软芯袋式白细胞滤器的研制及使用效果的评价

Development and Evaluation of a New Type of White Blood Cell Filter with Flexible Inner Package

目的研制一种新式的软芯袋式白细胞滤器,可与血袋一起离心分离制备所需制品,然后进行白细胞滤除。方法采用软质聚氯乙烯膜片为外壳,聚酯纤维为内层隔膜的滤芯结构等工艺制成的白细胞滤器;对滤器密合性进行压力试验;对滤器残余血量及过滤后制品进行白细胞去除率、红细胞回收率、游离血红蛋白测定。结果压力试验滤器无泄漏,密合性好;滤器残余血量<30mL、白细胞去除率≥99.99%、红细胞回收率>91%、游离血红蛋白<200mg/L。结论软芯袋式白细胞滤器符合YY0329-2002《一次性使用去白细胞滤器》质量要求;该滤器所制备的血液制品符合《血站基本标准》要求;该滤器是最佳的白细胞滤器。

Objective To develop a new type of white blood cell filter with flexible inner package,which can work together with blood bag to centrifugalize the blood and filter all white blood cell out. Methods We used flexible PVC membrane as the shell and polyester fiber as the inner septum to build the cartridge of white blood cell filter,and carried out pressure testing to ensure the filter tightness, and calculated the surplus amount of blood in filter, the filtering rate of white blood cell, the recycling rate of red blood cell and free hemoglobin concentration. Results There was no leak during the pressure testing into the filter and good performance in the tightness, and the surplus amount of blood was less than 30ml,the filtering rate of white blood cell was over 99.99% ,the recycling rate of red blood cell was over 91% ,free hemoglobin concentration was less than 200mg/L. Conclusion The new type of white blood cell filter with flexible inner package is measured up to the quality standard YY0329-2002 for ＇Disposable white blood cell filters＇. The blood products were measured up to the quality standard of ＇Primary standard of blood station＇, which is proved as one of the best white blood cell filters.