医用分子筛制氧设备质量控制要点及对策分析.pdf

研究论著RESEARCHWORK

医用分子筛制氧设备质量控制要点

及对策分析

李国勇，肖杰，任希力，杨阳，马素华，夏文龙

山东省食品药品审评查验中心，山东济南250014

[摘要]医用氧气是重症呼吸系统疾病患者的重要治疗手段。分子筛变压吸附制氧具有简单方便、成本低、耗能少、易于

调控等特点，已成为临床用氧的重要制备方式。但在临床使用中部分产品存在氧浓度过低、杂质含量过高、输出流量不稳

定等问题，给临床应用带来很大隐患。本文基于产品安全、有效的基本要求，围绕产品质量控制中的主要关注点，如氧浓

度、氧气洁净度、水分含量、氧流量稳定性、高海拔下性能、家用要求、电气安全性等，开展详细阐述及分析，以期为该

产品的设计生产、注册审批、日常监管提供参考。

[关键词]医用制氧设备；变压吸附；质量控制；要点分析；医用氧气

QualityControlKeyPointsandCountermeasuresofMedical

MolecularSieveOxygenGenerators

LIGuoyong,XIAOJie,RENXili,YANGYang,MASuhua,XIAWenlong

ShandongCenterforFoodandDrugEvaluationInspection,JinanShandong250014,China

Abstract:Medicaloxygenisanimportanttreatmentforrespiratorydiseasessuchasseverenovelcoronaviruspatients.Molecular

sievepressureswingadsorptionoxygenproductionmethodissimpleandconvenient,lowcost,lessenergyconsumption,easyto

controlandsoon,hasbecomeanimportantpreparationmethodofclinicaloxygen.However,intheclinicaluseofsomemolecular

sieveequipment,oxygenconcentrationistoolow,thecontentofimpuritiesistoohigh,andtheoutputflowisunstable,whichbrings

greatriskstotheclinicalapplication.Basedonthebasicrequirementsofproductsafetyandeffectiveness,thispaperaimstoelaborate

andanalyzethemainconcernsinproductqualitycontrol,suchasoxygenconcentration,oxygencleanliness,moisturecontent,oxygen

flowstability,performanceathighaltitude,andsafetyrequirementstoprovidereferenceforthedesignandproduction,registration

andapproval,dailysupervisionoftheproduct.

Keywords:medicaloxygengenerators;pressureswingadsorption;qualitycontrol;analysisofkeypoints;medicaloxygen

[中图分类号]R197.39[文献标识码]A

doi：10.3969/j.issn.1