Airtight film patch for antifungal drugs

Abstract

An antifungal drug airtight thin film patch is formed by bonding an airtight thin film layer, a viscous base layer and a drug layer from outside to inside, the airtight thin film layer is waterproof, isolates oxygen and blocks oxygen supply of superficial fungi so as to restrain growth of the fungi, the viscous base layer fixes the drug layer to the skin of an affected part, displacement caused by movement is avoided, and the drug layer is not prone to falling off. Fungi are killed through the antifungal drug of the drug layer. The air tightness of the film is utilized to reduce the skin breathing level of an affected part, inhibit the growth of related fungi, prevent the antifungal ointment or cream from quickly losing water or drying, ensure that the applied antifungal ointment or cream is always in a moist and moisture-sufficient state, prolong the skin medication time as much as possible, prevent the body temperature loss of the skin of the affected part, and improve the curative effect of the antifungal ointment or cream. The temperature of the skin of the affected part is increased, the antifungal drug is further promoted to diffuse to the deeper position of the skin of the affected part, pathogenic bacterium death is accelerated, the purpose of enhancing the antibacterial effect of the external antifungal drug is achieved, and meanwhile the awkward situation that unguent or cream is wiped off by clothes of a patient and cannot keep clean and sanitary is avoided by means of shielding of the airtight film.

Description

Technical Field

[0001] This application belongs to the field of antifungal drug technology, and particularly relates to an airtight film patch for antifungal drugs. Background Technology

[0002] Fungi are eukaryotic, sporulating, chloroplast-free eukaryotic organisms, and are heterotrophic. Fungal infections in the human body can cause fungal diseases. Clinically, pathogenic fungi are classified into superficial and deep fungi. Skin diseases, including tinea manuum, tinea pedis, tinea corporis, tinea cruris, and tinea versicolor, are infectious diseases caused by superficial fungi (dermatophytes) (such as Trichophyton mentagrophytes, Microsporum canis, and Epidermophyton floccosum) invading the stratum corneum, hair, and nails of the skin. They are characterized by high incidence, long course, high infectivity, and high rates of reinfection or recurrence after treatment. Dermatophytes are often confined to the stratum corneum of the epidermis. When they invade deeper dermis and subcutaneous tissue, they can form granulomas, infecting the stratum corneum and skin appendages from superficial to deep, destroying the structure of the skin and subcutaneous tissue, including muscle and connective tissue, and accompanied by varying degrees of host immune response, resulting in symptoms such as redness, swelling, skin lesions, itching, erosion, exudation, crusting, and fissures. Human skin consists of two layers: the epidermis and the dermis. The epidermis, located on the skin's surface, is further divided into the stratum corneum and the germinal layer. The dermis, beneath the epidermis, is a dense connective tissue containing numerous elastic and collagen fibers, as well as abundant blood vessels and nerves. Below the skin lies the subcutaneous tissue, a loose connective tissue containing a large number of fat cells. When fungal infection damages the structure of the skin and subcutaneous tissue, symptoms such as redness, swelling, and itching occur due to inflammation and congestion of the dermal blood vessels and stimulation of nerves beneath the epidermis. The more intense the itching, the more the patient scratches to relieve the itch, sometimes uncontrollably. Unrestrained scratching further damages and breaks down the skin, making it more susceptible to fungal infection. As a result, more and more skin becomes infected, the affected area expands, and the infection deepens. In some areas, subcutaneous lumps may appear, or blisters, pustules, and ulcers may develop, causing significant harm and discomfort to the patient. In addition, for a long time, due to excessive concern that covering the infected skin of patients might have an adverse effect on the skin inflammation, topical antifungal drugs have basically been applied by directly applying antifungal ointments or creams, with virtually no other auxiliary treatment measures or means, resulting in very limited actual antifungal effects.

