Gel composition for wound dressing comprising alloferon as active ingredient

Abstract

The present invention relates to a gel composition for wound dressing comprising alloferon as an active ingredient, wherein the composition comprises alloferon having excellent anti-inflammatory activity, and further comprises additional components capable of forming a physical barrier on damaged skin tissue to protect a wound site and to provide and retain moisture. The composition of the present invention protects a wound site vulnerable to ultraviolet radiation, alleviates inflammation, and prevents destruction of elastic fibers in the skin and epidermal hyperplasia. Accordingly, the composition can be advantageously utilized as a gel composition for wound dressing to prevent, ameliorate, alleviate, or treat skin inflammation induced by ultraviolet radiation.

Description

A wound dressing gel composition containing alloferon as an active ingredient

[0001] The present invention relates to a wound dressing gel composition comprising alloferon as an active ingredient.

[0002] The present invention claims priority based on Korean Patent Application No. 10-2024-0193921 filed on December 23, 2024, and all contents disclosed in the specification and drawings of said applications are incorporated by reference.

[0003] The skin is a vital organ occupying the largest surface area of ​​our body; extensive damage to the skin can lead to death due to dehydration. Furthermore, it plays a crucial role in protecting against various harmful environmental factors such as external microorganisms, ultraviolet rays, and chemicals, as well as preventing dehydration and regulating body temperature by inhibiting water evaporation. Consequently, the skin must be resistant to physical stimuli and possess elasticity to adequately perform its functions while the body sustains life.

[0004] However, skin damage caused by various factors such as trauma, wounds, and skin diseases occurs frequently; for example, wounds that cannot be closed in primary sutures can leave severe defects that necessitate skin grafting. Furthermore, unhealed wounds lead to cutaneous chronic wounds, which are characterized by delayed normal skin healing and excessive tissue destruction caused by persistent inflammation.

[0005] Furthermore, damaged blood vessels obstruct oxygen delivery to the wound and generate excessive reactive oxygen species (ROS), inducing oxidative stress and exacerbating the inflammatory response. Since this increases the risk of infection from prolonged exposure to the external environment and can lead to non-traumatic amputation, the repair of damaged skin tissue is a critical issue; therefore, wound care using appropriate dressings is essential to promote rapid healing and minimize various secondary side effects.

[0006] To address these issues, various types of wound dressings have been proposed. Wound dressings are medical preparations that play a role in reconstructing tissue by inducing cell migration, proliferation, and differentiation, as well as protecting the wound site to heal skin damage. However, there have been few reports on gel compositions for wound dressings that exhibit excellent skin protective activity by forming a barrier while also providing anti-inflammatory activity and preventing skin damage caused by ultraviolet rays.

[0007] The object of the present invention is to provide a wound dressing gel composition comprising alloferon as an active ingredient.

[0008] Another objective of the present invention is to provide a topical skin composition for preventing or improving wounds, comprising alloferon as an active ingredient.

[0009] Another objective of the present invention is to provide a cosmetic composition for preventing or improving wounds, comprising alloferon or a cosmetically effective salt thereof as an active ingredient.

[0010] Another objective of the present invention is to provide a pharmaceutical composition for the prevention or treatment of wounds, comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0011] Another objective of the present invention is to provide a kit for preventing or treating wounds, comprising the above composition and instructions.

[0012]

[0013] However, the technical problems that the present invention aims to solve are not limited to those mentioned above, and other unmentioned problems will be clearly understood by those skilled in the art to which the present invention belongs from the description below.

[0014] The present invention provides a wound dressing gel composition comprising alloferon as an active ingredient.

[0015] In one embodiment of the present invention, the wound may be skin damage caused by ultraviolet rays, but is not limited thereto.

[0016] In one embodiment of the present invention, the skin damage may be one or more selected from the group consisting of inflammation caused by ultraviolet rays and an increase in the thickness of the stratum corneum caused by ultraviolet rays, but is not limited thereto.

[0017] In one embodiment of the present invention, the composition may include one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethyl cellulose, but is not limited thereto.

[0018] In one embodiment of the present invention, the wound site may be a non-open wound site, but is not limited thereto.

[0019] In one embodiment of the present invention, the concentration of alloferon in the composition may be 0.002 mg / mL to 0.1 mg / mL based on the total composition, but is not limited thereto.

[0020] In one embodiment of the present invention, the concentrations of polynucleotide, hyaluronic acid, and carboxymethylcellulose in the composition may be 0.1 mg / mL to 30 mg / mL, 1 mg / mL to 20 mg / mL, and 0.1 mg / mL to 30 mg / mL, respectively, based on the total composition, but are not limited thereto.

[0021] In one embodiment of the present invention, the molecular weight of the polynucleotide may be 1000 kDa to 3000 kDa, the molecular weight of the hyaluronic acid may be 1000 kDa to 3500 kDa, and the molecular weight of the carboxymethylcellulose may be 100 kDa to 500 kDa, but is not limited thereto.

[0022] In one embodiment of the present invention, the composition may prevent, improve, or treat a wound, but is not limited thereto.

[0023] In one embodiment of the present invention, the composition may further include one or more moisturizers selected from the group consisting of glycerin and butylene glycol, but is not limited thereto.

[0024] In one embodiment of the present invention, the concentrations of glycerin and butylene glycol in the composition may be 30 to 80 mg / mL and 120 to 180 mg / mL, respectively, based on the total composition, but are not limited thereto.

[0025] In one embodiment of the present invention, the pH of the composition may be 6 to 7, but is not limited thereto.

[0026] In one embodiment of the present invention, the surface viscosity of the composition may be 4.5 Pa·s to 200 Pa·s, but is not limited thereto.

[0027] In one embodiment of the present invention, the composition may form a film, but is not limited thereto.

[0028] The present invention provides a topical skin composition for preventing or improving wounds, comprising alloferon as an active ingredient.

[0029] In one embodiment of the present invention, the composition may additionally include one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethylcellulose, but is not limited thereto.

[0030] The present invention provides a cosmetic composition for preventing or improving wounds, comprising alloferon or a cosmetically effective salt thereof as an active ingredient.

[0031] In one embodiment of the present invention, the composition may additionally include one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethylcellulose, but is not limited thereto.

[0032] The present invention provides a pharmaceutical composition for the prevention or treatment of wounds, comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0033] The present invention provides a kit for preventing or treating wounds, comprising the above composition and instructions.

[0034]

[0035] In addition, the present invention provides a method for preventing or treating a wound, comprising the step of administering a composition containing alloferon or a pharmaceutically effective salt thereof as an active ingredient to an individual in need of the same in a pharmaceutically effective amount.

[0036] In addition, the present invention provides a use for a composition comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient for the prevention, improvement, or treatment of wounds.

[0037] In addition, the present invention provides a use for preparing a preparation for the prevention, improvement, or treatment of wounds, comprising a composition containing alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0038] In addition, the present invention provides a use for preparing a topical skin preparation comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0039] In addition, the present invention provides a use for manufacturing a cosmetic formulation of a composition comprising alloferon or a cosmetically effective salt thereof as an active ingredient.

[0040] In addition, the present invention provides a use of a gel composition for wound dressing comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0041] According to a wound dressing gel composition containing alloferon as an active ingredient, alloferon, which has excellent anti-inflammatory activity, is included as an active ingredient, and additionally includes a composition capable of protecting the wound site, supplying moisture, and maintaining moisture by forming a physical film on damaged skin tissue. Since the composition of the present invention can protect a wound site vulnerable to ultraviolet rays and alleviate inflammation, and prevent the destruction of skin elastic fibers and epidermal hyperplasia, it can be usefully utilized as a wound dressing gel composition capable of preventing, improving, alleviating, or treating skin inflammation caused by ultraviolet rays.

[0042] Figure 1 is a graph confirming the anti-inflammatory effect of alloferon on skin keratinocytes.

[0043] FIGS. 2a and FIGS. 2b are experimental results confirming the physical film-forming ability of Examples 1 to 11 of the present invention, each of which is a photograph taken after applying Examples 1 to 11 and after drying.

[0044] Figure 3 is a graph showing the stratum corneum thickness at week 8 when ultraviolet rays were irradiated after application to a mouse, based on experimental results analyzing the activity of preventing or treating skin damage caused by ultraviolet rays in one embodiment of the present invention.

[0045] FIG. 4 shows the experimental results of analyzing the activity of preventing or treating skin damage caused by ultraviolet rays according to one embodiment of the present invention, and the staining results at weeks 2, 3, 4, and 8 when ultraviolet rays were irradiated after application to mice (scale bar: 100 μm).

[0046] A wound refers to a broad definition of damage that includes conditions where tissue continuity is disrupted or a defect occurs in a specific area due to external pressure. While mild wounds, such as simple trauma, can be regenerated through self-healing mechanisms, intractable wounds—such as severe burns, complex wounds, pressure ulcers, or surgical wounds—are difficult to fully repair. Since intractable or extensive wounds can leave defects in the tissue's natural function, treatment is essential to treat the wound site promptly and minimize various secondary side effects.

[0047] It is known that wounds heal about twice as fast when kept moist compared to when they are dry. Therefore, conventionally, dressings were applied using gauze soaked in physiological solutions or solutions containing disinfectants to maintain a moist state. However, this method was cumbersome to manage because the dressings had to be replaced frequently, and it caused skin irritation as not only the wound area but also the surrounding area remained wet with the physiological solutions or disinfectants.

[0048] In addition, efforts are being made to find active ingredients necessary for wound healing, not just the degree of moisture or dryness, and research is being conducted not only on the combination of the above active ingredients and the components of wound dressings, but also on compositions optimally suited for various types of wounds. As a result of continuing such research, the inventors of the present invention have completed the wound dressing composition of the present invention.

[0049] Accordingly, the present invention provides a wound dressing gel composition comprising alloferon as an active ingredient.

[0050] According to the present specification, including all claims below, in one embodiment of the present invention, the wound may be skin damage caused by ultraviolet rays, but is not limited thereto. In addition, in one embodiment of the present invention, the skin damage may be one or more selected from the group consisting of inflammation induced by ultraviolet rays and an increase in the thickness of the stratum corneum caused by ultraviolet rays, but is not limited thereto.

[0051] According to the present specification, including all claims below, it was confirmed that an anti-inflammatory response occurs when an inflammatory response is induced in skin keratinocytes by ultraviolet rays and treated with alloferon at various concentrations. Furthermore, it was confirmed that when alloferon, a viscosity modifier, and a moisturizer are added, the increase in the thickness of the stratum corneum induced by ultraviolet rays in mouse skin is significantly reduced. Therefore, the composition of the present invention was shown to be capable of reducing inflammation caused by ultraviolet rays and the stratum corneum thickened by ultraviolet exposure in wounds, thereby proving that it can prevent, improve, and treat skin damage caused by ultraviolet rays.

