A terbinafine hydrochloride film coating agent and a production process thereof

Abstract

The application discloses a terbinafine hydrochloride film coating agent and a production process thereof, and comprises the following raw materials in parts by weight: terbinafine hydrochloride 1-3 parts, polyvinylpyrrolidone K308 12 parts, acrylic resin No. IV 5-8 parts, xanthan gum 2-4 parts, anhydrous ethanol 30-45 parts, propylene glycol 8-15 parts, dibutyl phthalate 2-5 parts, glycerol 3-6 parts, polysorbate 80 1-3 parts, Span 800 0.5-2 parts, vitamin E acetate 0.3-1 part, disodium ethylenediaminetetraacetate 0.1-0.5 part, triethanolamine 0.5-2 parts, allantoin 0.1-0.5 part, phenoxyethanol 0.5-1.5 parts; the application builds a flexible skeleton through compounding of film forming materials, and xanthan gum cooperatively regulates the viscosity of the system, so that the problems of traditional film coating agents, such as brittle fracture and uneven dispersion, are solved; the dual solvent and the surfactant system improve the solubility and dispersibility of the drug and avoid precipitation; vitamin E acetate and disodium ethylenediaminetetraacetate build a stable system and delay the degradation of components.

Description

Technical Field

[0001] This invention relates to the field of terbinafine hydrochloride coating agents, specifically to a terbinafine hydrochloride coating agent and its production process. Background Technology

[0002] Terbinafine hydrochloride, a broad-spectrum antifungal drug, has a strong inhibitory effect on dermatophytes, and its topical formulations are widely used to treat fungal infections such as tinea pedis, tinea corporis, and tinea cruris. Existing terbinafine hydrochloride film-forming formulations mostly use a single film-forming material, which leads to problems such as film brittleness after formation, uneven drug release, and strong skin irritation. Some formulations introduce special cyclodextrin derivatives to improve stability, or rely on acid regulators to improve solubility, which not only increases costs but may also cause skin discomfort.

[0003] Currently, in the production of coating agents, process defects such as uneven mixing of raw materials and residual air bubbles can further affect the quality of the formulation. Therefore, there is an urgent need to develop a terbinafine hydrochloride coating agent to solve the aforementioned problems. Summary of the Invention

[0004] The purpose of this invention is to provide a terbinafine hydrochloride coating agent and its manufacturing process to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a terbinafine hydrochloride coating agent, comprising the following raw materials in parts by weight: 1-3 parts terbinafine hydrochloride, 8-12 parts polyvinylpyrrolidone K30, 5-8 parts acrylic resin IV, 2-4 parts xanthan gum, 30-45 parts anhydrous ethanol, 8-15 parts propylene glycol, 2-5 parts dibutyl phthalate, 3-6 parts glycerin, 1-3 parts polysorbate 80, 0.5-2 parts Span 80, 0.3-1 part vitamin E acetate, 0.1-0.5 parts disodium EDTA, 0.5-2 parts triethanolamine, 0.1-0.5 parts allantoin, and 0.5-1.5 parts phenoxyethanol.

[0006] Terbinafine hydrochloride: The core antifungal ingredient, which works by inhibiting fungal cell membrane synthesis; Polyvinylpyrrolidone K30 and acrylic resin IV are compounded to construct a flexible film-forming skeleton, which takes into account both adhesion and air permeability, and avoids the brittleness defects of a single film-forming material. Xanthan gum: a natural polymeric thickener that synergistically regulates coating viscosity and improves the uniformity of raw material dispersion; Anhydrous ethanol and propylene glycol: a dual solvent system that enhances the solubility of terbinafine hydrochloride, while propylene glycol has both moisturizing and penetration-enhancing effects. Dibutyl phthalate and glycerol: improve film-forming flexibility and reduce shrinkage and cracking during drying; Polysorbate 80 and Span 80: a combination of nonionic surfactants that promote the dispersion of oil phase components and improve the homogeneity of the formulation; Vitamin E acetate and disodium EDTA: dual stabilization through antioxidant and metal ion chelation, delaying component degradation; Triethanolamine: Adjusts the pH of the formulation to a suitable range for the skin, reducing irritation; Allantoin: Soothes the skin and relieves dryness and discomfort that may be caused by the medication; Phenoxyethanol: A broad-spectrum preservative that ensures the stability of the formulation during storage.

