心可舒片的质量控制

Study on Quality Control of Xinkeshu Tablet

摘要: 目的建立心可舒片的质量控制方法。方法采用高效液相色谱法对山楂中黄酮类成分进行定性鉴别，对木香中主要成分木香烃内酯与去氢木香内酯进行定量测定。结果鉴别方法分离度良好；木香烃内酯和去氢木香内酯与相邻峰完全分离；线性关系良好，平均加样回收率(n=9)分别为99.99%(RSD=1.3%)和99.68%(RSD=1.1%)。结论该方法专属性强、准确度高、重复性好，可用于心可舒片的质量控制。

Abstract: OBJECTIVE To establish the method for quality control of Xinkeshu tablet. METHODS Compositions of flavonoids in Crataegi Fructus was identified by HPLC. Costunolide and dehydrocostus lactone in Aucklandiae Radix were determined by HPLC. RESULTS The resolution of identification method was favorable. Costunolide and dehydrocostus lactone were separated literally. The linear relationships of calibration curves were favorable. The average spotting recoveries(n=9) of costunolide and dehydrocostus lactone were 99.99%(RSD=1.3%) and 99.68%(RSD=1.1%). CONCLUSION The established methods have favorable specificity, accuracy and repeatability, and can be applied for quality control of Xinkeshu tablet.