A compound gel and a preparation method thereof

Abstract

The application provides a compound gel and a preparation method thereof. The compound gel comprises active ingredients and pharmaceutically acceptable adjuvants, wherein the active ingredients are minoxidil and finasteride or pharmaceutically acceptable salts thereof, and the pharmaceutically acceptable adjuvants comprise penetration enhancers, organic solvents, gel bases, pH regulators and water. The compound gel provided by the application is simple to prepare, has good stability, is convenient to use, has good effects, can effectively improve the medication compliance of patients and has high application value.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical formulation technology, specifically to a minoxidil-finasteride compound gel and its preparation method. Background Technology

[0002] Androgenetic alopecia (AGA), also known as seborrheic alopecia, is a genetically predisposed androgen-dependent disease with a specific pattern of hair loss. AGA is primarily caused by the conversion of androgens in the blood into dihydrotestosterone (DHT) by type II 5α-reductase in the dermis of the scalp. DHT binds to androgen receptors in cells, leading to hair follicle atrophy, hair loss, and baldness. AGA patients exhibit elevated expression of androgen receptor genes and / or type II 5α-reductase genes, resulting in increased androgen activity on susceptible hair follicles.

[0003] Minoxidil and finasteride are two main FDA-approved drugs for the treatment of AGA (Advanced Growth Alopecia Areata). Minoxidil is a topical vasodilator that promotes hair growth; finasteride is an oral 5α-reductase inhibitor that inhibits DHT production, thereby slowing the hair loss process. They have different mechanisms of action, and current research suggests that combining them can achieve more significant and satisfactory therapeutic effects. Therefore, in clinical practice, a combination therapy of topical minoxidil and oral finasteride is commonly used. However, the potential side effects of oral finasteride still cause concern for many.

[0004] Recent clinical studies have also demonstrated that topical finasteride is a promising treatment, offering similar therapeutic effects and fewer side effects compared to oral finasteride, without the systemic side effects. Besides skin irritation or allergic reactions associated with topical formulations, the dissolution of minoxidil and finasteride, as well as the permeation and absorption of finasteride, are also concerns. To address this issue, patent application CN202411846380.0 provides a topical solution containing minoxidil and finasteride. In its embodiments, the propylene glycol content reaches 50%, which can cause significant skin irritation. Furthermore, when using diethylene glycol monoethyl ether as a penetration enhancer to prepare the sample, the viscosity is too high, resulting in a decrease in the intradermal retention of minoxidil and finasteride. Patent application CN202410466821.8 provides a minoxidil-finasteride solution, which reduces the amount of propylene glycol by increasing the amount of penetration enhancer. However, the total content of penetration enhancer, propylene glycol, and ethanol is still as high as 80%. Since the penetration enhancer itself can also cause skin irritation or allergies, it cannot completely solve the aforementioned problems. Summary of the Invention

[0005] This invention aims to at least partially solve the technical problems existing in the prior art. Therefore, the objective of this invention is to provide a compound gel agent and its preparation method. The compound gel agent of this invention has good efficacy, is simple to prepare, has good stability, is convenient to use, and has high application value.

[0006] In a first aspect, the present invention proposes a compound gel.

[0007] According to an embodiment of the present invention, the compound gel comprises: an active ingredient and pharmaceutically acceptable excipients, wherein the active ingredient is minoxidil and finasteride or a pharmaceutically acceptable salt thereof, and the pharmaceutically acceptable excipients include penetration enhancers, propylene glycol, ethanol, a gel matrix, a pH adjuster, and water.

[0008] According to embodiments of the present invention, the penetration enhancer is selected from one or more of diethylene glycol monoethyl ether, polyglycerol fatty acid ester, PEG-glycerol octanoate-capric acid, isopropyl myristate, and propylene carbonate.

[0009] According to embodiments of the present invention, the gel matrix is ​​selected from one or more of carbomer, alginate, gelatin, pectin, cellulose derivatives, starch and its derivatives, polyvinyl alcohol and polyacrylic acid.

[0010] According to an embodiment of the present invention, the pH adjuster is selected from one or more of triethanolamine, aminobutanetriol, ethylenediamine, diethylamine, laurylamine, ammonia solution, sodium bicarbonate, and sodium hydroxide.

