Abstract:Objective To explore the safety of the new high-performance biomedical magnesium alloy （JDBM） in vivo and to evaluate its influence on functions of organs and local response. Methods New Zealand rabbits were used to build the JDBM magnesium alloy implantation model. Regular observation of wound healing and general condition was firstly carried out. And then blood specimen was collected to detect the blood routine, coagulation function, hepatic and renal functions, cardiac function and the content of calcium, phosphate and magnesium. The heart, liver, spleen, lung, kidney and muscle tissues around the screw were collected for HE staining to observe pathological changes. X-ray was carried out to observe the changes in bone density around the screw, and the osteogenesis property of screw was preliminarily analyzed. Results This new material had no effect on the results of blood routine index, coagulation function, hepatic function, renal function and cardiac function. NO pathological changes of organs were observed, and no inflammatory reaction of foreign body was detected in musculi parenchyma as well by histological detection. X-rays showed no significant gas accumulated around the screw and the screw degraded slowly. The screw was clearly visible six months after operation, and an apparent thickening was found near the bone cortex which hinted a relatively strong bone formation. Conclusion JDBM is a new kind of magnesium alloy material with good biosecurity.

Key words:Magnesium alloy,Biosafety,Internal fixation,Animal experiment