LC/MSによる漢方処方エキスの確認試験への応用 -抑肝散エキス-

抄録

Many monographs dealing with the identification of crude drugs and Kampo formulae listed in the Japanese Pharmacopoeia (JP) describe tests using thin-layer chromatography (TLC). TLC identification tests are simple and easy but may not be applicable to some crude drugs due to their low sensitivity, and the objective identification of crude drugs by TLC can be difficult due to poor resolution. In addition, analogue data are not suitable for archival purposes.

In this study, we attempted to develop an alternative identification test which addresses these shortcomings. We studied Yokukansan Extract as a model Kampo formula using high-performance liquid chromatography coupled with mass spectrometry (LC/MS). Ions were detected by electrospray ionization (ESI) in a single quadrupole mass spectrometer by selected-ion monitoring (SIM), allowing the identification of Yokukasan Extract components with high sensitivity. Furthermore, minor components in Poria, Angelica and Cnidium, which cannot be identified by TLC, were observed using this technique. We confirmed the specificity and robustness of the proposed method by validation tests.

Application of the proposed LC/MS (SIM) identification test to Kampo formulae may provide higher efficiency, objectivity and accuracy than conventional TLC methods.