摘要缓释片是更具安全、有效、方便的新剂型,在口服药物中极具竞争力。而骨架控缓释技术更易推广,便于实现工业化生产,所以骨架缓释片的开发则是国内外业内所关注的重要目标。
本文对地巴唑缓释片的处方工艺进行研究。以羟丙基甲基纤文素(HPMC)作为构成亲水凝胶骨架片的主要缓释材料,对影响其溶出度的主要因素进行研究,确定最终处方及工艺。对样品片重差异、含量、溶出度及脆碎度进行检测,各检测指标均符合地巴唑缓释片新的质量标准和2010版中国药典的有关要求。
最后,本毕业论文较详尽的考察了地巴唑缓释片的稳定性,通过留样观察试验的研究,其含量及性状等各项质量指标均无明显变化,证明了地巴唑缓释片具有良好的稳定性。
关键词 地巴唑 缓释片 质量稳定性研究7958
毕业设计说明书(论文)外文摘要
Title The Pharmaceutic Research Of Dibazole Sustained Release Tablets
Abstract
Sustained release tablets has a safe, valid and convenient new a type more, having a competition ability very much in take orally the medicine. But the framework control to release a technique to alter expansion slowly, the easy to realization industrializes production, so the development of framework sustained release tablets then at home and abroad the important target paid attention to inside industry.
This text to Dibazole sustained release tablets the prescription craft to carry on a research slowly. Using HPMC as the composing gets close to water gel framework slice of main release material slowly, 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 Dibazole sustained release tablets to release a slice of new quality standard slowly with the relevant request of 2010 versions Chinese medical dictionary.
Finally, this text investigated more and in details the stability of Dibazole sustained release tablets. Using a kind observation to experiment of research, its content has no obvious variety, prove Dibazole sustained release tablets to have a good stability slowly.
Keyword Dibazole Sustained release tablets Quality stability
目 次
1 引言 1
1.1 缓释及控释制剂的概念及特点 1
1.2 药物缓释、控释制剂的研究开发现状 1
1.2.1 缓/控释制剂的剂型 1
1.2.2 缓/控释制剂的释药类型 2
1.2.3 缓控释制剂的种类 2
1.3 口服缓/控释制剂开发的意义 5
1.4 国内外缓释、控释制剂的发展趋势 5
1.4.1 国内缓释控释制剂发展趋势 5
1.4.2 国外缓释控释制剂发展趋势 5
1.5 辅料羟丙基甲基纤文素(HPMC)简介 5
1.5.1 释药机理 6
1.5.2 药物溶解度对HPMC骨架片体外释药的影响 6
1.5.3 HPMC用量对HPMC骨架片体外释药的影响 6
1.5.4 制片压力对药物从骨架片中释放速率的影响 6
1.6 地巴唑简介 7
1.6.1 理化性质 7
1.6.2 药理作用 7
1.6.3 临床应用 7
1.6.4 研究进展 7
1.7 本课题的研究内容 8
2 地巴唑缓释片处方工艺研究 9
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