Spray-type adhesive mucosal wound dressing

Abstract

The present invention relates to a spray-type adhesive mucosal wound dressing and a method for forming a coating film using same. The spray-type adhesive mucosal wound dressing comprises smectite clay and purified water. The spray-type adhesive mucosal wound dressing according to the present invention protects a wound site in mucosae, which is a wetter environment than typical skin, in a wetter environment, effectively prevents the infiltration of foreign substances, holds active ingredients such as drugs and then releases the active ingredients in a sustained manner, and thus is specific to mucosal wound protection and convenient to use.

Description

Spray-type adhesive mucosal wound dressing

[0001] The present invention relates to a spray-type adhesive mucosal wound dressing and a method for forming a film using the same.

[0002] The skin is a vital organ, occupying the largest surface area in the body. It not only protects the body from various harmful environmental factors, such as external microorganisms, UV rays, and chemicals, but also prevents dehydration by inhibiting water evaporation and regulates body temperature. However, because of its large surface area, it is also susceptible to damage and wounds for various reasons.

[0003] Healing skin damage or wounds requires a complex process involving the interaction of various molecules, including cytokines and growth factors, which induce the growth and regeneration of injured tissue. Furthermore, prolonged open wounds can lead to secondary complications, such as bacterial and viral infections. Furthermore, they can cause pain during healing and inconvenience in daily life. Therefore, prompt wound healing is crucial. Therefore, various types of wound dressings are widely used to protect the skin from bacterial infection and dehydration at the wound site. Recently, there has been a trend toward diversification based on the location of the wound.

[0004] Among these, the mucosa, located in the oral cavity, nasal cavity, trachea, vagina, or urethra, is composed of epithelial tissue with mucous glands, responsible for the functions of mucosal absorption and secretion. Mucosal wounds also frequently occur for various reasons, requiring a wound dressing that can effectively treat mucosal wounds while maintaining mucosal function.

[0005] However, the existing mucosal wound dressings mainly used only have the effect of effectively absorbing blood and exudates generated from the wound, maintaining a moist environment, and effectively protecting the wound area, but they do not have a defensive function against bacteria or foreign substances, do not have waterproofing, and have the problem of easily falling off when applied to curved areas of the body. In addition, because the moisture permeability is too high, there was a problem that the absorbent material adhered to the wound surface, causing damage to new tissue when the wound dressing was changed.

[0006] To solve these problems, recently, liquid polyvinylpyrrolidone (PVP) has been widely used as a wound dressing. However, PVP, as a wound dressing on normal skin, forms a transparent and thin film after drying. However, it cannot maintain a moist environment for a long time on the mucous membrane, which is a slightly more humid environment than normal skin, and thus has a weakness in protecting the wound site on the mucous membrane. In addition, once a film is formed on the mucous membrane wound site, the structure of the mucous membrane requires that external substances not penetrate thereafter to effectively protect the wound. However, the PVP film film is vulnerable to the penetration of external substances within a short period of time after film formation, making it vulnerable to the protection of the mucous membrane wound site. In addition, even if the PVP film film contains an active ingredient, it has a limitation in that it is rapidly released from the mucous membrane wound site.

[0007] Therefore, the development of a formulation that is specific for moist mucosal wounds and convenient to use is still necessary.

[0008] The problem to be solved by the present invention is to provide a spray-type adhesive mucosal wound dressing comprising smectite clay and purified water; a composition for forming a spray-type film for a mucosal wound; and a method for forming a film for a mucosal wound.

[0009] One object of the present invention is to provide a spray-type adhesive mucosal wound dressing comprising smectite clay and purified water.

[0010] Another object of the present invention is to provide a spray-type film-forming composition for mucosal wounds, comprising smectite clay and purified water.

[0011] Another object of the present invention is to provide a method for forming a film on a mucosal wound, comprising the step of spraying a composition comprising smectite clay and purified water onto a mucosal wound site.

[0012] A spray-type adhesive mucosal wound dressing according to one embodiment of the present invention protects a wound site in a mucosal membrane, which is a slightly more humid environment than general skin, to a more humid environment, effectively prevents penetration of foreign substances, and releases an active ingredient such as a drug in a sustained-release manner after containing the active ingredient, making it specific for mucosal wound protection and convenient to use.

