RU2379066C1 - Composite material, package and carrier made of composite material, and method for making composite material - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention concerns an oligodynamic composite material representing a layer of polymer material with electret properties wherein there is one first discrete element coming on one working surface of the electret material and made of metal particles of various electronic work function and able to show oligodynamic action. The composite material can also contain the other discrete elements representing a drug dispenser or absorption aids.

EFFECT: composite material distinguishes itself with high efficiency ensured by synergy effect of the electret material and the metal showing oligodynamic action.

17 cl, 4 dwg, 1 tbl, 18 ex

Description

The invention relates to the field of composite materials, as well as devices made on the basis of these composite materials, and can be used in medicine, medical cosmetology, hygiene and sanitation, in the production of carriers and packaging of medicinal, health, cosmetic, food, perfume products, in production household appliances and consumer goods, as a material of independent elements or elements included in more complex devices.

In the future, the following basic terms will be used:

The oligodynamic effect is the effect of very small concentrations of positive ions (mainly metals, for example Cu, Ag, Au, etc.) on living organisms. Under oligodynamic action, metal ions are concentrated on the surface of a biological object, which leads to the blocking of free carbonyl and sulfohydryl groups of surface structures. The oligodynamic effect extends to enzyme systems, as well as the activity of inorganic catalysts. The oligodynamic effect also includes the influence of negative ions that can inactivate enzyme systems.

Electrets are dielectrics that maintain a polarized state for a long time after the removal of the external effect that caused the polarization. Almost all known organic and inorganic dielectrics can be converted to an electret state. All electrets have a stable surface charge of ~ 10 ^-8 k / cm ² . They are used as sources of a constant electric field (microphones and telephones, vibration sensors, generators, etc.), also in electric meters, voltmeters, in dosimetry devices, in electric memory, as focusing devices in barometers, hygrometers and gas filters, etc. Research on the use of electrets is carried out in dentistry, traumatology, orthopedics, surgery, cardiac surgery, cosmetology and other fields.

Dielectric electronics is a field of physics engaged in the study and practical application of phenomena associated with the flow of electric currents in dielectrics. Investigations of thin dielectric films have shown that, upon contact with metal, electrons or holes pass into a dielectric, as a result of which a noticeable amount of free charge carriers appear in a thin layer of a dielectric.

Work function - the energy spent on removing an electron from a solid or liquid in a vacuum.

An integrated circuit is an integrated microcircuit, a micro-miniature electronic device, all or part of the elements of which are inseparably connected structurally and are interconnected electrically. The materials used are aluminum, gold, titanium, nichrome, tantalum oxide, silicon monoxide, barium titanate, tin oxide and others.

Synergy effect - the total effect of the material, in particular, on biological tissues and hydrophilic media, exceeding the effectiveness of its individual components

Biologically active substance - a substance produced by the body or obtained by it from the outside and which either stimulates or suppresses the processes occurring in the body. These include biolins, hormones, inhibitors, enzymes, phytohormones, biogenic stimulants, peptides, etc.

Various composite materials are known from the prior art, in particular those containing metals with oligodynamic properties.

Known silver-containing material from microcrystalline cellulose, which is made by impregnating cellulosic material with an aqueous solution of AgNO ₃ , with additional processing with a mixture of ammonia and glycerol (RU, 2256675). This material can be used only for medical dressings and often causes irritation of the wound surface, allergies, as it contains the products of thermochemical decomposition of chemicals and microcrystalline cellulose itself.

A wound dressing is known that contains one or more components consisting of water-soluble polymers of the polysaccharide class and their derivatives, which form the basis of the composition, particles of precious metals with sizes up to 100 nm in an amount of 0.001-3% are also included in the composition (RU, 2006120301). A dressing with silver in vacuum (RU 56493) is also proposed. As a disadvantage of the above materials, insufficient biological activity against the pathogenic flora should be noted.

Also known is a method of introducing drugs or other substances into the human or animal organism, including remote destruction by microwave exposure of the shell of a microcapsule previously introduced into the body, consisting of an internal cavity containing a substance intended for introduction into the body, and a shell in the form of a polymer film made from n differently charged polyelectrolyte layers, between which 1 to n-1 layers of metal nanoparticles or Fe, or Au, or Ag, or Ni, or Co nanoparticles are located (RU, 2006121560). The disadvantage of this method is the complexity of manufacture and possible harm from microwave exposure to the human or animal organism.

A device is proposed for the physical impact on the human body through acupuncture zones (RU, 2112497). The tool includes two electrodes. The cathode body is made in the form of a hollow cylindrical capsule made of a copper alloy - brass or tin bronze. Electrets are placed in the end parts of the capsule, and a mixture of minerals is placed between them. The anode body is made in the form of a hollow zinc-lead-tin alloy capsule. The disadvantages of the device include its bulkiness, high cost, high content of harmful impurities of tin and lead.

Known film material on a polyester basis with a nanoscale metal coating (RU, 2295448). The material provides an increase in the specific electric capacitance of the capacitor and is used only for the production of anodes of electrolytic capacitors.

Known porous spongy cellulose material for the treatment of wounds and burns containing zinc, copper, selenium and / or iron in amounts of from 0.1 μg / g of dry material (RU, 2281088, FI, 20011232, US, 60/297269).

A pharmaceutical preparation for transdermal administration is proposed, which includes a substrate and an adhesive layer containing metal chloride, an adhesive, a compound of propynylphenethylamine and its hydrochloride, where the adhesive layer is cross-linked (RU, 2006119611, JP, 2005-165051) and others.

