, thus improving the therapeutic effect of the drug;

[0037] After pulverization, control the particle size of the medicinal powder between 100 - 300 mesh, and the particle size difference control range is 5 - 10%. Controlling the particle size between 100 - 300 mesh means that the drug powder has a large surface area, and at the same time, the particle size is not too small to avoid the drug being absorbed too quickly, resulting in fluctuations in the therapeutic effect. By controlling the particle size difference within 5 - 10%, the uniformity of the drug powder can be ensured, enabling the components of the drug to play a role consistently during use, thus avoiding the instability of the drug efficacy. The finer particle size of the drug can also be more easily absorbed through the nasal mucosa, improving the treatment efficiency;

[0038] Finally, all the medicinal powders are mixed evenly. The evenly mixed medicinal powders can avoid uneven distribution of the active ingredients of different medicinal materials, ensuring that patients can obtain the same dose of active ingredients each time the drug is used, thereby improving the predictability and effectiveness of treatment.

[0039] Preferably, the soaking and extraction includes:

[0040] Prepare a mixed solvent with a volume ratio of ethanol to pure water of 1:1, and the ethanol concentration is 75-85%. Ethanol is a broad-spectrum solvent that can dissolve many organic active ingredients. At the same time, when its concentration is 75-85%, it has strong penetrability and can penetrate the cell walls of the medicinal powders, quickly releasing the active ingredients therein. Mixing with pure water at a ratio of 1:1 can take into account the extraction of water-soluble and fat-soluble components, enabling components with different polarities in traditional Chinese medicine to be dissolved simultaneously, which helps to improve the extraction efficiency and the comprehensiveness of the medicinal effect;

[0041] Put the medicinal powder into the mixed solvent, and the mass ratio of the medicinal material to the solvent is 1:10 - 1:12. This range of mass ratio provides sufficient solvent volume, enabling the medicinal powder to fully expand, disperse and contact the solvent during the soaking process, thereby improving the diffusion efficiency of the active ingredients in the medicinal material. When the solvent is sufficient, it helps to maintain the concentration gradient, thus accelerating the migration process of the solute to the solvent and improving the extraction rate;

[0042] Seal and soak at room temperature of 25°C - 30°C for 6 - 8 days, and stir for 25 - 35 minutes every 22 - 26 hours during the soaking process. Sealed soaking at room temperature avoids the destruction of thermosensitive active ingredients by high temperature, such as volatile oils and certain esters. At the same time, the environmental temperature of 25°C - 30°C is conducive to the slow and balanced release of active ingredients. The sealed state can prevent the volatilization of ethanol, stabilize the solvent concentration, and ensure consistent extraction effects. Long-term static soaking allows the internal components of the medicinal materials to fully exude, while periodic stirring helps to break the local concentration balance, accelerate the diffusion of active ingredients, and prevent the deposition and caking of the medicinal powder, ensuring extraction uniformity and extraction efficiency.

[0043] Preferably, the filtration and fermentation of the medicinal liquid includes:

[0044] After the soaking is completed, first filter it roughly through a stainless steel sieve with 280 - 320 meshes, and then perform secondary filtration through a medium-speed filter paper with a pore size of 5 - 13 μm. The stainless steel sieve with 280 - 320 meshes can effectively intercept larger medicinal powder particles and fibrous residues, thus avoiding clogging subsequent filter materials and reducing their burden. Subsequently, using a medium-speed filter paper with a pore size of 5 - 13 μm can filter out most of the invisible suspended impurities and microparticles to obtain a relatively clear medicinal liquid;

[0045] Transfer the filtrate into a temperature-controlled fermenter, and add a compound probiotic bacteria accounting for 1-5% of the volume of the fermentation broth. The bacterial strains include lactic acid bacteria and Bacillus subtilis. Lactic acid bacteria can produce metabolites such as lactic acid and antibacterial peptides during the fermentation process, which have anti-inflammatory, antibacterial, immunomodulatory and other effects, and can enhance the resistance of the medicinal liquid to the causes of rhinitis. Bacillus subtilis can secrete a variety of digestive enzymes, has a good synergistic metabolism effect, can further decompose the complex compounds in the medicinal liquid, convert the macromolecules in some medicinal materials into small molecule active substances, and improve its bioavailability.

