摘要
本文应用反相HPLC建立了阿糖腺苷毫微囊(Ara-A-NC)混悬型注射剂中Ara-A的含量测定方法,并以此法研究了Ara-A-NC的化学稳定性。结果表明,Ara-A-NC注射剂中Ara-A受热作用,按一级动力学降解,降解反应的活化能为46.49kJ/mol,初步预测Ara-A-NC有效期为10.47个月(25℃).
A rapid, simple and accurate HPLC method to determine the concentration of Ara-A in Ara-A-NC is established. The calibration curve is linear for a wide range of concentration.The recovery is 101. 4%. The thermal chemical stability of Ara-A-NC is studied by classical constant temperature method. Results show that Ara-A decomposition in Ara-A-NC injection follows the first order kinetics. The activation energy of Ara-A decomposition in Ara-A-NC is 46.67KJ/mol and the T0.9 (25°C) 10.47 months.
基金
国家自然科学基金
关键词
阿糖腺苷
化学稳定性
高效液相色谱
9-β-D-Arabinofuranosyl adenine
Nanocapsules
Chemical stability
HPLC
