美洛昔康分散片的制备及质量控制

Preparation and Quality Control of Meloxicam Dispersive Tablet

目的 :制备了美洛昔康分散片 ,建立美洛昔康分散片的溶出度测定法。方法 :采用正交试验选择出低取代羟丙纤维素为崩解剂 ,崩解剂内加和外加相结合的方法制成分散片 ,并对其热、湿、光等稳定性进行了考察。结果 :美洛昔康分散片工艺简单、稳定性良好 ,在 1min内全部崩解 ,符合分散片的各项质量指标。结论 :本品达到分散片要求 ,制剂质量稳定。

Objective: To establish a method to determine the dissolution for meloxicam dispersible tablet. Method: LS-HPC was selected for dispersive tablet according to orthogonal test. Result: The tablet could be disintegration within one minute, the quality accorded with the standard. Conclusion: The dispersible tablet could be used conveniently for clinic.