自制CPC纳米复合材料溶血试验和短期全身毒性试验的研究

目的依据相关标准初步评价自制CPC纳米复合材料的生物相容性,为材料的最终临床应用提供实验依据。方法根据YY/T0127.1-93和YY/T0244-1996标准,用体外溶血试验及经口途径短期全身急性毒性试验评价自制CPC纳米复合材料的安全性。结果自制材料浸提液对健康人血红细胞溶血率为0.1%（〈5%）,无溶血现象;经口途径短期全身急性毒性试验的大鼠每周食物利用率及体质量相对增长率与对照组之间均差异无统计学意义（P〉0.05）,心、肾、肝等重要脏器肉眼观察无异常改变,其组织切片未出现病理学变化。结论自制CPC纳米复合材料生物相容性符合国内的体内植入物的生物学评价标准,具有良好的生物相容性。

Hemolysis Test and Short-term Systemic Toxicity of CPC Nanocomposite Materials

Objective To evaluate the biocompatibility of self-CPC nanocomposite materials according to the relevant standards,and to provide the experimental basis for clinical application of the materials.Methods According to YY / T 0127.1-93 and YY/T 0244-1996 standards,self-CPC nanocomposites security was assessed by hemolysis test in vitro and short-term systemic acute toxicity test by oral means.Results The extracts of the self-made materials were considered to be no hemolysis and the healthy red blood cell hemolysis rate was 0.1%（〈5%）.In the short-term systemic acute toxicity tested mice by oral means,there was no significant difference in the weekly utilization rate of food and relative growth rate of body weight between the experimental group and control group（P〉0.05）.No abnormalities and pathological changes were observed by naked eye detection and tissue slices in heart,kidney,liver and other organs.Conclusion The biocompatibility of the self-CPC nanocomposite materials in vivo accords with the domestic biological implant evaluation criteria and possesses good biocompatibility.