井冈山大学学报（自然科学版）2025，Vol.46Issue(5)：34-43,10.DOI:10.3969/j.issn.1674-8085.2025.05.005
基于DOE设计原理的硼替佐米药物制剂化学工艺优化研究
CHEMICAL PROCESS OPTIMIZATION OF BORTEZOMIB DRUG FORMULATIONS BASED ON DOE DESIGN PRINCIPLE
摘要
Abstract
In this study,the initial screening of prescription factors for critical quality attributes in the chemical process of bortezomib drug formulations was carried out by factorial design method using DOE design of Minitab software.Key factors,including tert-butanol ratio,mixing temperature,solution volume,light exposure,and oxygen concentration,were systematically optimized.Response surface methodology(RSM)was subsequently applied to establish a predictive model through multi-objective optimization,leading to the identification of an optimal formulation process.The feasibility and robustness of this process were further validated via pilot-scale manufacturing trials.This work not only provides a scientific foundation for pharmaceutical formulation optimization but also highlights the efficacy of DOE-based strategies in the complex drug product development.关键词
硼替佐米/DOE设计/处方工艺/注射剂/关键质量属性Key words
Bortezomib/DOE design/prescription process/injectable/critical quality attributes分类
化学化工引用本文复制引用
刘震林,戴悦,王敏杰,李慧玉,罗舟,蒋梓沐,李伟,唐云..基于DOE设计原理的硼替佐米药物制剂化学工艺优化研究[J].井冈山大学学报（自然科学版）,2025,46(5):34-43,10.基金项目
江西省自然科学基金项目(20232BAB206160) （20232BAB206160）
江西省教育厅科技计划项目(GJJ2201634) （GJJ2201634）