[0003] Currently, the treatment of fungal skin diseases mainly involves two routes: oral antifungal drugs and topical antifungal ointments or creams. Antifungal drugs primarily include: imidazole drugs, such as miconazole, ketoconazole, and econazole; allylamine drugs, such as terbinafine hydrochloride, butenafine, and naftifine; echinocandins, such as caspofungin, anidoxuridine, and micafungin; flucytosine drugs, such as 5-fluorocytosine; and polyene drugs, such as amphotericin B and nystatin. Because drugs need to travel a long distance through the bloodstream and be absorbed systemically before finally diffusing through the dermis to the lesions in the skin and hair follicles, only a small portion of the oral medication is actually delivered to the lesions and exerts its antifungal effect. Ultimately, oral medication necessitates high doses. Only with high doses can the therapeutic goal be achieved. However, due to the strong toxic side effects of many antifungal drugs, oral medications may cause more and more serious side effects and adverse reactions compared to topical applications. Therefore, oral medications are chosen with great caution in the antifungal treatment of skin diseases. While topical antifungal ointments or creams can effectively avoid and reduce the toxic side effects of drugs, they are prone to drying out easily and are easily wiped off by the patient's clothing, making it difficult to remain on the skin for extended periods. Furthermore, the short contact time between the drug and the skin, coupled with the layers of skin barrier, results in a small amount of drug actually reaching the lesion and having a very short treatment time. Ultimately, very little drug actually reaches the lesion and exerts its antifungal effect, significantly reducing the actual therapeutic efficacy. Over time, inefficient and prolonged application of topical medications can lead to increased drug resistance, significantly reducing treatment effectiveness. Many patients lose faith in the treatment and are forced to abandon it altogether. The spread of the skin disease, its contagiousness, itching, and general discomfort then create endless distress and fear, leading to a vicious cycle. Ultimately, patients are forced to abandon topical treatment and return to oral medications or more complex treatment options. This is the current predicament of topical antifungal medications, an experience only those who have suffered from this disease can truly understand.

[0004] Although superficial and deep fungi have extremely low oxygen requirements, all fungi, including superficial and deep fungi, are aerobic. Fungi can only thrive in sufficient oxygen. For superficial fungi that cause skin diseases, even though their oxygen requirements are relatively low, a certain level of oxygen is still needed for normal growth in the skin. It has been reported that, in addition to the lungs and gills, the skin of many vertebrates can also respire, and human skin respiration accounts for about 1%-3% of their total respiration (Lin Chu. Respiratory function of animal skin. Invention and Innovation: Student Edition, 2007, (08): 8). Dermatologists at Ruhr University in Germany have also discovered that the skin at a depth of 0.25-0.4 mm directly obtains oxygen from the outside air. This depth is 10 times higher than previous estimates. In addition, the skin can also obtain oxygen and expel carbon dioxide from the blood flowing through the capillaries in the skin. The oxygen level in the microenvironment of the skin is crucial for the normal growth of infecting fungi. Therefore, when the skin at the site of a fungal infection is artificially sealed, the skin's respiration is impaired, naturally lowering the oxygen level in its microenvironment and inhibiting fungal growth due to oxygen deficiency. Simultaneously, because the skin is sealed, moisture cannot escape, thus maintaining the moisture content of the applied antifungal ointment or cream. Furthermore, the sealing prevents heat loss from the affected area, and the increased temperature facilitates the diffusion of antifungal drugs deeper into the affected area, ultimately accelerating the death of pathogens. Therefore, based on the structural and functional characteristics of the skin and the growth characteristics of superficial fungi, this invention involves applying antifungal ointments or creams to the adhesive base layer of an airtight adhesive film to create an airtight antifungal film patch, or dissolving the antifungal drug in an adhesive first, then evenly applying it to the surface of an airtight adhesive film to directly create an airtight antifungal film patch, which is then applied to the affected skin. By utilizing the airtight properties of the film to reduce the skin's respiration level at the affected area, the growth of related fungi is inhibited. At the same time, it prevents antifungal ointments or creams from rapidly losing water or drying out, ensuring that the applied antifungal ointment or cream remains moist and adequately hydrated. This extends the duration of skin application as much as possible, prevents the loss of body temperature from the affected skin, raises the temperature, and further promotes the diffusion of antifungal drugs into the deeper layers of the skin, accelerating the death of pathogens. The aim is to enhance the antifungal effect of topical antifungal drugs. In addition, the airtight film also helps to prevent the ointment or cream from being wiped off by the patient's clothing, thus avoiding the predicament of not being able to maintain cleanliness and hygiene.