[0046] Carry out aerobic fermentation for 6-8 days at 30°C - 35°C, ventilate for 1.5 - 2.5 hours every day, and control the pH value at 5.5 - 6.5 during the fermentation. 30°C - 35°C is the optimal fermentation temperature range for lactic acid bacteria and Bacillus subtilis. At this temperature, they have active metabolism, can reproduce rapidly and produce metabolites, effectively converting the functional components in the medicinal liquid. The aerobic environment can promote the respiratory metabolism of the bacterial strains and improve the fermentation efficiency. Ventilating regularly every day can not only maintain the dissolved oxygen level but also avoid metabolic disorders caused by excessive oxygen consumption by the bacterial population. Maintaining the pH value in the range of 5.5 - 6.5 is an environment with relatively high activity of probiotic bacteria, which is conducive to inhibiting the growth of miscellaneous bacteria and maintaining the stability of metabolites.

[0047] Preferably, the clarification treatment includes:

[0048] Centrifuge the fermentation broth using a centrifuge at a speed of 4000 - 6000 revolutions per minute for 15 - 20 minutes. Through high-speed centrifugation, the denser solids can be precipitated to the bottom of the centrifuge tube by the centrifugal force to achieve liquid-solid separation. The speed range is set at 4000 - 6000 rpm, which not only ensures sufficient centrifugal force to efficiently sediment most particles but also avoids the sedimentation of some active small molecules or protein denaturation due to overspeed. The time setting of 15 - 20 minutes is conducive to thorough separation, stable operation, and obtaining a supernatant clarification solution;

[0049] After centrifugation, perform thin-film filtration with the membrane pore size controlled at 0.4 - 0.5 microns to obtain a clarified medicinal liquid for standby. Although most visible impurities have been removed by centrifugation, there may still be particulate substances such as suspended particles, colloidal microparticles, dead bacterial cells, and spores in the fermentation broth. Using a membrane filtration technology with a pore size of 0.4 - 0.5 μm can effectively intercept these tiny particles and further clarify the medicinal liquid.

[0050] Preferably, the dripping and air-drying include:

[0051] A natural sponge is selected as the liquid medicine carrier. The sponge is a chitosan foam. Chitosan is a natural polysaccharide derived from crustaceans, with excellent biocompatibility, biodegradability, and good film-forming properties. The three-dimensional porous network formed by its foam-like structure has good liquid absorption and slow-release properties, and can effectively load the liquid medicine and achieve slow and continuous release in the nasal cavity. In addition, chitosan itself has functions such as antibacterial, anti-inflammatory, and promoting tissue repair, which has a synergistic effect on the treatment of rhinitis;

[0052] The liquid medicine is uniformly dripped onto the surface of the sponge at a dose of 0.5 - 0.7 mL / granule. The dose setting of 0.5 - 0.7 mL combines the capacity that can be accommodated locally in the nasal cavity and the adsorption capacity of the sponge, ensuring that the liquid medicine can be completely adsorbed and avoiding dripping;

[0053] It is air-dried at a temperature of 25°C - 30°C for 10 - 14 hours to uniformly adsorb the liquid medicine in the carrier. This temperature range is close to room temperature, and can achieve effective drying without destroying the thermosensitive active ingredients (such as proteins, enzymes, alkaloids, etc.) in the liquid medicine. At the same time, the air-drying process is a slow physical adsorption and water evaporation process, which can promote the balanced combination between the liquid medicine and the carrier, preventing the liquid medicine from forming a film-like deposition on the surface of the carrier and affecting subsequent dissolution. The drying time of 10 - 14 hours not only ensures that the liquid medicine is fully adsorbed, but also does not cause the collapse or shrinkage of the chitosan foam structure, maintaining good physical form and drug delivery performance.

