不同处方注射用单磷酸阿糖腺苷稳定性考察

Investigation on Stability of Vidarabine Monophosphate for Injection with Different Formulas

目的：探讨不同处方的注射用单磷酸阿糖腺苷的稳定性。方法：制备不同处方的单磷酸阿糖腺苷冻干粉针，按2010年版《中国药典（二部）》附录《原料药与药物制剂稳定性试验指导原则》进行加速试验，重点考察其性状、pH、含量等变化。结果：不同处方样品稳定性存在较大差异，同时加入依地酸二钠和磷酸盐缓冲对的处方稳定性最好。结论：筛选处方能有效解决注射用单磷酸阿糖腺苷的稳定性，可用于指导生产。

To investigate the stability of vidarabine monophosphate for injection with different formulas and select advanced prescription. Methods：Preparation of vidarabine monophosphate for injection with different formulas. According to the stability test of pharmaceutical preparations and guiding principles in the appendix of the Chinese Pharmacopoeia （edition 2010, Vo1. II）, the accelerated test was performed with the major investigation on the evaluation indexes of character, pH and content. Results：The data of stability test indicated that the large difference existed in the stability of vidarabine monophosphate for injection with different formulas. The best prescription was：added ethylenediamine tetraacetic acid disodium salt and phosphate buffer. Conclusion：The prescription of selection can effectively solve the stability of vidarabine monophosphate for injection and used to guide production.