那格列奈片的制剂学研究

Preparation study on Nateglinide tablets

目的:筛选那格列奈片的处方、优化工艺,并对本片进行质量研究。方法:处方及工艺研究采用比较法,含量测定、溶出度测定、有关物质检查采用HPLC法。结果:所选处方合理、工艺可行,HPLC方法灵敏、可靠、重复性好、操作简单,能够很好地控制本片的质量。结论:按照该处方及工艺压制的那格列奈片具有良好的稳定性,本研究为新药报批提供了制剂学研究资料。

Objective:To screen formulations,optimize preparing technics and study on quality control of Nateglinide tablets.Methods: The comparation method was used in formulation and technics study,and a HPLC method was applied in content determination,dissolution and related materials study.Results:A reasonable formulation and feasible technics were found,the HPLC method established were sensitive,reliable and simple with good reproductivity,and the quality of Nateglinide tablets were under control very well.Conclusion:Nateglinide tablets prepared with the optimized formulation and technics demonstrated good stability. This study offered preparation study data for the new drug registration.