A lung-clearing preparation of sophora fruit, loquat fruit and perilla seed and a preparation method thereof

Abstract

This invention discloses a lung-clearing preparation made from Sophora japonica, loquat, and perilla seeds, and its preparation method, relating to the field of pharmaceutical technology. The invention provides a lung-clearing preparation made from Sophora japonica, loquat, and perilla seeds, and its preparation method. The composition comprises Sophora japonica extract, loquat leaf extract, perilla seed extract, Polygonatum odoratum extract, turmeric extract, Astragalus membranaceus extract, vitamin B1, vitamin B2, filler, binder, and anti-caking agent. The components work synergistically to clear and moisten the lungs. The addition of titanium dioxide effectively blocks ultraviolet light, reducing the degradation of photosensitive components such as quercetin in the Sophora japonica extract and curcumin in the turmeric extract, thus extending the shelf life of the preparation. The polysaccharide cross-linked sodium alginate added to the binder is prepared using low-viscosity sodium alginate, exhibiting excellent water solubility and rapid dissolution rate. After cross-linking with dextran, it forms a uniform porous structure, providing channels for the dissolution of active ingredients and improving the dissolution rate of the preparation.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a lung-clearing preparation made from Sophora japonica, loquat, and perilla seeds, and its preparation method. Background Technology

[0002] The lungs are one of the most important organs in the human body, responsible for exhaling polluted air and inhaling fresh air, thus maintaining vital functions. In daily life, exogenous irritants such as air pollution, cigarette smoke, and smog can induce airway inflammation and lung damage, which can lead to serious respiratory diseases such as asthma and acute and chronic lung injury. Furthermore, lung infections can trigger inflammatory responses, and the prolonged stimulation of normal lung tissue by a large number of inflammatory factors can lead to fibrosis and eventually the formation of pulmonary nodules.

[0003] In order to prepare a lung-protective preparation with anti-inflammatory and immunomodulatory effects, and with preventive and therapeutic effects on chronic bronchitis and pulmonary fibrosis, and to improve the dissolution rate of the preparation, this application provides a lung-clearing preparation of Sophora japonica, loquat and perilla seeds and its preparation method. Summary of the Invention

[0004] The purpose of this invention is to provide a lung-clearing preparation of Sophora japonica, loquat and perilla seeds and its preparation method, so as to solve the problems raised in the prior art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: A method for preparing a lung-clearing preparation of Sophora japonica, loquat, and perilla seeds includes the following steps: Step 1: Take Sophora japonica flower extract, loquat leaf extract, perilla seed extract, Polygonatum odoratum extract, turmeric extract, and Astragalus membranaceus extract, mix them evenly to obtain a mixed powder; Step 2: Mix hydroxypropyl methylcellulose and sodium alginate evenly, add a mixture of polysaccharide-crosslinked sodium alginate and deionized water, add modified silica-titanium dioxide composite, mix evenly, dry, sieve, and then put it into a gamma-ray irradiator for irradiation treatment, granulation, and obtain modified composite adhesive. Step 3: Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix evenly to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation.

[0006] A more optimized method for preparing the modified silica-titanium dioxide composite is as follows: silica gel and anhydrous ethanol are sheared for 10-15 min to obtain a suspension; nano-titanium dioxide is added, sheared for 15-20 min, and dried to obtain the silica-titanium dioxide composite; KH570 and ethanol are taken and stirred evenly to obtain a KH570 solution; the KH570 solution is atomized and sprayed onto the surface of the silica-titanium dioxide composite, mixed evenly, heated to 50-52℃, and stirred for 20-25 min to obtain the modified silica-titanium dioxide composite.

[0007] More preferably, the filler is mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:(1-1.2):(1-1.2).

[0008] More preferably, the anti-caking agent is magnesium stearate and silica gel, with a mass ratio of magnesium stearate to silica gel of (4-5):1.

