IN order to formulate an aqueous topical preparation of epidermal growth factor(EGF) for the treatment of open wound and burn, the stability of EGF in aqueous vehicles containing various stabilizers was evaluated and the pharmacological activity
of
gel
preparations formulated with poloxamer 407 was determined with wound model. Various additives, which are knwn as potent stabilizers for proteins and polypeptides so far, were used to increase the stability of EGF in aqueous vehicles. The content
of
EGF
in the vehicles containing stabilizers were determined with an HPLC method after the storage at ℃, EGF was more stable in ultrapure water than RO water or aline. All the additives studied resulted in deleterious effects on EGF stability.
Therefore, it
was speculated that any additives or impurities in the vehicle made EGF unstable. However, nitrogen purge of solution increased the stability of EGF in aqueous vehicles The aqueous topical preparations of EGF were formulated with poloxamer 407 as
a
gel
base in saline. Gelatin or amastatin was employed as a protease inhibitor. The pharmacological effect of EGF gel was studied with open wound model in mice. EGF preparation, made of oleginous base or poloxamer gel base, showed significant healing
effect
compared to the control group(p<0.05). The addition of protease inhibitor in poloxamer 407 gel resulted insignificant healing effect compared to the gel without it(p<0.05). Body weights of mice treated wit EGF preparation were increased at the
first
day after the formation of open wound, while those of the control group were decreased.
The EGF gel made of poloxamer 407 containing a protease inhibitor would be a promising aqueous topical preparation for EGF.
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