基于UHPLC-LTQ-Orbitrap-MS化学成分和特征图谱的小儿肺热平胶囊质量评价

Quality evaluation of Xiao’er Feireping Capsules based on chemical constituents by UHPLC-LTQ-Orbitrap-MS and HPLC specific chromatogram

目的:分析儿童中药制剂小儿肺热平胶囊的化学成分并建立其特征图谱,整体分析该制剂质量。方法:采用超高液相色谱-线性子阱-静电轨道阱质谱联用(UHPLC-LTQ-Orbitrap-MS)技术,结合对照品比对以及相关文献查阅对小儿肺热平胶囊中的化学成分进行分析鉴别。采用HPLC-DAD法,以汉黄芩苷为参照色谱峰建立小儿肺热平胶囊特征图谱,同时使用SIMCA-P软件对小儿肺热平胶囊中的11个化学成分进行统计分析。结果:该方中共鉴别出36个化合物,包括黄连13个,黄芩11个,牛胆粉4个,平贝母3个,射干和甘草各2个,柴胡1个。建立了小儿肺热平胶囊特征图谱,确定11个共有特征峰,23批样品均能检出,且相对保留时间一致,但各批次样品相对峰面积差异较大。结论:小儿肺热平胶囊的内在质量差异较大,所建立的特征图谱-化学模式识别,能够较准确分析产品质量,为综合评价和控制产品质量提供参考。

OBJECTIVE To analyze the chemical constituents of Xiao’er Feireping Capsules, a traditional Chinese medicine preparation for children, and establish the specific chromatogram for the quality evaluation and control.METHODS The chemical constituents of Xiao’er Feireping Capsules were identified by UHPLC-LTQ-Orbitrap-MS,standards and related literatures.The specific chromatogram was established by HPLC-DAD with wogonoside as the reference chromatographic peak.And the mathematical statistics analysis of 11 chemical components was carried out by SIMCA-P software.RESULTS 36 chemical components were identified, 13 compounds from coptidis rhizoma, 11 compounds from scutellariae radix, 4 compounds from cattle bile powder, 3 compounds from fritillariae ussuriensis bulbus, 2 compounds from belamcandae rhizoma, 2 compounds from glycyrrhizae radix et rhizoma and 1 compound from bupleuri radix.The specific chromatogram of Xiao’er Feireping Capsules was established and 11 common characteristic peaks were detected in 23 batches of samples with consistent relative retention time.But the relative peak areas of each batch of samples varied greatly.CONCLUSION The internal quality of Xiao’er Feireping Capsules was quite different.The established specific chromatogram-chemical pattern recognition can accurately analyze the product quality and provide reference for comprehensive evaluation and control of product quality.