不同输液包材和输液器对静脉输液质量的影响和控制对策

The Influence of Different Infusion Materials and Infusion Sets on the Quality of Intravenous Infusion and its Control Measures

静脉滴注药液直接输入人体并快速分布全身,基础输液作为注射剂的溶媒直接影响临床静脉注射用药的安全有效,大输液产品对生产环境和工艺的要求极高,输液包装材质和输液器的性能也可影响输液质量。本文回顾了输液包材和输液器的发展变化,分析控制基础输液质量水平的主要监控指标,总结了输液生产、流通和使用各个环节中影响不溶性微粒数目、漏液率、容器与药液的相容性和残留量等方面的重要因素并就提高静脉输液质量的控制方法进行探究,旨在为我国输液包材行业的发展提供思路以及为临床遴选合适输液产品和降低输液不良反应风险提供参考。

Intravenous infusion is a dosage form directly injected into human body with rapid distribution. Basic infusion as the solvent of injection directly affects the safety and effectiveness of clinical intravenous infusion. Large infusion products expect much higher requirements on the production environment and technology. The materials of infusion packages and the performance of infusion sets can also affect the quality of infusion. This article was intended to review the development and changes of infusion packaging materials and infusion sets,analyze the important indicators controlling the quality level of basic infusion,summarize the significant factors showing an impact on the number of insoluble particles,leakage rate,compatibility between container and drug solution,and residues in the process of production,circulation and use,and then explore the control methods to improve the quality of intravenous infusion. The results of the study can provide ideas for the development of infusion packaging material industry in China,as well as provide reference for clinical selection of proper infusion and risk reduction of infusion adverse reactions.