Household water ionizers are known from the prior art, for example, containing a power source connected through an electric circuit to electrodes immersed in water, at least one of which, the anode is made of silver (Kulsky L.A. Silver Water. Kiev: Naukova Dumka 1982, p. 115-121.). Typical disadvantages of such devices include its attachment to the electric network, the inability to use it offline in the field, and the low level of electrical safety. Of the common shortcomings of the above examples, one can note the narrowness of practical application and the great labor costs for their manufacture.

The use of an electret as a medical patch for physiotherapeutic treatment and patient care is proposed (RU, 94020964). Despite the positive results of the application, this material does not have high biological efficiency, in particular, due to the lack of oligodynamic effect.

Known material based on woven and non-woven materials containing nanoparticles of silver, iron, aluminum, copper (RU, 2314834). This material may contain an additional layer, which in turn may contain medicinal substances, but the biological activity of the material is not high due to the lack of electret properties, which significantly narrows the scope of its application.

The closest technical solution is a device for wound healing, containing a film coating on a plastic basis of metal foil, which is coated with an electret coating of stoichiometric composition Ta ₂ O ₅ (RU, 2001114454). The method of preparation and composition of this device is fully consistent with the stated goals for its limited use, however, there is no biologically significant effect of interaction between metal particles having different electron work function.

The technical problem solved by the developed invention is to create a new composite material with a wide range of applications in various fields of human activity.

The technical result obtained by the implementation of the developed invention consists in the synergy effect - the total biological effect of the developed composite material, which exceeds the efficiency of its individual components, which greatly expands the functionality of devices created on the basis of this material.

Devices created on the basis of the developed composite material serve as a source of reducing the deficiency of important trace elements in the body, differ from analogues in high efficiency due to the synergy effect in the absence of external power sources, high electrical safety, miniature, versatility and breadth of practical application, low cost in serial production, comfortable in use, have improved sanitary and hygienic and anti-epidemic properties, easy disinfected.

To achieve the technical result, it is proposed to use a composite material characterized by the presence of a layer of material with electret properties, in the volume of which, with at least one working surface of the electret material, at least one first discrete element made of particles is located metals, preferably nanosized, with different electron work function and capable of exhibiting oligodynamic effects. When creating the first discrete element, it is preferable to use metals selected from among the metals necessary for the full functioning of a living organism. However, the introduction of the first discrete element and other metals is possible. The composite material may further comprise a layer of insulating material (in particular silicon dioxide) located between the layer of electret material and the first discrete element. Also, the composite material may additionally contain at least one second discrete element, which is a carrier-dispenser of drugs, biologically active substances, microelements, bacterial strains, and aromatic substances, located in the layer of material with electret properties with access to its working surface. In some implementation cases, the first discrete element may be located in the second discrete element. The second discrete element can be made with access to the second surface of the material with electret properties. Also, the composite material may additionally contain at least one third discrete element, which is a selective absorption means with a developed surface in the composition of the working surface, which is connected through a hole to the opposite side of the material, located in the layer of material with electret properties with access to its working surface with electret properties. In some cases, the implementation of the first discrete element is located in the volume of the third discrete element with access to the working surface. The third discrete element may contain a component capable of absorbing moisture from the atmosphere. The third and first discrete element can be performed with access to the second surface of the material with electret properties. The minimum thickness of the layers of the composite material is 50 nm. The maximum thickness of the layers is preferably 40 μm. For ease of use, a material with electret properties may have a base. It is preferable to use an adhesive base that is biocompatible with the tissues of a living organism. The specified biocompatible adhesive base can be made of a soluble polymer. A paper or fabric base may also be used.

The specified technical result can be achieved by using different packaging, characterized in that it is at least partially made of the above composite material.

The specified technical result can be achieved by using a different carrier, characterized in that it is at least partially made of the above composite material.

The specified technical result can be achieved by using the method of obtaining the above composite material, characterized in that discrete elements are formed by local application of discrete elements components to a material with electret properties in combination with preliminary or subsequent perforation of the material. In one embodiment, the components are applied by spraying the components under vacuum.

The proposed composite material was called "Novafor" ("Novafor", hereinafter NF). Each of the elements of the NF material can be created using nanotechnology, and also be perforated, contain through holes and / or be soluble, and / or have a biocompatible hypoallergenic adhesive base, for example, of polyacrylate compounds, for bonding the above layers, and / or have an additional paper / fabric base.

Metal ions from a layer of discrete elements and molecules of biologically active substances from sites of metering carriers diffuse through the electrolyte into contact media and are deposited there in concentrations acceptable for external (skin) application as well as for internal use, including aspiration during spraying of liquids and vapors. Metals with oligodynamic properties are selected mainly from a number of trace elements important for the full functioning of man, many representatives of the animal and plant world.

The layer of discrete elements contains mainly nanoscale metal particles, which can be arranged with the possibility of mutual diffusion, due to which the concentration of metal ions in the electrolyte increases. In combination with the electric field created by the electret layer, the effectiveness of the direct healing, disinfecting, analgesic, and immunostimulating effects is significantly increased by direct contact with a device made of NF material, as well as when it is used with a medicinal or other filling of discrete elements (inclusions) of a metering carrier for prevention and combined pharmacotherapy of a wide range of diseases.

Additional effects of devices made of NF film material for external use include local warming, normalization of metabolic processes, improved blood circulation, reflexotherapy effect on biologically active zones and biologically active points in the places of application.

NF material can be a component of devices of dielectric electronics, radio electronics, tribotechnics, and also find application in other industrial fields.

