6 major scientific and technological projects of new drug creation won 2014 National Science and Technology Award

1、 The foundation of science and technology of traditional Chinese medicine in China is relatively weak, resulting in the fuzzy function of traditional Chinese medicine, extensive pharmaceutical technology, backward quality control technology and weak process risk management and control These factors make the variety of traditional Chinese medicine bigger and stronger This project focuses on the major needs of growing and strengthening the varieties of Chinese patent medicine, puts forward the theory, method and technical strategy of secondary development of Chinese patent medicine, breaks through the common key core technology of secondary development of Chinese patent medicine, and constructs five core technology systems, including clinical positioning of Chinese patent medicine, overall system analysis of effective substances, system network pharmacology, process quality optimization and digital whole process quality control The core technology has been applied to nearly 100 enterprises in 19 provinces and cities in China, cultivated a large variety group of traditional Chinese medicine, greatly improved the concentration of traditional Chinese medicine industry, and promoted the technology upgrading of traditional Chinese medicine enterprises It can provide safe and effective drugs with high quality and low price for the prevention and control of major diseases, resulting in huge economic and social benefits Mainly completed by: Tianjin University of traditional Chinese medicine, Zhejiang University, Chinese Academy of traditional Chinese medicine, Zhengda qingqingbao Pharmaceutical Co., Ltd., Tianjin Pharmaceutical Group Co., Ltd Main completers: Zhang Boli, Cheng Yiyu, Qu Haibin, Liu Yang, fan Xiaohui, Xie Yanming, Gao Xiumei, Zhang Ping, Liu Li, Wang Yi, Zhang Junhua, Kang Liyuan, Hu Limin, Ren Ming, Zhang Yanjun 2、 Key technologies and applications of identification and acquisition of trace active substances in Chinese herbal medicine (National Science and technology progress award, second class) trace substances in Chinese herbal medicine have novel structure and significant biological activity This project has carried out in-depth and systematic research, created a new technology system of identification, acquisition and evaluation of trace active substances, and overcome the technical bottleneck of research on trace active substances Using the new technology system, we obtained a batch of new high activity trace components, revealed the trace key pharmacodynamic substances of 8 kinds of Chinese herbal medicines, selected a number of candidate new drugs with unique functions, and obtained a clinical research approval Three innovative drugs achieved technology transfer It has obtained 7 national invention patents and 1 international patent Ten traditional Chinese medicine enterprises applied this technology to solve the difficult technical problems in the past and improve the product quality The annual sales of representative products increased from 252 million yuan to 764 million yuan Mainly completed by: Institute of medicine, Chinese Academy of Medical Sciences, Beijing Kelaibo Pharmaceutical Development Co., Ltd Main completers: Yu Shishan, Shi Jiangong, Zhang Dongming, Yu Dequan, Wang Ke, Qu Jing, Chen Xiaoguang, Zhang Jianjun, Shen Zhufang, Ma Shuanggang 3、 The project breaks through the restriction of unclear material basis and mechanism of traditional Chinese medicine in the treatment of single disease of glycolipid metabolism, and takes the lead in the overall understanding and comprehensive treatment It was found that the liver plays a key role in the pathogenesis of glycolipid metabolic disease The method of "regulating the liver, activating the pivot and transforming the turbid" was first proposed, and an innovative Chinese medicine with clear composition and mechanism was developed, which has a comprehensive regulatory effect of lowering blood sugar, reducing blood fat, anti-inflammatory, protecting endothelium, etc it has obtained 10 invention patents in Europe, America and countries It is the first time to find the non dependence of insulin resistance on fat and AT1 signal, and to open the research channel of prevention and treatment of glycolipid metabolism disease; it is the first time to find a new mechanism of high cholesterol accelerating vascular calcification induced by vitamin D2, which has affected the American national diet and is at the international leading level The paper has been cited 706 times by authoritative journals such as pharmaceutical reviews The new sales volume of representative drugs is 524 million and the profits and taxes are 108 million The social and economic benefits are significant Main completion units: Guangdong Institute of medicine, Guangzhou Baiyunshan Heji Huangpu traditional Chinese Medicine Co., Ltd., Guangzhou University of traditional Chinese medicine, and Chinese Academy of traditional Chinese medicine main completion personnel: Guo Jiao, Li Chuyuan, Lei Yan, Bei Weijian, Rongxiang Road, Su Zhengzi, Wang delqin, Tang Futian, Tang Chunping, He Wei, four, research and application of the site conditions of Chinese medicine production and soil micro ecological environment remediation technology (National Science and technology progress award, second class) Aiming at the problems of heavy metal pollution and