EMAN RESEARCH PUBLISHING | <p>A Review of Comprehensive Safety And Toxicology on Herbal Products to Ensure They Meet Regulatory Standards and Can Be Used Safely in Biopharmaceutical Applications</p>
Advances in Herbal Research | online ISSN 2209-1890
REVIEWS   (Open Access)

A Review of Comprehensive Safety And Toxicology on Herbal Products to Ensure They Meet Regulatory Standards and Can Be Used Safely in Biopharmaceutical Applications

Md Shamsuddin Sultan Khan 1, Mohamed Khadeer Ahamed Basheer 1, Amin Malik Shah Abdul Majid 1*, Fouad Saleh Resq Al-Suede 1

+ Author Affiliations

Australian Herbal Insight 6 (1) 1-9 https://doi.org/10.25163/ahi.21073

Submitted: 25 February 2023 Revised: 15 April 2023  Published: 25 April 2023 


Abstract

Safety and toxicological research are integral for integrating herbal items into biopharmaceutical applications. As herbal products gain prominence in pharmaceutical development, rigorous safety evaluations ensure compliance with legal standards. These studies aim to ascertain safety profiles, assess potential negative impacts and toxin levels, minimizing risks associated with herbal product usage. Prioritizing toxicity studies enhances compliance and overall product quality, guiding informed decision-making and fostering a risk-conscious approach to innovation. Given the complexity of herbal compositions, thorough safety assessments are crucial. Safety evaluations are particularly significant considering the diverse applications of herbal products in biopharmaceuticals, ranging from innovative medicine discovery to traditional therapies. In summary, research on the safety and toxicology of herbal products is paramount for shaping the future of biopharmaceutical applications, facilitating their responsible and effective utilization in medicine.

Keywords: Herbal products, Safety studies, Toxicology,  Regulatory standards, Biopharmaceutical applications

References


Alépée, N., Grandidier, M. H., & Cotovio, J. (2014). Sub-categorisation of skin corrosive chemicals by the EpiSkin™ reconstructed human epidermis skin corrosion test method according to UN GHS: Revision of OECD Test Guideline 431. Toxicology in Vitro, 28(2), 131-145.

Amster, E., Tiwary, A., & Schenker, M. B. (2007). Case report: potential arsenic toxicosis secondary to herbal kelp supplement. Environmental Health Perspectives, 115(4), 606-608.

Arlt, V. M., Stiborova, M., & Schmeiser, H. H. (2002). Aristolochic acid as a probable human cancer hazard in herbal remedies: a review. Mutagenesis, 17(4), 265-277.

ASSAY, A. M. (2004). OECD Environment Health and Safety Publications Series on Testing and Assessment No. 46. Guidance Document on the Validation of (Quantitative) Structure Activity Relationship [(Q) SAR].

Balls, M., Botham, P. A., Bruner, L. H., & Spielmann, H. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicology in vitro, 9(6), 871-929.

Beecher, C. (2002). Metabolomics: The newest of the’omics’ sciences. Innovations in Pharmaceutical Technology, 2, 57-64.

Bent, S., & Ko, R. (2004). Commonly used herbal medicines in the United States: a review. The American journal of medicine, 116(7), 478-485.

Biggs, R. D., Sasson, J. M., & Baines, J. (1995). Medicine, surgery, and public health in ancient Mesopotamia. Civilizations of the ancient Near East; 3, 3, 1911-1924.

Botting, J. (2002). The history of thalidomide. Drug news & perspectives, 15(9), 604-611.

Breheny, D., Zhang, H., & Massey, E. D. (2005). Application of a two-stage Syrian hamster embryo cell transformation assay to cigarette smoke particulate matter. Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, 572(1-2), 45-57.

Bugrim, A., Nikolskaya, T., & Nikolsky, Y. (2004). Early prediction of drug metabolism and toxicity: systems biology approach and modeling. Drug discovery today, 9(3), 127-135.

