多条溶出曲线评价罗通定片的质量

Evaluation of Rotundine Tablets by Dissolution Profiles in Different Media

目的通过研究不同pH介质中罗通定片的溶出曲线,评价制剂质量。方法以0.1 mol/L盐酸溶液、醋酸盐缓冲液(pH 4.0)和磷酸盐缓冲液(pH 6.8)为溶出介质,采用光纤溶出度实时测定仪测定罗通定片的溶出曲线。结果通过比较溶出曲线,显示不同厂家的药品在不同pH介质中溶出行为差异很大。结论各厂家生产的罗通定片质量参差不齐。

Objective To evaluate the quality of Rotundine Tablets from several manufacturers using different stripping curves.Methods 0.1 mol/L HCl,acetate buffer（pH 4.0） and phosphate buffer（pH 6.8） were used as the dissolution media and stripping curves were determined by FODT-601 Fiber-optic Medicine Dissolution Process Real Time Test System.Results A comparision of the stripping curves by using different dissolution media indicates that the dissolution process of tablets from different manufacturers was quite different.Conclution There is significant difference in the quality of Rotundine Tablets from several manufacturers.