参花胶囊质量标准的研究

Study on Quality Standards for Shenhua Capsules

摘要:

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Ⅱ_A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Ⅱ_A在0.03~0.64 μg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。

Abstract:

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.