醒神复元合剂质量标准提升研究醒神复元合剂质量标准提升研究

Study on the Improvement of Quality Standard of Xingshen Fuyμan mixtμre

目的:提升醒神复元合剂制剂的质量标准。方法:利用薄层色谱法对醒神复元合剂中石菖蒲、当归、白芍、陈皮4味药材进行定性鉴别,运用高效液相色谱法测定合剂中芍药苷的含量。色谱条件:Phenomenex Kinetex XB C18(5μm,4.6×250mm),流动相条件:乙腈-0.1%磷酸溶液,利用230nm波长进行检测,流速1.0m L/min,柱温25℃,进样量为10μL。结果:建立的石菖蒲、当归、白芍、陈皮的TLC鉴别中,各味药材斑点清晰,分离度好,且无阴性干扰。芍药苷质量浓度在32.59~408.61μg/m L范围内,与峰面积线性关系良好,r=0.9999;平均加样回收率为96.75,RSD为1.22%。结论:该方法准确易行,精密度、稳定性、重复性均良好,可作为醒神复元合剂的质量控制。

Objective: To improve the qμality standard of Xingshen Fuyμanmixtμre. MethodsMethods: Acorμs tatarinowii Schott, Angelica sinensis, Paeonia lactiflora Pall and Citrμs reticμlata Blanco were identified by TLC. The content of matrineinthepaeoniflorin was determined by high performance liqμid chromatography(HPLC). Chromatographic conditions: Phenomenex Kinetex XB C18(5μm,4.6×250 mm), mobile phase conditions:acetonitrile-1% phosphoric acid, detection at 230 nm wavelength, flow rate1.0 m L/min, colμmntemperatμre 25℃, injection volμme 10μL. Results: In the established, TLC identification of Acorμstatarinowii Schott, Angelica sinensis, Paeonialactiflora Pall. and Citrμsreticμlata Blanco, the component spots were clear, the separation was good, and the negative control sample had no interference. The concentration of Sophoraflavescens was in the range of 32.59~408.61μg/m L,which has a good linear relationship with the peak area, r= 0.9999;the average sample recovery rate was 96.75%, and the RSD was 1.22%(n=6). Conclusion: The method is accμrate and easy to perform,with good precision,stability and repeatability, and can be μsed as a qμality standard for Xingshen Fμyμan mixtμre.