那格列奈分散片的制备及质量研究

Preparation and quality investigation of nateglinide dispersible tablets

目的 :制备那格列奈分散片 ,并建立那格列奈分散片的溶出度测定方法。方法 :采用正交试验选择出交联聚乙烯吡咯烷酮为崩解剂 ,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 :那格列奈分散片工艺简单、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 。

Objective:To prepare a fast action nateglinide dispersible tablets. Methods: Crospovidon was selected as disintegration agent according to orthogonal test. The dispersible tablets were prepared by the combination of internal addition and external addition of disintegration agent. The stability of the tablets was studied. Results: The tablets totally disintegrated within one minute,the quality conformed to the standard. Conclusions: The tablets prepared can meet the requirement for dispersible tablets.