康媛颗粒质量标准研究

Study on Quality Standard for Kangyuan Granula

目的建立康媛颗粒的质量标准。方法采用薄层色谱法对处方中黄芪、白芍、枸杞子和干草进行鉴别;用高效液相色谱法测定制剂中芍药苷的含量,采用AichromBond-AQ-C18色谱柱(4.6mm×150mm,5μm),流动相:水-乙腈(85∶15),检测波长为230nm,柱温30℃,流速1mL/min。结果薄层色谱专属性强;芍药苷的线性范围为0.0545～0.545μg,r=0.9995,平均加样回收率为97.90%,RSD=1.06%(n=6)。结论该方法简便、准确,重现性好,可作为康媛颗粒的质量控制标准。

Objective To establish the quality standard for Kangyuan Granula. Methods Radix Astragali, Radix Paeoniae Alba, Fructus Lycii and Radix et Rhizoma Glycyrrhizae in this prescription were identified by TLC. The content of the Paeonifiorin was determined by HPLC. The column of AichromBond-AQ-Cls （4.6 mm× 150 mm, 5 μm） was used, the mobile phase was Water-Acetonitrile （85 ： 15）, at the flow of 1.0 mL/mm, the column temperature of 30 ℃, and peaks were detected at 230 nm. Results The characteristic of identification by TLC was distinct and highly specific. The linear range of Paeonifiorin was 0.0545-0.545 μg, r=0.999 5, the average recovery was 97.90%, RSD=1.06% （n=6）. Conclusion The method was easy to operate with accurate result and good reproducibility. It can be used effectively for the quality control of this preparation. ~wor~： Kangyuan Granula： Paeonifiorin： HPLC： TLC： quality standard