Thus, the universal composite material NF is capable of efficiently generating metal ions in a given direction, absorbing some substances from contact media in the presence of an electrolyte into areas with a developed surface, and also biologically active substances contained in metering carriers of the base material can be metered into contact media, possessing the properties of an electret and, accordingly, being a source of a constant electric field. The presence of a constant electric field provides increased activity of metals and biologically active substances.

A significant difference between the claimed material and the known ones is that the total biological effect of the proposed composite material exceeds the efficiency of its individual components, and this greatly expands the functionality of the devices created on its basis. The universal composite material NF is able to efficiently generate metal ions with oligodynamic effects in a given direction, to absorb certain substances from contact media in the presence of an electrolyte in areas with increased adsorption, and also to accelerate the transfer of biologically active substances contained in a carrier-dispenser to the contact media having the properties of an electret and, accordingly, is a source of a constant electric field. The presence of a constant electric field in the material provides increased activity of metals and biologically active substances in the area of the working surface of the material, their effective transfer to contacting media, when the material is applied to the skin or mucous membranes as an intradermal or transdermal therapeutic system, in contact with liquids (water, skin and mucous secrets, as well as drinks, etc.), moisture-containing substances (flowing drugs and biologically active substances, food, including frozen th, and the like); as well as water-soluble substances (finely divided therapeutic, biologically active powders, solid solutions, etc.) due to areas with increased adsorption, containing a component that dissolves due to absorption of moisture from the atmosphere, which moistens the contacting surfaces and dissolves the active substances between them. When fixing the working surface of the material on any other surface, access to atmospheric moisture occurs through through holes that are connected to the interspersed material. The biological activity of the material in the presence of any electrolytic liquid also increases due to the interaction between metal particles having different electron work function.

Figure 1 shows a variant of the composite material NF with the separation of layers, figure 2 is a variant of the material in the form of a tape, square and circle, figure 3 is a view in section of the main elements, figure 4 is a view of the working surface; the form of all elements is arbitrary. The following notation was used: a discrete layer 1, consisting of particles or alloys of biocompatible metals, an electret layer 2, an insulator layer 3 located between the main layers 1 and 2, a dosing element (interspersed) 4 with access to the working surface of the material, discrete element (interspersed) 5, capable of selective absorption, through holes 6 between the layers; work surface 7 of the material; adhesive layer 8.

If necessary (not shown in graphic material), the device may further comprise power supply components and / or integrated circuits, and / or indicators connected to the device. Below are discussed the main options for methods of obtaining material NF.

Depending on economic and technological feasibility, any suitable materials of synthetic, natural origin or their derivatives are used to obtain layer 2 and additional elements 3, 4 and 5, for example, polymers selected from the group consisting of polyvinyl chloride, polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polyamide , polyethylene, polypropylene, polyester, fluoroplastic and many others, as well as copolymers, for example, a copolymer of N-hydroxy-1,4-ethylene piperazine and (N-carboxy) -1,4-ethylene piperazinium bromide, with added cm, e.g., cotton, viscose fibers or mixtures thereof, etc.

The technology for preparing the material may include the steps of: obtaining a solution of a carrier polymer, distributing biologically active substances and / or drugs in it, pouring the resulting mass onto a base and / or hydrophobic substrate in the presence of, for example, a strong constant electric field, by spraying metal particles, with subsequent drying at time and temperature conditions, determined by the type of films, perforation, cutting, sterilization and sealed packaging. For the manufacture of the proposed material can be used and finished electret films, including films containing metal-filled polymers. Depending on the methods of obtaining electrets, the characteristics of the applied metals and additional elements, the corresponding classification indices are assigned to the material (table).

Table Classification indices for Novafor * According to the properties of layer 1: monometallic - bimetallic AT polymetallic B + According to the methods of obtaining layer 2; mainly are: corona electret Ko electric electret E photoelectric F laser electret L thermoelectric T radio electret Re triboelectret Tr magnetoelectric Me cryoelectret Kr mechanoelectret M a combination of electrets FROM By the presence of additional elements; contain discrete layer 3 I blotches 4 D blotches 5 BUT By the presence of glue contain glue base K basics: do not contain - By solubility: soluble N insoluble - By configuration: film (sheet or curly) R unilateral V bilateral W filiform (straight or curly) N in the form of a roll or "sandwich" S * Note: all materials are suitable for use in medical and hygienic purposes, for contact with food products, and also pass control according to GOST 25209-82 (Plastics and polymer films. Methods for determining the surface charges of electrets).

A number of methods have been proposed for the manufacture of electrets (PW Chudleigh, Mechanism of Charge Transfer to a Polymer Surface by a Conducting Liquid Contact, 21 Appl. Phys. Lett., 547-548, Dec 1.1972; PW Chudleigh, Charging of Polymer Foils Using Liquid Contacts, 47 J. Appl. Phys., 4475-4483, October 1976; US 4215682; US 4588537; US 4798850; US 5280406; US 5411576 A; US 5496507 A; WO 97/07272 Al; US 5908598 A; RU 2189850; RU 2260866; RU 2266771; RU 2298245; RU 2002119973, etc.).