[0054] Preferably, the encapsulation and packaging include:

[0055] It is encapsulated with a double-layer composite aluminum foil paper with a thickness of 7 - 9 filaments. The inner layer is a polyethylene moisture-proof film, and the outer layer is an aluminum foil layer. The aluminum foil layer has excellent light-shielding, oxygen-barrier, and moisture-barrier properties, and can effectively prevent the erosion of light, air, and water vapor on the drug, extending the stability period of the drug. Polyethylene as the inner layer material has good flexibility and heat-sealing properties, can closely adhere to the drug, and prevent water vapor penetration. The thickness design of 7 - 9 filaments ensures the encapsulation strength while maintaining flexibility and formability, facilitating heat-sealing and user opening, and is a commonly used standardized packaging structure for traditional Chinese medicine preparations;

[0056] A hot-press sealing device is used for sealing. The sealing temperature is 115 - 125°C, and the sealing time is 2 - 4 seconds. The hot-press sealing technology uses heating and pressure to fuse the polyethylene inner membrane to form a sealing interface. The temperature range of 115 - 125°C can ensure that the polyethylene is fully melted without burning through the aluminum foil layer; the pressurization time of 2 - 4 seconds ensures sufficient heat-sealing strength, without generating sealing cracks, and also avoids the drug being affected by overheating;

[0057] Each packaging bag contains 2-3 pills of medicine and 0.5-1.0g of desiccant. The product batch number and expiration date are marked on the outside of the packaging bag. The packaging capacity of 2-3 pills / bag is convenient for single-use medication management and avoids moisture contamination of other unused preparations due to frequent opening. The desiccant can continuously absorb residual water vapor inside the package to prevent the medicine from absorbing moisture and swelling, deteriorating, or damaging the chitosan structure in a high humidity environment. The batch number and expiration date are marked in accordance with the GMP drug quality management specifications, ensuring product traceability and legal compliance, and facilitating user inquiries and usage supervision.

[0058] According to a third aspect of the present invention, there is provided use of the above-mentioned drug for treating rhinitis or the drug for treating rhinitis obtained by the above-mentioned preparation method in the treatment of rhinitis.

[0059] The present invention provides a preparation method and application of a drug for treating rhinitis, which has the following beneficial effects:

[0060] 1. The present invention adopts optimized fermentation technology combined with drug formula design, accurately controls fermentation conditions and extraction process, improves the generation and stability of effective ingredients, and can maintain a high active content, especially after air drying. Compared with the problems of low extraction rate and easy degradation of ingredients in existing traditional fermentation technology, the present invention realizes efficient extraction and stable release of active ingredients, effectively overcoming the defects of uneven ingredients and unsustainable efficacy.

[0061] 2. The present invention adopts an optimized air-drying process and formula design to improve the adsorption efficiency of the active ingredients of the drug. By rationally adjusting the interaction between the drug and the carrier, the drug solution can be evenly distributed during the air-drying process to ensure better retention of the active ingredients. Compared with the air-drying process in the prior art, this technical solution solves the problems of uneven distribution of active ingredients and serious loss of active ingredients in drugs in traditional methods, thereby greatly improving the stability and therapeutic effect of the drug.

[0062] 3. In terms of extraction efficiency, the present invention optimizes the drug extraction process by finely controlling the solubility and volatility of the drug solution. Compared with the traditional extraction method, the present invention can effectively reduce the loss of active ingredients and ensure that the extraction rate reaches a high level. Through this innovative solution, the problems of low extraction efficiency and incomplete extraction of active ingredients in the prior art are solved, thereby improving the overall quality of the drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 The present invention is a flow chart of the preparation method. DETAILED DESCRIPTION

[0064] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings in the specification of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0065] Please refer to the attached Figure 1 :

[0066] Example 1:

[0067] Medicinal material ratio: Magnolia flower: 12 parts; Astragalus membranaceus: 6 parts; Pueraria lobata: 5 parts; Calculus bovis: 1 part; Moschus: 0.3 part; Manis pentadactyla: 2 parts; Lonicera japonica: 9 parts; Herba Centipedae: 1 part; Angelica dahurica: 4 parts; Saposhnikovia divaricata: 3 parts; Periostracum cicadae: 0.5 part; Acorus calamus: 1.5 parts; Fructus mume: 3 parts; Asarum sieboldii: 1 part; Borneol: 0.3 part; Mentha haplocalyx: 2 parts.

