Finasteride film agent and preparation method thereof

Abstract

The invention belongs to the technical field of medicines, and relates to a film agent for treating androgen-derived alopecia, in particular to a finasteride film agent and a preparation method thereof. The film agent is prepared from the following raw materials in parts by weight: 2-3 parts of finasteride, 0.1-0.15 part of resveratrol, 10-15 parts of a film-forming agent, 10-12 parts of ethanol, 5-8 parts of a plasticizer, 1-5 parts of a penetration enhancer, 0.12-0.4 part of a stabilizer and 60-62 parts of purified water. The finasteride film agent prepared by the invention is convenient to administrate, good in permeability, good in patient compliance, uniform in drug distribution, stable in administration and strong in targeting property; according to the finasteride film agent provided by the invention, under the synergistic effect of the raw materials, the treatment effect is improved, and the medicine stability is excellent; the preparation method is simple and high in controllability; the design of the film agent can reduce medicine loss.

Description

Technical Field

[0001] The invention belongs to the field of medical technology and relates to a film for treating androgenic alopecia, and specifically relates to a finasteride film and a preparation method thereof. Background Art

[0002] The main ingredient of finasteride film is finasteride, whose chemical name is N-tert-butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. It is a white or off-white crystalline powder; odorless. This product is easily soluble in methanol and ethanol, slightly soluble in acetonitrile and ethyl acetate, and almost insoluble in water; it is easily soluble in glacial acetic acid.

[0003] Chemical name: N-tert-butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide Chemical structure: Molecular formula: C 23 H 36 N2O2 Molecular weight: 372.55 Finasteride is a 5α-reductase inhibitor, mainly used to treat diseases such as androgenic alopecia and prostatic hyperplasia. It inhibits the conversion of testosterone into dihydrotestosterone (DHT), reduces hair follicle atrophy, and promotes hair regeneration.

[0004] Finasteride spray was developed by Polichem SA of Switzerland. As a topical medication, it has been widely used to treat androgenic alopecia. Although the spray has certain advantages of convenience, such as easy operation and wide coverage, it also has some limitations in practical application. For example, the dosage control of the spray is not precise enough, and it is difficult for patients to grasp the uniform distribution of the drug each time they use it, which may lead to unstable drug usage. Secondly, the drug penetration depth of the spray may be limited to a certain extent, especially in areas with more scalp hair, where the drug may be difficult to fully penetrate into the target area. In addition, the volatile components of the spray may cause local skin irritation and affect patient compliance.

[0005] Based on the limitations of sprays, developing a new finasteride film that can control the drug content in each tablet, provide a more precise dosage, and utilize the effects of membrane matrix and penetration enhancers to enhance the absorption of the drug on the skin has become an urgent problem to be solved. Summary of the invention

[0006] The object of the present invention is to provide a finasteride film with high stability, which can treat androgenic alopecia and is easy to use, has good skin adhesion, is quickly absorbed, and is easy to carry, thereby improving patient compliance, reducing side effects, and reducing the risk of skin irritation.

[0007] The present invention also provides a method for preparing the finasteride film.

[0008] The technical solution adopted by the present invention to achieve the above-mentioned purpose is: The invention provides a finasteride film, which is composed of the following raw materials in parts by weight: 12-13 parts of finasteride, 0.1-0.15 parts of resveratrol, 50-75 parts of a film-forming agent, 55-60 parts of ethanol, 15-40 parts of a plasticizer, 4-15 parts of a penetration enhancer, 0-1 part of a stabilizer, and 300-350 parts of purified water.

[0009] Preferably, the film-forming agent is one or more of polyvinyl alcohol (PVA), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), chitosan, sodium hyaluronate, povidone, sodium carboxymethyl cellulose, polyethylene oxide, soluble starch, maltodextrin, gelatin and sodium alginate.

[0010] Preferably, the plasticizer is one or more of glycerol, propylene glycol, propylene alcohol, low molecular weight polyethylene glycol, dibutyl phthalate, dioctyl phthalate, triethyl citrate, tributyl citrate, acetyl citrate, triacetin and castor oil.

[0011] Preferably, the penetration enhancer is one or more of laurocaprol and peppermint oil.

