文章-基于降解动力学模型的盐酸艾司洛尔氯化钠注射液稳定性评估-20250310

　　

摘要 目的：采用加速稳定性评估程序（Accelerated stability assessment program，ASAP），通过短期强条件下稳定性研究，建立盐酸艾司洛尔氯化钠注射液的降解动力学模型，评估其API不过量投料及2%过量投料含量和有关物质的变化趋势。预测盐酸艾司洛尔氯化钠注射液长期（25℃,60%RH）条件下的稳定性。方法：利用ASAPprim 软件设计为期1个月的实验，温度范围50℃～ 80℃，相对湿度范围为0%RH ～ 50%RH，利用经湿度校正的Arrhenius方程建立盐酸艾司洛尔氯化钠注射液杂质FP-A的降解动力学模型，预测盐酸艾司洛尔氯化钠注射液的长期稳定性。结果： ASAP模型的拟合参数R²、Q²均在可接受范围内（R² ＞ 0.9，Q² ＞ 0.8），说明降解动力学模型拟合良好。采用拟合模型预测盐酸艾司洛尔氯化钠注射液中API 100%投料，产品含量有超出限度的风险，102%投料则可以满足使用当前包装，在25℃/60%RH条件下放置24个月的要求，为处方的确定、货架期的制定提供了数据支持。

Abstract Objective: The degradation kinetics model of esmolol hydrochloride sodium chloride injection was established by using the accelerated stability assessment program (ASAP) and the stability study under short-term strong conditions, and the API over-feeding and 2% over-feeding content and the change trend of related substances were evaluated. To predict the stability of esmolol hydrochloride sodium chloride injection under long-term (25°C, 60%RH) conditions. Methods: A one-month experiment was designed with ASAPprim software in the temperature range of 50°C~80°C and relative humidity in the range of 0%RH~50%RH, and the degradation kinetic model of the impurity FP-A of esmolol hydrochloride sodium chloride injection was established by using the humidity-corrected Arrhenius equation to predict the long-term stability of esmolol hydrochloride sodium chloride injection. Results: The fitting parameters R² and Q² of the ASAP model were within the acceptable range (R² > 0.9, Q² > 0.8), indicating that the degradation kinetic model was well fitted. The fitting model was used to predict that 100% of the API in esmolol hydrochloride sodium chloride injection was fed, and the product content was at risk of exceeding the limit, and the 102% dosing could meet the requirements of 24 months of storage at 25°C/60%RH using the current packaging, which provided data support for the determination of prescription and the formulation of shelf life.

订阅方式：
①在线订阅（推荐）：www.sdchem.net.cn
②邮局订阅：邮发代号24-109

投稿方式：
①在线投稿（推荐）：www.sdchem.net.cn
　　作者只需要简单注册获得用户名和密码后，就可随时进行投稿、查稿，全程跟踪稿件的发表过程，使您的论文发表更加方便、快捷、透明、高效。
②邮箱投稿：sdhgtg@163.com sdhg@sdchem.net
　　若“在线投稿”不成功，可使用邮箱投稿，投稿邮件主题：第一作者名字/稿件题目。
投稿时请注意以下事项：
　　①文前应有中英文“题目”、“作者姓名”、“单位”、“邮编”、“摘要”、“关键词”；
　　②作者简介包括：姓名、出生年、性别、民族、籍贯或出生地、工作单位、职务或职称、学位、研究方向；
　　③论文末应附“参考文献”，执行国标GB/T7714-2005标准，“参考文献”序号应与论文中出现的顺序相符；
　　④注明作者的联系方式，包括电话、E-mail、详细的通讯地址、邮编，以便联系并邮寄杂志。
　　 　                                                                                   山东化工稿件修改细则