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明胶冻力对尼莫地平软胶囊溶出稳定性的影响 被引量:2

Effect of Bloom Strength on Dissolution Stability of Nimodipine Soft Gelatin Capsules
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摘要 将不同来源和冻力差异的明胶制成软胶囊和胶皮后,通过测定软胶囊的溶出度、胶皮的平衡膨胀量和氨基酸残基含量,考察软胶囊的稳定性,对明胶的组分进行分离和测定,考察其交联反应活性。结果显示,加速条件下放置90 d后,软胶囊的溶出度显著降低(P<0.05),且明胶冻力越高,溶出度越低,胶皮的平衡膨胀量和ω-氨基酸残基含量亦有相同变化。DSC图谱显示,考察后样品囊壳吸热峰向温度较高的区域偏移,且明胶冻力越高,偏移幅度越大。明胶分子主要含有α、β和γ等组分,其中α组分与明胶的冻力有良好的相关性,各组分的交联反应活性依次为α>β>γ。 Gelatins from different sources and with different bloom strength were used to prepare soft capsules and flakes,and then the dissolution of soft capsules,the equilibrium swelling ratio and the residual ω-amino content of flakes were determinated.The content and the crosslinking activity of different components in gelatin were measured to explain the effect of bloom strength of gelatin on the stability of soft capsules.The results showed that dissolution of capsules stored in accelerating condition for 90 d was significantly decreased compared to the fresh prepared samples(P<0.05).The dissolution decreased with the increase of bloom strength.The same phenomenon could be observed in equilibrium swelling ratio and residual ω-amino content test.The DSC of soft capsule shell showed that the endothermic peak moved to the higher temperature area,the higher bloom strength,the more obviously drift.There were three main components consisting of α,β and γ in gelatin.The content of α component showed a good linear relationship with bloom strength.The cross-linking activity of different components was α> β> γ.
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2011年第6期426-431,共6页 Chinese Journal of Pharmaceuticals
基金 国家"重大新药创制"科技重大专项(2009ZX09310-004) 国家中医药管理局中医药科学技术研究课题计划项目(06-07ZP20) 国家基础科学人才培养基金(J0630858)
关键词 明胶冻力 软胶囊 溶出度 交联反应 α组分 bloom strength soft gelatin capsule dissolution crosslinking reaction α component
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