中药缓控释制剂的体外释放行为评价一直是制约中药缓控释制剂发展的难点问题与热点问题, 为从整体角度对中药复方缓控释制剂的体外释放行为进行评价, 在回顾分析现有评价模式利弊的基础上, 借鉴多元校正灰色分析计量原理, 前瞻性地提出了基于“物质粗糙集“的中药复方缓控释制剂随方同步/异步释放行为评价模式, 以合理评价制剂释放过程复方化学物质总量的动态变化特征, 建立符合中药复方复杂特点的缓控释制剂释放行为评价模式。

The release character evaluation in vitro has been the difficult and hot topic for sustained and controlled release preparation development of Chinese herbal formula.To evaluate the release character from holism,making use of multiple variables calibration grey assessment model,a tentative idea about the release character synchronism/asynchronism evaluation of Chinese herbal formula sustained and controlled release preparation based on Materials Rough Set theory has been proposed in this paper.And its aim is to reasonably evaluate the dynamic character of release material during releasing,to build the evalutaion pattern of sustained and controlled release preparation of Chinese herbal formula.

“重大新药创制专项”中药复方释药系统技术平台项目(2009ZX09310-5);“十一五”科技支撑计划项目(2006BA109B08-01);江西省卫生厅中医药科研项目(2009A061,2009A059)