柴胡桂枝颗粒质量标准研究

Study on the quality standard of Chaihuguizhi Granules

目的:建立柴胡桂枝颗粒质量标准。方法:采用薄层色谱法对处方中的君药柴胡进行定性鉴别;采用高效液相色谱法,色谱柱为Welch Ultimate XB-C18(250×4.6 mm,5μm),流动相为甲醇-0.1%磷酸(47:53),流速1.0 mL?min-1,检测波长280 nm,柱温25℃,对处方中黄芩的有效成分黄芩苷进行含量测定。结果:本品中柴胡定性鉴别薄层色谱特征明显,专属性强;有效成分黄芩苷含量测定专属性强,稳定性、重复性好,平均回收率为100.15%,RSD为1.22%(n=6)。结论:该方法简便、准确、重复性好,可作为柴胡桂枝颗粒的质量控制。

Objective： To establish the quality standard of Chaihuguizhi Granules. Method： TLC was used to identify Chaihu in the prescription. HPLC method was used to carry out the determination. Welch Ultimate XB-C18 column（250×4.6mm, 5μm） was used, and mobile phase was methanol-0.1% phosphoric acid（47：53）. The flow rate was 1.0 mL.min-l,and detection wavelength was 280 nm. The column temperature was set at 25℃. Result： TLC Chromatogram were clear without the interference of the blank control. The average recovery of Baicalin in Scutellariae Radix were 100.15% with RSD of 1.22% （n=6）. Conclusion： The methods of identification and quantification are convenient, accurate and reproducibility. They can be used effectively for the quality control of Chaihuguizhi Granules.