鼻炎灵丸质量标准的研究

Quality Standard of Biyanling Pill

摘要:

目的: 提高完善鼻炎灵丸的质量标准。 方法: 采用薄层色谱法对制剂中苍耳子、辛夷、薄荷、细辛4味药材进行定性鉴别,采用C₁₈柱,流动相甲醇-水-磷酸 (47∶53∶0.2),检测波长278 nm测定样品中黄芩苷的含量。 结果: 薄层鉴别的色谱斑点清晰,阴性对照无干扰;黄芩苷的线性范围在0.125 6~2.198 μg呈良好的线性关系(r=0.999 9),平均加样回收率98.05%,RSD 1.66%,精密度和重复性均良好。 结论: 该方法操作简便,重复性好,专属性强,可以用于鼻炎灵丸的质量控制。

Abstract:

Objective:To establish a method for quality control of Biyanling Pill. Method: Cocklebur fruit,Flos magnoliae liliflorae, Mentha haplocalyx and Asarum were identified by TLC, and the content of baicalin in pills was determined by HPLC with C₁₈ column and the mobile phase consisted of methanol-water-phosphoric acid solution (47∶53∶0.2). Detection wavelength was set at 278 nm. Result: Cocklebur fruit, Flos magnoliae liliflorae, Mentha haplocalyx and Asarum could be identified by TLC. The calibration curves of baicalin was in a good linearity in the range of 0.125 6-2.198 μg (r=0.999 9). The average recovery rate was 98.05% with RSD of 1.66% (n=6). Conclusion: The method is simple, accurate and can be applied to the quality control of Biyanling Pill.