和肝利胆胶囊的质量标准研究

Quality standard for Hegan Lidan capsule

目的建立和肝利胆胶囊的质量标准。方法采用薄层层析对制剂中黄芩、栀子、枳壳进行定性鉴别；采用高效液相色谱法对制剂中山柰素和槲皮素进行含量测定。结果薄层层析可鉴别出黄芩、栀子、枳壳；山柰素和槲皮素分别在0．00688～0．0516μg，0．008～0．06μg范围内呈良好的线性关系，r分别为0．9994和0．9992，平均回收率分别为97．8％和97．3％，RSD分别为1．6％和1．3％。结论本文建立的方法简便、快捷，重现性好，可用于该制荆的质量控制。

Objective To establish the quality standard for Hegan Lidan capsule. Methods Scutellariae radix, Gardeniae fructus and Aurantiifructus were qualitatively identified by TLC. Rhamnoluteun and quercetin were determined by HPLC. Results TLC could be used to identify Scutellariae radix, Gardeniae fructus and Aurantii fructus. The calibration curves were linear in the range of 0. 00688 - 0. 0516μg for rhamnoluteun （ r = 0. 9994） ,0. 008 - 0. 06 μg for quercetin （ r = 0. 9992 ）. The average recoveries were 97.8 % （ RSD 1.6% ） in rhamnoluteun,97.3% （RSD 1.3% ） in quercetin. Conclusion The established methods are simple,quick and reprodciable, which could be used for the quality control of Hegan Lidan capsule.