Refreshing and anti-fatigue traditional Chinese medicine composition and preparation method thereof

Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses a refreshing and anti-fatigue traditional Chinese medicine composition and a preparation method thereof. The invention discloses a refreshing and anti-fatigue traditional Chinese medicine composition. Comprising succinylated pachymaran, an ethyl cellulose aqueous dispersion, acetyl tributyl citrate, polyoxyethylene sorbitan monooleate, an ethanol aqueous solution, chitosan oligosaccharide, ginsenoside Rg1 nano-micelles, polyvinylpyrrolidone, deionized water, pseudo-ginseng powder, ginseng powder, a pachymaran extract, a Chinese wolfberry fruit polysaccharide extract and a lotus plumule alkali extract. The composition is prepared from microcrystalline cellulose, cross-linked povidone, colloidal silicon dioxide and magnesium stearate. According to the refreshing and anti-fatigue traditional Chinese medicine composition disclosed by the invention, the inner layer directly forms a nano-fiber net film with an ultra-large specific surface area on the surface of the tablet core through an electrostatic spinning technology, and the nano-fiber net film can generate an extremely strong capillary action after meeting water, so that a rapid disintegration effect is realized.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical preparation technology, and more specifically, to a traditional Chinese medicine composition for stimulating energy and relieving fatigue, and its preparation method. Background Technology

[0002] In the field of traditional Chinese medicine compound preparations, combining natural drugs such as Poria cocos, lotus seeds, wolfberries, Panax notoginseng, and ginseng to prepare anti-fatigue functional products has broad prospects. However, such TCM compositions usually contain a variety of odorous components, highly hygroscopic extracts, and active substances with varying solubility, which places certain requirements on the masking of taste, stability, and dissolution behavior of the preparation.

[0003] Gastric-soluble coating is a key technology widely used in solid oral dosage forms. Its purpose is to protect drug components, mask unpleasant odors, improve appearance, and enable rapid drug release in the gastric environment.

[0004] Currently, the most common gastric-soluble coating materials on the market are traditional polymers such as hydroxypropyl methylcellulose (HPMC). Traditional HPMC coatings hydrate upon contact with gastric juice, lacking a delayed-trigger mechanism for dissolution. This can lead to premature drug release in the esophagus or upper stomach, causing local irritation, and there is room for improvement in the uniformity and speed of drug release. The coating film formed by HPMC and other polymers has limited mechanical strength, making it prone to cracking or wear during transportation or coating. Furthermore, its strong hygroscopicity may affect the long-term stability of the drug, especially in high-humidity environments, easily leading to coating softening, adhesion, or drug degradation. Existing gastric-soluble coatings primarily serve as an isolation and gastric-soluble release mechanism, lacking the ability to promote drug absorption, achieve rapid disintegration, or synergistically integrate with other functional components (such as absorption enhancers), making it difficult to meet the diverse functional requirements of modern drug delivery systems. For drugs containing strongly bitter components, especially extracts of traditional Chinese medicine, a thicker coating layer is required to effectively mask the taste, which undoubtedly increases production costs and tablet volume, and may prolong disintegration time. Some high-performance coating processes (such as certain ethyl cellulose coatings) still rely on toxic and harmful organic solvents such as dichloromethane. This not only poses a threat to the health of operators, but also brings the risks of environmental pollution and solvent residues, which is inconsistent with the development trend of green pharmaceuticals.

[0005] Existing conventional gastric coating technologies struggle to address the inherent formulation challenges of traditional Chinese medicine compound preparations while ensuring rapid onset of action. Therefore, there is an urgent need in this field for a novel gastric coating technology that combines rapid disintegration, excellent mechanical strength, good moisture resistance, efficient taste masking, and environmental compliance, making it suitable for the development of high-performance, multi-component formulations such as anti-fatigue traditional Chinese medicine compositions. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine composition for invigorating the mind and relieving fatigue, and its preparation method.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A traditional Chinese medicine composition for invigorating and relieving fatigue, comprising, by weight parts: 15-25 parts succinylated Poria cocos polysaccharide, 4-8 parts ethyl cellulose aqueous dispersion, 2-4 parts acetyl tributyl citrate, 0.5-1.5 parts polyoxyethylene sorbitan monooleate, 80-100 parts ethanol aqueous solution, 6-10 parts chitosan oligosaccharide, 1-3 parts ginsenoside Rg1 nanomicelles, 10-20 parts polyvinylpyrrolidone, 20-40 parts deionized water, 20-30 parts Panax notoginseng powder, 15-25 parts ginseng powder, 10-20 parts Poria cocos polysaccharide extract, 10-20 parts Lycium barbarum polysaccharide extract, 2-6 parts lotus seed heart alkaloid extract, 15-25 parts microcrystalline cellulose, 3-6 parts cross-linked polyvinylpyrrolidone, 0.5-1.5 parts colloidal silica, and 0.5-1.5 parts magnesium stearate.

[0009] Furthermore, the preparation method of the succinylated Poria cocos polysaccharide includes the following steps:

[0010] S1. Weigh out 10-20 parts of Poria cocos polysaccharide extract, 5-15 parts of succinic anhydride, 1-2 parts of 4-dimethylaminopyridine, and 100-120 parts of dimethyl sulfoxide by weight.

[0011] S2. Add the Poria cocos polysaccharide to dimethyl sulfoxide and stir continuously in a constant temperature water bath at 60-80°C for 2-4 hours under nitrogen protection to obtain a viscous solution.

[0012] S3. Cool the viscous solution to 50-70°C. Add 4-dimethylaminopyridine and stir for 10-20 minutes to obtain the reaction solution;

[0013] S4. Slowly add succinic anhydride to the reaction solution in 3-5 portions, with an interval of 15-20 minutes between each portion. Under nitrogen protection, stir continuously at a temperature of 50-70°C and reflux for 4-8 hours. After the reaction is completed, allow the reaction product to cool naturally to room temperature.

[0014] S5. After cooling, the reaction product is slowly poured into 5-10 times its volume of anhydrous ethanol under vigorous stirring to form a flocculent precipitate. The precipitate is collected by filtration and washed with anhydrous ethanol 3-5 times until the washing liquid is colorless and neutral to completely remove unreacted succinic anhydride, catalyst and solvent, and to obtain crude product.

[0015] S6. The crude product is redissolved in deionized water and placed in a dialysis bag. Dialyze with NaCl solution for 12-24 hours, then with deionized water for 24-48 hours. Change the water every 6-8 hours. Take out the solution from the dialysis bag and freeze-dry it to form a white, loose, spongy solid, which yields succinylated Poria cocos polysaccharide.

[0016] Furthermore, the mass fraction of the NaCl solution in step S6 is 0.6%-1.2%.

[0017] Furthermore, the solid content of the ethyl cellulose aqueous dispersion is 20%-26%.

[0018] Furthermore, the mass fraction of the ethanol aqueous solution is 70%-80%.

