在固体药物剂型中对梅拉德反应进行全面的审查:专注于乳糖
Jia Xiang1,2,3, Shipeng Chen1,2, Songwen Tan1,3,4,5
1Hunan Provincial Key Laboratory of the Research and Development of Novel Pharmaceutical Preparations, Changsha Medical University, Changsha, Hunan, China.
Expert opinion on drug delivery
|January 7, 2026
概括
药物和乳糖等辅料之间的梅拉德反应可以降解固体剂型. 积极的战略,包括兼容性研究,对于优化配方和确保药物产品质量至关重要.
科学领域:
- 制药科学 制药科学
- 药物运输 药物运输 药物运输
- 化学动力学 化学动力学
背景情况:
- 固体剂型易受梅拉德反应的影响,梅拉德反应是一种涉及减少辅助剂和含有氨基基组的药物的化学过程.
- 这种反应会导致变色,杂质形成和活性成分降解,损害药品质量并影响辅助剂的选择.
研究的目的:
- 系统地探索 Maillard 反应在固体剂量形式使用乳糖作为模型减少辅助剂.
- 提供理论见解和实践指导,以优化制药配方,加强质量控制和推动药物产品开发方面的创新.
主要方法:
- 在实物剂量形式的Maillard反应研究的文献综述,利用谷歌学者和PubMed.
- 对反应机制,影响因素和控制策略的分析.
- 检查药品制剂中的潜在应用.
主要成果:
- 乳糖和含氨酸药物之间的梅拉德反应对制药物的稳定性和安全性构成重大风险.
- 控制这种反应对于仿制药的开发至关重要,以确保与参考列表药物 (RLD) 的生物等价性.
结论:
- 建议采取主动的方法,从开发的早期开始,通过兼容性评估和机制研究,而不仅仅是避免乳糖.
- 有效的控制措施可以将梅拉德反应的挑战转化为配方优化和创新的机会,从而产生更高质量的固体剂型.
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