目的建立HPLC法测定丹参药材水溶性成分的指纹图谱标准,确定指纹对照品对照法的作用,实现丹参药材指纹图谱标准的重现与易控.方法采用C18色谱柱,甲醇-1.0%冰醋酸溶液梯度程序洗脱,体积流量为1.0mL/min.以丹参对照药材制备指纹对照品进行色谱系统适用性试验,考察梯度洗脱程序、流动相酸度以及色谱柱填充剂对指纹图谱重现性的影响.结果建立的指纹图谱测定系统,对丹参水溶性成分分离良好,选择色谱图中15个特征峰作为指纹峰.将不同产地的10批药材的指纹图谱与同时测定的指纹对照品图谱进行比较,结果即使改变色谱柱填充剂也可以获得一致的相似性评价结论.结论色谱指纹图谱可以体现药材中多个成分的信息,但色谱系统的变化对指纹图谱的重现性有很大的影响,而且在不同的色谱柱条件下所得的指纹图谱结果不尽相同.因而为了实现指纹图谱标准的重复可控,应同时规定指纹图谱测定的色谱系统适用性条件和指纹对照品.

Objective To establish a stable and reliable HPLC method and fingerprint reference substance for the measurement of the fingerprint。the practical quality control，and assay of the water—soluble components of Salvia rniltiorrhiza．Methods The HPLC was run on C18 columns with methanol一1．0％glacial acetic acid solution as mobile phase in gradient elution mode at 8 flow rate of 1．0 mL/min．The chromatographic system suitability，the gradient elution mode，mobile phase acidity，and the effect of column type on fingerprint repeatability were tested．Results The HPLC fingerprints of the water—soluble extract of reference S．miltiorrhiza were obtained with very good resolution under the established chromatographic system．Fifteen peaks in the chromatograms were selected for the fingerprint identification and quality control of S miltiorrhiza．The quality of ten batches of S．miltiorrhiza samples from different hibitats were assessed by comparing their chromatographic fingerprints with the reference fingerprints obtained at the same time，and the similarity showed no difference，eventhough the column filler was changed．Conclusion Because the inherent complexity of medicinal material components has been reflected by chromatographic fingerprints，there are many factors affecting the fingerprint repeatability for the changes of column type．The Results of the quality assessment of S．miltiorrhiza· using fingerprints from different columns，are not all coincidence．In order to obtain the comparable and repeatable Results in different laboratories，it is much practical with both a defined chromatographic system suitability and a fingerprint reference substance．