枳黄利胆颗粒质量标准的研究

Quality Standard of Zhihuanglidan Granules

目的对枳黄利胆颗粒建立有效的质量控制方法。方法采用薄层色谱法对枳实、大黄、黄芩、白芍进行定性研究;采用高效液相色谱法,以甲醇-0.1%磷酸溶液(三乙胺调pH值6.0),(55∶45)为流动相,检测波长为280nm,采用Phenomenex C18分析柱(4.6mm×250mm×5μm),测定方中延胡索乙素的含量。结果薄层色谱斑点清晰,空白对照无干扰。延胡索乙素在进样量508.8～2544.0μg范围内线性良好,平均回收率为97.74%,相对标准差(RSD)为1.01%。结论所建立的方法简便、快速、准确,可有效地控制枳黄利胆颗粒的质量。

ObjectiveTo establish a method for the quality control of Zhihuanglidan granules. Methods Fructus Aurantii Immaturus, Radix et Rhizoma Rhei, Radix Scutellariae and Radix Paeoniae Alba in Zhihuanglidan granules were identified by thin-layer chromatography. The Tetrahydropalmatine was determined by HPLC. The Phenomenex C18（4. 6 mm × 250 mm, 5 μm） column, methanol-0. 1% phosphoric acid （with pH value adjusted to 6. 0 with triethylamine） （55： 45） was adopted as the mobile phase, and the detective wavelength was at UV 280 nm. Results The chromatographic spots were clear, without interference and easy to recognize. The calibraction curve was linear within 508.8 -2544.0 ng of paeoniflorin. The average recovery and RSD of Tetrahydropalmatine were 97.74% and 1.01%, respectively. Conclusion The method can be adopted for the quality control of Zhihuanglidan granules, and the determination method of Tetrahydropalmatine is simple, rapid, and accurate.