论文总字数：20488字

摘 要

抗生素是一种大家在日常生活、医疗过程中并不陌生的药物，它能够有效的抑制或杀灭病菌，常常用于治疗一些由病原微生物导致的疾病，从病发根源“病原细菌”着手治疗，使得治疗过程更有指向性，更加有效。

本文介绍大环内酯类抗生素中的一种——阿奇霉素。阿奇霉素在当今生活中使用的十分频繁，对此的质量把控也就十分重要。本文主要研究注射用阿奇霉素有关物质，对药品杂质的限度有所规定，以保障药品的质量合格规范。药品的卫生质量极为重要，该项检测项目的研究就显得格外重要。

本文首先对中国药典2015版所规定的有关物质检测进行梳理，随后与其他发表的杂志和他国药典中规定的有关物质项，进行对比综合，后根据实际情况分析本研究的实验路线及实验方法，分析注射用阿奇霉素的有关物质情况，从原料、生产环节、储存环境等方面，分析杂质的存在原因以及总结改善该环节避免产生杂质的方法。根据检测结果归纳总结杂质种类及限度规定，优化目前现有的检测方法及标准，并且对改良后的方法进行长期的阶段性校验调整，确定其可行性，以更好地控制阿奇霉素原料及其注射用冻干制剂的质量。

关键词：抗生素 阿奇霉素 有关物质 高效液相

Study on Azithromycin Related Substances for Injection

Abstract

Antibiotics are drugs that are not unfamiliar to everyone in daily life and medical treatment. They can effectively suppress or kill germs. They are often used to treat diseases caused by pathogenic microorganisms. They start from the root cause of pathogenic bacteria. This makes the treatment more directional and more effective.

This article describes one of the macrolide antibiotics called azithromycin. Azithromycin is used very frequently in daily life, and its quality is very important. This article mainly studies the injection of azithromycin related substances, the limits of drug impurities are prescribed to ensure the quality of drug standards. The quality of medicines is of utmost necessary, and the study of this item is particularly important.

This article first sorts out the relevant material tests as stipulated in the Chinese Pharmacopoeia (2015), and then compares and synthesizes them with other published journals and related substances defined in other countries' Pharmacopoeia. After that, the experimental route and experimental methods of this study are analyzed according to the actual situation. Analyze the situation of related substances of azithromycin for injection, analyze the reasons for the existence of impurities from the aspects of raw materials, production links, storage environment, etc., and summarize and improve the method of avoiding impurities in this link. According to the test results, summarize the impurity types and limits, optimize the existing detection methods and standards, and carry out long-term phase adjustment adjustments to the improved methods to determine their feasibility to better control the azithromycin raw materials and The quality of the freeze-dried preparation for injection.

Key Words: Antibiotics; Azithromycin; Related substances; HPLC

目录

摘要·····················································1

Abstract·················································2

1. 文献综述········································4
   1. 引言············································4
      1. 阿奇霉素简介······························4
      2. 阿奇霉素研究背景··························4
   2. 阿奇霉素有关物质研究现状························5
      1. 各国药典中有关物质规定····················5
      2. 国内外杂质的收录分析······················7
      3. 各国药典有关物质色谱条件比较··············9
   3. 对阿奇霉有关物质进行研究的目的及意义···········12
2. 注射用阿奇霉素有关物质研究实验·················13
   1. 实验仪器、试剂及实验样品·······················13
      1. 实验仪器·································13
      2. 实验试剂·································13
      3. 实验样品·································13
   2. 实验方案·······································16
      1. 实验采用色谱条件优化选择·················16
      2. 有关物质检测方法验证·····················20
      3. 阿奇霉素有关物质相对保留时间研究·········24
      4. 检测项、定量限确认·······················26
      5. 阿奇霉素有关物质校正因子研究·············27
      6. 注射用阿奇霉素有关物质检测···············30

结果与讨论··············································35

参考文献················································36

致谢····················································38

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