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目的建立复方茜草秦艽颗粒质量标准,使该药品质量可控。方法采用HPLC法对制剂中的茜草进行定性鉴别,色谱柱:Kromasil 100-5C18(250 mm×4.6 mm,5μm);流动相:甲醇-水(80∶20);检测波长:250 nm;流速:1.0ml·min~(-1)。用TLC法对制剂中的秦艽、甘草进行定性鉴别,HPLC法测定制剂中龙胆苦苷的含量。色谱柱:Kromasil 100-5C18(250 mm×4.6 mm,5μm);流动相:甲醇-水(20∶80);检测波长:273 nm;流速:1.0 ml·min~(-1)。结果龙胆苦苷的加样回收率平均为99.30%,RSD为0.95%(n=6)。TLC、HPLC鉴别阴性无干扰。结论试验结果表明,该方法重复性良好,方便控制该制剂的质量。
Objective To establish the compound quality standard of Rubia cordifolia and control the quality of the drug. Methods The HPLC method was used for the qualitative identification of Rubia cordifolia. The chromatographic column was Kromasil 100-5C18 (250 mm × 4.6 mm, 5 μm); the mobile phase was methanol-water (80:20); the detection wavelength was 250 nm; 1.0ml · min ~ (-1). TLC method for the qualitative identification of Gentiana macrophylla, licorice, HPLC determination of gentiopicroside content. Column: Kromasil 100-5C18 (250 mm × 4.6 mm, 5 μm); mobile phase: methanol-water (20:80); detection wavelength: 273 nm; flow rate: 1.0 ml · min -1. Results The average recoveries of gentiopicroside were 99.30% with RSD of 0.95% (n = 6). TLC, HPLC identification negative non-interference. Conclusion The experimental results show that the method is reproducible and easy to control the quality of the preparation.