阿莫西林颗粒中高分子杂质含量和生产工艺的相关性评价  

Evaluation on manufacture process by determination of high-molecular weight impurities in amoxicillin granules

作　　者：顾立素[1] 胡昌勤[1] 周进东 罗兴洪 赵耀军 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]海南先声药业有限公司,海口570026

出　　处：《药品评价》2005年第2期119-122,共4页Drug Evaluation

摘　　要：目的评价海南先声药业阿莫西林颗粒的生产工艺和其中高分子杂质的相关性。方法采用反相色谱和Superdex Peptide凝胶色谱分别测定阿莫西林颗粒和原料中的高分子杂质。结果6批阿莫西林颗粒中均无高聚物,其高分子杂质种类与原料一致,均为阿莫西林闭环二聚体和阿莫西林噻唑酸,且二者的含量均一、稳定。结论该阿莫西林颗粒制剂工艺较好,且水平稳定可控。Objective To evaluate manufacture process by determination of high-molecular weight (HMW) impurities in amoxicillin granules of Hainan Simcere Pharmaceutical Co. Ltd. Methods The content of HMW impurities in amoxicillin granules and its drug substance have been determined by reversed phase liquid chromatography (RPLC) and Superdex peptide gel filtration chromatography (GFC), respectively. Results Amoxicillin-dimer (ring-closed) and amoxicilloic acid detected in 6 batches of amoxicillin granules are homogeneous and no HMW polymers was detected in both dosage and drug substance. Conclusions Manufacture process of amoxicillin granules is good, stable and under control.

关 键 词：阿莫西林颗粒 生产工艺 相关性 杂质含量 高分子杂质 Peptide 反相色谱 凝胶色谱 制剂工艺 高聚物 二聚体 原料 

分 类 号：TQ465[化学工程—制药化工]