It is also known that, from a practical point of view, a method for producing composites synthesized on the basis of microparticles of thermoplastic polymers coated with metal nanoparticles is known to be effective. This approach allows you to get the most uniform distribution of the metal in the polymer matrix during the subsequent preparation of the material (Anisimov A.Yu., Grekhova OB Electrical conductivity and physicomechanical characteristics of nickel-filled oligomer-oligomer composite materials. // Journal of Applied Chemistry , 1998. T. 71. No. 10. S.1713-1716.). Acceptable methods that allow you to apply metal particles of layer 1 and additional elements on layer 2, for example, using extrusion lamination; spraying on a hot melt of biocompatible glue, which is applied to layer 2 in an amount of 5-20 g / m ² ; using vacuum plasma technology, spray drying method; combining heliography, or flexography, or offset printing methods (preferably with a resolution of up to 1 μm) with methods of evaporation and sublimation of metals under vacuum, as well as other methods. In particular, the known method of applying metals in a vacuum chamber using magnetron sputtering (RU, 2314834).

The proposed material is produced using as a stage one or more of the above methods. The method may include processing the material with a laser having a power equal to 1.5-300 watts, followed by perforation and cutting of the material. For application to the material, both the metals proposed earlier (RU, 2299057) and others with a pronounced oligodynamic effect are used. Additional elements of material 4 and 5 are formed by applying appropriate finely dispersed compositions, solutions with preliminary or subsequent perforation of the material to metal-filled electret films. The technology for producing the NF material and its elements may have additional features determined by the purpose of the material. NF therapeutic material is highly effective in the treatment of wound surfaces, abrasions, burns, stimulation of proliferative processes in wounds, can be used as pain reliever stimulants, individual first aid agents in the form of, for example, napkins, plasters, etc. The material does not cause allergic reactions with prolonged application to the wound surface. The possibility of additional content of layers allows to improve its sorption properties in the treatment of wounds with wound exudate, the material does not dry to the wounds, can be applied and removed painlessly. Films, patches, combined dressings or NF swabs are relevant for active local diffusion of drugs, which, depending on biologically active inclusions, in some cases can replace injections as a hygienically safe analogue. Based on the composition of the inclusions, NF may have enhanced analgesic, anti-inflammatory, healing, antimutagenic, anticholesterol, immunomodulating, detoxifying, hormone therapeutic membrane-protective, antioxidant and other effects. Such forms of release are safer compared to similar drugs in the form of tablets. It is possible to produce soluble NF capsules containing substances with the above effects or containing balanced additives of active trace elements, vitamins, provitamins, volatile, hormones, etc.

It is known that the active substance of the day of intradermal or transdermal administration should have a whole complex of necessary qualities: the ability to penetrate the skin without affecting the adhesion characteristics of the adhesive component of the material, without causing skin irritation and allergic reactions, have good pharmacokinetic and pharmacodynamic characteristics, metabolic characteristics that are satisfactory consistent with therapeutic effect with continuous administration, and also possess relatively a wide range of therapeutic effects. Currently, there is a long list of pharmaceutical substances that are administered percutaneously and / or intradermally.

Suitable antimicrobial or antibacterial compounds can be selected from the following: triclosan, neomycin, clindamycin, polymyxin, bacitracin, benzoyl peroxide, hydrogen peroxide, tetracyclines such as doxycycline or minocycline, sulfamide preparations such as sulfacetamide, penicillicines, penicillicines, penicillicines, and quinolones, such as lomefloxacin, olfloxacin or trovafloxacin. Suitable pain relievers are selected, for example, from the following: lidocaine, trimecaine, diclofenac, ketoprofen, and others. Suitable antifungal compounds are selected from the following: farnesol, clotrimazole, ketoconaeol, econazole, fluconazole, uvdecylenefenicide butylate, zinc or calcium olaimine cyclopirox, miconazole nitrate, sulconazole, nystatin and terbinafine hydrochloride. Suitable anti-inflammatory compounds are selected from the following: steroidal agents selected from hydrocortisone, fluocinolone acetonide, galcinonide, halobetazole propionate, clobetasol propionate, betamethasone dipropionate, betamethasone valerate and triamecinolone acetonide, non-steroidal, isoferofeno-venoferaenoperofenalepene-isofenolepene, inflammatory canadian willow; zinc and allantoin. Suitable antiviral compounds are selected from tamvir, acyclovir and penciclovir.

The invention is illustrated by the following examples, not exhaustive.

Example 1. Studies were performed on an outpatient basis at the medical center of St. Petersburg NPIGI. For the experimental group used perforated film material Novafor BKoDAKPV (see table 1.) with the content on the working surface of silver and copper nanoparticles in a ratio of 10: 3. An additional drug carrier was cotton viscose blotches on a perforated electret polyethylene film (40 μm thick), which were impregnated with an aqueous solution of polyethylene glycols with a molecular weight of 200-2000 and antiseptic and anesthetizing drugs with acceptable tolerance on the carrier: polyethylene glycols 10-30 mg / cm ² ; antiseptics 0.03-1.0 mg / cm ² (in particular, triclosan 0.1 mg / cm ^{2 was used} ) and anesthetics 0.05-1.2 mg / cm ² (in particular, 0.5% hydrochloride solution was used lidocaine (lidocaine content of 0.5 mg / cm ² ). Cotton viscous inclusions (25-120 g / m ² ) provided the sorption capacity of the material is not less than 8 g / g. The size of the holes 6 is not less than 0.3 mm. Perforation of the material is made in the form through channels, the total opening area of which is from 10% to 40% of the total area.The presence of through channels was able to ensure the outflow of, for example, wound exudate in chl optic viscous inclusions The material was used in the form of a transparent film 3.5 × 7.0 cm in a sealed sterile package of 5 pcs. Each of the plates contained open electret gaps on the working surface with an area of 0.5 cm ^{2. The} zone of growth inhibition of microorganisms was determined by the disk method according to the most common type of infection - Staphylococcus aureus. Absorption capacity was determined by comparing the weight of dry and wet material. Sterility was determined by the microbiological method by suppressing the growth of colonies of microorganisms in a Petri dish with agar-agar, on the surface of which a sample of the working surface of the material was placed.

