| 格列齐特缓释片处方及工艺研究 |
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| 引用本文： | 张克凤,李辉,黄守正,张霄翔,陈赵玲.格列齐特缓释片处方及工艺研究[J].安徽医药,2013,17(8):1276-1279. |
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| 作者姓名： | 张克凤 李辉 黄守正 张霄翔 陈赵玲 |
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| 作者单位： | 张克凤 (合肥工业大学制药工程系,安徽,合肥,230009)； 李辉 (安徽省医药科技实业公司,安徽,合肥,230001)； 黄守正 (安徽省医药科技实业公司,安徽,合肥,230001)； 张霄翔 (合肥工业大学制药工程系,安徽,合肥,230009)； 陈赵玲 (安徽省怀远县中医院,安徽,怀远,233400)； |
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| 摘 要： | 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。
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| 关 键 词： | 格列齐特 缓释片 处方工艺 羧甲基纤维素钠 正交实验 |
Formula and preparation technology of gliclazide controlled-release tablets |
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| Institution: | ZHANGN Ke-feng,LI Hui,HUANG Shou-zheng,et al(1.Department of Pharmaceutical Engineering,Hefei University of Technology,Hefei 230009,China;2.Anhui Medical Technology Industrial Company,Hefei 230001,China) |
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| Abstract: | 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. |
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| Keywords: | gliclazide controlled-release tablet formula and preparation technology carboxymeth-ylcellulose sodium orthogonal experiment |
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