芫花药材质量标准研究

Study on quality specifications of Flos Genkwa

目的:对17批芫花药材样品进行定性定量试验研究,提高芫花药材质量标准。方法:采用薄层色谱法鉴别芫花药材中芫花素成分;以高效液相色谱法测定其含量并制定限度要求,色谱柱为 Kromasil C_(18)(4.6 mm×250 mm,5 μm),流动相为甲醇-水-冰醋酸(65:35:0.5),流速为0.8 mL·min^(-1),柱温为40℃,检测波长为338 nm。结果:芫花药材中芫花素的薄层色谱鉴别特征明显,专属性强;芫花药材中芫花素的含量测定线性范围为0.086～0.432 μg(r=0.9998),平均回收率(n=5)为100.4%(RSD=2.4%),测得芫花药材中芫花素含量不低于0.2%。结论:本方法简单准确地对芫化药材的有效成分芜花素进行定性定量测定,为提高芫花药材的质控方法提供了实验数据,对于保证其质量和临床疗效具有重要的意义。

Objective：To develop a technical reference for the establishment of quality control of Flos Genkwa. Method ：Genkwanin was identified by TLC in Flos Genkwa. Its content was determined by HPLC, Kromasil C18 （4. 6 mm × 250 mm,5 μm） was used. The mobile phase was methanol - water - glacial acetic acid （65 ： 35 ： 0.5 ） at a flow rate of 0. 8 mL · min^-1. The column temperature was 40 ℃ and the detection wavelength was 338 nm. Results：The linear range of genkwanin was 0. 086 -0. 432 μg（r =0. 9998）. The average recovery was 100. 4% with RSD 2. 4% （n =5 ）. The content of genkwanin should be equal or over 0. 2% in Flos Genkwa by this HPLC method. Conclusion：This method is simple ,accurate with good reproducibility. It is suitable for quality control of Flos Genkwa.