Mirabegron sustained release preparation and preparation method thereof

Abstract

The invention discloses a mirabegron sustained release preparation and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The mirabegron sustained-release tablet comprises the following components in parts by mass: 60-90 parts of a mirabegron sustained-release compound, 20-80 parts of a film-forming agent, 1-20 parts of a plasticizer, 0-3 parts of a thickening agent and 0-1 part of a sweetening agent. The mirabegron sustained-release preparation prepared by the invention not only realizes the sustained-release effect of mirabegron, but also realizes accurate and controllable dosage, can be rapidly disintegrated in the oral cavity without water, is extremely convenient in administration mode, and greatly improves the medication compliance of patients.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical formulation technology, specifically relating to a mirabezone sustained-release formulation and its preparation method. Background Technology

[0002] The information disclosed in the background section of this invention is intended only to enhance the understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] In the field of pharmaceutical formulation, treatments for overactive bladder (OAB) have been a major research focus. Mirabelon, an effective drug for treating OAB, has a unique mechanism of action and is the first FDA-approved drug in 30 years to treat OAB with a novel mechanism. Other first-line anticholinergic drugs target the serotonin M3 receptor, affecting bladder contractility and causing side effects such as dry eyes, dry mouth, and difficulty urinating, resulting in poor tolerability. Mirabelon effectively avoids these problems.

[0004] Traditional mirabezone sustained-release formulations are primarily available in tablet and dry suspension forms. Tablets require water to be taken, which is extremely inconvenient for children, the elderly, and patients with swallowing difficulties. Dry suspensions require reconstitution with water before administration, followed by measurement using a measuring cup. This process is not only cumbersome but may also lead to inaccurate dosage, affecting therapeutic efficacy. Therefore, there is an urgent need in the field for a mirabezone sustained-release formulation that maintains the sustained-release properties of mirabezone while achieving precise dosage and convenient administration, especially suitable for specific populations. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a mirabegron sustained-release formulation and its preparation method. The preparation method provided by the present invention is simple and efficient. The mirabegron sustained-release formulation prepared not only achieves the sustained-release effect of mirabegron and precise and controllable dosage, but also rapidly disintegrates in the oral cavity without the need for water, making the administration method extremely convenient and greatly improving patient medication compliance.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: A first aspect of the present invention provides a mirabezon sustained-release formulation comprising, by weight parts: The ingredients are: 60-90 parts Miraberon sustained-release complex, 20-80 parts film-forming agent, 1-20 parts plasticizer, 0-3 parts thickener, and 0-1 parts sweetener.

[0007] In some embodiments of the present invention, the mirabezon sustained-release complex is a mirabezon-sodium polystyrene sulfonate complex. Specifically, the mirabezon sustained-release complex utilizes the mirabezon-sodium polystyrene sulfonate complex. After sodium polystyrene sulfonate and mirabezon form a complex, the release rate of mirabezon can be effectively controlled, allowing the drug to be released slowly in the body and maintaining a stable blood drug concentration, thereby achieving a sustained-release effect.

[0008] Furthermore, there is no particular limitation on the content of sodium polystyrene sulfonate in the mirabéron sustained-release complex, as long as it undergoes ion exchange with mirabéron under acidic conditions to form a complex, and the release rate of mirabéron can be controlled. More specifically, the content ratio of mirabéron to sodium polystyrene sulfonate (weight ratio of mirabéron to sodium polystyrene sulfonate) is 1:1 to 1:10, more preferably 1:1 to 1:5, and more preferably 1:1.5 to 1:3.

[0009] In some embodiments of the present invention, the film-forming agent is selected from at least one of hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl alcohol, polyoxyethylene, povidone, copovidone, and pullulan, preferably hydroxypropyl methylcellulose. The film-forming agent is the core of the orally dissolving film, directly determining the film's forming effect, flexibility, and dispersibility. The above-mentioned film-forming agents all possess good film-forming properties and good compatibility with excipients such as mirabezone sustained-release complex and plasticizers. They can fully swell and disperse in purified water to form a uniform gel, ensuring a smooth appearance and uniform thickness of the film. Among these, the preferred hydroxypropyl methylcellulose has a moderate viscosity, ensuring both the flexibility of the film after forming, preventing brittleness and breakage, facilitating carrying and storage, and enabling rapid dispersibility.

