UA92557U - Multilayer textile material for applications with biologically active coating - Google Patents

Abstract

The multilayer textile material for applications with the biologically active coating contains non-woven textile material soaked in the boric acid. The material is coated with two layers of the biocompatible biodegradable polymers with immobilized drugs. The internal layer contains Dioxidin (mass % 0.02-0.06) and Lidocaine (mass % 0.03-0.05). The external layer contains the emulsion of the medicinal vegetable oils mass % 2.5-5 – the oil from the walnut, or the buckthorn oil, or the dogrose oil, or the cedar oil. The coating also contains high-molecular polyvinyl alcohol, chitosan, carboxymethyl cellulose, and the biologically active substances such as chitosan lactate, iron lactate. Furthermore, the coating contains iodophor-dialdehyde of carboxymethyl cellulose, proxanol 268, glycerol or propylene glycol.

Description

The utility model belongs to health care and relates to surgical materials used in medicine as dressings, bandages, napkins, namely applications with a biologically active coating for primary medical care treatment of wounds, burns and muscle-bound structures with a prolonged therapeutic effect, and can be used in surgery to provide primary treatment of infected wounds, burns, ulcers, bedsores with varying degrees of exudation and the area of the affected surface.

A two-layer bandage is known for the treatment of wounds, burns, ulcers, bedsores and providing primary medical care with a curative effect (1). The bandage is made of a layer of cotton, viscose or cotton viscose non-woven material, which is combined with a draining layer of textile cloth or cloth based on artificial fibers with the distribution of medicinal compounds in them in amounts of 0.01-20 95 wt. The bandage provides the possibility of using antimicrobial, local anesthetic, hemostatic and medical drugs and their prolonged effect.

The disadvantages of this bandage are insufficient sorption and hemostatic action and lack of pain relief.

There is a second analogue - a multilayer medical material on a textile basis, which contains successive layers of textiles |2)І: a textile layer, a textile layer with a biocompatible polymer composition that contains a drug and a textile layer with a biocompatible polymer composition that contains another drug.

The material of the second analogue has insufficient effectiveness in the initial stage of treatment due to the absence of anesthetic and hemostatic compounds. In addition, the presence of moisture in the polymer composition imposes additional requirements for the storage of the finished material.

The closest technical solution both in essence and in terms of the tasks to be solved, which was chosen as the closest analogue (prototype), is a multilayer textile material for applications with a biologically active coating |Z)|, containing a non-woven textile material with hydrophilic properties, on which is sequentially applied two layers of biocompatible biodegradable polymer with immobilized drugs, namely in the inner layer - dioxidin mass. 95 0.02-0.06 and lidocaine wt. 95 0.03-0.05 and in the outer layer - emulsion of medicinal plant oils wt. 95 2.5-5 - walnut or sea buckthorn, or rosehip, or cedar oil.

However, the shortcomings of the prototype include insufficient effectiveness of antimicrobial and virucidal activity, biological and wound-healing effects of the specified material.

The basis of the useful model is the task, due to the presence of such components as polyvinyl alcohol, carboxymethylcellulose, chitosan, iron lactate, iodophor-dialdehyde carboxymethylcellulose, proxanol 268 and glycerin or propylene glycol in the claimed multilayer material for applications, to ensure an increase in the effectiveness of its antimicrobial and virucidal activity when acting on a wound.

The essence of the useful model is in the multilayer material for applications, which contains boric acid-impregnated non-woven textile material with hydrophilic properties, on which two layers of a biocompatible biodegradable polymer with immobilized drugs are sequentially applied, namely, in the inner layer - dioxidin mass. 905 0.02-0.06 and lidocaine wt. uyu 0.03-0.05 and in the outer layer - an emulsion of medicinal vegetable oils wt. 95 2.5-5 - walnut or sea buckthorn, or rosehip, or cedar oil consists of the fact that it includes high molecular weight polyvinyl alcohol, chitosan, carboxymethyl cellulose and biologically active compounds such as chitosan lactate and iron lactate, as well as iodophor-dialdehyde carboxymethyl cellulose, proxanol 268, glycerin or propylene glycol with the following ratio of these components, wt. 90: polyvinyl alcohol - 4.0-5.0; carboxymethylcellulose - 1.5-4.0; chitosan - 1.5-2.5; iron lactate - 0.5-1.0; carboxymethylcellulose iodophor-dialdehyde - 2.0-2.5; proxanol 268-0.5-1.0; glycerin or propylene glycol - 4.0-6.0; water the rest to 100 95.

