Quality control of herbal medicines in Japan

Herbal medicines in Japan are mostly used for the Kampo medicine, (the medicine traditionally practiced in Japan, based on ancient Chinese medicine). The Kampo medicine was established by the 18th century in Japan. A Kampo prescription traditionally is administered in many forms, but mainly in the form of decoction of five to ten different crude drugs (herbs). Nowadays, Kampo medicines are mainly distributed in the shape of ready-made granules, powders or tablets, containing a spray-dried decoction of crude drugs. The quality of the crude drugs is controlled by the Japanese Pharmacopoeia (JP) and the Japanese Herbal Medicine Codex (JHMC, non-JP crude drug standard). The 15th edition of JP (JP15) with the supplement 1 contains 153 crude drugs and 54 powdered ones. The JHMC covers additional 39 crude drugs and 2 powdered one. For each crude drug, the origin, physical properties and criteria for identification are rigorously specified by respective testing method. In addition, purity test and chemical assay are required. The quality of the ready-made Kampo products for ethical uses is controlled by the regulations for manufacturing control and quality control of ethical extract products in Kampo medicine formulations (the Kampo extract preparation GMP). The quality of the proprietary ones is also controlled by the corresponding regulations. These regulations are self-imposed ones of Japan Kampo-Medicine Manufactures Associations (JKMA: http://www.nikkankyoorg/frame. html). In the GMP, each crude drug must satisfy the criteria of JP or JHMC. Also, it is required to obtain data of TLC profile to identify individual crude drugs. In addition, quantitative HPLC analyses of the main constituents of at least two crude drugs are needed as indicator ingredients. The requirement of each Kampo extract preparation on TLC profile and HPLC analysis is written in JP or the corresponding letter of the approval. JP15 with the supplement 1 contains 8 monographs of Kampo extracts. It is planned that the monographs of the top 20 Kampo extracts at least appear in the JP16. In Japan, 148 Kampo formulae are approved for ethical use and the total sales of the top 20 extract products account for about 67%, in the whole sales of ethical Kampo products.