背景:为提高钛材料的抗菌性及生物相容性,前期研究制备了铜钛合金材料。目的:参照GB/T16886-ISO10993所规定的原则和实验方法对铜钛合金进行较为全面、系统的生物相容性评价。方法:根据预实验结果,选择含铜量10%的铜钛合金材料,通过口腔黏膜刺激实验、皮肤刺激实验、短期全身毒性实验、溶血实验、血浆复钙时间实验、凝血酶原时间实验及动态凝血实验验证铜钛合金的生物相容性。结果与结论:铜钛合金材料无口腔黏膜刺激性、无短期全身毒性、无溶血性、无皮肤致敏反应,具有良好的血液相容性。
BACKGROUND:Copper-titanium aloy has been fabricated in previous studies to improve the antibacterial property and biocompatibility of titanium materials. OBJECTIVE:With reference to the principle and experimental method specified by GB/T16886-ISO10993, to fuly and systematicaly assess the biocompatibility of copper-titanium aloy. METHODS:Based on the pre-experimental results, titanium aloy containing 10% copper was selected and subjected to oral mucosa stimulation experiment, skin stimulation test, acute systemic toxicity test, hemolytic test, prothrombin time test and dynamic coagulation test for biocompatibility evaluation. RESULTS AND CONCLUSION:The copper-titanium aloy has no oral mucous membrane irritation, no short-term systemic toxicity, no skin sensitization, and no hemolysis, indicating it has a good biocompatibility.