Objective To establish the quality standards for Shufeng Zhike Extract;To improve the controll ability of the extract and ensure medicine efficacy. Methods To establish a HPLC method for simultaneous differentiation of Paeoniae Radix Alba, Saposhnikoviae Radix, Polygoni Cuspidati Rhizomaet Radix, Glycyrrhizae Radix et Rhizoma, Belamcandae Rhizoma and Bupleurum in Shufeng Zhike Extract. Phenomenex Kintex C18 column (4.6 mm×100 mm, 2.6 µm) was used. Acetonitrile-0.05%phosphoric acid was as the mobile phase in gradient elution (0–25 min, 10%acetonitrile; 25–26 min, 10%→14% acetonitrile; 26–35 min, 14% acetonitrile; 35–36 min, 14%→34% acetonitrile;36–55 min, 34%acetonitrile) at flow rate of 0.8 mL/min, and column temperature was 40 ℃. The detection wavelength was 250 nm. To establish a HPLC method for simultaneous determination of Paeoniflorin and Prim-O-glucosylcimifugin in Shufeng Zhike Extract, Phenomenex Luna C18 column (4.6 mm×150 mm, 5 µm) was used; acetonitrile-0.05%phosphoric acid (12:88) was as the mobile phase at flow rate of 1 mL/min; column temperature was 40 ℃; the detection wavelength was 250 nm. Results The chromatographic peak separation with HPLC method for simultaneous differentiate of Paeoniae Radix Alba, Saposhnikoviae Radix, Polygoni Cuspidati Rhizoma et Radix, Glycyrrhizae Radix et Rhizoma, Belamcandae Rhizoma and Bupleurumin in Shufeng Zhike Extract was clear and negative control had no interference. The linear range of Paeoniflorin was 0.035 93–2.514 8 µg (r=0.999 5), and the average recovery was 100.54%(n=6). The linear range of Prim-O-glucosylcimifugin was 0.006 7–0.67 µg (r=0.999 5), and the average recovery was 100.39%(n=6). Conclusion The established quality standards are simple, reliable, and accurate. It can rapidly identificate Paeoniae Radix Alba, Saposhnikoviae Radix, Polygoni Cuspidati Rhizomaet Radix, Glycyrrhizae Radix et Rhizoma, Belamcandae Rhizoma and Bupleurum, and suitable for rapid determination of Paeoniflorin and Prim-O-glucosylcimifugin, which can provide the basis for the quality inspection of Shufeng Zhike Extract.%目的：建立疏风止咳提取物的质量标准，提高其质量可控性，保证成品药效。方法采用 HPLC同时对疏风止咳提取物中白芍、防风、虎杖、甘草、射干和北柴胡进行专属性鉴别，色谱柱为Phenomenex Kintex C18（4.6 mm×100 mm，2.6µm），流动相为乙腈-0.05%磷酸，梯度洗脱（0～25 min，10%乙腈；25～26 min，10%→14%乙腈；26～35 min，14%乙腈；35～36 min，14%→34%乙腈；36～55 min，34%乙腈），柱温40℃，流速0.8 mL/min，检测波长250 nm。采用HPLC同时测定疏风止咳提取物中芍药苷和升麻素苷含量。色谱柱为Phenomenex Luna C18（4.6 mm×150 mm，5µm），流动相为乙腈-0.05%磷酸（12∶88），柱温40℃，流速1 mL/min，检测波长250 nm。结果疏风止咳提取物中白芍、防风、虎杖、甘草、射干和北柴胡HPLC色谱峰分离度好且阴性无干扰。芍药苷在0.03593～2.5148µg范围内线性关系良好（r＝0.9995），平均加样回收率为100.54%（n＝6）；升麻素苷在0.0067～0.67µg范围内线性关系良好（r＝0.9995），平均加样回收率为100.39%（n＝6）。结论本研究建立的质量标准简便、可靠、准确，可快速鉴别疏风止咳提取物中白芍、防风、虎杖、甘草、射干和北柴胡，快速测定芍药苷和升麻素苷含量，为控制疏风止咳提取物的质量提供依据。
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