舒肝调气丸质量标准研究

目的：建立舒肝调气丸的质量标准。方法：采用薄层色谱法对制剂中香附、木香、厚朴及厚朴花、牡丹皮、延胡索行薄层色谱鉴别;采用高效液相色谱法对橙皮苷进行含量测定。色谱柱为Agilent ZORBAX SB-C18（4.6 mm×250mm,5μm）,以乙腈-0.1%磷酸溶液（19∶81）为流动相,流速为1 ml/min,检测波长为283 nm。结果：薄层色谱鉴别斑点清晰,阴性样品无干扰;含量测定中橙皮苷进样量在0.099 84~2.496μg范围内,与峰面积线性关系良好（r=0.999 9）;平均回收率为99.41%,RSD为1.25%（n=6）。结论：建立的方法操作简便、专属性和重复性好,可作为该制剂的质量控制方法。

Quality standard for Shugan Tiaoqi Pill

Objective： To establish quality standard for Shugan Tiaoqi Pill.Methods： Rhizoma Cyperi,Radix Aucklandiae,Cortex Magnoliae,Agnoliae Officinalis and Flos Magnoliae Officinalis,Cortex Moutan,Rhizoma Corydalis were identified by a thin layer chromatographic method（TLC）.Hesperidin was determined by an HPLC method.The chromatographic separation was achieved on an Agilent ZORBAX SB-C18（4.6 mm×250 mm,5 μm） column with the mobile phase of acetonitrile-0.1% phosphoric acid solution（19∶81）.The flow rate was 1.0 ml/min;the detection wavelength was set at 283 nm.Results： TLC spots developed were fairly clear and the blank test showed no interference.The calibration curve was linear within a range of 0.099 984～2.496 μg（r=0.999 9）.The average recovery was 99.41%,RSD was 1.25%（n=6）.Conclusion： The method is accurate,sensitive and specific.It can be used for the quality control of Shugan Tiaoqi Pill.