| 地奥司明栓剂的制备及质量控制研究 |
| 投稿时间：2016-12-15 修订日期：2017-06-05 点此下载全文 |
| 引用本文：王陈翔,黄爱芳,金辉,周彬,周子晔.地奥司明栓剂的制备及质量控制研究[J].药学实践杂志,2017,35(4):325~327,349 |
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| 基金项目:温州市科技计划项目（Y20130289） |
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| 中文摘要:目的 制备地奥司明栓剂，建立其质量控制方法。方法 以地奥司明为原料药，以聚乙二醇6000、聚乙二醇400和甘油为基质，用热熔法制备含药栓剂，并对其外观、含量均匀度、融变时限、质量差异进行评价。结果 地奥司明栓剂外观呈棕色，室温下能保持较好的硬度，含量均匀度、质量差异、融变时限、溶出度均符合栓剂要求。结论 本方法制备的地奥司明栓剂符合栓剂的质量要求，适合作为地奥司明的新剂型进行开发。 |
| 中文关键词:地奥司明 栓剂 制备工艺 质量评价 |
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| Preparation and quality control of diosmin suppository |
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| Abstract:Objective To prepare diosmin suppository and establish a method for its quality control. Methods Diosmin was used as active ingredient. Polyethylene glycol 6000, polyethylene glycol 400 and glycerol were chosen as substrates. Fusion method was applied to prepare the diosmin suppository. The appearance, content uniformity, weight variation and melting time of suppository were evaluated. Results The diosmin suppository has brown color with good hardness at room temperature. The content uniformity, weight variation, melting time and dissolution rate meet the requirements of quality control. Conclusion The diosmin suppository prepared by this method was satisfied the quality requirements of suppository and serves as a new formulation of diosmin. |
| keywords:diosmin suppository preparation quality evaluation |
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