RU2397781C1 - Nonwoven material of medicinal purpose which possesses wound-healing, antibacterial and antiviral activity and based on it bandaging means - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: described is nonwoven material of medicinal purpose, which contains fibrous base and inorganic powder, intended for wound closing. Nonwoven material, which possesses wound-healing antibacterial and antiviral activity, contains at least one layer of nonwoven polymer fibrous material, with highly porous particles of aluminium oxide hydrate being fixed on its fibres. Described is bandaging means possessing wound-healing, antibacterial and antiviral activity, which contains at least one second layer of described above nonwoven material, and at least one second layer of atraumatic material. Described is application of filtering material, which contains, as base, nonwoven polymer fibrous material, obtained by method of electroformation, on whose fibres fixed are particles of aluminium oxide hydrate, for manufacturing materials of medicinal purpose, which possess wound-healing, antibacterial and antiviral activity.

EFFECT: described bandaging means is flexible and elastic.

16 cl, 21 tbl, 5 dwg, 8 ex

Description

The invention relates to absorbent non-woven materials containing inorganic powders, and can be used in medicine, especially relates to the production of dressings (medical napkins, dressings, etc.) designed to close wounds.

Currently, a significant number of dressings used in clinical practice are known. However, there is no universal tool that would meet all the criteria for dressings.

The most famous agents used as dressings applied directly to the wound are sterile gauze wipes, either impregnated with various medicinal products or covering ointments and powders applied to tissues. The main disadvantage of gauze dressings is the high adhesive properties with respect to the wound surface. This slows healing, leads to pain and tissue trauma when changing the dressing. Changing the dressing leads to repeated pain and mechanical irritation of the wound, which, in turn, does not contribute to reducing the terms of wound regeneration.

Known wound cover [RU 2314834 C1, 2008] based on woven and non-woven materials of natural or synthetic origin, containing metal particles having biological activity against pathogenic flora, while it contains silver nanoparticles from 80 to 99.7% as metal particles, iron from 0.1 to 20%, aluminum from 0.1 to 20%, copper from 0.1 to 20%, which are deposited in a vacuum chamber using magnetron sputtering.

The use of metal particles related to heavy metals gives the wound coating some toxicity.

Known [US 200810026041 A1, 2008] is a medical non-woven structure comprising: a) alumina nanofibres, b) second fibers mixed with alumina nanofibres, and second fibers used to create asymmetric pores; and c) a large number of particles distributed on nanofibres of alumina, where the aforementioned particles are selected from the group consisting of a sorbent, a drug, and a bactericidal agent.

The resulting mass (composition) is converted into a fibrous structure using a vacuum system on the bottom of the screen, as in the technology when a sheet of paper is cast by hand or in a paper machine, these are well-known methods for creating non-woven material using wet processing technology .

The purpose and properties of such a medical structure are determined by metal particles belonging to heavy metals fixed on nanofibers, which gives the dressing some toxicity.

It is known [WO 2009024909 A2] an absorbent article containing an adsorbent layer with a coating containing inorganic nanoscale powders based on aluminum, silicon, etc., to improve the hydrophilicity of the adsorbent layer.

It is known [US 5795836, 1998] relating to medical non-woven materials containing complexes of inorganic powders. In particular, it relates to medical non-woven materials containing a complex of inorganic powders, which consists essentially of TiO ₂ , Al ₂ O ₃ and SiO ₂ , suitable for treating open wounds and damage to soft tissues. This material is the closest to the claimed material and is selected as a prototype.

The complex of inorganic powders used does not have an antimicrobial effect.

A dressing is known [RU 2134126 C1, 1999], selected as a prototype for the inventive dressing, made of an absorbent sheet fibrous layer containing cellulose and viscose fiber, and an atraumatic vapor-permeable layer facing the wound, while the absorbent sheet fibrous layer further comprises carbon-modified alumina having a specific surface area of 80-300 m ² / g, a pore volume of 0.08-0.250 cm ³ / g This tool is the closest to the claimed dressing and is selected as a prototype.

The disadvantage of the prototype is that the manufacturing technology of the material does not allow to obtain sufficiently flexible and elastic dressings, in addition, the given absorbency values are currently not optimal.

The objective of the invention is to expand the arsenal of non-woven materials for medical use and dressings with wound healing, antibacterial and antiviral activity.

The problem is achieved in that, like the well-known proposed non-woven material for medical purposes, having wound healing, antibacterial and antiviral activity, contains a fibrous base and inorganic powder.

What is new is that it contains at least one layer of non-woven polymeric fibrous material as a fibrous base, while highly porous particles of aluminum oxide hydrate are fixed to its fibers.

In addition, the nonwoven polymeric fibrous material is formed by fibers having a diameter of 0.1-10 μm, preferably 1-3 μm, from cellulose acetate, polysulfone or another biologically inert polymer.

In addition, the non-woven polymer fibrous material obtained by electrospinning, melt-blown technology or other methods that allow to obtain non-woven materials with the mentioned fiber diameter.

It is advisable that the highly porous particles of alumina hydrate be attached to the fibers both on the surface and in the bulk of the material.

In addition, the highly porous alumina hydrate particles attached to the fibers of the nonwoven polymeric fibrous material have a size of 0.2-5.0 μm, a specific surface area of 100-250 m ² / g and a porosity of 50-95% and are formed by nanofibers. Moreover, the nanofibers have a diameter of 5.0-8.0 and a length of 100-200 nm.

It is advisable that it additionally contains at least one layer of atraumatic material, intended, for example, to be placed on the wound surface.

Additionally, it may contain at least one layer of protective material located either on one or both sides.

In addition, it can be a dressing.

The task is also achieved by the fact that, like the well-known proposed dressing with wound healing, antibacterial and antiviral activity, contains at least one first layer of absorbent material and at least one second layer of atraumatic material.

What is new is that the above-described nonwoven material is used as the first mentioned layer.

It is advisable that it further comprises at least one layer of protective material located either on one or on both sides thereof.

In addition, it can be additionally equipped with elements for fixing it to the human body.

The task is also achieved by the fact that they carry out the use of the known filter material according to the patent of the Russian Federation No. 2317843, containing as a basis a non-woven polymer fibrous material obtained by the method of electrospinning, on the fibers of which particles of aluminum oxide hydrate are fixed, for the manufacture of materials and medical devices with wound healing , antibacterial and antiviral activity.

In addition, they carry out the use of a known filtering material containing, as a basis, a non-woven polymer fibrous material obtained by electrospinning, on the fibers of which particles of aluminum oxide hydrate are fixed, preferably for the manufacture of dressings with wound healing, antibacterial and antiviral activity

The problem is also achieved by the use of the known filtering material according to the patent of the Russian Federation No. 2317843, containing as a basis a non-woven polymer fibrous material obtained by electrospinning, on the fibers of which particles of aluminum oxide hydrate are fixed as a non-woven medical material with wound healing, antibacterial and antiviral activity.

Preferably, the nonwoven medical material additionally contains at least one layer of atraumatic material located on the side intended to be placed on the wound surface.

Additionally, the medical material may contain at least one layer of protective material located either on one or on both sides of the medical material.

Modern medical non-woven materials, especially those used as dressings, must meet a number of requirements, including must have good absorbent and sorption ability to absorb exudate and hold it well in its volume, capture and reliably isolate pathogenic microorganisms and at the same time at the same time, to prevent microorganisms from entering the wound from the outside. In addition, it is required that the dressing allows maintaining the optimal moisture regime in the wound, is vapor- and breathable, and also has a surface that does not adhere to the wound for atraumatic removal from the wound, which is achieved due to the smooth hydrophobic lint-free surface of the dressing on the contacting side with a wound surface.

