中文摘要：

目的：制备水飞蓟宾缓释微丸并考察其制备影响因素。方法：采用球晶技术固体自微乳法制备水飞蓟宾缓释微丸;通过考察微丸的粉体学性质、体外释药特性;以载药量、包封率、收率等为指标,通过单因素试验考察了处方因素和工艺因素对微丸质量的影响,并初步确定了各因素的取值范围。结果：水飞蓟宾（0.5 g）、HP-55（1.5 g）、Eudragit RS PO（0.5 g）、微粉硅胶（1.0g）、丙酮（20 ml）、二氯甲烷（20 ml）、0.008%SDS溶液（300 ml）为较优处方;搅拌速度（650 r·min^-1）、温度（25℃）、选择20～60目的微丸为较优工艺。结论：球晶技术适用于水飞蓟宾自微乳的固化,可以得到具有固体分散体结构的缓释微丸。

英文摘要：

OBJECrlVE To prepare the sustained-release microspheres of silybin and investigate the influential factors. METHODS The microspheres of silybin were prepared by solid self-microetnulsion method. The effects of formula factors and process factors on drug loading, entrapment efficiency, and yield were investigated by single-factor experiment, and value range of factors were determined initially. RESULTS The better formulation was as follows： silybin（0. 5 g）, HP45（1.5 g）, Eudragit RS PO（0. 5 g）, aerosil （1.0 g）, acetone（20 ml）, C[-[2C[2 （20 ml）, 0. 008% SDS（300 mD. The better process was that： agitation speed（650 r·min^-1 ）, temperature（25 ℃）, particle size（20 - 60 mesh）. CONCLUSION It is suitable to prepare solid selfmicroemulsion and solid dispersion by the spherical crystallization technique.