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30 June 2012EMA/CHMP/CVMP/QWP/199250/2009 corrCommittee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP)Guideline on setting specifications for related impurities in antibiotics抗生素中相关杂质质量标准制定的指导原则Final 定稿学习之名（译注）Table of contents 目录Executive summary1. Introduction (background)2. Scope3. Legal basis4. General requirements5. Impurity profiling and reporting, identification and qualification thresholds6. New applications and variations7. Specifications for medicinal products8. Analytical proceduresDefinitionsAnnex 1: Explanatory note regarding thresholds.Annex 2: ThresholdsAnnex 3: Example of “fingerprint chromatogram” approach to control very complex impurity profiles 概要1、背景介绍2、范围3、法规依据4、一般要求5、杂质分布以及报告、鉴别和界定阈值6、新申请和变更7、制剂产品质量标准8、分析方法定义附件1：关于阈值的注释附件2：阈值附件3：利用基于“指纹图谱”的方法对非常复杂的杂质分布进行控制举例Executive summary 概要Antibiotics active substances currently on the market are produced by fermentation, by fermentation followed by one or more synthetic steps (semi-synthetic substances) or by chemical synthesis. Fermentation processes are, in comparison to synthetic processes, more variable and less controllable, so the impurity profile of an active substance whose manufacturing process involves fermentation may be more complex and less predictable than that of a purely synthetic product. For this reason fermentation products and semi-synthetic substances are not included in the scope of the ICH Q3 and the VICH GL10/GL11 guidelines, which set thresholds for the identification, reporting and qualification of related impurities in active substances manufactured by chemical synthesis.目前上市的抗生素类活性物质是由发酵、发酵加一步或几步合成步骤（半合成）、化学合成制得。
抗生素英文Antibiotics are a type of medication used to treat bacterial infections. They work by killing or inhibiting the growth of bacteria, thus preventing the spread of infection. Antibiotics come in many different forms, including pills, capsules, creams, and injections. They are one of the most widely used medications in the world, and have saved countless lives since their discovery in the early 20th century. In this article, we will discuss the history of antibiotics, their mechanism of action, and the different types of antibiotics.History of antibioticsThe discovery of antibiotics is often attributed to Alexander Fleming, who in 1928 noticed that a mold called Penicillium notatum could prevent the growth of bacteria. He was awarded the Nobel Prize in Medicine in 1945 for his discovery. However, the use of natural substances to treat infections dates back thousands of years. For example, ancient Egyptians used moldy bread to treat wounds, and ancient Chinese texts describe the use of moldy soybeans to treat infected wounds.After Fleming's discovery, other researchers began searching for other natural substances with antibiotic properties. In the 1930s, the German chemist Gerhard Domagk discovered the first synthetic antibiotic, sulfanilamide. This was followed by the discovery of streptomycin in 1943 by researchers at Rutgers University, which is a type of antibiotic called an aminoglycoside.Since then, many different types of antibiotics have been discovered, each with their own unique mechanism of action.Mechanism of actionAntibiotics work by targeting the structures or processes that are unique to bacteria. This is important, as antibiotics need to be able to kill bacteria without harming the patient's own cells.One common target of antibiotics is the bacterial cell wall. Most bacteria have a cell wall made of peptidoglycan, a complex molecule that provides structural support to the cell. Antibiotics such as penicillin and cephalosporins target this cell wall, causing it to weaken and ultimately burst, killing the bacteria.Another target of antibiotics is the bacterial ribosome. Ribosomes are responsible for synthesizing proteins in the cell, and antibiotics such as tetracyclines and macrolides inhibit this process, preventing the bacteria from being able to grow and divide.Other antibiotics target the DNA or RNA of the bacterial cell, preventing it from being able to replicate or transcribe genes.Types of antibioticsThere are many different types of antibiotics, each with their own unique mechanism of action and spectrum of activity. Some common types of antibiotics include:1. Penicillins – These are one of the oldest and most widely used types of antibiotics. They work by targeting the bacterial cell wall, and are effective against many different types of bacteria.2. Cephalosporins – These are similar to penicillins in their mechanism of action, but are more resistant to bacterial enzymes that can break down penicillins. They are often used to treat more serious infections.3. Macrolides – These antibiotics inhibit bacterial protein synthesis by binding to the bacterial ribosome. They are often used to treat respiratory and skin infections.4. Tetracyclines – These antibiotics also inhibit bacterial protein synthesis, but by a different mechanism than macrolides. They are often used to treat acne, as well as respiratory and urinary tract infections.5. Aminoglycosides – These antibiotics also inhibit bacterial protein synthesis, but by a different mechanism than macrolides and tetracyclines. They are often used to treat serious infections such as sepsis and endocarditis.There are many other types of antibiotics as well, including fluoroquinolones, sulfonamides, and carbapenems.ConclusionAntibiotics are a powerful tool in the fight against bacterial infections, but they must be used responsibly to avoid the development of antibiotic-resistant bacteria. This occurs when bacteria evolve mechanisms to resist the effects of antibiotics, making them harder to treat. It is important to use antibiotics only when necessary, and to always complete the full course of treatment, even if you feel better before the prescription is finished. Overuse of antibiotics can cause more harm than good, so it is important to always follow the instructions of your healthcare provider when taking antibiotics.。