[0009] A more optimized method for preparing the polysaccharide-crosslinked sodium alginate is as follows: take dextran, add deionized water, stir evenly, add sodium alginate, heat to 40-45℃ and stir for 15-20 min; add calcium chloride solution dropwise, stir for 30-40 min, add epichlorohydrin, heat to 60-62℃ and react for 2-2.5 h, cool, centrifuge, collect the precipitate, freeze dry, and pulverize to obtain polysaccharide-crosslinked sodium alginate.

[0010] Ideally, the 1% viscosity of the sodium alginate is 850-1000 mPa·s.

[0011] In a more optimized form, the Sophora japonica, loquat, and perilla seed lung-clearing preparation comprises the following components, in parts by weight: 10-30 parts Sophora japonica extract, 12-25 parts loquat leaf extract, 8-20 parts perilla seed extract, 5-15 parts Polygonatum odoratum extract, 5-15 parts turmeric extract, 4-15 parts Astragalus membranaceus extract, 0.5-2 parts vitamin B1, 0.5-2 parts vitamin B2, 80-160 parts filler, 12-15 parts modified composite binder, 16-30 parts deionized water, and 2-2.5 parts anti-caking agent.

[0012] Compared with the prior art, the beneficial effects of the present invention are: 1. The lung-clearing preparation of Sophora japonica, loquat, and perilla seed provided in this application can clear and moisten the lungs, reduce inflammation, and dissipate nodules. Sophora japonica contains quercetin, one of the flavonoid compounds with high medicinal value. Quercetin has multiple functions such as expectoration, antitussive, antiasthmatic, antioxidant, blood pressure lowering, blood lipid lowering, myocardial protection, immune enhancement, and antibacterial properties. Quercetin can reduce the inflammatory response in rats with pulmonary fibrosis. Loquat leaves have a slight odor and a slightly bitter taste, and have the effects of clearing the lungs, relieving cough, and stopping vomiting. The effective active component of loquat leaves is triterpenic acid, which has significant anti-inflammatory and immunomodulatory effects, and has an ideal preventive and therapeutic effect on chronic bronchitis and pulmonary fibrosis. Perilla seeds have the effects of lowering qi and resolving phlegm, relieving cough and asthma, and moistening the intestines and promoting bowel movements. They are used to treat phlegm accumulation and shortness of breath, cough and asthma, and constipation due to intestinal dryness. Polygonatum odoratum can nourish yin and moisten the lungs, nourish the stomach and promote body fluid production. Suitable for those with lung yin deficiency, dry cough, and little phlegm, Polygonatum odoratum polysaccharides can effectively inhibit the proliferation of lung cancer cells. Curcumin, contained in turmeric, is a diketone compound with anti-inflammatory, antioxidant, lipid-regulating, antiviral, and anti-infective effects. Astragalus membranaceus has the effect of invigorating qi and promoting blood circulation.

[0013] The formula contains six ingredients: Sophora japonica buds, loquat leaves, and perilla seeds to clear the lungs and relieve cough; Polygonatum odoratum to nourish yin and moisten dryness; curcumin to fight bacteria and reduce inflammation; and Astragalus membranaceus to replenish qi and promote body fluid production. These six ingredients, which are both medicinal and edible and are new food ingredients, exert a protective effect on the lungs through multiple targets and pathways, and have the effects of clearing and moistening the lungs, reducing inflammation and dissipating nodules.

[0014] This invention provides a lung-clearing preparation made from Sophora japonica, loquat, and perilla seeds, and its preparation method. The composition comprises Sophora japonica extract, loquat leaf extract, perilla seed extract, Polygonatum odoratum extract, turmeric extract, Astragalus membranaceus extract, vitamin B1, vitamin B2, filler, binder, and anti-caking agent. The components work synergistically to clear and moisturize the lungs.

[0015] 2. The addition of titanium dioxide in this application can effectively block ultraviolet rays, reduce the degradation of photosensitive components such as quercetin in Sophora japonica extract and curcumin in turmeric extract, and extend the product's shelf life.

