Traditional Chinese medicine pellet targeted drug release system for cardiovascular and cerebrovascular diseases and preparation method of traditional Chinese medicine pellet targeted drug release system

Abstract

The invention relates to the technical field of cardiovascular and cerebrovascular diseases, in particular to a traditional Chinese medicine pellet targeted drug release system for cardiovascular and cerebrovascular diseases and a preparation method thereof, and the preparation method comprises the steps of raw material pretreatment, effective component extraction, purification, concentration, drying, auxiliary material mixing, pellet forming, coating and screening. A methacrylic acid copolymer or a cellulose acetate phthalic acid material is used on the surface of a traditional Chinese medicine pellet to coat the traditional Chinese medicine pellet, and meanwhile, a biological adhesive polymer is coated or doped on the surface of a pellet enteric coating. Therefore, the traditional Chinese medicine pellet is not dissolved in a gastric acid environment, the medicine is protected from being damaged by gastric acid, and when the traditional Chinese medicine pellet enters the small intestine, the enteric coating is dissolved, so that the traditional Chinese medicine is released in the small intestine in a targeted manner. As the surface of the pellet enteric coating is coated with or doped with the bioadhesive polymer, the traditional Chinese medicine pellet can be adhered to a mucous membrane at a specific part of a small intestinal tract after the polymer is dissolved, the residence time is prolonged, the medicine is locally released, and the targeted medicine release effect of the traditional Chinese medicine pellet is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of cardiovascular and cerebrovascular diseases, and in particular to a targeted drug release system of traditional Chinese medicine micropills for cardiovascular and cerebrovascular diseases and a preparation method thereof. Background Art

[0002] Treating cardiovascular and cerebrovascular diseases is one of Traditional Chinese Medicine's key strengths and unique areas. Numerous Chinese herbal remedies and their compound preparations have accumulated extensive experience and demonstrated excellent clinical efficacy in preventing and treating coronary heart disease, angina pectoris, myocardial ischemia, arrhythmias, heart failure, stroke, hypertension, and hyperlipidemia. These herbs primarily work by promoting blood circulation and removing blood stasis, invigorating qi and nourishing yin, resolving phlegm and unblocking meridians, calming the liver and extinguishing wind, and promoting aromatic warming and dispersing effects.

[0003] Existing traditional Chinese medicines use a decoction process to extract the active ingredients within the medicine. These active ingredients are then dissolved in a medicinal broth that can be taken orally and absorbed by the body to treat cardiovascular and cerebrovascular diseases. However, when the Chinese medicine broth is taken orally, it first passes through the stomach before entering the small intestine. While in the stomach, the highly acidic gastric acid secreted by the stomach can damage the active ingredients, thereby affecting their subsequent efficacy in treating cardiovascular and cerebrovascular diseases.

[0004] To this end, a targeted drug release system of traditional Chinese medicine micropellets for cardiovascular and cerebrovascular diseases is proposed to solve the above problems. Summary of the Invention

[0005] The purpose of the present invention is to provide a targeted drug release system for traditional Chinese medicine micropills for cardiovascular and cerebrovascular diseases, which solves the problem that gastric acid will cause certain damage to the effective ingredients of traditional Chinese medicine when traditional Chinese medicine enters the stomach. The effective ingredients of traditional Chinese medicine can be targetedly released in the small intestine after passing through the stomach and the residence time in the small intestine can be prolonged, thereby improving the therapeutic effect.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a targeted drug release system for traditional Chinese medicine micropills for cardiovascular and cerebrovascular diseases, comprising raw material pretreatment, effective ingredient extraction, purification, concentration, drying, mixing of excipients, micropill molding, coating, and screening, wherein the coating uses a methacrylic acid copolymer or cellulose acetate phthalate material to enteric-coat the micropills, and the surface of the enteric coating of the micropills is coated or incorporated with a bioadhesive polymer, wherein the bioadhesive polymer is one of carbomer, chitosan, sodium alginate, and polycarbophil.

