重庆市中心城区汇集浓缩血小板制备关键控制点确认探讨

Discussion on the confirmation of critical control points for the preparation of pooled concentrated plateletsin the central city of Chongqing

目的探讨汇集浓缩血小板在制备过程中,关键控制点和参数的确认,以期提高汇集血小板的产品质量并优化制备过程。方法随机选取街头采血84人份(每人份400 mL),采用白膜层(BC)方法,静置过夜法保存BC;(1)根据全血血小板含量及BC回收率确定汇集浓缩血小板的BC份数;(2)根据离心机性能、离心效果确认合适的离心参数;(3)比较汇集浓缩血小板和机采血小板相关质量指标:容量、血小板的含量、红细胞混入量、白细胞计数,储存期末pH值、无菌实验。结果(1)采用6个新鲜400 mL全血制备BC混合来制备汇集浓缩血小板;(2)离心机(美国Thermo cryofuge 8)第1次全血离心参数和第2次汇集BC离心参数分别为:离心力2283、291 g;加速均为9 g;减速均为4 g;时间均为12 min,第3次(减红细胞)离心参数:离心力145 g,加速9 g,减速4 g,时间5 min,离心效果均得到了良好印证;(3)对比同期单采血小板14份在采集第1、5天的检测结果,汇集浓缩血小板的容量、血小板含量,红细胞混入量高于机采血小板组,差异有统计学意义(P<0.05);白细胞计数和储存期末pH值差异均无统计学意义(P>0.05),无菌实验结果均为无菌生长。汇集浓缩血小板各质量指标除容量外,均在国标规定范围内。结论把控好关键控制点能有效提高制备成功率。

Objective To discuss the confirmation of critical control points and parameters in the preparation of pooledconcentrated platelets,so as to improve the product quality of pooled platelets and optimize the preparation process.Methods A total of 84 street blood samples(400 mL each)were randomly selected.The buffy coat(BC)method was adopted,and BC was preserved by standing overnight.According to the whole blood platelet content and BC recovery rate,the BC fraction of pooled concentrated platelets was determined.According to the centrifuge performance and centrifugal effect,the appropriate centrifugal parameters was confirmed.The related quality indexes of pooled concentrated platelets and mechanically collected platelets,such as volume,platelet content,red blood cell mixing amount,white blood cell count,pH value at the end of storage and aseptic experiment,were compared.Results A total of six BC prepared from fresh 400mL whole blood were mixed to prepare pooled concentrated platelets.The first whole blood centrifugal parameters and the second BC centrifugal parameters of the centrifuge(Thermo cryofuge 8,USA)were:centrifugal force 2283 g and 291 respectively;The acceleration was all 9 g;The deceleration was all 4 g;The time was all 12 min,and the parameters of the third centrifugation(reducing red blood cells)were centrifugal force of 145 g,acceleration of 9 g,deceleration of 4 g and time of 5 min,and the centrifugation effect was well confirmed.Comparing the test results of 14 platelets collected separately at the first and fifth days,the volume and content and the amount of red blood cells mixed in of pooled concentrated platelets were higher than those in the platelet collected by machine,with statistical significance(P<0.05).There was no significant difference between white blood cell count and pH value at the end of storage(P>0.05),a nd the results of aseptic test were all aseptic growth.All the quality indexes of pooled concentrated platelets were within the national standard except the volume.Conclusion Good control of critical control points can effectively improve the success rate of preparation.