云南化工2024，Vol.51Issue(7)：45-48,4.DOI:10.3969/j.issn.1004-275X.2024.07.11
基于质量源于设计理念的硼替佐米冻干粉针剂优化及验证
Formulation Optimization and Quality Verification of Bortezomib Lyophilized Powder Injection Based on the QbD Concept
摘要
Abstract
(Objective)To optimize the formulation of bortezomib original research drug and verify its quality based on the quality by design(QbD)concept.(Methods)Tert-butanol was added as a co-solvent,the dosage of main drugs and auxiliary materials in the prescription was screened,the CPPS were designed and optimized.The methodology was validated by controlling CQA such as intermediate content.(Results)The determination of bortezomib content in the sample was conducted by employing ultraviolet-visible spectrophotometry at a wavelength of 270 nm,with methanol serving as the reference.This approach adhered to the regulations regarding product content preparation;liquor was stable when it was placed at room temperature.(Conclusion)The preparation process is feasible;After the prescription optimization,the cost of the product was reduced and the stability and quality of the product were better than the expectation of the original product.关键词
质量源于设计/硼替佐米/冻干粉针剂/处方优化/质量验证Key words
Quality by Design(QbD)/Bortezomib/Lyophilized Powder Injection/Prescription Optimization/Quality Verification分类
医药卫生引用本文复制引用
宋梅,禹晓梅..基于质量源于设计理念的硼替佐米冻干粉针剂优化及验证[J].云南化工,2024,51(7):45-48,4.基金项目
江苏联合职业技术学院徐州医药分院自然科研课题. （）
