A compound traditional Chinese medicine powder inhaler for respiratory tract infections and its preparation method

Abstract

This invention discloses a compound traditional Chinese medicine powder inhaler for respiratory tract infections and its preparation method, relating to the field of pharmaceutical formulation technology. The compound traditional Chinese medicine powder inhaler for respiratory tract infections is composed of polysaccharide composite gel microspheres, forsythia, scutellaria, honeysuckle, and isatis root. The polysaccharide composite gel microspheres are composed of seaweed sulfated polysaccharide, lentinan, calcium chloride, and curcumin. Seaweed sulfated polysaccharide, lentinan, curcumin, and calcium chloride cross-link to form a three-dimensional network spherical structure, improving the particle morphology and flowability of the micropowder. Furthermore, due to its good hygroscopic and moisturizing properties, it competitively reduces the moisture absorption of the micropowder, preventing aggregation and further improving flowability. In addition, the gel microspheres have excellent adhesion, adhering to the infection site after entering the respiratory tract, reducing expulsion losses due to respiration, maintaining an effective drug concentration at the infection site, and improving therapeutic efficacy.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically referring to a compound traditional Chinese medicine powder inhaler for respiratory tract infections and its preparation method. Background Technology

[0002] Respiratory viruses are a collective term for a variety of seasonal and infectious viruses. Among them, the most common and prevalent viruses include respiratory syncytial virus, influenza virus, coronavirus, adenovirus, and rhinovirus. Mild respiratory virus infections can cause symptoms such as cough, fever, and runny nose, while severe infections can lead to pneumonia, asthma, and even death. Respiratory diseases are difficult to cure completely due to their wide spread, easy mutation, and tendency to develop drug resistance. Although chemical drugs are effective and fast-acting, their use is limited by drug resistance and adverse reactions. Traditional Chinese medicine, rooted in thousands of years of Chinese traditional culture, has a place in the prevention and treatment of respiratory diseases due to its unique theories and safe and definite curative effects.

[0003] Powder inhalers refer to a class of preparations in which one or more micronized drugs and carriers are stored in multiple dose reservoirs such as capsules or vesicles. After being administered through a special drug delivery device, the drugs enter the respiratory tract in dry powder form, allowing them to reach the treatment site or the lungs to exert systemic or local effects for therapeutic purposes. The drugs in powder inhalers are absorbed through the rich capillaries under the respiratory mucosa, and have the characteristics of targeted, high efficiency, rapid effect, low toxicity and side effects, and high bioavailability. They also avoid the problem of difficult synergistic effects of aerosol drug delivery and do not require the use of propellants, thus having unique advantages in the treatment of respiratory tract infections.

[0004] The existing technology currently has the following main problems:

[0005] After being micronized, Chinese medicine particles tend to aggregate, and their hygroscopicity also negatively affects dispersion, resulting in poor flowability. When administered via inhalation, the particles are expelled during respiration, making it difficult for them to settle at the site of respiratory infection, thus reducing the absorption rate and consequently lowering the efficacy. Summary of the Invention

[0006] In view of the above situation and to overcome the defects of the prior art, the present invention proposes a compound traditional Chinese medicine powder inhaler for respiratory tract infections, comprising the following components in parts by weight: 40-60 parts of polysaccharide composite gel microspheres, 5-10 parts of forsythia, 5-10 parts of scutellaria, 5-10 parts of honeysuckle, and 5-10 parts of isatis root.

[0007] The polysaccharide composite gel microspheres comprise the following components in parts by weight: 5-8 parts of seaweed sulfated polysaccharide, 5-10 parts of lentinan, 3-5 parts of calcium chloride, and 1-3 parts of curcumin.

[0008] The preparation method of the polysaccharide composite gel microspheres specifically includes the following steps:

[0009] (1) Wash the dried shiitake mushrooms, dry them at 50-60℃, pulverize them, and put 6-10g into an Erlenmeyer flask with a sieve mesh size of 40-60 mesh. Add 200mL of water and heat and stir in a constant temperature water bath for extraction. Control the temperature at 65-75℃ and the extraction time at 1-3h. The pH should be 6.0-7.0. If the extraction temperature is too high or the extraction time is too long, the polysaccharides will gradually oxidize and be lost. Therefore, it is necessary to strictly control the temperature and time. Since polysaccharides are easily degraded in acidic and alkaline environments, controlling the pH during extraction is beneficial to protect the shiitake mushroom polysaccharides and thus improve the extraction rate. Filter with double-layer gauze, transfer the obtained solids to the original Erlenmeyer flask, and extract 2-3 times again. Combine the filtrates obtained from each extraction and concentrate them under vacuum to 100-150mL. Add an 80-90% ethanol solution to the concentrate at a volume ratio of 1:1, allow to stand for 20-24 hours for alcohol precipitation, centrifuge at 3000-4000 rpm for 10-15 minutes, remove the filtrate, dry the precipitate, and add the crude lentinan to 200 mL of water, stir, then add 50 mL of a mixed solution of chloroform and n-butanol, shake thoroughly for 30-40 minutes, centrifuge at 3000-4000 rpm for 10-15 minutes, separate the chloroform layer and the aqueous layer, and extract with chloroform and n-butanol to effectively remove the protein in the crude polysaccharide, which is beneficial to the purification of the polysaccharide. Take the aqueous layer and freeze-dry it at -40 to -50℃ for 24-48 hours to obtain lentinan.

[0010] (2) Dissolve seaweed sulfate polysaccharide in 50 mL of water, then add the lentinan mentioned in step (1), then add curcumin, stir, stir at 300-500 rpm for 5-10 min. Seaweed sulfate polysaccharide and lentinan can improve the water solubility and stability of curcumin through electrostatic interaction to obtain polysaccharide complex.

[0011] (3) Dissolve calcium chloride in 40 mL of water. Calcium chloride can form complexes with the active groups of polysaccharides and curcumin to enhance antibacterial properties and obtain calcium chloride solution.

[0012] (4) Microspheres are prepared by electro-spraying the polysaccharide complex described in step (2) into a receiving device containing the calcium chloride solution described in step (3). During the electro-spraying process, the ambient temperature is 20-30℃, the voltage is 10-20kV, the propulsion rate is 20-25μL / min, and the receiving distance is 15-20cm. The average particle size of the prepared particles is 1-2μm. The microspheres prepared by this process have high roundness and integrity. The process is simple and easy to operate. A large number of microspheres can be prepared in a short time. Then, the mixture is stirred at 100-200rpm for 30-50min, filtered, and dried to obtain polysaccharide composite gel microspheres.