[0052] In all claims below, “alloferon” refers to an antiviral and antitumor peptide, in particular, alloferon-1 is known to stimulate natural cytotoxicity of human peripheral blood lymphocytes. Alloferon-1 can be isolated from the blood of the fly Calliphora vicina (Diptera). Alloferon has a cas number of 347884-61-1 and may be represented by the following structural formula, but is not limited thereto, and may mean any alloferon (such as a salt in an aqueous solution) of a form generally referred to as alloferon in the art.

[0053]

[0054] According to the present specification, including all claims below, in one embodiment of the present invention, the composition may include one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethyl cellulose, but is not limited thereto.

[0055] In the entire specification including the following claims, the term “viscosity modifier” may refer to a component for controlling the viscosity of a wound dressing composition having alloferon as an active ingredient, and in one embodiment of the present invention, polynucleotide (PN), hyaluronic acid (HA), and carboxymethyl cellulose (CMC) were used at specific concentrations to control the viscosity of the wound dressing composition. Accordingly, PN, HA, and CMC may each be referred to as a viscosity modifier in the entire specification including the following claims, and each viscosity modifier may exhibit anti-inflammatory activity against ultraviolet rays of alloferon and activity to improve skin damage by reducing the thickness of the stratum corneum when used with alloferon in combination of all components, and additionally when used at specific concentrations with moisturizers glycerin and butylene glycol.

[0056] In the entirety of the following claims, “polynucleotide (PN)” may mean a biopolymer composed of nucleotide monomers covalently bonded in a chain form, and DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) are examples of polynucleotides having different biological functions. In the entirety of the following claims, PN may be used interchangeably with other terms.

[0057] In all claims below, “Hyaluronic acid” refers to an anionic, unsulfated glycosaminoglycan widely distributed throughout connective, epithelial, and neural tissues. Hyaluronic acid is known to be one of the major components of the extracellular matrix and contributes significantly to cell proliferation and migration. Hyaluronic acid may be used interchangeably with HA and may be represented by the following structural formulas, but is not limited thereto, and means all forms accepted in the art.

[0058]

[0059] In all claims below, “Carboxymethylcellulose” is a cellulose derivative having a carboxymethyl group (-CH2-COOH) bonded to some hydroxyl groups of a glucopyranose monomer constituting a cellulose backbone. Carboxymethylcellulose may be used interchangeably with CMC, is Cas number 9004-32-4, and may be represented by the following structural formula, but is not limited thereto, and means including all forms accepted in the art.

[0060]

[0061] In all claims below, polynucleotides and hyaluronic acid are used as viscosity modifiers; however, each component does not perform the function of a viscosity modifier alone but may also function as an active ingredient. For example, polynucleotides and hyaluronic acid may perform the functions of improving the skin barrier and moisturizing. That is, the wound dressing gel composition of the present invention exhibits excellent therapeutic activity against skin damage caused by ultraviolet rays because it contains alloferon as an active ingredient, and polynucleotides and hyaluronic acid function as components that simultaneously act as viscosity modifiers, improve the skin barrier, and provide moisturization. Therefore, in the wound dressing gel composition of the present invention, polynucleotides and hyaluronic acid may be components that exhibit functions while also acting as viscosity modifiers.

[0062] According to the present specification including all claims below, in one embodiment of the present invention, the wound site may be a non-open wound site, but is not limited thereto. In the present specification including all claims below, the gel composition for wound dressing may treat skin damage caused by ultraviolet rays. In this case, the skin damaged by ultraviolet rays is skin with damaged epidermis, and since it can be used on a skin surface where biological tissue below the epidermis is not exposed, it may be applied to a non-open wound site. Accordingly, in the present specification including all claims below, “non-open wound site” may mean a site where the skin surface is damaged and biological tissue below the epidermis is not exposed, but is not limited thereto.

[0063] According to the present specification, including all claims below, in one embodiment of the present invention, the concentration of alloferon in the composition may be 0.002 mg / mL to 0.1 mg / mL based on the total composition, but is not limited thereto. For example, 0.002 mg / mL to 0.08 mg / mL, 0.002 mg / mL to 0.06 mg / mL, 0.002 mg / mL to 0.04 mg / mL, 0.002 mg / mL to 0.03 mg / mL, 0.002 mg / mL to 0.024 mg / mL, 0.004 mg / mL to 0.1 mg / mL, 0.004 mg / mL to 0.08 mg / mL, 0.004 mg / mL to 0.06 mg / mL, 0.004 mg / mL to 0.04 mg / mL, 0.004 mg / mL to 0.03 mg / mL, 0.004 mg / mL to 0.024 mg / mL, 0.006 mg / mL to 0.1 mg / mL, 0.006 mg / mL to 0.08 It may be mg / mL, 0.006 mg / mL to 0.06 mg / mL, 0.006 mg / mL to 0.04 mg / mL, or 0.006 mg / mL to 0.03 mg / mL. In one embodiment of the present invention, it was confirmed that anti-inflammatory activity against skin keratinocytes induced by ultraviolet rays was exhibited when treated with alloferon at concentrations of 0.006 mg / mL, 0.012 mg / mL, and 0.024 mg / mL. Therefore, in one embodiment of the present invention, the concentration of alloferon in the composition may be 0.006 mg / mL to 0.024 mg / mL based on the total composition, but is not limited thereto.

[0064] According to the present specification including all claims below, in one embodiment of the present invention, the concentrations of polynucleotide, hyaluronic acid, and carboxymethylcellulose in the composition may be 0.1 mg / mL to 30 mg / mL, 1 mg / mL to 20 mg / mL, and 0.1 mg / mL to 30 mg / mL, respectively, based on the total composition, but are not limited thereto.

[0065] Including all claims below, in this specification, for example, the polynucleotide is 0.1 mg / mL to 26 mg / mL, 0.1 mg / mL to 23 mg / mL, 0.1 mg / mL to 20 mg / mL, 0.1 mg / mL to 15 mg / mL, 1 mg / mL to 30 mg / mL, 1 mg / mL to 26 mg / mL, 1 mg / mL to 23 mg / mL, 1 mg / mL to 20 mg / mL, 1 mg / mL to 15 mg / mL, 1.5 mg / mL to 30 mg / mL, 1.5 mg / mL to 26 mg / mL, 1.5 mg / mL to 23 mg / mL, 1.5 mg / mL to 20 mg / mL, 1.5 mg / mL to 15 mg / mL, 2 mg / mL to 30 mg / mL, 2 mg / mL to 26 mg / mL, 2 It may be mg / mL to 23 mg / mL, 2 mg / mL to 20 mg / mL, or 2 mg / mL to 15 mg / mL, but is not limited thereto.

[0066] In this specification, including all claims below, hyaluronic acid is 1 mg / mL to 15 mg / mL, 1 mg / mL to 10 mg / mL, 1 mg / mL to 9 mg / mL, 1 mg / mL to 8 mg / mL, 4 mg / mL to 20 mg / mL, 4 mg / mL to 15 mg / mL, 4 mg / mL to 10 mg / mL, 4 mg / mL to 9 mg / mL, 4 mg / mL to 8 mg / mL, 6 mg / mL to 20 mg / mL, 6 mg / mL to 15 mg / mL, 6 mg / mL to 10 mg / mL, 6 mg / mL to 9 mg / mL, 6 mg / mL to 8 mg / mL, 8 mg / mL to 20 mg / mL, 8 mg / mL to 15 mg / mL, 8 mg / mL to 10 mg / mL, 8 mg / mL to 9 mg / mL, or 8 It may be mg / mL, but is not limited thereto.

[0067] Including all claims below, the carboxymethylcellulose is 0.1 mg / mL to 27 mg / mL, 0.1 mg / mL to 24 mg / mL, 0.1 mg / mL to 22 mg / mL, 0.1 mg / mL to 20 mg / mL, 1 mg / mL to 30 mg / mL, 1 mg / mL to 27 mg / mL, 1 mg / mL to 24 mg / mL, 1 mg / mL to 22 mg / mL, 1 mg / mL to 20 mg / mL, 1.5 mg / mL to 30 mg / mL, 1.5 mg / mL to 27 mg / mL, 1.5 mg / mL to 24 mg / mL, 1.5 mg / mL to 22 mg / mL, 1.5 mg / mL to 20 mg / mL, 2 mg / mL to 30 mg / mL, 2 mg / mL to 27 mg / mL, 2 It may be mg / mL to 24 mg / mL, 2 mg / mL to 22 mg / mL, or 2 mg / mL to 20 mg / mL, but is not limited thereto.

[0068] According to the present specification including all claims below, in one embodiment of the present invention, when the concentration of polynucleotide is 2 mg / mL to 15 mg / mL, the concentration of hyaluronic acid is 8 mg / mL, and the concentration of carboxymethylcellulose is 2 mg / mL to 20 mg / mL, it was confirmed that the wound dressing composition exhibits the best viscosity while also exhibiting the skin damage function of alloferon caused by ultraviolet rays.

[0069] According to the present specification, including all claims below, in one embodiment of the present invention, the molecular weight of the polynucleotide may be 1000 kDa to 3000 kDa, but is not limited thereto.

[0070] According to the present specification, including all claims below, in one embodiment of the present invention, the molecular weight of the hyaluronic acid may be 1000 kDa to 3500 kDa, but is not limited thereto.

[0071] According to the present specification, including all claims below, in one embodiment of the present invention, the molecular weight of the carboxymethylcellulose may be 100 kDa to 500 kDa, but is not limited thereto.

[0072] Including all claims below, in this specification, for example, the molecular weight of the polynucleotide is 1000 kDa to 2800 kDa, 1000 kDa to 2600 kDa, 1000 kDa to 2400 kDa, 1400 kDa to 3000 kDa, 1400 kDa to 2800 kDa, 1400 kDa to 2600 kDa, 1400 kDa to 2400 kDa, 1600 kDa to 3000 kDa, 1600 kDa to 2800 kDa, 1600 kDa to 2600 kDa, 1600 kDa to 2400 kDa, 1800 kDa to 3000 kDa, 1800 kDa to It may be 2800 kDa, 1800 kDa to 2600 kDa, or 1800 kDa to 2400 kDa, but is not limited thereto.

