参七复脉片质量控制标准的研究及确定

Quality control standard for shenqifumai tablet

目的研究并制定参七复脉片的质量控制标准。方法采用薄层鉴别法定性鉴别处方中的麦冬和太白三七;采用高效液相色谱法测定处方中凤尾三七的主要成分红景天苷的含量。结果定性鉴别分离度好,专属性强;红景天苷在0.518～3.626μg范围内呈良好的线性关系,相关系数r2=0.999 8,加样回收率为97.67%(RSD为0.87%)。结论所建立之方法准确可靠、灵敏度高、专属性强,可用于参七复脉片的质量控制。

Objective To establish the quality standard for Shenqifumai tablet. Methods Ophiopogon japonicus and Tonglolosa silaifolia Wolff in the formulation of Shenqifumai tablet were indtified by thin layer chromatography（TLC）;and the content of salidroside in the tablets was determined by high performance liquid chromatography（HPLC）. Results The characteristic identification by TLC was distinct and highly specific（RSD=0.87%）. Conclusion The method of TLC was reliable,accurate and specific.It can be used for the quality control of shenqifumai tablets.