[0013] Preferably, in step (1), the volume ratio of chloroform to n-butanol in the mixed solution is (4-5):1. The mixed solution of chloroform and n-butanol removes proteins more gently and does not affect the polysaccharide structure.

[0014] Preferably, in step (2), the mass fraction of seaweed sulfate polysaccharide is 2-4%, the mass fraction of lentinan is 3-5%, and the mass fraction of curcumin is 0.5-1.5%. Lentinan and curcumin can act as immune enhancers and work synergistically to combat respiratory infections.

[0015] Preferably, in step (3), the mass fraction of calcium chloride as a crosslinking agent is 2-3%.

[0016] This invention also provides a method for preparing a compound traditional Chinese medicine powder inhaler for respiratory tract infections, specifically including the following steps:

[0017] S1. Add 10-20g of Forsythia suspensa, 10-20g of Scutellaria baicalensis, 10-20g of Lonicera japonica and 10-20g of Isatis indigotica to 1000mL of water and soak in a decoction machine for 2-4 hours. The compound Chinese medicine mainly treats respiratory tract infections by directly killing the virus, inhibiting viral replication, reducing severe inflammatory response, and strengthening the body's immune response to the virus. Decoction is carried out 1-2 times, with gentle boiling for 2-4 hours. The decoctions are combined, the filter residue is discarded, and the collected filtrate is concentrated to 1 / 8-1 / 5 of the original volume. Vacuum pressure -0.06MPa, temperature 40-50℃, spray drying is carried out, and the average particle size of the prepared particles is 2-3μm, thus obtaining Chinese medicine micro powder.

[0018] S2. Mix the Chinese herbal powder described in step S1 with polysaccharide composite gel microspheres evenly, and then package them into No. 1-3 capsules to obtain a compound Chinese herbal powder inhaler for respiratory tract infections.

[0019] Preferably, in step S1, during spray drying, the spray pressure is 0.6-0.8 MPa, the feed rate is 10-20 mL / min, the air inlet temperature is 40-50°C, and the drying time is 30-50 min. Spray drying is beneficial for protecting the heat-labile active ingredients in traditional Chinese medicine and can also obtain small-diameter particles, which is beneficial for improving their flowability.

[0020] Preferably, in step S2, during the mixing process, the mixing speed is 500-600 rpm and the mixing time is 20-30 min, which is beneficial to improve the uniformity of the traditional Chinese medicine powder and the polysaccharide composite gel microspheres, and better exert the role of the polysaccharide composite gel microspheres in assisting to improve the flowability and dispersibility of the traditional Chinese medicine powder.

[0021] The beneficial effects achieved by this invention are as follows:

[0022] This invention utilizes polysaccharide composite gel microspheres as a carrier for traditional Chinese medicine powders, increasing the powder's flowability and enhancing its antiviral properties. This allows for effective deposition at respiratory infection sites, improving therapeutic efficacy. The polysaccharide composite gel microspheres contain cross-linked seaweed sulfate polysaccharide, lentinan, curcumin, and calcium chloride, forming a three-dimensional network spherical structure. This improves the particle morphology of the powder, reduces the number of contact points between powder particles, and lowers the adhesion between particles, thereby enhancing the powder's flowability. Furthermore, the gel microspheres possess excellent hygroscopic and moisturizing properties, competitively reducing the moisture absorption of the powder. This prevents the aggregation of microparticles and improves their flowability. Furthermore, the gel microspheres possess excellent adhesion, allowing them to adhere to the site of infection after entering the respiratory tract, reducing respiratory losses, increasing residence time, and maintaining an effective drug concentration at the site of infection, thus improving therapeutic efficacy. Lentinan gives the polysaccharide-based gel microspheres broad antiviral adaptability. By first interacting with cells, which then adsorb the virus, it inhibits the synthesis and replication of the virus within the cell. This reduction and blocking of viral adsorption achieves a strong antiviral effect. Seaweed sulfated polysaccharide, lentinan... Sugars, through electrostatic interactions, increase the water solubility and stability of curcumin, thereby improving its bioavailability, enhancing the immunomodulatory function of lentinan, effectively combating respiratory viral infections, accelerating pathogen clearance, inhibiting inflammatory cell activity, reducing the release of inflammatory factors, significantly alleviating respiratory symptoms, protecting the lungs from oxidative damage, and preventing the formation and development of pulmonary nodules. Calcium ions in calcium chloride can coordinate with the hydroxyl groups of polysaccharides, reducing the electrostatic repulsion between polysaccharide molecules, resulting in more uniform dispersion, and altering its viscosity and flow properties. The presence of calcium ions enhances the antiviral activity of the polysaccharide. Calcium ions can form complexes with the active groups of curcumin, protecting the stability and activity of curcumin and enhancing its immune function, thereby improving its antiviral effect. Simultaneously, calcium ions can reduce tissue permeability, preventing the release of allergic mediators and the occurrence of inflammatory responses. This invention uses polysaccharide composite gel microspheres, forsythia, scutellaria, honeysuckle, and isatis root to create a compound traditional Chinese medicine powder spray for respiratory tract infections. This significantly enhances fluidity and antiviral activity, and effectively deposits at the site of respiratory tract infection, improving therapeutic efficacy. Attached Figure Description

[0023] Figure 1 This is a scanning electron microscope image of the polysaccharide composite gel microspheres prepared in Example 1 of the present invention;

[0024] Figure 2 The diagram shows the repose angle results of Embodiments 1-4 and Comparative Examples 1-3 of the present invention;

[0025] Figure 3 These are antiviral results from Examples 1-4 and Comparative Examples 1-3 of the present invention;

[0026] Figure 4 The graph shows the treatment efficacy results of Examples 1-4 and Comparative Examples 1-3 of the present invention. Detailed Implementation

[0027] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The preferred embodiments and materials described herein are for illustrative purposes only and do not limit the scope of this application.

[0029] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods; unless otherwise specified, the experimental materials used in the following embodiments are all purchased from commercial channels.

[0030] The reagents used in the examples were sourced from the following sources:

[0031] Seaweed sulfated polysaccharide, brand name Yuanye, product number S29758-1g;

[0032] Curcumin CAS No: 458-37-7, Brand: Innochem, Product No.: A61061

[0033] Calcium chloride CAS No: 10043-52-4, brand Innochem, item number A01289;

[0034] Anhydrous ethanol CAS No: 64-17-5, Brand: Innochem, Product No. G00004;

[0035] Chloroform CAS No: 67-66-3, brand Fisher, item number BP1145-1;

[0036] n-Butanol CAS No: 71-36-3, brand Innochem, product number A38969.

