目的 制定寒湿痹颗粒的质量控制方法。方法 采用TLC法对处方中麻黄、白芍、甘草、黄芪进行了定性鉴别。采用反相高效液相色谱法测定寒湿痹颗粒中芍药苷，Diamonsil C18色谱柱（150 mm×4.6 mm，5 μm），以乙腈–0.1%磷酸溶液（14∶86）为流动相，检测波长为230 nm。结果 TLC鉴别方法专属性强，分离效果良好。芍药苷在0.202 7～4.054 0 μg线性关系良好（r=0.999 8），平均回收率为96.2%，RSD为1.9%（n=6）。结论 本方法灵敏、简便、准确，重现性好，可作为寒湿痹颗粒的质量控制方法。

Objective To establish the quality standard of Hanshibi Granula. Methods The TLC method was used for the qualitative identification of Ephedrae Herba, Paeoniae Alba Radix, Glycyrrhizae Radix et Rhizoma, and Astragali Radix in the formula. The contents of paeoniflorin in Hanshibi Granula were determined by RP-HPLC method with Diamonsil C18 (150 mm×4.6 mm, 5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid (14∶86). The detection wavelength was 230 nm. Results The identification study showed strong specificity. The calibration curves were linear in the range of 0.202 7—4.054 0 μg (r=0.999 8) for paeoniflorin. The average recovery rate was 96.2% with RSD 1.9% (n＝6). Conclusion The method is sensitive, simple, and accurate, and has the specificity and good reproducibility. It could be used in the quality control of Hanshibi Granula.

国家药典委员会2010版中国药典一部标准研究课题