注射用阿莫西林钠克拉维酸钾的质量评价  

Quality evaluation of amoxicillin sodium and clavulanate potassium for injection

作　　者：王松 张丹丹 赵海云 于明艳 杨蕙如 陈德俊 Wang Song;Zhang Dan-dan;Zhao Hai-yun;Yu Ming-yan;Yang Hui-ru;Chen De-jun(Shandong Institute for Food and Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Research Center of Engineering ang Technology for Consistency Evalution of Generic Drugs,Ji'nan 250101)

机构地区：[1]山东省食品药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,济南250101

出　　处：《中国抗生素杂志》2022年第2期145-151,共7页Chinese Journal of Antibiotics

摘　　要：目的 评价国产注射用阿莫西林钠克拉维酸钾的质量现状,并提出改进建议。方法 法定标准检验结合探索性研究,对产品的杂质谱、克拉维酸聚合物及其他荧光杂质、复溶行为、成盐率、包材密封性等进行比较研究。结果 212批次样品法定标准检验均符合规定;采用建立的杂质分析方法,对主要杂质的结构与来源进行确证;证明水分和温度易促进主成分的降解;此外,应严格控制原料成盐过程中的工艺参数,控制成盐剂的残留量;并关注包材密封完整性对产品全生命周期的影响。结论 注射用阿莫西林钠克拉维酸钾总体质量较好,现行质量标准有待提高。Objective To evaluate the quality of amoxicillin sodium and clavulanate potassium for injection,and the suggestion for improvement was put forwarded. Methods The statutory standard methods combined with exploratory researches were used to compare and study the impurity spectrum, clavulanate polymer and other fluorescent impurities, redissolution behaviors, salt-forming rate, and package integrity of the products. Results 212 batches of samples were all qualified according to the statutory test. The new analysis method was established to conform the structure and source of major impurity. It was demonstrated that water and high temperature promoted the degradation of the samples. The critical process parameters and the residue of salt forming agent should be controlled strictly during the salt forming process. The package integrity in the whole life cycle of products should be paid attention to. Conclusion The quality of amoxicillin sodium and clavulanate potassium for injection was satisfactory in general. The current statutory standards should be further improved.

关 键 词：注射用阿莫西林钠克拉维酸钾 质量评价 杂质谱 复溶行为 包材密封性 

分 类 号：R978.1[医药卫生—药品]