摘要
目的评价Triton X-100、环氧氯丙烷联合改性处理戊二醛固定的牛颈静脉带瓣管道的体内外生物相容性。方法取新鲜牛颈静脉,热缺血时间在2 h以内,依次经戊二醛、Triton X-100、环氧氯丙烷交联处理,制备出新型抗钙化牛颈静脉带瓣管道(EC+Tr组);以单纯戊二醛处理的牛颈静脉为对照(GA组),参照国家植入材料的检验标准,采用处理后牛颈静脉材料浸提液进行溶血试验、皮内注射刺激试验、急性全身毒性试验和细胞毒性试验。结果溶血试验中,EC+Tr组溶血率为2.6%,小于GA组3.7%的溶血率(P<0.05),符合国家标准(<5%);皮内刺激试验中,EC+Tr组PI(I原发性刺激指数)为0.5,小于GA组的0.87,提示对受试动物皮肤刺激轻微;急性全身毒性试验中,受试动物均未出现毒性症状;细胞毒性试验中,EC+Tr组培养的L-929小鼠成纤维细胞经100%浓度材料浸提液处理后形态良好,增殖率达87.55%,毒性评级为1级(合格),优于GA组结果(增值率为69.47%,毒性评级为2级,P<0.05)。结论 Triton X-100、环氧氯丙烷联合改性处理戊二醛固定的牛颈静脉带瓣管道符合国家标准,具有良好的生物相容性,为进一步临床应用提供了理论依据。
[Objective] To evaluate the biocompatibility performance of Triton X-IO0 and epoxy chloro- propane （EC） modification with glutaraldehyde-treated bovine jugular venous （BJV） in vitro and in vivo. [Methods] The BJV which hot isehemia time within two hours, is treatde by glutaraldehyde （GA）, Triton X- 100 and epoxy chloropropane, to prepare a new antiealeiiieation bovine jugular venous conduit （EC＋Tr group）; the BJV only treated by glutaraldehyde were used for control （GA group）. According to the manual of Nation- al implant materials evaluation standard, the GA and EC＋Tr group extracts were subjected to bioeompatibility evaluation, which included hemolysis test, intraeutaneous stimulation test, general acute toxicity test and cell culture cytotoxic test. [Results] The EC＋Tr group rate of hemolysis was 2.6%, which was lower than the GA group 3.7% （P〈0.05）, conform to the national standards （〈5%）. The EC＋Tr group primary irritation index （PII） in intraeultaneous stimulation test was 0.5, lower than GA group （0.87）, prompt stimulate slight. Both groups showed no toxicity in genera/ acute toxicity test. EC＋Tr group showed no obvious change of cell morphology and proliferation after L-929 mouse fibroblasts were treated by 100% material extracts, the RGR was 87.55%,the toxicity gradation was 1 （qualified）, significantly better than GA group （the RGR was 69.47%, the toxicity gradation was 2, P〈0.05）. [Conclusion] The Triton X-100 and epoxy chloropropane modification with glutaraldehyde-treated bovine jugular venous conduit had good biocompatibiiity and was conformity with the national standards, provided the basis for clinical application.
出处
《中国现代医学杂志》
CAS
CSCD
北大核心
2011年第35期4405-4408,4413,共5页
China Journal of Modern Medicine
基金
广东省科技计划项目(No:2007B031001008)