[0011] According to an embodiment of the present invention, based on the total weight of the compound gel, the content of minoxidil is 2.0-5.0%, the content of finasteride is 0.10-0.40%, the content of the penetration enhancer is 5-30%, the content of propylene glycol is 20-35%, the content of ethanol is 15-25%, the content of the gel matrix is ​​0.25%-0.60%, the content of the pH adjuster is 0.20%-0.30%, and the content of water is the balance.

[0012] According to an embodiment of the present invention, based on the total weight of the compound gel, the content of minoxidil is 2.0% to 5.0%, the content of finasteride is 0.10% to 0.40%, the content of the penetration enhancer is 10%, the content of propylene glycol is 30%, the content of ethanol is 20%, the content of the gel matrix is ​​0.25% to 0.60%, the content of the pH adjuster is 0.20% to 0.30%, and the content of water is the balance.

[0013] According to an embodiment of the present invention, based on the total weight of the compound gel, the content of minoxidil is 2.0% to 5.0%, the content of finasteride is 0.10% to 0.40%, the content of the penetration enhancer is 20%, the content of propylene glycol is 20%, the content of ethanol is 20%, the content of the gel matrix is ​​0.25% to 0.60%, the content of the pH adjuster is 0.20% to 0.30%, and the content of water is the balance.

[0014] Secondly, this invention proposes a method for preparing the aforementioned compound gel.

[0015] According to an embodiment of the present invention, the method includes the following steps:

[0016] S1: Minoxidil and finasteride, the penetration enhancer and the alcohol solvent are mixed to obtain a liquid phase;

[0017] S2: Prepare a matrix solution containing the gel matrix;

[0018] S3: Mix the drug liquid phase with the matrix solution, adjust the pH, and obtain the compound gel.

[0019] According to an embodiment of the present invention, step S1 includes: mixing minoxidil and finasteride, the penetration enhancer and the propylene glycol to obtain a first mixture, and mixing the first mixture with the ethanol to obtain the liquid phase.

[0020] According to an embodiment of the present invention, step S3 further includes a step of adjusting pH.

[0021] Thirdly, this invention proposes the application of the aforementioned compound gel or the compound gel prepared by the aforementioned method in the preparation of drugs for the prevention or treatment of hair loss.

[0022] This invention combines physical methods to promote dissolution, achieving complete dissolution of minoxidil and finasteride in relatively low concentrations of penetration enhancers and propylene glycol. The resulting gel is transparent and exhibits no morphological changes or precipitation of active substances after high-temperature storage, avoiding the potential precipitation issues that can occur with solutions using lower organic solvents. Furthermore, the compound gel provided by this invention offers excellent transdermal absorption, is easy to use, effectively improves patient compliance, and has high application value. Attached Figure Description

[0023] Figure 1 The diagrams shown in Example 3 depict the properties of the liquid phases prepared using different penetration enhancers (1a is Formula 6, 1b is Formula 7, 1c is Formula 8, 1d is Formula 9, and 1e is Formula 10). Detailed Implementation

[0024] The embodiments of the present invention are described in detail below. The embodiments described below are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in the art or according to the product manual. All instruments used, or those whose manufacturers are not specified, are conventional products that can be obtained commercially.

[0025] For numerical ranges, the endpoint values ​​of each range, the endpoint values ​​of each range and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein.

[0026] In this document, the terms “comprising” or “including” are open-ended expressions, meaning that they include the contents specified in this invention, but do not exclude other aspects.

[0027] Compound Gel

[0028] In one aspect of the invention, a compound gel is provided. According to an embodiment of the invention, the compound gel comprises: an active ingredient and pharmaceutically acceptable excipients, wherein the active ingredient is minoxidil and finasteride or a pharmaceutically acceptable salt thereof, and the pharmaceutically acceptable excipients include penetration enhancers, organic solvents, gel matrices, pH adjusters, and water.

[0029] In this document, the term "pharmaceutically acceptable salt" refers to the organic and inorganic salts of minoxidil and finasteride of the present invention.

