胶原蛋白缝线和胶原蛋白生物膜的生物相容性评价  

Biocompatibility evaluation of collagen suture and collagen biofilm

作　　者：石娜 张其清[2] 牛海涛 Shi Na;Zhang Qiqing;Niu Haitao(School of Medicine,Ji'nan University,Guangzhou 510632,China;China Academy of Medical Science&Peking Union Medical College,Institute of Biomedical Engineering,Tianjin 300192,China;Institute of Laboratory Animal Science,Ji'nan University,Guangzhou 510632,China)

机构地区：[1]暨南大学基础医学与公共卫生学院,广州510632 [2]中国医学科学院生物医学工程研究所,天津300192 [3]暨南大学实验动物中心,广州510632

出　　处：《国际生物医学工程杂志》2021年第5期347-351,366,共6页International Journal of Biomedical Engineering

基　　金：国家重点研发计划(2017YFC1103603)。

摘　　要：目的初步评价胶原蛋白缝线(CS)和胶原蛋白生物膜(CB)的生物相容性。方法通过热原实验判断CS和CB中所含热原量是否符合人体要求;分别采用皮肤和皮内刺激实验评价CS和CB对皮肤是否具有刺激作用;通过溶血实验评价CS和CB是否具有溶血作用;通过肌肉埋植实验评价CS和CB植入兔肌肉组织后的刺激和毒性反应。结果热原实验结果显示每组兔的体温升温值均低于0.6℃,且体温升温总和均低于1.4℃,表明CS和CB符合热原检查要求,热原实验合格;CS和CB的皮肤和皮内刺激实验结果均为阴性,表明两种材料对皮肤无刺激作用;CS和CB的溶血率分别为2.943%和4.127%(均<5%),表明这两种材料不会引起溶血反应;CS和CB埋植于兔肌肉组织后,肌肉组织耐受性良好,组织反应不严重,且随着时间的推移组织反应逐渐减轻。结论CS和CB具有良好的生物相容性。Objective To evaluate the biocompatibility of collagen suture(CS)and collagen biofilm(CB)preliminarily.Methods The pyrogenic contaminants test was used to analyze the pyrogen in CS and CB.The skin stimulation and intradermal stimulation tests were used to evaluate the stimulation effects of CS and CB to the skin.The hemolytic test was used to evaluate the hemolytic effect of CS and CB.The muscle implantation experiment was used to evaluate the stimulation and toxicity of CS and CB.Results The results of pyrogenic contaminants test show that the temperature increment of rabbits in each group is lower than 0.6℃,and the total temperature increment is lower than 1.4℃indicating that the two materials meet the requirements of pyrogenic examination and the pyrogenic contaminants test is qualified.The results of skin stimulation test and intradermal stimulation test of collagen suture and collagen biofilms were negative indicating that the two materials have no skin irritation.The hemolysis rates of collagen suture and collagen biofilm were 2.943%and 4.127%respectively(all P<0.05)indicating that the two materials will not cause hemolysis.The muscle was tolerated well and the tissue response was not serious after two biomaterials were embedded,which was reduced over time gradually.Conclusions Both the collagen suture and collagen biofilm have good biocompatibility.

关 键 词：胶原 生物相容性 胶原蛋白缝线 胶原蛋白生物膜 

分 类 号：R318[医药卫生—生物医学工程]