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。
Abstract
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
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Key words
cytochrome C /
quality evaluation /
quality standard /
standard improvement /
peptide mapping analysis /
activity determination /
HPLC
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中图分类号：
R917
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参考文献
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Ch. P (2010) VolⅡ(中国药典2010年版. 二部) . 2010: 508-509; appendix 130-147.
WANG Z H, WANG W, LI Y, et al. Sequence analysis and structure comparison of cytochrome C proteins . Bioinformatics (生物信息学), 2010, 8 (3): 274-278.
LIU L S, WANG X Y, LI F F, et al. Peptide mapping analysis of cytochrome C. Chin J Pharm Anal(药物分析杂志), 2014, 34 (11): 2060-2065.
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