2020 年 74 巻 1 号 p. 20-34
In December 2015, the “Application guidance for OTC (non-Kampo) single crude drug extract products” was published by the Ministry of Health, Labour and Welfare (Japan) for the quality control of crude drugs. To further expand on this guidance, we designed and verified methods for the identification tests and assays of three single crude drug extracts: Epimedium Herb Extract (1), Uncaria Hook Extract (2), and Ginger Extract (3) specified in Non-JP Crude Drug Standards (Non-JPS) 2018. Magnoflorine and icariin were selected as the marker compounds of 1 for the identification test using TLC and the assay using HPLC, respectively, and [6]-gingerol was selected for both tests of 3. The marker compounds of 2 were total alkaloids for the identification test using filter paper and rhynchophylline and hirsutine for the assay using HPLC.
Based on the results from this study, we determined both identification tests and assays for these three single crude drug extracts listed in the Non-JPS 2018.