HPLC analysis of Juzen-taiho-to and its variant formulations and their antimetastatic efficacies

Our previous study demonstrated that the oral administration of Juzen-taiho -to resulted in a significant inhibition of the liver metastasis of colon 2 6-L5 cells as compared with the untreated control, without side effects. We attempted to investigate the relationship between the HPLC pattern (referr ed to as the fingerprint) of the formulation and its component crude drugs and the inhibition of tumor metastasis in order to obtain the optimal effic acy and constant quality of the formulation, Two Juzen-taiho-to formulation s (batches #1 and # 2),,which were individually prepared using the same 10 crude drugs and the same preparation procedure, showed similar anti-metasta tic effects and absorbance patterns by HPLC analysis. Some variant formulat ions of Juzen-taiho-to, in which one crude drug was substituted with other crude drugs from different sources or places of origin, exhibited reduced e fficacy as compared with the original formulation, as well as differences i n the fingerprint pattern compared with the original formulation. Juzen (Na imo-Ogi-Kibana-Ogi), a variant formulation with the substitution of Astraga li radix of a different origin and place of harvest, showed significant inh ibition of the liver metastasis of tumor cells and a HPLC fingerprint patte rn similar to that of the original formulation, Thus, HPLC fingerprint anal ysis of Kampo medicines may provide a useful basis for obtaining their opti mal efficacy as well as constant quality of the formulation, although it ha s some problems and limitations, such as detectability by and senitivity to UV absorbance.