[0007] Preferably, the process of raw material pretreatment includes cleaning, processing, drying and crushing. During the processing, different processing methods (such as frying, roasting, steaming and boiling) need to be performed according to the prescription requirements.

[0008] Preferably, the extraction method in the active ingredient extraction process needs to adopt one or more of decoction, percolation, reflux extraction, ultrasonic extraction / microwave extraction, and supercritical fluid extraction according to the type of Chinese medicinal materials and the applicable type of cardiovascular and cerebrovascular diseases.

[0009] Preferably, the purification, concentration and drying process is performed first, then concentration and finally drying.

[0010] Preferably, in the purification process, the drug residue and insoluble impurities are removed by filtration / centrifugation, and macromolecular impurities such as starch, protein, and polysaccharides are removed by alcohol precipitation / water precipitation using ethanol or water of different concentrations. Then, the effective ingredients or effective parts are selectively adsorbed and separated by macroporous adsorption resin separation, and finally the required specific components are separated by extraction.

[0011] Preferably, in the concentration process, a vacuum concentration method or a thin film concentration method is used to concentrate the extract to an extract of a certain density.

[0012] Preferably, the drying process uses a spray drying method to atomize the concentrated liquid and instantly dry it into powder by contact with hot air. The drying process can also use a vacuum drying / freeze drying method or a microwave vacuum drying method according to the type of Chinese medicinal materials.

[0013] Preferably, one or more of fillers / diluents, binders, disintegrants, wetting agents / solvents, lubricants / glidants, and sustained-release materials can be used in the mixing excipient process as needed, and the Chinese medicine extract and the selected excipients can be fully mixed with a three-dimensional motion mixer or a V-type mixer.

[0014] Preferably, the micro-pellet forming process adopts an extrusion-spheronization method to extrude the mixed Chinese herbal extract into elongated cylindrical strips, and then uses a high-speed rotating spheronizer to break the strips into small segments of uniform length and spheronize them into spherical micro-pellet particles.

[0015] The present invention is achieved by following steps:

[0016] Step 1: Raw material pretreatment: First, select different types of Chinese medicine according to the type of cardiovascular and cerebrovascular disease to be treated, and remove the non-medicinal parts of the Chinese medicine; then process it to reduce toxicity, increase efficacy, change the medicinal properties, and make the preparation so that the water content of the Chinese medicine meets the requirements; finally, crush the Chinese medicine into 80-100 mesh or finer powder;

[0017] Step 2: Extraction of active ingredients: Depending on the type of Chinese medicine, decoction, percolation, reflux extraction, ultrasonic extraction / microwave extraction, and supercritical fluid extraction are used to enrich the active ingredients, remove invalid impurities, reduce the dosage, and improve the stability and uniformity of the preparation;

[0018] Step 3: Purification: Remove the medicinal residue and insoluble impurities by filtration / centrifugation, then use alcohol precipitation / water precipitation to remove macromolecular impurities such as starch, protein, and polysaccharides using different concentrations of ethanol or water. Then, selectively separate the active ingredients or effective parts through macroporous adsorption resin separation, and finally separate the required specific components of the Chinese medicine extract by extraction;

[0019] Step 4: Concentration: Use vacuum concentration or thin film concentration to concentrate the Chinese medicine extract to a certain density of extract;

[0020] Step 5: Drying: The TCM concentrate is atomized by spray drying and dried instantly into powder by contact with hot air. For TCM concentrates with high heat-sensitive components, vacuum drying / freeze drying or microwave vacuum drying can be used;

[0021] Step 6: Mixing excipients: One or more of fillers / diluents, binders, disintegrants, wetting agents / solvents, lubricants / glidants, and sustained-release materials are mixed with the Chinese herbal extract using a three-dimensional motion mixer or a V-type mixer, wherein:

[0022] Fillers / diluents can be microcrystalline cellulose, lactose, starch, pregelatinized starch, and mannitol to adjust dosage and improve powder properties;

[0023] Binders can be hypromellose, povidone, hydroxypropyl cellulose, starch slurry, syrup, etc., which are used to provide viscosity for wet granulation or extrusion;

[0024] Disintegrants can be cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose, which are used for pellets that require rapid disintegration;

[0025] The wetting agent / solvent can be water, ethanol or a water-ethanol mixture to induce the viscosity of the adhesive;

[0026] Lubricants / glidants can be magnesium stearate, micronized silica gel, and talc to improve the fluidity of particles and prevent sticking.

