注射用单磷酸阿糖腺苷与小儿电解质补给注射液的配伍稳定性考察

Compatible Stability of Vidarabine Monophosphate for Injection and Pediatric Electrolyte Supplements Injection

目的:考察注射用单磷酸阿糖腺苷与小儿电解质补给注射液配伍后的稳定性。方法:采用高效液相色谱法,测定在5、25、35℃避光和光照条件下24 h内配伍液中单磷酸阿糖腺苷的含量变化,并考察配伍前后配伍液外观、pH值及不溶性微粒的变化。结果:注射用单磷酸阿糖腺苷与小儿电解质补给注射液配伍后,在避光条件下,24 h内配伍液的外观、pH值均无明显变化,不溶性微粒均符合《中国药典》(2010年版)规定,单磷酸阿糖腺苷百分含量在99%以上(相对于0 h);而在光照条件下,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有所下降,pH值及不溶性微粒则无变化。结论:注射用单磷酸阿糖腺苷与小儿电解质补给注射液配伍后,24h内于避光条件下可稳定共存,光照是影响其稳定性的主要因素。

OBJECTIVE： To investigate the stability of Vidarabine monophosphate for injection mixed with Pediatric electrolyte supplements injection. METHODS： The content of vidarabine monophosphate in mixture was determined by HPLC within 24 h at 5 ℃, 25 ℃, 35 ℃ under dark and light condition, and the changes in appearance, pH value and insoluble particles were observed, RESULTS： After compatibility, there were no significant changes in appearance and pH value within 24 h; insoluble particles were in line with Chineese Pharmacopoeia （2010 edition）, and the relative percentage content of vidarabine monophosphate was above 99% within 24 h （compared with 0 h） under dark condition. Under light condition, as the temperature raised and the extension of storage time was prolonged, the content of vidarabine monophosphate had declined, while pH value and insoluble particles did not change. CONCLUSIONS： Vidarabine monophosphate for injection mixed with Pediatric electrolyte supplements injection is stable within 24 h under dark conditions, The light is the main influential factor ofthe stability.