CZ202591A3 - medicinal preparation for prevention of decubiti and topic therapy of skin lesions - Google Patents

Abstract

Decubitus prevention agent and topical skin therapy lesions in the form of a biological dressing made of biologically preferably atelocollagen type I and hyaluronan are preferred partly in the form of a salt with a polyvalent cation Mg2 *, Ca2 *, Zn2 *, Cr3 * and / or Zr4 * ions, wherein the distribution of hyaluronan in the vasculature is s advantageously concentrated at one of the surfaces and the hyaluronan content is between 0.05% and 5% based on the weight of atelocollagen.

Description

Technical Field τό / »/ (/ t

The invention relates to dressings for the prevention of pressure ulcers and for the topical treatment of skin lesions, for example, scalding, burns, abrasions and certain skin diseases such as eczema and / or leg ulcers. Such diseases are more common and ¹ the prevention or treatment of the common subjects of medical care in outpatient and clinical medical practice.

BACKGROUND OF THE INVENTION

Many devices for the topical therapy of skin lesions are known from the patent and medical literature, among which may be mentioned

1 / traditional textile dressings with or without sticky substrates 2 / non-woven dressing materials sometimes impregnated with pharmacologically active substances

3 / synthetic dressings in the form of films, gels or foams 4 / biological dressings

5 / non-bandages, eg cleansing granules, enzymatic and antibiotic creams and sprays, and j.

The subject matter of the application relates in particular to the category mentioned under number 4, which are physiologically non-irritating and tissue-tolerant porous substrates made of various natural materials. These biological dressings, whether of human or animal origin, are still at an early stage of commercial development. Most products are based on collagen, some are based on gelatin, chitosan, or keratin. Of these materials, collagen, the fibrillar protein found in connective tissues and bones, has reached the largest distribution. More than 10 types of collagens are known, for the purpose of biological dressings the most widely used is type I, characterized by a significant hemostatic effect. The ideal dressing material should be fully tolerated in both tissue and wound and not cause inflammatory reactions. Such collagen products do not possess such a capability, but modified collagen, designated atelocollagen, which is according to the process of our patent application PV 1079-91 ^of peptides that carry cross-species immunological reactions, is tolerated in the tissue without reaction. However, in addition to the full tolerance of the dressing material, a suitable effective agent should actively assist wound healing. A number of substances have been proposed for similar purposes, such as interleukin-1 growth promoters, alaptide, or various enzymes. But a brave situation in patients

- 2 who are immobile, or who have a natural disposition to produce leg ulcers or other skin lesions, show that this is a health problem requiring new and more effective; solution. The lack of these known biological enclosures may also be behind this condition because of their low stability and high cost of production.

SUMMARY OF THE INVENTION

It is an object of the present invention to combine two commercially available natural polymers of suitable purity to form a biological dressing with novel properties, which are non-irritant associated with antimicrobial resistance and enhancing healing effect associated with hematostopic collagen properties and beneficial effect of exogenous hyaluronan in skin tissue.

In this new combination, collagen, deprived of a significant proportion of non-collagen proteins, gelatin, and preferably telopeptides, is a suitable cushion carrier or, after acidification, a gel-like, well adhering substrate to the skin in which hyaluronan is deposited. with an enormous sorption capacity for the aqueous phase and, which is particularly important, creates a barrier against microflora. This property, together with a marked inhibitory effect on common, non-collagenolytic proteinases, gives the new biological dressing the ideal properties

J for non-sterile environments typical of immobilized patients and skin lesions;

Combination of low protein (below 1%) hyaluronan with a suitable molecular weight above 300,000 daltons, preferably aided by dimerization of the ions of the polyvalent cations, with a collagen derivative devoid of terminal telopeptides, also called atelecollagen, in which terminal peptides containing regions are removed antigenic determinants, is ideally tolerated in living human tissue without signs of inflammatory and immunogenic reactions. Both substances are commercially available, and in particular for hyaluronan, a very costly preparation so far, there have been rapid prices in recent years, so this new biological dressing can achieve widespread use in the treatment of skin lesions as well as in the prevention of pressure ulcers and ulcers.

DETAILED DESCRIPTION OF THE INVENTION

1. A mixture of collagen fibers obtained by the gradual purification of bovine tendon material in solutions of sodium chloride, calcium hydroxide and dilute acetic acid, enzymatically devoid of non-collagen proteins and telopeptides as described in PV 1079-91, is mixed with a solution of sodium hyaluronate and sodium hyaluronate. to a suspension containing 30 g / l of dry matter of collagen fibers and 0.15 g / l of magnesium sodium hyaluronate and 0.15 g / l of sodium hyaluronate. Mixture. The mixture is thoroughly mixed in a homogenizer and used to apply plates of suitable shape and size. The frozen plates are removed from the mold and freeze dried under reduced pressure. After drying, they are trimmed and shaped and packaged in airtight polyethylene containers, sealed and sterilized in gamma-radiation containers.

2. Prepare a solution of pharmaceutical grade hyaluronan in distilled pyrogen-free water to a concentration of 2 g / l. This solution is carefully poured into a mold made of silicone rubber having the shape and size of the desired dressing disc. The amount of solution is such that a 1-2 mm thick layer is formed at the bottom of the mold. The mold is placed in a freezer at - 25 ° and allowed to freeze. After freezing, the mold is made up with a suspension of atelocollagen fibers in deionized water containing 25 g / l dry matter and immediately frozen at -25 to -45 ° C. After freezing, the mold is placed in a freeze-dryer and freeze-dried. The dry plates are removed from the mold, wrapped in protective containers provided with a standard leaflet, sealed and sterilized by gamma irradiation. Spreadsheets; they are used in such a way that the hyaluronan-coated surface is laid on the wound.

3. The procedure of Example 1 is followed, but the mixture of collagen and hyaluronan formed is nano-frozen but acidified with 0.75% glacial acetic acid, well homogenized and stored in closed containers at about 5 ° C as a liquid gel-like preservative for skin lesion therapy. .

07 / -91

Claims (1)

PATENT LID Mesh A composition for the prevention of pressure sores and topical therapy of skin lesions in the form of a biological dressing or gel, comprising a type I collagen derivative containing less than 5% by weight of non-coagulant proteins, preferably at least partially depleted of terminal telopeptides, i.e. so-called atelo-collagen, and 0.05 to 5% by weight, based on the weight of the collagen derivative, of a high molecular weight hyaluronan of mol. weighing at least 300,000 daltons, preferably at least a portion of the hyaluronan is in the form of a salt of polyvalent metal ions selected from the group consisting of Ig ²⁺ , Ca ²⁺ , Zn ⁺ , Cr ^+, and / or Zr ⁴ | ⁺ and the distribution of hyaluronan is preferably concentrated on one or both surfaces in contact with the skin lesion. O