A film-forming composition containing an ionic liquid and a method for its preparation

Abstract

The application relates to a film-forming composition containing an ionic liquid and a preparation method thereof, the film-forming composition is formed by a drug (API) with an active ingredient and a counter ion corresponding thereto or an API-ILs novel drug delivery system formed by two different API, can realize liquidization of a solid drug, improve the solubility, skin permeability and bioavailability of a poorly soluble drug, prevent the drug from being precipitated due to drug supersaturation after the film-forming composition is formed into a film on the surface of the skin, meanwhile, the composition has a good plasticizing effect on a film-forming polymer without adding a plasticizer, and the use of the traditional plasticizer can be avoided, and safety hidden dangers and toxicity caused by the use of the traditional plasticizer can be avoided.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical formulation technology, specifically relating to a film-forming composition containing ionic liquid and its preparation method. Background Technology

[0002] The skin is the largest organ in the human body, covering the entire body. It is also the body's first line of defense against external aggressors, protecting various tissues and organs from mechanical, physical, chemical, and biological damage. When the skin is injured, symptoms such as cracking, pain, redness, swelling, inflammation, and itching often occur. Protecting and repairing the wound is crucial; improper treatment can worsen infection, leave scars, and affect appearance. In daily life, protecting intact or damaged skin from further damage is receiving increasing attention and importance.

[0003] In addition, the skin is also an important route for the transdermal delivery of active pharmaceutical ingredients. Transdermal drug delivery systems can administer drugs to the skin, allowing them to enter the bloodstream or subcutaneous tissue through epidermal penetration or skin appendages to achieve systemic or local therapeutic effects.

[0004] Traditional patches are painful to remove and are noticeable and unsightly, while gels, ointments, and creams are easily rubbed off by clothing and can easily spread to other areas, causing cross-contamination. Film-forming polymer solutions represent a new approach in this field, offering a viable alternative to conventional skin formulations such as ointments, creams, gels, or patches. Applied to the skin in liquid form, film-forming polymer solutions can form films of any size and shape, providing convenient administration, adjustable dosage, and a occlusive effect after drying, without hindering movement, staining clothing, or leaving the skin feeling non-sticky. Due to their flexibility and elasticity, they are suitable for treating irregular areas, especially elbows and knees where application is inconvenient. Once formed, the film moves freely with the skin and joints and is less prone to falling off.

[0005] Currently, film-forming materials in film-forming formulations often require the addition of plasticizers to increase their flexibility. Plasticizers are additives that can increase the plasticity of polymer materials; they are materials that can lower the melting temperature of polymer materials, improve the flowability of polymers in the molten state, and enhance the softness of finished products. However, while plasticizers improve the properties of polymers themselves, they also bring new problems, namely the impact of some plasticizer migration on the environment and human health. For example, phthalate plasticizers can migrate into the environment, mainly entering the human body through contact with the mouth, skin, and mucous membranes, posing safety hazards to human health. Summary of the Invention

[0006] To address the problems in the prior art, this invention provides a film-forming composition containing ionic liquids. This composition comprises a novel drug delivery system consisting of an active pharmaceutical ingredient (API) and its corresponding counterion, or API-ILs formed from two different APIs. It improves the solubility, skin penetration, and bioavailability of poorly soluble drugs, and prevents drug supersaturation and precipitation after film formation on the skin surface. Furthermore, this composition exhibits good plasticizing effects on film-forming polymers without the need for added plasticizers, avoiding the safety hazards and toxicity associated with the use of traditional plasticizers.

[0007] This film-forming composition can be applied to the skin surface by spraying, smearing, or other methods to form a film that covers the skin surface for a long time. It can be used for wound protection and treatment, and can also achieve continuous local or systemic drug delivery on the intact skin surface.

[0008] More specifically, the present invention provides a film-forming composition containing an ionic liquid, comprising:

[0009] (a) Ionic liquids;

[0010] (b) Film-forming materials;

[0011] (c) Solvent;

[0012] This includes, in percentage by mass:

[0013] The ionic liquid accounts for 0.01%-50% of the film-forming composition, preferably 0.5%-25%, preferably 1%-20%, preferably 1%-13%, preferably 5%-13%, and more preferably 5%-9%;

[0014] The film-forming material accounts for 0.1%-60% of the film-forming composition, preferably 0.5%-20%, and more preferably 2%-17%;

[0015] The solvent accounts for 0.01%-97% of the film-forming composition, preferably 60%-96%, preferably 70%-96%, more preferably 70%-85%, more preferably 72%-80%, or preferably 82%-96%, more preferably 84%-96%, more preferably 84%-92%.

