目的制备稳定的水飞蓟宾口服微乳。方法采用测定表面张力、绘制拟三元相图和正交设计相结合的方法进行处方筛选及工艺优化。结果鉴别了微乳类型,用光子相关光度法测定了微乳的平均粒径,并且用超速离心法测定了药物在微乳中的相分布。经过对微乳进行离心及影响因素实验,结果表明该微乳在室温下3个月内能维持均一稳定,并且受高温光照影响较小。结论该处方制备的水飞蓟宾口服微乳外观及稳定性良好,为进一步研究奠定了基础。

Objective To prepare stable silybin oral microemulsion. Methods The formulation of the silybin oral microemulsion was optimized by the combination of surface tension measure, pseudo-ternary phase diagram drawing and orthogonal design. Results Microemulsion type was identified. Average particle diameter was measured. Distribution of silybin in microemulsion was measured by ultracentrifugation. The centrifugalization and influencing factors experiment of microemulsion were carried out,which could keep homogeneous and stable for three months on the storage condition of room temperature. Meanwhile,the influence of high-temperature and illumination was a little. Conclusion Stable oral microemulsion silybin can be prepared in this formulation, with fine-looking and desirable stability which is better for the further studies.