Abstract: AIM:To study the pharmacokinetics of chlorogenic acid with a single and multiple doses of Mailuoning injection in healthy volunteers. METHODS: The concentration of chlorogenic acid in plasma was determined by LC/MS/MS after a single and multiple doses of Mailuoning injection via intravenous guttae (ivgtt) to 10 healthy volunteers. The concentrationtime curves were simulated by Drug And Statistic software (1. 0) and the pharmacokinetic parameters were calculated. RESULTS: After a single and multiple injections, the concentration-time curves of chlorogenic acid were consistent with the two-compartment model. The pharmacokinetic parameters after a single injection were as follows: C_max (252 ±66) μg/L, t_1/2β (1. 35 ± 0. 53) h, V(0. 70 ±0. 24) L/kg, CL(0. 37 ±0.10) L·kg^-1·h^-1, AUC_0-tn (404 ±110) μg·L^-1·h. The pharmacokinetic parameters after multiple injections were as follows: C_max (262 ±87) μg/L, t_1/2β (1. 37 ± 0. 27) h, V(0. 68 ±0. 24) L/kg, CL(0. 34 ±0.11) L·kg^-1·h^-1, AUC_0-tn (455 ±151) μg·L^-1·h. CONCLUSION: There were no significant differences on the pharmacokinetic parameters of chlorogenic acid after a single and multiple injections in healthy volunteers, there were no accumulations with multiple injections and no differences of physiological disposition between the male and female for chlorogenic acid.

Key words: Mailuoning injection, pharmacokinetics, LC/MS/MS