硫酸氢氯吡格雷球形结晶工艺及其生长机理

摘要

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.%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.