[0013] FIG. 1 is a diagram confirming the formation of a film (film) on a mucosal wound site of a wound dressing manufactured from lithium magnesium silicate or lithium magnesium sodium silicate and purified water according to one embodiment of the present invention.

[0014] FIG. 2 is a diagram confirming the ability of a wound dressing made of lithium magnesium silicate or lithium magnesium sodium silicate and purified water according to one embodiment of the present invention to prevent penetration of foreign substances into a mucosal wound site.

[0015] FIG. 3 is a diagram confirming the drug delivery ability of a film on a mucosal wound site of a wound dressing prepared with lithium magnesium silicate or lithium magnesium sodium silicate and purified water according to one embodiment of the present invention.

[0016] FIG. 4 is a diagram confirming the range in which a wound dressing manufactured from lithium magnesium silicate or lithium magnesium sodium silicate and purified water according to one embodiment of the present invention can be sprayed.

[0017] FIG. 5 is a diagram confirming the range in which a wound dressing manufactured from lithium magnesium silicate or lithium magnesium sodium silicate and purified water according to one embodiment of the present invention can be sprayed.

[0018] FIG. 6 is a diagram confirming a pH adjusting agent suitable for a wound dressing formulation prepared with lithium magnesium silicate or lithium magnesium sodium silicate and purified water according to one embodiment of the present invention.

[0019] This is explained in detail as follows. Meanwhile, each description and embodiment disclosed in the present invention can also be applied to each other description and embodiment. In other words, all combinations of the various elements disclosed in the present invention fall within the scope of the present invention. Furthermore, the scope of the present invention should not be considered limited by the specific descriptions described below.

[0020] Furthermore, those skilled in the art will recognize or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific embodiments of the invention described herein. Furthermore, such equivalents are intended to be encompassed by the present invention.

[0021]

[0022] The present invention recognizes the problems that existing wound dressings manufactured with PVP have a thin film when used on mucosal wounds, which insufficiently protect against a wet environment, allow foreign substances to penetrate in a short time, and rapidly deliver drugs related to mucosal wounds, and to solve these problems, a wound dressing manufactured with smectite clay is newly confirmed to have a transparent gel form that can be conveniently sprayed in the form of a spray, has adhesiveness to the mucosal wound area to form a film to protect the wound area for a long time, and can simultaneously deliver an effective drug to the mucosal wound in a sustained-release form while blocking the penetration of foreign substances for a long time.

[0023]

[0024] In order to solve the above-mentioned problems, one aspect of the present invention is a spray-type adhesive mucosal wound dressing comprising smectite clay and purified water.

[0025] This is explained in more detail below.

[0026]

[0027] The spray-type adhesive mucosal wound dressing of the present invention comprises smectite clay and purified water.

[0028] As an example of implementation, the spray-type adhesive mucosal wound dressing comprises more than 0.5 wt% and less than 7 wt% of smectite clay, and purified water, based on 100 wt% of the total composition.

[0029]

[0030] The above smectite clay is a material already used as an antidiarrheal agent, an angioembolizer, an adsorbent, and a personal care product, and is a type of natural clay containing a large amount of various minerals, including aluminum and magnesium.

[0031] The above smectite clay may be at least one selected from the group consisting of montmorillonite (MMT), hectorite, beidellite, nontronite, sauconite, bentonite, kaolinite, saponite, lithium magnesium sodium silicate, lithium magnesium silicate, vermiculite, illite, pyrophylite-talc, mica, brittle mica, and halloysite, and examples thereof include lithium magnesium silicate (or silicic acid, lithium magnesium salt), or lithium magnesium sodium silicate (or Silicic acid, lithium magnesium sodium salt).

