摘要：本论文期初的研究目的旨在对市面上已有阿仑膦酸钠和文生素D3的复方制剂进行分析，但由于后期实验时间紧迫，故最终仅对阿仑膦酸钠和文生素D3进行分析方法的建立，并对阿仑膦酸钠的单方片剂进行初步的处方筛选工作。实验结果表明：茚三酮显色法下，阿仑膦酸钠在4.5-45μg/mL 浓度范围内的线性关系良好（r蒸馏水=0.996、rpH6.8 =0.998、pH4.5不显色）；钼蓝比色法下，阿仑膦酸钠在3-30μg/mL 浓度范围内的线性关系良好（r蒸馏水=0.998、rpH4.5 =0.999、pH6.8不显色），其回收率、稳定性、精密度、重复性数据良好；当文生素D3检测的流动相选择正己烷:异丙醇(985:15，v/v)时的保留时间和峰的分离度最好；不同规格的羟丙基甲基纤文素（HPMC）直接影响药物的溶出度，其中K100M 能够缓慢的释药，满足本论文对阿仑膦酸钠12小时缓释的要求。20527
毕业论文关键词: 阿仑膦酸钠；文生素 D3；溶出度；处方筛选；紫外吸光度。
The preliminary study of osteoporosis drugs alendronate formulations
Abstract: The research purpose of this thesis beginning aimed to Allen already on the market of alendronate and vitamin D3 compound preparations, but due to the late experimental time is short, so in the end only alendronate and vitamin D3 analysis method is established, and the alendronate unilateral tablet prescription for a preliminary screening. The experimental results showed that: ninhydrin colorimetric method, alendronate linear concentration range within 4.5-45μg/mL good (rdistilled water = 0.996, rpH6.8 = 0.998, pH4.5 chromogenic reaction does not occur); under the molybdenum blue method, alendronate linear in the concentration range 3-30μg/mL good (rdistilled water = 0.998, rpH4.5 = 0.999, pH6.8 chromogenic reaction does not occur), its recovery, stability, precision, reproducibility data well; detected when vitamin D3 mobile phase selection hexane: isopropanol retention time (985:15, v / v), and when the best peak separation; different specifications of hydroxypropylmethylcellulose (HPMC) directly affect the dissolution rate of the drug , which can slow the release of K100M meet the thesis sustained release of alendronate 12 hours of request.
KeyWords: Alendronate; Vitamin D3; dissolution; prescription screening; UV absorbance.
目录
1引言 1
1.1 骨质疏松药物的研究进展 1
1.1.1 第一类——文生素D3 2
1.1.2 第二类——钙剂 2
1.1.3 第三类——雌激素 2
1.1.4 第四类——植物雌激素 3
1.1.5 第五类——双膦酸盐 3
1.2 阿仑膦酸钠制剂的研究 4
2 阿仑膦酸钠分析方法的建立 6
2.1 仪器与试药 6
2.2 介质溶液中紫外-可见分光光度法（茚三酮显色法）的建立 7
2.2.1 检测波长的选择 7
2.2.2 测定方法 7
2.2.3 标准曲线的制备 7
2.2.4 精密度实验 9
2.2.5 稳定性实验 9
2.2.6 重复性实验 10
2.2.7 回收率实验 10
2.2.8 小结： 11
2.3 介质溶液中紫外－可见分光光度法（钼蓝比色法）的建立 12
2.3.1 检测波长的选择 12
2.3.2 测定方法 13
2.3.3 标准曲线的制备 13
2.3.4 精密度实验 14
2.3.5 稳定性实验 15
2.3.6 重复性实验 15
2.3.7 回收率实验 15
2.3.8 小结 16 骨质疏松药物阿仑膦酸钠制剂的初步研究:http://www.751com.cn/yixue/lunwen_12339.html