[0019] Furthermore, the particle size of the Panax notoginseng powder is 5-15 μm.

[0020] Furthermore, the ginseng powder contains ≥80% ginsenosides.

[0021] Furthermore, the purity of the Poria cocos polysaccharide extract is ≥70%, the purity of the Lycium barbarum polysaccharide extract is ≥50%, and the purity of the lotus seed heart alkaloid extract is ≥50%.

[0022] Furthermore, the preparation method of the invigorating and fatigue-relieving traditional Chinese medicine composition includes the following steps:

[0023] (1) Weigh each raw material component according to the weight percentage;

[0024] (2) Slowly add succinylated Poria cocos polysaccharide into an ethanol aqueous solution and stir until completely dissolved to obtain a succinylated Poria cocos polysaccharide solution;

[0025] (3) Add acetyl tributyl citrate and polyoxyethylene sorbitan monooleate to the ethyl cellulose aqueous dispersion slowly under stirring, and continue stirring for 30-40 min to obtain a mixed dispersion;

[0026] (4) Add the succinylated Poria cocos polysaccharide solution to the mixed dispersion, and shear at a high speed of 10,000-12,000 rpm for 20-30 min. Pass the solution through a 100-120 mesh sieve to obtain the coating solution.

[0027] (5) Slowly add chitosan oligosaccharide to an appropriate amount of deionized water and stir magnetically for 4-6 hours to obtain chitosan oligosaccharide solution;

[0028] (6) Add polyvinylpyrrolidone to the remaining deionized water and stir until completely dissolved. Then add ginsenoside Rg1 nano micelles and continue stirring and mixing at room temperature to obtain a mixture.

[0029] (7) Slowly add the mixture to the chitosan oligosaccharide solution and stir continuously for 1-2 hours to form a uniform, clear, bubble-free spinning solution;

[0030] (8) Add Panax notoginseng powder, ginseng powder, Poria cocos polysaccharide extract, Lycium barbarum polysaccharide extract, Nelumbo nucifera heart alkaloid extract, microcrystalline cellulose and cross-linked polyvinylpyrrolidone into a three-dimensional mixer in sequence and mix at a speed of 15-25 rpm for 20-30 min to obtain the initial mixture;

[0031] (9) Add colloidal silica and magnesium stearate to the mixture and continue stirring at 10-20 rpm for 8-10 minutes to obtain the mixture;

[0032] (10) Place the mixture in a dry granulator and granulate it under the conditions of roller pressure of 3-6 MPa and roller speed of 5-15 rpm. Then place the granules in a rotary tablet press and press them into tablet cores with a hardness of 50-80 N at a tableting speed of 10-20 rpm.

[0033] (11) After preheating the core to 30-40℃, fix it on the roller receiver of the electrospinning equipment. Adjust the rotation speed of the roller receiver to 50-100rpm. Inject the spinning solution into the syringe of the electrospinning equipment. Adjust the distance from the needle tip of the syringe to the core to 12-18cm. Spray the spinning solution onto the surface of the core at a propulsion rate of 0.8-1.6mL / h under a voltage of 15-25kV. The spinning time for each batch of cores is 3-8min to obtain the first coated core.

[0034] (12) Place the tablet cores that have been initially coated into the tablet bed of the coating pan, adjust the distance between the spray gun of the coating pan and the tablet bed to 15-25cm, the air inlet temperature to 50-60℃, use a peristaltic pump, under the condition of compressed air pressure of 0.8-1.6Bar, spray the coating liquid onto the surface of the tablet cores that have been initially coated at a spray rate of 2-4g / min to increase their weight by 4%-6%, place them in an oven at 40-50℃ to dry for 8-12h, cool at room temperature, and package to obtain the invigorating and anti-fatigue traditional Chinese medicine composition.

[0035] In summary, this application includes at least the following beneficial effects:

[0036] (1) This invention uses a double-layer coating structure to protect the drug tablet core, preparing a traditional Chinese medicine composition for invigorating and relieving fatigue. The outer layer is composed of modified natural polymers and nano-plasticizers, effectively improving mechanical strength and moisture resistance, while also possessing excellent taste-masking effects. Poria cocos polysaccharide is a water-soluble polysaccharide extracted from Poria cocos and is the main active ingredient of Poria cocos. Through chemical modification, succinic anhydride esterification is used to introduce succinyl groups into its molecular chain. The carboxyl group on the succinyl group has strong hydrophilicity, increasing the hydrophilicity and film-forming properties of the polymer, and can significantly improve the dissolution rate of the modified polysaccharide in water and gastric juice. The carboxyl group is protonated (-COOH) in the gastric acid environment (pH 1.5-3.5), resulting in good solubility; in a neutral environment, it is ionized (-COO). - It exhibits better solubility, making it an excellent gastrointestinal coating material. The increased functional groups on the molecular chains of Poria cocos polysaccharides alter the interchain interactions, allowing for the formation of dense, robust films.

[0037] (2) The invigorating and fatigue-relieving traditional Chinese medicine composition of the present invention has an inner layer formed by electrospinning technology, directly forming a nanofiber network with an ultra-large specific surface area on the core surface. Upon contact with water, it generates a strong capillary effect, achieving rapid disintegration. Ginsenoside Rg1, extracted and purified from ginseng powder, forms nanomicelles through self-assembly. It is both an active ingredient and a natural surfactant, improving the properties of the spinning solution and exerting a synergistic anti-fatigue effect. Ethyl cellulose aqueous dispersion has excellent film-forming properties, providing good moisture resistance and mechanical strength. The formed nanofiber network has adhesive properties, effectively encapsulating and fixing bitter drug molecules while prolonging the drug's residence time at the absorption site. The outer layer of the traditional Chinese medicine composition dissolves first, followed by the instantaneous disintegration of the inner nanofibers, avoiding premature release and achieving rapid drug dissolution. Meanwhile, the nanofiber inner layer composed of chitosan oligosaccharide and polyvinylpyrrolidone not only serves for rapid disintegration, but also forms a loose, high-porosity buffer transition layer between the core and the outer coating. Even if a trace amount of water vapor penetrates the outer layer, it will be dispersed and adsorbed by the nanofiber layer, making it difficult to concentrate and attack the core. This allows the composition to disintegrate rapidly while also having dual moisture-proof and moisture-resistant properties.

