制药结晶中的先进过程控制

赵绍磊; 王耀国; 张腾; 周丽娜; 龚俊波; 汤伟伟

doi:10.11949/0438-1157.20190728

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制药结晶中的先进过程控制

综述与专论 | 更新时间：2026-07-24

- 制药结晶中的先进过程控制
- Advanced process control of pharmaceutical crystallization
- 化工学报 2020年71卷第2期页码：459-474
- 作者机构：
  
  天津大学化工学院，化学工程联合国家重点实验室，天津 300072
- 作者简介：
  
  赵绍磊（1994—），男，硕士研究生， shaoleizhao@tju.edu.cn
  龚俊波（1974—），男，博士，教授， junbo_gong@tju.edu.cn
  汤伟伟（1988—），男，博士，讲师， wwtang@tju.edu.cn
- 基金信息：
  
  国家自然科学基金项目(21808159;91634117);化学工程联合国家重点实验室开放课题(SKL-ChE-18B04)
- DOI：10.11949/0438-1157.20190728
  中图分类号： TQ 028.5
- 收稿：2019-06-27，
  
  修回：2019-11-22，
  
  网络首发：2020-08-14，
  
  纸质出版：2020-02-05
- 稿件说明：
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赵绍磊, 王耀国, 张腾, 周丽娜, 龚俊波, 汤伟伟. 制药结晶中的先进过程控制[J]. 化工学报, 2020, 71(2): 459-474

ZHAO Shaolei, WANG Yaoguo, ZHANG Teng, ZHOU Lina, GONG Junbo, TANG Weiwei. Advanced process control of pharmaceutical crystallization[J]. CIESC Journal, 2020, 71(2): 459-474
赵绍磊, 王耀国, 张腾, 周丽娜, 龚俊波, 汤伟伟. 制药结晶中的先进过程控制[J]. 化工学报, 2020, 71(2): 459-474 DOI： 10.11949/0438-1157.20190728.

ZHAO Shaolei, WANG Yaoguo, ZHANG Teng, ZHOU Lina, GONG Junbo, TANG Weiwei. Advanced process control of pharmaceutical crystallization[J]. CIESC Journal, 2020, 71(2): 459-474 DOI： 10.11949/0438-1157.20190728.

摘要

结晶作为固-液分离的重要手段，是实现医药产品高端高值化的关键技术。药物结晶过程的精准控制决定了晶体产品的多晶型、晶习、粒度及粒度分布等诸多特性，对生产效率和产品质量的提升具有重要的意义。基于国内外对药物结晶过程控制的研究现状，结合相关案例，系统总结了制药结晶中先进过程控制的理论模型、监测手段和控制策略，重点分析讨论了过程控制在产品工程中的应用并对其发展趋势进行了展望。

Abstract

As an important means of solid-liquid separation

the crystallization from solution is a key technology for achieving high value of pharmaceutical products. The precise control of pharmaceutical crystallization process can tailor the solid properties such as polymorph

crystal habit

particle size and particle size distribution

which has a significant effect on the overall efficiency of the solid production process and the quality of the final product. On the basis of the domestic and international research progresses on the topic of pharmaceutical crystallization and process control

this review systemically summarizes the theoretical models

monitoring methods and control strategies of advanced process control of pharmaceutical crystallization. It will mainly focus on the analysis and discussion of the application of process control technologies in product engineering and the trend of development towards complex systems.

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Keywords

references

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