《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

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 .