国产冻干人凝血酶原复合物质量标准的研究

目的通过对国产人凝血酶原复合物 (PCC)质量的研究 ,建立与国际接规的质量标准。方法用人凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ (FⅡ、FⅦ、FⅨ、FⅩ )浓制剂国家标准品 ,采用一期法测定国内用不同原料制备的PCC中FⅡ、FⅦ、FⅨ、FⅩ的效价 ;用正常人血浆作标准 ,用凝固法检测PCC的总效价及PCC中的肝素。结果用血浆作原料提纯制备的PCC ,FⅣ的效价能达到 1 0IU/ml以上 ,FⅦ效价最低 ;用组分Ⅲ作原料 ,FⅣ活性损失很大 ,只有 2 / 7批次能达到 1 0IU/ml;而FⅦ效价最高。无论用何种原料 ,FⅡ和FⅩ活性均能保持在一定水平。结论从血浆中直接提纯制备PCC ,能有效地保持FⅣ活性 ,各项指标易达到国外同品种的质量标准

Studies on the quality standard of freeze-dried human prothrombin complex concentrate made in China

PurposeTo study on the quality of human prothrombin complex concentrate so as to establish the same quality standard as the international standard of PCC.MethodsThe potencies of coagulation factor Ⅱ,Ⅶ,Ⅳ and Ⅹ present in PCC prepared from different starting materials were assayed against the national standard by one stage clotting method. The total potency of PCC was assayed against the normal human plasma by clotting method. Heparin present in PCC was assayed by clotting method.ResultsThe potency of FⅣ in PCC prepared from human plasma source can reach more than 10IU/ml; The potency of FⅦ is the lowest. The potency of FIX in PCC prepared from fraction Ⅲ lost greatly and only 2/7 batches can reach more than 10IU/ml; The potency of FⅦ is the highest. The potencies of FⅡ and Ⅹ can maintain the certain levels no matter which starting materials are used.ConclusionThe PCC prepared from human plasma source can effectively maintain the potency of FⅣ.The other items can easily reach the international standard of PCC.