张强. 从3D打印片批准上市谈释药系统的创新J. 药学学报, 2016,51(11): 1655-1658. doi: 10.16438/j.0513-4870.2016-0849
引用本文: 张强. 从3D打印片批准上市谈释药系统的创新J. 药学学报, 2016,51(11): 1655-1658. doi: 10.16438/j.0513-4870.2016-0849
ZHANG Qiang. From the approving of 3D printing tablet to the innovation of drug delivery systemsJ. Acta Pharmaceutica Sinica, 2016,51(11): 1655-1658. doi: 10.16438/j.0513-4870.2016-0849
Citation: ZHANG Qiang. From the approving of 3D printing tablet to the innovation of drug delivery systemsJ. Acta Pharmaceutica Sinica, 2016,51(11): 1655-1658. doi: 10.16438/j.0513-4870.2016-0849

从3D打印片批准上市谈释药系统的创新

From the approving of 3D printing tablet to the innovation of drug delivery systems

  • 摘要: 2015年8月3日FDA批准了全球第一个应用3D打印技术的新药——左乙拉西坦3D打印片剂。3D打印片代表着药物原料、药用辅料、药物剂型、制药设备和制备技术(包括软件设计与电脑控制)的完美结合。作为一个生动的实例,3D打印片的上市再次表明,释药系统的创新实际上离不开制剂技术、药用辅料、给药装置、制剂设备、检测设备和包装材料等创新。本评述首先简述了上述领域对释药系统的重要性及国内进展与存在问题,说明释药系统创新最重要特征就是跨学科研究,然后通过实例阐明了释药系统创新的自身规律性,并就当前释药系统创新面临的各种挑战进行了分析。最后,为促进我国释药系统的不断创新和发展提出了若干建议:①重视具有原创性的释药系统研究;②重视释药系统相关领域制剂技术、药用辅料等的创新研究;③重视多学科实质性交叉的释药系统研究和创新;④重视应用研究与相关应用基础研究的结合。

     

    Abstract: A 3D printing tablet of levetiracetam has been approved by FDA on August 3th, 2015, as the first pharmaceutical product based on 3D printing technique. 3D printing tablet indicates the perfect combination of active pharmaceutical ingredient (API), excipient, dosage form, pharmaceutical equipment and techniques including the software design and computer control. As a very vivid instance, the marketing of 3D printing tablet actually demonstrated again that the drug delivery systems (DDS) cannot work without preparation techniques, pharmaceutical excipient, device, manufacture and test equipment, package materials, and so on. This comment, briefly introduces the significance of these areas to DDS, as well as the advances and problems in China, followed by the indication that interdisciplinary study is the most critical feature for the innovation of DDS. It explains the rules of DDS innovation by various examples, and analyzes the challenges that we are facing. Finally, some suggestions are given to the innovation and development of DDS in China:① emphasizing the research on DDS with high originality; ② emphasizing the study on the areas closely related to the DDS, like preparation techniques, pharmaceutical excipient and so on; ③ emphasizing the substantially interdisciplinary research on DDS; ④ emphasizing the combination between the basic and translational study on DDS.

     

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