Production process and formula for clearing away lung-heat, nourishing lung and removing nodules

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation, and discloses a production process for clearing away lung-heat, nourishing lung and removing nodules, which comprises the following steps: classifying and pretreating medicinal materials, namely dividing the medicinal materials into a low-temperature extraction group, a medium-temperature extraction group and a high-temperature extraction group according to chemical properties of components, crushing the medicinal materials to 60-80 meshes, and mixing the medicinal materials according to the ratio of the weight of the medicinal materials to the volume of water of 1: 6-1: 10, and soaking for 1-2 hours at the temperature of 10-20 DEG C. The invention further provides a formula for clearing away the lung-heat, nourishing the lung and removing nodules, and the medicine comprises a lung-heat-clearing and detoxifying group, a drug delivery group, a drug delivery group and a drug delivery group, the lung moistening and nourishing group comprises lily, radix ophiopogonis and bulbus fritillariae cirrhosae; and the phlegm-reducing and stagnation-resolving group comprises bromelain, polyunsaturated phosphatidylcholine and kelp. By optimizing an extraction process, multi-step separation and purification, a dynamic balance technology and a granulation preparation process, the comprehensive effects of high extraction efficiency, excellent component purity, high preparation stability and remarkable curative effect are achieved.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparation, and in particular to a production process and a formula for treating lung clearing, nourishing and removing nodules. Background Art

[0002] In modern society, with the increasing air pollution and the prevalence of bad living habits such as smoking, lung health problems have become an important factor affecting people's health. In particular, the incidence of lung inflammation, fibrosis and small nodular lesions has increased year by year, seriously threatening the quality of life of patients. In order to effectively improve the respiratory discomfort and health hazards caused by lung diseases, treatment methods that clear the lungs, moisturize the lungs and remove lung nodules are particularly important.

[0003] In the existing technology, the application of traditional Chinese medicine in clearing and moistening the lungs, reducing inflammation, etc. has been realized through the combination of traditional Chinese medicine extraction technology and basic preparation technology. Some processes use unified extraction conditions, such as water extraction or alcohol extraction, to successfully reduce the impact of some impurities while maintaining the active ingredients of traditional Chinese medicine. In addition, a single separation method (such as precipitation or centrifugation) also shows a certain effect in improving the purity of the extract. In terms of drug preparations, some technologies meet the basic preparation molding requirements through simple drying or powdering processing.

[0004] However, the existing technology still has many shortcomings in extraction efficiency, component separation, preparation stability and synergistic effect design. First, the chemical properties of different components such as flavonoids, polysaccharides and saponins have not been optimized, resulting in low extraction rate of target components and high impurity content. In addition, separation technology is mostly based on a single method, lacking targeted purification means, and the purity of the extract is limited. In terms of drug preparation, the stability and hygroscopicity of the product have not been improved through granulation and excipient design. The directly dried powder is prone to agglomeration and degradation in a hot and humid environment, affecting the effect of the drug. At the same time, the existing technology does not give enough consideration to the dynamic equilibrium design of traditional Chinese medicine extracts, resulting in uneven distribution of components in the extract, affecting the subsequent processing quality and consistency of efficacy. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a production process and formula for treating lung clearing, nourishing the lungs and removing nodules, which solves the problems of low extraction efficiency, insufficient purity of active ingredients, poor preparation stability and insufficient synergistic effect of multiple ingredients in the prior art.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions: a production process for treating lung clearing, nourishing lungs and clearing nodules, comprising the following steps: Classification and pretreatment of medicinal materials: The medicinal materials are divided into low-temperature extraction group, medium-temperature extraction group and high-temperature extraction group according to the chemical properties of the components. The medicinal materials are crushed to 60-80 meshes and soaked at 10-20°C for 1-2 hours at a ratio of medicinal material weight to water volume of 1:6-1:10. The classification of medicinal materials and particle size optimization ensure the precise matching of extraction conditions for different components; soaking to soften the cell wall helps to completely release the target components in the subsequent extraction, significantly improving the extraction efficiency; Flavonoid extraction: Add the low-temperature extraction group herbs to a 25-30% ethanol solution, adjust the pH to 6.0-7.0, and extract at 25-40°C for 8-15 minutes. This step effectively avoids the degradation of flavonoid components under low temperature and weakly acidic conditions, and further improves the extraction efficiency by optimizing the solvent concentration and stirring conditions. Polysaccharide extraction: Add the medium-temperature extraction group herbs to deionized water, add 3-10% mannitol, and extract at 50-70°C for 30-60 minutes. This step improves the solubility and extraction efficiency of polysaccharides by adding mannitol to the solvent. At the same time, medium-temperature extraction effectively reduces the risk of high temperature degradation of polysaccharide molecules. Saponin extraction: Add the high-temperature extraction group medicinal materials to 40-60% ethanol solution, adjust the pH to 4.5-6.0, and extract for 30-45 minutes at 75-90°C and 0.1-0.3MPa. The saponin extraction step uses high temperature and high pressure conditions to quickly extract the target components and reduce the dissolution of impurities, thereby significantly improving the purity and extraction rate of saponin components; Highly selective separation of components: The extract is separated by membrane separation, solvent extraction and ion exchange resin purification. The separation technology can significantly improve the purity of flavonoids, polysaccharides and saponins, reduce the interference of impurities of non-target components, and provide high-purity extracts for subsequent steps; Extract integration and dynamic equilibrium transformation: The separated extracts are mixed in proportion and allowed to stand at 20-30°C for 10-14 hours. This step improves the stability and uniformity of the extracts through dynamic equilibrium transformation, ensuring the synergistic effect between different components. Preparation molding: The extract is spray-dried, and starch and dextrin are added in proportion to form granules or powder. The spray-drying and granulation processes improve the fluidity and stability of the preparation, making it easier to transport and take.

[0007] Preferably, the classification and pretreatment of medicinal materials include: Classify medicinal materials into low-temperature group, medium-temperature group and high-temperature group according to their chemical properties. By classifying medicinal materials into low-temperature group, medium-temperature group and high-temperature group, it can ensure that various medicinal materials are processed under suitable extraction conditions, avoid component loss and improve extraction efficiency; The medicinal materials are crushed to a particle size of 0.2-0.5 mm. Within this range, the medicinal material particles can fully contact the solvent, while avoiding over-crushing that leads to dusting or thermal oxidation of the active ingredients. The crushing process can use a low-temperature crusher or ordinary mechanical crushing equipment to maintain the chemical stability of the medicinal materials. By crushing to a suitable particle size, the contact area between the medicinal materials and the solvent is increased, the release rate of the target ingredients is accelerated, and the efficiency of the subsequent extraction process is guaranteed; The weight of the medicinal material and the volume of water are in a ratio of 1:6 to 1:10, and the mixture is soaked at 10 to 20°C for 1 to 2 hours. The soaking softens the cell wall and initially releases the water-soluble components, which provides favorable conditions for the subsequent extraction process and reduces the extraction time and energy consumption. Preferably, the flavonoid extraction comprises: A 25-30% ethanol solution is used as the extraction solvent. Ethanol is a polar organic solvent that can effectively dissolve the flavonoid components in the medicinal materials. The 25-30% ethanol solution improves the solubility and extraction rate of the flavonoid components by adjusting the polarity. The range of ethanol concentration is controlled within this range to balance the solubility of flavonoids and the dissolution amount of impurities, thereby achieving the effect of selective extraction; Adjusting the pH of the solvent to 6.0-7.0. Adjusting the pH to a buffer environment of 6.0-7.0 effectively avoids oxidation and decomposition of flavonoids during the extraction process, while reducing the dissolution of impurities. The extraction temperature is controlled at 25-40°C, and the extraction time is 8-15 minutes. Within the range of 25-40°C, the efficient dissolution of flavonoid components can be ensured, and the molecular diffusion rate can be accelerated through thermodynamic effects to improve the extraction efficiency. At the same time, the extraction time is controlled at 8-15 minutes to achieve the complete release of flavonoid components and reduce energy consumption. During the extraction process, the stirring speed is controlled at 60-120 rpm. Uniform stirring is used to promote full contact between the medicinal materials and the solvent, thereby accelerating the diffusion and dissolution of flavonoid molecules.

