The present invention relates to a wound care product containing nano boric acid particles as antibacterial ingredient and an antibiotic effective in acidic environment, and comprising additional ingredients for their complementary effects.

Background of the Invention

Since prehistoric times, various developments have been observed in the field of wound treatment. The wound can naturally heal on its own; however in ancient times, hunters and gatherers realized that the wound healed faster with various herbal materials. In addition to this approach, a great number of developments have been obtained in wound treatment in time with the requirements of providing hygiene around the wound and stopping bleeding.

Chemist Henry Drysdale developed Dakin Solution containing sodium hypochlorite and boric acid in order to clean the wounded area, and this solution was used for washing traumatic wounds during the First World War. Application of dressing from nylon, polyethylene, polypropylene and polyvinyl materials has emerged in 1950s, and it was observed that it protects the wound and accelerates healing in wound treatment process. Within a framework of a research published in the 1960s by George Winter and Howard Maibach, superior efficacy of moist wound dressing adoption was reported, and the adoption of moist wound dressing was recommended since it provided superior clinical outcomes.

In applications of modem era, there are numerous dressing applications such as dry dressing, wet to dry dressing, chemical impregnated dressing, foam dressing, alginate dressing, hydro-fiber dressing, transparent film dressing, hydrogel dressing, hydrocolloidal dressing, and self-compatible dressing. The dressings being hygienic is a feature especially sought as they are in direct contact with the wound. For this purpose, the dressings are frequently treated with silver salts having antiseptic properties. Silver nitrate, which is often preferred in this regard, is a very toxic material, even though it has antibacterial properties. Although it does not exhibit rapid side effects in short-term contact other than leaving a black and purple stain on the skin, it has harmful effects such as burns, irritation on the skin and especially in the eye in case of long-term exposure. This situation creates problems in the long-term use of dressings which are used due to their antibacterial properties and positioned on the skin, even on the wound.

Another material which can be used for this purpose in the state of the art is boric acid. Boric acid used in dilute form can be used as an antibacterial ingredient.

South Korean patent document no KR20020000580, an application known in the state of the art, discloses a wound dressing containing a chitosan/polyvinylalcohol hydrogel and method for producing the same. Here, the boric acid or borax is only used as a gelling agent, it is not a substrate or a matrix, and there is a gel covering the wound.

Negative pressure has been used for a long time in chronic wounds. Polyurethane sponge used while applying vacuum contains silver nitrate for anti -bacterial properties. Silver nitrate, which has no property apart from antibacterial properties, has known adverse effects.

Turkish patent document no TR 2018/17223, another application known in the state of the art, is a patent application of the present inventor and discloses production method of polyurethane foam structure comprising nano boric acid particles. It has been seen that the features of creating a synergic antibacterial effect and providing versatile healing properties, containing the materials that provide these effects together and releasing them in a controlled manner, thanks to the fact that the compound providing the acidic environment is also an antibacterial material itself, are not available in the state of the art.

Summary of the Invention The objective of the present invention is to use boric acid nanoparticles, which are more biocompatible, instead of silver nitrate particles, which are frequently used in the state of the art despite their harmful side effects, as an antibacterial ingredient. Another objective of the present invention is to increase efficacy as wound healing agent since the use of nano boric acid particles induce cell and lymphocyte proliferation.

Yet another objective of the present invention is to enable the wound to be healed without leaving a scar.

A further objective of the present invention is to accelerate wound healing process with a synergic effect by means of using boric acid nanoparticles together with an antibiotic effective in acidic environment.

Detailed Description of the Invention

A wound care product of the present invention contains nano boric acid particles and an additional antibiotic effective in acidic environment and at least one additional ingredient for its complementary effects selected from a group comprising additional antimicrobial or anti-fungal materials; materials blocking the protective film forming of bacteria; cell membrane permeabilizers to boost the efficiency of antibacterial and anti-fungal materials; homeostatic materials; materials promoting scarless healing of the wound; materials contributing to cell and lymphocyte proliferation required for wound healing; polymeric materials and crosslinkers for producing gels and films for the protective covering of wounds; antiallergic materials and combinations thereof.

The antibiotic effective in acidic environment that is used within the scope of the invention is preferably rifocin. In a different embodiment of the invention, this antibiotic is of natural origin including but not limited to chitosan, propolis, carvacrol (thyme oil), Quercus Infectoria (cyprus oak) and Cistus extract. Within the scope of the invention, chitosan is preferred among these.