[0005] Currently, there are no similar products or treatment methods that use an airtight film to cover the patient's diseased skin, thereby reducing the skin's respiration level, inhibiting the growth of related fungi, and enhancing the antifungal effect of topical antifungal drugs. Summary of the Invention

[0006] The purpose of this application is to provide an airtight film patch for antifungal drugs and its preparation method, aiming to solve the technical problems of inconvenient use, low efficacy and therapeutic effect of current topical antifungal ointments or creams.

[0007] To achieve the above-mentioned objectives, the technical solution adopted in this application is as follows:

[0008] An antifungal drug airtight film patch is composed of an airtight film layer, an adhesive base layer, and a drug layer bonded together from the outside to the inside. The airtight film layer is waterproof and isolates oxygen, blocking the oxygen supply to superficial fungi and thus inhibiting fungal growth. The adhesive base layer fixes the drug layer to the affected skin to prevent displacement due to movement. The antifungal drug in the drug layer kills the fungi.

[0009] The airtight film layer is made of an airtight film-forming material, and underneath the airtight film layer is an adhesive base layer, which is an adhesive adhesive evenly applied to one side of the airtight film.

[0010] Below the adhesive base layer is the drug layer, which is made by uniformly applying a drug layer of antifungal drugs mixed in a certain proportion on the surface of the adhesive base layer to form an airtight antifungal drug film patch.

[0011] Alternatively, the adhesive can be mixed with the antifungal drug in a certain proportion to form an adhesive containing the antifungal drug, and then evenly applied to one side of the airtight film to directly produce an antifungal drug airtight film patch.

[0012] Furthermore, the airtight film layer is selected from one of the airtight films made of polyvinyl chloride, polyethylene, polypropylene, polystyrene, rubber, and other high molecular polymers.

[0013] Furthermore, the adhesive substrate refers to any one or more combinations of acrylic pressure-sensitive adhesives, polyurethane pressure-sensitive adhesives, synthetic rubber pressure-sensitive adhesives, rubber-based pressure-sensitive adhesives, and silicone-based pressure-sensitive adhesives.

[0014] Furthermore, the drug layer refers to any one or more combinations of allylamine drugs, such as terbinafine hydrochloride, butenafine, and naftifine; imidazole drugs, such as miconazole, ketoconazole, econazole, bifonazole, clotrimazole, sertaconazole, and ruliconazole; and echinocandins, such as caspofungin, anidoxuridine, and micafungin.

[0015] Furthermore, the content of the active antifungal drug ingredient in the drug layer is 5-50 mg / cm³. 2 Thickness 0.1-2mm.

[0016] Furthermore, the drug layer is made using coating processes such as scraper coating, roller coating, and spray coating, by uniformly applying antifungal ointment or cream to the surface of the adhesive base layer of the viscous and airtight film, or by first dissolving the antifungal drug into a medical pressure-sensitive adhesive and then uniformly applying it to the surface of the film layer, thus creating an adhesive and airtight film with antifungal drug, avoiding interlayer peeling caused by winding and bonding.

[0017] Furthermore, the application time to the affected skin should be no less than 3 hours, preferably 6-12 hours.