[0008] Preferably, the polysaccharide extraction comprises: Deionized water is used as a solvent, and 3-10% mannitol is added. Deionized water avoids impurity contamination, while the addition of mannitol improves the dissolution efficiency and extraction stability of polysaccharides. Mannitol can form soluble complexes with polysaccharides through intermolecular hydrogen bonding, thereby improving the solubility and stability of polysaccharides, avoiding polysaccharide aggregation, and reducing the damage of high temperature to the polysaccharide structure. The extraction is carried out at an extraction temperature of 50-70°C. Within this range, the increase in temperature can accelerate the rupture of the cell wall of the medicinal material, release the polysaccharide components inside the cell, and promote the dissolution of polysaccharide molecules through thermodynamic effects; The extraction time is 30 to 60 minutes, and the circulation flow rate is controlled at 150 to 300 L / h. Through the dynamic control of the extraction time and flow rate, the full dissolution of the polysaccharide components is ensured, while the problems of solvent saturation and medicinal material accumulation are avoided, and the extraction uniformity and efficiency are improved; The extract is filtered to remove the drug residue. The filtration operation effectively removes the drug residue, improves the clarity and purity of the extract, and lays a good foundation for the subsequent separation steps.

[0009] Preferably, the saponin extraction comprises: Using 40-60% ethanol solution as the solvent. Ethanol is a polar solvent that can significantly improve the solubility of saponins. This range can improve the dissolution efficiency of saponins and inhibit the dissolution of impurities, thereby improving the purity of the extract. The pH of the solvent is adjusted to 4.5-6.0, and the extraction efficiency of saponin components is significantly improved by adjusting the pH with a weak acid buffer, while protecting the integrity of the molecular structure and reducing the amount of impurities extracted; The extraction temperature is 75-90°C and the pressure range is 0.1-0.3MPa. This temperature can accelerate the rupture of the cell wall of the medicinal material and promote the release of saponin components. At the same time, this pressure range helps to enhance the penetration of the solvent, ensuring that the saponin is efficiently dissolved in a short time and increasing the extraction rate. The extraction time is controlled at 30 to 45 minutes, and the dissolution efficiency is improved by stirring. This extraction time can ensure the full release of saponin components, while avoiding solvent saturation or increased energy consumption due to too long time. The role of stirring is to prevent the deposition of medicinal materials, ensure the uniform distribution between the solvent and the medicinal materials, and promote the diffusion and dissolution of saponin molecules through convection effect.

[0010] Preferably, the highly selective separation of components comprises: Use a nanofiltration membrane with a pore size of 0.5-0.8 nm to perform membrane separation at a pressure of 0.2-0.4 MPa and a temperature of 20-40°C. This nanofiltration membrane can effectively remove impurities with larger molecular weights (such as cellulose and protein) while retaining small molecular active ingredients such as flavonoids, polysaccharides and saponins. At the same time, this pressure range can ensure that the solution has a sufficient permeation rate on the membrane surface without reducing the separation efficiency due to too low pressure or damaging the membrane structure due to too high pressure. This temperature range can avoid damage to the membrane material due to high temperature and ensure the chemical stability of the target components. The flavonoid components are extracted by solvent, the extraction solvent is ethyl acetate: water phase = 1:2-1:4, the extraction temperature is 15-30°C, and the extraction time is 10-20 minutes. Ethyl acetate is a medium-polar organic solvent that can form stable hydrogen bonds and van der Waals interactions with flavonoid compounds, thereby improving the solubility of flavonoids. This temperature range can reduce the volatilization of the solvent while maintaining the activity and stability of flavonoids. At the same time, this time range can ensure the complete enrichment of flavonoids. The polysaccharide components are purified by DEAE-cellulose anion exchange resin, with an adsorption pH of 6.5-7.5, an adsorption temperature of 20-30°C, and an adsorption time of 20-40 minutes. The specific adsorption and purification of the polysaccharide components by the anion exchange resin greatly reduces the impurities in the extract and improves the purity of the polysaccharide. This adsorption range is the optimal range for the electrical neutrality or weak electronegative state of the polysaccharide, which helps it to effectively combine with the anion exchange resin. This adsorption temperature can not only avoid the degradation of the polysaccharide by high temperature, but also is conducive to the stable performance of the resin adsorption capacity. At the same time, this adsorption time can ensure the full combination of the polysaccharide.

[0011] Preferably, the extract integration and dynamic equilibrium transformation include: The extracts are mixed in a ratio of flavonoids: polysaccharides: saponins of 2-4:4-6:1-3, wherein the flavonoids are responsible for clearing away heat and detoxifying, the polysaccharides are responsible for moistening and nourishing the lungs, and the saponins have the effects of promoting blood circulation, removing blood stasis and dispersing nodules. This combination can not only give full play to the synergistic effect of various ingredients, but also avoid the inhibitory effect caused by excessive dosage of a certain ingredient; Adding antioxidant vitamin C at a concentration of 0.1-0.5% significantly slows down the oxidative degradation of active ingredients in the extract, ensuring the chemical stability and effectiveness of the extract; The extract is cooled and allowed to stand for 10 to 14 hours at 20 to 30°C to reduce the precipitation of impurities. The cooling and standing process effectively separates the impurities, improves the clarity and stability of the extract, and enhances the synergistic effect of the components.

[0012] Preferably, the preparation molding comprises: The extract is made into powder by spray drying. The drying conditions are an inlet temperature of 150-180°C and an outlet temperature of 70-90°C. Spray drying can quickly and efficiently convert the extract into a powdered finished product while ensuring the stability of the active ingredients and the storability of the product. Add 8-15% starch and 5-12% dextrin to the powder, and prepare granules through a drum granulator at a granulation speed of 150-250rpm. Starch acts as a carrier to increase the mechanical strength and particle size uniformity of the granules, while improving the fluidity of the granules. Dextrin, as a natural stabilizer, can enhance the cohesiveness of the granules, help shape them, and prevent the deliquescence or disintegration of the granules. In addition, dextrin can also help improve the taste of the granules, making them more suitable for direct consumption or further processing into tablets or capsules.

