摘要
目的对诺氟沙星胶囊的质量现状进行评价。方法按《中国药典》2005年版二部进行全检,统计分析检验结果,全面评价各项检验项目。结果所有抽验样品均符合规定;多数企业产品质量良好,但仍有一些值得注意的问题。结论目前诺氟沙星胶囊的制剂工艺较为稳定,总体质量较好,个别企业需加强自身监督,提高药品质量;应对诺氟沙星胶囊质量标准进行修订和提高;应加强对有关物质的监督检查。
Objective To evaluate the quality of norfloxacin capsules at present.Methods All the samples were experimented according to the Chp.2005.The data were analyzed by statistic methods and all the items were evaluated.Results All the samples complied with all requirements of the Chp.2005.The statistic data showed the qualities of majority samples were good but still could be improved.Conclusion The qualities of domestic norfloxacin capsules are satisfactory and the processes are stable in recent years,but among them there are some products that should be monitored continuously.The standard of norfloxacin capsules still need to be improved.The related substances should be checked in the future.
出处
《中国药事》
CAS
2010年第12期1204-1206,共3页
Chinese Pharmaceutical Affairs
关键词
诺氟沙星
监督检验
质量评价
质量标准
norfloxacin
supervised sample
quality evalution
quality standards
