In order to manufacture poly(glycolide-caprolactone)(PGCL) segmented block copolymer, first and second step polymerization was done. The first step polymerization of the glycolide and ε-caprolactone was conducted with molar ratio 60/40, and total molar ratio including second step polymerization was ...
In order to manufacture poly(glycolide-caprolactone)(PGCL) segmented block copolymer, first and second step polymerization was done. The first step polymerization of the glycolide and ε-caprolactone was conducted with molar ratio 60/40, and total molar ratio including second step polymerization was 75/25. The temperature and reaction time of the first step polymerization were 200 oC and 4~12 hours, respectively, which result in PGCL segmented block copolymer of high inherent viscosity. The addition of the catalyst 40 mol ppm and initiator 1,388 mol ppm result in a segmented block copolymer of high inherent viscosity, which was more than 2.0 dl/g. When the spinning temperature was 230-240oC, monofilament was flexible and smooth surface. And also tensile strength, knot strength and Young's modulus suitable for suture was obtained. The monofilament suture of PGCL was tested for retention strength rate under in-vitro and in-vivo. The results of tensile strength measured after immersing in-vitro remain 62% after one week, 20% after two weeks, 6% after three weeks, and none after four weeks. The retention strength under in-vivo conducted after implanted in a subcutaneous tissue of the SD rat showed 64% after one week, 23% after two weeks, 7% after three weeks, and none after four weeks. In-vivo study was performed to evaluate absorbability in rat. In sterility test, the test article, PGCL monofilament suture did not observe microbial growth, and the test article was considered to keep in an aseptic condition. In absorbability study under in-vivo, it was observed initial inflammatory response by implantation and implanted sample and muscle fiber necrosis in some individual at 2 days after implantation. However, there were no responses at 91 days. These results suggested that PGCL was absorbed within 91 days with recovery from inflammatory response. The cytotoxicity, sensitization, intracutaneous, systemic toxicity, genotoxicity, implantation, and pyrogen were tested as biocompatibility tests and all items passed.
In order to manufacture poly(glycolide-caprolactone)(PGCL) segmented block copolymer, first and second step polymerization was done. The first step polymerization of the glycolide and ε-caprolactone was conducted with molar ratio 60/40, and total molar ratio including second step polymerization was 75/25. The temperature and reaction time of the first step polymerization were 200 oC and 4~12 hours, respectively, which result in PGCL segmented block copolymer of high inherent viscosity. The addition of the catalyst 40 mol ppm and initiator 1,388 mol ppm result in a segmented block copolymer of high inherent viscosity, which was more than 2.0 dl/g. When the spinning temperature was 230-240oC, monofilament was flexible and smooth surface. And also tensile strength, knot strength and Young's modulus suitable for suture was obtained. The monofilament suture of PGCL was tested for retention strength rate under in-vitro and in-vivo. The results of tensile strength measured after immersing in-vitro remain 62% after one week, 20% after two weeks, 6% after three weeks, and none after four weeks. The retention strength under in-vivo conducted after implanted in a subcutaneous tissue of the SD rat showed 64% after one week, 23% after two weeks, 7% after three weeks, and none after four weeks. In-vivo study was performed to evaluate absorbability in rat. In sterility test, the test article, PGCL monofilament suture did not observe microbial growth, and the test article was considered to keep in an aseptic condition. In absorbability study under in-vivo, it was observed initial inflammatory response by implantation and implanted sample and muscle fiber necrosis in some individual at 2 days after implantation. However, there were no responses at 91 days. These results suggested that PGCL was absorbed within 91 days with recovery from inflammatory response. The cytotoxicity, sensitization, intracutaneous, systemic toxicity, genotoxicity, implantation, and pyrogen were tested as biocompatibility tests and all items passed.
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