杨亚光, 安广涛, 闫媛, 赵玉, 吴驿瑶, 祁东利. 过程分析技术在干法制粒条带性质测量中的应用进展J. 药学学报, 2026, 61(2): 453-464. DOI: 10.16438/j.0513-4870.2025-0314
引用本文: 杨亚光, 安广涛, 闫媛, 赵玉, 吴驿瑶, 祁东利. 过程分析技术在干法制粒条带性质测量中的应用进展J. 药学学报, 2026, 61(2): 453-464. DOI: 10.16438/j.0513-4870.2025-0314
YANG Ya-guang, AN Guang-tao, YAN Yuan, ZHAO Yu, WU Yi-yao, QI Dong-li. Advances in the application of process analytical technology in the measurement of ribbon properties in roller compaction dry granulationJ. Acta Pharmaceutica Sinica, 2026, 61(2): 453-464. DOI: 10.16438/j.0513-4870.2025-0314
Citation: YANG Ya-guang, AN Guang-tao, YAN Yuan, ZHAO Yu, WU Yi-yao, QI Dong-li. Advances in the application of process analytical technology in the measurement of ribbon properties in roller compaction dry granulationJ. Acta Pharmaceutica Sinica, 2026, 61(2): 453-464. DOI: 10.16438/j.0513-4870.2025-0314

过程分析技术在干法制粒条带性质测量中的应用进展

Advances in the application of process analytical technology in the measurement of ribbon properties in roller compaction dry granulation

  • 摘要: 干法制粒是一种机械化程度较高的药物颗粒制备方法, 其中辊压制粒是较为常用的干法制粒方法, 辊压条带的制备是干法制粒中的关键步骤, 条带的性质, 例如密度、固体分数及孔隙率等, 决定颗粒的成型率等性质, 显著影响颗粒的质量。条带性质的常规测定方法, 离线且耗时长, 已无法满足连续生产的需求。而新兴的过程分析技术能够在线实时检测条带性质, 结合数据分析技术, 可反馈、控制和改进条带制备过程, 获得高质量条带, 有利支撑辊压制粒连续生产。基于过程分析技术的条带性质检测方法取得显著进展, 已成为辊压制粒过程分析和控制研究热点。本文系统总结条带性质的常规测定方法和过程分析方法的最新研究进展, 以期对辊压条带性质监测和辊压制粒连续生产提供理论指导。

     

    Abstract: Dry granulation is a highly mechanized method for the preparation of drug granules. Roller compaction is a commonly used dry granulation method. The preparation of roller-compacted ribbons is a key step in dry granulation, and the properties of ribbons, such as density, solid fraction, and porosity, is related to the formation rate of drug granules, and directly determine their quality. The conventional method for measuring ribbons properties, which is off-line and time-consuming, can no longer meet the needs of continuous production. The emerging process analysis technology is capable of online real-time detection of ribbons properties. Combined with data analysis technology, it can provide feedback, control, and improve the ribbons preparation process to obtain high-quality ribbons, which is beneficial for continuous production of roller compaction. The method of detecting ribbon properties based on process analysis technology has made significant progress, and has become a hot topic in the analysis and control of roller compaction processes. This article systematically summarizes the latest progress in conventional determination methods and process analysis methods of ribbon properties, in order to provide theoretical guidance for the monitoring of ribbon properties and the continuous production of roller compaction dry granulation.

     

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