软胶囊胶皮交联的预防措施和评价方法的研究进展

发布时间：2018-01-19 04:38

本文关键词： 软胶囊明胶交联抗老化评价方法综述　出处：《中国医药工业杂志》2017年03期 　论文类型：期刊论文

【摘要】：软胶囊在贮存期间出现崩解或溶出迟缓的现象已受到广泛关注,产生这种现象的主要原因为囊壳材料明胶发生交联老化。明胶发生交联的机制主要是其分子内或两个相邻明胶分子间肽链的氨基酸残基间形成共价键,从而使明胶分子相互链接,形成巨大网状结构,阻碍水分子进入。要防止明胶交联老化,首先应最大限度地减少醛类物质的引入,其次还要注意囊壳中增塑剂、水分、色素、遮光剂等辅料对胶皮交联老化的影响。评价明胶交联程度的指标一般为平衡溶胀量(Seq)、ε-氨基酸残基含量、热稳定性和崩解时间等。一些新型检测方法,如圆二色谱(CD)、傅里叶变换红外光谱(FTIR)、扫描电镜(SEM)可从明胶胶皮的光学变化、化学官能团变化及形态变化等方面辅助评价其交联程度的大小。
[Abstract]:The phenomenon of disintegration or slow dissolution of soft capsules during storage has been paid more and more attention. The main reason for this phenomenon is gelatin gelatin crosslinking aging. The mechanism of gelatin crosslinking is the formation of covalent bonds between the amino acid residues of the two adjacent gelatin molecules. In order to prevent gelatin cross-linking aging, the introduction of aldehydes should be minimized, and the plasticizer in the capsule should be paid attention to. The effects of moisture, pigment, shading agent and other auxiliary materials on the crosslinking and aging of gelatin. The indexes to evaluate the crosslinking degree of gelatin are the equilibrium swelling amount and the content of 蔚 -amino acid residues. Some new detection methods, such as circular dichroism (CD), Fourier transform infrared spectroscopy (FTIR) and scanning electron microscope (SEM), can change the optical properties of gelatin. The degree of crosslinking was evaluated by chemical functional groups and morphological changes.
【作者单位】：中国医药工业研究总院药物制剂国家工程研究中心;
【分类号】：R943
【正文快照】： 究资料显示囊壳的老化主要是由囊壳主要材料明胶交联后老化所致,老化后的囊壳内壁会出现一层水不溶性的膜状物质,会明显延长软胶囊破裂和药物溶出时间,这一问题已成为制约我国软胶囊产业化发展的技术瓶颈。1明胶胶皮的老化机制明胶的老化主要通过交联反应产生。交联反应主要发

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