[0007] Preferably, the raw materials include the following by weight: 2 parts terbinafine hydrochloride, 10 parts polyvinylpyrrolidone K30, 6 parts acrylic resin IV, 3 parts xanthan gum, 38 parts anhydrous ethanol, 12 parts propylene glycol, 3 parts dibutyl phthalate, 4 parts glycerin, 2 parts polysorbate, 1 part Span 80, 0.6 parts vitamin E acetate, 0.3 parts disodium EDTA, 1 part triethanolamine, 0.3 parts allantoin, and 1 part phenoxyethanol.

[0008] Preferably, the raw materials include the following by weight: terbinafine hydrochloride 3 parts, polyvinylpyrrolidone K30 12 parts, acrylic resin IV 8 parts, xanthan gum 4 parts, anhydrous ethanol 45 parts, propylene glycol 15 parts, dibutyl phthalate 5 parts, glycerin 6 parts, polysorbate 80 3 parts, Span 80 2 parts, vitamin E acetate 1 part, disodium EDTA 0.5 parts, triethanolamine 2 parts, allantoin 0.5 parts, and phenoxyethanol 1.5 parts.

[0009] Preferably, the raw materials include the following by weight: 1 part terbinafine hydrochloride, 8 parts polyvinylpyrrolidone K30, 5 parts acrylic resin IV, 2 parts xanthan gum, 30 parts anhydrous ethanol, 8 parts propylene glycol, 2 parts dibutyl phthalate, 3 parts glycerin, 1 part polysorbate 80, 0.5 parts Span 80, 0.3 parts vitamin E acetate, 0.1 parts disodium EDTA, 0.5 parts triethanolamine, 0.1 parts allantoin, and 0.5 parts phenoxyethanol.

[0010] A manufacturing process for a terbinafine hydrochloride coating agent includes the following steps: Step 1: Raw material pretreatment: Take terbinafine hydrochloride raw material, remove surface impurities, place it in a drying oven for treatment, then put it into a pulverizer for pulverization, sieve it after pulverization, and collect the sieve powder for later use; take polyvinylpyrrolidone K30, acrylic resin IV, and xanthan gum and sieve them separately to remove agglomerated particles; filter liquid raw materials such as vitamin E acetate and phenoxyethanol to remove visible impurities; Step 2: Preparation of film-forming material solution: Add the prescribed amount of anhydrous ethanol to the mixing tank, start stirring, slowly add polyvinylpyrrolidone K30, and continue stirring until completely dissolved; after heating, add acrylic resin IV, and continue stirring until a uniform and transparent solution is formed; separately take a small amount of anhydrous ethanol to dissolve xanthan gum, let it stand to swell, and then slowly add it to the above solution, stirring until it is mixed evenly to obtain the film-forming material solution; Step 3: Preparation of drug mixture: Add propylene glycol to another mixing vessel, add terbinafine hydrochloride powder, and stir to fully wet the powder; add the remaining anhydrous ethanol and continue stirring until the drug is completely dissolved; add polysorbate 80, Span 80, vitamin E acetate, disodium EDTA, and allantoin in sequence, stirring until completely dispersed after each addition; Step 4, Mixing and Degassing: Slowly inject the drug mixture into the film-forming material solution while stirring; add dibutyl phthalate, glycerin, and phenoxyethanol, and continue stirring until a homogeneous system is formed; transfer the mixture to a vacuum degassing tank for degassing treatment until no more bubbles overflow. Step 5, pH adjustment and fine filtration: Slowly add triethanolamine dropwise to the defoamed mixture while stirring, and monitor the pH until it reaches the target range; then finely filter the adjusted solution through a filter membrane and collect the clear filtrate. Step 6, Dispensing and Inspection: Dispense the clarified filtrate quantitatively into pharmaceutical tubes, seal them, and then inspect for appearance, viscosity, microbial limits, etc. If the inspection is qualified, it is the finished product.

