单磷酸阿糖腺苷在小儿电解质补给注射液中的稳定性考察

Study on the Stability of Vidarabine Monophosphate in Pediatric Electrolyte Supplements Injection

关键词:  单磷酸阿糖腺苷  小儿电解质补给注射液  配伍稳定性  高效液相色谱法

Key words:  vidarabine monophosphate  Pediatric Electrolyte Supplements injection  compatible stability  HPLC

摘要:

目的 考察注射用单磷酸阿糖腺苷在小儿电解质补给注射液中的稳定性。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内小儿电解质补给注射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>99%(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伍，24 h内于避光条件下可稳定共存，而光照是影响其稳定性的主要因素。

Abstract:

OBJECTIVE To investigate the stability of vidarabine monophosphate for injection in Pediatric Electrolyte Supplements Injection. METHODS The relative content of vidarabine monophosphate in Pediatric Electrolyte Supplements injection was determined by HPLC in 24ｈat 5, 25, 35 ℃ under dark and light, and the changes in appearance, pH value and insoluble particles were observed. RESULTS There were no significant changes in appearance and pH value at 5, 25, 35 ℃ under dark, insoluble particles were in line with Chinese Pharmacopoeia(2010 edition), and the relative content of vidarabine monophosphate were above 99%(compared with 0 h) in 24 h. In the light conditions, as the temperature raised, the extension of storage time, the content of vidarabine monophosphate had declined, while pH value and insoluble particles did not change. CONCLUSION Vidarabine monophosphate for injection compatibled with pediatric electrolyte are stable under dark conditions in 24 h. The light is the main influential factor of the stability.