[0012] Preferably, the stabilizer is one or more of magnesium stearate, calcium stearate, polyethylene glycol, stearic acid, titanium dioxide and colloidal silicon dioxide.

[0013] Most preferably, the finasteride film provided by the present invention is composed of the following raw materials in parts by weight: 12.5 parts of finasteride, 0.12 parts of resveratrol, 65 parts of polyvinyl alcohol, 60 parts of ethanol, 40 parts of propylene glycol, 15 parts of laurocaprol, 0.6 parts of colloidal silicon dioxide, and 306.9 parts of purified water.

[0014] A method for preparing the finasteride film according to any one of claims 1 to 6, characterized in that it comprises the following steps: (1) Weigh the required amount of film-forming agent, slowly add it into purified water, and stir continuously until it is completely dissolved to form a uniform solution to obtain a film-forming agent solution; (2) Add finasteride to ethanol and stir until completely dissolved, then add plasticizer and stir evenly to obtain a finasteride solution; (3) slowly adding the penetration enhancer into the finasteride solution and stirring evenly to obtain a finasteride mixed solution 1; (4) gradually adding the finasteride mixed solution into the film-forming agent solution in step 1 and stirring evenly to obtain the finasteride mixed solution 2; (5) adding the stabilizer to the finasteride mixture 2, stirring evenly, and then adding resveratrol to obtain the finasteride mixture 3; (6) homogenizing and degassing the finasteride mixture 3; (7) Coating and drying: The prepared solution is evenly coated on the mold or substrate, and allowed to stand or dry by an appropriate drying method (such as air drying or heating) to form a transparent film with good adhesion.

[0015] (8) Cutting and packaging: Cut the dried film into required sizes and package it in moisture-proof materials to avoid contact with light and air.

[0016] The preferred film-forming material of the present invention, polyvinyl alcohol (Polyvinyl Alcohol), is a white to slightly yellow powder or translucent granules, which dissolves in water to form a clear or slightly turbid colloidal solution. It is a widely used film-forming material in pharmaceutical preparations, and forms a transparent, flexible, continuous and uniform film under appropriate conditions, and the film has excellent physical and mechanical properties. Polyvinyl alcohol is non-toxic, non-irritating, and safe to the human body.

[0017] The preferred plasticizer of the present invention, propylene glycol, is a colorless, clear, viscous liquid that is miscible with water and ethanol and has good compatibility with most polymers and other auxiliary materials. Propylene glycol molecules can be inserted between polymer molecular segments to increase the distance between molecules, thereby reducing the interaction force between polymer segments, increasing the flexibility and ductility of the film, and improving the mechanical strength of the film, making it less likely to break during preparation and use.

[0018] The preferred penetration enhancer of the present invention, laurocapram, is a colorless, transparent, viscous liquid. This product is easily soluble in anhydrous ethanol and is a commonly used transdermal absorption enhancer to enhance the ability of drugs to penetrate the skin. Laurocapram has less irritation to the skin and has good biocompatibility. The commonly used amount ranges from 1% to 5%.

[0019] The preferred stabilizer of the present invention, colloidal silicon dioxide (Colloidal Silicon Dioxide), is a white loose powder that is insoluble in water and dissolves in hot sodium hydroxide solution. It is commonly used as a flow aid, thickener, stabilizer, etc. in preparations. It is used as a thixotropic viscosity enhancer and suspending agent in gel and semi-solid preparations. It can form a transparent gel together with other components with similar refractive index. The increase in its viscosity depends on the polarity of the liquid (polar liquids require a higher concentration of differential silica gel than non-polar liquids). The viscosity is not affected by temperature. In the present invention, the mechanical strength of the film can be enhanced to make it more durable. This is because the particles of colloidal silicon dioxide can form a network structure inside the film, thereby improving the overall strength of the film. In the preparation process of the film, adding an appropriate amount of colloidal silicon dioxide can also help improve the rheological properties of the mixture, making the film more uniform during coating or casting, and helping to form a flat and defect-free film. Colloidal silicon dioxide has a certain hydrophobicity, which can reduce the viscosity of the film surface and prevent the film from sticking during storage. This is especially important for films that need to be stored for a long time or used in high temperature environments. Since colloidal silica has a large surface area, it can absorb moisture in the film, accelerate the drying process of the film, and shorten the production cycle. It can also help enhance the physical and chemical stability of the film, prevent drug degradation or film aging, and thus extend the shelf life of the film.

