通脉活血颗粒的定性定量方法研究

Method for qualitative and quantitative determination of Tongmai Huoxue granules

目的:建立通脉活血颗粒的定性定量方法。方法:采用TLC方法对通脉活血颗粒中的丹参、玄参、木香和甘草进行定性鉴别;采用HPLC法对通脉活血颗粒中的丹参酮ⅡA进行含量测定,使用Phenomenex Gemini C18色谱柱(250 mm×4.6 mm,5μm),以水-甲醇-乙腈(35∶35∶30)为流动相,流速1 mL.min-1,检测波长270 nm,柱温30℃。结果:丹参、玄参、木香和甘草的TLC鉴别斑点清晰,专属性强;HPLC法测定,丹参酮ⅡA进样量在16.3～652.8μg范围内与峰面积呈良好的线性关系(r=0.9999);平均回收率(n=6)为99.7%,RSD=2.0%。结论:所建立的方法可用于通脉活血颗粒的定性、定量检测。

Objective：To establish qualitative and quantitative determination methods for Tongmai Huoxue gran- ules. Method：Salviae Mihiorrhizae Radix et Rhizoma, Scrophulariae Radix, Aucklandiae Radix and Glyeyrrhizae Ra- dix et Rhizoma were identified by TLC. The content of tanshinone ⅡA in Tongmai Huoxue granules was determined by HPLC using Phenomenex Gemini Cis column （250 mm × 4.6 mm,5 μm） with water - methanol - acetonitrile （ 35 ： 35： 30）as mobile phase at a flow rate of 1 mL min-1 ,the detection wavelength was 270 nm. Results：The spots of above- mentioned TCM were distinctive and coincident with the respective reference crude drug. By using above mentioned chromatographic conditions, tanshinone ⅡA was baseline separated with other constituents in the sample, and determined with satisfactory accuracy and precision The linear range was 16. 32 -652. 8 μg（ r = 0. 9999 ）with average recovery of 99.7% （RSD = 2.0 ）. Conclusion：This method is suitable for the quality control of Tongmai Huoxue granules.