多指标定量指纹图谱用于中药复方缓释制剂体外释放度的评价

Evaluation on in vitro release of Chinese medicinal compound sustained release preparations using multi-index chromatographic fingerprint

目的:探讨多指标定量指纹图谱用于中药复方缓控释制剂体外释放度的评价。方法:以中药复方降压缓释片为模型药,采用HPLC,建立中药复方降压缓释片的指纹图谱,分别以刺槐素、芦丁、木犀草素等主要成分为指标进行测定,结合色谱指纹图谱,计算体外释放度。结果:各指标成分及指纹图谱分别符合不同的释药方程,提示其因理化性质的不同,体外释放度亦有所不同。结论:多指标定量指纹图谱既可同时反映多个成分的含量变化,又可反映中药复方整体的含量变化,可用于中药复方缓控释制剂的体外释放度评价,简单方便、快速、信息量大。

Objective.To establish a method to evaluate the in vitro release of Chinese medicinal compound sustained release preparations using multi-index chromatographic fingerprint.Method-With the Chinese medicinal compound Jiangya sustained tablets as model preparation,the in vitro cumulative release of the main component flavones and fingerprint were determined by HPLC fingerprint.Aacacetin,rutin,luteolin,fingerprint were determined simultaneously and used to calculate the in vitro cumulative release of the tablet...