[0027] Sustained-release materials can be ethyl cellulose, acrylic resin, flavoring agents, and coloring agents;

[0028] Step 7: Micropellet Forming: The mixed wet Chinese medicine material is passed through a screen or template with a certain aperture (such as a screen plate extruder, basket extruder, or screw extruder) to be extruded into a slender cylindrical strip. The extruded wet strip is then broken into small segments of uniform length and rolled into spherical micropellet particles in a high-speed rotating spheronizer through the action of friction, centrifugal force, and shear force. After forming, it needs to be dried to remove moisture or solvent.

[0029] Step 8: Coating: Coat the TCM micropellets with materials such as methacrylic acid copolymers (e.g., Eudragit L100, S100) or cellulose acetate phthalate. Bioadhesive polymers are then coated or incorporated into the surface of the enteric coating to enable the TCM micropellets to adhere to the mucosa at specific locations in the gastrointestinal tract, prolonging retention time and allowing for localized drug release.

[0030] Step 9: Screening: The coated TCM micropellets need to be screened through a vibrating screen to select micropellets that meet the target particle size range (such as 0.7-1.4mm) and remove the unevenly coated TCM micropellet particles to ensure particle size uniformity.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] The present invention coats the Chinese medicine micropills with methacrylic acid copolymer or cellulose acetate phthalate material on the surface of the Chinese medicine micropills, and at the same time coats or incorporates a bioadhesive polymer on the surface of the micropills' enteric coating. Thus, the Chinese medicine micropills do not dissolve in the acidic environment of the stomach, protecting the drug from being destroyed by gastric acid, and when the Chinese medicine micropills enter the small intestine, the coating made of methacrylic acid copolymer or cellulose acetate phthalate material is affected by the pH environment of the small intestine, and the enteric coating dissolves, allowing the Chinese medicine to be targeted and released in the small intestine. And because the surface of the micropills' enteric coating is coated or incorporated with a bioadhesive polymer, these polymers can enable the Chinese medicine micropills to adhere to the mucosa of a specific part of the small intestine after dissolution, prolonging the retention time and locally releasing the drug, thereby improving the targeted drug release therapeutic effect of the Chinese medicine micropills. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 The figure is a schematic diagram of the preparation process of the Chinese medicine pellets of the present invention. DETAILED DESCRIPTION

[0034] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0035] See also Figure 1A targeted drug release system for traditional Chinese medicine micropills for cardiovascular and cerebrovascular diseases includes raw material pretreatment, active ingredient extraction, purification, concentration, drying, mixing of excipients, micropill molding, coating, and screening. The micropills are enteric-coated with methacrylic acid copolymer or cellulose acetate phthalate material. The surface of the micropill enteric coating is coated with or incorporated with a bioadhesive polymer. The bioadhesive polymer is one of carbomer, chitosan, sodium alginate, and polycarbophil. By coating the surface of the traditional Chinese medicine micropills with methacrylic acid copolymer or cellulose acetate phthalate material, and then coating or incorporating a bioadhesive polymer on the surface of the micropill enteric coating, the traditional Chinese medicine micropills do not dissolve in the acidic environment of the stomach, protecting the drug from damage by stomach acid. When the traditional Chinese medicine micropills enter the small intestine, the coating made of methacrylic acid copolymer or cellulose acetate phthalate material is affected by the pH environment of the small intestine, and the enteric coating dissolves, allowing the traditional Chinese medicine to be targeted and released in the small intestine. And because the surface of the micropills' enteric coating is coated or incorporated with bioadhesive polymers, these polymers can enable the Chinese medicine micropills to adhere to the mucosa of specific parts of the small intestine after dissolution, prolonging the retention time and locally releasing the drug, thereby improving the targeted drug release effect of the Chinese medicine micropills.

