龙凯花, 刘峰, 张红, 杜霞, 王春柳, 刘洋, 杨东花, 李晔. 一测多评法同时测定冠心舒通胶囊中10个成分的含量J. 药学学报, 2022,57(6): 1880-1886. doi: 10.16438/j.0513-4870.2022-0123
引用本文: 龙凯花, 刘峰, 张红, 杜霞, 王春柳, 刘洋, 杨东花, 李晔. 一测多评法同时测定冠心舒通胶囊中10个成分的含量J. 药学学报, 2022,57(6): 1880-1886. doi: 10.16438/j.0513-4870.2022-0123
LONG Kai-hua, LIU Feng, ZHANG Hong, DU Xia, WANG Chun-liu, LIU Yang, YANG Dong-hua, LI Ye. Simultaneous determination of 10 components in Guanxinshutong capsules by quantitative analysis of multi-components by single markerJ. Acta Pharmaceutica Sinica, 2022,57(6): 1880-1886. doi: 10.16438/j.0513-4870.2022-0123
Citation: LONG Kai-hua, LIU Feng, ZHANG Hong, DU Xia, WANG Chun-liu, LIU Yang, YANG Dong-hua, LI Ye. Simultaneous determination of 10 components in Guanxinshutong capsules by quantitative analysis of multi-components by single markerJ. Acta Pharmaceutica Sinica, 2022,57(6): 1880-1886. doi: 10.16438/j.0513-4870.2022-0123

一测多评法同时测定冠心舒通胶囊中10个成分的含量

Simultaneous determination of 10 components in Guanxinshutong capsules by quantitative analysis of multi-components by single marker

  • 摘要: 基于一测多评法建立高效液相色谱法同时测定冠心舒通胶囊(广枣、丹参、丁香、冰片、天竺黄)中没食子酸、丹参素钠、原儿茶酸、原儿茶醛、香草醛、迷迭香酸、丹酚酸B、丁香酚、隐丹参酮、丹参酮ⅡA的含量。采用Agilent C18(ZORBAX Extend-RP C18,250 mm×4.6 mm,5 μm)色谱柱,以甲醇-0.4%甲酸水溶液为流动相梯度洗脱,流速1.0 mL·min-1,检测波长280 nm,柱温35℃,进样量5 μL。以原儿茶酸为内参物,计算相对校正因子并进行耐用性考察,通过一测多评法和外标法计算10个成分的含量。结果表明,10种成分专属性、线性关系、精密度、重复性、稳定性均良好,平均加样回收率98.20%~103.47%,RSD 1.26%~2.84%。计算其他9个成分的相对校正因子、含量(mg·g-1)分别为没食子酸(0.759,227.381)、丹参素钠(3.630,3.283)、原儿茶醛(0.185,0.150)、香草醛(0.532,65.213)、迷迭香酸(4.240,1.035)、丹酚酸B (3.245,18.204)、丁香酚(1.729,9.265)、隐丹参酮(0.691,1.449)、丹参酮ⅡA(0.702,1.939)。一测多评法所得结果与外标法接近,相对误差在-3%~3%之间。表明该方法稳定可靠,可用于冠心舒通胶囊中10个成分的含量测定。

     

    Abstract: This study establishes a quantitative analysis of multi-components by single marker (QAMS) method for the simultaneous determination of gallic acid, sodium danshensu, protocatechuic acid, protocatechuic aldehyde, vanillin, rosmarinic acid, salvianolic acid B, eugenol, cryptotanshinone and tanshinone IIA in Guanxinshutong capsules (Bambusae Concretio Silicea, Salvia miltiorrhiza, clove, borneol, Bambusae Concretio Silicea) by HPLC. Sample was loaded onto an Agilent C18 (ZORBAX Extend-RP C18, 250 mm×4.6 mm, 5 µm) column and eluted with methanol-0.4% aqueous formic acid solution as a flow phase gradient, flow speed 1.0 mL·min-1, detection wavelength 280 nm, column temperature 35℃ and sample intake of 5 µL. Using protocatechuic acid as the internal reference, a relative correction factor was calculated and the durability was investigated, and the content of 10 components was calculated by QAMS and external standard method (ESM). The results show that the specificity, linear relationship, precision, repeatability, and stability of the 10 components were good. The average recovery was 98.20%-103.47% and RSD was 1.26%-2.84%. The relative positive factors and contents of the other nine components were calculated as gallic acid (0.759, 227.381), sodium tanshinol (3.630, 3.283), protocatechualdehyde (0.185, 0.150), vanillin (0.532, 65.213), rosmarinic acid (4.240, 1.035), salvianolic acid B (3.245, 18.204), eugenol (1.729, 9.265), cryptotanshinone (0.691, 1.449), and tanshinone ⅡA (0.702, 1.939). The results of QAMS were consistent with ESM analysis, and the relative error was between -3% and 3%. This method is stable and reliable, and can be used for the determination of 10 components in Guanxinshutong capsules.

     

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