Ge Ai-Hua, Li Jin, Donnapee Sineeporn, Bai Yang, Liu Jiao, He Jun, Liu Er-Wei, Kang Li-Yuan, Gao Xiu-Mei, Chang Yan-Xu
Tianjin Key Laboratory of Phytochemistry and Pharmaceutical Analysis, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
J Food Drug Anal. 2015 Jun;23(2):267-278. doi: 10.1016/j.jfda.2014.10.013. Epub 2014 Dec 18.
A method with few markers to determine multicomponents was established and validated to evaluate the quality of Shenfu injection by ultraperformance liquid chromatography coupled with a photodiode array detector. The separations were performed on an ACQUITY UPLC BEH C (2.1 × 50 mm, 1.7 μm) column. Methanol and 0.1% formic acid aqueous solution were used as the mobile phase. The flow rate was 0.3 mL/min. 2 aconitum alkaloids and 12 ginsenosides could be perfectly separated within 15 minutes. Ginsenoside Rg and benzoylmesaconine, the easily available active components, were employed as the maker components to calculate the relative correction factors of other components in Shenfu injection, Panax ginseng and Aconitum carmichaeli. The external standard method was also established to validate the feasibility of the method with few markers to determine multicomponents. Parameter p and the principal component analysis method were employed to investigate the disparities among batches for the effective quality control of Shenfu injection. The results demonstrated that the ultraperformance liquid chromatography coupled with a photodiode array detector method with few markers to determine multicomponents could be used as a powerful tool for the quality evaluation of traditional Chinese medicines and their preparations.
建立了一种采用较少标志物测定多成分的方法,并通过超高效液相色谱-光电二极管阵列检测器联用技术对参附注射液的质量进行了验证。分离在ACQUITY UPLC BEH C(2.1×50mm,1.7μm)色谱柱上进行。以甲醇和0.1%甲酸水溶液作为流动相。流速为0.3mL/min。2种乌头生物碱和12种人参皂苷可在15分钟内完美分离。以人参皂苷Rg和苯甲酰新乌头原碱这两种易于获得的活性成分作为标志物成分,计算参附注射液、人参和附子中其他成分的相对校正因子。还建立了外标法来验证采用较少标志物测定多成分方法的可行性。采用参数p和主成分分析法研究批次间差异,以实现参附注射液的有效质量控制。结果表明,超高效液相色谱-光电二极管阵列检测器联用技术采用较少标志物测定多成分的方法可作为中药及其制剂质量评价的有力工具。