不透X射线栓塞微球的制备及其性质评价  

Preparation and evaluation of radiopaque microspheres

作　　者：张苑[1] 袁惠燕[1] 吴瑨威[1] 范田园[1] 

机构地区：[1]北京大学药学院药剂学系,北京100191

出　　处：《北京大学学报（医学版）》2009年第4期447-451,共5页Journal of Peking University:Health Sciences

摘　　要：目的:研究包载碘油的海藻酸钙微球(lipiodol-containing calcium alginate microspheres,LAMs)的制备方法、理化性质、栓塞性能和不透X射线的效果。方法:采用滴制法制备LAMs。通过正交实验考察乳剂处方中碘油与水相的比例、滴制操作中气流大小、砝码重量这3个因素对微球的数均粒径、粒径多分散性及碘油包封率的影响。以光学显微镜观察微球的形态,以物性测定仪考察微球的弹性,以视频旋转滴张力仪考察微球在导管内的推注性能,以X射线摄影系统考察微球在大鼠血管内的显影效果。结果:制备微球的最佳条件是碘油与水相的比例为3∶10,气流速度为40g/mL,所用砝码质量为100g。按正交实验优化工艺制备的微球,平均数均粒径为(493.9±42.6)μm,多分散性系数为1.02,碘油包封率为(88.97±1.09)%,微球圆整、表面光滑,微球变形60%时可承受的最大力平均值为(1.09±0.18)N,导管内推注性能良好。微球注入大鼠血管后,在X射线下显影效果清晰。结论:研制出的不透X射线微球外观圆整、粒径在栓塞所需范围内、弹性良好、导管内易推注、动物体内显影清晰,为介入栓塞治疗提供了一种新型的栓塞剂。Objective：To develop lipiodol-containing calcium alginate microspheres （LAMs） for embolization, and study the characterization for emoblization and the radiopacity. Methods： LAMs were prepared by dripping method. The preparation of LAMs was optimized by orthogonal experiment which involved effects of three factors （ the volume ratio of lipiodol to the external aqueous solution, airflow rate, and the weight pushing the injector） at three levels on the responses to the size, polydisperse index and entrapment efficiency of LAMs. The morphology of LAMs was observed under microscope. The elasticity of LAMs was investigated by texture analyzer. The capability injected through catheter of LAMs was moni- tored by video spinning-drop tensionmeter. The radiopacity of LAMs was measured by X-ray imaging system after LAMs were injected into vas of a rat. Results： The optimal condition for preparation of LAMs was： the volume ratio of lipiodol to the external aqueous solution was 3： 10, airflow rate was 40 g/mL and the weight pushing the injector was 100 g. According to the optimized condition, LAMs were prepared and characterized. The mean diameter of LAMs was （493.9 ± 42.6 ） μm, the polydisperse index was 1.02 and the entrapment efficiency was （88.97 ±1.09 ）%. The LAMs were with round shape and smooth surface in view of photograph of microscope. The maximum average load was （ 1.09±0. 18 ） N when LAMs were compressed to 60%. The LAMs were injected through catheter without much difficulty. The radiopacity of LAMs in rats was demonstrated to be visible under X-ray photography system. Conclusion： The radiopaque LAMs developed are suitable for the arterial embolization, with round shape, proper size, good elasticity, easy handling character and visible property under X-ray imaging. The radiopaque embolic agent is supposed to be useful for emoblization therapy.

关 键 词：栓塞 治疗性 放射摄影术 微球体 藻酸盐 碘化油 

分 类 号：R944[医药卫生—药剂学]