In one embodiment of the invention, a material selected from the group comprising fatty alcohol, a diol, fulvic acid, saponin or an extract of a saponin containing plant is used as the cell membrane permeabilizer. Such permeabilizers increase the efficacy of antibiotics by opening the cell membranes of target bacteria, thus making it easier for antibiotics to penetrate their cells.

In one embodiment of the invention, potassium iron sulfate double salt is used as the homeostatic product.

In one embodiment of the invention, the scar preventing product is boric acid and/or chitosan.

In one embodiment of the invention, the cell and lymphocyte proliferation inducing material is boric acid and/or chitosan.

In one embodiment of the invention, the film or gel forming material is polysaccharides, aloe vera extract, and/or chitosan.

In one embodiment of the invention, betaine, nettle extract or rosewood oil are preferred as the antiallergic material. In one embodiment of the invention, the wound care product of the present invention is in the form of polyurethane foam or a cellulosic sponge used for use in the anti-bacterial foam NPWT (negative pressure wound treatment) system. In one embodiment, the said wound care product is completely or partially immersed into water or in normal saline; and in another embodiment one or more of its functional materials are dissolved or dispersed in water or normal saline prior to immersion of the foam.

In a different embodiment of the invention, the wound care product of the present invention is in the form of a woven or non-woven cloth or similar substrate. Accordingly, the substrate in the wound care product is made partially or completely of chitosan or made of a woven or non-woven natural cotton or silk fiber. In case the wound care product of the present invention is in the said form, it is soaked in water or normal saline containing a solution and/or dispersion of functional materials.

In another embodiment of the invention, the wound care product is a mixture in form of a film or a gel containing biopolymers. Here, the film or gel forming material in the wound care product contains polysaccharides, aloe vera extract and/or chitosan.

In the state of the art, within the scope of the invention, nano boric acid particles are used instead of silver nitrate particles, which are frequently used as antibacterial agents but are started to be banned due to their adverse side effects. Boric acid is more biocompatible, and has similar antibacterial effects. Recent researches have shown that boric acid and boron products have a substantial effect on the wound. Some of these effects which the boric acid has are as follows: being well-known antibacterial and anti-fungal agents, being effective as a wound healing agent as it induces cell and lymphocyte proliferation, blocking the formation of bacterial films, facilitating scarless wound healing. Furthermore, the use of nano-sized boric acid within the scope of the invention increases the activity/efficiency/diffusion capacity by increasing the surface area. Its use with an antibiotic that can dissolve well in an acidic environment enables the wound healing process to be accelerated.

Within the scope of the invention, a new product has been developed to provide the antibacterial/antiseptic effect of boric acid and other newly discovered effects thereof in a stable and long-term manner. The product of the present invention is a 3-dimensional matrix (for example, a polyurethane sponge), and evenly distributed boric acid is present therein in nano-sizes and, thus in a physical distribution forming a very large surface. Therefore, the product preserves the release time of the boric acid up to 10 days without being modified. Additionally, low pH value provided by the boric acid also increases the synergic effect of Rifocin, which is the second ingredient. When our substrate is a sponge, it more successfully replaces the polyurethane sponge silver nitrate used as part of the system in NPWT (negative pressure wound treatment) systems used for healing chronic wounds by applying vacuum.

The product of the present invention solves many problems at the same time. Polyurethane sponges carrying nano boric acid reduce pH value, thereby enabling the wounds to heal faster in acidic environment and also increasing the synergic effect in combined use of antibiotics such as Rifocin, the effects of which increase in acidic environment. The novel product of the present invention enables the boric acid tol- provide antibacterial effect; 2- provide cell proliferating (wound healing) effect; 3- prevent harmful bacteria from forming films that protect themselves on the wound; 4- provide scarless wound healing; 5- provide a prolonged controlled release. For example, if boric acid is impregnated as a solution into a dressing, this dressing should be changed in every few hours. The controlled release of boric acid onto the wound from billions of nanoparticles in a carrier such as a polyurethane sponge or a dressing eliminates the need for frequent opening of the wound to change the dressing. The technical benefit provided by the subject matter of the invention and the essential part surpassing the state of the art is the use of the synergic effect of boric acid and its acidic environment in combination with special antibiotics effective in an acidic environment on wounds based on the fact that wounds heal more quickly in an acidic environment. Wound healing and other positive effects of boric acid are thus revealed. A superiority of the invention is that it is a product which alone can carry a plurality of materials providing many desired complementary properties and enables controlled release thereof.