[0030] According to embodiments of the present invention, the content of minoxidil is 2.0% to 5.0% based on the total weight of the compound gel. In some embodiments, the content of minoxidil is 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3.0%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4.0%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5.0%, or a range between any two of these values ​​as endpoints. This ensures sufficient dissolution of the active ingredient and better efficacy.

[0031] According to embodiments of the present invention, the content of finasteride is 0.10-0.40% based on the total weight of the compound gel. In some embodiments, the content of minoxidil is 0.10%, 0.11%, 0.12%, 0.13%, 0.14%, 0.15%, 0.16%, 0.17%, 0.18%, 0.19%, 0.20%, 0.21%, 0.22%, 0.23%, 0.24%, 0.25%, 0.26%, 0.27%, 0.28%, 0.29%, 0.30%, 0.31%, 0.32%, 0.33%, 0.34%, 0.35%, 0.36%, 0.37%, 0.38%, 0.39%, 0.40%, or a range between any two of these values ​​as endpoints. This ensures the full dissolution of the active ingredients and allows for better efficacy.

[0032] According to embodiments of the present invention, the content of the penetration enhancer is 5-30% based on the total weight of the compound gel. In some embodiments, the content of the penetration enhancer is 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, or any two of these values ​​as endpoints. This not only facilitates complete dissolution of the active ingredient and better promotes its transdermal absorption, but also reduces the amount of propylene glycol used, thereby reducing skin irritation.

[0033] According to embodiments of the present invention, the content of propylene glycol is 20-35% and the content of ethanol is 15-25% based on the total weight of the compound gel. In some embodiments, the content of propylene glycol is 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, or any two of these values ​​as a range between endpoints; in some embodiments, the content of ethanol is 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, or any two of these values ​​as a range between endpoints. This ensures the full dissolution of the active ingredients and promotes their transdermal absorption without causing significant skin irritation.

[0034] According to an embodiment of the present invention, the content of the gel matrix is ​​0.25% to 0.60% based on the total weight of the compound gel. In some embodiments, the content of the gel matrix is ​​0.25%, 0.26%, 0.27%, 0.28%, 0.29%, 0.30%, 0.31%, 0.32%, 0.33%, 0.34%, 0.35%, 0.36%, 0.37%, 0.38%, 0.39%, 0.40%, 0.41%, 0.42%, 0.43%, 0.44%, 0.45%, 0.46%, 0.47%, 0.48%, 0.49%, 0.50%, 0.51%, 0.52%, 0.53%, 0.54%, 0.55%, 0.56%, 0.57%, 0.58%, 0.59%, 0.60%, or a range between any two of these values ​​as endpoints. Therefore, it can provide a suitable consistency, without causing stickiness on the patient's scalp, and can be formulated into a spray for application, which is absorbed quickly, has a short duration of wetting sensation, and improves medication compliance.

[0035] According to embodiments of the present invention, the content of the pH adjuster is 0.20% to 0.30% based on the total weight of the compound gel. In some embodiments, the content of the pH adjuster is 0.20%, 0.21%, 0.22%, 0.23%, 0.24%, 0.25%, 0.26%, 0.27%, 0.28%, 0.29%, 0.30%, or a range between any two of these values ​​as endpoints, or other content that can adjust the compound gel to a suitable pH. Thus, the compound gel can have a pH value suitable for topical skin application.

[0036] Methods for preparing compound gels

[0037] In another aspect of the invention, a method for preparing the aforementioned compound gel is provided. According to an embodiment of the invention, the method includes the following steps:

[0038] S1: Minoxidil and finasteride, penetration enhancer and alcohol solvent are mixed to obtain the drug liquid phase;

[0039] S2: Prepare a matrix solution containing a gel matrix;

[0040] S3: Mix the drug liquid phase with the matrix solution to obtain a compound gel.

[0041] Therefore, the compound gel prepared according to the method of the present invention has good efficacy, stable quality, and high application value. Furthermore, the preparation method of the present invention is simple to operate, highly efficient, and low in cost, making it suitable for large-scale production.

