抗凝血医用硫酸化丝素蛋白材料的生物相容性评价

An Evaluation on Biocompatibility of Anticoagulant Sulfated Silk Fibroin Material for Medical Use

将家蚕丝素蛋白通过化学接枝反应制备具有抗凝血功效的硫酸化丝素蛋白医用材料。经动物的热原试验、皮内刺激试验、皮肤致敏试验、急性毒性试验以及体外溶血试验,对硫酸化丝素蛋白进行生物相容性评价。结果表明:3只注射受试硫酸化丝素蛋白溶液后的家兔体温仅升高0.2、0.3、0.1℃,未引起热原反应;家兔试验部位和周边组织出现的少量红斑或红肿在72 h后自然消退,无刺激反应;涂抹受试溶液后连续3 d,小鼠的试验部位和周边组织均未出现红斑、水肿等致敏反应;小鼠腹腔注射受试溶液后生理活动及生长正常,无毒性反应;受试溶液在体外溶血试验中无溶血现象。各项试验结果提示:硫酸化丝素蛋白材料有良好的生物相容性,具有在生物医学材料领域应用的前景。

Sulfated silk fibroin medical material with anticoagulant effect was prepared through chemical grafting reaction on silk fibroin.And pyrogenic test,intracutaneous stimulation test,skin sensitization test,acute toxicity test,and in vitro hemolysis test were performed to evaluate the biocompatibility of sulfated silk fibroin material.The results indicated that the body temperature of three rabbits injected with sulfated silk fibroin solution was only raised by 0.2,0.3 and 0.1 ℃ respectively,showing no pyrogenic response.A small amount of erythema or flare appeared at tested sites and surrounding tissues of the rabbits regressed spontaneously after 72 hours,showing no stimulation reaction.No erythema,dropsy and other sensitization reactions were observed at the tested site and surrounding tissue of the mice which were daubed with test solution continuously for 3 days.Mice intraperitoneally injected with the test solution had normal physiological activity and growth,showing no toxicity reaction.In vitro hemolysis test showed that no hemolytic reaction occurred to the test solution.The results of all above tests indicated that sulfated silk fibroin material has excellent biocompatibility,being a promising biomedical material for further development.