[0073] In all claims below, the molecular weight of hyaluronic acid is 1000 kDa to 3400 kDa, 1000 kDa to 3300 kDa, 1000 kDa to 3200 kDa, 1000 kDa to 3100 kDa, 1000 kDa to 3000 kDa, 1500 kDa to 3500 kDa, 1500 kDa to 3400 kDa, 1500 kDa to 3300 kDa, 1500 kDa to 3200 kDa, 1500 kDa to 3100 kDa, 1500 kDa to 3000 kDa, 1750 kDa to 3500 kDa, 1750 kDa to It may be 3400 kDa, 1750 kDa to 3300 kDa, 1750 kDa to 3200 kDa, 1750 kDa to 3100 kDa, 1750 kDa to 3000 kDa, 2000 kDa to 3500 kDa, 2000 kDa to 3400 kDa, 2000 kDa to 3300 kDa, 2000 kDa to 3200 kDa, 2000 kDa to 3100 kDa, or 2000 kDa to 3000 kDa, but is not limited thereto.

[0074] Including all claims below, the molecular weight of carboxymethylcellulose is 100 kDa to 450 kDa, 100 kDa to 425 kDa, 100 kDa to 400 kDa, 100 kDa to 395 kDa, 200 kDa to 500 kDa, 200 kDa to 450 kDa, 200 kDa to 425 kDa, 200 kDa to 400 kDa, 200 kDa to 395 kDa, 300 kDa to 500 kDa, 300 kDa to 450 kDa, 300 kDa to 425 kDa, 300 kDa to 400 kDa, 300 kDa to 395 kDa, It may be 350 kDa to 500 kDa, 350 kDa to 450 kDa, 350 kDa to 425 kDa, 350 kDa to 400 kDa, 350 kDa to 395 kDa, 395 kDa to 500 kDa, 395 kDa to 450 kDa, 395 kDa to 425 kDa, 395 kDa to 400 kDa, or 395 kDa, but is not limited thereto. In one embodiment of the present invention, a polynucleotide of 1800 to 2400 kDa, hyaluronic acid of 2000 kDa to 3000 kDa, and carboxymethylcellulose of about 395 kDa were each used, and it was confirmed that a composition containing alloferon as an active ingredient exhibits excellent viscosity as a wound dressing composition when combined under specific concentration conditions. Therefore, if the molecular weight range of each component used in the scope of the present specification, including the entire claims below, is outside the specified range, the film-forming ability may appear differently, and in this case, it may not be able to function as a viscosity modifier.

[0075] That is, according to the present specification including the entire claim below, in one embodiment of the present invention, it was confirmed that the molecular weight of the polynucleotide is 1800 to 2400 kDa and the concentration is 2 to 15 mg / mL, the molecular weight of the hyaluronic acid is 2000 kDa to 3000 kDa and the concentration is 8 mg / mL, and the concentration of the carboxymethylcellulose is 2 to 20 mg / mL, which is preferred for membrane formation and anti-inflammatory activity.

[0076] In the entire specification including the claims below, it has been confirmed that the stratum corneum of the skin does not thicken due to ultraviolet rays when the composition of the present invention is applied to the skin and then irradiated with ultraviolet rays as described above. In this respect, the present invention has confirmed that it not only improves skin wounds caused by ultraviolet rays but can also prevent skin damage simply by applying it before exposure to ultraviolet rays. Accordingly, in one embodiment of the present invention, the composition can prevent, improve, or treat wounds, but is not limited thereto.

[0077] According to the present specification, including all claims below, in one embodiment of the present invention, the composition may further include one or more moisturizers selected from the group consisting of glycerin and butylene glycol, but is not limited thereto.

[0078] According to the present specification, including all claims below, in one embodiment of the present invention, the concentrations of glycerin and butylene glycol in the composition may be 30 mg / mL to 80 mg / mL and 120 mg / mL to 180 mg / mL, respectively, based on the total composition, but are not limited thereto.

[0079] According to the present specification, including all claims below, in one embodiment of the present invention, glycerin and butylene glycol were used as moisturizers. For example, glycerin may be 30 mg / mL to 70 mg / mL, 30 mg / mL to 60 mg / mL, 30 mg / mL to 50 mg / mL, 40 mg / mL to 80 mg / mL, 40 mg / mL to 70 mg / mL, 40 mg / mL to 60 mg / mL, 40 mg / mL to 50 mg / mL, 45 mg / mL to 80 mg / mL, 45 mg / mL to 70 mg / mL, 45 mg / mL to 60 mg / mL, 45 mg / mL to 50 mg / mL, 50 mg / mL to 80 mg / mL, 50 mg / mL to 70 mg / mL, or 50 mg / mL to 60 mg / mL. In one embodiment of the present invention, glycerin was included in Examples 1 to 11 at a concentration of 50 mg / mL. In one embodiment of the present invention, the concentrations of glycerin and butylene glycol in the composition may be 50 mg / mL based on the total composition, but are not limited thereto.

[0080] Including all claims below, in this specification, for example, butylene glycol is 120 mg / mL to 170 mg / mL, 120 mg / mL to 160 mg / mL, 120 mg / mL to 150 mg / mL, 130 mg / mL to 180 mg / mL, 130 mg / mL to 170 mg / mL, 130 mg / mL to 160 mg / mL, 130 mg / mL to 150 mg / mL, 140 mg / mL to 180 mg / mL, 140 mg / mL to 170 mg / mL, 140 mg / mL to 160 mg / mL, 140 mg / mL to 150 mg / mL, 145 mg / mL to 180 mg / mL, 145 mg / mL to 170 mg / mL, 145 mg / mL to 160 mg / mL, or It may be 145 mg / mL to 150 mg / mL. In one embodiment of the present invention, glycerin was included in Examples 1 to 11 at a concentration of 150 mg / mL. In one embodiment of the present invention, the concentration of glycerin and butylene glycol in the composition may be 150 mg / mL based on the total composition, but is not limited thereto.

[0081] According to the present specification, including all claims below, in one embodiment of the present invention, the pH of the composition may be 6 to 7, but is not limited thereto. In one embodiment of the present invention, it was confirmed that the pH of the composition of the present invention is in the range of 6.5 to 6.9. Since the pH of the skin is generally characterized in the range of 4 to 7, it was confirmed that the composition of the present invention does not cause irritation as it matches the pH of the skin.

[0082] According to the present specification, including all claims below, in one embodiment of the present invention, Examples 1 to 11 were prepared and their surface-applying viscosity was confirmed, and the lowest value was 4.5 Pa·s and the highest was 189.6 Pa·s. Therefore, in one embodiment of the present invention, the surface-applying viscosity of the composition may be 4.5 Pa·s to 200 Pa·s, but is not limited thereto. However, in one embodiment of the present invention, it was confirmed that the viscosity of the gel composition for wound covering is most preferably 4.5 Pa·s to less than 50 Pa·s, and Examples 3 to 10 of the present invention were confirmed to have the best viscosity as a gel composition for wound covering according to the concentration ratio of each component, where the lowest viscosity was 4.5 Pa·s and the highest viscosity was 27.5 Pa·s. Furthermore, therefore, in one embodiment of the present invention, the surface-applying viscosity of the composition may be 4.5 Pa·s to 50 Pa·s, but is not limited thereto. In addition, in one embodiment of the present invention, the surface viscosity of the composition may be 4.5 Pa·s to 30 Pa·s, 4.5 Pa·s to 28 Pa·s, or 4.5 Pa·s to 27.5 Pa·s, but is not limited thereto.

[0083] According to the present specification, including all claims below, in one embodiment of the present invention, it was confirmed that when the composition of the present invention is applied to a wound, it forms a film and, as it gels, prevents the wound from drying out and protects against substances such as external bacteria, thereby maintaining a moist environment to enable improvement and treatment mechanisms. Accordingly, in one embodiment of the present invention, the composition may form a film, but is not limited thereto.

[0084] According to the present specification, including all claims below, in one embodiment of the present invention, it was confirmed that the viscosity and film-forming activity differ depending on each concentration ratio of the composition. For example, the viscosity and film-forming activity of the composition of the present invention may differ depending on the concentration ratio of the viscosity modifier, which is PN, HA, and CMC, which is a viscosity determining factor, and the active ingredient Alloferon, the concentration ratio of glycerin or butylene glycol relative to the total viscosity modifier, and the viscosity modifier ratio relative to the total composition.

[0085] In the entire specification including the following claims, for example, the concentration ratio of the total viscosity modifier to the alloferon concentration is (0.001 to 0.006) : (10 to 40), (0.001 to 0.006) : (10 to 37), (0.001 to 0.006) : (10 to 33), (0.001 to 0.006) : (13 to 40), (0.001 to 0.006) : (13 to 37), (0.001 to 0.006) : (13 to 33), (0.001 to 0.006) : (15 to 40), (0.001 to 0.006) : (15 to 37), (0.001 to 0.006) : (15 to 33), (0.003 to 0.006) : (10 to 40), (0.003 to 0.006) : (10 to 37), (0.003 to 0.006) : (10 to 33), (0.003 to 0.006) : (13 to 40), (0.003 to 0.006) : (13 to 37), (0.003 to 0.006) : (13 to 33), (0.003 to 0.006) : (15 to 40), (0.003 to 0.006) : (15 to 37), (0.003 to 0.006) : (15 to 33), 0.006 : (10 to 40), 0.006 : (10 to 37), 0.006 : (10 to 33), 0.006 : (13 to 40), 0.006 : (13 to 37), 0.006 : (13 to 33), 0.006 : (15 to 40), 0.006 : (15 to 37), or (15 to 33). In particular, the concentration ratio of the total viscosity modifier to the alloferon concentration in Examples 1 and 2, which failed to form a desirable viscosity, was found to be 0.006 : 6 and 0.006 : 9, and in Example 11, 0.006 : 50, respectively, which were confirmed to be outside the above range.

[0086] Including all claims below, in this specification, for example, the concentration ratio of the total viscosity modifier to the glycerin concentration is (30 to 70) : (10 to 40), (30 to 70) : (10 to 37), (30 to 70) : (13 to 33), (30 to 70) : (13 to 40), (30 to 70) : (13 to 37), (30 to 70) : (13 to 33), (30 to 70) : (15 to 40), (30 to 70) : (15 to 37), (30 to 70) : (15 to 33), (40 to 60) : (10 to 40), (40 to 60) : (10 to 37), (40 to 60) : (10 to 33), (40 to 60) : (13 to 40), (40 to 60) : (13 to 37), (40 to 60) : (13 to 33), (40 to 60) : (15 to 40), (40 to 60) : (15 to 37), (40 to 60) : (15 to 33), 50 : (10 to 40), 50 : (10 to 37), 50 : (10 to 33), 50 : (13 to 40), 50 : (13 to 37), 50 : (13 to 33), 50 : (15 to 40), 50 : (15 to 37), or 50 : (15 to 33). In particular, the ratio of the concentration of the total viscosity modifier to the glycerin concentration in Examples 1 and 2, which failed to form a desirable viscosity, was found to be 50:6 and 50:9, respectively, and in Example 11, 50:50, which was confirmed to be outside the above range.

