常见塑料包装输液生产工艺对比及选择策略  

Comparison and Selection Strategy of Common Plastic Packaging for Infusion Production Technology

作　　者：周子钰 冯儒澜 王哲豪 王镜 闫志强 ZHOU Zi-yu;FENG Ru-lan;WANG Zhe-hao;WANG Jing;YAN Zhi-qiang(School of Chemistry and Molecular Engineering,East China Normal University Shanghai Engineering Research Center of Molecular Therapeutics and New Drug Development)

机构地区：[1]华东师范大学化学与分子工程学院上海分子治疗与新药创制工程技术研究中心

出　　处：《中国食品药品监管》2023年第5期82-89,共8页China Food & Drug Administration Magazine

基　　金：国家自然科学基金资助项目(81872812、82073800)。

摘　　要：本文通过汇总国内外相关文献,并结合药品生产企业实践经验,对我国常见的塑料包装输液生产工艺及包装形式进行分析,综合比较聚丙烯输液瓶、非PVC软袋、直立式聚丙烯输液袋、内封式聚丙烯输液袋4种包装形式的输液生产工艺,以及其技术特点、设备性能及工艺步骤。尝试性地提出应从产品质量控制指标及药物经济性两个层面进行分析,以及应理性探讨在不同特定条件下药品生产企业如何结合自身发展和需要,选择最适宜的生产工艺,以期为相关单位选择策略提供参考。This paper summarizes relevant literature at home and abroad and combines practical production experience of pharmaceutical enterprises to analyze the production processes and packaging forms of common plastic packaging for infusions in China.Four packaging forms,including polypropylene infusion bottles,non-PVC soft bags,upright polypropylene bags,and blow-fill-seal bags,are comprehensively compared in terms of their production processes,technical characteristics,equipment performance,and process steps.The paper proposes an analysis based on product quality control indicators and drug economy,as well as rational discussions on how pharmaceutical manufacturers should choose the most appropriate production technology according to their own development and needs under different specific conditions.This study aims to provide references for relevant organizations in selecting appropriate strategies.

关 键 词：塑瓶 软袋 可立袋 BFS 质量控制指标 

分 类 号：TQ460[化学工程—制药化工]