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

关键词:  归芎益母散  定性鉴别  盐酸水苏碱定量鉴别

Key words:  Guixiong Yimu powder  qualitative identification  Quantitative identification of Stachydrine Hydrochloride  

摘要:

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 (R²=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。

Abstract:

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 (R²=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.