N6鞘内注射治疗脊髓损伤的生物安全性研究

Study on biological safety of N6 injected subarachnoid for treatment of spinal cord injury

目的:评估促神经再生复合剂鞘内注射治疗脊髓损伤的生物安全性。方法:即时制备以神经生长因子和神经节苷脂为主要成分的复合剂(N6,发明专利,专利号:ZL201210115594.1);将N6按不同剂量分别注射入大鼠L2、3水平的蛛网膜下腔、尾静脉、肌肉和腹腔,进行急性毒性试验;再按治疗剂量分别注射入大鼠L2、3水平的蛛网膜下腔、尾静脉、肌肉和腹腔,进行亚急性毒性试验;按治疗剂量体外行凝血和溶血试验。结果:急性毒性试验,实验动物无死亡;亚急性毒性试验前后实验动物的体重、红细胞、白细胞和血红蛋白均无统计学差别(P>0.05),对脑和脊髓无不良刺激作用,对肝脏、脾脏、肾脏、肺脏、肠道、脑和脊髓组织无伤害作用;N6在体外对溶血、凝血功能无影响。结论:N6鞘内注射具有良好的的生物安全性,可以作为新型药物治疗脊髓损伤。

Objective： To investigate the biological safety of N6（ a compound of promoting nerve regeneration factors）injected subarachnoid for treatment of spinal cord injury in rat. Methods： The essential components of our resently invented compound N6（ Patent number ZL201210115594. 1） were more than ten factors included ganglioside and nerve growth factor）. The N6 was prepared and injected immediately into the subarachnoid cavity,thought the tail vein,into the muscle and into the abdominal cavity in the rats with different dose for the acute toxicity test and the subacute toxicity test,and was tested by the function of hemolysis and coagulation in vitro. Results： None of the animals died in the acute toxicity test and the body weight,red blood cells,white blood cells and hemoglobin of the animals were not effected in the subacute toxicity test in vivo. The N6 did not effect the function and appearance of the brain and the spinal cord in vivo and did not effect the function of hemolysis and coagulation in vitro. Conclusion： The N6 injected subarachnoid had excellent biological safety and could be used as a new drug for the treatment of spinal cord injury.