[0010] In some embodiments of the present invention, the plasticizer is selected from at least one of polyethylene glycol 400, glycerol, propylene glycol, sorbitol, ethyl citrate, and glyceryl triacetate, preferably glycerol. The function of the plasticizer is to reduce the intermolecular forces of the film-forming agent, thereby increasing the flexibility and extensibility of the film.

[0011] In some embodiments of the present invention, the thickener is xanthan gum. Xanthan gum has excellent thickening, suspending, and stabilizing effects. When added to an orally soluble film formulation, it can, on the one hand, increase the viscosity of the drug-containing adhesive solution, preventing solid components such as mirabezone sustained-release complex from settling during stirring, standing, and coating, ensuring uniform dispersion of the adhesive solution, avoiding uneven component distribution and thickness in the film, and improving the uniformity of product quality; on the other hand, xanthan gum can synergistically work with film-forming agents and plasticizers to further improve the tensile strength and flexibility of the film, without affecting the rapid dissolution characteristics of the film.

[0012] In some embodiments of the present invention, the sweetener is selected from at least one of acesulfame potassium, sucralose, aspartame, and sucrose.

[0013] In some embodiments of the present invention, the components, by mass parts, include the following: The ingredients are: 70-80 parts of Miraberon sustained-release complex, 36-66 parts of film-forming agent, 7.3-13.7 parts of plasticizer, 0-3 parts of thickener, and 0-1 parts of sweetener; Preferably, the thickener is 0 or 0.7 to 2.45 parts; Preferably, the sweetener is 0 or 0.25 to 0.75 parts.

[0014] In some embodiments of the present invention, the mirabezon sustained-release formulation is an orally disintegrating film, and the content of the active pharmaceutical ingredient in each film, calculated as mirabezon, is 24 mg to 80 mg.

[0015] A second aspect of the present invention provides a method for preparing the mirabezon sustained-release formulation, comprising the following steps: The miraberione sustained-release complex, film-forming agent, plasticizer, thickener, and sweetener are stirred in purified water, defoamed, coated, dried, and cut to obtain the final product.

[0016] In some embodiments of the present invention, the stirring speed is 400-600 rpm and the stirring time is 2-4 h; The coating thickness is 0.2-1.0 mm.

[0017] The drying temperature is 50-80℃, and the drying time is 0.5-2h.

[0018] The beneficial effects of this invention are as follows: (1) The mirabegron sustained-release formulation provided by this invention not only achieves a stable sustained-release effect of mirabegron, ensuring the long-term efficacy and stability of the treatment, but also fundamentally solves the technical problems of existing mirabegron formulations, such as inconvenience in taking, inaccurate dosage, poor suitability for special populations, and inconvenience in carrying. Using the mirabegron-sodium polystyrene sulfonate complex as the sustained-release core, it controls drug release through an ion exchange mechanism. Then, by combining this complex with a specific ratio of film-forming agents, plasticizers, etc., the sustained-release unit is integrated into the orally disintegrating film. After the obtained mirabegron sustained-release formulation is placed in the oral cavity, it can be quickly moistened and disintegrated upon contact with saliva, without the need for water to take it. Moreover, the unit dose is accurate, especially solving the problems of inconvenient swallowing of traditional tablets and the need for temporary preparation and inaccurate dosage of dry suspensions. This provides great convenience for children, the elderly, and patients with swallowing dysfunction, thereby greatly improving medication adherence. In addition, the obtained film is flexible, not easily brittle, and small in size and easy to carry, making it very suitable for use in dynamic scenarios such as travel and outings.

[0019] (2) The preparation process of mirabezone sustained-release formulation provided by the present invention is simple, efficient and easy to operate. Attached Figure Description

[0020] The accompanying drawings, which form part of this specification, are used to provide a further understanding of the invention. The illustrative embodiments and descriptions of the invention are used to explain the invention and do not constitute an undue limitation thereof. Obviously, those skilled in the art can obtain other drawings based on these drawings without any inventive effort.

[0021] Figure 1 These are the drug release curves of Examples 4, 7, 10, 12, 13, Comparative Example 1, and Comparative Example 2 of the present invention. Detailed Implementation

[0022] To enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below with reference to specific embodiments.

[0023] Unless otherwise specified, the reagents, methods and equipment used in the following examples are all conventional reagents, methods and equipment in this technical field.

[0024] Example 1 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 1; Table 1

[0025] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0026] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex and hydroxypropyl methylcellulose E5 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 80℃ for 1 hour.

[0027] Example 2 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 2; Table 2

[0028] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0029] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex and hydroxypropyl methylcellulose E15 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 80℃ for 1 hour.