Non-woven polymeric materials with a fiber diameter of up to 10 μm have a more developed surface and a highly porous structure than materials of thicker fibers, which ensures their ability to quickly absorb and well retain the absorbed liquid, for example, to effectively remove exudate from the wound. Materials with such a fiber thickness from cellulose acetate, polysulfone, polypropylene, polyamide and other bioinert polymers can be obtained by electrospinning or melt-blown technology, or by other methods that make it possible to obtain non-woven materials with the mentioned fiber diameter.

This property of the present invention is proposed to be enhanced by the additional introduction of highly porous particles of aluminum oxide hydrate into the base.

The antimicrobial activity of the base is also ensured by the highly porous particles of aluminum oxide hydrate that have a high electropositive charge, a high specific surface area and porosity, and an optimal pore structure. Particles with such characteristics are formed during the hydrolysis of aluminum nanopowders obtained by the method of electric explosion of a conductor in an atmosphere of argon or nitrogen.

Known materials having an electropositive charge, which are effective adsorbents of microorganisms, for example, during microbiological treatment of water and other liquids. However, the magnitude of their zeta potential, which is a quantitative characteristic of the particle’s charge, usually lies in the range of 10–20 mV, while the particles of alumina hydrate obtained from electric explosive aluminum nanopowders have a zeta potential higher than 30 mV. A higher charge of particles contributes to a higher efficiency of adsorption of microorganisms not only when treating water, but also when using them as medical material.

The hydrolysis products of aluminum powders with micron-sized particles usually contain more or less large non-porous particles and their specific surface area is usually 50-150 m ² / g. The hydrolysis products of electroexplosive nanopowders are highly porous agglomerates of nanofibers and have a specific surface area of more than 300 m ^{2 /} g. Aluminum hydroxide sols obtained by precipitation from aluminates or aluminum salts have a comparable specific surface. However, the absence of a high electropositive charge and significantly smaller pores than the particles of alumina hydrate obtained from electroexplosive powders make them much less active adsorbents of microorganisms.

In addition, alumina hydrate particles obtained from electroexplosive aluminum nanopowders have high absorbency due to hydrophilicity and high specific surface area.

Thus, particles of aluminum oxide hydrate are capable of adsorbing microorganisms from a moist wound surface in the layers of material adjacent to the wound, thereby contributing to its cleaning, and at the same time inhibiting the penetration of microorganisms into the wound from the external environment.

The highly porous structure of the base formed by the microfiber base provides good air permeability and vapor permeability of the material, which helps maintain optimal moisture conditions in the wound.

For effective wound healing when using the proposed non-woven material as a dressing, a hydrophilic microfiber surface is required. When directly applied to the wound, particles of microfibers with coated particles of aluminum oxide hydrate can adhere to the surface of the wound and, when the dressing is removed, remain in the wound and contaminate it, as well as cause traumatic painful removal of the dressing. However, this drawback is easily overcome by applying an additional layer of smooth hydrophobic lint-free porous polymeric material (mesh), for example polypropylene, which is located on the side intended for contact with the wound surface, or on both sides of the material. It is advisable that this layer be integrated with the nonwoven material so as not to create a barrier layer between the wound surface and the sorbent and absorbent material.

According to the invention, it was also found that the filter material according to the patent of the Russian Federation No. 2317843 (the material is manufactured by Aquazon LLC under the AquaVallis trademark), intended for microbiological water treatment, has the main characteristics listed above, and therefore it is applicable for the manufacture of medical materials with wound healing , antibacterial and antiviral activity, mainly dressings.

The filtering material AquaVallis is a non-woven polymer fibrous material obtained by the method of electroforming (Petryanov’s fabric), on the fibers of which particles of alumina hydrate are fixed, which are agglomerates of nanofibers. The basis of the AquaVallis material is a non-woven microfiber material of a biologically inert polymer, preferably cellulose acetate or polysulfone. At the same time, highly porous particles of aluminum oxide hydrate are fixed on the fibers both on the surface and in the bulk of the base material. The highly porous particles of aluminum oxide hydrate have a size of 0.2-5.0 μm, a specific surface area of 100-250 m ² / g and a porosity of 50-95% and are formed by nanofibers, which in turn have a diameter of 5.0-8.0 and a length of 100 -200 nm.

Depending on the purpose, medical devices based on filter material can be made in various forms - bandages, wipes, pads, plasters of various sizes and thicknesses.

For ease of attachment of the product, for example dressings, it may additionally have fixation elements to the human body.

The invention is illustrated in graphic materials.

Figure 1 shows a photomicrograph of the filtering material AquaVallis - base fibers (Petryanov’s fabric FPA - 15-2.0 from cellulose acetate), modified by porous particles of aluminum oxide hydrate.

Figure 2 shows a schematic representation of a multilayer medical pillow (dressing), where 1-14 layers of AquaVallis 2 material is a layer of a hydrophobic lint-free thermoplastic material that creates an atraumatic layer of the pillow and 3 is a protective layer of breathable material.

Figure 3 shows the edge of the skin wound on the 7th day of observation.

A is gauze. The purulent necrotic layer, granulation tissue are developed. Newly formed epithelium with the phenomena of hyperkeratosis and acanthosis. Detachment of the epithelium from the underlying granulation tissue;

B - The claimed tool. Epithelialization of the wound with moderate symptoms of hyperkeratosis and acanthosis is observed. The absence of a purulent-necrotic layer is noted.

Figure 4 shows the edge of the skin wound on the 21st day of observation.

A is gauze. Complete epithelialization of the wound. Incomplete differentiation of the epidermis. Rough layer and increase in thickness of the epithelium. Hyperkeratosis;

B - The claimed tool. More perfect organotypic differentiation of the newly formed epithelium. Ripening granulation tissue.

Figure 5 shows the state of the wounds in animals against the background of seeding wounds St. Aureus.

A - The claimed tool.

B - gauze

The invention is further illustrated by examples of its specific implementation.

Example 1. For the manufacture of non-woven medical material with wound healing, antibacterial and antiviral activity, we used a sheet of 1400 × 950 mm in size of a two-layer filtering material AquaVallis, made on the basis of Petryanov’s fabric FPA - 15-2.0 from cellulose acetate and containing 30% particles alumina hydrate (FIG. 1).

Example 2. To obtain medical material with an atraumatic layer, an additional polypropylene non-woven fabric with a surface density of 22 g / m ^{2 was} additionally applied to the material of Example 1 on both sides.

Example 3. The sheet of material according to example 1 is cut into rectangles of the required size and formed from them multilayer napkins (dressing), consisting of 6 layers of material and two layers of polypropylene non-woven fabric, located on both sides of the multilayer napkin and integrated with its surface by thermal pressing ( example 2).

Example 4. For the manufacture of a multilayer pad (dressing) (Figure 2), consisting of 14 layers of filtering material AquaVallis, one layer of polypropylene non-woven fabric was applied (example 2), located on the side intended for application to the wound integrated with the surface of the filter material by thermal pressing and a protective fixing layer from a mesh knitted polyester fabric of a larger size on the opposite side.

Example 5. The absorbency of products depending on the thickness of the layers based on the filtering material AquaVallis was determined by the mass of distilled water held by 1 g of a sample of the product material after it was completely immersed in water. The results are shown in table 1.