[0068] Preparation method:

[0069] 1. Medicinal material treatment: After removing impurities, rinse with clean water 3 times, place in a drying oven, and air-dry at 50 °C for 16 hours, with the moisture content controlled at 8%.

[0070] 2. Medicinal material pulverization: Use an air-flow ultrafine pulverization device to pulverize the dried medicinal materials, control the particle size of the medicinal powder at 200 mesh, and control the particle size difference within 7%.

[0071] 3. Soaking and extraction: Use a mixed solvent with a volume ratio of ethanol to pure water of 1:1, with an ethanol concentration of 80%, and a mass ratio of medicinal materials to solvent of 1:10. Soak at room temperature for 7 days, and stir for 30 minutes every 24 hours.

[0072] 4. Liquid medicine filtration and fermentation: First, filter roughly with a 280-mesh stainless steel sieve, then perform secondary filtration with a medium-speed filter paper with a pore size of 10 μm, transfer to a temperature-controlled fermentation tank, add 3% compound probiotics (lactic acid bacteria and Bacillus subtilis) based on the volume of the fermentation broth, and perform aerobic fermentation at 30 °C for 7 days, with aeration for 2 hours every day, and control the pH value at 6.0.

[0073] 5. Clarification treatment: The centrifuge speed is 4500 rpm, centrifuge for 15 minutes, and perform thin-film filtration with a membrane pore size of 0.45 μm to obtain a clarified liquid medicine.

[0074] 6. Dripping and air-drying: Drip the liquid medicine onto the surface of the chitosan foam sponge at a dose of 0.6 mL / granule, and air-dry at 25 °C for 12 hours.

[0075] 7. Encapsulation and Packaging: Each bag contains 3 capsules of the drug, with 0.8 g of desiccant added. It is encapsulated with double-layer composite aluminum foil paper at a sealing temperature of 120 °C and a sealing time of 3 seconds. The batch number and expiration date are marked on the packaging bag.

[0076] Example Two:

[0077] Ratio of Medicinal Materials:

[0078] Magnolia Flower Bud: 10 parts; Astragalus Root: 4 parts; Kudzu Root: 6 parts; Calculus Bovis: 1.5 parts; Moschus: 0.2 parts; Pangolin Scales: 1.5 parts; Honeysuckle Flower: 8 parts; Centipeda minima: 1 part; Dahurian Angelica Root: 3 parts; Saposhnikovia Root: 2 parts; Cicada Slough: 0.3 part; Acorus Calamus: 1 part; Dark Plum: 2 parts; Asarum: 0.8 part; Borneol: 0.4 part; Mentha: 1.5 parts.

[0079] Preparation Method:

[0080] 1. Medicinal Material Treatment: Remove impurities on the surface of the medicinal materials, wash them 3 times, and air-dry them in a drying oven at 50 °C for 13 hours to ensure a moisture content of 9%.

[0081] 2. Medicinal Material Pulverization: Use a pneumatic ultrafine pulverizer to control the particle size of the medicinal powder at 250 mesh, with a particle size difference not exceeding 5%.

[0082] 3. Soaking and Extraction: Prepare a mixed solvent with a volume ratio of 75% ethanol to pure water of 1:1. The ratio of medicinal materials to the solvent is 1:12. Soak at room temperature for 6 days, and stir for 30 minutes every 24 hours.

[0083] 4. Filtration and Fermentation of the Medicinal Liquid: Coarsely filter with a 320-mesh stainless steel sieve, and then filter twice with a 5-μm medium-speed filter paper. Transfer the filtered liquid to a temperature-controlled fermentation tank, add 4% compound probiotics, ferment at 35 °C for 8 days, aerate for 2 hours every day, and control the pH value at 5.8.

[0084] 5. Clarification Treatment: Centrifuge at a speed of 5000 rpm for 20 minutes, and filter with a thin film with a pore size of 0.4 μm to obtain a clarified medicinal liquid.

[0085] 6. Dripping and Air-Drying: Drip the medicinal liquid onto the surface of the sponge at a dose of 0.7 mL per capsule, and air-dry at 25 °C for 14 hours.

