羟基磷灰石涂层钛合金材料生物相容性研究初探  

Biocompatibility of hydroxyapatite coated titanium alloy material

作　　者：朱丽丽[1] 姜华[1] 

机构地区：[1]天津市医疗器械质量监督检验中心,天津300384

出　　处：《生物医学工程与临床》2014年第4期323-326,共4页Biomedical Engineering and Clinical Medicine

摘　　要：目的探讨一种新型的代骨材料--羟基磷灰石涂层的钛合金材料的生物相容性。方法制备羟基磷灰石涂层钛合金材料浸提液后,采用细胞毒性实验以观察实验样品浸提液对L929小鼠成纤维细胞的毒性反应;通过对小鼠尾静脉及腹腔注射试验样品浸提液后,观察其对小鼠的急性全身毒性反应;Ames实验及迟发型超敏反应实验对其遗传毒性及致敏性进行安全性评价。结果羟基磷灰石涂层钛合金材料浸提液对L929小鼠成纤维细胞的相对增殖率(RGR)为96.9%,细胞毒性反应为1级,无细胞毒性反应;对小鼠亦无明显的急性全身毒性作用,实验样品组与阴性对照组动物体质量差异无统计学意义(P>0.05);遗传毒性Ames实验表明,在活化与非活化条件下,该材料浸提液对鼠伤寒沙门氏菌株的回变菌落数与对照组比均未增加2倍,对该菌株无诱变性;迟发型超敏反应实验显示,该材料浸提液无潜在的皮肤接触致敏性。结论羟基磷灰石涂层的钛合金材料具有良好的生物相容性。Objective To investigate the biocompatibility of newly type bone-substitute material, titanium alloy with hydroxyapatite coating. Methods The extract of hydroxyapatite coated titanium material was prepared, and its cytotoxicity against L929 cells was tested. The extract was injected into mice by intravenous and intraperitineal route to observe the acute systemic toxicity. Ames test and delayed-type hypersensitivity were used to evaluate gene toxicity and its sensitization. Results The relative growth rate（RGR） of L929 cells treated with the extract of the material was 96.9 %, and the cytotoxicity reaction was grade 1（non-toxic）（P ＆gt; 0.05）. Ames test showed that no more than 2-fold increase（as compared with the control） was observed in the revertant colonies of Salmonella typhimurim strain after treated with the extract either under activated or non-activated condition,indicated that it was not mutagenic. The delayed-type hypersensitivity test showed that the extract did not induce obvious skin contact sensitization. Conclusion It is demonstrated that the hydroxyapatite coated titanium alloy material has good biocompatibility.

关 键 词：羟基磷灰石 钛合金 细胞毒性实验 急性全身毒性实验 AMES实验 迟发型超敏反应实验 

分 类 号：R318.08[医药卫生—生物医学工程]