CAJ | 학술논문

本文测定了硫酸氢氯吡格雷Ⅰ、Ⅱ晶型在仲丁醇中的溶解度,通过过程分析和优化,制备了纯Ⅰ晶型的硫酸氢氯吡格雷球形晶体.与非球形晶体比较,球形晶体在堆密度、流动性、粒度分布以及稳定性等方面均占优势.本文考察了不同温度、残留溶剂对硫酸氢氯吡格雷晶习与晶型的影响,研究了硫酸氢氯吡格雷球形结晶过程晶体的生长机理.
본문측정료류산경록필격뢰Ⅰ、Ⅱ정형재중정순중적용해도,통과과정분석화우화,제비료순Ⅰ정형적류산경록필격뢰구형정체.여비구형정체비교,구형정체재퇴밀도、류동성、립도분포이급은정성등방면균점우세.본문고찰료불동온도、잔류용제대류산경록필격뢰정습여정형적영향,연구료류산경록필격뢰구형결정과정정체적생장궤리.
The difference between solubility of clopidogrel sulfate form Ⅰ and form Ⅱ in 2-butanol was determined by dynamic method. Based on process analysis and optimization of clopidogrel sulfate crystallization in solutions, clopidogrel sulfate of form Ⅰ was acquired with spherical shape. Compared with the non-spherical products, the spherical one possesses advantages in bulk density, flow ability, size distribution and stability. The crystal habit and crystal form of products prepared at different temperatures and residual solvents were investigated, the kinetics and growth mechanism of the spherical crystallization process was studied.