普卢利沙星3种晶型的制备、表征与稳定性研究  

Preparation,characterization and stability of three forms of prulifloxacin

作　　者：黄茵茵 张立雯[1] 刘静 陈静[1] 周远华[1] 许明哲[2] 姚尚辰[2] 王晨[2] 张现化[3] HUANG Yinyin;ZHANG Liwen;LIU Jing;CHEN Jing;ZHOU Yuanhua;XU Mingzhe;YAO Shangchen;WANG Chen;ZHANG Xianhua(Guangzhou Institute for Drug Control,Guangzhou Guangdong 510160,China;National Institutes for Food and Drug Control,Beijing 102629,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]广州市药品检验所,广东广州510160 [2]中国食品药品检定研究院,北京102629 [3]北京大学第三医院药剂科,北京100191

出　　处：《中国药物警戒》2023年第4期374-378,共5页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(SQ2022YFC3401205);广州市科技计划项目(202102080660)。

摘　　要：目的研究普卢利沙星的多晶型特征,为该药晶型杂质成分的质量控制提供科学依据。方法制备了普卢利沙星的3种晶型(晶型Ⅰ、晶型Ⅱ和晶型Ⅲ),采用粉末X射线衍射法、红外光谱法、差示扫描量热分析、拉曼光谱法对普卢利沙星3种晶型进行了表征分析,并通过混悬实验探索3种晶型之间的转化规律及稳定性关系。结果粉末X射线衍射法、红外光谱法、差示扫描量热分析、拉曼光谱法均能有效区分普卢利沙星的3种晶型,晶型间的稳定性关系为晶型Ⅰ>晶型Ⅱ>晶型Ⅲ。结论本实验建立的分析方法为普卢利沙星晶型控制标准的制定提供依据。Objective To study the polymorphism of prulifloxacin and provide a scientific basis for the quality control of the polymorphic impurities in the drug.Methods Three forms of prulifloxacin(formⅠ,formⅡand formⅢ)were prepared.The forms were characterized by using powder X-ray diffraction,infrared spectroscopy,differential scanning calorimetry and Raman spectroscopy,and the stability relationship and crystal transformation rules of the three forms were explored by suspension experiments.Results Powder X-ray diffraction,infrared spectroscopy,thermal analysis and Raman spectroscopy were used to identify the three polymorphs of prulifloxacin effectively.The stability relationship of forms is:formⅠ>formⅡ>formⅢ.Conclusion This study provides references for the formulation of the standard of prulifloxacin.

关 键 词：普卢利沙星 多晶型 表征 稳定性 粉末X射线衍射法 红外光谱法 差示扫描量热分析 拉曼光谱法 

分 类 号：R917[医药卫生—药物分析学]