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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。
Objective To obtain the stability data of citicoline sodium tablets in different environments through experiments and provide experimental evidence for the determination of drug storage and expiration date. Methods The content of citicoline sodium in citicoline sodium tablets was determined by high performance liquid chromatography (HPLC). Through the light test, high temperature test, high humidity test, accelerated test and long-term test, the kinetic formula Arrhenius equation and statistical principle Calculate K25 ℃ and predict drug expiration date. The results of citicoline tablets stability, prediction of validity and long-term test results are consistent. Conclusion Citrin sodium tablets stored at room temperature for 36 months.