解郁养心合剂的质量标准研究

Research on the Quality Standard of Jieyu Yangxin Mixture

摘要: 目的：制定解郁养心合剂的质量标准。方法：使用薄层色谱法鉴别其中的当归和白芍药材，利用高效液相色谱法测定其中柴胡皂苷a和柴胡皂苷d的含量。色谱柱：InertSustain C18 (5 um, 4.6 × 250 mm)；流动相：乙腈–水溶液(0~25 min：25% → 45%乙腈，25~40 min：45%乙腈，40~60 min：45% → 90%乙腈，60~75 min：90%乙腈)；检测波长：210 nm；柱温：25℃；流速：1 ml/min。结果：制定了解郁养心合剂中当归和白芍等药材的薄层鉴别方法和柴胡皂苷a和柴胡皂苷d的含量测定方法。结论：该分析方法目标成分无干扰、重现性好，基本可控制解郁养心合剂的质量。

Abstract: Objective: Establish the quality standard of Jieyu Yangxin Mixture. Methods: The Angelica sinensis and White Peony Root in Jieyu Yangxin Mixture were identified by TLC. High-performance liquid chromatography (HPLC) was used to determine the contents of Saikosaponin-a and Saikosaponin-d in Jieyu Yangxin Mixture. The InertSustain C18 column (5 um, 4.6 × 250 mm) was adopted with acetonitrile-aqueous solution (0~25 min: 25% → 45% acetonitrile, 25~40 min: 45% acetonitrile, 40~60min: 45% → 90% acetonitrile, 60~75 min: 90% acetonitrile), the detection wavelength was 210 nm, the column tempetature was 25˚C and the flow rate was 1 ml/min. Results: TLC of Angelica sinensis and White Peony Root, and HPLC of Saikosaponin-a and Saikosaponin-d in Jieyu Yangxin Mixture were made. Conclusion: This analytical method achieves target component identification free from interference, demonstrates excellent reproducibility, and effectively enables quality control of Jieyu Yangxin Mixture.