今日药学

2017, v.27(01) 13-16

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双丹片质量标准研究
Study on TLC identification and HPLC determination of Shuangdan Tablets

王秀芹;吕渭升;林彤;
WANG Xiuqin;LV Weisheng;LIN Tong;Guangzhou Institute for Drug Control;

摘要(Abstract):

目的建立双丹片的质量控制方法。方法采用薄层色谱法(TLC)对双丹片中丹参和牡丹皮2味药材进行定性鉴别;采用高效液相色谱(HPLC)法同时测定丹参素、丹酚酸B和丹皮酚3种成分含量。结果在TLC色谱中可检出丹参、牡丹皮的特征斑点,斑点清晰可见,易于观察;丹参素在0.73~10.95μg范围内进样量与其峰面积线性关系良好(r=1.000 0),平均加样回收率为96.5%,RSD=1.0%(n=6);丹酚酸B在0.37~5.55μg范围内进样量与其峰面积线性关系良好(r=1.000 0),平均加样回收率为98.6%,RSD为1.3%(n=6);丹皮酚在0.30~4.44μg范围内进样量与其峰面积线性关系良好(r=0.999 9),平均加样回收率为100.1%,RSD为1.6%(n=6)。结论该方法可以同时测定双丹片中3种特征性成分,方法简便、准确、稳定且无干扰,可作为双丹片的质量控制方法。
OBJECTIVE To establish the quality standard of Shuangdan Tablets. METHODS The Cortex Moutan and Salvia miltiorrhiza were identified by TLC. The content of Danshensu,Salvianolic acid B and Paeonol were determined by HPLC. RESULTS Cortex Moutan and Salvia miltiorrhiza could be identified by TLC,and the TLC spots of the constituents were fairly clear. Danshensu,Salvianolic acid B and Paeonol showed a good linear relationship at a range of 0.73-10.95 μg( r = 1.000 0),0.37-5.55 μg( r = 1.000 0),0.30-4.44 μg( r = 0.999 9),respectively.The average recovery rates of Salvianic acid A sodium,Salvianolic acid B and Paeonol were96.5%,98. 6%,100. 1% respectively with RSD value of 1. 0%,1. 3% and 1. 6%,individually. CONCLUSION Three characteristic components can be detected simultaneously by the revised method,which is simple,accurate,reliable,reproducible,and can be used as quality control standard of Shuangdan Tablets.

关键词(KeyWords): 双丹片;丹参素;丹酚酸B;丹皮酚;薄层鉴别;高效液相色谱法
shuangdan tablets;danshensu;salvianolic acid B;paeonol;TLC identification;HPLC

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作者(Author): 王秀芹;吕渭升;林彤;
WANG Xiuqin;LV Weisheng;LIN Tong;Guangzhou Institute for Drug Control;

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