| 中药现代化的示范性成果——丹参多酚酸盐及其注射用丹参多酚酸盐的研究与开发 |
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| 引用本文： | 王逸平,宣利江.中药现代化的示范性成果——丹参多酚酸盐及其注射用丹参多酚酸盐的研究与开发[J].中国科学院院刊,2005,20(5):377-380. |
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| 作者姓名： | 王逸平 宣利江 |
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| 作者单位： | 中国科学院上海药物研究所新药研究国家重点实验室,上海,201203 |
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| 基金项目： | 本项目获得中国科学院知识创新工程重大项目、国家"十五"重大科技专项、中国科学院生物科学与生物技术特别支持;上海市现代生物与医药产业发展基金、上海市科学技术发展基金的支持. |
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| 摘 要： | 丹参多酚酸盐及其注射用丹参多酚酸盐是由中药丹参经提取精制的多酚酸盐类化合物制备而成.经大量临床前药理学研究及多中心临床试验,证明是一个安全、高效、质量稳定、可控的治疗冠心病、心绞痛药物.2005年5月25日,经国家食品药品监督管理局(SFDA)批准,丹参多酚酸盐及其注射用丹参多酚酸盐的新药注册申请获得了新药证书和生产批文.相关技术获中国专利和美国专利的授权,是一项拥有自主知识产权的现代化中药新药.本文主要介绍丹参多酚酸盐及其注射用丹参多酚酸盐的研制背景、意义和取得的成果.
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| 关 键 词： | 丹参多酚酸盐 中药现代化 心血管药物 |
| 修稿时间： | 2005年8月4日 |
An Achievement on the Modernization of Chinese Traditional Medicine: Research and Development of Depsides Salts from Salvia Miltiorrhiza and Its Preparations |
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| Wang Yiping and Xuan Lijiang.An Achievement on the Modernization of Chinese Traditional Medicine: Research and Development of Depsides Salts from Salvia Miltiorrhiza and Its Preparations[J].Bulletin of the Chinese Academy of Sciences,2005,20(5):377-380. |
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| Authors: | Wang Yiping and Xuan Lijiang |
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| Institution: | State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, CAS, 201203 Shanghai;State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, CAS, 201203 Shanghai |
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| Abstract: | Depsides salts from Salvia miltiorrhiza and its preparations are novel cardiovascular drug with a definite effective component extracted from Saliva miltiorrhiza, featuring about 80% of magnesium lithospermate B and 100% of total depsides salts. The fingerprint technology is used for the overall quality control of the medicinal herbs, depsides salts from Salvia miltiorrhiza, and its preparations. Depsides salts from Salvia miltiorrhiza has been confirmed to be safe and effective for the treatment of patients with coronary artery disease and chronic angina pectoris in multi-centre clinical trials. On May 25, 2005, a New Drug Application (NDA) of depsides salts from Salvia miltiorrhiza and its preparation for the treatment of coronary artery disease had received official approval from State Food and Drug Administration (SFDA). The techniques related to the development of depsides salts from Salvia miltiorrhiza have been granted patents in China and the United States. It is an achievement with intellectual property rights on modernization of Chinese traditional medicine. The focus of this paper is mainly on the research background and significance, as well as the achievements in depsides salts from Salvia miltiorrhiza and its preparations. |
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| Keywords: | Depsides salts from Salvia miltiorrhiza modernization of Chinese traditional medicine cardiovascular drugs |
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