[0016] 3. The polysaccharide-crosslinked sodium alginate added to the adhesive in this application is prepared using low-viscosity sodium alginate (1% viscosity: 850-1000 mPa·s), which exhibits excellent water solubility and a fast dissolution rate. After crosslinking with dextran, it forms a uniform porous structure, providing channels for the dissolution of active ingredients and improving dissolution rate. The introduction of γ-ray irradiation modification allows for moderate crosslinking of hydroxypropyl methylcellulose and sodium alginate molecular chains, enhancing the film-forming properties and stability of the adhesive without excessive crosslinking leading to delayed dissolution. If high-viscosity sodium alginate is used to prepare the polysaccharide-crosslinked sodium alginate, its water solubility decreases, the dissolution rate slows down, and it is prone to aggregation, resulting in reduced reactivity. The narrow pore structure formed after crosslinking hinders the dissolution of active ingredients, ultimately significantly reducing the dissolution rate of the formulation.

[0017] 4. This application uses dextran to crosslink sodium alginate, improving biocompatibility and reducing the risk of gastrointestinal irritation. The hydroxyl and amino groups on the dextran molecular chain synergistically interact with the carboxyl groups of sodium alginate, forming a gel framework through ionic crosslinking with calcium chloride. Further structural stability is enhanced by covalent crosslinking with epichlorohydrin, ultimately resulting in a uniform and stable porous structure of polysaccharide-crosslinked sodium alginate. Furthermore, the active groups on the dextran molecule can form hydrogen bonds with the hydroxyl groups of hydroxypropyl methylcellulose and the siloxane groups on KH570, significantly enhancing the interfacial bonding between the pore-forming agent, the binder substrate, and the modified silica-titanium dioxide complex. This prevents the polysaccharide-crosslinked sodium alginate from detaching from the binder system, effectively suppressing dissolution fluctuations and improving the stability of the formulation release rate. Compared to sodium alginate alone, this polysaccharide-crosslinked sodium alginate has a more regular porous structure and higher porosity, providing more efficient channels for the dissolution of active ingredients and further improving the formulation's dissolution rate. Meanwhile, dextran has certain antioxidant properties, which can form a synergistic protection with the light-shielding effect of titanium dioxide. Titanium dioxide blocks ultraviolet radiation, while dextran inhibits the oxidation reaction of active ingredients, further inhibiting the degradation of photosensitive and easily oxidized components such as quercetin and curcumin, and extending the shelf life of the preparation. Detailed Implementation

[0018] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] The sources and types of substances involved in this application are not specifically limited. Exemplary examples include: silica gel: particle size: 10-20µm; nano titanium dioxide: particle size: 10-50nm; dextran: CAS: 9004-54-0, which can be purchased from Hanbang Huanyu Polysaccharide Biotechnology (Heyuan) Co., Ltd.; hydroxypropyl methylcellulose: CAS: 9004-65-3, which can be purchased from Jiangsu Aofu Biotechnology Co., Ltd.; sodium alginate: 1% viscosity: 850-1000mPa·s, type: S741815, which can be purchased from Maclean's; sodium alginate: 1% viscosity: 7000-10000mPa·s, type: H875028, which can be purchased from Maclean's.