[0020] The finasteride film prepared by the preparation method of the present invention has no insoluble particles in appearance, a smooth surface, no bubbles, uniform film thickness, good flexibility and good skin adhesion.

[0021] The beneficial effects of the present invention are: (1) The finasteride film prepared by the present invention is easy to administer, has good permeability, good patient compliance, and has uniform drug distribution, stable administration, and strong targeting; (2) The finasteride film provided by the present invention has improved therapeutic effects due to the synergistic effect of various raw materials, and has excellent drug stability; (3) The preparation method of the present invention is simple and highly controllable; the design of the film can reduce the loss of the drug. DETAILED DESCRIPTION

[0022] The finasteride film obtained by the present invention has the characteristics of simple method, good stability and high quality. The following examples further describe the present invention, but the examples are only used to illustrate the present invention rather than to limit the present invention.

[0023] The polymer film-forming material of the present invention comprises one of polyvinyl alcohol (PVA), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), chitosan, sodium hyaluronate, povidone, sodium carboxymethyl cellulose, polyethylene oxide, soluble starch, maltodextrin, gelatin, sodium alginate or a mixture thereof, and the concentration range is 10% to 15% (w / w).

[0024] The plasticizer includes one of glycerol, propylene glycol, allyl alcohol, low molecular weight polyethylene glycol, dimethyl, diethyl dibutyl phthalate, tributyl, triethyl, acetyl citrate, triacetin and castor oil or a mixture thereof, with a concentration range of 5% to 8% (w / w).

[0025] The stabilizer includes one or more of magnesium stearate, calcium stearate, polyethylene glycol, stearic acid, titanium dioxide, and colloidal silicon dioxide, and the concentration range is 0.12-0.4% (w / w).

[0026] The penetration enhancer includes one or more of polysorbate, isopropyl alcohol, oleic acid, linoleic acid, laurocaprol, and peppermint oil, with a concentration range of 1-5% (w / w).

[0027] Example 1 1. Prescription Finasteride 12.5g Resveratrol 0.12g Polyvinyl alcohol 75.0g Ethanol 60.0 Propylene glycol 22.5g Colloidal silicon dioxide 2.0g Laurocapse 4.0g Purified water 324.0g 2. Preparation process Weigh the required amount of Hydroxypropyl Methylcellulose (nominal viscosity is 13500-25200mPa.s), slowly add it to part of the purified water, and stir continuously until the HPMC is completely dissolved to form a uniform solution. Add finasteride to another container, add an appropriate amount of ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue to stir to ensure uniform mixing. Gradually add the finasteride solution in step 2 to the HPMC solution in step 1, and stir continuously until uniform. Add colloidal silicon dioxide to the above mixed solution and stir evenly. Adjust to the required weight with purified water to ensure that the final solution is uniform. Spread the prepared solution evenly on the substrate and dry at 60°C to form a film.

[0028] Example 2 1. Prescription Finasteride 12.5g Resveratrol 0.12g Hydroxypropyl methylcellulose 75.0g Ethanol 60.0 Propylene glycol 22.5g Laurocapse 4.0g Purified water 326.0g 2. Preparation process Weigh the required amount of Hydroxypropyl Methylcellulose (nominal viscosity 13500-25200mPa.s), slowly add to partially purified water, stirring continuously until HPMC is completely dissolved to form a uniform solution. Add finasteride to another container, add an appropriate amount of ethanol, and stir until finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, continue stirring to ensure uniform mixing. Gradually add the finasteride solution in step 2 to the HPMC solution in step 1, stirring continuously until uniform. 。 The whole mixture was adjusted to the required weight with purified water to ensure that the final solution was uniform. The prepared solution was evenly coated on the substrate and dried at 60°C to form a film.

