摘要
药物多晶型现象作为药学领域的重要研究课题，对药物的理化性质、生物利用度及临床疗效具有显著影响，因此其表征与控制策略一直是学术界和工业界的关注焦点本研究以多种典型药物为模型，系统探讨了多晶型现象的形成机制及其对药物性能的影响，并通过结合X射线衍射、差示扫描量热法、拉曼光谱等多种现代分析技术，建立了高效、精准的多晶型表征方法此外，研究创新性地提出了一种基于溶剂工程和温度调控的多晶型控制策略，该策略能够实现目标晶型的定向制备和稳定维持实验结果表明，所开发的方法不仅显著提高了目标晶型的纯度和产率，还有效解决了传统工艺中晶型不稳定的问题，为药物多晶型的质量控制提供了新思路总体而言，本研究在理论层面深化了对药物多晶型现象的理解，在应用层面为优化药物制剂工艺和提升药品质量奠定了基础，其研究成果对推动制药行业的技术创新具有重要意义
关键词：药物多晶型；表征方法；控制策略；溶剂工程；温度调控
Abstract
Pharmaceutical polymorphism, as a significant research topic in the field of pharmacy, has a profound impact on the physicochemical properties, bioavailability, and clinical efficacy of drugs. Consequently, its characterization and control strategies have remained focal points for both academia and industry. This study employed multiple typical drugs as models to systematically investigate the formation mechanisms of polymorphism and its influence on drug performance. By integrating modern analytical techniques such as X-ray diffraction, differential scanning calorimetry, and Raman spectroscopy, an efficient and precise method for polymorph characterization was established. Furthermore, an innovative polymorph control strategy based on solvent engineering and temperature modulation was proposed, enabling the directed preparation and stable maintenance of target polymorphs. Experimental results demonstrated that the developed methods not only significantly enhanced the purity and yield of the target polymorph but also effectively addressed the issue of polymorph instability encountered in traditional processes, providing new insights into the quality control of pharmaceutical polymorphism. Overall, this study deepened the theoretical understanding of pharmaceutical polymorphism while laying a foundation for optimizing drug formulation processes and improving drug quality at the application level. The research findings hold substantial significance for promoting technological innovation in the pharmaceutical industry.
Keywords：Drug Polymorphism; Characterization Methods; Control Strategies; Solvent Engineering; Temperature Regulation
目 录
摘要 I
Abstract II
一、绪论 1
(一) 药物多晶型现象的研究背景 1
(二) 表征与控制策略的研究意义 1
(三) 国内外研究现状分析 1
(四) 本文研究方法与结构安排 2
二、药物多晶型的表征技术 2
(一) X射线衍射技术的应用 2
(二) 红外光谱与拉曼光谱分析 2
(三) 差示扫描量热法的作用 3
(四) 表征技术的综合评价 3
三、多晶型形成机制与影响因素 4
(一) 晶体生长过程中的关键机制 4
(二) 温度与压力对多晶型的影响 5
(三) 溶剂效应与结晶条件优化 5
(四) 杂质与添加剂的作用分析 6
四、多晶型控制策略与应用实践 6
(一) 结晶工艺的优化设计 6
(二) 制备条件的精确调控 7
(三) 稳定性评估与质量控制 7
(四) 控制策略的实际案例分析 8
结 论 9
参考文献 10
