[Animal experiment of recombinant human lactoferrin based on the 28 days repeated oral toxicity].

Objective: To evaluate the food safety of recombinant human lactoferrin( rhLF) and its iron nutrition.

Methods: 100 SPF grade weanling SD rats with half male and female, were randomly divided into five groups and they were control group, 100 and200 g/kg bLF group, 100 and 200 g/kg rhLF group. Rates in control group were feed with AIN-93 laboratory rodent pure fodder, while bLF and rhLF group were feed with sample protein part and all alternative formulations existed casein component respectively. All Rates were free of water consumption and observed in 28 days. Body weight, food consumption, food utilization and organ coefficient were recorded, while hematology, iron nutrition index [serum iron( SI), total iron binding capacity( TIBC), Transferringsaturation( TS), Soluble transferrin receptor( s TfR) ] and clinical biochemistry were measured.

Results: There was no significant difference in body weight between 200 g/kg bLF group and 200 g/kg rhLF groups neither for male nor female animals, while both significantly lower than the control group( P < 0. 05). No significant change in clinical biochemistry hematology, anatomy and histopathology results were observed for 100 g/kg and 200 g/kg rhLF group. There was no significant difference in serum iron level and transferrin saturation between bLF group and rhLF group, but the serum iron level and transferrin saturation of both bLF group and rhLF group were higher than the control group.

Conclusion: No significant difference were observed in food safety indicators and iron nutrition improvement between 28-day rhLF and bLF in the present study.