Bunel, V., Ouedraogo, M., Nguyen, A. T., Stévigny, C., & Duez, P. (2014). Methods applied to the in vitro primary toxicology testing of natural products: state of the art, strengths, and limits. Planta medica, 80(14), 1210-1226.

Bush, T. M., Rayburn, K. S., Holloway, S. W., Sanchez-Yamamoto, D. S., Allen, B. L., Lam, T., … & Roth, L. W. (2007). Adverse interactions between herbal and dietary substances and prescription medications: a clinical survey. Alternative therapies in health and medicine, 13(2), 30-35.

Cheng, Z. F., & Zhen, C. (2004). The Cheng Zhi-Fan collectanea of medical history. Peking University Medical Press, Beijing, China.

Dwivedi, S. K., & Dey, S. (2002). Medicinal herbs: a potential source of toxic metal exposure for man and animals in India. Archives of Environmental Health: An International Journal, 57(3), 229-231.

Francis, G., Kerem, Z., Makkar, H. P., & Becker, K. (2002). The biological action of saponins in animal systems: a review. British journal of Nutrition, 88(6), 587-605.

Gamaniel, K. S. (2000). Toxicity from medicinal plants and their products. Nigerian Journal of Natural Products and Medicine, 4, 4-8.

Guengerich, F. P. (1997). Role of cytochrome P450 enzymes in drug-drug interactions. Advances in pharmacology, 43, 7-35.

Harvey, A. L. (2008). Natural products in drug discovery. Drug discovery today, 13(19-20), 894-901.

Ifeoma, O., & Oluwakanyinsola, S. (2013). Screening of herbal medicines for potential toxicities. New insights into toxicity and drug testing, 244, 63-88.

Ifeoma, O., & Oluwakanyinsola, S. (2013). Screening of herbal medicines for potential toxicities. New insights into toxicity and drug testing, 244, 63-88.

Institute of Laboratory Animal Resources (US). Committee on Care, & Use of Laboratory Animals. (1986). Guide for the care and use of laboratory animals (No. 86). US Department of Health and Human Services, Public Health Service, National Institutes of Health.

Izzo, A. A., & Ernst, E. (2009). Interactions between herbal medicines and prescribed drugs: an updated systematic review. Drugs, 69, 1777-1798.

Kawashima, K., Misawa, H., Moriwaki, Y., Fujii, Y. X., Fujii, T., Horiuchi, Y., … & Kamekura, M. (2007). Ubiquitous expression of acetylcholine and its biological functions in life forms without nervous systems. Life sciences, 80(24-25), 2206-2209.

Kennedy, D. O., & Wightman, E. L. (2011). Herbal extracts and phytochemicals: plant secondary metabolites and the enhancement of human brain function. Advances in Nutrition, 2(1), 32-50.

Kennedy, S. (2002). The role of proteomics in toxicology: identification of biomarkers of toxicity by protein expression analysis. Biomarkers, 7(4), 269-290.

Kinghorn, A. D., Pan, L., Fletcher, J. N., & Chai, H. (2011). The relevance of higher plants in lead compound discovery programs. Journal of natural products, 74(6), 1539-1555.

Malinin, G. I. (1973). Cytotoxic effect of dimethylsulfoxide on the ultrastructure of cultured rhesus kidney cells. Cryobiology, 10(1), 22-32.

Maurer, H. H. (2008). Toxicokinetics-variations due to genetics or interactions: Basics and ex-amples. Current Contributions to Forensic and Clinical Toxicology, 153-155.

Mosihuzzaman, M. (2012). Herbal medicine in healthcare-an overview. Natural Product Communications, 7(6), 1934578X1200700628.

Nässel, D. R., & Winther, Å. M. (2010). Drosophila neuropeptides in regulation of physiology and behavior. Progress in neurobiology, 92(1), 42-104.

O’Brien, P., & Haskins, J. R. (2006). In vitro cytotoxicity assessment. High Content Screening: A Powerful Approach to Systems Cell Biology and Drug Discovery, 415-425.

OECD. (1994). OECD Guidelines for the Testing of Chemicals. Oecd.

