普瑞巴林化学拆分过程研究

发布时间：2018-02-24 09:03

本文关键词： 普瑞巴林扁桃酸拆分过程制备　出处：《郑州大学学报(工学版)》2015年04期 　论文类型：期刊论文

【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]:Study on chemical separation process by S-. Pregabalin (+) - mandelic acid as resolution agent of pregabalin racemic chemical resolution, HPLC method was used to determine the content of each component in the separation process, the effects of different separation conditions component content changes, obtained better resolution of pregabalin conditions, and verified further testing. Based on the study of better separation conditions obtained with good reproducibility, can be more than 99.5% of Bahrain was obtained, fully meet the requirements of Chinese Pharmacopoeia, the size of each batch of qualified products can reach no less than 100 g. for the study of Bahrain Puri industrialization preparation provides valuable theoretical basis for research.

【作者单位】：郑州大学化工与能源学院;河南辅仁医药科技开发有限公司;
【基金】：河南省科技厅产学研合作项目(132107000016) 河南省教育厅科学技术研究重点资助项目(14A530007)
【分类号】：R914

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