[0037] Example 1

[0038] This embodiment proposes a compound traditional Chinese medicine powder inhaler for respiratory tract infections, comprising the following components in parts by weight: 60 parts polysaccharide composite gel microspheres, 10 parts forsythia, 10 parts scutellaria, 10 parts honeysuckle, and 10 parts isatis root.

[0039] The polysaccharide composite gel microspheres comprise the following components in parts by weight: 8 parts seaweed sulfated polysaccharide, 10 parts shiitake mushroom polysaccharide, 5 parts calcium chloride, and 3 parts curcumin.

[0040] The preparation method of polysaccharide composite gel microspheres specifically includes the following steps:

[0041] (1) Wash the dried shiitake mushrooms, dry them at 60℃, crush them, and put 10g into an Erlenmeyer flask with a 60-mesh sieve. Add 200mL of water and heat and stir in a constant temperature water bath for extraction. Control the temperature at 75℃, the extraction time at 3h, and the pH at 7.0. Because excessively high extraction temperature and long extraction time will cause polysaccharides to gradually oxidize and be lost, it is necessary to strictly control the temperature and time. Also, because polysaccharides are easily degraded in acidic and alkaline environments, controlling the pH during extraction is beneficial to protect the shiitake mushroom polysaccharides and thus improve the extraction rate. Filter with double-layer gauze, transfer the obtained solids to the original Erlenmeyer flask, and extract three more times. Combine the filtrates obtained from each extraction and concentrate them under vacuum to 150mL. Add 90% (by volume) of the concentrate to the concentrate at a volume ratio of 1:1. The ethanol solution was allowed to stand for 24 hours for alcohol precipitation, then centrifuged at 4000 rpm for 15 minutes. The filtrate was removed, and the precipitate was dried to obtain crude lentinan. The lentinan was added to 200 mL of water and stirred. Then, 50 mL of a mixed solution of chloroform and n-butanol was added. The volume ratio of chloroform to n-butanol in the mixed solution was 5:1. The mixed solution of chloroform and n-butanol removes proteins more gently and does not affect the polysaccharide structure. The mixture was shaken thoroughly for 40 minutes, then centrifuged at 4000 rpm for 15 minutes to separate the chloroform and aqueous layers. Extraction with chloroform and n-butanol effectively removes proteins from the crude polysaccharide, which is beneficial for polysaccharide purification. The aqueous layer was freeze-dried at -50℃ for 48 hours to obtain lentinan.

[0042] (2) Dissolve seaweed sulfate polysaccharide in 50 mL of water, then add lentinan from step (1), and then add curcumin. The mass fraction of seaweed sulfate polysaccharide is 4%, the mass fraction of lentinan is 5%, and the mass fraction of curcumin is 1.5%. Lentinan and curcumin can be used as immune enhancers to synergistically combat respiratory infections. Stir at 500 rpm for 10 min. Seaweed sulfate polysaccharide and lentinan can improve the water solubility and stability of curcumin through electrostatic interaction to obtain a polysaccharide complex.

[0043] (3) Dissolve calcium chloride in 40 mL of water as a crosslinking agent. The mass fraction of calcium chloride is 3%. Calcium chloride can form complexes with the active groups of polysaccharides and curcumin to enhance antibacterial properties and obtain calcium chloride solution.

[0044] (4) Microspheres are prepared by electro-spraying the polysaccharide complex described in step (2) into a receiving device containing the calcium chloride solution described in step (3). During the electro-spraying process, the ambient temperature is 30℃, the voltage is 20kV, the propulsion rate is 25μL / min, and the receiving distance is 20cm. The average particle size of the prepared particles is 2μm. The microspheres prepared by this process have high roundness and integrity. The process is simple and easy to operate. A large number of microspheres can be prepared in a short time. Then, the mixture is stirred at 200rpm for 50min, filtered, and dried to obtain polysaccharide composite gel microspheres.

[0045] This embodiment provides a method for preparing a compound traditional Chinese medicine powder inhaler for respiratory tract infections, specifically including the following steps:

[0046] S1. 20g of Forsythia suspensa, 20g of Scutellaria baicalensis, 20g of Lonicera japonica, and 20g of Isatis indigotica were added to 1000mL of water and soaked in a decoction machine for 4 hours. The compound Chinese medicine mainly treats respiratory infections by directly killing the virus, inhibiting viral replication, reducing severe inflammatory response, and strengthening the body's immune response to the virus. The decoction was boiled twice and extracted by gentle boiling for 4 hours. The decoctions were combined, the filter residue was discarded, and the collected filtrate was concentrated to 1 / 5 of the original volume. The vacuum pressure was -0.06MPa, the temperature was 50℃, and the spray drying was carried out. The average particle size of the prepared particles was 2μm. During the spray drying, the spray pressure was 0.8MPa, the feed rate was 20mL / min, the air inlet temperature was 50°C, and the drying time was 50min. Spray drying is beneficial for protecting the heat-labile effective components in Chinese medicine and can also obtain small-diameter particles, which is beneficial for improving their flow properties and obtaining Chinese medicine micro powder.

[0047] S2. Mix the Chinese herbal powder and polysaccharide composite gel microspheres as described in step S1 evenly. During the mixing process, the mixing speed is 600 rpm and the mixing time is 30 min. This helps to improve the uniformity of the Chinese herbal powder and polysaccharide composite gel microspheres and better exert the role of polysaccharide composite gel microspheres in improving the flowability and dispersibility of the Chinese herbal powder. Then, use No. 3 capsules for dispensing to obtain a compound Chinese herbal powder inhaler for respiratory tract infections.

[0048] In this embodiment, the prepared polysaccharide composite gel microspheres were observed using scanning electron microscopy to examine their microstructure. Figure 1 The image shows a 10,000x magnified SEM image of the polysaccharide composite gel microspheres prepared in Example 1. As shown in the figure, the polysaccharide composite gel microspheres prepared in this example have a spherical structure.

[0049] Example 2

[0050] This embodiment proposes a compound traditional Chinese medicine powder inhaler for respiratory tract infections, comprising the following components in parts by weight: 40 parts polysaccharide composite gel microspheres, 5 parts forsythia, 5 parts scutellaria, 5 parts honeysuckle, and 5 parts isatis root.

[0051] The polysaccharide composite gel microspheres comprise the following components in parts by weight: 5 parts seaweed sulfated polysaccharide, 5 parts shiitake mushroom polysaccharide, 3 parts calcium chloride, and 1 part curcumin.

