The relation between clinical effects of Tokishakuyakusan and the identity of Paeonia lactiflora materials.
OBJECTIVE
To investigate the relation between the clinical effects and the quality of crude drugs, we focused on Tokishakuyakusan (TS), consisted of 6 crude drugs.


METHODS
We prepared two kinds of TS containing either medicinal cultivar of Paeonia lactiflora (MTS) or ornamental one (OTS). Other components were the same. First, we assessed the clinical effects of two TS formulations by cross-over study among the anemia patients. Second, we investigated the chemical differences between them by using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Mössbauer analysis.


RESULTS
The clinical effects of these formulations (3 g/day for 8 weeks) were tested in the cross-over study consisted of 12 women patients who were diagnosed as having anemia (Hb ≤ 11 g/dl) and consented to participate to this study. Both TS formulations were effective for anemia symptoms as shown by the improvement of several hematological parameters, whereas their comprehensive effects were distinguishable by Genetic Algorithm Partial Least Squares (GA-PLS) analysis. There were no significant differences in organic ingredients and Fe content measured by ultra performance liquid chromatography (UPLC) and ICP-MS, respectively. Interestingly, Mössbauer spectra of Fe ion were remarkably different between two formulations. Fe ion in MTS was only one form, but that in OTS was at least two forms.


CONCLUSIONS
This study suggested that clinical effects of TS formulation reflect the quality of Paeoniae Radix.
Shimada
Kayoko
K
Graduate School of Pharmaceutical Sciences, Osaka University, 1-6, Yamada-oka, Suita, Osaka 565-0871, Japan. k-simada@phs.osaka-u.ac.jp
Kawase
Masaya
M
Shibahara
Naotoshi
N
Nakamura
Yuto
Y
Saito
Tadashi
T
Takahashi
Kyoko
K
D000740:Anemia / Q000188:drug therapy*; D018592:Cross-Over Studies; D004365:Drugs, Chinese Herbal / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007501:Iron / Q000032:analysis; D029596:Paeonia / Q000737:chemistry*; D008517:Phytotherapy; D015204:Spectroscopy, Mossbauer
D004365:Drugs, Chinese Herbal; C413220:toki-shakuyaku-san; D007501:Iron