疏肝与胃颗粒质量标准研究.docVIP

疏肝与胃颗粒质量标准研究 　　【摘 要】 目的：建立疏肝和胃颗粒的质量标准。方法：采用薄层色谱对元胡、大黄、香附进行定性鉴别；采用高效液相色谱测定制剂中高良姜素的含量，色谱柱为inertsil C18（150mm×4-6mm，5μm）；流动相为甲醇-0-2%磷酸溶液（60∶ 40）；检测波长为266nm；柱温31℃，理论塔板数按高良姜素计算应不低于6000。结果：薄层色谱斑点清晰，分离度良好，阴性无干扰，专属性强，重复性良好；高良姜素在0-081～1-62μg/ml（r=0-9999）区间内线性关系良好，平均回收率为97-93%，RSD为1-18%。结论：本方法方便、可靠、准确，可用于疏肝和胃颗粒的质量控制。 　　【关键词】 疏肝和胃颗粒；质量标准；高良姜素；薄层色谱；高效液相色谱 　　【中图分类号】R286-0 【文献标志码】 A 【文章编号】1007-8517（2015）18-0014-03 　　Research on the Quality Standard of Shugan Hewei Granules 　　MAO Heping ZOU Ganpeng LIU Guangbin* 　　Department of Pharmacy，jiugang Hospital，Jiayuguan 735100，China 　　Abstract：ObjectiveTo formulate the quality standard for Shugan Hewei granules.MethodsThe qualities of Yuanhu（Rhizoma Corydalis yanhusuo W.T.Wang），Dahuang（Radix et Rhizoma Rhei）and Xiangfu（Rhizoma Cyperus rotundus I）in the granules were identified by microscopic examination；Thenatures of Yuanhu， Dahuang and xiangfu were detected by layer chromatography（TLC）and the contents of it measured by HPLC were inertsil C18 column，（15mm×4-6mm，5μm）、methanol-0-2% H3PO4=60/40，v/v， as mobile phase，0-8ml/min as flow speed and wavelength 266nm. Results The result objectived by microscopy were obvious；The TLC spots developed were clear with efficient separating ability，which were negative noninterferencs with the characterstics of high specificity and satisfactory reproducibility；The linear relation between psoralen among 0-081μg/ml-1-62μg/ml（r=0-9999）was excellent；The average recoveries of psoralen and isopsoralen were 97-93% （RSD=1-18%，n=6）respectively。ConclusionTLC and HPLC are handy，safe and accurate for Shugan Hewei granules todetermine the quality。 　　Keywords：Shugan Hewei Granules；Quality Standard；Galangin；TLC；HPLC 　　疏肝和胃颗粒是酒钢医院的医院制剂，由高良姜、香附、白芍等7味药物组成，具有疏肝理气、温中和胃、控酸止痛之功效，临床常用于治疗肝胃失和所致的胃脘痛。研究采用薄层色谱法对元胡、大黄、香附进行鉴别，采用高效液相法（HPLC）测定高良姜素的含量，为全面有效控制疏肝和胃颗粒的质量提供实验依据。 　　1 仪器与材料 　　1-1 仪器 岛津LC-15C高效液相色谱仪（SPD-15C紫外检测器，LC solution15C色谱工作站）；分析天平（Sartorious）。 　　1-2 材料 高良姜素对照品（批号：111699-200501）、延胡索乙素对照品（批号：0726-200107）、大黄酸对照