单宁酸处理带瓣牛颈静脉的生物学评价  

Biological evaluation of valved bovine jugular veins treated by tannic acid

作　　者：韩茂生[1] 周建业 胡盛寿 梁智星 汪胜 王德 

机构地区：[1]中国医学科学院心血管病研究所阜外心血管病医院卫生部心血管疾病再生医学重点实验室

出　　处：《中华胸心血管外科杂志》2007年第5期332-334,共3页Chinese Journal of Thoracic and Cardiovascular Surgery

基　　金：北京市科技计划资助(Y0405003040291)

摘　　要：目的从生物学角度评价单宁酸处理的带瓣牛颈静脉是否符合国家医用材料的要求。方法带瓣牛颈静脉经单宁酸处理后按国家医用材料的要求进行浸提液的制备、细胞毒性试验、过敏试验、皮内刺激试验、原发性皮肤刺激试验、溶血试验、急性全身毒性试验及热原试验等生物学评价试验。试验方法均参照《医用有机硅材料生物学评价试验方法》GB/T16175-1996。结果培养的 L-929小鼠成纤维细胞经含浸提液的培养基培养后形态良好,增值旺盛,材料细胞毒性评级为0～1。无皮肤刺激反应和过敏反应,皮内刺激试验 PⅡ(原发性刺激指数)为0.4,和阴性对照组差异无统计学意义。全身毒性实验受试动物未出现毒性症状。溶血试验溶血率0.7%,符合国家标准(<5%)。热原试验经中国药品生物制品检定所检定,单宁酸处理后带瓣牛颈静脉无热原(样品批号:060802017)。结论单宁酸处理的带瓣牛颈静脉符合国家医用材料的要求,可以植入人体。Objective Evaluate whether valved bovine jugulr veins treated by tannic acid meet the national standards for medical materials. Methods Valved bovine jugular veins were treated by tannic acid. Cell culture cytotoxic test, skin allergy test, intracutaneous stimulation test, primary skin stimulation test, hemolysis test , general acute toxicity test and pyrogenicity test were performed according to the manual of the national standards of medical materials. Results ①There was no obvious change in cell attachment, morphology and proliferation after L-929 mouse fibroblasts were treated, by extracts or degenerated products. The toxicity gradation of the material of the material was 0 - 1. ②The results of skin stimulative and sensitive test were negative. The prinmary irritation index （PⅡ） in intracutaneous stimulation test was 0.4（no significant difference compared with control）.③Valved bovine jugular veins treated by tannic acid showed no toxicity in general acute toxicity test. ④The rate of hemolysis was 0.7%, under the standard criteria（5 % ）. ⑤Increase of the rectal temperature of 3 rabbits was less than 1.4℃ and average increase of temperature 〈 0.6℃ each rabbit. Conclusion The results of this study showed that valved bovine jugular veins treated by tannic acid are in conformity with the national standards for medical materials, implantion into the human body is feasable.

关 键 词：生物相容性材料 动物替代试验 单宁类 生物学鉴定法 

分 类 号：R318.08[医药卫生—生物医学工程]