苯磺酸氨氯地平分散片的制备及溶出度测定

Preparation and solubility determination of amlodipine besylate dispersible tablets

目的探讨苯磺酸氨氯地平分散片的制备工艺。方法选用交联聚维酮、低取代羟丙纤维素和羧甲基淀粉钠3种辅料联合使用作为崩解剂,聚维酮K30为黏合剂,阿斯帕坦为矫味剂、微粉硅胶为助流剂、硬脂酸镁为润滑剂、20%乙醇为润湿剂,并采用紫外分光光度法测定其溶出度。结果通过对苯磺酸氨氯地平分散片专属性、线性关系、稳定性、回收率、精密度、溶出度均一性实验的研究,建立了可控制其质量的溶出度测定方法。结论本制剂处方工艺可靠,检测方法简便、准确、适用于医院配制和应用。

Objective To study preparation technology of amlodipine besylate dispersible tablets.Methods Select crospovidone,low-hydroxypropylcellulose and carboxymethyl dtarch sodium for disintegrants,poridone for adhesives,asipatan for flavoring,aerosil for glidants,magnesium stearate for lubricants,20% ethanol for moistening agent.And the solubility of which was determined by UV spectrophotomery.Results The quality controllable solubility determination was developed through the exclusive,linearity,stability,recovery rate,exactitude,limitation of solubility and homogeneity for dispersible tablets of amlodipine besylate.Conclusion The preparation technology is reliable,The methods are simple,accurate,which can be used in hospital production and using.