复方返魂草片质量标准研究

Study on Quality Standard for Compound Fanhuncao Tablets

目的:建立复方返魂草片的定性定量方法。方法:采用TLC法对处方中黄芩、返魂草进行了定性鉴别;采用HPLC法,色谱柱为Shim-pack(岛津)C_(18)(150×4.6mm,5μm),以乙睛-0.4%磷酸水(10:90)为流动相;检测波长为326nm,流速1 mL·min^(-1),柱温25℃,进样量10μL,对方中返魂草所含绿原酸进行了含量测定。结果:复方返魂草片中黄芩、返魂草薄层色谱鉴别特征明显,专属性强;复方返魂草片中绿原酸的含量测定线性范围为0.04μg～0.40μg(r=0.9999),平均回收率为99.35%(RSD=1.62%,n=6)。结论:薄层色谱鉴别和含量测定方法准确可行,重复性好,可有效地控制复方返魂草片的质量。

Objective:To study the quality standard of Compoundfanhuncao Tablets.Methods:TLC was used to identify Scutellaria baicalensis,Seheciocannabifolius less were identified the content of Chlorogenic acid in Seheciocannabifolius less in the tables was determined by HPLC,Shim-pack(SHIMADZU)C_(18) column(150×4.6mm,5μm)was used.The mobile phase was used.Acetonitrile-0.4%phosphoric acid(10:90),the detection wavelength was at 326nm,column temperature at 25℃.the flow rate was 1 mL·min^(-1),and the injection volume was 10μL.Results:The linear range of Chlorogenic acid was 0.04μg-0.40μg(r=0.9999).The average recovery was 99.35%with RSD 1.62%(n=6).Conclusion:The method is simple.The result is accurate and the reproducibility is good.It can be used as the quality control methods for Compoundfanhuncao Tablets.