不同溶出介质评价盐酸雷尼替丁胶囊内在质量

Evaluation the Quality of Ranitidine Hydrochloride Capsule in Different Mediums

目的测定同一产家生产的不同批号盐酸雷尼替丁胶囊在不同溶出介质中的溶出度,通过溶出曲线来评价药品内在质量。方法在4种溶出介质中,采用转篮法进行溶出度试验,使用不同介质中的溶出曲线对结果进行分析和比较。结论不同批号盐酸雷尼替丁胶囊在不同溶出介质中溶出度差异较小,说明该厂家的质量均一性和稳定性较好。

OBJECTIVE To detect the dissolution of ranitidine hydrochloride capsule from different batches of the same pharmaceutical factory in 4 different mediums and evaluate the quality by dissolution curves. METHODS The dissolution test was carried out with rotating-basket method. To analyse and compare the results by the dissolution curves in different mediums. CONCLUSION The dissolution of different batches of Ranitidine Hydrochlorlde Capsules in different mediums verified no significant differences,indicating that the manufacturer＇s quality homogeneity and stability was well.