Institute of Medical Studies, Medical College, Rzeszów University, Al. mjr. W. Kopisto 2a, 35-959, Rzeszów, Poland.
Department of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Medyczna 9, 30-688, Kraków, Poland.
Biol Trace Elem Res. 2022 Feb;200(2):904-909. doi: 10.1007/s12011-021-02691-5. Epub 2021 Apr 1.
Studies related to the toxicological risk assessment (TRA) of heavy metal impurities (HMIs) in pharmaceuticals are an important issue but there is a lack of refereed literature around the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product (HMP) for the relief of mild nervous tension and sleep disorders according to lead and cadmium impurities. The aim of the study was to estimate the TRA of lead and cadmium in Valeriana officinalis L., radix (Valerian root) as HMP (n = 5) available in Polish pharmacies. In the case of herbal pharmaceuticals, it is particularly important to control the level of HMIs accumulated during the plant's growth. Perhaps, the exposure for a single dose is not relevant; however, justification of our studies is a fact that herbal therapies are usually long term. Therefore, even small HMI doses as present in particular plant may accumulate in patient body over a long period of time. Levels of lead and cadmium were measured by electrothermal atomization atomic absorption spectrometry. The levels of lead and cadmium as HMIs (independently of the producer and declared composition) are quite similar. Our results are satisfactory, confirming the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product for the relief of mild nervous tension and sleep disorders available in Polish pharmacies according to ICH guideline Q3D. To the best of our knowledge, this paper is the first study about lead and cadmium content as HMIs in HMP containing Valeriana officinalis L., radix (Valerian root).
关于重金属杂质 (HMIs) 在药品中的毒理学风险评估 (TRA) 的研究是一个重要问题，但关于缬草根作为草药药物 (HMP) 用于缓解轻度神经紧张和睡眠障碍的安全性的相关参考文献却很少，特别是针对铅和镉杂质。该研究的目的是评估波兰药店供应的缬草根 (HMP) 中铅和镉的 TRA (n = 5)。对于草药药品，控制植物生长过程中积累的 HMIs 水平尤为重要。也许，单次剂量的暴露并不相关；然而，我们研究的理由是草药疗法通常是长期的。因此，即使是特定植物中存在的少量 HMI 剂量，也可能在患者体内长时间积累。通过电热原子化原子吸收光谱法测量铅和镉的水平。作为 HMIs 的铅和镉水平（与生产商和申报的成分无关）非常相似。我们的结果令人满意，证实了在波兰药店供应的缬草根 (HMP) 作为草药药物用于缓解轻度神经紧张和睡眠障碍是安全的，符合 ICH 指南 Q3D。据我们所知，这是第一篇关于含有缬草根 (HMP) 的 HMI 中铅和镉含量的研究。
