Purpose: after preliminary in vitro experiments have established that already has antimicrobial properties in vitro, cell compatibility and compatibility of bone containing copper, titanium alloy, through systemic toxicity test, skin sensitization test, mucosa stimulation test, and blood compatibility experiment, further verify the biocompatibility of the titanium alloy containing copper, lay a theoretical foundation for further clinical application.Methods: 1. The preparation of titanium alloy containing copper leaching solution, the leaching solution of constant injection rat caudal vein, observing the experimental rats weight changes, the active state of life, and to test whether metabolic organs have toxic pathological changes, verify whether copper titanium alloy have systemic toxicity. 2. According to the experimental partition will extract intradermal injection of experimental animals, in the seventh day of experiment for intradermal induction, 14 days. Natural light observation of experimental animals 24 h, 48 h, 72 h, the change of the skin, through the experimental animal skin reflects the change of situation, verify whether copper titanium alloys have skin sensitization. 3. The test piece is clingy suture in experimental animal buccal mucosa, observed the pathological analysis, changes in areas of mucosal tissue around and verify whether copper titanium alloys have mucous membrane irritation. 4. By hemolysis test, plasma calcium compound experiment time, prothrombin time experiment and dynamic blood coagulation time, copper blood compatibility of titanium alloy.Results: 1. The experiment material leaching solution by systemic circulation did not cause any systemic symptom and liver tissue pathologic change, non-toxic acute toxic effects on tissues and organs is not. 2. Experimental animal skin reaction to negative, no edema appears erythema, and the negative control group no difference. 3. The experimental films without mucosal tissues surrounding mucosa inflammation, erosion or ulcer, then observe mucous membrane Angle, necrosis and inflammation. 4. The hemolysis rate of results is 2.297%, less than 5%, in line with national standards, the Cu- Ti alloy materials won’t produce hemolytic reaction to human body. Copper and titanium alloy material PRT, PT value between positive contrast material(glass) and the negative control(silicide glass). Titanium alloy containing copper initial setting time between control group and the negative control group, the setting time is higher than the control group.Conclusion: copper titanium alloy in vivo systemic toxicity, no skin sensitization effect, no mucous membrane irritation, has good blood compatibility and biocompatibility. |