目的：建立通脉丸的质量标准。方法：采用薄层色谱（TLC）法对制剂中丹参、当归、红花进行定性鉴别。采用高效液相色谱法测定制剂中阿魏酸的含量：色谱柱为Diamonsil C18，流动相为乙腈-0.1％磷酸（17∶83，V/V），流速为1 ml/min，检测波长为316 nm，柱温为30℃，进样量为10μl。结果：丹参、当归、红花TLC图斑点清晰，分离度好。阿魏酸检测质量浓度线性范围为8～80μg/ml（r＝0.9998）；精密度、稳定性、重复性试验的RSD＜2％；加样回收率为97.2％～99.6％（RSD＝1.2％，n＝6）。结论：该研究所建标准可用于通脉丸的质量控制。%OBJECTIVE:To establish the quality standard for Tongmai pill. METHODS:TLC was used for the qualitative iden-tification of Salvia miltiorrhiza,Angelica sinensis and Carthamus tinctorius. HPLC was used for the content determination of feru-lic acid. The column was Diamonsil C18 with mobile phase of acetonitrile-0.1% aqueous phosphoric acid (17∶83,V/V) at a flow rate of 1 ml/min,the detection wavelength was 316 nm,the column temperature was 30 ℃,and the injection volume was 10 μl.. RESULTS:The TLC of S. miltiorrhiza,A. sinensis and C. tinctorius showed clear spots and good separation. The linear range of ferulic acid was 8-80 μg/ml(r=0.999 8);RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was 97.2%-99.6%(RSD=1.2%,n=6). CONCLUSIONS:The standard can be used for the quality control of Tongmai pill.
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