[0087] In the entirety of the following claims, for example, the concentration ratio of the total viscosity modifier to the butylene glycol concentration is (120 to 170) : (10 to 40), (120 to 170) : (10 to 37), (120 to 170) : (10 to 33), (120 to 170) : (13 to 40), (120 to 170) : (13 to 37), (120 to 170) : (13 to 33), (120 to 170) : (15 to 40), (120 to 170) : (15 to 37), (120 to 170) : (15 to 33), (135 to 160) : (10 to 40), (135 to 160) : (10 to 37), (135 to 160) : (10 to 33), (135 to 160) : (13 to 40), (135 to 160) : (13 to 37), (120 to 170) : (13 to 33), (135 to 160) : (15 to 40), (135 to 160) : (15 to 37), (135 to 160) : (15 to 33), 150 : (10 to 40), 150 : (10 to 37), 150 : (10 to 33), 150 : (13 to 40), 150 : (13 to 37), 150 : (13 to 33), 150 : (15 to 40), 150 : (15 to 37), or 150 : (15 to 33), but may be It is not limited to this. In particular, the ratio of the concentration of the total viscosity modifier to the concentration of butylene glycol in Examples 1 and 2, which failed to form a desirable viscosity, was found to be 150:6 and 150:9, respectively, and in Example 11, 150:50, which were found to be outside the above range.

[0088] The present invention provides a topical skin composition for preventing or improving wounds, comprising alloferon as an active ingredient.

[0089] According to the present specification, including all claims below, in one embodiment of the present invention, the composition may additionally include one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethylcellulose, but is not limited thereto.

[0090] Including all claims below, when the composition of the present invention is used as a topical agent for the skin, it may additionally contain adjuvants commonly used in the field of dermatology, such as fatty substances, organic solvents, solvents, thickeners and gelling agents, emollients, antioxidants, suspending agents, stabilizers, foaming agents, fragrances, surfactants, water, ionic or non-ionic emulsifiers, fillers, metal ion chelating agents and chelating agents, preservatives, vitamins, blockers, humectants, essential oils, dyes, pigments, hydrophilic or lipophilic active agents, lipid vesicles, or any other ingredients commonly used in topical agents for the skin. Furthermore, said ingredients may be introduced in amounts commonly used in the field of dermatology.

[0091] Including all claims below, the skin external preparation according to the present embodiment may be formulated, for example, as a solution, suspension, emulsion, paste, gel, cream, lotion, powder, soap, surfactant-containing cleansing, oil, powder foundation, emulsion foundation, wax foundation, and spray, but is not limited thereto. More specifically, it may be prepared in the form of a softening lotion, a nourishing lotion, a nourishing cream, a massage cream, an essence, an eye cream, a cleansing cream, a cleansing foam, a cleansing water, a pack, a spray, or a powder. As an example, the skin external preparation may have a paste form, and specifically, may be manufactured into a product in the form of a moisturizing cream, a mask pack, a peel-off pack, or a mask.

[0092] The present invention provides a cosmetic composition for preventing or improving wounds, comprising alloferon or a cosmetically effective salt thereof as an active ingredient.

[0093] According to the present specification, including all claims below, in one embodiment of the present invention, the composition may additionally further comprise one or more selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethylcellulose, but is not limited thereto.

[0094] Including all claims below, the cosmetic composition of the present invention may comprise a cosmetically acceptable salt of alloferon. As used herein, the term “cosmetically acceptable salt” includes a salt derived from a cosmetically acceptable inorganic acid, organic acid, or base.

[0095] Including all claims below, examples of suitable acids in this specification include hydrochloric acid, bromic acid, sulfuric acid, nitric acid, perchloric acid, fumaric acid, maleic acid, phosphoric acid, glycolic acid, lactic acid, salicylic acid, succinic acid, toluene-p-sulfonic acid, tartaric acid, acetic acid, citric acid, methanesulfonic acid, formic acid, benzoic acid, malonic acid, gluconic acid, naphthalene-2-sulfonic acid, benzenesulfonic acid, etc. Acid addition salts can be prepared by conventional methods, for example, by dissolving a compound in an excess amount of an aqueous acid solution and precipitating the salt using a water-miscible organic solvent such as methanol, ethanol, acetone, or acetonitrile. Alternatively, they can be prepared by heating an equal molar amount of the compound and an acid or alcohol in water, followed by evaporating and drying the mixture, or by suction filtration of the precipitated salt.

[0096] In the entire specification including the following claims, salts derived from suitable bases may include, but are not limited to, alkali metals such as sodium and potassium, alkaline earth metals such as magnesium, and ammonium. Alkali metal or alkaline earth metal salts can be obtained, for example, by dissolving a compound in an excess amount of an alkali metal hydroxide or alkaline earth metal hydroxide solution, filtering the undissolved compound salt, and then evaporating and drying the filtrate. In this case, it is particularly suitable for pharmaceutical purposes to produce sodium, potassium, or calcium salts as metal salts, and the corresponding silver salts can be obtained by reacting an alkali metal or alkaline earth metal salt with a suitable silver salt (e.g., silver nitrate).

[0097] Including all claims below, the formulation of the cosmetic composition according to the present invention may be in the form of a skin lotion, skin softener, skin toner, astringent, lotion, milk lotion, moisture lotion, nourishing lotion, massage cream, nourishing cream, mist, moisture cream, hand cream, hand lotion, foundation, essence, nourishing essence, pack, soap, cleansing foam, cleansing lotion, cleansing cream, cleansing oil, cleansing balm, body lotion, or body cleanser.

[0098] Including the entire claims below, the cosmetic composition of the present invention may further comprise a composition selected from the group consisting of water-soluble vitamins, oil-soluble vitamins, high molecular weight peptides, high molecular weight polysaccharides, and sphingolipids.

[0099] In the present specification, including all claims below, any water-soluble vitamin that can be incorporated into cosmetics may be used, but examples include vitamin B1, vitamin B2, vitamin B6, pyridoxine, pyridoxine hydrochloride, vitamin B12, pantothenic acid, nicotinic acid, nicotinamide, folic acid, vitamin C, vitamin H, etc., and their salts (thiamine hydrochloride, sodium ascorbate, etc.) or derivatives (sodium ascorbate-2-phosphate, magnesium ascorbate-2-phosphate, etc.) are also included in the water-soluble vitamins that may be used in the present specification, including all claims below. Water-soluble vitamins may be obtained by conventional methods such as microbial conversion, purification from microbial cultures, enzymatic methods, or chemical synthesis methods.

[0100] In the present specification, including all claims below, any useful vitamin that can be incorporated into cosmetics may be used, but examples include vitamin A, carotene, vitamin D2, vitamin D3, vitamin E (d1-alpha tocopherol, d-alpha tocopherol, d-alpha tocopherol), and their derivatives (ascorbin palmitate, ascorbin stearate, ascorbin dipalmitate, dl-alpha tocopherol acetate, dl-alpha tocopherol nicotinate, vitamin E, DL-pantotenyl alcohol, D-pantotenyl alcohol, pantotenyl ethyl ether, etc.) are also included in the useful vitamins used in the present specification, including all claims below. Useful vitamins may be obtained by conventional methods such as microbial conversion, purification from microbial cultures, enzymes, or chemical synthesis.

[0101] In the present specification, including all claims below, any polymeric peptide that can be incorporated into cosmetics may be used, but examples include collagen, hydrolyzed collagen, gelatin, elastin, hydrolyzed elastin, keratin, etc. Polymeric peptides may be obtained by purification through conventional methods such as purification from a culture medium of microorganisms, enzymatic methods, or chemical synthesis methods, or they may be used by purifying from natural materials such as the dermis of pigs or cattle, or silk fibers of silkworms.

[0102] In the present specification, including all claims below, any polymeric polysaccharide that can be incorporated into cosmetics may be used, but examples include hydroxyethylcellulose, xanthan gum, sodium hyaluronate, chondroitin sulfate or its salt (sodium salt, etc.). For example, chondroitin sulfate or its salt, etc., can be used after purifying it from mammals or fish.

[0103] In the present specification, including all claims below, any sphingolipid that can be incorporated into cosmetics may be used, such as ceramide, phytosphingosine, sphingoglycolipid, etc. Sphingolipids can be obtained by purifying them by conventional methods or by chemical synthesis from mammals, fish, shellfish, yeast, plants, etc.

[0104] Including all claims below, the cosmetic composition of the present invention may include other ingredients conventionally used in cosmetics in addition to the essential ingredients as needed.

[0105] Including all claims below, the formulation ingredients that may be added in addition include oil ingredients, moisturizers, emollients, surfactants, organic and inorganic pigments, organic powders, UV absorbers, preservatives, disinfectants, antioxidants, plant extracts, pH adjusters, alcohols, dyes, fragrances, blood circulation promoters, cooling agents, antiperspirants, purified water, etc.

[0106] In the present specification, including all claims below, oil components may include ester oils, hydrocarbon oils, silicone oils, fluorine oils, animal oils, plant oils, etc.

