中国药物警戒 ›› 2022, Vol. 19 ›› Issue (5): 527-531.
DOI: 10.19803/j.1672-8629.2022.05.11

• 基础与临床研究 • 上一篇    下一篇

乳酸左氧氟沙星氯化钠注射液杂质谱研究

肖钦钦1, 陈希1, 段和祥1, 张银花1, 刘绪平1,*, 王晨2,#   

  1. 1江西省药品检验检测研究院, 国家药品监督管理局中成药质量评价重点实验室, 江西省药品与医疗器械质量工程技术研究中心,
    2中国食品药品检定研究院, 北京102629
  • 收稿日期:2021-04-19 出版日期:2022-05-15 发布日期:2022-05-18
  • 通讯作者: *刘绪平,男,硕士,主任药师,药物分析。E-mail：sanyezao@yeah.net;#为共同通信作者。
  • 作者简介:肖钦钦,女,硕士,主管药师,药物分析。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017zx09101001）

Analysis of impurity profile of levofloxacin lactate and sodium chloride injection

XIAO Qinqin1, CHEN Xi1, DUAN Hexiang1, ZHANG Yinhua1, LIU Xuping1,*, WANG Chen2,#   

  1. 1Jiangxi Institute for Drug Control, NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine, Jiangxi Province Engineering Research Center of Drug and Medical Device Quality, Nanchang Jiangxi 330029, China;
    2National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2021-04-19 Online:2022-05-15 Published:2022-05-18

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摘要： 目的 建立乳酸左氧氟沙星氯化钠注射液杂质谱,并对已知杂质进行毒性预测。 方法 参照《中华人民共和国药典》（2015年版）左氧氟沙星有关物质的检查方法对乳酸左氧氟沙星氯化钠注射液杂质谱进行研究,结合处方与工艺分析杂质来源及归属,研究处方中含金属络合剂对本品杂质的影响程度; 同时采用ADME/T性质预测软件对已知的相关杂质进行毒理性质参数预测。 结果 乳酸左氧氟沙星氯化钠注射液杂质谱中主要有8个杂质,4个降解杂质为杂质B、E、F、G和4个未知工艺杂质,制剂中检出杂质主要来源于原料,E为原料生产控制的关键杂质,G为制剂质量控制的关键光降解杂质,各杂质均存在不同程度的毒性。 结论 乳酸左氧氟沙星杂质谱的建立可为乳酸左氧氟沙星氯化钠注射液的一致性评价提供数据参考。

关键词: 乳酸左氧氟沙星, 杂质谱, 毒理性质, 一致性评价

Abstract: Objective To establish the impurity profile of levofloxacin lactate and sodium chloride injection, and predict the toxicity of the identified impurities. Methods The impurity profile of levofloxacin lactate and sodium chloride injection was studied according to the inspection method of levofloxacin related substances in ChP 2015 edition. Together with the prescription and process, the source and attribution of impurity were analyzed and the influence of metal complexing agent in the prescription on the impurities of the product was studied. At the same time, ADME/T property prediction software was used to predict the toxicological properties of the known impurities. Results Eight main impurities were found in levofloxacin lactate and sodium chloride injection, four degradation impurities B, E, F, G and four unknown process impurities, the impurities in preparations mainly come from raw materials, and key impurity E was key factor in raw materials producing control, impurities G, the light degradation impurity, was the key factor for quality control. All impurities were toxic with different levels. Conclusion The establishment of impurity profile of levofloxacin lactate can provide a data reference for consistency evaluation of levofloxacin lactate and sodium chloride injection.

Key words: levofloxacin lactate, impurity profile, toxicological property, consistency evaluation

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