丹香清脂颗粒质量标准研究

Quality Standard for Danxiang Qingzhi Granules

目的:建立丹香清脂颗粒的质量标准。方法:采用薄层色谱法对方中的川芎、大黄、莪术进行鉴别;采用高效液相色谱法对丹参中丹参酮IIA、丹酚酸B进行定量分析。结果:薄层分离度良好,专属性强;丹参酮IIA进样量在0.004~0.4μg范围内具有良好的线性关系,回收率101.8%;丹酚酸B进样量在0.03~1.9μg范围内具有良好的线性关系,回收率96.4%。结论:所建立之方法准确、灵敏度高、专属性强,可有效控制丹香清脂颗粒的质量。

Objective ： To establish the quality standard for Danxiang Qingzhi Granules. Methods ： Ligustieum wallichii, Rheum officinale and zedoary in Danxiang Qingzhi Granules were identified by TLC. Tanshinone IIA and Salvianolic acid B of Danxiang Qingzhi Granules were determined by HPLC. Results： The characteristic identification by TLC was distinct and highly specific. The quantitative evaluation of Tanshinone IIa had the linear range of 0.004-0.4 μ g. The average recovery of tanshinone IIA was 101.8%. Salvianolic acid B had the linear range of 0.03-1.9 μ g. The average recovery of salvianolic acid B was 96.4%. Conclusion ： The method is reliable, accurate and specific. It can be used for quality control of Danxiang Qingzhi Granules.