片剂创新设计与质量控制新技术应用进展

片剂一直是临床应用中的重要制剂，但传统片剂的开发设计模式、质量评价技术及生产质量控制模式难以满足现在的需求。本文综述了多变量数据分析技术、人工神经网络技术、3D打印技术在片剂设计开发的应用，实现了片剂的快速制备和个性化生产；论述了近红外光学技术、太赫兹脉冲成像技术、核磁共振成像技术等新型检测技术在片剂质量评价的应用，相比传统的检测技术，新的检测技术呈现出高效、灵敏、便捷等特点，同时在建立片剂开发与生产的质量控制策略中遵循质量源于设计的理念，对提升片剂安全性和有效性以及片剂的开发和生产具有重要意义。

Application Progress of New Technology for Innovative Design and Quality Control of Tablets

Tablets have always been an important preparation in clinical application, but the development and design mode, quality evaluation technology and production quality control mode of tablets can hardly meet the current demand. This paper summarized the application of multivariable data analysis technology, artificial neural network technology and 3D printing technology in the design and development of tablets to meet the rapid preparation and personalized production of tablets. It also discussed the near infrared optical technology, terahertz pulse imaging technology, nuclear magnetic resonance imaging technology and other new detection technologies in the quality evaluation of tablets. Compared with the traditional detection technology, the new detection technology is efficient, sensitive and convenient. At the same time, it follows the concept that quality originates from design in establishing the quality control strategy for the development and production of tablets. It is of great significance to improve the safety and effectiveness of tablets as well as the development and production of tablets.