中国临床药学杂志

目的 建立能同时测定活血合剂中丹参酮ⅡA、芒柄花素、芍药苷和丹皮酚含量的HPLC法。方法 采用HPLC法，色谱柱为Phenomenex Hyper Clore BDS-C₁₈(250 mm×4.6 mm,5.0μm)；流动相为乙腈-0.05%三氟乙酸，梯度洗脱；流速1.0mL·min^-1；柱温30 oC；检测波长为230、254、270nm。结果 HPLC法测定丹归活血合剂中丹参酮ⅡA、芍药苷、丹皮酚和芒柄花素含量的线性范围分别为0.025～0.504、0.038～0.766、0.052～1.040、0.034～0.690μg·mL^-1，平均加样回收率分别为98.11%、99.53%、98.97%和99.36%(n=6)，相对标准偏差(RSD)均<3%。6个批次样品中丹参酮ⅡA、芍药苷、丹皮酚、芒柄花素的含量分别为0.462 6～0.502 0、0.647 4～0.685 1、 0.787 2～0.820 8、0.931 2～0.989 6μg·mL^-1。结论 该方法操作简单、准确和重复性好，适用于丹归活血合剂的质量控制。

AIM To establish an HPLC method for the simultaneous content determination of tanshinone Ⅱ A,formononetin, paeoniflorin and paeonol in Dangui Huoxue mixture. METHODS The chromatographic separation was achieved an Phenomenex Hyper Clore BDS-C₁₈(250 mm×4.6 mm, 5.0 μm) column with mobile phase consisted of 0.05%TFA-acetonitrile for gradient elution at the flow rate of 1.0 mL·min^-1. The column temperature was 30 ℃ and the detection wavelength were 230, 254 and 270 nm, respectively. RESULTS The content of tanshinone Ⅱ A, formononetin,paeoniflorin and paeonol in Dangui Huoxue mixture had good linear relationship in the ranges of 0.025-0.504, 0.038-0.766,0.052-1.040 and 0.034-0.690 μg·mL^-1. The average sample recovery rate ranges were 98.11%, 99.53%, 98.97% and 99.36%, respectively(RSD < 3%). The content of tanshinone Ⅱ A, formononetin, paeoniflorin and paeonol in 6 batches of sample respectively were 0.462 6-0.502 0, 0.647 4-0.685 1, 0.787 2-0.820 8 and 0.931 2-0.989 6 μg·mL^-1, respectively.CONCLUSION The established method is simple, accurate and reproducible, and can provide the reference for the quality control of Dangui Huoxue mixture.