王瑞珣,杨文岭,史芳华,杨晓梅,刘然,李清
WANG Ruixun,YANG Wenling,SHI Fanghua,YANG Xiaomei,LIU Ran,LI Qing

• 1:沈阳药科大学药学院

摘要(Abstract)：

目的考察注射用硼替佐米仿制药(齐普乐)与原研药(万珂)的质量是否具有一致性。方法采用已建立的质量标准对注射用硼替佐米仿制药与原研药进行性质鉴别、杂质检查、含量测定等多方面质量指标的对比研究。结果注射用硼替佐米仿制药与原研药质量对比研究结果显示:二者各项检测指标均无显著性差异。结论实验结果显示,注射用硼替佐米仿制药与原研药的质量具有一致性。
Objective To evaluate the quality consistency of the original product( Velcade) and the generic)Bortezomibforinjection(Qipule).MethodsAcomprehensivecomparisonofqualitative indicators,impurity inspections,and content determinations of bortezomib injectables and original drugs with established quality standards were studied. Results Comparing the quality of generic and original drugs showed that there were no significant difference on all the detection indexes. Conclusion The quality of generic Bortezomib for injection( Qipule) is consistent with the quality of Velcade.

关键词(KeyWords)： 注射用硼替佐米;多发性骨髓瘤;质量一致性;仿制药
Bortezomib for injection;multiply myeloma;quality consistency;generic product

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 王瑞珣,杨文岭,史芳华,杨晓梅,刘然,李清
WANG Ruixun,YANG Wenling,SHI Fanghua,YANG Xiaomei,LIU Ran,LI Qing

DOI: 10.14066/j.cnki.cn21-1349/r.2018.07.011

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