中国药典2025年版“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 2025 Edition “Guidelines for Plastic Materials and Containers Used in Pharmaceutical Packaging

    • 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,其中通则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: Parmaceutical packaging serves as a critical barrier to ensure drug quality and safety, with its standardization and regulatory compliance directly impacting drug efficacy and patient safety. The Chinese Pharmacopoeia 2025 Edition 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 analyzed the framework and core content of these guidelines, offering a reference for the production, application, and quality control of pharmaceutical packaging materials.

       

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