薄膜包衣法制备枸橼酸钾缓释片的研制

摘要

目的:利用薄膜包衣技术制备枸橼酸钾缓释片.方法:采用丙烯酸树脂水分散体(Eudragit NE30D)包衣,滑石粉为抗黏剂,通过体外释放度试验筛选工艺参数.结果:在包衣增重7%,包衣锅转速30 r/min,包衣温度40℃喷液速度1ml/min的条件下,枸橼酸钾缓释片的释药行为符合设计要求.结论:该片工艺和处方简单,适合工业化生产,为水中极易溶解药物制备缓释片提供依据.%Objective: To apply film coating technology to make Potassium Citrate Sustained-release Tablets.Methods: Eudragit NE30D was used as a film material, talc powder was used as antiplastering aid.Technological parameters of tablets were screened by release.Results: The release behavior of Potassium Citrate Sustained-release Tablets met the design requirements in the layer weight of 7％, rotation speed of 30 r/min, coating temperature of 40℃ , spray rate of 1 ml/ min.Conclusion: This technology and formulation is simple, suitable for industrial production and provide the basis for preparation of sustained-release tablets of highly water-soluble drugs.