医药导报2025，Vol.44Issue(6)：894-899,6.DOI:10.3870/j.issn.1004-0781.2025.06.009
基于红外光谱技术米非司酮二元混晶体系定量分析
Quantitative Analysis of Mifepristone Binary Mixed Crystal System Based on Infrared Spectroscopy
摘要
Abstract
Objective The quantitative analysis model of mifepristone binary mixed crystal system was established by infrared spectroscopy to improve the quality control level of Mifepristone raw material.Methods Two mifepristone polymorphs samples were prepared and characterized,and the quantitative analysis model of infrared spectral data was constructed by classical linear regression method and chemometrics method respectively.On this basis,the influence of different factors on the model quality was investigated comprehensively.Results Infrared spectroscopy combined with classical linear regression method and stoichiometric method can build a quantitative analysis model for binary mifepristone polymorphs system,and the model has good linear regression coefficient(R2)and root mean square error of cross validation(RMSECV)values.Conclusions The two polymorphs of mifepristone have independent infrared spectral characteristic peaks that can be used for quantitative study,so the classical linear regression method has more significant methodical advantages for this system.The chemometrics method is more suitable for the quantitative study of complex mixed polymorphs system.关键词
米非司酮/药物多晶型/红外光谱/定量分析Key words
Mifepristone/Polymorphism/Infrared spectroscopy/Quantitative analysis分类
药学引用本文复制引用
周健,杨世颖,张丽,方莲花,杜冠华,吕扬..基于红外光谱技术米非司酮二元混晶体系定量分析[J].医药导报,2025,44(6):894-899,6.基金项目
中国医学科学院医学与健康科技创新工程重大协同创新项目(2022-I2M-1-015) （2022-I2M-1-015）
北京市自然科学基金面上项目(7232258) （7232258）
中央级公益性科研院所基本科研业务费资助项目(2022-RW350-02) （2022-RW350-02）
第四届滕州英才专项 （）
枣庄市自主创新及成果转化计划(重大科技创新工程项目)(2022GH15) （重大科技创新工程项目）
新疆维吾尔自治区2023年天池英才项目. （）
