Tags

Type your tag names separated by a space and hit enter

Assessment of genotoxicity of herbal medicinal products: application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root).
Phytomedicine. 2014 Jul-Aug; 21(8-9):1124-9.P

Abstract

An assessment of genotoxicity is a precondition for marketing authorization respectively registration of herbal medicinal products (HMPs), as well as for inclusion into the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' established by the European Commission in accordance with Directive 2001/83/EC as amended, and based on proposals from the Committee on Herbal Medicinal Products (HMPC). In the 'Guideline on the assessment of genotoxicity of herbal substances/preparations' (EMEA/HMPC/107079/2007) HMPC has described a stepwise approach for genotoxicity testing, according to which the Ames test is a sufficient base for the assessment of genotoxicity in case of an unequivocally negative result. For reducing efforts for testing of individual herbal substances/preparations, HMPC has also developed the 'guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products' (EMEA/HMPC/67644/2009) with the aim to allow testing of a standard range of test materials which could be considered representative of the commonly used preparations from a specific herbal drug according to a 'bracketing/matrixing' approach. The purpose of this paper is to provide data on the practical application of this bracketing and matrixing concept using the example of Valerianae radix, with the intention of facilitating its inclusion in the "Community list". Five extraction solvents, representing the extremes of the polarity range and including also mid-range extraction solvents, were used, covering the entire spectrum of phytochemical constituents of Valerianae radix, thereby including polar and non-polar constituents. Extracts were tested in the Ames test according to all relevant guidelines. Results were unequivocally negative for all extracts. A review of the literature showed that this result is in accordance with the available data, thus demonstrating the lack of a genotoxic potential. In conclusion the two guidelines on genotoxicity provide a practically applicable concept. Valerianae radix has no genotoxic potential, supporting its use in HMPs and its inclusion in the Community list.

Authors+Show Affiliations

Kooperation Phytopharmaka GbR, 53173 Bonn, Germany(2).Kooperation Phytopharmaka GbR, 53173 Bonn, Germany(2).Kooperation Phytopharmaka GbR, 53173 Bonn, Germany(2).Kooperation Phytopharmaka GbR, 53173 Bonn, Germany(2).Federal Institute for Drugs and Medical Devices (BfArM), 53175 Bonn, Germany(3).Federal Institute for Drugs and Medical Devices (BfArM), 53175 Bonn, Germany(3).Kooperation Phytopharmaka GbR, 53173 Bonn, Germany(2). Electronic address: koop.phyto.bonn@t-online.de.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

24837473

Citation

Kelber, Olaf, et al. "Assessment of Genotoxicity of Herbal Medicinal Products: Application of the "bracketing and Matrixing" Concept Using the Example of Valerianae Radix (valerian Root)." Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, vol. 21, no. 8-9, 2014, pp. 1124-9.
Kelber O, Wegener T, Steinhoff B, et al. Assessment of genotoxicity of herbal medicinal products: application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root). Phytomedicine. 2014;21(8-9):1124-9.
Kelber, O., Wegener, T., Steinhoff, B., Staiger, C., Wiesner, J., Knöss, W., & Kraft, K. (2014). Assessment of genotoxicity of herbal medicinal products: application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root). Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, 21(8-9), 1124-9. https://doi.org/10.1016/j.phymed.2014.04.003
Kelber O, et al. Assessment of Genotoxicity of Herbal Medicinal Products: Application of the "bracketing and Matrixing" Concept Using the Example of Valerianae Radix (valerian Root). Phytomedicine. 2014 Jul-Aug;21(8-9):1124-9. PubMed PMID: 24837473.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessment of genotoxicity of herbal medicinal products: application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root). AU - Kelber,Olaf, AU - Wegener,Tankred, AU - Steinhoff,Barbara, AU - Staiger,Christiane, AU - Wiesner,Jacqueline, AU - Knöss,Werner, AU - Kraft,Karin, Y1 - 2014/05/16/ PY - 2013/10/03/received PY - 2014/02/12/revised PY - 2014/04/02/accepted PY - 2014/5/20/entrez PY - 2014/5/20/pubmed PY - 2015/4/22/medline KW - Ames-test KW - Bracketing and matrixing KW - Genotoxicity KW - HMPC KW - Herbal medicinal products KW - Valerian root SP - 1124 EP - 9 JF - Phytomedicine : international journal of phytotherapy and phytopharmacology JO - Phytomedicine VL - 21 IS - 8-9 N2 - An assessment of genotoxicity is a precondition for marketing authorization respectively registration of herbal medicinal products (HMPs), as well as for inclusion into the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' established by the European Commission in accordance with Directive 2001/83/EC as amended, and based on proposals from the Committee on Herbal Medicinal Products (HMPC). In the 'Guideline on the assessment of genotoxicity of herbal substances/preparations' (EMEA/HMPC/107079/2007) HMPC has described a stepwise approach for genotoxicity testing, according to which the Ames test is a sufficient base for the assessment of genotoxicity in case of an unequivocally negative result. For reducing efforts for testing of individual herbal substances/preparations, HMPC has also developed the 'guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products' (EMEA/HMPC/67644/2009) with the aim to allow testing of a standard range of test materials which could be considered representative of the commonly used preparations from a specific herbal drug according to a 'bracketing/matrixing' approach. The purpose of this paper is to provide data on the practical application of this bracketing and matrixing concept using the example of Valerianae radix, with the intention of facilitating its inclusion in the "Community list". Five extraction solvents, representing the extremes of the polarity range and including also mid-range extraction solvents, were used, covering the entire spectrum of phytochemical constituents of Valerianae radix, thereby including polar and non-polar constituents. Extracts were tested in the Ames test according to all relevant guidelines. Results were unequivocally negative for all extracts. A review of the literature showed that this result is in accordance with the available data, thus demonstrating the lack of a genotoxic potential. In conclusion the two guidelines on genotoxicity provide a practically applicable concept. Valerianae radix has no genotoxic potential, supporting its use in HMPs and its inclusion in the Community list. SN - 1618-095X UR - https://www.unboundmedicine.com/medline/citation/24837473/Assessment_of_genotoxicity_of_herbal_medicinal_products:_application_of_the_"bracketing_and_matrixing"_concept_using_the_example_of_Valerianae_radix__valerian_root__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0944-7113(14)00148-2 DB - PRIME DP - Unbound Medicine ER -