考察聚乳酸微球体外长期释放和加速释放的相关

文档编号:HG252   文档字数:19685,页数:32

 摘要
 目的：本实验是考察聚乳酸微球体外长期释放和加速释放的相关性，建立异环磷酰聚乳酸微球的体外加速释放方法。方法：用紫外分光光度法测定微球中异环磷酰胺的含量。本研究采用动态透析法分别在不同的温度的介质中进行体外加速度释放试验和长期释放试验。及进行两者相关性的考察。结果：本研究异环磷酰胺制备聚乳酸微球在37℃放置145小时内释放达到94.90%，微球在42℃，47℃，55℃和58℃下的加速释放均明显加速，释放动力学分别符合一级释放方程及Higuchi方程。异环磷酰胺制备聚乳酸微球在55℃的条件的加速释放与在37℃长期释放有较良好的相关性。结论：异环磷酰胺制备聚乳酸微球具有很好的缓释能力，采用体外加速试验的方法可以快速考察异环磷酰胺聚乳酸微球的体外释药能力。
 
 
关键词：异环磷酰胺  聚乳酸  加速释放  紫外分光光度法  微球

【Abstract】
Objective: This experiment is the inspection gathers the relevance which lactic acid microballoons in vitro releases for a long time and accelerates to release, constructs takes ifosfamide to gather lactic acid microballoons in vitro to accelerate to release the method. Method: Determines in the microballoons with the ultraviolet spectrophotometric method Ifosfamide content. This research uses the dynamic dialysis law to carry on vitro acceleration release experiment and the long-term release separately in the different temperature medium experiments. And carries on both relevant inspection. Finally: This research  Ifosfamide preparation gathers the lactic acid microballoons, in 37℃ lays aside in 145 hours to release achieves 94.90%, the microballoons accelerate the release in 42℃,47℃,55℃ and 58℃ under obviously to accelerate, release dynamics conforms to as well as the release equation and the Higuchi equation separately. The Ifosfamide preparation gathers the lactic acid microballoons in 55℃ the condition accelerates the release with to have the good relevance at 37℃ the long-term release. Conclusion: The Ifosfamide preparation gathers the lactic acid microballoons to have the very good slow release ability, uses in vitro the acceleration test the method to be possible to inspect the Ifosfamide to gather fast lactic acid microballoons in vitro to release the medicine ability.
 
 
key word: Ifosfamide gathers the lactic acid to accelerate to release    ultraviolet spectrophotometric method microballoons
 
 
 
目录
第一章  文献综述 5
1.1缓释制剂概念及特点 5
1.2缓控释制剂释药类型 6
1.3 缓释制剂体外药物释放度试验 6
1.3.1  仪器装置 6
1.3.2  温度控制 6
1.3.3  释放介质 6
1.3.4  释放度取样时间点 6
1.3.5 释药模型的拟合 7
1.4 异环磷酰胺 7
1.4.1异环磷酰胺性质及检测方法 7
1.4.2 药理毒理 8
1.4.3 药代动力学 9
1.4.4 适应症 9
1.4.5 不良反应 9
1.5微球的制备技术及特点 10
1.5.1概述 10
1.5.2制备方法多样 10
1.5.3试验采用的方法 12
1.5.4 微球载体的应用 12
1.5.5 微球技术的发展前景 15
1.6聚乳酸概述 16
1.7 微球释药测定方法 16
1.7.1膜扩散法 16
1.7.2动态透析法（本实验采用的方法） 17
1.7.3取样分离法 17
1.8 本课题研究的目的和意义 17
第二章   异环磷酰胺聚乳酸微球制备及体外释放实验 18
2.1试药及仪器 18
2.2实验样品的制备 18
2.3异环磷酰胺标准曲线测定 19
2.3.1 测定波长的选择 19
2.3.2  标准曲线的建立 20
2.4微球载药量及包封率的测定 20
2.5异环磷酰胺聚乳酸微球的体外释放 21
2.5.1 透析袋及透析膜的前处理 21
2.5.2 异环磷酰胺聚乳酸微球体外长期释放 22
2.5.3 异环磷酰胺聚乳酸微球的加速释放 22
2.5.4  加速释放与长期释放的相关性 22
第三章  实验结果及分析 23
3.1异环磷酰胺在释放介质中标准曲线 23
3.2异环磷酰胺聚乳酸微球载药量、包封率的测定 24
3.3体外长期释放结果及讨论 24
3.4 体外加速释放实验结果和讨论 25
3.5微球加速释放与长期释放的相关性 26
3.6讨 论 28
第四章 结 论 29
参考文献 30
致    谢 32

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