[0020] Example 1: A method for preparing a lung-clearing preparation of Sophora japonica, loquat, and perilla seed, comprising the following steps: Take Sophora japonica flower extract, Eriobotrya japonica leaf extract, Perilla frutescens seed extract, Polygonatum odoratum extract, Curcuma longa extract, and Astragalus membranaceus extract, mix them for 25 minutes until they are evenly mixed to obtain a mixed powder; Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix for 35 minutes until evenly mixed to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation. The Sophora japonica, loquat, and perilla seed lung-clearing preparation is composed of the following ingredients, by weight: 20 parts Sophora japonica extract, 22 parts loquat leaf extract, 15 parts perilla seed extract, 12 parts Polygonatum odoratum extract, 12 parts turmeric extract, 12 parts Astragalus membranaceus extract, 1 part vitamin B1, 1 part vitamin B2, 120 parts filler, 13 parts modified composite binder, 22 parts deionized water, and 2.2 parts anti-caking agent; The fillers are mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:1:1; the anti-caking agents are magnesium stearate and silica gel, with a mass ratio of 4.5:1. The preparation method of the modified composite adhesive includes the following steps: Take 10g of dextran, add 100mL of deionized water, stir well, add 20g of sodium alginate, heat to 42℃ and stir for 18min; add 5mL of 2% calcium chloride solution, stir for 35min, add 0.5g of epichlorohydrin, heat to 61℃ and react for 2.2h, cool, centrifuge, collect the precipitate, freeze dry and pulverize to obtain polysaccharide crosslinked sodium alginate; Take 13g of silica gel and 100mL of anhydrous ethanol, shear for 12min to obtain a suspension; add 3g of nano-titanium dioxide, shear for 18min, and dry to obtain a silica gel-titanium dioxide composite; take 0.5g of KH570 and 5mL of ethanol, stir evenly to obtain a KH570 solution; atomize the KH570 solution onto the surface of the silica gel-titanium dioxide composite, mix evenly, heat to 51℃, and stir for 22min to obtain a modified silica gel-titanium dioxide composite; 60g of hydroxypropyl methylcellulose and 18g of sodium alginate were stirred for 8 minutes. A mixture of 4g of polysaccharide-crosslinked sodium alginate and 10mL of deionized water was added. Modified silica-titanium dioxide composite was added, stirred evenly, dried, and sieved. Then, it was placed in a gamma-ray irradiator with an irradiation dose of 2kGy / min, an irradiation temperature of 25℃, and an irradiation time of 30 minutes. Granulation was performed to obtain the modified composite adhesive.

[0021] Example 2: A method for preparing a lung-clearing preparation of Sophora japonica, loquat, and perilla seeds, comprising the following steps: Take Sophora japonica flower extract, Eriobotrya japonica leaf extract, Perilla frutescens seed extract, Polygonatum odoratum extract, Curcuma longa extract, and Astragalus membranaceus extract, mix them for 20 minutes until they are evenly mixed to obtain a mixed powder; Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix for 30 minutes until evenly mixed to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation. The Sophora japonica, loquat, and perilla seed lung-clearing preparation is composed of the following ingredients, by weight: 10 parts Sophora japonica extract, 12 parts loquat leaf extract, 8 parts perilla seed extract, 5 parts Polygonatum odoratum extract, 5 parts turmeric extract, 4 parts Astragalus membranaceus extract, 0.5 parts vitamin B1, 0.5 parts vitamin B2, 80 parts filler, 12 parts modified composite binder, 16 parts deionized water, and 2 parts anti-caking agent. The fillers are mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:1:1; the anti-caking agents are magnesium stearate and silica gel; the mass ratio of magnesium stearate and silica gel is 4:1. The preparation method of the modified composite adhesive includes the following steps: Take 10g of dextran, add 100mL of deionized water, stir well, add 20g of sodium alginate, heat to 40℃ and stir for 15min; add 5mL of 2% calcium chloride solution, stir for 30min, add 0.5g of epichlorohydrin, heat to 60℃ and react for 2h, cool, centrifuge, collect the precipitate, freeze dry and pulverize to obtain polysaccharide crosslinked sodium alginate; Take 13g of silica gel and 100mL of anhydrous ethanol, shear for 10min to obtain a suspension; add 3g of nano-titanium dioxide, shear for 15min, and dry to obtain a silica gel-titanium dioxide composite; take 0.5g of KH570 and 5mL of ethanol, stir evenly to obtain a KH570 solution; atomize the KH570 solution onto the surface of the silica gel-titanium dioxide composite, mix evenly, heat to 50℃, and stir for 20min to obtain a modified silica gel-titanium dioxide composite. 60g of hydroxypropyl methylcellulose and 18g of sodium alginate were stirred for 5 minutes. A mixture of 4g of polysaccharide-crosslinked sodium alginate and 10mL of deionized water was added. Modified silica-titanium dioxide composite was added, stirred evenly, dried, and sieved. Then, it was placed in a gamma-ray irradiator with an irradiation dose of 2kGy / min, an irradiation temperature of 25℃, and an irradiation time of 30 minutes. Granulation was performed to obtain the modified composite adhesive.

