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
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篇名: | 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 |
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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。 |
ABSTRACT: | 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 |
AUTHORS: | 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 |
阅读数: | 1223 次 |
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