[0029] Example 3 1. Prescription Finasteride 12.5g Resveratrol 0.12g Hydroxypropyl methylcellulose 75.0g Ethanol 60.0 Propylene glycol 22.5g Colloidal silicon dioxide 1.0g Laurocapse 4.0g Purified water 325.0g 2. Preparation process Weigh the required amount of Hydroxypropyl Methylcellulose (nominal viscosity is 4-6mPa.s), slowly add it to part of the purified water, and stir continuously until the HPMC is completely dissolved to form a uniform solution. Add finasteride to another container, add an appropriate amount of ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue to stir to ensure uniform mixing. Gradually add the finasteride solution in step 2 to the HPMC solution in step 1, and stir continuously until uniform. Add colloidal silicon dioxide to the above mixed solution and stir evenly. Adjust to the required weight with purified water to ensure that the final solution is uniform. Spread the prepared solution evenly on the substrate and dry at 60°C to form a film.

[0030] According to Examples 1 to 3, the film-forming properties and other appearance characteristics and mechanical properties of the film-forming agent when the film-forming material hydroxypropyl methylcellulose has different specifications are compared to determine the specifications and dosage of the film-forming material.

[0031] Table 1 Screening results of film-forming materials As can be seen from the above table, the samples of Examples 1 to 3 have good film-forming properties and good toughness, but the film surfaces are all spotted and uneven. It can also be found that the high-viscosity hydroxypropyl methylcellulose slightly increases the film thickness, has poor transparency, and has average folding resistance, and the film without the addition of colloidal silicon dioxide is not easy to demould. Considering the thickness of the film and other appearance properties and mechanical properties, the prescription of Example 3 is preferred.

[0032] The uneven and streaky surface of the film may be due to the lack of degassing and the fact that the colloidal silica is in a suspended state and unevenly distributed in the gel solution. This can be improved by degassing and homogenizing.

[0033] Example 4 1. Prescription Finasteride 12.5g Resveratrol 0.12g Polyvinyl alcohol 65.0g Ethanol 60.0g Propylene glycol 40.0g Colloidal silicon dioxide 1.0g Laurocapse 15.0g Purified water 306.5g 2. Preparation process Weigh the required amount of polyvinyl alcohol (PVA) and slowly add it to the prescribed amount of purified water, stirring continuously until the PVA is completely dissolved to form a uniform solution. Add finasteride to another container, add ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue stirring to ensure uniform mixing. Gradually add the finasteride solution to the PVA solution and stir continuously until uniform. Pass colloidal silicon dioxide through a 30-mesh sieve and add it to the above mixed solution and stir evenly. Homogenize the final solution through a homogenizer and perform ultrasonic degassing. Spread the prepared solution evenly on the substrate and dry it at 60°C to form a film.

[0034] Example 5 1. Prescription Finasteride 12.5g Resveratrol 0.12g Polyvinyl alcohol 65.0g Ethanol 60.0g Propylene glycol 15.0g Colloidal silicon dioxide 1.0g Laurocapse 15.0g Purified water 331.5g 2. Preparation process Weigh the required amount of polyvinyl alcohol, slowly add it to the prescribed amount of purified water, and stir continuously until the PVA is completely dissolved to form a uniform solution. Add finasteride to another container, add ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue stirring to ensure uniform mixing. Gradually add the finasteride solution to the PVA solution and stir continuously until uniform. Pass colloidal silicon dioxide through a 30-mesh sieve and add it to the above mixed solution and stir evenly. Homogenize the final solution through a homogenizer and perform ultrasonic degassing. Spread the prepared solution evenly on the substrate and dry it at 60°C to form a film.

[0035] Example 6 1. Prescription Finasteride 12.5g Resveratrol 0.12g Polyvinyl alcohol 50.0g Ethanol 60.0g Propylene glycol 15.0g Colloidal silicon dioxide 0.6g Laurocapse 15.0g Purified water 346.9g 2. Preparation process Weigh the required amount of polyvinyl alcohol (PVA) and slowly add it to the prescribed amount of purified water, stirring continuously until the polyvinyl alcohol is completely dissolved to form a uniform solution. Add finasteride to another container, add ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue stirring to ensure uniform mixing. Gradually add the finasteride solution to the polyvinyl alcohol solution and stir continuously until uniform. Pass colloidal silicon dioxide through a 30-mesh sieve and add it to the above mixed solution and stir evenly. Homogenize the final solution through a homogenizer and perform ultrasonic degassing. Spread the prepared solution evenly on the substrate and dry it at 60°C to form a film.

