壳聚糖-氟伐他汀新型制剂的制备研究

制药工程论文编号:ZY054    论文字数:10152,页数:30

目  录
中文摘要..........................................................I
英文摘要..........................................................II
目录..............................................................III
1. 绪论...........................................................1
 1.1 引言......................................................1
 1.2 研究现状..................................................1
 1.3 立题依据..................................................5
2. 实验部分.......................................................6
 2.1 实验仪器与试剂............................................6
 2.2 实验的制备过程............................................7
 2.3 载药量的测定..............................................9
 2.4 纳米粒粒径的测定..........................................12
3. 偶联物CHS-F的检测..............................................13
 3.1 紫外扫描..................................................13
 3.2 傅立叶红外分析............................................15
 3.3 差示量扫描热DSC...........................................17
 3.4 高效分离..................................................18
 
4. 结果与讨论.....................................................19
 4.1 氟伐他汀钠合成过程分析....................................19
 4.2 偶联物的制备过程分析......................................20
 4.3 CHS-F彻底水解的酸碱比较...................................21
 4.4 纳米粒的高效分离测定分析..................................21
 4.5 载药量的比较..............................................22
 4.6 实验小结..................................................22
5. 总结与展望.....................................................23
 5.1 实验总结..................................................23
 5.2 展望......................................................23
致谢..............................................................24
参考文献..........................................................25

摘 要：氟伐他汀酯经氢氧化钠（1N）水解制备得到降血脂药物氟伐他汀钠。为对其进行剂型改造研究，我们采用两种方法制备壳聚糖-氟伐他汀的偶联物和纳米粒。偶联物通过UV、IR、DSC进行结构确认，得到以酰胺键相联的壳聚糖-氟伐他汀偶联物；纳米粒通过激光粒度纳米仪进行粒径测定。两种制备方法制备得到的壳聚糖-氟伐他汀通过高效液相来测定其含量，并计算出载药量，纳米粒的载药量达到43.67%，偶联物的载药量达到25.03%。
关键词：壳聚糖；氟伐他汀；偶联物；纳米粒
 
 
 
 Abstract: Fluvastatin sodium，a hypolipidemic drug，was prepared by ester hydrolysis from fluvastatin ester with 1N sodium hydroxide. In order to enrich the dosage forms of chitosan-fluvastatin combination, we choosed two kind of methods to to prepare fluvastatin-chitosan conjugate and nanoparticles. Fluvastatin was chemically coupled to chitosan to form chitosan-fluvastatin conjugate, which was confirmed by UV、IR、DSC. The size of nanoparticles was determined by laser scattering instrument. The concentration of the two kinds of chitosan- fluvastatin were determined by HPLC, then calculated the drug-loading rate. After experiment, the drug-loading rate of nanoparticles was 43.67%, and conjugate was 25.03%.
Keywords：Chitosan; Fluvastatin; conjugate; nanoparticle