论文总字数：19049字

摘 要

阿尔兹海默症是由中枢神经退行性病变引发的，常见于老年时期且无法治愈，困扰着无数家庭，是当今医学急需攻克的重要领域，而盐酸美金刚是治疗阿尔兹海默症和帕金森痴呆的重要药物，由于其合成时设计多种有害有机溶剂，需要严格管控，所以我们进行一系列的实验对其进行检测是很必要的。

本次实验的目的是对盐酸美金刚溶剂的成品进行检测，通过气相色谱法确定溶剂中各组分反应物的残留分量，观测其是否符合药典中进行的要求，是否达标。同时尝试是否可以提高检测效率，检测的准确度，这次试验我们先进行了方法学验证，通过三次的对照实验拟定了测定时的气相色谱仪的最佳参数，根据所拟定的数据，选择三批成品，对生产药品时涉及的7种有机溶剂进行专属性、定量限检测限、线性、溶液稳定性、准确度、精密度、耐用性的实验，为患者是否可以安全用药提供一定的建议，最后的实验的结果与药典进行比较，发现所抽选的3批产品各项均符合药典内的规定，老年的患者可以放心地服用该药品去改善他们的老年生活质量。

希望在已发现的各种对阿尔兹海默症有效的药物能够在与阿尔兹海默症的抗争中为我们带来更多的帮助，让我们可以更快地在这场无硝烟的战争中胜利。

关键词: 阿尔兹海默症，帕金森痴呆，盐酸美金刚，气相色谱法。

Abstract

Alzheimer's disease is caused by degenerative disease of the central nervous system. It is common in old age and cannot be cured. It troubles countless families and is an important field that medicine urgently needs to overcome. Memantine hydrochloride is an important drug for Alzheimer's disease and Parkinson's dementia. The design of a variety of harmful organic solvents during its synthesis requires strict control, so it is necessary to conduct a series of experiments to detect them.

The purpose of this experiment is to test the finished product of memantine hydrochloride solvent, to determine the residual content of each component reactant in the solvent by gas chromatography, and observe whether it meets the requirements of the Pharmacopoeia and whether it meets the standard. At the same time,improving the detection accuracy. In this experiment, we first conducted methodological verification. Through three controlled experiments, the optimal parameters of the gas chromatograph were determined. Based on the data prepared, three batches of finished products were selected. Conduct experiments on specificity, limit of detection, linearity, solution stability, accuracy, precision, and durability, and provide some suggestions for whether patients can use the drug safely. The selected three batches of products are in compliance with the provisions of the Pharmacopoeia, and elderly patients can safely take the drug to improve their quality of life in old age.

I hope that the various drugs that have been found to be effective for Alzheimer's disease will bring us more help in the fight against Alzheimer's disease, so that we can fight in the smokeless war faster victory.

Keywords: Alzheimer's disease, Parkinson's dementia ,memantine hydrochloride, gas chromatography

目录

摘要 I

Abstract II

第一章 文献综述 1

关于盐酸美金刚的简单介绍： 2

盐酸美金刚的结构： 2

盐酸美金刚的临床应用： 2

气相色谱法的简单介绍： 3

第二章 实验方法 4

1盐酸美金刚生产中的有机溶剂 4

1.1仪器、试剂及样品 4

1.1.1仪器 4

1.1.2试剂 4

1.1.3样品 5

1.2方法学验证 5

1.2.1色谱条件摸索 5

1.2.2色谱条件拟定 8

1.2.3专属性 8

1.2.4进样精密度试验 9

1.2.5定量限及检测限 9

1.2.6线性与范围 10

1.2.7溶液稳定性 11

1.2.8溶液的重复性 12

1.2.9回收率试验 12

1.2.10中间精密度试验 16

1.2.11耐用性试验 17

1.3样品测定 18

参考文献 19

致谢 22

第一章 文献综述

关于盐酸美金刚的简单介绍：

Memantine hydrochloride是一种作用于NMDA受体的金刚烷胺盐酸盐，^[1]该药用于治疗重度阿尔茨海默氏症，盐酸美金刚是一种非竞争性受体拮抗剂同时对晚期阿尔兹海默症患者依然有效。^[2]该药在合成过程中使用了几种可能引起中毒的有机溶剂，所以需要对产品进行监控。^[11]

盐酸美金刚的结构：

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