注射用氨苄西林钠质量评价  

Quality evaluate of ampicillin sodium for injection

作　　者：刘旭春 姚羽 付晓丽 王丹 张玲变 周晓溪 Liu Xuchun;Yao Yu;Fu Xiaoli;Wang Dan;Zhang Lingbian;Zhou Xiaoxi(Shanxi Inspection and Testing Center,Taiyuan 030031)

机构地区：[1]山西省检验检测中心,太原030031

出　　处：《中国抗生素杂志》2024年第3期304-309,共6页Chinese Journal of Antibiotics

摘　　要：目的对注射用氨苄西林钠的质量进行评价。方法采用法定标准结合探索性研究对95批次注射用氨苄西林钠进行检验,并与往年的两次国抽结果进行纵向比较,评价本品的质量状况。结果按法定标准检验,95批次样品全部符合规定。原料为冷冻干燥和溶媒结晶工艺的产品在碱度、有关物质、水分、含量等方面存在明显差异。表现为冷冻干燥工艺的产品碱度相对较低,含量(按无水物计算)相对较低,杂质量、水分相对较高。探索性研究表明,在加速试验条件下放置,随着时间的增长,原料为冷冻干燥工艺的产品颜色加深,杂质增大;而溶媒结晶工艺的产品颜色和杂质变化较小。结论注射用氨苄西林钠总体质量较好,采用溶媒结晶工艺为原料的产品质量相对更优,原料是影响本品质量的主要因素。Objective To evaluate the quality of ampicillin sodium for injection.Methods The quality of this product was assessed by conducting tests on 95 batches of samples using both the statutory standard procedures and exploratory research methods.Additionally,the product's quality was reviewed by comparing its results with three national random drug testing outcomes over a period of time.Results According to the statutory standards,95 batches of samples all met the requirements.There were obvious differences in alkalinity,related substances,water and the content of samples between freeze-drying and solvent crystallization processes.The alkalinity and content calculated by anhydrous substance of freeze-dried products were relatively low.The impurities and moisture of freezedrying products were relatively high.Under the condition of the accelerated test,the exploratory study showed that the color of raw materials with the freeze-drying process was deepened and the impurities increased,with the passage of time.However,the color and impurity of the products changed little in the process of solvent crystallization.Conclusions The quality of ampicillin sodium for injection was generally of good quality.The quality of products using the solvent crystallization process as the raw material was relatively better.The production process of the raw material was the main factor affecting the quality of the product.

关 键 词：注射用氨苄西林钠 质量评价 生产工艺 

分 类 号：R978.1[医药卫生—药品]