中药制剂归芎益母散的质量标准研究

Study on the Quality Standard of Gui Xiong Yi Mu San

为了研究归芎益母散的质量标准,为控制产品质量做奠基。采用薄层色谱法对归芎益母散中的益母草、红花、当归、川芎定性鉴别研究、使用ELSD对盐酸水苏碱进行定量鉴别研究。定性鉴别结果图中,益母草、红花、当归、川芎的斑点清晰,专属性强;定量鉴别结果显示归芎益母散阴性对照无干扰,方法具有专一性。盐酸水苏碱在0.0507~0.8115 mg/mL(R 2=0.9996)的范围内与峰面积的外标对数呈良好的线性。加样回收率107.15%,RSD为1.90%。研究所建立的方法操作简单,重现性好,准确可靠,所建立的标准可以有效控制归芎益母散的质量。

To study the quality standard of Guixiong Yimu powder and lay a foundation for the quality control of the product.Leonurus Japonicus,Safflower,Angelica Sinensis and ligusticum Chuanxiong in Guixiong Yimusan were identified by Thin layer chromatography,and stachydrine hydrochloride was identified by ELSD.Results:the spots of Leonurus japonicus,safflower,Angelica Sinensis and ligusticum Chuanxiong were clear and the specificity was strong in the results of qualitative identification.Stachydrine hydrochloride showed a good linear relationship with the external standard logarithm of peak area in the range of 0.0507~0.8115 mg/mL(R 2=0.9996).The recovery was 107.15%,RSD was 1.90%.Conclusion:The method established in this study is simple,reproducible,accurate and reliable,the established standard can effectively control the quality of Guixiong Yimu powder.