目的：制备枸橼酸钾缓释片并对其体外释放度进行研究。方法：采用正交设计法对枸橼酸钾缓释片处方进行优化，并采用相似因子对其体外释放行为进行评价；以高效液相色谱法检测枸橼酸钾缓释片的释放度。结果：正交设计结果表明，硬脂酸对枸橼酸钾的释放影响较为明显，通过Higuchi方程及Peppas方程拟合，确定枸橼酸钾缓释片的释药机制为扩散与溶蚀双重作用。结论：应用硬脂酸为骨架材料即可制备具有理想释药行为的枸橼酸钾缓释片，其释放度符合《中华人民共和国药典》2010年版标准且与参比缓释片（UROCIT-K）相似。%Objective: To prepare the potassium citrate sustained-release tablets and to investigate the release profile in vitro of the sustained-release tablets. Methods: HPLC was used as the analytical method, an orthogonal design method was used to optimize the formulation and a similarity factor method was used to evaluate the in vitro release behavior. Results: Stearic acid affected the release more obviously. Determined by Higuchi equation and Peppas equation fitting, the release of potassium citrate sustained-release tablets included dual mechanisms of diffusion and erosion. Conclusion: Applying stearic acid as the backbone, potassium citrate extended release tablets have the desired release behavior, in line with the release standard of "Chinese Pharmacopoeia" 2010 version, and is similar to the reference sustained-release tablets (UROCIT-K).
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