摘要:目的 制备兰索拉唑肠溶微丸并评价制备工艺。方法 建立HPLC法测定兰索拉唑肠溶微丸体外溶出度，通过控制处方中不同比例的辅料来比较肠溶微丸的溶出性能从而选择最优处方，并制备三批兰索拉唑肠溶微丸进行体外溶出度测定，考察其体外溶出性能。结果 色谱柱：GL SCIENCES ODS-SP（4.6 mm×250 mm，5 μm）;流动相：甲醇-水-三乙胺-磷酸溶液（700:300:5:1.5）；磷酸调节pH值至7.3；检测波长：284 nm；柱温：30 ℃；22898
流速：1.0 mL/min；进样量：20 μL。方法学考查结果表明，兰索拉唑浓度在1~320 μg/mL范围内有良好的线性关系（r=0.99958）、回收率分别为101.1%、100.4%、101.5%，精密度、稳定性良好，方法准确可靠。最佳处方为隔离层增重10%，肠溶层占丸重的30%。结论 我们本次论文制备的兰索拉唑肠溶微丸具有很好的完整度，而且制备的工艺也具有一定的可行性，最后通过测其溶出度发现符合《中国药典》2010版要求。
毕业论文关键词： 兰索拉唑；肠溶胶囊；溶出度；高效液相色谱法
Preparation and solubility study on Lansoprazole enteric coated pellets
Abstract:Objective:The preparation of Lansoprazole enteric coated micro pill and the evaluation of preparation. Method:Establishing a set of in vitro analysis method to determine the content and solubility of LS. Then choose the best prescription through determining the solubility of LS prepared by different proportions of excipients.Using fluidized bed granulator to prepare LS.Finally,determining the solubility of three different batches of LS. Results:Column:GL SCIENCES ODS-SP(4.6 mm×250 mm，5μm);mobile phase:methanol - water - triethylamine - phosphate solution (700:300:5:1.5); adjust the pH to 7.3 with phosphoric acid; detection wavelength: 284nm; column temperature: 30 ℃; flow rate: 1.0 mL / min; injection volume: 20μL. The results of methodological test showed that the linear relationship of concentration of lansoprazole is good (r = 0.99958) in the range of 1 ~ 320ug/mL ,recoveries were 101.1%, 100.4%, 101.5%, precision and stability are good. The method is accurate and reliable.The best prescription is that the isolation layer weight increase of 10% and the enteric layer accounting for the 30% weight.Almost all of micro pills are integrated.The recovery rate, the degree of precision and the stability are all in line with the related requirements in the 2010 edition of "Chinese Pharmacopoeia". Conclusion:The analytical method we established is reliable , the preparation technology is feasible.
Keywords: lansoprazole,enteric-coated capsule;solubility;HPLC
目录
1绪论 1
1.1 研究背景 1
1.2 课题意义 1
2文献综述 2
2.1 兰索拉唑的性质 2
2.2 兰索拉唑肠溶微丸胶囊的制备及处方工艺 2
2.3 分析及检测方法 3
2.4 药理毒理学 4
2.5 临床应用 4
2.6 口服缓控释制剂研究进展 6
2.6.1口服缓控释制剂优点 6
2.6.2 口服缓控释制剂研究现状及发展前景 7
2.6.3肠道定位释放系统 7
2.7 微丸及微丸制备方法简介 7
3试验部分 8
3.1 试药 8
3.2 仪器 8
3.3 高效液相色谱分离系统及定量方法学的建立 8
3.3.1 测定波长的选择 9
3.3.2 液相色谱条件 9
3.3.3系统适应性 10
3.3.4 线性试验 11
3.3.5 精密度试验 12
3.3.6 回收率试验 13
3.3.7 样品溶液的稳定性考察 13 兰索拉唑肠溶微丸的制备及溶出度的测定:http://www.751com.cn/yixue/lunwen_15742.html