[0052] The preparation method of polysaccharide composite gel microspheres specifically includes the following steps:

[0053] (1) Wash the dried shiitake mushrooms, dry them at 50℃, crush them, and put 6g into an Erlenmeyer flask with a sieve mesh size of 40 mesh. Add 200mL of water and heat and stir in a constant temperature water bath for extraction. Control the temperature at 65℃, the extraction time at 1h, and the pH at 6.0. Because excessively high extraction temperature and long extraction time will cause polysaccharides to gradually oxidize and be lost, it is necessary to strictly control the temperature and time. Also, because polysaccharides are easily degraded in acidic and alkaline environments, controlling the pH during extraction is beneficial to protect the shiitake mushroom polysaccharides and thus improve the extraction rate. Filter with double-layer gauze, transfer the obtained solids to the original Erlenmeyer flask, and extract twice more. Combine the filtrates obtained from each extraction and concentrate them under vacuum to 100mL. Add 80% by volume to the concentrate at a volume ratio of 1:1. Ethanol solution was allowed to stand for 20 hours for alcohol precipitation, then centrifuged at 3000 rpm for 10 minutes. The filtrate was removed, and the precipitate was dried to obtain crude lentinan. The lentinan was added to 200 mL of water and stirred. Then, 50 mL of a mixed solution of chloroform and n-butanol was added. The volume ratio of chloroform to n-butanol in the mixed solution was 4:1. The mixed solution of chloroform and n-butanol removes proteins more gently and does not affect the polysaccharide structure. The mixture was shaken thoroughly for 30 minutes, then centrifuged at 3000 rpm for 10 minutes to separate the chloroform and aqueous layers. Extraction with chloroform and n-butanol effectively removes proteins from the crude polysaccharide, which is beneficial for polysaccharide purification. The aqueous layer was freeze-dried at -40℃ for 24 hours to obtain lentinan.

[0054] (2) Dissolve seaweed sulfate polysaccharide in 50 mL of water, then add lentinan from step (1), and then add curcumin. The mass fraction of seaweed sulfate polysaccharide is 2%, the mass fraction of lentinan is 3%, and the mass fraction of curcumin is 0.5%. Lentinan and curcumin can be used as immune enhancers to synergistically combat respiratory infections. Stir at 300 rpm for 5 min. Seaweed sulfate polysaccharide and lentinan can improve the water solubility and stability of curcumin through electrostatic interaction to obtain a polysaccharide complex.

[0055] (3) Dissolve calcium chloride in 40 mL of water as a crosslinking agent. The mass fraction of calcium chloride is 2%. Calcium chloride can form complexes with the active groups of polysaccharides and curcumin to enhance antibacterial properties and obtain calcium chloride solution.

[0056] (4) Microspheres are prepared by electro-spraying the polysaccharide complex described in step (2) into a receiving device containing the calcium chloride solution described in step (3). During the electro-spraying process, the ambient temperature is 20℃, the voltage is 10kV, the propulsion rate is 20μL / min, and the receiving distance is 15cm. The average particle size of the prepared particles is 1μm. The microspheres prepared by this process have high roundness and integrity. The process is simple and easy to operate. A large number of microspheres can be prepared in a short time. Then, the mixture is stirred at 100rpm for 30min, filtered, and dried to obtain polysaccharide composite gel microspheres.

[0057] This embodiment provides a method for preparing a compound traditional Chinese medicine powder inhaler for respiratory tract infections, specifically including the following steps:

[0058] S1. Add 10g of Forsythia suspensa, 10g of Scutellaria baicalensis, 10g of Lonicera japonica and 10g of Isatis indigotica to 1000mL of water and soak for 2 hours in a decoction machine. The compound Chinese medicine mainly treats respiratory tract infections by directly killing the virus, inhibiting viral replication, reducing severe inflammatory response, and strengthening the body's immune response to the virus. Decoction is prepared once and extracted by gentle boiling for 2 hours. The decoctions are combined, the filter residue is discarded, and the collected filtrate is concentrated to 1 / 8 of the original volume. Vacuum pressure -0.06MPa, temperature 40℃, spray drying. The average particle size of the prepared particles is 3μm. During spray drying, the spray pressure is 0.6MPa, the feed rate is 10mL / min, the air inlet temperature is 40°C, and the drying time is 30min. Spray drying is beneficial for protecting the heat-labile effective components in Chinese medicine and can also obtain small particle size particles, which is beneficial for improving its flowability and obtaining Chinese medicine micro powder.

[0059] S2. Mix the Chinese herbal powder and polysaccharide composite gel microspheres obtained in step S1 evenly. During the mixing process, the mixing speed is 500 rpm and the mixing time is 20 min. This helps to improve the uniformity of the Chinese herbal powder and polysaccharide composite gel microspheres and better exert the role of polysaccharide composite gel microspheres in improving the flowability and dispersibility of the Chinese herbal powder. Then, use No. 1 capsules for dispensing to obtain a compound Chinese herbal powder inhaler for respiratory tract infections.

[0060] Example 3

[0061] This embodiment proposes a compound traditional Chinese medicine powder inhaler for respiratory tract infections, comprising the following components in parts by weight: 50 parts polysaccharide composite gel microspheres, 7.5 parts forsythia, 7.5 parts scutellaria, 7.5 parts honeysuckle, and 7.5 parts isatis root.

[0062] The polysaccharide composite gel microspheres comprise the following components in parts by weight: 6.5 parts of seaweed sulfated polysaccharide, 7.5 parts of shiitake mushroom polysaccharide, 4 parts of calcium chloride, and 2 parts of curcumin.

[0063] The preparation method of polysaccharide composite gel microspheres specifically includes the following steps:

[0064] (1) Wash the dried shiitake mushrooms, dry them at 55℃, crush them, and put 8g into an Erlenmeyer flask with a sieve mesh size of 50 mesh. Add 200mL of water and heat and stir in a constant temperature water bath for extraction. Control the temperature at 70℃, the extraction time at 2h, and the pH at 6.5. Because excessively high extraction temperature and long extraction time will cause polysaccharides to gradually oxidize and be lost, it is necessary to strictly control the temperature and time. Also, because polysaccharides are easily degraded in acidic and alkaline environments, controlling the pH during extraction is beneficial to protect the shiitake mushroom polysaccharides and thus improve the extraction rate. Filter with double-layer gauze, transfer the obtained solids to the original Erlenmeyer flask, and extract twice more. Combine the filtrates obtained from each extraction and concentrate them under vacuum to 125mL. Add 85% ethanol solution at a volume ratio of 1:1 to the concentrate. The liquid was allowed to stand for 22 hours for alcohol precipitation, then centrifuged at 3500 rpm for 12.5 minutes. The filtrate was removed, and the precipitate was dried to obtain crude lentinan. This was added to 200 mL of water and stirred. Then, 50 mL of a mixed solution of chloroform and n-butanol was added. The volume ratio of chloroform to n-butanol in the mixed solution was 4.5:1. The mixed solution of chloroform and n-butanol removes protein more gently and does not affect the polysaccharide structure. The mixture was shaken thoroughly for 35 minutes, then centrifuged at 3500 rpm for 12.5 minutes to separate the chloroform and aqueous layers. Extraction with chloroform and n-butanol effectively removes protein from the crude polysaccharide, which is beneficial for polysaccharide purification. The aqueous layer was then freeze-dried at -45℃ for 36 hours to obtain lentinan.

