葛根湯エキス製剤および湯剤の同等性に関する研究(I)

概要

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In order to obtain basic information of the bio-equivalence between the Kakkonto decoction and its extract product, a crossover study was performed involving 6 healthy adult males as study participants randomly divided into 2 groups. The change of concentrations of the two marker compounds, ephedrine (E) and pseudoephedrine (PE), in human blood plasma was observed after their oral administration. As the results, no significant differences in the plasma levels between the decoction and the product were noted at any sampling times. Variance analysis of the maximum plasma concentration (C_<max>) and the area under the plasma concentration-time curve (AUC) on both E and PE revealed no significant differences between the decoction and the product or between the administration days. The statistical power (1-β) was determined to be sufficient (more than 80%) for both C_<max> and AUC on PE, but not on E. However, assuming that the standard deviation was the same as our result for E, when the number of the study participants is increased to 14 it is revealed that its statistical power become sufficient (more than 80%) for both C_<max> and AUC on E. Since E and PE are known to be important biologically active components in Kakkonto formula, these results suggest that E and PE may be used as the marker compounds for the bio-equivalence judgment between preparations, although further study is needed to clarify this issue.
2014-02-20