摘要
目的对2018年我省专项监督抽验口服头孢菌素类抗生素的有关物质进行考察,并对现行标准进行探讨。方法按规定的检验标准对2018年省抽样品进行有关物质检查,并对结果进行分析。结果58批次样品的有关物质含量均符合规定。结论按规定标准检验,本次省专项监督抽验头孢菌素类抗生素的有关物质情况良好。建议优化各品种的质量标准,以期更好的控制药物的质量。
Objective To investigate the related substances of oral solid preparation of cephalosporin antibiotics from special supervision sampling in our province in 2018,and to discuss the current standard.Methods According to specified inspection standard,the related substances in the samples of the province in 2018 were examined and the results were analyzed.Results 58 batches of related substances met the requirements.Conclusion According to the specified standard test,the related substances of cephalosporin antibiotics from special supervision sampling in 2018 are in good condition.In order to control the quality of drugs better,it is suggested to optimize the quality standards of each species.
作者
梅芊
李茜
李杨
刘英
Mei Qian;Li Qian;Li Yang;Liu Ying(Henan Provincial Institute of Food and Drug Control,Henan,Zhengzhou 450018)
出处
《国外医药（抗生素分册）》
CAS
2020年第4期325-330,共6页
World Notes on Antibiotics
关键词
口服头孢菌素类抗生素
有关物质
质量评价
oral solid preparation of cephalosporin antibiotics
related substances
quality evaluation