[0036] In Example 4, 5 and 6, based on Example 3, hydroxypropyl methylcellulose was replaced with polyvinyl alcohol, the compatibility of polyvinyl alcohol and propylene glycol was adjusted, and the amount of colloidal silicon dioxide was reduced. At the same time, homogenization and ultrasonic degassing of the drug gel were added to the process, and the formulation process was further optimized through the appearance and skin adhesion of the obtained film.

[0037] Table 2 Effect of plasticizer on film Example 7 1. Prescription Finasteride 12.5g Resveratrol 0.12g Polyvinyl alcohol 65.0g Ethanol 60.0g Propylene glycol 40.0g Colloidal silicon dioxide 0.6g Laurocapse 15.0g Purified water 306.9g 2. Preparation process Weigh the required amount of polyvinyl alcohol and slowly add it to the prescribed amount of purified water, stirring continuously until the polyvinyl alcohol is completely dissolved to form a uniform solution. Add finasteride to another container, add ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue stirring to ensure uniform mixing. Gradually add the finasteride solution to the polyvinyl alcohol solution and stir continuously until uniform. Pass the colloidal silicon dioxide through a 30-mesh sieve and add it to the above mixed solution and stir evenly. Homogenize the final solution through a homogenizer and perform ultrasonic degassing.

[0038] The prepared solution was evenly coated on the substrate and dried at 60°C to a moisture content of about 5% to form a film.

[0039] Example 8 1. Prescription Finasteride 12.5g Resveratrol 0.12g Polyvinyl alcohol 65.0g Ethanol 60.0g Propylene glycol 40.0g Colloidal silicon dioxide 0.4g Laurocapse 15.0g Purified water 306.9g 2. Preparation process Weigh the required amount of polyvinyl alcohol and slowly add it to the prescribed amount of purified water, stirring continuously until the polyvinyl alcohol is completely dissolved to form a uniform solution. Add finasteride to another container, add ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue stirring to ensure uniform mixing. Gradually add the finasteride solution to the polyvinyl alcohol solution and stir continuously until uniform. Pass the colloidal silicon dioxide through a 30-mesh sieve and add it to the above mixed solution and stir evenly. Homogenize the final solution through a homogenizer and perform ultrasonic degassing.

[0040] The prepared solution was evenly coated on the substrate and dried at 60°C to a moisture content of about 10% to form a film.

[0041] Examples 7 and 8 investigate reducing the amount of colloidal silicon dioxide used on the basis of Example 4. In the process, the moisture content of the film is controlled by the drying time, and the formulation process is further optimized by the appearance and skin adhesion of the obtained film.

[0042] Table 3 Effect of moisture content on film According to Examples 7 and 8, the obtained films have good appearance and mechanical properties, so the prescriptions of Examples 7 and 8 are preferred, and the moisture content of the films is controlled between 5% and 10%.

[0043] Comparative Example 1 1. Prescription Finasteride 12.5g Polyvinyl alcohol 65.0g Ethanol 60.0g Propylene glycol 40.0g Colloidal silicon dioxide 0.6g Laurocapse 15.0g Purified water 306.9g 2. Preparation process Weigh the required amount of polyvinyl alcohol and slowly add it to the prescribed amount of purified water, stirring continuously until the polyvinyl alcohol is completely dissolved to form a uniform solution. Add finasteride to another container, add ethanol, and stir until the finasteride is completely dissolved. Slowly add propylene glycol and laurocaprolactone to the finasteride and ethanol solution, and continue stirring to ensure uniform mixing. Gradually add the finasteride solution to the polyvinyl alcohol solution and stir continuously until uniform. Pass the colloidal silicon dioxide through a 30-mesh sieve and add it to the above mixed solution and stir evenly. Homogenize the final solution through a homogenizer and perform ultrasonic degassing.

