金嗓散结丸质量标准的研究

Quality standard for Jinsangsanjie pill

目的建立金嗓散结丸的质量标准。方法采用薄层色谱法对处方中蒲公英、玄参、桃仁、醋莪术进行定性鉴别;并用HPLC法对处方中丹参酮ⅡA进行含量测定。结果薄层色谱法定性鉴别专属性强。丹参酮ⅡA在0.112-0.560μg/ml的范围内呈良好的线性关系(r=1),加样回收率为98.75%,RSD为0.36%(n=6)。结论所建立的方法准确可靠,灵敏度高,专属性强,可更有效地控制金嗓散结丸的质量。

Objective To establish the quality standard for Jinsangsanjie pill.Methods Semen Pruni Persicae,Taraxacum Weber,Radix scrophulariae,Vinegar backed Rhizoma Curcuma in Jinsangsanjie pill were identified by thin layer chromatography（TLC）.Content of Tanshinone ⅡA in the pill was determined by HPLC method.Results The qualitative determination showed a strong specificity.The quantitative evaluation of tanshinone ⅡA showed a linear relationship in the range of 0.112-0.560 μg/ml.The average recovery was 98.75% and RSD was 0.36%（n=6）.Conclusion The established method is reliable,accurate and specific.It can be used for the quality control of Jinsangsanjie pill.