雷贝拉唑钠树脂复合物的制备及评价  

Preparation and evaluation of sodium rabeprazole-resinate complex

作　　者：陈丽丽[1] 安杉杉 陈燕忠[1] 吕竹芬[1] 谢清春[1] 

机构地区：[1]广东药学院药物研究所/广东省药物新剂型重点实验室,广州510006

出　　处：《西北药学杂志》2016年第3期297-301,326,共6页Northwest Pharmaceutical Journal

摘　　要：目的制备雷贝拉唑钠树脂复合物,探讨其形成机理并考察其稳定性。方法用静态离子交换法制备雷贝拉唑钠树脂复合物,通过正交设计法优化处方制备工艺;通过光学显微镜观察药物树脂复合物的形态外观;通过X-ray衍射分析、差示扫描量热分析以及红外光谱分析探讨药物树脂复合物的形成机理;通过吸湿平衡曲线评价雷贝拉唑钠树脂复合物的防潮性能;通过破坏性实验评价雷贝拉唑钠树脂复合物的耐酸性能。结果优化所得最佳制备工艺:药物初始浓度为1.0g·L^(-1),药物树脂质量比为1︰3,溶液介质离子强度为0.001mol·L^(-1)的氢氧化钠溶液,制备温度为30℃。经红外光谱分析、X-ray衍射和DSC分析,药物树脂复合物所载药物是以化学键的形式结合到离子交换树脂上的。雷贝拉唑钠树脂复合物也具有一定的防潮和耐酸性能。结论雷贝拉唑钠树脂复合物是通过化学键形成的,且在一定程度上能够提高药物的稳定性。Objective To confirm the formation mechanism of the sodium rabeprazole-resinate complex,and assess its stability.Methods The sodium rabeprazole-resinate complex was prepared by using ion exchange resin（IER）as a carrier,and the formulations were optimized by an orthogonal design.The sodium rabeprazole-resinate complex was characterized by morphology which was observed using an optical microscope.X-ray diffraction,differential scanning calorimetry and FTIR were employed to confirm the formation mechanism of the sodium rabeprazole-resinate complex.Under different humidity environments,the moisture proof capability of the sodium rabeprazole-resinate complex was investigated.Under the conditions of different acid and alkali,the acid resistance of the sodium rabeprazole-resinate complex was investigated.Result The drug concentration that prepared the sodium rabeprazole-resinate complex was 1.0g·L^-1,and the ratio of drug and resin was 1︰3.The ion strength of NaOH was0.001mol·L^-1,and the preparation temperature was 30 ℃.By X-ray diffraction analysis,differential scanning calorimetry and FTIR,the drug in sodium rabeprazole-resinate complex was combined with ion-exchange resins by chemical bond.The moisture absorption-liquefaction problem of sodium rabeprazole was alleviated to some extent.Conclusion The drug in sodium rabeprazoleresinate complex was combined with ion-exchange resins by chemical bond,and the stability of sodium rabeprazole was alleviated.

关 键 词：雷贝拉唑钠 离子交换树脂 药物树脂复合物 稳定性 

分 类 号：R944.9[医药卫生—药剂学]