2023 Volume 77 Issue 2 Pages 69-75
In order to search for maker compounds to evaluate the bioequivalence of Kampo formulations, a clinical trial was conducted of 20 patients who received Kakkonto formulation and decoction. Five compounds were set as measurement targets, and it was possible to measure the plasma concentration transition of puerarin (PU) derived from pueraria root, and glycyrrhizic acid derived from glycyrrhiza. PU met the bioequivalence criteria for the 90% confidence interval in the difference between the mean logarithmic values of AUC24 and Cmax. On the other hand, in the present results, the power to detect the difference in Cmax of PU may be insufficient, and the blood sampling time of 24 hours may also be insufficient. Thus, it was considered necessary to examine the design (number of subjects and blood sampling time) of the clinical trial.
In this study, the possibility of utilizing PU, which is a compound contained in pueraria root, as a marker compound of bioequivalence was shown. In the three Kampo formulas that contain pueraria root among the currently approved ethical Kampo formulations, an evaluation of the bioequivalence of PU as a marker compound was expected to lead to additional dosage forms of ethical Kampo formulations. In addition, similar to PU, other C-glycoside compounds may also serve as marker compounds for evaluating bioequivalence.
