The Safety Assessment On Nano-Hydroxyapatite/Polyvinyl Alcohol Biocomposites

Objective: To early assess the safety of hydroxyapatite/polyvinyl alcohol biocomposites(n-HA/PVA) for articular cartilage reconstruction and repair,according to the national evaluate criteria of medical implanted materials.Method: according to the national evaluate criteria of medical implanted materials,biology and animal trial recommend in GB/T 16886.1-1997-ISO 10993-1:1992,we select and conduct a serial trial in vivo,or in vitro to assess the safety of hydroxyapatite/polyvinyl alcohol biocomposites. In this study,three methods including acute toxity test, hemolysis test, intradermally stimulation reaction test, the guinea pig maximization test (GPMT) are used.Results: (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 defferent period(P>0.05).(2)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 thefirst method.(3)In the intradermally stimulation reaction test,primary irritation index(PII) was measured 0-0.4 after the mareial extracts was injected into the back of the animals intradermally,and the stimulation reaction was very slight according to the criteria. (4)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 defferent period,so the n-HA/PVA biocomposites had no sensibilization.Conclusion: The new type n-HA/PVA biocomposites for articular cartilage reconstruction and repair has biocompatibility and safty.