2016 Volume 70 Issue 2 Pages 65-71
Extracts of Kampo formulations have been listed in the Japanese Pharmacopoeia since its 15th edition and their importance as pharmaceuticals is increasing, as is the recognition of the need to ensure the safety of them. The purity test for extracts of Kampo formulations includes tests for heavy metals and arsenic, but since the Heavy Metals Limit Test uses a colorimetric method, there is no specificity for individual metals. Meanwhile, with the development of highly sensitive instrumental analytical methods, it is now a trend worldwide to set standards for individual elements based on degree of hazard. Accordingly, the JKMA have investigated the amount of arsenic, cadmium, lead and mercury, which are significantly toxic, in the target 22 extracts of Kampo formulations manufactured by the member companies and listed in the 16th Edition of the Japanese Pharmacopoeia in 2012 and 2013. As a result, data were provided for 613 samples for arsenic and 524 samples for cadmium, lead and mercury, and all of them were confirmed to be below the criteria values indicated in the Japanese Pharmacopoeia and Hong Kong Chinese Materia Medica Standards.
