免疫球蛋白缓释微囊的制备、结构表征与性能研究

Study on the Preparation, Structure, and Properties of Immunoglobulin Sustained-release Microcapsules

微囊化是实现生物药物制剂缓控释放的最重要方法之一。以乙基纤维素(EC)为囊材,采用物理化学方法制备了免疫球蛋白乙基纤维素微囊。用扫描电镜(SEM)考察了微囊的孔结构和形貌特征,并通过体外溶出实验考察了微囊的缓释效果。结果表明,在给定制备条件下制得的微囊圆整度好,孔径分布范围较窄,在模拟条件下具有良好的缓释性能。微囊最佳制备工艺条件如下:囊心囊材比2.5∶1,30℃下反应6h,搅拌速率250r/min,吐温80用量8ml。

Microcapsulation was one of the most important methods by which the sustained- release and controlled- release of biopharmaceuticals could be readily achieved. The Ig microcapsules were prepared by a physical chemistry method, ethycellulose used as wall materials. The pore structures and morphology of the Ig microcapsules were investigated by SEM, and their controlled-release behavior was studied with the tests in vitro. The results showed that the resulted microcapsules, which were prepared under the given conditions, were round, the distribution of the particle size was narrow, and the better sustained-release character was obtained under the simulated conditions. The optimum condition of preparing Ig microcapsules was as following ： the ratio of wall and core materials being 2.5：1 ,reacting at 30℃ for 6h, stirring at 250r/min, and 8ml of Tween-80 added.