人凝血酶原复合物生产过程中凝血因子活化分析

目的通过比较以组分Ⅲ沉淀和血浆为原料制备人凝血酶原复合物(Prothrombin complex concentrates,PCC)过程中凝血因子活化情况,为选择最适PCC制备原料提供数据支持。方法分别对以组分Ⅲ沉淀和血浆为原料制备PCC过程中中间品的活化的凝血因子活性和人凝血酶活性两个项目进行检定,分析凝血因子的活化情况。观察以组分Ⅲ沉淀为原料制备PCC过程中添加肝素能否抑制PCC中凝血因子的活化。结果以组分Ⅲ沉淀为原料制备的PCC中间品活化的凝血因子活性和人凝血酶活性两个项目均不合格。以组分Ⅲ沉淀为原料制备PCC生产过程中添加肝素后,PCC中间品的活化的凝血因子活性和人凝血酶活性均不合格。以血浆为原料制备的PCC中间品活化的凝血因子活性和人凝血酶活性两个项目均合格。结论组分Ⅲ沉淀为原料制备PCC会增加凝血因子活化的风险,新鲜冰冻血浆可作为制备PCC的原料。

Analysis of coagulation factor activation in producing process of human prothrombin complex concentrates

Objective To explore coagulation factor activaties of the prothrombin complex concentrates（ PCC） manufactured using FⅢ precipitate and plasma as primary materials. Methods The PCC products were manufactured with using F Ⅲ precipitate and plasma as primary materials,respectively. Heparin was added in the manufacturing process of PCC created by FⅢ precipitate,and then detecting the activity of coagulation factor and thrombogenicity. Results In the condition of PCC manufactured by using FⅢ precipitate as materials,the activated coagulation factor＇s activity and thrombogenicity have not been achieved the standard requirements whereas their activities were accorded with the demands after adding heparin in the manufacturing process. In the case of using plasma as primary materials their activities were also in keeping with the quality requirements. Conclusions Using the FⅢ precipitate as raw material take a risk of increasing coagulation factor activation. The plasma is a good material used for manufacturing PCC.