重组人表皮生长因子软膏经阴道给药对家兔血清表皮生长因子水平的影响

The Effect of Vaginal Administration of the Ointment of Recombinant Human Epidermal Growth Factor on its Concentration and Absorption

目的观察重组人表皮生长因子软膏经家兔阴道黏膜给药对血清表皮生长因子浓度的影响。方法实验分单剂量、多剂量给药。单剂量给药,选用新西兰雌性家兔,按体质量2.0g/kg单剂量阴道给予重组人表皮生长因子软膏,分别在0、1、2、3、4、6、8、12、24h取耳缘静脉血,收集血清样本;多剂量给药,按上述方法与剂量,1次/d,连续用药1周,分别于给药前及给药后第3、5、7、14天收集血清样本。采用放免法测定血清中表皮生长因子浓度。结果单剂量给药后,在不同时间点血清表皮生长因子浓度与给药前相比变化不明显;多剂量给药后血清表皮生长因子浓度较用药前有一定升高,用药期间的血清水平保持相对恒定,停药1周后血清表皮生长因子浓度恢复至用药前的水平。结论重组人表皮生长因子软膏经阴道黏膜给药无明显吸收,连续用药体内无明显蓄积现象。

Objective To evaluate the effect of vaginal administration of the ointment of recombinant human epidermal growth factor on the serum concentrations of epidermal growth factor.Methods In single-dose studies,the vaginal of female rabbits was swabbed with recombinant human epidermal growth factor（10 μg/g ointment）at 2.0 g/kg dose.The blood samples were drawn from the ear vein of the animals at 0,1,2,3,4,6,8,12 and 24 h after dosing.In multiple-dose studies,the ointment of recombinant human epidermal growth factor was administrated once daily for 7 consecutive days and the blood samples were collected prior to and 3,5,7,14 days after vaginal administration.Serum epidermal growth factor concentrations were measured by radioimmunoassay method.Results Following a single vaginal administration,the serum concentrations of epidermal growth factor had no obvious change.After multiple-dose administration,there were also no significant differences in the serum epidermal growth factor concentrations.Furthermore,after one week of multiple-dose administration,no statistically significant difference was observed in the serum epidermal growth factor concentrations.Conclusion There was little Absorption after vaginal administration of ointment of recombinant human epidermal growth faotor.There was no accumulation upon multiple doses of recombinant human epidermal growth faotor ointment in the rabbit.