[0030] Example 3 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 3; Table 3

[0031] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0032] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex and hydroxypropyl methylcellulose E15 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 80℃ for 1 hour.

[0033] Example 4 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 4; Table 4

[0034] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0035] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex and hydroxypropyl methylcellulose E15 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 80℃ for 1 hour.

[0036] Example 5 This embodiment provides a miraberione sustained-release formulation, the specific formulation of which is shown in Table 5; Table 5

[0037] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0038] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex and hydroxypropyl methylcellulose E15 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0039] Example 6 This embodiment provides a mirabezon extended-release formulation, the specific formulation of which is shown in Table 6. Table 6

[0040] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0041] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex and hydroxypropyl methylcellulose E15 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0042] Example 7 This embodiment provides a miraberione sustained-release formulation, the specific formulation of which is shown in Table 7; Table 7

[0043] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0044] The specific preparation method is as follows: Place purified water and polyethylene glycol 400 in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex and hydroxypropyl methylcellulose E15 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the adhesive solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed adhesive solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0045] Example 8 This embodiment provides a miraberione sustained-release formulation, the specific formulation of which is shown in Table 8; Table 8

[0046] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0047] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex, hydroxypropyl methylcellulose E15, and hydroxypropyl methylcellulose E5 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0048] Example 9 This embodiment provides a miraberione sustained-release formulation, the specific formulation of which is shown in Table 9; Table 9

[0049] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0050] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex, hydroxypropyl methylcellulose E15, and hydroxypropyl methylcellulose E5 (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0051] Example 10 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 10; Table 10

[0052] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0053] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add the mirabeleon-sodium polystyrene sulfonate complex, hydroxypropyl methylcellulose E15, hydroxypropyl methylcellulose E5, and xanthan gum (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0054] Example 11 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 11; Table 11

[0055] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0056] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add mirabeleon-sodium polystyrene sulfonate complex, hydroxypropyl methylcellulose E15, xanthan gum, and acesulfame potassium (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0057] Example 12 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 12; Table 12

[0058] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0059] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add mirabeleon-sodium polystyrene sulfonate complex, hydroxypropyl methylcellulose E15, xanthan gum, and acesulfame potassium (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0060] Example 13 This embodiment provides a mirabezone sustained-release formulation, the specific formulation of which is shown in Table 13; Table 13

[0061] The 75.3 mg Miraberon-Sodium Polystyrene Sulfonate Complex contains 24 mg Miraberon.

[0062] The specific preparation method is as follows: Place purified water and glycerin in a beaker and stir using a top stirrer. Add mirabeleon-sodium polystyrene sulfonate complex, hydroxypropyl methylcellulose E15, xanthan gum, and acesulfame potassium (in suspension) at a suitable stirring speed. Adjust the stirring speed to 500 rpm and stir for 3 hours. Seal the gel solution with plastic wrap, making several small holes in the wrap, and allow it to stand at room temperature to defoam. Apply the defoamed gel solution using a coating machine, setting the coating thickness to 0.5 mm. After coating, transfer the film to a vacuum drying oven and dry at 60℃ for 1 hour.

[0063] Comparative Example 1 This comparative example provides a miraberione sustained-release dry suspension, the specific formulation of which is shown in Table 14; Table 14

[0064] The specific preparation method is as follows: Miraberon, sodium polystyrene sulfonate, and hydrochloric acid were subjected to an ion exchange reaction, followed by spray drying to obtain a complex. This complex was then mixed with hydroxypropyl methylcellulose, xanthan gum, mannitol, simethicone, acesulfame potassium, methylparaben, and ethylparaben, granulated, and dried. Finally, it was mixed evenly with magnesium stearate and silica. The mixture was then bottled in 8.3g portions.

[0065] Comparative Example 2 This comparative example provides a miraberione sustained-release dry suspension, the specific formulation of which is shown in Table 15; Table 15

[0066] The specific preparation method is as follows: Miraberon, sodium polystyrene sulfonate, and hydrochloric acid were subjected to an ion exchange reaction, followed by spray drying to obtain a complex. This complex was then mixed with hydroxypropyl methylcellulose, xanthan gum, mannitol, simethicone, acesulfame potassium, methylparaben, and ethylparaben, granulated, and dried. Finally, it was mixed evenly with magnesium stearate and silica. The mixture was then bottled in 8.3g portions.