Pethkar, A. V., Gaikaiwari, R. P., & Paknikar, K. M. (2001). Biosorptive removal of contaminating heavy metals from plant extracts of medicinal value. Current Science, 1216-1219.

Ponti, J., Sabbioni, E., Munaro, B., Broggi, F., Marmorato, P., Franchini, F., … & Rossi, F. (2009). Genotoxicity and morphological transformation induced by cobalt nanoparticles and cobalt chloride: an in vitro study in Balb/3T3 mouse fibroblasts. Mutagenesis, 24(5), 439-445.

Rattan, R. S. (2010). Mechanism of action of insecticidal secondary metabolites of plant origin. Crop protection, 29(9), 913-920.

Romero-Daza, N. (2002). Traditional medicine in Africa. The Annals of the American Academy of Political and Social Science, 583(1), 173-176.

Savelev, S. U., Okello, E. J., & Perry, E. K. (2004). Butyryl-and acetyl-cholinesterase inhibitory activities in essential oils of Salvia species and their constituents. Phytotherapy Research: An International Journal Devoted to Pharmacological and Toxicological Evaluation of Natural Product Derivatives, 18(4), 315-324.

South African Department of Health. (2006). Guidelines for good practice in the Conduct of Clinical Trials with Human Participants in South Africa.

Stephens, T. D., Bunde, C. J., & Fillmore, B. J. (2000). Mechanism of action in thalidomide teratogenesis. Biochemical pharmacology, 59(12), 1489-1499.

Takahashi, Y., Koike, M., Honda, H., Ito, Y., Sakaguchi, H., Suzuki, H., & Nishiyama, N. (2008). Development of the short time exposure (STE) test: an in vitro eye irritation test using SIRC cells. Toxicology in vitro, 22(3), 760-770.

Ukelis, U., Kramer, P. J., Olejniczak, K., & Mueller, S. O. (2008). Replacement of in vivo acute oral toxicity studies by in vitro cytotoxicity methods: Opportunities, limits and regulatory status. Regulatory Toxicology and Pharmacology, 51(1), 108-118.

WANG, X. Q. (2005). Operational guidance: Information needed to support clinical trials of herbal products. Chinese Journal of Clinical Pharmacology and Therapeutics, 12(5), 582.

Waring, J. F., Gum, R., Morfitt, D., Jolly, R. A., Ciurlionis, R., Heindel, M., … & Ulrich, R. G. (2002). Identifying toxic mechanisms using DNA microarrays: evidence that an experimental inhibitor of cell adhesion molecule expression signals through the aryl hydrocarbon nuclear receptor. Toxicology, 181, 537-550.

Wienkers, L. C., & Heath, T. G. (2005). Predicting in vivo drug interactions from in vitro drug discovery data. Nature reviews Drug discovery, 4(10), 825-833.

Williams, J. A., Hyland, R., Jones, B. C., Smith, D. A., Hurst, S., Goosen, T. C., … & Ball, S. E. (2004). Drug-drug interactions for UDP-glucuronosyltransferase substrates: a pharmacokinetic explanation for typically observed low exposure (AUCi/AUC) ratios. Drug Metabolism and Disposition, 32(11), 1201-1208.

Wink, M. (2003). Evolution of secondary metabolites from an ecological and molecular phylogenetic perspective. Phytochemistry, 64(1), 3-19.

Winston, D. (2019). Adaptogens: herbs for strength, stamina, and stress relief. Simon and Schuster.

World Health Organization. (2002). The importance of pharmacovigilance.

World Health Organization. (2007). WHO guidelines on good manufacturing practices (GMP) for herbal medicines. World Health Organization.

Youns, M., Hoheisel, J. D., & Efferth, T. (2010). Toxicogenomics for the prediction of toxicity related to herbs from traditional Chinese medicine. Planta Medica, 76(17), 2019-2025.

Committee on Publication Ethics

Abstract
Export Citation

View Dimensions


View Plumx


View Altmetric




Save
0
Citation
106
View

Share