[0107] In this specification, including all claims below, the ester-based oils include tri2-ethylhexanoate glyceryl, 2-ethylhexanoate cetyl, isopropyl myristate, butyl myristate, isopropyl palmitate, ethyl stearate, octyl palmitate, isocetyl isocetyl isostearate, butyl stearate, ethyl linoleate, isopropyl linoleate, ethyl oleate, isocetyl myristate, isostearyl myristate, isostearyl palmitate, octyldodecyl myristate, isocetyl isostearate, diethyl sebacate, diisopropyl adipate, isoalkyl neopentanoate, tri(capryl, capric acid)glyceryl, tri2-ethylhexanoate trimethylolpropane, triisostearate trimethylolpropane, tetra2-ethylhexanoate pentaelislitol, cetyl caprylate, Decyl lauric acid, hexyl lauric acid, decyl myristate, myristyl myristate, cetyl myristate, stearyl stearate, decyl oleic acid, cetyl lisinooleic acid, isostearyl lauric acid, isotridecyl myristate, isocetyl palmitate, octyl stearate, isocetyl stearate, isodecyl oleic acid, octyldodecyl oleic acid, octyldodecyl linoleic acid, isopropyl isostearate, 2-cetostearyl ethylhexanoate, 2-stearyl ethylhexanoate, hexyl isostearate, ethylene glycol dioctanoate, ethylene glycol dioleate, propylene glycol dicaprine, di(capryl, capric acid)propylene glycol, propylene glycol dicaprylate, neopentyl glycol dicaprine, neopentyl glycol dioctanoate, Glyceryl tricaprylate, Glyceryl triundecylate, Glyceryl triisopalmitate, Glyceryl triisostearate, Octyldodecyl neopentanoate, Isostearyl octanoate, Octyl isononanoate, Hexyldecyl neodecanoate, Octyldodecyl neodecanoate, Isocetyl isostearate, Isostearyl isostearate, Octyldecyl isostearate, Polyglycerin oleic acid ester, Polyglycerin isostearic acid ester, Triisocetyl citrate, Triisoalkyl citrate, Triisooctyl citrate, Lauryl lactate, Myristyl lactate, Cetyl lactate, Octyldecyl lactate, Triethyl citrate, Acetyltriethyl citrate, Acetyltributyl citrate, Trioctyl citrate, Diisostearyl malate, 2-ethylhexyl hydroxystearic acid, di2-ethylhexyl succinate,Examples include ester compounds such as diisobutyl adipate, diisopropyl sebacate, dioctyl sebacate, cholesteryl stearate, cholesteryl isostearate, cholesteryl hydroxystearate, cholesteryl oleate, dihydrocholesteryl oleate, pitsteryl isostearate, pitsteryl oleate, isocetyl 12-stealloylhydroxystearate, stearyl 12-stealloylhydroxystearate, and isostearyl 12-stealloylhydroxystearate.

[0108] In the present specification, including all claims below, hydrocarbon oils may include squalene, liquid paraffin, alpha-olefin oligomer, isoparaffin, ceresin, paraffin, liquid isoparaffin, polybutene, microcrystalline wax, Vaseline, etc.

[0109] In the present specification, including all claims below, silicone-based oils may include polymethylsilicon, methylphenylsilicon, methylcyclopolysiloxane, octamethylpolysiloxane, decamethylpolysiloxane, dodecamethylcyclosiloxane, dimethylsiloxane-methylcetyloxysiloxane copolymer, dimethylsiloxane-methylstealoxysiloxane copolymer, alkyl-modified silicone oil, amino-modified silicone oil, etc.

[0110] In the present specification, including all claims below, fluorinated oils may include perfluoropolyethers, etc.

[0111] In the present specification, including all claims below, animal or plant oils may include avocado oil, almond oil, olive oil, sesame oil, rice bran oil, safflower oil, soybean oil, corn oil, rapeseed oil, apricot kernel oil, palm kernel oil, palm oil, castor oil, sunflower oil, grapeseed oil, cottonseed oil, coconut oil, cucui nut oil, wheat germ oil, rice germ oil, shea butter, laurel oil, macadamia nut oil, meadowsweet oil, egg yolk oil, beef tallow, horse oil, mink oil, orange raffia oil, jojoba oil, candelilla wax, carnaba wax, liquid lanolin, hydrogenated castor oil, etc.

[0112] In the present specification, including all claims below, examples of moisturizers include water-soluble low molecular weight moisturizers, oil-soluble molecular moisturizers, water-soluble polymers, oil-soluble polymers, etc.

[0113] In the present specification, including all claims below, examples of water-soluble low molecular weight moisturizers include serine, glutamine, sorbitol, mannitol, pyrrolidone-sodium carboxylate, glycerin, propylene glycol, 1,3-butylene glycol, ethylene glycol, polyethylene glycol B (degree of polymerization n = 2 or more), polypropylene glycol (degree of polymerization n = 2 or more), polyglycerin B (degree of polymerization n = 2 or more), lactic acid, lactate, etc.

[0114] In the present specification, including all claims below, examples of fat-soluble low molecular weight moisturizers include cholesterol, cholesterol esters, etc.

[0115] In the present specification, including all claims below, examples of water-soluble polymers include carboxyvinyl polymer, polyaspartate, tragacanth, xanthan gum, methylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, water-soluble chitin, chitosan, dextrin, etc.

[0116] In the present specification, including all claims below, examples of fat-soluble polymers include polyvinylpyrrolidone-eicocene copolymer, polyvinylpyrrolidone-hexadecene copolymer, nitrocellulose, dextrin fatty acid ester, polymeric silicone, etc.

[0117] In the present specification, including all claims below, examples of emollient agents include long-chain acylglutamic acid cholesteryl ester, hydroxystearic acid cholesteryl, 12-hydroxystearic acid, stearic acid, rosin acid, lanolin fatty acid cholesteryl ester, etc.

[0118] In the present specification, including all claims below, surfactants may include nonionic surfactants, anionic surfactants, cationic surfactants, amphoteric surfactants, etc.

[0119] Including all claims below, nonionic surfactants may include self-emulsifying monostearate glycerin, propylene glycol fatty acid ester, glycerin fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, POE (polyoxyethylene) sorbitan fatty acid ester, POE sorbitan fatty acid ester, POE glycerin fatty acid ester, POE alkyl ether, POE fatty acid ester, POE hydrogenated castor oil, POE castor oil, POE·POP (polyoxyethylene·polyoxypropylene) copolymer, POE·POP alkyl ether, polyether-modified silicone, lauric acid alkanolamide, alkylamine oxide, hydrogenated soybean phospholipid, etc.

[0120] In the present specification, including all claims below, examples of anionic surfactants include fatty acid soap, alpha-acylsulfonate, alkylsulfonate, alkylallylsulfonate, alkylnaphthalenesulfonate, alkyl sulfate, POE alkyl ether sulfate, alkylamide sulfate, alkyl phosphate, POE alkyl phosphate, alkylamide phosphate, alkylloylalkyl taurine salt, N-acylamino acid, POE alkyl ether carboxylate, alkyl sulfosuccinate, sodium alkyl sulfoacetate, acylated hydrolyzed collagen peptide salt, perfluoroalkyl phosphate ester, etc.

[0121] In the present specification, including all claims below, cationic surfactants may include alkyltrimethylammonium chloride, stearyltrimethylammonium chloride, stearyltrimethylammonium bromide, cetostearyltrimethylammonium chloride, distearyldimethylammonium chloride, stearyldimethylbenzylammonium chloride, behenyltrimethylammonium bromide, benzalkonium chloride, diethylaminoethylamide stearate, dimethylaminopropylamide stearate, lanolin derivative quaternary ammonium salts, etc.

[0122] In the present specification, including all claims below, examples of amphoteric surfactants include carboxybetaine type, amidebetaine type, sulfobetaine type, hydroxysulfobetaine type, amidesulfobetaine type, phosphobetaine type, aminocarboxylate type, imidazoline derivative type, amideamine type, etc.

[0123] Including all claims below, the organic and inorganic pigments comprises inorganic pigments such as silica, anhydrous silica, magnesium silicate, talc, sericite, mica, kaolin, bengala, clay, bentonite, titanium-coated mica, bismuth oxychloride, zirconium oxide, magnesium oxide, zinc oxide, titanium oxide, aluminum oxide, calcium sulfate, barium sulfate, magnesium sulfate, calcium carbonate, magnesium carbonate, iron oxide, ultramarine, chromium oxide, chromium hydroxide, calamine, and complexes thereof; Examples include organic pigments such as polyamide, polyester, polypropylene, polystyrene, polyurethane, vinyl resin, urea resin, phenolic resin, fluoropolymer, silicone resin, acrylic resin, melamine resin, epoxy resin, polycarbonate resin, divinylbenzene-styrene copolymer, silk powder, cellulose, CI pigment yellow, CI pigment orange, etc., and composite pigments of inorganic pigments and organic pigments thereof.

[0124] Including all claims below, the organic powder comprises: a metal soap such as calcium stearate; a metal alkyl phosphate salt such as sodium zinc cetylphosphate, zinc laurylphosphate, or calcium laurylphosphate; a polyvalent acyl amino acid salt such as N-lauroyl-beta-alanine calcium, N-lauroyl-beta-alanine zinc, or N-lauroylglycine calcium; a polyvalent amide sulfonic acid salt such as N-lauroyl-taurine calcium or N-palmitoyl-taurine calcium; N-acyl basic amino acids such as N-epsilon-lauroyl-L-lysine, N-epsilon-palmitoyllysine, N-alpha-palitoylolnitine, N-alpha-lauroyl arginine, or N-alpha-hydrogenated beef tallow fatty acid acyl arginine; or an N-acyl polypeptide such as N-lauroylglycylglycine. Alpha-amino fatty acids such as alpha-aminocaprilic acid and alpha-aminolauric acid; examples include polyethylene, polypropylene, nylon, polymethyl methacrylate, polystyrene, divinylbenzene-styrene copolymer, tetrafluoroethylene, etc.

[0125] Including all claims below, the ultraviolet absorber comprises para-aminobenzoic acid, ethyl para-aminobenzoate, amyl para-aminobenzoate, octyl para-aminobenzoate, ethylene glycol salicylate, phenyl salicylate, octyl salicylate, benzyl salicylate, butylphenyl salicylate, homomentyl salicylate, benzyl cinnamonate, paramethoxycinnamic acid-2-ethoxyethyl paramethoxycinnamic acid, octyl paramethoxycinnamic acid, diparamethoxycinnamic acid mono-2-ethylhexaneglyceryl, isopropyl paramethoxycinnamic acid, a mixture of diisopropyl and diisopropyl cinnamonic acid esters, urocanic acid, ethyl urocanic acid, hydroxymethoxybenzophenone, hydroxymethoxybenzophenonesulfonic acid and its salts, dihydroxymethoxybenzophenone, sodium dihydroxymethoxybenzophenonedisulfonate, dihydroxybenzophenone, Examples include tetrahydroxybenzophenone, 4-tert-butyl-4'-methoxydibenzoylmethane, 2,4,6-trianilino-p-(carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazine, 2-(2-hydroxy-5-methylphenyl)benzotriazole, etc.

[0126] Including all claims below, examples of disinfectants in this specification include hinokitiol, triclosan, trichlorohydroxydiphenyl ether, chlorhexidine gluconate, phenoxyethanol, resorcinol, isopropylmethylphenol, azulene, salicylic acid, zincphyllithion, benzalkonium chloride, photosensitive agent 301, mononitroguaiacol sodium, undecylenic acid, etc.