[0065] (2) Dissolve seaweed sulfate polysaccharide in 50 mL of water, then add lentinan from step (1), and then add curcumin. The mass fraction of seaweed sulfate polysaccharide is 3%, the mass fraction of lentinan is 4%, and the mass fraction of curcumin is 1%. Lentinan and curcumin can be used as immune enhancers to work synergistically against respiratory infections. Stir at 400 rpm for 7.5 min. Seaweed sulfate polysaccharide and lentinan can improve the water solubility and stability of curcumin through electrostatic interaction to obtain polysaccharide complex.

[0066] (3) Dissolve calcium chloride in 40 mL of water as a crosslinking agent. The mass fraction of calcium chloride is 2.5%. Calcium chloride can form complexes with the active groups of polysaccharides and curcumin to enhance antibacterial properties and obtain calcium chloride solution.

[0067] (4) Microspheres were prepared from the polysaccharide complex described in step (2) using an electro-spraying device. The electro-spraying was performed in a receiving device containing the calcium chloride solution described in step (3). During the electro-spraying process, the ambient temperature was 25℃, the voltage was 15kV, the propulsion rate was 22.5μL / min, and the receiving distance was 17.5cm. The average particle size of the prepared particles was 1.5μm. The microspheres prepared by this process have high roundness and integrity. The process is simple and easy to operate. A large number of microspheres can be prepared in a short time. Then, the mixture was stirred at 150rpm for 40min, filtered, and dried to obtain polysaccharide composite gel microspheres.

[0068] This embodiment provides a method for preparing a compound traditional Chinese medicine powder inhaler for respiratory tract infections, specifically including the following steps:

[0069] S1. Add 15g of Forsythia suspensa, 15g of Scutellaria baicalensis, 15g of Lonicera japonica and 15g of Isatis indigotica to 1000mL of water and soak for 3 hours in a decoction machine. The compound Chinese medicine mainly treats respiratory tract infections by directly killing the virus, inhibiting viral replication, reducing severe inflammatory response, and strengthening the body's immune response to the virus. Decoction is prepared once and extracted by gentle boiling for 3 hours. The decoctions are combined, the filter residue is discarded, and the collected filtrate is concentrated to 1 / 8 of the original volume. Vacuum pressure -0.06MPa, temperature 45℃, spray drying. The average particle size of the prepared particles is 2.5μm. During spray drying, the spray pressure is 0.7MPa, the feed rate is 15mL / min, the air inlet temperature is 45°C, and the drying time is 40min. Spray drying is beneficial for protecting the heat-labile effective components in Chinese medicine and can also obtain small particle size particles, which is beneficial for improving its flowability and obtaining Chinese medicine micro powder.

[0070] S2. Mix the Chinese herbal powder and polysaccharide composite gel microspheres obtained in step S1 evenly. During the mixing process, the mixing speed is 550 rpm and the mixing time is 25 min. This helps to improve the uniformity of the Chinese herbal powder and polysaccharide composite gel microspheres and better exert the role of polysaccharide composite gel microspheres in improving the flowability and dispersibility of the Chinese herbal powder. Then, use No. 2 capsules for dispensing to obtain a compound Chinese herbal powder inhaler for respiratory tract infections.

[0071] Example 4

[0072] This embodiment proposes a compound traditional Chinese medicine powder inhaler for respiratory tract infections, comprising the following components in parts by weight: 60 parts polysaccharide composite gel microspheres, 5 parts forsythia, 5 parts scutellaria, 5 parts honeysuckle, and 5 parts isatis root.

[0073] The polysaccharide composite gel microspheres comprise the following components in parts by weight: 5 parts seaweed sulfated polysaccharide, 5 parts shiitake mushroom polysaccharide, 3 parts calcium chloride, and 1 part curcumin.

[0074] The preparation method of polysaccharide composite gel microspheres specifically includes the following steps:

[0075] (1) Wash the dried shiitake mushrooms, dry them at 60℃, crush them, and put 10g into an Erlenmeyer flask with a 60-mesh sieve. Add 200mL of water and heat and stir in a constant temperature water bath for extraction. Control the temperature at 75℃, the extraction time at 3h, and the pH at 7.0. Because excessively high extraction temperature and long extraction time will cause polysaccharides to gradually oxidize and be lost, it is necessary to strictly control the temperature and time. Also, because polysaccharides are easily degraded in acidic and alkaline environments, controlling the pH during extraction is beneficial to protect the shiitake mushroom polysaccharides and thus improve the extraction rate. Filter with double-layer gauze, transfer the obtained solids to the original Erlenmeyer flask, and extract three more times. Combine the filtrates obtained from each extraction and concentrate them under vacuum to 150mL. Add 90% (by volume) of the concentrate to the concentrate at a volume ratio of 1:1. The ethanol solution was allowed to stand for 24 hours for alcohol precipitation, then centrifuged at 4000 rpm for 15 minutes. The filtrate was removed, and the precipitate was dried to obtain crude lentinan. The crude lentinan was added to 200 mL of water and stirred. Then, 50 mL of a mixed solution of chloroform and n-butanol was added. The volume ratio of chloroform to n-butanol in the mixed solution was 5:1. The mixed solution of chloroform and n-butanol removes protein more gently and does not affect the polysaccharide structure. The mixture was shaken thoroughly for 40 minutes, then centrifuged at 4000 rpm for 15 minutes to separate the chloroform and aqueous layers. Extraction with chloroform and n-butanol effectively removes protein from the crude polysaccharide, which is beneficial for polysaccharide purification. The aqueous layer was freeze-dried at -50℃ for 24 hours to obtain lentinan.

