RU2252749C1 - Method for manufacturing remedy for prophylaxis of wound suppuration - Google Patents

Abstract

FIELD: pharmaceutics.

SUBSTANCE: the innovation deals with manufacturing remedies to prevent wound suppuration based upon polymeric matrix and antimicrobial substance due to mixing components in solution, forming the film to obtain a powder-like medicinal form by providing the safety of antimicrobial activity of medicinal preparation. The obtained remedy is completely biodestructed in the body and requires no repeated operation on its removal after the end of tissue regeneration processes.

EFFECT: higher efficiency of manufacturing.

1 cl, 3 ex, 1 tbl

Description

The invention relates to pharmacy, and in particular to a technology for the production of medicines.

A known method for the production of drugs for the prevention of postoperative suppuration in the form of tablets is to obtain powdered mixtures of antimicrobial substances with inert fillers and then compress these mixtures to obtain tablets of various sizes and configurations (Industrial Technology of Medicines. Edited by Chueshov, Kharkov, 2002 , pp. 445-448). However, these funds are suitable only for oral use and require repeated use during the postoperative management of patients.

Closest to the proposed method is the production of medicines for the prevention of suppuration of wounds in the form of either single balls of polymethyl methacrylate containing an antibiotic, or beads of them on a thin metal wire, while the balls themselves are obtained by mixing methyl methacrylate or polymethyl methacrylate with an antibiotic, followed by molding from a mixture balls by polymerization or pressing with an axial channel and assembling them into a bead on a metal wire. The disadvantage of this method is that in the process of forming balls, partial deactivation of the antibiotic is possible, and when the agent is used, diffusion of the antibiotic from the finished product is very slow, which does not always provide the necessary therapeutic concentrations of the antibiotic in the damage zone. In addition, after the completion of the regeneration processes, the balls themselves or beads based on them must be removed from the operating area, which is associated with additional injury. (Majid S.A., Lindberg L.T. Gunterberg B. at all, Gentomicin - PMMA beads in the Tretment Chronic osteimyelitis, Asta - ortopedi scand - 1985. - vol. 56. - p. 265-268).

The technical task of the proposed invention is to provide a method for the production of a medicinal product for the prevention of suppuration of postoperative wounds, which ensures the preservation of high activity of the antimicrobial substance, and the agent itself, after introducing and suturing the wound, maintains the necessary therapeutic concentrations of medicinal substances at the site of the operation and does not require additional surgery recovery after completion of the regeneration processes.

The technical result is achieved by the fact that in the method for the production of an agent for the prevention of suppuration of wounds by mixing an antimicrobial medicinal substance and a polymeric carrier, the vinylpyrrolidone-butyl methacrylate copolymer is dissolved in ethanol, the antimicrobial substance is introduced in the ratio of components, wt.%:

a copolymer of vinyl pyrrolidone with butyl methacrylate 25.0-35.0;

antimicrobial substance 0.25-9.0;

ethyl alcohol 74.75-56.0.

The resulting solution or suspension of the antimicrobial substance is applied to a solid substrate with a layer thickness of 1 to 20 mm and dried in vacuum with a residual pressure of not more than 20 mm RT. column at a temperature of from 50 to 75 ° C to a residual alcohol content of not more than 5 wt.% and the solid product is crushed to a particle size of from 50 to 350 microns.

When using alcohol-insoluble antimicrobial substances, they are additionally ground in a polymer solution to a particle size of less than 15 microns.

The proposed method is illustrated by examples.

Example 1

30 g of a copolymer of vinyl pyrrolidone with butyl methacrylate grade PPB-1 is dissolved in 87.5 ml (65 g) of ethanol, 5 g of powdered dioxidine are introduced, the resulting suspension is processed in a rotary grinder to a particle size of dioxidine less than 15 μm, the resulting suspension is poured onto a stainless steel strip with a layer 1 mm thick and dried at a temperature of 50 ° C for 12 hours to a residual volatile content of 3.5 wt.%.

The resulting solid film is crushed in a ball mill to a particle size of 200-350 microns. The resulting powder is packaged in 200 mg in bags of laminated foil and sterilized by the radiation method, or by gas sterilization.

Example 2

25 g of the PPB-1 copolymer are dissolved in 92.8 ml (74.25 g) of ethyl alcohol, 0.25 g of crystalline iodine is introduced into the solution with stirring and stirred until the iodine is completely dissolved. The resulting solution is poured into a 10 mm thick layer in a metal tray coated with a plastic film and dried in vacuum at a temperature of 55-60 ° C to a residual alcohol content of 4 wt.%.

The resulting solid product is ground in a ball mill to a particle size of 50-150 microns, Packed in 300 mg in glass bottles and sterilized by radiation.

Example 3

The PPB-1 copolymer is dissolved in 70 ml (56 g) of ethyl alcohol, 9 g of gentamicitin sulfate are added and mixed until the drug is completely dissolved. A solution with a thickness of 20 mm is poured into a plastic tray coated with a polypropylene film and dried in vacuum at a temperature of 70-75 ° C to a residual alcohol content of 3.5 wt.%.

The resulting solid product is crushed in a disintegrator to a particle size of 100-200 microns, Packed in 300 mg in glass bottles and sterilized by radiation.

Thus, the proposed method allows to obtain drugs that can be entered directly into the surgical field, as well as into open wounds and burns, while maintaining therapeutic concentrations in the healing period (postoperative period).

Table 1 “No. Parameter Name According to the prototype According to the proposed method 1. The required dosage to provide local therapeutic concentration, mg 450-600 75 2. The loss of antimicrobial activity in the production process,% 20-30 1-2 3. Particle size, microns 2000-3000 50-350 4. The need for operations to extract funds Yes not 5. The presence of a reaction in patients to a foreign body,% 20-28 0

Claims (2)

1. A method of manufacturing a means for the prevention of suppuration of wounds by mixing an antimicrobial medicinal substance and a polymeric carrier, characterized in that a vinyl pyrrolidone-butyl methacrylate copolymer is used as a polymeric carrier, which is dissolved in ethanol, then an antimicrobial medicinal substance is introduced into the solution in the following ratio of components, wt.%: vinylpyrrolidone copolymer with butyl methacrylate 25.0-35.0 antimicrobial substance 0.25-9.0 ethyl alcohol 56.0-77.75, the resulting solution or suspension of a drug substance in a copolymer solution is applied to a solid substrate with a layer thickness of 1 - 20 mm and dried in vacuum at a temperature of 50 - 75 ° C and a residual pressure of not higher than 20 mm RT. Art. to a residual alcohol content of not more than 5 wt.% and the solid product is crushed to a particle size of 50 - 350 microns. 2. The method according to claim 1, characterized in that when using alcohol-insoluble antimicrobial substances, the antimicrobial substances are additionally ground to a particle size of less than 15 microns after introduction of the copolymer into the solution.