[0013] The present invention also provides a formula for treating lung clearing, nourishing and clearing nodules, the medicine comprising: Lung clearing and detoxification group: including honeysuckle, liposomal quercetin, and isatis root. Honeysuckle is rich in active ingredients such as chlorogenic acid and luteolin, and has significant anti-inflammatory and antibacterial effects, which can effectively remove inflammatory factors caused by lung infection; liposomal quercetin inhibits the NF-κB signaling pathway, reduces the release of inflammatory factors, and protects alveolar cells from free radical damage; isatis root is rich in indigo and indirubin, and its antiviral properties make it particularly suitable for relieving lung inflammation and cough caused by viral infection; Lung nourishing group: including lily, ophiopogon, and Fritillaria cirrhosa. Lily is rich in polysaccharides, which can promote lung cell repair and relieve dry cough and throat discomfort; the saponins and polysaccharides in ophiopogon can moisten the lungs and promote the production of body fluids, improve the antioxidant capacity of lung cells, and reduce the inflammatory response caused by dry lungs; the fritillary alkaloids in Fritillaria cirrhosa can clear away heat and resolve phlegm, relieve cough, and protect alveolar cells from inflammation and fibrosis damage; Phlegm-dissolving and nodule-dispersing group: including bromelain, polyunsaturated phosphatidylcholine, and kelp. Bromelain is a highly efficient proteolytic enzyme that can decompose mucus proteins in the airways, reduce sputum viscosity, and make it easier to discharge; polyunsaturated phosphatidylcholine has a cell membrane repairing effect, which can improve the integrity of alveolar cell membranes and reduce cell damage caused by inflammatory responses. PPC can also promote the softening and metabolism of pulmonary fibrosis nodules, providing conditions for nodule absorption; kelp polysaccharides in kelp have a significant anti-fibrosis effect, which can inhibit the formation of lung nodules, and at the same time promote the gradual softening and absorption of already formed nodules; The Qi-tonifying and Strengthening Group includes Astragalus and Radix Pseudostellariae. Astragalus contains astragaloside IV and astragaloside polysaccharides, which can enhance the immune function of the lungs, improve the susceptibility caused by Qi deficiency, and improve the body's disease resistance. Radix Pseudostellariae is rich in polysaccharides and saponins, which can nourish the spleen and lungs, enhance the resistance of lung tissue to external pathogens, and promote the repair of damaged lung tissue. Blood circulation and stasis removal group: including salvia miltiorrhiza, red peony root, and genistein. Among them, salvianolic acid B and tanshinone in salvia miltiorrhiza can dilate blood vessels, improve pulmonary microcirculation, and alleviate lung tissue hypoxia caused by blood stasis; red peony root has anti-inflammatory and anti-fibrotic effects, and reduces the occurrence of pulmonary fibrosis by inhibiting the proliferation of fibroblasts; genistein can further enhance the function of the blood circulation and stasis removal group by regulating the immune system and inhibiting the expression of fibrosis factors. At the same time, its phytoestrogen-like effect can reduce the overreaction of the immune system and stabilize the lung tissue structure; Auxiliary medicinal materials: including licorice, loquat leaves, and dendrobium. Among them, licorice contains glycyrrhizic acid and glycyrrhizin, which have anti-inflammatory and antioxidant effects. At the same time, it can harmonize the medicinal properties and reduce the toxic side effects that may be caused by other medicinal materials; ursolic acid and amygdalin in loquat leaves have the effect of moistening the lungs and relieving cough, which can significantly improve the cough symptoms caused by lung heat or lung dryness; dendrobium polysaccharides and alkaloids in dendrobium have the effect of promoting fluid production and moisturizing dryness, which can significantly improve the inflammatory environment of the lungs and protect alveolar cells.

[0014] Preferably, the drug comprises the following components in parts by weight: 10-20 parts of honeysuckle, 5-15 parts of liposomal quercetin, and 5-12 parts of isatis root. This component reduces the spread of lung infection sources through the comprehensive effects of anti-inflammatory, heat-clearing and antibacterial, and inhibits the excessive release of inflammatory factors. The ratio of this type of medicinal materials can maximize the effect of clearing heat and detoxifying, quickly improve the state of lung inflammation, and provide favorable conditions for subsequent repair; 10-15 parts of lily, 8-12 parts of ophiopogon, 2-6 parts of Fritillaria cirrhosa. Through the anti-inflammatory and cell repair effects of polysaccharides, this component can repair damage caused by dry lungs and inflammation, and improve chronic cough caused by dry lungs. At the same time, the expectorant and alveolar cell protection effects of Fritillaria cirrhosa can further improve the lung moistening effect and enhance the resistance of alveolar cells to external stimuli. 6-12 parts of bromelain, 8-15 parts of polyunsaturated phosphatidylcholine, and 8-15 parts of kelp. This component can relieve airway obstruction by increasing alveolar fluid secretion and promoting sputum discharge. At the same time, polyunsaturated phosphatidylcholine and kelp polysaccharides and iodide can further soften lung nodules and promote their absorption by regulating thyroid hormone levels and inhibiting fibrosis. 10-20 parts of Astragalus and 5-10 parts of Radix Pseudostellariae. The Yiqi Fuzheng group can strengthen the lung immune barrier function by replenishing qi and nourishing yin, improve the susceptibility of the lung to pathogens in the state of qi deficiency, and promote the repair of lung inflammation damage. This ratio enables Astragalus and Radix Pseudostellariae to synergistically play an immune regulation and repair role, improving the overall treatment effect; 6-12 parts of Danshen, 5-10 parts of Red Peony Root, and 3-8 parts of Genistein. This component can relieve the ischemic and hypoxic state of the lungs by promoting blood circulation and removing blood stasis and improving blood circulation, while inhibiting the progression of fibrosis and promoting the repair and recovery of lung nodule tissue. This ratio optimizes the balance between the blood-activating and hemostatic effects, ensuring safety and maximizing the effect. 2-6 parts of licorice, 4-8 parts of loquat leaves, and 5-10 parts of dendrobium are auxiliary medicinal materials that coordinate the full range of medicinal effects, making the main effects of clearing the lungs, moistening the lungs, and resolving phlegm consistent, while protecting the stability of lung tissue and reducing possible side effects of drugs.

[0015] The present invention provides a production process and formula for treating lung clearing, nourishing and removing nodules. It has the following beneficial effects: 1. The present invention adopts multi-step gradient extraction and dynamic adjustment technology, and optimizes the extraction conditions of flavonoids, polysaccharides and saponins step by step to ensure that each type of component is in the best extraction environment. The effect of improving extraction efficiency and purity is achieved. Compared with the existing technology with unified extraction conditions, the problem of low component extraction efficiency and high impurities is solved.

[0016] 2. The present invention significantly improves the purity of the target component in the extract by using the combined separation technology of nanofiltration membrane, solvent extraction and ion exchange resin. It achieves the effect of efficient separation and pure extract. Compared with the existing technology of single separation means, it solves the problem of high impurities and low concentration of target components.

[0017] 3. The present invention is based on the comprehensive concept of clearing the lungs, moistening the lungs, resolving phlegm, invigorating qi, and activating blood circulation, optimizes the proportion of components and the synergistic mechanism, and strengthens the effects of eliminating lung inflammation and absorbing nodules. It achieves the effect of combined treatment and significantly improves the efficacy. Compared with the single functional component solution, it solves the problem of limited therapeutic effect.

[0018] 4. The present invention adopts spray drying and granulation molding technology, combined with auxiliary materials such as vitamin C, to significantly improve the stability and safety of the preparation. It achieves the effect of low degradation rate and convenient storage. Compared with the existing technology, it solves the problems of component loss and poor stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 The figure is a flow chart of the method of the present invention. DETAILED DESCRIPTION

[0020] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] Please see attached Figure 1 : Example 1: Production process for treating lung clearing, nourishing and removing nodules Preparation and classification of medicinal materials Prepare 15 parts of honeysuckle, 10 parts of liposomal quercetin, 8 parts of isatis root, 12 parts of lily, 10 parts of ophiopogon, 4 parts of fritillaria, 10 parts of bromelain, 12 parts of polyunsaturated phospholipid choline, 10 parts of kelp, 15 parts of astragalus, 7 parts of pseudoginseng, 9 parts of salvia miltiorrhiza, 7 parts of red peony root, 5 parts of genistein, 4 parts of liquorice, 6 parts of loquat leaf, and 8 parts of dendrobium by weight.

