重组人表皮生长因子不同制剂稳定性考察

A Study on the Stability of Human Epidermal Growth Factor Preparations

目的考察不同条件下重组人表皮生长因子(rhEGF)制剂的稳定性。方法制备rhEGF溶液、凝胶、冻干粉剂,不同条件(4℃、25℃、37℃)下贮存,采用放射免疫分析法测定不同时间(0、2、4、6、8个月)内rhEGF含量,并进行外观观察。结果观察期间制剂外观均无明显变化;不同剂型的rhEGF贮存稳定性均随温度的升高而降低,凝胶剂的稳定性明显优于溶液剂。结论不同的保存条件对rhEGF的稳定性有显著影响。4℃、室温条件下贮存分别在8个月和4个月内稳定,高于室温贮存不易超过1个月。上述结果为医院合理贮存与患者使用过程中存放提供了依据。

Aim To investigate the stability of the recombination human at EGF （rhEGF） under different conditions.Methods The rhEGF solution and gel was prepared and stored at different temperatures （4℃,25℃,37℃）.The residual level of rhEGF at different points of time （0,2,4,6,8 months） using radio immunoassay.Results There was no obvious change in preparation appearance in the course of observation.The stability of different preparations of rhEGF decrensed with the rise of temperature.The gel more stable than the solution.Conclusion Difference in storage conditions has a remarkable effect on the stability of rhEGF.The preparation is stable for 8 months when stored at 4℃ and for 4 months at room temperature.Storage above room temperature should not exceed one month.The above-mentioned finding provides refereme for reasonable storage and use.