A comparative analysis of the technical solution with the prototype shows that the claimed multilayer material for applications differs in that it includes high molecular weight polyvinyl alcohol, chitosan, carboxymethylcellulose and biologically active compounds such as chitosan lactate and iron lactate, as well as iodophor-dialdehyde carboxymethylcellulose, proxanol 268, glycerin or propylene glycol with the following ratio of these components, wt. o: polyvinyl alcohol - 4.0-5.0; carboxymethylcellulose - 1.5-4.0; chitosan - 1.5-2.5; iron lactate - 0.5-1.0; carboxymethylcellulose iodophor-dialdehyde - 2.0-2.5; proxanol 268-0.5-1.0; glycerin or propylene glycol - 4.0-6.0; the rest of the water up to 100 95; and also the fact that the inner layer of the application, which is located directly on the textile carrier, contains polyvinyl alcohol, sodium carboxymethylcellulose, the anesthetic lidocaine, antimicrobial compounds - dioxidine and carboxymethylcellulose dialdehyde as a cross-linking reagent and iodophor reagent, and the fact that the outer layer of the application contains a hemostatic agent - iron lactate.

The technical result of the claimed multilayer material for applications is provided due to the extended spectrum of biological activity of the composition of the components: - iodoform - provides increased bactericidal and virulicidal effect on gram-positive and gram-negative bacteria and a positive immunomodulatory effect, - chitosan lactate, which increases the biological activity of the emulsion of vegetable oils stimulate epithelialization of tissues and accelerate the nutrition of wounds, - polyvinyl alcohol and carboxymethyl cellulose provide extreme draining properties for the sorption of wound fluid and provide the necessary vapor-gas exchange for the wound.

The used iodophor is one of the most active antimicrobial agents, which has a rapid bactericidal and virulicidal effect on gram-positive and gram-negative bacteria and a positive immunomodulatory effect. The therapeutic effect (anti-inflammatory, necrolytic, healing) when biologically active substances are immobilized in the structure of the claimed composition is provided by the features of desorption from the film of medicinal components into the wound environment.

Thus, the claimed multi-layer material for applications meets the utility model criterion of "novelty".

The proposed useful model solves the problem of creating material from applications, dressings for primary medical care of wound treatment with a prolonged therapeutic effect with better operational properties: analgesic, antimicrobial, hemostatic, wound healing acceleration compounds.

A useful model solves the problem of creating a medical material that relieves pain syndrome, accelerates the healing and treatment processes without traumatic changes in bandages.

The multi-layer material of prolonged therapeutic effect is made in the form of a textile material with hydrophilic properties, on which two layers of a biocompatible biodegradable polymer with immobilized medicinal compounds are applied. The layer located directly on the textile material contains an antimicrobial and anesthetic agent, and the outer layer, facing the wound, includes a biologically active layer based on polysaccharides, which, when in contact with exudate, turn into a gel. In addition, the layer located on the textile material may additionally contain an antioxidant agent, as well as an agent that stimulates epithelialization of damaged tissues. The outer layer may additionally contain

A hemostatic agent. Textile material with hydrophilic properties is represented by non-woven fabric, including quilted fabric. Biocompatible biodegradable polymer can be represented by polyvinyl alcohol, sodium carboxymethyl cellulose or chitosan lactate. As an antimicrobial material, it may contain iodopyrone, dioxidine or carboxymethylcellulose dialdehyde. Lidocaine was used as an anesthetic. Walnut or sea buckthorn oil, or rosehip oil, or cedar oil was used as a means simulating epithelialization of tissues. The outer layer additionally included a hemostatic agent - iron lactate. To facilitate the change of the spent material and to minimize damage to the wound surface during dressings, an atraumatic gel layer was additionally placed in the material, located between the outer layer of biocompatible biodegradable polymer with immobilized drugs or inside the above-mentioned layer.

The rate of release of the medicinal product into the body is determined by the diffusion movement of complexes of medicinal compounds with the biopolymer in the process of its biodegradation. The low diffusion coefficient of the drug does not lead to its significant redistribution within the layer of the polymer coating and mixing of the therapeutic concentration of drugs.

