[关键词]
[摘要]
一测多评法(quantitative analysis of multi-components by single marker,QAMS)已成熟应用于中药材、中药提取物及中成药领域等中药复杂体系的质量评价研究中,有效解决了因对照品缺乏而导致的多指标质控技术推广难问题。本文查阅近五年的国内外研究文献,重点总结了高效液相色谱、气相色谱和质谱等技术在QAMS法中药质量控制中的应用。高效液相色谱联用紫外检测器(UV)技术应用最为广泛,最适合于中药QAMS法定量,结果稳定、准确;而高效液相色谱联用蒸发光检测器在中药QAMS法应用中,其测定准确性和适用性仍然需进一步探索和验证。液质联用技术虽然具有灵敏度高、线性范围宽等优点,但易受仪器参数、基质效应等的影响。进一步发展HPLC-UV技术在中成药制剂质量评价中的应用,是QAMS法多成分定量值得关注的方向;探索LC-MS和GC技术在中药QAMS质量评价中的稳定性和普适性是未来将面临的挑战。
[Key word]
[Abstract]
Quantitative analysis of multi-components by single marker (QAMS) is a novel and rational method for quality control of botanical products, traditional Chinese medicines (TCMs) and Chinese patent drug. In this review, advances in these methods including high performance liquid chromatography combined with ultraviolet detector (HPLC-UV), LC-mass spectrometry (LC-MS) and gas chromatography (GC) is summarized in order to provide scientific basis for the application of QAMS in quality control of TCM. HPLC-UV is considered as the most suitable method for QAMS due to its stable and accurate results, while the accuracy of QAMS method using HPLC combined with evaporative light-scattering detector (HPLC-ELSD) should be developed. LC-MS has the advantages of high sensitivity and wide linear range, but it is easily affected by instrument parameters and matrix effect. Thus, a series of future improvements for quality evaluation of Chinese patent medicine using QAMS based on HPLC-UV are proposed. In addition, the stability and universality of LC-MS and GC technology applied in QAMS quality evaluation of TCMs should be explored.
[中图分类号]
R2-03
[基金项目]
国家自然科学基金青年基金(81603289);国家自然科学基金青年基金(816003251)