[0086] 7. Encapsulation and Packaging: Each bag contains 2 capsules of the drug, with 0.9 g of desiccant added. It is encapsulated with double-layer composite aluminum foil paper at a sealing temperature of 125 °C and a sealing time of 2 seconds. The batch number and expiration date are marked on the packaging bag.

[0087] Example Three:

[0088] Ratio of Medicinal Materials:

[0089] Magnolia flower: 8 parts; Astragalus membranaceus: 5 parts; Kudzu root: 7 parts; Calculus bovis: 0.8 part; Moschus: 0.1 part; Manis pentadactyla: 3 parts; Honeysuckle flower: 10 parts; Herba Centipedae: 1 part; Angelica dahurica: 5 parts; Saposhnikovia divaricata: 4 parts; Periostracum cicadae: 0.5 part; Acorus calamus: 1.2 parts; Fructus mume: 4 parts; Asarum sieboldii: 1.2 parts; Borneol: 0.2 part; Mentha haplocalyx: 2 parts.

[0090] Preparation method:

[0091] 1. Medicinal material treatment: Remove surface impurities, wash 4 times, air-dry at 50 °C for 17 hours to ensure that the moisture content is controlled at 9%.

[0092] 2. Medicinal material pulverization: Pulverize using a pneumatic ultrafine pulverization device, control the particle size at 150 mesh, and control the particle size difference within 8%.

[0093] 3. Soaking extraction: Prepare a mixed solvent of ethanol and water at a ratio of 1:1, with an ethanol concentration of 85%, and a ratio of medicinal materials to solvent of 1:11. Soak at room temperature for 7 days, and stir for 30 minutes every 24 hours.

[0094] 4. Liquid medicine filtration and fermentation: First, conduct rough filtration through a 300-mesh sieve, then conduct secondary filtration using a filter paper with a pore size of 10 μm, transfer to a fermentation tank, add 3% compound probiotics, and ferment aerobically at 30 °C for 7 days. Ventilate for 2 hours every day, and control the pH value at 6.0 during fermentation.

[0095] 5. Clarification treatment: The centrifuge speed is 4500 rpm, the centrifugation time is 18 minutes, and the filtration pore size is 0.5 μm to obtain clarified liquid medicine.

[0096] 6. Dripping and air-drying: Drip the liquid medicine onto the surface of the chitosan foam sponge at 0.6 mL / granule, and air-dry for 12 hours, with the temperature controlled at 27 °C.

[0097] 7. Encapsulation and packaging: Encapsulate 3 pills of the drug in each bag, add 0.7 g of desiccant, encapsulate using composite aluminum foil paper, seal at a temperature of 118 °C for 3 seconds, and mark the batch number and expiration date.

[0098] Experiment 1:

[0099] Experiment purpose: Evaluate the performance of different examples (Examples 1-3) and comparative examples (Comparative Examples 1-6) in terms of drug efficacy and stability, including the therapeutic effect of the drug on rhinitis symptoms and storage stability.

[0100] Experiment steps:

[0101] 1. Drug preparation:

[0102] Prepare drugs according to the formulas of Examples 1-3 and Comparative Examples 1-6 respectively, and ensure that the dosage, ratio, and preparation process of each group of drugs fully meet the standards in the claims.

[0103] When packaging the drug, 2 - 3 pills are encapsulated in each group, and a desiccant is added.

[0104] 2. Efficacy test:

[0105] An efficacy test is conducted using a mouse rhinitis model. Twenty healthy mice are selected and divided into 8 groups (1 group for each example and comparative example, 3 mice / group).

[0106] The drug is dropped into the nasal cavity of each mouse, and the alleviation of rhinitis symptoms is observed according to the following criteria:

[0107] Nasal congestion (0: asymptomatic, 1: mild nasal congestion, 2: severe nasal congestion)

[0108] Runny nose (0: no runny nose, 1: mild runny nose, 2: profuse runny nose)

[0109] Record the symptom changes before treatment, 1 hour, 24 hours, and 48 hours after treatment, and calculate the improvement in the effect of drug treatment (the degree of symptom alleviation).

[0110] 3. Stability test:

[0111] Each group of drug samples is stored in an environment of normal temperature (25°C) and high humidity (40°C, relative humidity 80%) for 30 days.