It was established that the change of treatment regimes due to the gradual degradation of the composition of the polymer coating of the application takes place without changing the bandage within 1-3 days. In addition, in the case of using drugs that do not mix with each other, they can be distributed in the material, alternating layers many times with the necessary therapeutic effect.

The most used thickness of the first polymer layer was 0.5-1.5 of the thickness of all polymer layers and determined the time of changing treatment modes when using one application of the proposed material. However, for special cases of treatment, napkins can be made with the appropriate thickness of each layer. All layers can contain both different and the same biocompatible biodegradable polymer. In this case, the material can be produced by successive immobilization of drugs in the polymer layer. The material may additionally contain a layer of sorption material located on the textile material from the side adjacent to the layers of biocompatible biodegradable polymer with drugs immobilized in them. This layer can be made from a polymer that has sorption properties, and from other materials (modified textile, carbon fibers, cotton, polymer, and the like). In this embodiment, the claimed material has increased sorption characteristics in relation to the microbial composition and exudate,

ensuring the outflow of wound exudates and contributing to the creation of optimal conditions for regeneration processes in the wound. When drugs are impregnated/mobilized in polymer layers on a textile carrier, their concentration in injured tissues varies within the allowed therapeutic norms for each of the drugs used. The table shows the ranges of concentration values that were used in the manufacture of the multilayer material described above. These concentrations are preferred, but not limiting, of the possible ranges of concentration values presented in Table 1.

Table 1

The composition and properties of the obtained multilayer materials for applications

Membrane. 25 :-4 Adsorbing mail (vol. 95) about vapor permeability, | and the integrity of Uo mass. What about mass. Uo carboxymethyl cellulose - 2.5; 5.0 carboxymethyl cellulose - 30; carboxymethyl cellulose - 5.0; 5.0

Oil of walnut or sea buckthorn, or rosehip, or cedar - 6.0;

With |Polyvinyl alcohol-36.0;. | 11420 |5Omg/cm'h.| 80 carboxymethyl cellulose - 10.0; 5.0;

Oil of walnut or sea buckthorn, or rosehip, or cedar - 6.0;

Before use, the material is moistened with a physiological solution, the biocompatible biodegradable polymer turns into a gel-like state, which ensures prolonged transport of drugs into the wound environment and low trauma. The claimed multi-layered material for applications with a biologically active coating can be used both for providing first aid and for dressing injured patients in outpatient and inpatient settings. The use of this material is especially effective in areas of emergency situations and military and military conditions. A useful model is illustrated, but not limited, by the following examples.

Example 1. A 0.2 mm thick layer of a mixture of polyvinyl alcohol, sodium carboxymethylcellulose with immobilized carboxymethylcellulose dialdehyde (antimicrobial agent), lidocaine (anesthetic agent), and dioxidin (antimicrobial agent) was applied to a nonwoven textile material with hydrophilic properties pretreated with a boric acid solution. , and then a layer of a mixture of chitosan lactate (biocompatible biodegradable polymer), lidocaine (anesthetic agent) 0.1 mm thick. Then the obtained material is cut into napkins, which are packed in moisture-proof packaging, for example sealed in polyethylene.

The packaged napkin is sterilized using gamma radiation. In hermetic packaging, it does not lose its therapeutic effectiveness for 2 years, in fact, its shelf life is determined by the preservation of sterile packaging.

Example 2. The same as in example 1, only the outer layer facing the wound consisted of a mixture of chitosan lactate and dimethyl sulfoxide (concentrations 5-20 95).

Example 3. The same as in example 1, only the outer layer facing the wound consisted of a mixture of chitosan lactate, plasticized with an emulsion solution of medicinal vegetable oils, stabilized by chitosan-lecithin membranes. The thickness of the outer layer of the polymer facing the wound in relation to the total thickness of the polymer layer was 0.3. The ratio of the thicknesses of the polymer layers in relation to the total thickness of the material was 1:0.3:0.45.

Example 3. The same as in example 1, only the outer layer facing the wound consisted of a mixture of chitosan lactate (a biocompatible biodegradable polymer), lidocaine (an anesthetic), and iodomidol (an antimicrobial agent), and iron lactate (a hemostatic agent)

Example 4. A layer of plasticized mixture of polyvinyl alcohol, carboxymethyl cellulose (biocompatible biodegradable polymer), lidocaine (anesthetic) and iodomidol (antimicrobial) was applied to a non-woven textile material with hydrophilic properties pretreated with a boric acid solution, with sea buckthorn oil immobilized in it (an agent that stimulates epithelialization tissues). The layer facing the wound contained lidocaine (an anesthetic) and carboxymethylcellulose dialdehyde (an antimicrobial agent). The ratio of the thickness of the outer layer of the polymer facing the wound to the total thickness of the polymer layers was 0.15. Such napkins are used for burns and non-bleeding wounds.

