Nitrosamine Impurities in Herbal Formulations: A Review of Risks and Mitigation Strategies.

IF 1.7 Q3 PHARMACOLOGY & PHARMACY Drug Research Pub Date : 2023-10-01 Epub Date: 2023-07-24 DOI:10.1055/a-2081-4232
Nunavath Raja Shekhar, Krishnaveni Nagappan, Madhu Tanya Singh, S P Dhanabal
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Abstract

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.

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草药配方中的亚硝胺杂质:风险和缓解策略综述。
亚硝胺是一类化合物,已被发现是各种药品中的杂质。这些杂质由于其潜在的致癌作用而引起了人们的关注。最近的研究已经确定亚硝胺是许多药物产品中的杂质,包括血管紧张素II受体阻滞剂(ARBs)和质子泵抑制剂(PPIs)。亚硝胺在这些产品中的存在已导致召回和市场退出。除了药物外,在一些草药中也发现了亚硝胺,特别是那些含有中药材成分的草药。草药配方中亚硝胺的存在对公众健康构成重大风险,并突出了草药行业质量控制和监管的必要性。本文旨在探讨亚硝胺杂质(NMI)在草药配方中的突出原因、风险和预防NMI的科学策略。本研究的主要目的是检查草药配方中亚硝胺污染的来源、与这些污染物相关的风险以及减少这些污染物的方法。还强调了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。总之,亚硝胺的存在不仅限于医药产品,而且对草药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生产草药并向普通人群分发草药至关重要。
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来源期刊
Drug Research
Drug Research PHARMACOLOGY & PHARMACY-
CiteScore
3.50
自引率
0.00%
发文量
67
期刊介绍: Drug Research (formerly Arzneimittelforschung) is an international peer-reviewed journal with expedited processing times presenting the very latest research results related to novel and established drug molecules and the evaluation of new drug development. A key focus of the publication is translational medicine and the application of biological discoveries in the development of drugs for use in the clinical environment. Articles and experimental data from across the field of drug research address not only the issue of drug discovery, but also the mathematical and statistical methods for evaluating results from industrial investigations and clinical trials. Publishing twelve times a year, Drug Research includes original research articles as well as reviews, commentaries and short communications in the following areas: analytics applied to clinical trials chemistry and biochemistry clinical and experimental pharmacology drug interactions efficacy testing pharmacodynamics pharmacokinetics teratology toxicology.
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