[0076] (2) Dissolve seaweed sulfate polysaccharide in 50 mL of water, then add lentinan from step (1), and then add curcumin. The mass fraction of seaweed sulfate polysaccharide is 4%, the mass fraction of lentinan is 5%, and the mass fraction of curcumin is 1.5%. Lentinan and curcumin can be used as immune enhancers to synergistically combat respiratory infections. Stir at 500 rpm for 10 min. Seaweed sulfate polysaccharide and lentinan can improve the water solubility and stability of curcumin through electrostatic interaction to obtain a polysaccharide complex.

[0077] (3) Dissolve calcium chloride in 40 mL of water as a crosslinking agent. The mass fraction of calcium chloride is 3%. Calcium chloride can form complexes with the active groups of polysaccharides and curcumin to enhance antibacterial properties and obtain calcium chloride solution.

[0078] (4) Microspheres are prepared by electro-spraying the polysaccharide complex described in step (2) into a receiving device containing the calcium chloride solution described in step (3). During the electro-spraying process, the ambient temperature is 30℃, the voltage is 20kV, the propulsion rate is 25μL / min, and the receiving distance is 20cm. The average particle size of the prepared particles is 2μm. The microspheres prepared by this process have high roundness and integrity. The process is simple and easy to operate. A large number of microspheres can be prepared in a short time. Then, the mixture is stirred at 200rpm for 50min, filtered, and dried to obtain polysaccharide composite gel microspheres.

[0079] This embodiment provides a method for preparing a compound traditional Chinese medicine powder inhaler for respiratory tract infections, specifically including the following steps:

[0080] S1. Add 20g of Forsythia suspensa, 20g of Scutellaria baicalensis, 20g of Lonicera japonica and 20g of Isatis indigotica to 1000mL of water and soak for 4 hours in a decoction machine. The compound Chinese medicine mainly treats respiratory tract infections by directly killing the virus, inhibiting viral replication, reducing severe inflammatory response, and strengthening the body's immune response to the virus. The decoction is boiled twice and extracted by gentle boiling for 4 hours. The decoctions are combined, the filter residue is discarded, and the collected filtrate is concentrated to 1 / 5 of the original volume. The vacuum pressure is -0.06MPa, the temperature is 50℃, and the spray drying is carried out. The average particle size of the prepared particles is 3μm. During the spray drying, the spray pressure is 0.8MPa, the feed rate is 20mL / min, the air inlet temperature is 50°C, and the drying time is 50min. Spray drying is beneficial to protecting the heat-labile effective components in Chinese medicine and can also obtain small particle size particles, which is beneficial to improving its flow properties and obtaining Chinese medicine micro powder.

[0081] S2. Mix the Chinese herbal powder and polysaccharide composite gel microspheres as described in step S1 evenly. During the mixing process, the mixing speed is 600 rpm and the mixing time is 30 min. This helps to improve the uniformity of the Chinese herbal powder and polysaccharide composite gel microspheres and better exert the role of polysaccharide composite gel microspheres in improving the flowability and dispersibility of the Chinese herbal powder. Then, use No. 3 capsules for dispensing to obtain a compound Chinese herbal powder inhaler for respiratory tract infections.

[0082] Comparative Example 1

[0083] This comparative example provides a compound traditional Chinese medicine powder inhaler for respiratory tract infections. The difference between this example and Example 1 is that the compound traditional Chinese medicine powder inhaler for respiratory tract infections does not contain polysaccharide composite gel microspheres; the preparation method of the compound traditional Chinese medicine powder inhaler for respiratory tract infections is the same as that of Example 1.

[0084] Comparative Example 2

[0085] This comparative example provides a compound traditional Chinese medicine powder inhaler for respiratory tract infections. The difference between this example and Example 1 is that the polysaccharide composite gel microspheres do not contain lentinan; the preparation method of the polysaccharide composite gel microspheres does not include step (1); and the preparation method of the compound traditional Chinese medicine powder inhaler for respiratory tract infections is the same as that of Example 1.

[0086] Comparative Example 3

[0087] This comparative example provides a compound traditional Chinese medicine powder inhaler for respiratory tract infections. The difference between this example and Example 1 is that the polysaccharide composite gel microspheres do not contain calcium chloride; the preparation method of the polysaccharide composite gel microspheres does not include step (3); and the preparation method of the compound traditional Chinese medicine powder inhaler for respiratory tract infections is the same as that of Example 1.

[0088] Experimental Example 1

[0089] Liquidity Experiment

[0090] Test samples: Compound Chinese medicine powders for respiratory tract infections prepared in Examples 1-4 and Comparative Examples 1-3.

[0091] Test method: The flowability of powder is generally expressed by the angle of repose. Place a glass funnel at a height of about 4.0-5.0 cm from the center of the disc. Remove the capsule from the test sample and continuously add the powder into the glass funnel, allowing the powder to fall slowly and evenly into the center of the disc. The powder gradually forms a cone. Stop feeding when the powder falls freely from the inclined side of the cone along the edge of the disc. The angle formed between the inclined side of the cone and the disc is the angle of repose (°). The smaller the angle of repose, the better the flowability.

[0092] Figure 2 The figures show the angles of repose for Examples 1-4 and Comparative Examples 1-3. As shown, the angles of repose for Examples 1-4 were 35.8-38.9°, all <40°, indicating good flowability. The angles of repose for Comparative Examples 1-3 were 41.3-47.8°, all >40°, indicating poor flowability. Comparative Example 1, a compound traditional Chinese medicine powder for respiratory infections, does not contain polysaccharide composite gel microspheres and lacks a three-dimensional network spherical structure, thus failing to improve the particle morphology of the micropowder and resulting in poor flowability. Comparative Example 2... The polysaccharide composite gel microspheres in Comparative Example 1 do not contain lentinan, which weakens the density and adhesion of the three-dimensional network structure, adversely affecting the performance of the polysaccharide composite gel microspheres. This is not conducive to reducing the adhesion between powder particles, nor to preventing the aggregation of microparticles, resulting in poor flowability. The polysaccharide composite gel microspheres in Comparative Example 3 do not contain calcium chloride, which cannot reduce the electrostatic repulsion between polysaccharide molecules, which is not conducive to the adhesion and flowability of polysaccharide molecules, thus affecting the performance of the polysaccharide composite gel microspheres and resulting in poor flowability.

[0093] Experiment Example 2

[0094] Antiviral experiment

[0095] Test samples: Compound Chinese medicine powders for respiratory tract infections prepared in Examples 1-4 and Comparative Examples 1-3.

