升血小板片质量标准

Study on Quality Standards of Shengxue Xiaoban Tablets

目的:建立升血小板片的质量标准。方法:采用TLC鉴别青黛、连翘、牡丹皮,以靛玉红为定量指标,通过RP-HPLC测定靛玉红含量,采用Discovery C18色谱柱(4.6 mm×200 mm,5μm),流动相甲醇-0.1 mol.L-1乙酸铵溶液-乙酸(80∶20∶1),检测波长290 nm。结果:TLC鉴别表明阴性对照均无干扰;靛玉红线性范围0.010 95～0.394 2μg(r=0.999 8),平均加样回收率97.4%,RSD 0.7%。结论:建立的质量标准方法简便、准确,可用于升血小板片的质量控制。

Objective： To establish quality standards of Shengxue Xiaoban tablets.Method： TLC was adopted to identify Indigo Naturalis,Forsythiae Fructus and Moutan Cortex.Indirubin was as quantitative indicroe,whose content was determined by RP-HPLC,chromatography conditions were as follows： Discovery C18 column（4.6 mm × 200 mm,5 μm）,mobile phase of methanol-0.1 mol.L-1 ammonium acetate solution-acetic acid（80∶ 20∶ 1）,detection wavelength 290 nm.Result： TLC identification showed that negative controls were no interference;Linear range of indirubin was 0.010 95-0.394 2 μg（r = 0.999 8）,average recovery was 97.4% with RSD of 0.7%.Conclusion： This established method was simple and accurate which could be used to quality control of Shengxue Xiaoban tablets.