[0016] In one embodiment of the present invention, the ionic liquid is composed of an active pharmaceutical component and a corresponding counterion, wherein the molar ratio of the active pharmaceutical component to the counterion component is 1:9 to 9:1; preferably 2:8 to 8:2, preferably 3:7 to 7:3, preferably 4:6 to 6:4, preferably 6:4 to 7:3 or preferably 5:5 to 7:3.

[0017] In one embodiment of the present invention, the active pharmaceutical ingredient is selected from one or more of local anesthetics and nonsteroidal anti-inflammatory drugs.

[0018] In certain preferred embodiments of the present invention, the active pharmaceutical ingredient may be a local anesthetic, including but not limited to lidocaine, bupivacaine, levobupivacaine, ropivacaine, tetracaine, dibutylcaine, prilocaine, mepivacaine, piperocaine, benzocaine, procaine, chloroprocaine, eticaine, celecoxib, amicaine, butylamine, cyclomicaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, prilocaine, and any combination thereof. The active agent (drug) can be in a basic form or a pharmaceutically acceptable salt, polymorph, complex, prodrug, or derivative of the active agent.

[0019] In one embodiment of the present invention, the local anesthetic is selected from one or more of lidocaine, procaine, bupivacaine, or pharmaceutically acceptable salts thereof.

[0020] In one embodiment of the present invention, the counterion includes an ionic liquid anion or an ionic liquid cation;

[0021] The ionic liquid anion is selected from one or more of fatty acids or carboxylic acids; preferably, the fatty acids or carboxylic acids are selected from one or more of oleic acid, decanoic acid, ibuprofen, salicylic acid, diclofenac, and diclofenac sodium.

[0022] The cation of the ionic liquid is one or more of the following: imidazole, amino acid ester, pyridine, quaternary ammonium salt, quaternary phosphate salt, and choline.

[0023] In one embodiment of the present invention, the ionic liquid is selected from lidocaine and oleic acid, lidocaine and salicylic acid, lidocaine and decanoic acid, lidocaine and ibuprofen, lidocaine hydrochloride and diclofenac sodium, bupivacaine and diclofenac, procaine and oleic acid, procaine and decanoic acid, procaine and salicylic acid, or procaine and ibuprofen.

[0024] In one embodiment of the present invention, the film-forming material is selected from natural polymers, semi-synthetic polymers, and synthetic polymers.

[0025] Preferably, the film-forming material is selected from gelatin, shellac, pectin, vegan gum, gellan gum, rhamnose gum, dextrin, seaweed extract, sodium alginate, xanthan gum, hyaluronic acid, starch and modified starch, synthetic gums (low-methoxyl pectin, propylene glycol alginate, carboxymethyl locust bean gum and carboxymethyl guar gum), chitosan, dextran, methylcellulose, ethylcellulose, cellulose acetate, nitrocellulose, hydroxymethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, sodium carboxymethyl starch, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol-polyvinyl alcohol graft copolymer, polyvinylcaprolactam-polyvinyl acetate-polyvinyl glycol graft copolymer, polyoxyethylene-polyoxypropylene copolymer, acrylic resin One or more of the following: lipid polymers, acrylate polymers or copolymers, methacrylic acid polymers or copolymers, alkenyl amide / ester / acid or alcohol polymers or copolymers, acrylate / octylacrylamide copolymers, ethylene-vinyl acetate copolymers, polyvinyl butyral, polyacrylamide, polyurethane, polyisobutylene, AMP-acrylate copolymers, butyl methacrylate-dimethylaminoethyl methacrylate-methyl methacrylate copolymers, methacrylic acid-ethyl acrylate copolymers, methacrylic acid-methyl methacrylate copolymers, ethyl acrylate-methyl methacrylate-trimethylaminoethyl methacrylate chloride copolymers, and methacrylic acid-methyl acrylate-methyl methacrylate copolymers.

