乳疾宁片质量标准研究

Study on the Quality Standard of Rujining Tablets

目的:建立乳疾宁片的质量控制方法。方法:采用薄层色谱法对方中当归、赤芍进行定性鉴别;采用高效液相色谱法测定样品中阿魏酸的含量。色谱条件:色谱柱为Hypersil ODS2 C_(18)柱(150 mm×4.6 mm,5μm);流动相:乙腈-2%醋酸液=(12:88);流速:1 ml·min^(-1);柱温:室温;检测波长:323nm。结果:薄层定性鉴别的斑点清晰,分离效果良好;阿魏酸含量在1.15～36.80μg·ml^(-1)范围内线性关系良好(r=0.999 9),平均加样回收率为98.50%,RSD为0.79%(n=6)。结论:本试验简单易行,结果准确,重复性好,可作为该制刺的质量控制标准。

Objective：To establish the quality standaid lor Rujining tablets.Method：Radix Angelica？ Sinensis and Radix Paeoniae Rubra were identified by TLC.The ferulic acid in Rujining tablets was determined by IIPLC.A Hypersil ODS2 C_（18）（150 mm×4.6 mm,5μm） column wad used.The mobile phase consisted of aretonitrile-2%glacial acetic acid（12：88） with a flow rate of 1.0 ml ？ min^（-1）.The detection wavelength was set at 323 nm under room temperature.Result：The spots in TLC were clear,and ferulic acid showed a good linearity within the range of 1.15-36.80μg ？ ml（r =0.999 9）.The average recovery was 98.50%with RS/） of 0.79%（n =6）.Conclusion：The method is simple and accurate with good repeatability,and can be used in the quality control of Rujining tablets.