本文選題：抗凝劑　切入點(diǎn)：硬脂酸鏈修飾多肽　出處：《軍事醫(yī)學(xué)》2015年12期

【摘要】：目的考察抗凝血多肽Hirulog-S原料藥及凍干劑的穩(wěn)定性,為該藥臨床應(yīng)用及保存條件的制定奠定基礎(chǔ)。方法采用高效液相色譜法,通過影響因素實(shí)驗(yàn)、加速實(shí)驗(yàn)和長(zhǎng)期穩(wěn)定性實(shí)驗(yàn)測(cè)定Hirulog-S原料藥及凍干劑的含量及有關(guān)物質(zhì)的變化。結(jié)果影響因素實(shí)驗(yàn)結(jié)果表明,溫度、濕度對(duì)Hirulog-S原料藥、凍干劑的含量及有關(guān)物質(zhì)變化影響不大;加速實(shí)驗(yàn)(40℃,RH75%)、24個(gè)月室溫及4℃長(zhǎng)期穩(wěn)定性實(shí)驗(yàn)顯示,Hirulog-S原料藥及凍干劑含量及有關(guān)物質(zhì)均無顯著變化。結(jié)論 Hirulog-S原料藥及凍干劑具有較高穩(wěn)定性,原料藥室溫避光密封保存、凍干粉4℃避光密封保存,暫定有效期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，

本文編號(hào)：1659232