[0022] Example 3: A method for preparing a lung-clearing preparation of Sophora japonica, loquat, and perilla seeds, comprising the following steps: Take Sophora japonica flower extract, loquat leaf extract, perilla seed extract, Polygonatum odoratum extract, turmeric extract, and Astragalus membranaceus extract, mix for 30 minutes until evenly mixed to obtain a mixed powder; Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix for 40 minutes until evenly mixed to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation. The Sophora japonica, loquat, and perilla seed lung-clearing preparation is composed of the following ingredients, by weight: 30 parts Sophora japonica extract, 25 parts loquat leaf extract, 20 parts perilla seed extract, 15 parts Polygonatum odoratum extract, 15 parts turmeric extract, 15 parts Astragalus membranaceus extract, 2 parts vitamin B1, 2 parts vitamin B2, 160 parts filler, 15 parts modified composite binder, 30 parts deionized water, and 2.5 parts anti-caking agent. The fillers are mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:1:1; the anti-caking agents are magnesium stearate and silica gel, with a mass ratio of 5:1. The preparation method of the modified composite adhesive includes the following steps: Take 10g of dextran, add 100mL of deionized water, stir well, add 20g of sodium alginate, heat to 45℃ and stir for 20min; add 5mL of 2% calcium chloride solution, stir for 40min, add 0.5g of epichlorohydrin, heat to 62℃ and react for 2.5h, cool, centrifuge, collect the precipitate, freeze dry and pulverize to obtain polysaccharide crosslinked sodium alginate; Take 13g of silica gel and 100mL of anhydrous ethanol, shear for 15min to obtain a suspension; add 3g of nano-titanium dioxide, shear for 20min, and dry to obtain a silica gel-titanium dioxide composite; take 0.5g of KH570 and 5mL of ethanol, stir evenly to obtain a KH570 solution; atomize the KH570 solution onto the surface of the silica gel-titanium dioxide composite, mix evenly, heat to 52℃, and stir for 25min to obtain a modified silica gel-titanium dioxide composite. 60g of hydroxypropyl methylcellulose and 18g of sodium alginate were stirred for 10 minutes. A mixture of 4g of polysaccharide-crosslinked sodium alginate and 10mL of deionized water was added. Modified silica-titanium dioxide composite was added, stirred evenly, dried, and sieved. Then, it was placed in a gamma-ray irradiator with an irradiation dose of 2kGy / min, an irradiation temperature of 25℃, and an irradiation time of 30 minutes. Granulation was performed to obtain the modified composite adhesive.

[0023] Comparative Example 1: Sodium alginate was not modified with dextran; all other aspects were the same as in Example 1. Take Sophora japonica flower extract, Eriobotrya japonica leaf extract, Perilla frutescens seed extract, Polygonatum odoratum extract, Curcuma longa extract, and Astragalus membranaceus extract, mix them for 25 minutes until they are evenly mixed to obtain a mixed powder; Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix for 35 minutes until evenly mixed to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation. The Sophora japonica, loquat, and perilla seed lung-clearing preparation is composed of the following ingredients, by weight: 20 parts Sophora japonica extract, 22 parts loquat leaf extract, 15 parts perilla seed extract, 12 parts Polygonatum odoratum extract, 12 parts turmeric extract, 12 parts Astragalus membranaceus extract, 1 part vitamin B1, 1 part vitamin B2, 120 parts filler, 13 parts modified composite binder, 22 parts deionized water, and 2.2 parts anti-caking agent; The fillers are mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:1:1; the anti-caking agents are magnesium stearate and silica gel, with a mass ratio of 4.5:1. The preparation method of the modified composite adhesive includes the following steps: Take 13g of silica gel and 100mL of anhydrous ethanol, shear for 12min to obtain a suspension; add 3g of nano-titanium dioxide, shear for 18min, and dry to obtain a silica gel-titanium dioxide composite; take 0.5g of KH570 and 5mL of ethanol, stir evenly to obtain a KH570 solution; atomize the KH570 solution onto the surface of the silica gel-titanium dioxide composite, mix evenly, heat to 51℃, and stir for 22min to obtain a modified silica gel-titanium dioxide composite; 60g of hydroxypropyl methylcellulose and 22g of sodium alginate were stirred for 8 minutes, 10mL of deionized water was added and mixed evenly, the modified silica-titanium dioxide composite was added and stirred evenly, dried and sieved, and then placed in a gamma-ray irradiator with an irradiation dose of 2kGy / min, an irradiation temperature of 25℃ and an irradiation time of 30 minutes. Granulation was then performed to obtain the modified composite adhesive.

