Araliae Continentalis Radix Lab Report

The average contents (±SD) of kaurenoic acid in the Araliae Continentalis Radix extract powder were estimated as 1.147±0.008 mg in 1.0054 g, usual dose of Araliae Continentalis Radix.

Quantification of kaurenoic acid
UPLC–MS/MS has been emerging as a powerful analytical technique for the determination of analyte in biological samples to improve sensitivity and selectivity. Herein, we developed a simple, selective, and sensitive bioanalytical UPLC-MS/MS method for the quantification of kaurenoic acid after the oral administration of Aralia Continentalis Radix extract powder in humans. Prior to this study, Gasparetto et al. (2015) attempted to determine kaurenoic acid and coumarin metabolites in human after the oral administration of guaco
The typical linear regression equation of calibration curve was y = (0.15222 ± 0.01135)x + (0.00614 ± 0.01223) for kaurenoic acid by the plotting the peak area ratio (y) of kaurenoic acid to IS versus the nominal concentration (x) of kaurenoic acid with weighted (1/x2). The developed UPLC-MS/MS analysis in our study provided LLOQ, which were sufficient for further PK study after the oral administration of Araliae Continentalis Radix extract powder in humans.
Tables 1 and 2 summarize the intra- and inter-batch precision, and accuracy and the stability for kaurenoic acid under various conditions. The CVs of precision were within the 10.55% for QC samples, and the results of intra- and inter-batch accuracy ranged from 94.07 to 102.90%. The detected concentration for five replicates at low and high concentrations deviated within ±14.65%, demonstrating that kaurenoic acid was stable in the human plasma at room temperature for 8 h, at −80 °C for 3 months, after three freeze and thaw cycles and at 10 °C in the autosampler for 6 h after the preparation procedure.
The extraction recoveries of kaurenoic acid from human plasma was 95.1±5.4%, and the recovery of IS was 93.4±9.8%. This simple LLE method was successfully applied to the determination of kaurenoic acid in the human plasma after the
The compatibility of each PK model based on AIC, condition numbers, count of minimization iteration, et cetera was compared for the investigation of the best optimized PK model. Among the simulated PK models including one- and two-compartment model and with/without lag time, the model of two-compartment first-order absorption with lag time was decided, because of its significantly low AIC, condition numbers, and count of the minimization iteration comparing with another models. The plasma concentration–time curve of kaurenoic acid described by the two-compartment model first-order absorption with lag time is illustrated in Fig. 4. The mean parameters were 24.09 L/h , 42.31 L, and 52.66 ng∙h/mL for CL/F, V1/F, and AUC0-∞,. The mean t1/2 was 1.22 h. The estimated PK parameters of kaurenoic acid including CL/F, V1, t1/2, AUC0-∞, Cmax, Tmax, Tlag, Ka are listed in Table 3. The value of the PK parameters was described with CVs, and the evaluated PKs of karenoic acid from this phase I trial could be helpful to the population PK analysis of kaurenoic