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楊瑾1, 加茂智嗣2, 能瀨愛加2 1. 天津中新藥業(yè)集團股份有限公司樂仁堂制藥廠, 天津 300112; 2. 日本星火產(chǎn)業(yè)株式會社, 日本 【摘要】日本漢方藥源于中醫(yī)藥,，但在長期的歷史發(fā)展過程中,，逐漸形成了具有日本特色的漢方藥文化，并建立了完善的漢方藥生產(chǎn)質(zhì)量管理規(guī)范及注冊管理制度,，形成了有別于我國中成藥發(fā)展的漢方藥研究開發(fā)模式及質(zhì)量控制管理體系,，在很多方面與我國中成藥目前的現(xiàn)狀是有差異的,，特別是在質(zhì)量管理方面的很多經(jīng)驗值得學習和借鑒。 【關鍵詞】日本漢方藥; 注冊管理; 中成藥; 質(zhì)量控制; 中醫(yī)藥 Development and current situation of Chinese prescription medicine in JapanYANG Jin1, KAMO Satoshi2, NOSE Manaka2 1. Le Ren Tang Pharmaceutical Factory, Tianjin Zhongxin Pharmaceutical Group Co., Ltd., Tianjin 300112, China; 2. Iskra Industry Co., Ltd., Japan 【Abstract】Chinese prescription medicine in Japan derives from China's traditional Chinese medicine. Yet during the long histroy of development, the management system of production, quality standard, and registration have been gradually establised in Japan. Research and development pattern and quality control management system for Chinese prescription medicine are formed and are different from those in China. Many of them are different with our current situation, especially in the aspect of quality management. Thus their experience is worth learning and using for reference. 【Keywords】Chinese prescription medicine in Japan; registration management; Chinese patent medicine; quality control; traditional Chinese medicine 收稿日期：2016-04-12 |
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