口服固体制剂常用包装材料及容器的研究进展

Research Progress of Common Packaging Materials and Containers of Oral Solid Preparations

目的 为不同口服固体制剂准确选用合适包装容器提供理论参考和现实依据。方法 从口服固体制剂常用包装容器的原材料和辅料特性入手,通过解析不同包装容器的技术要求,介绍国内药品包材审评制度和现阶段国家药监局药品审评中心药用包装材料登记数据,对口服固体制剂不同包装容器的特点和使用进展进行综述。结果 对剂量要求精准、单日服用剂量较小的制剂宜选用单剂量独立包装的泡罩包装;对需长期用药、单日服用剂量较大的药物宜选用塑料瓶包装;颗粒剂和散剂多选用复合膜、袋包装;包装规格较大但不宜用塑料瓶包装的芳香性、油脂性、挥发性及易氧化药物,可选用玻璃瓶包装。结论 药品生产企业在选择药品包装时,应结合包装原材料物化性质、与承装药品相容性、力学性能、装量范围、携带使用方便性和价格成本等多方面因素,综合考虑选择合适的包装容器,以保证药品质量稳定和安全有效。

The work aims to provide theoretical reference and practical basis for accurately choosing the suitable packaging containers for different oral solid preparations. Based on the characteristics of raw materials and auxiliary materials in the commonly used packaging containers of oral solid preparations, the characteristics and research and application progress of different packaging containers for oral solid preparations were reviewed by analyzing the technical requirements of different packaging containers, and introducing the domestic review system of pharmaceutical packaging materials and the current registration information of pharmaceutical packaging materials in the Center for Drug Evaluation, NMPA. For preparations with precise dose requirements or small daily dose, the single-dose individually packaged blister packs should be chosen. For drugs requiring long-term medication or drugs with large daily dose, the pharmaceutical plastic bottles should be chosen. The pharmaceutical laminated films and pouches were mostly used for granules and powders. For aromatic, greasy, volatile and oxidizable drugs with larger packaging specifications but not suitable for storage in plastic bottles, glass bottles should be chosen. The drug manufacturers should comprehensively consider the physicochemical properties of packaging raw materials, compatibility with packaged drugs, mechanical properties,content, convenience in carrying and use, and price-cost when choosing drug packaging, and choose the appropriate packaging container to ensure the stability, safety and effectivity of drugs.