细胞色素C注射剂质量评价及研究  

Quality Evaluation and Research of Cytochrome C Injection

作　　者：刘莉莎[1] 邓利娟[1] 郝苏丽[1] 王鑫钰 廖海明[1] 王悦[1] 高志峰[1] 范慧红[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药学杂志》2015年第11期987-992,共6页Chinese Pharmaceutical Journal

摘　　要：目的对细胞色素C注射剂进行标准检验及探索性研究,从而对该品种的质量及标准现状做出总体评价及分析。方法标准检验依据《中国药典》2010年版二部,探索性研究采用肽图分析鉴别种属来源,3,3',5,5'-四甲基联苯胺(TMB)底物生色法测定活力,高效液相色谱法检测有关物质。结果按照法定标准检验,44批细胞色素C注射液合格率100%,6批注射用细胞色素C合格率50%。结论通过法定标准检验及探索性研究,发现该品种在质量标准及产品质量上均存在一定的问题。作为生物提取类高风险生化药品种,建议对该品种进行标准提高。OBJECTIVE To evaluate the quality status and current standard of cytochrome C injection and to carry out exploratory research on its standard. METHODS Samples were tested according to the current quality standard in the Pharmacopoeia of the People＇s Republic of China（ 2010） Volume Ⅱ. Exploratory researches including peptide mapping analysis,activity determination by TMB substrate chromogenic method,and related substances detection by HPLC were carried out. RESULTS The passing rate of cytochrome C injection was 100%,and that of freeze-dried cytochrome C powder for injections was 50%. CONCLUSION There existed some problems with both the quality status and current standard of cytochrome C injection. The exploratory researches indicate that it is necessary to improve the statutory standard of cytochrome C.

关 键 词：细胞色素C 质量评价 质量标准 标准提高 肽图分析 活力测定 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]