CAJ | 학술논문

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50 mL 规格贮存袋装载50 mL 液体、250 mL 贮存袋装载80 mL 液体是安全的。
목적：신형호적제대혈냉동저존대계용전，수요진행일계렬적측시，이험증저존대능부체도제대혈냉동저존적사용요구。방법추취28개신형호냉동저존대，안조표준조작정서장제대혈세포냉동보존화용해복온，연후검측저존대적물리완정성급대내제대혈세포적각항질량지표，항목포괄유핵세포활솔、세포회수솔、CD34양성세포、간세포집락배양、무균측시이급험증저존대적최대장재용량。결과28개측시적저존대，균통과료완정성측시，소보존적세포각항검측지표부합사용요구。결론신형저존대성능효과여원래적기본일치，병학인50 mL 규격저존대장재50 mL 액체、250 mL 저존대장재80 mL 액체시안전적。
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.