奥沙利铂注射剂质量分析和探索性研究.PDFVIP

中国药事 2018年9月 第32卷 第9期 1211 ·质量评价· 奥沙利铂注射剂质量分析及探索性研究 江燕，谢华，王觉晓，傅萍 （四川省食品药品检验检测院，成都 610097 ） 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。 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 R927.1 A 1002-7777(2018)09-1211-06 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.09.009 Quality Analysis and Exploratory Research of Oxaliplatin Injections Jiang Yan, Xie Hua, Wang Juexiao, Fu Ping (Sichuan Institute for Food and Drug Control, Chengdu 610097, China) Abstract 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: