复方丹参片中丹参酮ⅡA含量测定方法改进

Improvement of Determination Method of Tanshinone Ⅱ A in Fufang Danshen Tablets

目的对复方丹参片中丹参酮ⅡA含量测定方法改进的研究分析。方法在《中国药典》HPLC测定方法的基础上,采用改变流动相的配比关系,并与中国药典方法进行比较。结果改进后的方法测定丹参酮ⅡA含量,色谱峰峰形好,丹参酮ⅡA主峰和其它峰分离度及拖尾因子,符合要求;同时对不同厂家三个批次的复方丹参片测定,结果表明没有显著性差异。结论改进后的方法重现性好,测定结果准确可靠,缩短检测时间和减少流动相溶剂,降低检验成本。

Objective To analyze the contrast of determination of TanshinoneⅡA In Fufang Danshen tablets between pharmacopoeia method and improvement of determination method.Methods To change the mobile phase into CH3OH：water（80：20） and make a distinction between pharmacopoeia method and improvement of determination method on base of pharmacopoeia method.Results Chromatogram peaks and peaks shape of improvement of determination method were better.The separate rate and temporize rate of TanshinoneⅡA peak and other peaks was in accordance with require.The result of determination of 3 batches different pharmaceutical factories were notability discrepancy（P0.05）.Conclusion Using the determination improvement of determination method may save time and decrease solvent of mobile phase.The improvement of determination method is valuable substitute.