用X射线衍射法分析多晶型药物晶型一致性  

Experiments on the crystal consistency of polymorphic drug by X-ray diffraction analysis

作　　者：王帅 陈永康[1] 张笑旻[1] 王勇 Wang Shuai;Chen Yongkang;Zhang Xiaomin;Wang Yong(Shanghai Institute of Measurement and Testing Technology)

机构地区：[1]上海市计量测试技术研究院

出　　处：《上海计量测试》2023年第5期14-17,共4页Shanghai Measurement and Testing

摘　　要：通过X射线衍射法对多晶型药物的晶型进行分析,以确认不同批次样品与标准品的晶型一致性。采用X射线衍射分析方法,对药物样品和标准品的特征衍射峰进行了系统性的分析和比较,并对该方法精密度、专属性、耐用性进行了验证研究。不同批次样品与标准品的主要特征峰的2θ值相对标准偏差小于5%,同晶型样品与标准品的主要特征峰2θ值的偏差均小于0.2°。X射线衍射法能够准确、快速地对药物晶型进行一致性确认,并广泛应用于药物的多晶型分析中。The crystal form of polymorphic drugs was analyzed by X-ray diffraction to confirm the crystal form consistency of different batches of samples with standard.The characteristic diffraction peaks of drug samples and standard were systematically analyzed and compared by X-ray diffraction analysis,and the precision,specificity and durability of the method were verified and studied.The relative standard deviation of the 2θvalue of the characteristic peak of different batches of samples and the standard was less than 5%,and the deviation of the characteristic peak 2θvalue of sample and standard was less than 0.2°.X-ray diffraction can confirm the consistency of drug crystal form specifically,accurately and quickly,and can be widely used in drug polymorph analysis.

关 键 词：X射线衍射 药物多晶型 晶型一致性 方法验证 

分 类 号：R917[医药卫生—药物分析学]