[0026] Preferably, the film-forming material is selected from one or more of polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinyl butyral (PVB), methyl acrylate resin C, polyacrylic acid resin II, and polyacrylic acid resin III.

[0027] More preferably, the film-forming material is selected from 15% PVP and 1.5% HPMC, 2% HPMC and 1% HPC, 15% polyacrylic resin II, 15% polyacrylic resin III, 15% methyl acrylate resin C, 5% PVB, or 10% PVP and 2% HPC.

[0028] In one embodiment of the present invention, the solvent is selected from one or more of ethanol, isopropanol, butyl acetate, n-hexane, ethyl acetate, acetone, n-butanol, methanol, propylene glycol, polyethylene glycol, mineral oil, dichloromethane, methylene dimethyl ether, siloxane, water, propane, isobutane, n-butane, propane-butane, tetrafluoroethane, heptafluoropropane, dimethyl ether, and liquefied petroleum gas.

[0029] Preferably, the solvent is selected from an aqueous ethanol solution, wherein the proportion of ethanol in the aqueous ethanol solution is 20%-100% (v / v), preferably 20%-95% (v / v), preferably 60%-95% (v / v), preferably 70.5%-96% (v / v), or preferably 82%-96% (v / v), more preferably 84%-92% (v / v), or preferably 70.5%-82.5% (v / v), more preferably 72%-80% (v / v).

[0030] In one embodiment of the invention, the composition does not contain a pharmaceutically acceptable plasticizer; preferably, the plasticizer is selected from one or more of phthalates, phosphates, polyol esters, epoxidized oils, and chlorine-containing compounds.

[0031] Preferably, the phthalates are selected from dioctyl phthalate, dibutyl phthalate, diisobutyl phthalate and dicyclohexyl phthalate; and the dicarboxylic acid esters are selected from one or more of adipic acid ester, azelaic acid ester and sebacic acid ester.

[0032] Preferably, the phosphate ester is selected from one or more of tricresyl phosphate, trioctyl phosphate, triphenyl phosphate, and tributyl phosphate.

[0033] Preferably, the polyol esters are selected from one or more of propylene glycol, glycerol, diol fatty acid esters, polydiol fatty acid esters, triol fatty acid esters, tetraol fatty acid esters, dipentaerythritol esters, diol benzoate esters, polydiol benzoate esters, triol benzoate esters, tetraol benzoate esters, and triglyceride esters.

[0034] Preferably, the epoxidized oil is selected from one or more of epoxidized oils, epoxidized fatty acid monoesters, and epoxidized tetrahydrophthalic acid esters.

[0035] Preferably, the chlorine-containing compound is selected from one or more of chlorinated paraffin containing 42% chlorine and chlorinated paraffin containing 52% chlorine.

[0036] In one embodiment of the invention, the composition further comprises other pharmaceutically acceptable excipients, including one or more of pharmaceutically acceptable absorption enhancers, antioxidants, preservatives, humectants, pH adjusters, and defoamers; preferably, an appropriate amount of excipients is added, wherein the amount of excipients does not exceed 50%, preferably not more than 20%, preferably not more than 10%, preferably not more than 5%, and more preferably not more than 2%.

[0037] The present invention adopts the above technical solution and has the following technical effects compared with the prior art:

[0038] The present invention provides a film-forming composition using ionic liquids as plasticizers. APIs-ILs can act as both active pharmaceutical ingredients and plasticizers, and have a better plasticizing effect on polymers than commercially available plasticizers. This avoids the use of traditional plasticizers while liquefying solid drugs, promoting the skin permeability of drugs, and preventing drug precipitation after film formation.

[0039] This film-forming composition, upon application to the skin, rapidly evaporates the solvent, forming a film on the skin surface within minutes, which can last for 24 hours or longer. It adheres to the skin surface without breaking during joint movement, providing continuous drug delivery while isolating and protecting the wound. It is breathable, waterproof, and dustproof, and can be used on intact skin surfaces to relieve pain and inflammation from sprains, rheumatism, acute or chronic neuralgia, and nociceptive pain, or for wound care of abrasions, burns, cuts, and postoperative injuries. The composition is easy to use and simple to prepare, making it particularly suitable for irregular areas. Attached Figure Description

[0040] Figure 1 Film formation on dish T1-15 of composition in Example 1

[0041] Figure 2 Film formation on dish T1-25 of composition in Example 1.

