「生薬エキス製剤の製造販売承認申請に係るガイダンス」を踏まえたケイヒ末単味製剤における指標成分及び定量法の設定に関する検討

抄録

Cinnamon Bark (“Keihi”) is an important crude drug used in Kampo-medicine. Recently, powdered cinnamon bark formulation was approved as an “efficacious treatment for dry mouth, thirst, and diabetes,” and it became possible to commercialize the product as an over-the-counter (OTC) agent. To obtain this approval, the examination of quality control-related characteristics is necessary and, so, we considered developing a testing method. Therefore, we established a quantitative method for (E)-cinnamic acid and coumarin determination. In particular, it is important to establish a quantitative method for coumarin because its association with hepatic injury is a concern.