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采用高效液相色谱法(HPLC)和圆二色谱法(CD)考察了p H值、温度、糖类化合物和锌离子等对艾塞那肽溶液稳定性的影响。结果表明,当磷酸盐缓冲液(PBS)p H值为4.0、7.4时,37℃放置10 d时艾塞那肽降解了18%和77%;p H 7.4 PBS于25℃放置10 d时,艾塞那肽降解了33%,4℃放置10 d则无明显降解。添加与药物质量比为1∶1的海藻糖或蔗糖、或添加低浓度锌离子可使艾塞那肽溶液的热变性温度从72.8℃分别提高至94.9、83.0和85.0℃。本研究表明p H值偏中性或温度升高,会使艾塞那肽稳定性降低,而添加海藻糖、蔗糖或锌离子可提高其稳定性。
The effects of p H value, temperature, carbohydrates and zinc ions on the stability of exenatide solution were investigated by high performance liquid chromatography (HPLC) and circular dichroism (CD). The results showed that exenatide degraded 18% and 77% at 37 ℃ for 10 days when pH value of phosphate buffer solution (PBS) was 4.0 and 7.4, respectively. When p H and 7.4 PBS were stored at 25 ℃ for 10 days, Exenatide degradation of 33%, 4 ℃ for 10 d no significant degradation. The addition of trehalose or sucrose to the drug at a mass ratio of 1: 1 or the addition of zinc ions at low concentrations increased the denaturation temperature of the exenatide solution from 72.8 ° C to 94.9, 83.0 and 85.0 ° C, respectively. The present study shows that partial neutral or elevated temperature of p H decreases the stability of exenatide, whereas the addition of trehalose, sucrose or zinc ions improves its stability.