Ti6Al4V-AlTiN涂层材料的急性毒性试验

Acute toxicity test of Ti6Al4V-AlTiN coating materials

背景:AlTiN陶瓷涂层具有高硬度、优良的摩擦磨损性能、良好的化学惰性和附着力强的特点,非常符合生物陶瓷的特征。为能够进入临床安全使用,需全面评价AlTiN涂层的急性毒性。目的:对Ti6Al4V-AlTiN涂层材料进行急性毒性试验研究,为长期毒性试验和其他毒理学试验提供参考依据。方法:将小鼠左右两侧股四头肌内无菌操作一次注入受试样品Ti6Al4V-AlTiN涂层材料,观察注入受试样品后14d动物全身情况及注射局部反应情况,试验中设置生理盐水作为阴性对照。结果与结论:小鼠两侧股四头肌内一次注射受试样品,观察14d后,受试样品各组动物体质量增长与阴性对照组差异无显著性意义。饮食、外观、分泌物、排泄物、呼吸、中枢神经系统及四肢活动无异常、注射局部无充血、红肿、无动物死亡情况及中毒现象。

BACKGROUND：AlTiN ceramic coatings have many advantages such as high hardness,excellent wear properties,good chemical inertness and strong adhesion,which are all consistent with the characteristics of bio-ceramics.To achieve the clinical safety,a comprehensive evaluation of acute toxicity AlTiN coating is needed.OBJECTIVE：To test acute toxicity of Ti6Al4V-AlTiN coating materials,and to provide a reference for long-term toxicity and other toxicological tests.METHODS：The mouse left and right femoral quadriceps muscle was injected with aseptic Ti6Al4V-AlTiN coating material,the general condition and reaction on the injection site of animals were observed at 14 days after injection,normal saline served as the negative control.RESULTS AND CONCLUSION：At 14 days after Ti6AI4V-AITiN injection into mouse quadriceps muscle on both sides,there was no significant difference in body mass growth between test sample group and negative control group.The animals showed normal diet,appearance,secretions,excretions,respiratory condition,central nervous system and limb activities,with no local congestion or swelling in the injection site,no animals died or showed poisoning.