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目的采用挤出滚圆法制备出稳定性良好的双氯芬酸钾缓释微丸。方法通过挤出滚圆法制备双氯芬酸钾缓释微丸。以制剂体外释放度及加速试验中制剂稳定性为指标,筛选了骨架剂的种类和卡波姆974P用量等影响因素。结果以卡波姆974P为凝胶型骨架剂,载药量为25%(w)时,制备微丸的释放度符合日本药典标准(0.5 h释放20~45%(w),2 h释放40~70%(w),8 h释放70%(w)以上)。结论成功地制备了双氯芬酸钾凝胶骨架型缓释微丸,该制备工艺重现性好,具有理想的缓释效果,加速试验稳定性良好。
Objective To prepare diclofenac potassium sustained-release pellets with good stability by extrusion spheronization. Methods Diclofenac potassium sustained release pellets were prepared by extrusion spheronization. Based on the in vitro release rate of the preparation and the stability of the preparation in the accelerated test, the influencing factors such as the type of the scaffold and the amount of carbomer 974P were screened. Results When carbomer 974P was used as a gel-type matrix and drug loading was 25% (w), the release of prepared pellets was in accordance with the Japanese Pharmacopoeia (20-45% w 0.5 h, 40 h w / ~ 70% (w), 8 h release of more than 70% (w)). Conclusion Diclofenac potassium gel matrix sustained-release pellets have been successfully prepared. The preparation has good reproducibility, ideal sustained-release effect and good stability in accelerated test.