摘要
目的用新辅料甲壳胺 (CS)与三聚磷酸钠 (TPP Na)发生聚合反应 ,生成复合骨架材料 ,以双氯灭痛为模型药物 ,制备缓释复合骨架微丸 ,并对其制备工艺影响因素进行考察。方法通过对反应温度、干燥条件、丸径、聚合反应时间、TPP Na的浓度、pH值、含药量、(CS)的粘度、浓度、脱乙酰度 (D .D) %等项试验 ,以释放度为检验指标确定制备工艺条件。结果所得缓释微丸外观圆整、粒子大小分布均匀 ,流动性好。反应温度干燥条件对微丸性质有影响。其他条件对微丸性质影响不大。缓释结果符合《中华人民共和国药典》规定。结论甲壳胺 三聚磷酸钠可以作为双氯灭痛缓释微丸的骨架材料。
Objective Using chitosan tripolyphosphate sodium (TPP Na) as the complex matrix material, the factors affecting the preparing procedure of sodium dichofenac (DS) loaded pellets were studied and optimal conditions for the formulation were chosen. Methods The optimal conditions for the formulation were established by changing the reaction temperature, drying conditions, pellets diameters, polymerization time, concentrations of TPP Na, pH, loading capacity, viscosity, concentrations and degree of deacetylation of chitosan while the release degree of DS from the pellets acted as a determination index. Results All of the sustained release pellets appeared to be round, uniform and well distributed as well as well mobile. The reaction temperature and drying conditions had an effect on the characterization of the pellets and other factors influence to a less degree. The results of sustained release properties coincided with Ch. P. Conclusions Chitosan tripolyphosphate sodium could be used as a complex matrix material for sustained release pellets loading DS.
出处
《沈阳药科大学学报》
CAS
CSCD
2002年第5期320-324,共5页
Journal of Shenyang Pharmaceutical University
