目的:考察陈白清肝微丸缓释制剂的体外释放行为,建立其质量评价方法。方法:采用HPLC法进行释放介质指纹图谱分析,选择陈白清肝微丸内柚皮苷为参照峰,分别求出其他指纹峰与对照峰面积的线性相关方程,计算相对释放度。结果:陈白清肝微丸不是同步释放的缓释制剂,每个成分的释放情况均不一致,释药过程符合零级、一级、Higuchi和Ritger-Peppas释药模型。结论:以指纹图谱相关峰为指标可以更加科学全面地评价陈白清肝微丸缓释制剂的体外释放行为。 OBJECTIVE: To investigate the in vitro release behavior of Chenbaiqing Hepatic Pellets for sustained release preparation and to establish the quality evaluation method. Methods: The HPLC fingerprint was used to analyze the fingerprint of the release media. The naringin in the Chenbai Qinggan Pellets was selected as the reference peak. The linear correlation equations of peak areas of the other fingerprints and the control area were calculated respectively, and the relative release was calculated. RESULTS: Chenbaiqing Hepatic Pellets was not a sustained release preparation with simultaneous release. The release of each ingredient was inconsistent. The drug release process was in accordance with the zero and first order, Higuchi and Ritger-Peppas release models. Conclusion: The correlation peak of fingerprint can be used as an index to evaluate the in vitro release behavior of Chenbaiqing Hepatic Pills sustained-release preparation in a more scientific and comprehensive way.