Simultaneous determination of four components of Shuganning Injection in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study

KANG Ning-fang1 LI Mei1 HU He-jia1 XIAO Hong-qin1 LIU Li-qin1 LI Yin1 LI Yue-ting1 WANG Ai-min1 WANG Yong-lin1 ZHANG Yun2 HE Feng1 GONG Zi-peng1

(1.Provincial Key Laboratory of Pharmaceutics in Guizhou, State Key Laboratory of Functions and Applications of Medicinal Plants, Guizhou Provincial Engineering Research Center for the Development and Application of Ethnic Medicine and Traditional Chinese Medicine, School of Pharmacy, Guizhou Medical University, Guiyang, Guizhou, China 550004)
(2.Guizhou Ruihe Pharmaceutical Co., Ltd., Guiyang, Guizhou, China 550000)

【Abstract】This study aims to reveal the pharmacokinetics of Shuganning Injection in normal rats. In this experiment, ultra-high performance liquid chromatography-electrospray-tandem mass spectrometry (UPLC-ESI-MS/MS) was used to establish an analytical method for simultaneous determination of chlorogenic acid, gardenioside, oroxylin A and baicalin in rat plasma. Then, the non-compartmental model (NCA) in Phoenix WinNonLin 6.4 software was used to fit pharmacokinetic parameters. The methodological validation showed that the linear relationship of the components in rat plasma samples was good (r > 0.995). The recovery rate and matrix effect of plasma samples with low, middle and high concentration were 79.14%–101.4%. The intra-day and inter-day precision, accuracy and stability met the requirements of biological sample analysis. The half-life (t1/2) of chlorogenic acid, gardenioside, oroxylin A did not change significantly and the area under blood concentration-time curve (AUC0–t) was proportional to the dose, which suggested that three components showed a linear kinetic characteristics, but baicalin showed nonlinear kinetic characteristics. Moreover, the retention time of each component in rats was short. The established UPLC-MS/MS quantitative analysis method was rapid, sensitive and accurate, which can be used for the determination of chlorogenic acid, gardenioside, oroxylin A and baicalin in rat plasma and pharmacokinetic study of Shuganning Injection.

【Keywords】 Shuganning Injection; chlorogenic acid; gardenioside; oroxylin A; baicalin; pharmacokinetics;

【DOI】

【Funds】 Guizhou Province Science and Technology Plan Project [QKH (2016) No. 2850] Scientific and Technological Innovation Talent Team for Research on the Material Basis of the Efficacy of Ethnic Medicine in Guizhou Province/High-level Innovative Talent Training (Hundred-level) Project in Guizhou Province [QKHPTRC (2016) No. 5613/5677] Local Science and Technology Special Project Guided by the Central Government [QKZYD (2018) No. 4006] Guiyang Scientific Research and Innovation Team Project [ZKHT (2017) No. 30-29]

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(Translated by FU LJ)

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This Article

ISSN:1001-5302

CN:11-2272/R

Vol 45, No. 11, Pages 2626-2633

June 2020

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Article Outline

Abstract

  • 1 Materials
  • 2 Methods
  • 3 Results
  • 4 Discussion
  • References