日本汉方制剂的发展现状及其经验启示.PDF

·494 · 中草药 Chinese Traditional and Herbal Drugs 第49 卷 第2 期 2018 年1 月 日本汉方制剂的发展现状及其经验启示 1 1* 2 1 1 于翠婷 ，田 侃 ，住田尚之 ，杨 毅 ，曾慧婷 1. 南京中医药大学卫生经济管理学院, 江苏 南京 210023 2. 日本曾我法律事务所，日本 摘 要：以日本质量管理体系 （QMS ）为切入点，从汉方制剂的研制、生产、销售 3 个环节对日本汉方制剂的发展进行综 述，为我国中药的研发及质量标准化管理体系建设提供参考。研究结果表明，我国有必要参考日本良好的管理理念及完整的 质量管理体系，借鉴日本汉方制剂发展的成功经验，提高中药材的种植水平、中成药的生产技术水平、中成药制备全流程的 质量管理水平，从而促进中药产业的发展。 关键词：汉方制剂；研制；生产；销售；质量管理体系 中图分类号：R288 文献标志码：A 文章编号：0253 - 2670(2018)02 - 0494 - 05 DOI: 10.7501/j.issn.0253-2670.2018.02.034 Development and current situation of Japanese Kampo Preparations and its meaning for Chinese materia medicine 1 1 2 1 1 YU Cui-ting , TIAN Kan , Sumida Takayuki , YANG Yi , ZENG Hui-ting 1. School of Health Economics and Management, Nanjing University of Chinese Medicine, Nanjing 210023, China 2. Japan’s Sogo Law Office, Japan Abstract: With the development of the Japanese quality management system (QMS) as the starting point, the development of the Kampo Preparations is described from three aspects of the development, production and sales of the Kampo to provide reference for the research and development of traditional Chinese medicine preparation and the construction of quality standard management system. It is necessary to refer to Japan’s good management philosophy and a complete quality management system. Learning from their successful experience of the development of Japanese Kampo preparations to improve the level of Chinese herbal medicine cultivation, proprietary Chinese medicine production technology and the quality management of the whole process of proprietary Chinese medicine preparation, thus promoting the development of Chinese medicine industry. Key words: Kampo preparations; research and development; production; sales; quality