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一测多评法同时测定五灵胶囊中8种成分的含量

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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ⅡA、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-C18色谱柱(4.6 mm×250 mm,5 μm);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ⅡA、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ⅡA、丹酚酸B、隐丹参酮分别在9.58~191.50,9.10~182.02,1.04~25.89,2.00~50.10,5.37~134.35,1.00~25.08,8.27~206.72,1.07~26.67 µg/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.
Simultaneous Determination of Eight Components in Wuling Capsules by QAMS
Objective To establish a method for simultaneous determination of saikosaponin a,saikosaponin d,schisandrin A,schisandrin B,schisandrol A,tanshinone ⅡA,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-C18 column(4.6 mm×250 mm,5 μm)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 ⅡA,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 ⅡA,salvianolic acid B and cryptotanshinone showed good linear relationships within the ranges of 9.58-191.50,9.10-182.02,1.04-25.89,2.00-50.10,5.37-134.35,1.00-25.08,8.27-206.72,1.07-26.67 µg/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.

Wuling CapsulesQAMSsaikosaponin asaikosaponin dschisandrin Aschisandrin Bschisandrol Atanshinone ⅡAsalvianolic acid Bcryptotanshinone

李怀伟、马昌豪、曹鲁娜、毕天琛、王劲

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菏泽市食品药品检验检测研究院,山东 菏泽 274000

山东省食品药品审评查验中心,山东 济南 250014

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ⅡA 丹酚酸B 隐丹参酮

2024

食品与药品
山东省生物药物研究院

食品与药品

CSTPCD
影响因子:0.537
ISSN:1672-979X
年,卷(期):2024.26(5)
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