一测多评法在血府逐瘀丸质量评价中的应用

Application of QAMS method in quantitative evaluation of Xuefu Zhuyu Pills

目的建立血府逐瘀丸(XZP)中芍药苷、阿魏酸、苦杏仁苷、甘草苷、梓醇、β-蜕皮甾酮、羟基红花黄色素A、柚皮苷、新橙皮苷、柴胡皂苷a 10种化合物一测多评评价模式,检验该方法是否适用于XZP的质量控制。方法以XZP为研究对象,选择芍药苷作为内参物,采用多点校正法,建立芍药苷与阿魏酸、苦杏仁苷、甘草苷、梓醇、β-蜕皮甾酮、羟基红花黄色素A、柚皮苷、新橙皮苷及柴胡皂苷a之间的相对校正因子(f);同时进行定量计算,实现一测多评。采用外标法测定16批XZP样品中10种成分的量,并将外标法测定值与f计算所测值进行对比,检验所建立方法的准确性。结果在一定的线性范围内,芍药苷与阿魏酸、苦杏仁苷、甘草苷、梓醇、β-蜕皮甾酮、羟基红花黄色素A、柚皮苷、新橙皮苷及柴胡皂苷a之间的f分别为2.22、1.73、0.56、3.55、2.03、2.31、1.03、1.68、1.13,以校正方式所得f计算值与实测值间无显著差异,16批次供试品中梓醇、苦杏仁苷、柴胡皂苷a、阿魏酸、柚皮苷、新橙皮苷、甘草苷、β-蜕皮甾酮、羟基红花黄色素A和芍药苷的量分别为0.47~0.72、0.63~0.94、0.37~0.74、0.11~0.33、1.15~1.37、0.64~0.84、1.47~1.88、0.38~0.62、0.17~0.34、1.16~1.48 mg/g。结论一测多评的质量评价模式简单、精确且可行,适用于XZP的质量评价和控制。

Objective To establish a quantitative analysis of multi-components by single marker（QAMS） method for the determination of ten components in Xuefu Zhuyu Pills（XZP）, which are paeoniflorin, ferulic acid, amygdalin, liquiritin, catalpol, β-ecdysone, hydroxysafflor yellow A, naringin, neohesperidin, and saikosaponin A, and to examine the feasibilities of the method for quality control of XZP. Methods Using XZP as the research object, paeoniflorin was chosen as the internal reference substance by correction methods. The relative correlation factors（f） of ferulic acid, amygdalin, liquiritin, catalpol, β-ecdysone, hydroxysafflor yellow A, naringin, neohesperidin, and saikosaponin A to paeoniflorin were established. The contents of ten components in 16 batches of samples were determined by the external standard method and QAMS, and the measured values of the external standard method were compared with the calculated results of correction factor in order to test the accuracy of established method. The results were compared with the methods finally. Results The f value of ferulic acid, amygdalin, liquiritin, catalpol, β-ecdysone, hydroxysafflor yellow A, naringin, neohesperidin, and saikosaponin A to paeoniflorin were 2.22, 1.73, 0.56, 3.55, 2.03, 2.31, 1.03, 1.68, and 1.13, respectively; There was no significant difference between the calculated value and the measured value of f by correction method. The contents of nine batches of catalpol, amygdalin, saikosaponin A, ferulic acid, naringin, neohesperidin, liquiritin, β-ecdysone, hydroxysafflor yellow A, and paeoniflorin were 0.47—0.72, 0.63—0.94, 0.37—0.74, 0.11—0.33, 1.15—1.37, 0.64—0.84, 1.47—1.88, 0.38—0.62, 0.17—0.34, and 1.16—1.48 mg/g, respectively. Conclusion The QAMS method is feasible and credible, and could be used to determine and control the multiple components in XZP.