Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.
Department of Pharmacology, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.
Drug Res (Stuttg). 2023 Oct;73(8):431-440. doi: 10.1055/a-2081-4232. Epub 2023 Jul 24.
Nitrosamines are a class of chemical compounds that have been found to be impurities in a variety of pharmaceutical products. These impurities have raised concerns due to their potential carcinogenic effects. Recent studies have identified nitrosamines as impurities in a number of pharmaceutical products including angiotensin II receptor blockers (ARBs) and proton pump inhibitors (PPIs). The presence of nitrosamines in these products has led to recalls and market withdrawals. In addition to pharmaceuticals, nitrosamines have also been found in some herbal medicines particularly those containing traditional Chinese medicinal ingredients. The presence of nitrosamines in herbal formulations poses a significant risk to public health and highlights the need for quality control and regulations in the herbal drug industry. The present review article aims to discuss nitrosamine impurities (NMI) prominent causes, risks and scientific strategies for preventing NMI in herbal formulations. The primary objective of this study is to examine the origins of nitrosamine contamination in herbal formulations, the risks associated with these contaminants, and the methods for reducing them. The significance of thorough testing and examination before releasing herbal products to the public is also emphasized. In conclusion, the presence of nitrosamines is not limited to pharmaceutical products and poses a significant threat to the safety of herbal drugs as well. Adequate testing and extensive research are crucial for producing and distributing herbal medicines to the general population.
亚硝胺类是一类已被发现存在于多种药物产品中的杂质化合物。由于其潜在的致癌作用，这些杂质引起了人们的关注。最近的研究已经确定亚硝胺类是包括血管紧张素 II 受体阻滞剂 (ARB) 和质子泵抑制剂 (PPI) 在内的多种药物产品中的杂质。这些产品中存在亚硝胺类导致了召回和市场撤出。除了药物，亚硝胺类也被发现存在于一些草药中，特别是那些含有传统中药成分的草药。草药制剂中亚硝胺类的存在对公众健康构成了重大风险，突出了草药药物行业需要质量控制和监管。本文旨在讨论亚硝胺杂质（NMI）的主要原因、风险以及预防草药制剂中 NMI 的科学策略。本研究的主要目的是检查草药制剂中亚硝胺污染的来源、这些污染物的风险以及减少它们的方法。在向公众发布草药产品之前进行彻底测试和检查的重要性也得到了强调。总之，亚硝胺类不仅存在于药物产品中，而且对草药药物的安全性也构成了重大威胁。充分的测试和广泛的研究对于向普通大众生产和分发草药至关重要。
