国产雷帕霉素-肝素洗脱支架的制备及其体外实验研究  

Study of China-made peripheral arterial sirolimus-heparin eluting stent and its pharmacokinetics: in vitro experiment

作　　者：冯博[1] 夏永辉[1] 石强[1] 梁松年[1] 黄莹莹[2] 齐民[2] 徐克[1] 

机构地区：[1]中国医科大学附属第一医院放射科,辽宁沈阳110001 [2]大连理工大学材料学院,辽宁大连116023

出　　处：《中国临床医学影像杂志》2008年第2期94-98,共5页Journal of China Clinic Medical Imaging

基　　金：国家自然科学基金资助项目(30470521)

摘　　要：目的:探讨国产外周动脉雷帕霉素-肝素洗脱支架的物理性能、生物相容性及体外药代动力学特性。方法:利用喷涂装置将聚丙交酯乙交酯(PLGA)与肝素的混合溶液雾化喷出,在涂载雷帕霉素聚合物涂层的12枚镍钛合金支架表面形成载肝素聚合物涂层。对载药涂层支架进行物理性能检测、降解特性检测、血液相容性试验及药物释放特性研究。结果:雷帕霉素-肝素支架表面质量良好,与支架有良好的结合力。降解实验表明:PLGA和PLGA载雷帕霉素薄膜的降解时间为3个月左右。血液相容性实验结果表明:PLGA涂层与血小板接触,血小板粘附量明显较少,变形较小,未引起大量聚集;载药的PLGA涂层表面粘附的血小板数量更少,没有变形,未引起进一步的聚集;载药涂层的凝血时间长,凝血因子被激活的程度低。体外药物释放结果表明:雷帕霉素涂层释放曲线为线性释放,可持续释放时间约3个月。肝素涂层在释放初期存在突释,为60%左右,后期释放较平缓,在1个月左右释放为总量的70%,全部释放约50天。结论:国产外周动脉雷帕霉素-肝素洗脱支架具有良好的生物相容性,雷帕霉素及肝素能够持续缓慢释放,提高了洗脱支架的预防再狭窄及抗凝性能。Objective： To evaluate the China-made sirolimus-heparin eluting stent＇s physical performance, biocompatibility and phannacokinetics in vitro. Methods： Coated PLGA-heparin complex to the sirolimus-coated stents with self-made printing equipment to gain the multiple membrane. Evaluated the physical and degrading efficiency, blood compatibility and phannacokinetics in vitro of the stents coated with multiple membrane. Results： The China-made sirolimus-heparin stent had good surface performance and had good combining power with polymer. The test showed that degradation time of PLGA and PLGA with sirolimus membrane was 3 months; The blood compatibility test of the china-made stent show that platelet adhesion on PLGA membrane was reduced, and no obvious aggregation. The PLGA membrane with drugs had even less platelet adhesion. The clotting time of drug coating was prolonged and blood coagulation factors were activated in a low level. The pharmacoki- netics test in vitro showed that the sirolimus slowed down within 3 months and the heparin slowed down within 50 days. Conclusion： The China-made sirolimus-heparin eluting stent had good biocompatibility, sirolimus and heparin could release slowly and could inhibit in-stent stenosis and thrombosis.

关 键 词：支架 西罗莫司 肝素 

分 类 号：R815[医药卫生—放射医学]