摘要
中药生产智能化已成为中药发展必然趋势,中药制剂生产过程信息化、自动化是实现中药智能制造的前提,其中输入物料属性、输出产品质量属性辨识与表征、大数据统计与积累即为信息化基础。物料属性研究对于终产品质量控制具有重要意义,但目前缺乏对中药丸剂属性研究的系统归纳与总结。因此,笔者从粉体学属性、流变属性、质构属性3种分类出发,对中药丸剂单元工艺中涉及原料、辅料与中间体属性进行总结,分析物料属性对终产品质量的影响规律;对丸剂工艺中涉及的属性表征技术进行总结,并对终产品质量属性表征方法提出建议;基于质量源于设计(QbD)理念,提出物料属性研究应与过程分析技术(PAT)相结合,将药品质量控制重心前移,指导装备升级,以期实现中药丸剂智能化连续制造。
As intelligent production of traditional Chinese medicine(TCM)has been inevitable,informatization and automation of the production process have become the precondition for realizing intelligent manufacturing of TCM,of which the accumulation of critical material attribute and the critical quality attribute are the basis.The study of material properties is of great significance to achieve the quality control of the final product in the process,but there is a lack of systematic induction and summary of the research on the attribute of TCM pills.Therefore,the authors analyzed and summarized the attributes of raw materials,excipients and intermediates in the pill unit process according to the classification of powder properties,rheological properties and texture properties.What’s more,the impact of material attributes on the quality of the final product was summarized.Besides,this review summarized the attribute characterization techniques involved in the pill process and provided some suggestions for the characterization of product quality attributes.Finally,based on the concept of quality by design(QbD),the authors proposed that the study of material attribute should be combined with process analytical technology(PAT),and the focus of drug quality control should be moved forward to guide equipment upgrading,so as to realize intelligent continuous manufacturing of TCM pills.
作者
赵舒婷
杨白雪
谢佳蓉
熊皓舒
孙玉侠
李艳梅
章顺楠
柳文媛
ZHAO Shu-ting;YANG Bai-xue;XIE Jia-rong;XIONG Hao-shu;SUN Yu-xia;LI Yan-mei;ZHANG Shun-nan;LIU Wen-yuan(China Pharmaceutical University,Nanjing 211198,China;National&Local United Engineering Laboratory for Traditional Chinese Medicine Advanced Manufacturing Technology,Tasly Pharmaceutical Group Co.Ltd.,Tianjin 300410,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2022年第3期259-265,共7页
Chinese Journal of Experimental Traditional Medical Formulae
基金
天津市工信局中药口服制剂智能制造试点示范项目。
关键词
中药
丸剂
物料属性
质量源于设计(QbD)
质量控制
智能化
traditional Chinese medicine
pills
material attributes
quality by design(QbD)
quality control
intelligent
