本文旨在探讨高端制剂药用辅料(高端辅料)的研发方式和质量提高关键点,并对高端辅料的创新进行展望。高端制剂是相对于传统制剂具有更高技术含量、更优疗效、更小副作用、不易仿制等优点的制剂,而其核心就是关键辅料。近年来,我国高端辅料的发展得到关注。本文阐述了高端辅料的创新方式,对学术界、工业界和政府监管的共同创新进行了展望。
<<This report aimed to discuss the research and development methods and key points of quality improvement of high-end pharmaceutical excipients(high-end excipients),and predicted the future of the innovation of high-end excipients. High-end preparations were preparations that had the advantages of higher technical content,better efficacy,less side effects,and less possibility of being imitated than traditional preparations,and the core was the key excipients. In recent years,the development of high-end excipients got a lot of attention in China. This report described the innovation of high-end excipients,and looked forward to the joint innovation of the academia,industry and government regulators.
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