摘要：泛影酸为诊断用X射线造影剂，适用于心脑血管、周围血管、泌尿系统等多处组织和系统的造影，效力好，毒性低，价格低廉，市场需求量大。但目前的生产工艺存在许多不合理因素，导致产品的游离芳胺含量经常超标，影响了泛影酸的正常生产。本课题的研究目的是对现有工艺条件进行改进，以降低产品的游离芳胺含量。根据对各步反应的反应机理的分析，本课题选取了影响产品游离芳胺含量的主要因素进行了对照实验，最终确定了一条相对合理可行的工艺条件，有效地降低了产品的游离芳胺含量，同时增强了中间过程的可控性和操作的安全性。 57284

毕业论文关键词：泛影酸；游离芳胺；质量优化

The Research on Synthesis Process of Diatrizoic Acid

Abstract: Diatrizoic acid, as a diagnostic X-ray contrast agent, is applied for many kinds of tissue and system, such as cardio-cerebral vessel, surrounding vessel and urinary system. It has broad market demand because of good effect, low toxity, inexpensive price. However, there are many unreasonable factors in the present production process, which lead to excess of content of free aromatic amine in product and hamper the normal production. The topic is aimed at improving present production process so as to reduce the content of the free aromatic amine in product. According to analysis of reaction mechanism, we choose main factors which affect the content of the free aromatic amine in product to proceed contrast experiment. In the end, a relatively feasible process is determined, which can effectively reduce the content of the free aromatic amine in product and enhance the stability and security of operation course.

Key Words: Diatrizoic acid; Free aromatic amine; Quality optimization

目  录

1 前言 1

1.1 泛影酸的简介 1

1.2 泛影酸的药代学特征 1

1.3 药物的相互作用 2

1.4 泛影酸的不良反应 2

1.5 造影剂的发展史 2

1.6 造影剂的种类与结构 3

1.7 造影剂的市场情况 4

2 文献综述与方案论证 5

2.1 文献综述 5

2.2 方案论证 7

2.2.1 还原反应 7

2.2.2 碘化反应 7

2.2.3 乙酰化反应 8 

2.2.4 脱色精制 8

2.3 实验内容 8

3 实验部分 10

3.1 试剂与仪器 10

3.1.1 试剂 10

3.1.2 仪器 10

3.2 实验方法 11

3.2.1 还原反应 11

3.2.2 碘化反应 12

3.2.3 乙酰化反应 13

3.2.4 脱色精制 15

4 实验讨论 17

4.1 还原反应 17

4.1.1 还原反应机理 17

4.1.2 反应影响因素分析 17

4.1.3 铁粉颗粒度对游离芳胺含量的影响