摘要
目的对注射用头孢噻肟钠3个厂家的国内制剂与原研制剂的杂质谱进行对比分析,对检出的杂质来源进行分析。方法在美国药典头孢噻肟钠有关物质的方法的基础上改进,能够有效的分离美国药典10个已知杂质及未知杂质,进行了方法学验证,并对3个厂家的国内制剂与原研制剂的杂质谱进行对比分析,进行了影响因素考察,明确杂质性质。结果厂家A的杂质水平与原研制剂一致,优于其他两家制剂。结论建议在中国药典中增加已知降解杂质的控制。
Objective To compare the impurity profiles of cefotaxime sodium for injection produced by three domestic pharmaceutical manufactures and the original drugs,and study the sources of impurities.Methods Based on the improvement of the method of cefotaxime sodium related substances in American Pharmacopoeia,ten known and unknown impurities in American Pharmacopoeia were effectively separated and validated by methodology.The impurity profiles of three domestic pharmaceutical manufactures and the original drugs were compared and analyzed,and the influencing factors were investigated to clarify the impurities.Results The impurity level of manufacturer A was the same as that of the original drugs,which was superior to the other two preparations.Conclusion It is suggested to strengthen the control of known impurities in Chinese Pharmacopoeia.
作者
表亚囡
李敏
张锁庆
于晓娜
李亚卿
胡利敏
Biao ya-nan;Li Min;Zhang Suo-qing;Yu Xiao-na;Li Ya-qing;Hu Li-min(Huabei Pharmaceutical Hebei Huamin Pharmaceutical Co.,Ltd,Shijiazhuang 052165)
出处
《中国抗生素杂志》
CAS
CSCD
2020年第10期1027-1033,共7页
Chinese Journal of Antibiotics
关键词
头孢噻肟钠
杂质谱
参比制剂
影响因素
Cefotaxime sodium
The impurity profiles
Original drugs
Influence factor
