脐带血库启用新冷冻贮存袋的验证研究  

A validation study of starting use of new freezing bags in cord blood bank

作　　者：陈劲松 吴洁莹 陆琰 谢闺娥 许遵鹏 李焱 

机构地区：[1]广州市妇女儿童医疗中心脐血库,广东广州510623

出　　处：《国际检验医学杂志》2014年第20期2820-2822,共3页International Journal of Laboratory Medicine

基　　金：广东省科技厅项目(2011B031800375);广州市卫生局项目(201102A213061);博士启动项目(201011)

摘　　要：目的新型号的脐带血冷冻贮存袋启用前,需要进行一系列的测试,以验证贮存袋能否达到脐带血冷冻贮存的使用要求。方法抽取28个新型号冷冻贮存袋,按照标准操作程序将脐带血细胞冷冻保存和溶解复温,然后检测贮存袋的物理完整性及袋内脐带血细胞的各项质量指标,项目包括有核细胞活率、细胞回收率、CD34阳性细胞、干细胞集落培养、无菌测试以及验证贮存袋的最大装载容量。结果 28个测试的贮存袋,均通过了完整性测试,所保存的细胞各项检测指标符合使用要求。结论新型贮存袋性能效果与原来的基本一致,并确认50mL规格贮存袋装载50mL液体、250mL贮存袋装载80mL液体是安全的。Objective To verify whether the storage bag can reach the use requirement of cord blood freezing storage by conduc-ting a series of tests before staring use of new type cryopreservation bag for cord blood.Methods According to the standard opera-tion procedure,28 new type cryopreservation bags were extracted.The cord blood units were performed the cryostorage and thaw for rewarming according to the standard operating procedures.Then the physical integrity and various quality indicators of cord blood in bag were detected,including the nucleated cell viability,cell recovery rate,CD34-positive cell,colony-forming cultivation of stem cells,sterility test and verification of actual load volume.Results All the tested storage bags passed the integrity test,and the various testing indicators of the preserved cells conformed to the use requirements.Conclusion The new type storage bag has the same performance and effect to original bag,it is verified that the maximum loading volume of 50 mL（for 50 mL specification of storage bag）and 80mL（for 250mL specification of storage bag）is safe.

关 键 词：冷冻贮存袋 低温储存 脐带血 造血干细胞 液氮 

分 类 号：R197.3[医药卫生—卫生事业管理]