Pharmacokinetics and Toxicity Study of a Single Intravenous Dose of Distilled Extract of Zanthoxylum piperitum in ICR Mice

This study aimed to investigate the pharmacokinetics and acute toxicity of a single intravenous dose of distilled Zanthoxylum piperitum (deZP) extract in ICR mice. The focus was on understanding the absorption, distribution, and elimination of Terpinen-4-ol, the major active component of deZP, as well as assessing its safety at the administered dose. ICR mice were administered a single intravenous dose of deZP (2.4 mg/kg), and plasma concentrations of Terpinen-4-ol were measured using LC-MS/MS at various time points. Pharmacokinetic parameters such as Cmax, Tmax, half-life, and clearance rate were calculated. In addition, clinical signs, mortality, and biochemical markers were monitored to evaluate acute toxicity. Terpinen-4-ol was rapidly absorbed, reaching a peak plasma concentration (Cmax) of 609.0 ng/mL within 0.083 hours (Tmax). It exhibited a short half-life of 0.168 hours and a high clearance rate of 194.1 L/h/kg. No mortality or significant clinical signs of toxicity were observed. Biochemical parameters, including liver and kidney function markers, remained within normal ranges, indicating that the administered dose was well-tolerated. The pharmacokinetic profile of deZP suggests rapid absorption and elimination of Terpinen-4-ol, while the toxicity assessment indicates good tolerability at the tested dose in ICR mice. These findings provide a foundation for further exploration of deZP's therapeutic potential.