复方白芍颗粒质量控制研究

A Study of Quality Control of Compound Radix Paeoniae Alba Granule

目的建立复方白芍颗粒的质量标准。方法采用薄层色谱法对制剂中的白芍﹑泽泻进行定性鉴别,采用高效液相色谱法测定制剂中芍药苷含量。结果薄层色谱斑点清晰,且阴性对照无干扰;芍药苷浓度在33.35~333.50μg/mL范围内与峰面积的线性关系良好,平均回收率为97.39%（RSD=1.35%,n=6）。结论所建立的方法操作简单,重复性好,可有效控制复方白芍颗粒质量。

Objective To establish a quality standard for Compound Radix Paeoniae Alba Granule. Methods The qualitative identification of Radix Paeoniae Alba and Rhizoma Alismatis in Compound Ra- dix Paeoniae Alba Granule was performed by thin-layer chromatography （TLC）, and the content of paeon- iflorin in Compound Radix Paeoniae Alba Granule was determined by high-performance liquid chromatog- raphy. Results The relevant spots of Radix Paeoniae Alba and Rhizoma Alismatis on TLC plates were clear without interference from the negative control. A good linear relationship with peak area was achieved when the concentration of paeoniflorin ranged between 33.35 and 333.5 /lg/mL. The average recovery rate was 97.39%, and the relative standard deviation was 1.35% （n=6）. Conclusion The established method is simple and repeat- able to effectively control the quality of Compound Radix Paeoniae Alba Granule.