三七三醇皂苷微丸的处方优化及制备工艺研究

Optimization of the Formula and Preparation Technology Study of Panaxatriol Saponins Pellets

目的:研究三七三醇皂苷微丸的处方及其制备工艺。方法:以微丸成丸性能及物理学表征参数为指标,采用单因素试验优选三七三醇皂苷微丸处方及其挤出滚圆法和流化床法的制备工艺参数,并对两种制备方法进行比较。结果:优选的处方为三七三醇皂苷120g、微晶纤维素90g、淀粉90g、6g聚乙烯吡咯烷酮(PVP)K30,含8%PVPK30的50%乙醇溶液为黏合剂。采用流化床包衣法制备的微丸圆整度好,硬度适宜,粒度分布均匀,收率均在93%以上。结论:应用流化床法制备三七三醇皂苷微丸,工艺简便、易行,制得的微丸质量好,适宜进行进一步肠溶包衣。

OBJECTIVE ： To study the formula and preparation technology of Panaxatriol saponins pellets. METHODS ： The for-mula Panaxatriol saponins pellets, preparation technology parameters of extrusion-spheronization and fluid bed coating technology were optimized with single factor test, using forming characteristics and physical parameters as indicators. RESULTS： Optimized formula was as follows： panaxatriol saponins 120 g, cellulose microcrystalline cellulose 90 g, starch 90g, PVP K30 6.0 g, 50% ethanol solution containing 8% PVP K30 as adhensive agent; The pellets prepared by fluid bed coating technology were all spheral completely with appropriate hardness and uniform particle size distribution; the yield of the pellet was not less than 93%. CON-CLUSIONS： The fluid bed coating technology is simple and fesiable, prepared pellets were excellent in quality and suitable for fur-ther enteric coating.