人凝血酶原复合物制备工艺研究现状  

The progress on preparation of human prothrombin complex concentrates

作　　者：包正琦[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,兰州730046

出　　处：《微生物学免疫学进展》2013年第4期79-84,共6页Progress In Microbiology and Immunology

摘　　要：人凝血酶原复合物(Prothrombin complex concentrates,PCC)是一种含有凝血因子II、VII、IX、X四种维生素K依赖性凝血因子,能够促进血液凝固的血浆蛋白制剂。目前,多数生产厂家采用DEAE Sephadex A-50凝胶从混合血浆中制备PCC。PCC制备工艺的选择、制备原料的挑选及质量控制、关键工艺参数的优化及控制等方面对PCC制品的质量至关重要。因此,主要对PCC的制备工艺、制备原料、关键工艺参数的优化及生产过程中凝血因子活化的控制策略进行了综述。Prothrombin complex concentrates are haemostatic blood products containing four vitamin K-dependent clotting factors（II,VII,IX and X）.It is produced by ion-exchange chromatography on DEAE Sephadex A-50 resin from large pool plasma.Preparation technology,the choose of materials,quality control and optimization of critical parameters play a critical role in quality control of PCC.This paper mainly summarizes the preparation of PCC technology conditions,materials,critical parameters and the control strategy of coagulation factor activation.

关 键 词：人凝血酶原复合物 制备工艺 关键工艺参数优化 

分 类 号：R944[医药卫生—药剂学]