目的 探究应用DEAE Sephadex A-50凝胶吸附法从去冷沉淀血浆上清液（cryoprecipitate reduced plasma supernatant, CRPS）分离纯化人凝血酶原复合物（human prothrombin complex concentrate, PCC）的可行性。方法 采用凝胶吸附法从CRPS中连续制备3批次PCC制品，对该工艺中PCC原液、半成品和成品的人凝血因子Ⅸ（human coagulation factor Ⅸ, FⅨ）效价回收率、杂蛋白含量、干热病毒灭活效果进行检测分析；对PCC成品进行检定分析和稳定性试验。结果 以CRPS中FⅨ效价为100%，凝胶吸附工艺中PCC原液、半成品、成品的FⅨ效价回收率分别为（65.0±2.1）%、（56.3±4.2）%、（40.3±1.8）%；原液中杂蛋白含量较低；干热处理前后各项质量指标均合格。PCC成品检定显示，其物理、化学、效价与FⅨ比活性、活化凝血因子活性等质量指标均满足中国药典2020年版三部要求。加速和长期稳定性试验的各项质量指标检测结果与0个月相比虽有所浮动，但均合格。结论 采用DEAE Sephadex A-50凝胶吸附法可成功从CRPS中分离纯化出PCC。

Objective To explore the feasibility of using DEAE Sephadex A-50 gel adsorption to separate and purify human prothrombin complex concentrate (PCC) from cryoprecipitate reduced plasma supernatant (CRPS). Methods The gel adsorption method was used to continuously prepare 3 batches of PCC products from CRPS. The recovery rate of human coagulation factor Ⅸ (FⅨ) titer, the content of miscellaneous proteins, and the effect of dry heat virus inactivation were detected and analyzed in PCC bulks, final bulks, and final products of the gel adsorption process. The PCC final products were subjected to verification analysis and stability tests. Results With FⅨ titer in CRPS as 100.0%, the recovery rates of FⅨ titer of PCC bulks,final bulks, and final products in gel adsorption process were （65.0±2.1）%，（56.3±4.2）%，and（40.3±1.8）%, respectively. The content of miscellaneous proteins in PCC bulks was low, and all quality indicators before and after dry heat treatment were qualified. The verification of PCC final products showed that quality indicators such as physical and chemical properties, titer, FⅨspecific activity, and activated coagulation factor activity met the requirements of the Chinese pharmacopoeia 2020 edition volume Ⅲ. Although the detection results of various quality indicators in the accelerated and long-term stability tests fluctuated compared with those at 0 month, all were qualified. Conclusion The DEAE Sephadex A-50 gel adsorption method can successfully separate and purify PCC from CRPS.