硫酸氢氯吡格雷软胶囊的研究

发布时间：2018-02-14 20:32

本文关键词： 硫酸氢氯吡格雷软胶囊稳定性　出处：《河北大学》2014年硕士论文　论文类型：学位论文

【摘要】：硫酸氢氯吡格雷化学式为(S)-α-(2-氯苯基)-6,7-二氢噻吩并[3,2-e]吡啶-5(4H)乙酸甲酯硫酸氢盐,是新一代的抗血小板凝聚剂。本品是一种用于急性冠脉综合症的抗血小板临床常用药,能选择性地抑制ADP与血小板受体的结合,随后抑制激活ADP与糖蛋白GP IIb/IIIa复合物,从而抑制血小板的聚集,也可抑制非ADP引起的血小板聚集,不影响磷酸二酯酶的活性。通过不可逆地改变血小板ADP受体,使血小板的寿命受到影响。本研究的目的是制备硫酸氢氯吡格雷软胶囊,建立硫酸氢氯吡格雷软胶囊的质量标准,并对其稳定性进行研究。本章共分五部分:第一章对硫酸氢氯吡格雷的基本情况、合成路线以及最近的研究进展进行了综述。第二章介绍了硫酸氢氯吡格雷软胶囊的制备。第三章建立了硫酸氢氯吡格雷软胶囊的质量标准。第四章对硫酸氢氯吡格雷的稳定性进行了考察,包括光稳定性以及在p H1.2缓冲溶液中的稳定性。最后对全文进行了总结,硫酸氢氯吡格雷软胶囊对光敏感,需要避光保存,而在p H1.2胃p H环境下较为稳定。
[Abstract]:Hydrogen clopidogrel sulfate is a new generation of antiplatelet coagulant. It is a common antiplatelet drug for acute coronary syndrome. It can selectively inhibit the binding of ADP to platelet receptor, and then inhibit the activation of ADP / GP IIb/IIIa complex, thereby inhibiting platelet aggregation, but also inhibiting platelet aggregation induced by non-#en3#. The activity of phosphodiesterase was not affected. The platelet life was affected by irreversibly changing platelet ADP receptor. The aim of this study was to prepare hydroclopidogrel sulfate soft capsule and to establish the quality standard of hydroclopidogrel sulfate soft capsule. This chapter is divided into five parts: the first chapter is about the basic situation of hydrogen clopidogrel sulfate. The preparation of clopidogrel sulfate soft capsules is introduced in chapter 2. The quality standard of clopidogrel sulfate soft capsules is established in chapter 3. Chapter 4th is about the preparation of clopidogrel sulfate soft capsules. Gray's stability was investigated. The results showed that clopidogrel sulfate soft capsule was sensitive to light and needed to be preserved without light, but it was stable in pH 1.2 gastric pH environment.
【学位授予单位】：河北大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R943

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