市售头孢克肟颗粒质量分析与风险评价  

Quality Analysis and Risk Assessment of Commercially Available Cefixime Granules

作　　者：卢蓉娜 罗枭灼 吕冠欣 LU Rongna;LUO Xiaozhuo;LYU Guanxin(Foshan Shunde Institute for Drug Control,Foshan Guangdong 528300,China;Key Laboratory of Drug Metabolism Research and Evaluation,SDA,Guangzhou Guangdong 510515,China.)

机构地区：[1]佛山市顺德区药品检验所,广东佛山528300 [2]国家药品监督管理局药物代谢研究与评价重点实验室,广东广州510515

出　　处：《药品评价》2024年第1期27-31,共5页Drug Evaluation

摘　　要：目的对市售头孢克肟颗粒进行质量分析,为提高产品质量的均一性和标准检验方法的改进提供参考。方法采用法定检验方法对7家生产企业共28批头孢克肟颗粒进行全项检验,并对检验结果进行统计分析;测定溶出度曲线,找出仿制样品体外溶出行为与原研药物的差异;测定产品聚合物和有关物质,考察不同温湿度存储条件下聚合物和特定杂质的变化。结果28批样品按法定检验标准检查均合格,但部分产品检验标准、储存条件、是否含糖和产品标签之间存在不一致;水分、体外溶出曲线和聚合物三个项目上存在较大差异。7家生产企业中仅1家生产企业对聚合物进行了控制,在未进行聚合物控制的6家生产企业中有3家生产企业的产品聚合物检测结果偏高,接近或等于标准限值,A生产企业的溶出曲线与其他企业存在较大差异,D生产企业的水分平均值远高于其他生产企业。高湿条件下导致聚合物和特定杂质含量上升。结论头孢克肟颗粒总体质量合格,但仍需要进一步完善统一标准,加强质量控制。Objective To analyze the quality of cefixime granules in the market,and to provide reference for improving the uniformity of product quality and standard testing methods.Methods A total of 28 batches of cefixime granules from 7 manufacturers were tested by legal test method,and the test results were analyzed statistically.The dissolution curve was determined to find out the difference of dissolution behavior between the imitation sample and the original drug.The product polymers and related substances were measured,and the changes of polymers and specific impurities under different temperature and humidity storage conditions were investigated.Results All 28 batches of samples passed the inspection according to the statutory standards.However,there were inconsistencies between the inspection standards,storage conditions,whether sugar was present,and the product labeling.Significant differences were observed in three areas:moisture content,in vitro dissolution,and polymer.Only 1 of the 7 production enterprises controlled the polymer,3 of the 6 production enterprises did not control the polymer,the product polymer test results were high,close to or equal to the standard limit,the dissolution curve of the A production enterprise was significantly different from that of other enterprises,and the average water content of the D production enterprise was much higher than that of other enterprises.High humidity conditions lead to increased levels of polymers and specific impurities.Conclusion The overall quality of cefixime granules is qualified,but it is still necessary to further improve the unified standard and strengthen the quality control.

关 键 词：头孢克肟颗粒 聚合物 溶出曲线 有关物质 风险评价 

分 类 号：R927.1[医药卫生—药学]