摘要
药物包装材料作为保障药品质量的重要组成部分，其对药物稳定性的影响日益受到关注。本研究旨在探讨不同包装材料对药物稳定性的作用机制及其实际应用效果，以期为优化药物包装设计提供科学依据。研究选取了常用包装材料（如玻璃、聚乙烯、铝箔等）并结合加速和长期稳定性试验进行系统评估。通过模拟不同环境条件下的光照、温度和湿度变化，分析包装材料的阻隔性能、化学稳定性和机械强度对药物降解速率的影响。结果表明，高阻隔性材料能够显著降低外界因素对药物活性成分的干扰，延长药物的有效期；同时，特定材料与药物成分之间可能存在相互作用，需在包装选择中加以考虑。本研究创新性地引入了多因素交互分析模型，揭示了包装材料特性与药物稳定性之间的定量关系，并提出了基于风险评估的包装材料优选策略。这一成果不仅丰富了药物包装领域的理论基础，也为制药行业提供了更具针对性的技术指导，有助于提升药品的整体质量和安全性。
关键词：药物稳定性；包装材料；阻隔性能；相互作用；风险评估
Abstract
Pharmaceutical packaging materials, as a critical component for ensuring drug quality, have increasingly drawn attention regarding their impact on drug stability. This study aims to explore the mechanisms by which different packaging materials affect drug stability and evaluate their practical application effects, thereby providing scientific evidence for optimizing pharmaceutical packaging design. Commonly used packaging materials, such as glass, polyethylene, and aluminum foil, were selected and systematically assessed through accelerated and long-term stability tests. By simulating variations in light exposure, temperature, and humidity under diverse environmental conditions, the study analyzed how the barrier properties, chemical stability, and mechanical strength of packaging materials influence the degradation rate of drugs. The results indicate that high-barrier materials can significantly reduce interference from external factors on the active ingredients of drugs, thereby extending their shelf life. Additionally, potential interactions between specific materials and drug components must be considered during packaging selection. Innovatively, this study introduced a multi-factor interaction analysis model to reveal the quantitative relationship between packaging material characteristics and drug stability, proposing a risk-assessment-based strategy for selecting optimal packaging materials. This achievement not only enriches the theoretical foundation of pharmaceutical packaging but also offers more targeted technical guidance to the pharmaceutical industry, contributing to the overall improvement of drug quality and safety.
Keywords：Drug Stability; Packaging Materials; Barrier Performance; Interaction; Risk Assessment
目 录
摘要 I
Abstract II
一、绪论 1
(一) 药物包装材料与稳定性的背景 1
(二) 国内外研究现状分析 1
(三) 研究方法与技术路线 2
二、药物包装材料的特性分析 2
(一) 包装材料的物理性能评估 2
(二) 包装材料的化学稳定性研究 3
(三) 包装材料对环境因素的响应 3
三、包装材料对药物稳定性的影响机制 4
(一) 水分渗透对药物稳定性的影响 4
(二) 氧气透过对药物降解的作用 4
(三) 光线穿透与药物光敏性关联 5
四、包装材料优化与药物稳定性提升策略 5
(一) 新型包装材料的应用探索 5
(二) 包装设计对药物保护的效果 6
(三) 实验验证与案例分析 7
结 论 8
参考文献 9