[0032] The above smectite clay may be included in an amount of more than 0.5 wt% and less than 10 wt% when the total composition is 100 wt%, specifically, more than 0.5 wt% and less than 7 wt%, more than 0.5 wt% and less than 5.5 wt%, more than 1 wt% and less than 10 wt%, more than 1 wt% and less than 7 wt%, more than 1 wt% and less than 5.5 wt%, more than 1.5 wt% and less than 10 wt%, more than 1.5 wt% and less than 7 wt%, more than 1.5 wt% and less than 5.5 wt%, 2 wt% to 10 wt%, 2 wt% to 7 wt%, 2 wt% to 6 wt%, 2 wt% to 5.5 wt%, and more specifically, more than 0.5 wt% and less than 7 wt%, more than 0.5 wt% and less than 5.5 wt%, and even more specifically, 2 wt% to 5.5 wt%.

[0033] The above smectite clay may be characterized by forming a transparent gel at a concentration of more than 0.5 wt% and less than 7 wt% or from 2 wt% to 5.5 wt% based on 100 wt% of the total composition, thereby forming a film at a mucosal wound site.

[0034]

[0035] Lithium magnesium silicate (silicic acid, lithium magnesium salt) or lithium magnesium sodium silicate (lithium magnesium sodium salt) is a synthetic smectite nano-clay material of the magnesium silicate series, also called laponite. It forms a transparent and colorless colloidal dispersion in water or aqueous alcohol solutions. It is a viscoelastic gel type that easily becomes fluid when external stress (shear or pressure) is applied, and very quickly recovers its original viscosity when the external stress stops. It hydrates and swells in distilled water to form a transparent and colorless colloidal dispersion with low viscosity, which is effective in stabilizing O / W emulsions, and can be used with up to 40% ethanol, but can be added to formulations containing more than 60% ethanol when used with a thickener.

[0036] Lithium magnesium silicate or lithium magnesium sodium silicate is a synthetic particle composed of two silica sheets sandwiched between a central magnesium sheet, forming a disc-shaped particle with a diameter of about 25 nm and a depth of 1 nm, and has a negative surface charge and a positive edge charge with different charge distributions of negative and weak positive charges.

[0037] Polyvinylpyrrolidone (PVP), used as a comparative example in the present invention, is a substance that was used as an artificial blood plasma in Germany during World War II, which began in 1939, and received attention from various countries after the war. It was formerly called Haemodyn. The substitute blood plasma manufactured by Farbenfabriken Bayer AG in Germany is called Peristone, and this is derived from dissolving 3.5% of polyvinylpyrrolidone (average molecular weight 25000) in dilute saline solution.

[0038] The efficacy of polyvinypyrrolidone (Polyvinypyrrolidone - abbreviation: PVP) is used as a water-soluble synthetic or semi-synthetic polymer raw material to obtain the above wound dressing, and a hydrogel containing water forms a protective film after application to the wound to protect the wound.

[0039] In a specific embodiment of the present invention, lithium magnesium sodium silicate (Laponite, BYK) was used, and when the total composition was 100 wt%, gelation occurred at 2 wt% or more of lithium magnesium sodium silicate, and it was conveniently sprayable at 5.5 wt% or less, and it was confirmed that it effectively formed a film by being applied without flowing down in a wet environment (environment) compared to a wound dressing made of PVP.

[0040] The above smectite clay may be a drug carrier.

[0041] The above term, “drug” refers to a drug that treats mucosal wounds, and may be, for example, an anti-inflammatory agent, a growth factor, or a hemostatic agent, but is not limited thereto.

[0042] The above smectite clay may be characterized by releasing the loaded drug in a sustained release manner.

[0043]

[0044] The above term, purified water, is a solvent for smectite clay and can be used interchangeably with water. Since the wound dressing of the present invention contains smectite clay in an amount exceeding 0.5 wt% and less than 7 wt% when the total composition is 100 wt%, the purified water may be included in an amount excluding that. In addition, when containing additional components other than smectite clay, the content of purified water may be adjusted to contain the additional components.

[0045]

[0046] The wound dressing of the present invention may additionally include a pH adjusting agent.

[0047] The above term, “pH regulator”, is a substance that can regulate the pH of a wound dressing within a certain range, and is characterized by specifically adjusting the pH to 3 to 12, and more specifically to 4 to 8.

