【从3D打印片剂获批到给药系统创新】。

药学学报 Pub Date : 2016-11-01
Qiang Zhang
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引用次数: 0

摘要

3D打印左乙拉西坦片剂已于2015年8月3日获得FDA批准,成为首个基于3D打印技术的药品。3D打印片剂标志着原料药、赋形剂、剂型、制药设备和工艺的完美结合,包括软件设计和计算机控制。作为一个非常生动的例子,3D打印片剂的营销实际上再次证明了药物传递系统(DDS)的工作离不开制备技术、药用辅料、设备、制造和测试设备、包装材料等。本文简要介绍了这些领域对DDS的意义,以及国内的进展和问题,并指出跨学科研究是DDS创新的最关键特征。通过实例阐述了DDS创新的规律,分析了我们面临的挑战。最后,对国内DDS的创新与发展提出了几点建议:1、重视高独创性的DDS研究;2 .重视与DDS密切相关的制备技术、药用辅料等领域的研究;强调DDS的跨学科研究;4强调DDS的基础研究与转化研究相结合。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[From the approving of 3D printing tablet to the innovation of drug delivery systems].

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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来源期刊
药学学报
药学学报 Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
1.20
自引率
0.00%
发文量
0
期刊介绍: Acta Pharmaceutica Sinica B (APSB) is a bimonthly English peer-reviewed online journal in ScienceDirect, which publishes significant original research articles, communications and high quality reviews of recent advances. APSB encourages submissions from all areas of pharmaceutical sciences, including pharmacology, pharmaceutics, medicinal chemistry, natural products, pharmacognosy, pharmaceutical analysis and pharmacokinetics. APSB is a part of the series Acta Pharmaceutica Sinica, which was founded in 1953. The journal is co-published by Elsevier B.V., in association with the Institute of MateriaMedica, Chinese Academy of Medical Sciences and Chinese Pharmaceutical Association.
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