新型羟基磷灰石涂层钛种植材料生物安全性的初步评价  

Initial evaluation of biological safety of hydroxyapatite-coated-titanium implant material fabricated by SIM method

作　　者：朱文军[1] 程祥荣[2] 潘杏兰[3] 张倩[2] 

机构地区：[1]中山大学光华口腔医学院,广州510055 [2]武汉大学口腔医学院 [3]广州医学院附属第二医院口腔科

出　　处：《口腔材料器械杂志》2004年第3期122-124,136,共4页Chinese Journal of Dental Materials and Devices

基　　金：国家自然科学基金(39970800)

摘　　要：目的 评价表面诱导矿化(SIM)法羟基磷灰石涂层钛种植材料的生物安全性。方法 本实验共选择了三种体内外试验,即短期全身毒性试验(经口途径)、静脉注射急性全身毒性试验和溶血试验。结果经口毒性试验中试验组大白鼠都无明显毒性体征,其食物利用率、体重相对增长率等指标均与对照组无明显差别(P>0.05),内脏组织无病理性改变;急性全身毒性试验:试验组小白鼠无明显毒性表现,体重分别增加了2.8～4.8g,其体重变化量同对照组无显著性差异(P>0.05),内脏组织均未见病理性改变;体外急性溶血率为1.16％。结论 SIM法羟基磷灰石涂层钛种植材料对动物无急性全身toxic action,也无体外溶血作用,可初步认为其具有良好的生物安全性。Objective To evaluate the biological safety of hydroxyapatite-coated-titanium implant material fabri- cated by SIM method. Methods Three tests were chosen in this study, namely short-term systemic toxicity test (oral route), acute systemic toxicity test (intravenous route) and haemolysis test. Results Test 1. None of the rats was abnor- mal. There was no significant difference in utility rate of forage and relative rising rate of weight between the experimental group and control group (P>0.05). The internal organs had no pathological change. Test 2. All mice had no toxic sign and gained weight from 2.8g to 4.8g. There was no signilicant difference in the chang of weight between the experimental group and control group(P>0.05). No parthological change was found in the internal organs. Test 3. Acute haemolysis rate in vitro of the material was 1.16%. Conclusion Hydroxyapatite- coated-titanium implant material fabricated by SIM method had no acute systemic toxic action on animals and heamolysis effect in vitro. This study initially demonstrated that the new material had excellent biological safety.

关 键 词：纯钛 羟基磷灰石 溶血 急性全身毒性 种植材料 

分 类 号：R783.1[医药卫生—口腔医学]