[0022] The medicinal materials were classified according to the properties of their ingredients into low-temperature group (honeysuckle, liposomal quercetin, isatis root), medium-temperature group (lily, ophiopogon, fritillaria cirrhosa), and high-temperature group (bromelain, polyunsaturated phospholipid choline, kelp, astragalus, pseudoginseng, salvia miltiorrhiza, red peony root, genistein, licorice, loquat leaf, and dendrobium).

[0023] Extraction steps Flavonoid extraction: Crush the low-temperature group herbs to 60 mesh, add 25% ethanol solution, adjust the pH to 6.5, extract at 30°C for 10 minutes, and control the stirring speed at 100 rpm.

[0024] Polysaccharide extraction: Add the medium temperature group herbs to deionized water and add 5% mannitol. Extract at 60°C for 40 minutes, with the circulation flow rate controlled at 200L / h. Filter to remove the residue and collect the extract.

[0025] Saponin extraction: The high temperature group herbs were crushed to 80 mesh, and 50% ethanol solution was used as solvent, and the pH was adjusted to 5.5. The extraction was carried out at 85°C and 0.2MPa pressure for 35 minutes.

[0026] Separation steps The extract was separated by a nanofiltration membrane with a pore size of 0.6 nm, the pressure was set to 0.3 MPa, the temperature was 25 ° C, and the macromolecular impurities were removed. The flavonoid extract was solvent extracted with ethyl acetate: water = 1:3, the extraction time was 15 minutes, and the temperature was 20 ° C. The polysaccharide extract was purified by DEAE anion resin, the adsorption pH was 7.0, and the time was 30 minutes.

[0027] Extract integration The extract was mixed in a ratio of flavonoids: polysaccharides: saponins = 3:5:2, and 0.3% vitamin C was added as an antioxidant. It was left to stand at 25°C for 12 hours to reduce the precipitation of impurities and stabilize the ingredients.

[0028] Molding steps The extract was spray dried at an inlet temperature of 165°C and an outlet temperature of 80°C to prepare a powder. 10% starch and 8% dextrin were added and granules were prepared by a drum granulator at a granulation speed of 200 rpm.

[0029] Example 2: Production process with rapid expectorant effect Preparation of medicinal materials Prepare 12 parts of honeysuckle, 8 parts of liposomal quercetin, 10 parts of isatis root, 10 parts of lily, 8 parts of ophiopogon, 6 parts of fritillaria, 12 parts of bromelain, 10 parts of polyunsaturated phospholipid choline, 15 parts of kelp, 18 parts of astragalus, 8 parts of pseudoginseng, 10 parts of salvia, 8 parts of red peony root, 6 parts of genistein, 5 parts of liquorice, 7 parts of loquat leaf, and 7 parts of dendrobium. The classification is the same as that in Example 1.

[0030] Extraction steps Flavonoid extraction: The low temperature group herbs were crushed to 80 mesh, 30% ethanol solution was added, and the pH was adjusted to 6.0. The extraction was carried out at 25°C for 15 minutes with a stirring speed of 80 rpm.

[0031] Polysaccharide extraction: For the medium temperature group of herbs, use deionized water and add 3% mannitol. Extract at 55°C for 30 minutes with a circulation flow rate of 150L / h. Collect the extract after filtration.

[0032] Saponin extraction: The high temperature group herbs were crushed to 60 mesh, 40% ethanol solution was used as solvent, pH was adjusted to 4.5, and the extraction was carried out at 90°C and 0.3 MPa for 45 minutes.

[0033] Separation steps The nanofiltration membrane had a pore size of 0.7 nm, the pressure was set to 0.2 MPa, and the temperature was 30°C to remove macromolecular impurities. Flavonoids were extracted using ethyl acetate: water = 1:4, the extraction temperature was 15°C, and the time was 20 minutes. Polysaccharides were purified by DEAE resin, the adsorption time was 20 minutes, and the adsorption pH was 6.5.

[0034] The extract was integrated and the extract was mixed in a ratio of flavonoids: polysaccharides: saponins = 4:4:2, and 0.2% vitamin C was added. The standing time was controlled to 10 hours and the temperature was set to 20°C.

[0035] Molding steps The spray drying inlet temperature was 170°C and the outlet temperature was 75°C to produce a powder. 8% starch and 10% dextrin were added, and the drum granulation speed was set at 180 rpm to produce granules.

[0036] Example 3: Production process for enhancing immune effect Preparation of medicinal materials Prepare 15 parts of honeysuckle, 12 parts of liposomal quercetin, 10 parts of isatis root, 12 parts of lily, 10 parts of ophiopogon, 5 parts of fritillaria, 8 parts of bromelain, 12 parts of polyunsaturated phosphatidylcholine, 12 parts of kelp, 20 parts of astragalus, 10 parts of pseudoginseng, 8 parts of salvia miltiorrhiza, 7 parts of red peony root, 4 parts of genistein, 4 parts of liquorice, 6 parts of loquat leaf, and 9 parts of dendrobium.

[0037] Extraction steps Flavonoid extraction: The low-temperature group of medicinal materials was extracted with 25% ethanol solution, the pH was adjusted to 6.8, and the extraction was carried out at 28°C for 12 min with a stirring speed of 90 rpm.

[0038] Polysaccharide extraction: Deionized water with a mannitol content of 10% was added to the medium temperature group of medicinal materials, the extraction temperature was 65°C, the time was 40 minutes, and the circulation flow rate was 250L / h.

[0039] Saponin extraction: The high temperature group herbs were crushed to 80 mesh, and the pH was adjusted to 5.0 with 50% ethanol solution. The extraction was carried out at 80°C and 0.2 MPa for 30 minutes.

[0040] Separation steps The nanofiltration membrane had a pore size of 0.5 nm, the pressure was set to 0.4 MPa, and the temperature was set to 25°C to filter out impurities. The flavonoids were extracted with ethyl acetate: water = 1:2 solvent for 10 minutes at 18°C. The polysaccharide extract was purified using DEAE resin at pH 7.5 for 30 minutes.

[0041] Extract integration Mix flavonoids: polysaccharides: saponins in a ratio of 3:6:1, and add 0.5% vitamin C. Let stand for 12 hours, and control the temperature at 25°C.

[0042] Molding steps The spray drying inlet temperature was 160°C and the outlet temperature was 80°C to obtain powder. 10% starch and 9% dextrin were added as auxiliary materials, and the drum granulation speed was set at 220 rpm to form granules.

[0043] Example 4: Production process for promoting absorption of lung nodules Preparation of medicinal materials 10 parts of honeysuckle, 10 parts of liposomal quercetin, 8 parts of isatis root, 15 parts of lily, 12 parts of ophiopogon, 5 parts of fritillaria, 10 parts of bromelain, 15 parts of polyunsaturated phosphatidylcholine, 12 parts of kelp, 18 parts of astragalus, 7 parts of pseudoginseng, 10 parts of salvia miltiorrhiza, 6 parts of red peony root, 5 parts of genistein, 4 parts of liquorice, 6 parts of loquat leaf, and 7 parts of dendrobium.

[0044] Extraction steps Flavonoid extraction: The low-temperature group of medicinal materials was extracted with 30% ethanol solution, the pH was adjusted to 6.3, and the extraction was carried out at 27 °C for 10 min with a stirring speed of 70 rpm.

[0045] Polysaccharide extraction: Deionized water was added to the medium temperature group of medicinal materials, the proportion of mannitol was 6%, the extraction temperature was 60°C, the time was 35 minutes, and the circulation flow rate was 180L / h.