[0018] The technical effects and advantages of this invention are as follows:

[0019] An airtight antifungal patch comprises, from the outside in, an airtight film layer, an adhesive base layer, and a drug layer. The airtight film layer is waterproof and isolates oxygen, blocking the oxygen supply to superficial fungi and thus killing them. The adhesive base layer fixes the drug layer to the affected skin, preventing displacement due to movement. The antifungal drug in the drug layer kills the fungi. It is manufactured using application processes such as scraper application, roller application, and spraying, avoiding interlayer delamination caused by wrapping and bonding. This invention, for the first time, addresses the structural and functional characteristics of skin and the growth characteristics of superficial fungi by employing an airtight film to shield the patient's affected skin and antifungal medication. By preparing an airtight film containing the antifungal drug, the respiration level of the affected skin is reduced, inhibiting the growth of related fungi. The airtight film also prevents the antifungal ointment or cream from rapidly losing moisture or drying out, ensuring that the applied antifungal ointment or cream remains moist and adequately hydrated. This maximizes the duration of skin application, prevents heat loss from the affected skin, raises the temperature, further promotes the diffusion of the antifungal drug into the deeper layers of the skin, accelerates the death of pathogens, and enhances the antifungal effect of the topical antifungal medication. Simultaneously, the airtight film prevents the ointment or cream from being wiped off by the patient's clothing, thus maintaining cleanliness and hygiene. This is completely different from existing technologies and patents. Attached Figure Description

[0020] Figure 1 The patient has had a fungal infection of the feet for 14 years without treatment.

[0021] Figure 2 The symptoms improved after one month of treatment with conventional drugs without a film layer, but the condition could not be cured.

[0022] Figure 3 This describes the situation after fungal activation using a thin film layer without antifungal drugs;

[0023] Figure 4 The effect of treatment with the antifungal drug airtight film patch of the present invention (formulation of Example 20) after 1 month;

[0024] Figure 5The results of treatment with the antifungal drug airtight film patch of the present invention (formulation of Example 20) for 3.5 months show that the symptoms have basically disappeared and the patient's skin has returned to normal in the later stage;

[0025] Figure 6 The results of treatment with the antifungal drug airtight film patch of the present invention (formulation of Example 4) for 2 months show that the right foot, which had been infected for 8 years, has basically fully recovered.

[0026] Figure 7 The results of treatment with the antifungal drug airtight film patch of the present invention (formulation of Example 8) for 2.5 months show that the left hand, which had been infected for 8 years, has basically fully recovered.

[0027] Figure 8 The results of treatment with the antifungal drug airtight film patch of the present invention (formulation of Example 2) after 2 months show that the right hand, which had been infected for 5 years, has basically fully recovered. Detailed Implementation

[0028] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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 skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] like Figure 1-7 As shown:

[0030] Example 1

[0031] First, prepare an ointment with a terbinafine hydrochloride concentration of 50 mg / mL. Then, evenly apply this ointment to the adhesive layer surface of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The content of terbinafine hydrochloride is 5 mg / cm³. 2 A viscous, airtight film.

[0032] Example 2

[0033] First, prepare an ointment with a terbinafine hydrochloride concentration of 100 mg / mL. Then, evenly apply this ointment to the adhesive layer surface of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The content of terbinafine hydrochloride is 10 mg / cm³. 2 A viscous, airtight film.

[0034] Example 3

[0035] First, prepare an ointment with a terbinafine hydrochloride concentration of 150 mg / mL. Then, evenly apply this ointment to the adhesive layer surface of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The terbinafine hydrochloride content is 15 mg / cm³. 2 A viscous, airtight film.

[0036] Example 4

[0037] First, prepare an ointment with a terbinafine hydrochloride concentration of 200 mg / mL. Then, evenly apply this ointment to the adhesive layer surface of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The terbinafine hydrochloride content is 20 mg / cm³. 2 A viscous, airtight film.

[0038] Example 5

[0039] First, prepare an ointment with a terbinafine hydrochloride concentration of 250 mg / mL. Then, evenly apply this ointment to the adhesive layer surface of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The terbinafine hydrochloride content is 25 mg / cm³. 2 A viscous, airtight film.

