药品中亚硝胺类杂质介绍

doi:10.5246/jcps.2023.03.020

中国药学(英文版) ›› 2023, Vol. 32 ›› Issue (3): 223-230.DOI: 10.5246/jcps.2023.03.020

• 【药事管理与临床药学专栏】 • 上一篇下一篇

药品中亚硝胺类杂质介绍

牛剑钊, 杨东升, 冯玉飞, 孙百浩, 关皓月^*(), 马玲云^*()

中国食品药品检定研究院, 北京 100050

收稿日期:2022-10-24 修回日期:2022-12-08 接受日期:2022-01-10 出版日期:2023-03-31 发布日期:2023-03-30
通讯作者: 关皓月, 马玲云
作者简介:
+ Tel.: +86-13681009480, E-mail: mlyun@nifdc.org.cn
+ Tel.: +86-13311235933, E-mail: guanhaoyue@nifdc.org.cn
基金资助:
Carry out quality evaluation research of generic medicinal product control based on domestic product, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China.

The introduction of nitrosamine impurities in medicinal products

Jianzhao Niu, Dongsheng Yang, Yufei Feng, Baihao Sun, Haoyue Guan^*(), Lingyun Ma^*()

National Institutes for Food and Drug Control, Beijing 100050, China

Received:2022-10-24 Revised:2022-12-08 Accepted:2022-01-10 Online:2023-03-31 Published:2023-03-30
Contact: Haoyue Guan, Lingyun Ma

摘要/Abstract

摘要：

药品中被报道可能出现亚硝胺类杂质是近年来医药领域的新热点问题。目前, 因可能存在亚硝胺杂质而被报道的药品共有5类: 沙坦类、含二甲双胍类、雷尼替丁类、利福平类和酒石酸伐尼克兰片。本文介绍了“亚硝胺类杂质形成的来源和潜在的根本原因”, “原料药和药品中潜在或已发现的亚硝胺杂质”, 以及“对这些杂质建议的可接受摄入限度”, 并总结了目前药品中涉及亚硝胺杂质的情况, 以及FDA和EMA采取的相应控制策略, 以期为中外医药企业以及监管部门提供参考, 对药品中亚硝胺类杂质进行全面的了解。

关键词: 亚硝胺类杂质, 药品, 食品药品监督管理局, 欧洲药品管理局, 原料药

Abstract:

Nitrosamine impurities being reported to potentially present in medicinal products are the new hot issues in the pharmaceutical field during recent years. Five classes of medicinal products are being reported due to the possible presence of nitrosamine impurities: Sartan medicines, Metformin-containing medicines, Ranitidine medicines, Rifampicin medicines, and Champix. In this paper, we introduced the source and potential root causes of nitrosamine formation, potential or founded nitrosamine impurities in API and medicinal products, and acceptable intake limits recommended for those impurities. Moreover, we also summarized the current nitrosamine impurities concerned with medicinal products and corresponding control strategies adopted by the FDA and EMA, and it is expected to give reference for the Chinese or foreign pharmaceutical enterprises, as well as the regulatory authority, to get the comprehensive understanding of the nitrosamine impurities in the medicinal products.

Key words: Nitrosamine impurities, Medicinal product, Food and Drug Administration, European Medicines Agency, Active Pharmaceutical Ingredient

Supporting:

牛剑钊, 杨东升, 冯玉飞, 孙百浩, 关皓月, 马玲云. 药品中亚硝胺类杂质介绍[J]. 中国药学(英文版), 2023, 32(3): 223-230.

Jianzhao Niu, Dongsheng Yang, Yufei Feng, Baihao Sun, Haoyue Guan, Lingyun Ma. The introduction of nitrosamine impurities in medicinal products[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(3): 223-230.

图/表 2

参考文献 20

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药品中亚硝胺类杂质介绍

The introduction of nitrosamine impurities in medicinal products

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