羟基铬处理的生物瓣瓣叶材料的生物学评价  

Biological Evaluation of the Bioprosthetic Leaflet Materials Treated by Hydroxyl chromium

作　　者：任兵[1] 朱晓东[1] 张燕平 汪胜[1] 

机构地区：[1]中国医学科学院中国协和医科大学心血管病研究所

出　　处：《中国循环杂志》1996年第8期501-503,共3页Chinese Circulation Journal

摘　　要：目的：从生物学角度评价羟基铬处理的生物瓣瓣叶材料的毒性作用是否符合国家医用材料的要求。方法：将新鲜的生物瓣瓣叶材料用羟基铬处理并对其浸提液按国家医用材料的要求进行“家兔皮内刺激”、“热原”、“皮肤致敏”及“溶血”等生物学评价实验。结果：羟基铬处理的生物瓣瓣叶材料对皮内无刺激性；热原检查３只家兔体温升高均低于０．６℃／只，且升高总数低于１．４℃／３只；皮肤致敏率在０％～８％以内，与阴性对照无差别；溶血率为０％合乎国家规定（＜５％）。结论：羟基铬处理的生物瓣瓣叶材料符合国家医用材料的要求，亦即这种生物瓣可植入人体。Objective:To evaluate whether the toxicity,if any,of the bioprosthetic leaflet materials treated by hydroxyl chromium meets the national standards of medical materials. Methods:Fresh bioprosthetic leaflet materials were treated by hydroxyl chromium.Tests on rabbit intracutaneous stimulation,pyrogenicity,skin allergy and hemolysis were performed according to the manual of the national standards of medical materials. Results:All the tests mentioned above were negative,i.e.negative rabbit intracutaneous stimulation;increase of the rectal temperature of 3 rabbit was less than 1 4℃(average increase of temperature<0 6℃/rabbit);the rate of skin allergy was 0% 8%(no significant difference with control);the rate of hemolysis was 0%. Conclusion:The bioprosthetic leaflet materials treated by hydroxyl chromium is in conformity with the national standards of medical materials,so the bioprosthesis can be implanted into the human body.

关 键 词：羟基铬 生物瓣 生物学评价 瓣叶材料 

分 类 号：R654.205[医药卫生—外科学] R318.11[医药卫生—临床医学]