[0127] In the present specification, including the entire claims below, examples of antioxidants include butylhydroxyanisole, propyl gallic acid, elisorbic acid, etc.

[0128] In the present specification, including all claims below, pH adjusting agents may include citric acid, sodium citrate, malic acid, sodium malate, fumaric acid, sodium fumarate, succinic acid, sodium succinate, sodium hydroxide, sodium monohydrogen phosphate, etc.

[0129] In the present specification, including all claims below, alcohols may include higher alcohols such as cetyl alcohol.

[0130] In addition, the formulation components that may be added in addition to the above claims, including the entire claim below, are not limited thereto, and any of the above components may be formulated within a range that does not impair the purpose and effect of the present invention, but may be formulated in an amount of 0.01-5% by weight or 0.01-3% by weight with respect to the total weight.

[0131] In the entire specification including the following claims, when the formulation of the present invention is a lotion, paste, cream, or gel, animal fiber, plant fiber, wax, paraffin, starch, tracanth, cellulose derivative, polyethylene glycol, silicone, bentonite, silica, talc, or zinc oxide, etc. may be used as a carrier component.

[0132] Including all claims below, in the specification, when the formulation of the present invention is a powder or a spray, lactose, talc, silica, aluminum hydroxide, calcium silicate, or polyamide powder may be used as a carrier component, and particularly in the case of a spray, may additionally include a propellant such as chlorofluorohydrocarbon, propane / butane, or dimethyl ether.

[0133] In the entire specification including the following claims, when the formulation of the present invention is a solution or emulsion, a solvent, a solvating agent, or an emulsifying agent is used as a carrier component, such as water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butyl glycol oil, glycerol aliphatic ester, polyethylene glycol, or fatty acid ester of sorbitan.

[0134] In the entire specification including the following claims, when the formulation of the present invention is a suspension, a liquid diluent such as water, ethanol, or propylene glycol, a suspending agent such as ethoxylated isostearyl alcohol, polyoxyethylene sorbitol ester, and polyoxyethylene sorbitan ester, microcrystalline cellulose, aluminum metahydroxide, bentonite, agar, or tracanthera may be used as a carrier component.

[0135] In the present specification, including all claims below, when the formulation of the present invention is a surfactant-containing cleansing agent, aliphatic alcohol sulfate, aliphatic alcohol ether sulfate, sulfosuccinic acid monoester, isethionate, imidazolinium derivative, methyl taurate, sarcosinate, fatty acid amide ether sulfate, alkylamidobetaine, aliphatic alcohol, fatty acid glyceride, fatty acid diethanolamide, vegetable oil, linolin derivative, or ethoxylated glycerol fatty acid ester, etc. may be used as a carrier component.

[0136] The present invention provides a pharmaceutical composition for the prevention or treatment of wounds, comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0137] Including all claims below, the pharmaceutical composition according to the present invention may further comprise a suitable carrier, excipient, and diluent commonly used in the manufacture of pharmaceutical compositions. The excipient may be one or more selected from the group consisting of, for example, diluents, binders, disintegrants, lubricants, adsorbents, humectants, film-coating materials, and controlled-release additives.

[0138] Including all claims below, as set forth herein, the pharmaceutical composition according to the present invention may be formulated and used in the form of external preparations such as powders, granules, sustained-release granules, enteric granules, liquids, ophthalmic preparations, oleic acid preparations, emulsions, suspensions, ethanol preparations, troches, aromatic preparations, limonene adrenergic preparations, tablets, sustained-release tablets, enteric tablets, sublingual tablets, hard capsules, soft capsules, sustained-release capsules, enteric capsules, pills, tinctures, soft extracts, dry extracts, fluid extracts, injectables, capsules, irrigation solutions, warning agents, lotions, pastes, sprays, inhalants, patches, sterile injectable solutions, or aerosols, respectively, according to conventional methods, and said external preparations may be used as creams, gels, patches, sprays, ointments, warning agents, lotions, liniments, pastes, or cataplasms, etc. It can have a formulation.

[0139] Including all claims below, carriers, excipients, and diluents that may be included in the pharmaceutical composition according to the present invention may include lactose, dextrose, sucrose, oligosaccharides, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil.

[0140] Including all claims below, the formulation is prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants.

[0141] Including all claims below, as an additive to tablets, powders, granules, capsules, pills, and lozenges according to the present invention, excipients such as corn starch, potato starch, wheat starch, lactose, sucrose, glucose, fructose, D-mannitol, precipitated calcium carbonate, synthetic aluminum silicate, calcium monohydrogen phosphate, calcium sulfate, sodium chloride, sodium bicarbonate, refined lanolin, microcrystalline cellulose, dextrin, sodium alginate, methylcellulose, sodium carboxymethylcellulose, kaolin, urea, colloidal silica gel, hydroxypropyl starch, hydroxypropylmethylcellulose (HPMC) 1928, HPMC 2208, HPMC 2906, HPMC 2910, propylene glycol, casein, calcium lactate, primogel, etc.; Gelatin, gum arabic, ethanol, agar powder, cellulose phthalate, carboxymethylcellulose, calcium carboxymethylcellulose, glucose, purified water, sodium casein, glycerin, stearic acid, sodium carboxymethylcellulose, sodium methylcellulose, methylcellulose, microcrystalline cellulose, dextrin, hydroxycellulose, hydroxypropyl starch, hydroxymethylcellulose, refined shellac, starch paste, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, etc. may be used as binders, and hydroxypropylmethylcellulose, corn starch, agar powder, methylcellulose, bentonite, hydroxypropyl starch, sodium carboxymethylcellulose, sodium alginate, Calcium carboxymethylcellulose, calcium citrate, sodium lauryl sulfate, anhydrous silica, 1-hydroxypropylcellulose, dextran, ion exchange resin, polyvinyl acetate, formaldehyde-treated casein and gelatin, alginic acid, amylose, guar gum, sodium bicarbonate, polyvinylpyrrolidone, calcium phosphate, gelled starch, gum arabic, amylopectin, pectin, sodium polyphosphate, ethylcellulose, sucrose, magnesium aluminum silicate, D-sorbitol solution, hard anhydrous silica, etc. disintegrants;Lubricants such as calcium stearate, magnesium stearate, stearic acid, hydrogenated vegetable oil, talc, lycopodium pods, kaolin, petroleum jelly, sodium stearate, cocoa paste, sodium salicylate, magnesium salicylate, polyethylene glycol (PEG) 4000, PEG 6000, liquid paraffin, hydrogenated soybean oil (Lubri wax), aluminum stearate, zinc stearate, sodium lauryl sulfate, magnesium oxide, macrogol, synthetic aluminum silicate, anhydrous silica, higher fatty acids, higher alcohols, silicone oil, paraffin oil, polyethylene glycol fatty acid ether, starch, sodium chloride, sodium acetate, sodium oleate, dl-leucine, and hard anhydrous silica may be used.

[0142] Including all claims below, as used in this specification, additives to the liquid formulation according to the present invention may include water, dilute hydrochloric acid, dilute sulfuric acid, sodium citrate, monostearic acid sucroses, polyoxyethylene sorbitol fatty acid esters (tween esters), polyoxyethylene monoalkyl ethers, lanolin ethers, lanolin esters, acetic acid, hydrochloric acid, water ammonia, ammonium carbonate, potassium hydroxide, sodium hydroxide, prolamine, polyvinylpyrrolidone, ethylcellulose, sodium carboxymethylcellulose, etc.

[0143] Including all claims below, the syrup formulation according to the present invention may use a solution of white sugar, other sugars or sweeteners, etc., and, if necessary, flavoring agents, coloring agents, preservatives, stabilizers, suspending agents, emulsifiers, viscosity enhancers, etc.

[0144] Including all claims below, the emulsion according to the present invention may use purified water, and may use emulsifiers, preservatives, stabilizers, fragrances, etc. as needed.

[0145] Including all claims below, the suspending agent according to the present invention may use acacia, tragacanthus, methylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, microcrystalline cellulose, sodium alginate, hydroxypropylmethylcellulose (HPMC), HPMC 1828, HPMC 2906, HPMC 2910, etc., and, if necessary, surfactants, preservatives, stabilizers, coloring agents, and fragrances may be used.

[0146] Including all claims below, the injectable formulation according to the present invention comprises: solvents such as distilled water for injection, 0.9% sodium chloride injection solution, Ringer's injection solution, dextrose injection solution, dextrose + sodium chloride injection solution, PEG, lactated Ringer's injection solution, ethanol, propylene glycol, non-volatile oils—sesame oil, cottonseed oil, peanut oil, soybean oil, corn oil, ethyl oleate, isopropyl myristate, and benzene benzoate; and solubilizing agents such as sodium benzoate, sodium salicylate, sodium acetate, urea, urethane, monoethylacetamide, butazolidine, propylene glycol, Tween, nijungtinamide, hexamine, and dimethylacetamide; Buffers such as weak acids and their salts (acetic acid and sodium acetate), weak bases and their salts (ammonia and ammonium acetate), organic compounds, proteins, albumin, peptone, and gums; isotonic agents such as sodium chloride; stabilizers such as sodium bisulfite (NaHSO3), carbon dioxide gas, sodium metabisulfite (Na2S2O5), sodium sulfite (Na2SO3), nitrogen gas (N2), and ethylenediaminetetraacetic acid; sulfating agents such as sodium bisulfide 0.1%, sodium formaldehyde sulfoxylate, thiourea, disodium ethylenediaminetetraacetic acid, and sodium bisulfite acetone; analgesics such as benzyl alcohol, chlorobutanol, procaine hydrochloride, glucose, and calcium gluconate; It may include suspending agents such as sodium CMC, sodium alginate, Tween 80, and aluminum monostearate.

[0147] Including all claims below, as provided herein, the suppositories according to the present invention comprise: cocoa gluten, lanolin, Witepsol, polyethylene glycol, glycerogelatin, methylcellulose, carboxymethylcellulose, a mixture of stearic acid and oleic acid, Subanal, cottonseed oil, peanut oil, palm oil, cocoa butter + cholesterol, lecithin, lanette wax, glycerol monostearate, Tween or Spandex, Imhausen, monollene (propylene glycol monostearate), glycerin, Adeps solidus, Buytyrum Tego-G, Cebes Pharma 16, hexalide base 95, Cotomar, Hydroccote SP, S-70-XXA, S-70-XX75 (S-70-XX95), Bases such as Hydrokote 25, Hydrokote 711, Idropostal, Massa estrarium (A, AS, B, C, D, E, I, T), Massa-MF, Masupol, Masupol-15, Neosupostal-N, Paramount-B, Suposiro (OSI, OSIX, A, B, C, D, H, L), suppository base type IV (AB, B, A, BC, BBG, E, BGF, C, D, 299), Supostal (N, Es), Wecobi (W, R, S, M, Fs), and Tegestor triglyceride base (TG-95, MA, 57) may be used.

