| 刘涓,任连杰.化学药品注射剂可提取物和浸出物杂质评估与控制的一般考虑[J].中国药事,2022,36(2):139-145 |
| 化学药品注射剂可提取物和浸出物杂质评估与控制的一般考虑 |
| General Considerations for Assessment and Control of Impurities in Extractables and Leachables of Chemical Injections |
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| DOI：10.16153/j.1002-7777.2022.02.004 |
| 中文关键词: 可提取物 浸出物 总体思路 研究方法 安全性评估及阈值 风险管理 评估和控制策略 |
| 英文关键词: extractables leachables overall consideration study methods safety assessment and thresholds risk management assessment and control strategy |
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| 摘要点击次数: 1822 |
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| 中文摘要: |
| 目的： 从总体思路、研究方法、安全性评估及阈值等方面探讨化学药品注射剂可提取物、浸出物杂质评估和控制的一般考虑，为相关研究人员提供参考。方法：根据我国已发布的相容性研究技术指导原则以及当前国际通行的技术要求，结合技术审评过程中发现和总结的若干典型案例进行分析。结果与结论：注射剂中浸出物杂质所引入的风险是由接触时间、接触条件、制剂和材料特性等各种因素综合决定的。研究者应结合风险评估情况，制定适宜的评估和控制策略。 |
| 英文摘要: |
| Objective: The general considerations for the evaluation and control of extractable and leachable impurities (E&Ls) of chemical injection were discussed from the aspects of general idea, study methods, safety assessment and thresholds, etc., which may provide references for related researchers. Methods: It was analyzed on the technical guidelines of compatibility study published in China and the current international technical requirements, and some typical cases found and summarized in the process of technical review. Results and Conclusion: The risks introduced by leachable impurities in injections are determined by a combination of factors, such as contact time, exposure conditions, preparation and materials properties. Based on the risk management outcome, researchers should establish an appropriate assessment and control strategy. |
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