[0036] In this embodiment, the raw material pretreatment process includes cleaning, processing, drying, and crushing. During the processing, different processing methods (such as frying, roasting, steaming, and boiling) need to be performed according to the prescription requirements.

[0037] In this embodiment, the extraction method in the effective ingredient extraction process needs to adopt one or more of decoction, percolation, reflux extraction, ultrasonic extraction / microwave extraction, and supercritical fluid extraction according to the type of Chinese medicinal materials and the applicable cardiovascular and cerebrovascular disease type.

[0038] In this embodiment, the purification, concentration and drying process is first purification, then concentration and finally drying.

[0039] In this embodiment, in the purification process, the drug residue and insoluble impurities are removed by filtration / centrifugation, and macromolecular impurities such as starch, protein, and polysaccharides are removed by alcohol precipitation / water precipitation using ethanol or water of different concentrations. Then, the effective ingredients or effective parts are selectively adsorbed and separated by macroporous adsorption resin separation, and finally the required specific components are separated by extraction.

[0040] In this embodiment, the concentration process uses a reduced pressure concentration method or a thin film concentration method to concentrate the extract to an extract of a certain density.

[0041] In this embodiment, the drying process uses a spray drying method to atomize the concentrated liquid and instantly dry it into powder by contact with hot air. The drying process can also use a vacuum drying / freeze drying method or a microwave vacuum drying method according to the type of Chinese medicinal materials.

[0042] In this embodiment, in the process of mixing excipients, one or more of fillers / diluents, binders, disintegrants, wetting agents / solvents, lubricants / glidants, and sustained-release materials can be used as needed to mix the excipients and use a three-dimensional motion mixer or a V-type mixer to fully mix the Chinese medicine extract and the selected excipients.

[0043] In this embodiment, the pellet forming process uses an extrusion-spheronization method to extrude the mixed Chinese herbal extract into elongated cylindrical strips, which are then broken into small segments of uniform length using a high-speed rotating spheronizer and spheronized into spherical pellet particles.

[0044] The present invention is achieved by following steps:

[0045] Step 1: Raw material pretreatment: First, select different types of Chinese medicine according to the type of cardiovascular and cerebrovascular disease to be treated, and remove the non-medicinal parts of the Chinese medicine; then process it to reduce toxicity, increase efficacy, change the medicinal properties, and make the preparation so that the water content of the Chinese medicine meets the requirements; finally, crush the Chinese medicine into 80-100 mesh or finer powder;

[0046] Step 2: Extraction of active ingredients: Depending on the type of Chinese medicine, decoction, percolation, reflux extraction, ultrasonic extraction / microwave extraction, and supercritical fluid extraction are used to enrich the active ingredients, remove invalid impurities, reduce the dosage, and improve the stability and uniformity of the preparation;

[0047] Step 3: Purification: Remove the medicinal residue and insoluble impurities by filtration / centrifugation, then use alcohol precipitation / water precipitation to remove macromolecular impurities such as starch, protein, and polysaccharides using different concentrations of ethanol or water. Then, selectively separate the active ingredients or effective parts through macroporous adsorption resin separation, and finally separate the required specific components of the Chinese medicine extract by extraction;

[0048] Step 4: Concentration: Use vacuum concentration or thin film concentration to concentrate the Chinese medicine extract to a certain density of extract;

[0049] Step 5: Drying: The TCM concentrate is atomized by spray drying and dried instantly into powder by contact with hot air. For TCM concentrates with high heat-sensitive components, vacuum drying / freeze drying or microwave vacuum drying can be used;

[0050] Step 6: Mixing excipients: One or more of fillers / diluents, binders, disintegrants, wetting agents / solvents, lubricants / glidants, and sustained-release materials are mixed with the Chinese herbal extract using a three-dimensional motion mixer or a V-type mixer, wherein:

[0051] Fillers / diluents can be microcrystalline cellulose, lactose, starch, pregelatinized starch, and mannitol to adjust dosage and improve powder properties;

[0052] Binders can be hypromellose, povidone, hydroxypropyl cellulose, starch slurry, syrup, etc., which are used to provide viscosity for wet granulation or extrusion;

[0053] Disintegrants can be cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose, which are used for pellets that require rapid disintegration;

[0054] The wetting agent / solvent can be water, ethanol or a water-ethanol mixture to induce the viscosity of the adhesive;

[0055] Lubricants / glidants can be magnesium stearate, micronized silica gel, and talc to improve the fluidity of particles and prevent sticking.

