^(125)I辐照的聚醚醚酮粒子链的生物安全性  

Bio-safety of iodine-125 irradiated polyetheretherketone particle chain

作　　者：石峰[1] 柴文文[1] 曾理[1] 李军[1] 王铖锴 

机构地区：[1]湖南省肿瘤医院核医学科,湖南省长沙市410013 [2]四川大学化工学院,四川省成都市610000

出　　处：《中国组织工程研究》2016年第38期5716-5721,共6页Chinese Journal of Tissue Engineering Research

基　　金：湖南省科技厅项目(2014FJ3029)~~

摘　　要：背景:研究表明聚醚醚酮很有潜质,能携带具治疗作用的短射程辐射物参与临床治疗。然而,目前国内外尚未有任何有关碘粒子辐照后聚醚醚酮及其复合材料的生物安全性评价。目的:评价125I密封籽源辐照的聚醚醚酮粒子链的生物安全性。方法:参考GBT-16886制作聚醚醚酮粒子链浸提液,进行小鼠、兔急性毒性实验、兔热原实验及兔皮内刺激性实验。实验分3组,实验组、材料对照组及阴性对照组分别给予辐照后聚醚醚酮粒子链浸提液、未辐照聚醚醚酮粒子链浸提液和浸提液进行对比观察实验。结果与结论:(1)兔及小鼠急性全身毒性实验:聚醚醚酮粒子链辐照后浸提液对全部动物的呼吸、活动、毛发、分泌物、体质量等一般情况以及心肝脾肺肾等重要脏器的病理组织学等均无影响;(2)热原实验:有3只兔的体温升高最大值为0.4℃(<0.6℃),总和为0.7℃(<1.3℃);(3)皮内注射实验:兔红斑和水肿反应评分均为0;(4)结果说明:聚醚醚酮粒子链辐照后浸提液无急性全身毒性、无热原反应,无皮内注射刺激性反应,说明经125I粒子辐照后的聚醚醚酮粒子链生物安全性良好。BACKGROUND： Polyetheretherketone（PEEK） has the potential to carry short-range radiations for cancer treatment. However, there is a lack of bio-safety assessment focusing on125 I irradiated PEEK particle chain. OBJECTIVE： To evaluate bio-safety of the 125 I brachytherapy source irradiated PEEK particle chain. METHODS： PEEK particle chain extracts were prepared according to GBT-16886 and applied in acute toxicity test on mice and rabbits, rabbit pyrogen test and rabbit intradermal reaction test. Animals in experimental, material and negative control groups were given irradiated PEEK particle chain extracts, non-irradiated PEEK particle chain extracts and extracts, respectively, to compare the experimental results. RESULTS AND CONCLUSION： In mouse and rabbit acute toxicity test： irradiated PEEK particle chain extracts made no effects on the animal general conditions like breathing, activity, hair, secretion and body weight and morphology of the heart, liver, spleen, lung and kidney and other vital organs. In pyrogen test： the maximum temperature in three rabbits reached 0.4 ℃（ 〈0.6 ℃）, and the sum was 0.7 ℃（ 〈1.3 ℃）. In intradermal reaction test： the rabbit erythema and edema reaction scores both were 0. To conclude, 125 I irradiated PEEK particle chain exhibits a good bio-safety, presenting no acute toxicity, pyogen reaction and intradermal reaction.

关 键 词：组织工程 生物相容性材料 碘 生物材料 缓释材料 聚醚醚酮 材料生物相容性 125I密封籽源 肿瘤治疗 粒子链 碘粒子 浸提液 生物安全性评价 全身急性毒性实验 热原反应实验 皮内注射实验 

分 类 号：R318[医药卫生—生物医学工程]