[0038] (3) This invention selects succinylated Poria cocos polysaccharide and ginsenoside Rg1 nanomicelles as key coating materials to achieve excellent adhesion by enhancing the "molecular compatibility" between the coating layer and the tablet core. The tablet core of this invention is rich in natural active ingredients extracted from ginseng, Panax notoginseng, Poria cocos, and Lycium barbarum, etc., whose chemical nature is saponins, polysaccharides, alkaloids, etc. Succinylated Poria cocos polysaccharide is a chemically modified product derived from Poria cocos polysaccharide, and has a similar natural product skeleton and polar groups to the Poria cocos polysaccharide and other polysaccharides and saponins in the tablet core. Ginsenoside Rg1 nanomicelles are directly derived from ginseng, and their chemical structure is exactly the same or highly similar to that of ginsenosides in the tablet core. According to the principle of "like dissolves like," substances with similar chemical structures or polarities have stronger affinity. When the coating solution is sprayed onto the surface of the tablet core, succinylated Poria cocos polysaccharide and ginsenoside Rg1 nanomicelles can generate strong, spontaneous molecular recognition and adsorption with similar active ingredients on the tablet core surface through intermolecular forces such as hydrogen bonds and van der Waals forces. This breaks the inherent, clear physical interface between traditional synthetic polymers and complex components of traditional Chinese medicine. Simultaneously, ginsenoside Rg1 nanomicelles play a crucial role as a "molecular anchor" or "interface bridge," with its hydrophilic sugar chain portion interacting well with succinylated Poria cocos polysaccharide and chitosan oligosaccharide in the coating layer. Its hydrophobic sterol backbone portion can easily embed itself into the tablet core or bind to the hydrophobic regions of other ginsenosides and notoginsenosides in the tablet core. This allows one end of the Rg1 nanomicelles to be firmly anchored to the tablet core surface, while the other end is woven into the network of the coating layer, achieving a "seamless weld" between the coating layer and the tablet core at the microscopic level. This superior adhesion based on molecular compatibility effectively prevents coating delamination and peeling. During subsequent processing, transportation, and storage, the coating layer is extremely difficult to peel off from the tablet core, ensuring the product's appearance integrity and quality reliability. Simultaneously, the coating material forms a more uniform and defect-free film. Its excellent wettability and spreadability allow the coating solution to evenly cover the tablet core, avoiding defects such as "orange peel" and poor edge coverage that may occur with traditional coatings, significantly improving coating efficiency and yield.

[0039] (4) The present invention provides a traditional Chinese medicine composition for invigorating and relieving fatigue, the preparation process of which is safe, non-toxic and environmentally friendly. The solvents used are all non-toxic and environmentally friendly green solvents, which meet the requirements of modern green pharmaceutical manufacturing. Detailed Implementation

[0040] It should be noted that, where there is no conflict, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to the embodiments.

[0041] It should be noted that, unless otherwise specified, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0042] This invention provides a method for preparing a traditional Chinese medicine composition for invigorating the mind and relieving fatigue, comprising the following steps:

[0043] (1) Weigh out 10-20 parts of Poria cocos polysaccharide extract, 5-15 parts of succinic anhydride, 1-2 parts of 4-dimethylaminopyridine, and 100-120 parts of dimethyl sulfoxide by weight.

[0044] (2) Add the polysaccharide of Poria cocos to dimethyl sulfoxide and stir continuously in a constant temperature water bath at 60-80°C for 2-4 hours under nitrogen protection to obtain a viscous solution;

[0045] (3) Cool the viscous solution to 50-70°C. Add 4-dimethylaminopyridine and stir for 10-20 min to obtain the reaction solution;

[0046] (4) Succinic anhydride is slowly added to the reaction solution in 3-5 portions, with an interval of 15-20 minutes between each portion. Under nitrogen protection, the mixture is continuously stirred and refluxed at a temperature of 50-70°C for 4-8 hours. After the reaction is completed, the reaction product is naturally cooled to room temperature.

[0047] (5) The cooled reaction product is slowly poured into 5-10 times the volume of anhydrous ethanol under vigorous stirring to form a flocculent precipitate. The precipitate is collected by filtration and washed with anhydrous ethanol 3-5 times until the washing liquid is colorless and neutral to completely remove unreacted succinic anhydride, catalyst and solvent, and to obtain crude product.

[0048] (6) The crude product is redissolved in deionized water and placed in a dialysis bag. Dialyze with 0.6%-1.2% NaCl solution for 12-24 hours, then dialyze with deionized water for 24-48 hours. Change the water every 6-8 hours. Take out the solution in the dialysis bag and freeze-dry it to form a white, loose, spongy solid, which yields succinylated Poria cocos polysaccharide.

[0049] (7) Weigh out the following components by weight: 15-25 parts of succinylated Poria cocos polysaccharide, 4-8 parts of ethyl cellulose aqueous dispersion with a solid content of 20%-26%, 2-4 parts of acetyl tributyl citrate, 0.5-1.5 parts of polyoxyethylene sorbitan monooleate, 80-100 parts of ethanol aqueous solution with a mass fraction of 70%-80%, 6-10 parts of chitosan oligosaccharide, 1-3 parts of ginsenoside Rg1 nanomicelles, and polyethylene glycol. 10-20 parts of pyrrolidone, 20-40 parts of deionized water, 20-30 parts of Panax notoginseng powder with a particle size of 5-15 μm, 15-25 parts of ginseng powder, 10-20 parts of Poria cocos polysaccharide extract, 10-20 parts of Lycium barbarum polysaccharide extract, 2-6 parts of lotus seed heart alkaloid extract, 15-25 parts of microcrystalline cellulose, 3-6 parts of crospovidone, 0.5-1.5 parts of colloidal silica, and 0.5-1.5 parts of magnesium stearate;

[0050] (8) Slowly add succinylated Poria cocos polysaccharide to an ethanol aqueous solution and stir until completely dissolved to obtain succinylated Poria cocos polysaccharide solution;

[0051] (9) Add acetyl tributyl citrate and polyoxyethylene sorbitan monooleate to the ethyl cellulose aqueous dispersion slowly under stirring, and continue stirring for 30-40 min to obtain a mixed dispersion;

[0052] (10) Add the succinylated Poria cocos polysaccharide solution to the mixed dispersion, and shear at a high speed of 10,000-12,000 rpm for 20-30 min. Pass the solution through a 100-120 mesh sieve to obtain the coating solution.

[0053] (11) Slowly add chitosan oligosaccharide to an appropriate amount of deionized water and stir magnetically for 4-6 hours to obtain chitosan oligosaccharide solution;

[0054] (12) Add polyvinylpyrrolidone to the remaining deionized water and stir until completely dissolved. Then add ginsenoside Rg1 nano micelles and continue stirring and mixing at room temperature to obtain a mixture.

[0055] (13) Slowly add the mixture to the chitosan oligosaccharide solution and stir continuously for 1-2 hours to form a uniform, clear, bubble-free spinning solution;

[0056] (14) Add Panax notoginseng powder, ginseng powder, Poria cocos polysaccharide extract, Lycium barbarum polysaccharide extract, Nelumbo nucifera heart alkaloid extract, microcrystalline cellulose and cross-linked polyvinylpyrrolidone into a three-dimensional mixer in sequence and mix at a speed of 15-25 rpm for 20-30 min to obtain the initial mixture;

[0057] (15) Add colloidal silica and magnesium stearate to the mixture and continue stirring at 10-20 rpm for 8-10 min to obtain the mixture;

[0058] (16) Place the mixture in a dry granulator and granulate it under the conditions of roller pressure of 3-6 MPa and roller speed of 5-15 rpm. Then place the granules in a rotary tablet press and press them into tablet cores with a hardness of 50-80 N at a tableting speed of 10-20 rpm.

