摘要
目的:建立硫酸氯吡格雷晶型的测定方法,并对国内硫酸氯吡格雷原料的晶型进行考察。方法:差示扫描量热法(DSC),热重分析法(TG),中红外和近红外光谱法(MIR&NIR)及 X 射线衍射(X-ray)法。结果:国内厂家生产的硫酸氯吡格雷原料存在晶型不一致的现象。结论:硫酸氯吡格雷的晶型可以采用热分析法、NIR 法及 X-ray 法测定,其中 NIR 法及 DSC法简便易行。
Objective：To establish determination method of clopidogrel hydrogensulfate polymorphs, to analyze the polymorphs of raw material of clopidogrel hydrogensulfate at home. Methods： Differential scanning calorimeter （DSC） , thermogravimetry （TG） , mid- infrared spectroscopy and near- infrared spectroscopy （MIR＆NIR） and X -ray. Results：Raw material of clopidogrel hydrogensulfate produced by pharmaceutical factory at home had different polymorphs. Conclusion ： polymorphs of clopidogrel hydrogensulfate could be determined by thermal analysis, NIR and X -ray. Among the methods NIR and DSC were simple and practical.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第9期1115-1118,共4页
Chinese Journal of Pharmaceutical Analysis