[0096] Test method: In this experiment, influenza A virus strain (A / H1N1 / Jingfang) was selected as the virus strain for antiviral experiments; MDCK cells were seeded in 96-well plates at a cell density of 2×10⁶ cells / well. 4 Each well contains 100 TCID45 cells. After the cells have grown into a monolayer, the culture medium is discarded. A cell control group, a virus control group, and a test group are set up. Five different concentrations of test samples (four serial dilutions of TC0 and below) are used, with four replicates for each concentration. Except for the cell control group, each group is inoculated with 100 TCID45 cells. 50 100 μL of virus solution was incubated at 35°C in a 5% CO2 incubator for 1 hour for adsorption. The virus solution was then discarded, and the cell surface was washed twice with maintenance medium. Different concentrations of the drug solution were added to the test groups, while maintenance medium was added to the cell control and virus control groups (100 μL / well). The culture plates were incubated at 35°C in a 5% CO2 incubator. Cell cytopathic effects were observed daily. Experimental results were recorded when the virus control group showed grade 4 cytopathic effects. The half-maximal inhibitory concentration (IC50) was calculated using the Reed-Muench method. 50 (μg / mL), Selectivity index SI=TC 50 / IC 50 IC 50 To test the half-maximal inhibitory concentration (IC50) of the sample against the virus, IC50 was used. 50 The smaller the value, the stronger the inhibitory effect on the virus. SI stands for Selectivity Index. The larger the SI value, the wider the safety range.

[0097] Figure 3 Figures show the antiviral results of Examples 1-4 and Comparative Examples 1-3; as shown, the IC of Examples 1-4... 50 The concentration was 1.6-2.1 μg / mL, and the SI was 16.6-21.8, indicating strong antiviral activity; the IC50 of comparative examples 1-3 was... 50 The concentration was 3-4.5 μg / mL, and the SI was 7.7-11.6, indicating weak antiviral activity. Comparative Example 1, a compound traditional Chinese medicine powder for respiratory infections, did not contain polysaccharide complex gel microspheres, nor did it contain seaweed sulfated polysaccharide, lentinan, curcumin, or calcium chloride, thus lacking antiviral activity and resulting in weak antiviral activity. Comparative Example 2's polysaccharide complex gel microspheres did not contain lentinan, failing to effectively reduce or block viral adsorption and thus failing to exert a general antiviral effect. It also weakened the protection of curcumin, reducing its activity and bioavailability, leading to weak antiviral activity. Comparative Example 3's polysaccharide complex gel microspheres did not contain calcium chloride, failing to enhance the antiviral activity of the polysaccharides and weakening the protective effect on curcumin, resulting in weak antiviral activity.

[0098] Experimental Example 3

[0099] Treatment efficacy experiment

[0100] Test samples: Compound Chinese medicine powders for respiratory tract infections prepared in Examples 1-4 and Comparative Examples 1-3.

[0101] Test Method: 140 patients aged 35-65 years with varying degrees of respiratory infection symptoms (specifically fever, cough, runny nose, pneumonia, etc.) were selected. Patients were randomly assigned to 7 groups (20 patients per group) based on their admission date. Each group received the corresponding test sample twice daily (morning and evening). The effects were observed after 5 days. Treatment efficacy was assessed according to the following criteria, and the effective rate (%) was calculated:

[0102] Effective: Body temperature returns to normal or decreases, respiratory infection symptoms completely disappear, respiratory infection symptoms change from severe to moderate, from moderate to mild, and from mild to normal.

[0103] Ineffective: Body temperature does not decrease or even increases, and respiratory infection symptoms do not improve significantly.

[0104] The formula for calculating the treatment effectiveness rate is as follows:

[0105] Treatment effectiveness rate (%) = (Number of effective cases / 20) × 100%

[0106] Figure 4 The figures show the treatment efficacy results of Examples 1-4 and Comparative Examples 1-3. As shown, the treatment efficacy rate of Examples 1-4 was 90-100%, indicating good treatment effect; the treatment efficacy rate of Comparative Examples 1-3 was 60-75%, indicating poor treatment effect. Comparative Example 1, a compound traditional Chinese medicine powder for respiratory tract infections, did not contain polysaccharide composite gel microspheres, nor did it contain antiviral seaweed sulfated polysaccharide, lentinan, curcumin, or calcium chloride, and therefore could not improve the flowability of the micropowder, resulting in poor treatment effect. Comparative Example 2's polysaccharide composite gel microspheres did not contain lentinan, weakening the performance of the polysaccharide composite gel microspheres and adversely affecting the flowability and adhesion of the powder, failing to effectively maintain the drug concentration at the infection site, resulting in poor treatment effect. Comparative Example 3's polysaccharide composite gel microspheres did not contain calcium chloride, failing to enhance the activity of polysaccharides and curcumin, which was detrimental to enhancing antiviral effects, resulting in poor treatment effect.

[0107] The above experimental results show that the fluidity, antiviral properties, and therapeutic effects of Examples 1-4 of the present invention are significantly better than those of Comparative Examples 1-3. Among them, Example 1, which uses polysaccharide composite gel microspheres, has better fluidity, stronger antiviral properties, and better therapeutic effects. The cross-linking of seaweed sulfate polysaccharide, lentinan, curcumin, and calcium chloride forms a three-dimensional network spherical structure, which improves the particle morphology of the micropowder, reduces the number of contact points between powder particles, and reduces the adhesion between powder particles, thus improving the fluidity of the micropowder. In addition, because the gel microspheres have good hygroscopic and moisturizing properties, they can competitively reduce the moisture absorption of the micropowder, thereby preventing the aggregation of the micropowder and also improving the fluidity of the micropowder. Furthermore, the gel microspheres also have excellent adhesion. After entering the respiratory tract, they can adhere to the site of infection, reduce the loss caused by respiration, maintain the effective drug concentration at the site of infection, and improve the therapeutic effect.

[0108] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention.

[0109] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention. The actual application is not limited to this. In conclusion, if those skilled in the art are inspired by this description and design similar methods and embodiments without departing from the spirit of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A compound traditional Chinese medicine powder inhaler for respiratory tract infections, characterized in that: The compound traditional Chinese medicine powder for respiratory tract infections is composed of the following components in parts by weight: 40-60 parts polysaccharide composite gel microspheres, 5-10 parts forsythia, 5-10 parts scutellaria, 5-10 parts honeysuckle, and 5-10 parts isatis root; the polysaccharide composite gel microspheres include the following components in parts by weight: 5-8 parts seaweed sulfated polysaccharide, 5-10 parts lentinan, 3-5 parts calcium chloride, and 1-3 parts curcumin; The preparation method of the polysaccharide composite gel microspheres specifically includes the following steps: (1) Wash the dried shiitake mushrooms, dry them at 50-60℃, pulverize them, and put 6-10g into an Erlenmeyer flask with a sieve mesh size of 40-60 mesh. Add 200mL of water and heat and stir in a constant temperature water bath to extract the shiitake mushrooms. Control the temperature at 65-75℃, the extraction time at 1-3h, and the pH at 6.0-7.

