丹七滴丸的质量标准研究

Study on the quality standard of Danqidi pills

目的建立丹七滴丸中丹参、三七的定性和定量方法。方法采用TCL法对丹参、三七进行定性鉴别；采用十八烷基硅烷键合硅胶为填充剂（ZORBAXSB—C18），以甲醇-1％冰醋酸（10：90）为流动相，检测波长280nm测定丹参素钠含量；以乙腈-0．1％磷酸（22：78）为流动相，检测波长203nm测定三七皂苷R1含量。结果丹参、三七鉴别特征明显、专属性强、阴性无干扰；丹参素钠在0．4008～2．004μg范围内线性关系良好，平均回收率为97．08％；三七皂苷R1在1．0～5．0μg范围内线性关系良好，平均回收率98．58％。结论本鉴别和含量测定方法简单、快速、准确，可作为本品定性和定量的检测方法。

Objective To establish the quality control standard for quantitative and qualitative determination of Danqidi pills. Methods The TCL method was used for identification of Salviae Mihiorrhizae and Notoginseng in Danqidi pills. The content of sodium salvianic A and notoginsenoside R1 in Danqidi pills were determined respectivly by HPLC. A Zorbax SB - C18 column was used. The content of sodium salvianic A was determined with mobile phase consisting of methanol - 1% acetic acid （ 10：90） and the detection wavelength was at 280nm. The content of notoginsenoside R1 was determined with the mobile phase consisting of acetonitrile -0.1% phosphoric acid （22：78） and the detection wavelength was at 203nm. Results The TLC spots were highly clear without the interference of negative sample and were reproductive; A good linear relationship for sodium salvianic A was in the range of 0.4008 - 2.004μg, 1.0 -5.0μg for notoginsenoside R1; the average recovery were 97.11% for sodium salvianic A and 98.58% for notoginsenoside R1. Conclusion This method is simple, rapid and accurate,and can be used for the quantitatively and qualltitively determination of Danqidi pills.