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作 者:刘学勇[1] 刘吉泉[1] 邓纯博[1] 吴东朝[1] 隋国鑫[2]
机构地区:[1]中国医科大学附属盛京医院骨科,辽宁沈阳110004 [2]中国科学院沈阳金属研究所,辽宁沈阳110016
出 处:《生物医学工程与临床》2010年第6期481-484,共4页Biomedical Engineering and Clinical Medicine
基 金:辽宁省教育厅资助项目(20060988);辽宁省科技厅资助项目(20072108)
摘 要:目的对新型复合材料聚醚醚酮/羟基磷灰石/碳纤维的组织相容性进行综合性评价。方法依据GB/T 16886系列标准,应用大鼠对聚醚醚酮/羟基磷灰石/碳纤维复合材料进行急性全身毒性实验、热原实验、溶血实验及皮内反应实验。结果急性全身毒性实验,各实验组大鼠一般状况良好,各时相体质量变化差异无统计学意义(P﹥0.05),无急性全身毒性反应,肝肾标本与对照组比较无阳性病理改变;热原实验,各组大鼠在各时间段内测得的体温变化均符合热原实验评价标准;溶血实验,复合材料浸提液的溶血百分率均低于标准规定的5%;皮内反应实验,皮下组织在各时相点水肿极轻微,无红斑形成。结论新型复合材料聚醚醚酮/羟基磷灰石/碳纤维初步研究证明具有良好的组织相容性和安全性。Objective To comprehensively evaluate the histocompatibility of polyetheretherketone/hydroxyapatite/carbon fiber as a new composite material.Methods The acute systemic test of toxicity pyrogen,hemolysis,intradermal reaction of the composite material was performed in rats with GB/T 16886 criterion.Results In acute systemic toxicity test,the general condition of rats was good in experimented groups.Data of body weight change had no significant difference between experimental group and control group(P〉0.05),and no acute systemic toxic reaction was found.No significant difference in pathological examination of liver and kidney were found between experimental group and control group.The body temperature change of experimental group was under the standard criteria in pyrogen test.The hemolysis rate in composite extract liquid was under the standard criteria(5 %).The slight edema without erythema was observed at different time points in intradermal reaction test.Conclusion It is demonstrated that the new composite material has excellent histocompatibility and safety.
分 类 号:R318.08[医药卫生—生物医学工程]
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