[0046] Saponin extraction: The high temperature group herbs were crushed to 70 mesh, and extracted with 40% ethanol solution, pH adjusted to 5.5, at 85°C and 0.1 MPa for 40 min.

[0047] Separation steps Nanofiltration membrane pore size 0.8nm, pressure 0.3MPa, temperature 20℃, impurities removed. Flavonoids were extracted with ethyl acetate: water = 1:3 ratio, temperature 22℃, time 18 minutes. Polysaccharides were purified by DEAE resin, pH 7.0, adsorption time 25 minutes.

[0048] Extract integration Mix flavonoids: polysaccharides: saponins in a ratio of 4:5:1, add 0.4% vitamin C, let stand for 12 hours at a temperature of 23°C.

[0049] Molding steps The spray drying inlet temperature was 165° C. and the outlet temperature was 85° C. 12% starch and 8% dextrin were added to the powder, and the granulation speed was set at 200 rpm to form granules.

[0050] Example 5: Production process for comprehensively improving lung function Preparation of medicinal materials Prepare 18 parts of honeysuckle, 12 parts of liposomal quercetin, 10 parts of isatis root, 13 parts of lily, 9 parts of ophiopogon, 6 parts of fritillaria, 10 parts of bromelain, 10 parts of polyunsaturated phospholipid choline, 15 parts of kelp, 16 parts of astragalus, 8 parts of pseudoginseng, 9 parts of salvia miltiorrhiza, 7 parts of red peony root, 6 parts of genistein, 5 parts of liquorice, 7 parts of loquat leaf, and 9 parts of dendrobium by weight.

[0051] The medicinal materials were classified into low-temperature group (lung clearing and detoxifying group), medium-temperature group (lung moistening and nourishing group), high-temperature group (phlegm-resolving and knot-dispersing group, qi-invigorating and strengthening group, blood-activating and blood-stasis-removing group and auxiliary medicinal materials).

[0052] Extraction steps Flavonoids extraction (low temperature group) The low-temperature group of medicinal materials were crushed into 60-80 mesh, 25% ethanol solution was added as a solvent, the pH was adjusted to 6.5, the temperature was controlled at 30°C, the stirring speed was set to 90 rpm, and the extraction was performed for 12 minutes. After the extraction was completed, the residue was filtered out and the extract was collected.

[0053] Polysaccharide extraction (medium temperature group) Add deionized water to the medium temperature group of herbs, and add 5% mannitol as a solubilizer according to the weight of the herbs. The extraction temperature is controlled at 60°C, the time is set to 40 minutes, and the circulation flow rate is maintained at 200L / h. After filtering to remove the residue, collect the clear liquid.

[0054] Saponin extraction (high temperature group) The high temperature group of herbs were crushed to 70 mesh, and 50% ethanol solution was added to adjust the pH to 5.0. The extract was extracted at 85°C and 0.2MPa for 35 minutes. The extract was filtered and the residue was removed for later use.

[0055] Separation steps Membrane separation The extract was separated using a nanofiltration membrane with a pore size of 0.6 nm at a pressure of 0.3 MPa and a temperature of 25°C to remove macromolecular impurities such as cellulose and protein. The extract after membrane separation was clearer and purer.

[0056] Flavonoids separation The flavonoid extract was extracted with ethyl acetate and water in a ratio of 1:3. The extraction temperature was set at 20°C and the extraction time was 15 minutes. The flavonoid active ingredients were enriched and the water-soluble impurities were reduced.

[0057] Polysaccharide purification The polysaccharide extract was purified using DEAE-cellulose anion exchange resin, with the adsorption conditions being pH 7.0, the adsorption temperature being controlled at 25°C, and the adsorption time being 30 minutes. The purity of the polysaccharide was significantly improved after desorption.

[0058] Extract integration The three types of extracts were mixed in a ratio of flavonoids: polysaccharides: saponins = 3:5:2, stirred evenly, and then 0.3% vitamin C was added as an antioxidant. The extracts were cooled at 25°C and left to stand for 12 hours to promote the precipitation of impurities and achieve dynamic balance of components.

[0059] Molding steps Spray drying The integrated extract was sent to a spray drying device with the inlet temperature set at 165°C and the outlet temperature controlled at 80°C for rapid drying to generate a powdered product.

[0060] Particle preparation 10% starch and 8% dextrin were added to the spray-dried powder in proportion, and granules were prepared using a drum granulator. The granulation speed was set at 200 rpm to ensure uniform granule size and good formability.

[0061] Comparative Example 1 (corresponding to Example 1) The main difference is that in Example 1, all medicinal materials were processed under uniform extraction conditions without classified extraction.

[0062] Preparation process: Medicinal material processing: mix 15 parts of honeysuckle, 10 parts of liposomal quercetin, 8 parts of isatis root, 12 parts of lily, 10 parts of ophiopogon, 4 parts of fritillaria, 10 parts of bromelain, 12 parts of polyunsaturated phospholipid choline, 10 parts of kelp, 15 parts of astragalus, 7 parts of pseudoginseng, 9 parts of salvia miltiorrhiza, 7 parts of red peony root, 5 parts of genistein, 4 parts of liquorice, 6 parts of loquat leaf and 8 parts of dendrobium, and grind them into 60-80 mesh.

[0063] Extraction conditions: Add the medicinal materials directly into deionized water, with a medicinal material weight to water volume ratio of 1:8, extraction temperature of 80°C, time of 60 minutes, no pH adjustment, and collect the extract by filtration.

[0064] Separation step: Simple centrifugation (3000 rpm, 15 minutes) was used to remove the drug residue without nanofiltration membrane separation or solvent extraction.

[0065] Extract integration and molding: The extract is directly spray-dried, with an inlet temperature of 170°C and an outlet temperature of 90°C. No antioxidant is added and no granulation is performed.

[0066] Comparative Example 2 (corresponding to Example 2) The main difference is that the extraction conditions of flavonoids, polysaccharides and saponins were not optimized in Comparative Example 2, and all medicinal materials were extracted with the same ethanol concentration (50%).

[0067] Preparation process: Medicinal material processing: mix 12 parts of honeysuckle, 8 parts of liposomal quercetin, 10 parts of isatis root, 10 parts of lily, 8 parts of ophiopogon, 6 parts of fritillaria, 12 parts of bromelain, 10 parts of polyunsaturated phospholipid choline, 15 parts of kelp, 18 parts of astragalus, 8 parts of pseudoginseng, 10 parts of salvia miltiorrhiza, 8 parts of red peony root, 6 parts of genistein, 5 parts of liquorice, 7 parts of loquat leaf and 7 parts of dendrobium, and grind to 70 mesh.

[0068] Extraction conditions: All medicinal materials were added to 50% ethanol solution (ratio of medicinal materials to solvent was 1:10), the extraction temperature was 75°C, the time was 40 minutes, and the stirring speed was 80 rpm.

[0069] Separation steps: Use simple filtration to remove drug residues, without solvent extraction or resin purification.

[0070] Integration and molding of the extract: The extract was directly spray-dried without adjusting the ratio, with an inlet temperature of 160°C and an outlet temperature of 80°C. No auxiliary materials were added or granulation was performed.

[0071] Comparative Example 3 (corresponding to Example 3) The main difference is that in comparative example 3, the step-by-step extraction process is cancelled and all medicinal materials are extracted under uniform conditions.

[0072] Preparation process: Medicinal material processing: mix 15 parts of honeysuckle, 12 parts of liposomal quercetin, 10 parts of isatis root, 12 parts of lily, 10 parts of ophiopogon, 5 parts of fritillaria, 8 parts of bromelain, 12 parts of polyunsaturated phospholipid choline, 12 parts of kelp, 20 parts of astragalus, 10 parts of pseudoginseng, 8 parts of salvia miltiorrhiza, 7 parts of red peony root, 4 parts of genistein, 4 parts of liquorice, 6 parts of loquat leaf and 9 parts of dendrobium, and grind to 80 mesh.

