Advances in Safety Evaluation of Medical Magnesium and Alloy Materials
ZHANG Mei-ling;CHEN Hong;ZHAO Dan-mei;WANG Chun-ren;China Pharmaceutical University;National Institutes for Food and Drug Control;
With the development of metallurgical technology, more and more metallic materials begin to be used in clinical,the most used materials in clinical practice currently are stainless steel, titanium and its alloys, cobalt based alloys, nickel-titanium shape memory alloys. But many disadvantages still exist in these traditional medical metallic materials, such as crevice corrosion, friction corrosion; elastic modulus difference with human bones, which results in stress shielding effect, slow healing, and even implant failure. Biologically inert materials, which cannot degrade, and need surgery to remove them again. But the magnesium metal and its alloys can overcome the disadvantages of the metal materials above, which are biodegradable, whose density and modulus of elasticity are similar to human bones. Besides the magnesium is an essential element of human body, which is rich in the earth, etc., so the magnesium is an ideal metal implant material. But magnesium as medical materials is still in the research stage, so amounts of safety evaluation data in vitro and vivo is still required if used in a clinical practice. In this paper, we make a brief review of cytotoxicity, blood compatibility, long-term toxicity, degradation, absorption, distribution and metabolism in vivo, clinical safety evaluation and other aspects of the magnesium alloy material for medical use.