Development of p-Coumaric Acid Analysis in Human Plasma and Its Clinical Application to PK/PD Study.

It has been recognized that p-Coumaric acid (p-CA) has protective effects as an antioxidant, anti-inflammatory agent. A sensitive and efficient Liquid Chromatography-Mass Spectrometry (LC-MS) method for maximum determination of p-CA in human plasma has been established using Ultra-performance liquid Chromatography-tandem mass Spectrometry (UPLC-MS/MS). This study provides the developed analysis of p-CA extracted from Bambusae Caulis in Taeniam (BC) to examine the improvement of the treatment p-CA, IGF-1 and Osteocalcin level in human children which are important factors on the growth of children's height through Pharmacokinetics/Pharmacodynamics (PK/PD) model. p-CA and internal standard in a plasma sample were detected by the Multiple Reaction Monitoring (MRM) scan mode with positive ion detection. The sample participating in the study was made of 34 subjects (placebo = 18, treatment = 16). The subjects were enrolled to be randomized to the control group and BC group. Randomized subjects took tested treatment twice a day, three capsules with oral administration (258 mg/capsule) each time after a meal. Standard calibration curves (reproducibility) were constructed and the lower limit of quantitation (LLOQ) for p-CA was found to be 0.2 ng/mL on injection of the sample into the UPLC-MS/MS system. Accuracy and precision were evaluated and the intra-accuracy was 99.2-103.8% with precision of 1.0-5.6% and inter-accuracy was 99.6-108.4% and precision of 1.3-6.4% for p-CA. The method has been successfully applied to PK/PD studies of p-CA in human plasma. The p-CA, BC in Taeniam extract increased the level of IGF-1 and Osteocalcin, and changed the height from baseline, which suggested that the p-CA could play an important role in longitudinal bone growth. Therefore, the p-CA extracted from BC in Taeniam might be a good alternative medicine to growth hormone (GH) therapy.

RCT Entities:   Population Interventions Outcomes