RU103295U1 - MICROCONTAINER POLYMERIC WITH A MEDICINAL SUBSTANCE, PROVIDING A LOCAL PROLONGED ANTIMICROBE ACTION - Google Patents

Abstract

The utility model relates to medical devices and can be used in traumatology and general surgery for application to wound surfaces of internal organs and tissues. The microcontainer consists of two parts: the central one, made in the form of granules with a size of the described diameter from 0.05 to 1.5 mm, made of a copolymer of vinyl pyrrolidone with butyl methacrylate and an antimicrobial substance and an outer shell of a copolymer of vinyl pyrrolidone with butyl methacrylate, with a thickness of 0.05 to 0.2 mm. Using the utility model provides effective sorption of wound exudates, reduces the number of injections of antimicrobial substances during the course of treatment, provides a long-term local antimicrobial effect for 4-12 days and reduces the total dose of the used antimicrobial substance by 10-300 times.

Description

The utility model relates to medical devices, namely, products used in dermatology, traumatology and general surgery

It is known that an ointment containing an antimicrobial substance, for example, gentamicin sulfate, is applied from a tube to the outer surface of a patient’s skin (M.D. Mashkovsky Medicines, 2007, M. P.799). This method of drug administration has several disadvantages:

- ointment can be used only for external use,

- the tool has low bioavailability,

- requires repeated application to a damaged surface.

Injection of an antimicrobial substance into a patient is known; for example, gentamicin sulfate using a medical syringe. (M.D. Mashkovsky, Medicines, 2007, M., p. 800) This method of administration has the following disadvantages:

- requires multiple administration of the drug (up to 20 injections) within 5-7 days,

- not able to provide the necessary directed therapeutic effect,

- has a traumatic effect,

- requires the introduction of large total doses of the drug substance, which can cause unwanted adverse reactions and leads to an increase in the cost of treatment

The technical task of the proposed Utility model is the creation of microcontainers from biocompatible polymers containing antimicrobial agents, capable of sorption of postoperative exudates, capable of absorbing after the operation within the body, capable of exerting a long-term local antimicrobial effect directly in the area of tissue damage and allowing to reduce the total dose of the used antimicrobial substance.

The technical result is achieved in that the microcontainer consists of two parts: the central part (1), made in the form of granules with a size of the described diameter from 0.05 to 1.5 mm, made of a copolymer of vinylpyrrolidone with butyl methacrylate, for example, PPB-1 (TU 2216-025-17712704-04) and antimicrobial substances in the following ratio of constituent parts (% wt.):

Vinylpyrrolidone copolymer with

butyl methacrylate 65.0-99.0; antimicrobial substance 1.0-35.0;

and the outer shell (2) of a copolymer of vinylpyrrolidone with butyl methacrylate with a thickness of 0.05 to 0.2 mm.

The boundary sizes of the granules are due to the fact that granules with a size of less than 0.05 mm do not provide the necessary duration of the release of painkillers into adjacent tissues, and granules with a size of more than 1.5 mm can cause an undesirable reaction of adjacent tissues to a foreign body due to the mechanical irritating effect of large particulate matter. The thickness of the protective layer less than 0.05 mm does not ensure the continuity of the protective layer, which does not allow you to adjust the rate of release of antimicrobial substances, and a thickness of more than 0.2 mm leads to an increase in the size of the microcontiner, which can cause an undesirable reaction (irritation) of surrounding tissues.

The granules are made of a biocompatible copolymer of vinyl pyrrolidone with butyl methacrylate, for example, PPB-1 brand, which is able to completely biodegrade in the body within 14 to 60 days depending on the particle size and implantation site without toxic effects both on the surrounding tissues and the body as a whole. Antimicrobial substances undergo metabolic processes and are completely eliminated from the body in terms determined by their structure and properties.

The amount of antimicrobial substance is from 1.0 to 35.0%. The boundary concentrations of antimicrobial substances are due to the fact that when the antimicrobial content is less than 1%, the required local therapeutic concentrations in the adjacent tissues are not achieved, and at concentrations of more than 35% there is a sharp release of the drug on the first day, which leads to an excess of permissible concentrations in the adjacent tissues .

The outer shell is made of the same or another biocompatible copolymer, capable of absorbing in the body at the same time as the material of the central part.

The use of polymer antimicrobial microcontainer allows the following:

- to ensure reliable fixation of particles on the wound surface due to the high adhesion of the copolymer to soft tissues,

- provide sorption of wound exudates from the wound surface,

- eliminate the unwanted reaction of tissues to a long stay of a foreign body inside the body due to the complete biodegradation of the material,

- to provide long-term local antimicrobial action in the operating area,

- reduce the total dose of the used antimicrobial substance and in some cases completely eliminate the conduct of traditional postoperative antibiotic therapy.