Table 1 Specimen characteristic Dry sample weight, g The mass of the wet sample, g Absorbency, g / g number of layers size cm 2 22.0 × 9.0 1.8 32,2 eighteen 6 8.0 × 5.5 1,1 19.6 eighteen 10 7.4 × 4.6 1,6 26.2 16 fourteen 7.5 × 4.5 2,8 34.8 12

Example 6. The determination of the ability of the inventive dressing to have an antibacterial effect was carried out in vitro according to the "Methodological recommendations for experimental (preclinical) study of drugs for local treatment of purulent wounds" (M., 1989, under the editorship of Dotsenko). Bacterial cultures were used: Staphylococcus aureus (Staphylococcus aureus) P-209 and 8538-p, Pseudomonas aeruginosa (Pseudomonas aeruginosa) - strain n / a, Escherichia coli (Escherichia coli), Klebsiella pneumoniae (Klebsiella pneumonia), Proteys vulgaric (vulgaris), Cand mushrooms p yes Candida.) A suspension of daily cultures of all the indicated microorganism strains was prepared at a concentration of 2000 microbial bodies in 1 ml of sterile physiological saline, total volume of 5 ml (6 test tubes for each microorganism). The test sterile material was lowered into each test tube (inventive dressing) the same sizes Control: in control test tubes with cultures, a sterile base product of the appropriate size was lowered (6 tubes for each microorganism). The initial concentration of colony forming units in all experiments was 10 ⁷ CFU / ml. Experimental and control tubes were placed in a thermostat at 37 ° C. After 1 h, 12 h, 24 h, 48 h, from all tubes, 0.1 ml of bacterial suspension was plated on Petri dishes with nutrient medium and distributed over the surface of the medium with a sterile spatula. The cups were placed in a thermostat for 24 hours. The number of grown colonies was counted and the number of colony forming units (CFU) per 1 ml was calculated.

In the study of the antimicrobial spectrum of action of the claimed agent, it was shown that with direct contact, the claimed agent had a pronounced antimicrobial effect on all groups of pathogens after 24 hours (table 2). After 72 hours, this effect persisted.

Table 2 shows the antimicrobial spectrum of the inventive dressing (sowing microorganisms, expressed in colony forming units - CFU)

table 2 Try Germs The concentration of microorganisms, CFU / ml 1 hour 12 h 24 h 48 h The control St.aureus 200 200 200 200 No. 1 St.aureus 200 200 eleven 0 The control P.aeruginosa 200 200 200 200 Number 2 P.aeruginosa 200 152 eighteen eighteen The control E.coli 200 200 200 200 Number 3 E.coli 200 200 5 6 The control P.vulgaris 200 200 200 116 Number 4 P.vulgaris 200 58 0 0 The control K.pneumoniae 200 200 200 130 Number 5 K.pneumoniae 200 eighteen 10 10 The control C.albicans 200 200 200 154 Number 6 C.albicans 200 118 63 35

Example 7. The virucidal properties of products based on AquaVallis filtering material were determined using the example of a model virus, the MS-2 coliphage, which is widely used in various experimental studies both in our country and abroad. Coliphage MS-2 strain RN-1505 was used; E. coli K12 KS507 strain 3254 ^{F + Str-r was} used as a suppressible culture. Both strains were obtained from the All-Russian collection of industrial microorganisms FSUE GosNII Genetics. A coliphage was applied to a sample of 14-layer material in the form of a disk with a diameter of 47 mm by filtering 300 ml of tap water containing coliphage at a concentration of 10 ² PFU / ₁₀₀ ml through the sample. In this case, all coliphages were absorbed by a sample of material, which was established by the absence of a coliphage in the filtrate. Then, the test sample was placed in a sterile Petri dish and poured with meat-peptone agar containing TTX and E. coli suspension. Petri dishes were incubated with samples at 37 ° C for 24 hours, after which the presence of coliphages in the sample was determined by the appearance or absence of lysis zones. The absence of coliphages in the material samples indicated its virucidal activity.

Example 8. In animal experiments, a multilayer dressing obtained from the material of example 4 was used, consisting of 14 layers of filtering material AquaVallis, one layer of polypropylene non-woven fabric located on the side intended for application to the wound, integrated with the surface of the filtering material by heat pressing and one protective fixing layer of a mesh knitted polyester fabric of a larger size with the side opposite to the wound. The division of animals into groups was carried out as follows:

1. A group with an experimental wound without treatment (a scab from the wound was removed every day for 21 days) - control 1 (20 pcs.).

2. Group with an experimental wound with a gauze dressing (the most widely used material) (scab from the wound was removed every day for 21 days) - control 2 (20 pcs.).

3. A group with an experimental wound with composite dressings (the scab from the wound was removed every day for 21 days) - experience (20 pcs.).

The effect of the dressing on the healing of a wound defect was studied using a “skin flap” model [1]. A skin flap 10 × 10 mm in size was cut out on a depilated back area in mice under ether anesthesia. To simulate longer healing, the scabs from the experimental wound were regularly (every day) removed. The following indicators served as the criteria for the development of the pathological process: general condition of animals, visual assessment of the condition of the defect and surrounding tissue, average diameter of the wound, number of animals (%) with healed wounds, acceleration of healing time (HSS = time for complete healing of wounds in the control - time for complete healing wounds in the experiment / time for complete wound healing in the control × 100%), the number of animals (%) with vocalization when removing the scab from the wound, analysis of the morphological structure of the wound defect. All experimental manipulations were performed in the first half of daylight hours.

For histological examination, a skin site with a wound was taken, fixed in 10% formalin, embedded in paraffin and vertical sections were made with a thickness of 7 μm through all layers of the wound. Deparaffined sections were stained with hematoxylin and eosin and picrofuxin on connective tissue. Morphometric evaluation of the results was carried out by computer graphic analysis using a “Digital micro” micro-video camera with an image transfer program to a computer of Elecard company (Tomsk). On the standard area of the histological skin section in the area of granulation tissue, the area of blood vessels was measured on preparations stained with hematoxylin and eosin, and the area of collagen fibers on preparations stained according to Van Gieson. The thickness of the newly formed epidermis was measured using an eyepiece micrometer.

Statistical processing of the results was carried out using the parametric (Student's test) and non-parametric (Wilcoxon's test) methods. To compare the experimental results, where the indicators were expressed in fractions, the reliability was determined using the Fisher angular transformation method. The significance of the differences was considered significant at Pt, Pu, Pφ≤0.05 [2].

The use of a dressing contributed to a significant decrease (by 79%) in the average diameter of the wounds on the 14th day of observation in comparison with control 2, where the animals were applied a gauze bandage. Acceleration of healing time (HSS) under the influence of the claimed funds amounted to 11% both in comparison with control 1 (without treatment) and in comparison with gauze (control 2) (table 3). From the data obtained it also follows that by 14 days in 73.3% of the animals of the experimental group complete wound healing was observed, while in the control group 1 (without treatment) such animals were 1.6 times less. In the form of a distinct trend, a difference of this indicator with control 2 (gauze) was recorded, only 53.8% of the animals of this group recorded complete healing of wounds in this period.

