Tekstilni materijali za medicinsku namenu sa kombinovanim biološkim dejstvom

Abstract

U ovom radu ispitani su i prouceni dobijeni antimikrobni tekstilni materijali sa širokim spektrom dejstva i selektivnim antimikrobnim dejstvom, kao i medicinski tekstilni materijali sa kombinovanim antimikrobnim i anestezijskim biološkim dejstvom. Antimikrobni tekstilni material okarakterisan je in vitro i in vivo uslovima, preko efikasnosti antimikrobnog delovanja na razlicite indikatorske sojeve patogenih mikroorganizama (Staphilococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella, Candida albicans) i biokompatibilnosti u pretklinickom ispitivanju. U okviru ove doktorske disertacije detaljno su ispitana i proucena svojstva netkanog tekstilnog materijala od mešavine polipropilenskih (PP) i viskoznih vlakana kao podloge za formiranje biomedicinskog materijala. Polimer nosac aktivne supstance je polisaharid D-glukozamin, hitozan, a aktivna supstanca širokog spektra dejstva aminoglikozidni antibiotik, gentamicinsulfat. Aktivna suptanca selektivnog dejstva je natrijumfusidat, a za dobijanje biomedicinskih tekstilnih materijala kombinovanog dejstva korišcen je lidokainhidrohlorid u kombinaciji sa gentamicinsulfatom. Razvijen je matematicki model, na bazi drugog Fikovog zakona, za pracenje otpuštanja aktivne supstance, leka, sa bioaktivnog tekstilnog materijala, kao transdermalnog sistema. Francova difuziona celija simulirala je in vivo uslove i na osnovu dobijenih rezultata utvrđena je kinetika otpuštanja leka. Promena poroznosti strukture pre i nakon antimikrobnog tretmana netkanog tekstilnog materijala ispitivana je metodom živine porozimetrije. Rezultati istraživanja su pokazali odlicnu biokompatibilnost antimikrobnih biomedicinskih tekstilnih materijala, bez citotoksicnosti, senzibilizacije i iritacije, što je omogucilo klinicka ispitivanja mogucnosti primene u prevenciji bakterijske kontaminacije centralnog venskog katetera. Na osnovu rezultata istraživanja biomedicinskih tekstilnih materijala programiranih svojstava, izvršenih pretklinickih, a nakon toga i klinickih ispitivanja, postignuto je originalno rešenje mogucnosti njihove bezbedne aplikacije u medicinskoj praksi.

The subject of this thesis is the development and behaviour of the antimicrobial textile materials characterized by a broad spectrum of activity and a selective antimicrobial activity, as well as the medical textile materials with combined antimicrobial and anesthetic biological effects. The antimicrobial textile material has been characterised in vitro and in vivo conditions through the efficiency of the antimicrobial effect on different indicating sorts of pathogenic microorganisms (Staphilococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella, Candida albicans), as well as through the biocompatibility within pre-clinical research. This doctoral dissertation provides a detailed analysis of the nonwoven textile base which contains PP / viscose, a polymer carrier and an antimicrobial active substance. The polymer carrier of the active substance is the polysaccharide D-glucosamine (chitosan), and the active substance with a broad spectrum of effects is the amino glucose antibiotic, gentamicin sulfate. The active substance of selective effects is sodium fusidate and in order to obtain the biomedical textile materials of a combined activity, the combination of lidocaine hydrochloride and gentamicin sulfate has been used. Furthermore, this study includes a mathematical model which has been developed in order to control the release of the active substance of the medicine, from a bioactive textile material as a transdermal system. The mathematical model is formulated through the Fick’s second law. The Franz diffusion cell has simulated the in vivo conditions and on the basis of the obtained results, the kinetics of the release of the medicine has been determined. Mercury intrusion porosimetry was used in order to estimate the influence of the antimicrobial impregnation on the pore structure of the nonwoven textile material. The results of the research have shown excellent biocompatibility of the antimicrobial biomedical textile materials, with no citotoxicity, sensibilisation and irritation, which made it possible to clinically research their use in the prevention of the bacterial contamination of the central vein catheter. Having researched the biomedical textile materials of programmed activity and having done both, the preclinical research and clinical trials, an original solution concerning the possibility of their safe application in the medical practice has been obtained.