【摘要】 目的：以 含量变化 为指标 ，对 穿琥 宁注 射 液的 稳定 剂 和制 备 工艺 筛选 ，拟 出新 方。 方法 ：采用经典 恒温加速 试验法 ，研究了 新处 方 变色 和含 量 变化 规律 。结 果：显 示 两者 均符 合 一级 降 解反应。按 含量变化 计算，贮 存期为２ ．５３ａ ，活化能 为１ ０５ ．６９ｋ Ｊ／ ｍ ｏｌ ；按原始 透光率 降低２０ ％ ，以４ 种方法计算，贮 存期分 别 为 ２ ．４０ａ ，２ ．３４ａ ，２ ．１８ａ 和 ２ ．４３ａ ； 活 化 能 为 ９８ ．４８ｋ Ｊ／ ｍ ｏｌ ，９７ ．０７ ｋ Ｊ／ ｍ ｏｌ ，１００ ．２４ ｋ Ｊ／ ｍ ｏｌ 和９８ ．７９ ｋ Ｊ／ ｍ ｏｌ 。 结论：这些 参数可 作为评价 注射剂 稳定性的 指标。更多还原

【Abstract】 Objective: A new optimum formula of Chuanhuning injection was selected based on an indicator of the variation in the content of injection. Methods: To estimate the stability of this new formula, samples were subjected to the classical isothermal accelerated stability test at elevated temperatures. Results: The results show that both of the discoloration and variation in the concentration of the new formula against time obey the first order degradation reaction. According to the calculation of the variation in the concentration of the injection, the shelf life is about 2.53 years and the energy of activation is about 105.69kJ/mol. On the base of a decrease by 20% in transparency from the initial value, the discoloration shelf life calculated by four methods is 2.40,2.34,2.18,2.43 years and the activation energy is 98.49, 97.07,100.24,98.79kJ/mol respectively. Conclusion: These parameters can be regarded as an indicator of storage time index.更多还原