Effect of high temperature environment on quality characteristics of oral solid dosage forms
高温环境对口服固体制剂质量特性的影响

摘要

随着全球气候变暖及药品流通环节温度波动，高温环境对口服固体制剂质量特性的影响备受关注。阐述高温致使口服固体制剂发生物理化学变化，破坏药物稳定性、崩解性与溶出度，进而影响疗效与安全性。分析高温加速药物降解、引发制剂物理形态改变等作用机制，提出优化处方工艺、改进包装材料、完善储存运输条件等应对策略。经系统研究，明确高温与口服固体制剂质量特性的关联，为保障药品质量提供理论与实践依据。

Abstract

As global warming and temperature fluctuations in the pharmaceutical distribution process increase, the impact of high-temperature environments on the quality characteristics of oral solid dosage forms has garnered significant attention. This paper elucidates how high temperatures cause physical and chemical changes in oral solid dosage forms, compromising drug stability, disintegration, and dissolution, thereby affecting efficacy and safety. It analyzes the mechanisms by which high temperatures accelerate drug degradation and alter the physical properties of formulations, proposing strategies such as optimizing formulation processes, improving packaging materials, and enhancing storage and transportation conditions. Through systematic research, the relationship between high temperatures and the quality characteristics of oral solid dosage forms is clarified, providing theoretical and practical support for ensuring drug quality.