[0148] Including all claims below, the present specification includes solid dosage forms for oral administration such as tablets, pills, powders, granules, capsules, etc., and these solid dosage forms are prepared by mixing at least one excipient, for example, starch, calcium carbonate, sucrose or lactose, gelatin, etc. with the extract. In addition, lubricants such as magnesium styrate talc are also used in addition to simple excipients.

[0149] In the present specification, including all claims below, liquid formulations for oral administration include suspensions, liquid formulations, emulsions, syrups, etc., and may include various excipients, such as humectants, sweeteners, flavorings, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized formulations, and suppositories. Non-aqueous solvents and suspensions may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate.

[0150] Including all claims below, the pharmaceutical composition according to the present invention is administered in a pharmaceutically effective amount. In the present invention, “pharmaceutically effective amount” means an amount sufficient to treat a disease with a reasonable benefit / risk ratio applicable to medical treatment, and the effective dose level may be determined based on factors including the type and severity of the patient’s disease, drug activity, sensitivity to the drug, time of administration, route of administration and elimination rate, duration of treatment, concurrently used drugs, and other factors well known in the medical field.

[0151] Including all claims below, the pharmaceutical composition according to the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, may be administered sequentially or simultaneously with conventional therapeutic agents, and may be administered as a single or multiple doses. It is important to administer an amount that obtains maximum effect with a minimum amount without side effects, taking into account all of the above factors, and this can be easily determined by a person skilled in the art to which the present invention pertains.

[0152] Including all claims below, the pharmaceutical composition of the present invention may be administered to an individual by various routes. All modes of administration may be anticipated, for example, by oral administration, subcutaneous injection, intraperitoneal administration, intramuscular injection, intrathecal (intradural) injection, sublingual administration, buccal mucosal administration, rectal insertion, vaginal insertion, ocular administration, ear administration, nasal administration, inhalation, spray through the mouth or nose, skin administration, transdermal administration, etc.

[0153] In all claims below, the pharmaceutical composition of the present invention is determined by the type of active ingredient drug, along with various relevant factors such as the disease to be treated, the route of administration, the patient's age, gender, weight, and the severity of the disease. Specifically, the effective dose of the composition according to the present invention may vary depending on the patient's age, gender, and weight, and generally, 0.001 to 150 mg, preferably 0.01 to 100 mg per kg of body weight, may be administered daily or every other day, or divided into 1 to 3 doses per day. However, since the dose may be increased or decreased depending on the route of administration, the severity of the disease, gender, weight, age, etc., the above dosage does not limit the scope of the present invention in any way.

[0154] In addition, the present invention provides a method for preventing or treating a wound, comprising the step of administering a composition containing alloferon or a pharmaceutically effective salt thereof as an active ingredient to an individual in need of the same in a pharmaceutically effective amount.

[0155] In addition, the present invention provides a use for a composition comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient for the prevention, improvement, or treatment of wounds.

[0156] In addition, the present invention provides a use for preparing a preparation for the prevention, improvement, or treatment of wounds, comprising a composition containing alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0157] Including all claims below, the term “individual” in this specification means an object requiring treatment for a disease, and more specifically means mammals such as humans or non-human primates, mice, rats, dogs, cats, horses, and cattle.

[0158] Including all claims below, the term “administration” in this specification means providing a specific composition of the present invention to an individual by any appropriate method.

[0159] In this specification, including all claims below, “prevention” means any act of suppressing or delaying the onset of a target disease; “treatment” means any act of improving or beneficially altering a target disease and associated metabolic abnormality symptoms by administering a pharmaceutical composition according to the present invention; and “improvement” means any act of reducing parameters related to a target disease, such as the severity of symptoms, by administering a composition according to the present invention.

[0160] The present invention provides a method for preparing a gel composition for wound dressing, comprising the following steps:

[0161] A step of adding alloferon, PN, HA, CMC, butylene glycol, and glycerin in that order to a mixer and stirring at a temperature of 30°C to 75°C and for 2 to 10 hours.

[0162] Including all claims below, the stirring temperature in the above step may be 30 ℃ to 65 ℃, 30 ℃ to 60 ℃, 30 ℃ to 55 ℃, 30 ℃ to 50 ℃, 40 ℃ to 75 ℃, 40 ℃ to 65 ℃, 40 ℃ to 60 ℃, 40 ℃ to 55 ℃, 40 ℃ to 50 ℃, 45 ℃ to 75 ℃, 45 ℃ to 65 ℃, 45 ℃ to 60 ℃, 45 ℃ to 55 ℃, 45 ℃ to 50 ℃, 50 ℃ to 75 ℃, 50 ℃ to 65 ℃, 50 ℃ to 60 ℃, 50 ℃ to 55 ℃, or 50 ℃. no.

[0163] Additionally, as per the entire claim below, the stirring time in the above step may be 2 to 9 hours, 2 to 8 hours, 2 to 7 hours, 2 to 6 hours, 4 to 10 hours, 4 to 9 hours, 4 to 8 hours, 4 to 7 hours, 4 to 6 hours, 5 to 10 hours, 5 to 9 hours, 5 to 8 hours, 5 to 7 hours, 5 to 6 hours, 6 to 10 hours, 6 to 9 hours, 6 to 8 hours, 6 to 7 hours, or 6 hours, but is not limited thereto.

[0164] At this time, the order of addition of each component may be in the order of raw materials that hydrate and dissolve well in the water for injection and in the order of liquid raw materials, but is not limited thereto.

[0165] Furthermore, as per the entire claim below, in the above-mentioned specification, stirring in the mixer in the above step may be applied in any composition and method as long as each component can be well mixed, and it is obvious that a wound dressing composition according to one embodiment of the present invention can be prepared when performed in accordance with common sense of the art.

[0166] In addition, the present invention provides a use for preparing a topical skin preparation comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0167] In addition, the present invention provides a use for manufacturing a cosmetic formulation of a composition comprising alloferon or a cosmetically effective salt thereof as an active ingredient.

[0168] In addition, the present invention provides a use of a gel composition for wound dressing comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

[0169]

[0170] The present invention provides a kit for preventing or treating wounds, comprising the above composition and instructions.

[0171] In this specification, including all claims below, the term “kit” refers to a tool that enables the prevention, improvement, or treatment of wounds using a composition containing the alloferon of the present invention as an active ingredient. In addition to the above-mentioned material, the kit of the present invention may include other components, compositions, solutions, devices, etc., that are typically required for the storage and processing of such materials. As a specific example, each component may be applied one or more times without limitation on the number of times, there is no restriction on the order in which each material is applied, and the application of each material may proceed simultaneously or sequentially.

[0172] Including all claims below, the kit may include a container; instructions; etc. The container may serve to package the material and may also serve to store and secure it. The material of the container may take the form, for example, a bottle, a tub, a sachet, an envelope, a tube, an ampoule, etc., and may be formed partially or wholly from plastic, glass, paper, foil, wax, etc. The container may be equipped with a cap that is initially part of the container or can be attached to the container by mechanical, adhesive, or other means and may also be equipped with a stopper that allows access to the contents by a needle. The kit may include an outer package, and the outer package may include instructions regarding the use of the components.

[0173] Preferred embodiments are presented below to aid in understanding the present invention. However, the following embodiments are provided merely to facilitate a better understanding of the invention, and the scope of the invention is not limited by the following embodiments.

[0174]

[0175] [Example]

[0176]

[0177] Experimental Example 1. Confirmation of the activity of Alloferon in reducing inflammatory responses induced by ultraviolet rays

[0178] When skin is exposed to ultraviolet (UVB) with wavelengths of 280–320 nm, skin inflammation occurs; during this process, keratinocytes in the epidermis release inflammatory cytokines such as interleukins (ILs), e.g., IL-1, IL-6, IL-8, or IL-10. Therefore, in this experimental example, to determine whether allferon has alleviative, improving, or therapeutic effects on inflammation induced by ultraviolet radiation, the expression level of the inflammatory cytokine IL-6 was measured by performing an ELISA analysis. Specifically, HaCaT cells, which are human keratinocytes, were seeded at a density of 3.5 x 10^6 cells in a cell culture dish, and after 24 hours, an ultraviolet irradiator was applied at 100 J / m² 2 UVB was irradiated. Then, Alloferon was treated at different concentrations, and after 24 hours, the expression levels were checked using an ELISA kit to see if there were differences in the expression of IL-6. The experiment was conducted by dividing the experimental groups into a normal group (No treatment), a UVB cell group irradiated with UVB, and cell groups treated with Alloferon at different concentrations after UVB irradiation (UVB+Alloferon 0.006 mg / mL, UVB+Alloferon 0.012 mg / mL, UVB+Alloferon 0.024 mg / mL).

[0179]

[0180] As a result, it was confirmed as shown in Table 1 and Figure 1.

[0181]

[0182]

[0183] Specifically, while no IL-6 was expressed in the normal group, IL-6 expression was measured at 167.86 pg / mL in the UVB cell group. In addition, in the groups treated with 0.006 mg / mL, 0.012 mg / mL, and 0.024 mg / mL of alloferon after UVB irradiation, IL-6 expression levels were investigated as 143.06 pg / mL, 134.08 pg / mL, and 157.15 pg / mL, respectively, ranging from approximately 134 pg / mL to 157 pg / mL. These IL-6 levels were 79% to 93% of those in the UVB cell group, confirming a maximum cytokine reduction of approximately 20%.

[0184]

[0185] According to these results, Alloferon was found to significantly reduce the inflammatory response induced by ultraviolet rays when applied to skin keratinocytes, confirming that it can function as an active ingredient capable of improving and treating skin damage caused by ultraviolet rays.

[0186] In addition, since it was determined that there was no difference in effect depending on the concentration of alloferon, it was prepared by fixing the concentration at 0.006 mg / mL in the following experiments.

