论文总字数：20427字

摘 要

头孢米诺钠是一种头孢类抗生素，对大肠杆菌、克雷伯杆菌、变形杆菌、流感杆菌、拟杆菌、及链球菌具较强抗菌活性。在实际生产中，头孢米诺钠的含量和有关物质检验方法一般是高效液相色谱法。但是由于不同厂家生产仪器和色谱柱的不同，实际上检验方法也是有所差异的。

本课程设计所用的方法是在药典记载方法的基础上进行的改进：通过改变流动相配置比例，色谱柱型号，检验是色谱柱柱温来找出最适合的方法。加大特征峰的分离度，从而更为准确的得出我们所需要的数据。

通过这次研究，可以找到一个在本公司现有条件下检测的最佳方法，这可以使检测结果更为准确，药品质量得到更加严格的控制。对患者来说他们也可以放心的用药。

关键词：头孢米诺钠 高效液相色谱法 检验

Cefminox sodium actual test method for improving the production process^[1][2][3]

Abstract

Sodium Cefminox is a cephalosporin antibiotic, against E. coli, Klebsiella, Proteus, Haemophilus influenzae, Bacteroides, and Streptococcus with strong antibacterial activity. In actual production, content and related substances test methods Cefminox sodium is generally high performance liquid chromatography. However, due to the different instruments and columns from different manufacturers, in fact, the test methods also vary.
This course is designed to improve the methodology used is based on the method described in the pharmacopoeia carried out: by changing the configuration of the mobile phase ratio of the column type, column oven test is to identify the most suitable method. To increase the degree of separation peaks thus obtained more accurate data we need.

Through this research, you can find the best method in the detection of the existing conditions, which can make the test results more accurate, more stringent pharmaceutical quality control. For patients they can also be assured of medication.

Key Words: Cefminox sodium;HPLC;test

目 录

摘要······································································I

ABSTRACT·······························································II

第一章 前言·······························································3

1.1头孢米诺简介·························································3

1.2头孢米诺钠的优势和市场前景···········································3

1.3头孢米诺的作用机制和抗菌谱···········································4

1.4药理作用·····························································5

1.5药代动力学···························································5

第二章 实验的材料与方法·················································6

2.1实验仪器·····························································6

2.2实验试剂·····························································6

2.3色谱条件·····························································6

2.4头孢米诺钠检验方法确认内容及合格标准·································7

第三章 实验步骤与数据···················································10

3.1头孢米诺钠含量检验实验步骤··········································10

3.2头孢米诺钠有关物质I检验实验步骤····································11

3.3头孢米诺钠有关物质II检验实验步骤···································12

3.4实验偏差····························································13

3.5实验数据····························································13

第四章 结果与讨论·······················································20

参考文献··································································27

致谢·······································································28

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