In the experimental group there were 7 outpatients, 3 of them were men and 4 women aged 22 to 57 years with the consequences of domestic injuries: minor wounds, abrasions, burns of the II-IIIa degree (two cases).

The control group consisted of 5 outpatients, 2 of them men and 3 women aged 24 to 42 years with wounds and abrasions, who underwent traditional therapy of the wound process with a daily change of aseptic cotton-gauze dressings soaked with triclosan (0.8 mg / cm3) ² ) and 2% lidocaine hydrochloride solution. In the control group, dressings were used on an area from 0.3 to 1% of the body surface.

Treatment in both groups began 2-4 days after the injury (at the time of the first treatment), the duration of treatment ranged from 3 to 12 days.

In the experimental group, a bandage made of NF material was applied on an area from 0.5 to 2% of the body surface. Dressings were performed every 3 days until the wounds were completely epithelized. With superficial burns, when the amount of wound discharge was significantly reduced, the dressing was left on the wound until complete epithelization. The dressing began to be applied in the first phase of the wound process. Against the background of treatment, by 3 days (after the first dressing) the phenomena of perifocal inflammation significantly decreased, and with burns of the II-IIIa degree a dry scab formed. The wound discharge was absorbed by the sorption layer and dried. In case of burns of the II-IIIa degree after scab rejection, the dressing was left on the wound until complete epithelization and self-separation of the coating, while the epithelization time was on average 10 days after the injury. In the experimental group of suppurations under a bandage was not noted, the number of staphylococci on wound surfaces was 1-2% of the original population, while in the control group this value reached 15-17%, in two patients there was a suppuration of abrasions. Uncomplicated epithelization of wound surfaces on the 6th day of treatment was observed in 73% of patients in the experimental group and in 58% of patients in the control group. In the experimental group, 65% of cases of pain decreased after 20-40 minutes and in 85% of cases the pain stopped after 2-3 hours. In the experimental group, these indicators were, respectively, 41% and 68%.

Tests have shown that when using the material, the phenomena of inflammation in the wound and pain syndrome are effectively stopped, small wound surfaces and abrasions are accelerated epithelialization. Due to the pronounced sorption properties of the working surface of the material, in combination with the action of polyethylene glycols and metal nanoparticles, a dry scab is quickly formed under a dressing for burns of the II-IIIa degree, the coating has distinct antibacterial properties and allows significant relief of pain due to the oligodynamic and electret properties of the material in combination with triclosan (0.1 mg / cm ² ) and lidocaine (0.5 mg / cm ² ).

It was found that the above combination of material properties allows you to effectively use the minimum therapeutic doses of these additional therapeutic drugs, significantly reducing the risk of drug intoxication and allergic manifestations in patients. The material is able to provide penetration through the skin of the maximum possible amount of active substances. The material adheres well to the wound surface, when using it, visual control of the course of the wound process due to the transparency of the material is maintained, a micro-outflow of wound exudate through the material is ensured, daily replacement is not required, labor costs for patient dressing are significantly reduced, dressing material is economically spent. The terms for replacing dressings are prolonged and, accordingly, wound surfaces are less prone to injury. The subjects did not reveal any allergic reactions or side effects. NF material in vice transparent film measuring 3.5 × 7.0 cm in a sealed sterile package of 5 pcs. it is most convenient in the treatment of small wound surfaces, extensive abrasions, with burns of the II-IIIa degree, and may also be appropriate in the complex treatment of trophic ulcers, pressure sores in the granulation stage, etc. The material is easily and atraumatically removed after impregnation with conventional antiseptics. No microbial contamination of the wounds was noted. The use of NF film material does not preclude the use of water-soluble ointments or solutions on top of the material. Due to the content of metal nanoparticles with oligodynamic properties, the material has improved anti-epidemic and sanitary-hygienic properties, has good skin tolerance, physical and chemical stability during long-term storage and use, and also has good adhesive properties. It is stored in a sterile package, easy to use.

Example 2. The research task was to create effective and inexpensive products that are alternative or additional to existing antiperspirant deodorants.

The studies were conducted on an outpatient basis at the medical center of the sports camp of St. Petersburg NPIGI. We used Novafor BLPV material (see Table 1.) with a 10: 1 ratio of silver and zinc nanoparticles on the working surface of an electret polymethyl methacrylate film (30 μm thick). And cotton viscose blotches (120 g / m ² ), having exits to the working surface of the material, ensured the sorption ability of the material. Perforation of the material is made in the form of through channels, the total area of the holes of which amounted to 30% of the total area. The size of the holes is at least 0.5 mm. The material was used in the form of translucent film stickers measuring 4.5 × 4.5 cm in a sealed sterile package of 2 pcs. It is assumed that such material has antimicrobial, sorption and deodorizing activity.

The effectiveness of the use of NF material was determined in comparison with placebo organoleptic tests (for the formation of odors) in a group of 17 healthy volunteers, of which 6 men and 11 women, the average age of 29.5 years. A placebo used a perforated non-metallic non-electret polymethylmethacrylate film with cotton viscose interspersed (120 g / m ² ), size 4.5 × 4.5 cm in a sealed sterile package of 2 pcs.

The subjects were asked to shave or epilate the axillary regions (axillary regions) two days before the start of the study. Every morning, volunteers washed their armpits with ordinary toilet soap in the morning. After that, two stickers of the experimental material were fixed in one axillary region of each subject, and two stickers of placebo material in the other.