0. Filter the shiitake mushrooms with double-layer gauze. Transfer the obtained solids to the original Erlenmeyer flask and extract them again 2-3 times. Combine the filtrates obtained from each extraction and concentrate them under vacuum to 100-150mL. Add 80-90% ethyl acetate to the concentrate at a volume ratio of 1:

1. The alcohol solution was allowed to stand for 20-24 hours to precipitate alcohol. After centrifugation at 3000-4000 rpm for 10-15 minutes, the filtrate was removed, and the precipitate was dried to obtain crude lentinan. The lentinan was added to 200 mL of water and stirred. Then, 50 mL of a mixed solution of chloroform and n-butanol was added and shaken thoroughly for 30-40 minutes. After centrifugation at 3000-4000 rpm for 10-15 minutes, the chloroform layer and the aqueous layer were separated. The aqueous layer was then freeze-dried at -40 to -50°C for 24-48 hours to obtain lentinan. (2) Dissolve seaweed sulfate polysaccharide in 50 mL of water, then add the shiitake mushroom polysaccharide mentioned in step (1), then add curcumin, stir, stir at 300-500 rpm for 5-10 min, and obtain polysaccharide complex. (3) Dissolve calcium chloride in 40 mL of water to obtain a calcium chloride solution; (4) Microspheres are prepared by electro-spraying the polysaccharide complex described in step (2) into a receiving device containing the calcium chloride solution described in step (3). During the electro-spraying process, the ambient temperature is 20-30℃, the voltage is 10-20kV, the propulsion rate is 20-25μL / min, the receiving distance is 15-20cm, and the average particle size of the prepared particles is 1-2μm. Then, the mixture is stirred at 100-200rpm for 30-50min, filtered, and dried to obtain polysaccharide composite gel microspheres.

2. A method for preparing a compound traditional Chinese medicine powder inhaler for respiratory tract infections according to claim 1, characterized in that: Specifically, the following steps are included: S1. Add 10-20g of Forsythia suspensa, 10-20g of Scutellaria baicalensis, 10-20g of Lonicera japonica and 10-20g of Isatis indigotica to 1000mL of water and soak in a decoction machine for 2-4 hours. Decoction is carried out 1-2 times and extracted by gentle boiling for 2-4 hours. The decoctions are combined, the filter residue is discarded, and the collected filtrate is concentrated to 1 / 8-1 / 5 of the original volume. The filtrate is spray-dried under vacuum pressure of -0.06MPa and temperature of 40-50℃. The average particle size of the prepared particles is 2-3μm, thus obtaining Chinese herbal micro powder. S2. Mix the Chinese herbal powder described in step S1 with polysaccharide composite gel microspheres evenly, and then package them into No. 1-3 capsules to obtain a compound Chinese herbal powder inhaler for respiratory tract infections. The preparation method of the polysaccharide composite gel microspheres specifically includes the following steps: (1) Wash the dried shiitake mushrooms, dry them at 50-60℃, pulverize them, and put 6-10g into an Erlenmeyer flask with a sieve mesh size of 40-60 mesh. Add 200mL of water and heat and stir in a constant temperature water bath to extract the shiitake mushrooms. Control the temperature at 65-75℃, the extraction time at 1-3h, and the pH at 6.0-7.

0. Filter the shiitake mushrooms with double-layer gauze. Transfer the obtained solids to the original Erlenmeyer flask and extract them again 2-3 times. Combine the filtrates obtained from each extraction and concentrate them under vacuum to 100-150mL. Add 80-90% ethyl acetate to the concentrate at a volume ratio of 1:

1. The alcohol solution was allowed to stand for 20-24 hours to precipitate alcohol. After centrifugation at 3000-4000 rpm for 10-15 minutes, the filtrate was removed, and the precipitate was dried to obtain crude lentinan. The lentinan was added to 200 mL of water and stirred. Then, 50 mL of a mixed solution of chloroform and n-butanol was added and shaken thoroughly for 30-40 minutes. After centrifugation at 3000-4000 rpm for 10-15 minutes, the chloroform layer and the aqueous layer were separated. The aqueous layer was then freeze-dried at -40 to -50°C for 24-48 hours to obtain lentinan. (2) Dissolve seaweed sulfate polysaccharide in 50 mL of water, then add the shiitake mushroom polysaccharide mentioned in step (1), then add curcumin, stir, stir at 300-500 rpm for 5-10 min, and obtain polysaccharide complex. (3) Dissolve calcium chloride in 40 mL of water to obtain a calcium chloride solution; (4) Microspheres are prepared by electro-spraying the polysaccharide complex described in step (2) into a receiving device containing the calcium chloride solution described in step (3). During the electro-spraying process, the ambient temperature is 20-30℃, the voltage is 10-20kV, the propulsion rate is 20-25μL / min, the receiving distance is 15-20cm, and the average particle size of the prepared particles is 1-2μm. Then, the mixture is stirred at 100-200rpm for 30-50min, filtered, and dried to obtain polysaccharide composite gel microspheres.

3. The method for preparing the compound traditional Chinese medicine powder inhaler for respiratory tract infections according to claim 2, characterized in that: In step S1, during spray drying, the spray pressure is 0.6-0.8 MPa, the feed rate is 10-20 mL / min, the inlet air temperature is 40-50°C, and the drying time is 30-50 min.

4. The method for preparing the compound traditional Chinese medicine powder inhaler for respiratory tract infections according to claim 3, characterized in that: In step S2, during the mixing process, the mixing speed is 500-600 rpm and the mixing time is 20-30 min.

5. The method for preparing the compound traditional Chinese medicine powder inhaler for respiratory tract infections according to claim 4, characterized in that: In step (1), the volume ratio of chloroform to n-butanol in the mixed solution of chloroform and n-butanol is 4-5:

1.

6. The method for preparing the compound traditional Chinese medicine powder inhaler for respiratory tract infections according to claim 5, characterized in that: In step (2), the mass fraction of seaweed sulfate polysaccharide is 2-4%, the mass fraction of shiitake mushroom polysaccharide is 3-5%, and the mass fraction of curcumin is 0.5-1.5%.

7. The method for preparing the compound traditional Chinese medicine powder inhaler for respiratory tract infections according to claim 6, characterized in that: In step (3), the mass fraction of calcium chloride is 2-3%.

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