绞股蓝皂苷微丸的制备工艺

研究绞股蓝皂苷微丸的制备工艺。以挤出频率、滚圆频率、滚圆时间为考察因素,以微丸的圆整度为评价指标,利用单因素法研究制备微丸的最优工艺条件。采用挤出滚圆法制备空白微丸;采用流化床法制备绞股蓝皂苷微丸。并对微丸的粉体学性质和体外释放度进行测定;用红外光谱法、X-射线粉末衍射法、扫描电子显微镜法对其进行表征。结果显示,制备微丸的最佳工艺参数为挤出频率30 Hz、滚圆频率50 Hz、滚圆时间4 min。采用流化床底喷上药包衣法制备的绞股蓝皂苷微丸体外释放度为95.98%,符合药典规定;脆碎度为0.90%;圆整度为0.80,表面较为光滑;堆密度较好、大小均匀;休止角为38.70°,流动性较好。电镜、红外、X-衍射等表征结果表明微丸圆整,绞股蓝皂苷分布均匀。利用挤出滚圆-流化床包衣法制备绞股蓝皂苷微丸,该工艺简便易行,可工业化生产。

Preparation Technique of Gypenoside Pellets

The preparation technique of gypenoside pellets was investigated in this work. The optimum technical parameters for producing gypenoside pellet were obtained by single factor test. The extrusion frequency, spheronization frequency, and spheronization time were used as the influencing factors and the roundness of the pellets as the evaluationindex. The blank and gypenoside pellets were prepared by extrusion sphemnization and fluid-bed coating technology, respectively. Micromeritic properties and in vitro release of pellets were determined. The properties of gypenoside pellets were evaluated by infrared spectroscopy (FT-IR), X-ray diffraction (XRD) and scanning electron microscope (SEM). The results showed that the extrusion velocity, spheroization velocity and spheroization time were 30 Hz, 50 Hz, 4 min, respectively. The cumulative amount of gypenoside pellets was 95.98±8.92%, indicating the product complied with the requirements in pharmacopoeia. The friability, the roundness and the angle of repose of gypenoside pellets were 0.90%, 0.80±0.17, 38.70°. The pellets were uniform in diameter, round and smooth, and the fluidity was good. The results of electron microscopy, infrared and X-ray diffraction showed that the pellets were round and the distribution of gypenosides was uniform. It indicated that the process of preparation by extrusion-spheronization and fluid bed coating machines was simple and feasible. It can be applied industrially.