复方丹参片指纹图谱及含量测定研究

HPLC fingerprint and determination of its main components of Compound Danshen Tablet

目的:建立复方丹参片(丹参、三七、冰片)的HPLC指纹图谱,同法同时测定丹参酮ⅡA的含量。方法:采用HPLC法测定不同批次复方丹参片脂溶性成分的指纹图谱及主要成分的含量,并用生成的对照指纹图谱对复方丹参片进行检测。结果:通过对10批复方丹参片的化学成分指纹图谱的分析,以中位数法模拟了复方丹参片的对照指纹图谱,通过"中药色谱指纹图谱相似度评价系统2004A版",计算出10批复方丹参片指纹图谱相似度均在0.9以上。结论:该方法准确可靠,重复性好,简单快捷,为更好地控制复方丹参片内在质量提供科学依据。

AIM： The method of HPLC was established for the analysis of fingerprint of Compound Danshen Tablet （Radix et Rhizoma Salvial miltiorrhizal, Radix et Rhizoma Notoginseng, Borneolum Syntheticum ） and the determination of its main components. METHODS： The fingerprint chromatograms of liposoluble constituents of Compound Danshen Tablet were set up and its main components of 10 batches were determined. RESULTS： The fingerprint chromatograms were simulated with mean method and the analysis of different batches of Compound Danshen Tablet was made after the analysis of the fingerprint chromatograms from different groups of Compound Dansh- en Tablet. The similarities which were proved to be higher than 0.99 were calculated with the help of The Similarity Calculation Soft of Fingerprint Chromatography of Traditional Chinese Medicin. CONCLUSION： This method is accurate and provides a scientific basis for controlling the quality of Compound Danshen Tablet.