| 江燕,谢华,王觉晓,傅萍.奥沙利铂注射剂质量分析及探索性研究[J].中国药事,2018,32(9):1211-1216 |
| 奥沙利铂注射剂质量分析及探索性研究 |
| Quality Analysis and Exploratory Research of Oxaliplatin Injections |
| 投稿时间：2018-01-04 |
| DOI：10.16153/j.1002-7777.2018.09.009 |
| 中文关键词: 奥沙利铂注射剂 国家评价性抽验 药品质量分析 杂质谱 稳定性 |
| 英文关键词: oxaliplatin injections national assessment programs drug quality analysis impurity profile stability |
| 基金项目: |
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| 摘要点击次数: 1518 |
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| 中文摘要: |
| 目的：评价国内不同企业生产的奥沙利铂注射剂的质量。为奥沙利铂注射剂的标准提高和质量控制提供合理化建议。方法：将法定检验与探索性研究相结合，对抽验样品进行检验和研究，对结果进行统计分析。结果：共抽取样品51批次，按法定检验合格率100%。但现行注射液法定标准无法完全检出奥沙利铂已知和未知杂质，本研究建立了专属性更高的杂质检查方法，并通过杂质谱的比较，发现注射液剂型杂质检出量明显高于注射用无菌粉末。进一步研究表明注射液剂型的终端灭菌方式、贮藏时间、贮藏温度、金属离子含量等影响了奥沙利铂稳定性。结论：目前国内注射用奥沙利铂总体质量较好，奥沙利铂注射液（小水针和大输液）总体质量一般。注射液剂型现行标准有待进一步提高。建议小水针和大输液企业加强药品生产全过程风险管控，对各影响因素进行有效控制。 |
| 英文摘要: |
| Objective: To evaluate the quality of oxaliplatin injections produced by different enterprises in China in order to provide reasonable suggestions for standard improvement and quality control of oxaliplatin injections.Methods: Statutory testing was combined with the exploratory research to test and study the sampling. The results were statistically analyzed.Results: A total of 51 batches of samples were taken and the qualified rate was 100% according to the statutory testing. However, the known and unknown impurities of oxaliplatin could not be completely detected through the current statutory standard of injection. A more specific impurity detection method was established and the amount of impurity of injections was significantly higher than that of the sterile powder for injection by comparing the impurity profile of oxaliplatin products. Further research showed that the terminal sterilization method, storage time, storage temperature and metal ion content of oxaliplatin injections affected the stability of oxaliplatin.Conclusion: At present, the overall quality of oxaliplatin for injections is good, and the overall quality of oxaliplatin injection (Small and Large Volume Parenteral) is not satisfactory. The current standard of injection formulation should be further improved. It is recommended that Small and Large Volume Parenteral manufacturers should strengthen the risk control of the whole process of production and effectively control all the influencing factors. |
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