Security Of BFGF Lyophilized Powder For Transdermal Administration

Basic fibroblast growth factor(bFGF)plays a significant role in the wound recovery.At present,we have successfully prepared the oil body lyophilized powder with biological activity of linseed mustard oil body fusion bFGF protein in Camelina sativa.Moreover oleosin bFGF could accelerate the healing of skin wounds using the skin trauma model of SD male rats.However,the skin administration may cause other side effects and other symptoms.Hence,this study is of great significance for its preclinical drug security systematically.We used the animal substitution test published by European Union OECD.The safety of lyophilized powder of oleosin bFGF was evaluated by long-term skin toxicity test in rats,skin sensitization test in guinea pigs and skin irritation test in rabbits.The results are as follows:1.There was no significant difference in the general state,the weight change,the blood routine,the blood biochemical index and the organ coefficient between the rats and the control group after 90 days of continuous administration.Oleosin bFGF freeze-dried powder had no significant effect on the index of blood,the liver function and renal function of the rats in long-term skin toxicity test.2.No visible pathological changes were found in the main organs of the dissected rats,and no sign of poisoning in all rats in the long-term skin toxicity test.This result indicated that the long-term application of oleosin bFGF on the skin of the rats would not cause the morphological changes of the organs.3.The results of skin irritation test showed that the skin before administration showed no obvious difference between the drug group and the negative group.Lyophilized powder of oleosin bFGF had no irritation to the intact and damaged skin of rabbits.4.The results of skin sensitization test demonstrated that there was a very obvious skin allergy in the positive control group,and the allergic rate of the positive control group reached 100%.Oppositely,no skin allergy was observed in the oleosin bFGF freeze-dried powder group.Therefore,lyophilized powder of oleosin bFGF has no effect of sensitivity on skin.