| ?-lactam antibiotic is one of the most commonly used basic drugs in clinical.But the adverse reactions,especially the allergic reaction becomes more and more obviously and damages to the patients' health seriously.Polymer impurities in the antibiotics are the main reasons that cause allergic reactions.This paper focuses on the separation analysis of ceftriaxone sodium impurities and allergen research and the testing analysis of doripenem polymer impurities.This paper includes six parts as follows:In chapter one,the application prospect,the small molecule impurities and polymer impurities of ceftriaxone were elucidated.The separation method and allergen research of ceftriaxone were introduced,too.In chapter two,improved the pharmacopoeia method,a HPLC gradient elution method was established to separate the small molecule impurities of ceftriaxone sodium.The separation was effectly,precision and repeatability conformed to requirements.In chapter three,a method coupled size exclusion chromatography with mass spectrum was established for the determination of polymers in ceftriaxone sodium,with short separation time and good separating degree.This method which provided basis for the separation and analysis of ?-lactams polymers could be used to improve the quality of product.In chapter four,polymer impurities were obtained by nanofiltration.This method was simple and the operation time was short.The polymers could be stored easily.In chapter five,test passive cutaneous anaphylaxis reaction was studied for allergen research.The result showed that the polymer impurities could cause allergic reactions and were the major allergen of ceftriaxone sodium.In chapter six,the method separated ceftriaxone polymer impurities was used to separate and analyze the polymer impurities of doripenem,showed that the method coupled size exclusion chromatography with mass spectrum had certain universality and could be used for other antibiotic medicines polymer impurities detection and analysis. |
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