妇得乐颗粒的质量标准研究

Study on Quality Standard of Fudele Granule

目的:建立妇得乐颗粒的质量标准。方法:采用薄层色谱法对妇得乐颗粒中的丹参、赤芍进行鉴别;采用高效液相色谱法测定其中丹参酮IIA的含量。结果:在薄层色谱中检出丹参、赤芍;丹参酮IIA在0.039μg～0.401μg范围内线性关系良好,r=0.9993,平均回收率97.33%,RSD为1.67%。结论:所建立的方法可准确地进行定性、定量检测,可用于该制剂的质量控制。

Objective：To establish the quality standard for Fudele granule. Methods： Radix Salviae miltiorrhizae and Radix Paeoniae Alba in Fudele granule were indentified by TLC. The content of tanshinone ⅡA was determined by HPLC. Result： Radix Salviae mihiorrhizae and Radix Paeoniae Alba could be detected by TLC. The liner range of tanshinone ⅡA was 0.039 μg-0.401 μg,r=0.999 3. The average recovery rate was 97.33%,RSD=1.67%（n=9）. Conclusion： The method is actuate and can be used for the quality control of FudeLe granule.