医用聚己内酯长期毒性动物实验研究  

Study on Long-Term Toxicity of PCL Implant

作　　者：武莉[1] 孙洪范[1] 杨菁[1] 施化莲[1] 王彭延[1] 宋存先[1] 

机构地区：[1]中国医学科学院生物医学工程研究所,天津市生物医用材料重点实验室,300192

出　　处：《天津医药》2008年第2期126-129,共4页Tianjin Medical Journal

基　　金：国家高技术研究发展计划(863计划)项目(项目编号:2004AA2Z3060)

摘　　要：目的:观察聚己内酯埋植剂对动物的长期毒性及中毒靶器官,为临床安全应用提供依据。方法:长期毒性实验用犬,设144mg/kg、45mg/kg聚己内酯剂量组和对照组(仅进行埋植手术),背部皮下埋植聚己内酯材料2年,观察动物的饮食、质量。动物取血、尿,测定血常规、尿常规及其他生化指标,2年后取出主要脏器行组织病理学检查。结果:小剂量组和大剂量组动物饮食、质量正常,血液及生化指标均未见异常,主要脏器组织学观察未见病理改变。结论:聚己内酯埋植剂长期皮下埋植是安全的。Objective： To study the long - term toxicity of poly （ε-caprolactone）（PCL ）implant and toxic target organ in animals for providing the basis for the safety of using this biodegradable materials in clinical. Methods： Two treatment groups （PCL 144 mg/kg and QL 45 mg/kg）and one control group were included. PCL was subcutaneous implanted in dogs for 2 years. The effects of PCL on blood and urine routine examination,biochemical blood test and main organs＇pathology were investigated. Results： The animals in both low and high doses of PCL groups had normal diets and body weights. No changes were observed in blood and urine routine examination,biochemical blood test and pathology during 2-year implantation. Conclusion： It is safe to take PCL for subcutaneous implantation.

关 键 词：动物实验 内酯类 埋藏疗法 毒性试验 

分 类 号：R318.08[医药卫生—生物医学工程] R285.1[医药卫生—基础医学]