Establishment of Quantitative Method and Examination of Characteristic Constituents for Quality Control of Powdered Cinnamon Bark Formulation. Based on “Guidance on Approval Application of Manufacture and Sales of Crude Drug Extracts”

Abstract

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.