[0112] Every 7 days, detect the appearance of the drug (whether there is deterioration or discoloration), the content of the active ingredient (detected by HPLC), the sealing tightness of the package, and the integrity of the packaging bag.

[0113] Use an airtightness test device to check the sealing tightness of the package and record the changes.

[0114] 4. Data recording and analysis:

[0115] Record the data on the improvement of drug efficacy and calculate the symptom improvement index for each group.

[0116] Summarize the stability data of each group of drugs, mainly focusing on the retention rate of the active ingredient of the drug, the change in the appearance of the drug, and the integrity of the packaging.

[0117] 5. Experiment conclusion and result analysis:

[0118] Comprehensively evaluate the drug treatment effects of each example and comparative example, and analyze the influence of the formulation and encapsulation process on drug efficacy and stability (the experimental results are shown in Table 1).

[0119] Table 1: Experimental data of drug efficacy and stability

[0120]

[0121]

[0122] As can be seen from Table 1:

[0123] The experimental results show that the drug formulations of Example 1 and Example 2 perform well in terms of drug efficacy, probably because the component ratios are more in line with the synergistic effects of the active ingredients. The relatively high retention rate of the active ingredients and the relatively small decline rate of drug efficacy verify the effectiveness and stability of these ratios in pharmacological effects.

[0124] In terms of stability, the data in the experiment also show that the retention of the active ingredients of the drug is closely related to its encapsulation process. The packaging of Example 1 and Example 3 has good sealing performance, which can effectively prevent moisture from entering, thereby reducing the degradation of the active ingredients of the drug. The appearance of the drug remains good, without obvious discoloration or mildew, indicating that the combination of the medicinal materials used in the formulation and the encapsulation technology effectively extends the stability period of the drug. In the comparative group, especially in Comparative Example 1 and Comparative Example 2, obvious appearance changes such as discoloration and mildew occurred during storage, which may be related to the instability of the active ingredients caused by improper encapsulation process or unreasonable medicinal material ratio.

[0125] From the perspective of drug mechanism, components such as mint and asarum play a key role in the rapid relief of drug efficacy, and these components have an important impact on the release rate and absorption rate of the drug. In Example 1 and Comparative Example 6, the optimization of the mint ratio may accelerate the exertion of drug efficacy. Especially when the mint component is reduced in the comparative group, the persistence of drug efficacy is poor. The air-drying effect of the drug and the release characteristics of the drug in the body are also affected by the formulation and production process. During the air-drying process, the adsorption amount and uniformity of the liquid medicine are directly related to the persistence of drug efficacy. The formulation optimization of Example 1 and Example 3 ensures the uniform distribution of the liquid medicine, which helps the more uniform release of the drug in the body, thereby improving the treatment effect.

[0126] Experiment 2:

[0127] Experimental purpose: To evaluate the liquid medicine adsorption effect and the extraction efficiency of active ingredients after air-drying of different examples (Example 1 - 3) and comparative examples (Comparative Example 1 - 6).

[0128] Experimental steps:

[0129] 1. Drug preparation:

[0130] Prepare the liquid medicine according to the formulations of Example 1 - 3 and Comparative Example 1 - 6 respectively, and keep the drug doses of each example and comparative example consistent to ensure that the drug doses of each group are the same.

[0131] After the liquid medicine is prepared, drop it into the sponge body for adsorption in the same method.

[0132] 2. Liquid medicine adsorption:

[0133] Place each group of spongy bodies in a clean experimental environment to ensure consistent temperature and humidity conditions.

[0134] Add a fixed dose of liquid medicine to each group of spongy bodies, and control the amount of liquid medicine added each time to be consistent.

[0135] After the liquid medicine is adsorbed, place the spongy bodies in a ventilated environment for natural air drying. The air drying time for each group of liquid medicine is kept consistent, and record the mass change of the spongy bodies before and after air drying.

[0136] Record the liquid medicine adsorption amount (i.e., the total mass of the adsorbed liquid medicine) of each spongy body, and ensure that there are 5 spongy bodies in each group as samples.

[0137] 3. Extraction efficiency test:

[0138] Analyze the content of the main active ingredients (such as Astragalus membranaceus, Magnolia liliflora Desr., etc.) in the extract by high performance liquid chromatography (HPLC) and gas chromatography (GC).

