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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。
Objective To establish the quality control method of Qiju Shangqing Pill (Da Mi Pill). Methods TLC was used to qualitatively identify Radix Paeoniae Alba, Chrysanthemum, Gardenia jasminoides and Rhizoma Coptidis. The content of baicalin in the preparation was determined by high performance liquid chromatography. Results TLC showed a clear color and the negative control did not interfere. Baicalin has a good linear relationship in the range of 0.004 96-0.248 mg.mL-1, with an average recovery of 96.6% and RSD of 1.1%. Conclusion This method is simple, accurate and reproducible. It can be used for quality control of Qiju Shangqing Pill (Da Mi Pill).