According to the notification for definition of pharmaceuticals from the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health Labour and Welfare of Japan, the roots of Scutellaria baicalensis (Chinese skullcap) and S. lateriflora (skullcap) are classified as “the raw materials exclusively used as pharmaceuticals”, but their aerial parts are classified as “non-pharmaceuticals” so, in principle, there are no health claims for these materials and no descriptions of drug-like dosages or administration directions. Dried root of S. baicalensis is also registered in Japanese Pharmacopoeia XV as scutellaria root. Scutellaria root is considered to have the adverse drug reactions of interstitial pneumonia and drug-induced hepatopathy in kampo medicines (Japanese traditional herbal formulations), and baicalin, its major constituent, is considered to be the cause of the adverse reaction. This study was conducted to evaluate the validity of this borderline between pharmaceuticals and non-pharmaceuticals by analyzing the amounts of four flavonoids, including baicalin, in the roots, stems, and leaves of S. baicalensis and S. lateriflora, and in the commercial products herbal tea and dietary supplements prepared from S. lateriflora. These flavonoids were found in the root of S. baicalensis; its aerial parts, however, did not contain them. On the other hand, the amounts of those flavonoids in the aerial parts of S. lateriflora were larger than in the root. Herbal tea and dietary supplements of S. lateriflora obtained commercially also contained those flavonoids, and the dietary supplements contained amounts of them comparable with that in kampo medicine. These results suggest that classification that the aerial parts of S. lateriflora as non-pharmaceuticals in Japan needs reconsideration.
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We are grateful to Dr Nobuhiro Ohtake, Tsumura Co. Ltd. for kind supply of wogonin-7-O-glucuronide. This work was supported by a Grant-in Aid for Scientific Research of the Ministry of Health, Labour and Welfare of Japan.
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Makino, T., Hishida, A., Goda, Y. et al. Comparison of the major flavonoid content of S. baicalensis, S. lateriflora, and their commercial products. J Nat Med 62, 294–299 (2008). https://doi.org/10.1007/s11418-008-0230-7