[0024] Comparative Example 2: No γ-ray irradiation modification was introduced; all other aspects were the same as in Example 1. Take Sophora japonica flower extract, Eriobotrya japonica leaf extract, Perilla frutescens seed extract, Polygonatum odoratum extract, Curcuma longa extract, and Astragalus membranaceus extract, mix them for 25 minutes until they are evenly mixed to obtain a mixed powder; Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix for 35 minutes until evenly mixed to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation. The Sophora japonica, loquat, and perilla seed lung-clearing preparation is composed of the following ingredients, by weight: 20 parts Sophora japonica extract, 22 parts loquat leaf extract, 15 parts perilla seed extract, 12 parts Polygonatum odoratum extract, 12 parts turmeric extract, 12 parts Astragalus membranaceus extract, 1 part vitamin B1, 1 part vitamin B2, 120 parts filler, 13 parts modified composite binder, 22 parts deionized water, and 2.2 parts anti-caking agent; The fillers are mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:1:1; the anti-caking agents are magnesium stearate and silica gel, with a mass ratio of 4.5:1. The preparation method of the modified composite adhesive includes the following steps: Take 10g of dextran, add 100mL of deionized water, stir well, add 20g of sodium alginate, heat to 42℃ and stir for 18min; add 5mL of 2% calcium chloride solution, stir for 35min, add 0.5g of epichlorohydrin, heat to 61℃ and react for 2.2h, cool, centrifuge, collect the precipitate, freeze dry and pulverize to obtain polysaccharide crosslinked sodium alginate; Take 13g of silica gel and 100mL of anhydrous ethanol, shear for 12min to obtain a suspension; add 3g of nano-titanium dioxide, shear for 18min, and dry to obtain a silica gel-titanium dioxide composite; take 0.5g of KH570 and 5mL of ethanol, stir evenly to obtain a KH570 solution; atomize the KH570 solution onto the surface of the silica gel-titanium dioxide composite, mix evenly, heat to 51℃, and stir for 22min to obtain a modified silica gel-titanium dioxide composite; Mix 60g of hydroxypropyl methylcellulose and 18g of sodium alginate for 8 minutes, add a mixture of 4g of polysaccharide-crosslinked sodium alginate and 10mL of deionized water, add the modified silica-titanium dioxide composite, stir evenly, dry, sieve, and granulate to obtain the modified composite adhesive.

[0025] Comparative Example 3: 1% sodium alginate with a viscosity of 7000-10000 mPa·s was used, and the rest was the same as in Example 1.

[0026] Comparative Example 4: No titanium dioxide was added; all other aspects were the same as in Example 1. Take Sophora japonica flower extract, Eriobotrya japonica leaf extract, Perilla frutescens seed extract, Polygonatum odoratum extract, Curcuma longa extract, and Astragalus membranaceus extract, mix them for 25 minutes until they are evenly mixed to obtain a mixed powder; Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix for 35 minutes until evenly mixed to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation. The Sophora japonica, loquat, and perilla seed lung-clearing preparation is composed of the following ingredients, by weight: 20 parts Sophora japonica extract, 22 parts loquat leaf extract, 15 parts perilla seed extract, 12 parts Polygonatum odoratum extract, 12 parts turmeric extract, 12 parts Astragalus membranaceus extract, 1 part vitamin B1, 1 part vitamin B2, 120 parts filler, 13 parts modified composite binder, 22 parts deionized water, and 2.2 parts anti-caking agent; The fillers are mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:1:1; the anti-caking agents are magnesium stearate and silica gel, with a mass ratio of 4.5:1. The preparation method of the modified composite adhesive includes the following steps: Take 10g of dextran, add 100mL of deionized water, stir well, add 20g of sodium alginate, heat to 42℃ and stir for 18min; add 5mL of 2% calcium chloride solution, stir for 35min, add 0.5g of epichlorohydrin, heat to 61℃ and react for 2.2h, cool, centrifuge, collect the precipitate, freeze dry and pulverize to obtain polysaccharide crosslinked sodium alginate; Take 0.5g KH570 and 5mL ethanol, stir well to obtain KH570 solution; spray KH570 solution onto silica gel surface by atomization, mix well, heat to 51℃, stir for 22min to obtain modified silica gel. 60g of hydroxypropyl methylcellulose and 18g of sodium alginate were stirred for 8 minutes. A mixture of 4g of polysaccharide-crosslinked sodium alginate and 10mL of deionized water was added. Modified silica gel was added, stirred evenly, dried, and sieved. Then, it was placed in a gamma-ray irradiator with an irradiation dose of 2kGy / min, an irradiation temperature of 25℃, and an irradiation time of 30 minutes. Granulation was performed to obtain the modified composite adhesive.