[0042] Figure 3 Film formation on dish T1-29 of composition in Example 1.

[0043] Figure 4 Film formation on dish T1-34 of composition in Example 1.

[0044] Figure 5 Film formation on dish T1-51 of composition in Example 1

[0045] Figure 6 Film formation on dish T2-5 of composition in Example 2

[0046] Figure 7 Film formation on dish T2-11 of composition in Example 2

[0047] Figure 8 Film formation on dish T2-18 of composition in Example 2

[0048] Figure 9 Film formation on dish T2-31 for composition of Example 2

[0049] Figure 10 Film formation on dish T2-54 of composition in Example 2. Detailed Implementation

[0050] The present invention will be further described in detail below with reference to the accompanying drawings, specific embodiments, and comparative examples, but this should not be construed as limiting the invention. Any modifications or substitutions made to the methods, steps, or conditions of the present invention without departing from the spirit and essence of the invention are within the scope of the invention. Experimental methods not specifically described in the embodiments and reagents not specified in the formulations are operated according to conventional conditions in the art.

[0051] Example 1: Lidocaine-counterion ionic liquid film agent

[0052] According to the prescription in Table 1-1-1-6, add solvent, film material, and ionic liquid and stir overnight. Coat a thin film with a length of 8cm and a width of 3cm on a clean steel plate. After it dries naturally, judge the film formation.

[0053] The method for preparing ionic liquids is as follows: ionic liquids are prepared by mixing them according to existing technical methods in a specific molar ratio.

[0054] Table 1-1 Formulation of lidocaine-oleic acid ionic liquid film preparation precursor solution

[0055]

[0056] Table 1-2 Formulations of lidocaine-oleic acid ionic liquid precursor solutions for different membrane materials

[0057]

[0058] Table 1-3 Formulation of lidocaine-ibuprofen ionic liquid film preparation precursor solution

[0059]

[0060] Table 1-4 Formulations of lidocaine-based ionic liquid film precursor solutions in different solvents

[0061]

[0062]

[0063] Table 1-5 Formulations of lidocaine-based ionic liquid membrane precursor solutions for different membrane materials

[0064]

[0065] Table 1-6 Formulations of lidocaine-based ionic liquid membrane precursor solutions for different membrane materials

[0066]

[0067]

[0068] Example 2: Procaine-counterion ionic liquid film agent

[0069] According to the prescription in Table 2-1-2-4, add solvent, film material, and ionic liquid and stir overnight. Coat a thin film with a length of 8cm and a width of 3cm on a clean steel plate. After it dries naturally, judge the film formation.

[0070] The method for preparing ionic liquids is as follows: ionic liquids are prepared by mixing them according to existing technical methods in a specific molar ratio.

[0071] Table 2-1 Formulation of Procaine-Oleic Acid Ionic Liquid Film Precursor Solution

[0072]

[0073] Table 2-2 Formulation of Procaine-Cecaponic Acid Ion Liquid Film Precursor Solution

[0074]

[0075]

[0076] Table 2-3 Formulations of Procaine-Ibuprofen and Procaine-Salicylate Ionic Liquid Film Precursor Solutions

[0077]

[0078] Table 2-4 Formulations of procaine-based ionic liquid film-forming agent precursor solutions in different solvents

[0079]

[0080]

[0081] Table 2-5 Formulations of procaine-based ionic liquid membrane precursor solutions for different membrane materials

[0082]

[0083] Table 2-6 Formulations of Procaine Ionic Liquid Film Precursor Solutions for Different Film Materials

[0084]

[0085]

[0086] Example 3: Experimental results of the maximum tensile force and elastic modulus of the film agent of the present invention.

[0087] Test method: Apply the coating agent to a stainless steel plate, and peel it off after it dries. Cut the resulting film into five parts evenly, and select the film with the most uniform thickness to measure the maximum load, tensile strength, elongation at break and elastic modulus.