Interesting data were obtained when registering vocalization when removing scabs from wounds. Significant differences on the 5th day of observation were recorded with control 1 (without treatment) - there were 1.9 times fewer animals in the experimental group that squeaked when the scab was removed. On days 7 and 9, these differences were recorded in comparison with control 2 (the basic tool) - 1.9 and 5.7 times, respectively, there were fewer animals with vocalization. This fact indicates that the mice that applied the claimed agent to the wound experienced a less painful reaction when removing the scab than mice with a gauze bandage.

Table 3 Group of animals Number of animals The average diameter of the wound (mm) Day of observation 1st 3rd 5th 7th 9th 11th 14th 16th 18th Control 1 (without treatment) 19 12.5 ± 0.2 10.4 ± 0.3 9.3 ± 0.3 8.4 ± 0.4 6.6 ± 0.4 5.3 ± 0.4 1.1 ± 0.4 0.2 ± 0.1 0 Control 2 (gauze) twenty 12.4 ± 0.2 10.6 ± 0.3 9.3 ± 0.4 8.6 ± 0.5 7.1 ± 0.4 5.1 ± 0.5 1.4 ± 0.5 0.5 ± 0.2 0 The claimed tool 21 12.5 ± 0.1 10.2 ± 0.3 9.3 ± 0.2 9.0 ± 0.3 7.3 ± 0.3 4.4 ± 0.4 0.3 ± 0.1 ^∗ 0 NOTE: * - the differences are statistically significant compared with control 2 at Pu, t <0.05.

Histological studies have shown the benefits of the claimed dressings already on the seventh day of use (figure 3). In mice with a dressing from the claimed dressing on the 14th day of the experiment there was almost complete epithelization of the skin wound. The layer of the newly formed epithelium is as thick and uneven as when using a gauze bandage, but the effects of acanthosis and hyperkeratosis are much less pronounced. On the 21st day of the experiment, complete epithelization of the skin wound occurred in mice of all groups. However, the degree of organotypic differentiation of the epidermis in the control groups and when using the claimed means is different. The newly formed epithelium when using the prototype remains uneven in thickness throughout. The phenomena of hyperkeratosis persist (figure 4). In mice with a bandage from the claimed means, at this time of observation, the layer of epithelial cells is thinner and more even. The thickness of the stratum corneum is significantly less than when using a gauze bandage. In the same group, more active maturation of granulation tissue occurs. It reliably decreases the relative area of blood vessels - they differentiate in arteries and veins and increase the relative area of collagen fibers. The results of the study showed that the claimed tool has a positive effect on the healing of skin patchwork, reducing the healing time of wound damage, increasing the number of animals with complete epithelization of the wound defect, reducing the number of animals with vocalization. The inventive dressing leads to a more perfect organotypic differentiation of the resulting epidermis and accelerates the maturation of granulation tissue.

Bacteriological analysis of a purulent discharge of an infected wound was also carried out. Animals under anesthesia performed shaving of the skin on the back in the interscapular region. At this place, 1 ml of a suspension of bacteria of Staphylococcus aureus and Pseudomonas aeruginosa was administered at a dose of 5 × 10 ⁸ CFU / ml. After 24 hours, abscess cavities were opened, wounds were sown with tampons, and the claimed agent was introduced into the cavities (5 rats in a group) and gauze balls (5 rats in a group), similar in volume. Wounds were sutured tightly. Visual assessment, taking material for microbiological research, a change in the claimed dressing and gauze balls were performed the next day, after 3 and 7 days. An analysis of the purulent discharge of an infected wound was carried out by plating with a swab on Petri dishes with blood agar. The cups were placed in a thermostat at 37 ° C; in a day, the growth rate of bacteria was assessed with subsequent microscopic control. It was shown that the antibacterial effect was expressed during the first three days (Table 4). Thus, it was found that the claimed tool has antibacterial and antifungal effects. The onset of the effect is recorded 12 hours after the contact of the claimed drug with microorganisms (Pseudomonas aeruginosa, Proteus, Klebsiella pneumonia, Candida) and is clearly expressed by 24-48 hours of the study (staphylococcus, Escherichia coli). Table 4 shows the inoculation of bacteria from a separable wound of experimental animals (rats) infected with S.aureus and P.aeroginosa

Table 4 No. Try 1 day 3 days 7 days one S.aureus + the claimed remedy 0 0 300 2 S.aureus + gauze one > 300 > 300 3 Ps.aerug + the claimed tool 120 0 0 four Ps.aerug + gauze 500 500 300

When using the claimed means as a dressing material, a decrease in bacterial contamination in the wound is observed for 3-4 days, which is especially significant when infected with Pseudomonas aeruginosa. It can be assumed that the mechanism of this effect is associated with the sorption properties of the material. The ability of the claimed drug to have an antibacterial effect against pathogens of purulent-inflammatory processes (staphylococcus, Pseudomonas aeruginosa, Proteus) makes it possible to use it as a basis for dressings in purulent surgery. The antimycotic effect (table 2) in relation to Candida fungus can be used in gynecological practice and for the local treatment of candidomycosis (thrush) in children.

The study of the wound healing effect of the dressing in vivo on the model of purulent wounds was carried out according to [3]. The experiments were carried out on 15 white purebred sexually mature male rats weighing 300-350 g of the layout of the nursery "Dawn". The animals were kept in accordance with Order No. 267 of June 19, 2003 “On the Approval of Laboratory Technique Rules” and the rules adopted by the European Convention for the Protection of Vertebrate Animals used for experimental and other scientific purposes (Strasbourg, 1986). Experimental animals were kept under standard conditions of a typical vivarium in plastic cages (one individual per cage) on a litter of sawdust under conditions of free access to water and food (standard diet) under natural light conditions. The distribution of animals in this series of experiments was carried out as follows:

Group number 1. Wounds infected with St.aureus - the claimed remedy (4 rats);

Group number 2. Wounds infected with St.aureus - gauze (4 rats);

Group number 3. Wounds infected with Ps.aerogynosa - the claimed remedy (4 rats);

Group number 4. Wounds infected with Ps.aerogynosa - gauze (3 rats).

The objective of the observation: a comparative assessment of the effect of the claimed agent and sterile gauze on the degree of microbial contamination of the infected wounds of St.aureus and Ps.aerogynosa in the dynamics of 4-7 days and visually assessed parameters of the state of the wounds in the dynamics of 1-7 days.

Animals of all groups under ether anesthesia under aseptic operating conditions after hair removal in the interscapular region were incised with cut round, planar skin wounds with a scalpel by removing the dermis to the papillary layer and the appearance of persistent bloody dew with a diameter of 20 mm and an area of 3.14 ± 0.31 cm ² . Before further manipulations, the rats were sedimented and kept throughout the experiment in cells of one individual to prevent mutual chewing of dressings. To simulate a purulent wound, animals of groups No. 1 and No. 2 applied 1 ml of a suspension of daily agar cultures of St. aureus strain 638P at a dilution of 10 ⁴ (50 million × ml), and animals of groups No. 3 and No. 4 Ps.aerogynosa strain b / n at a dilution of 10 ⁴ (50 million × ml). 2 hours after the wound was seeded and subsequently daily (1 time per day, at the same time) for 7 days, slices from the claimed agent (according to the size and shape of the wound) or tampons from sterile gauze were applied to the wounds, respectively. Daily conducted a visual assessment of the wound surface, determined the nature and phase of the wound process. On the 4th, 5th, 6th and 7th day after the wound was applied (after the appearance of purulent infiltrate in the animals of the control groups), material was taken (smears from the bottom of the wound, purulent discharge) from the infected wound for bacteriological analysis by plating on nutrient media with microscopic control . When studying the wound healing effect on the model of a purulent wound, it was shown that a protective inflammatory reaction to both the base (gauze) and the claimed agent develops by 7 days from the start of subcutaneous placement of dressings. However, this reaction is less pronounced in the presence of the claimed material. At the same time of observation, infected wounds with the claimed agent became cleaner, without a specific unpleasant odor and pus, which became more pronounced in wounds with gauze. The bottom of the wound was made of pink granulations, necrotic tissue and purulent inflammation represented by a rim of 3-5 mm at the edge of the composite material (figure 5).