After eight hours, two expert physicians evaluated the odor intensity in the axillary regions of the subjects. After the first day, they chose in 89% of cases the use of experimental material, after the second - in 95%, after the third - in 92%.

Selective microbiological studies have shown that the proposed material effectively inhibits the growth of bacteria for a long period. So, when used after 8 hours, the number of staphylococci and Corynebacteria was 5-8% of the original population, while in control cases (placebo material) this value reached 39-43%.

It was found that the proposed material has an effective antimicrobial and deodorizing effect, due to the intradermal effect of its active components directly on the body of the apocrine sweat glands of the axillary regions, the secret of which contains a large amount of protein substances - a nutrient medium for the rapid multiplication of opportunistic bacterial flora, which contributes to the development of a sharp the smell of sweat. The use of the proposed material is possible as an alternative or a highly effective addition to existing antiperspirant deodorants and to reduce the risk of allergic and side effects.

The therapeutic and cosmetic material NF can be used both independently and in the form of elements, for example, as part of ball / roller dispensers (such as roll-on) and others for accelerated intradermal or transdermal administration of therapeutic and nutritional substances, effective use of body care products, normalization of tissue metabolism, elimination of cosmetic defects and increase the regenerative capabilities of the skin, as well as for the rehabilitation of the effects of injuries, surgical interventions, in dermatology. Modifications to the above nozzles are also suitable for use in stick dispensers. The working surface of all nozzles can be interchangeable.

Example 3. Individual therapeutic film material NF, containing (in contrast to example 1.) only the main layers 1 and 2 without drugs, is used as a transdermal donor to fill the deficiency of trace elements (metals), for local bactericidal and wound healing effects, non-specific local immunostimulation, normalization of metabolic processes, improvement of blood circulation, warming and reflexotherapeutic action on biologically active zones in places of use.

Method of application: before use, the sticker is removed from the sealed paper bag, and, if necessary, it can be cut with scissors to give a convenient size and shape. When fixing, the material is placed on the working surface to the skin, or directly to the wound surface, or through layers of gauze. It is applicable at all stages of the reparative process, when the bottom of the wound surface is viable tissue (there are no deep necrotic sites). Exposure time - from several hours to several days based on medical indications and subjective sensations of the patient. The advantage of the proposed material is the possibility of using it together with commonly used dosage forms - solutions, ointments, gels, as well as, for example, finely divided powders - in the presence of inclusions of 5 containing material that dissolves due to absorption of moisture from the atmosphere. The management of the wound process does not differ from the usual method of treating wounds.

Example 4. The therapeutic film material NF, additionally containing inclusions 4 and 5, is used as an effective penetrator, which further facilitates the penetration through the skin of many medicinal and biologically active preparations intended for external use without changing their pharmacological properties, for combination pharmacotherapy and synergistic combination with the effects described above, as well as to remove secretions of sebaceous, sweat glands and non-abundant, mainly non-purulent exudate with wound surfaces. Exposure time - from 10 minutes to several hours is specified based on the characteristics of the applied drug and the subjective feelings of the patient.

In sports medicine, it is advisable to use NF for the treatment and prevention of injuries, during training and competitions, in the rehabilitation period. NF film material with special inclusions neutralizes the pain syndrome caused by the accumulation of lactic acid in the muscles of athletes during intense exertion, and can increase the reaction rate. It is used in the form of individual individual skin stickers in the axillary and other areas, removable stickers on the arms of sports equipment, removable stickers on the shoe support of summer shoes, etc.

NF may be relevant as part of a hypoallergenic biocompatible suture material in surgery, in the production of orthopedic, dental, bone implants.

Method of application: therapeutic material is fixed on top of a thin layer of the drug used, previously applied to the skin, while the internal adhesive edges of the film should protrude around the perimeter beyond the area covered by the drug. Before use, the medical sticker (as well as its cosmetic, perfume analogues) is removed from a sealed paper bag, and, if necessary, it can be cut with scissors to give the desired size and convenient shape. At the time of fixation on the skin, the outer protective layer is removed from the film sticker. The material has a working surface to the skin. It is convenient to use varieties of NF material in stationary, outpatient and field conditions, while the risk of contamination of clothing with drugs is reduced. The material is suitable for washing, disinfection and repeated individual use, the risk of contamination of clothing is reduced.

Example 5. Therapeutic and cosmetic stickers with therapeutic and nutritional compositions are convenient to use in SPA salons and at home, the risk of contamination of clothing with drugs is reduced.

Method of application: before use, the sticker is removed from the sealed paper bag and at the time of fixation on the skin, the outer protective layer of adhesive-based paper is removed from it. The paper backing layer may have a “visor” for ease of separation from the material. The material has a working surface to the skin.

It is advisable to use devices made of composite material NF as an effective disinfecting and healing element for personal hygiene products, for example, in the form of axillary antiperspirant and deodorizing applicators, as part of surfaces and / or reservoirs of jet, drip and other dispensers in contact with the body, and the internal parts of various sprayers, pulverizers of hygienic, medical and cosmetic, cosmetic, repellent and other means of individual use, as well as toothbrushes, bri in, shoe insoles, etc.

In addition to medicine, medical cosmetology and hygiene, NF has important practical applications for a wide range of consumer products.

