229批国产注射用头孢噻肟钠的质量评价  

Quality Assessment for 229 Batches of Domestic Cefotaxime Sodium Injection Samples

作　　者：姚蕾[1] 王立新[2] 王红梅[3] 高志峰[2] 胡昌勤[2] 

机构地区：[1]中国食品药品检定研究院食品药品技术监督所,北京100050 [2]中国食品药品检定研究院化学药品检定所,北京100050 [3]厦门市药品检验所抗生素室,福建厦门361012

出　　处：《药品评价》2012年第11期22-27,共6页Drug Evaluation

摘　　要：目的:对国产注射用头孢噻肟钠的质量现状进行评价。方法:按中国药典及有关标准进行检验,利用统计学方法分析检验结果。结果:44个企业生产的229批注射用头孢噻肟钠中,12批不合格,占5.24%,涉及8个厂家。溶液的澄清度是主要的不合格项。结论:目前国产注射用头孢噻肟钠存在的主要质量问题是溶液的澄清度和成盐问题。Objective： To evaluate the quality of cefotaxime sodium for injections at present. Methods： All the samples were examined according to the Chp. and other approved criteria. The data were analyzed by statistic methods. Results： 12 batches of samples produced by 8 pharmaceutical factories were found unqualified among 229 batches of samples produced by 44 pharmaceutical factories, with the disqualification rate of 5.24%. The clarity of cefotaxime solution was the major item of disqualification in all these preparations. Conclusions： The solution＇s clarity and the salification of cefotaxime were the main problems for qualities of these domestic preparations.

关 键 词：注射用头孢噻肟钠 质量评价 

分 类 号：R927.2[医药卫生—药学]