Experimental study of human fibrinogen on vascular irritation and hemolysis test

HUANG Fan; ZHANG Liling; HUANG Yi; DENG Zhihua

doi:10.3969/j.issn.1671-8631.2025.4.sxlcyy202504013

Abstract：Objective:To evaluate the vascular irritation and hemolysis of the company's self—made human fibrino-gen.Methods:According to the technical guidance principles such as the"Drug Registration Management Measure""Technical Guidelines for the Study of Drug Irritation,Allergy,and Hemolysis",New Zealand rabbits were used as con-trols on both sides,administered once a day for 8 consecutive days,to observe vascular irritation symptoms.After the last administration was completed,4 animals were dissected at 72 hours and 14 days,respectively,for pathological prep-aration and histopathological examination.New Zealand rabbit red blood cells were used as the in vitro hemolysis test subjects.Negative control tubes(sodium chloride injection),positive control tubes(injection water),and different drug dilution tubes were set up.After sample addition,the tubes were incubated at 37 ℃ for 3 hours.Observations were made at different time points(15 min,30 min,45 min,1 h,2 h,3 h)to determine whether the red blood cells had dis-solved or aggregated.Results:During the administration and discontinuation periods,no significant abnormalities were observed in the general observation of the animals.Through histopathological examination and pathological observation scoring,it can be concluded that human fibrinogen does not stimulate the ear vein of New Zealand rabbits.In terms of hemolysis experiments,the hemolysis reaction of the experimental group and negative control group with different dilu-tion concentrations of human fibrinogen showed negative,while the positive control group showed positive.Conclusion:No hemolysis and vascular irritation of the self—made human fibrinogen product on New Zealand rabbits.