[0059] (17) After preheating the core to 30-40℃, fix it on the roller receiver of the electrospinning equipment. Adjust the rotation speed of the roller receiver to 50-100rpm. Inject the spinning solution into the syringe of the electrospinning equipment. Adjust the distance from the needle tip of the syringe to the core to 12-18cm. Spray the spinning solution onto the surface of the core at a propulsion rate of 0.8-1.6mL / h under a voltage of 15-25kV. The spinning time for each batch of cores is 3-8min, and the first coated core is obtained.

[0060] (18) Place the tablet cores that have been initially coated into the tablet bed of the coating pan, adjust the distance between the spray gun of the coating pan and the tablet bed to 15-25cm, set the air inlet temperature to 50-60℃, use a peristaltic pump, and spray the coating liquid onto the surface of the tablet cores at a spray rate of 2-4g / min under the condition of compressed air pressure of 0.8-1.6Bar to increase their weight by 4%-6%, place them in an oven at 40-50℃ to dry for 8-12h, cool at room temperature, and package to obtain the invigorating and anti-fatigue traditional Chinese medicine composition.

[0061] The ginseng powder contains ≥80% ginsenosides, the poria cocos polysaccharide extract has a purity of ≥70%, the wolfberry polysaccharide extract has a purity of ≥50%, and the lotus seed heart alkaloid extract has a purity of ≥50%.

[0062] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0063] Example 1

[0064] The preparation method of the invigorating and fatigue-relieving traditional Chinese medicine composition in this embodiment includes the following steps:

[0065] (1) Weigh out 10 parts of Poria cocos polysaccharide extract, 5 parts of succinic anhydride, 1 part of 4-dimethylaminopyridine, and 100 parts of dimethyl sulfoxide by weight.

[0066] (2) Add the polysaccharide of Poria cocos to dimethyl sulfoxide and stir continuously for 2 hours in a constant temperature water bath at 60°C under nitrogen protection to obtain a viscous solution;

[0067] (3) Cool the viscous solution to 50°C. Add 4-dimethylaminopyridine and stir for 10 min to obtain the reaction solution;

[0068] (4) Succinic anhydride was slowly added to the reaction solution in three portions, with an interval of 15 minutes between each portion. The mixture was stirred and refluxed at 50°C for 4 hours under nitrogen protection. After the reaction was completed, the reaction product was naturally cooled to room temperature.

[0069] (5) The cooled reaction product is slowly poured into 5 times the volume of anhydrous ethanol under vigorous stirring to form a flocculent precipitate. The precipitate is collected by filtration and washed with anhydrous ethanol 3-5 times until the washing liquid is colorless and neutral to completely remove unreacted succinic anhydride, catalyst and solvent to obtain crude product.

[0070] (6) The crude product was redissolved in deionized water and placed in a dialysis bag. It was first dialyzed with 0.6% NaCl solution for 12 hours, and then dialyzed with deionized water for 24 hours. The water was changed every 6 hours. The solution in the dialysis bag was taken out and freeze-dried to form a white, loose, spongy solid, which yielded succinylated Poria cocos polysaccharide.

[0071] (7) Weigh out the following by weight: 15 parts of succinylated Poria cocos polysaccharide, 4 parts of ethyl cellulose aqueous dispersion with 20% solid content, 2 parts of acetyl tributyl citrate, 0.5 parts of polyoxyethylene sorbitan monooleate, 80 parts of ethanol aqueous solution with 70% mass fraction, 6 parts of chitosan oligosaccharide, 1 part of ginsenoside Rg1 nano micelles, 10 parts of polyvinylpyrrolidone, 20 parts of deionized water, 20 parts of Panax notoginseng powder with a particle size of 5 μm, 15 parts of ginseng powder, 10 parts of Poria cocos polysaccharide extract, 10 parts of Lycium barbarum polysaccharide extract, 2 parts of lotus seed heart alkaloid extract, 15 parts of microcrystalline cellulose, 3 parts of cross-linked polyvinylpyrrolidone, 0.5 parts of colloidal silica, and 0.5 parts of magnesium stearate.

[0072] (8) Slowly add succinylated Poria cocos polysaccharide to an ethanol aqueous solution and stir until completely dissolved to obtain succinylated Poria cocos polysaccharide solution;

[0073] (9) Add acetyl tributyl citrate and polyoxyethylene sorbitan monooleate to the ethyl cellulose aqueous dispersion slowly under stirring, and continue stirring for 30 min to obtain a mixed dispersion;

[0074] (10) Add the succinylated Poria cocos polysaccharide solution to the mixed dispersion, shear at 10,000 rpm for 20 min, and pass through a 100-mesh sieve to obtain the coating solution.

[0075] (11) Slowly add chitosan oligosaccharide to 1 / 2 of the volume of deionized water and stir magnetically for 4 hours to obtain chitosan oligosaccharide solution;

[0076] (12) Add polyvinylpyrrolidone to the remaining 1 / 2 of the deionized water, stir until completely dissolved, then add ginsenoside Rg1 nano micelles, and continue stirring and mixing at room temperature to obtain a mixture.

[0077] (13) Slowly add the mixture to the chitosan oligosaccharide solution and stir continuously for 1 hour to form a uniform, clear, bubble-free spinning solution;

[0078] (14) Add Panax notoginseng powder, ginseng powder, Poria cocos polysaccharide extract, Lycium barbarum polysaccharide extract, Nelumbo nucifera heart alkaloid extract, microcrystalline cellulose and cross-linked polyvinylpyrrolidone into a three-dimensional mixer in sequence and mix at 15 rpm for 20 min to obtain the initial mixture;

[0079] (15) Add colloidal silica and magnesium stearate to the mixture and continue stirring at 10 rpm for 8 minutes to obtain the mixture;

[0080] (16) Place the mixture in a dry granulator and granulate it under the conditions of 3MPa roller pressure and 5rpm roller speed. Then place the granules in a rotary tablet press and press them into tablet cores with a hardness of 50N at a tableting speed of 10rpm.

[0081] (17) After preheating the core to 30°C, fix it on the roller receiver of the electrospinning equipment. Adjust the rotation speed of the roller receiver to 50 rpm. Inject the spinning solution into the syringe of the electrospinning equipment. Adjust the distance from the needle tip of the syringe to the core to 12 cm. Spray the spinning solution onto the surface of the core at a propulsion rate of 0.8 mL / h under a voltage of 15 kV. The spinning time for each batch of cores is 3 min to obtain the first coated core.