[0139] Compare the extraction rates of the active ingredients in different examples and comparative examples, calculate the extraction efficiency (percentage) of each group, and analyze the influence of the air drying process on the extraction of the active ingredients.

[0140] 4. Data recording and analysis:

[0141] Record the liquid medicine adsorption amount, the drug mass change after air drying, and the extraction efficiency of each group.

[0142] Compare the differences in liquid medicine adsorption and active ingredient extraction efficiency after air drying among different groups, analyze the differences among groups, and discuss the relevance of air drying conditions, formulations, and drug extraction.

[0143] 5. Experiment end and result analysis:

[0144] Summarize all data, evaluate the liquid medicine adsorption effect and extraction efficiency during the air drying process of different examples and comparative examples. Combining the extraction rate and the stability of the drug components, put forward optimization suggestions (the experimental results are shown in Table 2).

[0145] Table 2: Experimental data of air drying effect and extraction efficiency

[0146]

[0147] It can be obtained from Table 2 that:

[0148] The results of Experiment 2 revealed the crucial roles of the drug formulation and the air-drying process in the liquid medicine adsorption effect and the extraction efficiency of active ingredients. Among them, the air-drying process promoted the uniform distribution of active ingredients in the liquid medicine on the carrier material by evaporating water, and this process was affected by the interaction between drug molecules and the carrier. The liquid medicine adsorption amounts after air-drying in Example 1 and Example 3 were relatively large, indicating that the adsorption force between drug molecules and the carrier in these two formulations was stronger, and the active ingredients in the liquid medicine could be fixed on the carrier more effectively. Especially in Example 3, due to the component ratio and structural characteristics in the drug being more conducive to binding with the carrier, during the air-drying process, the stability of drug molecules and the retention rate of active ingredients were relatively high, and the final extraction rate was relatively excellent.

[0149] In terms of the mechanism of extraction efficiency, the solubility and volatility of drug active ingredients are crucial for the extraction effect. The formulations of Example 1 and Example 3 optimized the solubility of drug components, enabling the active ingredients to dissolve fully during the extraction process, thereby improving the extraction rate. Especially in Example 3, due to some components in the formulation being more hydrophilic, the active ingredients in the liquid medicine could be better adsorbed by the carrier and maintained a relatively high concentration during the extraction process. In contrast, the drug formulations of Comparative Example 1 and Comparative Example 5 had problems of poor solubility or excessive volatility during the extraction process, resulting in significant losses of active ingredients during the air-drying process, thereby affecting the extraction efficiency.

[0150] The air-drying process is not only a process of water evaporation but also involves the migration and fixation of drug components in the carrier. The relatively high extraction efficiency of Example 1 and Example 3 is closely related to the uniform thin film formed by liquid medicine molecules on the surface of the carrier during the air-drying process. The uniform distribution of the liquid medicine helps to release more active ingredients during the extraction process, while the low extraction efficiency of the comparative example groups is closely related to the non-uniform distribution of the drug on the carrier and the unstable binding force. The stability of the drug during the air-drying process is jointly affected by temperature, humidity, and the nature of the drug components themselves, and these factors directly determine the preservation and release effects of the medicinal components in the final drug.

[0151] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A drug for treating rhinitis, characterized in that: The medicine for treating rhinitis comprises the following components in parts by weight: Magnolia: 5-15 parts; Astragalus: 3-10 parts; Pueraria root: 2-8 parts; Bezoar: 0.5-2 parts; Musk: 0.1-0.5 parts; Pangolin: 1-4 servings; Honeysuckle: 4-12 portions; Geese do not eat grass: 0.5-2 servings; Angelica dahurica: 2-6 parts; Windproof: 1-5 servings; Huatui: 0.2-1 part; Calamus: 0.5-2 parts; Black plum: 1-4 servings; Asarum: 0.5-1.5 parts; Borneol: 0.1-0.5 parts; Mint: 1-3 servings.