[0040] Example 6

[0041] First, prepare an acrylic pressure-sensitive adhesive with a terbinafine hydrochloride content of 50 mg / mL. Then, evenly apply this adhesive to the surface of an airtight film to a thickness of 1 mm. Each 1 mL of adhesive can directly form a 10 cm thick film. 2 The content of terbinafine hydrochloride is 5 mg / cm³. 2 A viscous, airtight film.

[0042] Example 7

[0043] First, prepare an acrylic pressure-sensitive adhesive with a terbinafine hydrochloride content of 100 mg / mL. Then, evenly apply this adhesive to the surface of an airtight film to a thickness of 1 mm. Each 1 mL of adhesive can directly form a 10 cm thick film. 2 The content of terbinafine hydrochloride is 10 mg / cm³. 2 A viscous, airtight film.

[0044] Example 8

[0045] First, prepare an acrylic pressure-sensitive adhesive with a terbinafine hydrochloride content of 150 mg / mL. Then, evenly apply this ointment to the surface of an airtight film, with an adhesive thickness of 1 mm. Each 1 mL of adhesive can directly form a 10 cm thick film. 2 The terbinafine hydrochloride content is 15 mg / cm³. 2 A viscous, airtight film.

[0046] Example 9

[0047] First, prepare an acrylic pressure-sensitive adhesive with a terbinafine hydrochloride content of 200 mg / mL. Then, evenly apply this ointment to the surface of an airtight film, with an adhesive thickness of 1 mm. Each 1 mL of adhesive can directly form a 10 cm thick film. 2 The terbinafine hydrochloride content is 20 mg / cm³. 2 A viscous, airtight film.

[0048] Example 10

[0049] First, prepare an acrylic pressure-sensitive adhesive with a terbinafine hydrochloride content of 250 mg / mL. Then, evenly apply this ointment to the surface of an airtight film, with an adhesive thickness of 1 mm. Each 1 mL of adhesive can directly form a 10 cm thick film. 2 The terbinafine hydrochloride content is 25 mg / cm³. 2 A viscous, airtight film.

[0050] Example 11

[0051] First, prepare an ointment with a ketoconazole concentration of 100 mg / mL. Then, evenly apply this ointment to the adhesive layer of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The ketoconazole content was 10 mg / cm³. 2 A viscous, airtight film.

[0052] Example 12

[0053] First, prepare an ointment with a ketoconazole concentration of 150 mg / mL. Then, evenly apply this ointment to the adhesive layer of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The ketoconazole content was 15 mg / cm³. 2 A viscous, airtight film.

[0054] Example 13

[0055] First, prepare an ointment with a ketoconazole concentration of 200 mg / mL. Then, evenly apply this ointment to the adhesive layer of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The ketoconazole content was 20 mg / cm³. 2 A viscous, airtight film.

[0056] Example 14

[0057] First, prepare an ointment with a ketoconazole concentration of 250 mg / mL. Then, evenly apply the ointment to the adhesive layer of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The ketoconazole content was 25 mg / cm³. 2 A viscous, airtight film.

[0058] Example 15

[0059] First, prepare an ointment with a terbinafine hydrochloride concentration of 300 mg / mL. Then, evenly apply this ointment to the adhesive layer surface of an airtight adhesive film, with a thickness of 1 mm. Each 1 mL of ointment can make 10 cm of [unclear - possibly a specific product or product]. 2 The ketoconazole content was 30 mg / cm³. 2 A viscous, airtight film.

[0060] Example 16

[0061] First, prepare an acrylic pressure-sensitive adhesive with a miconazole nitrate content of 150 mg / mL. Then, evenly apply this adhesive to the surface of an airtight film to a thickness of 1 mm. Each 1 mL of adhesive can form a 10 cm thick film. 2 The content of miconazole nitrate was 15 mg / cm³. 2 A viscous, airtight film.

