Comparison of five pre-purification processes of human prothrombin complex
10.13200/j.cnki.cjb.004678
- VernacularTitle:人凝血酶原复合物5种预纯化工艺纯化效果的比较
- Author:
Wei YU
1
Author Information
1. Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610041, Sichuan Province, China
- Publication Type:Journal Article
- Keywords:
Human prothrombin complex(PCC);
Pre-purification;
Batch adsorption;
Human coagulation factor Ⅶ(FⅦ);
Protein C
- From:
Chinese Journal of Biologicals
2026;39(04):430-435
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the purification effects of five pre-purification processes on human prothrombin complex(PCC), in order to screen a better PCC pre-purification process.MethodsThe dilution plasma adsorption process, semicontinuous adsorption process, cyclic adsorption process, low-temperature batch adsorption process and temperature-rising batch adsorption process were used to separate and purify PCC in cryoprecipitate-removed supernatant plasma, and the titers of human coagulation factor Ⅶ(FⅦ) and FⅨ were detected according to the method specified in the Chinese Pharmacopoeia(Volume Ⅲ, 2025 edition).ResultsUnder three different plasma conductivity conditions, the yield of F Ⅶ and F Ⅸ in dilution plasma process was lower than that of the temperature-rising batch adsorption process without changing plasma conductivity. The adsorption effect of semi-continuous flow adsorption process on FⅦ and FⅨ at different temperatures was inferior to that of temperature-rising batch adsorption process. The yield of FⅦ and FⅨ in the eluent of cyclic adsorption process was also much lower than that of temperature-rising batch adsorption process. There was no significant difference in FⅨ yield between the two adsorption processes, but the FⅦ yield in the temperature-rising batch adsorption process was much higher than that in the low-temperature batch adsorption process. The adsorption capacity of the two adsorption processes for protein C(PC) and protein S(PS) was superior to that of foreign products.ConclusionThe temperature-rising batch adsorption process is superior to the other four PCC pre-purification processes in terms of adsorption time, FⅦ and FⅨ yields, and PC and PS purification effects, and has high potential for processability.
