复方定志小丸正丁醇提部位的HPLC-ELSD指纹图谱研究

Studies on fingerprint chromatograms of n-butanol extracts of Fufang Dingzhi pills by HPLC-ELSD

目的：建立复方定志小丸正丁醇提部位的高效液相色谱-蒸发光散射检测（HPLC-ELSD）指纹图谱,为评价该制剂质量提供可靠方法。方法：采用Agilent Zorbax SB-C18色谱柱（4.6 mm×250 mm,5μm）,以0.05%醋酸水溶液为流动相A,乙腈（含0.05%冰醋酸）为流动相B,梯度洗脱（0～25 min,20%A→20%A;25～40 min,20%A→50%A;40～50 min;50%A→90%A）,柱温35℃,进样量10μL,蒸发光散射检测器采集数据;色谱图经＂中药色谱指纹图谱相似度评价系统＂（2004 A版）进行评价,建立共有模式图,评价相似性。结果：建立了定志小丸正丁醇提部位HPLC-ELSD的共有模式,确定17个共有峰,以共有模式对10批复方定志小丸进行评价,相似度均在0.95以上。结论：建立的指纹图谱具有较好的针对性,为定志小丸的质量控制提供依据。

Objective： To establish HPLC-ELSD fingerprint of n-butanol extract of Fufang Dingzhi pills,which provides a new approach to assessing the quality of this medicine. Methods： The Agilent Zorbax SB-C18column（ 4. 6 mm × 250 mm,5 μm） was adopted with the gradient elution solvent system composed of 0. 05% glacial acetic acid（ A）-acetonitrile containing 0. 05% glacial acetic acid（ B）（ 0-25 min,20% A→20% A; 25-40 min,20% A→50% A; 40-50 min; 50% A →90% A） as the mobile phase. The column temperature was set at 35 ℃. The sample size was 10 μL. An evaporative light scattering detector was used to detect ingredients. The chromatogram data of ten batches of Fufang Dingzhi pills were analyzed by ＂Similarity Evaluation for Chromatographic Fingerprint of Traditional Chinese Medicine＂software（ 2004 version A）. The common pattern was established and the similarity was evaluated. Results： Seventeen characteristic peaks were selected in chromatograms, all of them were identified. Ten batches of samples were determined with the method,and their similarities were above 0. 95. Conclusion： The fingerprint is specific and can be used for comprehensive evaluation and quality control of Fufang Dingzhi pills.