摘要
目的:对利巴韦林注射液有关物质检查方法进行探讨。方法:按照《中国药典》2010年版二部利巴韦林注射液有关物质检查的方法,对利巴韦林注射液进行破坏性试验,同时对利巴韦林的降解产物进行考察。结果:利巴韦林杂质峰与氯化钠峰难以分开。因此,利巴韦林注射液处方中如有氯化钠的存在,将干扰利巴韦林注射液有关物质的检查。结论:建议有关物质检测时扣除氯化钠峰的影响,或者企业在利巴韦林注射液的处方中标注氯化钠的量或不加氯化钠。
Objective： To discuss the related substance test method for ribavirin injections. Methods：The related substance test method for ribavirin injections in Chinese Pharmacopoeia Volume Ⅱ （2010 Edi_tion） was employed to determine the related substances in ribavirin injections of different manufacturers. Meanwhile, ribavirin injections were subjected to forced degradation studies under different conditions, and the degradation products of ribavirin were detected. Results： The HPLC of this related substance test method could not effectively separate the degradation product of ribavirin from sodium chloride. Conclu_sion： It is suggested that the peak area of sodium chloride should be deducted in the related substance test for ribavirin injections. In addition, the content of sodium chloride should be described in the pre_scriptions of ribavirin injections, or sodium chloride should not be included in ribavirin injections..
出处
《药学与临床研究》
2014年第6期506-508,共3页
Pharmaceutical and Clinical Research
关键词
利巴韦林
有关物质
氯化钠
Ribavirion Related substance Sodium chloride
