新型防钙化无支架生物心脏瓣膜的毒性试验研究  

Toxicity evaluation experiment of a new type anticalcificative stentless prosthesis valve

作　　者：魏旭峰[1] 易定华[1] 谭红梅[1] 胡巧霞[1] 赵东鄂[1] 

机构地区：[1]第四军医大学西京医院心血管外科,陕西西安710033

出　　处：《第四军医大学学报》2002年第20期1884-1887,共4页Journal of the Fourth Military Medical University

基　　金：陕西省自然科学基金 (2 0 0 0 SM3 1)

摘　　要：目的　对采用环氧氯丙烷和 Triton X- 10 0联合处理的新型防钙化无支架生物心脏瓣膜进行临床应用前毒性试验研究 .方法　参考美国《ASTM医用装置标准》试验方法 ,对该生物瓣膜进行细胞毒性、小鼠全身毒性、溶血、皮内注射刺激等试验 .结果　 1直接接触法细胞毒性试验表明 ,该种生物瓣膜对 L - 92 9小鼠成纤维细胞株的生长无明显毒性作用 ;2用该材料的浸提液进行小鼠全身毒性试验、溶血试验、皮内注射刺激试验 ,表明毒性符合《ASTM医用装置标准》要求 ;3戊二醛处理的猪主动脉瓣 ,经环氧氯丙烷和 Triton X- 10 0联合化学改性后 ,毒性较单纯戊二醛处理的猪主动脉瓣减轻 .结论　对新鲜猪主动脉瓣依次用戊二醛、环氧氯丙烷、TritonX- 10 0联合防钙化处理 ,再以独特的缝合技术制作的新型防钙化无支架生物心脏瓣膜 ,从本组毒性试验研究的结果看符合美国《ASTM医用装置标准》,有开发和利用价值 ,可以进一步进行试验研究 .AIM To evaluate toxicity of a new type anticalcificative stentless prosthesis valve pretreated by glutaraldehyde, epoxy chloropropan and Triton X 100. METHODS According to the methods of American 《ASTM Standards for Medical Devices》, we practiced evaluating the toxicity of the valves by experiments of direct contact cell culture, assessment of hemolytic properties, systemic injection in mice, and primary skin irritation in rabbits. RESULTS ① Direct contact cell culture test indicated that this material has no obvious cytotoxicity to L 929 fibroblast strain. ② (the material extraction) with Assessment indicated that the toxicity of this material fit the American 《ASTM Standards for Medical Devices》. ③ Glutaraldehyde treated porcine aortic valve with epoxy chloropropane and Triton X 100 chemical treatment showed mild toxicity as compared with those freated with glufaraldehyde only. CONCLUSION The new type anticalcificative stentless prosthesis valve pretreated by glutaraldehyde, epoxy chloropropane and Triton X 100 meet the American 《ASTM Standards for Medical Devices》, and could be researched for clinical use.

关 键 词：人工心脏瓣膜 细胞毒性试验 溶血试验 环氧氯丙烷 TRITON X-100 血流动力学 

分 类 号：R318.11[医药卫生—生物医学工程] R654.2[医药卫生—基础医学]