摘要
药物制剂中辅料的选择与功能化是现代药剂学研究的重要领域，其对药物的稳定性、释放行为及生物利用度具有关键影响。本研究旨在探讨不同辅料在药物制剂中的作用机制，并通过功能化设计优化辅料性能，以满足特定治疗需求。研究选取了多种常用辅料，包括填充剂、崩解剂、包衣材料等，采用体外模拟实验与分子动力学模拟相结合的方法，系统分析了辅料的理化性质及其对药物释放动力学的影响。结果表明，通过表面修饰或结构改性，可显著改善某些辅料的功能特性，例如提高崩解速度或调控药物释放速率。此外，研究还发现特定辅料组合能够形成协同效应，进一步增强制剂的整体性能。本研究的创新点在于提出了基于“功能导向”的辅料选择策略，并成功开发了一种新型多功能复合辅料，该辅料在缓控释制剂中表现出优异的稳定性和可控性。这一成果为药物制剂的设计提供了新思路，同时为个性化医疗背景下的精准给药奠定了理论和技术基础。
关键词：药物辅料；功能化设计；释放动力学；协同效应；多功能复合辅料
Abstract
The selection and functionalization of excipients in drug formulations represent a critical area of modern pharmaceutics, significantly influencing drug stability, release behavior, and bioavailability. This study investigates the mechanisms of different excipients in drug formulations and optimizes their performance through functional design to meet specific therapeutic requirements. A variety of commonly used excipients, including fillers, disintegrants, and coating materials, were selected for analysis. By combining in vitro simulation experiments with molecular dynamics simulations, the physicochemical properties of these excipients and their effects on drug release kinetics were systematically evaluated. The results demonstrate that surface modification or structural alteration can substantially enhance certain functional characteristics of excipients, such as accelerating disintegration rates or modulating drug release rates. Furthermore, it was found that specific combinations of excipients can produce synergistic effects, thereby improving the overall performance of formulations. An innovative aspect of this study is the proposal of a function-oriented strategy for excipient selection, leading to the successful development of a novel multifunctional composite excipient. This excipient exhibits superior stability and controllability in sustained- and controlled-release formulations. These findings provide new insights into the design of drug formulations and establish a theoretical and technical foundation for precise drug delivery in the context of personalized medicine.
Keywords：Drug Excipients; Functional Design; Release Kinetics; Synergistic Effect; Multifunctional Composite Excipients
目 录
摘要 I
Abstract II
一、绪论 1
(一) 药物制剂中辅料研究的背景与意义 1
(二) 国内外辅料选择与功能化研究现状 1
(三) 本文研究方法与技术路线 1
二、辅料选择的关键因素分析 2
(一) 辅料物理化学性质对制剂的影响 2
(二) 生物相容性与安全性评估标准 3
(三) 制剂稳定性与辅料匹配性研究 3
三、辅料功能化的机制与实现路径 4
(一) 功能化辅料的设计原则与方法 4
(二) 表面修饰技术在辅料中的应用 4
(三) 靶向递送与控释功能的实现策略 5
四、功能化辅料的实际应用与案例分析 5
(一) 在口服固体制剂中的应用研究 5
(二) 在注射剂与纳米制剂中的功能体现 6
(三) 新型功能化辅料开发的挑战与前景 7
结 论 8
参考文献 9
