碳-硅橡胶的机械性能和生物安全性评价-第三军医大学学报.DOC

碳-硅橡胶机械性能和生物安全性的初步研究 陈兴，周鑫，张一鸣，石小花，樊东力（400037，重庆，第三军医大学新桥医院整形美容科） [摘要] 采用碳离子注入对硅橡胶进行表面改性，得到碳-硅橡胶，评价碳-硅橡胶的机械性能和生物安全性。 按照国标准，采用邵氏硬度计（A型）和电子万能实验机，测量其邵氏硬度、抗拉强度、断裂伸长率以及断裂强度等机械性能参数；采用红细胞溶血实验、全身毒性实验、过敏与刺激实验、热源实验对其生物安全性进行评价。 邵氏硬度计和电子万能实验机测量结果表明碳离子注入法未改变硅橡胶机械性能；红细胞溶血实验显示材料溶血率均小于国家标准，说明材料植入体内后不会引起溶血反应；全身毒性实验的结果表明材料不具有毒性；刺激实验刺激率为0；致敏实验致敏率为0；热源反应中家兔平均体温升高为0.1℃，其不具有致热源作用，符合生物医用材料的要求。 碳离子注入硅橡胶表面未改变硅橡胶的机械性能，并具有良好的生物安全性，对进一步的研究及临床应用提供了依据。 R318.08; TG115.5; TQ333.93 ［文献标识码］ A Mechanical properties and bio-safety evaluation of the carbon ion implanted silicone rubber Chen Xing, Zhou Xin, Zhang Yiming, Shi Xiaohua, Fan Dongli ( Department of Plastic and Cosmetic Surgery, Xinqiao Hospital, Third Military Medical University, Chongqing, 400037, China) [Abstract] Objective To evaluate the mechanical properties and the bio-safety of the carbon ion implanted silicone rubber (C-SR). Methods According to the national standard, the mechanical properties were performed by shore durometer (type A) and electronic universal testing machine, to gain parameters of the shore A hardness, tensile strength, elongation at break and tear strength. The bio-safety were performed by the erythrocyte haemolysis test, systemic toxicity test, subcutaneous implant test, allergic and dermal irritation test, pyrogenic test. Results The results of the shore A hardness, tensile strength, elongation at break and tear strength, show that the carbon ion implanted SR has the same mechanical properties with the pure SR. The erythrocyte hemolysis test show that the all rate of hemolysis was lower than the national standard, it was indicated that the in vivo transplantation of the materials could not cause the hemolytic reaction of the body. The subcutaneous implant test indicated that it has good safety and compatibility in the body. The rate of allergic and dermal irritation test was 0, which had no significant difference from negative control, suggesting that the materials have no allergic and dermal irr