注射用单磷酸阿糖腺苷与阿昔洛韦注射液配伍稳定性考察 点击下载
论文标题： 注射用单磷酸阿糖腺苷与阿昔洛韦注射液配伍稳定性考察
英文标题：
中文摘要： 目的：考察注射用单磷酸阿糖腺苷与阿昔洛韦注射液的配伍稳定性。方法：采用高效液相色谱（HPLC）法，测定在5、25、35 ℃避光和光照条件下８h内配伍液中两药的含量变化，并考察配伍前后外观、性状、pH及不溶性微粒（24 h内）的变化。结果：在避光条件下，8 h内配伍液的外观、pH均无明显变化，不溶性微粒均符合《中国药典》（2010年版）规定，配伍液中单磷酸阿糖腺苷与阿昔洛韦的百分含量均在99％以上（相对于0 h）；在光照条件下，随着温度的升高，放置时间的延长，配伍液中单磷酸阿糖腺苷的含量没有明显下降，而阿昔洛韦的含量下降较明显（4 h及以后），配伍液pH也有一定程度的升高，不溶性微粒则无明显变化。结论：注射用单磷酸阿糖腺苷与阿昔洛韦注射液在0.9％氯化钠注射液中配伍后，8 h内于避光条件下可稳定共存。为保障临床用药的安全性，建议临床最好在单磷酸阿糖腺苷与阿昔洛韦配伍后的4 h内用完，且尽量避光。
英文摘要： OBJECTIVE： To investigate the stability of Vidarabine monophosphate for injection combined with Aciclovir injection. METHODS： HPLC method was adopted. The content variations of two drugs in mixture were determined within 8 h at 5 ℃，25 ℃，35 ℃ under dark and light. The changes in appearance， property， pH value and insoluble particles （within 24 h） were investigated before and after compatibility. RESULTS： There were no significant changes in appearance and pH value at 5 ℃，25 ℃，35 ℃ under dark， and insoluble particles were in line with Chinese Pharmacopoeia（2010 edition），and the relative content of vidarabine monophosphate and aciclovir were above 99％ （compared with 0 h） within 8 h. Under the light conditions， as the temperature raised and the extension of storage time， the content of vidarabine monophosphate did not significantly decrease， but that of aciclovir had declined significantly（4 h and after 4 h）， while pH value also had a certain degree of rise； the insoluble particles had no obvious change. CONCLUSIONS： The mixture of vidarabine monophosphate and aciclovir in 0.9％ Sodium chloride injections is stable under dark conditions within 8 h； it is suggested that the mixture should be used up within 4 h after mixing and protect from light to guarantee the safety of drug use in the clinic.
期刊： 2016年第27卷第5期
作者： 刘跃林
英文作者： LIU Yuelin
关键字： 单磷酸阿糖腺苷；阿昔洛韦；配伍稳定性；高效液相色谱法
KEYWORDS： Vidarabine monophosphate； Aciclovir； Compatible stability； HPLC
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