建模与模拟在口服固体制剂研发中的应用

Application of Modeling and Simulation in the Development of Oral Solid Dosage Forms

口服固体制剂(oralsolid dosage forms,OSD)具有服用、运输、携带方便,质量稳定性好,释放速率可满足不同临床需求等特点,在保护和促进公众健康方面发挥着重要作用。但是,现行的实验设计研究方法囿于耗时长、成本高且结果不可预测的困境。本文介绍了建模与模拟方法的优势,以及课题组在OSD建模与模拟方面的研究进展,以期为OSD由批制造向数字化、连续化和智能化等先进制造转变提供理论基础及研究范式的转变思路。

Oral solid dosage forms(OSD)exhibit characteristics of convenient transportation,good quality stability,and can meet different clinical needs for release rates,playing an important role in protecting and promoting public health.However,current experimental design research methods are limited by the challenges of time-consuming processes,high costs,and unpredictable results.This article introduces the advantages of modeling and simulation methods,as well as the research progress of the research team in OSD modeling and simulation,in order to provide a theoretical basis and paradigm shift for the transformation of OSD from batch manufacturing to advanced manufacturing approaches such as digitalization,continuity,and intelligence.