[1]李雯,刘春霞,于玉振,等.普瑞巴林化学拆分过程研究[J].郑州大学学报(工学版),2015,36(04):33-36.[doi:10.3969/ j.issn.1671 -6833.2015.04.008]
　Ll Wen,LIU Chun-xia,YU Yu-zheng,et al.Research of the Chemical Resolution Process for Pregabalin[J].Journal of Zhengzhou University (Engineering Science),2015,36(04):33-36.[doi:10.3969/ j.issn.1671 -6833.2015.04.008]
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普瑞巴林化学拆分过程研究()
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《郑州大学学报(工学版)》[ISSN:1671-6833/CN:41-1339/T]

卷:
36卷
期数:
2015年04期
页码:
33-36
栏目:
出版日期:
2015-08-31

文章信息/Info

Title:
Research of the Chemical Resolution Process for Pregabalin
作者:
李雯1; 刘春霞1; 于玉振1; 张―华1; 陈水库2; 张方杰2
1.郑州大学化工与能源学院,河南郑州450001;2.河南辅仁医药科技开发有限公司,河南郑州450003
Author(s):
Ll Wen1; LIU Chun-xia1; YU Yu-zheng2; ZHANG Hua1; CHEN Shui-ku1; ZHANG Fang-jie1
1. School of Chemical Engineering and Energy ,Zhengzhou University ,Zhengzhou 450001，China;2.Henan Furen Pharmaceutical Technology Development Co. Ltd ，Zhengzhou 450002，China
关键词:
普瑞巴林; 扁桃酸; 拆分过程; 制备
Keywords:
S-Mandelic acid ;  chemical resolution ;  preparation
分类号:
R971.6
DOI:
10.3969/ j.issn.1671 -6833.2015.04.008
文献标志码:
A
摘要:
对普瑞巴林化学拆分过程进行研究.以S -( +) -扁桃酸为拆分剂对普瑞巴林消旋体进行化学拆分,采用HPLC法测定拆分过程中各组分含量,考察不同拆分条件下各组分含量变化的规律,得出普瑞巴林较佳拆分条件,并进行进一步的验证试验.基于该研究所获得的较佳拆分条件重复性良好,所获得的巴林含量可达99.5%以上,完全符合药典要求,规模可达到每批次合格品不少于100 g.该研究为普瑞巴林工业化制备提供了有价值的理论研究依据．
Abstract:
This paper studies the chemical resolution process of Pregabalin.Process for resolving racemic Pre-gabalin to S- Pregabalin by using S- mandelic acid as the resolving agent, the content of each component in theresolution process were determined by HPLC method. The optimum resolution conditions were obtained by theinvestigations of the rule in the content variations of different components under different conditions and veri-fied by the further tests. The optimum resolution conditions obtained from this study have good repeatability ,and the content of Pregabalin could reach more than 99.5% which fully meets the requirements of Pharmaco-poeia， the amount per batch of qualified products is not less than 100 g. This study provides a valuable theo-retical foundation for the industrialized preparation of Pregabalin.
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