[0082] (18) Place the first coated tablet core in the tablet bed of the coating pan, adjust the spray gun of the coating pan to maintain a distance of 15cm from the tablet bed, set the air inlet temperature to 50℃, use a peristaltic pump, and spray the coating liquid onto the surface of the first coated tablet core at a spray rate of 2g / min under the condition of compressed air pressure of 0.8Bar to increase its weight by 4%, place it in an oven at 40℃ to dry for 8h, cool at room temperature, and package to obtain the invigorating and anti-fatigue traditional Chinese medicine composition.

[0083] Example 2

[0084] The preparation method of the invigorating and fatigue-relieving traditional Chinese medicine composition in this embodiment includes the following steps:

[0085] (1) Weigh out 15 parts of Poria cocos polysaccharide extract, 10 parts of succinic anhydride, 1.5 parts of 4-dimethylaminopyridine, and 110 parts of dimethyl sulfoxide by weight.

[0086] (2) Add the polysaccharide of Poria cocos to dimethyl sulfoxide and stir continuously for 3 hours in a constant temperature water bath at 70°C under nitrogen protection to obtain a viscous solution;

[0087] (3) Cool the viscous solution to 60°C. Add 4-dimethylaminopyridine and stir for 15 min to obtain the reaction solution;

[0088] (4) Succinic anhydride was slowly added to the reaction solution in 4 portions, with an interval of 17 minutes between each portion. The mixture was stirred and refluxed at 60°C under nitrogen protection for 6 hours. After the reaction was completed, the reaction product was naturally cooled to room temperature.

[0089] (5) The cooled reaction product was slowly poured into 7 times the volume of anhydrous ethanol under vigorous stirring to form a flocculent precipitate. The precipitate was collected by filtration and washed 4 times with anhydrous ethanol until the washing liquid was colorless and neutral, so as to completely remove unreacted succinic anhydride, catalyst and solvent, and obtain crude product.

[0090] (6) The crude product was redissolved in deionized water and placed in a dialysis bag. It was first dialyzed with 0.9% NaCl solution for 18 hours, and then dialyzed with deionized water for 36 hours. The water was changed every 7 hours. The solution in the dialysis bag was taken out and freeze-dried to form a white, loose, spongy solid, which yielded succinylated Poria cocos polysaccharide.

[0091] (7) Weigh out the following by weight: 20 parts of succinylated Poria cocos polysaccharide, 6 parts of ethyl cellulose aqueous dispersion with a solid content of 23%, 3 parts of acetyl tributyl citrate, 1 part of polyoxyethylene sorbitan monooleate, 90 parts of ethanol aqueous solution with a mass fraction of 75%, 8 parts of chitosan oligosaccharide, 2 parts of ginsenoside Rg1 nano micelles, 15 parts of polyvinylpyrrolidone, 30 parts of deionized water, 25 parts of Panax notoginseng powder with a particle size of 10 μm, 20 parts of ginseng powder, 15 parts of Poria cocos polysaccharide extract, 15 parts of Lycium barbarum polysaccharide extract, 4 parts of lotus seed heart alkaloid extract, 20 parts of microcrystalline cellulose, 4.5 parts of cross-linked polyvinylpyrrolidone, 1 part of colloidal silica, and 1 part of magnesium stearate.

[0092] (8) Slowly add succinylated Poria cocos polysaccharide to an ethanol aqueous solution and stir until completely dissolved to obtain succinylated Poria cocos polysaccharide solution;

[0093] (9) Add acetyl tributyl citrate and polyoxyethylene sorbitan monooleate to the ethyl cellulose aqueous dispersion slowly under stirring, and continue stirring for 35 min to obtain a mixed dispersion;

[0094] (10) Add the succinylated Poria cocos polysaccharide solution to the mixed dispersion, shear at 11000 rpm for 25 min, and pass through a 110 mesh sieve to obtain the coating solution.

[0095] (11) Slowly add chitosan oligosaccharide to 1 / 2 of the deionized water and stir magnetically for 5 hours to obtain chitosan oligosaccharide solution;

[0096] (12) Add polyvinylpyrrolidone to the remaining 1 / 2 of the deionized water, stir until completely dissolved, then add ginsenoside Rg1 nano micelles, and continue stirring and mixing at room temperature to obtain a mixture.

[0097] (13) Slowly add the mixture to the chitosan oligosaccharide solution and stir continuously for 1.5 hours to form a uniform, clear, bubble-free spinning solution;

[0098] (14) Add Panax notoginseng powder, ginseng powder, Poria cocos polysaccharide extract, Lycium barbarum polysaccharide extract, Nelumbo nucifera heart alkaloid extract, microcrystalline cellulose and cross-linked polyvinylpyrrolidone into a three-dimensional mixer in sequence and mix at 20 rpm for 25 min to obtain the initial mixture;

[0099] (15) Add colloidal silica and magnesium stearate to the mixture and continue stirring at 15 rpm for 9 min to obtain the mixture;

[0100] (16) Place the mixture in a dry granulator and granulate it under the conditions of 4.5 MPa roller pressure and 10 rpm roller speed. Then place the granules in a rotary tablet press and press them into tablet cores with a hardness of 65 N at a tableting speed of 15 rpm.

[0101] (17) After preheating the core to 35°C, fix it on the roller receiver of the electrospinning equipment. Adjust the rotation speed of the roller receiver to 75 rpm. Inject the spinning solution into the syringe of the electrospinning equipment. Adjust the distance from the needle tip of the syringe to the core to 15 cm. Spray the spinning solution onto the surface of the core at a propulsion rate of 1.2 mL / h under a voltage of 20 kV. The spinning time for each batch of cores is 5 min to obtain the first coated core.

[0102] (18) Place the first coated tablet core in the tablet bed of the coating pan, adjust the spray gun of the coating pan to maintain a distance of 20 cm from the tablet bed, set the air inlet temperature to 55°C, use a peristaltic pump, spray the coating liquid onto the surface of the first coated tablet core at a spray rate of 3 g / min under the condition of compressed air pressure of 1.2 Bar, so that the weight increases by 5%, place it in an oven at 45°C and dry for 10 h, cool at room temperature, package, and obtain the invigorating and anti-fatigue traditional Chinese medicine composition.

[0103] Example 3

[0104] The preparation method of the invigorating and fatigue-relieving traditional Chinese medicine composition in this embodiment includes the following steps:

[0105] (1) Weigh out 20 parts of Poria cocos polysaccharide extract, 15 parts of succinic anhydride, 2 parts of 4-dimethylaminopyridine, and 120 parts of dimethyl sulfoxide by weight.

[0106] (2) Add the polysaccharide of Poria cocos to dimethyl sulfoxide and stir continuously in a constant temperature water bath at 80°C for 4 hours under nitrogen protection to obtain a viscous solution;

[0107] (3) Cool the viscous solution to 70°C. Add 4-dimethylaminopyridine and stir for 20 min to obtain the reaction solution;

[0108] (4) Succinic anhydride was slowly added to the reaction solution in 5 portions, with an interval of 20 minutes between each portion. The mixture was stirred and refluxed at 70°C under nitrogen protection for 8 hours. After the reaction was completed, the reaction product was naturally cooled to room temperature.

