格列齐特缓释片处方及工艺研究

Formula and preparation technology of gliclazide controlled-release tablets

目的筛选格列齐特缓释片的处方及工艺。方法以体外释放度为考察指标,优选格列齐特缓释片的骨架材料、填充剂、释放速率调节剂、黏合剂等。结果确定了以羧甲基纤维素钠(CMC-Na)(低黏度CMC-Na 52 mg、高黏度CMC-Na 32 mg)作为基本骨架材料,磷酸氢钙(150 mg)作为填充剂,糊精(22 mg)作为释放速率调节剂,85%乙醇为黏合剂,硬脂酸镁、微粉硅胶为润滑剂和助流剂的处方。制备的格列齐特缓释片释放行为与参比制剂基本相似。结论优选的处方合理、工艺稳定、可行,且大大降低了生产成本。

Objective To optimize the formula and preparation technology of gliclazide controlled-release tablets.Methods Taking release rate of gliclazide controlled-release tablets as index,the suitable gel-matrix materials,fillers,moderator of release rate and adhesive were optimized.Results The optimized formula of gliclazide controlled-release tablets was determined as follows： with carboxymethylcellulose sodium（low-grade viscosity： 52 mg,superior viscosity： 32 mg） as gel-matrix materials,calcium hydrogen phosphate（150 mg） as filler,dextrin（22 mg） as moderator of release rate,85% alcohol as binder,magnesium stearate and gum acacia as lubricant and glidant.Gliclazide controlled-release tablets showed a similar release rate as the reference samples.Conclusion This formula is reasonable.The preparation procedure is stable and feasible.The production cost is significantly reduced.