Wang Di, Li Qing, Liu Ran, Xu Huarong, Yin Yidi, Wang Yifan, Wang Huijia, Bi Kaishun
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China.
National and Local United Engineering Laboratory for Key Technology of Chinese Material Medical Quality Control, Shenyang Pharmaceutical University, Shenyang 110016, China.
J Pharm Anal. 2019 Dec;9(6):406-413. doi: 10.1016/j.jpha.2019.01.001. Epub 2019 Jan 2.
A sensitive, fast and comprehensive method for the quality assessment of (SZS) standard decoction with characterization of its chemical components was developed and validated. UPLC-Q/TOF-MS/MS system was used to identify thirty-six chemical components of SZS standard decoction which included nucleosides, phenolic acids, alkaloids, and flavonoids. Furthermore, a UPLC-PDA method was validated to simultaneously determine adenosine, protocatechuic acid, magnoflorine, catechin, protocatechin, vicenin II, spinosin, kaempferol-3-rutinoside, and 6'''-feruloylspinosin which represent four species of characteristic compounds. The qualitative method had been validated according to Chinese Pharmacopoeia (2015 edition) in terms of lineary, repeatability, recovery and stability for all analytes, with the results showing good precision, accuracy and stability. In conclusion, the method using UPLC combined with MS and PDA provided a novel way for the standardization and identification of SZS standard decoction, and also offered a basis for qualitative analysis and quality assessment of the preparations for SZS standard decoction.
建立并验证了一种灵敏、快速且全面的方法，用于对（SZS）标准汤剂进行质量评估并表征其化学成分。采用超高效液相色谱-四极杆/飞行时间串联质谱（UPLC-Q/TOF-MS/MS）系统鉴定了SZS标准汤剂中的36种化学成分，包括核苷、酚酸、生物碱和黄酮类化合物。此外，还验证了一种超高效液相色谱-光电二极管阵列检测法（UPLC-PDA），用于同时测定代表四种特征化合物的腺苷、原儿茶酸、木兰花碱、儿茶素、原儿茶素、异荭草苷、斯皮诺素、山柰酚-3-芸香糖苷和6'''-阿魏酰斯皮诺素。该定性方法已按照《中国药典》（2015年版）对所有分析物的线性、重复性、回收率和稳定性进行了验证，结果显示具有良好的精密度、准确性和稳定性。总之，采用UPLC结合MS和PDA的方法为SZS标准汤剂的标准化和鉴定提供了一种新途径，也为SZS标准汤剂制剂的定性分析和质量评估提供了依据。