[0011] Preferably, in step one, terbinafine hydrochloride is pulverized and sieved, and polyvinylpyrrolidone K30, acrylic resin IV, and xanthan gum are also sieved.

[0012] Preferably, during the vacuum degassing process in step four, the mixture is kept stirred, and after degassing, it is allowed to stand for observation to ensure that no bubbles remain.

[0013] Compared with the prior art, the beneficial effects of the present invention are: This invention solves the problems of brittleness and uneven dispersion in traditional film-forming agents by constructing a flexible framework through a compound of film-forming materials and using xanthan gum to synergistically regulate the system viscosity. A dual solvent and surfactant system enhances drug solubility and dispersibility, preventing precipitation. Vitamin E acetate and disodium EDTA form a stable system, delaying component degradation. Allantoin and triethanolamine reduce skin irritation and improve user comfort. In the production process, raw material pretreatment ensures uniform particle size, stepwise dissolution and vacuum degassing reduce bubbles and impurities, and fine filtration ensures formulation clarity. Compared with existing technologies, the formulation of this invention exhibits good film-forming properties, high stability, excellent skin compatibility, and strong process controllability, making it suitable for large-scale production. Attached Figure Description

[0014] Figure 1This is a process flow diagram of the present invention. Detailed Implementation

[0015] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0016] Please see Figure 1 This invention provides a terbinafine hydrochloride coating agent, comprising the following raw materials in parts by weight: 1-3 parts terbinafine hydrochloride, 8-12 parts polyvinylpyrrolidone K30, 5-8 parts acrylic resin IV, 2-4 parts xanthan gum, 30-45 parts anhydrous ethanol, 8-15 parts propylene glycol, 2-5 parts dibutyl phthalate, 3-6 parts glycerin, 1-3 parts polysorbate 80, 0.5-2 parts Span 80, 0.3-1 part vitamin E acetate, 0.1-0.5 parts disodium EDTA, 0.5-2 parts triethanolamine, 0.1-0.5 parts allantoin, and 0.5-1.5 parts phenoxyethanol.

[0017] Terbinafine hydrochloride: The core antifungal ingredient, which works by inhibiting fungal cell membrane synthesis; Polyvinylpyrrolidone K30 and acrylic resin IV are compounded to construct a flexible film-forming skeleton, which takes into account both adhesion and air permeability, and avoids the brittleness defects of a single film-forming material. Xanthan gum: a natural polymeric thickener that synergistically regulates coating viscosity and improves the uniformity of raw material dispersion; Anhydrous ethanol and propylene glycol: a dual solvent system that enhances the solubility of terbinafine hydrochloride, while propylene glycol has both moisturizing and penetration-enhancing effects. Dibutyl phthalate and glycerol: improve film-forming flexibility and reduce shrinkage and cracking during drying; Polysorbate 80 and Span 80: a combination of nonionic surfactants that promote the dispersion of oil phase components and improve the homogeneity of the formulation; Vitamin E acetate and disodium EDTA: dual stabilization through antioxidant and metal ion chelation, delaying component degradation; Triethanolamine: Adjusts the pH of the formulation to a suitable range for the skin, reducing irritation; Allantoin: Soothes the skin and relieves dryness and discomfort that may be caused by the medication; Phenoxyethanol: A broad-spectrum preservative that ensures the stability of the formulation during storage.

[0018] A manufacturing process for a terbinafine hydrochloride coating agent includes the following steps: Step 1: Raw material pretreatment Take terbinafine hydrochloride raw material, remove surface impurities, place it in a drying oven for treatment, then put it into a pulverizer for pulverization, sieve it after pulverization, and collect the sieve powder for later use; take polyvinylpyrrolidone K30, acrylic resin IV, and xanthan gum and sieve them separately to remove agglomerated particles; filter liquid raw materials such as vitamin E acetate and phenoxyethanol to remove visible impurities.

[0019] Step 2: Preparation of film-forming material solution Add the prescribed amount of anhydrous ethanol to the mixing tank, start stirring, slowly add polyvinylpyrrolidone K30, and continue stirring until completely dissolved; after heating, add acrylic resin IV and continue stirring until a uniform and transparent solution is formed; separately take a small amount of anhydrous ethanol to dissolve xanthan gum, let it stand to swell, and then slowly add it to the above solution, stirring until it is mixed evenly to obtain the film-forming material solution.

