CAJ | 학술논문

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。
목적：통과비교이조분Ⅲ침정화혈장위원료제비인응혈매원복합물( Prothrombin complex concentrates,PCC)과정중응혈인자활화정황,위선택최괄PCC제비원료제공수거지지。방법분별대이조분Ⅲ침정화혈장위원료제비PCC과정중중간품적활화적응혈인자활성화인응혈매활성량개항목진행검정,분석응혈인자적활화정황。관찰이조분Ⅲ침정위원료제비PCC과정중첨가간소능부억제PCC중응혈인자적활화。결과이조분Ⅲ침정위원료제비적PCC중간품활화적응혈인자활성화인응혈매활성량개항목균불합격。이조분Ⅲ침정위원료제비PCC생산과정중첨가간소후,PCC중간품적활화적응혈인자활성화인응혈매활성균불합격。이혈장위원료제비적PCC중간품활화적응혈인자활성화인응혈매활성량개항목균합격。결론조분Ⅲ침정위원료제비PCC회증가응혈인자활화적풍험,신선빙동혈장가작위제비PCC적원료。
Objective To explore coagulation factor activaties of the prothrombin complex concentrates ( PCC) manufac-tured using FⅢprecipitate and plasma as primary materials. Methods The PCC products were manufactured with using FⅢ precipitate and plasma as primary materials,respectively. Heparin was added in the manufacturing process of PCC crea-ted by FⅢprecipitate, 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 hep-arin 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 FⅢprecipitate as raw material take a risk of increasing coagulation fac-tor activation. The plasma is a good material used for manufacturing PCC.