当归补血颗粒的质量标准研究

摘要

In order to establish the quality detection standard of Danggui Buxue Keli,ligustilide,the effective constituent of Angelica sinensis in the prescription,was identified by thin-layer chromatography (TLC), and the method of HPLC for the detection of ferulic acide,astragaloside,the effective constituents of An-gelica sinensis and Astragalus membranaceus was studied.The results showed that the dots of TLC were clear,separation degree was good,specificity was strong.The ferulic acid had a good linearity in the range of 0.502 μg/mL-20.06 μg/mL(R2=0.999 5),the precision RSD of 3 concentrations of ferulic acid was no more than 1.5%,repeatability test RSD was 0.63%,stability test RSD was 0.93%,the average recovery rate was 98.21%.The negative control had no interference,the specificity was good.The astragaloside had a good linearity in the range of 0.401 μg/mL-8.016 μg/mL(R2=0.999 2),the precision RSD of 3 concentra-tions of astragaloside was no more than 1.5%,repeatability test RSD was 1.76%,stability test RSD was 1. 66%,the average recovery rate was 97.68%.The negative control had no interference,the specificity was good.The detection method established in this study is simple,accurate,specific and reproducible,which can effectively control the quality of Danggui Buxue Keli.%为了建立当归补血颗粒的质量检测标准,采用薄层色谱法(TLC)对组方药物当归有效成分藁本内酯进行鉴别,采用高效液相色谱法(HPLC)分别对组方药当归中的阿魏酸和黄芪中的有效成分黄芪甲苷进行含量测定.结果表明,藁本内酯薄层色谱斑点清晰,分离度好,特异性强;阿魏酸浓度在0.502 μg/mL~20.06 μg/mL范围内与峰面积呈良好的线性关系(R2=0.9995),3种浓度阿魏酸对照品精密度 RSD均不大于1.5%,重复性试验RSD为0.63%,稳定性试验RSD为0.93%,加样回收率平均为98.21%,色谱图中阴性对照无干扰,专属性良好.黄芪甲苷浓度在0.401 μg/mL~8.016 μg/mL 范围内与峰面积呈良好的线性关系(R2=0.9992),3种浓度黄芪甲苷对照品精密度RSD均不大于1.5%,重复性试验RSD为1.76%,稳定性试验RSD为1.66%,加样回收率平均为97.68%,色谱图中阴性对照无干扰,专属性良好.说明建立的检测方法简便、准确、专属性强、重复性好,可对当归补血颗粒的质量进行有效控制.