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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 ,制剂质量稳定
OBJECTIVE: To prepare nateglinide dispersible tablets and to establish a dissolution assay for nateglinide dispersible tablets. Methods: The orthogonal test was used to select the cross-linked polyvinylpyrrolidone as the disintegrant, and the disintegrant was added into the dispersible tablets by the method of combining with external additive. The stability of heat, moisture and light were also investigated. Results: Nateglinide dispersible tablets with simple process, good stability, all in 1min disintegration, in line with the quality of the dispersible tablets. Conclusion: The product meets the requirements of dispersible tablets and the preparation quality is stable