参花胶囊质量标准的研究

Study on Quality Standards for Shenhua Capsules

目的：建立参花胶囊的质量标准。方法：采用TLC法对本方中的川芎、丹参进行定性鉴别;采用HPLC法对处方中主要成分丹参酮ⅡA进行含量测定。结果：薄层色谱斑点清晰,阴性对照无干扰。含量测定丹参酮ⅡA在0.03~0.64μg范围呈良好的线性关系,r=0.999 8,平均回收率99.57%,RSD为0.99%（n=6）。结论：所建立的方法可靠准确地进行定性、定量检测,可用于该制剂的质量控制。

Objective：To establish the quality standard for Shenhua capsules.Methods：The TLC method was used to identify Szechwan Lovage Rhizome and Danshen Root and the HPLC method was used to determine tanshinone Ⅱ_A in the preparation.Results：TLC spots clear and specific.A good linear relationship between peak areas and concentrations of tanshinoneⅡ_A was found at the range of 0.03～0.64 μg with a correlation coefficient of r=（0.999 8）.The average recovery of tanshinoneⅡ_A was 99.57% and RSD was 0.99%（n=6）.Conclusions：The method is reliable,accurate and specific.It can be used for the quality control of Shenhua Capsules.