摘要
目的 对日本医疗用汉方医药品和一般用汉方医药品市场占有率最大的企业日本津村制药公司和Kracie制药公司2008-2020年间申请的专利内容进行综述,为国内中药经典名方和保健食品研发、知识产权保护提供参考。方法 通过日本专利局的官方检索渠道J-PlatPat平台,检索日本津村制药公司和Kracie制药公司在2008年至2020年间申请的专利,并进行专利布局和技术内容分析。结果 共收集43项日本津村制药公司特许和实用新案专利,其围绕汉方制剂产品全过程质量控制构建了坚实的专利技术体系;共收集52项Kracie制药公司特许和实用新案专利,其致力于功能性制剂和组合物的开发,重点在生活改善、老龄化和癌症等领域进行专利布局,还创建了多种产品功效和功能的客观评价方法。结论 津村制药近十年专利布局提示在中药现代化制造和走向国际的过程中,应把提高品质作为主攻方向,树立持续质量改进理念,完善产品有效性证据链。Kracie制药公司践行的以人为中心的汉方药设计理念,以及精准满足消费者健康需求的研发模式值得借鉴。
Objective To summarize the patent contents applied by Tsumura pharmaceutical company and Kracie pharmaceutical company, which have the largest market share of Kampo medicine for medical use and general use,respectively, and to provide reference for the research and development of Chinese medicine and health food, and well as the intellectual property protection in China.Methods The patents applied by Tsumura pharmaceutical company and Kracie pharmaceutical company from 2008 to 2020, were retrieved on the J-PlatPat platform, the official search channel of Japan Patent Office. The patent portfolio and technological contents were analyzed.Results A total of 43 patents of Tsumura pharmaceutical company were collected. It was found that a solid patent technology system was built around the overall process quality control of Kampo medicine products. A total of 52 new patents of Kracie pharmaceutical company were collected. It revealed that Kracie was committed to the development of functional preparations and compositions,particularly in the fields of life improvement, aging prevention and anti-cancer. Moreover, Kracie created some objective methods for evaluating the product’s efficacy or function. Conclusion The patent layout of Tsumura pharmaceutical company in recent ten years suggests that in the progress of modern manufacturing and internationalization of Chinese medicine, the quality-centered approaches should be taken, the concept of continuous quality improvement should be established, and the evidence chain of product effectiveness should be guaranteed. The human-centered design and development philosophy of Kampo medicines practiced by Kracie pharmaceuticals and the R&D model for precisely meeting consumer’s health needs are worthy of reference.
作者
刘岳琪
宿军慧
曹君杰
王雅雯
谷洪顺
乔延江
徐冰
Liu Yueqi;Su Junhui;Cao Junjie;Wang Yawen;Gu Hongshun;Qiao Yanjang;Xu Bing(Department of Chinese Medicine Information Science,Beijing University of Chinese Medicine,Beijing 102400,China;Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine,Beijing Municipal Science&Technology Commission,Beijing 102400,China;Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development,Ministry of Education of People's Republic of China,Beijing 102400,China;Beijing Cairui Medical Technology Research Institute Co.,Ltd.,Beijing 100094,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2022年第5期1970-1980,共11页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家自然科学基金委员会面上项目(82074033):模型驱动的中药片剂处方和成型工艺协同设计方法研究,负责人:徐冰
中华中医药学会青年人才托举工程项目(2019-QNRC2-C11),负责人:徐冰
江西中医药大学创新药物与高效节能降耗制药设备国家重点实验室开放基金项目(GZSYS202007):中药混合过程离散元模拟研究,负责人:徐冰。
关键词
汉方药
全过程质量控制
处方药
非处方药
专利布局
Kampo medicine
Overall process quality control
Prescription drug
Over the counter(OTC)drug
Patent portfolio