Example 6. A transparent NF sticker with a perfume composition in the form of, for example, a circle of confetti with a persistent metered aroma. The transparent sticker can be discreetly fixed, for example, behind the ear. Before use, the sticker is removed from the sealed paper bag and at the time of fixation on the skin, the outer protective layer of paper is removed from it on a hypoallergenic adhesive base consisting, for example, of polyacrylate compounds. The paper backing layer may have a “visor” for ease of separation from the material. Unlike NF healing and cosmetic films, when fixed, the surface with aromatic inclusions does not come in contact with the skin, but faces outward. When you remove the sticker, the "bored" aroma completely disappears.

The studies were conducted on an outpatient basis on the basis of St. Petersburg IGI. The study used NF material with the BLAKPV classification index, based on a non-perforated electret polytetrafluoroethylene film (30 μm thick) containing 10: 1 silver and zinc nanoparticles on the working surface (to prevent skin irritations at the material fixation site), and also containing only on the outer (opposite working) surface of cotton viscous inclusions (25-30 g / m ² ) with preliminary perfume impregnation. Discrete cotton viscose blotches were saturated: Pure Poison (Dior) perfumes - for test women; Cologne brand Cerruti Si (Cerruti) - for test men. The shape of the material was translucent fine-grained “confetti” circles with a diameter of 0.7 cm. Adhesive edges and work surfaces were covered with a layer of waxed paper with “peaks” for the convenience of separating the material. This material was hermetically sealed (sealed) in plastic bags of 1.5 × 1.5 cm with a designated tear line and an indication of the location of the adhesive side, which must be fixed to the skin for the convenience of users. The main indicators by which the certification was carried out were the quality of the smell and its durability. Odor resistance was determined organoleptically in several stages. As standards, pieces of gauze were prepared, which were impregnated with the above perfume liquids, dried in a room with a temperature of + 20 ° С and hermetically packed in plastic bags, which were opened during testing. The above-mentioned perfumery goods and the procedure for their testing comply with GOST and TU: Perfumery liquid products, GOST 17237-93 pl. 1.1., 1.3 .; Perfumery and cosmetic products. Gas chromatographic method for the determination of ethyl alcohol. 29188.0-91. Perfumery and cosmetic products. Acceptance rules, sampling, methods of organoleptic testing.

Studies were carried out for 5 hours in a group of 12 volunteers, of which 5 men and 7 women aged 21-36 years. On the first day of the test, 2 men and 3 women from among the subjects were included in the second (control) group, they were applied with a measuring pipette appropriate perfume compositions to open skin areas in an amount of 0.1-0.2. ml On the second day, the subjects of the control and experimental groups switched places. Comparative organoleptic analysis was carried out: the first stage - 15 minutes after applying perfume compositions, then the second, third and fourth stage with intervals of 1.5 hours. Three testers in turn compared the smells of samples of material recorded in open areas of the skin of the subjects (behind the auricle on the right or left) with the smells of subjects from the control group, as well as with opened gauze standards. At the first stage, the “initial note” created by the most volatile components of perfume compositions was determined. In the experimental group, the “initial note” is defined as persistent and identical with respect to the control group. At the second and third stages, the “note of the heart" created by the basic aromas of the compositions was determined. It is defined as a persistent and prolonged in relation to the control group (according to existing standards, a "heart note" should last at least 3-4 hours, less persistent compositions are not industrially suitable). At the fourth stage of research, the “final note” was determined - the final stage of evaporation with the manifestation of musky, vanilla, amber and other finishing aromas. The "final note" in the experimental group was defined as prolonged and "devoid of unpleasant shades" in relation to the control group. The research results showed statistically significant that when using the proposed material with perfume samples, the main stages of the manifestation of aromas (“heart note” and “final note”) are prolonged on average by 0.5 hours in 80% of cases. Irritation of the skin in places of fixation of the material is not marked. The subjective discomfort during the fixation, wearing of the material and its removal, the subjects did not feel. As an additional convenience, volunteers (60% of men and 75% of women) noted the possibility of a quick disappearance of aroma after removing material from the skin. The research results create significant prerequisites for the industrial production of perfume compositions on the proposed carrier, including, for example, those recognized previously unsuitable due to insufficient aromatic resistance or increased viscosity, which will allow to reduce the cost of raw materials and will serve as an incentive for the widespread development of economical raw materials and perfume materials .

Example 7. In reservoirs, reservoirs, jugs for drinking water, a film filter of post-treatment of water with a content of, for example, silver, copper, fluorine is used. Method of application: NF material is fixed with an acceptable adhesive base directly to the inner wall of an empty container, then water is poured into which the working surface of the film is immersed. Recommended exposure time is at least 8 hours. It allows to improve the organoleptic and anti-epidemic properties of water, to preserve its consumer qualities longer.

Example 8. A prolongator of presentation, “welcome” or “tasty” NF flavors, containing a layer with inclusions capable of metered evaporation of aromatic substances, volatile, in the form of stickers on interior elements of premises or, for example, on the outer part of the packaging of goods and food products.

Example 9. A variant of the NF sticker as an odor absorber with a simultaneous aromatherapy effect, it is advisable to use in replaceable clothing elements, for example, in contact with the skin in the axillary region, in shoe insoles.

Example 10. Food packaging may consist (or contain an inner liner) of NF material, since the electric field of negative polarity of the electret layer allows you to increase the shelf life, preserve the organoleptic and physical characteristics of the products. The internal elements of the NF material that are in direct contact with moisture-containing products, including frozen ones, as well as with any drinks, juices, milk and fermented milk products, may include inclusions of trace elements, balanced additives of active vitamins, provitamins, phytoncides, etc. It is proved that the electric charge of electret packaging reduces the growth rate of medium acidity by an average of 10 ° T, slows down the vital activity of microorganisms. Also, the distribution, for example, in a medium of packaged milk, of a negative charge of an electret avoids premature coagulation of casein and other milk constituents. (A.N. Borisova, M.F. Galikhanov, R.Ya. Deberdeev and others, Electroactivation material for packaging milk, KSTU, 2006.). Food packaging from the proposed material can be additionally enriched with necessary trace elements, biologically active substances, anticholesterol additives, etc.

