评价生物材料毒性的体内外试验相关性研究——流式细胞仪法与软组织皮下埋植试验

Study on Correlation Between in Vitro and in Vivo Biocompatibility Test of Biomaterials-the Flow Cytometry Method and the Subcutaneous Implant Test

目的 探讨应用流式细胞仪的方法与体内皮下埋植试验检测生物材料的细胞毒性是否具有相关性,方法 体外培养的L929细胞经七种生物材料浸渍液的作用后,再用流式相胞仪测定其DNA期的细胞百分比,以此衡量材料的细胞毒性。将一定规格的生物材料植入大鼠背脊皮下组织,通过组织学观察,评价材料的毒性程度。用SPEARMAN秩相关方法进行相关分析。结果 两种方法均测得2#材料毒性最大,1#材料毒性最小,其余材料毒性居中。统计学分析r>0.8,P<0.05,说明有相关性。结论 流式细胞仪方法与软组织皮下埋植试验有良好的相关性。

Objective To investigate whether there is correlation between the flow cytometry method and the subcutaneous implant test. Method We detected the persentage of cytotoxicity of S-period cells by flow cytometry when L929 incubateed with extraction of seven kind of biomaterials. In addition,we implant the biomertials in rats suhcutaneously to evaluate toxicity in vivo. Then.analyse the correlation between the in vivo and in vitro mothed Result 2 # material showed the highest toxicity while 1 # material showed the lowest toxicity, and the rest of materials showed medium toxicity in both two methods. The statistic analyse came out as r>0. 8,P<0. 05. proved these two methods did have correlation. Conclusion The results of these two methods had good correlation.