[0044] The prepared solution was evenly coated on the substrate and dried at 60°C to a moisture content of about 10% to form a film.

[0045] Effect verification The finasteride films prepared in Example 7 and Comparative Example 1 were evaluated for their effects on promoting hair regeneration: Experimental method: A testosterone-induced androgenic alopecia mouse model was established. The hair on the back of each 8-9 week old C57BL / 6 mouse was removed using an animal shaver and depilatory cream. After 24 hours, testosterone was dissolved in a mixed solution of ethanol: 1,2-propylene glycol: ultrapure water (volume ratio of 54:26:20) and applied daily to the depilatory area of ​​mice except the blank group at a testosterone concentration of 0.5% (w / v).

[0046] A blank group was set up: no testosterone treatment was used, and only physiological saline was applied; a model group: after the model was established, no other treatment was performed; an experimental group: after the model was established, the finasteride film prepared in Example 7 was used; a control group: after the model was established, the finasteride film prepared in Comparative Example 1 was used; during the medication period, the hair regeneration of each experimental group was observed; after the drug was used, the number of days when the hair removal area was basically covered with hair was counted; on the 28th day, the weight of newly grown hair in the same area was counted; the specific results are shown in Table 4.

[0047] Table 4 The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any technician familiar with the technical field can make equivalent substitutions or changes according to the technical solutions and inventive concepts of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A finasteride film, characterized in that: The invention is composed of the following raw materials in parts by weight: 12-13 parts of finasteride, 0.1-0.15 parts of resveratrol, 50-75 parts of film-forming agent, 55-60 parts of ethanol, 15-40 parts of plasticizer, 4-15 parts of penetration enhancer, 0-1 part of stabilizer and 300-350 parts of purified water.

2. The finasteride film according to claim 1, characterized in that: The film-forming agent is one or more of polyvinyl alcohol (PVA), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), chitosan, sodium hyaluronate, povidone, sodium carboxymethyl cellulose, polyethylene oxide, soluble starch, maltodextrin, gelatin and sodium alginate.

3. The finasteride film according to claim 1, characterized in that: The plasticizer is one or more of glycerol, propylene glycol, propylene alcohol, low molecular weight polyethylene glycol, dibutyl phthalate, dioctyl phthalate, triethyl citrate, tributyl citrate, acetyl citrate, triacetin and castor oil.

4. The finasteride film according to claim 1, characterized in that: The penetration enhancer is one or more of laurocaprol and peppermint oil.

5. The finasteride film according to claim 1, characterized in that: The stabilizer is one or more of magnesium stearate, calcium stearate, polyethylene glycol, stearic acid, titanium dioxide and colloidal silicon dioxide.

6. The finasteride film according to any one of claims 1 to 5, characterized in that: The invention is composed of the following raw materials in parts by weight: 12.5 parts of finasteride, 0.12 parts of resveratrol, 65 parts of polyvinyl alcohol, 60 parts of ethanol, 40 parts of propylene glycol, 15 parts of laurocaprol, 0.6 parts of colloidal silicon dioxide and 306.9 parts of purified water.

7. A method for preparing the finasteride film according to any one of claims 1 to 6, characterized in that: The following steps are involved: (1) Weigh the required amount of film-forming agent, slowly add it into purified water, and stir continuously until it is completely dissolved to form a uniform solution to obtain a film-forming agent solution; (2) Add finasteride to ethanol and stir until completely dissolved, then add plasticizer and stir evenly to obtain a finasteride solution; (3) slowly adding the penetration enhancer into the finasteride solution and stirring evenly to obtain a finasteride mixed solution 1; (4) gradually adding the finasteride mixed solution into the film-forming agent solution in step 1 and stirring evenly to obtain the finasteride mixed solution 2; (5) adding the stabilizer to the finasteride mixture 2, stirring evenly, and then adding resveratrol to obtain the finasteride mixture 3; (6) homogenizing and degassing the finasteride mixture 3; (7) Coating and drying: The prepared solution is evenly coated on the mold or substrate, and allowed to stand or dry to form a transparent film with good adhesion. (8) Cutting and packaging: Cut the dried film into required sizes and package it in moisture-proof materials to avoid contact with light and air.

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