枳黄利胆颗粒质量标准的研究Quality Standard of Zhihuanglidan Granules
卢伟玲
LU Wei-ling(Guangdong Medi-word Pharmaceutical Co.
摘要(Abstract)：
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.
关键词(KeyWords)：
枳黄利胆颗粒;质量标准;延胡索乙素;高效液相色谱法
Zhihuanglidan granules; quality specification; Tetrahydropalmatine; HPLC
基金项目(Foundation):
作者(Author):
卢伟玲
LU Wei-ling(Guangdong Medi-word Pharmaceutical Co.