日本汉方药概况及其对我国中医古代经典名方制剂研发的启示

General Situation of Japanese Kampo and Its Inspiration to the Research and Development of TCM Ancient Classical Representative Prescriptions

我国的"古代经典名方"研发工作正在推进中,日本汉方药与中医古代经典名方制剂有一定的相似性,又有其本国特点。本文从日本汉方发展的背景、制剂审批基准、制剂生产、销售等方面进行了概述,并将其与中医复方制剂的审批条件、市场规模等方面进行了比较。中医古代经典名方的研发监管应借鉴日本汉方质量管理、知识产权保护等经验,汲取其中药西用的历史教训,以期更好地发展及惠及民众。

The project of the research and development about Ancient Classical TCM Representative Prescriptions are carrying forward. There are a certain similarities between Japanese Kampo and ancient classical TCM representative prescriptions, but Japanese Kampo has its own national characteristics. This article summarized from the background of the development of Japanese Kampo, preparations approval benchmark, preparation production, sales and other aspects, and it also compared the examination and approval conditions and market scale of Japanese Kampo with TCM compound formulations. The development and supervision of ancient classical TCM representative prescriptions should use the experience of Japanese Kampo in quality management and intellectual property protection for reference, and draw lessons from the Western use of Chinese medicine. Then it can better develop TCM and benefit the people.