Thus, the claimed tool has pronounced wound healing and antibacterial properties in comparison with a standard gauze dressing. The material reduces the healing period of the wound and significantly accelerates the rehabilitation of the infected wound, having a positive effect on the processes of tissue regeneration in the wound.

A study of the toxicity of the claimed dressings was carried out in a chronic experiment in 80 rats (males and females) and 12 rabbits according to the guidelines [4]. The effect was studied with its skin application in the back (interscapular region) to rats in two doses (sizes) for 30 days. As a fixative of dressings on the skin, a hypoallergenic breathable fixing plaster of artificial silk was used for patients with sensitive skin manufactured by Paul Hartmann AG (Germany; Per. Udostov. FS No. 2006/2316). The exposure was carried out around the clock. The control was animals in which only fixing material was used. We used dressings in the following sizes: 1 × 1; 2 × 2 cm in rats (group 1 and 2, respectively) and 2 × 2 cm and 4 × 4 cm in rabbits (group 1 and 2, respectively). In the control groups, animals received the basic tool. The weight of the material with a size of 1 cm ² is 0.08 g. The toxicity of the material was judged by the general condition, weekly (or after 2 weeks) dynamics of the total mass, body temperature, picture of peripheral blood, bone marrow, liver, kidney, nervous system, heart function (ECG), as well as after killing (decapitation) according to morphological studies of internal organs and their mass (brain, lungs, heart, gastrointestinal tract, thymus, spleen, lymph nodes, sex glands, bladder, adrenal glands, kidneys and other). Studies in rats were carried out after 30 days of use of the material and not less than 2 weeks after its cancellation. A daily assessment was made of the condition of the skin area under the applied material, in particular, redness, thickness of the skin fold, soreness, swelling, scratching, etc. In the peripheral blood taken from the tail of rats after amputation of its tip or from the marginal vein of the ear of rabbits, the hematocrit, hemoglobin were determined , the content of erythrocytes, reticulocytes, platelets, leukocytes, leukogram indicators, ESR, using an Abacus automatic hematology analyzer (“Diatron”, Austria) and generally accepted manual research methods [5, 6, 7, 8].

The state of bone marrow hematopoiesis in rats was evaluated by counting the total number of myelokaryocytes (OCC) on the femur (10 ⁶ / thigh) and myelograms on smears prepared from the homogenate of a fragment of myeloid tissue taken from the sternum segment and autologous serum (1: 1), combined stained with fixative-dye May-Grunwald and azure II-eosin according to Noht. The percentage of individual cell forms when calculating rat myelograms was translated into absolute numbers - × 10 ⁶ cells per hip [9]. In rabbits, myelogram indices in relative units (%) were determined in bone marrow taken from the sternum segment. We studied the biochemical parameters of blood serum characterizing protein, carbohydrate, enzymatic and other metabolic functions of the liver. In the blood serum, the activity of aspartate and alanine aminotransferases (AsAT and AlAT), alkaline phosphatase (ALP), glucose, protein, urea, creatinine, cholesterol, bilirubin was determined by conventional methods [10, 11] using a Cormay semi-automatic biochemical analyzer , standard sets of firms Cormay, Biocon (Germany), Vital Diagnostics (St. Petersburg), Vector-Best (Novosibirsk).

To assess renal metabolism in rat urine, the following parameters were determined: daily diuresis, glucose, bilirubin, ketones, specific gravity, occult blood, protein, urobilinogen, nitrites, leukocytes and pH. The studies were performed on a CLINITEK-50 automated urine analyzer on URS-10 strips (USA). Urine collection in rats was carried out in individual metabolic cages in which the animals were kept for 24 hours after preliminary adaptation and water load. Distilled water was introduced with a probe at the rate of 2% of body weight. The heart function of rats was evaluated according to electrocardiography [12]. The electrocardiogram of rats was recorded on an EC1T-O3M electrocardiograph in a second standard lead with a gain of 1mV = 20 mm and a recording speed of 50 mm / s under ether anesthesia with the animals upside down. Based on the recorded electrocardiogram in rats, males and females together, due to the absence of differences on the ECG depending on gender, the heart rate (HR) was calculated, the amplitude of the P, R, T waves and the duration of the intervals PQ, QT, QRS were measured.

The locally irritating effect of the dressing was evaluated by histological examination of the injection site in rats and rabbits [13]. Analysis of the results obtained in rats (males and females) 30 days and two weeks after the abolition of cutaneous application of dressing in two groups did not reveal changes in peripheral blood indices (Tables 5-8).

Table 5 Peripheral blood indices in male rats after 1 month of cutaneous application of dressing, X ± m Indicators 1 group, 1 × 1 cm 2 group, 2 × 2 cm The control Hemoglobin, g / l 160.4 ± 3.4 161.6 ± 1.5 155.0 ± 3.1 Red blood cells, T / L 9.17 ± 0.19 9.12 ± 0.19 8.98 ± 0.07 Reticulocytes, ‰ 31.80 ± 0.80 38.60 ± 6.45 34.20 ± 2.13 Hematocrit% 44.6 ± 1.39 44.3 ± 0.4 42.8 ± 0.9 Platelets, g / l 728 ± 127 659 ± 94 878 ± 58 ESR, mm / h 0.90 ± 0.56 1.54 ± 0.54 1.10 ± 0.64 The total number of leukocytes, g / l 18.72 ± 1.47 17.30 ± 1.10 17.70 ± 1.95 Basophils, g / l 0.14 ± 0.11 0.00 ± 0.00 0.11 ± 0.08 Eosinophils, g / l 0.32 ± 0.12 0.17 ± 0.04 0.21 ± 0.03 Immature neutrophils, g / l 0.08 ± 0.05 0.00 ± 0.00 0.03 ± 0.03 Mature neutrophils, g / l 3.15 ± 0.68 3.10 ± 0.25 3.37 ± 0.48 Monocytes, g / l 0.96 ± 0.27 0.80 ± 0.22 0.99 ± 0.25 Lymphocytes, g / l 14.06 ± 0.88 14.62 ± 1.05 12,99 ± 1,87

Table 6 Peripheral blood indices in female rats after 1 month of cutaneous application of dressing, X ± m Indicators 1 group, 1 × 1 cm 2 group, 2 × 2 cm The control Hemoglobin, g / l 153.2 ± 7.8 158.0 ± 4.8 153.4 ± 5.2 Red blood cells, T / L 8.13 ± 0.39 8.56 ± 0.38 8.37 ± 0.28 Reticulocytes, ‰ 35.00 ± 1.30 32.80 ± 1.32 33.20 ± 0.66 Hematocrit% 40.6 ± 2.3 42.9 ± 1.7 41.6 ± 1.8 Platelets, g / l 891 ± 102 856 ± 124 784 ± 87 ESR, mm / h 1.10 ± 0.33 1.40 ± 0.56 0.40 ± 0.19 The total number of leukocytes, g / l 0.05 ± 0.03 0.15 ± 0.09 0.03 ± 0.03 Eosinophils, g / l 0.13 ± 0.07 0.09 ± 0.06 0.15 ± 0.07 Immature neutrophils, g / l 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 Mature neutrophils, g / l 2.21 ± 0.48 4.22 ± 1.46 1.88 ± 0.15 Monocytes, g / l 0.55 ± 0.14 0.95 ± 0.11 0.75 ± 0.13 Lymphocytes, g / l 11.63 ± 1.32 11.09 ± 0.71 11.13 ± 0.95

