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摘要缓释剂是目前口服药物中具有安全、有效、方便等特点的新剂型。而缓释片是所有缓释制剂中应用最广、技术最成熟的一种剂型。其中的骨架缓释片则是临床应用最广的缓释片类型，因此骨架缓释片的应用是制剂行业最关注的产品之一。33506
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本文研究苯妥英钠缓释片的处方工艺。制备不同处方的苯妥英钠缓释片，对不同处方的溶出度的进行研究，寻找最优的处方及工艺。对样品的含量、片重差异、溶出度等进行检测，各项检测结果均符合苯妥英钠缓释片的质量标准。
之后对缓释片样品进行稳定性考察，通过留样观察，样品的含量及性状等质量指标均未发生明显变化，苯妥英钠缓释片样品具有较好稳定性。
关键词 苯妥英钠 缓释片 稳定性检测
毕业论文设计说明书外文摘要
Title The Pharmaceutic Research Of Phenytoinum Natricum Sustained Release Tablets
Abstract
Retarder has a safe, valid and convenient new a type more. And retarder is the most widely used and the most mature technology type of medicine. Sustained-release tablets is the most extensive clinical application type of retarder, so application of sustained release tablets is one of the important target paid attention to inside industry.
This text to phenytoin sodium sustained release tablets the prescription craft to carry on a research slowly. Lining-up different prescriptions of phenytoin sodium sustained release tablets, carry on research, certain end prescription and craft towards influencing the main factor that it releases a degree. To sample slice heavy difference, content, release degree and the frailty ground degree to carry on an examination, each examination index sign all matches phenytoin sodium sustained release tablets to release a slice of quality standard slowly.
The last part is the investigation on stability of phenytoin sodium sustained release tablets. Using observation to experiment of research, its content has no obvious variety, prove phenytoin sodium sustained release tablets to have a good stability slowly.
Keywords Phenytoinum Natricum Sustained Release Tablets Quality stability
目 次
1 引言 1
1.1 缓释/控释制剂的概念及特点 1
1.2 缓释/控释制剂的研究现状 1
1.3 缓释片剂的类型 2
1.4 国内外缓/控释制剂研究现状的差异 4
1.5 缓控释制剂发展前景 4
1.6 苯妥英钠简介 4
1.7 本课题研究内容 5
2 苯妥英钠缓释片处方研究 6
2.1 实验药品和仪器 6
2.2 缓释片制备原理 6
2.3 缓释片制备工艺流程 7
2.4 缓释片处方的选择及辅料说明 7
2.5 苯妥英钠缓释片的制备 8
2.6 苯妥英钠缓释片处方选择 8
2.7 本章小结 11
3 薄层层析鉴别苯妥英钠 12
3.1 实验药品和仪器 12
3.2 实验原理 12
3.3 展开剂配比的选择 12
3.4 苯妥英钠缓释片的薄层层析 14
3.5 本章小结 14
4 苯妥英钠缓释片中苯妥英钠含量测定 16
4.1 实验药品和仪器 16
4.2 苯妥英钠最大吸收波长的确定 16