Method for manufacturing remedy for prophylaxis of wound suppuration

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

 

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

The known method of production of means for the prevention of postoperative suppurations in the form of tablets, consisting in obtaining powdered mixtures of antimicrobial substances with inert fillers and subsequent pressing of these mixtures in order to obtain tablets of various sizes and configurations (Industrial technology of drugs. Edited Chueshov, Kharkov, 2002, pp. 445-448). However, these tools are only suitable for oral administration and require repeated use in the postoperative management of patients.

Closest to the present invention is a method of production of drugs for the prevention of suppuration of wounds in the form or single beads of polymethylmethacrylate containing the antibiotic, or beads from them on a thin metal wire, the beads obtained by mixing methyl methacrylate or methyl methacrylate) with antibiotic and subsequent formation of a mixture of balls by polymerization or extrusion with the axial channel and the Assembly of these beads on a metal wire. The drawback of this method is that in the process of forming balls of possible partial decontamination of the antibiotic, and upon application, the diffusion of the antibiotic from ready what about the product is very slow, that does not always provide the necessary therapeutic concentrations of the antibiotic in the damage zone. In addition, after completion of the regeneration processes themselves beads or beads on their basis, it is necessary to extract from the operating zone that is associated with the application of additional injury. (Majid SA, Lindberg L.T. Gunterberg Century at all, Gentomicin - PMMA beads in the Tretment Chronic osteimyelitis, Asta - ortopedi scand - 1985. - vol.56. - p.265-268).

The technical objective of the proposed invention is to provide a method of manufacture of a medicinal product for the prevention of suppuration of postoperative wounds, which ensures that the high activity of antimicrobial substances, and the tool itself after the introduction and the suturing of the wound provides for the maintenance of the operation place the necessary therapeutic concentrations of drug substances and does not require additional surgery recovery after completion of the regeneration processes.

The technical result is achieved in that in the method of production tools for the prevention of suppuration of wounds by mixing an antimicrobial drug and the polymer carrier is a copolymer of vinylpyrrolidone with butylmethacrylate dissolved in ethyl alcohol, introducing an antimicrobial substance in a ratio of components, wt.%:

copolymer of vinylpyrrolidone with butylmethacrylate 25.0-35.0;

antimicrobial wishesto-9.0;

ethyl alcohol 74.75-56.0.

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

When using spirtorastvorimymi antimicrobial substances additional ground in the polymer solution prior to particle size less than 15 microns.

The proposed method is illustrated by examples.

Example 1.

30 g of a copolymer of vinylpyrrolidone with butylmethacrylate brand of SPD-1 is dissolved in 87.5 ml (65 g) of ethanol administered 5 g powdered dioksidina, the resulting suspension is treated in a rotary grinder until the particle size dioksidina less than 15 μm, the resulting suspension is poured onto a stainless steel belt layer with a thickness of 1 mm and dried at a temperature of 50°C for 12 hours to a residual volatile content of 3.5 wt.%.

The obtained solid film pulverized in a ball mill until the particle size of 200-350 μm. The resulting powder was Packed 200 mg in bags made of laminated foil and sterilized by radiation method, or gas sterilization.

Example 2.

25 g of a copolymer brand of SPD-1 is dissolved in 92.8 ml (74.25 g) of ethyl alcohol, the ri stirring solution give 0.25 g of crystalline iodine and interfere until dissolved iodine. The resulting solution was poured with a layer thickness of 10 mm in a metal tray covered with a polyethylene film and dried in a vacuum at a temperature of 55-60°to a residual alcohol content is 4 wt.%.

The obtained solid product is ground in a ball vibrating mill until the particle size of 50-150 microns, Packed with 300 mg of glass bottles and sterilized by radiation method.

Example 3.

The copolymer brand of SPD-1 is dissolved in 70 ml (56 g) of ethanol, add 9 g of gentamicin sulfate and stirred until complete dissolution of the drug substance. The solution layer thickness of 20 mm is poured into a plastic tray, covered with a film of polypropylene, and dried in a vacuum at a temperature of 70-75°to a residual alcohol content of 3.5 wt.%.

The obtained solid product is ground in disintegrator to the particle size of 100-200 μm, Packed with 300 mg of glass bottles and sterilized by radiation method.

Thus, the proposed method allows to obtain medicines that can be injected directly into the surgical field, as well as in open wounds and burns, while ensuring the maintenance of therapeutic concentrations in the healing period (postoperative period).

Table 1
“No. p/pThe Naim is Finance PrototypeThe proposed method
1.Required dosage for local therapeutic concentrations, mg450-60075
2.The loss of activity of antimicrobial substances in the production process, %20-301-2
3.Particle size, microns2000-300050-350
4.The need for recovery operations toolsYesno
5.The presence of a reaction in patients on a foreign body %20-280

1. Method for the production of tools for the prevention of suppuration of wounds by mixing an antimicrobial drug and the polymer carrier, characterized in that the polymer carrier used is a copolymer of vinylpyrrolidone with butylmethacrylate which is dissolved in ethanol, then in the antimicrobial solution is injected drugs in the following ratio, wt.%:

copolymer of vinylpyrrolidone

with butylmethacrylate 25,0-35,0

the antimicrobial substance of 0.25-9,0

ethyl alcohol 56,0-77,75,

the resulting solution or suspension of drug-ve is esta in the copolymer solution is applied on a solid substrate with a layer thickness of 1 - 20 mm and dried in a vacuum at a temperature of 50 - 75°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 to 350 μm.

2. The method according to claim 1, characterized in that when using spirtorastvorimymi antimicrobials antimicrobial substances after the introduction into the solution of the copolymer additionally crushed to particle size less than 15 microns.



 

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