HPLC法同时测定逍遥丸中5个化学成分的含量

Simultaneous determination of five Components in Xiaoyao Pill by HPLC

目的:建立高效液相色谱法在三个波长下同时测定逍遥丸中芍药苷、甘草苷、柴胡皂苷b_2、白术内酯Ⅱ及阿魏酸五个成分的方法。方法:采用C_(18)柱(4.6 mm×250 mm,5μm),以乙腈-0.2%磷酸水溶液梯度洗脱,流速1.0 mL·min^(-1),检测波长分别为230 nm(芍药苷、甘草苷和柴胡皂苷b_2),278 nm(白术内酯Ⅱ),325 nm(阿魏酸)。结果:芍药苷、甘草苷、柴胡皂苷b_2、白术内酯Ⅱ及阿魏酸分别在1.21~18.15μg、0.18~2.19μg、0.38~2.34μg、0.102~0.612 4μg及0.022~0.437μg之间呈良好的线性关系。平均回收率分别为98.1%、100.1%、99.3%、102.2%、102.3%,RSD%分别为1.9%、3.3%、3.2%、1.4%及2.4%(n=6)。结论:不同剂型之间以及同一剂型不同企业间分析物含量差异显著,提示除原药材质量可能直接导致含量差异外,不同剂型的工艺对化学成分也有直接的影响。所建立的方法能适用于逍遥丸所有剂型,方法重现性好,可为有效控制逍遥丸质量提供依据。

Objective： To establish an HPLC method for simultaneous determination of five components of pae-oniflorin, liquiritin, saikosaponin b2, atractylenolide H and ferulic acid in Xiaoyao Pill at three wavelengths. Methods：The test was performed in C18 column （4.6 mmx 250 mm, 5 μm） under the gradient elution of acetonitrile -0.2% phosphoric acid solution. The flow rate was 1.0 mL·min^-1 The detection wavelengths were 230 nm for paeoniflorin, liquiritin and saikosaponin bE , 278 nm for atractylenolide II and 325 nm for ferulic acid respectively. Results： The good linearity was shown in the ranges of 1.21 - 18. 15μg, 0. 18 -2. 19μg, 0.38 - 2.34μg, 0. 102 - 0. 6124μg and 0. 022 - 0. 437μg for paeoniflorin, liquiritin and saikosaponin b2 , atraetylenolide U and ferulie acid respectively. The average recoveries were 98. 1% , 100. 1%, 99.3%, 102.2%, 102.3% with RSDs as 1.9%, 3.3%, 3.2%, 1.4% and 2.4% （n=6） for paeoniflorin, liquiritin and saikosaponin bE , atraetylenolide Ⅱ and ferulic acid respectively. Conclusion： There were significant differences in the contents of components between different dosage forms and among the differentmanufacturers＇ samples with same dosage form. That indicated that the quality of Chinese medicinal materials might lead to the content differences directly, and the process of different dosage forms also had a direct influence on the contents of components. The established method can be applied to all the dosage forms of Xiaoyao Pill. The method reproducibility is good, and it can provide the basis for the effective quality con- trol of Xiaoyao Pill.