[0109] (5) The cooled reaction product was slowly poured into 10 times the volume of anhydrous ethanol under vigorous stirring to form a flocculent precipitate. The precipitate was collected by filtration and washed 5 times with anhydrous ethanol until the washing liquid was colorless and neutral, so as to completely remove unreacted succinic anhydride, catalyst and solvent, and obtain crude product.

[0110] (6) The crude product was redissolved in deionized water and placed in a dialysis bag. Dialysis was performed for 24 hours with a 1.2% NaCl solution and then for 48 hours with deionized water. The water was changed every 8 hours. The solution in the dialysis bag was taken out and freeze-dried to form a white, loose, spongy solid, which yielded succinylated Poria cocos polysaccharide.

[0111] (7) Weigh out the following by weight: 25 parts of succinylated Poria cocos polysaccharide, 8 parts of ethyl cellulose aqueous dispersion with a solid content of 26%, 4 parts of acetyl tributyl citrate, 1.5 parts of polyoxyethylene sorbitan monooleate, 100 parts of ethanol aqueous solution with a mass fraction of 80%, 10 parts of chitosan oligosaccharide, 3 parts of ginsenoside Rg1 nano micelles, 20 parts of polyvinylpyrrolidone, 40 parts of deionized water, 30 parts of Panax notoginseng powder with a particle size of 15 μm, 25 parts of ginseng powder, 20 parts of Poria cocos polysaccharide extract, 20 parts of Lycium barbarum polysaccharide extract, 6 parts of lotus seed heart alkaloid extract, 25 parts of microcrystalline cellulose, 6 parts of cross-linked polyvinylpyrrolidone, 1.5 parts of colloidal silica, and 1.5 parts of magnesium stearate.

[0112] (8) Slowly add succinylated Poria cocos polysaccharide to an ethanol aqueous solution and stir until completely dissolved to obtain succinylated Poria cocos polysaccharide solution;

[0113] (9) Add acetyl tributyl citrate and polyoxyethylene sorbitan monooleate to the ethyl cellulose aqueous dispersion slowly under stirring, and continue stirring for 40 min to obtain a mixed dispersion;

[0114] (10) Add the succinylated Poria cocos polysaccharide solution to the mixed dispersion, shear at a high speed of 12000 rpm for 30 min, and pass through a 120 mesh sieve to obtain the coating solution;

[0115] (11) Slowly add chitosan oligosaccharide to 1 / 2 of the volume of deionized water and stir magnetically for 6 hours to obtain chitosan oligosaccharide solution;

[0116] (12) Add polyvinylpyrrolidone to the remaining 1 / 2 of the deionized water, stir until completely dissolved, then add ginsenoside Rg1 nano micelles, and continue stirring and mixing at room temperature to obtain a mixture.

[0117] (13) Slowly add the mixture to the chitosan oligosaccharide solution and stir continuously for 2 hours to form a uniform, clear, bubble-free spinning solution;

[0118] (14) Add Panax notoginseng powder, ginseng powder, Poria cocos polysaccharide extract, Lycium barbarum polysaccharide extract, Nelumbo nucifera heart alkaloid extract, microcrystalline cellulose and cross-linked polyvinylpyrrolidone into a three-dimensional mixer in sequence and mix at 25 rpm for 30 min to obtain the initial mixture;

[0119] (15) Add colloidal silica and magnesium stearate to the mixture and continue stirring at 20 rpm for 10 min to obtain the mixture;

[0120] (16) Place the mixture in a dry granulator and granulate it under the conditions of 6 MPa roller pressure and 15 rpm roller speed. Then place the granules in a rotary tablet press and press them into tablet cores with a hardness of 80 N at a tableting speed of 20 rpm.

[0121] (17) After preheating the core to 40°C, fix it on the roller receiver of the electrospinning equipment. Adjust the rotation speed of the roller receiver to 100 rpm. Inject the spinning solution into the syringe of the electrospinning equipment. Adjust the distance from the needle tip of the syringe to the core to 18 cm. Spray the spinning solution onto the surface of the core at a propulsion rate of 1.6 mL / h under a voltage of 25 kV. The spinning time for each batch of cores is 8 min to obtain the first coated core.

[0122] (18) Place the first coated tablet cores in the tablet bed of the coating pan, adjust the spray gun of the coating pan to maintain a distance of 25cm from the tablet bed, set the air inlet temperature to 60℃, use a peristaltic pump, and spray the coating liquid onto the surface of the first coated tablet cores at a spray rate of 4g / min under the condition of compressed air pressure of 1.6Bar to increase its weight by 6%, place it in an oven at 50℃ to dry for 12h, cool it at room temperature, and package it to obtain the invigorating and anti-fatigue traditional Chinese medicine composition.

[0123] Comparative Example 1

[0124] The preparation method of the tablet core in this comparative example is the same as that in Example 1. The coating is carried out using a traditional aqueous solution of hydroxypropyl methylcellulose. The weight gain of the coating is the same as that of the outer coating in Example 1.

[0125] Comparative Example 2

[0126] The preparation method of the tablet core in this comparative example is the same as that in Example 1. The coating skips the electrostatic spinning spraying spinning solution bag step and directly sprays the outer coating solution of Example 1.

[0127] Comparative Example 3

[0128] The preparation method of the tablet core and the electrospun nanofiber layer of the coating inner layer of this comparative example of the invigorating and anti-fatigue traditional Chinese medicine composition are the same as those in Example 1. The outer layer uses unmodified Poria cocos polysaccharide instead of succinylated Poria cocos polysaccharide. Other components and coating weight gain are exactly the same as in Example 1.

[0129] Experimental Example

[0130] Samples from Examples 1-3 and Comparative Examples 1-3 were selected for various performance tests, including:

[0131] Following the methods in the Chinese Pharmacopoeia, disintegration time and dissolution rate at 15 minutes were determined using a disintegration apparatus and a dissolution apparatus, respectively.

[0132] Medium: 900 mL simulated gastric fluid (pH 1.2), temperature 37 ± 0.5 °C.

[0133] Disintegration time: Record the time it takes for each sample to completely disintegrate and pass through the sieve.

[0134] Dissolution: Samples were taken at predetermined time points (2, 5, 10, 15, 30, 45 minutes), and the cumulative dissolution percentage of ginsenoside Rg1 and notoginsenoside R1 was determined by HPLC.

[0135] Appearance hardness: Each sample was placed in a constant temperature and humidity chamber at 40℃ and 75% relative humidity for 3 months. The appearance hardness, moisture absorption weight gain, disintegration time, and content of major components were tested after 3 months. The specific results are shown in Table 1.

