Makino Toshiaki, Hishida Atsuyuki, Goda Yukihiro, Mizukami Hajime
Graduate School of Pharmaceutical Sciences, Nagoya City University, 3-1 Tanabe-dori, Mizuho-ku, Nagoya, 467-8603, Japan.
J Nat Med. 2008 Jul;62(3):294-9. doi: 10.1007/s11418-008-0230-7. Epub 2008 Feb 15.
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.
根据日本厚生劳动省医药食品安全局局长发布的药品定义通知，黄芩和半枝莲的根部被归类为“仅用作药品的原料”，但其地上部分被归类为“非药品”，因此原则上这些材料没有健康声称，也没有类药物剂量或服用说明的描述。黄芩干燥根在《日本药局方》第十五版中也作为黄芩根登记。在汉方药（日本传统草药制剂）中，黄芩根被认为有间质性肺炎和药物性肝病的不良反应，其主要成分黄芩苷被认为是不良反应的原因。本研究通过分析黄芩和半枝莲的根、茎、叶以及由半枝莲制备的商业产品凉茶和膳食补充剂中包括黄芩苷在内的四种黄酮类化合物的含量，来评估这种药品与非药品界限的合理性。在黄芩根中发现了这些黄酮类化合物；然而，其地上部分不含这些化合物。另一方面，半枝莲地上部分的这些黄酮类化合物含量高于根部。市售的半枝莲凉茶和膳食补充剂也含有这些黄酮类化合物，并且膳食补充剂中的含量与汉方药中的相当。这些结果表明，日本将半枝莲地上部分归类为非药品的分类需要重新考虑。
