Валидация Методики Определения Ртути, Свинца, Кадмия И Мышьяка В Лекарственном Растительном Сырье И Лекарственных Средствах На Его Основе Методом Масс-Спектрометрии С Индуктивно-Связанной Плазмой

Щукин, В. М.; Жигилей, Евгения Сергеевна; Ерина, А. А.; Shvetsova, Yu. N.; Кузьмина, Наталия Евгеньевна; Лутцева, А. И.

doi:10.30906/0023-1134-2020-54-9-57-64

Cited by 4 publications

(4 citation statements)

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“…Элементный состав слоевищ исследованных видов ламинарий северного полушария приведен в таблице 1. Собственные экспериментальные данные для видов S. japonica и S. latissima получены методом масс-спектрометрии с индуктивно связанной плазмой с использованием микроволнового разложения органической матрицы по методике [51]. Количественное определение содержания элементов осуществляли, фиксируя интенсивности сигналов по следующим атомным единицам массы (а.е.м.…”

Section: содержание элементов в слоевищах водорослей семейства ламина...unclassified

Elemental Composition of Kelp Thalli (<i>Laminariae thalli</i>) of Various Origins

Щукин¹,

Blinkova²,

Кузьмина³

et al. 2023

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Brown seaweeds (Laminariaceae) vary considerably in the content of toxic and essential elements; these variations depend on the taxonomic group and geographical factors. Seaweeds are extensively used in the food industry and widely applied in medicine for both humans and animals. Therefore, it is relevant to examine the correlation between the elemental composition and the geographical origin of kelp thalli obtained from different sources.The aim of the study was to collect, collate, and analyse primary and secondary data on the accumulation of essential, toxic and potentially carcinogenic elements, including iodine, in the thalli of brown seaweeds (Laminariaceae).Materials and methods. This study investigated the concentrations of 17 elements in Laminaria spp. (Al, As, Cd, Cr, Co, Cu, Fe, Hg, Mn, Mo, Ni, Se, Pb, Sr, V, Zn, and I). Experiments were conducted on an Agilent 7900 inductively coupled plasma mass spectrometer. The authors studied publications on the elemental composition of brown seaweeds (Laminariaceae) using literature search and data analysis methods.Results. This article reflects the updated classification of brown seaweeds (Laminariaceae) and summarises information about the mechanisms by which iodine and other elements accumulate in the thallus. The authors established species-specific variations in the order of element uptake and in the accumulation of elemental toxicants. The mutual influence of elements on their accumulation in brown seaweeds (Laminariaceae) was evaluated using Spearman’s rank correlation coefficients.Conclusions. The study results can inform the implementation of a risk-based quality control strategy for herbal medicinal products aimed at reducing human exposure to toxic elements. The authors suggest that the upper limit of iodine content in kelp-based food products should be standardised.

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Section: содержание элементов в слоевищах водорослей семейства ламина...unclassified

Elemental Composition of Kelp Thalli (<i>Laminariae thalli</i>) of Various Origins

Щукин¹,

Blinkova²,

Кузьмина³

et al. 2023

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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“…Среднее содержание Pb в исследованных образцах семян тыквы составляет 0,08 мг/кг при максимальном значении 0,4 мг/кг, что значительно ниже ПДК (6 мг/кг) 13 . По литературным данным содержание этого элемента в семенах тыквы не превышает 0,6 мг/кг [16].…”

Section: таблица 1 содержание нормируемых элементных токсикантов в се...unclassified

Determination of Heavy Metals, Arsenic, and Aluminum Content in Pumpkin Seed Herbal Substance and Native Products, by Inductively Coupled Plasma Mass Spectrometry

