近红外光谱法在药物多晶型定量中的研究策略  

Research Strategy of Near Infrared Spectroscopy in Quantitative Analyzing Drug Polymorphism

作　　者：周浩 赵媛媛 王欢 张士博 闫庆芳 王慧洁 Zhou Hao;Zhao Yuanyuan;Wang Huan;Zhang Shibo;Yan Qingfang;Wang Huijie(Chia Tai Tianqing Pharmaceutical Co.,Ltd.,Nanjing 211100,China)

机构地区：[1]正大天晴药业集团股份有限公司,江苏南京211100

出　　处：《山东化工》2023年第5期105-107,共3页Shandong Chemical Industry

摘　　要：为建立可靠、准确的药物多晶型定量研究方法,根据国内外晶型研究指导原则和NIRS分析技术重要标准及实际研发工作经验,从代表性样本集的制备、NIRS建模、方法验证等方面,对多晶型定量研究的关键问题进行系统的分析与探讨研究,解决近红外光谱(Near Infrared Spectroscopy, NIRS)分析技术在多晶型定量研究中的应用问题,对后续制药企业应用NIRS法进行产品质量控制提供参考,通过综述NIRS在药物多晶型定量研究中方法开发和验证的基本策略,提供科学的NIRS多晶型定量研究思路。To establish a reliable and accurate method for drug polymorphism quantitative research,on the basis of pharmaceutical solid polymorphism guiding principles and NIRS important standards,combined with practical R&D work experience,the key issues of polymorphism quantitative research are systematically analyzed and discussed,from the aspects of preparation of representative sample sets,NIRS model development,and method validation.To solve the application problems of NIRS analysis technology in polymorphism quantitative study,and provides references for pharmaceutical enterprises to meet the product quality control requirements using near infrared spectroscopy(NIRS).This article reviews the basic strategies for method development and validation of NIRS in the quantitative study of drug polymorphism,providing scientific ideas for polymorphism quantitative research of NIRS.

关 键 词：药物多晶型 定量分析 近红外光谱法 方法开发与验证 

分 类 号：TQ460.7[化学工程—制药化工] O657.3[理学—分析化学]