continuous cropping obstacles in the soil of traditional Chinese medicine cultivation, the project selected a variety of important traditional Chinese medicine with high requirements for site conditions, suitable land shortage and serious continuous cropping obstacles, and carried out systematic exploration and Research on key common technologies such as comprehensive treatment of agricultural heavy metals in the soil of traditional Chinese medicine cultivation, reduction of continuous cropping self toxicity, nutrient balance, etc., and carried out traditional Chinese medicine For the ecological restoration of continuous cropping soil, the index system for the comprehensive evaluation of soil fertility of traditional Chinese medicine and the technical system for mycorrhizal cultivation of traditional Chinese medicine have been established, the technical service platform for ecological research of traditional Chinese medicine resources has been formed, a series of technical packages for social services have been formed, and the special fertilizer for traditional Chinese medicine has been developed, The ISO international standard for heavy metals in Chinese herbal medicines was submitted, which filled in the blank of comprehensive treatment of heavy metals in Chinese herbal soils Mainly completed by: Institute of traditional Chinese medicine, Chinese Academy of Sciences, Zhejiang University, research center of ecological environment, Chinese Academy of Sciences, Beijing University of traditional Chinese medicine, Institute of medicinal plants, Yunnan Academy of Agricultural Sciences, Kunming University of science and technology, West Anhui University Mainly completed by: Guo Lanping, Huang Luqi, Yu Yunlong, Chen Baodong, Wang Wenquan, Cui Xiuming, Liu Congress, Chen Naifu, Han Bangxing, Yang Guangwu, construction and application of pharmacodynamic evaluation system of traditional Chinese medicine originated from clinical practice of traditional Chinese medicine (National Science and technology progress award, second class) Aiming at the key scientific problems of pharmacodynamics research of traditional Chinese medicine, this project puts forward a new idea of pharmacodynamics research of traditional Chinese medicine originated from the clinical practice of traditional Chinese medicine, establishes a new method of animal model quasi clinical research, prepares 11 animal models close to the clinical practice of traditional Chinese medicine, creates 3 new methods of TCM Syndrome Evaluation of animal models, and constructs 83 models and 220 SOPs of traditional Chinese medicine originated from the clinical practice of traditional Chinese medicine Effectiveness evaluation system The system has been popularized in 50 scientific research institutes at home and abroad It has evaluated 120 new Chinese medicine drugs for 80 domestic and foreign enterprises and scientific research institutes, obtained 10 new drug certificates, 22 clinical approvals, and obtained 17.8 billion yuan of indirect economic benefits and 5.2 billion yuan of profits and taxes in the past three years Through the construction of the system, the project supporting unit has built a leading platform for pharmacodynamic evaluation of traditional Chinese medicine at home and abroad, which has formed a wide range of academic influence at home and abroad, not only improving the research and development level of new drugs in China, but also enhancing the competitiveness and influence of traditional Chinese medicine in the world Main completion unit: Xiyuan Hospital, Chinese Academy of traditional Chinese medicine Main completers: Liu Jianxun, Lin Chengren, Li Lei, Ren Junguo, Li Xinzhi, Miao LAN, Fu Jianhua, Ren Jianxun, sun Mingqian, Hou Jincai 6、 The key technology and industrialization of acarbose raw materials and preparations (National Science and technology progress award, second class) acarbose is the largest oral hypoglycemic drug in China In this project, high efficient and high-throughput breeding technology of acarbose high-yield strain was established, and high-yield industrial strain with independent intellectual property rights was obtained By revealing the mechanism of synthesis promotion mediated by small molecular substances, a new technology of continuous variable speed fed fermentation was established to greatly improve the fermentation potency of acarbose The technology of low-temperature pretreatment and two-step chromatography for the separation and purification of acarbose was invented to improve the yield and quality of acarbose, optimize the formulation of the tablet, and give the acarbose tablet superior stability and quality The project has obtained 10 national invention patents, built a complete independent intellectual property system, successfully realized the localization and internationalization of acarbose, broke the long-term technology and market monopoly of international pharmaceutical giants, reduced the drug cost of diabetes treatment, benefited 100 million diabetes patients, and promoted the development of public health in China Mainly completed by: Zhejiang University of technology, Chengdu University, Huadong Pharmaceutical Co., Ltd., Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd and Hangzhou Huadong Pharmaceutical Group New Drug Research Institute Co., Ltd mainly completed by: Zheng Yuguo, Li Bangliang, he Bimei, sun min, Wu Hui, Wang Yuanshan, Wang Yajun, Zhou Lujin, Yao Zhongli, Zhang Ying