目的:建立丹芍合剂的定性鉴别和含量测定方法。方法:采用薄层色谱法(TLC)对制剂中所含的丹参、赤芍、枳壳分别进行定性鉴别;采用高效液相法(HPLC)同时测定制剂中丹酚酸B、芍药苷和柚皮苷3种成分的含量,色谱柱为Waters XBridgeTM C18柱(4.6 mm×250 mm,5μm);流动相为乙腈-0.1%磷酸水溶液,梯度洗脱;检测波长为230 nm;柱温为25℃;体积流量1.0 m L·min~(-1)。结果:薄层色谱斑点对应清晰且阴性无干扰;丹酚酸B、芍药苷和柚皮苷分别在0.02176~0.4353μg(r=0.9998)、0.01692~0.3384μg(r=0.9999)、0.01034~0.2068μg(r=0.9999)的范围内线性关系良好;平均回收率分别为99.33%(RSD=1.24%)、99.67%(RSD=0.57%)、99.77%(RSD=0.33%)(n=9)。结论:所建立的TLC和HPLC方法操作简便、快速、准确,并且重复性较好,可用于丹芍合剂的质量控制。 Objective: To establish a qualitative identification and determination of Dan-peony mixture. Methods: The TLC, TLC and TLC were used to identify the Salvia miltiorrhiza, Paeonia lactiflora and Citrus aurantium respectively. The contents of Salvianolic acid B, Paeoniflorin and pomelo peel in the preparations were determined by high performance liquid chromatography (HPLC) Glycosides were separated on a Waters XBridgeTM C18 column (4.6 mm × 250 mm, 5 μm). The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution with gradient elution. The detection wavelength was 230 nm. The column temperature was 25 ℃. The volume flow rate is 1.0 m L · min ~ (-1). Results: The TLC spots were clear and negative without interference. The concentrations of salvianolic acid B, paeoniflorin and naringin were in the ranges of 0.02176-0.4353μg (r = 0.9998), 0.01692-0.384μg (r = 0.9999), 0.01034-0.2068μg (r = 0.9999). The average recoveries were 99.33% (RSD = 1.24%), 99.67% (RSD = 0.57%) and 99.77% (RSD = 0.33%) respectively. Conclusion: The established TLC and HPLC methods are simple, rapid, accurate and reproducible. They can be used for the quality control of Dan Shao Mixture.