冠心静片质量标准研究

Study on Quality Criteria of Guanxinjing Tablet

关键词:  冠心静片  TCL  HPLC  原儿茶醛

Key words:  Guanxingjing tablet  TCLi HPLC  Protoctechualdehyde

摘要:

[目的]建立冠心静片质量控制方法。[方法]采用薄层层析色谱法(TCL)对处方中的川芎、冰片、苏合香进行定性鉴别;采用高效液相色谱(HPLC)法测定方中原儿茶醛的含量。[结果]定性鉴别分离度好,专属性强;原儿茶醛的质量在19～190ng(r=0.9999)范围内与峰面积呈良好的线性关系,加样回收率为98.0%。[结论]所建立的方法对处方中3味药材能准确、快速地进行定性、定量检测,可用于冠心静片的质量控制。

Abstract:

[Objective] To establish the quality criteria of Guanxinjing Tablet.[Methods] The nature differentiation of Rhizoma Chuanxiong,Borneolum,Styrax were determined by TLC method and content of Protoctechualdehyde in Guanxinjing Tablet was determined by HPLC method.[Results] The nature differentiation separate degree was kind and special attribute was strong.The linearly was obtained over the range of 19～190 ng (r=0.999 9) and the average recovery rate was 98.0%.[Conclusions] The method was simple,convenient and accurate.The sensitivity was high.It can be used in the quality control of Guanxingjing Tablet.