中国药典《药品包装用塑料材料和容器指导原则》的框架体系与核心内容解析

Analysis of the Framework and Core Content of the Chinese Pharmacopoeia Guidelines for Plastic Materials and Containers Used in Pharmaceutical Packaging

关键词:  中国药典  药包材  指导原则  塑料材料和容器

Key words:  Chinese Pharmacopoeia  Pharmaceutical packaging  Guideline  Plastic materials and containers

摘要:

药品包装作为保障药品质量与安全的重要屏障,其标准化与规范化程度直接影响药品的有效性和患者用药安全。《中国药典》2025年版对药品包装材料与容器的质量标准进行了全面升级,其中9624《药品包装用塑料材料和容器指导原则》作为塑料类药包材的核心技术规范,为制药行业和药包材生产企业提供了科学、系统的质量控制标准,本文对药品包装用塑料材料和容器指导原则的框架体系及核心内容进行系统解析,为药品包装材料的生产、使用和质量控制提供参考依据。

Abstract:

Harmaceutical packaging serves as a critical barrier to ensuring drug quality and safety, with its standardization and regulatory compliance directly impacting drug efficacy and patient safety. The 2025 edition of the Chinese Pharmacopoeia has comprehensively upgraded the quality standards for pharmaceutical packaging materials and containers. Among these, General Chapter 9624—Guidelines for Plastic Materials and Containers Used in Pharmaceutical Packaging—stands as the core technical regulation for plastic-based pharmaceutical packaging materials, providing the pharmaceutical industry and packaging manufacturers with scientific and systematic quality control standards. This article systematically analyzes the framework and core content of these guidelines, offering a reference for the production, application, and quality control of pharmaceutical packaging materials.