[0020] Step 3: Preparation of drug mixture Add propylene glycol to another mixing vessel, then add terbinafine hydrochloride powder and stir to fully wet the powder; add the remaining anhydrous ethanol and continue stirring until the drug is completely dissolved; add polysorbate 80, Span 80, vitamin E acetate, disodium EDTA, and allantoin in sequence, stirring until completely dispersed after each addition.

[0021] Step 4: Mixing and Degassing Slowly inject the drug mixture into the film-forming material solution while stirring; add dibutyl phthalate, glycerol, and phenoxyethanol, and continue stirring until a homogeneous system is formed; transfer the mixture to a vacuum degassing tank for degassing treatment until no bubbles overflow.

[0022] Step 5: pH Adjustment and Fine Filtration Triethanolamine was slowly added dropwise to the defoamed mixture while stirring, and the pH was monitored until it reached the target range. The adjusted solution was then filtered through a filter membrane, and the clear filtrate was collected.

[0023] Step Six: Packaging and Inspection The clarified filtrate is quantitatively dispensed into pharmaceutical tubes, sealed, and then tested for appearance, viscosity, microbial limits, etc. Qualified products are considered finished products.

[0024] Example 1: Formula composition (parts by weight): Terbinafine hydrochloride 2 parts, polyvinylpyrrolidone K30 10 parts, acrylic resin IV 6 parts, xanthan gum 3 parts, anhydrous ethanol 38 parts, propylene glycol 12 parts, dibutyl phthalate 3 parts, glycerin 4 parts, polysorbate 80 2 parts, Span 80 1 parts, vitamin E acetate 0.6 parts, disodium EDTA 0.3 parts, triethanolamine 1 part, allantoin 0.3 parts, phenoxyethanol 1 part.

[0025] Preparation method: (1) Raw material pretreatment: Terbinafine hydrochloride was dried, pulverized and sieved after removing impurities; Polyvinylpyrrolidone K30, Acrylic Resin IV and Xanthan Gum were sieved; Vitamin E Acetate and Phenoxyethanol were filtered.

[0026] (2) Preparation of film-forming material solution: 38 parts of anhydrous ethanol were added to a stirring tank, and 10 parts of polyvinylpyrrolidone K30 were added under stirring until dissolved; after heating, 6 parts of acrylic resin IV were added and stirred until transparent; 3 parts of xanthan gum were dissolved in a small amount of ethanol, and after swelling, it was added and mixed evenly.

[0027] (3) Preparation of drug mixture: Add 2 parts of terbinafine hydrochloride to 12 parts of propylene glycol, stir to moisten, and then add the remaining anhydrous ethanol (if available) to dissolve; add 2 parts of polysorbate 80, 1 part of Span 80, 0.6 parts of vitamin E acetate, 0.3 parts of disodium EDTA, and 0.3 parts of allantoin in sequence, and stir to disperse.

[0028] (4) Mixing and degassing: Inject the drug solution into the film-forming material solution, add 3 parts dibutyl phthalate, 4 parts glycerol and 1 part phenoxyethanol, stir evenly and then degas under vacuum.

[0029] (5) pH adjustment and fine filtration: Add 1 part of triethanolamine to adjust the pH, and then perform fine filtration through the filter membrane.

[0030] (6) Packaging and inspection: The product is obtained after packaging and inspection.

[0031] Example 2: Formula composition (parts by weight): Terbinafine hydrochloride 1.5 parts, polyvinylpyrrolidone K30 9 parts, acrylic resin IV 7 parts, xanthan gum 3.5 parts, anhydrous ethanol 42 parts, propylene glycol 10 parts, dibutyl phthalate 4 parts, glycerin 5 parts, polysorbate 80 1.5 parts, Span 80 1.2 parts, vitamin E acetate 0.8 parts, disodium EDTA 0.2 parts, triethanolamine 1.5 parts, allantoin 0.2 parts, phenoxyethanol 1.2 parts.

