Stability of Recombinant Tissue Plasminogen Activator at −30 °C over One Year

Pharmaceuticals

关键词: cryopreservation;    fibrinolysis;    stability;    tissue plasminogen activator;   

DOI  :  10.3390/ph6010025

来源: DOAJ

【 摘 要 】

Recombinant tissue plasminogen activator (rt-PA) is used to restore patency and avoid inadvertent removal of peripheral and central venous catheters. rt-PA was reconstituted (1 mg/mL) then cryopreserved at −30 °C for 1, 2, 3, 6, 8, and 12 months and, then its stability was determined. After cryopreservation for one and two months, rt-PA kept more than 95% of its activity compared to standard samples, while cryopreservation for three months caused 8% loss of activity. However, after cryopreservation for six months or more, rt-PA retained only 87.5% or less activity compared to standard samples. Therefore, it is recommended that reconstituted rt-PA be cryopreserved at −30 °C for a maximum period of three months.

【 授权许可】

Unknown