目的制备双氯芬酸钾亲水凝胶骨架型缓释片剂,对影响药物释放的处方因素和工艺因素进行考察。方法以HPMC为骨架材料、EC为阻滞剂,通过正交设计确定了最优处方,在此基础上分别考察了制粒及制片压力等工艺因素的影响。结果最优处方在各时间点的释放均符合要求,而工艺因素对片剂的释放没有明显的影响。结论该制剂达到了预期的实验目的。 OBJECTIVE To prepare diclofenac potassium hydrophilic gel matrix sustained-release tablets and investigate the prescription and technological factors that affect drug release. Methods Using HPMC as matrix material and EC as blocker, the optimal formulation was determined by orthogonal design. On the basis of this, the effects of process factors such as granulation and tabletting pressure were investigated respectively. Results The release of the optimal prescription at each time point met the requirements, while the process factors had no obvious effect on the release of tablets. Conclusion The preparation achieves the intended experimental purpose.