舒肝散结片质量标准研究

摘要

目的 建立舒肝散结片的质量控制标准.方法 采用薄层色谱法鉴别方中的柴胡、白芍、当归、夏枯草,采用高效液相色谱法测定方中橙皮苷的含量.色谱条件为Phenomenex Gemini C1s柱(250 mm×4.6 mm,5μm),检测波长为284 nm,流动相为乙腈-0.1％磷酸溶液(17:83),流速为1.0 mL/min,柱温为室温,理论板数以橙皮苷峰计算不低于3000.结果 橙皮苷进样量在63.92 ～1 278.40 μg范围内与峰面积积分值线性关系良好,r=0.9999,平均回收率为98.73％,RSD为1.03％(n=9).结论 鉴别方法简便、专属性强,定量方法准确、重现性好,该质量标准可有效地控制舒肝散结片的质量.%Objective To establish the quality control standard of Shugansanjie Tablets.Methods TLC was adopted to identify Bupleuri Radix,Paeoniae Radix Alba,Angelicae Sinensis Radix and Prunellae Spica in this tablet preparation.HPLC was used to determine the content of hesperidin.The chromatographic conditions were as follows:the Phenomenex Gemini C1s column (250 mm×4.6 mm,5 μm),the detection wavelength of 284 nm,the mobile phase of acetonitrile-0.1％ phosphoric acid(17:83),the flow velocity of 1.0 mL/min,the room temperature as the column temperature and the theoretical plate number no less than 3 000.Results The linearity of hesperidin was obtained during the range of 63.92-1 278.40 μg,r =0.999 9.The average recovery rate of hesperidin was 98.73％with RSD of 1.03％ (n =9).Conclusion This identification method is simple and highly specific.The method of the quantitative determination is accurate with good reproducibility.The quality standard can effectively control the quality of Shugansanjie Tablets.