[0042] According to an embodiment of the present invention, step S1 includes: mixing minoxidil and finasteride, a penetration enhancer, and propylene glycol to obtain a first mixture; and mixing the first mixture with ethanol to obtain the liquid phase of the drug. In some embodiments, after mixing minoxidil and finasteride, the penetration enhancer, and propylene glycol, high-speed shearing is applied to completely dissolve them to obtain the first mixture. In some embodiments, ethanol is added after the first mixture has cooled to room temperature.

[0043] According to an embodiment of the present invention, the shear rate in step S1 is 8000 rpm to 12000 rpm. This allows for the complete dissolution of minoxidil and finasteride in lower concentrations of penetration enhancer and propylene glycol.

[0044] According to an embodiment of the present invention, step S2 includes: adding the gel matrix to purified water and stirring until it swells completely.

[0045] According to an embodiment of the present invention, step S3 includes: mixing the drug liquid phase with the matrix solution to allow the gel matrix to swell completely a second time.

[0046] According to an embodiment of the present invention, step S3 further includes adjusting the pH. In some embodiments, the pH is adjusted to a point value of 6, 7, 8, or any two of these values.

[0047] application

[0048] In another aspect, the present invention proposes the application of the aforementioned compound gel or the compound gel prepared by the aforementioned method in the preparation of a medicament. According to embodiments of the present invention, the medicament is used for the prevention or treatment of hair loss. Thus, the medicament of the present invention offers advantages such as ease of use, low stickiness, good transdermal absorption, high patient compliance, and high application value.

[0049] Experimental methods

[0050] (1) Preparation of compound gel

[0051] Minoxidil and finasteride were added to a mixed solution of propylene glycol and a penetration enhancer and subjected to high-speed shearing (shear rate: 8000 rpm to 12000 rpm) to completely dissolve them. After the solution returned to room temperature, ethanol was added and stirred until homogeneous to obtain the drug liquid phase.

[0052] Add the gel matrix to purified water and stir until it swells completely to obtain a gel matrix solution.

[0053] Add the drug liquid phase to the gel matrix solution to allow the gel matrix to swell completely a second time, and adjust the pH to 6-8 to obtain the final product.

[0054] (2) Viscosity determination of compound gel

[0055] Take an appropriate amount of sample and place it on the rheometer measuring plate. The shear rate is 2s. -1 Read viscosity data for 120 seconds.

[0056] (3) Determination of the transdermal effect of compound gel

[0057] The Franz diffusion cell method was used, with the following parameters:

[0058] Receiving medium: physiological saline; Skin: pigskin with a thickness of 0.5 mm ± 0.2 mm and a resistivity more than 3 times the background; Receiving cell temperature: 32℃ ± 0.5℃; Rotation speed: 600 rpm; Diffusion cell volume: 8 mL; Contact area between receiving solution and skin: 3.14 cm² 2 Transdermal test duration: 24 hours.

[0059] (4) Determination of content and related substances

[0060] Content determination:

[0061] Chromatographic column: ACE Ultracore 2.5super C18 100*4.6mm; Mobile phase A: 0.1% perchloric acid aqueous solution, Mobile phase B: methanol; Detection wavelength: 210nm; Injection volume: 20μL; Flow rate: 1mL / min; Column temperature: 30℃; Gradient elution conditions are shown in Table 1:

[0062] Table 1

[0063] Time / min Mobile phase A% Mobile phase B% 0 60 40 4 60 40 5 30 70 12 30 70 13 60 40 17 60 40

[0064] Test solution: Weigh approximately 0.5 g of minoxidil-finasteride gel accurately and place it in a 50 mL volumetric flask. Add 10 mL of 0.1 M calcium chloride solution, sonicate for 60 s to dissolve, then add 25 mL of methanol and ultrapure water to make up to volume. Shake well, centrifuge at 8000 rpm for 5 min, filter through a 0.22 μm PTFE membrane, discard the initial filtrate, and collect the subsequent filtrate.

