Scholarlink

<p>Natural products (NPs) including herbal teas are widely consumed in Malaysia but lack stringent regulation. Naturally occurring phytochemicals including estragole (genotoxic), aristolochic acids (AAs; Group 1 carcinogen) and certain pyrrolizidine alkaloids (PAs; Group 2B carcinogen) pose severe hepatotoxic and nephrotoxic risk. An integrated risk assessment using the Margin of Exposure (MOE) and the RISK21 framework was applied to 90 NPs (30 per compound). The samples were identified through National Pharmaceutical Regulatory Agency (NPRA) QUEST3 + database and analyzed using validated UPLC-DAD and LC-MS methods. Estragole, AAs, and PAs were detected in 30% (55.0–418.0&#xa0;µg/g), 16.7% (8.7–2256.3&#xa0;µg/g), and 36.7% (0.02–21.1&#xa0;µg/g) of samples, respectively. Lifetime exposure to estragole and AAs, and eight PA-positive samples, resulted in MOE values &lt; 10 000, indicating high priority for risk management. RISK21 characterization placed AAs in the red zone, representing unacceptable risk. Notably, half of estragole-positive products targeted women’s health, raising concerns for vulnerable populations, including potential neonatal exposure via breast milk. Furthermore, simultaneous product use may result in potential cumulative effects. Malaysians face significant long-term health risks from toxic phytochemicals in NPs, particularly AAs. The integrated framework provides a critical decision-support tool to strengthen regulatory oversight and enforce stricter quality control.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Integrated risk characterization of estragole, aristolochic acids, and pyrrolizidine alkaloids in natural products using margin of exposure and RISK21

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年6月22日

查看全文
  • Nur Azra Mohamad Pauzi,
  • Mohd Firdaus Razali,
  • Mohd Yusmaidie Aziz,
  • Razali Mirad,
  • Manraj Singh Cheema,
  • Amin Ismail,
  • Ahmad Rohi Ghazali,
  • Rozaini Abdullah

摘要

Natural products (NPs) including herbal teas are widely consumed in Malaysia but lack stringent regulation. Naturally occurring phytochemicals including estragole (genotoxic), aristolochic acids (AAs; Group 1 carcinogen) and certain pyrrolizidine alkaloids (PAs; Group 2B carcinogen) pose severe hepatotoxic and nephrotoxic risk. An integrated risk assessment using the Margin of Exposure (MOE) and the RISK21 framework was applied to 90 NPs (30 per compound). The samples were identified through National Pharmaceutical Regulatory Agency (NPRA) QUEST3 + database and analyzed using validated UPLC-DAD and LC-MS methods. Estragole, AAs, and PAs were detected in 30% (55.0–418.0 µg/g), 16.7% (8.7–2256.3 µg/g), and 36.7% (0.02–21.1 µg/g) of samples, respectively. Lifetime exposure to estragole and AAs, and eight PA-positive samples, resulted in MOE values < 10 000, indicating high priority for risk management. RISK21 characterization placed AAs in the red zone, representing unacceptable risk. Notably, half of estragole-positive products targeted women’s health, raising concerns for vulnerable populations, including potential neonatal exposure via breast milk. Furthermore, simultaneous product use may result in potential cumulative effects. Malaysians face significant long-term health risks from toxic phytochemicals in NPs, particularly AAs. The integrated framework provides a critical decision-support tool to strengthen regulatory oversight and enforce stricter quality control.