[0048] The pH adjusting agent may be at least one selected from the group consisting of acetic acid, citric acid, lactic acid, malic acid, benzoic acid, sodium dihydrogen phosphate, citrate buffer, sodium hydroxide, potassium hydroxide, succinis acid, aminomethyl propanediol, ammonium hydroxide, disodium phosphate, and triethanolamine.

[0049]

[0050] The wound dressing of the present invention may additionally include at least one selected from the group consisting of a preservative, a moisturizer, an antioxidant, a flavoring agent, a sweetener, a humectant, an anti-foaming agent, and a viscosity modifier.

[0051] The above preservative is a substance for protecting against spoilage, discoloration, etc. and inhibiting or stopping the growth or action of microorganisms, and specifically may be at least one selected from the group consisting of benzoic acid preservatives, alcohol preservatives, paraben preservatives, and cationic preservatives.

[0052] The above benzoic acid preservative may be benzoic acid, sodium benzoate or a combination thereof.

[0053] The above alcohol-based preservative may be at least one selected from the group consisting of phenoxy ethanol (phenoxy EtOH), phenoxy isopropanol, 1,2-hexandiol phenol, benzyl alcohol, and butyl alcohol.

[0054] The above paraben preservative may be at least one selected from the group consisting of methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, and butyl parahydroxybenzoate.

[0055] The above preservative may have an antiseptic effect against bacteria, fungi, etc.

[0056] Specifically, it may have a safe formulation that exhibits an antiseptic effect against P. aeruginosa, S. aureus, E. coli, Agaricus brasiliensis, or C. albicans.

[0057]

[0058] The above moisturizer is a substance that supplies moisture, and may be a water-soluble peptide drug such as, but is not limited to, RH oligopeptide (IndiLipo rhEGF).

[0059] The above-mentioned flavoring agent is a substance that provides a fragrance and can be used in combination with a fragrance, and specifically, may be menthol, geraniol, coumarin, and bergamot, but is not limited thereto.

[0060] The above sweetener is an organic compound having a sweet taste, and since it is a mucosal wound dressing, it may additionally include a sweetener or sweeteners. For example, it may include a natural sweetener of the Stevia (Stevia rebaudiana) type, such as steviol, steviol glycosides, and enzyme-processed stevia, and it may include a natural sugar alcohol of the pentitol (pentahydric alcohol) type, such as D-xylitol, mannitol, and erythritol, but is not limited thereto.

[0061] The above humectant is a substance that can have appropriate moisture and may be, but is not limited to, glycerin, panthenol, propylene glycol, and hyaluronic acid.

[0062] The above-mentioned antifoaming agent is a substance for preventing or reducing the formation of foam, and may be an anionic surfactant such as, but not limited to, sodium lauryl sulfate (SLS), sodium laureth sulfate (SLES), and coco-glucoside.

[0063]

[0064] Another aspect of the present invention is a method for producing a spray-type wound dressing for a mucosal wound, comprising smectite clay and purified water.

[0065] The above terms, “smectite clay”, “purified water”, “mucous membrane”, “wound dressing”, etc., are as described above.

[0066] The above wound dressing manufacturing method can be manufactured without limitation using a known method.

[0067] As an example of implementation, after washing the stirring and emulsifying device until there is no foreign matter in the stirrer, drying the stirrer by heating, adding purified water (water) as a solvent to the dried stirrer, pouring lithium magnesium silicate or lithium magnesium sodium silicate while the stirrer is running, covering the stirrer lid and rotating it so that the lithium magnesium silicate or lithium magnesium sodium silicate is completely dispersed in the water. After stopping the rotation of the stirrer, opening the lid, adding additional ingredients such as a sweetener, a moisturizer, a flavoring agent, a preservative, and a pH adjuster, rotating the stirrer so that they are completely dissolved, and stirring and emulsifying to manufacture a wound dressing.

[0068]

[0069] Another aspect of the present invention is a spray-type film-forming composition for mucosal wounds, comprising smectite clay and purified water.

[0070] In addition, another aspect is a method for forming a film on a mucosal wound, comprising the step of spraying a composition comprising smectite clay and purified water onto a mucosal wound site.

[0071] The above terms, “smectite clay”, “purified water”, “mucosal wound”, etc., are as described above.

