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目的:建立黄白止痢颗粒的质量标准。方法:采用薄层色谱法对黄白止痢颗粒中黄连、大黄炭、白头翁进行定性鉴别,并采用高效液相色谱法测定盐酸小檗碱含量。Agilent Eclipse XDB-C18色谱柱(4.6 mm×250 mm,5μm);流动相乙腈-0.3%磷酸水溶液(32∶68),检测波长348 nm,柱温25℃,流速1.0 mL·min-1,进样量10μL。结果:在薄层鉴别中黄连、大黄炭、白头翁有良好的鉴别特征有效成分盐酸小檗碱含量在0.008 8～0.11 g·L-1具有良好的线性关系(r=0.999 1),平均加样回收率为98.58%,RSD 1.05%。结论:使用薄层色谱法对黄连、大黄炭、白头翁进行定性鉴别,操作简便、重复性好,且阴性对照无干扰;盐酸小檗碱的含量测定方法简便、快速、准确,具有良好的重复性和回收率,可作为黄白止痢颗粒的质量控制方法。
Objective: To establish the quality standard of Huangbai Zhili granules. Methods: The contents of Coptis chinensis, Rhubarb and Pulsatilla were identified by TLC. The contents of berberine hydrochloride were determined by HPLC. Agilent Eclipse XDB-C18 column (4.6 mm × 250 mm, 5 μm); mobile phase of acetonitrile-0.3% phosphoric acid solution (32:68), detection wavelength of 348 nm, column temperature of 25 ℃ and flow rate of 1.0 mL · min -1 Sample size 10μL. RESULTS: The results showed that berberine hydrochloride has a good linear relationship (r = 0.999 1) with the content of berberine hydrochloride of 0.008 8 ~ 0.11 g · L-1, The recovery rate was 98.58% and RSD 1.05%. Conclusion: The TLC, HPLC and HPLC were used for the qualitative identification of Coptis chinensis, Rhubarb, and Pulsatilla, which were simple and easy to operate with good reproducibility and no interference with the negative control. The determination of berberine hydrochloride was simple, rapid, accurate and reproducible And recovery, can be used as quality control methods Huangzhi Zhili particles.