[0136] Table 1: Performance Test Results of Oral Film Samples from Examples and Comparative Examples

[0137] project Disintegration time (min) Dissolution rate at 15 minutes (Rg1+R1) Appearance hardness (3 months) Moisture absorption and weight gain The content of main components decreased Example 1 2.5 92% No change 1.7% 2.2% Example 2 2.3 94% No change 1.6% 1.9% Example 3 2.6 91% No change 1.9% 2.3% Comparative Example 1 9.4 73% Rough surface, slight adhesion 9.2% 8.9% Comparative Example 2 5.6 82% No change 4.6% 5.2% Comparative Example 3 13.5 57% Rough surface, prone to adhesion 6.8% 9.7%

[0138] A comparison of Example 1 and Comparative Example 1 in Table 1 shows that Comparative Example 1 uses traditional hydroxypropyl methylcellulose as the coating layer, which has a slow dissolution and disintegration time, resulting in delayed and incomplete drug dissolution and low dissolution rate. Furthermore, hydroxypropyl methylcellulose is a hydrophilic polymer with hydroxyl groups in its molecular chains, making it highly hygroscopic. Although the film formed is continuous, it is essentially a hydrogel structure, allowing water to penetrate and swell, resulting in insufficient moisture protection. It easily adsorbs water molecules from the environment through hydrogen bonds, and prolonged exposure to a humid environment leads to softening of the coating. The highly hygroscopic herbal extracts inside the tablet core absorb a large amount of moisture, increasing their weight and accelerating drug degradation, thus significantly reducing the content of the main drug components. In contrast, Example 1 uses a double-layer coating structure to protect the drug tablet core. The outer coating layer is composed of modified natural polymers and nano-plasticizers, providing mechanical strength, moisture protection, and excellent taste masking effect. The Poria cocos polysaccharide is modified by succinic anhydride esterification, introducing succinyl groups onto its molecular chain. The carboxyl group on the succinyl group has strong hydrophilicity, increasing the hydrophilicity and film-forming properties of the polymer. This significantly improves the solubility of the modified polysaccharide in water and gastric juice. The carboxyl group protonates in the acidic environment of the stomach, resulting in good solubility; in a neutral environment, it ionizes, further enhancing solubility. Simultaneously, the increased functional groups on the molecular chain of the Poria cocos polysaccharide alter the interchain interactions, allowing for the formation of a dense and robust film. This effectively extends the shelf life of the composition in humid environments while simultaneously enabling rapid disintegration in gastric acid. The inner coating layer is a nanofiber mesh with an ultra-large specific surface area, exhibiting strong capillary action upon contact with water, achieving rapid disintegration. Ginsenoside Rg1, extracted and purified from ginseng powder, forms nanomicelles through self-assembly. It serves as both an active ingredient and a natural surfactant, improving the properties of the spinning solution and exerting a synergistic anti-fatigue effect. Ethyl cellulose aqueous dispersion exhibits excellent film-forming properties, providing good moisture resistance and mechanical strength. The resulting nanofiber network possesses adhesive properties, effectively encapsulating and immobilizing bitter-tasting drug molecules while prolonging the drug's residence time at the absorption site. The outer layer of the traditional Chinese medicine composition dissolves first, followed by the instantaneous disintegration of the inner nanofiber layer, thus avoiding premature release and achieving rapid drug dissolution.

[0139] A comparison of Example 1 and Comparative Example 2 in Table 1 shows that Comparative Example 2 omits the nanofiber mesh inner coating layer compared to Example 1. Due to the lack of the nanofiber layer, the core disintegrates only after the outer layer dissolves, resulting in a slower disintegration rate than in Example 1. Furthermore, this nanofiber layer not only facilitates rapid disintegration but also forms a loose, high-porosity buffer transition layer between the core and the outer coating. The combined effect of the dense outer coating and the inner nanofiber layer ensures that even if trace amounts of moisture penetrate the outer layer, they are dispersed and adsorbed by the nanofiber layer, making it difficult for them to concentrate on attacking the core. In contrast, in Comparative Example 2, once moisture penetrates the outer layer, it directly affects the surface of the core, leading to increased local humidity, moisture absorption, and a higher rate of decrease in the content of the main components. This demonstrates that the inner nanofiber layer and the dense outer coating in Example 1 have a synergistic moisture-proof effect, and the double-layer coating structure enhances the robustness of the entire coating system.

[0140] A comparison of Example 1 and Comparative Example 3 in Table 1 shows that Comparative Example 3 used unmodified Poria cocos polysaccharide as the outer coating material. Because the molecular chains of unmodified Poria cocos polysaccharide are covered with hydrophilic hydroxyl groups, it is a "sponge"-like molecule, easily absorbing water, easily swelling, and having weak film-forming properties. After absorbing moisture, the coating layer softens, loses mechanical strength, and leads to adhesion between molecules, and is more easily deformed under pressure. Simultaneously, unmodified Poria cocos polysaccharide has poor compatibility with hydrophobic ethyl cellulose nanoparticles, resulting in an unstable coating solution that cannot form a dense and continuous film. The resulting film has a loose and porous structure with an inherently rough surface, providing sites for water adsorption and adhesion of the drug tablet core. The high moisture content provides favorable conditions for drug degradation and microbial growth, accelerating the destruction of the active ingredients, thus leading to a significant decrease in the content of the main drug components. Although unmodified Poria cocos polysaccharide is highly hydrophilic, it lacks pH responsiveness. In gastric juice, it hydrates too quickly to form a viscous gel layer. This gel layer becomes a barrier to the diffusion of water molecules and drugs, leading to delayed disintegration and prolonged disintegration time. The delayed and incomplete disintegration directly results in slow and incomplete drug dissolution. The gel barrier hinders the rapid release of the drug, causing most of the drug to remain trapped in the tablet core and gel layer at the critical 15-minute time point, significantly reducing drug dissolution. In contrast, Example 1 uses succinylated modified Poria cocos polysaccharide, where some hydroxyl groups are replaced by hydrophobic succinyl groups, and carboxyl groups that can form intermolecular hydrogen bonds are introduced. This reduces the overall hydrophilicity and water vapor permeability of the polymer, thus providing excellent moisture resistance. At the same time, the carboxyl groups protonate in the gastric acid environment, resulting in good solubility; in a neutral environment, they ionize, further improving solubility. This effectively increases the disintegration rate of the outer coating in gastric acid, ensuring that the drug tablet core quickly contacts and dissolves in gastric acid. This allows the composition to disintegrate rapidly while also providing excellent moisture-proof and damp-resistant properties.

[0141] This invention provides a traditional Chinese medicine composition for invigorating the mind and relieving fatigue. Its preparation process is safe, non-toxic, and environmentally friendly. The solvents used are all non-toxic and environmentally friendly green solvents, meeting the requirements of modern green pharmaceutical manufacturing and possessing promising medical applications.

