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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 conduct a standard test and exploratory research on cytochrome C injection to make an overall evaluation and analysis of the quality and standard status of the cultivars. Methods The standard test was based on the 2010 edition of Chinese Pharmacopoeia (2). The exploratory study identified the source of species by peptide mapping. The activity of 3,3 ’, 5,5’-tetramethylbenzidine (TMB) , High performance liquid chromatography detection of related substances. Results According to statutory standards, 44 batches of cytochrome C injection rate of 100%, 6 batches of cytochrome C injection rate of 50%. Conclusion Through statutory standard test and exploratory research, we found that there are some problems in the quality standard and product quality of this variety. As a kind of biological extraction of high-risk biochemical drugs, it is recommended to raise the standard of the species.