《中国药典》2015年版盐酸头孢他美酯干混悬剂有关物质检查方法的商榷  

Discussion on the Examination Methods for the Related Substances of Cefetamet Pivoxil Hydrochloride for Suspension in Chinese Pharmacopoeia 2015

作　　者：阮昊 张筱红[2] 陈丹丹 陈悦 

机构地区：[1]浙江省食品药品检验研究院,杭州310051 [2]国家药典委员会,北京100061

出　　处：《中国药品标准》2016年第2期93-95,共3页Drug Standards of China

摘　　要：目的:通过对2个厂家8批盐酸头孢他美酯干混悬剂的检验和进一步研究,对该品种有关物质项检查方法进行优化改进。方法:依据《中国药典》2015年版标准进行检验,延长检测时间并考察2个厂家辅料的干扰情况。结果:盐酸头孢他美酯干混悬剂标准中有关物质检查项,需要增加检测时间至主峰保留时间的5倍,对于辅料峰的扣除必要时应采用辅料对照实验进行。结论:建议修订盐酸头孢他美酯干混悬剂标准的有关物质项目,以利于更好地控制该药品质量。Objective：To improve and optimize the examination methods for the related substances of Cefetamet Pivoxil Hydrochloride for Suspension by researching on 8 batches of samples from 2 manufacturers.Methods：Statutory standard tests were proceeded accord-ing to ChP 2015.The detection times were extend and the interferences of excipients were studied.Results：The detection time should be extended to 5 times of the retention time of the main peak in the examination items of the standard of Cefetamet Pivoxil Hydrochlo-ride for Suspension .To disregard the peaks of the excipient, the excipient blank test was recommende if necessary.Conclusion：The related substances items of the standard of Cefetamet Pivoxil Hydrochloride for Suspension should be revised in order to control the quality .

关 键 词：盐酸头孢他美酯干混悬剂 《中国药典》2015年版 有关物质 CHP 2015 

分 类 号：R921.2[医药卫生—药学]