摘要
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。
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.
出处
《军事医学》
CAS
CSCD
北大核心
2015年第12期934-937,共4页
Military Medical Sciences
基金
国家重大新药创制专项资助项目(2009ZX09503-15)
