一测多评法同时测定五灵胶囊中8种成分的含量  

Simultaneous Determination of Eight Components in Wuling Capsules by QAMS

作　　者：李怀伟 马昌豪 曹鲁娜 毕天琛 王劲 LI Huai-wei;MA Chang-hao;CAO Lu-na;BI Tian-chen;WANG Jin(Heze Institute for Food and Drug Control,Heze 274000,China;Shandong Food and Drug Evaluation and Inspection Center,Jinan 250014,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274000 [2]山东省食品药品审评查验中心,山东济南250014

出　　处：《食品与药品》2024年第5期443-449,共7页Food and Drug

摘　　要：目的建立一测多评法同时测定五灵胶囊中柴胡皂苷a、柴胡皂苷d、五味子甲素、五味子乙素、五味子醇甲、丹参酮II_(A)、丹酚酸B、隐丹参酮的含量。方法采用高效液相色谱法,色谱柱为Agilent ZORBAX SB-C_(18)色谱柱(4.6 mm×250 mm,5μm);流动相为乙腈-0.1%磷酸溶液,梯度洗脱;流速1.0 ml/min;检测波长210 nm;柱温30℃。以五味子醇甲为内参物,建立柴胡皂苷a、柴胡皂苷d、五味子甲素、五味子乙素、丹参酮II_(A)、丹酚酸B、隐丹参酮的相对校正因子;计算8种成分的含量,并与外标法测定结果进行对比分析。结果柴胡皂苷a、柴胡皂苷d、五味子甲素、五味子乙素、五味子醇甲、丹参酮II_(A)、丹酚酸B、隐丹参酮分别在9.58~191.50,9.10~182.02,1.04~25.89,2.00~50.10,5.37~134.35,1.00~25.08,8.27~206.72,1.07~26.67µg/ml范围内线性关系良好(r≥0.9992);精密度、重复性、稳定性实验RSD均小于2%;平均加样回收率为97.06%~99.95%,RSD为0.53%~1.73%。一测多评法与外标法测定结果一致。结论该方法简便、准确,可用于五灵胶囊的质量评价。Objective To establish a method for simultaneous determination of saikosaponin a,saikosaponin d,schisandrin A,schisandrin B,schisandrol A,tanshinone II_(A),salvianolic acid B and cryptotanshinone in Wuling Capsules by quantitative analysis of multi-components by single marker(QAMS).Methods The HPLC separation was achieved on an Agilent ZORBAX SB-C_(18)column(4.6 mm×250 mm,5μm)with acetonitrile-0.1%phosphoric acid as mobile phase of gradient elution,which was at a flow rate of 1.0 ml/min.The determination wavelength was 210 nm.The column temperature was set at 30℃.With schisandrol A as the internal reference,the relative correction factors of saikosaponin a,saikosaponin d,schisandrin A,schisandrin B,tanshinone II_(A),salvianolic acid B and cryptotanshinone were calculated.The contents of 8 components were calculated and compared with those determined by the external standard method(ESM).Results Saikosaponin a,saikosaponin d,schisandrin A,schisandrin B,schisandrol A,tanshinone II_(A),salvianolic acid B and cryptotanshinone showed good linear relationships within the ranges of 9.58-191.50,9.10-182.02,1.04-25.89,2.00-50.10,5.37-134.35,1.00-25.08,8.27-206.72,1.07-26.67µg/ml(r≥0.9992).RSDs of precision,repeatability and stability tests were all less than 2%.The average recoveries were 97.06%-99.95%,with the RSDs of 0.53%-1.73%.The results of QAMS were consistent with those of ESM.Conclusion The method is simple and accurate,and can be used to evaluate the quality of Wuling Capsules.

关 键 词：五灵胶囊 一测多评法 柴胡皂苷A 柴胡皂苷D 五味子甲素 五味子乙素 五味子醇甲 丹参酮II_(A) 丹酚酸B 隐丹参酮 

分 类 号：R927[医药卫生—药学]