The proposed Utility Model operates as follows.

At the end of the operation, immediately before tissue suturing, all layers of the surgical wound are uniformly sprinkled with a non-continuous layer of particles of microcontainers, be sure to avoid the formation of a continuous layer or a heterogeneous thick layer. After applying microcontainers, the wound is sutured in layers tightly or with drainage.

Examples of manufacturing a utility model.

Example No. 1.

20 g of a copolymer of vinylpyrrolidone with butyl methacrylate grade PPB-1 (TU 2216-025-17712304-04) (65%) are dissolved in 50 g of ethanol and after complete dissolution of the copolymer, 10.8 g of sulfapyridazine (35%) are added with stirring, and the resulting formed the suspension on a polypropylene substrate is dried in vacuum at a temperature of 80 C for 4 hours and ground in a mill to obtain granules of the central part 0.3-0.4 mm in size. then. By spraying "in a suspended" layer at a temperature of 60 C from an acetone solution of polyvinylpyrrolidone on the surface of the granules form an outer layer with a thickness of 0.12-0.15 mm. Microcontainers are used for application to the wound surface during liver resection. The sorption capacity of the sorbent is 110-120%. The duration of local antimicrobial action is 5-8 days. The time of complete destruction of the sorbent is 20 days.

Example No. 2.

20 g of a copolymer of vinylpyrrolidone with butyl methacrylate (nitrogen content 4.7% by weight) (99%) are dissolved in 40 g of ethanol and after complete dissolution of the copolymer, 0.2 g of crystalline iodine (1%) is added with stirring, the mixture is stirred until complete dissolution . The resulting solution is poured onto a polymer substrate and dried at a temperature of 75 ° C for 8 hours, the dried film is removed from the substrate and ground in a mill to obtain granules with a size of 0.05-0.08 mm. The granules are loaded into liquid paraffin and an acetone solution of the PPB-1 copolymer is added to the suspension with stirring. The method of removing acetone while passing air and a temperature of 50 C on the surface of the granules form the outer layer with a thickness of 0.05-0.07 mm Microcontainers are used for application to the surface of the intestine during the formation of intestinal anastomosis. Sorption capacity of the sorbent is 100-110%. The duration of local antimicrobial action is 12-14 days. The time of complete destruction of the sorbent is 14 days.

Example No. 3. 20 g of a copolymer of vinylpyrrolidone with butyl methacrylate (nitrogen content 7.8% by weight) (80%) are dissolved in 45 g of ethanol and, after complete dissolution of the copolymer, 5 g of gentamicin sulfate (20%) are added with stirring. The resulting suspension is poured onto a polymer substrate, dried in vacuum at a temperature of 60 ° C, the film of the undercoat is removed and ground in a mill to obtain granules with a size of 1.0-1.5 mm. The microcontainer is used to apply to the damaged fascia during bone osteosynthesis of tubular bones. The granules are loaded into liquid paraffin and a 12% solution of a copolymer of vinylpyrrolidone with butimethacrylate (nitrogen content 6.7% by weight) is introduced into the suspension with stirring. The method of removing acetone while passing nitrogen and a temperature of 50 C on the surface to form an outer layer with a thickness of 0.18-0.2 mm The sorption capacity of the sorbent is 120-130%. The duration of local antimicrobial action is 4-7 days. The time of complete destruction of the sorbent is 40 days.

The advantages of the proposed utility model in comparison with the prototype are shown in table No. 1

Comparative results of the use of microcontainers according to the prototype and the proposed model. No. Parameter Name Parameter value According to the prototype According to the proposed utility model, By examples one 2 3 one The terms of resorption within the body, day 0.1-0.2 twenty fourteen 40 2 The number of injections of antimicrobial substances during the course of treatment 15-21 one one one 3 The total dose of antimicrobial substances, mg 1600 175 5 one hundred four The duration of local antimicrobial activity, day 0.2-0.5 5-8 10-12 4-7 5 Sorption ability in relation to exudates,% 0 110-120 100-110 120-130

Claims (1)

A polymer microcontainer for application to a wound surface, characterized in that it consists of two parts: a central part made in the form of granules with a described circle diameter of 0.05-1.5 mm, made from a copolymer of vinylpyrrolidone with butyl methacrylate and an antimicrobial substance in the following the ratio of constituent parts, wt.%: vinylpyrrolidone copolymer with butyl methacrylate 65.0-99.0 antimicrobial substance 1.0-35.0 and an outer shell of a vinylpyrrolidone copolymer with butyl methacrylate with a thickness of 0.05 to 0.2 mm.