胶原基骨修复材料生物安全性评价

Biosafety Evaluation of Collagen-based Bone Repairing Material

为了评价胶原基骨修复材料的生物安全性,我们将供试品或对照品植入大鼠体内观察相关指标(动物体征观察、血常规检查、免疫器官系数分析、各器官和组织的病理学检查、NK细胞杀伤活性测定、淋巴细胞亚群分析、血清中IL-1、IL-6、TNF-α、免疫球蛋白含量测定)。最终结果显示:各处理组大鼠实验前后精神状态无异常,在血常规检查、免疫器官系数分析、各器官和组织的病理学检查、NK细胞杀伤活性测定、淋巴细胞亚群分析、血清中IL-1、IL-6、TNF-α含量的检测、免疫球蛋白含量检测方面,实验组与对照组相比无显著差异。该材料对大鼠会产生轻微而短暂的刺激作用,但未见明显的炎症反应。

To evaluate the biological safety of collagen-based bone repairing material, we implanted the sample or ref- erence substance into rats, and observed relative signs, including the specific inspection targets in animals, blood ex- amination, analysis of immune organ, the pathological examination of organs and tissues, NK cell killing activity as- say, lymphocyte group analysis, serum IL-1, IL-6, TNF-α detection, detection of immune globulin. Meanwhile, we set control group, sham group, and immunosuppression group. The final results showed that there was no abnormal mental state before and after the experiment. Compared with the control group, the tested group indicated no signifi- cant difference in blood test, immune organ analysis, the pathological examination of organs and tissues, NK cell killing activity assay, lymphocyte subset analysis serum IL-1, IL-6, TNF-α detection, and detection of immune glob- ulin. Collagen-based bone repairing material produced a slight and transient stimulation on the rats, but created no significant inflammatory responses.