[0065] Related substance determination:

[0066] Chromatographic column: ACE Ultracore 2.5super C18 100*4.6mm; Mobile phase A: 0.1% perchloric acid aqueous solution, Mobile phase B: methanol; Detection wavelength: 230nm; Injection volume: 50μL; Flow rate: 1mL / min; Column temperature: 30℃; Gradient elution conditions are shown in Table 2:

[0067] Table 2

[0068] Time / min Mobile phase A% Mobile phase B% 0 70 30 50 20 80 50.1 70 30 55 70 30

[0069] Test solution: Weigh approximately 1.0 g of minoxidil-finasteride gel accurately and place it in a 25 mL volumetric flask. Add 5 mL of 0.1 M calcium chloride solution, sonicate for 60 s to dissolve, then add 12.5 mL of methanol and ultrapure water to make up to volume. Shake well, centrifuge at 8000 rpm for 5 min, filter through a 0.22 μm PTFE membrane, discard the initial filtrate, and collect the subsequent filtrate.

[0070] Example 1: Types of Gel Matrix

[0071] Prepare compound gels according to the prescriptions shown in Table 3:

[0072] Table 3

[0073]

[0074] Note: All diethylene glycol monoethyl ethers used in this application are of the following type: P Gattefossé;Sepineo P600 is an acrylamide / sodium acryloyl dimethyl taurate copolymer, isohexadecane, polysorbate 80, and sorbitan oleate.

[0075] The compound gels prepared by prescriptions 1-2 are all transparent gels, while the compound gel prepared by prescription 3 is a white latex.

[0076] Example 2: Amount of gel matrix

[0077] Prepare compound gels according to the prescriptions shown in Table 4:

[0078] Table 4

[0079]

[0080]

[0081] The viscosity of the compound gels prepared by Formula 1 and Formulas 4-5 was measured respectively, and the results are shown in Table 5:

[0082] Table 5

[0083]

[0084] Based on the common viscosity of commercially available gels, the amount of gel matrix in this product formulation does not exceed 0.6%, and the resulting compound gel can provide a better user experience.

[0085] Example 3: Types of Penetration Enhancers

[0086] Prepare compound gels according to the prescriptions shown in Table 6:

[0087] Table 6

[0088]

[0089]

[0090] The liquid composition of each of the above prescriptions is as follows Figure 1 As shown: the liquid phase of prescription 6 is clear and transparent and completely dissolved; the liquid phase of prescription 7 is an immiscible turbid solution that can be completely dissolved; prescription 8 is a red mixed solution that cannot be completely dissolved; prescription 9 is a layered solution that cannot be completely dissolved; prescription 10 is a miscible transparent solution, but cannot be completely dissolved.

[0091] The compound gels prepared according to formulations 6-7 were analyzed using the Franz diffusion cell method, and the results are shown in Table 7.

[0092] Table 7

[0093]

[0094] The compound gels prepared by formulations 6 and 7 all have good 24-hour cumulative penetration, intradermal retention, and finasteride intradermal retention, with formulation 6 being superior.

[0095] Example 4: Dosage of penetration enhancer

[0096] Prepare compound gels according to the prescriptions shown in Table 8:

[0097] Table 8

[0098]

[0099] The Franz diffusion cell method was used to determine the compound gel prepared from the formulations shown in Table 8, as well as several commercially available products. The results are shown in Table 9.

[0100] Table 9

[0101]

[0102] Note: Commercially available product 1: 2.2% minoxidil gel, manufacturer: Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd.; Commercially available product 2: 0.25% finasteride spray, manufacturer: Difa Cooper SpA; Commercially available product 3: 5% minoxidil and 0.1% finasteride topical solution, manufacturer:

[0103] ASTONEALABS PVT.LTD.

[0104] The cumulative 24-hour penetration of minoxidil in the compound gels prepared by formulations 1, 6, and 11-12 is significantly higher than that of commercially available product 3 (5% minoxidil and 0.1% finasteride topical solution). The intradermal retention of minoxidil in the compound gels prepared by formulations 1 and 12 is comparable to that of commercially available product 3. The cumulative 24-hour penetration of minoxidil in the compound gels prepared by formulations 1, 6, and 11-12 is comparable to that of commercially available product 1 (2.2% minoxidil gel), and the intradermal retention is higher than that of commercially available product 1, with formulations 1 and 12 showing more significant advantages. The intradermal retention of finasteride in the compound gels prepared by formulations 1, 6, and 11-12 is significantly higher than that of commercially available product 2 (0.25% finasteride spray) and commercially available product 3.

