Pyrrolizidine alkaloid contamination in herbal medicinal products: Limits and occurrence

Steinhoff, Barbara

doi:10.1016/j.fct.2019.05.026

Cited by 28 publications

(18 citation statements)

References 3 publications

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“…For herbal drugs the compilation of data demonstrates that between 2016 and 2018 the proportion of samples with a higher PA content (> 1.0 μg/d) has been reduced successively from 64% to 41% and to 37%, and for herbal extracts from 64% to 29% and to 18%. In the same period, for herbal drugs the proportion of samples with lower PA contents (≤ 1.0 μg/d or ≤ 0.35 μg/d, respectively) increased from 36% to 59% and to 63% and from 24% to 33% and to 37%, respectively, for herbal extracts from 62% to 71% and to 82% as well as from 43% to 52% and 68%, respectively 29 …”

Section: Pa Contamination By Weedsmentioning

confidence: 89%

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Challenges in the quality of herbal medicinal products with a specific focus on contaminants

Steinhoff¹

2019

Phytochemical Analysis

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Background The complex regulatory framework for the quality of herbal medicinal products, in particular with regard to potential contaminants, consists of legal provisions including Pharmacopoeia requirements, relating to limits as well as in most cases to methods for determination. Objective This review intends to provide an overview on the legal requirements for testing potential contaminants in herbal drugs used for the production of herbal medicinal products. Methodology The following issues are described and discussed: For the assessment of pesticide residues, Chapter 2.8.13 of the European Pharmacopoeia and Regulation (EC) 396/2005 applies, for heavy metals the general Pharmacopoeia monograph as well as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D guideline on elemental impurities. The Pharmacopoeia also includes limits and acceptance criteria for microbiological purity and aflatoxins, respectively. Polycyclic aromatic hydrocarbons are mentioned in Regulation (EC) 1881/2006 for food as well as in a Reflection Paper on herbal medicinal products. For several years, a potential contamination with pyrrolizidine alkaloids was discussed which led to measures being imposed on industry and health authorities. Results Various examples demonstrate that the evaluation of data from daily analytical practice is extremely useful to gain an overview on the occurrence of residues and/or contaminants in herbal drugs and herbal preparations. Such evaluations might assist manufacturers in their individual risk assessment and the definition of their testing strategies and contribute to guarantee the quality and safety of the marketed products. Conclusion Annual data evaluations demonstrate that a remarkable decrease of the pyrrolizidine alkaloid content burden in herbal drugs and extracts used for the production of herbal medicinal products has been achieved over the past few years. However, it has also become clear that this issue cannot be completely solved in the near future.

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Section: Pa Contamination By Weedsmentioning

confidence: 89%

“…In order to establish a relation between these limits and the PA content of the herbal drug/extract, the maximum daily dose according to the HMPC monograph was used. In so far, these calculations represent a worst‐case scenario for all products, although the actual daily doses of many products are normally much lower 29 …”

Section: Pa Contamination By Weedsmentioning

confidence: 99%

Challenges in the quality of herbal medicinal products with a specific focus on contaminants

Steinhoff¹

2019

Phytochemical Analysis

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“…This led to a transitional risk assessment by the German Federal Institute for Risk Assessment (BfR) with a maximum daily PA intake of 0.007 µg/kg body weight (0.42 µg/60 kg adult), which is not legally binding (BfR 2011/2013). Currently, the Herbal Medicinal Products Committee at the European Medicines Agency recommends a transitional limit of 1.0 μg pyrrolizidine alkaloids per day related to the final product (Steinhoff et al 2019).…”

Section: Oral Intake Limit and Risk Assessmentmentioning

confidence: 99%

“…They should adapt their Code of Practice by monitoring PA contamination and collecting data and also participate in research projects. The aim is to reduce PA contamination and eliminate peak exposures (Rückert et al 2019, Steinhoff et al 2019.…”

Section: Reduction Of Pa Contamination and Problemsmentioning

confidence: 99%

Is it possible to avoid pyrrolizidine alkaloid contamination in equine herb containing nutraceuticals?

Schwarz¹,

Alber²

2021

PHK

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“…This is important since the products derived from medicinal plants may not contain the active ingredient in adequate quantity due the environmental influences, absence of nutrients in the soil [2]. Other issues comprise chemical and microbial (or their toxins) contamination [3,4]. These failures contribute to the lack of confidence of medical professionals in prescribing their patients medicinal plants [5].…”

Section: Introductionmentioning

confidence: 99%

Bioguided Purification of Active Compounds from Leaves of Anadenanthera colubrina var. cebil (Griseb.) Altschul

et al. 2019

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Anadenanthera colubrina var cebil (Griseb.) Altschul is a medicinal plant found throughout the Brazilian semi-arid area. This work performed a bioguided purification of active substances present in ethyl acetate extract from A. colubrina leaves. The anti-Staphylococcus aureus and antioxidant actions were used as markers of bioactivity. The extract was subjected to flash chromatography resulting in five fractions (F1, F2, F3, F4, and F5). The fractions F2 and F4 presented the highest antimicrobial action, with a dose able to inhibit 50% of bacteria growth (IN50) of 19.53 μg/mL for S. aureus UFPEDA 02; whereas F4 showed higher inhibitory action towards DPPH radical (2,2-diphenyl-1-picryl-hydrazyl-hydrate) [dose able to inhibit 50% of the radical (IC50) = 133 ± 9 μg/mL]. F2 and F4 were then subjected to preparative high-performance liquid chromatography (HPLC) and nuclear magnetic resonance (NMR), resulting in the identification of p-hydroxybenzoic acid and hyperoside as the major compounds in F2 and F4, respectively. Hyperoside and p-hydroxybenzoic acid presented IN50 values of 250 μg/mL and 500 μg/mL against S. aureus UFPEDA 02, respectively. However, the hyperoside had an IN50 of 62.5 μg/mL against S. aureus UFPEDA 705, a clinical isolate with multidrug resistant phenotype. Among the purified compounds, the proanthocyanidins obtained from F2 exhibited the higher antioxidant potentials. Taken together, these results highlight the potential of A. colubrina leaves as an alternative source of biomolecules of interest for the pharmaceutical, food, and cosmetic industries.

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Pyrrolizidine alkaloid contamination in herbal medicinal products: Limits and occurrence

Cited by 28 publications

References 3 publications

Challenges in the quality of herbal medicinal products with a specific focus on contaminants

Challenges in the quality of herbal medicinal products with a specific focus on contaminants

Is it possible to avoid pyrrolizidine alkaloid contamination in equine herb containing nutraceuticals?

Bioguided Purification of Active Compounds from Leaves of Anadenanthera colubrina var. cebil (Griseb.) Altschul

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