[0072]

[0073] The above term, "spray type", refers to a type of formulation that can be sprayed, and refers to a type in which the mucosal wound dressing of the present invention is a liquid and gelled formulation that can be sprayed so as to form a film on the mucosal wound site. The spray type may be used interchangeably with sprayable, spray type, atomized type, etc.

[0074] The above term, “step of spraying on a mucosal wound site” means a step of spraying the wound dressing material sprayed in the form of a spray onto a mucosal wound or wound site, and there is no particular limitation on the spraying speed or number of sprays, and any wound dressing material of the present invention that forms a film (film) on the mucosal wound site can be included.

[0075] The above term, "film formation", refers to the formation of a thin film that can cover the wound site with a wound dressing at the site of a mucosal wound, and the film may be used interchangeably with a film or just a film.

[0076] The above term, “mucosa” may include oral mucosa, nasal mucosa, bronchial mucosa, vaginal mucosa, or urethral mucosa.

[0077] In a specific embodiment of the present invention, it was confirmed that the spray-type adhesive mucosal wound dressing according to the present invention protects a wound site in a mucosal membrane, which is a slightly more humid environment than general skin, by maintaining a moist environment for a long period of time, effectively prevents penetration of foreign substances, and releases an active ingredient such as a drug in a sustained-release manner, thereby being a formulation that is specific for protecting mucosal wounds, convenient to use, and safe.

[0078] Hereinafter, the present invention will be described in more detail through examples and experimental examples. However, these examples and experimental examples are intended to exemplify the present invention, and the scope of the present invention is not limited to these examples and experimental examples.

[0079]

[0080] Manufacturing Example 1: Manufacturing of a sprayable adhesive mucosal wound dressing containing smectite clay

[0081] Prepare lithium magnesium silicate or lithium magnesium sodium silicate (Laponite, BYK).

[0082] First, the stirrer was washed with a stirring and emulsifying device until there was no foreign matter in the stirrer. Then, the cleaned stirrer was heated to dry the stirrer, and about 10,000 ml of purified water (water) as a solvent was added to the dried stirrer and the stirrer was turned on. The measured lithium magnesium silicate or lithium magnesium sodium silicate was slowly poured into the stirrer little by little, and at this time, the lithium magnesium silicate or lithium magnesium sodium silicate was poured while the stirrer was turned on so that the lithium magnesium silicate or lithium magnesium sodium silicate could be easily dispersed. This is to visually confirm that it is dispersed in the water because lumps are likely to form if poured all at once.

[0083] Also, when pouring lithium magnesium silicate or lithium magnesium sodium silicate, the solution may splash, so be careful and pour all 300 g of lithium magnesium silicate or lithium magnesium sodium silicate into the stirrer. Then, after covering the stirrer with a lid, the stirrer was rotated for about 30 minutes to completely disperse the lithium magnesium silicate or lithium magnesium sodium silicate in the water. After that, the rotation of the stirrer was stopped, the lid was opened, and additional ingredients such as sweeteners, moisturizers, flavoring agents, preservatives, and pH adjusters were added, and then the stirrer was rotated for about 30 minutes to completely dissolve, and the product was manufactured by stirring and emulsifying.

[0084]

[0085] Example 1: Confirmation of film formation for protecting mucosal wounds in a mucosal-simulating environment.

[0086] It was confirmed whether the spray-type adhesive mucosal wound dressing of the present invention manufactured in the above manufacturing example formed a film (film) at the mucosal wound site.

[0087] Specifically, a mucosal mimicking environment was created by adjusting the temperature to 37℃ and humidity to 60-70%, and 1 ml of the spray-type adhesive mucosal wound dressing of the present invention and the wound dressing made of PVP of the comparative example (Muragen K of Subio, Ivancare of Amospharm, etc.) were dispensed onto the mucosal wound site, and then drying, flowability, and film formation were checked.

[0088] At this time, the dryness and flowability were visually confirmed, and the film formation was confirmed visually and using a scanning electron microscope from COXEM.

[0089]

[0090] As a result, as can be seen in Fig. 1, in the case of a wound dressing made of PVP, which is widely used in the past, a transparent and thin film is formed after drying, but in the case of a wound dressing made of smectite clay of the present invention, it was confirmed that a relatively thick film (film) is formed after drying compared to the PVP wound dressing.

