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目的研究建立十三味消炎灵颗粒的质量标准。方法采用TLC法对制剂中的板蓝根、连翘、大青叶、陈皮和紫花地丁进行定性鉴别,采用HPLC法分别测定(R,S)-告依春和连翘苷的含量。结果 TLC鉴别板蓝根、连翘、大青叶、陈皮和紫花地丁色谱特征明显、灵敏度高。(R,S)-告依春、连翘苷的质量浓度分别在0.5020~20.0799μg·ml-1、0.0201~0.8032mg·ml-1范围内与各峰面积积分值呈良好的线性关系(r=1.0000);(R,S)-告依春、连翘苷的加样回收率分别为99.60%、99.96%;RSD分别为1.25%、1.41%(n=3)。结论建立的定性定量方法可作为十三味消炎灵颗粒的质量检测标准,从而用于其质量控制。
Objective To establish the quality standards of Shisanwei Xiaoyanling granules. Methods TLC method was used to qualitatively identify Radix Isatidis, Forsythia suspense, Folium Isatidis, Citrus rehmanniae and Viola yedoensis, and the content of (R, S) Results TLC identification Radix, Forsythia, Folium, Citrus and Viola have obvious chromatographic characteristics, high sensitivity. (R, S) -supehenchun, the concentration of forsythin in the range of 0.5020 ~ 20.0799μg · ml-1, 1.0201 ~ 0.8032mg · ml-1 and the peak area integral showed a good linear relationship (r = 1.0000). The recoveries of (F, S) -phenanthrene and forsythin were 99.60% and 99.96%, respectively; RSD was 1.25% and 1.41% respectively (n = 3). Conclusion The established qualitative and quantitative method can be used as the quality test standard of Shisanwei Xiaoyanling granules for its quality control.