藿香正气片质量标准研究

Study on Quality Standard for Huoxiangzhengqi Tablets

目的:建立藿香正气片质量控制标准。方法:采用薄层色谱法对处方中广藿香、厚朴、白芷、陈皮进行定性鉴别;采用Ve-nusil XBP C18(L)色谱柱(4.6 mm×250.0 mm,5μm);甲醇-4%冰醋酸水(3565)为流动相;流速1.0 mL.min-1,检测波长为284 nm,柱温30℃,对方中陈皮的有效成分橙皮苷进行含量测定。结果:本品中厚朴、陈皮、广藿香、白芷定性鉴别薄层色谱特征明显,专属性强;有效成分橙皮苷含量测定的平均回收率为99.8%,RSD为1.36%(n=6)。结论:该法简便、准确、专属性强,可作为藿香正气片的质量控制方法。

Objective：To establish the quality standard for Huoxiangzhengqi Tablets.Methods：To establish a method for the quality control of Herba Pogostemonis,Pericarpium Citri Reticulatae,Radix Angelicae Dahuricae in Huoxiangzhengqi Tablets were identified by TLC.A Venusil XBP C18（L） column（4.6 mm × 250 mm,5 μm） was used with the methanol-4%acetic acid as mobile phrase（3565）.The determination wavelength was set at 284 nm.The flow rate was 1.0 mL·min-1 at 30 ℃.Results：TLC plates were clear without the interference of the blank control.The average recovery rates of hesperiden were 99.8%,RSD=1.36%（n=6）.Conclusion：The methods of identification and quantification were easy accurate,realizableand reproducible.It can be used effectively for the quality control of Huoxiangzhengqi Tablets.