新型生物可降解材料PHB的全身毒性试验
汤苏阳 艾玉峰 董兆麟 杨青芳 施新猷
作者单位:汤苏阳、艾玉峰 第四军医大学西京医院整形外科中心
董兆麟 西北大学杨青芳 西北工业大学施新猷 第四军医大学动物实验中心 本课题受国家"863"计划新材料领域资助(715-004-0160)
摘 要 目的:评价生物可降解性材料聚β羟基丁酯在动物体内 的急、慢性全身毒性。方法:参照ISO对医用植入材料的评价标准和所推荐的生物学试验, 对PHB进行其浸出液经静脉注射后的急性全身性毒性反应和PHB长期埋植动物体内血液常规、 血液生化指标的观察。结果:PHB在动物体内的急性全身性毒性反应为无毒,慢性长期埋 置PHB在动物体内不引起明显的血液常规、血液生化学的改变。结论:新型可降解材料PH B具有优良的生物相容性及安全性。
关键词 生物可降解材料 PHB 全身毒性反应试验 生物相容性 生物安全性
THE ACUTE AND CHRONIC GENERAL TOXICITY TO A NEWBIODEGRDA BLE POLY3HYDROXYBUTYRATE
Tang Suyang,Ai Yufeng,Dong Zhaoki n,Yang Qingfang,Shi Xinyou
Plastic Surgical Center of XiJing Hospital The Fourth Military Medical Un iversity (Xian 710032)
Abstract Objective:To evaluate the acute and chr onic general toxicity to a new biodegradable PHB. Methods:According to ISO ab out biological evaluationand and test of medical materias. We carried out a syst emic biological evaluation of domestic medical PHB including acute general toxic ity and embeded under skins for long time to proceed the blood routine examinati on and serum biochemical tests. Result:The acute general toxicity of PHB is n early no The chronic general toxicity of PHB embedding suggest no significative changes in the blood routine examination and serum biochemical tests.Conclusion : The result showed that this new medical biodegradable PHB has good biocompat ibilty and biological safety. ......
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