抗凝血多肽Hirulog-S的稳定性研究

摘要

Objective To study the stability of anticoagulant peptide Hirulog-S and its lyophilized product, and to provide data on the storage conditions and clinical applications.Methods RP-HPLC was used to determine the content and the related substances of Hirulog-S and its lyophilized powder with influence factor test, accelerated test and long-term storage test.Results Light, temperature and humidity had no significant effect on the stability of Hirulog-S and its lyophilized powder in the influence factor test.The content and related substances of Hirulog-S and its lyophilized powder did not significantly change in the accelerated test ( 40℃, RH75%) and 24-month long-term storage test at room temperature and 4℃.Conclusion Hirulog-S and its lyophilized product are very stable, even after being stored at room temperature for two years.%目的 考察抗凝血多肽Hirulog-S原料药及冻干剂的稳定性,为该药临床应用及保存条件的制定奠定基础. 方法 采用高效液相色谱法,通过影响因素实验、加速实验和长期稳定性实验测定Hirulog-S原料药及冻干剂的含量及有关物质的变化. 结果 影响因素实验结果表明,温度、湿度对Hirulog-S原料药、冻干剂的含量及有关物质变化影响不大;加速实验(40℃,RH75%)、24个月室温及4℃长期稳定性实验显示,Hirulog-S原料药及冻干剂含量及有关物质均无显著变化. 结论 Hirulog-S原料药及冻干剂具有较高稳定性,原料药室温避光密封保存、冻干粉4℃避光密封保存,暂定有效期2年.