| 引用本文: | 徐诗军,王学成,伍振峰,李远辉,刘振峰,罗小荣,周同辉,杨明.片剂创新设计与质量控制新技术应用进展[J].中国现代应用药学,2022,39(20):2658-2668. |
| XU Shijun,WANG Xuecheng,WU Zhenfeng,LI Yuanhui,LIU Zhenfeng,LUO Xiaorong,ZHOU Tonghui,YANG Ming.Application Progress of New Technology for Innovative Design and Quality Control of Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(20):2658-2668. |
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| 片剂创新设计与质量控制新技术应用进展 |
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徐诗军1, 王学成1, 伍振峰1, 李远辉1, 刘振峰2, 罗小荣3, 周同辉4, 杨明1
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1.江西中医药大学创新药物与高效节能降耗制药设备国家重点实验室, 现代中药制剂教育部重点实验室, 南昌 330004;2.宜春万申制药机械有限公司, 江西 宜春 336000;3.江中药业股份有限公司, 南昌 330004;4.杭州今同健康技术有限公司, 杭州 310004
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| 摘要: |
| 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。 |
| 关键词: 片剂 创新设计 新兴技术 质量评价 应用进展 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.20.014 |
| 分类号:R944 |
| 基金项目:江西省重大科技创新平台(20203CCD41007)；江西省5511重大专项(20182ABC28009)；江西省重点研发计划项目(20201BBG71005) |
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| Application Progress of New Technology for Innovative Design and Quality Control of Tablets |
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XU Shijun1, WANG Xuecheng1, WU Zhenfeng1, LI Yuanhui1, LIU Zhenfeng2, LUO Xiaorong3, ZHOU Tonghui4, YANG Ming1
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1.State Key Laboratory of Innovation Drug and Efficient Energy-Saving Pharmaceutical Equipment, Key Laboratory of Modern Preparation of TCM, Ministry of Education, Jiangxi University of Chinese Medicine, Nanchang 330004, China;2.Yichun Wanshen Pharmaceutical Machinery Co., Ltd., Yichun 336000, China;3.Jiangzhong Pharmaceutical Co., Ltd., Nanchang 330004, China;4.Hangzhou Jintong Health Technology Co., Ltd., Hangzhou 310004, China
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| Abstract: |
| 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. |
| Key words: tablets innovation design emerging technology quality evaluation application progress |
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