中药标准化

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同仁堂科技:荣获国家药典标准提高课题 完成芪参颗粒Ⅱ期临床用药生产
Zheng Quan Ri Bao Zhi Sheng· 2025-08-29 03:40
Core Viewpoint - The company is actively transforming the traditional Chinese medicine industry through scientific and standardized practices, showcasing its capabilities in national strategic research and innovation [1][3]. Group 1: Research and Development Initiatives - The company has been approved as the leading unit for a national pharmacopoeia standard research project, focusing on the "Guiding Principles for the Determination of Biological Activity of Traditional Chinese Medicine" [1]. - The project aims to establish a "component-activity-efficacy" evaluation system to enhance quality control in traditional Chinese medicine, addressing common industry challenges [1][3]. - The innovative drug "Qi Shen Granules," a completely new type of traditional Chinese medicine, has successfully completed Phase II clinical production and is intended for chronic heart failure treatment [3]. Group 2: Quality Control and Standards - The company has implemented three new group standards for traditional Chinese medicine traceability in collaboration with the China Traditional Chinese Medicine Association [3]. - The company has achieved CNAS accreditation for its testing centers, indicating compliance with international standards and enhancing its competitive edge in both domestic and international markets [4][7]. - The focus on "zero defect quality management" is reinforced by high-quality inspection levels and ongoing improvements in laboratory standardization [4]. Group 3: Future Directions - The company plans to continue driving high-quality development through a dual-engine strategy of "quality" and "innovation," increasing resource investment to enhance its core competitiveness [7].
著名分析化学家姚守拙院士逝世,曾研制出几十种中草药功效成分标准品
Guan Cha Zhe Wang· 2025-08-28 23:31
Core Viewpoint - The article reports the passing of Yao Shouzhuo, a prominent Chinese chemist and academician, who made significant contributions to analytical chemistry and traditional Chinese medicine [1][3][5]. Group 1: Personal Background - Yao Shouzhuo was born in March 1936 in Shanghai and graduated from Nankai University in 1959 after studying at Leningrad University in the Soviet Union [3]. - He held teaching positions at Tsinghua University and later at Hunan University, where he became an academician of the Chinese Academy of Sciences in 1999 [3]. Group 2: Academic Achievements - Yao published over 400 papers indexed by SCI and authored four monographs, with his work being cited more than 800 times [5]. - His research led to nine national and provincial awards, including the National Natural Science Award and the National Science and Technology Progress Award [5]. Group 3: Contributions to Traditional Chinese Medicine - Yao conducted extensive research on the separation and analysis of active components in traditional Chinese medicine, successfully isolating and purifying numerous compounds [5]. - He emphasized the importance of standardization in traditional Chinese medicine to address issues such as low efficacy and quality control challenges [7].
数字赋能产业结构性升级,“老广”买中药饮片也能“标准化”了
Guang Zhou Ri Bao· 2025-08-06 05:21
Core Insights - The State Council issued an opinion to enhance the quality of traditional Chinese medicine (TCM) and promote high-quality development in the industry, focusing on optimizing industrial structure, improving manufacturing quality, and standardizing TCM [1][2] Industry Overview - The TCM decoction pieces industry is experiencing structural upgrades due to digital transformation, with retail pharmacies becoming a significant consumption market, ranked as the third largest for TCM decoction pieces [1] - Consumers prefer purchasing TCM from retail pharmacies for convenience, and the market share is expected to grow as chain pharmacies become more commercialized [1] Digital Transformation - The digital service platform, Yaoshi Bang, initiated a full industry chain layout in 2021, addressing the non-standard issues in TCM decoction pieces by establishing 271 gold standards for core varieties [2] - The platform promotes a shift from traditional procurement methods to a digital supply chain, enhancing quality control throughout the production process [2] Regulatory Impact - The new policies are expected to bring favorable conditions for the TCM industry, leading to a more competitive environment where stronger players will dominate [2]