2005年国产头孢拉定制剂监督抽验结果与质量评价  

Results and statistic analysis of domestic cefradine preparations in 2005

作　　者：张斗胜[1] 李进[1] 顾立素[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药品评价》2006年第1期53-56,共4页Drug Evaluation

摘　　要：目的对国产头孢拉定的质量现状进行评价。方法按中国药典2000年版进行全检,统计分析检验结果,并与2002年头孢拉定质量评价结果进行比较。结果所有抽验样品均符合规定;各项统计分析结果表明多数企业产品质量良好,较2002年有稳步提升,但仍存在一些应当注意的问题。结论目前国产头孢拉定制剂的工艺较为稳定,质量总体较好,但仍有个别企业产品需加强监督。有关物质检查是今后头孢拉定制剂质量监督评价重点。Objective To evaluate the quality of cefradine preparations at present. Methods All the samples were experimented according to the Chp.2000. The data were analyzed by statistic methods and compared with evaluation results of 2002. Results All the samples comply with all requirements of the Chp.2000. The statistic data show the qualities of majority samples are good but still could be improved. Conclusions The qualities of domestic cefradine preparations are satisfactory at this time and the processes are stable in recent years, but among them there is some products should be supervised continuously. The item of related substance is still the emphasis of supervision and evaluation for cefradine preparations in future years.

关 键 词：头孢拉定 监督抽验 质量评价 

分 类 号：R927.1[医药卫生—药学]