四物颗粒的质量标准研究

Quality Standard for Siwukeli Granule

目的:建立四物颗粒质量控制方法。方法:采用TLC法对处方中的白芍、川芎进行定性鉴别,采用HPLC法测定芍药苷的含量。结果:薄层色谱鉴别方法专属性强。芍药苷量在0.1958μg～4.895μg范围内线性关系良好,r=0.9999,加样回收率为99.11%,RSD为0.58%。结论:该方法准确、可靠、重现性好,能有效控制该制剂的质量。

Objective ：To establish the quality standard for Siwukeli granule. Methods：Radix Paeoniae Alba and Rhizoma Chuanxiong were identified by Thin layer chromatography, and the content of Paeoniflorin was determined by HPLC. Results： Identification of Radix Paeoniae Alba and Rhizoma Chuanxiong by TLC was special. Paeoniflorin showed a good linear relationship within the range of 0. 1958 - 4.895 μg, r = 0.9999. The average recovery was 99.11%, and RSD was 0.58%. Conclusion： The method is accurate and reliable with a good reproducibility,and can control the quality of Siwukeli granule.