雅塔普拉森泰国多草药配方中的元素杂质:取决于来源的变化,以及分析方法验证.
Jaenjira Angsusing1,2, Yu-Ki Tanaka1, Chuda Chittasupho2
1Laboratory of Toxicology and Environmental Health, Graduate School of Pharmaceutical Sciences, Chiba University.
The Journal of toxicological sciences
|February 1, 2026
概括
传统Yataprasen (YTPS) 草药补充剂中,与和等有毒金属的污染是令人担忧的. 自然收集的YTPS比商业来源含有更高的金属含量,这表明毒理风险更大.
科学领域:
- 分析化学 分析化学
- 药理学是指药理学,即药理学是指药理学.
- 环境科学 环境科学
背景情况:
- 全球对补充和替代医学 (CAM) 的消费正在增加.
- 有关草药产品中元素杂质存在安全问题.
- 雅塔普拉森 (YTPS) 是泰国传统的多草药配方,需要对有毒金属进行安全评估.
研究的目的:
- 优化和验证一种用于量化YTPS中有毒金属 (As,Cd,Pb,Hg) 的分析方法.
- 评估来自不同来源的YTPS元素杂质的毒理风险.
- 为了确定YTPS中元素杂质的草药贡献者.
主要方法:
- 使用了诱导合等离子体质谱法 (ICP-MS).
- 评估了四种酸消化方案,以获得最佳的样本准备.
- 方法验证包括线性,精度,回收,LOD和LOQ评估.
- 毒理风险评估遵循ICH Q3D的指导方针.
主要成果:
- 使用1毫升HNO3的消化产生了最高的精度和回收.
- 验证的方法显示出极好的准确性 (93.6-107.5%的回收率) 和线性 (R2 > 0.998).
- 与商业YTPS相比,自然收集的YTPS的As,Cd,Pb和Hg度显著更高.
- 鉴定出Allium sativum L.,Cymbopogon nardus (L.) Rendle和Melia azedarach L.是造成杂质的主要原因之一.
结论:
- 元素杂质的来源依赖的变化对自然收集的YTPS造成了更大的毒理问题.
- 经过验证的ICP-MS方法是对多草药配方的质量控制和监管评估的一个强有力的工具.
- 由于矩阵效应,自然来源的样品需要标准添加,而商业样品则需要外部校准.
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