[0056] Sustained-release materials can be ethyl cellulose, acrylic resin, flavoring agents, and coloring agents;

[0057] Step 7: Micropellet Forming: The mixed wet Chinese medicine material is passed through a screen or template with a certain aperture (such as a screen plate extruder, basket extruder, or screw extruder) to be extruded into a slender cylindrical strip. The extruded wet strip is then broken into small segments of uniform length and rolled into spherical micropellet particles in a high-speed rotating spheronizer through the action of friction, centrifugal force, and shear force. After forming, it needs to be dried to remove moisture or solvent.

[0058] Step 8: Coating: Coat the TCM micropellets with materials such as methacrylic acid copolymers (e.g., Eudragit L100, S100) or cellulose acetate phthalate. Bioadhesive polymers are then coated or incorporated into the surface of the enteric coating to enable the TCM micropellets to adhere to the mucosa at specific locations in the gastrointestinal tract, prolonging retention time and allowing for localized drug release.

[0059] Step 9: Screening: The coated TCM micropellets need to be screened through a vibrating screen to select micropellets that meet the target particle size range (such as 0.7-1.4mm) and remove the unevenly coated TCM micropellet particles to ensure particle size uniformity.

[0060] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A targeted drug delivery system for Chinese medicine pellets for cardiovascular and cerebrovascular diseases, characterized by: The method includes raw material pretreatment, effective ingredient extraction, purification, concentration, drying, mixing of excipients, micropill molding, coating and screening. The micropills are enteric-coated with methacrylic acid copolymer or cellulose acetate phthalate material. The surface of the micropill enteric coating is coated or incorporated with a bioadhesive polymer. The bioadhesive polymer is one of carbomer, chitosan, sodium alginate and polycarbophil.

2. A targeted drug delivery system for Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: The process of raw material pretreatment includes cleaning, processing, drying and crushing. During the processing, different processing methods (such as frying, roasting, steaming and boiling) need to be performed according to the prescription requirements.

3. The targeted drug delivery system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: The extraction method in the active ingredient extraction process needs to adopt one or more of decoction, percolation, reflux extraction, ultrasonic extraction / microwave extraction, and supercritical fluid extraction according to the type of Chinese medicinal materials and the applicable cardiovascular and cerebrovascular disease types.

4. The targeted drug delivery system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: The purification, concentration and drying process is first purification, then concentration and finally drying.

5. The targeted drug delivery system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: In the purification process, the drug residue and insoluble impurities are removed by filtration / centrifugation, and macromolecular impurities such as starch, protein, and polysaccharides are removed by alcohol precipitation / water precipitation using ethanol or water of different concentrations. Then, the effective ingredients or effective parts are selectively adsorbed and separated by macroporous adsorption resin separation, and finally the required specific components are separated by extraction.

6. The targeted drug delivery system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: In the concentration process, a reduced pressure concentration method or a thin film concentration method is used to concentrate the extract to an extract with a certain density.

7. The targeted drug delivery system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: The drying process uses a spray drying method to atomize the concentrated liquid and instantly dry it into powder by contacting it with hot air. The drying process can also use a vacuum drying / freeze drying method or a microwave vacuum drying method according to the type of Chinese medicinal materials.

8. The targeted drug delivery system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: In the mixing excipient process, one or more of fillers / diluents, adhesives, disintegrants, wetting agents / solvents, lubricants / glidants, and sustained-release materials can be used as needed. The mixing excipients are mixed with the traditional Chinese medicine extract and the selected excipients using a three-dimensional motion mixer or a V-type mixer.