[0091] Accordingly, it was confirmed that the wound dressing made of the smectite clay of the present invention is more suitable for mucosal wounds by maintaining the mucosal wound area in a more moist environment for a longer period of time compared to the existing PVP wound dressing.

[0092]

[0093] Example 2: Confirmation of the ability to prevent penetration of foreign substances to protect mucosal wound sites in a mucosal-simulating environment.

[0094] The spray-type adhesive mucosal wound dressing of the present invention manufactured in the above manufacturing example was examined to determine the extent of its ability to prevent penetration of foreign substances to protect mucosal wound sites. Here, the comparative example is the same as the PVP wound dressing of Example 1.

[0095] Specifically, as in Example 1, a simulated environment was created by adjusting the temperature to 37°C and the humidity to 60-70%, and 1 ml of the spray-type adhesive mucosal wound dressing of the present invention and the wound dressing made of PVP of the comparative example (Muragen K of Subio, Ivancare of Amospharm, etc.) were each dispensed onto the mucosal wound site, and then 1 ml of water was added to one side and 1 ml of water with dye diluted therein to the other side to check whether the dye was diffusion through the film.

[0096] At this time, the diffusion of dye in the film was confirmed visually.

[0097]

[0098] As a result, as can be confirmed in Fig. 2, in the case of the existing PVP wound dressing, it was confirmed that the film did not prevent the penetration of the dye and instead diffused within a short period of 5 minutes, but in contrast, in the case of the wound dressing manufactured with the smectite clay of the present invention, it was confirmed that the film inhibited the diffusion of the dye even after 1 hour.

[0099] Accordingly, it was confirmed that the wound dressing made of the smectite clay of the present invention effectively suppresses foreign substances in the mucosal wound area for a long period of time of more than 1 hour compared to the existing PVP wound dressing, thereby confirming that it has a formulation more suitable for mucosal wounds.

[0100]

[0101] Example 3: Confirmation of drug delivery to mucosal wound sites in a mucosal-mimetic environment

[0102] The spray-type adhesive mucosal wound dressing of the present invention manufactured in the above manufacturing example was confirmed to have the ability to deliver drugs to a mucosal wound site and its release power. Here, the comparative example is the same as the PVP wound dressing of Example 1.

[0103] Specifically, as in Example 1, a mucosal mimicking environment was created by adjusting the temperature to 37°C and the humidity to 60-70%, and a dye that acts as a drug was mixed and loaded into the sprayable adhesive mucosal wound dressing of the present invention and the wound dressing made of PVP of the comparative example (Muragen K of Subio, Ivancare of Amospharm, etc.), and then pure water was added to the left and right to check whether the dye was released.

[0104] At this time, the release of dye was confirmed visually.

[0105]

[0106] As a result, as can be confirmed in Fig. 3, both the existing PVP wound dressing and the wound dressing manufactured with the smectite clay of the present invention were found to diffuse the absorbed dye to the surroundings, but the PVP wound dressing was rapidly dissolved, whereas the wound dressing manufactured with the smectite clay of the present invention was found to be a sustained-release formulation that was released after 1 hour (Fig. 2). Based on these results, it can be seen that since the drug is slowly released in a sustained-release form, the effect can be maintained with a small number of doses without the need for continuous drug administration, thereby increasing convenience, and since the concentration does not increase rapidly, side effects due to the drug are reduced.

[0107]

[0108] Example 4: Confirmation of sprayable range for protecting mucosal wound sites in a mucosal-simulating environment

[0109] In order to manufacture the wound dressing made of the present invention's smectite clay into a spray form that can be conveniently used, the sprayable range while forming a film on the mucous membrane was confirmed according to the content of the composition.

[0110] Specifically, the range of smectite clay capable of forming a film on the mucous membrane was established, and the feasibility of spraying from there was verified through visual evaluation and discharge tests. The degree of adsorption to the mucous membrane and the formulation were verified through visual evaluation and images. This is summarized in Table 1 below.

