芪蛭通络胶囊的质量标准研究

Study on Quality Standard of Qizhi Tongluo Capsule

目的建立芪蛭通络胶囊的质量标准。方法采用薄层色谱法鉴别方中土鳖虫、肉桂、冰片及制何首乌;采用高效液相色谱法对丹参中丹参素和赤芍中芍药苷进行含量测定。结果在薄层色谱中可检出土鳖虫、肉桂、冰片、制何首乌的特征斑点,阴性对照无干扰;丹参素钠在0.1633～3.2666μg范围内线性关系良好(r=1.0000),平均加样回收率为102.53%(RSD=1.48%,n=6);芍药苷在0.1012～2.0240μg范围内线性关系良好(r=1.0000),平均加样回收率为99.55%(RSD=1.75%,n=6)。结论所建立的方法能准确可靠的进行定性、定量检测,重复性好,可作为芪蛭通络胶囊的质量控制标准。

Objective To establish the quality standard for Qizhi Tongluo Capsule（QTC）.Methods TLC method was used to identify Eupolyphaga seu Steleophaga,Cortex Cinnamomi,Borneolum Syntheicum,and Radix Polygoni Multiflori Praeparata.HPLC method was used to determine the danshensu in Radix Salviae Miltiorrhizae and the paeoniflorin in Radix Paeoniae Rubra.Results The specific spots of these drugs were presented clearly by TLC,without interference of the negative control.Sodium danshensu showed a good linear relationship in the range of 0.1633-3.2666 μg,and the average recovery was 102.53 %（RSD=1.48 %,n=6）.Paeoniflorin showed a good linear relationship in the range of 0.1012-2.0240 μg,and the average recovery was 99.55 %（RSD=1.75 %,n=6）.Conclusion The method is accurate and reliable,and with good reproducibility,which can be used as quality control standard of Qizhi Tongluo Capsule.