[0073] Extraction conditions: All medicinal materials were directly extracted with 25% ethanol solution, the extraction temperature was 50°C, the time was 45 minutes, and the stirring speed was 70 rpm.

[0074] Separation step: The extract was separated from the drug residue only by centrifugation (3000 rpm, 10 minutes), without nanofiltration membrane separation or polysaccharide purification.

[0075] Extract integration and molding: The extract ratio was not adjusted, directly spray dried, inlet temperature was 165°C, outlet temperature was 90°C, and no vitamin C was added.

[0076] Comparative Example 4 (corresponding to Example 4) Main differences: Comparative Example 4 did not use dynamic equilibrium technology, and the vitamin C addition and standing steps were eliminated.

[0077] Preparation process: Medicinal material processing: 10 parts of honeysuckle, 10 parts of liposomal quercetin, 8 parts of isatis root, 15 parts of lily, 12 parts of ophiopogon, 5 parts of fritillaria, 10 parts of bromelain, 15 parts of polyunsaturated phospholipid choline, 12 parts of kelp, 18 parts of astragalus, 7 parts of pseudoginseng, 10 parts of salvia miltiorrhiza, 6 parts of red peony root, 5 parts of genistein, 4 parts of liquorice, 6 parts of loquat leaf and 7 parts of dendrobium were mixed and crushed to 60 mesh.

[0078] Extraction conditions: Classified extraction, but the extraction conditions were not optimized according to the various components. All medicinal materials used 40% ethanol solution (ratio of medicinal materials to solvent was 1:8), temperature was 75°C, and time was 40 minutes.

[0079] Separation steps: Simple centrifugation is used to remove the drug residue without membrane separation and solvent extraction.

[0080] Extraction liquid integration: The extraction liquid is mixed according to the actual extraction amount ratio, directly spray dried, the inlet temperature is 170℃, and the outlet temperature is 80℃.

[0081] Comparative Example 5 (corresponding to Example 5) The main difference is that in Comparative Example 5, the spray drying and particle preparation steps are omitted and the extract is directly dried.

[0082] Preparation process: Medicinal material processing: mix 18 parts of honeysuckle, 12 parts of liposomal quercetin, 10 parts of isatis root, 13 parts of lily, 9 parts of ophiopogon, 6 parts of fritillaria, 10 parts of bromelain, 10 parts of polyunsaturated phospholipid choline, 15 parts of kelp, 16 parts of astragalus, 8 parts of pseudoginseng, 9 parts of salvia miltiorrhiza, 7 parts of red peony root, 6 parts of genistein, 5 parts of liquorice, 7 parts of loquat leaf and 9 parts of dendrobium, and grind to 80 mesh.

[0083] Extraction conditions: Step-by-step extraction was used, with 25% ethanol solution for flavonoids, deionized water (without mannitol added) for polysaccharides, and 50% ethanol solution for saponins. The extraction temperature was set at 60°C and the extraction time was uniformly set at 30 minutes.

[0084] Separation step: The drug residue and impurities were separated by nanofiltration membrane, but no solvent extraction or resin purification was performed.

[0085] Extract processing: The extract is directly concentrated and dried without spray drying and granulation, and no auxiliary materials are added.

[0086] Experiment 1: Comparison of extraction efficiency of main active ingredients Experimental procedures Medicinal material processing: Example 1: The materials were prepared and the extraction process was classified according to Example 1. The low-temperature group (honeysuckle, liposomal quercetin, and isatis root) used 25% ethanol solution, the extraction temperature was 30°C, and the time was 10 minutes; the medium-temperature group (lily, ophiopogon, and fritillaria cirrhosa) used deionized water and 5% mannitol, the extraction temperature was 60°C, and the time was 40 minutes; the high-temperature group (bromelain, polyunsaturated phosphatidylcholine, kelp, etc.) used 50% ethanol solution, the extraction temperature was 85°C, and the time was 35 minutes.

[0087] Comparative Example 1: directly mix all medicinal materials, extract uniformly with deionized water, extract at 80°C for 60 minutes, without grouping and without adjusting pH.

[0088] Comparative Example 3: The medicinal materials were grouped and processed according to Example 1, but all groups were subjected to uniform extraction conditions (25% ethanol solution, 50° C., and 30 minutes).

[0089] Extract collection: The extracts of all groups were filtered to remove the residue, and the supernatant was collected for subsequent detection.

[0090] Target component detection: Flavonoid content detection: Take an appropriate amount of extract, add an appropriate amount of methanol to dilute it, measure the absorbance at 360nm with a UV spectrophotometer, and calculate the flavonoid content (mg / mL).

[0091] Polysaccharide content detection: The extract was diluted and determined by the phenol-sulfuric acid method, and the concentration (mg / mL) was calculated using the dextran standard curve.

[0092] Saponin content detection: The extract was diluted with methanol and detected by high performance liquid chromatography (HPLC), and the saponin content was calculated according to the standard curve (mg / mL).

[0093] Data Records: Each group of experiments was repeated 3 times and the average value was taken.

[0094] Contents of main active ingredients in extracts from different groups The results of this experiment clearly demonstrate the effect of different extraction methods on the extraction efficiency of the main active ingredients. Example 1 uses step-by-step gradient extraction to optimize the extraction conditions for flavonoids, polysaccharides and saponins, respectively, so that each type of component is released and enriched under the most suitable conditions. In contrast, both Comparative Examples 1 and 3 fail to fully consider the solubility characteristics of the components, resulting in significantly lower flavonoid and saponin contents than Example 1, and a significant difference in polysaccharide content. It can be seen that failure to extract in steps will lead to insufficient dissolution of some components, which will directly affect the extraction efficiency; The fundamental reason for this difference lies in the different chemical properties of the ingredients: flavonoids are stable and soluble in low-temperature, weakly acidic environments, while polysaccharides require moderate temperatures and the presence of solubilizers, and saponins require high temperatures and high pressures to be released efficiently. Example 1 solves the problem of mismatched extraction conditions through a multi-step extraction process, thereby improving the extraction efficiency from the root. The unified extraction method used in the comparative example has a low extraction rate of the target ingredient and relatively more impurities due to the incompatibility of temperature and solvent concentration with various ingredients. The experiment also shows that the combination of extraction efficiency and separation technology is the key. In Example 1, each group of medicinal material extraction conditions is designed for specific components to avoid mutual interference of various compounds. At the same time, by optimizing the purity of the extract step by step, the extraction efficiency of flavonoids, polysaccharides and saponins reaches a high level. The unified treatment method in the comparative example ignores the unique solubility and chemical stability of the components, and ultimately shows a poor extraction effect.

[0095] Experiment 2: Comparison of the purity of the main components in the extract Experimental procedures Sample preparation: Example 2: According to the process of Example 2, step-by-step extraction was performed. The flavonoid, polysaccharide and saponin extracts were treated separately using solvent extraction (ethyl acetate) and ion exchange resin purification technology to optimize the purity of the extracts.

[0096] Comparative Example 2: According to the process of Comparative Example 2, solvent extraction and resin purification technology were not used, and the extract was obtained only by coarse filtration.

[0097] Impurity content detection: Total solid matter determination method: dry the extract at 105°C to constant weight and weigh the total solid content; use ethanol to precipitate non-target components in the extract, determine the mass of the precipitate after centrifugation, and calculate the impurity ratio (the percentage of impurities in the total solids).