[0062] Example 17

[0063] First, prepare an acrylic pressure-sensitive adhesive with a miconazole nitrate content of 200 mg / mL. Then, evenly apply this adhesive to the surface of an airtight film to a thickness of 1 mm. Each 1 mL of adhesive can form a 10 cm thick film. 2 The content of miconazole nitrate was 20 mg / cm³. 2 A viscous, airtight film.

[0064] Example 18

[0065] First, prepare an acrylic pressure-sensitive adhesive with a miconazole nitrate content of 250 mg / mL. Then, evenly apply this ointment to the surface of an airtight film, with an adhesive thickness of 1 mm. Each 1 mL of adhesive can form a 10 cm thick film.2 The content of miconazole nitrate was 25 mg / cm³. 2 A viscous, airtight film.

[0066] Example 19

[0067] First, prepare an acrylic pressure-sensitive adhesive with a miconazole nitrate content of 300 mg / mL. Then, evenly apply this ointment to the surface of an airtight film, with an adhesive thickness of 1 mm. Each 1 mL of adhesive can form a 10 cm thick film. 2 The content of miconazole nitrate was 30 mg / cm³. 2 A viscous, airtight film.

[0068] Example 20

[0069] First, prepare an acrylic pressure-sensitive adhesive with a miconazole nitrate content of 350 mg / mL. Then, evenly apply this ointment to the surface of an airtight film, with an adhesive thickness of 1 mm. Each 1 mL of adhesive can form a 10 cm thick film. 2 The content of miconazole nitrate was 35 mg / cm³. 2 A viscous, airtight film.

[0070] Other antifungal drugs can also be prepared into corresponding adhesive, airtight films containing antifungal drugs using similar methods.

[0071] Table 1 analyzes the efficacy of airtight antifungal patches in patients with infections at 5, 8, and 14 years of infection.