Ovsienko¹,

Щукин²,

Blinkova³

et al. 2022

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Pumpkin seeds belong to the so-called native products. Their characteristic feature is that they can be consumed directly, without prior extraction of the starting material. All elemental toxicants contained in pumpkin seeds are transferred in full to the native product. Therefore, it is important to study specific aspects of elemental toxicant accumulation by pumpkin seeds.The aim of the study was to determine the content of heavy metals, As, and Al in pumpkin seed herbal substance and native products, and to assess the degree of accumulation of these elements, depending on the vegetation area.Materials and methods: the study evaluated pumpkin seed native products by Russian manufacturers as well as pumpkin seeds harvested in areas with different anthropogenic load. The sample preparation was performed by microwave digestion, and the determination of the elemental toxicants was perfomed by inductively coupled plasma mass spectrometry.Results: the pumpkin seeds were shown to contain essential, probably essential, potentially toxic, and toxic elements. The authors performed comparative analysis of the elemental composition of pumpkin seeds as well as seeds, grains, and beans of various oil-bearing, grain, and leguminous crops.Conclusions: the content of the specified elemental toxicants (As, Cd, Hg, Pb) in the tested samples of pumpkin seed herbal substance and herbal medicinal products did not exceed the limits established by the Russian Pharmacopoeia. The unspecified toxic elements were either absent in pumpkin seeds (Tl) or found in trace amounts (Al). The content of a number of essential elements (Zn, Fe, Mn, Cu, Mo, Cr) in pumpkin seeds was higher than in the seeds of many oil-bearing crops. The vegetation area had no significant influence on the content of the tested elements in the pumpkin seeds. Pumpkin seeds are capable of accumulating abnormally high amounts of Cd, Co, and Ni in areas with high environmental pollution.

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“…Рекомендации составлены на основе собственного опыта проведения элементного анализа различных видов ЛРС и ЛРП [6,7], обобщения данных научной литературы, требований ГФ РФ XIV изд., Фармакопеи США (USP), Европейской фармакопеи (Ph. Eur.…”

Section: материалы и методыunclassified

Development and Validation of Procedures for Determination of Elemental Toxicants in Herbal Substances and Herbal Medicinal Products

Щукин¹,

Кузьмина²,

Shvetsova³

et al. 2022

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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When the approach to quality control of herbal substances (HSs) and herbal medicinal products (HMPs) changed from determination of the total content of heavy metals by calorimetry to selective determination by spectrometric techniques, many manufacturers of such products failed to meet the new requirements in their registration dossiers. Test procedures submitted by manufacturers often need to be clarified, and validation protocols often lack data.The aim of the study was to provide recommendations to HS and HMP manufacturers on the choice of test methods, materials, reagents, methods of organic matrix mineralisation, and main validation parameters, as well as recommendations on validation of the procedure for elemental toxicants determination, and preparation of the “Heavy metals and arsenic” part of the regulatory submission.Materials and methods: the study included analysis and systematisation of scientific literature, requirements of the Russian and foreign pharmacopoeias, guidelines, manuals on instrumental methods of analysis, and first-hand experience in elemental analysis of various types of HSs and HMPs.Results: the authors formulated recommendations on the choice of sample mineralisation conditions for quantification of elemental impurities in biological products, and substantiated requirements for the reagents, materials, and equipment. The paper compares different methods of elemental analysis. It was demonstrated that the main mistakes made by manufacturers stem from disregard to the organic matrix effect on the measurement results and lack of agreement between the impurity concentration being determined and the range of the calibration curve used. The paper gives acceptance criteria for validation parameters of test procedures for heavy metals and arsenic determination in HSs and HMPs.Conclusions: it is not correct to use reference standards containing heavy metals as inorganic salts not bound to organic compounds, for HS and HMP analysis. The criteria given in the European Pharmacopoeia and the United State Pharmacopoeia can be used for a number of validation parameters, when they are not included in the Russian Pharmacopoeia.

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Cited by 4 publications

References 0 publications

Elemental Composition of Kelp Thalli (<i>Laminariae thalli</i>) of Various Origins

Elemental Composition of Kelp Thalli (<i>Laminariae thalli</i>) of Various Origins

Determination of Heavy Metals, Arsenic, and Aluminum Content in Pumpkin Seed Herbal Substance and Native Products, by Inductively Coupled Plasma Mass Spectrometry

Development and Validation of Procedures for Determination of Elemental Toxicants in Herbal Substances and Herbal Medicinal Products

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