[0111]

[0112]

[0113] As a result, as can be seen in FIGS. 4 and 5, it was confirmed that when the total composition is 100 wt% and the smectite clay is included in an amount of more than 0.5 wt% and less than 7 wt%, the formulation forms a film on the mucous membrane and has a gel-like formulation that can be sprayed.

[0114] In particular, it was confirmed that the formulation containing 2 to 5.5 wt% of smectite clay was more effectively a gel-like form close to a liquid that could be sprayed in a spray form. When it was less than 2 wt%, although it was a liquid, it was not absorbed into the mucous membrane and flowed down, and when it exceeded 5.5 wt%, it was confirmed that it was difficult to eject in terms of spraying force and was not sprayed well in a spray form.

[0115]

[0116] Example 5: Confirmation of a pH regulator suitable for the mucosal wound dressing of the present invention.

[0117] It was confirmed what type of pH regulator is suitable for use in a formulation that can be sprayed in the form of a spray while forming a film on the mucous membrane manufactured in Example 4 above.

[0118] As a result, as can be seen in Fig. 6, when hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, or hydrogen chloride was added, it was confirmed that the transparent gel did not maintain its shape and became cloudy.

[0119] Through this, it was confirmed that the pH for effectively spraying the wound dressing containing the smectite clay of the present invention on a mucosal wound site is 6 to 12, and that a pH regulator that adjusts within this range is effective, and a cationic pH regulator prevents the wound dressing of the present invention from maintaining the spray-type formulation.

[0120]

[0121] Example 6: Confirmation of a Preservative Suitable for the Mucosal Wound Covering Material of the Present Invention

[0122] In the formulation manufactured in Example 4 above, a suitable form of preservative that can be used in a spray-type formulation while forming a film on the mucous membrane was identified, and the preservative properties of each preservative were confirmed.

[0123]

[0124] The specific method is as follows.

[0125]

[0126] Example 1) 3g of laponite was added to 96ml of purified water and dispersed. After complete dispersion, 1g of phenoxyethanol was added and dispersed. Then, a preservative test was conducted. As a result, it was confirmed that the product exhibited an antiseptic effect against the bacteria P. aeruginosa, S. aureus, E. coli, the fungus A. brasiliensis, and the yeast C. albicans.

[0127] Example 2) 3g of laponite was added to 95.99ml of purified water and dispersed. After complete dispersion, 1g of phenoxyethanol and 0.01g of propylparaben were added and dispersed, and then a preservative test was conducted. As a result, it was confirmed that the product exhibited an antiseptic effect against bacteria P. aeruginosa, S. aureus, E. coli, fungus A. brasiliensis, and yeast C. albicans.

[0128] Example 3) 3g of laponite was added to 100ml of purified water and dispersed. After complete dispersion, 0.01g of Propylparaben was added and dispersed. A preservative test was conducted. As a result, it was confirmed that the product exhibited a preservative effect against the fungus A. brasiliensis. In addition, it was confirmed that the product exhibited a preservative effect against the bacteria S. aureus, E. coli, the fungus A. brasiliensis, and the yeast C. albicans.

[0129] Example 4) 3g of laponite was added to 96.95ml of purified water and dispersed. After complete dispersion, 0.05g of benzoic acid chloride was added and dispersed. A preservative test was conducted. As a result, it was confirmed that the solution exhibited an antiseptic effect against S. aureus.

[0130] Example 5) 3g of laponite was added to 100ml of purified water and dispersed. After complete dispersion, 0.01g of methyl paraben was added and dispersed. A preservative test was conducted. As a result, it was confirmed that the product exhibited a preservative effect against the fungus A. brasiliensis.

[0131]

[0132] Through the above results, it can be confirmed that the wound dressing manufactured using the smectite clay of the present invention is not particularly limited in terms of preservatives, and although there are some differences depending on the preservative, it has an antiseptic effect on all of the bacteria P. aeruginosa, S. aureus, E. coli, fungus A. brasiliensis, and yeast C. albicans, and is a safe formulation for protecting mucosal wounds.