[0072] Serial Number symptom Drug Name Handling method Post-medication status Treatment effect 1 The patient has a 14-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, pain, keratinization, skin lesions, erosion, crusting, and cracking. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively deep hard mass. none none none No. Symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting worsen significantly, necessitating the use of medication. 2 The patient has a 14-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, pain, keratinization, skin lesions, erosion, crusting, and cracking. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively deep hard mass. A non-antifungal adhesive film. Apply for 6 hours daily, once in the morning and once in the evening. It is initially moist, but dries quickly. If symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting do not improve and instead worsen, stop immediately. 3 The patient has a 14-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, pain, keratinization, skin lesions, erosion, crusting, and cracking. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively deep hard mass. 1% Terbinafine Hydrochloride Ointment. Apply to the affected skin daily, leave on for 30 minutes, once in the morning and once in the evening. The ointment dries out easily and is easily wiped off, leaving the affected skin dry. It lasted for 3 years, with slight improvement, but it could not be cured. 4 The patient has a 14-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, pain, keratinization, skin lesions, erosion, crusting, and cracking. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively deep hard mass. <![CDATA[Terbinafine hydrochloride content is 25 mg / cm 2 of the viscous airtight film (Example 5).]]> Apply to the affected skin daily and leave for 10 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after three months, with the skin regaining its normal color and function. 5 The patient has a 14-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, pain, keratinization, skin lesions, erosion, crusting, and cracking. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively deep hard mass. <![CDATA[Terbinafine hydrochloride content is 25 mg / cm 2 of the viscous airtight film (Example 10).]]> Apply to the affected skin daily and leave for 10 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after three months, with the skin regaining its normal color and function. 6 The patient has a 14-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, pain, keratinization, skin lesions, erosion, crusting, and cracking. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively deep hard mass. <![CDATA[Miconazole nitrate content is 30 mg / cm 2 of the viscous airtight film (Example 19).]]> Apply to the affected skin daily and leave for 10 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after four months, with the skin regaining its normal color and function. 7 The patient has a 14-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, pain, keratinization, skin lesions, erosion, crusting, and cracking. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively deep hard mass. <![CDATA[A sticky and airtight film (Example 20) with a miconazole nitrate content of 35 mg / cm 2 .]]> Apply to the affected skin daily and leave for 10 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after 3.5 months, with the skin regaining its normal color and function. 8 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[A sticky airtight film with a terbinafine hydrochloride content of 5 mg / cm 2 . (Example 1)]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after three months, with the skin regaining its normal color and function. 9 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[Terbinafine hydrochloride content is 10 mg / cm 2 of the viscous airtight film (Example 2).]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. After one month, the condition improved significantly, and after two months, the above symptoms disappeared, and the skin returned to its normal color and function. 10 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[The viscous airtight tape with a ketoconazole content of 25 mg / cm 2 (Example 14).]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. After one month, the condition improved significantly, and after two months, the above symptoms disappeared, and the skin returned to its normal color and function. 11 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[Terbinafine hydrochloride content is 5 mg / cm 2 of the viscous airtight film (Example 6).]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after three months, with the skin regaining its normal color and function. 12 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[Terbinafine hydrochloride content is 10 mg / cm 2 of the viscous airtight film (Example 7).]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. After one month, the condition improved significantly, and after two months, the above symptoms disappeared, and the skin returned to its normal color and function. 13 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[A viscous airtight film with a ketoconazole content of 20 mg / cm 2 . (Example 13).]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after 2.5 months, with the skin regaining its normal color and function. 14 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[A viscous airtight film with a ketoconazole content of 10 mg / cm 2 . (Example 11)]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after 3.5 months, with the skin regaining its normal color and function. 15 The patient has a 5-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection and a small amount of thickening of the subcutaneous soft tissue. <![CDATA[Ketoconazole content is 15 mg / cm 2 of the viscous airtight tape (Example 12)]]> Apply to the affected skin daily and leave for 6 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after three months, with the skin regaining its normal color and function. 16 The patient has an 8-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and some subcutaneous soft tissue shows patchy thickening. <![CDATA[Terbinafine hydrochloride content is 15 mg / cm 2 of the viscous airtight film (Example 8).]]> Apply to the affected skin daily and leave for 7 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after 2.5 months, with the skin regaining its normal color and function. 17 The patient has an 8-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and some subcutaneous soft tissue shows patchy thickening. <![CDATA[A sticky and airtight film with 15 mg / cm of terbinafine hydrochloride (Example 3).]]> 2 > Apply to the affected skin daily and leave for 7 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after 2.5 months, with the skin regaining its normal color and function. 18 The patient has an 8-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and some subcutaneous soft tissue shows patchy thickening. <![CDATA[The viscous airtight film with a ketoconazole content of 30 mg / cm 2 (Example 15).]]> Apply to the affected skin daily and leave for 7 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after three months, with the skin regaining its normal color and function. 19 The patient has an 8-year history of skin disease on the back of the hand, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and some subcutaneous soft tissue shows patchy thickening. A viscous, airtight film with a miconazole nitrate content of 15 mg / cm² (Example 16). Apply to the affected skin daily and leave for 7 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after four months, with the skin regaining its normal color and function. 20 The patient has an 8-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively thick and hard mass. <![CDATA[Miconazole nitrate content is 20 mg / cm 2 of the viscous airtight film (Example 17).]]> Apply to the affected skin daily and leave for 8 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after 3.5 months, with the skin regaining its normal color and function. 21 The patient has an 8-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively thick and hard mass. <![CDATA[Miconazole nitrate content is 25 mg / cm 2 of the viscous airtight film (Example 18).]]> Apply to the affected skin daily and leave for 8 hours, once in the morning and once in the evening. Keep it moist. Significant improvement was observed after one month, and the above symptoms disappeared after three months, with the skin regaining its normal color and function. 22 The patient has an 8-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively thick and hard mass. <![CDATA[Terbinafine hydrochloride content is 20 mg / cm 2 of the viscous airtight film (Example 4).]]> Apply to the affected skin daily and leave for 8 hours, once in the morning and once in the evening. Keep moist After one month, the condition improved significantly, and after two months, the above symptoms disappeared, and the skin returned to its normal color and function. 23 The patient has an 8-year history of skin disease on the soles of the feet, presenting with symptoms such as redness, swelling, itching, skin lesions, erosion, and crusting. There is a superficial infection, and the local subcutaneous soft tissue shows a relatively thick and hard mass. <![CDATA[Viscous airtight film with terbinafine hydrochloride content of 20 mg / cm 2 (Example 9).]]> Apply to the affected skin daily and leave for 8 hours, once in the morning and once in the evening. Keep moist After one month, the condition improved significantly, and after two months, the above symptoms disappeared, and the skin returned to its normal color and function.

