丹归活血合剂的质量控制  

Quality control of Dangui Huoxue mixture

作　　者：梁健 杨春欣 吕迁洲 李晓宇 胡亚男 王强 沈熊 LIANG Jian;YANG Chunxin;LYU Qianzhou;LI Xiaoyu;HU Yanan;WANG Qiang;SHEN Xiong(Department of Pharmacy,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Dermatology,Zhongshan Hospital,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属中山医院药剂科,上海200032 [2]复旦大学附属中山医院皮肤科,上海200032

出　　处：《中国临床药学杂志》2023年第4期292-296,共5页Chinese Journal of Clinical Pharmacy

基　　金：上海市科委生物医药领域重点项目(编号18401931700);上海市卫健委/上海市中医药管理局科研项目(编号2016ZJP001)。

摘　　要：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-C_(18)(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-C_(18)(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.

关 键 词：丹归活血合剂 丹参酮ⅡA 芒柄花素 芍药苷 丹皮酚 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]