LT5549B - Preparation for wound healing and prevention of bandage adhesion to the wound - Google Patents

Abstract

Preparation for wound healing and prevention of adhesion to the wound containing a physiologically acceptable salt of hyaluronic acid, iodine and potassium iodine.

Description

The present invention relates to a preparation based on a pharmacologically acceptable salt of hyaluronic acid, which is applied to the wound and which can prevent the dressing from sticking to the wound and at the same time speed up the healing process.

State of the art

The current state of healing of major or non-healing severe wounds relies on a number of different materials and techniques. Of course, the ideal solution is to clean the wound and then repair it with surgical treatment (stitching, skin extensions, etc.). However, this treatment is only applicable to a small number of skin defects and applies to surgical wounds and deep uninfected wounds.

Most large deep wounds are infected and contain necrotic particles. Bacterial infections can be predicted in non-healing wounds, and in almost all cases they are somewhat necrotic. These large extremely deep and healing wounds are very difficult to heal.

Currently, the following systems described below are used for the treatment of large and non-healing wounds.

One of the systems is re-dressing with moistened gauze, which provides a permanent moist medium for wound healing. The gauze is moistened with saline or an antiseptic solution (betadine, chloramine, rivanol, etc.). This method is troublesome because it requires frequent bandages every 4-6 hours and does not ensure complete wound sterilization and does not protect the skin from wetting around the wound.

Because dressings that are not regularly moisturized very often stick to the wound, they are often covered with petroleum jelly, a so-called greasy dressing. Vaseline is often mixed with iodine to give the bandage antimicrobial properties. The disadvantage of this application is that Vaseline closes the wound and spreads necrotic spots and infection under the bandage. Problems also occur in removing petroleum jelly from deeper wounds during reshaping. For this reason, this technique is only used for superficial wounds.

Smaller deep wounds often have plastic bandages applied to keep the wound moist. The bandage contains a cellulose derivative and also sometimes contains seaweed extract (alginate). Such a bandage essentially has a covering function because it does not disinfect the wound and the bandage itself does not help to eliminate necrotic tissue. There are very sophisticated and expensive systems on the market that use, for example, collagenase or ointment or cream based papain to remove necrotic tissue. Tissue secretion is mainly eliminated by preparations containing activated carbon.

If the necrotic parts are removed and the wound is disinfected, preparations containing a hydrated medium that is conducive to wound healing are used. Mostly alginate, a polysaccharide, is used, which is derived from seaweed. Some companies use carboxymethylcellulose to keep the wound medium hydrated, which is essential for its healing. The disadvantage of this system is that it requires wound cleaning in a separate step before applying wound healing agents and, moreover, it is impossible to keep the wound sterile and without additional efforts to prevent subsequent spread of infection.

Some formulations use different growth factors and hyaluronic acid sodium to enhance the healing effects. The disadvantage of the system in this case is that it also requires wound cleaning in a separate step, before applying wound healing agents. In addition, said preparations cannot sustain a sterile wound without additional effort and prevent the development of infection.

The combination of collagen and chemically modified cellulose is also used in healing wounds. Unless this system is supplemented with other materials, it is impossible to guarantee disinfection of the wound by self-extracting secretions, etc.

In addition, some authors recommend the use of oxygen therapy in hyperbaric chambers for the treatment of non-healing wounds (especially in diabetic patients). However, this therapy requires a great deal of effort due to the use of the apparatus.

Vacuum therapy is a type of treatment in which a porous elastic sponge is applied to the wound and the wound is covered with airtight tissue. The air is then drawn out of the wound and the resulting reduced pressure ensures the wound to be cleaned and excreted. The sponge is changed at regular intervals. It is a very demanding machine and is only suitable for use in well-adapted working conditions and is limited to specific diagnoses.

WO 97/02845 A1 describes a thin dressing for wound healing comprising sodium hyaluronate. The bandage may also contain antibacterial agents.

Description of the Invention

It is an object of the present invention to provide a preparation which, when applied to a wound, creates a medium that protects the wound from infections and at the same time disinfects the wound. In addition, one that would extract the secretions from the wound and thus prevent wound and skin from wetting and maintain good wound hydration and the presence of tissue mediators and enzymes. The preparation must also provide the ideal medium for granulation tissue formation and other wound regeneration processes. It must prevent the bandage from sticking to the wound, protect the skin around the wound, and allow it to spot any changes in the wound (especially bleeding).

According to the invention, the drawbacks indicated in the prior art and the above objects are solved by a preparation for wound healing and protection against adherence of the bandage to the wound. SUMMARY OF THE INVENTION The present invention is directed to a preparation comprising a physiologically acceptable salt of hyaluronic acid having a molecular weight in the range of 200,000 to 2,500,000, in a gel or in solution together with iodine and potassium iodide.

The proposed physiologically acceptable salt of hyaluronic acid is selected from the group consisting of sodium salt, potassium salt, lithium salt, calcium salt, magnesium salt, zinc salt, cobalt salt, manganese salt or combinations thereof. The preparation according to the invention is preferably in the form of a viscous aqueous solution or gel.

