肠安颗粒的质量标准研究

Quality standard of Chang'an granules

目的 建立肠安颗粒剂的质量控制方法。方法采用薄层色谱法对方中白术、延胡索、五味子进行定性研究，采用高效液相色谱法，以乙腈-水（17：83）为流动相，检测波长为230nm，采用Kromasil 100-5 C18分析柱（200mm×4．6mm，5 μm），测定方中白芍中芍药苷的含量。结果 白术、延胡索、五味子可用薄层色谱鉴别；芍药苷在0．092 8～1．856 μg线性关系良好（r＝0．9999），平均回收率为101．810，RSD＝1．31％（n＝6）。结论 所建立的方法简便、快速、准确，能有效控制肠安颗粒剂的质量。

Objective To establish a method for quality control of Chang＇an granules. Methods Atractylodes Macro-cephala, Corydalis Tuber, and Schisandra Chinensis in Chang＇an granules were identified by thin-layer chromatography. The paeoniflorin was determined by HPLC. The condition of HPLC was Kromasil 100-5 C18 column, acetonitrile-water （17 ： 83） as the mobile phase and detective wavelength at UV 230 nm Results Atractylodes Macrocephala, Corydalis Tuber, and Schisandra Chinensis were identified by thin-layer chromatography; The calibration curve was linear within 0. 092 8～1. 856 μg of paeoniflorin （r=0. 999 9）. The average recovery and RSD of paeoniflorin were 101.81% and 1.31%, respectively. Conclusion The method can be adopted for the quality control of Chang＇an granules and the determination method of paeoniflorin is simple, rapid and accurate.