[0142] Based on the above-described preferred embodiments of the present invention, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the inventive concept. The technical scope of this invention is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A refreshing and anti-fatigue traditional Chinese medicine composition, characterized in that, The raw materials include, in parts by weight: succinylized Pachyman 15-25 parts, ethyl cellulose aqueous dispersion 4-8 parts, acetyl tributyl citrate 2-4 parts, polyoxyethylene sorbitan monooleate 0.5-1.5 parts, aqueous ethanol solution 80-100 parts, chitosan oligosaccharide 6-10 parts, ginsenoside Rg1 nanomicelles 1-3 parts, polyvinylpyrrolidone 10-20 parts, deionized water 20-40 parts, Sanqi powder 20-30 parts, ginseng powder 15-25 parts, Pachyman extract 10-20 parts, Medlar polysaccharide extract 10-20 parts, Nelumbine extract 2-6 parts, microcrystalline cellulose 15-25 parts, cross-linked polyvinylpyrrolidone 3-6 parts, colloidal silicon dioxide 0.5-1.5 parts, and magnesium stearate 0.5-1.5 parts.

2. The refreshing and anti-fatigue traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the succinylized Pachyman includes the following steps: S1. In parts by weight, respectively weigh Pachyman extract 10-20 parts, succinic anhydride 5-15 parts, 4-dimethylaminopyridine 1-2 parts, and dimethyl sulfoxide 100-120 parts; S2. Add the Pachyman to the dimethyl sulfoxide, continuously stir in a 60-80°C constant temperature water bath under nitrogen protection for 2-4 hours to obtain a viscous solution; S3. Reduce the temperature of the viscous solution to 50-70°C, add 4-dimethylaminopyridine, and stir for 10-20 minutes to obtain a reaction solution; S4. Slowly add the succinic anhydride to the reaction solution in 3-5 portions with an interval of 15-20 minutes, continuously stir and reflux at a temperature of 50-70°C for 4-8 hours under nitrogen protection, and after the reaction is completed, naturally cool the reaction product to room temperature; S5. Slowly pour the cooled reaction product into 5-10 times the volume of anhydrous ethanol under vigorous stirring to form a flocculent precipitate, collect the precipitate by suction filtration, wash with anhydrous ethanol for 3-5 times until the washing liquid is colorless and neutral to completely remove unreacted succinic anhydride, catalyst and solvent, and obtain a crude product; S6. Redissolve the crude product in deionized water, load into a dialysis bag, first dialyze with a NaCl solution for 12-24 hours, then dialyze with deionized water for 24-48 hours, replace the water every 6-8 hours, take out the solution in the dialysis bag, and freeze-dry to form a white, loose sponge-like solid to obtain the succinylized Pachyman.

3. The refreshing and anti-fatigue traditional Chinese medicine composition according to claim 2, characterized in that, The mass fraction of the NaCl solution in step S6 is 0.6%-1.2%.

4. The refreshing and anti-fatigue traditional Chinese medicine composition according to claim 1, characterized in that, The solid content of the ethyl cellulose aqueous dispersion is 20%-26%.

5. The refreshing and anti-fatigue traditional Chinese medicine composition according to claim 1, characterized in that, The mass fraction of the aqueous ethanol solution is 70%-80%.

6. The refreshing and anti-fatigue traditional Chinese medicine composition according to claim 1, characterized in that, The particle size of the Sanqi powder is 5-15 μm.

7. The refreshing and anti-fatigue traditional Chinese medicine composition according to claim 1, characterized in that, The content of ginsenosides in the ginseng powder is ≥80%.

8. The refreshing and anti-fatigue traditional Chinese medicine composition according to claim 1, characterized in that, The purity of the Pachyman extract is ≥70%, the purity of the Medlar polysaccharide extract is ≥50%, and the purity of the Nelumbine extract is ≥50%.

9. A method for preparing the refreshing and anti-fatigue traditional Chinese medicine composition according to any one of claims 1-8, characterized in that, The method includes the following steps: (1) weigh each raw material component by weight; (2) slowly add the succinylized Pachyman to the aqueous ethanol solution, stir until completely dissolved, and obtain a succinylized Pachyman solution; (3) slowly add acetyl tributyl citrate and polyoxyethylene sorbitan monooleate into the ethyl cellulose water dispersion with stirring, continue stirring for 30-40 min, to obtain a mixed dispersion; (4) add succinylated Pachyman solution into the mixed dispersion, high speed shearing at 10000-12000 rpm for 20-30 min, pass through a 100-120 mesh sieve, to obtain a coating liquid; (5) slowly add chitosan into a proper amount of deionized water, magnetic stirring for 4-6 h, to obtain a chitosan solution; (6) add polyvinylpyrrolidone into the remaining deionized water, stirring until completely dissolved, then add ginsenoside Rg1 nanomicelles, continue stirring at room temperature until well mixed, to obtain a mixed solution; (7) slowly add the mixed solution into the chitosan solution, continue stirring for 1-2 h, to form a uniform, clear, bubble-free spinning solution; (8) add notoginseng powder, ginseng powder, Pachyman extract, Lycium barbarum polysaccharide extract, nuciferine extract, microcrystalline cellulose and cross-linked polyvinylpyrrolidone into a three-dimensional mixer in sequence, mix at a speed of 15-25 rpm for 20-30 min, to obtain a preliminary mixture; (9) add colloidal silicon dioxide and magnesium stearate into the mixture, continue stirring and mixing at a speed of 10-20 rpm for 8-10 min, to obtain a mixture; (10) place the mixture in a dry granulator, granulate under the conditions of roller pressure 3-6 MPa and roller speed 5-15 rpm, then place the obtained granules in a rotary tablet press, and press the granules into tablet cores with a hardness of 50-80 N at a tabletting speed of 10-20 rpm; (11) after preheating the tablet cores to 30-40℃, fix them on the drum receiver of the electrospinning equipment, adjust the speed of the drum receiver to 50-100 rpm, inject the spinning solution into the syringe of the electrospinning equipment, adjust the distance between the needle tip of the syringe and the tablet cores to 12-18 cm, spray the spinning solution onto the surface of the tablet cores at a voltage of 15-25 kV and a pushing rate of 0.8-1.6 mL / h, the spinning time for each batch of tablet cores is 3-8 min, to obtain the tablet cores coated for the first time; (12) place the tablet cores coated for the first time in the tablet bed of the coating pan, adjust the distance between the spray gun of the coating pan and the tablet bed to 15-25 cm, the inlet air temperature to 50-60℃, use a peristaltic pump to spray the coating liquid onto the surface of the tablet cores coated for the first time at a spraying rate of 2-4 g / min under the condition of compressed air pressure 0.8-1.6 Bar, to make the tablet cores gain a weight of 4%-6%, then place them in an oven at 40-50℃ for 8-12 h, cool at room temperature, package, to obtain the refreshing and anti-fatigue traditional Chinese medicine composition.