[0133]

[0134] In summary, the wound dressing made of the smectite clay of the present invention protects the wound site in the mucous membrane, which is a moist environment, for a long time, compared to the wound dressing made of the conventional PVP, effectively prevents the penetration of foreign substances, and releases the active ingredient such as a drug in a sustained release form after loading it, making it specific for the protection of mucous membrane wounds and convenient to use in the form of a spray.

[0135]

[0136] From the above description, those skilled in the art will understand that the present invention can be implemented in other specific forms without altering its technical spirit or essential characteristics. In this regard, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. The scope of the present invention should be interpreted as encompassing all changes or modifications derived from the meaning and scope of the following claims and their equivalent concepts, rather than the detailed description above.

Claims

1. A spray-type adhesive mucosal wound dressing containing smectite clay and purified water.

2. A spray-type adhesive mucosal wound dressing according to claim 1, wherein the smectite clay is at least one selected from the group consisting of montmorillonite (MMT), hectorite, beidellite, nontronite, sauconite, bentonite, kaolinite, saponite, lithium magnesium silicate, lithium magnesium sodium silicate, vermiculite, illite, pyrophylite-talc, mica, brittle mica, and halloysite.

3. A spray-type adhesive mucosal wound dressing, wherein the smectite clay is contained in an amount of more than 0.5 wt% and less than 7 wt% based on 100 wt% of the total composition.

4. A spray-type adhesive mucosal wound dressing, characterized in that the smectite clay in the first paragraph is gelled at a concentration of more than 0.5 wt% and less than 7 wt% relative to 100 wt% of the total composition.

5. A spray-type adhesive mucosal wound dressing, wherein the smectite clay in the first paragraph carries a drug.

6. A spray-type adhesive mucosal wound dressing according to claim 5, wherein the drug comprises at least one of an anti-inflammatory agent, a growth factor, and a hemostatic agent.

7. A spray-type adhesive mucosal wound dressing, characterized in that the smectite clay in paragraph 5 releases the loaded drug in a sustained-release manner.

8. A spray-type adhesive mucosal wound dressing, further comprising a pH regulator, in accordance with claim 1.

9. A spray-type adhesive mucosal wound dressing, wherein the pH adjusting agent in paragraph 8 adjusts the pH of the wound dressing to 3 to 12.

10. In paragraph 8, the pH adjusting agent is at least one selected from the group consisting of organic acids such as acetic acid, citric acid, lactic acid, malic acid, and benzoic acid, sodium dihydrogen phosphate, citrate buffer, sodium hydroxide, potassium hydroxide, succinic acid, aminomethyl propanediol, ammonium hydroxide, disodium phosphate, and triethanolamine.

11. A spray-type adhesive mucosal wound dressing, further comprising at least one selected from the group consisting of a preservative, a moisturizer, an antioxidant, a flavoring agent, a sweetener, a humectant, an anti-foaming agent, and a viscosity modifier, in accordance with paragraph 1.

12. A spray-type adhesive mucosal wound dressing, wherein the preservative in paragraph 11 is at least one selected from the group consisting of a benzoic acid-based preservative, an alcohol-based preservative, a paraben-based preservative, and a cationic preservative.

13. A spray-type adhesive mucosal wound dressing in accordance with paragraph 12, wherein the benzoic acid-based preservative is benzoic acid, sodium benzoate, or a combination thereof.

14. A spray-type adhesive mucosal wound dressing, wherein the alcohol-based preservative is at least one selected from the group consisting of phenoxy ethanol (phenoxy EtOH), phenoxy isopropanol, 1,2-hexandiol phenol, benzyl alcohol, and butyl alcohol.

15. A spray-type adhesive mucosal wound dressing, wherein the paraben-based preservative in paragraph 12 is at least one selected from the group consisting of methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, and butyl parahydroxybenzoate.

16. A spray-type adhesive mucosal wound dressing according to claim 11, wherein the preservative exhibits an antiseptic effect against at least one selected from the group consisting of P. aeruginosa, Staphylococcus aureus, E. coli, Agaricus brasiliensis, and Candida albicans.

17. A spray-type film-forming composition for mucosal wounds, comprising smectite clay and purified water.

18. A method for forming a film on a mucosal wound, comprising the step of spraying a composition containing smectite clay and purified water onto a mucosal wound site.

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