双氯芬酸钠淀粉微球的制备及其质量评价

发布时间：2018-05-03 19:29

  本文选题：双氯芬酸钠 + 淀粉微球　； 参考：《中国药学杂志》2016年07期

【摘要】：目的以可溶性淀粉为原料,N,N'-亚甲基双丙烯酰胺为交联剂,双氯芬酸钠为主药,通过反相乳化交联法制备双氯芬酸钠载药淀粉微球。方法以微球平均粒径和包封率为指标,采用单因素及正交实验优化微球的处方和制备工艺。采用光学显微镜、透射电镜、红外光谱仪及差热分析仪对所获微球的外观和结构进行表征,并通过透析法对载药微球的体外释药情况进行考察。结果经正交实验优化后的制备条件为:淀粉浓度10%,交联温度55℃,交联剂用量0.2 g,油水体积比5∶1,乳化剂用量5 m L,交联时间60 min,此条件制得的淀粉微球平均粒径为9μm,形状近球形,包封率为67.52%。红外光谱和差热分析表明淀粉已发生交联。结论载药淀粉微球具有较好的缓释作用,药物的体外释放符合Weibull方程。
[Abstract]:Objective to prepare diclofenac sodium loaded starch microspheres by reverse phase emulsification and crosslinking with soluble starch as raw material and diclofenac sodium as crosslinking agent and diclofenac sodium as crosslinking agent. Methods the formulation and preparation process of the microspheres were optimized by single factor and orthogonal experiment, based on the average particle size and encapsulation efficiency of the microspheres. The appearance and structure of the microspheres were characterized by optical microscope, transmission electron microscope, infrared spectrometer and differential thermal analyzer, and the drug release in vitro was investigated by dialysis. Results the optimized preparation conditions were as follows: starch concentration was 10, crosslinking temperature was 55 鈩，

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