葛根湯エキス製剤及び湯剤の同等性に関する研究（III）

抄録

As previously reported (Horii C., et al., Shoyakugaku Zasshi, 68 (1), 9-12 (2014), Shoyakugaku Zasshi, 69 (2), 59-65 (2015), Shoyakugaku Zasshi, 68 (2), 65-69 (2014), Shoyakugaku Zasshi, 73 (2), 73-83 (2019), and Shoyakugaku Zasshi, 74 (1), 46-57 (2020)), we investigated the bioequivalence of the decoctions and extract preparations of Kakkonto, Shoseiryuto and Hachimijiogan, demonstrating that some components may serve as marker compounds for the evaluation of bioequivalence. Of them, ephedrine and pseudoephedrine contained in the Ephedra Herba might serve as the most effective marker compounds for examining the bioequivalence between the decoction and the extract preparation in an increased number of subjects.

The present study examined the bioequivalence between the decoction and the extract preparation of Kakkonto by comparing the plasma concentrations of the components of the decoction of Kakkonto and Kracie Kakkonto extract fine granules, prepared with the same crude drug, as test and control drugs, respectively, after administration to 20 human subjects. As a result, the decoction and the extract preparation showed no significant difference in the plasma concentrations, maximum plasma concentrations (C_max), or areas under the plasma concentration versus time curve (AUC_24 h) at any blood sampling time. As the 90% confidence interval of the difference in the mean logarithmic values of the C_max and AUC_24 h of ephedrine and pseudoephedrine between the decoction and the extract preparation were within the range of log (0.80) to log (1.25) (criterion for bioequivalence), a statistical power (1-β) was employed. As a result, the C_max and AUC_24 h in ephedrine and pseudoephedrine had sufficient power (more than 80%), suggesting that the bioequivalence of the decoction and extract preparation of Kakkonto can be evaluated using ephedrine and pseudoephedrine as marker compounds.