[0187]

[0188] Experimental Example 2. Preparation of a wound dressing gel composition containing alloferon as an active ingredient

[0189] In addition to functional active substances such as anti-inflammatory and hemostatic agents, a wound dressing composition must have an appropriate viscosity to serve as a wound dressing that prevents fluid loss from the skin, creates a moist environment, and protects the wound by forming a physical film when applied to damaged skin. Therefore, in this experimental example, various examples were prepared so that the UV damage treatment activity of Alloferon confirmed in Experimental Example 1 could be exhibited while also being utilized as a wound dressing gel composition. Specifically, the composition of the examples included polynucleotide (PN, HTL, 1,800 ~ 2,400 kDa), hyaluronic acid (HA, Humedix, 2,000 ~ 3,000 kDa), Alloferon (BeadTech, 1264 Da), and carboxymethylcellulose (CMC, Ashland, 395 kDa). Examples 1 to 11 were prepared according to Table 2 by varying the concentrations of polynucleotide (PN), hyaluronic acid (HA), and carboxymethylcellulose (CMC), which can affect the viscosity of the gel composition. Each example additionally contained glycerin (Glycerin, Daejeong Chemical) and butylene glycol (Butylene glycol, OQ Chemical) at 50 mg / mL and 150 mg / mL, respectively, and the detailed concentrations are as shown in Table 2 below.

[0190] Examples 1 to 11 were prepared by adding alloferon, PN, HA, CMC, butylene glycol, and glycerin in that order according to each composition in Table 2, and stirring at a stirring temperature of 50°C for 6 hours. At this time, since CMC does not dissolve well, it was added to ensure even distribution.

[0191]

[0192]

[0193]

[0194] Experimental Example 3. Confirmation of physical characteristics of Examples 1 to 11, which are wound dressing gel compositions containing alloferon as an active ingredient.

[0195] In Experimental Example 3, the physical characteristics of Examples 1 to 11 prepared in Experimental Example 2 were verified. Considering that the composition of the present invention is applied directly to the skin, the pH, friction viscosity, and film-forming ability (physical film formation) were analyzed as physical characteristics. Specifically, pH and friction viscosity were measured using a pH meter and a rotary rheometer, respectively. The conditions for measuring friction viscosity were as follows: Geometry - Cone plate (4°, 40 mm), Shear rate - 1.00 s⁻¹, Analysis time - 600 sec, Analysis interval - 30 sec. In addition, film-forming ability was verified by checking whether a film is formed when the composition is evenly applied to a glass plate and dried at room temperature. First, a sample was applied to a thickness of 1 mm on a glass plate measuring 2.5 cm (width) x 5.5 cm (length), and then the applied sample was stabilized at room temperature for 5 minutes, followed by maintaining the sample in a vertically tilted or inverted state for 6 hours. Afterwards, visually inspect the condition of the sample to check for any deformation (sagging, dripping).

[0196]

[0197] As a result, it was confirmed as shown in Table 3, Fig. 2a, and Fig. 2b.

[0198]

[0199]

[0200] First, the pH measurement results of Examples 1 to 11 were confirmed to be 6.5 to 6.9. Since the pH of normal skin is between 4 and 7 and can irritate the skin if it falls outside this range, it was confirmed that Examples 1 to 11 prepared in Experimental Example 2 do not cause skin irritation.

[0201]

[0202] As a result of viscosity measurement, the viscosity of the composition was found to be 0.1 to 189.6 Pa·s depending on the concentrations of PN, HA, and CMC. In addition, according to the analysis of film-forming ability, all of them formed a film on a glass plate, except for Examples 1 and 2.

[0203]

[0204] At this time, when the results of the analysis of viscosity and film-forming ability were combined, it was confirmed that physical film formation is possible when the viscosity is 4.5 Pa·s or higher. If the viscosity is less than 4.5 Pa, the composition flows down when applied to the wound site, making it inconvenient to use and difficult to form a film. Furthermore, if the viscosity is 50 Pa or higher, the viscosity is too high, so when the composition is applied to the wound site, it does not spread evenly and requires repeated rubbing to apply evenly. In addition, there are difficulties in the manufacturing process and the economic effect is low relative to the amount used. Therefore, it has been proven that Examples 3 to 10 of the present invention all exhibit excellent viscosity as wound dressing compositions, as their viscosity falls within the range of 4.5 Pa to less than 50 Pa.

[0205]

[0206] Experimental Example 4. Confirmation of the preventive and therapeutic effects of a wound dressing gel composition containing alloferon as an active ingredient on skin damage caused by ultraviolet rays

[0207] As a result of analyzing the physical characteristics of Examples 1 to 11 in Experimental Example 3, it was confirmed that Examples 3 to 10 were suitable. In Experimental Example 4, it was confirmed whether a wound dressing gel composition containing alloferon as an active ingredient prevents and treats skin damage caused by ultraviolet rays.

[0208] When skin is exposed to ultraviolet rays, it increases reactive oxygen species within the tissue, destroying elastic fibers such as collagen and elastin, thereby reducing skin elasticity and moisture retention. Furthermore, it causes chronic inflammation, which thickens the stratum corneum—the outermost layer of the skin—hindering the elimination of waste products and potentially leading to skin problems. Therefore, to verify the efficacy of a wound dressing gel composition containing alloferon, Example 4 was applied to the dorsal skin of mice, and the thickness of the stratum corneum was confirmed through tissue staining (H&E) after irradiation with ultraviolet rays. Specifically, the experimental method is as follows. First, nude mice (6 weeks old) were classified into the following three groups:

[0209] Normal group - no treatment, UV irradiation group - UV irradiation directly onto the skin of the back, UV irradiation + Example 4 treatment group - UV irradiation after application of the Example to the skin of the back.

[0210] Example 4 was applied once at intervals of 2 to 3 days for a total of 3 applications per week, and 0.1 g of the sample was applied to the skin on the back for each application (1 application per application). Then, as shown in Table 4, the amount of UV radiation was gradually increased and the experiment was conducted for a total of 8 weeks. Afterward, skin tissue was obtained, fixed in paraformaldehyde, and H&E staining was performed to measure the thickness of the stratum corneum.

[0211]

[0212]

[0213] As a result, results such as those shown in Figures 3 and 4 were confirmed.

[0214] Specifically, it was confirmed that the thickness of the stratum corneum in the UV irradiation group was 53.6 μm at week 8, which is about 1.4 times thicker than the normal group (37.1 μm). On the other hand, the thickness of the stratum corneum in the UV irradiation + Example 4 treatment group was 24.5 μm at week 8, confirming that the stratum corneum did not thicken despite UV irradiation. In addition, according to Figure 4, the stratum corneum thickness in the UV irradiation + Example 4 treatment group remained stably thin without thickening throughout the entire experimental period from week 2 to week 8, and this was confirmed to be more uniform than that of the normal group when compared to the initial skin stratum corneum staining results of the normal group.

[0215] According to these results, the composition of the present invention means that it can not only effectively treat but also prevent skin damage caused by UV irritation ranging from short-term UV exposure to long-term UV effects.

[0216]

[0217] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will understand that other specific forms can be easily modified without altering the technical spirit or essential features of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive.

[0218] According to a wound dressing gel composition containing alloferon as an active ingredient, alloferon, which has excellent anti-inflammatory activity, is included as an active ingredient, and additionally includes a composition capable of protecting the wound site, supplying moisture, and maintaining moisture by forming a physical film on damaged skin tissue. Since the composition of the present invention can protect a wound site vulnerable to ultraviolet rays and alleviate inflammation, and prevent the destruction of skin elastic fibers and epidermal hyperplasia, it can be usefully utilized as a wound dressing gel composition capable of preventing, improving, alleviating, or treating skin inflammation caused by ultraviolet rays, and thus has industrial applicability.

Claims

1. A wound covering gel composition comprising alloferon as an active ingredient.

2. In Paragraph 1, A composition in which the above wound is skin damage caused by ultraviolet rays.

3. In Paragraph 2, A composition wherein the above-mentioned skin damage is one or more selected from the group consisting of inflammation caused by ultraviolet rays and an increase in the thickness of the stratum corneum caused by ultraviolet rays.

4. In Paragraph 1, The above composition comprises one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethyl cellulose.

5. In Paragraph 1, A composition in which the above-mentioned wound site is a non-open wound site.

6. In Paragraph 1, A composition in which the concentration of alloferon in the above composition is 0.002 mg / mL to 0.1 mg / mL based on the total composition.

7. In Paragraph 4, A composition in which the concentrations of polynucleotide, hyaluronic acid, and carboxymethylcellulose in the above composition are 0.1 mg / mL to 30 mg / mL, 1 mg / mL to 20 mg / mL, and 0.1 mg / mL to 30 mg / mL, respectively, based on the total composition.

8. In Paragraph 4, The molecular weight of the above polynucleotide is 1,000 kDa to 3,000 kDa, and The molecular weight of the above hyaluronic acid is 1,000 kDa to 3,500 kDa, and A composition in which the molecular weight of the carboxymethylcellulose is 100 kDa to 500 kDa.

9. In Paragraph 1, The above composition is a composition that prevents, improves, or treats a wound.

10. In Paragraph 4, The above composition further comprises one or more moisturizers selected from the group consisting of glycerin and butylene glycol.

11. In Paragraph 10, A composition in which the concentrations of glycerin and butylene glycol in the above composition are 30 to 80 mg / mL and 120 to 180 mg / mL, respectively, based on the total composition.

12. In Paragraph 1, A composition having a pH of 6 to 7.

13. In Paragraph 1, A composition having a surface viscosity of 4.5 Pa·s to 200 Pa·s.

14. In Paragraph 1, The above composition is a composition that forms a film.

15. A topical skin composition for preventing or improving wounds, comprising alloferon as an active ingredient.

16. In Paragraph 15, The above composition further comprises one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethylcellulose.

17. A cosmetic composition for preventing or improving wounds, comprising alloferon or a cosmetically effective salt thereof as an active ingredient.

18. In Paragraph 17, The above composition further comprises one or more viscosity modifiers selected from the group consisting of polynucleotide, hyaluronic acid, and carboxymethylcellulose.

19. A pharmaceutical composition for the prevention or treatment of wounds, comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

20. A kit for the prevention or treatment of wounds, comprising the composition of claim 19 and instructions.

21. A method for preventing or treating a wound, comprising the step of administering a composition containing alloferon or a pharmaceutically effective salt thereof as an active ingredient to an individual in need of the same in a pharmaceutically effective amount.

22. Use for the prevention, improvement, or treatment of wounds of a composition comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

23. Use in preparing a preparation for the prevention, improvement, or treatment of wounds, comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

24. Use in preparing a topical skin preparation of a composition comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

25. Use in manufacturing cosmetic formulations of a composition comprising alloferon or a cosmetically effective salt thereof as an active ingredient.

26. Use of a gel composition for wound dressing comprising alloferon or a pharmaceutically effective salt thereof as an active ingredient.

Images