[0088] The results are shown in Tables 3-1 to 3-4.

[0089] Table 3-1 Maximum load of the film-forming agent of the present invention

[0090] Composition Maximum load (Fmax) / N T1-18 6.77 T1-20 15.05 T1-27 16.1 T1-28 22.83 T1-29 7.75 T1-42 7.21 T2-1 5.80 T2-9 6.99

[0091] Table 3-2 Tensile strength of the film-forming agent of the present invention

[0092] Composition Tensile strength (σM) / MPa T1-20 11.6 T1-27 16.2 T1-28 22.74 T1-29 6.77 T2-1 5.95 T2-7 5.92 T2-9 7.52

[0093] Table 3-3 Elongation at break of the film-forming agent of the present invention

[0094]

[0095]

[0096] Table 3-4 Elastic modulus of the film-forming agent of the present invention

[0097] Composition Elastic modulus / MPa T1-18 252.466 T1-20 316.076 T1-27 205.845 T1-28 259.293 T1-42 115.616 T2-1 97.920 T2-7 152.287 T2-8 92.024 T2-22 62.844

[0098] The results showed that the film prepared by the method of the present invention was complete and smooth, with consistent thickness, uniform color, and moderate tensile strength.

[0099] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several modifications and improvements can be made without departing from the principle of the present invention, and these modifications and improvements should also be considered within the scope of protection of the present invention.

Claims

1. A film-forming composition containing an ionic liquid, comprising: (a) Ionic liquids; (b) Film-forming materials; (c) Solvent; This includes, in percentage by mass: The ionic liquid accounts for 0.01%-50% of the film-forming composition, preferably 0.5%-25%, preferably 1%-20%, preferably 1%-13%, preferably 5%-13%, and more preferably 5%-9%; The film-forming material accounts for 0.1%-60% of the film-forming composition, preferably 0.5%-20%, and more preferably 2%-17%; The solvent accounts for 0.01%-97% of the film-forming composition, preferably 60%-96%, preferably 70%-96%, more preferably 70%-85%, more preferably 72%-80%, or preferably 82%-96%, more preferably 84%-96%, more preferably 84%-92%.

2. The film-forming composition according to claim 1, wherein, The ionic liquid is composed of an active pharmaceutical component and a corresponding counterion, wherein the molar ratio of the active pharmaceutical component to the counterion component is 1:9 to 9:1; preferably 2:8 to 8:2, preferably 3:7 to 7:3, preferably 4:6 to 6:4, preferably 6:4 to 7:3 or preferably 5:5 to 7:

3.

3. The film-forming composition according to claim 2, wherein, The active pharmaceutical ingredient is selected from one or more local anesthetics and their pharmaceutically acceptable derivatives; Preferably, the local anesthetic is selected from one or more of lidocaine, procaine, bupivacaine, or pharmaceutically acceptable salts thereof.

4. The film-forming composition according to claim 2, wherein, Counterions include ionic liquid anions or ionic liquid cations; The ionic liquid anion is selected from one or more of fatty acids or carboxylic acids; preferably, the fatty acids or carboxylic acids are selected from one or more of oleic acid, decanoic acid, ibuprofen, salicylic acid, diclofenac, and diclofenac sodium. The cation of the ionic liquid is one or more of the following: imidazole, amino acid ester, pyridine, quaternary ammonium salt, quaternary phosphate salt, and choline.

5. The film-forming composition according to claim 2, wherein the ionic liquid is selected from lidocaine and oleic acid, lidocaine and salicylic acid, lidocaine and decanoic acid, lidocaine and ibuprofen, lidocaine hydrochloride and diclofenac sodium, bupivacaine and diclofenac, procaine and oleic acid, procaine and decanoic acid, procaine and salicylic acid, or procaine and ibuprofen.

