拉曼光谱在咪唑斯汀缓释片晶型鉴别中的应用  

Application of Raman Spectroscopy in Crystal Identification of Mizolastine Sustained-Release Tablet

作　　者：陈东 杨震 王重文 高明 刘晖晖 吴传斌[1] Chen Dong;Yang Zhen;Wang Zhongwen;Gao Ming;Liu Huihui;Wu Chuanbin(School of pharmacy,Sun Yat sen University,Guangzhou 510006;China Resources Sanjiu Pharmaceutical Co.,Ltd,Shenzhen 518110;Nycrist Pharmatech Limited,Shenzhen 518107)

机构地区：[1]中山大学药学院,广州510006 [2]华润三九医药股份有限公司,深圳518110 [3]深圳市新阳唯康科技有限公司,深圳518107

出　　处：《生命科学仪器》2020年第3期59-65,共7页Life Science Instruments

基　　金：广东省小分子新药创新中心项目。

摘　　要：固体制剂多晶型药物仿制药一致性评价研究工作中,需对自制制剂和参比制剂中主药晶型的一致性进行研究。咪唑斯汀缓释片中主药含量占比低于5%,且辅料组分乳糖对主药晶型分析具有干扰,单独采用X射线粉末衍射法进行制剂晶型分析难度较大。本文采用拉曼光谱法,辅以X射线粉末衍射法对咪唑斯汀缓释片中咪唑斯汀的晶型进行鉴别。应用拉曼成像的方法,定位活性成分在缓释片制剂中分布较为集中的区域,再采用单点检测,精准采集制剂活性成分拉曼信号。将经X射线粉末衍射法确证为Form A的原料药进行拉曼单点检测,并与制剂中活性成分的拉曼信号进行对比。结果显示,自制咪唑斯汀缓释片中主药为Form A,且与原研制剂一致。证明本方法在制剂中主药含量低且辅料对主药X射线衍射分析有干扰的晶型鉴别中具有应用价值。The crystal form of mizolastine in sustained-release tablets was identified by Raman spectroscopy and X-ray powder diffraction.Raman microscope was used to locate the active ingredient in tablet,and Single Point Detection was used to collect the Raman signal of mizolastine.The collected signals of mizolastine in sustained-release tablets were compared with the signal of mizolastine Form A(as indicated by XRPD).The results showed that the crystal form of mizolastine in sustained-release tablets is Form A,which is consistent with the Original Preparation.

关 键 词：拉曼光谱 X射线粉末衍射 咪唑斯汀 晶型 质量和疗效一致性评价 

分 类 号：O657.37[理学—分析化学]