胞磷胆碱钠片的稳定性研究

目的通过试验得出不同环境下胞磷胆碱钠片的稳定性数据,为药品储存、有效期的确定提供实验依据。方法采用高效液相色谱法测定胞磷胆碱钠片中胞磷胆碱钠的含量,通过光照试验、高温试验、高湿试验、加速试验和长期试验,应用动力学公式Arrhenius方程及统计学原理计算出K25℃和预测药品有效期。结果胞磷胆碱片稳定性好,预测有效期与长期试验结果相吻合。结论胞磷胆碱钠片在室温条件下储存的有效期为36个月。

Study on stability of Cyticoline Sodium Tablets

Objective To obtain stability data of Cyticoline Sodium Tablets under different surroundings through experiments,providing basis for drug storage and determination of expiration date.Methods The content of cyticoline sodium in Cyticoline Sodium Tablets was detected by HPLC.The stability of Cyticoline Sodium Tablets was determined by light test,high-temperature test,high-humidity test,accelerated test and long-term test.K25 ℃ was calculated by arrhenius equation and the statistical principle and the expiration date was predicted.Results Cyticoline Sodium Tablets were stable.The result of long-term tests was consistent with the predicated expiration date.Conclusion The expiration date of Cyticoline Sodium Tablets was 36 months under room temperature.