国产与原研苯磺酸左旋氨氯地平片体外溶出曲线一致性评价

摘要仿制药在我国医药市场占有很大的比例，对解决我国人民缺医少药的问题有重大意义。国务院发布的《国家药品安全“十二五”规划》中就明确提出了要全面提高仿制药质量，开展仿制药质量的一致性评价。本文主要采用紫外分光光度法测定4种不同厂家生产的药品在不同介质（pH 1.0、pH 1.2、pH 2.0、pH 4.0、pH 6.8和水）中不同时间点的体外溶出情况，采用f2因子法比较溶出曲线，以进行一致性评价。结果表明，苏州东瑞制药的安美平和江西施美制药的施美力健与辉瑞制药的络活喜溶出曲线基本相似，溶出行为有较小差异(除去水介质中的)。北京红林制药的久保舒在偏酸介质（pH=1.0、pH=1.2）溶出情况与进口药络活喜有较大差异。52543
关键词苯磺酸左旋氨氯地平仿制药溶出度紫外分光光度法 f2因子

毕业论文设计说明书外文摘要
Title Evaluation of Domestic and Imported Levamlodipine Besylate Tablets in Vitro Dissolution Profile Consistency

Abstract

Generics account for a large proportion in Chinese pharmaceutical market,have great significance to solve the problem of shortage of doctors and medicine in China.The State Council issue “the plan of national drug safety in 12th Five-Year”made it clear that we should comprehensively improve the quality of genertic drugs,to carry out quality consistency evalution of generic drugs.In this paper,UV spectrophotometry was used to determine the dissolution of 4 different kinds of drugs at different time points in different medium(pH 1.0,pH 1.2,pH 2.0,pH 4.0,pH 6.8 and water).Using f2 factor method to compare dissolution curve,in order to evaluate the consistency.The results show that Anmeipin’s and Shimeilijian’s dissolution curve is similar with Norvasc’s dissolution curve ,there are minor difference in dissolution behavior,except in the water.But Jiubaoshu dissolution condition is different from Norvasc in partial acid medium(pH=1.0 and pH=1.2).

Keywords Levamlodipinine Besylate Generics Dissolution UV f2 Factor

1 绪论 1

1.1 苯磺酸左旋氨氯地平的概述 1

1.1.1 苯磺酸左旋氨氯地平的理化性质 1

1.1.2 苯磺酸左旋氨氯地平的药理作用 1

1.1.3 苯磺酸左旋氨氯地平的不良反应 2

1.1.4 苯磺酸左旋氨氯地平与其他药物的联合治疗 2

1.2 仿制药一致性评价 2

1.2.1 我国仿制药质量存在的问题 2

1.2.2 仿制药质量评价内容 2

1.3 紫外分光光度法概述 3

1.4 f2因子法简述 3

1.5 仿制药一致性评价的展望 3

2 国产与原研苯磺酸左旋氨氯地平片体外溶出一致性研究 4

2.1 实验材料和仪器 4

2.1.1 实验药品 4

2.1.2 实验试剂 5

2.1.3 实验仪器 5

2.2 方法和结果 6

2.2.1 苯磺酸左旋氨氯地平的最大吸收波长的确定国产与原研苯磺酸左旋氨氯地平片体外溶出曲线一致性评价:http://www.youerw.com/yixue/lunwen_43039.html