参白浓缩丸质量标准研究

Studies on Qualitative and Quantitative Methods of Shenbai Concentrated Pills

目的:研究建立参白浓缩丸的质量标准。方法:采用薄层色谱法分别对参白浓缩丸中的丹参和苦参进行了定性鉴别,采用HPLC法对制剂中的主要有效成分黄芪甲苷和芍药苷进行了含量测定。结果:参白浓缩丸中丹参和苦参的薄层色谱鉴别斑点清晰,分离较好,阴性对照无干扰。HPLC含量测定结果显示,黄芪甲苷的平均加样回收率为100.82%(RSD为1.73%),精密度RSD为2.79%,重复性RSD为1.48%,稳定性RSD为1.44%;芍药苷的平均加样回收率为99.83%(RSD为2.34%),精密度RSD为2.25%,重复性RSD为2.16%,稳定性RSD为1.60%。结论:所建立的方法简便准确,分离度高,专属性强,重复性好,可有效控制参白浓缩丸的质量。

Objective：To study the qualitative and quantitative methods of Shenbai concentrated pills. Methods： Danshen root and lightyellow sophora root in Shenbai concentrated pills were identified with the method of TLC. The contents of astragaloside Ⅳ and paeoniflorin were determined with the method of HPLC. Results： For TLC, the spots of the two herbal drugs were well separated and without interference. Quantitative analysis of HPLC showed that the average recovery of astragaloside Ⅳ was 100.82% （RSD1.73%） with the RSD values of precision, repeatability and stability tests were 2.79 %, 1.48 % and 1.44%, respectively; and the average recovery of paeoniflorin was 99.83 % （RSD2.34%） with the RSD values of precision, repeataibility and stability tests were 2.25%, 2.16% and 1.60%, respectively. Conclusions： The methods set up by this study are accurate and easy to perform with the merits of good resolution, specificity and reproducibility. It could effectively control the quality of Shenbai concentrated pills.