[0032] Preparation method: (1) Raw material pretreatment: Terbinafine hydrochloride is dried, pulverized and sieved; solid excipients are sieved and liquid raw materials are filtered.

[0033] (2) Preparation of film-forming material solution: Dissolve 42 parts of anhydrous ethanol with 9 parts of polyvinylpyrrolidone K30; heat up and add 7 parts of acrylic resin IV and stir until transparent; dissolve 3.5 parts of xanthan gum in ethanol, swell and mix in.

[0034] (3) Preparation of drug mixture: 10 parts of propylene glycol are moistened with 1.5 parts of terbinafine hydrochloride and dissolved in ethanol; 1.5 parts of polysorbate 80, 1.2 parts of Span 80, 0.8 parts of vitamin E acetate, 0.2 parts of disodium EDTA and 0.2 parts of allantoin are added and stirred.

[0035] (4) Mixing and degassing: Combine the solutions, add 4 parts dibutyl phthalate, 5 parts glycerol and 1.2 parts phenoxyethanol, stir and then degas under vacuum.

[0036] (5) pH adjustment and fine filtration: Add 1.5 parts of triethanolamine to adjust the pH and then perform fine filtration.

[0037] (6) Packaging and inspection: The product is obtained after passing the packaging and inspection.

[0038] Comparative Example 1: Formula composition (parts by weight): Terbinafine hydrochloride 2 parts, polyvinylpyrrolidone K301 3 parts, acrylic resin IV 6 parts, anhydrous ethanol 38 parts, propylene glycol 12 parts, dibutyl phthalate 3 parts, glycerin 4 parts, polysorbate 802 parts, Span 801 parts, disodium EDTA 0.3 parts, triethanolamine 1 part, phenoxyethanol 1 part.

[0039] Preparation method: (1) Raw material pretreatment: Terbinafine hydrochloride was dried, pulverized and sieved after removing impurities; Polyvinylpyrrolidone K30, Acrylic Resin IV and Xanthan Gum were sieved; Vitamin E Acetate and Phenoxyethanol were filtered.

[0040] (2) Preparation of film-forming material solution: 38 parts of anhydrous ethanol were added to a stirring tank, and 10 parts of polyvinylpyrrolidone K30 were added under stirring until dissolved; after heating, 6 parts of acrylic resin IV were added and stirred until transparent.

[0041] (3) Preparation of drug mixture: Add 2 parts of terbinafine hydrochloride to 12 parts of propylene glycol, stir to moisten, and then add the remaining anhydrous ethanol (if available) to dissolve; add 2 parts of polysorbate 80, 1 part of Span 80, and 0.3 parts of disodium ethylenediaminetetraacetate in sequence, and stir to disperse.

[0042] (4) Mixing and degassing: Inject the drug solution into the film-forming material solution, add 3 parts dibutyl phthalate, 4 parts glycerol and 1 part phenoxyethanol, stir evenly and then degas under vacuum.

[0043] (5) pH adjustment and fine filtration: Add 1 part of triethanolamine to adjust the pH, and then perform fine filtration through the filter membrane.

[0044] (6) Packaging and inspection: The product is obtained after packaging and inspection.

[0045] Comparative Example 2: Formula composition (parts by weight): Terbinafine hydrochloride 2 parts, polyvinylpyrrolidone K30 10 parts, acrylic resin IV 6 parts, xanthan gum 3 parts, anhydrous ethanol 38 parts, propylene glycol 12 parts, dibutyl phthalate 3 parts, glycerin 4 parts, vitamin E acetate 0.6 parts, disodium EDTA 0.3 parts, triethanolamine 1 part, allantoin 0.3 parts, phenoxyethanol 1 part.

[0046] Preparation method: (1) Raw material pretreatment: Terbinafine hydrochloride was dried, pulverized and sieved after removing impurities; Polyvinylpyrrolidone K30, Acrylic Resin IV and Xanthan Gum were sieved; Vitamin E Acetate and Phenoxyethanol were filtered.

[0047] (2) Preparation of film-forming material solution: 38 parts of anhydrous ethanol were added to a stirring tank, and 10 parts of polyvinylpyrrolidone K30 were added under stirring until dissolved; after heating, 6 parts of acrylic resin IV were added and stirred until transparent; 3 parts of xanthan gum were dissolved in a small amount of ethanol, and after swelling, it was added and mixed evenly.

