目的 从效应动力学角度研究复方丹参缓释片体外释放行为过程,探讨并阐释复方丹参缓释片体外释放行为特征。方法 基于中性粒细胞呼吸爆发效应的生物化学发光检测技术,在规定的时间点对复方丹参缓释片体外释放样品进行测定,以表征体外释放行为的变化。结果 复方丹参缓释片体外可缓释12 h,基本达到缓释制剂设计的要求。结论 借鉴效应动力学的评价方法,成功构建了一种基于中性粒细胞呼吸爆发效应的生物化学发光检测技术,为中药复方缓控释制剂的体外释放评价提供新的借鉴和参考。

Objective Based on the biological effect-kinetic methods,to study the compound Danshen sustained release tablets in vitro release kinetics of the process,and to explain the in vitro release characteristics of compound Danshen tablets.Methods Biochemical effects with chemiluminescene detection technology based on the neutrophil respiratory burst,the in vitro release samples of compound Danshen preparations were analyzed in the determined timepoints,which could show the differences of compound Danshen tablets in vitro release.Results Compund Danshen sustained tablets could release in 12 h,which achieved the quality design requirements of sustained release preparation.Conclusion In this study,the biological effect-kinetic method is successfully used.The method of the biochemical effects of chemlumiscence detection technology based on neutrophil respiratory burst is first constructed and used to study compound Danshen tablets in vitro release kinetics,which could be referred as the in vitro release evaluation of compound Chinese medicine sustained release preparation.

“十一五”科技支撑计划项目(2006BA109B08-01)；国家“十一五”重大新药创制专项(2009ZX09310-005)；江西省卫生厅中医药科研项目(2009A059,2009A061)