芎菊上清丸质量标准研究

The Quality Standards Study of Xiongju Shangqing Pills

摘要: 目的建立芎菊上清丸（大蜜丸）质量控制方法。方法采用薄层色谱法对制剂中的白芷、菊花、栀子、黄连进行定性鉴别；采用高效液相色谱法测定制剂中黄芩苷的含量。结果薄层色谱显色清晰且阴性对照无干扰。黄芩苷在0.004 96～-0.248 mg·mL-1内呈良好的线性关系，平均回收率为96.6%，RSD= 1.1%。结论本法操作简便，结果准确、重复性好，可用于芎菊上清丸（大蜜丸）的质量控制。

Abstract: OBJECTIVE To develop a method of quality control for Xiongju Shangqing pills. METHODS Radix Angelicae Dahuricae, Flos Chrysanthemi, Fructus Gardeniae and Rhizoma Coptidis were identified by TLC. HPLC was used for the determination of baicalin. RESULTS The chromatographic spots were identified without the interference of negative control. Baicalin had a good linearity over the concentration range of 0.004 96-0.248 mg·mL-1, the average recoveries was 96.6% with relatively standard deviations of 1.1%. CONCLUSION This method was found to be reliable, accurate and specific, it can be used for the quality control of Xiongju Shangqing pills.