国产注射用磺苄西林钠的质量评价

发布时间：2018-11-02 12:46

【摘要】：目的评价国内不同企业生产的注射用磺苄西林钠的质量。方法按国家标准检验与探索性研究相结合,对抽验样品进行检验,对检验结果进行统计分析。结果共抽取样品72批次,按国家标准检验合格率100%。探索性研究对磺苄西林D/L异构体的抑菌活性进行评价,结果反映D(-)磺苄西林的抑菌活性强于L(+)磺苄西林;结合有关物质检查法与稳定性研究,对主要杂质的来源与结构进行研究;通过检验项目结果间关联分析,明确水分对注射用磺苄西林钠的有关物质及聚合物均有影响;结论目前国内注射用磺苄西林钠的总体质量较好;现行标准有待进一步提高,建议现行标准增加磺苄西林对映体检查、提高水分限度要求、收录磺苄西林降解杂质结构信息;建议企业对原料工艺进行优选,以提高产品质量。
[Abstract]:Objective to evaluate the quality of sulfampicillin sodium for injection produced by different enterprises in China. Methods according to the national standard inspection and exploratory research, the sampling samples were tested and the results were statistically analyzed. Results A total of 72 batches of samples were collected, and the qualified rate was 100 according to the national standard. The results showed that the antibacterial activity of D (-) sulfampicillin was stronger than that of L (). The source and structure of the main impurity were studied by the method of related substance inspection and the stability study, and the correlation analysis between the results of the test items showed that the moisture had an effect on the related substances and polymers of sulfampicillin sodium for injection. Conclusion the overall quality of sulfampicillin sodium for injection in China is good and the current standard needs to be further improved. It is suggested that the enantiomeric examination of sulfampicillin should be added to the present standard, and the water limit requirement should be raised, and the information on impurity structure of sulfampicillin degradation should be included. In order to improve the quality of products, it is suggested that enterprises should select the raw materials.
【作者单位】：中国食品药品检定研究院;
【分类号】：R927.1

【参考文献】