GQ142高速管式分离机在血浆冷沉淀离心工艺中的应用  

The application of GQ142 high speed tubular centrifuge in plasma cryoprecipitate extraction process

作　　者：刘晓[1] 李青[1] 窦姿 韩祥东[1] 张金[1] 张安山[1] 何彦林[1] 

机构地区：[1]兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《中国输血杂志》2016年第9期923-925,共3页Chinese Journal of Blood Transfusion

摘　　要：目的对血浆冷沉淀离心工艺的关键设备GQ142高速管式分离机进行确认、试生产和生产试验,确保离心机能够满足冷沉淀离心工艺的要求。方法对GQ142高速管式分离机进行安装确认、运行确认、性能确认、3批试生产试验和10批冷沉淀生产。对冷沉淀离心工艺过程中的进出液温度、所有用具冲淋水内毒素、血浆微生物限度的监测。采用ACL7000全自动凝血分析仪检测凝血因子Ⅷ效价。采用双缩脲法检测冷沉淀溶解液蛋白含量。计算冷沉淀的收率和比活性。结果通过对离心机的确认,确保了离心机能够满足冷沉淀提取工艺的要求。冷沉淀离心工艺过程中的进出液温度、所有用具冲淋水内毒素、血浆微生物限度均符合质控标准。10批血浆冷沉淀的离心过程中,血浆的进液温度、出液温度符合工艺要求,冷沉淀收获率平均(9.3±0.8)kg/L,10批冷沉淀的比活性平均(34.4±8.0)IU/g,符合质量标准。结论通过对GQ142高速管式分离机的确认、试生产和生产试验,表明此离心机能够满足冷沉淀的提取工艺要求。Objective To ensure that the GQ142 high speed tube separator can meet the requirements of cryoprecipitate extraction process by validation, trial production and production test. Methods Installation, operational and performance verification, with the addition of three batches of pilot trial production and a batch of ten cryoprecipitate production were implemented on the GQ142 high speed tubular separator. The temperature of the liquid in the process, the endotoxin and the limit of the microorganism in the plasma were monitored. ACL7000 automatic coagulation analyzer was used to detect the titer of human coagulation factor Ⅷ. The protein content of cryoprecipitate solution was detected by biuret method. The yield and speeifie activity of cryopreeipitate were estimated. Results The confirmation of the centrifuge ensured that the centrifuge can meet the requirements of the process of cryoprecipitate extraction. The inlet and outlet liquid temperature, endotoxin and plasma microbial limit of the cryoprecipitate extraction process are in accordance with the quality standard of the cold precipitation. The yield, endotoxin and specific activity of the cryopreeipitates are in accordance with the quality standard of the cryoprecipitates. Conclusion GQ142 high speed tubular centrifuge is successfully applied to plasma cryoprecipitate extraction process.

关 键 词：GQ142高速管式分离机 原料血浆 冷沉淀 

分 类 号：R457.1[医药卫生—治疗学]