[0027] Experiment 1: The lung-clearing preparations of Sophora japonica, Eriobotrya japonica, and Perilla frutescens seeds prepared in Examples 1-3 and Comparative Examples 1-4 were subjected to performance testing. The dissolution rate was determined at 5, 15, and 30 min according to Method II of Appendix XC, Part II of the 2005 edition of the Chinese Pharmacopoeia. The data obtained are shown in Table 1 below. Table 1

[0028] Conclusion: The data comparison in the table shows that Comparative Example 1, without modification of sodium alginate using dextran, exhibits poor stability in the formulation release rate and decreased dissolution. Comparative Example 2, without γ-ray irradiation modification, results in excessive cross-linking and reduced dissolution. Comparative Example 3, using 1% sodium alginate with a viscosity of 7000-10000 mPa·s, suffers from decreased water solubility, slower dissolution rate, and easy aggregation, leading to reduced reactivity. The narrow pore structure formed after cross-linking hinders the dissolution of active ingredients, ultimately significantly reducing the formulation's dissolution. The polysaccharide-crosslinked sodium alginate added to the binder in this application, prepared using low-viscosity sodium alginate (1% viscosity: 850-1000 mPa·s), exhibits excellent water solubility and a fast dissolution rate. After cross-linking with dextran, it forms a uniform porous structure, providing channels for the dissolution of active ingredients and improving dissolution. The introduction of gamma-ray irradiation modification allows for moderate cross-linking of the molecular chains of hydroxypropyl methylcellulose and sodium alginate, enhancing the film-forming properties and stability of the adhesive without causing excessive cross-linking that leads to slow dissolution.

[0029] Experiment 2: The lung-clearing preparations made from Sophora japonica, Eriobotrya japonica, and Perilla frutescens seeds prepared in Examples 1-3, Comparative Examples 1 and 4 were subjected to performance testing. The preparations underwent photostability testing (total illuminance 1.2 million Lux·hr), and the residual content of photosensitive components such as quercetin and curcumin was determined by HPLC. The data obtained are shown in Table 2 below. Table 2

[0030] Conclusion: The data comparison in the table shows that in Comparative Example 1, without the use of dextran to modify sodium alginate, the residual content of photosensitive components such as quercetin and curcumin decreased after light irradiation. In the examples, the addition of dextran, which possesses certain antioxidant properties, forms a synergistic protective mechanism with the light-blocking effect of titanium dioxide: titanium dioxide blocks ultraviolet radiation, and dextran inhibits the oxidation reaction of active ingredients, further inhibiting the degradation of photosensitive and easily oxidized components such as quercetin and curcumin under this dual effect. In Comparative Example 4, without the addition of titanium dioxide, the levels of photosensitive components such as quercetin and curcumin decreased. The addition of titanium dioxide in this application effectively blocks ultraviolet radiation, reduces the degradation of photosensitive components such as quercetin in Sophora japonica extract and curcumin in turmeric extract, and extends the product's shelf life.

[0031] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within the present invention.

