Study on Quality Standards for Shufeng Zhike Extract / 中国中医药信息杂志

ABSTRACT

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 (1288) 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.