拉呋替丁片的处方工艺及稳定性研究

目的 考察新处方工艺制备的拉呋替丁片并做稳定性研究.方法 以有关物质、含量和溶出度为指标,通过加速试验和长期试验并与参比制剂进行对比试验.结果 新处方溶出度、含量和有关物质分别为98.8％、100.0％和0.23％.三批样品的6个月加速试验和36个月长期稳定性试验结果分别为：溶出度97.9％～99.1％和95.4％～97.6％,含量99.0％～99.5％和97.0％～98.0％,有关物质为0.36％～0.41％和0.59％～0.65％.各项指标符合规定且优于参比制剂.结论 该处方和制备工艺简单可行,质量稳定可控.

Study on the preparation and stability of Lafutidine Tablets

Objective To study the preparation and stability of Lafutidine Tablets.Methods The accelerated test and long-term test were carried out.Then related substances,content and dissolution rate of Lafutidine Tablets were examined and compared with the reference tablets.Results The dissolution rate,content and related substances of new preparation were 98.8％,100.0％ and 0.23％,respectively.The results of accelerated test （6 months） and long-term test （36 months） were as follow：dissolution rate were 97.9％-99.1％ and 95.4％-97.6％,content were 99.0％-99.5％ and 97.0％-98.0％,related substances were 0.36％-0.41％ and 0.59％-0.65％,respectively.All indexes conformed to the standards and were superior to reference tables.Conclusion The preparation is simple and feasible.The quality is stable and controllable.