抗凝血多肽Hirulog-S的稳定性研究

发布时间：2018-03-24 17:07

  本文选题：抗凝剂　切入点：硬脂酸链修饰多肽　出处：《军事医学》2015年12期

【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。
[Abstract]:Objective to investigate the stability of anticoagulant polypeptide Hirulog-S raw material and freeze-dried agent, and to lay a foundation for its clinical application and preservation conditions. The effects of temperature and humidity on the contents and related substances of Hirulog-S bulk drug and freeze-dried agent were studied. Results the results showed that temperature and humidity had little effect on the content and related substances of Hirulog-S bulk drug and freeze-dried agent. The long-term stability tests at room temperature for 24 months and at 4 鈩，

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