学術雑誌論文 葛根湯エキス製剤および湯剤の同等性に関する研究(II)
Studies on Bioequivalence of Kakkonto Decoction and Its Extract Preparation (II)

堀井, 周文  ,  小此木, 明  ,  鎌倉, 浩之  ,  袴塚, 高志  ,  合田, 幸広  ,  Chikafumi, Horii  ,  Akira, Okonogi  ,  Hiroyuki, Kamakura  ,  Takashi, Hakamatsuka  ,  Yukihiro, Goda  ,  クラシエ製薬株式会社漢方研究所  ,  クラシエ製薬株式会社漢方研究所  ,  国立医薬品食品衛生研究所  ,  国立医薬品食品衛生研究所  ,  国立医薬品食品衛生研究所  ,  Kampo Research Laboratories, Kracie Pharma, Ltd.  ,  Kampo Research Laboratories, Kracie Pharma, Ltd.  ,  National Institute of Health Sciences  ,  National Institute of Health Sciences  ,  National Institute of Health Sciences

内容記述
In a previous report (Horii, C., et al., Shoyakugaku Zasshi, 68(1), 9-12, 2014), a crossover study was performed in order to obtain basic information about the bio-equivalence between the Kakkonto decoction and its extract product. The result suggested that ephedrine and pseudoephed-rine may be used as the marker compounds for the bio-equivalence judgment between preparations. In this study, we selected 3 components of the Kakkonto formula, Puerariae Radix, Glycyrrhizae Radix and Paeoniae Radix. The change in concentration of the five marker compounds, puerarin, daidzein, glycyrrhizic acid, liquiritin and paeoniflorin, in human blood plasma was observed after their oral administration. As a result, the dispersion of those plasma levels in the decoction and the product were observed at various sampling times. Variance analysis of the maximum plasma concentration (C_<max>) and the area under the plasma concentration-time curve (AUC_<0-4>) for the five marker compounds revealed no significant differences between the decoction and the product or between the administration days. The statistical power (1-β) was determined to be insufficient (less than 80%) for both C_<max>, and AUC_<0-4> on the five marker compounds. However, assuming that the standard deviation was the same as our result for puerarin and daidzein, when the number of the study participants is increased to 8 and 16 it is revealed that the statistical power become sufficient (more than 80%) for both C_<max> and AUC_<0-4> on puerarin and daidzein. Since puerarin and daidzein are known to be important biological active components in the Kakkonto formula, these results suggest that both compounds may be used as markers for a bio-equivalence judgment between preparations, although further study is needed to clarify this issue.
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