6. The film-forming composition according to claim 1, wherein the film-forming material is selected from natural polymers, semi-synthetic polymers, and synthetic polymers; preferably, the film-forming material is selected from gelatin, shellac, pectin, vetiver gum, gellan gum, rhamnose gum, dextrin, seaweed extract, sodium alginate, xanthan gum, hyaluronic acid, starch and modified starch, synthetic gums (low-methoxyl pectin, propylene glycol alginate, carboxymethyl locust bean gum and carboxymethyl guar gum), chitosan, dextran, methylcellulose, ethylcellulose, cellulose acetate, nitrocellulose, hydroxymethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, sodium carboxymethyl starch, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol-polyvinyl alcohol graft copolymer, and polyvinylcaprolactam-polyvinyl acetate-polyethylene glycol. Graft copolymers, polyoxyethylene-polyoxypropylene copolymers, acrylic resin polymers, acrylate polymers or copolymers, methacrylic acid polymers or copolymers, alkenyl amide / ester / acid or alcohol polymers or copolymers, acrylate / octylacrylamide copolymers, ethylene-vinyl acetate copolymers, polyvinyl butyral, polyacrylamide, polyurethane, polyisobutylene, AMP-acrylate copolymers, butyl methacrylate-dimethylaminoethyl methacrylate-methyl methacrylate copolymers, methacrylic acid-ethyl acrylate copolymers, methacrylic acid-methyl methacrylate copolymers, ethyl acrylate-methyl methacrylate copolymers, ethyl acrylate-methyl methacrylate-trimethylaminoethyl methacrylate copolymers, methacrylic acid-methyl acrylate-methyl methacrylate copolymers, and one or more of the following: Preferably, the film-forming material is selected from one or more of polyvinylpyrrolidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl butyral, methyl acrylate resin C, polyacrylate resin II, and polyacrylate resin III; More preferably, the film-forming material is selected from 15% PVP and 1.5% HPMC, 2% HPMC and 1% HPC, 15% polyacrylic resin II, 15% polyacrylic resin III, 15% methyl acrylate resin C, 5% PVB, or 10% PVP and 2% HPC.

7. The film-forming composition according to claim 1, wherein, The solvent is selected from one or more of the following: ethanol, isopropanol, butyl acetate, n-hexane, ethyl acetate, acetone, n-butanol, methanol, propylene glycol, polyethylene glycol, mineral oil, dichloromethane, methylene dimethyl ether, siloxane, water, propane, isobutane, n-butane, propane-butane, tetrafluoroethane, heptafluoropropane, dimethyl ether, and liquefied petroleum gas. Preferably, the solvent is selected from an aqueous ethanol solution, wherein the proportion of ethanol in the aqueous ethanol solution is 20%-100% (v / v), preferably 20%-95% (v / v), preferably 60%-95% (v / v), preferably 70.5%-96% (v / v), or preferably 82%-96% (v / v), more preferably 84%-92% (v / v), or preferably 70.5%-82.5% (v / v), more preferably 72%-80% (v / v).

8. The film-forming composition according to claim 1, characterized in that, The composition is free of pharmaceutically acceptable plasticizers; preferably, the plasticizers are selected from phthalate esters: dioctyl phthalate, dibutyl phthalate, diisobutyl phthalate, and dicyclohexyl phthalate; dicarboxylic acid esters: adipate, azelaic acid, and sebacic acid; phosphate esters: tricresyl phosphate, trioctyl phosphate, triphenyl phosphate, and tributyl phosphate; polyol esters: propylene glycol, glycerol, diol fatty acid esters, polydiol fatty acid esters, triol fatty acid esters, tetraol fatty acid esters, dipentaerythritol esters, diol benzoates, polydiol benzoates, triol benzoates, tetraol benzoates, and triglycerides; epoxidized oils: epoxidized oils, epoxy fatty acid monoesters, and epoxy tetrahydrophthalates; and chlorinated compounds: one or more of chlorinated paraffins containing 42% chlorine and chlorinated paraffins containing 52% chlorine.

9. The film-forming composition according to claim 1, characterized in that, The composition further comprises other excipients, including one or more of absorption promoters, antioxidants, preservatives, humectants, pH adjusters, and defoamers; preferably, an appropriate amount of excipients is added, wherein the amount of excipients does not exceed 50%, preferably not more than 20%, preferably not more than 10%, preferably not more than 5%, and more preferably not more than 2%.

10. The film-forming composition according to any one of claims 1-9, characterized in that, The composition can be used for administration by methods such as application or spraying, and remains on the skin surface to exert local or systemic therapeutic effects.

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