局外生規2022新規収載単味生薬エキスの確認試験及び定量法の設定について

抄録

To promote the effective utilization and quality control of single crude drug extract products, the “Application guidance for OTC of (non-Kampo) single crude drug extract products” was published by the Ministry of Health, Labour and Welfare of Japan in December 2015. For further expansion of this guidance, we previously reported the standardization of three single crude drug extracts, which were listed in Non-JP Crude Drug Standards (Non-JPS) 2018. In this study, we report the designed and verified methods for the identification tests and assay of six single crude drug extracts, i.e. Ginseng Extract (1), Red Ginseng Extract (2), Polygala Root Extract (3), Bupleurum Root Extract (4), Peony Root Extract (5), and Citrus Unshiu Peel Extract (6), which were newly listed in Non-JPS 2022, published in March 2022.

Ginsenoside Rg₁ was selected as the marker compound (MC) of 1 and 2 for the identification test by TLC, and ginsenoside Rg₁ and ginsenoside Rb₁ were selected as the MCs of 1 and 2 for the assay by HPLC. Tenuifolin and 3,6’-di-O-sinapoylsucrose were selected as the MCs of 3 for the identification test by TLC and the assay by HPLC, respectively. Saikosaponins a and c were selected as the MCs of 4 for the identification test by TLC. Saikosaponin b₂ was selected as the MC of 4 for the assay using HPLC. Paeoniflorin was selected as the MC of 5 for the identification test using TLC and the assay using HPLC. Hesperidin and narirutin were selected as the MCs of 6 for the identification test using HPLC and hesperidin was selected as the MC of 6 for the assay using HPLC.