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

作　　者：宋梅 禹晓梅 Song Mei;Yu Xiaomei(Jiangsu Union Technical Institute,Xuzhou Medical Branch,Xuzhou 221116,China)

机构地区：[1]江苏联合职业技术学院徐州医药分院,江苏徐州221116

出　　处：《云南化工》2024年第7期45-48,共4页Yunnan Chemical Technology

基　　金：江苏联合职业技术学院徐州医药分院自然科研课题。

摘　　要：目的:基于质量源于(QbD)设计理念对硼替佐米原研药制剂进行优化,并进行质量验证。方法:加入叔丁醇作为助溶剂,对处方中主药、辅料的用量进行筛选;设计优化关键工艺参数(CPPS),并通过中间体含量测定关键质量属性(CQA)的控制进行方法学验证。结果:采用紫外可见分光光度法于270 nm波长,以甲醇为参比,按对照品比较法以吸光度计算样品中硼替佐米含量符合制剂产品的含量规定;在室温下放置,溶液的稳定性良好。结论:优化方案可行,处方优化后达到降低产品成本、产品稳定性和质量均优于原研产品的预期。(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 

分 类 号：R97[医药卫生—药品]