Institute of Medical Studies, Medical College, Rzeszów University, Aleja Majora Wacława 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 Apr;200(4):1981-1987. doi: 10.1007/s12011-021-02842-8. Epub 2021 Jul 31.
Essential elements like Cu, Mn and Zn are extremely important for herbs' growth and physiological functions; however, from a toxicological point of view, the exposure of these elements (as essential elemental impurities) can exhibit potential harmful effects for patients. In Europe, very popular are ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products for adjunctively in rhinitis (runny nose). Based on posology of ointments with Marjoram herb extract, the exposure to these elemental impurities may be high during long-term use. Hence, the aim of this article is the health risk assessment of essential elemental impurities (Cu, Mn and Zn) through the dermal exposure of ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products applied adjunctively in rhinitis available in Polish pharmacies. The investigated essential elements were determined by well-validated methodology (R > 0.997, recoveries, LOD and LOQ values were acceptable) based on flame atomic absorption spectrometry (FAAS). Our results indicated that all analysed herbal medicinal products with Marjoram herb extract available in Polish pharmacies contain relatively low levels of essential element impurities, i.e. Cu (0.14-0.49 mg/kg), Mn (0.31-2.57 mg/kg) and Zn (0.73-3.19 mg/kg). The estimated exposure of the investigated elemental impurities confirms the safety of all products. To the best of our knowledge, the study about Cu, Mn and Zn contents in HMPs with Majoranae herbae extractum is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view due to ICH Q3D elemental impurity guideline for pharmaceuticals.
铜、锰和锌等必需元素对草药的生长和生理功能极为重要；然而，从毒理学角度来看，这些元素（作为必需的元素杂质）的暴露可能对患者产生潜在的有害影响。在欧洲，以马郁兰草药提取物（ Majoranae herbae extractum ）为主要成分的软膏非常受欢迎，被用作治疗鼻炎（流鼻涕）的顺势疗法药物。基于马郁兰草药提取物软膏的用量，长期使用可能会导致这些元素杂质的暴露量较高。因此，本文的目的是通过对波兰药店中顺势疗法药物马郁兰草药提取物（ Majoranae herbae extractum ）软膏进行皮肤暴露，评估这些必需元素杂质（铜、锰和锌）的健康风险。通过火焰原子吸收光谱法（ FAAS ），采用经过良好验证的方法（ R ＞ 0.997 ，回收率、LOD 和 LOQ 值可接受），对这些必需元素进行了测定。我们的研究结果表明，波兰药店中所有含有马郁兰草药提取物的顺势疗法药物均含有相对较低水平的必需元素杂质，即铜（0.14-0.49mg/kg）、锰（0.31-2.57mg/kg）和锌（0.73-3.19mg/kg）。对所研究元素杂质的暴露评估证实了所有产品的安全性。据我们所知，这是首次对含有马郁兰草药提取物的 HMP 中铜、锰和锌含量进行的研究。由于 ICH Q3D 元素杂质指南对制药行业具有监管毒理学意义，因此该方法和结果极其重要。
