明胶胶囊交联机制与其检测方法的研究进展

Research progress on cross-linking mechanism and detection methods of gelatin capsules

目的明胶胶囊在贮存条件不适当或者时间过长都会发生不同程度的交联,从而影响胶囊的崩解时限,致使药物的溶出度下降,药物不能正常发挥疗效,交联程度的检测方法值得更加深入的研究。因此,本文对明胶胶囊交联机制及检测交联程度的方法进行总结。方法通过对国内外70余篇相关文献整理分析,本文主要分析了明胶交联机制及检测明胶交联程度的方法。结果本文从多角度阐明了明胶交联的原因,总结出了多种明胶交联程度的检测方法。结论分析明胶胶囊交联机制并总结明胶胶囊交联程度的检测方法,对检测方法的选择提供指导。

Purpose Gelatin capsules will be cross-linked in varying degrees when the storage conditions are not appropriate or the storage time is too long,which will affect the disintegration time of the capsules,resulting in a decrease in the dissolution of drug,and the drug cannot function normally.The detection methods of cross-linking degree are worthy of further study.Therefore,this paper summarizes the cross-linking mechanism of gelatin capsules and the methods to detect the degree of cross-linking.Methods Through analyzing more than 70 related literatures in recent years,this paper mainly analyzed the mechanism of gelatin cross-linking and the methods to detect the degree of gelatin cross-linking.Results The reasons of gelatin cross-linking were clarified from many aspects,and a variety of detection methods of gelatin cross-linking degree were summarized.Conclusion Analyzing the cross-linking mechanism of gelatin capsules and summarizing the detection methods of cross-linking degree of gelatin capsules will provide a theoretical basis for the selection of detection methods.