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A validated LC-MS/MS method for the determination of hederasaponin C: Application to Pharmacokinetic-pharmacodynamic studies in the therapeutic area of acetic acid-induced ulcerative colitis in rats.

Hederasaponin C (HSC), one of the main components of pulsatilla chinensis, is considered as a potential drug for the treatment of inflammatory bowel disease. In the present research, we developed a PK-PD model to describe the concentration-effect course of drug action following intraperitoneal injection of HSC in colitis rats. A sensitive UPLC-MS/MS method was firstly established for the the determination of HSC in rat plasma to explore the pharmacokinetics properties. The separation was performed on an Accucore C18 column (2.1mm×100mm, 2.6μm) with the flow phase consisted of acetonitrile and 0.1% formic acid water. The assay method was validated and demonstrated good adaptability for application in the pharmacokinetic study. Then the levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) in colon tissues were measured by ELISA assay. The levels of TNF-α, IL-1β and IL-6 was decreased after HSC administration, suggesting that HSC can significantly improve the level of inflammatory syndrome factor. The pharmacokinetics study showed that the Tmax of HSC was 1 h. The concentration-effect curves showed hysteresis loop. And there has a hysteresis between the peaked concentration and the maximum effect of HSC. The present study established in vivo PK/PD models and the result showed a great potential of HSC for treating ulcerative colitis.