基于铁迁移动力学和热力学规律对藿香正气软胶囊生产技术的研究

Research on Production Technology of Huoxiang Zhengqi Soft Capsules Based on Iron Migration Kinetics and Thermodynamics

目的:研究铁元素迁移对藿香正气软胶囊稳定性的影响。方法:利用紫外分光光度计法和电感耦合等离子体质谱测定藿香正气软胶囊中铁元素的分布情况。并通过吸附热力学模型、准二级动力学模型及叶洛维奇(Elovich)模型等对铁元素的迁移进行研究。结果:研究发现,铁离子从内容物向囊壳迁移的过程是一个吸热、熵驱动的自发过程,温度越高迁移越快;保质期内其迁移行为基本符合准二级动力学模型,超出保质期后的迁移行为可用叶洛维奇模型来描述。结论:本研究成果可应用于推测藿香正气软胶囊中铁元素的迁移规律,为制定产品质量控制技术标准提供一定的依据。

Objective:To study the effects of iron migration on the stability of Huoxiang Zhengqi Soft Capsule.Methods:The distribution of iron in Huoxiang Zhengqi Soft Capsule was determined by UV and ICP-MS.The transport of iron was studied by adsorption thermodynamics model,quasi second-order kinetics model and Elovich model.Results:It was found that the migration of iron ions from the content to the shell was a spontaneous process driven by endothermic and entropy.The higher the temperature was,the faster the migration was;the migration behavior within the shelf life was basically in accordance with the quasi second-order dynamics model,and the migration behavior beyond the shelf life could be described by the Elovich model.Conclusion:The results of this study can be used to speculate the migration rule of iron in Huoxiangzhengqi Soft Capsule,and provide some basis for the formulation of product quality standards.