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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 To study the in vitro release behavior of compound Danshen sustained-release tablets from the perspective of effect kinetics and investigate the in vitro release behavior of compound Danshen sustained-release tablets. Methods Based on the biochemical chemiluminescence detection of neutrophil respiratory burst, the in vitro release samples of compound Danshen sustained-release tablets were measured at specified time points to characterize the changes of in vitro release behavior. Results The compound Danshen sustained-release tablets can be slowly released for 12 h in vitro, basically meeting the requirements of the design of sustained-release preparations. Conclusion Based on the evaluation of kinetic kinetics, a biochemoluminescence detection technique based on neutrophil respiratory burst was successfully constructed, which provided a new reference for the in vitro release evaluation of traditional Chinese medicine compound controlled-release formulations.