绒草清带片质量标准研究

Study on quality standard for Rongcao Qingdai tablets

目的:建立绒草清带片的定性定量方法。方法:采用 TLC 法对处方中秦皮、赤芍、香附进行了定性鉴别;采用 HPLC 法,色谱柱:Shim-pack(岛津)C_(18)(150 mm×4.6 mm,5μm),以乙腈-0.1%磷酸水(每100 mL 磷酸水中加0.1 g 十二烷基硫酸钠)(46:54)为流动相,检测波长为265 nm,流速1 mL·min^(-1),柱温25℃,进样量10μL,对方中关黄柏所含小檗碱进行含量测定。结果:绒草清带片中秦皮、赤芍、香附薄层色谱鉴别特征明显,专属性强;绒草清带片中小檗碱的含量测定线性范围为0.09～0.45μg(r=0.9999),平均回收率为99.8%(RSD=0.96%,n=5)。结论:薄层色谱鉴别和含量测定方法准确可行,重复性好,可有效地控制绒草清带片的质量。

Objective ： To study the quality standard of Rongcao Qingdai tablets. Methods： TLC was used to identify Cortex Fraxini, Radix Paeoniae Rubra, Rhizoma Cyperi, and the content of berberine in Cortex Phellodendri Amurensis of the tablets was determined by HPLC, Shim - pack （ SHIMADZU ） C18 column （ 150mm×4.6mm,5μm） was used. The mobile phase was acetonitrile -0. 1% phosphoric acid （0. 1 g SDS was dissolved in 100 mL phosphoric acid ） （45： 55） ,the detection wavelength was at 265 nm,column temperature at 25℃. the flow rate was 1 mL·min^-1, and the injection volume was 10 μL. Results：The linear range of berberine was 0. 09 -0. 45 pug. The average recovery was 99. 8% with RSD 0. 96% （n = 5 ）. Conclusion：The method is simple. The result is accurate and the reproducibility is good. It can be used as the quality control methods for Rongcao Qingdai tablets.