灯盏花素分散片质量标准研究

Study on Quality Standard of Breviscapine Dispersible Tablets

目的建立灯盏花素分散片的质量标准。方法采用薄层色谱法对灯盏花素分散片中野黄芩苷进行定性鉴别,建立灯盏花素分散片中焦袂康酸的限量检查方法,并采用高效液相色谱法对野黄芩苷进行含量测定。结果薄层色谱斑点清晰,专属性好;焦袂康酸对照品进样量在0.010 2～0.848μg范围内与峰面积线性关系良好(r=0.999 0),平均加样回收率为98.74%,RSD为0.92%(n=6);野黄芩苷对照品进样量在0.053～2.12μg范围内与峰面积线性关系良好(r=0.999 8),平均加样回收率为99.01%,RSD为1.11%(n=6)。结论所建立的方法准确简便、专属性强、重现性好,可以有效控制灯盏花素分散片的质量。

Objective To establish the quality standard for Breviscapine Dispersible Tablets.Methods TLC was used for the qualitative identification of scutellarin.The limit test method of pyromeconic acid in Breviscapine Dispersible Tablets was established and the HPLC method was adopted to determine the content of scutellarin.Results The TLC detection spots were clear with good specificity.The linear range of pyromeconic acid was 0.010 2-0.848 μg（ r = 0.999 0） with an average recovery rate of 98.74%,RSD = 0.92%（n = 6）. The linear range of scutellarin was 0.053-2.12 μg（ r = 0.999 8） with an average recovery rate of 99.01%（ RSD = 1.11%）. Conclusion The established methods are accurate and simple with strong specificity and good reproducibility,which can effectively control the quality of Breviscapine Dispersible Tablets.