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目的:对橘半枳术丸的质量控制方法进行研究,建立橘半枳术丸定性和定量检测方法。方法:采用薄层色谱法对制剂中的枳实、陈皮、白术进行定性鉴别;采用HPLC法测定黄芩中黄芩苷的含量,甲醇-水-磷酸(47∶53∶0.2)为流动相,流速为1.0 ml.min-1,柱温:40℃,检测波长为280 nm。结果:TLC鉴别法能特征鉴别枳实、陈皮和白术,斑点显色清晰,阴性样品无干扰。黄芩苷在0.078～1.561μg范围内线性关系良好,平均加样回收率99.9%,RSD为1.49%(n=6)。结论:本法操作简便、准确、重复性好,可用于该制剂的质量控制。
OBJECTIVE: To study the quality control method of orange half Zhizhu pill and to establish the qualitative and quantitative test method of orange half Zhizhu pill. Methods: TLC, TLC, Atractylodes macrocephala and Atractylodes macrocephala were identified qualitatively. The contents of baicalin in Scutellaria baicalensis Georgi were determined by HPLC. The mobile phase consisted of methanol - water - phosphoric acid (47:53:0.2) 1.0 ml.min-1, column temperature: 40 ℃, detection wavelength of 280 nm. Results: The method of TLC identification could distinguish the Fructus Aurantii Immaturus, Citrus aurantii and Atractylodes macrocephala, the spots were clear and the negative samples had no interference. The linearity of baicalin in the range of 0.078-1.561μg was good with an average recovery of 99.9% and a RSD of 1.49% (n = 6). Conclusion: This method is simple, accurate, reproducible and can be used for the quality control of this preparation.