加巴喷丁缓释微丸处方工艺研究制备及质量评价 摘要：本论文的目标在于制备具有缓释功能的加巴喷丁微丸，并建立分析方法对其质量进行初步评价。最终选定使用“茚三酮光度法”测定加巴喷丁，该实验方法操作较为简单且灵敏度高，能够快速出的数据并加以分析改进。
确定加巴喷丁显色液在569.5nm处有最大吸收波长。绘制标准曲线、观察线性关系，依次进行回收率实验、精密度实验、稳定性实验、不同pH介质中加巴喷丁的稳定性实验。测得的一系列实验数据均表明该些性质良好，因此得到该系统方法学研究是可行且准确的。
在初步测定加巴喷丁在水溶液中的溶解度后，进行上药和缓释包衣层的喷涂。对缓释微丸的含药量和溶出度进行测定，数据结果表明微丸的平均含药量接近理论值，含药量较高，损失较少，且在不同时间的释放度良好，实验达到了预期的目的和效果。
关键词：加巴喷丁；分析方法；茚三酮光度法；缓释微丸
Evaluation on Preparation and Quality
of sustained-release pellets
Abstract：The aim of this paper is to prepare gabapentin pellets with sustained-release functions and to establish analytical methods for the preliminary evaluation of its quality. The final selection of the method of measuring gabapentin is " Ninhydrin photometric method ", which is relatively simple, high sensitivity and can quickly analyze the data for improvement.
Determine the maximum absorption wavelength of gabapentin is 569.5nm. Making standard curve and observing the linear relationship. Then conducting recovery experiments, precision experiments, stability experiments, and stability experiments with different pH media. In a series of these experiments, the measured data shows that these properties are optimal, so the methodology is feasible and accurate.
After the preliminary determination of the gabapentin’s solubility in the aqueous solution, conducting gabapentin pellet and sustained-release coating layer. Measuring the drug-containing and dissolution of the sustained-release pellets, the data shows that the average drug-containing of the pellets is close to the theoretical value, the drug content is relatively high and low loss, the result of the dissolution rate experiment is fine at different times. Experiment achieved the expected goals and results.
Keywords：gabapentin; analytical methods; Ninhydrin photometric method; sustained-release pellets
目 录
1 前言1
2 加巴喷丁分析方法的建立5
2.1 试剂和仪器5
2.2 分析方法的建立6
2.2.1 溶液的配制7
2.2.2 检测波长的确定8
2.2.3 线性关系10
2.2.4 回收率12
2.2.5 精密度12
2.2.6 溶液稳定性12
2.2.7 不同pH介质中加巴喷丁的稳定性14
2.3 结论15
3 加巴喷丁缓释微丸处方工艺的初步研究 16
3.1 流化床包衣16
3.1.1 操作参数的选择17
3.2 处方一18
3.2.1 溶液上药法载药18
3.2.2 上药后含药量的测定18
3.2.3 包衣液的配制19
3.2.4 包衣后含药量的测定19
3.2.5 水中的释放度20
3.3 处方二21
3.3.1 溶液上药法载药21
3.3.2 上药后含药量的测定21
3.3.3 包衣液的配制21
3.3.4 包衣后含药量的测定22
3.3.5 水中的释放度22
3.3.6 小结24
3.4 含药微丸粒径分布24
4 全文结论26
5 致谢27
参考文献28 ，3544
[1] [2] [3] [4] [5] [6] [7] 下一页