[0105] During the transdermal test of the compound gel prepared by this invention, no drug crystals were precipitated on the skin surface, and there were no obvious water stains on the skin surface after the test, indicating that the product will be quickly absorbed after use and will not cause a sticky feeling on the scalp.

[0106] Example 5: Stability

[0107] Table 10 shows the stability data of some of the compound gels prepared from the formulations and commercially available products:

[0108] Table 10

[0109]

[0110] Note: Commercially available product 1: 2.2% minoxidil gel, manufacturer: Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd.; Commercially available product 2: 0.25% finasteride spray, manufacturer: Difa Cooper SpA;

[0111] The compound gels prepared by prescriptions 1-2, 4, 6-7, and 11-12 were consistent with commercially available samples. Their appearance did not change after being placed at high temperatures, no content degradation occurred, and no related substances were detected.

[0112] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A compound gel, characterized in that, include: The active ingredient and pharmaceutically acceptable excipients, wherein the active ingredient is minoxidil and finasteride or a pharmaceutically acceptable salt thereof, and the pharmaceutically acceptable excipients include penetration enhancers, propylene glycol, ethanol, gel matrix, pH adjusters and water.

2. The compound gel according to claim 1, characterized in that, The penetration enhancer is selected from one or more of diethylene glycol monoethyl ether, polyglycerol fatty acid ester, octanoic acid-capric acid-polyethylene glycol glycerol ester, isopropyl myristate, and propylene carbonate.

3. The compound gel according to claim 1, characterized in that, The gel matrix is ​​selected from one or more of carbomer, polycarbofil, alginate, gelatin, pectin, cellulose derivatives, starch and its derivatives, polyvinyl alcohol and polyacrylic acid.

4. The compound gel according to claim 1, characterized in that, The pH adjuster is selected from one or more of triethanolamine, aminobutanetriol, ethylenediamine, diethylamine, laurylamine, ammonia solution, sodium bicarbonate, and sodium hydroxide.

5. The compound gel according to claim 1, characterized in that, Based on the total weight of the compound gel, the content of minoxidil is 2.0-5.0%, the content of finasteride is 0.10-0.40%, the content of the penetration enhancer is 5-30%, the content of propylene glycol is 20-35%, the content of ethanol is 15-25%, the content of the gel matrix is ​​0.25%-0.60%, the content of the pH adjuster is 0.20%-0.30%, and the content of water is the balance.

6. The compound gel according to claim 1, characterized in that, Based on the total weight of the compound gel, the content of minoxidil is 2.0-5.0%, the content of finasteride is 0.10-0.40%, the content of the penetration enhancer is 10%, the content of propylene glycol is 30%, the content of ethanol is 20%, the content of the gel matrix is ​​0.25%-0.60%, the content of the pH adjuster is 0.20%-0.30%, and the content of water is the balance.

7. The compound gel according to claim 1, characterized in that, Based on the total weight of the compound gel, the content of minoxidil is 2.0-5.0%, the content of finasteride is 0.10-0.40%, the content of the penetration enhancer is 20%, the content of propylene glycol is 20%, the content of ethanol is 20%, the content of the gel matrix is ​​0.25%-0.60%, the content of the pH adjuster is 0.20%-0.30%, and the content of water is the balance.

8. A method for preparing the compound gel according to any one of claims 1-7, characterized in that, Includes the following steps: S1: Minoxidil and finasteride, the penetration enhancer and the alcohol solvent are mixed to obtain a liquid phase; S2: Prepare a matrix solution containing the gel matrix; S3: Mix the drug liquid phase with the matrix solution, adjust the pH, and obtain the compound gel.

9. The method according to claim 8, characterized in that, Step S1 includes: mixing minoxidil and finasteride, the penetration enhancer and propylene glycol to obtain a first mixture, and mixing the first mixture with ethanol to obtain the liquid phase of the drug.

10. The use of the compound gel according to any one of claims 1-7 or the compound gel prepared by the method according to any one of claims 8-9 in the preparation of a drug for the prevention or treatment of hair loss.

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