Integrated identification, qualification and quantification strategy for pharmacokinetic profile study of Guizhi Fuling capsule in healthy volunteers

Autor: Guangji Wang, Yu Wang, Jiye Aa, Ke-Rong Zhang, Bingchen Ouyang, Jianguo Sun, Zhen-Zhong Wang, Xiaoliang Jin, Wei Xiao, Shiyin Gu, Ying Peng, Yunxi Zhong
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: Scientific Reports
ISSN: 2045-2322
Popis: Guizhi Fuling capsule (GZFL), a traditional Chinese medicine formulation, is widely used in China to relieve pain from dysmenorrhea and is now in a Phase II clinical trial in the USA. Due to the low exposure of the five main medicative ingredients (amygdalin, cinnamic acid, gallic acid, paeoniflorin and paeonol) of GZFL in human, a strategy was built to qualitatively and quantitatively identify the possible metabolites of GZFL and to describe the pharmacokinetic profiles of GZFL in human. In this strategy, LC-Q-TOF/MS was used to identify and structurally elucidate the possible metabolites of GZFL in vivo; and a time-based metabolite-confirming step (TBMCs) was used to confirm uncertain metabolites. The simultaneously quantitation results by LC-MS/MS showed low exposure of the five medicative ingredients. According to the strategy we built, a total of 36 metabolites were found and structurally elucidated. The simultaneously semi-quantitative analysis by LC-MS/MS showed that obvious time-concentration curves could be established for 12 of the metabolites and most of them showed a relatively higher exposure. This study provides a better understanding of the metabolic processes of GZFL in human.
Databáze: OpenAIRE