Table 7 Peripheral blood indices in male rats 1.5 months after gluing dressing onto the skin, X ± m Indicators 1 group, 1 × 1 cm 2 group, 2 × 2 cm The control Hemoglobin, g / l 158.2 ± 2.5 157.2 ± 3.4 151.8 ± 5.2 Red blood cells, T / L 9.18 ± 0.11 8.76 ± 0.29 9.03 ± 0.39 Reticulocytes, ‰ 31.80 ± 1.85 32.00 ± 0.42 34.00 ± 0.71 Hematocrit% 43.3 ± 0.4 42.7 ± 1.0 42.6 ± 1.8 Platelets, g / l 848 ± 66 899 ± 71 803 ± 136 ESR, mm / h 0.92 ± 0.59 0.20 ± 0.12 0.46 ± 0.39 The total number of leukocytes, g / l 15.42 ± 2.24 16.96 ± 1.44 14.18 ± 1.40 Basophils, g / l 0.03 ± 0.03 0.08 ± 0.05 0.06 ± 0.06 Eosinophils, g / l 0.13 ± 0.06 0,07 ± 0,04 0.16 ± 0.01 Immature neutrophils, g / l 0.06 ± 0.06 0.08 ± 0.05 0.00 ± 0.00 Mature neutrophils, g / l 4.49 ± 0.76 4.57 ± 1.14 3.27 ± 0.68 Monocytes, g / l 1.25 ± 0.43 0.71 ± 0.12 0.66 ± 0.10 Lymphocytes, g / l 14.47 ± 1.35 13.47 ± 1.94 10.02 ± 1.95

Table 8 Peripheral blood indices in female rats 1.5 months after gluing dressing onto the skin, X ± m Indicators 1 group, 1 × 1 cm 2 group, 2 × 2 cm The control Hemoglobin, g / l 157.8 ± 3.5 155.4 ± 2.4 153.4 ± 5.1 Red blood cells, T / L 8.35 ± 0.19 8.25 ± 0.17 8.26 ± 0.43 Reticulocytes, ‰ 31.60 ± 0.68 33.00 ± 0.71 33.20 ± 1.83 Hematocrit% 41.3 ± 0.9 40.8 ± 0.8 40.5 ± 1.9 Platelets, g / l 884 ± 63 979 ± 87 853 ± 141 ESR, mm / h 1.12 ± 0.74 0.72 ± 0.37 0.28 ± 0.18 The total number of leukocytes, g / l 16.88 ± 1.77 14.54 ± 1.62 14.72 ± 2.00 Basophils, g / l 0.08 ± 0.05 0.02 ± 0.02 0.02 ± 0.02 Eosinophils, g / l 0.20 ± 0.04 0.15 ± 0.04 0.20 ± 0.04 Immature neutrophils, g / l 0.00 ± 0.00 0.04 ± 0.04 0.00 ± 0.00 Mature neutrophils, g / l 3.36 ± 0.40 2.56 ± 0.55 2.56 ± 0.18 Monocytes, g / l 0.58 ± 0.10 0.71 ± 0.17 0.59 ± 0.17 Lymphocytes, g / l 12.66 ± 1.41 11.06 ± 1.33 11.35 ± 1.75

In the peripheral blood taken from the marginal vein of the ear of rabbits after 1.0 month of cutaneous application in two groups of animals, the majority of the studied indicators of the shaped elements (erythrocytes, leukocytes and platelets) in the experimental animals (I and II) and the control groups did not statistically significantly differ ( table 9).

Table 9 Peripheral blood indices in rabbits after 1 month of dressing on the skin, X ± m Indicators 1 group, 2 × 2 cm 2 group, 4 × 4 cm The control Hemoglobin, g / l 132.3 ± 4.4 131.0 ± 2.2 125.8 ± 4.1 Red blood cells, T / L 6.01 ± 0.33 5.93 ± 0.16 5.71 ± 0.17 Reticulocytes, ‰ 50.00 ± 2.94 52.00 ± 1.08 57.25 ± 3.64 Hematocrit% 34.8 ± 1.6 34.1 ± 0.4 33.9 ± 0.9 Platelets, g / l 392 ± 38 403 ± 63 359 ± 151 ESR, mm / h 0.45 ± 0.35 0.15 ± 0.12 0.25 ± 0.14 The total number of leukocytes, g / l 12.81 ± 1.78 9.37 ± 1.54 11.78 ± 1.76 Basophils, g / l 0.26 ± 0.04 0.28 ± 0.03 0.32 ± 0.07 Eosinophils, g / l 0.30 ± 0.06 0.28 ± 0.07 0.27 ± 0.04 Immature neutrophils, g / l 0.00 ± 0.00 0.00 ± 0.00 0.07 ± 0.05 Mature neutrophils, g / l 3.20 ± 0.36 2.21 ± 0.10 3.91 ± 1.52 Monocytes, g / l 0.31 ± 0.12 0.23 ± 0.06 0.77 ± 0.35 Lymphocytes, g / l 9.15 ± 1.53 7.57 ± 1.41 6.45 ± 1.00

The study of bone marrow in rats after cutaneous application of dressing did not reveal any natural dose-dependent pathological changes (Tables 10, 11).

Table 10 Bone marrow indices in male rats after 1 month. (numerator) and 1.5 months. (denominator) skin dressing, X ± m Indicators, 10 ⁶ / hip Groups of experience, doses I group, 1 × 1 cm II group, 2 × 2 cm The control Undifferentiated blasts

Myeloblasts

Immature neutrophils

Mature neutrophils

Eosinophils

Basophils

Granulocyte cell mitosis

Lymphocytes

Monocytes

Plasma cells

Macrophages

Megakaryocytes

Erythronormoblasts

Erythroid cell mitosis

OKC

Table 11 Bone marrow indices in female rats 1 month. (numerator) and 1.5 months (denominator) of adhesive dressing on the skin, X ± m Groups of experience, doses Indicators, 10 ⁶ / hip I group, 1 × 1 cm II group, 2 × 2 cm The control Undifferentiated blasts

Myeloblasts

Immature neutrophils

Mature neutrophils

Eosinophils

Basophils

Granulocyte cell mitosis

Lymphocytes

Monocytes

Plasma cells

Macrophages

Megakaryocytes

Erythronormoblasts

Erythroid cell mitosis

OKC

On smears prepared from a bone marrow tissue homogenate from a segment of the sternum of rabbits and autologous blood serum (1: 2), myelograms (%) were counted after 1 month of application of the dressing in different groups (experimental groups I and II).

It was found that the dressing does not have a toxic effect on the bone marrow indices of rabbits during its long-term cutaneous use (Table 12).