2. A method for preparing a drug for treating rhinitis, characterized in that: The method for preparing a drug for treating rhinitis as described in claim 1 comprises the following steps: S1. Medicinal material processing: remove impurities from each medicinal material and clean it, then dry it; S2. Crush the medicinal materials: Crush the dried medicinal materials to make the powder uniform; S3, soaking and extraction: adding the crushed medicinal materials into the solvent for soaking and extraction to ensure the extraction of effective ingredients; S4, liquid medicine filtration and fermentation: filtering the liquid medicine after soaking, adding probiotics for fermentation to promote the biotransformation of ingredients; S5, clarification treatment: centrifuging and thin-layer filtering the fermented medicinal liquid to obtain a medicinal liquid; S6, dripping and air drying: dripping the drug solution into the natural sponge and air drying to ensure that the drug solution is completely absorbed; S7. Encapsulation and packaging: Encapsulate the sponge that absorbs the drug solution and carry out appropriate packaging treatment to ensure the stability of the drug.

3. The method for preparing a drug for treating rhinitis according to claim 2, characterized in that: The medicinal material processing includes: Remove surface impurities and sand from the raw materials one by one and rinse with clean water 2-4 times; Place the cleaned medicinal materials in a drying oven and air-dry them at 50-60°C for 12-18 hours; After drying, the moisture content of each medicinal material is controlled between 8 and 10%.

4. The method for preparing a drug for treating rhinitis according to claim 2, characterized in that: The medicinal material pulverization comprises: Use airflow ultrafine grinding equipment to grind the dried medicinal materials; The particle size of the powder after crushing is controlled within 100-300 meshes, and the particle size difference is controlled within the range of 5-10%; Finally, mix all the powders evenly.

5. The method for preparing a drug for treating rhinitis according to claim 2, characterized in that: The soaking extraction comprises: Prepare a mixed solvent with a volume ratio of ethanol to pure water of 1:1, and the ethanol concentration is 75-85%; Put the drug powder into the mixed solvent, the mass ratio of drug material to solvent is 1:10-1:12; Seal and soak at room temperature 25℃-30℃ for 6-8 days. Stir for 25-35 minutes every 22-26 hours during the soaking process.

6. The method for preparing a drug for treating rhinitis according to claim 2, characterized in that: The liquid filtration and fermentation comprises: After soaking, it is first coarsely filtered through a 280-320 mesh stainless steel screen, and then filtered twice through a medium-speed filter paper with a pore size of 5-13μm; The filtrate is transferred into a temperature-controlled fermentation tank, and 1 to 5% of the volume of the fermentation liquid is added with composite probiotics, the strains of which include lactic acid bacteria and Bacillus subtilis; Aerobic fermentation was carried out at 30°C-35°C for 6-8 days with daily aeration for 1.5-2.5 hours. The pH value was controlled at 5.5-6.5 during the fermentation period.

7. The method for preparing a drug for treating rhinitis according to claim 2, characterized in that: The clarification process includes: The fermentation liquid is centrifuged using a centrifuge at a speed of 4000-6000 rpm for 15-20 minutes; After centrifugation, thin-layer membrane filtration is performed with the membrane pore size controlled at 0.4-0.5 microns to obtain a clarified drug solution for use.

8. The method for preparing a drug for treating rhinitis according to claim 2, characterized in that: The instillation and air drying include: A natural sponge is selected as a liquid medicine carrier, wherein the sponge is chitosan foam; Evenly drip the drug solution onto the surface of the cavernous body at a dose of 0.5-0.7 mL / pill; Air-dry at 25°C-30°C for 10-14 hours to allow the drug solution to be evenly adsorbed into the carrier.

9. The method for preparing a drug for treating rhinitis according to claim 2, characterized in that: The packaging and packing include: Use double-layer composite aluminum foil paper with a thickness of 7-9 silk for packaging, the inner layer is a polyethylene moisture-proof film, and the outer layer is an aluminum foil layer; The hot pressing sealing equipment is used for sealing, the sealing temperature is 115-125℃, and the sealing time is 2-4 seconds; Each packaging bag contains 2-3 pills of medicine and 0.5-1.0g of desiccant. The product batch number and expiration date are marked on the outside of the packaging bag.

10. Use of the drug for treating rhinitis as claimed in claim 1 in the treatment of rhinitis.

Images