| To early assess the safety of hydroxyapatite/polyvinyl alcohol biocomposites(n-HA/PVA) for articular cartilage and artificial cornea reconstruction and repair,according to the national evaluate criteria of medical implanted materials.according to the national evaluate criteria of medical implanted materials,biology and animal trial recommend in GB/T 16886.5,6,10,11, we select and conduct a serial trial in vivo,or in vitro to assess the safety of hydroxyapatite/polyvinyl alcohol biocomposites. In this study,six methods including acute toxity test, cytotoxicity test, hemolysis test, intradermally stimulation reaction test, the guinea pig maximization test (GPMT)and implantation test are used.(1)the results of the acute toxity test showed that the n-HA/PVA biocomposites had no apparent inflammatory reaction in vivo. There was no obvious significance between the treatment group and the contral group at different period(P>0.05).(2) the results of the cytotoxicity test showed that dissolution indication and extent indication≤1. evaluation: normal. (3)In the hemolysis test,the rate of hemolysis(direct contact method) was 0.27% under the standard criteria 5%,so it showed the n-HA/PVA biocomposites would not induce hemolysis. The results of the indirect contact method also showed there was no hemolysis andcoacervation of blood at defferent period,same to the first method.(4)In the intradermally stimulation reaction test,primary irritation index(PII) was measured 0-0.4 and the stimulation reaction was very slight according to the criteria.(5)In the guinea pig maximization test (GPMT), the skin reactions of the clipped area of the flanks reactions after challenge showed no erythema and swelling at different period,so the n-HA/PVA biocomposites had no sensibilization.(6) implantation test:no pathological change.The new type n-HA/PVA biocomposites for articular cartilage and artificial cornea reconstruction and repair have biocompatibility and salty.
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