Claims

1. A method for preparing a lung-clearing preparation of Sophora japonica, Eriobotrya japonica, and Perilla frutescens seeds, characterized in that: Includes the following steps: Step 1: Take Sophora japonica flower extract, loquat leaf extract, perilla seed extract, Polygonatum odoratum extract, turmeric extract, and Astragalus membranaceus extract, mix them evenly to obtain a mixed powder; Step 2: Mix hydroxypropyl methylcellulose and sodium alginate evenly, add a mixture of polysaccharide-crosslinked sodium alginate and deionized water, add modified silica-titanium dioxide composite, mix evenly, dry, sieve, and then put it into a gamma-ray irradiator for irradiation treatment, granulation, and obtain modified composite adhesive. Step 3: Take the modified composite adhesive and deionized water, dissolve them to obtain a slurry, add the slurry to the mixed powder, stir evenly, granulate, dry, granulate, add vitamin B1, vitamin B2, filler and anti-caking agent, mix evenly to obtain a mixture, compress into tablets to obtain the Sophora japonica, loquat and perilla seed lung-clearing preparation.

2. The preparation method of the lung-clearing preparation of Sophora japonica, Eriobotrya japonica, and Perilla frutescens according to claim 1, characterized in that: The modified silica-titanium dioxide composite is prepared as follows: silica gel and anhydrous ethanol are sheared for 10-15 min to obtain a suspension; nano-titanium dioxide is added, sheared for 15-20 min, and dried to obtain the silica-titanium dioxide composite; KH570 and ethanol are taken and stirred evenly to obtain a KH570 solution; the KH570 solution is atomized and sprayed onto the surface of the silica-titanium dioxide composite, mixed evenly, heated to 50-52℃, and stirred for 20-25 min to obtain the modified silica-titanium dioxide composite.

3. The preparation method of the lung-clearing preparation of Sophora japonica, Eriobotrya japonica, and Perilla frutescens according to claim 1, characterized in that: The filler is mannitol, microcrystalline cellulose, and maltodextrin; the mass ratio of mannitol, microcrystalline cellulose, and maltodextrin is 2:(1-1.2):(1-1.2).

4. The preparation method of the lung-clearing preparation of Sophora japonica, Eriobotrya japonica, and Perilla frutescens according to claim 1, characterized in that: The anti-caking agent is magnesium stearate and silica gel, with a mass ratio of magnesium stearate to silica gel of (4-5):

1.

5. The preparation method of the lung-clearing preparation of Sophora japonica, Eriobotrya japonica, and Perilla frutescens according to claim 1, characterized in that: The preparation method of the polysaccharide crosslinked sodium alginate is as follows: take dextran, add deionized water, stir evenly, add sodium alginate, heat to 40-45℃ and stir for 15-20 minutes. Add calcium chloride solution dropwise, stir for 30-40 minutes, add epichlorohydrin, heat to 60-62℃ and react for 2-2.5 hours, cool, centrifuge, collect the precipitate, freeze dry and pulverize to obtain polysaccharide crosslinked sodium alginate.

6. The preparation method of the lung-clearing preparation of Sophora japonica, Eriobotrya japonica, and Perilla frutescens according to claim 5, characterized in that: The 1% viscosity of the sodium alginate is 850-1000 mPa·s.

7. The preparation method of the lung-clearing preparation of Sophora japonica, Eriobotrya japonica, and Perilla frutescens according to claim 1, characterized in that: The sophora japonica, loquat, and perilla seed lung-clearing preparation is composed of the following ingredients, in parts by weight: 10-30 parts sophora japonica extract, 12-25 parts loquat leaf extract, 8-20 parts perilla seed extract, 5-15 parts polygonatum odoratum extract, 5-15 parts turmeric extract, 4-15 parts astragalus membranaceus extract, 0.5-2 parts vitamin B1, 0.5-2 parts vitamin B2, 80-160 parts filler, 12-15 parts modified composite binder, 16-30 parts deionized water, and 2-2.5 parts anti-caking agent.

8. The lung-clearing preparation of Sophora japonica, loquat and perilla seeds prepared by the method according to any one of claims 1-7.

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