[0073] As can be seen from the above embodiments and the effects of using different embodiments, based on the selection of different patches, there are four specific situations:

[0074] 1. If a sealing film is not used and no medication is applied, the fungus will grow normally, but the symptoms will worsen due to itching and scratching.

[0075] Second, applying antifungal medication only is effective against superficial fungi, but it is difficult to kill deep-seated fungi, so the effect is not significant.

[0076] Third, using only an airtight film without applying medication can lead to more rapid fungal infection. The lack of oxygen can also damage normal skin cells, causing more skin cells to become infected by fungi.

[0077] Fourth, the use of airtight film patches containing antifungal drugs can kill deep-seated fungi, eradicate fungal infections, and achieve outstanding results with the shortest treatment time.

[0078] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. 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. An antifungal drug airtight film patch, from outside to inside by airtight film layer, adhesive base layer and drug layer, the airtight film layer prevents water and isolates oxygen, blocks the oxygen supply of superficial fungi and thus inhibits fungal growth, the adhesive base layer fixes the drug layer on the skin of the affected area, avoids displacement due to movement, and kills fungi through the antifungal drug of the drug layer. The airtight film layer is composed of air-impermeable film-forming material, and the adhesive base layer is below the airtight film layer, that is, the adhesive base layer is uniformly coated on one side of the airtight film. The drug layer is below the adhesive base layer, that is, the drug layer is uniformly coated on the surface of the adhesive base layer, which is made of antifungal drugs mixed in a certain proportion, to make the antifungal drug airtight film patch.

2. The antifungal drug impermeable film patch according to claim 1, characterized by, The air-tight film layer is selected from polyvinyl chloride, polyethylene, polypropylene, polystyrene, rubber and other High molecular polymer made Air tightness one of the films.

3. The antifungal drug impermeable film patch according to claim 1, characterized by, The adhesive base layer refers to any one or a combination of more than one of acrylic pressure-sensitive adhesive, polyurethane pressure-sensitive adhesive, synthetic rubber pressure-sensitive adhesive, rubber-based pressure-sensitive adhesive, and silicone-based pressure-sensitive adhesive.

4. The antifungal drug impermeable film patch according to claim 1, characterized by, The drug layer refers to any one or a combination of more than one of propylene amine drugs such as terbinafine hydrochloride, butenafine, and naftifine; imidazole drugs such as miconazole, ketoconazole, econazole, bifonazole, clotrimazole, sertaconazole, and luliconazole; and echinocandin drugs such as caspofungin, anidulafungin, and micafungin.

5. The antifungal drug impermeable film patch of claim 1, wherein The antifungal drug effective component content of the drug layer is 5-50 mg / cm 2 , and the thickness is 0.1-2 mm.

6. The antifungal drug impermeable film patch of claim 1, wherein The drug layer is made by coating processes such as doctor blade coating, roll coating, and spraying, and the antifungal ointment or cream is uniformly coated on the surface of the airtight adhesive film adhesive base layer, or the antifungal drug is first dissolved in the medical pressure-sensitive adhesive and then uniformly coated on the surface of the film layer, to make the adhesive film with antifungal drugs, avoiding interlayer peeling caused by winding and sticking.

7. The antifungal drug impermeable film patch of claim 1, wherein The skin of the affected area is applied for not less than 3 hours, preferably 6-12 hours.

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