基于粉体学特性的独活防风颗粒制备过程质量控制研究OA

Objective To construct physical fingerprints of the intermediates and granules of Duhuo Fangfeng Granule(独活防风颗粒,DHFFG),and to establish an evaluation method for quality control during the preparation process.Methods The micromeritic properties of the intermediates and finished granules were characterized based on 14 parameters including sphericity(S),aspect ratio(AR),bulk density(Da),tap density(Dc),interparticle porosity(Ie),etc.Physical fingerprints were constructed,and fingerprint similarity con-sistency was evaluated.Multivariate statistical analysis was utilized to evaluate correlations and identify abnormal samples.Results The similarity between the physical fingerprints of the intermediates from 20 batches of DHFFG ranged from 0.9430 to 0.9960,and that of the granules ranged from 0.9981 to 0.9998.Through multivariate statistical analysis,the correlations among physical parameters and the classification relationships among samples were obtained,and a quality consistency evaluation method for the preparation process was constructed.Conclusion The constructed quality consistency evaluation method can effectively discriminate abnormal batches of the granules,providing a reference for quality control during the preparation process of traditional Chinese medicine(TCM)preparations.