[0098] Purity determination of target components: Flavonoids: The extract was extracted and tested by HPLC to calculate the proportion of flavonoids in the total solids of the extract.

[0099] Polysaccharides: After the extract was diluted, the polysaccharide concentration was determined by the phenol-sulfuric acid method and its proportion in the total solids was calculated.

[0100] Saponin: The ratio of saponin to the total solids in the extract was calculated by HPLC.

[0101] Experimental repetition: Each group of extracts was repeated 3 times and the average value was taken.

[0102] Purity and impurity content of main components in extracts of different groups It can be seen from the experimental data that the purity of the extract in Example 2 is significantly higher than that in Comparative Example 2. Example 2 uses solvent extraction and ion exchange resin purification technology, which not only effectively enriches the target component, but also significantly reduces the proportion of impurities. This separation technology makes full use of the difference in solubility of the target component in different solvents and the adsorption characteristics of the resin to ionic impurities to optimize the quality of the extract. In Comparative Example 2, only coarse filtration was used, and the impurity ratio was significantly high, which directly affected the purity of flavonoids, polysaccharides and saponins. The lack of subsequent purification means resulted in the enrichment of a large number of invalid components in the crude extract, which ultimately led to a serious decrease in the proportion of the target component; The present invention demonstrates precise process design in the separation and purification of the extract. Through solvent extraction technology, flavonoid components that are easily soluble in organic solvents are effectively separated while avoiding the mixing of water-soluble impurities. Polysaccharides and saponins are purified by ion exchange resins, eliminating interference from impurities such as inorganic salts and proteins, thereby greatly increasing the proportion of the target components.

[0103] Experiment 3: Drug efficacy evaluation - lung clearing and lung moistening effect test Experimental Description Experimental animals and groups: Healthy SD rats (200±20g) were selected, half male and half female, and randomly divided into 5 groups, with 10 rats in each group: Example 3 group: the extract prepared in Example 3 was used.

[0104] Comparative Example 3 group: the extract prepared in Comparative Example 3 was used.

[0105] Positive control group: commercially available lung-clearing and lung-moistening preparations were used.

[0106] Model control group: only the pneumonia model was established without any drug intervention.

[0107] Blank group: No pneumonia model was established, and normal saline was administered intragastrically.

[0108] The experiments were carried out after the rats were adapted to feeding for 7 days.

[0109] Model building: By intratracheal instillation, 0.1 mL of Staphylococcus aureus (1×10 8 CFU / mL) solution was used to establish the bacterial pneumonia model. The blank group was injected with sterile saline only.

[0110] Dosage regimen: Each group of rats was gavaged with the corresponding extract at a dose of 1 g / kg body weight, twice a day, for 7 consecutive days. The model group and the blank group were gavaged with an equal amount of normal saline.

[0111] Detection indicators: Detection of inflammatory factor levels: After the experiment ended on the 7th day, the lung tissues of the rats were obtained and homogenates were prepared. The concentrations of IL-6 and TNF-α (pg / mg) were detected by ELISA.

[0112] Pathological examination: Lung tissue samples were taken for HE staining to observe the alveolar structure and inflammatory cell infiltration.

[0113] Lung moisture content test: Weigh the wet weight of the right lung, weigh the dry weight after drying, and calculate the wet / dry ratio (wet weight / dry weight).

[0114] Data Records: Each test index was measured on 10 rats and the average value was taken.

[0115] Pulmonary inflammatory factors, pathological scores and lung moisture test results in different groups The experimental results show that the Example 3 group is significantly better than the Comparative Example 3 group in reducing inflammatory factors and improving lung pathological structure, and is close to or even partially better than the positive control group. The step-by-step extraction and component optimization technology used in Example 3 not only shows a stronger therapeutic effect in clearing and moistening the lungs, but also effectively reduces the damage of inflammation to lung tissue. In contrast, the Comparative Example 3 has obviously insufficient efficacy because the extraction conditions are not optimized according to the characteristics of different components. Its inflammatory factor levels and pathological scores show higher values, which further verifies the importance of step-by-step extraction technology.

[0116] The decrease in inflammatory factors is mainly due to the synergistic effect of flavonoids and saponins in Example 3. Flavonoids reduce the production of inflammatory factors by inhibiting the release of IL-6 and TNF-α, while saponins reduce the immune overreaction of lung tissue by inhibiting the activation of inflammatory mediators. In addition, the participation of polysaccharide components improves the antioxidant capacity of lung tissue and reduces cell damage caused by oxidative stress. In Comparative Example 3, since the extraction process does not fully release flavonoids, polysaccharides and saponins, the drug efficacy is insufficient, especially in improving the level of inflammatory factors and moistening the lungs.

[0117] Experiment 4: Comparison of dynamic balance techniques for extracts Experimental Description Sample preparation: Example 4: An extract was prepared according to the process of Example 4, 0.3% vitamin C was added after extraction, and the mixture was allowed to stand at 25°C for 12 hours, and the supernatant was collected for detection.

[0118] Comparative Example 4: The extract was prepared according to the process of Comparative Example 4, without adding vitamin C and without standing treatment, and the extract was directly filtered and collected for detection.

[0119] Dynamic balance test: Component uniformity test: samples of the extract were taken 6 hours and 12 hours after standing, and the concentrations of flavonoids, polysaccharides and saponins were tested by HPLC, and the concentration changes were calculated.

[0120] Impurity precipitation detection: After the extract is allowed to stand, take the supernatant and use a spectrophotometer to measure the transmittance (OD value, wavelength 600nm), which reflects the clarity of the extract.

[0121] Component stability test: The extract was stored at 25°C for 24 hours, and the concentration change rates of flavonoids, polysaccharides and saponins were measured respectively.

[0122] Experimental repetition: Each experiment was repeated 3 times and the results were averaged.

[0123] Test results of composition stability, uniformity and clarity of different extracts The experimental data clearly show that the dynamic balance technology in Example 4 significantly improves the stability and uniformity of the extract, while greatly reducing the interference of impurities on the extract. The core role of dynamic balance is to fully settle the impurities in the extract and achieve concentration balance between the components through static treatment, thereby improving the clarity of the extract and the stability of the component distribution. In Comparative Example 4, since no static treatment was performed, the component distribution in the extract fluctuated greatly, especially the volatility of saponins, indicating that the extract that has not been balanced has obvious concentration unevenness.

[0124] The advantages of the dynamic balance technology of the present invention are also reflected in the precipitation of impurities. In Example 4, by adding the antioxidant vitamin C, not only the oxidative degradation of flavonoid components is inhibited, but also the aggregation and precipitation of insoluble impurities in the extract are accelerated, thereby significantly improving the light transmittance of the extract. Comparative Example 4 lacks this step, resulting in more suspended particles in the extract and lower light transmittance, which ultimately affects the purity of the extract and the stability of subsequent preparation processing.

[0125] Experiment 5: Preparation stability test Experimental Description Sample preparation: Example 5 group: A granular preparation was prepared according to the process of Example 5, and the extract was spray-dried, and then 10% starch and 8% dextrin were added, and the extract was granulated by roller.

[0126] Comparative Example 5: A dry preparation was prepared according to the process of Comparative Example 5, but the extract was not spray-dried or granulated, and the powder was obtained only by direct drying.

[0127] Experimental setup: The two groups of preparations were stored under the following conditions: High temperature and high humidity conditions: 40°C, 75% relative humidity.

[0128] Normal temperature conditions: 25°C, 60% relative humidity.

[0129] Testing time points: sampling and testing were carried out at 0 days, 15 days and 30 days.

