Crystallization process and growth mechanism for spherical products of clopidogrel sulfate

doi:10.11949/j.issn.0438-1157.20151084

CIESC Journal ›› 2015, Vol. 66 ›› Issue (9): 3633-3639.DOI: 10.11949/j.issn.0438-1157.20151084

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Crystallization process and growth mechanism for spherical products of clopidogrel sulfate

WANG Haiyang^1,2, DU Yanni^1,2, LI Zhenfang^1,2, SONG Xiaopeng^1,2, TAN Duanming³, GONG Junbo^1,2

1 School of Chemical Engineering, State Key Laboratory of Chemical Engineering, Tianjin University, Tianjin 300072, China;
2 Collaborative Innovation Center of Chemical Science and Engineering (Tianjin), Tianjin 300072, China;
3 Salubris Pharmaceutical Co., Ltd., Shenzhen 518102, China

Received:2015-07-07 Revised:2015-07-18 Online:2015-09-05 Published:2015-09-05
Supported by:
supported by the National Natural Science Foundation of China (21376174).

硫酸氢氯吡格雷球形结晶工艺及其生长机理

王海洋^1,2, 杜艳妮^1,2, 李振方^1,2, 宋晓鹏^1,2, 谭端明³, 龚俊波^1,2

1 天津大学化工学院化学工程联合国家重点实验室, 天津 300072;
2 天津化学化工协同创新中心, 天津 300072;
3 深圳信立泰药业股份有限公司, 深圳 518102

通讯作者: 龚俊波
基金资助:
国家自然科学基金项目(21376174)。

Abstract

Abstract:

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.

Key words: clopidogrel sulfate, polymorphism, spherical crystallization, growth mechanism

摘要：

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。

关键词: 硫酸氢氯吡格雷, 多晶型, 球形结晶, 生长机理

CLC Number:

TQ463⁺.54

WANG Haiyang, DU Yanni, LI Zhenfang, SONG Xiaopeng, TAN Duanming, GONG Junbo. Crystallization process and growth mechanism for spherical products of clopidogrel sulfate[J]. CIESC Journal, 2015, 66(9): 3633-3639.

王海洋, 杜艳妮, 李振方, 宋晓鹏, 谭端明, 龚俊波. 硫酸氢氯吡格雷球形结晶工艺及其生长机理[J]. 化工学报, 2015, 66(9): 3633-3639.

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Crystallization process and growth mechanism for spherical products of clopidogrel sulfate

硫酸氢氯吡格雷球形结晶工艺及其生长机理

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