Example 11. NF material with bactericidal inclusions used as a microphone membrane for telephones, concert, dispatch microphones for a long time has significantly improved sanitary and hygienic and anti-epidemic characteristics.

Example 12. In the tobacco industry, NF is of interest as an additional absorber of nicotine and resins, a flavoring agent in tobacco product filters.

Example 13. A wide range of application of NF stickers with repellent additives for repelling blood-sucking insects and prevention, for example, tick-borne encephalitis. NF repellent patches are also relevant for animals, including livestock.

Example 14. In decontamination: the proposed material with a special "filling" enhances the ability to deactivate technogenic chemical, radioactive and bacteriological contaminants in the field. It can be used in protective masks, respirators, various filters, sanitary napkins, etc. A wide range of applications in production, in the services of the Ministry of Emergencies, the army.

Example 15. NF in the form of a film with an integrated circuit, a semiconductor photoelectric generator and an energy converting element can be used as an autonomous energy source.

Example 16. The film aeroionator NF can be used in the form of a smart layer of window glasses, lamps for industrial and non-industrial premises, cars, liners, etc.

Example 17. In the electric power industry, electronics and nanoelectronics, NF can be used in the manufacture of capacitors, integrated circuits, components of household appliances, cellular and cordless telephones, etc. NF materials with an integrated microcircuit can also be used as electronic markers of wide groups of consumer goods to optimize trade and prevent the spread of counterfeit products.

Example 18. The use of NF in control and measuring devices, in particular, for monitoring leaks of industrial and domestic gas, for controlling the content of natural hydrocarbons in the atmosphere of mines, metro, in sewer systems, etc. A semiconductor sensor for detecting explosive gases in air is an electret-containing material containing monocrystalline silicon inclusion with a layer of silicon dioxide and a temperature sensor placed on it in the form of a resistive bridge. It can be used in the original device without an external power source, in particular, together with an electronic threshold-amplifier unit and an audible alarm and / or LED indicator, in contrast to the invention (RU, 2231779), adopted, in this case, as a prototype, where the dioxide layer silicon layer is sequentially deposited a single-crystal silicon layer with a porous surface, a second layer of silicon dioxide, a thermocatalytic layer, and an insulating layer is deposited in two asymmetric shoulders of the resistive bridge catalytic layer from the atmosphere. In the other two asymmetrical arms of the resistive bridge, the thermocatalytic layer is left open, which ensures the occurrence of the oxidative reaction of flameless combustion of the gas component of the registered explosive compound with atmospheric oxygen with the release of heat, which leads to the imbalance of the bridge and the appearance of an electrical signal.

There are other possible uses of the NF material in electronics, radio electronics, tribotechnology and other industrial fields, taking into account the technical feasibility and advantageous features of the proposed material. It is obvious that some features of the invention, the description of which is given for clarity in connection with individual embodiments of the invention, can also be combined into one embodiment of the invention. Conversely, various features of the invention, the description of which for brevity is given in connection with one embodiment of the invention, may also be presented separately or in any suitable subcombination.

Claims (17)

1. Oligodynamic composite material, characterized by the presence of a layer of a polymer material with electret properties, in the volume of which at least one first discrete element made of metal particles with different work function is located with at least one working surface of the electret exit electrons and capable of exhibiting oligodynamic effects. 2. The composite material according to claim 1, characterized in that the metal nanoparticles are used. 3. The composite material according to claim 1, characterized in that the metals used are selected from among the metals necessary for the life of a living organism. 4. The composite material according to claim 1, characterized in that it further comprises a layer of insulating material located between the layer of polymer material with electret properties and a discrete element. 5. The composite material according to claim 1, characterized in that it further comprises at least one second discrete element, which is a drug dispensing carrier of biologically active substances, located in the layer of polymer material with electret properties with access to its working surface , trace elements, strains of bacteria, aromatic substances. 6. The composite material according to claim 5, characterized in that the first discrete element is located in the second discrete element. 7. The composite material according to claim 5, characterized in that the second discrete element is made with access to the second surface of the polymeric material with electret properties. 8. The composite material according to claim 1, characterized in that it further comprises at least one third discrete element, which is a selective absorption means with a developed surface in the composition, located in the layer of polymer material with electret properties with access to its working surface a work surface that is connected through a hole with the opposite side of the material with electret properties. 9. Composite material according to claim 8, characterized in that the first discrete element is located in the third discrete element. 10. The composite material of claim 8, characterized in that the third discrete element contains a component capable of absorbing moisture from the atmosphere. 11. Composite material according to claim 8, characterized in that the third discrete element is made with access to the second surface of the polymeric material with electret properties. 12. The composite material according to claim 1, characterized in that the first discrete element is made with access to the second surface of the polymeric material with electret properties. 13. The composite material according to claim 1, characterized in that the thickness of the layers of the composite material is from 0.050 to 40 microns. 14. The composite material according to claim 1, characterized in that the polymer material with electret properties is fixed on the basis. 15. The composite material according to 14, characterized in that it contains an adhesive base that is biocompatible with the tissues of a living organism. 16. The composite material according to clause 15, wherein the biocompatible adhesive base is made of a soluble polymer. 17. The composite material according to 14, characterized in that the paper or fabric base is used.

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