四物汤配方颗粒的质量标准研究

目的：建立四物汤配方颗粒的质量控制方法。方法：采用薄层色谱（TLC）法鉴别四物汤配方颗粒中的熟地黄、当归、川芎、白芍,采用高效液相色谱（HPLC）法测定四物汤配方颗粒中的芍药苷、阿魏酸的含量。结果：TLC法分离较好,阴性无干扰;HPLC法芍药苷线性范围为0.1031~1.6496μg,r=1.000;阿魏酸线性范围为0.0209~0.3344μg,r=0.9997。平均回收率分别为100.46%、101.55%,RSD均小于2.0%。结论：该方法专属性强,重复性好,可用于控制四物汤配方颗粒的质量。

Objective：To establish a quality standard for Siwutang Peifangkeli. Methods：Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Chuanxiong and Radix Rehmanniae were indentified by TLC. The contents of Paeoniflorin and Ferulic acid were determined by HPLC. Results：The specific spots of Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Chuanxiong and Radix Rehmanniae could be detected by TLC. The linear calibration curves were established in the concentration range of 0.1031-1.6496lxg （r=1.000）for Paeoniflorin and 0.0209-0.33441xg （r=0.9997）for Ferulic acid. The average recoveries of Paeoniflorin and Ferulic acid were 100.46% and 101.55%, respectively. All the relative standard deviations were Less than2.0%. Conclusion：The method is simple, feasible and reoroducible. It can be used for nualitv control of Siwutanz Peifanzkeli.