血府逐瘀丸高效液相色谱数字化定量指纹图谱研究

目的 建立血府逐瘀丸( Xuefuzhuyu Pill,XFZYP) HPLC数字化定量指纹图谱,对其进行数字化整体质量控制.方法 采用RP-HPLC法,以阿魏酸对照品(ferulic acid,FA)为参照物峰,确定42个共有指纹峰,建立了XFZYP-HPLC数字化定量指纹图谱.以47个数字化参数评价指纹图谱,并用6级系统指纹定量法(6-SFQM)鉴定1 5批XFZYPs质量.结果 用16个数字化指数鉴别出2批样品不合格,用6-SFQM鉴别出11批质量极好(1级),1批质量很好(2级),3批质量良好(4级).结论 所建立XFZYP-HPLC数字化定量指纹谱可准确反映XFZYP质量特征.

Digitized and quantified HPLC fingerprints of Xuefuzhuyu Pill

Objective To establish a digitized and quantified HPLC fingerprints for Xuefuzhuyu Pill(XFZYP) to control its authentic quality from the multiple digital aspect.Methods The chromatographic fingerprints(CFPs) were determined by RP-HPLC,in which 42 co-possessing peaks were selected while taking ferulic acid peaks as the reference peak.We used 47 digitized parameters to assess the CFP differences in 15 batches of XFZYPs and identified their quality levels.In addition,the 6 level systematically quantified fingerprint method(6-SQFM) was applied to evaluate the XFZYP quality.Results The CFPs were successfully established,in which 2 batches of XFZYP were unqualified by the 16 digital indices.The quality of 11 batches was identified as the best(grade 1),that of 1 batch was grade 3,that of 3 batches was(grade 4) by the 6-SQFM.Conclusion The developed XFZYP digitized and quantified HPLC fingerprints can accurately reflect the characteristics of XFZYPs.