摘 要

由俄罗斯Valenta（瓦伦塔制药公司）公司开发，于2008年在俄罗斯批准上市，2009年正式投放市场，用于治疗成人流行性感冒。2009年6月俄罗斯卫生及社会发展部发表一个通告，允许将英加韦林作为甲型流行性感冒的治疗药物，并载其新发布的《成人甲型H1N1流感防治指南》中此外，由于英加韦林是作用于流感病毒核蛋白上稳定且不易发生变化的保守序列，因此产生抗药性流感病毒的概率非常小。目前已有研究表明，英加韦林对腺病毒、甲型流感病毒（包括H1N1）。

本次实验主要针对于英加韦林的方法学验证，主要是它六种性质的测定包括线性，精密性，准确性，耐用性，稳定性和专属性。仪器采用高效液相色谱仪做出不同条件下，几组对照样品的色谱图，有图谱的数据间接判定它的属性优良。

药品的生产与储存过程中产生的杂志和降解物质，由于这些有关物质的存在会影响到药品的纯度，进而可能会产生毒副作用，所以有关物质的控制是药品研发的一个重要方面，也是我们在药品审评中一直重点关注的要点之一。

关键字：英加韦林 胶囊 方法学验证

Abstract

Russian Valenta developed in 2008 approved for marketing in Russia in 2009, officially on the market for the treatment of adults with influenza. June 2009 Russia and the Ministry of Health and Social Development published notice, the British Jiawei Lin as influenza A H1N1 influenza therapeutic agents, and load its newly released "adult H1N1 Influenza Prevention Guide" In addition Since the British Jiawei Lin stabilizing role on the influenza virus nucleoprotein and less prone to change conserved sequence, therefore the probability of resistant influenza virus is very small. At present, research shows that the British Jiawei Lin adenovirus, influenza A viruses (including H1N1,）

The experiment focused on learning English Jiawei Lin method validation, it is the determination of the six main properties include linearity, precision, accuracy, durability, stability and specificity. Instruments used to make high performance liquid chromatography under different conditions, the chromatogram of the control sample sets, indirectly determined by the map data of its excellent properties

Impurities or degradation products during storage and production of drugs produced. Because of these related substances will affect the purity of the drug, which may cause toxic side effects, the control-related substances is an important aspect of drug development, it is one of the points we have been focusing on the review of drugs.

Key words:Plans ingavirinamp;reg capsule Method validation

目录

1. 绪论.....................................................................................................................................1

1.1. 研究背景和意义........................................................................................................1

1.2. 研究进展.....................................................................................................................2

1.2.1. 国外英加韦林研究进展....................................................................................2

1.2.2. 国内英加韦林研究进展....................................................................................2

1.3. 主要研究方法及思路.................................................................................................3

1.3.1. 实验方法............................................................................................................3

1.3.2. 数据处理............................................................................................................4

1. 英加韦林含量测定及方法学验证....................................................................................5

2.1. 含量测定方法.............................................................................................................5

2.2. 含量测定方法学验证.................................................................................................5

2.2.1. 线性与范围测定................................................................................................6

2.2.2. 耐用性测定........................................................................................................7

2.2.3. 溶液稳定性测定................................................................................................8

2.2.4. 专属性测定........................................................................................................9

2.2,5. 准确度测定........................................................................................................11

2.2.6. 精密度测定........................................................................................................12

1. 未来发展前景.....................................................................................................................13

3.1 在医药领域.................................................................................................................13

3.1.1. 临床科研.............................................................................................................13