9. The targeted drug delivery system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claim 1, characterized in that: In the micro-pill forming process, the mixed Chinese herbal medicine extract is squeezed into an elongated cylindrical strip by an extrusion-spheronization method, and then broken into small segments with uniform length by a high-speed rotating spheronizer, and then spheronized into spherical micro-pill particles.

10. The method for preparing a targeted drug release system of traditional Chinese medicine pellets for cardiovascular and cerebrovascular diseases according to claims 1-9, characterized in that: The following steps are involved: Step 1: Raw material pretreatment: First, select different types of Chinese medicine according to the type of cardiovascular and cerebrovascular disease to be treated, and remove the non-medicinal parts of the Chinese medicine; Then, the medicine is processed to reduce toxicity, increase efficacy, change medicinal properties and make the water content of the Chinese medicine meet the requirements; finally, the Chinese medicine is crushed into 80-100 mesh or finer powder; Step 2: Extraction of active ingredients: Depending on the type of Chinese medicine, decoction, percolation, reflux extraction, ultrasonic extraction / microwave extraction, and supercritical fluid extraction are used to enrich the active ingredients, remove invalid impurities, reduce the dosage, and improve the stability and uniformity of the preparation; Step 3: Purification: Filtration / centrifugation is used to remove medicinal residues and insoluble impurities. Alcohol precipitation / water precipitation is then used to remove macromolecular impurities such as starch, protein, and polysaccharides using ethanol or water of varying concentrations. Macroporous adsorption resins are then used to selectively separate the active ingredients or active parts. Finally, extraction is used to separate the desired specific component of the Chinese medicine extract. Step 4: Concentration: Use vacuum concentration or thin film concentration to concentrate the Chinese medicine extract to a certain density of extract; Step 5: Drying: The TCM concentrate is atomized by spray drying and dried instantly into powder by contact with hot air. For TCM concentrates with high heat-sensitive components, vacuum drying / freeze drying or microwave vacuum drying can be used; Step 6: Mixing excipients: One or more of fillers / diluents, binders, disintegrants, wetting agents / solvents, lubricants / glidants, and sustained-release materials are mixed with the Chinese herbal extract using a three-dimensional motion mixer or a V-type mixer, wherein: Fillers / diluents can be microcrystalline cellulose, lactose, starch, pregelatinized starch, and mannitol to adjust dosage and improve powder properties; Binders can be hypromellose, povidone, hydroxypropyl cellulose, starch slurry, syrup, etc., which are used to provide viscosity for wet granulation or extrusion; Disintegrants can be cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose, which are used for pellets that require rapid disintegration; The wetting agent / solvent can be water, ethanol or a water-ethanol mixture to induce the viscosity of the adhesive; Lubricants / glidants can be magnesium stearate, micronized silica gel, and talc to improve the fluidity of particles and prevent sticking. Sustained-release materials can be ethyl cellulose, acrylic resin, flavoring agents, and coloring agents; Step 7: Micropellet Forming: The mixed wet Chinese medicine material is passed through a screen or template with a certain aperture (such as a screen plate extruder, basket extruder, or screw extruder) to be extruded into a slender cylindrical strip. The extruded wet strip is broken into small segments of uniform length and rounded into spherical micropellets with a diameter of 0.7-1.4 mm by the action of friction, centrifugal force, and shear force in a high-speed rotating spheronizer. After forming, it needs to be dried to remove moisture or solvent. Step 8: Coating: Coat the TCM micropellets with methacrylic acid copolymers (e.g., Eudragit L100, S100) or cellulose acetate phthalate. Bioadhesive polymers are then coated or incorporated into the surface of the enteric coating to allow the TCM micropellets to adhere to the mucosa at specific locations in the gastrointestinal tract, prolonging drug retention and allowing for localized drug release. Step 9: Screening: The coated TCM micropellets need to be screened through a vibrating screen to select micropellets that meet the target particle size range and remove the unevenly coated TCM micropellet particles to ensure particle size uniformity.

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