重组人尿激酶原病毒安全性研究

Safety evaluation of the rhpro-urokinase

目的:对经过提纯及病毒灭活处理后的重组人尿激酶原(rhpro-UK)进行病毒安全性实验研究。方法:将SRSV/3T3细胞以及本产品Sp2/0基因工程细胞培养上清液感染NIH/3T3细胞分别作阳性对照组1和2,将不同浓度的rhpro-UK原液感染NIH/3T3细胞为实验组。各组细胞盲传3代,分别进行XC细胞合胞形成实验和透射电子显微镜观察病毒颗粒。结果:rhpro-UK原液的高、中、低3个浓度组(1,0．15,0．03mg·mL^(-1))均未见到合胞体形成,透射电子显微镜下均未观察到病毒颗粒,与2个阳性对照组比较有显著性差异(P＜0．01)。结论:重组人尿激酶原(rhpro-UK)原液中不含有逆转录病毒。

Objective：To probe whether the purified and inactivated recombinant human prou- rokinase （rhpro-UK） carries the infecting retrovirus. Methods： The SRSV/3T3 cell lines and NIH/3T3 cell lines infected by the culture supernatant of Sp2/0 ceils were used as positive controls. The NIH/3T3 cell lines were infected by rhpro-UK solutions 1,0.15 and 0.03 mg· mL^-1, respectively. The virological features of the rhpro-UK in these cell lines were blinded passage 3 generations and then detected by XC cell fusion assay and transmission electric microscope （TEM） technique. Results： No fusion ceils and retrovirus granules were found in the rhpro-UK infected NIH/3T3 cell lines, which were significant different compared with the ones in the positive control cell lines （P 〈 0.01 ）. Conclusion ：The rhpro-UK has no endogenous retrovirus.