难溶性药物肠溶微丸胶囊质量研究
关键词: 肠溶微丸；精密度；回收率；溶出曲线；相似因子4352
Insoluble drug enteric-coated capsule quality research
Abstract: This thesis is to study the quality of enteric pellets, to determine the analysis methods of self-made enteric-coated capsules, and to study the recovery rate, linear, precision, reproducibility, stability of the stripping of medium degree analysis method validation activities, since the completion of preparation and reference curve comparison solution the preparation, and by calculating the similarity factor ƒ2 to study preparation and reference preparation similarity. In this thesis, using UV spectrophotometer determination, determined the detection wavelength was 230nm. After measure, get the recovery rate is 99.17%, the reproducibility of the RSD=0.3341%, the precision of RSD=0.2314%, medium stability results showed, API in four kinds of stripping 24h good stability in the medium, according to these results, stripping analysis method is feasible to meet the basic requirements of the determination of the solubility curve. In pH=6.8 phosphate buffer solution curve measured the similarity factor ƒ2=42.91<50, illustrate the preparation and reference preparation stripping curve is not similar, need further optimization of prescription.
Keywords: enteric-coated pellets; precision; recovery; dissolution profile; similarity factor
目 录
1 前言 1
1.1 研究背景 •1
1.2 研究意义 •4
1.3 研究内容 •4
2 溶出度方法学研究 5
2.1 仪器与材料5
2.1.1 仪器 •5
2.1.2 材料5
2.2 检测波长的确定6
2.2.1 实验方法 •6
2.2.2 检测波长测定的结果6
2.3 线性研究（标准曲线的制备）•9
2.3.1 标准曲线的制备方法9
2.3.2 标准曲线的测定结果10
2.4 回收率•11
2.4.1 回收率的测定方法11
2.4.2 回收率的测定结果11
2.5 重现性•12
2.5.1 重现性的测定方法12
2.5.2 重现性的测定结果12
2.6 精密度•12
2.6.1 精密度的测定方法•12
2.6.2 精密度的测定结果•12
2.7 介质稳定性•13
2.7.1 溶液配制方法13
2.7.2 介质稳定性的测定结果13
3 溶出度质量研究17
3.1 溶出度测定的意义 17
3.2 溶出曲线的绘制 17
3.3 相似因子ƒ2•19
4 结果与讨论21
5 谢辞23
6 参考文献24
1 前言
1.1 研究背景
微丸是指药物粉末和辅料构成的直径小于2.5mm的圆球状实体，属于多分散体系，每个给药剂量可包含许多个微丸，近年来，以微丸制剂为代表的多单元性给药系统以其特有的优越性，已经逐渐成为制剂研究的重点之一。微丸的特点是：①流动性好且外形美观，易于处理②可以根据需要制成缓释或控释微丸③能有效提高药物的生物利用度④能够改善药物稳定性，掩盖不良道⑤含药量大且服用剂量小⑥局部刺激性小。