[0130] Detection indicators: Appearance stability: observe changes in color and shape, and record changes in hygroscopicity.

[0131] Component degradation rate: HPLC was used to detect the concentrations of flavonoids, polysaccharides and saponins, and the degradation rates were calculated.

[0132] Flowability test: The repose angle method is used to measure the particle flowability. The smaller the repose angle value, the better the flowability.

[0133] Experimental repetition: Each group of preparations was tested 3 times and the average value was recorded.

[0134] Stability and component degradation rate of different preparations From the experimental results, the granule preparation of Example 5 showed significant stability advantages under high temperature and high humidity conditions. Spray drying and granulation treatment formed a protective structure of the outer layer of the granules, which effectively isolated the erosion of moisture and oxygen on the active ingredients and delayed the degradation of flavonoids, polysaccharides and saponins. However, the directly dried powder of Comparative Example 5 was very easy to absorb moisture and agglomerate due to the loose particle shape and the addition of no protective excipients, resulting in rapid degradation of the active ingredients, which significantly affected the quality of the preparation and the use effect.

[0135] During storage, the color and morphology of the granule preparation of Example 5 hardly changed significantly, indicating that the optimized temperature control during the spray drying process effectively avoided the initial degradation of the active ingredient. The added starch and dextrin also formed a hydrophobic protective film on the surface of the particles, further slowing down the damage of the preparation to the humid and hot environment. Comparative Example 5 lacked such protective treatment, resulting in strong hygroscopicity under humid and hot conditions, and even agglomeration and unmeasurable fluidity, which could not meet the actual storage requirements.

[0136] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A production process for treating lung clearing, nourishing and removing nodules, characterized in that: The following steps are involved: Classification and pretreatment of medicinal materials: The medicinal materials are divided into a low-temperature extraction group, a medium-temperature extraction group and a high-temperature extraction group according to the chemical properties of the components. The medicinal materials are crushed to 60-80 meshes and soaked at 10-20°C for 1-2 hours at a ratio of medicinal material weight to water volume of 1:6-1:10; Flavonoid extraction: Add the low-temperature extraction group herbs to 25-30% ethanol solution, adjust the pH to 6.0-7.0, and extract at 25-40°C for 8-15 minutes; Polysaccharide extraction: Add the medium temperature extraction group herbs into deionized water, add 3-10% mannitol, and extract at 50-70°C for 30-60 minutes; Saponin extraction: Add the high temperature extraction group herbs into 40-60% ethanol solution, adjust the pH to 4.5-6.0, and extract at 75-90℃ and 0.1-0.3MPa for 30-45 minutes; Highly selective separation of components: separation of extracts by membrane separation, solvent extraction and ion exchange resin purification; Extract integration and dynamic equilibrium transformation: the separated extracts are mixed in proportion and allowed to stand at 20-30°C for 10-14 hours; Preparation molding: The extract is spray-dried, and starch and dextrin are added in proportion to form granules or powder.

2. The production process for treating lung clearing, nourishing and removing nodules according to claim 1, characterized in that: The medicinal material classification and pretreatment include: According to chemical properties, medicinal materials are classified into low-temperature group, medium-temperature group and high-temperature group; The medicinal materials are crushed to a particle size of 0.2-0.5 mm; The ratio of medicinal material weight to water volume is 1:6-1:10, and soak for 1-2 hours at 10-20℃.

3. The production process for treating lung clearing, nourishing and removing nodules according to claim 1, characterized in that: The flavonoid extraction comprises: Use 25-30% ethanol solution as the extraction solvent; Adjust the pH of the solvent to 6.0-7.0; The extraction temperature is controlled at 25-40°C and the extraction time is 8-15 minutes; During the extraction process, the stirring speed was controlled at 60-120 rpm.

4. The production process for treating lung clearing, nourishing and removing nodules according to claim 1, characterized in that: The polysaccharide extraction comprises: Use deionized water as the solvent and add 3-10% mannitol; The extraction is carried out at an extraction temperature of 50 to 70°C; The extraction time is 30 to 60 minutes, and the circulation flow rate is controlled at 150 to 300 L / h; The extract is filtered to remove the residue.

5. The production process for treating lung clearing, nourishing and removing nodules according to claim 1, characterized in that: The saponin extraction comprises: Use 40-60% ethanol solution as solvent; Adjust the pH of the solvent to 4.5-6.0 using a weakly acidic buffer; The extraction temperature is 75-90°C and the pressure range is 0.1-0.3MPa; The extraction time is controlled at 30 to 45 minutes, and the dissolution efficiency is improved by stirring.

6. The production process for treating lung clearing, nourishing and removing nodules according to claim 1, characterized in that: The highly selective separation of the components includes: Use a nanofiltration membrane with a pore size of 0.5 to 0.8 nm to perform membrane separation at a pressure of 0.2 to 0.4 MPa and a temperature of 20 to 40°C; The flavonoid components are extracted by solvent, the extraction solvent is ethyl acetate: water phase = 1:2-1:4, the extraction temperature is 15-30°C, and the extraction time is 10-20 minutes; The polysaccharide component is purified by using DEAE-cellulose anion exchange resin, the adsorption pH is 6.5-7.5, the adsorption temperature is 20-30°C, and the adsorption time is 20-40 minutes.

7. The production process for treating lung clearing, nourishing and removing nodules according to claim 1, characterized in that: The extract integration and dynamic equilibrium transformation include: The extracts are mixed in a ratio of flavonoids: polysaccharide: saponin of 2-4:4-6:1-3; Add antioxidant vitamin C at a concentration of 0.1-0.5%; Cool and let stand at 20-30℃ for 10-14 hours to reduce the sedimentation of impurities.

8. The production process for treating lung clearing, nourishing and removing nodules according to claim 1, characterized in that: The preparation molding comprises: The extract is spray-dried into powder under the conditions of inlet temperature of 150-180°C and outlet temperature of 70-90°C; 8-15% starch and 5-12% dextrin are added to the powder, and granules are prepared by a drum granulator at a granulation speed of 150-250 rpm.

9. A formula for treating lung clearing, nourishing and clearing nodules, characterized in that: A production process for treating lung clearing, nourishing and clearing nodules according to any one of claims 1 to 8 is used, and the medicine comprises: Lung cleansing and detoxification group: including honeysuckle, liposomal quercetin, and isatis root; Lung nourishing group: including lily, ophiopogon japonicus, and fritillaria cirrhosa; Phlegm-dissolving and nodule-dispersing group: including bromelain, polyunsaturated phosphatidylcholine, and kelp; The Qi-tonifying and strengthening group includes Astragalus and Pseudostellaria; Blood circulation and stasis removal group: including salvia miltiorrhiza, red peony root, and genistein; Auxiliary medicinal materials: including licorice, loquat leaves, and dendrobium.

10. A formula for treating lung clearing, nourishing and clearing nodules according to claim 9, characterized in that: The drug comprises the following components in parts by weight: 10-20 parts of honeysuckle, 5-15 parts of liposomal quercetin, and 5-12 parts of isatis root; 10-15 parts of lily bulbs, 8-12 parts of ophiopogon japonicus, 2-6 parts of fritillaria cirrhosa; 6-12 parts of bromelain, 8-15 parts of polyunsaturated phosphatidylcholine, and 8-15 parts of kelp; 10-20 parts of Astragalus, 5-10 parts of Pseudostellariae Radix; 6-12 parts of Salvia miltiorrhiza, 5-10 parts of Paeonia lactiflora, 3-8 parts of Genistein; 2-6 parts of licorice, 4-8 parts of loquat leaves, and 5-10 parts of dendrobium.

Images