Determination of β- d -glucan and endotoxin levels in Kampo extracts : β- d -glucan and endotoxin in Kampo extracts

Aims Kampo medicine is based on the use of established formulations combining natural extracts with no “brand-name” products or corresponding “generic” formulation. Due to differences in manufacturing practices, products of different pharmaceutical companies may contain different concentrations of β-d-glucan and endotoxins. The aim of this study was to compare the concentrations of β-d-glucan and endotoxins in five Kampo extracts from four pharmaceutical companies. Methods Packages of Kampo extracts were dissolved in distilled water. β-d-Glucan and endotoxin concentrations were measured using high-sensitivity kinetic turbidimetric Limulus assay. Results All Kampo extracts examined in this study were found to contain detectable concentrations of β-d-glucan and endotoxins. Significant differences in the concentration of β-d-glucan and endotoxins (P = 0.0024 and P = 0.0013, respectively) were observed between products of different pharmaceutical companies. Conclusions High β-d-glucan and endotoxin contents were detected in Kampo extracts, with a large variability in the concentrations of both β-d-glucan and endotoxins among extracts from different pharmaceutical companies.