Table 12 Indices of bone marrow in rabbits after 1.0 month of application of a dressing, X ± m Indicators, % I group II group The control Undifferentiated blasts 0.13 ± 0.13 0.28 ± 0.16 0.53 ± 0.09 Myeloblasts 1.25 ± 0.25 1.35 ± 0.21 1.93 ± 0.21 Immature neutrophils 17.38 ± 1.68 13.80 ± 0.82 15.43 ± 1.18 Mature neutrophils 36.00 ± 2.21 35.95 ± 1.21 33.60 ± 4.07 Eosinophils 6.58 ± 0.57 8.40 ± 1.40 5.90 ± 1.80 Basophils 0.50 ± 0.35 0.83 ± 0.17 0.40 ± 0.28 Granulocyte mitosis 0.4 ± 0.18 0.55 ± 0.18 0.40 ± 0.16 Lymphocytes 10.05 ± 1.30 12.15 ± 0.88 11.53 ± 1.22 Monocytes 2.28 ± 0.46 1.65 ± 0.57 3.03 ± 0.77 Plasma cells 0.78 ± 0.13 0.53 ± 0.21 0.83 ± 0.27 Macrophages 0.90 ± 0.23 1.58 ± 0.43 0.90 ± 0.38 Megakaryocytes 0.13 ± 0.13 0.40 ± 0.14 0.43 ± 0.02 Erythronormoblasts 22.75 ± 2.37 21.90 ± 0.88 23.63 ± 1.40 Erythroid mitosis 0.88 ± 0.43 0.93 ± 0.21 1.13 ± 0.15 L / E 2.93 ± 0.44 2.70 ± 0.29 2.63 ± 0.23 ISN 0.42 ± 0.06 0.42 ± 0.03 0.48 ± 0.07 ISE 0.46 ± 0.06 0.39 ± 0.11 0.40 ± 0.17

The experimental results showed that the use of dressings for 1 month does not lead to a change in blood biochemical parameters and, consequently, to a violation of the functional state of the liver in rats (13, 14).

Table 13 Biochemical blood parameters of male rats after 1 month of application of dressings, (X ± m) Indicators Groups one 2 The control AlAT, mkkat / l 0.54 ± 0.04 0.55 ± 0.01 0.54 ± 0.04 AsAT, mkkat / l 0.58 ± 0.04 0.62 ± 0.02 0.56 ± 0.06 Alkaline phosphate, E / l 257.1 ± 27.5 267.7 ± 19.4 198.7 ± 19.4 Glucose, mmol / L 4.51 ± 0.15 4.37 ± 0.17 4.62 ± 0.25 Creatinine, μmol / L 86.32 ± 4.44 105.11 ± 5.66 96.36 ± 3.04 Urea, mmol / L 6.35 ± 0.52 5.21 ± 0.42 5.87 ± 0.70 Protein, g / l 63.95 ± 1.64 72.32 ± 2.35 67.49 ± 1.93 Cholesterol, mmol / L 1.26 ± 0.09 1.40 ± 0.07 1.38 ± 0.19 Bilirubin, μmol / L 6.82 ± 0.38 10.92 ± 1.57 9.11 ± 1.63

Table 14 Biochemical blood parameters of female rats after 1 month of application of dressings, (X ± m) Indicators Groups one 2 The control AlAT, mkkat / l 0.52 ± 0.04 0.48 ± 0.02 0.47 ± 0.03 AcAT, μkat / L 0.60 ± 0.02 0.65 ± 0.02 0.60 ± 0.02 Alkaline phosphate, E / l 197.1 ± 37.4 180.7 ± 25.8 127.0 ± 3.5 Glucose, mmol / L 4.33 ± 0.37 4.45 ± 0.30 4.36 ± 0.39 Creatinine, μmol / L 101.61 ± 9.64 102.05 ± 3.47 108.15 ± 3.35 Urea, mmol / L 7.40 ± 0.54 6.55 ± 0.75 6.37 ± 0.29 Protein, g / l 73.98 ± 2.05 73.91 ± 2.91 69.93 ± 0.99 Cholesterol, mmol / L 1.35 ± 0.11 1.67 ± 0.20 1.34 ± 0.20 Bilirubin, μmol / L 4.06 ± 0.38 4.48 ± 0.78 4.54 ± 0.62

In rabbits, the use of dressings for 1 month for rabbits does not have a toxic effect on the functional state of the liver (Table 15).

Table 15 Biochemical blood parameters of rabbits after 1 month of application of dressings, (X ± m) Indicators Groups one 2 The control AlAT, mkkat / l 0.22 ± 0.03 0.21 ± 0.04 0.38 ± 0.08 AsAT, mkkat / l 0.16 ± 0.01 0.14 ± 0.04 0.22 ± 0.02 Alkaline phosphate, E / l 166.7 ± 14.4 181.1 ± 16.1 162.6 ± 46.2 Glucose, mmol / L 8.24 ± 0.52 9.10 ± 0.64 8.53 ± 1.01 Creatinine, μmol / L 140.82 ± 7.70 132.75 ± 11.94 152.85 ± 7.09 Urea, mmol / L 6.21 ± 0.54 6.03 ± 0.66 6.47 ± 1.42 Protein, g / l 70.00 ± 1.76 72.23 ± 2.08 70.05 ± 4.11 Cholesterol, mmol / L 0.72 ± 0.14 1.16 ± 0.19 0.96 ± 0.09 Bilirubin, μmol / L 6.07 ± 2.05 3.58 ± 0.79 4.27 ± 1.59

The experiments showed that the use of dressing in rats does not lead to a change in indicators reflecting the functional state of the kidneys after 1 month of use and two weeks after cancellation (Table 16-19). Thus, the levels of glucose, protein, urobilinogen, nitrites, ketones, the presence of leukocytes and latent blood in urine do not differ in the experimental and control groups.

Table 16 shows the indicators of the functional state of the kidneys of male rats after 1 month of application of the proposed dressing, (X ± m)

Table 16 Indicators Groups one 2 The control pH 8.1 ± 0.1 8.2 ± 0.2 7.9 ± 0.1 Specific gravity 1.009 ± 0.001 1.008 ± 0.001 1.010 ± 0.00 Daily volume, ml 9.48 ± 0.98 10.04 ± 0.83 10.28 ± 1.09

Table 17 shows the functional status of the kidneys of female rats after 1 month of application of a dressing, (X ± m)

Table 17 Indicators Groups one 2 The control pH 7.9 ± 0.2 7.8 ± 0.2 7.6 ± 0.1 Specific gravity 1.008 ± 0.001 1.009 ± 0.001 1.007 ± 0.001 Daily volume, ml 11.1 ± 0.7 9.5 ± 0.4 9.9 ± 0.7

Table 18 shows the functional status of the kidneys of male rats after the abolition of the dressing, (X ± m).

Table 18 Indicators Groups one 2 The control pH 7.7 ± 0.6 7.8 ± 0.3 7.6 ± 0.3 Specific gravity 1.012 ± 0.002 1.009 ± 0.001 1.009 ± 0.001 Daily volume, ml 10.2 ± 0.9 12.7 ± 2.1 11.0 ± 1.2

Table 19 shows the indicators of the functional state of the kidneys of female rats after cancellation of the dressing, (X ± m)

Table 19 Indicators Groups one 2 The control pH 7.7 ± 0.1 7.7 ± 0.1 7.3 ± 0.1 Specific gravity 1.010 ± 0.002 1.009 ± 0.001 1.006 ± 0.001 Daily volume, ml 11.1 ± 1.1 10.1 ± 1.5 10.5 ± 0.3

In rats of all studied groups, regardless of the size of the material used and the duration of observation, no cardiac conduction disturbances were detected. The duration of the intervals and the amplitude of the teeth of the electrocardiogram did not statistically significantly differ from their values in the animals of the control group and did not go beyond the physiological norms accepted for this animal species (Tables 20, 21).