Example 5 Same as Example 4, only the layer located on the textile contained oil

From rose hips (an agent that stimulates epithelialization of tissues), dioxidin (an antimicrobial agent) and lidocaine (an anesthetic).

The multi-layered material of prolonged therapeutic action for providing first aid, manufactured according to a useful model, is a material of a wide spectrum of action, has improved operational properties, accelerates healing processes and reduces treatment time due to an atraumatic change of treatment regimens without changing bandages. In the treatment of infected wounds and burns, trophic wounds and bedsores, the dressing made of the obtained material absorbed the wound exudates well. In addition, the use of this multi-layered material of applications with a biologically active coating ensures the sequential therapeutic actions of unmixed drugs that have antimicrobial, local anesthetic, hemostatic, antioxidant or other therapeutic effects, which contribute to the achievement of an increased therapeutic effect, ensuring faster healing of wounds, less frequent change of bandages with almost complete atraumaticity.

Table 2 shows the characteristics of the obtained materials for applications.

Table 2

Indicators of the characteristics of the obtained materials for applications

In nick PN

With 50 x 200 mm, N (kgf): 6 | Hygroscopicity. 96/77 | At least 89-972 shD.-::.:6.::GoS"U 8 | Sorption capacity//-/::77771111111Ї1111111111111 95114111

Capillarity, mm

As can be seen from the data given in Tables 1 and 2, the claimed multilayer material for applications due to its composition has the following properties: - absorbs wound exudate and bacterial toxins; - prevents dehydration of the wound as a result of evaporation of water from its surface; - prevents infection of the wound, pain syndrome; - provides extreme draining properties for sorption of wound fluid; - provides the necessary vapor-gas exchange for the wound - prevents blood loss; - provides a moist environment in the wound that is optimal for healing; - does not have excessive adhesion to the wound and healthy skin, which allows you to painlessly change or remove the bandage if necessary; - does not break down on the surface of the wound; - does not cause allergic reactions; - compatible with other dressings.

Sources of information: 1. Patent of the Russian Federation No. 2143281, published on December 27, 1999 - analogue. 2. Patent of the Russian Federation Mo A 981160005, published on 06.20.2000 - analog. 3. Patent of the Russian Federation No. 2247580, published on August 20, 2004 - prototype.

Claims (3)

USEFUL MODEL FORMULA 1. Multi-layered textile material for applications with a biologically active coating, which contains boric acid-impregnated non-woven textile material with hydrophilic properties, on which two layers of biocompatible biodegradable polymer with immobilized drugs are successively applied, namely, in the inner layer - dioxidin mass. 95 0.02-0.06 parts of lidocaine by weight. 95 0.03-0.05 and in the outer layer - emulsion of medicinal plant oils wt. in 2.5-5 - walnut or sea buckthorn, or rosehip, or cedar oil, which is distinguished by the fact that it includes high molecular weight polyvinyl alcohol, chitosan, carboxymethyl cellulose and biologically active compounds such as chitosan lactate and iron lactate, as well as iodophor-dialdehyde carboxymethyl cellulose , proxanol 268, glycerin or propylene glycol with the following ratio of these components, wt. bo: polyvinyl alcohol 4.0-5.0 carboxymethyl cellulose 1.5-4.0 chitosan 1.5-2.5 iron lactate 0.5-1.0 iodophor-dialdehyde 20-25 carboxymethyl cellulose Mo proxanol 268 0.5- 1.0 glycerin or propylene glycol 4.0-6.0 the rest to water d 100 95. 2. The material according to claim 1, which differs in that the inner layer of the application, located directly on the textile carrier, contains polyvinyl alcohol, sodium carboxymethylcellulose, anesthetic lidocaine, antimicrobial compounds - dioxidine and carboxymethylcellulose dialdehyde as a crosslinking reagent and an iodophor reagent. 3. The material according to claim 1, which differs in that the outer layer of the application contains a hemostatic agent - iron lactate.