[0048] (3) Preparation of drug mixture: Add 2 parts of terbinafine hydrochloride to 12 parts of propylene glycol, stir to moisten, and then add the remaining anhydrous ethanol (if available) to dissolve; add 0.6 parts of vitamin E acetate, 0.3 parts of disodium ethylenediaminetetraacetate, and 0.3 parts of allantoin in sequence, and stir to mix as usual.

[0049] (4) Mixing and degassing: Inject the drug solution into the film-forming material solution, add 3 parts dibutyl phthalate, 4 parts glycerol and 1 part phenoxyethanol, stir evenly and then degas under vacuum.

[0050] (5) pH adjustment and fine filtration: Add 1 part of triethanolamine to adjust the pH, and then perform fine filtration through the filter membrane.

[0051] (6) Packaging and inspection: The product is obtained after packaging and inspection.

[0052] The following table compares the above Examples 1 and 2 with Comparative Examples 1 and 2: Comparison Projects Example 1 Example 2 Comparative Example 1 Comparative Example 2 Formula characteristics Contains xanthan gum, dual surfactants, and soothing ingredients. Contains xanthan gum, dual surfactants, and soothing ingredients. Lacking xanthan gum, antioxidants, and soothing ingredients Lack of dual surfactants Film-forming properties The film forms uniformly, has good flexibility, and is free from cracking. The film forms uniformly, has good flexibility, and is free from cracking. The film is prone to cracking and has poor adhesion. Uneven film formation, with localized particles. Drug stability Drug content remains stable after storage Drug content remains stable after storage The drug content decreased significantly after storage. Slight drug precipitation occurred after storage. Skin tolerance It is non-irritating and leaves the skin feeling moisturized after application. It is non-irritating and leaves the skin feeling moisturized after application. Some users experienced dryness and stinging. The skin feels rough after application. Coating appearance Clear and transparent, with no visible impurities. Clear and transparent, with no visible impurities. Slightly cloudy with a small amount of sediment. Slightly cloudy, containing fine particles This invention solves the problems of brittleness and uneven dispersion in traditional film-forming agents by constructing a flexible framework through a compound of film-forming materials and using xanthan gum to synergistically regulate the system viscosity. A dual solvent and surfactant system enhances drug solubility and dispersibility, preventing precipitation. Vitamin E acetate and disodium EDTA form a stable system, delaying component degradation. Allantoin and triethanolamine reduce skin irritation and improve user comfort. In the production process, raw material pretreatment ensures uniform particle size, stepwise dissolution and vacuum degassing reduce bubbles and impurities, and fine filtration ensures formulation clarity. Compared with existing technologies, the formulation of this invention exhibits good film-forming properties, high stability, excellent skin compatibility, and strong process controllability, making it suitable for large-scale production.

[0053] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A terbinafine hydrochloride coating agent, characterized in that, The product contains the following raw materials in parts by weight: terbinafine hydrochloride 1-3 parts, polyvinylpyrrolidone K30 8-12 parts, acrylic resin IV 5-8 parts, xanthan gum 2-4 parts, anhydrous ethanol 30-45 parts, propylene glycol 8-15 parts, dibutyl phthalate 2-5 parts, glycerin 3-6 parts, polysorbate 80 1-3 parts, Span 80 0.5-2 parts, vitamin E acetate 0.3-1 part, disodium EDTA 0.1-0.5 parts, triethanolamine 0.5-2 parts, allantoin 0.1-0.5 parts, and phenoxyethanol 0.5-1.5 parts.

2. The terbinafine hydrochloride coating agent according to claim 1, characterized in that, The product contains the following raw materials in parts by weight: terbinafine hydrochloride 2 parts, polyvinylpyrrolidone K30 10 parts, acrylic resin IV 6 parts, xanthan gum 3 parts, anhydrous ethanol 38 parts, propylene glycol 12 parts, dibutyl phthalate 3 parts, glycerin 4 parts, polysorbate 80 2 parts, Span 80 1 parts, vitamin E acetate 0.6 parts, disodium EDTA 0.3 parts, triethanolamine 1 part, allantoin 0.3 parts, and phenoxyethanol 1 part.