The preparation according to the invention preferably contains a physiologically acceptable salt of hyaluronic acid in a concentration of 0.05 to 10% by weight, iodine in a concentration of 0.05 to 2.5% by weight and potassium iodide in a concentration of 0.05 to 5% by weight. , as substances having antiseptic properties which act bacteriostatically and fungistically.

A preferred embodiment of the invention is a formulation comprising a physiologically acceptable salt of hyaluronic acid at a concentration of 0.05 to 10.0% by weight, an iodine at a concentration of 0.075 to 1% by weight and a potassium iodide at a concentration of 0.075 to 1% by weight.

The preparation according to the invention is obtained by dissolving the above materials in sterile water.

The preparation for wound healing and prevention of adhesion of the bandage to the wound is applied either directly to the wound or applied in the required amount on the side of the bandage which is then applied to the wound.

The combination of suitable salts of hyaluronic acid with iodine or potassium iodide is suitable to meet the above conditions. Hyaluronic acid salts belong to the most hydrophilic type of molecule. The product provides tissue fluid secretion after application on gauze and wound and also provides a constant moist medium. The combination of iodine and potassium iodide disinfects the wound for a short period of time, ensuring a clean wound environment. Hyaluronic acid salts also have a strong healing effect and are very active at all stages of the treatment process. All this has a positive effect on the formation of tissue granulation and subsequent epithelialization and thus wound healing. The advantage is also the ability to observe the bandage, and the fact is that only the wound itself is hydrated and the skin around the wound is not touched.

The preparation of the invention activates keratinocytes to produce cytokines, in contrast to iodine and potassium iodide alone (iodine complex) and hyaluronan separately. The resulting cytokines are activators and chemoattractants for different white-cell cells, which are expressed in accelerated wound cleaning and wound surface formation, granulation tissue formation. In addition, they activate keratinocytes, which promote wound healing. The above unintended effects are not demonstrated by any of the three formulations of the invention when used alone. Iodine in combination with other oligomeric or polymeric substances is used in some formulations (eg betadine). In our case, it is impossible to use the combination of hyaluronan as a polymeric material and iodine directly, since it is impossible to achieve the desired concentration of iodine in the solution. For this reason, a formed iodine complex is added. The iodine complex has the desired water solubility, and the combination of iodine and potassium iodide is more acceptable to cells than one iodine.

Examples of the Invention Example

0.1 g of iodine is dissolved in 0.15 g of potassium iodide in 50 ml of sterile water for injections. In addition, 1.5 g of sodium hyaluronate, of a molecular weight of 1 000 000, are dissolved in 50 ml of sterile water for injection. The solutions are prepared separately and sterilized separately. They are mixed together under sterile conditions after sterilization. The high viscosity solution that is obtained can be applied directly to the wound, which is then applied to the bandage, or it can be applied to the bandage, which is then applied to the wound.

example

1.0 g of iodine is dissolved in 1.5 g of potassium iodide in 50 ml of sterile water for injections. In addition, 1.5 g of sodium hyaluronate of 1500000 molecular weight are dissolved in 50 ml of sterile water for injection. The solutions are prepared separately and sterilized separately. They are mixed together under sterile conditions after sterilization. The high viscosity solution that is obtained can be applied directly to the wound, which is then applied to the bandage, or it can be applied to the bandage, which is then applied to the wound.

example

0.5 g of iodine is dissolved in 0.75 g of potassium iodide in 50 ml of sterile water for injections. Hyaluronate gel of 1500000 molecular weight is obtained by mixing 2 g of hyaluronan with 50 ml of sterile water for injection in a separate flask. The solution and gel are prepared separately and sterilized separately. They are mixed together under sterile conditions after sterilization.

It is possible to apply a thin layer of the resulting gel directly onto the wound, which is then applied to the dressing.

Claims (5)

DEFINITION CLAIMS 1. A preparation for wound healing and prevention of adherence to a wound, comprising iodine and potassium iodide in a physiologically acceptable salt of hyaluronic acid having a molecular weight of between 2,000,000 and 2,500,000. 2. A formulation according to claim 1, wherein said physiologically acceptable salt of hyaluronic acid is selected from the group consisting of sodium salt, potassium salt, lithium salt, calcium salt, magnesium salt, zinc salt, cobalt salt, and a combination thereof. 3. A formulation according to claim 1, wherein the physiologically acceptable salt of hyaluronic acid ranges from 0.05 to 10.0% by weight, the iodine concentration ranges from 0.05 to 2.5% by weight, and the potassium iodide concentration ranges from 0, 05 to 5% by weight. 4. A formulation according to claim 3 wherein the concentration of the physiologically acceptable salt of hyaluronic acid ranges from 0.05 to 10.0% by weight, the iodine concentration ranges from 0.075 to 1% by weight, and the potassium iodide concentration ranges from 0.075 to 1% by weight. 5. A formulation according to claim 1, which is in the form of a sterile aqueous solution or gel.