Table 20 Indicators of electrical activity of the heart after application of a dressing 1 month, X ± m Indicators Groups, dose 1 (1 × 1) 2 (2 × 2) The control PQ, ms 48.3 ± 3.07 53.3 ± 3.33 54.0 ± 2.45 P, ms 13.33 ± 2.11 15.00 ± 2.24 16.00 ± 2.45 P _am , μV 66.67 ± 10.54 75.0 ± 11.18 80.0 ± 12.24 QRS, ms 17.5 ± 1.12 20.0 ± 1.29 19.0 ± 1.87 QT, ms 93.3 ± 4.22 96.7 ± 3.33 92.0 ± 4.9 T, μV 183.3 ± 24.72 166.7 ± 16.67 210.0 ± 33.17 R, μV 316.7 ± 85.31 466.7 ± 24.72 520.0 ± 58.31 Heart rate, beats / min 302.0 ± 10.9 308.2 ± 13.4 328.2 ± 13.8

Table 21 Indicators of electrical activity of the heart 2 weeks after cancellation of the dressing, X ± m Indicators Groups, dose 1 (1 × 1) 2 (2 × 2) The control PQ, ms 50.00 ± 2.58 55.00 ± 2.24 54.00 ± 2.45 P, ms 18.33 ± 1.67 18.33 ± 1.67 16.00 ± 2.45 Pam, μV 75.00 ± 11.18 66.67 ± 10.54 70.00 ± 12.25 QRS, ms 20.00 ± 1.29 20.83 ± 0.83 21.00 ± 1.00 QT, ms 93.33 ± 4.21 96.67 ± 3.33 96.00 ± 4.00 T, μV 133.33 ± 10.54 133.33 ± 10.54 160.00 ± 10.00 R, μV 525.00 ± 49.58 433.33 ± 30.73 491.67 ± 27.13 Heart rate, beats / min 305.50 ± 5.50 314.50 ± 16.33 307.80 ± 11.41

Morphological examination of the skin after applying a dressing on the skin of rabbits with an area of 2 cm ² and 4 cm ² and rats 1 cm ² and 2 cm ² for 30 days does not have a toxic and locally irritating effect.

Thus, the chronic use of the inventive dressings in two animal species (rats and rabbits) does not have a toxic effect on the studied organs and systems of the body of experimental animals, does not have a locally irritating effect.

The dressing proposed as an invention has both wound healing, antibacterial and antiviral activity, non-toxic and significantly more effective than gauze dressings widely used in practical public health.

Information sources

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2. Digay A.M., Golosov OS, Agafonov V.I. Age-related characteristics of hematopoietic tissue of white rats. // Mechanisms of pathological reactions. - Tomsk, 1981. - P.32-37.

3. Lakin G.F. Biometrics. M., 1980, 344 p.

4. Directory of laboratory research methods: Edited by V.V. Menshikov. - M., 1987. S. 110, 118, 122, 123, 186-191, 215-222, 228, 230.

5. Karpova G.V., Abramova E.V. Evaluation of automatic blood test parameters of healthy white laboratory rats. Baltic. J. Lab. Anim. Sci., 2003, 13. P.140-145.

6. Karpova G.V., Churin A.A. Bone marrow indices and assessment of parameters of automatic blood analysis of healthy rabbits. // Bulletin of experimental biology and medicine. - 2007, Appendix, No. 1, p. 54-58.

7. Kolb V.G., Kamyshnikov B.C. Clinical biochemistry. Minsk, 1982, 366 p.

8. Merkulov G.A. Course of histopathological technology. Medicine, Leningrad Department., 1969. S.168-171.

9. Dotsenko B.M., Biryukova S.V., Tamm T.I. and other guidelines for experimental (preclinical) study of drugs for local treatment of purulent wounds. M.: Ministry of Health of the USSR, 1989.48 s.

10. Fenchin K.M. Wound healing. Kiev: Health, 1979, 167 p.

11. Zapadnyuk I.P., Zapadnyuk V.I., Zakharia E.A., Zapadnyuk B.V. Laboratory animals: Breeding, keeping, using in experiment. Kiev: Vishka school., 1983. P.199.

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Claims (16)

1. Non-woven material for medical purposes, having wound healing, antibacterial and antiviral activity, containing a fibrous base and inorganic powder, characterized in that as a fibrous base it contains at least one layer of non-woven polymeric fibrous material, on the fibers of which highly porous particles are attached alumina hydrate formed by nanofibres. 2. Non-woven material according to claim 1, characterized in that the non-woven polymeric fibrous material is formed by fibers of cellulose acetate, polysulfone or another bioinert polymer having a diameter of 0.1-10 μm, preferably 1-3 μm. 3. Non-woven material according to claim 2, characterized in that it is obtained by electrospinning, melt-blown technology, or other methods that make it possible to obtain non-woven materials with the mentioned fiber diameter. 4. The nonwoven material according to claim 1, characterized in that the highly porous particles of aluminum oxide hydrate are fixed to the fibers, both on the surface and in the bulk of the material. 5. The nonwoven material according to claim 1, characterized in that the highly porous particles of alumina hydrate mounted on the fibers of the nonwoven polymeric fibrous material have a size of 0.2-5.0 μm, a specific surface area of 100-250 m ² / g and a porosity of 50 -95%. 6. The nonwoven material according to claim 5, characterized in that the nanofibers have a diameter of 5.0-8.0 and a length of 100-200 nm. 7. Non-woven material according to claims 1 to 6, characterized in that for using it as a medical material, it additionally contains at least one layer of atraumatic material, intended, for example, to be placed on the wound surface. 8. Non-woven material according to claims 1 to 6, characterized in that it further comprises at least one layer of protective material located either on one or on both sides thereof. 9. A dressing with wound healing, antibacterial and antiviral activity, containing at least one first layer of absorbent material and at least one second layer of atraumatic material, characterized in that the non-woven material according to any from claims 1-6. 10. The dressing according to claim 9, characterized in that it further comprises at least one layer of protective material located either on one or on both sides thereof. 11. The dressing according to claim 9 or 10, characterized in that in addition it can be equipped with elements for fixing it to the human body. 12. The use of filter material containing as a basis a non-woven polymeric fibrous material obtained by electrospinning, on the fibers of which particles of aluminum oxide hydrate are fixed for the manufacture of non-woven materials for medical use according to claim 1, having wound healing, antibacterial and antiviral activity. 13. The use according to claim 12, characterized in that the filter material containing as a basis a non-woven polymer fibrous material obtained by electrospinning, on the fibers of which particles of aluminum oxide hydrate are fixed, is preferably used for the manufacture of dressings with wound healing, antibacterial and antiviral activity. 14. The use of a filter material containing as a basis a non-woven polymer fibrous material obtained by the method of electroforming, on the fibers of which particles of aluminum oxide hydrate are fixed as a nonwoven fabric for medical use according to claim 1, having wound healing, antibacterial and antiviral activity. 15. The application of clause 14, wherein the non-woven material for medical purposes further comprises at least one layer of atraumatic material located on the side intended to be placed on the wound surface. 16. The application of clause 15, wherein the non-woven material for medical use further comprises at least one layer of protective material located either on one or on both sides of the medical material.

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