[0067] Effect verification test 1. The above embodiments 1 to 13 were tested for effectiveness, including: thickness, tensile strength, strain, and disintegration time. The specific test methods are as follows: Thickness was measured according to the standard operating procedure of the thickness gauge, tensile strength and strain were measured according to the standard operating procedure of the tensile testing machine, and disintegration time was measured according to the method specified in the pharmacopoeia.

[0068] The test results of thickness, tensile strength, strain, and disintegration time of Examples 1 to 13 are shown in Table 16.

[0069] Table 16 Results of Mechanical Properties and Disintegration Time of Oral Solvent Film-Resolution Agents

[0070] As shown in Table 16, the disintegration time of Examples 1-13 is less than 40 seconds, enabling rapid disintegration in the oral cavity. Tests on tensile strength and strain indicate that the orally disintegrating film possesses excellent mechanical properties and is easy to carry. Furthermore, the dosage can be flexibly and accurately adjusted by modifying the cutting size.

[0071] 2. The effects of Examples 4, 7, 10, 12, 13, Comparative Example 1, and Comparative Example 2 were tested, including testing the dissolution curves of the samples. The specific testing methods are as follows: The dissolution conditions used were those of the second method, with a rotation speed of 100 rpm, a medium volume of 1000 ml, a release medium of pH 6.8 phosphate buffer solution, and a detection method of HPLC.

[0072] The drug release curves of Examples 4, 7, 10, 12, 13, Comparative Example 1, and Comparative Example 2 are as follows: Figure 1 As shown, the oral soluble film formulation of Mirabelon has the same sustained-release effect as the dry suspension formulation, and with appropriate formulation adjustments, a release curve similar to that of the dry suspension can be achieved.

[0073] The specific data results of the dissolution curves of the drug samples in Examples 4, 7, 10, 12, and 13 and Comparative Examples 1 and 2 are shown in Table 17.

[0074] Table 17 Dissolution curve results

[0075] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A mirabezon sustained-release formulation, characterized in that, By mass, it includes the following components: The ingredients are: 60-90 parts Miraberon sustained-release complex, 20-80 parts film-forming agent, 1-20 parts plasticizer, 0-3 parts thickener, and 0-1 parts sweetener.

2. The mirabezon sustained-release formulation as described in claim 1, characterized in that, The Miraberon sustained-release complex is a Miraberon-sodium polystyrene sulfonate complex.

3. The mirabezon sustained-release formulation as described in claim 1, characterized in that, The film-forming agent is selected from at least one of hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl alcohol, polyoxyethylene, povidone, copovidone, and pullulan, preferably hydroxypropyl methylcellulose.

4. The mirabezon sustained-release formulation as described in claim 1, characterized in that, The plasticizer is selected from at least one of polyethylene glycol 400, glycerin, propylene glycol, sorbitol, ethyl citrate, and glyceryl triacetate, preferably glycerin.

5. The mirabezon sustained-release formulation as described in claim 1, characterized in that, The thickener is xanthan gum.

6. The mirabezon sustained-release formulation as described in claim 1, characterized in that, The sweetener is selected from at least one of acesulfame potassium, sucralose, aspartame, and sucrose.

7. The mirabezon sustained-release formulation as described in claim 1, characterized in that, By mass, it includes the following components: The ingredients are: 70-80 parts of Miraberon sustained-release complex, 36-66 parts of film-forming agent, 7.3-13.7 parts of plasticizer, 0-3 parts of thickener, and 0-1 parts of sweetener; Preferably, the thickener is 0 or 0.7 to 2.45 parts; Preferably, the sweetener is 0 or 0.25 to 0.75 parts.

8. The mirabezon sustained-release formulation as described in claim 1, characterized in that, The mirabezon sustained-release formulation is an orally disintegrating film, and the content of the active pharmaceutical ingredient in each film, calculated as mirabezon, is 24mg to 80mg.

9. A method for preparing a mirabezon sustained-release formulation according to any one of claims 1-8, characterized in that, Includes the following steps: The miraberione sustained-release complex, film-forming agent, plasticizer, thickener, and sweetener are stirred in purified water, defoamed, coated, dried, and cut to obtain the final product.

10. The method for preparing the mirabezon sustained-release formulation as described in claim 9, characterized in that, The stirring speed is 400-600 rpm, and the stirring time is 2-4 hours; The coating thickness is 0.2-1.0 mm; The drying temperature is 50-80℃, and the drying time is 0.5-2h.

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