3. The terbinafine hydrochloride coating agent according to claim 1, characterized in that, The product contains the following raw materials in parts by weight: terbinafine hydrochloride 3 parts, polyvinylpyrrolidone K30 12 parts, acrylic resin IV 8 parts, xanthan gum 4 parts, anhydrous ethanol 45 parts, propylene glycol 15 parts, dibutyl phthalate 5 parts, glycerin 6 parts, polysorbate 80 3 parts, Span 80 2 parts, vitamin E acetate 1 part, disodium EDTA 0.5 parts, triethanolamine 2 parts, allantoin 0.5 parts, and phenoxyethanol 1.5 parts.

4. The terbinafine hydrochloride coating agent according to claim 1, characterized in that, The product contains the following raw materials in parts by weight: terbinafine hydrochloride 1 part, polyvinylpyrrolidone K30 8 parts, acrylic resin IV 5 parts, xanthan gum 2 parts, anhydrous ethanol 30 parts, propylene glycol 8 parts, dibutyl phthalate 2 parts, glycerin 3 parts, polysorbate 80 1 part, Span 80 0.5 parts, vitamin E acetate 0.3 parts, disodium EDTA 0.1 parts, triethanolamine 0.5 parts, allantoin 0.1 parts, and phenoxyethanol 0.5 parts.

5. The production process of a terbinafine hydrochloride coating agent according to any one of claims 1-4, characterized in that, Includes the following steps: Step 1: Raw material pretreatment: Take terbinafine hydrochloride raw material, remove surface impurities, place it in a drying oven for treatment, then put it into a pulverizer for pulverization, sieve it after pulverization, and collect the sieve powder for later use; take polyvinylpyrrolidone K30, acrylic resin IV, and xanthan gum and sieve them separately to remove agglomerated particles; filter liquid raw materials such as vitamin E acetate and phenoxyethanol to remove visible impurities; Step 2: Preparation of film-forming material solution: Add the prescribed amount of anhydrous ethanol to the mixing tank, start stirring, slowly add polyvinylpyrrolidone K30, and continue stirring until completely dissolved; after heating, add acrylic resin IV, and continue stirring until a uniform and transparent solution is formed; separately take a small amount of anhydrous ethanol to dissolve xanthan gum, let it stand to swell, and then slowly add it to the above solution, stirring until it is mixed evenly to obtain the film-forming material solution; Step 3: Preparation of drug mixture: Add propylene glycol to another mixing vessel, add terbinafine hydrochloride powder, and stir to fully wet the powder; add the remaining anhydrous ethanol and continue stirring until the drug is completely dissolved; add polysorbate 80, Span 80, vitamin E acetate, disodium EDTA, and allantoin in sequence, stirring until completely dispersed after each addition; Step 4, Mixing and Degassing: Slowly inject the drug mixture into the film-forming material solution while stirring; add dibutyl phthalate, glycerin, and phenoxyethanol, and continue stirring until a homogeneous system is formed; transfer the mixture to a vacuum degassing tank for degassing treatment until no more bubbles overflow. Step 5, pH adjustment and fine filtration: Slowly add triethanolamine dropwise to the defoamed mixture while stirring, and monitor the pH until it reaches the target range; then finely filter the adjusted solution through a filter membrane and collect the clear filtrate. Step 6, Dispensing and Inspection: Dispense the clarified filtrate quantitatively into pharmaceutical tubes, seal them, and then inspect for appearance, viscosity, microbial limits, etc. If the inspection is qualified, it is the finished product.

6. The production process of a terbinafine hydrochloride coating agent according to claim 5, characterized in that, In step one, terbinafine hydrochloride was pulverized and sieved, and polyvinylpyrrolidone K30, acrylic resin IV, and xanthan gum were also sieved.

7. The production process of a terbinafine hydrochloride coating agent according to claim 5, characterized in that, During the vacuum degassing process in step four, maintain stirring and observe after degassing to ensure no air bubbles remain.

Images