兰花颗粒质量标准研究

目的建立兰花颗粒的质量标准。方法采用薄层色谱法(TLC)鉴别本制剂中的板蓝根、大青叶和忍冬藤;采用高效液相色谱法(HPLC)测定制剂中(R,S)-告依春的含量,色谱柱为Spursil C18(250mm×4.6mm,5μm);流动相为甲醇-水(7∶93);检测波长为245nm。结果在选定的薄层色谱条件下,斑点显色清晰,分离效果良好。(R,S)-告依春质量浓度在0.30~2.12μg·mL~(-1)内呈良好的线性关系(r=0.999 7);平均回收率为87.5%,RSD为1.0%(n=9)。结论该方法专属性强、重复性好、简便可行,可用于兰花颗粒的质量控制。

Study on the quality standard of Lanhua Granules

Objective To establish the quality standard of Lanhua Granules .Methods Radix isatidis ,Foliumi isatidis and Caulis lonicerae stem in Lanhua Granules were identified qualitatively by TLC .The content of (R ,S)‐goitrin in the preparation was deter‐mined by HPLC .The chromatographic column was Spursil C18 (250 mm × 4 .6 mm ,5μm) ,with methanol‐water(7∶93) as the mo‐bile phase ,detection wavelength at 245 nm .Results Under the selected TLC conditions ,the spots were clear ,and the separation effect was good .(R ,S)‐goitrin showed a good linear relationship in the range of 0 .30‐2 .12 μg · mL -1 with r=0 .999 7 ,and the average recovery was 87 .5% with RSD 1 .0% (n=9) .Conclusion The method is specific ,repeatable and simple ,and can be used for the quality control of Lanhua Granules .